[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Rules and Regulations]
[Pages 62568-63563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24086]



[[Page 62567]]

Vol. 84

Friday,

No. 221

November 15, 2019

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 403, 409, 410, et al.





Medicare Program; CY 2020 Revisions to 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; 
Establishment of an Ambulance Data Collection System; Updates to the 
Quality Payment Program; Medicare Enrollment of Opioid Treatment 
Programs and Enhancements to Provider Enrollment Regulations Concerning 
Improper Prescribing and Patient Harm; and Amendments to Physician 
Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding 
and Payment for Evaluation and Management, Observation and Provision of 
Self-Administered Esketamine; Final and Interim Final Rules

  Federal Register / Vol. 84 , No. 221 / Friday, November 15, 2019 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 409, 410, 411, 414, 415, 416, 418, 424, 425, 489, 
and 498

[CMS-1715-F and IFC]
RIN 0938-AT72


Medicare Program; CY 2020 Revisions to 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; 
Establishment of an Ambulance Data Collection System; Updates to the 
Quality Payment Program; Medicare Enrollment of Opioid Treatment 
Programs and Enhancements to Provider Enrollment Regulations Concerning 
Improper Prescribing and Patient Harm; and Amendments to Physician 
Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding 
and Payment for Evaluation and Management, Observation and Provision of 
Self-Administered Esketamine Interim Final Rule

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

ACTION: Final rule and interim final rule.

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SUMMARY: This major final rule addresses: Changes to the physician fee 
schedule (PFS); other changes to Medicare Part B payment policies to 
ensure that payment systems are updated to reflect changes in medical 
practice, relative value of services, and changes in the statute; 
Medicare Shared Savings Program quality reporting requirements; 
Medicaid Promoting Interoperability Program requirements for eligible 
professionals; the establishment of an ambulance data collection 
system; updates to the Quality Payment Program; Medicare enrollment of 
Opioid Treatment Programs and enhancements to provider enrollment 
regulations concerning improper prescribing and patient harm; and 
amendments to Physician Self-Referral Law advisory opinion regulations. 
In addition, we are issuing an interim final rule with comment period 
(IFC) to establish coding and payment for evaluation and management, 
observation and the provision of self-administered Esketamine to 
facilitate beneficiary access to care for treatment-resistant 
depression as efficiently as possible.

DATES: 
    Effective date: These regulations are effective on January 1, 2020.
    Comment date: Comments will be accepted/considered ONLY on the 
Interim Rule ``Coding and Payment for Evaluation and Management, 
Observation and Provision of Self-Administered Esketamine'' contained 
in section V. of the preamble of this document. To be assured 
consideration, comments must be received at one of the addresses 
provided below, no later than 5 p.m. on December 31, 2019.

ADDRESSES: In commenting, please refer to file code CMS-1715-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to 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-1715-IFC, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1715-IFC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

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 impacts.
    Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-
4735, for issues related to malpractice RVUs and geographic practice 
cost indices (GPCIs).
    Larry Chan, (410) 786-6864, or Geri Mondowney, (410) 786-1172, for 
issues related to potentially misvalued services under the PFS.
    Lindsey Baldwin, (410) 786-1694, Emily Yoder, (410) 786-1804, or 
Patrick Sartini, (410) 786-9252, for issues related to telehealth 
services.
    Pierre Yong, (410) 786-8896, or Lindsey Baldwin, (410) 786-1694, 
for issues related to Medicare coverage of opioid use disorder 
treatment services furnished by opioid treatment programs (OTPs).
    Lindsey Baldwin, (410) 786-1694, for issues related to bundled 
payments under the PFS for substance use disorders.
    Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237, 
for issues related to the comment solicitation on opportunities for 
bundled payments under the PFS.
    Regina Walker-Wren, (410) 786-9160, for issues related to physician 
supervision for physician assistant (PA) services and review and 
verification of medical record documentation.
    Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, Liane 
Grayson, (410) 786-6583, or Christiane LaBonte (410) 786-7237, for 
issues related to care management services.
    Terry Simananda, (410) 786-8144, for issues related to interim 
final rule with comment period (payment for self-administered 
esketamine).
    Kathy Bryant, (410) 786-3448, for issues related to coinsurance for 
colorectal cancer screening tests and global surgery data collection.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, or 
Christiane LaBonte, (410) 786-7237, for issues related to payment for 
evaluation and management services.
    Thomas Kessler, (410) 786-1991, for issues related to ambulance 
physician certification statement.
    Felicia Eggleston, (410) 786-9287, or Amy Gruber, (410) 786-1542, 
for issues related to the ambulance fee schedule and the requirements 
related to the Medicare ground ambulance data collection system.
    Linda Gousis, (410) 786-8616, for issues related to intensive 
cardiac rehabilitation.
    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 Measures.
    Katie Mucklow, (410) 786-0537, or Diana Behrendt (410) 786-6192, 
for issues related to open payments.
    Cheryl Gilbreath, (410) 786-5919, for issues related to home 
infusion therapy benefit.
    Joseph Schultz, (410) 786-2656, for issues related to Medicare 
enrollment of opioid treatment programs, and enhancements to provider 
enrollment regulations concerning improper prescribing and patient 
harm.

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    Jacqueline Leach, (410) 786-4282, for issues related to Deferring 
to State Scope of Practice Requirements: Ambulatory Surgical Centers 
(ASC).
    Mary Rossi-Coajou, (410) 786-6051, for issues related to Deferring 
to State Scope of Practice Requirements: Hospice.
    [email protected], for issues related to Advisory 
Opinions on Application of the Physician Self-referral law.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Brittany LaCouture, (410) 786-0481, for inquiries related to 
Alternative Payment Models (APMs).
    Patricia Taft, (410) 786-4561, for issues related to Physician 
Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes Annual 
Update.

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 final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Click on the link on the left side of the 
screen titled, ``PFS Federal Regulations Notices'' for a chronological 
list of PFS Federal Register and other related documents. For the CY 
2020 PFS final rule, refer to item CMS-1715-F. Readers with questions 
related to accessing any of the Addenda or other supporting documents 
referenced in this final rule and posted on the CMS website identified 
above should contact Jamie Hermansen at (410) 786-2064.
    CPT (Current Procedural Terminology) Copyright Notice: Throughout 
this final rule, we use CPT codes and descriptions to refer to a 
variety of services. We note that CPT codes and descriptions are 
copyright 2019 American Medical Association. All Rights Reserved. CPT 
is a registered trademark of the American Medical Association (AMA). 
Applicable Federal Acquisition Regulations (FAR) and Defense Federal 
Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major final rule revises payment polices under the Medicare 
PFS and makes other policy changes, including provisions 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, applicable to 
services furnished in CY 2020 and thereafter. In addition, this final 
rule includes provisions related to other payment policy changes that 
are addressed in section III. of this final rule.
    To facilitate beneficiary access to treatment for treatment-
resistant depression (TRD) as using esketamine, we are creating two new 
HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim 
final basis. For 2020, we are establishing RVUs for these services that 
reflect the relative resource costs associated with the evaluation and 
management (E/M), observation and provision of the self-administered 
esketamine product.
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 final rule, we are establishing RVUs for CY 2020 for the 
PFS to ensure that our payment systems are updated to reflect changes 
in medical practice and the relative value of services, as well as 
changes in the statute. This final rule also includes discussions and 
provisions regarding several other Medicare Part B payment policies, 
Medicare Shared Savings Program quality reporting requirements, 
Medicaid Promoting Interoperability Program requirements for eligible 
professionals, the establishment of a ground ambulance data collection 
system, updates to the Quality Payment Program, Medicare enrollment of 
Opioid Treatment Programs and enhancements to provider enrollment 
regulations concerning improper prescribing and patient harm; and 
amendments to Physician Self-Referral Law advisory opinion regulations. 
Specifically, this final rule addresses:
 Practice Expense RVUs (section II.B.)
 Malpractice RVUs (section II.C.)
 Geographic Practice Cost Indices (GPCIs) (section II.D.)
 Potentially Misvalued Services under the PFS (section II.E.)
 Telehealth Services (section II.F.)
 Medicare Coverage for Opioid Use Disorder Treatment Services 
Furnished by Opioid Treatment Programs (section II.G.)
 Bundled Payments Under the PFS for Substance Use Disorders 
(section II.H.)
 Physician Supervision for Physician Assistant (PA) Services 
(section II.I.)
 Review and Verification of Medical Record Documentation 
(section II.J.)
 Care Management Services (section II.K.)
 Coinsurance for Colorectal Cancer Screening Tests (section 
II.L.)
 Therapy Services (section II.M.)
 Valuation of Specific Codes (section II.N.)
 Comment Solicitation on Opportunities for Bundled Payments 
under the PFS (section II.O.)
 Payment for Evaluation and Management (E/M) Services (section 
II.P.)
 Ambulance Coverage Services--Physician Certification Statement 
(section III.A.)
 Ambulance Fee Schedule--Medicare Ground Ambulance Data 
Collection System (section III.B.)
 Intensive Cardiac Rehabilitation (section III.C.)
 Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs) (section III.D.)
 Medicare Shared Savings Program Quality Measures (section 
III.E.)
 Open Payments (section III.F.)
 Home Infusion Therapy Benefit (section III.G.)
 Medicare Enrollment of Opioid Treatment Programs and 
Enhancements to Existing General Enrollment Policies Related to 
Improper Prescribing and Patient Harm (section III.H.)
 Deferring to State Scope of Practice Requirements (section 
III.I.)
 Advisory Opinions on the Application of the Physician Self-
Referral Law (section III.J.)

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 Updates to the Quality Payment Program (section III.K.)
 Physician Self-Referral Law: Annual Update to the List of CPT/
HCPCS Codes (section IV.)
 Interim Final Rule with Comment Period: Coding and Payment for 
Evaluation and Management, Observation and Provision of Self-
Administered Esketamine (HCPCS codes G2082 and G2083) (section V.)
 Collection of Information Requirements (section VI.)
 Regulatory Impact Analysis (section VII.)
2. Summary of Costs and Benefits
    We have determined that this final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII. of this final rule.

II. Provisions of the Final Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the 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 major final rule, unless otherwise 
noted, the term ``practitioner'' is used to describe both physicians 
and nonphysician practitioners (NPPs) who are permitted to bill 
Medicare under the PFS for the services they furnish to Medicare 
beneficiaries.
1. Development of the RVUs
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the federal government. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other public commenters, and the 
rationale for their recommendations. In the CY 2011 PFS final rule with 
comment period (75 FR 73328 through 73329), we discussed a variety of 
methodologies and approaches used to develop work RVUs, including 
survey data, building blocks, crosswalk to key reference or similar 
codes, and magnitude estimation. More information on these issues is 
available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on 
October 31, 1994), amended 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 of 1997) delayed implementation 
of the resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA of 1997 provided for a 4-year transition 
period from the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in the November 2, 1998 final rule (63 FR 58814), effective for 
services furnished in CY 1999. Based on the requirement to transition 
to a resource-based system for PE over a 4-year period, payment rates 
were not fully based upon resource-based PE RVUs until CY 2002. This 
resource-based system was based on two significant sources of actual PE 
data: the Clinical Practice Expert Panel (CPEP) data; and the AMA's 
Socioeconomic Monitoring System (SMS) data. These data sources are 
described in greater detail in the CY 2012 PFS final rule with comment 
period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some resource costs are borne by the 
facility. Medicare's payment to the facility (such as the outpatient 
prospective payment system (OPPS) payment to the HOPD) would reflect 
costs typically incurred by the facility. Thus, payment associated with 
those specific facility resource costs is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which we accept and use, to the maximum extent practicable and 
consistent with sound data practices, data collected or developed by 
entities and organizations to supplement the data we normally collect 
in determining the PE component. On May 3, 2000, we published the 
interim final rule (65 FR 25664) that set forth the criteria for the 
submission of these supplemental PE survey data. The criteria were 
modified in response to comments received, and

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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 of 1997 amended section 1848(c) of the 
Act to require that we implement resource-based MP RVUs for services 
furnished on or after CY 2000. The resource-based MP RVUs were 
implemented in the PFS final rule with comment period published 
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and 
physician-owned insurers' MP insurance premium data from all the 
states, the District of Columbia, and Puerto Rico. For more information 
on MP RVUs, see section II.C. of this final rule, Determination of 
Malpractice Relative Value Units.
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 final rule, the Regulatory 
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of 
the Act, if revisions to the RVUs cause expenditures for the year to 
change by more than $20 million, we make adjustments to ensure that 
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each 
component. Please refer to the CY 2017 PFS final rule with comment 
period for a discussion of the last GPCI update (81 FR 80261 through 
80270), and to the GPCI section of this current rule for the CY 2020 
update.
    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

[[Page 62572]]

methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 
PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file called ``CY 2020 PFS Proposed Rule PE/HR'' on the 
CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2020, we have incorporated the available utilization data 
for two new specialties, each of which became a recognized Medicare 
specialty during 2018. These specialties are Medical Toxicology and 
Hematopoietic Cell Transplantation and Cellular Therapy. We proposed to 
use proxy PE/HR values for these new specialties, as there are no PPIS 
data for these specialties, by crosswalking the PE/HR as follows from 
specialties that furnish similar services in the Medicare claims data:
     Medical Toxicology from Emergency Medicine; and
     Hematopoietic Cell Transplantation and Cellular Therapy 
from Hematology/Oncology.
    These updates are reflected in the ``CY 2020 PFS Final Rule PE/HR'' 
file available on the CMS website under the supporting data files for 
the CY 2020 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We did not receive any public comments on the use of the proposed 
PE/HR proxy values for Medical Toxicology and Hematopoietic Cell 
Transplantation and Cellular Therapy. Therefore, we are finalizing our 
PE/HR crosswalks as proposed.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00

[[Page 62573]]

(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 called ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2020 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 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.

[[Page 62574]]

    For CY 2020, we proposed to clarify the expected specialty 
assignment for a series of cardiothoracic services. Prior to the 
creation of the expected specialty list for low volume services in CY 
2018, we previously finalized through rulemaking a crosswalk to the 
thoracic surgery specialty for a series of cardiothoracic services that 
typically had fewer than 100 services reported each year (see, for 
example, the CY 2012 PFS final rule (76 FR 73188-73189)). However, we 
noted that for many of the affected codes, the expected specialty list 
for low volume services incorrectly listed a crosswalk to the cardiac 
surgery specialty instead of the thoracic surgery specialty. We 
proposed to update the expected specialty list to accurately reflect 
the previously finalized crosswalk to thoracic surgery for these 
services. The affected codes are shown in Table 1.
BILLING CODE 4120-01-P

[[Page 62575]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.000

BILLING CODE 4120-01-C
    We note that the cardiac surgery and thoracic surgery specialties 
are similar to one another, sharing the same PE/HR data for PE 
valuation and nearly

[[Page 62576]]

identical MP risk factors for MP valuation. As a result, we noted that 
we did not anticipate the proposal having a discernible effect on the 
valuation of the codes listed above. The complete list of expected 
specialty assignments for individual low volume services, including the 
assignments for the codes identified in Table 1, is available on our 
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.
    We received public comments on the proposed updates to the expected 
specialty list. The following is a summary of the comments we received 
and our responses.
    Comment: Several commenters stated that CMS had indicated that the 
expected specialty would be updated to include a column specifying if a 
service was identified as a low volume service for CY 2020, indicating 
if the service-level override was being applied for CY 2020. However, 
commenters noted that this additional column did not appear in the 
download version and asked for additional information.
    Response: We thank the commenters for identifying this missing 
information and we apologize for the technical oversight that caused 
this information not to be displayed for the proposed rule. We will 
include this additional column in the public use files released with 
the final rule.
    Comment: Several commenters disagreed with the CMS proposal to 
update the expected specialty list to accurately reflect the previously 
finalized crosswalk to thoracic surgery for these services. Commenters 
stated that when the expected specialty list was developed, the 
affected specialties specifically selected the cardiac surgery 
specialty for these codes. Commenters also stated that, for nearly all 
of the applicable codes, cardiac surgery was the dominant provider in 
the 2018 Medicare claims data. Commenters acknowledged that the MP risk 
factor for both cardiac surgery and thoracic surgery is naturally very 
similar, but still asked that CMS assign the codes listed in Table 1 to 
the cardiac surgery specialty.
    Response: As we stated in the proposed rule, we did not propose to 
assign the codes listed in Table 1 to the cardiac surgery specialty. 
Instead, we proposed to update the incorrect documentation in our 
expected specialty list to accurately reflect the previously finalized 
crosswalk to thoracic surgery for these services. The previously 
finalized assignment of the cardiac specialty to these services has 
been in place since the CY 2012 rule cycle, and we believe that the 
expected specialty list should be updated to reflect the correct 
specialty assignment.
    Comment: Several commenters disagreed with the CMS methodology used 
to determine low volume service status; that is, codes that have fewer 
than 100 allowed services in the non-modified 3-year average of 
Medicare claims data. Commenters stated that utilization frequencies 
are adjusted in the RUC database for certain codes based on the CPT 
modifiers that were appended to the code to ensure that certain 
services are not over- or underweighted, such as changes made for 
bilateral modifier 50, post-op only modifier 55 and anesthesia 
modifiers QK, QX and QY. Commenters stated that CMS does not discount 
the utilization when determining what constitutes a low volume service 
and instead uses the non-modified 3-year service count for this 
criterion. Commenters stated that this could lead to double-counting 
and overestimating utilization for the purposes of determining low 
volume status, and requested that CMS use discounted utilization for 
this purpose.
    Response: We disagree that it would be more accurate to use a 
discounted form of utilization to determine low volume status. We 
finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 
59283) to use claims data to determine which codes are low volume for 
the coming year, defining ``low volume'' as those that had fewer than 
100 allowed services in the Medicare claims data. We did not finalize a 
policy to discount this utilization and we do not believe that it would 
be more accurate to do so, as a service is still performed even if a 
payment discount is applied to its billing. More importantly, we did 
not make any proposals concerning the methodology to determine what 
constitute a low volume service in the proposed rule, and therefore, we 
are not finalizing any changes to this methodology.
    Comment: One commenter provided a list of 112 additional codes that 
the commenter stated were low volume procedures, with an expected 
specialty for each code. The commenter recommended that CMS append this 
list to the anticipated specialty assignment for low volume services. 
Another commenter stated that gastroenterologists do not perform CPT 
code 96571 on a current basis, and recommended that CMS remove 
gastroenterology as the expected specialty for this code.
    Response: We appreciate the list of additional services identified 
by the commenter. As we have stated in previous rulemaking (82 FR 
52982), we consider recommendations from the RUC and other stakeholders 
on changes to this list on an annual basis. In reviewing the submitted 
list of 112 additional codes, we noted that they generally fell into 
two categories--codes with a restricted coverage status code (``R'') or 
codes that exceed 100 services in the claims data, and therefore, did 
not meet our criteria for low volume status. We are finalizing the 
addition of these 112 codes to the low volume services list with the 
recommended expected specialty; however, we caution that many of these 
codes will continue to have utilization too high to meet the criteria 
for expected specialty assignment. We are adding these codes to the 
list in the interest of maintaining payment stability, such that, if 
they were to fall below 100 annual services at a future date, then an 
expected specialty would be assigned. We do not have indirect PE data 
for two of the specialties on the recommended list, and as a result we 
are substituting the established PE/HR crosswalk for these specialties. 
(The full list of all established PE/HR crosswalks is available on our 
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.) The two 
affected specialties are Interventional Cardiology (crosswalked to 
Cardiology) and Surgical Oncology (crosswalked to General Surgery). We 
are also finalizing a change to the expected specialty for CPT code 
96571 in response to the information supplied by the commenter, which 
we are changing to Pulmonary Disease to match the dominant specialty in 
the claims data. The complete list of additional updates to the low 
volume services list is detailed in Table 2.
BILLING CODE 4120-01-P

[[Page 62577]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.001


[[Page 62578]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.002

BILLING CODE 4120-01-C
    Comment: Several commenters stated that the non-facility PE RVUs 
for CPT code 55874 (Transperineal placement of biodegradable material, 
peri-prostatic, single or multiple injection(s), including image 
guidance, when performed) are projected to decrease 13 percent for CY 
2020, which the commenter believed to be attributed to the current 
specialty mix utilizing the code. The commenters stated that the 
projected decrease for CY 2020 was due to CMS using the first year of 
actual claims data, which had a different ratio of the urology and 
radiation oncology specialties than in the previously projected 
utilization crosswalk. The commenters requested that CMS address the 
proposed decreases for CPT code 55874 in the final rule.
    Response: We agree with the commenters that the proposed decreases 
for CPT code 55874 were due to changes in the specialty mix, as the 
code shifted from projected utilization to reported claims data. 
However, we do not agree with the commenters that there is a need to 
address the valuation of this code, as we believe that it is important 
to use actual claims data as opposed to utilization projections once 
the data for new codes has become available. The specialty mix on 
reported claims will necessarily be more accurate than the utilization 
projections created in advance before claims data exists. We also note 
that the specialty mix associated with CPT code 55874 in the claims 
data is unrelated to the low volume list or the assignment of an 
expected specialty.
    Comment: A commenter stated that CPT codes 33271 (Insertion of 
subcutaneous implantable defibrillator electrode) and 33273 
(Repositioning of previously implanted subcutaneous implantable 
defibrillator electrode) are low volume service codes that are proposed 
to have a service-level override to the anticipated specialty of 
cardiology. The commenter supported this expected specialty assignment.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing our 
proposal to update the expected specialty list to accurately reflect 
the previously finalized crosswalk to thoracic surgery for these 
services. We are also finalizing the updates to the expected specialty 
list detailed above in Table 2; we reiterate again that we do not 
anticipate this finalized proposal having a discernible effect on the 
valuation of the codes in the table due to the similarity between the 
cardiac surgery and thoracic surgery specialties.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: The direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: Indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators

[[Page 62579]]

for all PFS services for a specialty by adding the product of the 
adjusted indirect PE allocator for each service and the utilization 
data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE 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 2.

[[Page 62580]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.003

     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

[[Page 62581]]

accordingly. Table 4 details the manner in which the modifiers are 
applied.
[GRAPHIC] [TIFF OMITTED] TR15NO19.004

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

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

Where:

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

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system.
    Comment: A commenter stated that they disagreed with the 90 percent 
utilization metric for CT and MRI equipment, as the commenter did not 
believe it to be realistic in a typical outpatient imaging setting, but 
the commenter recognized that the percentage is dictated by statute. 
The commenter stated that the 90 percent equipment usage assumption for 
CT and MRI is inconsistent with actual imaging center practice and 
ignores scheduling in the ``real world,'' such as lunch and other 
mandated breaks, complicated patients, and downtime for maintenance and 
quality control. The commenter stated that to achieve a 90 percent 
utilization rate under ideal conditions would require two employees per 
unit; one doing pre-service tasks while the other is setting up the 
machine as opposed to assumptions of one CT or MRI technologist per 
scanner.
    Response: We disagree with the commenters regarding the equipment 
time assigned to highly technical equipment such as CT or MRI machines. 
We continue to believe that certain highly technical pieces of 
equipment

[[Page 62582]]

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 and are typically available for other patients 
even when one member of clinical staff may be occupied with a 
preservice or postservice task related to the procedure. For a more 
detailed description of this topic, we refer readers to the CY 2015 PFS 
final rule with comment period (79 FR 67639 through 67640).
    Comment: One commenter stated that most ophthalmology diagnostic 
equipment is in use far less than 50 percent of the time. The commenter 
indicated that they had developed a survey instrument that asked 
ophthalmic technicians to provide time usage estimates for the 16 most-
utilized pieces of diagnostic testing equipment. The commenter stated 
that their preliminary survey results produced a utilization rate of 22 
percent, much lower than the 50 percent assumption currently used by 
CMS. The commenter suggested that CMS should work with the RUC to do a 
robust survey to help determine a more valid utilization rate, 
including the possibility of specialty-specific equipment utilization 
rates. The commenter also requested a meeting to discuss what options 
CMS would find acceptable in undertaking their own survey for 
ophthalmology services.
    Response: We are always looking for more accurate information to 
improve our PE methodology. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items, and we will review any 
information that the RUC's PE subcommittee or other stakeholders are 
willing to submit through the public comment process. We concur with 
the commenter that a wide-ranging survey or similar study designed to 
address the subject of equipment utilization rates would be an 
appropriate tool to investigate this subject in further detail. At the 
moment, we believe that absent robust, objective, auditable data 
regarding the use of particular items, the 50 percent assumption is the 
most appropriate within the relative value system. We welcome further 
submission of data that illustrates an alternative rate.
    Maintenance: This factor for maintenance was finalized in the CY 
1998 PFS final rule with comment period (62 FR 33164). As we previously 
stated in the CY 2016 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 did not propose a variable maintenance 
factor for equipment cost per minute pricing as we noted that we did 
not believe that we have sufficient information at present to do so. We 
continue to investigate potential avenues for determining equipment 
maintenance costs across a broad range of equipment items.
    Comment: A commenter stated that they continue to believe that 
maintenance costs for imaging equipment are much higher than the 
current 5 percent assumption. The commenter stated that the maintenance 
costs for an MRI unit include servicing the scanner itself plus 
replacing cryogens for a cost well in excess of 5 percent even using 
CMS' low assumptions of MRI and CT room cost.
    Response: As detailed above, we continue to believe that the 
current 5 percent maintenance factor likely understates the true cost 
of maintaining some equipment and overstates the maintenance costs for 
other equipment. We continue at this time to lack publicly available 
datasets regarding equipment maintenance costs or another systematic 
data collection methodology for determining maintenance factor. We 
remind readers that 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.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). We 
did not propose any changes to these interest rates for CY 2020. The 
Interest rates are listed in Table 5.
[GRAPHIC] [TIFF OMITTED] TR15NO19.005

    Comment: A commenter stated that they did not support the continued 
use of the 2012 SBA maximum interest rates, which the commenter stated 
are significantly lower than the 2019 rates. The commenter stated that 
CMS should also update the interest rates used to calculate PE RVUs for 
such items based on current SBA data.
    Response: We appreciate the additional information regarding SBA

[[Page 62583]]

maximum interest rates from the commenter. However, we did not propose 
any changes to these interest rates for CY 2020; we will consider 
potential changes to the interest rates used in the equipment cost per 
minute calculation for possible future rulemaking.
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 67640-67641), we continue to make improvements to the direct PE 
input database to provide the number of clinical labor minutes assigned 
for each task for every code in the database instead of only including 
the number of clinical labor minutes for the preservice, service, and 
postservice periods for each code. In addition to increasing the 
transparency of the information used to set PE RVUs, this level of 
detail would allow us to compare clinical labor times for activities 
associated with services across the PFS, which we believe is important 
to maintaining the relativity of the direct PE inputs. This information 
would facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of equipment minutes based on clinical labor times. 
Finally, we believe that the detailed information can be useful in 
maintaining standard times for particular clinical labor tasks that can 
be applied consistently to many codes as they are valued over several 
years, similar in principle to the use of physician preservice time 
packages. We believe that setting and maintaining such standards would 
provide greater consistency among codes that share the same clinical 
labor tasks and could improve relativity of values among codes. For 
example, as medical practice and technologies change over time, changes 
in the standards could be updated simultaneously for all codes with the 
applicable clinical labor tasks, instead of waiting for individual 
codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS.'' Exam completed in RIS system 
to generate billing process and to populate images into Radiologist 
work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through 
80186), we finalized a 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 clinical labor tasks 
associated with pathology services in the CY 2016 PFS final rule with 
comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
prepare for examination'', 0.5 minutes for ``Assemble and deliver 
slides with paperwork to pathologists'', 0.5 minutes for ``Assemble 
other light microscopy slides, open nerve biopsy slides, and clinical 
history, and present to pathologist to prepare clinical pathologic 
interpretation'', 1 minute for ``Clean room/equipment following 
procedure'', 1 minute for ``Dispose of remaining specimens, spent 
chemicals/other consumables, and hazardous waste'', and 1 minute for 
``Prepare, pack and transport specimens and records for in-house 
storage and external storage (where applicable).'' We do not believe 
these activities would be dependent on number of blocks or batch size, 
and we believe that these values accurately reflect the typical time it 
takes to perform these clinical labor tasks.
    In reviewing the RUC-recommended direct PE inputs for CY 2019, we 
noticed that the 3 minutes of clinical labor time traditionally 
assigned to the ``Prepare room, equipment and supplies'' (CA013) 
clinical labor activity were split into 2 minutes for the ``Prepare 
room, equipment and supplies'' activity and 1 minute for the ``Confirm 
order, protocol exam'' (CA014) activity. We proposed to maintain the 3 
minutes of clinical labor time for the ``Prepare room, equipment and 
supplies'' activity and remove the clinical labor time for the 
``Confirm order, protocol exam'' activity wherever we observed this 
pattern in the RUC-recommended direct PE inputs. Commenters explained 
in response that when the new version of the PE worksheet introduced 
the activity codes for clinical labor, there was a need to translate 
old clinical labor tasks into the new activity codes, and that a prior 
clinical labor task was split into two of the new clinical labor 
activity codes: CA007 (``Review patient clinical extant information and 
questionnaire'') in the preservice period, and CA014 (``Confirm order, 
protocol exam'') in the service period. Commenters stated that the same 
clinical labor from the old PE worksheet was now divided into the CA007 
and CA014 activity codes, with a standard of 1 minute for each 
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity 
code and 1 minute for the CA014 activity code in situations where this 
was the case. However, when reviewing the clinical labor for the 
reviewed codes affected by this issue, we found that several of the 
codes did not include this old clinical labor task, and we also noted 
that several of the reviewed codes that contained the CA014 clinical 
labor activity code did not contain any clinical labor for the CA007 
activity. In these situations, we continue to believe that in these 
cases the 3 total minutes of clinical staff time would be more 
accurately described by the CA013 ``Prepare room, equipment and 
supplies'' activity code, and we finalized these clinical labor 
refinements. For additional details, we direct readers to the 
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
    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

[[Page 62584]]

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 2020, 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 2020 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: A commenter wrote to express their concerns with the 
manner in which data was displayed in the Proposed CY 2020 Direct PE 
Refinements table in the proposed rule (84 FR 40623-40666), 
specifically the common refinements to equipment time. The commenter 
stated that nearly 64 percent of the total PE refinements were related 
to equipment, and 59 percent of these refinements were listed as ``E15: 
Refined equipment time to conform to changes in clinical labor time.'' 
The commenter stated that they did not agree that these are separate 
refinements; rather, they are the formulaic result of the applying 
refinements to the clinical labor time. The commenter stated that 
including these instances as refinements adds a large quantity of rows 
to the PE refinement table and gives the impression that there are 
major inaccuracies in the RUC PE recommendations. The commenter 
provided an example of a single clinical labor refinement to a code 
family creating 32 rows of subsequent equipment refinements, and 
contended that articulating these edits was not necessary as they do 
not reflect either an error or a policy discrepancy with the RUC. The 
commenter requested that CMS no longer include refinements based on 
``E15: Refined equipment time to conform to changes in clinical labor 
time'' in the refinement table of the proposed rule.
    Response: We agree with the commenter that these equipment time 
refinements generated in response to clinical labor time refinements 
are indeed the result of applying standard equipment time formulas, and 
they do not reflect errors in the equipment recommendations or policy 
discrepancies with the RUC. We also agree that these refinements add a 
significant number of rows to the table of direct PE refinements. 
However, we disagree with the commenter on the subject of whether these 
constitute separate refinements, and we believe that it is important to 
publish the specific equipment times that we are proposing (or 
finalizing in the case of the final rule) when they differ from the 
recommended values. We include the direct cost change in dollars 
resulting from our PE refinements on the aforementioned table, and if 
we were to avoid including these equipment refinements, it would not 
always be clear what effect they were having on the direct costs for 
the procedure. For example, a modest reduction of a few minutes in 
clinical labor time can result in a substantial decrease in direct 
costs for procedures that employ highly expensive equipment. We believe 
that it is more important to provide additional transparency regarding 
the changes in direct costs resulting from our equipment time 
refinements so that the public can better comment on our proposals, as 
opposed to limiting the total number of printed equipment refinements.
    However, we agree with the commenter that the information displayed 
in the table of direct PE refinements can be confusing and 
overwhelming, and we believe that it could potentially be provided to 
the public in a more useful fashion. For this CY PFS 2020 final rule, 
we will separate out the ``E15: Refined equipment time to conform to 
changes in clinical labor time'' direct PE refinements and print them 
in a separate table of refinements. We believe that this will help to 
address the issues raised by the commenter while also retaining all of 
the data included in previous rules. We refer readers to Table 28 in 
section II.N. of this final rule, the Valuation of Specific Codes 
section, for additional details.
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

[[Page 62585]]

to codes with inputs reviewed prior to CY 2017. We also solicited 
comment on this separate pricing structure for scopes, scope video 
systems, and scope accessories, which we noted we could consider 
proposing to apply to other codes in future rulemaking. We did not 
finalize price increases for a series of other scopes and scope 
accessories, as the invoices submitted for these components indicated 
that they are different forms of equipment with different product IDs 
and different prices. We did not receive any data to indicate that the 
equipment on the newly submitted invoices was more typical in its use 
than the equipment that we were currently using for pricing.
    We did not make further changes to existing scope equipment in CY 
2017 to allow the RUC's PE Subcommittee the opportunity to provide 
feedback. However, we believed there was some miscommunication on this 
point, as the RUC's PE Subcommittee workgroup that was created to 
address scope systems stated that no further action was required 
following the finalization of our proposal. Therefore, we made further 
proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962) 
to continue clarifying scope equipment inputs, and sought comments 
regarding the new set of scope proposals. We considered creating a 
single scope equipment code for each of the five categories detailed in 
this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video 
flexible scope; (4) a non-channeled flexible video scope; and (5) a 
channeled flexible video scope. Under the current classification 
system, there are many different scopes in each category depending on 
the medical specialty furnishing the service and the part of the body 
affected. We stated our belief that the variation between these scopes 
was not significant enough to warrant maintaining these distinctions, 
and we believed that creating and pricing a single scope equipment code 
for each category would help provide additional clarity. We sought 
public comment on the merits of this potential scope organization, as 
well as any pricing information regarding these five new scope 
categories.
    After considering the comments on the CY 2018 PFS proposed rule, we 
did not finalize our proposal to create and price a single scope 
equipment code for each of the five categories previously identified. 
Instead, we supported the recommendation from the commenters to create 
scope equipment codes on a per-specialty basis for six categories of 
scopes as applicable, including the addition of a new sixth category of 
multi-channeled flexible video scopes. Our goal was to create an 
administratively simple scheme that would be easier to maintain and 
help to reduce administrative burden. In 2018, the RUC convened a Scope 
Equipment Reorganization Workgroup to incorporate feedback from expert 
stakeholders with the intention of making recommendations to us on 
scope organization and scope pricing. Since the workgroup was not 
convened in time to submit recommendations for the CY 2019 PFS 
rulemaking cycle, we delayed proposals for any further changes to scope 
equipment until CY 2020 in order to incorporate the feedback from the 
aforementioned workgroup.
(2) Scope Video System
    We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 
46177) to define the scope video system as including: (1) A monitor; 
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a 
printer. We believe that these equipment components represent the 
typical case for a scope video system. Our model for this system was 
the ``video system, endoscopy (processor, digital capture, monitor, 
printer, cart)'' equipment item (ES031), which we proposed to re-price 
as part of this separate pricing approach. We obtained current pricing 
invoices for the endoscopy video system as part of our investigation of 
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a 
digital capture device to the endoscopy video system (ES031) in the CY 
2017 PFS final rule (81 FR 80188). We finalized our proposal to price 
the system at $33,391, based on component prices of $9,000 for the 
processor, $18,346 for the digital capture device, $2,000 for the 
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did 
not finalize, a proposal to add an LED light source into the cost of 
the scope video system (ES031), which would remove the need for a 
separate light source in these procedures. We also described a proposal 
to increase the price of the scope video system by $1,000 to cover the 
expense of miscellaneous small equipment associated with the system 
that falls below the threshold of individual equipment pricing as scope 
accessories (such as cables, microphones, foot pedals, etc.). With the 
addition of the LED light (equipment code EQ382 at a price of $1,915), 
the updated total price of the scope video system would be set at 
$36,306.
    We did not finalize this updated pricing to the scope video system 
in CY 2018, but we did propose and finalize the updated pricing for CY 
2019 to $36,306 along with changing the name of the ES031 equipment 
item to ``scope video system (monitor, processor, digital capture, 
cart, printer, LED light)'' to reflect the fact that the use of the 
ES031 scope video system is not limited to endoscopy procedures.
(3) Scope Accessories
    We understand that there may be other accessories associated with 
the use of scopes. We finalized a proposal in the CY 2017 PFS final 
rule (81 FR 80188) to separately price any scope accessories outside 
the use of the scope video system, and individually evaluate their 
inclusion or exclusion as direct PE inputs for particular codes as 
usual under our current policy based on whether they are typically used 
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2020
    The Scope Equipment Reorganization Workgroup organized by the RUC 
submitted detailed recommendations to CMS for consideration in the CY 
2020 rule cycle, describing 23 different types of scope equipment, the 
HCPCS codes associated with each scope type, and a series of invoices 
for scope pricing. We appreciate the information provided by the 
workgroup and continue to welcome additional comments and feedback from 
stakeholders. Based on the recommendations from the workgroup, we 
proposed to establish 23 new scope equipment codes as detailed in Table 
6.

[[Page 62586]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.006

    We note that we did not receive invoices for many of the new scope 
equipment items. There also was some inconsistency in the workgroup 
recommendations regarding the non-channeled flexible digital scope, 
laryngoscopy (ES080) equipment item and the non-video flexible scope, 
laryngoscopy (ES092) equipment item. These scopes were listed as a 
single equipment item in some of the workgroup materials and listed as 
separate equipment items in other materials. We proposed to establish 
them as separate equipment items based on the submitted invoices, which 
demonstrated that these were two different types of scopes with 
distinct price points of approximately $17,000 and $5,000 respectively.
    We noted a similar issue with the submitted invoices for the rigid 
scope, laryngoscopy (ES075) equipment item. Among the eight total 
invoices, five of them were clustered around a price point of 
approximately $4,000 while the other three invoices had prices of 
roughly $15,000 apiece. The invoices indicated that these prices came 
from two distinct types of equipment, and as a result we proposed to 
consider these items separately. We proposed to use the initial five 
invoices to establish a proposed price of $3,966.08 for the rigid 
scope, laryngoscopy (ES075) equipment item. We noted that this is a 
close match for the current price of $3,178.08 used by the endoscope, 
rigid, laryngoscopy (ES010) equipment, which is the closest equivalent 
scope equipment. We also noted that the other three invoices appear to 
describe a type of stroboscopy system rather than a scope, and they 
have an average price of $14,737. This is a reasonably close match for 
the price of our current stroboscoby system (ES065) equipment, which 
has a CY 2020 price of $17,950.28 as it transitions to a final CY 2022 
destination price of $16,843.87 (see the 4-year pricing transition of 
the market-based supply and equipment pricing update discussed later in 
this section for more information). We stated that we believe that 
these invoices reinforce the value established by the market-based 
pricing update for the stroboscoby system carried out last year, and we 
did not propose to update the price of the ES065 equipment. We also 
noted that we were open to feedback from stakeholders if they believe 
it would be more accurate to assign a price of $14,737 to the 
stroboscoby system based on these invoice submissions, as opposed to 
maintaining the current pricing transition to a CY 2022 price of 
$16,843.87.
    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. We noted that we received recommendations from 
the RUC's scope workgroup regarding which HCPCS codes make use of the 
new scope equipment items, and we proposed to make this scope 
replacement for approximately 100 HCPCS codes in total (see Table 7).

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[GRAPHIC] [TIFF OMITTED] TR15NO19.010

    In all but three cases (as identified with an asterisk (*) in Table 
7), we proposed for the new scope equipment item to replace the 
existing scope with the identical amount of equipment time. For CPT 
codes 92612 (Flexible endoscopic evaluation of swallowing by cine or 
video recording), 92614 (Flexible endoscopic evaluation, laryngeal 
sensory testing by cine or video recording), and 92616 (Flexible 
endoscopic evaluation of swallowing and laryngeal sensory testing by 
cine or video recording), we noted the current scopes in use are the 
FEES video system

[[Page 62591]]

(ES027) and the FEESST video system (ES028). Since we proposed the use 
of a non-channeled flexible digital scope that requires a corresponding 
scope video system, we also proposed to add the ES080 equipment at the 
same equipment time to these three procedures rather than replacing the 
ES027 and ES028 equipment. In all other cases, we proposed to replace 
the current scope equipment listed in Table 7 with the new scope 
equipment, while maintaining the same amount of equipment time.
    We identified inconsistencies with the workgroup recommendations 
for a small number of HCPCS codes. CPT code 45350 (Sigmoidoscopy, 
flexible; with band ligation(s) (e.g., hemorrhoids)) was recommended to 
include a multi-channeled flexible digital scope, flexible 
sigmoidoscopy (ES085); however, we noted that this CPT code does not 
include any scopes among its current direct PE inputs. CPT code 31595 
was recommended to include a non-channeled flexible digital scope, 
laryngoscopy (ES080) but it no longer exists as a CPT code after having 
been deleted for CY 2019. CPT code 43232 (Esophagoscopy, flexible, 
transoral; with transendoscopic ultrasound-guided intramural or 
transmural fine needle aspiration/biopsy(s)) was recommended to include 
a multi-channeled flexible digital scope, esophagoscopy (ES088), but it 
does not include a scope amongst its direct PE inputs any longer 
following clarification from the same workgroup recommendations that 
CPT code 43232 is never performed in the nonfacility setting. In all 
three of these cases, we did not propose to add one of the new scope 
equipment items to these procedures.
    We noted that we did not receive pricing information along with the 
workgroup recommendations for the other 15 new scope equipment items. 
Therefore, we proposed to establish new equipment codes for these 
scopes as detailed in Table 6. However, we noted that due to a lack of 
pricing information, 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. We welcomed additional feedback 
from stakeholders regarding the pricing of these scope equipment items, 
especially the submission of detailed invoices with pricing data. We 
proposed to transition the scopes for which we did have pricing 
information over to the new equipment items for CY 2020, and we noted 
that we looked forward to engaging with stakeholders to assist in 
pricing and then transitioning the remaining scopes in future 
rulemaking.
    We received public comments on our scope equipment proposals. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters stated that they appreciated the 
proposal of the recommended 23 new scope equipment codes and the 
proposed pricing of 8 of those new scope equipment codes. Commenters 
also stated that they appreciated the proposal of scope replacements 
for 100 CPT codes as recommended by the RUC utilizing the 8 scopes that 
CMS was able to price. One commenter encouraged CMS to continue to work 
with the RUC workgroup and other stakeholders to obtain detailed 
invoices for the scopes for which it did not have pricing data to 
assist in the correct pricing and transition of these equipment items.
    Response: We appreciate the support for our proposals from the 
commenters. We welcome the submission of additional pricing data from 
the RUC scope workgroup and other stakeholders regarding the pricing of 
the remaining scope equipment items.
    Comment: One commenter stated that they appreciated the recognition 
of the existing specialized equipment that is required in addition to 
the proposed scope equipment, and they supported the proposal to add 
ES080 and retain ES027 or ES028 at the same equipment time for CPT 
codes 92612, 92614, and 92616.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: Several commenters stated it was their understanding that 
additional scope pricing information submitted now would be considered 
for the CY 2021 PFS proposed rule. These commenters asked for 
clarification that the CPT codes impacted by any scope proposals for CY 
2021 will be outlined in a table just as the impacted codes for CY 2020 
were outlined in Table 7, so that they will be subject to stakeholder 
review and comment prior to implementation.
    Response: As we stated in the proposed rule, we welcome additional 
feedback from stakeholders regarding the pricing of these remaining 
scope equipment items, especially the submission of detailed invoices 
with pricing data. Any future proposals that we make regarding scope 
equipment will be subject to notice and comment rulemaking, including 
displaying information in a table similar Table 7, if it would be 
appropriate to do so.
    Comment: A commenter stated that they had identified 
inconsistencies with the scope workgroup recommendations for a small 
number of HCPCS codes. The commenter stated that CPT code 45350 
(Sigmoidoscopy, flexible; with band ligation(s) (e.g., hemorrhoids)) 
was recommended by the workgroup to include a multi-channeled flexible 
digital scope, flexible sigmoidoscopy (ES085); however, CMS noted in 
the proposed rule that this CPT code does not include any scopes among 
its current direct PE inputs. The commenter stated that all codes in 
the flexible sigmoidoscopy family require a flexible sigmoidoscope in 
order to perform the procedure, and therefore, the commenter requested 
that CMS add the ES085 scope equipment to CPT code 45350.
    Response: We appreciate the feedback from the commenter in pointing 
out this inconsistency in the direct PE inputs for CPT code 45350. 
Based on the information supplied by the commenter, we are finalizing 
the addition of the ES085 scope equipment to CPT code 45350. We are 
finalizing an equipment time of 59 minutes based on the use of our 
standard equipment time formula for scopes.
    Comment: A commenter requested that the ``rigid scope, 
hysteroscopy'' (ES071) equipment be updated to read ``rigid scope, 
channeled, hysteroscopy'' and that the hysteroscopy codes (that is, CPT 
codes 58555, 58562, 58565) be valued with ES071. The commenter 
submitted an invoice with pricing information associated with the ES071 
scope equipment.
    Response: We appreciate the submission of an invoice from the 
commenter for use in pricing the ES071 scope. Based on the information 
provided by the commenter, we are finalizing a change in the name of 
the ES071 scope from ``rigid scope, hysteroscopy'' to ``rigid scope, 
channeled, hysteroscopy.'' We are also finalizing a price of $6,795 for 
the ES071 scope based on the pricing data supplied by the commenter, 
and we are finalizing the replacement of the existing ``endoscope, 
rigid, hysteroscopy'' (ES009) scope with the new ES071 scope equipment. 
The CPT codes affected by this replacement are CPT codes 58555, 58562, 
and 58565 as identified by the commenter, as well as CPT code 58563 
which is the only other code that previously employed the ES009 scope. 
These scope replacements are summarized below in Table 9.
    Comment: One commenter provided a series of invoices for different 
types of rigid scopes in response to the comment solicitation.
    Response: We appreciate the submission of additional invoices from 
the commenter. Based on the

[[Page 62592]]

information included in these invoices, we are finalizing prices for 
three scopes that did not previously have pricing data. We are 
finalizing a price of $2,333.98 for the ``rigid scope, otoscopy'' 
(ES072) equipment, a price of $3,004.75 for the ``rigid scope, nasal/
sinus endoscopy'' (ES073) equipment, and a price of $21,923.425 for the 
``non-channeled flexible digital scope, nasopharyngoscopy'' (ES078) 
equipment. We are not finalizing the replacement of any of the old 
scope equipment codes with these three new scope equipment items for CY 
2020, as the commenter did not identify the HCPCS codes in which this 
replacement would take place. We will consider additional scope pricing 
information for these three scope equipment codes, including the HCPCS 
codes in which they would typically be employed, as part of the CY 2021 
PFS proposed rule.
    The commenter also provided five new invoices for the pricing of 
the ``non-video flexible scope, laryngoscopy'' (ES092) equipment. These 
five invoices had an average price of $5,105.97, which was nearly 
identical to our proposed price of $5,078.04 for the ES092 scope. We 
believe that these invoices reinforce the accuracy of the proposed 
pricing. We are finalizing an increase in the price of the ES092 scope 
to $5,105.97, which will slightly increase the direct costs for the 14 
HCPCS codes containing this scope listed above in Table 7.
    Comment: Several commenters sent a series of additional invoices, 
and recommended crosswalks from existing equipment codes to the 
proposed equipment codes to ensure that the equipment currently listed 
for GI endoscopy procedures was appropriately attributed to the correct 
new scopes. Although the commenters did not provide information to 
update any of the proposed scope equipment prices, the commenters did 
clarify that several of the new scope equipment items which lacked 
proposed prices in fact shared the same current scope equipment codes 
as other new scope equipment items that did have proposed pricing. For 
example, CMS proposed to replace the ``videoscope, gastroscopy'' 
(ES034) scope equipment with the new ``multi-channeled flexible digital 
scope, esophagoscopy'' (ES088) scope equipment. The commenters 
clarified that this same ES034 equipment, when used in additional CPT 
codes, would be replaced by either the ``multi-channeled flexible 
digital scope, esophagoscopy gastroscopy duodenoscopy'' (ES087) or the 
``multi-channeled flexible digital scope, ileoscopy'' (ES089) equipment 
items, all of which should share the same proposed price of $34,585.35. 
The commenter also explained that the same ``Video Sigmoidoscope'' 
(ES043) equipment which CMS proposed to replace with the ``multi-
channeled flexible digital scope, pouchoscopy'' (ES090) new scope 
equipment would, in additional CPT codes, be replaced by the new 
``multi-channeled flexible digital scope, flexible sigmoidoscopy'' 
(ES085) scope equipment, and that both ES085 and ES090 should share the 
same proposed price of $19,308.56. Finally, the commenter also stated 
that the new ``ultrasound digital scope, endoscopic ultrasound'' 
(ES091) equipment item would only be used in the facility setting, and 
that none of the HCPCS codes that included this scope contained direct 
PE inputs.
    Response: We appreciate the submission of additional invoices and 
the clarification of the relationship between the former scope 
equipment codes and the newly created scope equipment codes. After 
considering this additional information supplied by the commenters, we 
are updating Table 8 of CY 2020 new scope equipment codes.

[[Page 62593]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.011

    We note again that we are not finalizing changes to the pricing of 
the group of new scope equipment codes with previously proposed prices, 
aside from the minor increase in the price of the ES092 equipment, only 
newly pricing several scopes that previously lacked pricing, and 
extending proposed pricing such that the ES087 and ES089 scopes share 
the same price with the ES088 scope, and the ES090 scope shares the 
same price with the ES085 scope. The new scope equipment codes ES087, 
ES088, and ES089 all share the same price because they are replacing 
the same current scope equipment code (ES034), and similarly the new 
ES085 and ES090 scope equipment codes share the same price because they 
are both replacing the same current scope equipment code (ES043). There 
are 21 HCPCS codes which are affected by the new scope replacements; 
these codes are detailed in Table 9.
BILLING CODE 4120-01-P

[[Page 62594]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.012


[[Page 62595]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.013

BILLING CODE 4120-01-C
    Although we are updating the scope equipment pricing for CY 2020 
such that the ES087 and ES089 scopes share the same price with the 
ES088 scope, and the ES090 scope shares the same price with the ES085 
scope, we do not mean to suggest that these scopes that share pricing 
are identical with one another. We are assigning the same price to 
these scopes because they are replacing the same current scope 
equipment codes, and because we do not have individual pricing 
information for them at the moment. We are open to the submission of 
additional invoices in future rule cycles to establish individual 
pricing for these scopes, and we continue to welcome more data to help 
identify pricing for the remaining 7 scope equipment codes that still 
lack invoices.
    After consideration of the public comments, we are finalizing 
pricing for the new scope equipment as detailed above in Table 8. We 
are also finalizing the scope equipment replacements as detailed in 
Tables 7 and 9.
c. Technical Corrections To Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2019 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We proposed to correct these inconsistencies as 
described below and reflected in the CY 2020 proposed direct PE input 
database displayed on the CMS website under downloads for the CY 2020 
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2020, we proposed to address the following inconsistencies:
     The RUC's Scope Equipment Reorganization Workgroup 
recommended deletion of the non-facility inputs for CPT codes 43231 
(Esophagoscopy, flexible, transoral; with endoscopic ultrasound 
examination) and 43232 (Esophagoscopy, flexible, transoral; with 
transendoscopic ultrasound-guided intramural or transmural fine needle 
aspiration/biopsy(s)). The gastroenterology specialty societies stated 
that these services are never performed in the non-facility setting. 
After our own review of these services, we agreed with the workgroup's 
recommendation, and we proposed to remove the non-facility direct PE 
inputs for these two CPT codes.
     In rulemaking for CY 2018, we reviewed a series of CPT 
codes describing nasal sinus endoscopy surgeries. At that time, we 
sought comments on whether the broader family of nasal sinus endoscopy 
surgery services should be subject to the special rules for multiple 
endoscopic procedures instead of the standard multiple procedure 
payment reduction. We received very few comments in response to our 
solicitation. In the CY 2018 PFS final rule (82 FR 53043), we indicated 
that we would continue to explore this option for future rulemaking. We 
proposed to apply the special rule for multiple endoscopic procedures 
to this family of codes beginning in CY 2020. We noted this proposal 
would treat this group of CPT codes consistently with other similar 
endoscopic procedures when codes within the CPT code family are billed 
together with another endoscopy service in the same family. Similar to 
other similar endoscopic procedure code families, we proposed that CPT 
code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral 
(separate procedure)) would be the base procedure for the remainder of 
nasal sinus endoscopies. The codes affected by the proposal are 
detailed in Table 10.

[[Page 62596]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.014

    Special rules for multiple endoscopic procedures would apply if any 
of the procedures listed in Table 10 are billed together for the same 
patient on the same day. We apply the multiple endoscopy payment rules 
to a code family before ranking the family with other procedures 
performed on the same day (for example, if multiple endoscopies in the 
same family are reported on the same day as endoscopies in another 
family, or on the same day as a non-endoscopic procedure). If an 
endoscopic procedure is reported together with its base procedure, we 
do not pay separately for the base procedure. Payment for the base 
procedure is included in the payment for the other endoscopy. For 
additional information about the payment adjustment under the special 
rule for multiple endoscopic services, we refer readers to the CY 1992 
PFS final rule where this policy was established (56 FR 59515) and to 
Public Law 100-04, Medicare Claims Processing Manual, Chapter 23 
(available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf).
    We received public comments on the proposed technical corrections 
to the direct PE input database and supporting files. The following is 
a summary of the comments we received and our responses.
    Comment: One commenter agreed with the RUC workgroup's 
recommendation and the CMS proposal to remove the non-facility direct 
PE inputs from CPT code 43231 and 43232.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: One commenter stated that the proposed approach for nasal 
sinus endoscopy procedure better reflects the work RVU associated with 
the different levels of sinus endoscopy procedures and stated their 
support for this payment change. The commenter requested clarification 
regarding the application of the bilateral adjustment in conjunction 
with the special rules for multiple endoscopic procedures. The 
commenter stated that it was their understanding that if the CPT code 
is reported as a bilateral procedure and is reported with other 
procedure codes on the same day, the guidance is to apply the bilateral 
adjustment before applying any form of multiple procedure rules.
    Response: The special rule for multiple endoscopic procedures has 
been described correctly in general terms by the commenter, although we 
encourage readers once again to refer to the CY 1992 PFS final rule 
where this policy was established (56 FR 59515) and to Public Law 100-
04, Medicare Claims Processing Manual, Chapter 23. This manual text 
states that special rules for multiple endoscopic procedures apply if 
the procedure is billed with another endoscopy in the same family 
(i.e., another endoscopy that has the same base procedure). The base 
procedure for each code with this indicator is identified in the 
endoscopic base code field. In these situations, we apply the multiple 
endoscopy rules to a family before ranking the family with other 
procedures performed on the same day (for example, if multiple 
endoscopies in the same family are reported on the same day as 
endoscopies in another family or on the same day as a non-endoscopic 
procedure). If an endoscopic procedure is reported with only its base 
procedure, we do not pay separately for the base procedure. Payment for 
the base procedure is included in the payment for the other endoscopy.
    Comment: A commenter requested clarification regarding the proposal 
to apply the special rule for multiple endoscopic procedures to the 
family of codes listed in Table 10. The commenter stated that it was 
their understanding that that the diagnostic endoscopy described by CPT 
code 31231 is included in the valuation of all of the surgical 
procedure codes on the list (for example, CPT codes 31254, 31256, 
31276, etc.), and therefore, CPT Code 31231 would not be billed on the 
same side that any nasal endoscopic surgical code(s) are performed. 
However, the commenter stated that it was their understanding that CPT 
code 31231 could be billed for one side of the nose if it was the only 
procedure performed and there was no surgical intervention on that 
side. Assuming that this interpretation was correct, the commenter 
stated that they supported the application of the special rules for 
endoscopy to the nasal endoscopy family.
    Response: We reiterate that the special rule for multiple 
endoscopic procedures has been described correctly in general terms by 
the commenter, although we encourage readers once again to refer to the 
CY 1992 PFS final rule where this policy was established (56 FR 59515) 
and to Public Law 100-

[[Page 62597]]

04, Medicare Claims Processing Manual, Chapter 23. We encourage 
stakeholders to contact their local Medicare Administrative Contractor 
(MAC) for information regarding proper billing instructions for CPT 
code 31231.
    Comment: One commenter stated that they were troubled by the 
proposal to apply the multiple endoscopy payment methodology to the CPT 
codes included in Table 10 without further clarification in the 
regulatory language or the Medicare Carriers Manual about the number of 
multiple procedure modifiers CMS can append to one claim. The commenter 
questioned whether these 27 codes will be assigned a multiple procedure 
indicator of ``3'' and if that would override the prior multiple 
procedure indicator of ``4''. The commenter stated that they did not 
support the application of multiple endoscopy payment rules if CMS 
intended to assign reductions for both multiple endoscopy and multiple 
procedures, as application of both payment rules would result in 
inappropriate reductions to this set of services.
    Response: In response to the commenter's question, only one 
multiple procedure indicator can be applied to each HCPCS code. We also 
clarify that our proposal would assign a multiple procedure indicator 
of ``3'' to all of the codes listed in Table 10 aside from CPT code 
31231, which would be the endoscopic ``base code'' and would be 
assigned a multiple procedure indicator of ``2''. We also note that 
none of these codes previously contained a multiple procedure indicator 
of ``4'', which is associated with certain diagnostic imaging services. 
We encourage readers once again to refer to the CY 1992 PFS final rule 
where this policy was established (56 FR 59515) and to Pub. 100-04, 
Medicare Claims Processing Manual, Chapter 23.
    Comment: One commenter stated that although they recognized that by 
including the nasal endoscopy family among the codes using the special 
rule for multiple endoscopies, CMS may be trying to harmonize 
endoscopic procedures, and they stated that the unique situation 
surrounding the nasal endoscopy code family should prohibit the 
application of this special rule. The commenter stated that the nasal 
endoscopy code family differed significantly from colonoscopy 
procedures in that there is not uniformity across the sites of service 
where these sinus procedures are performed, since these services could 
be performed in both the facility and non-facility settings. The 
commenter stated that applying the special rules for multiple 
endoscopic procedures to this group would result in a significant 
inappropriate reduction in the value of the secondary and subsequent 
nasal surgical codes performed on the same patient on the same day when 
performed in the office setting, and the commenter stated that they 
opposed the application of the special rules for multiple endoscopies 
to the nasal endoscopy family in the non-facility setting.
    Response: We disagree that this nasal endoscopy code family differs 
significantly from other colonoscopy families where the special rule 
for multiple endoscopic procedures has long been in place. Although the 
commenter stated that the nasal endoscopy codes were unique in the 
sense that they could be performed in both the facility and non-
facility settings, and that the base code for the family, CPT code 
31231, is typically an office-based procedure with significant PE built 
into the code, we note in response that there are many other groups of 
codes which utilize the special rule for multiple endoscopic procedures 
and are also performed in both the facility and non-facility settings. 
These include CPT codes 31573-31579 (base CPT code 31575), CPT codes 
43220-43229 (base CPT code 43220), CPT codes 44389-44394 (base CPT code 
44388), and CPT codes 45303-45320 (base CPT code 45300). There are 
dozens of these codes which can be performed in both the facility and 
non-facility settings, many of them with significant PE inputs built 
into their non-facility valuation. In light of this evidence, we 
disagree with the commenter that there is a unique situation regarding 
the nasal endoscopy family of codes.
    Comment: Several commenters requested that CMS utilize the RUC-
recommended direct PE inputs to publish PE relative value units for CPT 
code 90460, which was reviewed by the RUC in October 2009. Rather than 
finalize the RUC recommendations, CMS crosswalked CPT code 90460 from 
CPT code 90471, which is crosswalked from CPT code 96372 (formerly CPT 
code 90772 and then 90782). Commenters stated that the recent measles 
crisis spotlights the importance of immunization administration being 
appropriately valued, and that the crosswalk from CPT code 96372 to 
codes CPT codes 90471/90460 has brought about a 60 percent reduction in 
PE RVUs. Commenters stated that CMS typically only uses a crosswalk for 
work values, not PE values, and requested that CMS disconnect the codes 
after the initial crosswalk so that changes to the source code no 
longer affect the crosswalked code. One commenter stated that CMS was 
proposing to reduce the non-facility PE RVUs for CPT code 90471 from 
0.29 in 2019 to 0.22 in 2020, and while this may appear to be a 
relatively small change in RVUs, if finalized it would reduce the 
national unadjusted payment for CPT code 90471 (and consequently the 
payment rates for HCPCS codes G0008 and G0009) by 15 percent.
    Response: We appreciate the feedback from the commenters and note 
that we finalized the crosswalks associated with CPT code 90460 in the 
CY 2011 final rule (75 FR 73306). However, we note that we are 
separately addressing the valuation of HCPCS codes G0008, G0009, and 
G0010 in the codes valuation section of this rule.
    We also received comments regarding a variety of subjects about 
which we did not make proposals for CY 2020. These included comments 
regarding the proper specialty employed to determine indirect cost 
factors for home PT/INR monitoring services and the application of the 
multiple procedure payment reduction to physical therapist services. We 
will take the feedback from the commenters on these subjects into 
consideration for future rulemaking.
    After consideration of the public comments, we are finalizing the 
proposal to remove the non-facility direct PE inputs from CPT code 
43231 and 43232. We are also finalizing the proposal to apply the 
special rule for multiple endoscopic procedures to the family of codes 
listed in Table 10 without refinement.
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 2020, 
we proposed the following price updates for existing direct PE inputs.
    We proposed to update the price of one supply and one equipment 
item in response to the public submission of invoices. As these pricing 
updates were each part of the formal review for a code family, we 
proposed that the new pricing take effect for CY 2020 for these items 
instead of being phased in over 4 years.
    We also proposed to update the name of the EP001 equipment item 
from ``DNA/digital image analyzer (ACIS)'' to ``DNA/Digital Image 
Analyzer'' due to

[[Page 62598]]

clarification from stakeholders regarding the typical use of this 
equipment.
(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) 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 1,300 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).
     Federal Register, current DPEI data, historical proposed 
and final rules prior to CY 2018, and other resources; that is, AMA RUC 
reports (References).
    StrategyGen prioritized the equipment and supply research based on 
current share of PE RVUs attributable by item provided by CMS. 
StrategyGen developed the preliminary Recommended Price (RP) 
methodology based on the following rules in hierarchical order 
considering both data representativeness and reliability.
    (1) If the market share, as well as the sample size, for the top 
three commercial products were available, the weighted average price 
(weighted by percent market share) was the reported RP. Commercial 
price, as a weighted average of market share, represents a more robust 
estimate for each piece of equipment and a more precise reference for 
the RP.
    (2) If no data were available for commercial products, the current 
CMS prices were used as the RP.
    GSA prices were not used to calculate the StrategyGen recommended 
prices, due to our concern that the GSA system curtails the number and 
type of suppliers whose products may be accessed on the GSA Advantage 
website, and that the GSA prices may often be lower than prices that 
are available to non-governmental purchasers. After reviewing the 
StrategyGen report, we proposed to adopt the updated direct PE input 
prices for supplies and equipment as recommended by StrategyGen.
    StrategyGen found that despite technological advancements, the 
average commercial price for medical equipment and supplies has 
remained relatively consistent with the current CMS price. 
Specifically, preliminary data indicated that there was no 
statistically significant difference between the estimated commercial 
prices and the current CMS prices for both equipment and supplies. This 
cumulative stable pricing for medical equipment and supplies appears 
similar to the pricing impacts of non-medical technology advancements 
where some historically high-priced equipment (that is, desktop PCs) 
has been increasingly substituted with current technology (that is, 
laptops and tablets) at similar or lower price points. However, while 
there were no statistically significant differences in pricing at the 
aggregate level, medical specialties would experience increases or 
decreases in their Medicare payments if CMS were to adopt the pricing 
updates recommended by StrategyGen. At the service level, there may be 
large shifts in PE RVUs for individual codes that happened to contain 
supplies and/or equipment with major changes in pricing, although we 
note that codes with a sizable PE RVU decrease would be limited by the 
requirement to phase in significant reductions in RVUs, as required by 
section 1848(c)(7) of the Act. The phase-in requirement limits the 
maximum 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

[[Page 62599]]

fully implemented for CY 2022. An example of the transition from the 
current to the fully-implemented new pricing is provided in Table 11.
[GRAPHIC] [TIFF OMITTED] TR15NO19.015

    For new supply and equipment codes for which we establish prices 
during the transition years (CYs 2019, 2020 and 2021) based on the 
public submission of invoices, we proposed to fully implement those 
prices with no transition since there are no current prices for these 
supply and equipment items. These new supply and equipment codes would 
immediately be priced at their newly established values. We also 
proposed that, for existing supply and equipment codes, when we 
establish prices based on invoices that are submitted as part of a 
revaluation or comprehensive review of a code or code family, they will 
be fully implemented for the year they are adopted without being phased 
in over the 4-year pricing transition. The formal review process for a 
HCPCS code includes a review of pricing of the supplies and equipment 
included in the code. When we find that the price on the submitted 
invoice is typical for the item in question, we believe it would be 
appropriate to finalize the new pricing immediately along with any 
other revisions we adopt for the code valuation.
    For existing supply and equipment codes that are not part of a 
comprehensive review and valuation of a code family and for which we 
establish prices based on invoices submitted by the public, we proposed 
to implement the established invoice price as the updated price and to 
phase in the new price over the remaining years of the proposed 4-year 
pricing transition. During the proposed transition period, where price 
changes for supplies and equipment are adopted without a formal review 
of the HCPCS codes that include them (as is the case for the many 
updated prices we proposed to phase in over the 4-year transition 
period), we believe it is important to include them in the remaining 
transition toward the updated price. We also proposed to phase in any 
updated pricing we establish during the 4-year transition period for 
very commonly used supplies and equipment that are included in 100 or 
more codes, such as sterile gloves (SB024) or exam tables (EF023), even 
if invoices are provided as part of the formal review of a code family. 
We would implement the new prices for any such supplies and equipment 
over the remaining years of the proposed 4-year transition period. Our 
proposal was intended to minimize any potential disruptive effects 
during the proposed transition period that could be caused by other 
sudden shifts in RVUs due to the high number of services that make use 
of these very common supply and equipment items (meaning that these 
items are included in 100 or more codes).
    We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining 
stability and allowing stakeholders the opportunity to address 
potential concerns about changes in payment for particular items. 
Updating the pricing of direct PE inputs for supplies and equipment 
over a longer timeframe will allow more opportunities for public 
comment and submission of additional, applicable data. We welcomed 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration.
    We received many comments regarding the market-based supply and 
equipment pricing proposal following the publication of the CY 2019 PFS 
proposed rule. For a full discussion of these comments, we direct 
readers to the CY 2019 PFS final rule (83 FR 59475-59480). 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 
59479-59480).
    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 2020, we received invoice submissions for approximately 30 
supply and equipment codes from stakeholders as part of the second year 
of the market-based supply and

[[Page 62600]]

equipment pricing update. These invoices were reviewed by the 
StrategyGen contractor and the submitted invoices were used in many 
cases to supplement the pricing originally proposed for the CY 2019 PFS 
rule cycle. The contractor reviewed the invoices, as well as prior data 
for the relevant supply/equipment codes to make sure the item in the 
invoice was representative of the supply/equipment item in question and 
aligned with past research. Based on this research, we proposed to 
update the prices of the supply and equipment items listed in Table 9 
of the CY 2020 PFS proposed rule.
    For most supply and equipment items, there was an alignment between 
the research carried out by the StrategyGen contractor and the 
submitted invoice. The updated CY 2020 pricing was calculated using an 
average between the previous market research and the newly submitted 
invoices in these cases. In some cases the submitted invoices were not 
representative of market prices, such as for the centrifuge with rotor 
(EP007) equipment item where the invoice price of $8,563 appeared to be 
an outlier. We did not use the invoices to calculate our pricing 
recommendation in these situations and instead continued to rely on our 
prior pricing data. In other instances, such as for the kit, probe, 
cryoablation, prostate (Galil-Endocare) (SA099) supply item, our 
research indicated that the submitted invoice price was more 
representative of the commercial price than our CY 2019 research and 
pricing. We proposed the new invoice prices for these supply and 
equipment items due to our belief in their greater accuracy.
    For some of the remaining supply and equipment items, such as the 
five-gallon paraffin (EP031) equipment and the Olympus DP21 camera 
(EP089) equipment, we maintained the extant pricing for CY 2019 due to 
a lack of sufficient data to update the pricing. In these situations 
where we did not have an updated price for CY 2019, we believe that the 
newly submitted invoices are more representative of the current 
commercial prices that are being paid on the market. We proposed the 
new invoice prices for these supply and equipment items due to our 
belief in their greater accuracy.
    In addition, we were alerted by stakeholders that the price of the 
EM visit pack (SA047) supply did not match the sum of the component 
prices of the supplies included in the pack. After reviewing the prices 
of the individual component supplies, we agree with the stakeholders 
that there was a discrepancy in the previous pricing of this supply 
pack. We proposed to update the price of the EM visit pack to $5.47 to 
match the sum of the prices of the component supplies, and proposed to 
continue to transition towards this price over the remaining years of 
the phase-in period.
    We finalized a policy last year 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 11. For CY 2020, one third of the difference between 
the CY 2019 price and the final price will be implemented as per the 
previously finalized policy. Table 12 contains the list of proposed CY 
2020 market-based supply and equipment pricing updates:
BILLING CODE 4120-01-P

[[Page 62601]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.016


[[Page 62602]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.017

BILLING CODE 4120-01-C
(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 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We received public comments on updates to prices for existing 
direct PE inputs. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters were supportive of the proposed update to 
supply and equipment pricing based on the submission of additional 
invoices as detailed in Table 12. One commenter thanked CMS for 
gathering additional pertinent information and proposing a more 
accurate price for the balloon sinus surgery kit (SA106) supply for CY 
2020. Several commenters urged CMS to finalize the proposed updates to 
the direct PE supplies and equipment prices as listed in the table. One 
commenter encouraged CMS to continue to carefully consider all pricing 
data including invoices and other supporting evidence that they receive 
from the specialty societies throughout this comment period and the 
entirety of the 4-year transition period.
    Response: We will continue to carefully consider all pricing data 
submitted from commenters throughout the 4-year transition period.
    Comment: Several commenters stated that they were concerned that 
supply and equipment pricing will quickly become outdated once the 
transition to updated prices is complete in CY 2022. The commenters 
encouraged CMS to move to an ongoing update process for supplies and 
equipment, as well as for clinical labor staff costs, one that is open 
for public comment through the rulemaking process.
    Response: We share the concerns from the commenters that the supply 
and equipment pricing will eventually become outdated again after the 
pricing transition is complete. We welcome additional feedback from 
stakeholders on potential solutions to this issue, and we will consider 
the possibility of different approaches to supply and equipment pricing 
for use in future rulemaking.
    Comment: One commenter stated that they appreciated and supported 
recognition by CMS that the supplies and equipment associated with 
physician services were past due for review, but noted that there 
remains large numbers of supplies and equipment that are overdue for 
updates. The commenter stated that they supported a gradual transition 
of the pricing given the widespread impact on the PE values; however, 
doing so creates a situation in which items that have seen dramatic 
increases over a short time are not being adequately compensated for 
several years. The commenter asked CMS to consider shortening the 
transition period from 4 years to 3 years for the supply and equipment 
pricing.
    Response: Although we appreciate the feedback from the commenter, 
we finalized a policy last year 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 (83 FR 59479-59480). We did not propose any changes 
to this transition period, and therefore, we decline to adopt a 
different approach.
    Comment: One commenter stated that they supported the CMS proposal 
to update the price of the EM visit pack (SA047) supply to $5.47 to 
match the sum of the prices of the component supplies. The commenter 
also stated that they had concerns over the pricing of the other 
bundled supply items (such as kits, trays, and packs) that may have 
been similarly mispriced by StrategyGen. The commenter stated that they 
could not assist CMS in correcting supply codes that may have been 
incorrectly priced without details about the pricing for individual 
component supplies.
    Response: We appreciate the support for our proposed pricing of the 
EM visit pack (SA047) supply by the commenter. We encourage 
stakeholders to comment

[[Page 62603]]

upon and submit pricing information for any supply items that they 
believe may have been mispriced by StrategyGen. In the absence of 
alternative pricing information, we continue to believe that our 
proposed prices are the most accurate source of data.
    Comment: One commenter recommended CMS consider only the best 
available evidence and market research data in proposing any changes to 
the pricing approach of the balloon sinus surgery kit (SA106). The 
commenter stated that the use of navigation instruments has increased 
for this supply kit, particularly in the lower cost office setting, 
which enhances the ability to navigate the complex sinus anatomy, 
resulting in improved safety and reliability of the procedure, which 
benefits the patient.
    Response: We note that the commenter did not make any specific 
recommendations regarding the pricing of this supply or submit invoices 
with additional pricing information. In the absence of alternative 
pricing information, we continue to believe that our proposed prices 
are the most accurate source of data.
    Comment: Several commenters stated that they supported and urged 
CMS to finalize the proposed prices for the general ultrasound room 
(EL015) and vascular ultrasound room (EL016) equipment. Commenters 
stated that the proposed prices more accurately reflected the costs 
faced by vascular ultrasound practitioners and would reduce health care 
costs by ensuring ultrasound services are readily available to the most 
vulnerable Medicare beneficiaries.
    Response: We appreciate the support for our proposed pricing by the 
commenters.
    Comment: One commenter disagreed with the proposed pricing of the 
general ultrasound room (EL015) equipment. The commenter stated that 
the proposed pricing would drastically reduce the general ultrasound 
room price by 65 percent, which would have a downstream impact on the 
vascular ultrasound room, resulting in a 57 percent reduction. The 
commenter stated that a 40 percent reduction in payment as a result of 
this pricing would significantly reduce patient access to ultrasound 
services across the board.
    Response: We clarify for the commenter that we did not propose a 
reduction in the price of the general ultrasound room (EL015) 
equipment. We proposed to update the price of the general ultrasound 
room to $410,303.32 and proposed to continue to transition towards this 
price over the remaining years of the phase-in period, with a CY 2020 
price of $383,397.77. We note that this is a slight increase over the 
finalized CY 2019 price of $369,945.00; we encourage readers to consult 
the full list of supply and equipment pricing as detailed in the public 
use files.
    Comment: Several commenters disagreed with the proposed pricing of 
the ``HDR Afterload System, Nucletron--Oldelft'' (ER003) equipment, the 
``treatment planning system, IMRT (Corvus w-Peregrine 3D Monte Carlo)'' 
(ED033) equipment, and the ``SRS system, SBRT, six systems, average'' 
(ER083) equipment. The commenters stated that all of these equipment 
items have proposed prices that are below industry standards, and that 
given the high cost of these items and their substantial utilization in 
certain radiation oncology delivery codes, it was imperative that the 
CMS inputs accurately reflect the marketplace pricing. The commenters 
recommended that CMS conduct additional research regarding fair and 
accurate market pricing for equipment items ER003, ED033 and ER083. 
Another commenter also disagreed with the proposed pricing of the ER003 
equipment, and stated that StrategyGen may have included updated 
pricing for a less costly electronic brachytherapy system used to treat 
non-melanoma skin cancer, or alternatively the proposed price for ER003 
may represent an equipment upgrade or refurbished equipment.
    Response: We share the concerns of the commenters on the importance 
to ensure fair and accurate market-based pricing for supplies and 
equipment. However, the commenters did not submit invoices or other 
pricing data for the ER003, ED033, and ER083 equipment items, and, as 
previously stated, in the absence of alternative pricing information, 
we continue to believe that our proposed prices are the most accurate 
source of data. We continue to welcome feedback from stakeholders on 
the proposed updated supply and equipment pricing over the ongoing 4-
year transition period, including the submission of additional invoices 
for consideration.
    Comment: Several commenters stated that they supported the efforts 
by CMS to ensure accurate pricing for direct PE inputs and supported 
the updated valuation of the ultrasound room and vascular ultrasound 
room. However, the commenters stated that there was an inconsistency 
with the pricing for the CT room (EL007), PET room (EL009), and PET-CT 
room (EL010) equipment. The commenters stated that it did not follow 
logically that the EL009 equipment is increasing from $1,328,996 to 
$2,410,677 and the EL007 equipment is increasing from $1,284,000 to 
$1,429,967 while a room that is a combination of these two, EL010, is 
decreasing from $2,136,283 to $206,326. The commenters asked that CMS 
investigate this issue further while delaying any price change for this 
one item.
    Response: With regards to the pricing of the PET-CT room (EL010) 
equipment, we share the desire of the commenters to ensure fair and 
accurate market-based pricing for this equipment item. However, as we 
noted in the previous comment response, the commenters did not submit 
invoices or other pricing data for the EL010 equipment, and, as 
previously stated, in the absence of alternative pricing information, 
we continue to believe that our proposed prices are the most accurate 
source of data. We remind stakeholders that the proposed pricing was 
based on market research carried out by the StrategyGen contractor 
during the prior rule cycle. We continue to welcome feedback from 
stakeholders on the proposed updated supply and equipment pricing over 
the ongoing 4-year transition period, and we are willing to revisit the 
subject of pricing for this equipment if provided with market-based 
pricing data.
    Comment: Several commenters disagreed with the proposed price of 
the ``stent, vascular, deployment system, Cordis SMART'' (SA103) and 
``stent, balloon, implantable'' (SD299) supplies. Commenters stated 
that the Cordis SMART stent (SA103) supply is not FDA approved to stent 
iliac veins in CPT codes 37238-37239 due to the markedly undersized 
diameters of the available stents, and that this supply is essentially 
never used in iliac veins due to its much smaller size. The commenter 
stated that they believe the proposed pricing of the SA103 supply to be 
inaccurate, and stated that they were submitting 10 invoices in the 
hopes of pricing a new supply code at $2,537 which would replace the 
SA103 supply in these CPT codes. The commenters also stated a desire to 
work with CMS to reconsider pricing of the SD299 supply given the 
likely non-viability by CY 2022 of the services represented by CPT 
codes 37236 and 37237 in the office setting, and to resolve the lack of 
clarity surrounding the implantable stent balloon.
    Response: We appreciate the desire on the part of the commenters to 
submit invoices with additional pricing data. However, despite an 
exhaustive search of the comments, we were unable to find the 10 
invoices mentioned in the letters from the commenters, which

[[Page 62604]]

were not included along with the rest of the submitted text. Although 
we are willing to consider these invoices if they were to be submitted, 
as previously stated, in the absence of alternative pricing 
information, we continue to believe that our proposed prices are the 
most accurate source of data. We urge commenters submitting invoices to 
include them as part of their comment letter to avoid any potential for 
miscommunication. We also note for the commenters that we did not make 
any proposals regarding CPT codes 37238-37239 or CPT codes 37236-37237, 
and therefore, we decline to make changes to the supplies for these 
codes at this time.
    Comment: Several commenters disagreed with the proposed price of 
the percutaneous neuro test stimulation kit (SA022) supply. The 
commenters stated that the proposed price of $114.52 was insufficient 
to reflect the cost associated with the SA022 supply, and that there 
may have been some misunderstanding about what items comprise the 
sacral nerve test kit. The commenters stated that it appears that the 
line item reflecting the device that generates the neurostimulation, 
which is the most expensive component of the test kit, was not included 
in the proposed pricing for this supply, which instead reflects the 
costs of the test kit leads only. The commenters stated that they 
reviewed all of the paid invoices for kits sold during January and 
February 2019, which resulted in pricing that was more in line with the 
CY 2018 pricing of $420 for the kit. One commenter submitted a random 
sample of 120 paid invoices (out of the 481 paid invoices that the 
commenter accumulated in total) for consideration by CMS.
    Response: We appreciate the submission of a large quantity of 
additional invoices with pricing data from the commenter. After further 
review, we agree with the commenters that the proposed price failed to 
incorporate all of the components of the test kit. Based on the data 
submitted by the commenters, we are finalizing an update in the price 
of the percutaneous neuro test stimulation kit (SA022) supply to 
$413.24, and we will continue to transition towards this price over the 
remaining years of the phase-in period.
    Comment: One commenter stated that the proposed price of $752.40 
for the ``plasma LDL adsorption column (Liposorber)'' (SD186) supply 
did not accurately reflect the actual average prices paid by their 
provider customers. The commenter submitted copies of all U.S. customer 
invoices for purchases of the SD186 supply for the most recent three-
month period from June 1 through August 30, 2019 and requested that the 
price should be updated to reflect the average market pricing.
    Response: We appreciate the submission of a large quantity of 
additional invoices with pricing data from the commenter. Based on the 
data submitted by the commenter, we are finalizing an update in the 
price of the ``plasma LDL adsorption column (Liposorber)'' (SD186) 
supply to $1118.06, and we will continue to transition towards this 
price over the remaining years of the phase-in period.
    Comment: The same commenter stated that the ``plasma antibody 
adsorption column (Prosorba)'' (SD185) supply was withdrawn from the 
market by its manufacturer more than 10 years ago, and the associated 
procedure code (CPT code 36515) has been deleted. The commenter also 
stated that the blood warmer tubing set (SC084) supply is not utilized 
to perform LDL apheresis with a Liposorber System, and therefore, 
recommended that this supply should be delisted as a direct PE input 
for CPT code 36516.
    Response: We appreciate the additional information provided by the 
commenter regarding these supply items. After conducting our own 
review, we agree with the commenter that there is no longer any need 
for the ``plasma antibody adsorption column (Prosorba)'' (SD185) 
supply, which is not utilized by any HCPCS codes and has been withdrawn 
from the market. Therefore, we are finalizing the deletion of the SD185 
supply code. We are not finalizing the removal of the blood warmer 
tubing set (SC084) supply at this time, as it is currently utilized in 
two codes (CPT codes 36514 and 36516), and we did not make any 
proposals on this issue. We welcome additional feedback from 
stakeholders regarding the use of the SC084 supply for potential future 
rulemaking.
    Comment: One commenter stated that they appreciated recent efforts 
by CMS to update the price of supply and equipment inputs to better 
reflect current market rates. The commenter requested that CMS update 
the price inputs for three inputs: The Biodegradable Material Kit--
PeriProstatic (SA126) supply, the Rezum delivery device kit (SA128) 
supply, and the water thermotherapy procedure generator (EQ389) 
equipment. The commenter submitted invoices with updated pricing data 
for consideration by CMS.
    Response: Based on the data submitted by the commenters, we are 
finalizing an update in the price of all three of these direct PE 
inputs. We are finalizing an increase in the price of the Biodegradable 
Material Kit--PeriProstatic (SA126) supply from $2,850 to $2,965 based 
on averaging the submission of eight invoices. We are finalizing an 
increase in the price of the Rezum delivery device kit (SA128) supply 
from $1,150 to $1,220 based on averaging the submission of ten 
invoices. Finally, we are finalizing an increase in the price of the 
water thermotherapy procedure generator (EQ389) equipment from $27,538 
to $33,950 based on averaging the submission of two invoices.
    Comment: One commenter disagreed with the proposed pricing for the 
``fluorescein inj (5ml uou)'' (SH033) supply. The commenter stated that 
the proposed price for injectable fluorescein was concerning as it did 
not reflect the most recent price increase of nearly 60 percent. The 
commenter stated that for several months practices have been paying 
$38.02 per vial and submitted four invoices to this effect.
    Response: After reviewing the submitted invoices, we are finalizing 
an increase of the price of the SH033 supply to $38.02 to match the 
information detailed by the commenter.
    Comment: One commenter disagreed with the proposed pricing for 
HCPCS code G0166 (External counterpulsation, per treatment session) and 
stated that the reductions in the proposed pricing would decrease the 
availability of this service and have already impacted their ability to 
provide external counterpulsation (ECP) therapy. The commenter stated 
that the prior review of HCPCS code G0166 in the CY 2019 rule cycle 
contained major errors, including omissions that artificially deflated 
the cost of the equipment associated with ECP therapy, inappropriate 
valuation of the ECP therapy equipment, and a failure to reflect the 
clinical guidelines and requirements for delivering ECP therapy. The 
commenter requested that CMS reverse the CY 2019 RVU reductions such 
that ECP therapy would return to the CY 2018 payment rates, or 
alternately pause any future reductions until CMS considered and acted 
upon forthcoming RUC recommendations for HCPCS code G0166. The 
commenter also submitted a series of invoices for the EECP external 
counterpulsation system (EQ012) equipment and a number of additional 
equipment items that previously lacked pricing.
    Response: We remind commenters that we nominated HCPCS code G0166 
as potentially misvalued in the CY 2020 PFS proposed rule (84 FR 40516) 
due to concerns that the RVUs for this code did not fully reflect the 
total resources required to deliver the service. Aside from nominating 
HCPCS code G0166 as

[[Page 62605]]

potentially misvalued, we did not make any other proposals concerning 
this code. We are aware that the RUC plans to review HCPCS code G0166 
for the CY 2021 PFS rule cycle, and we look forward to considering 
their recommendations for next year's rulemaking.
    However, although we are not reviewing the work RVU or direct PE 
inputs for HCPCS code G0166 for CY 2020, we were able to consider the 
submission of invoices from the commenter as part of our market-based 
supply and equipment pricing transition. Based on the information 
provided by the commenters, we are finalizing an increase in the price 
of the EECP external counterpulsation system (EQ012) equipment from 
$61,490.75 to $117,495.00. For the additional equipment items submitted 
by the commenter, which are not currently included in the direct PE 
inputs for HCPCS code G0166, we are finalizing the use of a proxy item 
for equipment pricing. We are finalizing the addition of a medium 
instrument pack (EQ138) priced at $1,500.00 at the same equipment time 
of 73 minutes used by the EECP external counterpulsation system as a 
proxy to represent the cost of these additional items. Although the 
medium instrument pack is a collection of surgical instruments and not 
table accessories, it contains 20 different small items which 
individually fall under our $500 threshold for equipment pricing, much 
as the additional equipment items on the submitted invoices also failed 
to meet the typical $500 threshold. We will further consider pricing 
for both the EECP external counterpulsation as part of the review 
process for this code along with the RUC recommendations when they 
arrive for CY 2021.
    Comment: One commenter disagreed with the proposed pricing of the 
INR analysis and reporting system w-software (EQ312) equipment. The 
commenter stated that the finalized price for the INR analysis and 
reporting system during the CY 2019 rule cycle was orders of magnitude 
lower than the amount submitted by the home INR manufacturers and 
suppliers, and the commenter was under the belief that the pricing for 
this equipment was not reviewed and/or updated. The commenter urged CMS 
to review and update the price for the PT/INR analysis and reporting 
system based on current market invoices; the commenter also submitted 
additional invoices from the same vendor with their letter.
    Response: We clarify for the commenter that we did review the 
invoices that they submitted during the previous rule cycle in CY 2019. 
Those invoices, along with the additional invoices submitted for the 
current CY 2020 rule cycle from the same vendor, did not contain 
pricing information for the purchase of an INR analysis and reporting 
system (EQ312) equipment item. These invoices instead constituted a 
monthly service fee for ``customization and management of provided 
applications'' as detailed on the billing form. Under our PE 
methodology, monthly service fees are a form of administrative expense, 
and payment for these costs is included as part of our indirect PE 
allocation. We did not use these invoices for pricing in CY 2019 and we 
are not using them for pricing in CY 2020, as they detail a form of 
indirect PE under our methodology. We also note that the equipment per-
minute cost formula includes maintenance costs, interest costs, and a 
useful life assumption; this formula already incorporates equipment 
costs that extend across multiple years. Taking a monthly service fee 
and multiplying it across 12 months and then again across 5 years, as 
the commenters suggested should take place for these invoices, would 
result in equipment costs that are inappropriately excessive, such as 
the $6 million equipment price detailed on these invoices. We will 
continue to price the INR analysis and reporting system at $19,325 and 
continue to transition towards this price over the remaining years of 
the phase-in period.
    After consideration of the public comments, we are finalizing the 
market-based supply and equipment pricing updates listed in Table 12, 
along with the additional finalized pricing changes detailed in the 
preceding paragraphs. 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 2020 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 2020, we noted that 
some stakeholders have submitted invoices for new, revised, or 
potentially misvalued codes after the February 10th deadline 
established for code valuation recommendations. To be included in a 
given year's proposed rule, we generally need to receive invoices by 
the same February 10th deadline we noted for consideration of RUC 
recommendations. However, we would consider invoices submitted as 
public comments during the comment period following the publication of 
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.
(3) 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 2020, we proposed to continue with the third year of 
the transition of this adjustment to the standard process for 
allocating indirect PE.
    We did not receive any public comments on the proposed adjustments 
to allocation of indirect PE for some office-based services. Therefore, 
we are finalizing the continuation of the third year of the transition 
as proposed.
e. Technical Evaluation 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 
part of this study, RAND will be convening a technical expert panel in 
late 2019 or early 2020 to obtain input from stakeholders including 
physicians, practice and health system managers, health care 
accountants, and health policy experts. The expert panel's 
recommendations will be discussed in a

[[Page 62606]]

report to be published by RAND in CY 2020.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that each service paid under 
the PFS be composed of three components: Work, PE, and malpractice (MP) 
expense. As required by section 1848(c)(2)(C)(iii) of the Act, 
beginning in CY 2000, MP RVUs are resource based. Section 
1848(c)(2)(B)(i) of the Act also requires that we review, and if 
necessary adjust, RVUs no less often than every 5 years. In the CY 2015 
PFS final rule with comment period (79 FR 67591 through 67596), we 
implemented the third review and update of MP RVUs. For a comprehensive 
discussion of the third review and update of MP RVUs, see the CY 2015 
PFS proposed rule (79 FR 40349 through 40355) and final rule with 
comment period (79 FR 67591 through 67596). In the CY 2018 PFS proposed 
rule (82 FR 33965 through 33970), we proposed to update the specialty-
level risk factors, used in the calculation of MP RVUs, prior to the 
next required 5 year update (CY 2020), using the updated MP premium 
data that were used in the eighth Geographic Practice Cost Index (GPCI) 
update for CY 2017; however the proposal was ultimately not finalized 
for CY 2018.
    We consider the following factors when we determine MP RVUs for 
individual PFS services: (1) Specialty-level risk factors derived from 
data on specialty-specific MP premiums incurred by practitioners; (2) 
service-level risk factors derived from Medicare claims data of the 
weighted average risk factors of the specialties that furnish each 
service; and (3) an intensity/complexity of service adjustment to the 
service-level risk factor based on either the higher of the work RVU or 
clinical labor portion of the direct PE RVU. Prior to CY 2016, MP RVUs 
were only updated once every 5 years, except in the case of new and 
revised codes.
    As explained in the CY 2011 PFS final rule with comment period (75 
FR 73208), MP RVUs for new and revised codes effective before the next 
5-year review of MP RVUs were determined either by a direct crosswalk 
from a similar source code or by a modified crosswalk to account for 
differences in work RVUs between the new/revised code and the source 
code. For the modified crosswalk approach, we adjusted (or scaled) the 
MP RVU for the new/revised code to reflect the difference in work RVU 
between the source code and the new/revised work RVU (or, if greater, 
the difference in the clinical labor portion of the fully implemented 
PE RVU) for the new code. For example, if the proposed work RVU for a 
revised code was 10 percent higher than the work RVU for its source 
code, the MP RVU for the revised code would be increased by 10 percent 
over the source code MP RVU. Under this approach, the same risk factor 
(RF) was applied for the new/revised code and source code, but the work 
RVU for the new/revised code was used to adjust the MP RVUs for risk.
    In the CY 2016 PFS final rule with comment period (80 FR 70906 
through 70910), we finalized a policy to begin conducting annual MP RVU 
updates to reflect changes in the mix of practitioners providing 
services (using Medicare claims data), and to adjust MP RVUs for risk 
for intensity and complexity (using the work RVU or clinical labor 
RVU). We also finalized a policy to modify the specialty mix assignment 
methodology (for both MP and PE RVU calculations) to use an average of 
the three most recent years of data instead of a single year of data. 
Under this approach, for new and revised codes, we generally assign a 
specialty-level risk factor to individual codes based on the same 
utilization assumptions we make regarding specialty mix we use for 
calculating PE RVUs and for PFS budget neutrality. We continue to use 
the work RVU or clinical labor RVU to adjust the MP RVU for each code 
for intensity and complexity. In finalizing this policy, we stated that 
the specialty-level risk factors would continue to be updated through 
notice and comment rulemaking every 5 years using updated premium data, 
but would remain unchanged between the 5-year reviews.
    Section 1848(e)(1)(C) of the Act requires us to review, and if 
necessary, adjust the GPCIs at least every 3 years. For CY 2020, we are 
conducting the statutorily required 3-year review of the GPCIs, which 
coincides with the statutorily required 5-year review of the MP RVUs. 
We note that the MP premium data used to update the MP GPCIs are the 
same data used to determine the specialty-level risk factors, which are 
used in the calculation of MP RVUs. Going forward, we believe it would 
be logical and efficient to align the update of MP premium data used to 
determine the MP RVUs with the update of the MP GPCIs. Therefore, we 
proposed to align the update of MP premium data with the update to the 
MP GPCIs, that is, we proposed to review, and if necessary update the 
MP RVUs at least every 3 years, similar to our review and update of the 
GPCIs. If we align the two updates, we would conduct the next 
statutorily-mandated review and update of both the GPCI and MP RVU for 
implementation in CY 2023. We proposed to implement the fourth 
comprehensive review and update of MP RVUs for CY 2020 and are seeking 
comment on these proposals.
    We received no specific comment regarding our proposal to align the 
update of MP premium data with the update to the MP GPCIs. That is, to 
review, and if necessary update the MP RVUs at least every 3 years, 
similar to our review and update of the GPCIs; therefore, we are 
finalizing as proposed.
2. Methodology for the Proposed Revision of Resource-Based Malpractice 
(MP) RVUs
a. General Discussion
    We calculated the proposed MP RVUs using updated MP premium data 
obtained from state insurance rate filings. The methodology used in 
calculating the proposed CY 2020 review and update of resource-based MP 
RVUs largely parallels the process used in the CY 2015 update; however, 
we proposed to incorporate several methodological refinements, which 
are described below. The MP RVU calculation requires us to obtain 
information on specialty-specific MP premiums that are linked to 
specific services, and using this information, we derive relative risk 
factors (RFs) for the various specialties that furnish a particular 
service. Because MP premiums vary by state and specialty, the MP 
premium information must be weighted geographically and by specialty. 
We calculated the proposed MP RVUs using four data sources: MP premium 
data presumed to be in effect as of December 31, 2017; CY 2018 Medicare 
payment and utilization data; higher of the CY 2020 proposed work RVUs 
or the clinical labor portion of the direct PE RVUs); and CY 2019 
GPCIs. We used the higher of the CY 2020 final work RVUs or clinical 
labor portion of the direct PE RVUs in our calculation to develop the 
CY 2020 final MP RVUs while maintaining overall PFS budget neutrality.
    Similar to the CY 2015 update, the proposed MP RVUs were calculated 
using specialty-specific MP premium data because they represent the 
expense incurred by practitioners to obtain MP insurance as reported by 
insurers. For CY 2020, the most current MP premium data available, with 
a presumed effective date of no later than December 31, 2017, were 
obtained from insurers with the largest market share in each

[[Page 62607]]

state. We identified insurers with the largest market share using the 
National Association of Insurance Commissioners (NAIC) market share 
report. This annual report provides state-level market share for 
entities that provide premium liability insurance (PLI) in a state. 
Premium data were downloaded from the System for Electronic Rates & 
Forms Filing Access Interface (SERFF) (accessed from the NAIC website) 
for participating states. For non-SERFF states, data were downloaded 
from the state-specific website (if available online) or obtained 
directly from the state's alternate access to filings. For SERFF states 
and non-SERFF states with online access to filings, the 2017 market 
share report was used to select companies. For non-SERFF states without 
online access to filings, the 2016 market share report was used to 
identify companies. These were the most current data available during 
the data collection and acquisition process.
    MP insurance premium data were collected from all 50 States, and 
the District of Columbia. Efforts were made to collect filings from 
Puerto Rico; however, no recent filings were submitted at the time of 
data collection, and therefore, filings from the previous update were 
used. Consistent with the CY 2015 update, no filings were collected for 
the other U.S. territories: American Samoa, Guam, Virgin Islands, or 
Northern Mariana Islands. MP premiums were collected for coverage 
limits of $1 million/$3 million, mature, claims-made policies (policies 
covering claims made, rather than those covering losses occurring, 
during the policy term). A $1 million/$3 million liability limit policy 
means that the most that would be paid on any claim is $1 million and 
the most that the policy would pay for claims over the timeframe of the 
policy is $3 million. Adjustments were made to the premium data to 
reflect mandatory surcharges for patient compensation funds (PCF, funds 
used to pay for any claim beyond the state's statutory amount, thereby 
limiting an individual physician's liability in cases of a large suit) 
in states where participation in such funds is mandatory.
    Premium data were included for all physician and nonphysician 
practitioner (NPP) specialties, and all risk classifications available 
in the collected rate filings. Although premium data were collected 
from all states, the District of Columbia, and previous filings for 
Puerto Rico were utilized, not all specialties had distinct premium 
data in the rate filings from all states. In previous updates, 
specialties for which premium data were not available for at least 35 
states, and specialties for which there were not distinct risk groups 
(surgical, non-surgical, and surgical with obstetrics) among premium 
data in the rate filings, were crosswalked to a similar specialty, 
either conceptually or based on available premium data. This resulted 
in not using those premium data because the 35 state threshold was not 
met. In the CY 2020 PFS proposed rule, we noted that the proposed 
methodological improvements discussed below expands the specialties and 
amount of filings data used to develop the proposed risk factors, which 
are used to develop the proposed MP RVUs.
b. Proposed Methodological Refinements
    For the CY 2020 update, we proposed the following methodological 
improvements to the development of MP premium data:
    (1) Downloading and using a broader set of filings from the largest 
market share insurers in each state, beyond those listed as 
``physician'' and ``surgeon'' to obtain a more comprehensive data set.
    We received public comments on the proposed methodological 
improvement to download and use a broader set of filings from the 
largest market share insurers in each state, beyond those listed as 
``physician'' and ``surgeon'' to obtain a more comprehensive data. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters noted appreciation for CMS' efforts to improve 
the premium data collection process and the opportunity to provide 
comments on the new methodology. Commenters were supportive of our 
proposed methodological refinement to download and use a broader set of 
filings from the largest market share insurers in each state, beyond 
those listed as ``physician'' and ``surgeon'' to obtain a more 
comprehensive data set.
    Response: We thank commenters for their feedback and support; we 
are finalizing as proposed.
    (2) Combining minor surgery and major surgery premiums to create 
the surgery service risk group, which yields a more representative 
surgical risk factor. In the previous update, only premiums for major 
surgery were used in developing the surgical risk factor.
    We received public comments on the proposed methodological 
improvement to combine minor surgery and major surgery premiums to 
create the surgery service risk group, which yields a more 
representative surgical risk factor. In the previous update, only 
premium data for major surgery were used in developing the surgical 
risk factor. The following is a summary of the comments we received and 
our responses.
    Comment: Commenters stated they appreciated that CMS considered 
methods to calculate surgical risk factors, but noted concerns with the 
method CMS used to classify surgeries as either minor or major, stating 
it was arbitrary and inconsistent with other CMS policy. Commenters 
further noted that the definition of minor surgeries and major 
surgeries should be consistent and developed with a consensus 
methodology among physician specialties. Commenters recommended that 
CMS work with the physician community to more accurately define major 
and minor surgeries.
    Response: We thank commenters for their appreciation of our work to 
calculate a more representative surgical risk factor. We note that we 
did not propose definitions for minor and major surgery and will 
continue to work with all interested stakeholders on our proposals.
    Comment: Commenters were not supportive of our proposal to 
categorize services between HCPCS 59000 and HCPCS 59899 as OB services 
and services between HCPCS 10000 and HCPCS 69999 (excluding the OB 
services) as surgical, with a physician work value greater than 5.00 as 
``major'' surgery, for the purpose of the analysis. Commenters noted 
that in doing so, CMS selected an arbitrary and misguided definition of 
``minor'' surgery for any code between the HCPCS 10000 and HCPCS 69999 
section of the CPT code book with a physician work value less than 
5.00. Commenters noted that if CMS intends to collect data at the minor 
vs major level, the data must reflect the different risk factors for 
those specialties and specifically be applied to codes defined as minor 
vs major surgery, and not broadly applied to an entire specialty. 
Commenters noted that the proposal could lead to an unfair valuation 
for certain specialties and services. The commenter further noted that 
CMS should hold off on moving to differentiating between minor and 
major surgeries until CMS is able to work with the RUC and impacted 
specialties to establish such definitions.
    Response: We reiterate that we did not propose to define minor 
surgery and major surgery. The proposal leveraged an existing policy 
(64 FR 59834), that categorized services within the surgical range of 
HCPCS codes (and the list of invasive cardiology services outside the 
surgical range) as surgical. Building upon that existing policy, we 
proposed a methodological improvement to

[[Page 62608]]

combine minor surgery and major surgery premiums when both were 
delineated in rate filings for a specialty and to set a threshold of a 
physician work RVU greater 5.00 to categorize surgical services as 
major surgery, (surgical services under 5.00 would be categorized as 
minor surgery) for the purpose of the analysis. The methodological 
improvement would have developed a more representative surgical risk 
factor by combining minor surgery and major surgery premiums. We 
further note that this would have produced more data to use in the 
analysis and enabled the analysis to reflect a more representative risk 
factor for specialties that could have been applied to the code level 
for services categorized as minor surgery or major surgery. We note 
that in previous updates only major surgery premium data were used 
(when both minor surgery and major surgery are delineated on the rate 
filings for a specialty) to develop the surgical risk factors, this was 
based on a physician work RVU threshold of greater than 5.0, but was 
based on rate filings that delineated major surgery for a specialty.
    In consideration of concerns from commenters, we are not finalizing 
our proposed methodological refinement to combine major surgery and 
minor surgery premiums when both are delineated on the rate filings for 
a specialty nor are we finalizing our proposal to use a physician work 
RVU greater than 5.00 as a threshold to categorize surgical services as 
major surgery (or to categorize surgical services under 5.00 as minor 
surgery), for the purpose of the analysis. Instead we are finalizing to 
maintain the current methodology and only use major surgery premium 
data when both minor surgery and major surgery are delineated in the 
rate filings for a specialty (minor surgery premium data are discarded 
in those cases) and to use minor surgery premium data when only minor 
surgery premium data are delineated in the rate filings for a 
specialty--to develop surgical risk factors. However, we note that the 
objective of our proposal was to develop a more representative surgical 
risk factor by refining our current methodology to allow for the use of 
rate filings data that delineated minor and major surgery. Our work to 
establish methods to categorize surgical services as minor and major 
surgery is ongoing, we look forward to working with and receiving 
feedback from stakeholders for consideration in future rulemaking.
    (3) Utilizing partial and total imputation to develop a more 
comprehensive data set when CMS specialty names are not distinctly 
identified in the insurer filings, which sometimes use unique specialty 
names.
    In instances where insurers report data for some (but not all) 
specialties that explicitly corresponded to a CMS specialty, where 
those data were missing, we proposed to use partial imputation based on 
available data to establish what the premiums would likely have been 
had that specialty been delineated in the filing. In instances where 
there were no data corresponding to a CMS specialty in the filing, we 
proposed to use total imputation to establish premiums.
    For example, if a specialty of Sleep Medicine is listed on some 
insurers' rate filings, this rate will be matched to the CMS specialty 
Sleep Medicine (C0)--partial imputation. However, if the Sleep Medicine 
specialty is not listed on the insurer's rate filing, under our 
proposed methodology, the insurer's rate filing for General Practice 
would be matched to the CMS specialty of Sleep Medicine (C0)--total 
imputation. In this example, we believe (consistent with the 
longstanding mappings of the regulatory impact table included in all 
PFS Federal Register notices) that the rate for General Practice is 
likely to be consistent with the rate that a Sleep Medicine provider 
would be charged by that insurer, this principle for mapping is used 
for the appropriate type of imputation. We note the proposed 
methodological improvement would mean that instead of discarding 
specialty-specific information from some insurers' filings because 
other insurers lacked that same level of detail, we would instead 
impute the missing rates at the insurer/specialty level to utilize as 
much of the information from the filings as possible.
    We solicited comment on these proposed methodological improvements. 
Additional technical details about our proposal are available in our 
interim report, ``Interim Report for the CY 2020 Update of GPCIs and MP 
RVUs for the Medicare Physician Fee Schedule,'' on our website. It is 
located under the supporting documents section for the CY 2020 PFS 
proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    We received public comments on the proposed methodological 
improvement to utilize partial and total imputation to develop a more 
comprehensive data set when CMS specialty names are not distinctly 
identified in the insurer filings, which sometimes use unique specialty 
names. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters disagreed with some of the proposed 
specialty mappings for partial and total imputation. Some of these 
commenters recommended that CMS use different mappings other than those 
that were proposed. A few commenters recommended that CMS publish 
impacts for all CMS specialties and not attempt to bundle or map 
specialties to what CMS believes are related specialties or 
professions.
    Response: We note that the MP RVU calculation requires us to obtain 
information on specialty-specific MP premiums that are linked to 
specific services, and using this information, we derive relative risk 
factors for the various specialties that furnish a particular service. 
We reiterate that the proposed mappings for partial imputation parallel 
the longstanding mappings of the regulatory impact table included in 
all PFS Federal Register notices that group CMS specialties (present on 
Medicare claims) into clusters of related specialties (impact 
specialties) when CMS examines the potential impact of PFS payment 
policies on the distribution of payments by providers. This table is 
included in section VII. of this final rule, the Regulatory Impact 
Analysis.
    Furthermore, the proposed mappings for total imputation (when a CMS 
specialty name is not listed on the insurer's rate filing) reflect the 
speciality-specifc relationship of the underlying principle to identify 
the premium that an individual in a specialty would have been charged. 
The proposed mappings for total imputation, specifically for NPP 
specialties, parallel the proposal to crosswalk NPP specialties for 
which we do not have sufficient comparable professional liability data, 
to the lowest physician specialty, which was found to be allergy/
immunology.
    We note that partial and total imputation are necessary to expand 
the specialty specific filings data used to develop the proposed risk 
factors, which are used to develop the proposed MP RVUs. This 
improvement resulted in the development of a more comprehensive data 
set, when CMS specialty names were not distinctly identified in the 
insurer filings, which sometimes use unique specialty names; we are 
finalizing as proposed.
    Comment: A commenter noted that they joined the RUC in urging CMS 
to collect premium data for specialties that are missing data or where 
data are not available, and in the meantime, to work

[[Page 62609]]

with the RUC to better identify appropriate crosswalks.
    Response: We reiterate that we have, and will continue to work with 
the RUC and all interested stakeholders to improve the premium data 
collection. Moreover, we continue to make progress in this area as 
evidenced in the CY 2020 PFS proposed rule (84 FR 40506), where we 
determined that there were sufficient data for surgery and non-surgery 
premiums, as well as sufficient differences in rates between classes 
for 15 specialties, there were 10 such specialties in the CY 2015 
update.
    Comment: Commenters recommended that CMS utilize any and all 
premium data available to determine accurate crosswalks for specialties 
that cannot be directly matched to one of CMS' specialty names.
    Response: We reiterate that we use all of the premium data 
collected to match CMS specialties to the rate that a provider in the 
specialty would have been charged under each filing, even though PLI 
insurers use their own distinctive specialty names.
    Comment: One commenter recommended that CMS map RFs for cardiac 
electrophysiology to the risk factor for cardiology (surgery) and 
cardiology (no surgery). The commenter noted that they did not 
understand the rationale that CMS applied to determine that the RF 
should be set at 1.89 and ask CMS to detail how it arrived at that 
recommended RF. One commenter noted that electrophysiology is a 
distinct specialty of cardiology, with eligibility for board 
certification in clinical cardiac electrophysiology through the 
American Board of Internal Medicine, as well as in cardiology. Several 
commenters noted that cardiac electrophysiology is a relatively small 
specialty that may not clearly show in premium data. These commenters 
further noted that it would not make sense for services like pacemaker 
implantation that includes placing transvenous wires inside the heart 
or catheter ablations to treat cardiac arrhythmias inside the heart to 
receive a non-surgical PLI risk factor. Several commenters noted that 
cardiac electrophysiology currently has a surgery and non-surgery risk 
factor.
    Response: We reiterate that details on the data sources and the 
methodological approach used to develop RFs are detailed in the CY 2020 
PFS proposed rule (84 FR 40504) and the interim report for the CY 2020 
Update of GPCIs and MP RVUs for the Medicare PFS. We also remind 
stakeholders that we are using updated premium data as reported in the 
SERFF for participating states and downloaded from the state-specific 
website for non-SERFF states or obtained directly from the state's 
alternate access to filings to develop RFs. We were able to collect 
more data, and use those data to develop specialty-specific RFs for 
specialties that were previously entirely mapped to a different 
specialty out of necessity, because we did not have sufficient data. 
Therefore, we create a specialty-specific RF based on the distinct data 
of each specialty, as reflected in the rate filings, when sufficient. 
Thus, the RFs may be considerably different from the previous update, 
as a result of utilizing the specialty's own data and not that of a 
crosswalk to another specialty as was the case for cardiac 
electrophysiology in the proposed rule. Using these data, as reflected 
in the filings, more accurately reflects premiums associated with the 
specialty.
    We appreciate the additional information provided by the commenters 
as to why cardiac electrophysiology should remain mapped to the RF for 
cardiology (surgery) and cardiology (no surgery). Upon additional 
review of the additional information provided by commenters, we are not 
finalizing our proposal to map cardiac electrophysiology to a RF of 
1.89, and instead we are finalizing the mapping of RFs for cardiac 
electrophysiology to the risk factor for cardiology (surgery) and 
cardiology (no surgery).
    Comment: One commenter stated that while the proposal maintains 
CMS' established policy of applying the cardiology surgical risk factor 
to the procedures identified in Table 15 of the CY 2015 PFS proposed 
rule (79 FR 40353 through 40354), it is inconsistent with the CY 2015 
PFS final rule, wherein CMS finalized that the cardiology surgical risk 
factor would apply to a list of procedures (classified as injection 
procedures used in conjunction with cardiac catheterization) that are 
outside the code range that CMS considered surgical. This same 
commenter stated they are concerned that the proposal to have fewer 
subgroups for cardiac electrophysiology inadvertently undervalues many 
cardiology surgical procedures on the basis of subspecialty mix 
performing the procedure, rather than valuing the procedure on its 
surgical status.
    Response: We believe the commenter may have misinterpreted both the 
CY 2015 PFS proposed rule (79 FR 40353) and CY 2015 PFS final rule (79 
FR 67595), which led to a subsequently misinterpreting what CMS 
proposed to maintain in the CY 2020 PFS proposed rule (84 FR 40504). In 
CY 2015, we finalized a policy to classify invasive cardiology services 
(cardiac catheterizations and angioplasties) that are outside of the 
surgical HCPCS code range as surgery for purposes of assigning 
specialty-specific risk factors, and to apply the higher cardiology 
surgical risk factor to the list of codes outside of the surgical HCPCS 
code range, when those services are performed by providers with a 
specialty of cardiology. To that end, this is not to imply that we 
apply the higher cardiology surgical risk factor to the cardiology 
services that are outside the surgical code range regardless of the 
provider specialty performing those services, as indicated by the 
commenter. We note that the higher surgical risk factor is applied to 
the list of codes outside of the surgical HCPCS code range only when 
performed by a provider with a specialty of cardiology.
    We reiterate, we calculate service level risk factors based on the 
mix of specialties that furnish a given service as indicated by 
Medicare claims data. Medicare claims data reflect the service volume 
by Medicare primary specialty designations. For CY 2020, we continue to 
classify services that are outside of the surgical HCPCS code range as 
surgery for purposes of assigning specialty-specific risk factors, and 
when furnished by providers with cardiology as the Medicare primary 
specialty code on the Medicare claim, apply the higher cardiology 
surgical risk factor.
    Comment: One commenter expressed concern with the statement that 
cardiac electrophysiology is not typically associated with the number 
and mix of surgical services of other surgical specialties. The 
commenter further noted that cardiac electrophysiology accounts for 
about 75 percent of the utilization, on average, across the cardiac 
ablation codes, with the specialty of cardiology accounting for most of 
the remainder.
    Response: We note that the statement ``cardiac electrophysiology is 
not typically associated with the number and mix of surgical services 
of cardiologists'' was not made to imply that providers with a 
specialty of cardiac electrophysiology do not perform surgical 
procedures. We acknowledge that providers with the specialty of cardiac 
electrophysiology perform surgical procedures, as evidenced by our 
classification of codes outside of the surgical HCPCS code range as 
surgery for purposes of assigning specialty-specific risk factors, 
which are performed by providers with specialty of cardiac 
electrophysiology and other specialties.

[[Page 62610]]

    Furthermore, in the case of the list of invasive cardiology 
services, classified as surgery for purposes of assigning service level 
risk factors, we note that the percentage of allowed services 
attributed to cardiology decreased for some of these service codes 
while the percentage of allowed services furnished by other specialties 
with risk factors lower than cardiology, such as cardiac physiology, 
increased.
    Additionally, we received several general comments related to the 
proposed methodological refinements.
    Comment: One commenter noted appreciation for CMS' attempt to 
improve the premium data collection process, stating that the Agency 
was successful in acquiring national premium data for 16 specialties 
that were formerly mapped entirely to another specialty, and that there 
is no longer a mention of the arbitrary 35 state threshold used in the 
previous update that triggered the CMS crosswalk methodology used to 
develop PLI RVUs for specialties for which there was not premium data 
for at least 35 states.
    Response: We note that implementation of the methodological 
refinements noted above, no longer necessitated the 35 state threshold.
    Comment: One commenter noted concerns about the percentage of 
market share premium data that was collected for Connecticut and 
Massachusetts, noting that only 30 percent of market share data were 
collected in that locality, even though Connecticut has relatively high 
PLI premiums, when compared to the rest of the country.
    Response: As detailed in the ``Final Report for the CY 2020 Update 
of GPCIs and MP RVUs for the Medicare PFS'', which is available on the 
CMS website under the downloads section of the CY 2020 PFS final rule 
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html medical professional liability insurance 
is issued at maximum coverage limits. Premiums were collected for 
coverage limits of $1 million per occurrence and $3 million aggregate. 
States with Patient Compensation Funds may have different coverage 
limits, which we accounted for, as noted in the aforementioned final 
report. Although data collection for a state may not have met the 
threshold of collecting filings until either cumulative market share 
met or exceeded 50 percent or filings had been collected for four 
groups or companies, it does not imply that premiums were collected for 
coverage limits below $1 million per occurrence and $3 million 
aggregate.
    We note that the market share filings for Connecticut met the 
threshold, because we collected data for four groups. In the case of 
Massachusetts, this is a non-SERFF state, so we were limited to the 
amount of data provided by the state in response to our request to the 
state for these data; we have revised Table 7.A in the final report to 
easily identify non-SERFF states.
    Additionally, in our review of the findings reported in Table 7.A 
in the final report, we recognized the need for additional 
clarification for two states. We clarify that data collection for New 
York State did not meet either threshold, because some of the filings 
collected were incomplete and unusable, leaving data for three groups, 
accounting for 32 percent remaining for the market share analysis. In 
the case of Rhode Island, we identified a typographical error in the 
chart, which has been fixed.
    Comment: Several commenters noted concerns with the data displayed 
in Table 8.B Volume-weighted Distribution of 2017 Physician Work RVUs 
by Service Type by CMS Specialty the final report.
    Response: We thank commenters for noting their concerns. These data 
display the share of total work RVUs by service risk group used when 
combining or splitting premiums across service risk groups as reported 
by specialties on rate filings to match the final set of specialty/
service risk groups used in the analysis. The data displayed in that 
table are solely for the purposes of the analysis. In consideration of 
the comments we received, we have provided additional details on the 
calculations in the ``Final Report for the CY 2020 Update of GPCIs and 
MP RVUs for the Medicare PFS'', which is available on the CMS website 
under the downloads section of the CY 2020 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Additionally, the table has been revised 
to reflect that we are not finalizing our proposed methodological 
refinement to combine minor and major surgery premiums when both are 
present in the filings for a specialty.
c. Steps for Calculating Malpractice RVUs
    Calculation of the proposed MP RVUs conceptually follows the 
specialty-weighted approach used in the CY 2015 PFS final rule with 
comment period (79 FR 67591), along with the above proposed 
methodological improvements. The specialty-weighted approach bases the 
MP RVUs for a given service on a weighted average of the risk factors 
of all specialties furnishing the service. This approach ensures that 
all specialties furnishing a given service are reflected in the 
calculation of the MP RVUs. The steps for calculating the proposed MP 
RVUs are described below. We note that not all of the proposed 
methodological refinements are being finalized, and therefore, some of 
steps for calculating malpractice RVUs differ from the proposal.
    Step (1): Compute a preliminary national average premium for each 
specialty.
    Insurance rating area MP premiums for each specialty are mapped to 
the county level. The specialty premium for each county is then 
multiplied by its share of the total U.S. population (from the U.S. 
Census Bureau's 2013-2017 American Community Survey (ACS) 5-year 
estimates). This is in contrast to the method used for creating 
national average premiums for each specialty in the 2015 update; in 
that update, specialty premiums were weighted by the total RVU per 
county, rather than by the county share of the total U.S. population. 
We refer readers to the CY 2016 PFS final rule with comment period (80 
FR 70909) for a discussion of why we have adopted a weighting method 
based on share of total U.S. population. This calculation is then 
divided by the average MP GPCI across all counties for each specialty 
to yield a normalized national average premium for each specialty. The 
specialty premiums are normalized for geographic variation so that the 
locality cost differences (as reflected by the 2019 GPCIs) would not be 
counted twice. Without the geographic variation adjustment, the cost 
differences among fee schedule areas would be reflected once under the 
methodology used to calculate the MP RVUs and again when computing the 
service specific payment amount for a given fee schedule area.
    Step (2): Determine which premium service risk groups to use within 
each specialty.
    Some specialties had premium rates that differed for surgery, 
surgery with obstetrics, and non-surgery. These premium classes are 
designed to reflect differences in risk of professional liability and 
the cost of MP claims if they occur. To account for the presence of 
different classes in the MP premium data and the task of mapping these 
premiums to procedures, we calculated distinct risk factors for 
surgical, surgical with obstetrics, and nonsurgical procedures where 
applicable. However, the availability of data by surgery and non-
surgery varied across specialties. Historically, no single approach 
accurately addressed the variability in premium class among 
specialties, and we previously employed several

[[Page 62611]]

methods for calculating average premiums by specialty. These methods 
are discussed below.
    Developing Distinct Service Risk Groups: We determined that there 
were sufficient data for surgery and non-surgery premiums, as well as 
sufficient differences in rates between classes for 15 specialties 
(there were 10 such specialties in the CY 2015 update). These 
specialties are listed in Table 13. Additionally, as described in the 
proposed methodological refinements, in some instances, we combined 
minor surgery and major surgery premiums to create a premium to develop 
the surgery service risk group, rather than discard minor surgery 
premium data as was done in the previous update. We note that we are 
not finalizing the proposed methodological change to combine minor 
surgery and major surgery premium data when both are delineated the 
rate filings for a specialty. For all other specialties (those that are 
not listed in Table 13) that typically do not distinguish premiums as 
described above, a single risk factor was calculated, and that 
specialty risk factor was applied to all services performed by those 
specialties.
    This is consistent with prior practice; however, we have refined 
the nomenclature to more precisely describe that some specialties are 
delineated into service risk groups, as is the case for surgical, non-
surgical, and surgical with obstetrics, and some specialties are not 
further delineated into service risk subgroups and are instead referred 
to as ``All''--meaning that all services performed by that specialty 
receive the same risk factor. 
[GRAPHIC] [TIFF OMITTED] TR15NO19.018

    Step (3): Calculate a risk factor for each specialty.
    The relative differences in national average premiums between 
specialties are expressed in our methodology as a specialty-level risk 
factor. These risk factors are calculated by dividing the national 
average premium for each specialty by the national average premium for 
the specialty with the lowest premiums for which we had sufficient and 
reliable data, which remains allergy and immunology (03). For 
specialties with rate filings that are indicative of sufficient 
surgical and non-surgical premium data, we recognized those service-
risk groups (that is, surgical, and non-surgical) as risk groups of the 
specialty and we calculated both a surgical and non-surgical risk 
factor. Similarly, for specialties with rate filings that distinguished 
surgical premiums with obstetrics, we recognized that service-risk 
subgroup of the specialty and calculated a separate surgical with 
obstetrics risk factor.
(a) Technical Component (TC) Only Services
    We note that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for 
independent diagnostic testing facilities (IDTFs) that we used in the 
CY 2010 update. Those data were obtained from a survey conducted by the 
Radiology Business Management Association (RBMA) in 2009; we ultimately 
used those data to calculate an updated TC specialty risk factor. We 
applied the updated TC specialty risk factor to suppliers of TC-only 
services. In the CY 2015 PFS final rule with comment period (79 FR 
67595), RBMA voluntarily submitted updated MP premium information 
collected from IDTFs in 2014, and requested that we use those data to 
calculate the CY 2015 MP RVUs for TC-only services. We declined to 
utilize those data and stated that we believe further study is 
necessary and we would consider this matter and propose any changes 
through future rulemaking. We continue to believe that data for a 
broader set of TC-only services are needed, and are working to acquire 
a broader set of data.
    For CY 2020, we proposed to assign a risk factor of 1.00 for TC-
only services, which corresponds to the lowest physician specialty-
level risk factor. We assigned the risk factor of 1.00 to the TC-only 
services because we do not have sufficient comparable professional 
liability premium data for the full range of clinicians that furnish 
TC-only services. In lieu of comprehensive, comparable data, we propose 
to assign 1.00, the lowest physician specialty-level risk factor 
calculated using the updated premium data, as the default minimum risk 
factor. However, we seek information on the most comparable and 
appropriate proxy for the broader set of TC-only services for future 
use, as well as any empirical information that would support assignment 
of an alternative risk factor for these services.
    Table 14 shows the risk factors by specialty type and service risk 
group.
BILLING CODE 4120-01-P

[[Page 62612]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.019


[[Page 62613]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.020

BILLING CODE 4120-01-C
    We received public comments on the steps for calculating MP RVUs. 
The following is a summary of the comments we received and our 
responses.
    Comment: Commenters disagreed with our proposal to assign a risk 
factor of 1.00, which is the risk factor of the lowest physician 
specialty, to TC-only services because of insufficient comparable 
professional liability premium data for the full range of health 
professionals that furnish TC-only services. The commenters recommended 
retaining the current RF for TC-only services until comprehensive data 
is acquired rather

[[Page 62614]]

than assigning the lowest physician specialty-level risk factor to 
these services. Commenters noted that we should continue to work with 
stakeholders to obtain these data.
    Response: We reiterate that we have, and will continue to work in 
collaboration with all interested stakeholders to find sufficient 
comparable professional liability data for the full range of clinicians 
that furnish TC-only services. In general, we continue to make progress 
in acquiring premium data as evidenced by the fact that for the CY 2020 
update we collected service-specific premium data for an increasing 
number of specialties, as compared to the CY 2015 update. We note that 
the current RF for TC-only services is 0.91. Although we were able to 
find some data for health professionals that furnish TC-only services, 
we were unable to find sufficient comparable professional liability 
premium data for the full range of health professionals that furnish 
TC-only services. We are finalizing our proposal to assign a RF of 
1.00, which is the RF of the lowest physician specialty (allergy/
immunology), to TC-only services.
    Comment: Commenters noted that consistent with the previous update 
CMS continued to assign the RF of the lowest physician specialty to 
NPPs for which there were insufficient or no premium data. We received 
contrasting comments on this proposal. For instance, one commenter was 
supportive of our proposal to continue assigning the risk factor of the 
lowest physician specialty to NPPs for which CMS was unable to collect 
sufficient data. In contrast, a few commenters, including the RUC, 
stated that CMS should not crosswalk NPPs to the lowest physician 
specialty, which is allergy and immunology, and to continue to 
aggressively collect premium data on NPPs.
    Response: Our efforts to improve the premium data collection for 
NPPs is ongoing. We have made progress in acquiring premium data as 
evidenced by the fact that for the CY 2020 update we collected service-
specific premium data for an increasing number of specialties, as 
compared to the CY 2015 update, including some NPP specialties, for 
which we previously did not have data that were mapped entirely to 
another specialty. Although we were able to find data for several NPPs 
for which we previously did not have data, we were unable to find 
premium data for the full range of NPPs. Premium data collection for 
NPPs is ongoing and will continue ahead of the next MP RVU update. We 
are finalizing a policy to maintain the current assignment of a RF of 
1.00 for NPP specialties, which corresponds to the lowest physician 
specialty RF, allergy and immunology.
    Comment: One commenter stated that an alternate option to 
crosswalking NPPs to the lowest physician risk factor of allergy and 
immunology would be to assign them the RF of another NPP specialty for 
which CMS was able to obtain data, the commenter recommended optometry.
    Response: We reiterate that our proposal was to maintain the 
crosswalk of NPPs for which we had insufficient or no premium data to 
the lowest physician specialty, not to crosswalk NPPs to the RF of a 
NPP for which we were able to collect data. At this time, because we 
were unable to find premium data for the full range of NPPs, we do not 
believe it is appropriate, as suggested by commenters, to assign all 
NPPs for which we had insufficient or no premium data to the RF of 
optometry, another NPP specialty for which we were able to find some 
data. We reiterate that CMS' efforts to improve the premium data 
collection for all NPP specialties is ongoing and will continue ahead 
of the next MP RVU update.
    Comment: One commenter suggested that the Agency assign codes 
performed predominantly by the select NPPs a 0.00 PLI as their premiums 
are so inconsequential that even a 0.01 PLI overcompensate them for 
their minimal PLI premiums.
    Response: We disagree that NPPs should be assigned a 0.00 PLI and 
moreover, we disagree that even a 0.01 PLI overcompensate them for 
their minimal PLI premiums. This incorrectly implies that there is zero 
risk for NPPs to provide medical services. We reiterate that although 
we were able to find data for several NPP specialties for which we 
previously did not have data, we were unable to find premium data for 
the full range of NPP specialties. Premium data collection for NPP 
specialties is ongoing and will continue ahead of the next update.
    Comment: One commenter noted that they previously referenced an 
insurance carrier, Health Providers Service Organization (HPSO) 
(www.hpso.com), as a source of potential premium data for most NPPs. 
This same commenter provided PLI premium data for several NPPs for a 
single state from this source, which ranged from $153 to $1,008.
    Response: We thank the commenter for their feedback and potential 
data source, as CMS continues efforts to collect premium data on the 
full range of NPP specialties ahead of the next MP RVU update.
    Step (4): Calculate MP RVUs for each CPT/HCPCS code.
    Resource-based MP RVUs were calculated for each CPT/HCPCS code that 
has work or PE RVUs. The first step was to identify the percentage of 
services furnished by each specialty for each respective CPT/HCPCS 
code. This percentage was then multiplied by each respective 
specialty's risk factor as calculated in Step 3. The products for all 
specialties for the CPT/HCPCS code were then added together, yielding a 
specialty-weighted service specific risk factor reflecting the weighted 
MP costs across all specialties furnishing that procedure. The service 
specific risk factor was multiplied by the greater of the work RVU or 
clinical labor portion of the direct PE RVU for that service, to 
reflect differences in the complexity and risk-of-service between 
services.
    Low volume service codes: As we discussed above in this final rule, 
for low volume services code, we finalized the proposal in the CY 2018 
PFS final rule (82 FR 53000 through 53006) to apply the list of 
expected specialties instead of the claims-based specialty mix for low 
volume services to address stakeholder concerns about the year to year 
variability in PE and MP RVUs for low volume services (which also 
includes no volume services); these are defined as codes that have 100 
allowed services or fewer. These service-level overrides are used to 
determine the specialty for low volume procedures for both PE and MP.
    In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also 
finalized our proposal to eliminate general use of an MP-specific 
specialty-mix crosswalk for new and revised codes. However, we 
indicated that we would continue to consider, in conjunction with 
annual recommendations, specific recommendations regarding specialty 
mix assignments for new and revised codes, particularly in cases where 
coding changes are expected to result in differential reporting of 
services by specialty, or where the new or revised code is expected to 
be low-volume. Absent such information, the specialty mix assumption 
for a new or revised code would derive from the analytic crosswalk in 
the first year, followed by the introduction of actual claims data, 
which is consistent with our approach for developing PE RVUs.
    For CY 2020, we solicited public comment on the list of expected 
specialties. We also noted that the list has been updated to include a 
column indicating if a service is identified as a low volume service 
for CY 2020, and therefore, whether or not the service-level override 
is being applied for CY

[[Page 62615]]

2020. The proposed list of codes and expected specialties is available 
on our website under downloads for the CY 2020 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We received public comments on the proposed updates to the expected 
specialty list for low volume services. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters stated that CMS had indicated that the 
expected specialty list would be updated to include a column specifying 
if a service was identified as a low volume service for CY 2020, 
indicating if the service-level override was being applied for CY 2020. 
However, commenters noted that this additional column did not appear in 
the download version and asked for additional information.
    Response: We thank the commenters for identifying this missing 
information and we apologize for the technical oversight that caused 
this information not to be displayed for the proposed rule. We are 
finalizing a policy to include this additional column in the public use 
files released with the final rule. Additional comments on the proposed 
updates to the expected specialty list have been addressed in section 
II.B. of this final rule.
    Step (5): Rescale for budget neutrality.
    The statute requires that changes to fee schedule RVUs must be 
budget neutral. Thus, the last step is to adjust for relativity by 
rescaling the proposed MP RVUs so that the total proposed resource 
based MP RVUs are equal to the total current resource based MP RVUs 
scaled by the ratio of the pools of the proposed and current MP and 
work RVUs. This scaling is necessary to maintain the work RVUs for 
individual services from year to year while also maintaining the 
overall relationship among work, PE, and MP RVUs.
    Specialties Excluded from Ratesetting Calculation: In section II.B. 
of this final rule, Determination of Practice Expense Relative Value 
Units, we discuss specialties that are excluded from ratesetting for 
the purposes of calculating PE RVUs. We proposed to treat those 
excluded specialties in a consistent manner for the purposes of 
calculating MP RVUs. We note that all specialties are included for 
purposes of calculating the final BN adjustment. The list of 
specialties excluded from the ratesetting calculation for the purpose 
of calculating the PE RVUs that we proposed to also exclude for the 
purpose of calculating MP RVUs is available in section II.B. of this 
final rule, Determination of Practice Expense Relative Value Units. The 
resource-based MP RVUs are shown in Addendum B, which is available on 
the CMS website under the downloads section of the CY 2020 PFS rule at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    Because a different share of the resources involved in furnishing 
PFS services is reflected in each of the three fee schedule components, 
implementation of the resource-based MP RVU update will have much 
smaller payment effects than implementing updates of resource-based 
work RVUs and resource-based PE RVUs. On average, work represents about 
50.9 percent of payment for a service under the fee schedule, PE about 
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change 
in PE RVUs or work RVUs for a service would result in a change in 
payment of about 11 to 13 percent. In contrast, a corresponding 25 
percent change in MP values for a service would yield a change in 
payment of only about 1 percent. Estimates of the effects on payment by 
specialty type is detailed in section VII. of this final rule, the 
Regulatory Impact Analysis.
    We received no specific comments regarding our proposal to treat 
excluded specialties in a consistent manner for the purposes of 
calculating MP RVUs, we are finalizing as proposed.
    Additional information on our methodology for updating the MP RVUs 
is available in the ``Final Report for the CY 2020 Update of GPCIs and 
MP RVUs for the Medicare Physician Fee Schedule,'' which is available 
on the CMS website under the downloads section of the CY 2020 PFS final 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    After consideration of the comments, we are finalizing the CY 2020 
update as proposed with minor modifications, as indicated above. We are 
finalizing our proposal to download and use a broader set of filings 
from the largest market share insurers in each state, beyond those 
listed as ``physician'' and ``surgeon'' to obtain a more comprehensive 
data set. We are not finalizing our proposal to combine minor and major 
surgery premiums when both are delineated on rate filings for a 
specialty nor are we finalizing our proposal to use a physician work 
RVU of greater than 5.00, as a threshold to identify surgical services 
as major surgery (or to categorize surgical services under 5.00 as 
minor surgery). Instead, we are finalizing a policy to develop RFs by 
maintaining the current methodology to only use major surgery premium 
data when both minor surgery and major surgery are delineated on rate 
filings for a specialty, and to use the minor surgery premium data when 
it is the only premium type in the rate filings for a specialty. We are 
finalizing a policy to map risk factors for cardiac electrophysiology 
to the risk factor for cardiology (surgery) and cardiology (no 
surgery). We are finalizing our proposal to assign the RF of the lowest 
physician specialty (allergy/immunology) to TC-only services, which is 
a RF of 1.00. We are finalizing a policy to maintain assigning the 
current RF of the lowest physician specialty (allergy/immunology), 
which is a RF of 1.00 to NPP specialties. We are finalizing our 
proposal to include an additional column on the anticipated low volume 
specialty list which specifies if a service was identified as a low 
volume service for CY 2020, indicating if the service-level override 
was being applied for CY 2020. We are finalizing our proposal to treat 
excluded specialties in a consistent manner for the purposes of 
calculating MP RVUs.

D. Geographic Practice Cost Indices (GPCIs)

1. Background
    Section 1848(e)(1)(A) of the Act requires us to develop separate 
Geographic Practice Cost Indices (GPCIs) to measure relative cost 
differences among localities compared to the national average for each 
of the three fee schedule components (that is, work, practice expense 
(PE), and malpractice (MP)). We discuss the localities established 
under the PFS below in this section. Although the statute requires that 
the PE and MP GPCIs reflect full relative cost differences, section 
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only 
one-quarter of the relative cost differences compared to the national 
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 
1.5 work GPCI floor for services furnished in Alaska beginning January 
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE 
GPCI floor for services furnished in frontier states (as defined in 
section 1848(e)(1)(I) of the Act) beginning January 1, 2011. 
Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor 
for the work GPCIs, which was set to expire at the end of 2017. Section 
50201 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
123,

[[Page 62616]]

enacted February 9, 2018) amended the statute to extend the 1.0 floor 
for the work GPCIs through CY 2019 (that is, for services furnished no 
later than December 31, 2019).
    Section 1848(e)(1)(C) of the Act requires us to review and, if 
necessary, adjust the GPCIs at least every 3 years. Section 
1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed 
since the date of the last previous GPCI adjustment, the adjustment to 
be applied in the first year of the next adjustment shall be \1/2\ of 
the adjustment that otherwise would be made. Therefore, since the 
previous GPCI update was implemented in CYs 2017 and 2018, we proposed 
to phase in \1/2\ of the latest GPCI adjustment in CY 2020.
    We have completed a review of the GPCIs and are finalizing new 
GPCIs in this final rule. We also calculate a geographic adjustment 
factor (GAF) for each PFS locality. The GAFs are a weighted composite 
of each PFS locality's work, PE and MP expense GPCIs using the national 
GPCI cost share weights. While we do not actually use GAFs in computing 
the fee schedule payment for a specific service, they are useful in 
comparing overall areas costs and payments. The actual effect on 
payment for any actual service would deviate from the GAF to the extent 
that the proportions of work, PE and MP RVUs for the service differ 
from those of the GAF.
    As noted above, section 50201 of the BBA of 2018 extended the 1.0 
work GPCI floor for services furnished only through December 31, 2019. 
Therefore, the final CY 2020 work GPCIs and summarized GAFs do not 
reflect the 1.0 work floor. However, as required by sections 
1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor for Alaska 
and the 1.0 PE GPCI floor for frontier states are permanent, and 
therefore, applicable in CY 2020. See Addenda D and E to this final 
rule for the CY 2020 final GPCIs and summarized GAFs available on the 
CMS website under the supporting documents section of the CY 2020 PFS 
final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Payment Locality Background
    Prior to 1992, Medicare payments for physicians' services were made 
under the reasonable charge system. Payments under this system largely 
reflected the charging patterns of physicians, which resulted in large 
differences in payment for physicians' services among types of 
services, physician specialties and geographic payment areas.
    Local Medicare carriers initially established 210 payment 
localities, to reflect local physician charging patterns and economic 
conditions. These localities changed little between the inception of 
Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we 
undertook a study that culminated in a comprehensive locality revision 
(based on locality resource cost differences as reflected by the GPCIs) 
that we implemented in 1997. The development of the current locality 
structure is described in detail in the CY 1997 PFS final rule (61 FR 
34615) and the subsequent final rule with comment period (61 FR 59494). 
The revised locality structure reduced the number of localities from 
210 to 89, and increased the number of statewide localities from 22 to 
34.
    Section 220(h) of the Protecting Access to Medicare Act (PAMA) 
(Pub. L. 113-93, enacted April 1, 2014) required modifications to the 
payment localities in California for payment purposes beginning with 
2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through 
80268) we established 23 additional localities, increasing the total 
number of PFS localities from 89 to 112. The current 112 payment 
localities include 34 statewide areas (that is, only one locality for 
the entire state) and 75 localities in the other 16 states, with 10 
states having two localities, two states having three localities, one 
state having four localities, and three states having five or more 
localities. The remainder of the 112 PFS payment localities are 
comprised as follows: the combined District of Columbia, Maryland, and 
Virginia suburbs; Puerto Rico; and the Virgin Islands. We note that the 
localities generally represent a grouping of one or more constituent 
counties.
    The current 112 fee schedule areas, also referred to as payment 
localities, are defined alternatively by state boundaries (statewide 
areas for example, Wisconsin), metropolitan areas (for example, 
Metropolitan St. Louis, MO), portions of a metropolitan area (for 
example, Manhattan), or rest-of-state areas that exclude metropolitan 
areas (for example, Rest of Missouri). This locality configuration is 
used to calculate the GPCIs that are in turn used to calculate locality 
adjusted payments for physicians' services under the PFS.
    As stated in the CY 2011 PFS final rule with comment period (75 FR 
73261), changes to the PFS locality structure would generally result in 
changes that are budget neutral within a state. For many years, before 
making any locality changes, we have sought consensus from among the 
professionals whose payments would be affected. We refer readers to the 
CY 2014 PFS final rule with comment period (78 FR 74384 through 74386) 
for further discussion regarding additional information about locality 
configuration considerations.
3. GPCI Update
    As required by the statute, we developed GPCIs to measure relative 
cost differences among payment localities compared to the national 
average for each of the three fee schedule components (that is, work, 
PE, and MP). We describe the data sources and methodologies we use to 
calculate each of the three GPCIs below in this section. Additional 
information on the CY 2020 GPCI update is available in a final report, 
``Final Report for the CY 2020 Update of GPCIs and MP RVUs for the 
Medicare PFS,'' on our website located under the supporting documents 
section for the CY 2020 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
a. Work GPCIs
    The work GPCIs are designed to reflect the relative cost of 
physician labor by Medicare PFS locality. As required by statute, the 
work GPCI reflects one quarter of the relative wage differences for 
each locality compared to the national average.
    To calculate the work GPCIs, we use wage data for seven 
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to 
the national average, as a proxy for physicians' wages. Physicians' 
wages are not included in the occupation categories used in calculating 
the work GPCI because Medicare payments are a key determinant of 
physicians' earnings. Including physician wage data in calculating the 
work GPCIs would potentially introduce some circularity to the 
adjustment since Medicare payments typically contribute to or influence 
physician wages. That is, including physicians' wages in the physician 
work GPCIs would, in effect, make the indices, to some extent, 
dependent upon Medicare payments.
    The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based 
on professional earnings data from the 2000 Census. However, for the CY 
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage 
and earnings data were not available from the more recent Census 
because the ``long form'' was discontinued. Therefore, we used the 
median hourly earnings from the 2006 through 2008 Bureau of Labor 
Statistics (BLS) Occupational

[[Page 62617]]

Employment Statistics (OES) wage data as a replacement for the 2000 
Census data. The BLS OES data meet several criteria that we consider to 
be important for selecting a data source for purposes of calculating 
the GPCIs. For example, the BLS OES wage and employment data are 
derived from a large sample size of approximately 200,000 
establishments of varying sizes nationwide from every metropolitan area 
and can be easily accessible to the public at no cost. Additionally, 
the BLS OES is updated regularly, and includes a comprehensive set of 
occupations and industries (for example, 800 occupations in 450 
industries). For the CY 2014 GPCI update, we used updated BLS OES data 
(2009 through 2011) as a replacement for the 2006 through 2008 data to 
compute the work GPCIs; and for the CY 2017 GPCI update, we used 
updated BLS OES data (2011 through 2014) as a replacement for the 2009 
through 2011 data to compute the work GPCIs.
    Because of its reliability, public availability, level of detail, 
and national scope, we believe the BLS OES data continue to be the most 
appropriate source of wage and employment data for use in calculating 
the work GPCIs (and as discussed below, the employee wage component and 
purchased services component of the PE GPCI). Therefore, for the CY 
2020 GPCI update, we used updated BLS OES data (2014 through 2017) as a 
replacement for the 2011 through 2014 data to compute the work GPCIs.
b. Practice Expense (PE) GPCIs
    The PE GPCIs are designed to measure the relative cost difference 
in the mix of goods and services comprising PEs (not including MP 
expenses) among the PFS localities as compared to the national average 
of these costs. Whereas the physician work GPCIs (and as discussed 
later in this section, the MP GPCIs) are comprised of a single index, 
the PE GPCIs are comprised of four component indices (employee wages; 
purchased services; office rent; and equipment, supplies and other 
miscellaneous expenses). The employee wage index component measures 
geographic variation in the cost of the kinds of skilled and unskilled 
labor that would be directly employed by a physician practice. Although 
the employee wage index adjusts for geographic variation in the cost of 
labor employed directly by physician practices, it does not account for 
geographic variation in the cost of services that typically would be 
purchased from other entities, such as law firms, accounting firms, 
information technology consultants, building service managers, or any 
other third-party vendor. The purchased services index component of the 
PE GPCI (which is a separate index from employee wages) measures 
geographic variation in the cost of contracted services that physician 
practices would typically buy. For more information on the development 
of the purchased service index, we refer readers to the CY 2012 PFS 
final rule with comment period (76 FR 73084 through 73085). The office 
rent index component of the PE GPCI measures relative geographic 
variation in the cost of typical physician office rents. For the 
medical equipment, supplies, and miscellaneous expenses component, we 
believe there is a national market for these items such that there is 
not significant geographic variation in costs. Therefore, the 
equipment, supplies and other miscellaneous expense cost index 
component of the PE GPCI is given a value of 1.000 for each PFS 
locality.
    For the previous update to the GPCIs (implemented in CY 2017), we 
used 2011 through 2014 BLS OES data to calculate the employee wage and 
purchased services indices for the PE GPCI. As discussed previously in 
this section, because of its reliability, public availability, level of 
detail, and national scope, we continue to believe the BLS OES is the 
most appropriate data source for collecting wage and employment data. 
Therefore, in calculating the CY 2020 GPCI update, we used updated BLS 
OES data (2014 through 2017) as a replacement for the 2011 through 2014 
data for purposes of calculating the employee wage component and 
purchased service index component of the PE GPCI. In calculating the CY 
2020 GPCI update, for the office rent index component of the PE GPCI we 
used the most recently available, 2013 through 2017, American Community 
Survey (ACS) 5-year estimates as a replacement for the 2009 through 
2013 ACS data.
c. Malpractice Expense (MP) GPCIs
    The MP GPCIs measure the relative cost differences among PFS 
localities for the purchase of professional liability insurance (PLI). 
The MP GPCIs are calculated based on insurer rate filings of premium 
data for $1 million/$3 million mature claims-made policies (policies 
for claims made rather than losses occurring during the policy term). 
For the CY 2017 GPCI update, we used 2014 and 2015 malpractice premium 
data. The CY 2020 MP GPCI update reflects premium data presumed in 
effect as of December 30, 2017. We note that we finalized a few 
technical refinements to the MP GPCI methodology in CY 2017, and refer 
readers to the CY 2017 PFS final rule (81 FR 80270) for additional 
discussion.
d. GPCI Cost Share Weights
    For CY 2020 GPCIs, we proposed to continue to use the current cost 
share weights for determining the PE GPCI values and locality GAFs. We 
refer readers to the CY 2014 PFS final rule with comment period (78 FR 
74382 through 74383), for further discussion regarding the 2006-based 
MEI cost share weights revised in CY 2014 that we also finalized for 
use in the CY 2017 GPCI update.
    The GPCI cost share weights for CY 2020 are displayed in Table 15.
    [GRAPHIC] [TIFF OMITTED] TR15NO19.021
    

[[Page 62618]]


e. PE GPCI Floor for Frontier States
    Section 10324(c) of the Affordable Care Act added a new 
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0 
PE GPCI floor for physicians' services furnished in frontier states 
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of 
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for 
physicians' services furnished in states determined to be frontier 
states. In general, a frontier state is one in which at least 50 
percent of the counties are ``frontier counties,'' which are those that 
have a population per square mile of less than 6. For more information 
on the criteria used to define a frontier state, we refer readers to 
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75 
FR 50160 through 50161). There are no changes in the states identified 
as Frontier States for the CY 2020 PFS final rule. The qualifying 
states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada. 
In accordance with statute, we will apply a 1.0 PE GPCI floor for these 
states in CY 2020.
f. Methodology for Calculating GPCIs in the U.S. Territories
    Prior to CY 2017, for all the island territories other than Puerto 
Rico, the lack of comprehensive data about unique costs for island 
territories had minimal impact on GPCIs because we used either the 
Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and 
Northern Mariana Islands) or used the unadjusted national averages (for 
the Virgin Islands). In an effort to provide greater consistency in the 
calculation of GPCIs given the lack of comprehensive data regarding the 
validity of applying the proxy data used in the States in accurately 
accounting for variability of costs for these island territories, in 
the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a 
policy to treat the Caribbean Island territories (the Virgin Islands 
and Puerto Rico) in a consistent manner. We do so by assigning the 
national average of 1.0 to each GPCI index for both Puerto Rico and the 
Virgin Islands. We refer readers to the CY 2017 PFS final rule for a 
comprehensive discussion of this policy.
g. California Locality Update to the Fee Schedule Areas Used for 
Payment Under Section 220(h) of the Protecting Access to Medicare Act
    Section 220(h) of the PAMA added a new section 1848(e)(6) to the 
Act that modified the fee schedule areas used for payment purposes in 
California beginning in CY 2017. Prior to CY 2017, the fee schedule 
areas used for payment in California were based on the revised locality 
structure that was implemented in 1997 as previously discussed. 
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that 
the fee schedule areas used for payment in California must be 
Metropolitan Statistical Areas (MSAs) as defined by the Office of 
Management and Budget (OMB) as of December 31 of the previous year; and 
section 1848(e)(6)(A)(ii) of the Act required that all areas not 
located in an MSA must be treated as a single rest-of-state fee 
schedule area. The resulting modifications to California's locality 
structure increased its number of localities from 9 under the current 
locality structure to 27 under the MSA-based locality structure; 
although for the purposes of payment the actual number of localities 
under the MSA-based locality structure is 32. We refer readers to the 
CY 2017 PFS final rule (81 FR 80267) for a detailed discussion of this 
operational consideration.
    Section 1848(e)(6)(D) of the Act defined transition areas as the 
fee schedule areas for 2013 that were the rest-of-state locality, and 
locality 3, which was comprised of Marin County, Napa County, and 
Solano County. Section 1848(e)(6)(B) of the Act specified that the GPCI 
values used for payment in a transition area are to be phased in over 6 
years, from 2017 through 2022, using a weighted sum of the GPCIs 
calculated under the new MSA-based locality structure and the GPCIs 
calculated under the PFS locality structure that was in place prior to 
CY 2017. That is, the GPCI values applicable for these areas during 
this transition period are a blend of what the GPCI values would have 
been for California under the locality structure that was in place 
prior to CY 2017, and what the GPCI values would be for California 
under the MSA-based locality structure. For example, in CY 2020, which 
represents the fourth year, the applicable GPCI values for counties 
that were previously in rest-of-state or locality 3 and are now in MSAs 
are a blend of \2/3\ of the GPCI value calculated for the year under 
the MSA-based locality structure, and \1/3\ of the GPCI value 
calculated for the year under the locality structure that was in place 
prior to CY 2017. The proportions continue to shift by \1/6\ in each 
subsequent year so that, by CY 2021, the applicable GPCI values for 
counties within transition areas are a blend of \5/6\ of the GPCI value 
for the year under the MSA-based locality structure, and \1/6\ of the 
GPCI value for the year under the locality structure that was in place 
prior to CY 2017. Beginning in CY 2022, the applicable GPCI values for 
counties in transition areas are the values calculated solely under the 
new MSA-based locality structure. For clarity, we reiterate that this 
incremental phase-in is only applicable to those counties that are in 
transition areas that are now in MSAs, which are only some of the 
counties in the 2013 California rest-of state locality and locality 3.
    Additionally, section 1848(e)(6)(C) of the Act establishes a hold 
harmless for transition areas beginning with CY 2017 whereby the 
applicable GPCI values for a year under the new MSA-based locality 
structure may not be less than what they would have been for the year 
under the locality structure that was in place prior to CY 2017. There 
are a total of 58 counties in California, 50 of which are in transition 
areas as defined in section 1848(e)(6)(D) of the Act. The eight 
counties that are not within transition areas are: Orange; Los Angeles; 
Alameda; Contra Costa; San Francisco; San Mateo; Santa Clara; and 
Ventura counties.
    For the purposes of calculating budget neutrality and consistent 
with the PFS budget neutrality requirements as specified under section 
1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by 
calculating the national GPCIs as if the localities that were in place 
prior to CY 2017 are still applicable nationwide; then, for the 
purposes of payment in California, we override the GPCI values with the 
values that are applicable for California consistent with the 
requirements of section 1848(e)(6) of the Act. This approach is 
consistent with the implementation of the GPCI floor provisions that 
have previously been implemented--that is, as an after-the-fact 
adjustment that is implemented for purposes of payment after both the 
GPCIs and PFS budget neutrality have already been calculated.
    Additionally, section 1848(e)(1)(C) of the Act requires that, if 
more than 1 year has elapsed since the date of the last previous GPCI 
adjustment, the adjustment to be applied in the first year of the next 
adjustment shall be \1/2\ of the adjustment that otherwise would be 
made. However, since section 1848(e)(6)(B) of the Act provides for a 
gradual phase in of the GPCI values under the new MSA-based locality 
structure for California, specifically in one-sixth increments over 6 
years, if we were to also apply the requirement to phase in \1/2\ of 
the adjustment in year 1 of the GPCI update then the first year 
increment would effectively be 1/12.

[[Page 62619]]

Therefore, in CY 2017, we finalized a policy that the requirement at 
section 1848(e)(1)(C) of the Act to phase in \1/2\ of the adjustment in 
year 1 of the GPCI update would not apply to counties that were 
previously in the rest-of-state or locality 3 and are now in MSAs that 
are subject to the blended phase-in as described above in this section. 
We reiterate that this is only applicable through CY 2021 since, 
beginning in CY 2022, the GPCI values for such areas in an MSA would be 
fully based on the values calculated under the new MSA-based locality 
structure for California. For a comprehensive discussion of this 
provision, transition areas, and operational considerations, we refer 
readers to the CY 2017 PFS final rule (81 FR 80265 through 80268).
h. Refinements to the GPCI Methodology
    In the process of calculating GPCIs for the purposes of this final 
rule, we identified two technical refinements to the methodology that 
yield improvements over the current method; these refinements are 
applicable to the work GPCI and the employee wage index and purchased 
services index components of the PE GPCI. We proposed to weight by 
total employment when computing county median wages for each occupation 
code which addresses the fact that the occupation wage can vary by 
industry within a county. Additionally, we proposed to use a weighted 
average when calculating the final county-level wage index; this 
removes the possibility that a county index would imply a wage of 0 for 
any occupation group not present in the county's data. These 
methodological refinements yield improved mathematical precision. 
Additional information on the GPCI methodology and the refinements are 
available in the final report, ``Final Report for the CY 2020 Update of 
GPCIs and MP RVUs for the Medicare PFS'' on our website located under 
the supporting documents section of the CY 2020 PFS final rule at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
i. Proposed GPCI Update Summary
    As explained above in the Background section above in this section, 
the periodic review and adjustment of GPCIs is mandated by section 
1848(e)(1)(C) of the Act. At each update, the GPCIs are published in 
the PFS proposed rule to provide an opportunity for public comment and 
further revisions in response to comments prior to implementation. The 
CY 2020 updated GPCIs for the first and second year of the 2-year 
phase-in, along with the GAFs, are displayed in Addenda D and E to this 
final rule available on our website under the supporting documents 
section of the CY 2020 PFS final rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    The following is a summary of the comments we received on the GPCI 
proposals and our responses.
    Comment: A few commenters expressed concern over the expiring work 
GPCI floor of 1.0. Some of the commenters stated an objection to any 
proposals that could have a negative impact on rural areas such as the 
expiration of the work GPCI floor and stated that the GPCIs needs to 
account for the unique practice needs of rural providers.
    Response: The 1.0 work GPCI floor is established by statute and 
expires on December 31, 2019. We do not have the authority to extend 
the 1.0 work GPCI floor beyond December 31, 2019. We note that 34 
states have a statewide payment locality, which means that physicians, 
whether in urban or rural areas, receive the same geographic adjustment 
thus reducing rural/urban payment differentials within a state.
    Comment: A few commenters expressed support for the elimination of 
all GAFs under the PFS, except those designed to achieve a specific 
public policy goal, such as to encourage physicians to practice in 
underserved areas. The commenters stated that GPCIs tend to favor urban 
localities over their rural counterparts and works at cross purposes to 
the health professional shortage area (HPSA) bonus and other incentives 
intended to encourage and support rural physicians. The commenters also 
stated that rural beneficiaries would be better served if the GPCIs 
were eliminated from the PFS so that the HPSA bonus and other 
incentives are not undermined in their efforts to sustain the rural 
physician workforce needed to care for those beneficiaries.
    Response: As previously discussed, section 1848(e)(1)(A) of the Act 
requires us to develop separate GPCIs to measure resource cost 
differences among localities compared to the national average for each 
of the three GPCI components, and section 1848(e)(1)(C) of the Act 
requires us to review and, if necessary, adjust the GPCIs at least 
every 3 years; and based on new data GPCI values may increase or 
decrease. Additionally, as noted above, 34 states have a statewide 
locality, thus reducing rural/urban payment differentials within a 
state.
    Comment: One commenter stated that CMS uses salary data for 
individuals with 5 or more years of college, and should instead 
evaluate the feasibility of using salary data only from individuals 
with graduate degrees in the work GPCI calculations. The commenter also 
stated that CMS should also consider that physicians invest a portion 
of their compensation in the practice and that portion should not be 
counted as salary.
    Response: We note that physicians are not one of the seven 
occupation groups used in the work GPCI calculation; therefore, we are 
unclear about the commenter's assertion that investments of a portion 
of a physician's salary back into the practice should not be counted as 
salary. As described above, and consistent with our longstanding 
practice, a set of occupation groups representing a variety of 
professionals are used in the calculation. We note that the proxy 
occupations currently used represent highly educated professional 
occupation categories, and therefore, we believe we are already 
including salary data for individuals with advanced degrees.
    Comment: One commenter stated concern that the work GPCI does not 
utilize actual physician wage data, and states that CMS' statement that 
including physician wage data in calculating the work GPCI would 
potentially introduce some circularity to the adjustment since Medicare 
payments typically contribute to physician wages is flawed. The 
commenter stated that in the era of increasing physician employment, 
more physicians receive a salary dependent upon local market conditions 
and not the portion of their patient panel on Medicare. The commenter 
also stated that two of the proxy professional wage categories--
pharmacists, and registered nurses--are professions whose wages are 
also comprised, in part, of income gained from participation in the 
Medicare program.
    Response: We note that we have long maintained that including 
physicians' wages in the physician work GPCI would, in effect make the 
physician work GPCI to some extent dependent upon Medicare payments 
which in turn are impacted by the indices. We do not dispute the 
assertion that local market conditions may also play a role in 
determination of a physician's salary; however, we do not believe that 
mitigates the potential for circularity and maintain that, still, 
Medicare payment is a significant determinant of physician's earnings. 
We also recognize that the seven proxy professional wage

[[Page 62620]]

categories span several different industries, including pharmacists, 
and registered nurses which demonstrates that the healthcare industry 
is represented in those proxy wage categories; however, physicians in 
particular are not included in those categories as previously 
described. We continue to believe in the majority of instances, the 
earnings of physicians will vary among areas to the same degree that 
the earnings of other professionals across an array of industries vary. 
We reiterate that the work GPCI is not an absolute measure of physician 
earnings, rather it is a measure of the relative wage differences for 
each locality as compared to the national average. Additionally, the 
work GPCI reflects only one quarter of those relative wage differences 
consistent with the statutory requirement as discussed previously in 
this section.
    Comment: A few commenters stated that CMS should re-evaluate 
existing databases to find or develop a nationwide measure of 
commercial office rents for use in calculating PE GPCIs. One commenter 
stated that CMS should either collect true medical office expense data 
or alternatively use data sources available to federal agencies such as 
office expense data from the Federally Qualified Health Center Network.
    Response: We appreciate the commenter's feedback. We note that our 
efforts are ongoing to identify a publicly-available, robust, 
nationally representative commercial rent data source that could be 
made available to CMS for this purpose. Further, we welcome 
opportunities to discuss such data sources with stakeholders and to 
incorporate such data, as appropriate in the GPCI calculation process, 
through our standard annual rulemaking process.
    Comment: One commenter expressed support for the proposed 
methodological refinements and stated that it could yield improvements 
that would be beneficial to all fields of medicine.
    Response: We thank the commenter for the support of our proposed 
methodological refinements.
    Comment: A few commenters stated that the proposed refinement to 
the weighting of the physician work, employee wage, and purchased 
services indices results in inconsistent comparisons of occupational 
wages from one county to the next, because industry wages within an 
occupational group will vary from one county to the next based on 
employment. The commenters recommended using the previous methodology 
and also stated that for counties with zero inputs that we use inputs 
from MSAs as is done for the rent index or use the national average as 
used in the previous update.
    Response: The use of employment weights better captures variation 
in median wages themselves, which is exactly what the indices are meant 
to reflect. As the commenter indicated, the unweighted approach 
captures variation in wages reported by category in an index-like 
manner. This is undesirable both substantively and mathematically, 
since it makes the GPCIs an index based on an index rather than on the 
underlying data of interest. We have reviewed the process for 
developing county-level median wages as described in the proposed rule, 
and continue to believe that the use of employment weights, as we 
proposed, is an improvement over the use of unweighted values as 
requested by the commenter. We intend to continue considering how 
measures are weighted and summarized throughout the GPCI development 
process and will invite public comment on any additional potential 
improvements we identify through future rulemaking.
    Comment: A few commenters stated that they find it challenging to 
extract and collate the publicly-available BLS OES data (available from 
the BLS website), that are used for the work and PE GPCIs in a manner 
that enables them to reproduce the data sets used in the work GPCI and 
the employee wages, and purchased services components of the PE GPCI; 
the commenters stated that CMS should provide more detailed information 
in the interest of transparency.
    Response: We note that we provide web links to the publicly-
available data sources used in this GPCI update, the methodological 
parameters, as well as an overview of how we develop each GPCI 
component in the final report for the CY 2020 Update of GPCIs and MP 
RVUs for the Medicare PFS. This practice is consistent with previous 
updates. However, in consideration of the commenters' concerns that 
navigating the publicly-available BLS OES data on the BLS website is 
cumbersome, we have included more detailed steps in the aforementioned 
report to further assist interested parties in navigating these data.
    Comment: One commenter stated that the GPCIs in Hawaii do not 
account for the unique costs of providing medical services in Hawaii 
and that this will lead to an accelerating shortage of health care 
providers across the state of Hawaii. The commenter stated that 
Hawaii's unique geography makes providing care more expensive and that 
the cost of living ranks amongst the highest in the nation, and the 
data used by CMS do not reflect the cost of living. The commenter 
stated that it disputes the assertion that the equipment, supplies, and 
miscellaneous expenses component of the PE GPCI do not vary by 
geographic area, and therefore, do not require updating. The commenter 
stated that the high cost of shipping equipment plays a major part in 
the high cost of healthcare in Hawaii and the PEs should reflect that 
additional cost that exists in Hawaii and not in the mainland United 
States. The commenter stated that the 1.5 work GPCI floor for Alaska, 
and the 1.0 PE GPCI floor for the frontier states should serve as a 
basis for reevaluating the cost of providing medical services in 
Hawaii. The commenter stated that the GPCIs should be adjusted to 
reflect a factor at least equal to Alaska's work GPCI.
    Response: We reiterate that the GPCIs, in particular the work GPCI 
and the PE GPCI to which the commenter refers, are based on nationally-
representative and publicly-available wage data from the BLS OES for 
the work GPCI and employee wage and purchased services components of 
the PE GPCI, and the Census Bureau's ACS data for the rent index 
component of the PE GPCI. The GPCIs are a measure of relative resource 
cost differences among localities compared to the national average as 
informed by the data (not a measure of absolute costs). With regards to 
the supplies, equipment, and miscellaneous expense cost index component 
of the PE GPCIs, we have stated that we believe there is a national 
market for these items and there is not significant geographic 
variation in those costs, and as such we assign a value of 1.00 for 
this component for each locality, consistent with the national average. 
Stakeholders have previously indicated that shipping and transportation 
expenses increase the cost of acquiring medical equipment and supplies 
in islands relative to the mainland. We have previously attempted to 
locate data sources specific to geographic variation in shipping costs, 
and we found no comprehensive national data source for this 
information, and therefore, we have not been able to quantify variation 
in costs specific to islands as indicated by the commenter (we refer 
readers to 78 FR 74387 through 74388 for a detailed discussion of this 
issue). The commenter did not provide any data to quantify the 
variation. We would encourage the commenter and other stakeholders to 
submit data supporting this assertion for consideration in future 
rulemaking; specifically, we would be

[[Page 62621]]

interested in information regarding potential data sources for shipping 
costs for medical equipment and supplies that are accessible to the 
public, available on a national basis for both urban and rural areas, 
and updated regularly. We remind commenters that the work GPCI value 
for Alaska is not based on the data for that state, instead section 
1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for 
Alaska. Similarly, section 1848(e)(1) of the Act sets a permanent PE 
GPCI floor of 1.0 for the frontier states. Additionally, we note that 
the GAF in Hawaii, displayed in Addendum D, which represents the 
weighted composite of each PFS localities GPCIs, is increasing in the 
GPCI update from CY 2019 to years 1 and 2 of the update (CY 2020 and CY 
2021).
    Comment: One commenter noted that the MP GPCIs changed more 
significantly than other GPCIs, but also acknowledged that MP accounts 
for a small share of average total payments so these swings generally 
translate into modest payment changes. The commenter urged CMS to give 
consideration to comments from state medical associations and other 
organizations representing physicians who practice in localities facing 
reductions to ensure that the data driving reductions are accurate.
    Response: We note that larger changes in MP GPCI values in an 
update year are not unprecedented, and the commenter has correctly 
characterized that changes in MP will equate to minimal changes in 
payment because MP represents a small share of average total payments. 
As discussed in section II.C of this final rule, there were several 
proposed methodological refinements in the development of the MP 
premium data which underlies the MP risk factors used in determining 
both MP RVUs and MP GPCIs which has also contributed to some of the 
changes; we note that not all of those proposed methodological 
refinements were finalized for CY 2020, and the final MP GPCIs in 
Addendum E of this final rule are reflective of that.
    We emphasize that we do give consideration to the public comments 
that we receive. We note that only a few comments were received with 
regards to the GPCI proposals, though during the process of developing 
the CY 2020 final rule GPCIs, which includes reviewing the underlying 
data (which are obtained from publicly-available sources as previously 
discussed) and reviewing our programming, we did observe the following 
issue. The work, PE, and MP GPCIs are based on the 2017 utilization 
data as described in the final report for the CY 2020 Update of GPCIs 
and MP RVUs for the Medicare PFS. These data became available after the 
CY 2020 PFS proposed rule analytic programs had been written for these 
measures, but for the purposes of developing the analytic programs the 
CY 2016 utilization data were used as a placeholder. During the final 
rule development we realized an oversight whereby the 2016 utilization 
data had not been replaced with the 2017 utilization data for the work 
and PE GPCIs, though we note that for the MP GPCI, the 2017 utilization 
data were being used. We have resolved this issue for the final rule 
and all 3 GPCI components reflect the updated 2017 utilization data as 
described in the aforementioned report. We note that utilization data 
are highly correlated year to year so the effect of this change on 
final GPCI values was quite modest; specifically, the updated 
utilization data had virtually no effect on the resulting work, PE, and 
MP GPCIs and the GAFs. Outside of California (see below for a 
discussion regarding California), the correlation coefficient between 
each of the three GPCIs and the GAF in the proposed rule, and their 
corresponding values in the final rule is 0.999.
    Comment: A few commenters expressed concern with regards to the 
county rent indices delineated in the county-level data public use file 
whereby they noted consistent discrepancies in New England states as 
compared to the rest of the country. The commenters stated that before 
finalizing the PE GPCIs, CMS should review the indices to ensure that 
the relative differences in the indices accurately reflect the relative 
differences in rents from the source data file. One of the commenters 
indicated that this issue is not observed in any areas outside of New 
England.
    Response: We note that during the review of the underlying data and 
analytic programs for the final rule, we identified an issue with the 
data in New England (Maine, New Hampshire, Vermont, Massachusetts, 
Rhode Island, and Connecticut) where the raw data values were defined 
at sub-county areas in New England, but were not summarized to the 
county-level in the development of the proposed CY 2020 GPCI values. 
This led to distorted office rent index values for the six states in 
New England, which in turn affected the proposed PE GPCIs in those 
states. The CY 2020 PFS final rule office rent index that underlies the 
PE GPCI has been corrected so that the input data element is now 
summarized at the county-level before being used to develop the index. 
Similar to the aforementioned update to the utilization data, the 
corrected mapping of raw data values in New England as described above 
had virtually no effect on the resulting work, PE, and MP GPCIs and the 
GAFs. Outside of California (see below for a discussion regarding 
California), the correlation coefficient between each of the three 
GPCIs and the GAF in the proposed rule, and their corresponding values 
in the final rule is 0.999.
    Comment: One commenter expressed concern with the implementation of 
the GPCI requirements in California consistent with section 1848(e)(6) 
of the Act which was implemented in the CY 2017 PFS final rule (81 FR 
80261 through 80270). The commenter requested that CMS remedy any 
errors in the GPCI values. Specifically, the commenter indicated that 
CMS did not accurately implement the California MSA-based structure in 
the CY 2020 PFS proposed rule consistent with the methodology finalized 
in CY 2017 based on the requirements of the statute. The commenter 
specifically highlighted issues with the GPCIs for the San Francisco-
Oakland-Hayward localities (localities 05, 06, 07, and 53); the San 
Jose-Sunnyvale-Santa Clara localities (localities 09, and 65); and the 
Los Angeles-Long Beach-Anaheim localities (localities 26, and 18). The 
commenter provided their analysis with their commenter letter, and 
stated that based on their findings, the proposed GPCIs for the nine 
counties contained in the eight aforementioned localities are 
inaccurate. The commenter also requested that CMS provide the 
traditional source data for the PE rent and wage indices or the 
relative value units (RVUs) by county that have been published in the 
past. Aside from the issues with these eight localities as described 
above, the commenter indicated that for the remaining California 
localities, they support and agree with the proposed GPCIs and commend 
CMS for accurately completing the difficult calculations as required by 
statute.
    Response: We appreciate the analysis provided by the commenter with 
regards to the eight aforementioned localities and thank the commenter 
for bringing this to our attention. We agree with the commenter that 
there were issues with the calculation of the GPCI values reflected in 
the CY 2020 PFS proposed rule for California. In the programming, we 
inadvertently used the 32 MSA-based localities for which current GPCIs 
are defined to account for different treatment of some counties within 
MSAs when creating the new GPCIs, as opposed to using the 27 MSA-based 
localities to determine the new MSA-based payment area GPCI amounts. 
Additionally, we identified a

[[Page 62622]]

sequencing issue in our programming that led to issues in establishing 
the transition values and applying the hold harmless provision. We 
apologize for the confusion caused by these issues and have resolved 
these programming issues and recalculated the California GPCIs. The 
final CY 2020 GPCI values in California reflect the transition and hold 
harmless provisions executed in the proper order based on the 
requirements of the law. In summary, in California the issue was the 
level of aggregation used to create the proposed rule values, which 
erroneously resulted in different proposed rule values for counties 
within payment localities where there should not be any differences. 
Correcting this, along with other changes in the final rule relative to 
the proposed rule, led to GAFs that are higher in all but three of the 
32 payment localities in California. In those three, the GAF is lower 
because it is now correctly equal among non-transition counties within 
the new MSA-based payment areas; these three counties had higher values 
when erroneously calculated as individual payment localities in the 
proposed rule than they have when correctly averaged within the MSA for 
the final rule GPCIs. The final rule GAFs for these three areas are 
lower than those published in the proposed rule by 0.1 percent in 
locality 26 (Los Angeles-Long Beach-Anaheim (Orange cty)), 1.4 percent 
in locality 05 (San Francisco-Oakland-Hayward (San Francisco cty)), and 
1.8 percent in locality 06 (San Francisco-Oakland-Hayward (San Mateo 
cty)), but all three localities have CY 2020 PFS final rule GAFs that 
are higher than their current CY 2019 values. In the other 29 
California payment localities, the increase in final rule GAFs relative 
to the proposed rule values ranges from 0.5 percent to 6.2 percent, 
with 13 areas experiencing an increase of 1.2 percent.
    Additionally, we note that we have provided a county-level GPCI 
data file as one of the GPCI public use files in the downloads section 
of the CY 2020 PFS final rule on the CMS website, that delineates the 
requested source data, as well as the RVUs by county, consistent with 
what has been published in the past. We reiterate that the county-level 
data file also reflects the correction to the oversight in the proposed 
rule whereby we inadvertently used the 2016 utilization data for the 
work and PE GPCIs (though we correctly used the 2017 utilization data 
for the MP GPCIs) as previously discussed.
    Comment: One commenter stated that for CY 2020 in California there 
should be 29 distinct fee schedule areas and not 32 fee schedule areas 
as finalized when this provision was implemented in CY 2017. The 
commenter stated that some of the distinct fee schedule areas that were 
used during the period between CY 2017 and CY 2018 are no longer 
necessary. The commenter stated that Orange and Los Angeles counties, 
which are both in the Los-Angeles-Long Beach-Anaheim MSA, should have 
the same GPCI values and be one locality number instead of two. 
Similarly, Alameda, Contra Cosa, San Francisco and San Mateo counties 
(all in the San Francisco-Oakland-Hayward MSA) should be identified by 
one locality number instead of three, and the San Francisco-Oakland-
Hayward (Marin cnty) locality would remain its own distinct locality 
number.
    Response: There are 27 MSAs in California, and when CMS implemented 
the MSA-based locality structure for California as discussed above, for 
operational considerations, we finalized 32 unique MSA-based locality 
numbers. We did not propose to make changes to the number of unique 
locality numbers for California for CY 2020. Since two of the MSAs that 
required multiple unique locality numbers (San Francisco-Oakland-
Hayward, and San Jose-Sunnyvale-Santa Clara) to address operational 
considerations as described in the CY 2017 PFS final rule (81 FR 80265 
through 80268) contain both transition and non-transition counties, we 
would still need to maintain some unique locality numbers. We remind 
the commenter that though starting in CY 2022, the applicable GPCIs for 
counties in transition areas will be calculated solely under the MSA-
based locality structure as described above, the statutorily-required 
hold-harmless provision for counties in transition areas is permanent.
    With regards to the Los Angeles-Long Beach-Anaheim MSA, which 
contains 2 counties (across two unique locality numbers: 18 and 26) 
that are not transition areas, we acknowledge that the Los Angeles-Long 
Beach-Anaheim MSA only needed separate unique locality numbers, for 
payment purposes, in year 1 (CY 2017) of the implementation of the MSA-
based structure as neither of the counties in the MSA (Orange nor Los 
Angeles counties) are transition counties (and therefore, are not 
subject to aforementioned the one-sixth incremental phase-in nor hold-
harmless provision). We will consider the feasibility of assigning one 
locality number for that MSA in future rulemaking since there will be 
no difference in the GPCI values, for payment purposes, for those 
localities going forward. Similarly, the San Francisco-Oakland-Hayward 
MSA contains four counties (across three unique locality numbers: 05, 
06, and 07) that are not transition areas and will receive the same 
GPCI values, for payment purposes, going forward (San Francisco, San 
Mateo, Alameda, and Contra Costa counties). As such, we will consider 
the feasibility of collapsing those three unique locality numbers and 
assigning one unique locality number in future rulemaking. If we 
determine that to be operationally feasible, we would propose any 
changes in future rulemaking. We note that it would ultimately change 
the number of distinct fee schedule areas needed, for payment purposes, 
in California from 32 to 29 as suggested by the commenter.
    Additionally, during the development of the CY 2020 PFS final rule 
GPCIs, we identified typographical errors in the naming conventions of 
four of the California MSA-based localities in Addendum D and Addendum 
E: Locality 05-San Francisco-Oakland-Hayward (San Francisco cnty) was 
listed as San Francisco; locality 06-San Francisco-Oakland-Hayward (San 
Mateo cnty) was listed as San Mateo; locality 07-San Francisco-Oakland-
Hayward (Alameda/Contra Costa cnty) was listed as Oakland/Berkeley; and 
San Jose-Sunnyvale-Santa Clara (Santa Clara cnty) was listed as Santa 
Clara. This display issue has been corrected in Addendum D and Addendum 
E for the final rule.
    Comment: One commenter stated that it believes large cuts to rural 
and rest-of-state areas should be avoided or minimized, but locality 
boundaries with large payment differences should not be in the middle 
of urban areas, because they create payment cliffs where payment can 
change if an office is moved across a street or down a block. The 
commenter stated that CMS should create locality definitions that are 
not constrained by county boundaries, and advocated implementing 
locality definitions based on Metropolitan Statistical Areas.
    Response: We appreciate the suggestions for revisions to the PFS 
locality structure; however, we did not propose any changes to the PFS 
locality structure and decline to do so at this time. Further, we 
clarify that just as the localities under the locality structure used 
in the PFS are comprised of one or more constituent counties, so are 
Metropolitan Statistical Areas. Therefore, the concept of a payment 
cliff between neighboring counties as described by the commenter would 
not necessarily be mitigated by a change from PFS fee schedule areas to 
Metropolitan Fee Schedule Areas.

[[Page 62623]]

    After consideration of the comments, we are finalizing the CY 2020 
GPCI update, and the methodological refinements as proposed. The final 
GPCIs and summarized GAFs in Addenda D and E to this final rule also 
reflect the correction of the underlying programming issues described 
above.

E. Potentially Misvalued Services Under the PFS

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) of the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued codes under the PFS, using the 
same criteria used to identify potentially misvalued codes, and to make 
appropriate adjustments.
    As discussed in section II.N. of this final rule, Valuation of 
Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the RUC, MedPAC, 
and other stakeholders. For many years, the RUC has provided us with 
recommendations on the appropriate relative values for new, revised, 
and potentially misvalued PFS services. We review these recommendations 
on a code-by-code basis and consider these recommendations in 
conjunction with analyses of other data, such as claims data, to inform 
the decision-making process as authorized by law. We may also consider 
analyses of work time, work RVUs, or direct PE inputs using other data 
sources, such as Department of Veteran Affairs (VA), National Surgical 
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons 
(STS), and the 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 declines. This 
can happen when the costs of equipment and supplies fall, or when 
equipment is used more frequently than is estimated in the PE 
methodology, reducing its cost per use. Likewise, services can become 
undervalued when physician work increases or PE rises.
    As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in PE.
     Codes that describe new technologies or services within an 
appropriate time period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to 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

[[Page 62624]]

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'' in the subject line. Physical letters for nominations 
should be sent via the U.S. Postal Service to the Centers for Medicare 
and Medicaid Service, 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 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).
    In the Medicare Program; Revisions to Payment Policies under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2016 final 
rule with comment period (80 FR 70886) (hereinafter referred to as the 
``CY 2016 PFS final rule with comment period''), we finalized for 
review a list of potentially misvalued services, which included eight 
codes in the neurostimulators analysis-programming family (CPT codes 
95970-95982). We also finalized as potentially misvalued 103 codes 
identified through our screen of high expenditure services across 
specialties.
    In the Medicare Program; Revisions to Payment Policies under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2017; 
Medicare Advantage Bid Pricing Data Release; Medicare Advantage and 
Part D Medical Loss Ratio Data Release; Medicare Advantage Provider 
Network Requirements; Expansion of Medicare Diabetes Prevention Program 
Model; Medicare Shared Savings Program Requirements final rule (81 FR 
80170) (hereinafter referred to as the ``CY 2017 PFS final rule''), we 
finalized for review a list of potentially misvalued services, which 
included eight codes in the end-stage renal disease home dialysis 
family (CPT codes 90963-90970). We also finalized as potentially 
misvalued 19 codes identified through our screen for 0-day global 
services that are typically billed with an evaluation and management 
(E/M) service with modifier 25.
    In the CY 2018 PFS final rule, we finalized arthrodesis of 
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the 
use of comment solicitations with regard to specific codes, we also 
examined the valuations of other services, in addition to, new 
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2020 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 
through 67608), we modified this process whereby the public and 
stakeholders may nominate potentially misvalued codes for review by 
submitting the code with supporting documentation by February 10th of 
each year. Supporting documentation for codes nominated for the annual 
review of potentially misvalued codes may include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that demonstrate changes in physician work due to one or 
more of the following: Technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.
     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a

[[Page 62625]]

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 three submissions that nominated codes for review under 
the potentially misvalued code initiative, prior to our February 10, 
2019 deadline. In addition to three public nominations, CMS also 
nominated one additional code for review.
    One commenter requested that CMS consider CPT code 10005 (Fine 
needle aspiration biopsy, including ultrasound guidance; first lesion) 
and CPT code 10021 (Fine needle aspiration biopsy, without imaging 
guidance; first lesion) for nomination as potentially misvalued. We 
note that these two CPT codes were recently reviewed within a family of 
13 similar codes. Our review of these codes and our rationale for 
finalizing the current values are discussed extensively in the CY 2019 
PFS final rule (83 FR 59517). For CPT code 10021, the RUC recommended a 
32 percent reduction from its previous physician time and a 5 percent 
reduction in the work RVU. The commenter disagreed with this change and 
stated that there was a change in intensity of the procedure now as 
compared to what it was in 1995 when this code was last evaluated. The 
commenter also stated that there was a change in intensity of the work 
performed due to use of more complicated equipment, more stringent 
specimen sampling that allow for extensive examination of smaller and 
deeper lesions within the body. The commenter disagreed with the CMS' 
crosswalked CPT code 36440 (Push blood transfusion, patient 2 years or 
younger) and presented CPT codes 40490 (Biopsy of lip) and 95865 
(Needle measurement and recording of electrical activity of muscles of 
voice box) as more appropriate crosswalks.
    Another commenter requested that CMS consider HCPCS code G0166 
(External counterpulsation, per treatment session) as potentially 
misvalued. This code was reviewed for the CY 2019 PFS final rule (83 FR 
59578), and the work RVU and direct PE inputs as recommended by the AMA 
RUC were finalized by CMS. We finalized the valuation of this code with 
no refinements. However, the commenter noted that the PE inputs that 
were considered for this code did not fully reflect the total resources 
required to deliver the service. We stated we would review the 
commenter's submission of additional new data and public comments 
received in combination with what was previously presented in the CY 
2019 PFS final rule.
    CMS nominated CPT code 76377 (3D rendering with interpretation and 
reporting of computed tomography, magnetic resonance imaging, 
ultrasound, or other tomographic modality with image postprocessing 
under concurrent supervision; requiring image postprocessing on an 
independent workstation) as potentially misvalued. CPT code 76376 (3D 
rendering with interpretation and reporting of computed tomography, 
magnetic resonance imaging, ultrasound, or other tomographic modality 
with image postprocessing under concurrent supervision; not requiring 
image postprocessing on an independent workstation) was reviewed by the 
AMA RUC at the April 2018 RUC meeting. However, CPT code 76377, which 
is very similar to CPT code 76376, was not reviewed, and is likely now 
misvalued, in light of the similarities between the two codes. The 
specialty societies noted that the two codes are different because they 
are utilized by different patient populations (as evidenced by the ICD-
10 diagnoses); however, we view both codes to be similar enough that 
CPT code 76377 should be reviewed to maintain relativity in the code 
family.
    We have received and reviewed all public comments to all these 
codes that were nominated as potentially misvalued. Below, we present 
the summarizations of all these public comments.
    Comment: One commenter provided information to CMS in which they 
stated that the work involved in furnishing services represented by the 
office/outpatient E/M code set (CPT codes 99201-99215) has changed 
sufficiently to warrant revaluation. Specifically, the commenter stated 
that these codes have not been reviewed in over 12 years and in that 
time have suffered passive devaluation as more and more procedures and 
other services have been added to the CPT code set, which are 
subsequently valued in a budget neutral manner, through notice and 
comment rulemaking, on the Medicare PFS. The commenter also stated that 
re-evaluation of these codes is critical to the success of CMS' 
objective of advancing value-based care through the introduction of 
Advanced Alternative Payment Models (APMs) as these APMs rely on the 
underlying E/M codes as the basis for payment or reference price for 
bundled payments.
    Response: We acknowledge the points made by the commenter regarding 
the valuation of E/M codes for office and outpatient visits. We agreed, 
in principle, that the existing set of office/outpatient E/M CPT codes 
may not be correctly valued. In recent years, we have specifically 
considered how best to update and revalue the E/M codes, which 
represent a significant proportion of PFS expenditures, and have also 
engaged in ongoing dialogue with the practitioner community. In the CY 
2019 PFS proposed and final rules, in part due to these ongoing 
stakeholder discussions, we proposed and finalized changes to E/M 
payment and documentation requirements to implement policy objectives 
focused on reducing provider documentation burden (83 FR 59625).
    As we stated in the proposed rule, concurrently, the CPT Editorial 
Panel, under similar policy objectives, convened a workgroup and 
proposed to refine the existing E/M office/outpatient code set. Shortly 
thereafter, the AMA RUC revalued these services and submitted 
recommendations to CMS for review. In the CY 2020 PFS proposed rule, we 
considered the RUC-recommended values for office/outpatient E/M codes 
in proposing new values for CY 2021. For more detail on our review and 
consideration of the revalued office/outpatient E/M services please 
refer to section II.P of this final rule.
    Table 16 lists the HCPCS and CPT codes that we proposed as 
potentially misvalued.

[[Page 62626]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.022

    We received public comments on the HCPCS and CPT codes that we 
proposed as potentially misvalued. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters submitted comments about HCPCS code 
G0166 and claimed that in the CY 2019 PFS final rule, CMS did not have 
the complete list of inputs for this ``Practice Expense only'' code, 
which resulted in an under-valuation of its payment.
    Response: We note that the AMA RUC in its comment letter to the 
proposed rule informed CMS that it would review this service and 
forward any recommendations to CMS for review. We will review the AMA 
RUC's forthcoming recommendations and will consider any refinements to 
the valuation for this code through our standard rulemaking process for 
CY 2021.
    Comment: Several commenters highlighted the payment reduction to 
code G0166 in CY 2019 relative to CY 2018 and requested that CMS revert 
back to the CY 2018 payment. Commenters also noted that the current and 
reduced payment may endanger continued offering of this service, 
particularly to beneficiaries with coronary artery disease with angina 
for whom surgical intervention may not be appropriate and where 
medications have proved to be ineffective.
    Response: We acknowledge the receipt of all comments related to 
HCPCS code G0166 outlining that it may be inaccurately valued. We have 
reviewed the information included in the comments received, and look 
forward to reviewing the AMA RUC recommendations for this service. We 
will review the AMA RUC's forthcoming recommendations and will consider 
any refinements to the valuation for this code through our standard 
rulemaking process for CY 2021.
    We refer readers to section II.B of this final rule for details on 
the limited updates to the supply and equipment pricing for HCPCS code 
G0166.
    Comment: Several commenters responded to the inclusion of CPT codes 
10005 and 10021 on the potentially misvalued codes list, with the 
majority urging CMS to revise the CY 2019 finalized RVUs by adopting 
the higher RUC recommended RVUs.
    Response: We appreciate commenters' perspective on the valuation of 
CPT codes 10005 and 10021 but refer the commenters to our CY 2019 PFS 
final rule for our review of the relevant inputs and RUC 
recommendations for these codes. We have reviewed the comments 
received, including any additional information in response to our 
discussion of these codes under the potentially misvalued code 
initiative. We believe our refinements to the valuations for these 
services continue to be valid, as no new compelling information has 
been presented.
    Comment: Commenters disagreed with using the crosswalked CPT code 
36440 as the reference code for valuing CPT code 10021, even though the 
physician work times for both codes are very similar. One commenter 
stated that the previous values for work time (1995) were also based on 
a crosswalk (CPT codes 88170 and 88171) and not a survey, and 
therefore, the decrease in work time did not warrant a proportional 
change in work RVU as the previous times were inaccurate. Also, as 
discussed in the CY 2019 PFS final rule with comment period (83 FR 
59517), commenters stated that the work intensity for both codes are 
unequal as well their incongruous procedure descriptors, pointing out 
the fact that CPT codes 36440, 88170, and 88171 are clinically very 
different to CPT code 10021.
    Response: As we have discussed in previous rules, we agree that it 
is important to use the most recent data available regarding time, and 
we note that when many years have passed between when time is measured, 
significant discrepancies can occur. However, we continue to believe 
that our operating assumption regarding the validity of the existing 
values as a point of comparison is critical to the integrity of the 
relative value system as currently constructed. The times currently 
associated with codes play a very important role in PFS ratesetting, 
both as points of comparison in establishing work RVUs and in the 
allocation of indirect PE RVUs by specialty. If we were to operate 
under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. We continue to disagree 
with commenters' distinction of different types of physician work times 
as being better or worse in their measure of validity in comparison to 
each other, and believe that CPT code 36440 is a good comparable code 
to CPT code 10021 in physician work and physician work times.
    Comment: For CPT code 10021, one commenter disagreed with CMS 
maintaining the code's global indicator of ``XXX'' (global concept does 
not apply) and recommended a change to ``000'' (minor surgery/zero day 
global).
    Response: We did change the multiple procedure indicator for CPT 
code 10021 from a ``0'' (payment rules do not apply) to a ``2'' 
(standard payment adjustments do apply), but as we stated in CY 2019 
PFS final rule (83 FR 59520), we do not agree that it would have been 
more accurate to use codes with a 0-day global period as references for 
the codes in this family, and the multiple procedure policy continues 
to apply for CPT code 10021.
    In concluding our review of all the comments submitted for the 
nominated potentially misvalued CPT codes of 10005 and 10021, we do not 
believe we have received any additional

[[Page 62627]]

information to consider in the context of our previous review of these 
services. Therefore, we are not including CPT codes 10005 and 10021 on 
our final list of potentially misvalued codes for CY 2020.
    Comment: One commenter noted on the CMS nominated CPT code 76377 
(which we found to be very similar to CPT code 76376 that was AMA RUC 
reviewed for CY 2020), that although both code descriptors are similar, 
they have different clinical indications, different patients, different 
complexity in the work and require different resources and equipment, 
and that CPT code 76377 was not identified on any of the normal 
screens.
    Response: CMS' nominated CPT code 76377 as potentially misvalued 
due to its similarity to CPT code 76376 (3D rendering with 
interpretation and reporting of computed tomography, magnetic resonance 
imaging, ultrasound, or other tomographic modality with image 
postprocessing under concurrent supervision; not requiring image 
postprocessing on an independent workstation), which is reviewed and 
finalized for 2020. Due to the refinements made to CPT code 76376, CPT 
code 76377 should be similarly reviewed to resolve the two codes' 
likely discrepancies. We will consider the valuation of this code in 
future rulemaking. During this review, we will determine if the 
clinical indications, the complexity of the work, and the resources 
that are required, are similar or different for both of these codes.
    Comment: We received several comments regarding the AMA RUC's 
survey and recommended values for the E/M office/outpatient evaluation 
and management codes (99201-99015) for CY 2021.
    Response: We refer readers to section II. P. of this final rule 
where we discuss these codes in detail.
    After consideration of the comments received, in summary, we are 
including CPT code 76377 and HCPCS code G0166 on our final list of 
potentially misvalued codes for CY 2020. However, we are not including 
CPT codes 10005 and 10021 on our final list of potentially misvalued 
codes for CY 2020.
4. 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).
    Diabetes is the sixth leading cause of death in the United States, 
and approximately 20 million Americans have diabetes with an estimated 
20.9 percent of the senior population age 60 and older being affected. 
Millions of people have diabetes and do not know it. Left undiagnosed, 
diabetes can lead to severe complications such as heart disease, 
stroke, blindness, kidney failure, leg and foot amputations, and death 
related to pneumonia and flu. Scientific evidence now shows that early 
detection and treatment of diabetes with diet, physical activity, and 
new medicines can prevent or delay much of the illness and 
complications associated with diabetes. As with management of other 
chronic conditions, we believe innovative technologies that provide 
improved data to physicians and patients can be important tools in 
promoting patient-centered care.
    The codes that describe the implantation, removal, and removal and 
implantation of implantable interstitial glucose sensors are currently 
contractor-priced. Since the publication of the CY 2020 PFS proposed 
rule, we have become aware that the contractor pricing for these 
services has contributed to significant confusion in the community with 
regards to Medicare payment rules for these kinds of monitoring 
systems. We understand that this confusion has led to inhibited access 
to these services for Medicare beneficiaries.
    Given the immediate needs of Medicare beneficiaries with diabetes, 
including some who could benefit from these innovative technologies, we 
are seeking information from stakeholders to ensure proper payment for 
this important physician's service by establishing national payment 
rates in future rulemaking.
    We are seeking information from stakeholders on the resources 
involved in furnishing the services described by Category III CPT codes 
0446T (Creation of subcutaneous pocket with insertion of implantable 
interstitial glucose sensor, including system activation and patient 
training), 0447T (Removal of implantable interstitial glucose sensor 
from subcutaneous pocket via incision), and 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). We are specifically seeking 
recommendations, including the work RVUs, work time, and direct PE 
inputs, associated with the resources involved in inserting and 
removing the device, as well as the resource costs of the implantable 
device and disposable supplies (that is, the supply costs of the 
implantable device ``implantable interstitial glucose sensor'', and the 
smart transmitter).
    Under our existing policies, we welcome recommendations on 
appropriate valuation for these services and any recommendations 
submitted by February 10, 2020 would be considered for CY 2021 PFS 
rulemaking.

F. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act

    As discussed in this 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.
1. Adding Services to the List of Medicare Telehealth Services
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a process for adding services to or deleting services from 
the list of Medicare telehealth services in accordance with section 
1834(m)(4)(F)(ii) of the Act. This process provides the public with an 
ongoing opportunity to submit requests for adding services, which are 
then reviewed by us. Under this process, we assign any submitted 
request to add to the list of telehealth services to one of the 
following two categories:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to those on the 
current list of

[[Page 62628]]

telehealth services. Our review of these requests includes an 
assessment of whether the service is accurately described by the 
corresponding code when furnished via telehealth and whether the use of 
a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the additions described 
later in this section, can be located on the CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    Historically, requests to add services to the list of Medicare 
telehealth services had to be submitted and received no later than 
December 31 of each calendar year to be considered for the next 
rulemaking cycle. However, beginning in CY 2019 we stated that for CY 
2019 and onward, we intend to accept requests through February 10, 
consistent with the deadline for our receipt of code valuation 
recommendations from the RUC. For example, to be considered during PFS 
rulemaking for CY 2021, requests to add services to the list of 
Medicare telehealth services must be submitted and received by February 
10, 2020. Each request to add a service to the list of Medicare 
telehealth services must include any supporting documentation the 
requester wishes us to consider as we review the request. Because we 
use the annual PFS rulemaking process as the vehicle to make changes to 
the list of Medicare telehealth services, requesters should be advised 
that any information submitted as part of a request is subject to 
public disclosure for this purpose. For more information on submitting 
a request to add services to the list of Medicare telehealth services, 
including where to mail these requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
2. Requests To Add Services to the List of Telehealth Services for CY 
2020
    Under our current policy, we add services to the telehealth list on 
a Category 1 basis when we determine that they are similar to services 
on the existing telehealth list for the roles of, and interactions 
among, the beneficiary, physician (or other practitioner) at the 
distant site and, if necessary, the telepresenter. As we stated in the 
CY 2012 PFS final rule with comment period (76 FR 73098), we believe 
that the Category 1 criteria not only streamline our review process for 
publicly requested services that fall into this category, but also 
expedite our ability to identify codes for the telehealth list that 
resemble those services already on this list.
    We did not receive any requests from the public for additions to 
the Medicare Telehealth list for CY 2020. We believe that the vast 
majority of services under the PFS that can be appropriately furnished 
as Medicare telehealth services have already been added to the list.
    However, we proposed adding three new HCPCS G codes describing new 
bundled services for treatment of opioid use disorders in section II.H. 
of the CY 2020 PFS proposed rule which we noted are sufficiently 
similar to services currently on the telehealth list to be added on a 
Category 1 basis. Therefore, we proposed to add the face-to-face 
portions of the following services to the telehealth list on a Category 
1 basis for CY 2020:
     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).
    We note that in the CY 2020 PFS proposed rule (84 FR 40518), we 
referred to these services using placeholder codes, HCPCS codes GYYY1, 
GYYY2, and GYYY3, which are being replaced with the final G codes 
above. Similar to our addition of the required face-to-face visit 
component of TCM services to the Medicare Telehealth list in the CY 
2014 PFS final rule with comment period (78 FR 74403), since HCPCS 
codes G2086, G2087, and G2088 include face-to-face psychotherapy 
services, we believe that the face-to-face portions of these services 
are sufficiently similar to services currently on the list of Medicare 
telehealth services for these services to be added under Category 1. 
Specifically, we believe that the psychotherapy portions of the bundled 
codes are similar to the psychotherapy codes described by CPT codes 
90832 and 90853, which are currently on the Medicare telehealth list. 
We note that like certain other non-face-to-face PFS services, the 
other components of HCPCS codes G2086-G2088 describing care 
coordination are commonly furnished remotely using telecommunications 
technology, and do not require the patient to be present in-person with 
the practitioner when they are furnished. As such, we do not need to 
consider whether the non-face-to-face aspects of HCPCS codes G2086-
G2088 are similar to other telehealth services. Were these components 
of HCPCS codes G2086-G2088 separately billable, they would not need to 
be on the Medicare telehealth list to be covered and paid in the same 
way as services delivered without the use of telecommunications 
technology. We also note that by considering the face-to-face portion 
of these services to be eligible for telehealth services, the 
originating site facility fee could be reported, consistent with all 
other rules, when these services are furnished via telehealth.
    As discussed in the CY 2019 PFS final rule (83 FR 59496), we note 
that section 2001(a) of the SUPPORT Act (Pub. L. 115-271, October 24, 
2018) amended section 1834(m) of the Act, adding a new paragraph (7) 
that removes the geographic limitations for telehealth services 
furnished on or after July 1, 2019, for individuals diagnosed with a

[[Page 62629]]

substance use disorder (SUD) for the purpose of treating the SUD or a 
co-occurring mental health disorder. Section 1834(m)(7) of the Act also 
allows telehealth services for treatment of a diagnosed SUD or co-
occurring mental health disorder to be furnished to individuals at any 
telehealth originating site (other than a renal dialysis facility), 
including in a patient's home. Section 2001(a) of the SUPPORT Act 
additionally amended section 1834(m) of the Act to require that no 
originating site facility fee will be paid in instances when the 
individual's home is the originating site. We believe that adding HCPCS 
codes G2086, G2087, and G2088 to the Medicare telehealth list will 
complement the existing policies related to flexibilities in treating 
SUDs.
    We note that we welcome public nominations for additions to the 
Medicare telehealth list. More information on the nomination process is 
posted under the Telehealth section of the CMS website, which can be 
accessed at the following web address https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    We received public comments on the proposed HCPCS codes for 
addition to the telehealth list on a Category 1 basis. The following is 
a summary of the comments we received and our responses.
    Comment: The majority of commenters supported our proposal to add 
HCPCS codes G2086, G2087, and G2088 to the Medicare telehealth list, 
although a few disagreed, stating that these services should only be 
furnished in person.
    Response: We thank the commenters for their support and feedback. 
We note that the psychotherapy services that are included in this 
bundled payment are already on the list of Medicare telehealth 
services. After consideration of the comments received, we are 
finalizing our proposal to add HCPCS codes G2086, G2087, and G2088 to 
the Medicare telehealth list beginning in CY 2020.
    Comment: Several commenters disagreed with CMS' statement that most 
eligible services had been added to the Medicare telehealth list and 
suggested that CMS should continue to engage with stakeholders to 
identify other services that could be furnished via Medicare telehealth 
or communication technology-based services. A few commenters also 
provided recommendations for additional services that could be added to 
the Medicare telehealth list, as well as suggestions for how CMS could 
improve the process of requesting that services be added. Commenters 
reiterated as they have for many years that the statutory restrictions 
under section 1834(m) of the Act limit availability of telehealth 
services, and many encouraged CMS to utilize its demonstration 
authority to waive restrictions.
    Response: We will continue to engage with stakeholders to identify 
services to add to the Medicare telehealth list and other ways to 
leverage technology in furnishing services under the PFS within the 
scope of the statute. We note that the deadline for submitting requests 
for additions to the Medicare Telehealth list is February 10 of the 
year prior to the year in which the codes could be added to the 
Medicare telehealth list, and any requests that are received after that 
time will be considered in the following year's rulemaking.
    Comment: A few commenters requested that CMS allow visits with the 
prescribing physician for medications that require medical visits for 
monitoring (for example, buprenorphine) to also be furnished via 
telehealth.
    Response: We note that the majority of the E/M visit codes are 
already on the Medicare telehealth list and can be furnished in 
addition to HCPCS codes G2086, G2087, and G2088. Specific requests for 
consideration of additional codes for the Medicare telehealth list 
should be submitted through the process outlined above. We also note 
that there are existing rules related to telemedicine and prescribing 
buprenorphine for the treatment of OUD (https://www.hhs.gov/opioids/sites/default/files/2018-09/hhs-telemedicine-hhs-statement-final-508compliant.pdf).
3. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001 through December 31, 2002, at $20.00. 
For telehealth services furnished on or after January 1 of each 
subsequent calendar year, the telehealth originating site facility fee 
is increased by the percentage increase in the Medicare Economic Index 
(MEI) as defined in section 1842(i)(3) of the Act. The originating site 
facility fee for telehealth services furnished in CY 2019 is $26.15. 
The MEI increase for 2020 is 1.9 percent and is based on the most 
recent historical update of the MEI through 2019Q2 (2.4 percent), and 
the most recent historical multifactor productivity adjustment (MFP) 
through calendar year 2018 (0.5 percent). Therefore, for CY 2020, the 
payment amount for HCPCS code Q3014 (Telehealth originating site 
facility fee) is 80 percent of the lesser of the actual charge or 
$26.65. The Medicare telehealth originating site facility fee and the 
MEI increase by the applicable time period is shown in Table 17.

[[Page 62630]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.023

G. Medicare Coverage for Opioid Use Disorder Treatment Services 
Furnished by Opioid Treatment Programs (OTPs)

1. Overview
    Opioid use disorder (OUD) and deaths from prescription and illegal 
opioid overdoses have reached alarming levels. The Centers for Disease 
Control and Prevention (CDC) estimated 47,000 overdose deaths were from 
opioids in 2017 and 36 percent of those deaths were from prescription 
opioids.\1\ OUD has become a public health crisis. On October 26, 2017, 
Acting Health and Human Services Secretary, Eric D. Hargan declared a 
nationwide public health emergency on the opioid crisis as requested by 
President Donald Trump.\2\ This public health emergency was renewed by 
Secretary Alex M. Azar II on January 24, 2018, April 24, 2018, July 23, 
2018, and October 21, 2018, January 17, 2019, April 19, 2019, July 17, 
2019, and most recently, October 16, 2019.\3\
---------------------------------------------------------------------------

    \1\ https://www.cdc.gov/drugoverdose/data/index.html.
    \2\ https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.
    \3\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/opioid-16oct2019.aspx.
---------------------------------------------------------------------------

    The Medicare population, including individuals who are eligible for 
both Medicare and Medicaid, has the fastest growing prevalence of OUD 
compared to the general adult population, with more than 300,000 
beneficiaries diagnosed with OUD in 2014.\4\ An effective treatment for 
OUD is known as medication-assisted treatment (MAT). The Substance 
Abuse and Mental Health Services Administration (SAMHSA) defines MAT as 
the use of medication in combination with behavioral health services to 
provide an individualized approach to the treatment of substance use 
disorder (SUD), including OUD (Sec.  8.2). Currently, Medicare covers 
medications for MAT, including buprenorphine, buprenorphine-naloxone 
combination products, and extended-release injectable naltrexone under 
Part B or Part D, but does not cover methadone. Medicare also covers 
counseling and behavioral therapy services that are reasonable and 
necessary and furnished by practitioners that can bill and receive 
payment under Medicare.
---------------------------------------------------------------------------

    \4\ https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2535238.
---------------------------------------------------------------------------

    Historically, Medicare has not covered methadone for MAT because of 
the unique manner in which this drug is dispensed and administered. 
Medicare Part B covers physician-administered drugs, drugs used in 
conjunction with durable medical equipment, and certain other 
statutorily-specified drugs. Medicare Part D covers drugs that are 
dispensed upon a prescription by a pharmacy. Methadone for MAT is not a 
drug administered by a physician under the ``incident to'' benefit like 
other MAT drugs (that is, implanted buprenorphine or injectable 
extended-release naltrexone) and therefore has not previously been 
covered by Medicare Part B. Methadone for MAT is also not a drug 
dispensed by a pharmacy like certain other MAT drugs (that is 
buprenorphine or buprenorphine-naloxone combination products) and 
therefore is not covered under Medicare Part D. Methadone for MAT is a 
schedule II controlled substance that is highly regulated because it 
has a high potential for abuse which may lead to severe psychological 
or physical dependence. As a result, methadone for MAT can only be 
dispensed and administered by an opioid treatment program (OTP) as 
provided under section 303(g)(1) of the Controlled Substances Act (21 
U.S.C. 823(g)(1)) and 42 CFR part 8. Additionally, OTPs, which are 
healthcare entities that focus on providing MAT for people diagnosed 
with OUD, were not previously entities that could bill and receive 
payment from Medicare for the services they furnish. Therefore, there 
has historically been a gap in Medicare coverage of MAT for OUD since 
methadone (one of the three Food and Drug Administration (FDA)-approved 
drugs for MAT) has not been covered.
    Section 2005 of the Substance Use-Disorder Prevention that Promotes 
Opioid Recovery and Treatment for Patients and Communities Act (the 
SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) added a new

[[Page 62631]]

section 1861(jjj) to the Act, establishing a new Part B benefit 
category for OUD treatment services furnished by an OTP beginning on or 
after January 1, 2020. Section 1861(jjj)(1) of the Act defines OUD 
treatment services as items and services furnished by an OTP (as 
defined in section 1861(jjj)(2) of the Act) for treatment of OUD. 
Section 2005 of the SUPPORT Act also amended the definition of 
``medical and other health services'' in section 1861(s) of the Act to 
provide for coverage of OUD treatment services and added a new section 
1834(w) to the Act and amended section 1833(a)(1) of the Act to 
establish a bundled payment to OTPs for OUD treatment services 
furnished during an episode of care beginning on or after January 1, 
2020.
    OTPs must have a current, valid certification from SAMHSA to 
satisfy the Controlled Substances Act registration requirement under 21 
U.S.C. 823(g)(1). To obtain SAMHSA certification, OTPs must have a 
valid accreditation by an accrediting body approved by SAMHSA, and must 
be certified by SAMHSA as meeting federal opioid treatment standards in 
Sec.  8.12. There are currently about 1,700 OTPs nationwide.\5\ All 
states except Wyoming have OTPs. Approximately 74 percent of patients 
receiving services from OTPs receive methadone for MAT, with the vast 
majority of the remaining patients receiving buprenorphine.\6\
---------------------------------------------------------------------------

    \5\ https://dpt2.samhsa.gov/treatment/directory.aspx.
    \6\ https://wwwdasis.samhsa.gov/dasis2/nssats.htm.
---------------------------------------------------------------------------

    Many payers currently cover MAT services for treatment of OUD. 
Medicaid \7\ is one of the largest payers of medications for SUD, 
including methadone for MAT provided in OTPs.\8\ OUD treatment services 
and MAT are also covered by other payers such as TRICARE and private 
insurers. TRICARE established coverage and payment for MAT and OUD 
treatment services furnished by OTPs in late 2016 (81 FR 61068). In 
addition, as discussed in the ``Patient Protection and Affordable Care 
Act; HHS Notice of Benefit and Payment Parameters for 2020'' final 
rule, many qualified health plans covered MAT medications for plan year 
2018 (84 FR 17536).
---------------------------------------------------------------------------

    \7\ Medicaid provides health care coverage to 65.9 million 
Americans, including low-income adults, children, pregnant women, 
elderly adults and people with disabilities. Medicaid is 
administered by states, according to federal requirements, and is 
funded jointly by states and the federal government. States have the 
flexibility to administer the Medicaid program to meet their own 
state needs within the Medicaid program parameters set forth in 
federal statute and regulations. As a result, there is variation in 
how each state implements its programs.
    \8\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
---------------------------------------------------------------------------

    In the CY 2019 PFS final rule (83 FR 59497), we included a Request 
for Information (RFI) to solicit public comments on the implementation 
of the new Medicare benefit category for OUD treatment services 
furnished by OTPs established by section 2005 of the SUPPORT Act. We 
received 9 public comments. Commenters were generally supportive of the 
new benefit and expanding access to OUD treatment for Medicare 
beneficiaries. We received feedback that the bundled payments to OTPs 
should recognize the intensity of services furnished in the initiation 
stages, durations of care, the needs of patients with more complex 
needs, costs of emerging technologies, and use of peer support groups. 
We also received feedback that costs associated with care coordination 
among the beneficiary's practitioners should be included in the bundled 
payment given the myriad of health issues beneficiaries with OUD face. 
We considered this feedback as we developed our proposals for 
implementing the new benefit category for OUD treatment services 
furnished by OTPs and the proposed bundled payments for these services.
    To implement section 2005 of the SUPPORT Act, we proposed to 
establish rules to govern Medicare coverage of and payment for OUD 
treatment services furnished in OTPs. We proposed to establish 
definitions of OUD treatment services and OTP for purposes of the 
Medicare Program. We also proposed a methodology for determining 
Medicare payment for such services provided by OTPs. We proposed to 
codify these policies in a new section of the regulations at Sec.  
410.67. For a discussion about Medicare enrollment requirements and the 
program integrity approach for OTPs, we refer readers to section III.H. 
in this final rule, Medicare Enrollment of Opioid Treatment Programs.
2. Definitions
a. Opioid Use Disorder Treatment Services
    The SUPPORT Act amended section 1861 of the Act by adding a new 
subsection (jjj)(1) that defines ``opioid use disorder treatment 
services'' as the items and services that are furnished by an OTP for 
the treatment of OUD, as set forth in subparagraphs (A) through (F) of 
section 1861(jjj)(1) of the Act which include:
     Opioid agonist and antagonist treatment medications 
(including oral, injected, or implanted versions) that are approved by 
the Food and Drug Administration (FDA) under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 355) for use in the 
treatment of OUD;
     Dispensing and administration of such medications, if 
applicable;
     Substance use counseling by a professional to the extent 
authorized under state law to furnish such services;
     Individual and group therapy with a physician or 
psychologist (or other mental health professional to the extent 
authorized under state law);
     Toxicology testing; and
     Other items and services that the Secretary determines are 
appropriate (but in no event to include meals or transportation).
    As described previously, section 1861(jjj)(1)(A) of the Act defines 
covered OUD treatment services to include oral, injected, and implanted 
opioid agonist and antagonist medications approved by the FDA under 
section 505 of the FFDCA for use in the treatment of OUD. There are 
three drugs currently approved by the FDA for the treatment of opioid 
dependence: Buprenorphine, methadone, and naltrexone.\9\ FDA notes that 
all three of these medications have been demonstrated to be safe and 
effective in combination with counseling and psychosocial support and 
that those seeking treatment for an OUD should be offered access to all 
three options as this allows providers to work with patients to select 
the medication best suited to an individual's needs.\10\ Each of these 
medications is discussed below in more detail.
---------------------------------------------------------------------------

    \9\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \10\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
---------------------------------------------------------------------------

    Buprenorphine is FDA-approved for acute and chronic pain in 
addition to opioid dependence. It is listed by the Drug Enforcement 
Administration (DEA) as a Schedule III controlled substance because of 
its moderate to low potential for physical and psychological 
dependence.11 12 The medication's partial agonist properties 
allow for its use in opioid replacement therapy, which is a process of 
treating OUD by using a substance, for example, buprenorphine or 
methadone, to substitute for a stronger full agonist opioid.\13\ 
Buprenorphine drug products that are currently FDA-approved and 
marketed for the treatment of opioid dependence include oral 
buprenorphine tablets, oral buprenorphine with

[[Page 62632]]

naloxone \14\ films and tablets, an extended-release buprenorphine 
injection for subcutaneous use, and a buprenorphine implant for 
subdermal administration.\15\ In most patients with opioid dependence, 
the initial oral dose is 2 to 4 mg per day with a maintenance dose of 
8-12 mg per day.\16\ Dosing for the extended-release injection is 300 
mg monthly for the first 2 months followed by a maintenance dose of 100 
mg monthly.\17\ The extended-release injection is indicated for 
patients who have initiated treatment with an oral buprenorphine 
product for a minimum of 7 days.\18\ The buprenorphine implant consists 
of four rods containing 74.2 mg of buprenorphine each, and provides up 
to 6 months of treatment for patients who are clinically stable on low-
to-moderate doses of an oral buprenorphine-containing product.\19\ 
Currently, federal regulations permit buprenorphine to be prescribed or 
dispensed by qualifying physicians and qualifying other practitioners 
at office-based practices and dispensed in OTPs.20 21
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    \11\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
    \12\ https://www.dea.gov/drug-scheduling.
    \13\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
    \14\ Naloxone is added to buprenorphine to reduce its abuse 
potential and limit diversion.
    \15\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \16\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
    \17\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
    \18\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
    \19\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf.
    \20\ https://www.fda.gov/Drugs/NewsEvents/ucm611659.htm.
    \21\ 21 U.S.C. 823(g)(2).
---------------------------------------------------------------------------

    Methadone is FDA-approved for management of severe pain in addition 
to opioid dependence. It is listed by the DEA as a Schedule II 
controlled substance because of its high potential for abuse, with use 
potentially leading to severe psychological or physical 
dependence.22 23 Methadone drug products that are FDA-
approved for the treatment of opioid dependence include oral methadone 
concentrate and tablets.\24\ In patients with opioid dependence, the 
total daily dose of methadone on the first day of treatment should not 
ordinarily exceed 40 mg, unless the program physician documents in the 
patient's record that 40 mg did not suppress opioid abstinence, with 
clinical stability generally achieved at doses between 80 to 120 mg/
day.\25\ By law, methadone used for treatment of OUD can only be 
dispensed through an OTP certified by SAMHSA except in certain, very 
limited circumstances.\26\
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    \22\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
    \23\ https://www.dea.gov/drug-scheduling.
    \24\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \25\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf.
    \26\ https://www.samhsa.gov/medication-assisted-treatment/treatment/methadone.
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    Naltrexone is FDA-approved to treat alcohol dependence in addition 
to OUD.\27\ Unlike buprenorphine and methadone, which activate opioid 
receptors, naltrexone binds and blocks opioid receptors and reduces 
opioid cravings.\28\ Therefore, naltrexone is not a scheduled 
substance; there is no abuse and diversion potential with 
naltrexone.29 30 The naltrexone drug product that is FDA-
approved for the treatment of opioid dependence is an extended-release, 
intramuscular injection.\31\ The recommended dose is 380 mg delivered 
intramuscularly every 4 weeks or once a month after the patient has 
achieved an opioid-free duration of a minimum of 7-10 days.\32\ 
Naltrexone can be prescribed by any health care provider who is 
licensed to prescribe medications.\33\
---------------------------------------------------------------------------

    \27\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
    \28\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
    \29\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
    \30\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
    \31\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \32\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
    \33\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
---------------------------------------------------------------------------

    We proposed that the OUD treatment services that may be furnished 
by OTPs include the first five items and services listed in the 
statutory definition described above, specifically the medications 
approved by the FDA under section 505 of the FFDCA for use in the 
treatment of OUD; the dispensing and administration of such medication, 
if applicable; substance use counseling; individual and group therapy; 
and toxicology testing. We also proposed to use our discretion under 
section 1861(jjj)(1)(F) of the Act to include other items and services 
that the Secretary determines are appropriate to include the use of 
telecommunications for certain services, as discussed later in this 
section. We proposed to codify this definition of OUD treatment 
services furnished by OTPs at Sec.  410.67(b). As part of this 
definition, we also proposed to specify that an OUD treatment service 
is an item or service that is furnished by an OTP that meets the 
applicable requirements to participate in the Medicare Program and 
receive payment.
    We solicited comment on any other items and services (not including 
meals or transportation as they are statutorily prohibited) currently 
covered and paid for under Medicare Part B when furnished by Medicare-
enrolled providers/suppliers that the Secretary should consider adding 
to this definition, including any evidence supporting the impact of the 
use of such items and services in the treatment of OUD and enumeration 
of their costs. We noted we were particularly interested in public 
feedback on whether intake activities, which may include services such 
as an initial physical examination, initial assessments and preparation 
of a treatment plan, as well as periodic assessments, should be 
included in the definition of OUD treatment services. Additionally, we 
noted that while the current FDA-approved medications under section 505 
of the FFDCA for the treatment of OUD are opioid agonists and 
antagonist medications, other medications that are not opioid agonist 
and antagonist medications, including drugs and biologicals, could be 
developed for the treatment of OUD in the future. We solicited public 
feedback on whether there are any drug development efforts in the 
pipeline that could result in medications intended for use in the 
treatment of OUD with a novel mechanism of action that does not involve 
opioid agonist and antagonist mechanisms (that is, outside of 
activating and/or blocking opioid receptors). We also solicited comment 
on how medications that may be approved by the FDA in the future for 
use in the treatment of OUD with a novel mechanism of action, such as 
medications approved under section 505 of the FFDCA to treat OUD and 
biological products licensed under section 351 of the Public Health 
Service Act to treat OUD, should be considered in the context of OUD 
treatment services provided by OTPs, and whether CMS should use the 
discretion afforded under section 1861(jjj)(1)(F) of the Act to include 
such medications in the definition of OUD treatment services given the 
possibility that such medications could be approved in the future.
    We received a number of public comments on the proposed definition 
of ``opioid use disorder treatment services.'' The following is a 
summary of the comments we received and our responses.
    Comment: Commenters were generally supportive of including the five 
statutorily-required items and services in the definition of OUD 
treatment services: (1) Opioid agonist and antagonist treatment 
medications approved by the FDA for treatment of OUD; (2) dispensing 
and administration

[[Page 62633]]

of such medications; (3) substance use counseling; (4) individual and 
group therapy; and (5) toxicology testing. Commenters were also 
generally supportive of the use of telecommunications for substance use 
counseling and individual and group therapy services.
    Response: We thank commenters for their support of including the 
five statutorily-required items and services and the use of 
telecommunications for certain services in the definition of OUD 
treatment services. We are finalizing a definition of OUD treatment 
services that includes these items and services at Sec.  410.67(b).
    Comment: Many commenters expressed support for allowing licensed 
mental health professionals to directly bill Medicare for counseling 
and therapy services provided in an OTP. Some commenters requested 
clarification on whether OUD treatment services would only include 
substance use counseling and individual and group therapy services 
furnished by physicians, psychologists, and practitioners that can bill 
Medicare directly and not services furnished by other types of mental 
health professionals that are licensed by the state, such as licensed 
professional counselors, licensed mental health counselors, and 
licensed clinical professional counselors. These commenters raised 
concerns that only allowing physicians and psychologists to furnish 
these services and not including other mental health professionals 
authorized by the state to furnish counseling and therapy services 
would limit access to care due to workforce shortages. Some commenters 
requested that we clarify the distinction between substance use 
counseling and individual and group therapy services or allow these 
terms to be generally used interchangeably.
    Response: Under sections 1861(jjj)(1)(C) and (D) of the Act, 
substance use counseling for OUD treatment can be provided by ``a 
professional to the extent authorized under State law to furnish such 
services,'' while individual and group therapy can be ``with a 
physician or psychologist (or other mental health professional to the 
extent authorized under State law).'' Consistent with the statute, in 
the proposed rule we did not propose to limit the professionals that 
can provide these services to physicians, psychologists, or other 
practitioners who can bill Medicare directly. Instead, we noted that 
the professionals that could provide such services could include 
licensed professional counselors, licensed clinical alcohol and drug 
counselors, and certified peer specialists that are permitted to 
furnish this type of therapy or counseling by state law and scope of 
practice. To the extent that the individuals furnishing therapy or 
counseling services are not authorized under state law to furnish such 
services, the therapy or counseling services provided by these 
professionals would not be covered as OUD treatment services. Regarding 
the commenters' request for clarification of the distinction between 
substance use counseling and therapy services, we are not specifying 
the differences between these two types of services, but would note 
that different types of professionals may be authorized to furnish 
substance use counseling versus therapy services under state law. 
Regarding the comments that supported allowing licensed mental health 
professionals to directly bill Medicare for counseling and therapy 
services provided in an OTP, we note that only OTPs can bill for the 
bundled payment for furnishing OUD treatment services.
    Comment: Several commenters opined on the types of toxicology 
testing that should be included in the definition of OUD treatment 
services. One commenter recommended that we clarify the language 
regarding ``toxicology testing'' in the definition of OUD treatment 
services to include ``presumptive and definitive drug testing in line 
with clinical best practice'' to better de-stigmatize the use of these 
services. Other commenters suggested that only presumptive toxicology 
testing be included in the definition and that definitive testing be 
billed separately under the Medicare Clinical Laboratory Fee Schedule 
(CLFS). Alternatively, if definitive testing were to be included, 
commenters suggested that the bundled payment rate should be updated to 
reflect the cost of this type of toxicology testing by increasing the 
bundled payment rate or establishing add-on payments for definitive 
testing. Commenters raised the differences in complexities and costs 
between presumptive and definitive toxicology testing. These commenters 
explained that presumptive testing is an initial test that is conducted 
through point of care rapid result cup testing, which has testing and 
accuracy limitations. OTPs typically perform presumptive toxicology 
testing for drugs of abuse on-site using cups and dipsticks that 
indicate the presence or absence of drug classes as long as the test 
systems that are used are classified as waived test systems under the 
regulations implementing the Clinical Laboratory Improvement Amendments 
(CLIA) (Pub. L. 100-578, enacted October 31, 1988), as amended, 42 CFR 
part 493, and the OTP has a valid certificate of waiver that authorizes 
it to perform CLIA waived tests.
    Due to limitations of presumptive testing, OTPs may also send urine 
samples to reference labs for definitive drug testing to make sure they 
know exactly which drugs have been ingested. Definitive drug testing 
uses liquid or gas chromatography coupled with mass spectrometry to 
identify hundreds of specific drugs and their metabolites. Definitive 
drug testing identifies and precisely quantifies specific drugs and/or 
metabolites that are positive in a sample. A treating physician may 
order a confirmatory test despite the outcome of the presumptive 
testing to obtain more information on the drugs that a patient is 
taking. Commenters raised the cost differences under the CY 2019 
Medicare CLFS between the two types of tests ranging from $12.60-$64.65 
for presumptive testing to $114.43-$246.92 for definitive testing. Some 
commenters requested clarification of the distinction between the 
toxicology testing that would be included in the definition of OUD 
treatment services and would be paid under the bundle and medically-
necessary toxicology testing that is billed and paid under the Medicare 
CLFS.
    Response: We noted in the CY 2020 PFS proposed rule that under 
SAMHSA certification standards at Sec.  8.12(f)(6), OTPs are required 
to provide adequate testing or analysis for drugs of abuse, including 
at least eight random drug abuse tests per year, per patient in 
maintenance treatment in accordance with generally accepted clinical 
practice. These drug abuse tests are used for diagnosing, monitoring 
and evaluating progress in treatment (84 FR 40527). Consistent with the 
discussion of the different types of toxicology testing in the proposed 
rule, we are clarifying that the reference to toxicology testing in the 
definition of OUD treatment services includes both presumptive and 
definitive testing. We are also clarifying that all types of toxicology 
testing that are used for diagnosing, monitoring and evaluating the 
progress in treatment at the OTP are included in the definition of OUD 
treatment services and would be paid under the bundled payment. 
Toxicology tests that are unrelated to the care and treatment for OUD 
at an OTP may be paid separately under the CLFS, if reasonable and 
necessary, since toxicology tests for these purposes are not included 
in the bundled payments to OTPs. CMS expects that the ordering

[[Page 62634]]

practitioner would document the medical necessity for this additional 
testing in the beneficiary's medical record.
    Comment: Many commenters supported the inclusion of intake 
activities, such as the initial physician examination, initial 
assessment and preparation of a treatment plan, as well as periodic 
assessments in the definition of OUD treatment services. One of the 
commenters noted these were significant activities performed by the 
treatment teams that were not included in the proposed bundle, nor are 
they paid for separately in the OTPs, and stated these services should 
be included. Another commenter stated that initial assessment and 
treatment planning activities are generally the first part of OUD 
treatment and that treatment planning cannot always be linear and must, 
at times, be revised. The commenter noted that these activities are 
typical of any substance abuse treatment program and should be included 
in the definition of OUD treatment services.
    Response: We agree with commenters that intake activities, such as 
the initial physician examination, initial assessment and preparation 
of a treatment plan, should be included in the definition of OUD 
treatment services. We also agree with commenters that periodic 
assessment should be included in the definition of OUD treatment 
services. We note that an initial medical examination and both initial 
and periodic assessments are required under the SAMHSA regulations. 
Specifically, under the SAMHSA requirements at Sec.  8.12(f)(2), OTPs 
shall require each patient to undergo a complete, fully documented 
physical evaluation by a program physician or a primary care physician, 
or an authorized healthcare professional under the supervision of a 
program physician, before admission to the OTP. The full medical 
examination, including the results of serology and other tests, must be 
completed within 14 days following admission.
    Under Sec.  8.12(f)(4), OTPs are required to do initial and 
periodic assessments. Each patient accepted for treatment at an OTP 
shall be assessed initially and periodically by qualified personnel to 
determine the most appropriate combination of services and treatment. 
The initial assessment must include 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, psychosocial, economic, legal, or other supportive 
services that a patient needs. The treatment plan also must identify 
the frequency with which these services are to be provided. The plan 
must be reviewed and updated to reflect that patient's personal 
history, his or her current needs for medical, social, and 
psychological services, and his or her current needs for education, 
vocational rehabilitation, and employment services. We understand that 
intake activities and periodic assessments are integral services for 
the establishment and maintenance of OUD treatment for a beneficiary at 
an OTP. Therefore, we are believe it is reasonable to include these 
services in the definition of OUD treatment services. Accordingly, we 
are finalizing a revised definition of OUD treatment services in Sec.  
410.67(b) that reflects the required intake activities and periodic 
assessments. We discuss coding and payment for these services in the 
Coding section below.
    Comment: A few commenters requested that CMS publish a detailed 
list of the items and services that are covered as OUD treatment 
services and would be included in the bundled payment to the OTPs.
    Response: The items and services included in the definition of OUD 
treatment services are listed in the preamble of this final rule and in 
the regulations at Sec.  410.67(b). We note that the items and services 
that are medically-necessary for OUD treatment could in some cases also 
be furnished and billed by other Medicare practitioners under another 
Medicare benefit category. For example, we anticipate that some 
beneficiaries receiving counseling or therapy as part of an OTP bundle 
of services may also be receiving medically reasonable and necessary 
counseling or therapy as part of a physician's service during the same 
time period. In this scenario, the counseling or therapy provided as 
part of a physician's service could be billed separately.
    Comment: One commenter supported a definition of OUD treatment 
services that would allow for coverage of innovative therapies in 
development that have not yet been approved by the FDA for treatment of 
OUD. The commenter suggested changing the proposed regulatory language 
in Sec.  410.67(b)(1) to ``Therapies approved by the Food and Drug 
Administration under section 505 of the Federal, Food, Drug, and 
Cosmetic Act for use in treatment of opioid use disorder.'' A few 
commenters recommended that drugs used for opioid detoxification 
withdrawal and management maintenance such as naloxone, clonidine, and 
lofexidine be included in the definition of OUD treatment services.
    Response: We thank the commenters for their feedback on including 
drugs that are not opioid agonist or antagonist medications in the 
definition of OUD treatment services. For CY 2020, we are finalizing a 
definition of OUD treatment services that reflects the statutory 
requirement in section 1861(jjj)(1)(A) of the Act to include opioid 
agonist and antagonist treatment medications approved by the FDA in the 
definition of OUD treatment services. We will consider these comments 
on additional drugs to include in the definition of OUD treatment 
services under our discretionary authority in section 1861(jjj)(1)(F) 
of the Act as we continue to work on refining this new Medicare benefit 
in future rulemaking.
    Comment: In response to the request for comment on adding various 
other types of items and services to the definition of OUD treatment 
services, several commenters indicated that case management and care 
coordination are services furnished by OTPs and should be included in 
the definition of OUD treatment services. Some commenters also 
requested that peer-to-peer support, crisis management, and non-opioid 
alternative treatment be included in the definition of OUD treatment 
services. One commenter urged CMS to include Medical Nutrition Therapy 
services that are furnished by registered dietician nutritionists as a 
core component of OTPs because individuals with OUD suffer from 
gastrointestinal issues, eating disorders and malnutrition. The 
commenter stated it is essential that CMS build a payment model that 
leverages the different expertises of the full health care team, 
including registered dietician nutritionists. Another commenter urged 
CMS to include physical therapy within the list of OUD treatment 
services and recommended adjusting the bundled payment rates to account 
for instances in which effective treatment requires physical therapy 
and other nonpharmacological treatment services. Some commenters noted 
that the proposed bundled payment should include both e-prescribing and 
behavioral health information technology consultation and support 
services. One commenter urged that the definition of OUD treatment 
services include services performed by pharmacists including 
psychiatric pharmacists, such as medication adherence, management, and 
education or counseling. Some commenters suggested adding other 
laboratory tests, including HIV, Hepatitis, liver disease,

[[Page 62635]]

or infectious diseases. Other commenters noted SAMHSA requirements for 
treatment for tobacco use disorder, alcohol use disorder, and family 
services for OTPs and recommended that these should be included in the 
definition of OUD treatment.
    Response: We appreciate the comments recommending additional types 
of items and services that could be added to the definition of OUD 
treatment services. For CY 2020, we are finalizing a definition of OUD 
treatment services that includes those items and services that we 
understand are required for all OTPs to furnish as specified in SAMHSA 
regulations (part 8). Because this is the first year of the OTP 
benefit, we believe it would be premature to include in the definition 
additional items and services until we have additional information 
regarding their use by OTPs in the treatment of Medicare beneficiaries 
with OUD. However, we note that the definition of OUD treatment 
services does not prevent an OTP from furnishing the additional items 
and services suggested above in accordance with best practices as 
clinically appropriate, SAMHSA regulations and guidance, and State law. 
We may consider the items and services suggested by commenters further 
as we continue to work on refining this new Medicare benefit in future 
rulemaking. Accordingly, we are interested in continued feedback and 
data on the specific items and services, including their frequency, 
furnished to beneficiaries by an OTP.
    After consideration of the public comments, we are finalizing our 
proposal to include the five statutorily-required items and services in 
the definition of OUD treatment services in Sec.  410.67(b). For the 
reasons discussed previously, we will also include intake activities 
and periodic assessments required under Sec.  8.14(f)(4) in the 
definition of OUD treatment services in Sec.  410.67(b).
b. Opioid Treatment Program
    Section 2005 of the SUPPORT Act also amended section 1861 of the 
Act by adding a new subsection (jjj)(2) to define an OTP as an entity 
meeting the definition of OTP in 42 CFR 8.2 or any successor regulation 
(that is, a program or practitioner engaged in opioid treatment of 
individuals with an opioid agonist treatment medication registered 
under 21 U.S.C. 823(g)(1)), that meets the additional requirements set 
forth in subparagraphs (A) through (D) of section 1861(jjj)(2) of the 
Act. Specifically, the OTP:
     Is enrolled under section 1866(j) of the Act;
     Has in effect a certification by SAMHSA for such a 
program;
     Is accredited by an accrediting body approved by SAMHSA; 
and
     Meets such additional conditions as the Secretary may find 
necessary to ensure the health and safety of individuals being 
furnished services under such program and the effective and efficient 
furnishing of such services.
    These requirements are discussed in more detail in this section.
(1) Enrollment
    As discussed previously, under section 1861(jjj)(2)(A) of the Act, 
an OTP must be enrolled in Medicare to receive Medicare payment for 
covered OUD treatment services under section 1861(jjj)(1) of the Act. 
We refer the reader to section III.H. of this final rule, Medicare 
Enrollment of Opioid Treatment Programs, for further details on our 
policies related to enrollment of OTPs.
(2) Certification by SAMHSA
    As provided in section 1861(jjj)(2)(B) of the Act, OTPs must be 
certified by SAMHSA to furnish Medicare-covered OUD treatment services. 
SAMHSA has created a system to certify and accredit OTPs, which is 
governed by part 8, subparts B and C. This regulatory framework allows 
SAMHSA to focus its oversight efforts on improving treatment rather 
than solely ensuring that OTPs are meeting regulatory criteria, and 
preserves states' authority to regulate OTPs. To be certified by 
SAMHSA, OTPs must comply with the federal opioid treatment standards as 
outlined in Sec.  8.12, be accredited by a SAMHSA-approved 
accreditation body, and comply with any other conditions for 
certification established by SAMHSA. Specifically, SAMHSA requires OTPs 
to provide the following services:
     General--OTPs shall provide adequate medical, counseling, 
vocational, educational, and other assessment and treatment services.
     Initial medical examination services--OTPs shall require 
each patient to undergo a complete, fully documented physical 
evaluation by a program physician or a primary care physician, or an 
authorized healthcare professional under the supervision of a program 
physician, before admission to the OTP.
     Special services for pregnant patients--OTPs must maintain 
current policies and procedures that reflect the special needs of 
patients who are pregnant. Prenatal care and other gender specific 
services for pregnant patients must be provided either by the OTP or by 
referral to appropriate healthcare providers.
     Initial and periodic assessment services--Each patient 
accepted for treatment at an OTP shall be assessed initially and 
periodically by qualified personnel to determine the most appropriate 
combination of services and treatment.
     Counseling services--OTPs must provide adequate substance 
abuse counseling to each patient as clinically necessary by a program 
counselor, qualified by education, training, or experience to assess 
the patient's psychological and sociological background.
     Drug abuse testing services--OTPs must provide adequate 
testing or analysis for drugs of abuse, including at least eight random 
drug abuse tests per year, per patient in maintenance treatment, in 
accordance with generally accepted clinical practice. For patients in 
short-term detoxification treatment, defined in Sec.  8.2 as 
detoxification treatment not in excess of 30 days, the OTP shall 
perform at least one initial drug abuse test. For patients receiving 
long-term detoxification treatment, the program shall perform initial 
and monthly random tests on each patient.
    The provisions governing recordkeeping and patient confidentiality 
at Sec.  8.12(g)(1) require that OTPs shall establish and maintain a 
recordkeeping system that is adequate to document and monitor patient 
care. All records are required to be kept confidential in accordance 
with all applicable federal and state requirements. The requirements at 
Sec.  8.12(g)(2) state that OTPs shall document in each patient's 
record that the OTP made a good faith effort to review whether or not 
the patient is enrolled in any other OTP. A patient enrolled in an OTP 
shall not be permitted to obtain treatment in any other OTP except in 
exceptional circumstances, as determined by the medical director or 
program physician of the OTP in which the patient is enrolled (Sec.  
8.12(g)(2)). Additionally, the requirements at Sec.  8.12(h) address 
medication administration, dispensing, and use.
    SAMHSA requires that OTPs shall ensure that opioid agonist 
treatment medications are administered or dispensed only by a 
practitioner licensed under the appropriate state law and registered 
under the appropriate state and federal laws to administer or dispense 
opioid drugs, or by an agent of such a practitioner, supervised by and 
under the order of the licensed practitioner. OTPs shall use only those

[[Page 62636]]

opioid agonist treatment medications that are approved by the FDA for 
use in the treatment of OUD. They must maintain current procedures that 
are adequate to ensure that the dosing requirements are met, and each 
opioid agonist treatment medication used by the program is administered 
and dispensed in accordance with its approved product labeling.
    At Sec.  8.12(i), regarding unsupervised or ``take-home'' use of 
opioid agonist treatment medications, SAMHSA has specified that OTPs 
must follow requirements specified by SAMHSA to limit the potential for 
diversion of opioid agonist treatment medications to the illicit market 
when dispensed to patients as take-homes, including maintaining current 
procedures to identify the theft or diversion of take-home medications. 
The requirements at Sec.  8.12(j) for interim maintenance treatment, 
state that the program sponsor of a public or nonprofit private OTP 
subject to the approval of SAMHSA and the state, may place an 
individual, who is eligible for admission to comprehensive maintenance 
treatment, in interim maintenance treatment if the individual cannot be 
placed in a public or nonprofit private comprehensive program within a 
reasonable geographic area and within 14 days of the individual's 
application for admission to comprehensive maintenance treatment. 
Patients in interim maintenance treatment are permitted to receive 
daily dosing, but take-homes are not permitted. During interim 
maintenance treatment, initial treatment plans and periodic treatment 
plan evaluations are not required and a primary counselor is not 
required to be assigned to the patient. The OTP must be able to 
transfer these patients from interim maintenance into comprehensive 
maintenance treatment within 120 days. Interim maintenance treatment 
must be provided in a manner consistent with all applicable federal and 
state laws.
    The SAMHSA requirements at Sec.  8.12(b) address administrative and 
organizational structure, requiring that an OTP's organizational 
structure and facilities shall be adequate to ensure quality patient 
care and meet the requirements of all pertinent federal, state, and 
local laws and regulations. At a minimum, each OTP shall formally 
designate a program sponsor and medical director who is a physician who 
is licensed to practice medicine in the jurisdiction in which the OTP 
is located. The program sponsor shall agree on behalf of the OTP to 
adhere to all requirements set forth in part 8, subpart C, and any 
regulations regarding the use of opioid agonist treatment medications 
in the treatment of OUD that may be promulgated in the future. The 
medical director shall assume responsibility for administering all 
medical services performed by the OTP. In addition, the medical 
director shall be responsible for ensuring that the OTP is in 
compliance with all applicable federal, state, and local laws and 
regulations.
    The provision governing patient admission criteria at Sec.  8.12(e) 
requires that an OTP shall maintain current procedures designed to 
ensure that patients are admitted to maintenance treatment by qualified 
personnel who have determined, using accepted medical criteria such as 
those listed in the Diagnostic and Statistical Manual of Mental 
Disorders, that the person has had an OUD for at least 1 year before 
admission for treatment. If under 18 years of age, the patient is 
required to have had two documented unsuccessful attempts at short-term 
detoxification or drug-free treatment within a 12-month period and have 
the written consent of a parent, legal guardian, or responsible adult 
designated by the relevant state authority, to be eligible for 
maintenance treatment.
    To ensure continuous quality improvement, the requirements at Sec.  
8.12(c) state that an OTP must maintain current quality assurance and 
quality control plans that include, among other things, annual reviews 
of program policies and procedures and ongoing assessment of patient 
outcomes, and a current Diversion Control Plan as part of its quality 
assurance program.
    The requirements at Sec.  8.12(d) with respect to staff 
credentials, state that each person engaged in the treatment of OUD 
must have sufficient education, training, and experience, or any 
combination thereof, to enable that person to perform the assigned 
functions. In addition, all physicians, nurses, and other licensed 
professional care providers, including addiction counselors, must 
comply with the credentialing requirements of their respective 
professions.
    In addition to meeting the criteria described above, OTPs must 
apply to SAMHSA for certification. As part of the conditions for 
certification, SAMHSA specifies that OTPs shall:
     Comply with all pertinent state laws and regulations.
     Allow inspections and surveys by duly authorized employees 
of SAMHSA, by accreditation bodies, by the DEA, and by authorized 
employees of any relevant State or federal governmental authority.
     Comply with the provisions of 42 CFR part 2 (regarding 
confidentiality of SUD patient records).
     Notify SAMHSA within 3 weeks of any replacement or other 
change in the status of the program sponsor or medical director.
     Comply with all regulations enforced by the DEA under 21 
CFR chapter II, and be registered by the DEA before administering or 
dispensing opioid agonist treatment medications.
     Operate in accordance with federal opioid treatment 
standards and approved accreditation elements.
    Furthermore, SAMHSA has issued additional guidance for OTPs that 
describes how programs can achieve and maintain compliance with federal 
regulations.\34\
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    \34\ https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf.
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(3) Accreditation of OTPs by a SAMHSA-Approved Accrediting Body
    As provided in section 1861(jjj)(2)(C) of the Act, OTPs must be 
accredited by a SAMHSA-approved accrediting body in order to furnish 
Medicare-covered OUD treatment services. In 2001, the Department of 
Health and Human Services (HHS) and SAMHSA issued final regulations to 
establish a new oversight system for the treatment of SUDs with MAT 
(part 8). SAMHSA-approved accrediting bodies evaluate OTPs and perform 
site visits to ensure SAMHSA's opioid dependency treatment standards 
are met. SAMHSA also requires OTPs to be accredited by a SAMHSA-
approved accrediting body (Sec.  8.11).
    The SAMHSA regulations establish procedures for an entity to apply 
to become a SAMHSA-approved accrediting body (Sec.  8.3). When 
determining whether to approve an applicant as an accreditation body, 
SAMHSA examines the following:
     Evidence of the nonprofit status of the applicant (that 
is, of fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a state governmental entity or 
political subdivision;
     The applicant's accreditation elements or standards and a 
detailed discussion showing how the proposed accreditation elements or 
standards will ensure that each OTP surveyed by the applicant is 
qualified to meet or is meeting each of the federal opioid treatment 
standards set forth in Sec.  8.12;
     A detailed description of the applicant's decision-making 
process, including:
    ++ Procedures for initiating and performing onsite accreditation 
surveys of OTPs;

[[Page 62637]]

    ++ Procedures for assessing OTP personnel qualifications;
    ++ Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs 
during the accreditation process;
    ++ Policies and procedures for notifying OTPs and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTPs; 
for suspending or revoking an OTP's accreditation; and to ensure 
processing of applications for accreditation and for renewal of 
accreditation within a timeframe approved by SAMHSA; and;
    ++ A description of the applicant's appeals process to allow OTPs 
to contest adverse accreditation decisions.
     Policies and procedures established by the accreditation 
body to avoid conflicts of interest, or the appearance of conflicts of 
interest;
     A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician on the applicant's staff;
     A description of the applicant's training policies;
     Fee schedules, with supporting cost data;
     Satisfactory assurances that the applicant will comply 
with the requirements of Sec.  8.4, including a contingency plan for 
investigating complaints under Sec.  8.4(e);
     Policies and procedures established to protect 
confidential information the applicant will collect or receive in its 
role as an accreditation body; and
     Any other information SAMHSA may require.
    SAMHSA periodically evaluates the performance of accreditation 
bodies primarily by inspecting a selected sample of the OTPs accredited 
by the accrediting body and by evaluating the accreditation body's 
reports of surveys conducted, to determine whether the OTPs surveyed 
and accredited by the accreditation body are in compliance with the 
federal opioid treatment standards. There are currently six SAMHSA-
approved accreditation bodies.\35\
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    \35\ https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-accrediting-bodies/approved.
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(4) Provider Agreement
    Section 2005(d) of the SUPPORT Act amended section 1866(e) of the 
Act by adding a new paragraph (3) which includes OTPs (but only with 
respect to the furnishing of OUD treatment services) as a ``provider of 
services'' for purposes of section 1866 of the Act. All providers of 
services under section 1866 of the Act must enter into a provider 
agreement with the Secretary and comply with other requirements 
specified in that section. These requirements are codified at 42 CFR 
part 489. Therefore, we proposed to amend part 489 to include OTPs (but 
only for furnishing OUD treatment services) as a provider. 
Specifically, we proposed to add OTPs (but only for the furnishing of 
OUD treatment services) to the list of providers in Sec.  489.2. This 
addition makes clear that the other requirements specified in section 
1866 of the Act, and implemented in part 489, which include the limits 
on charges to beneficiaries, will apply to OTPs (in connection with the 
furnishing of OUD treatment services). We also proposed additional 
changes to make clear that certain parts of part 489, which implement 
statutory requirements other than section 1866 of the Act, do not apply 
to OTPs. For example, since we did not propose any conditions of 
participation for OTPs, we proposed to amend Sec.  489.10(a), which 
states that providers specified in Sec.  489.2 must meet conditions of 
participation, to add that OTPs must meet the requirements set forth in 
part 489 and elsewhere in that chapter. In addition, we proposed to 
specify that the effective date of the provider agreement is the date 
on which CMS accepts a signed agreement (proposed amendment to Sec.  
489.13(a)(2)), and is not dependent on surveys or an accrediting 
organization's determination related to conditions of participation. As 
noted earlier in the preamble to this final rule, OTPs are required to 
be certified by SAMHSA and accredited by an accrediting body approved 
by SAMHSA. In Sec.  489.53, we proposed to create a basis for 
termination of the provider agreement if the OTP no longer meets the 
requirements set forth in part 489 or elsewhere in that chapter 
(including if it no longer has a SAMHSA certification or accreditation 
by a SAMHSA-approved accrediting body). Finally, we proposed to revise 
42 CFR part 498 to ensure that OTPs have access to the appeal process 
in case of an adverse determination concerning continued participation 
in the Medicare program. Specifically, we proposed to amend the 
definition of provider in Sec.  498.2 to include OTPs. We also 
indicated that we would continue to review the application of the 
provider agreement requirements to OTPs to determine whether any 
further amendments to parts 489 and 498 were needed to ensure that the 
existing provider agreement regulations are applied to OTPs consistent 
with our proposals and section 2005 of the SUPPORT Act.
    Comment: Multiple commenters questioned whether provider 
agreements, once executed, will be made retroactive to January 1, 2020.
    Response: We proposed in Sec.  489.13(a)(2)(i) that the effective 
date of an OTP provider agreement would be the date on which we accept 
a signed agreement that ensures that the OTP meets all federal 
requirements. Yet, as discussed in section III.H of the final rule we 
also proposed retrospective billing dates in Sec.  424.520(d) and Sec.  
424.521(a) if the requirements of those sections were met. To ensure 
that the provider agreement and billing effective dates are uniform, we 
are not finalizing our proposed change to Sec.  489.13(a)(2)(i). 
Instead, we will establish a new Sec.  489.13(a)(2)(iii) stating that 
the provider agreement effective date is to be consistent with the 
billing effective date established pursuant Sec.  424.520(d) or Sec.  
424.521(a), as applicable. In sum, the effective dates of OTP provider 
agreements will not automatically be made retroactive to January 1, 
2020, but will instead be governed by Sec.  489.13(a)(2)(iii).
    After consideration of comments received, we are making changes to 
Sec.  489.13(a)(2)(i) to align with the provider agreement effective 
date to the billing effective date under Sec.  424.520(d) or Sec.  
424.521(a), as applicable. We did not receive any other comments on the 
proposals for the provider agreement requirements in Sec. Sec.  489.2, 
489.10, 489.43, and 498.2., and are finalizing these changes as 
proposed.
(5) Additional Conditions
    As provided in section 1861(jjj)(2)(D) of the Act, to furnish 
Medicare-covered OUD treatment services, OTPs must meet any additional 
conditions as the Secretary may find necessary to ensure the health and 
safety of individuals being furnished services under such program and 
the effective and efficient furnishing of such services. The 
comprehensive OTP standards for certification of OTPs address the same 
topics as would be addressed by CMS supplier standards, such as client 
assessment and the services required to be provided. Furthermore, the 
detailed process established by SAMHSA for selecting and overseeing its 
accreditation organizations is similar to the accrediting organization 
oversight process that would typically be established by CMS. Thus, in 
the proposed rule, we stated that we believe the existing SAMHSA 
certification and accreditation requirements are both

[[Page 62638]]

appropriate and sufficient to ensure the health and safety of 
individuals being furnished services by OTPs, as well as the effective 
and efficient furnishing of such services. We also indicated that we 
believe that creating additional conditions at this time for 
participation in Medicare by OTPs could create unnecessary regulatory 
duplication and could be potentially burdensome for OTPs. Therefore, we 
did not propose any additional conditions for participation in Medicare 
by OTPs in the CY 2020 PFS proposed rule. We solicited public comments 
on our proposed approach, including input on whether there are any 
additional conditions that should be required for OTPs furnishing 
Medicare-covered OUD treatment services.
(6) Proposed Definition of Opioid Treatment Program
    We proposed to define ``opioid treatment program'' at Sec.  
410.67(b) as an entity that is an OTP as defined in Sec.  8.2 (or any 
successor regulation) and meets the applicable requirements for an OTP. 
We proposed to codify this definition at Sec.  410.67(b). In addition, 
we proposed that for an OTP to participate and receive payment under 
the Medicare program, the OTP must be enrolled under section 1866(j) of 
the Act, have in effect a certification by SAMHSA for such a program, 
and be accredited by an accrediting body approved by SAMHSA. We also 
proposed that an OTP must have a provider agreement as required by 
section 1866(a) of the Act. We proposed to codify these requirements at 
Sec.  410.67(c). We solicited public comments on the proposed 
definition of OTP and the proposed Medicare requirements for OTPs.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters generally supported the proposed definition of 
OTP, including the requirements that OTPs be enrolled under section 
1866(j) of the Act, have in effect a certification by SAMHSA for such a 
program, and be accredited by an accrediting body approved by SAMHSA. 
One commenter stated that these policies represent only the start of an 
ongoing effort to address the opioid epidemic.
    Response: We appreciate the support for the proposed definition of 
OTPs. We understand the importance of combating the opioid epidemic and 
intend to monitor the implementation of this new Medicare benefit and 
may propose further refinements in future rulemaking. After 
consideration of the comments received, we are finalizing our proposed 
definition of ``opioid treatment program'' at Sec.  410.67(b).
    Comment: Commenters supported the proposed Medicare requirements 
for OTPs, including the requirement that they have in effect a provider 
agreement with the Secretary. One commenter welcomed CMS' reminder to 
providers that being a Medicare provider carries with it a limit on 
charges to beneficiaries, and stated that in addition to the proposal 
for zero cost sharing for OTP services, this policy would help to 
protect beneficiary access to care and economic security.
    Response: We appreciate the support for the proposal to require 
OTPs to enter into a provider agreement and are finalizing this 
requirement at Sec.  410.67(c), along with Sec.  424.67(b). 
Additionally, we reiterate that as indicated in the Health Insurance 
Benefit Agreement (Form CMS-1561),\36\ the provider agrees to conform 
to the provisions of section 1866 of the Social Security Act and the 
applicable provisions in Title 42 Code of Federal Regulations (CFR), 
which in part establish the requirement that a provider must accept 
assignment of Medicare payment.
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    \36\ https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1561.pdf.
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    Comment: Many commenters supported CMS' view that the comprehensive 
OTP standards for certification of OTPs established by SAMHSA address 
the same topics as would be addressed by CMS conditions of 
participation, and that the detailed process established by SAMHSA for 
selecting and overseeing its accreditation organizations is similar to 
the accrediting organization oversight process that would typically be 
established by CMS. Furthermore, commenters agreed with CMS' conclusion 
that the existing SAMHSA certification and accreditation requirements 
are both appropriate and sufficient to ensure the health and safety of 
individuals receiving services from OTPs, as well as the effective and 
efficient furnishing of such services. Commenters also noted the 
regulations established by the DEA and the regulations established by 
states for licensure purposes as additional assurances of patient 
health and safety. The commenters agreed that creating additional 
conditions at this time for participation in Medicare by OTPs could 
create unnecessary regulatory duplication and could be potentially 
burdensome for OTPs. Thus, the commenters supported the proposal to 
accept the existing SAMHSA requirements for certification and 
accreditation as the health and safety standards that must be met in 
order for an OTP to participate in Medicare.
    Response: We are finalizing our proposal to adopt the existing 
SAMHSA requirements for certification and accreditation as the health 
and safety standards that must be met in order for an OTP to 
participate in Medicare. This approach will avoid unnecessary 
regulatory duplication while assuring Medicare beneficiary safety at 
OTPs.
    After consideration of the comments, we are finalizing the proposed 
definition of ``opioid treatment program'' at Sec.  410.67(b). We are 
also finalizing the proposed Medicare requirements for OTPs at Sec.  
410.67(c). Specifically, in order for an OTP to participate and receive 
payment under the Medicare program, the OTP must be enrolled under 
section 1866(j) of the Act, have in effect certification by SAMHSA, and 
be accredited by an accrediting body approved by SAMHSA. Additionally, 
we are finalizing our proposal that an OTP must have a provider 
agreement as required by section 1866(a) of the Act.
3. Bundled Payments for OUD Treatment Services
    Section 1834(w) of the Act, added by section 2005 of the SUPPORT 
Act, directs the Secretary to pay to the OTP an amount that is equal to 
100 percent of a bundled payment for OUD treatment services that are 
furnished by the OTP to an individual during an episode of care. We 
proposed to establish bundled payments for OUD treatment services 
which, as discussed above, would include the medications approved by 
the FDA under section 505 of the FFDCA for use in the treatment of OUD; 
the dispensing and administration of such medication, if applicable; 
substance use counseling; individual and group therapy; and toxicology 
testing. In calculating the bundled payments, we proposed to apply 
separate payment methodologies for the drug component (which includes 
the medications approved by the FDA under section 505 of the FFDCA for 
use in the treatment of OUD) and the non-drug component (which includes 
the dispensing and administration of such medications, if applicable; 
substance use counseling; individual and group therapy; and toxicology 
testing) of the bundled payments. We proposed to calculate the full 
bundled payment rate by combining the drug component and the non-drug 
components. We outlined our proposals for determining the bundled 
payments for OUD treatment services addressing payment rates for these 
services under the Medicaid and

[[Page 62639]]

TRICARE programs, duration of the episode of care for which the bundled 
payment is made (including partial episodes), methodology for 
determining bundled payment rates for the drug and non-drug components, 
site of service, coding and beneficiary cost sharing. We proposed to 
codify the methodology for determining the bundled payment rates for 
OUD treatment services at Sec.  410.67(d).
    We received a number of public comments on the proposed approach to 
calculating the full bundled payment rate. The following is a summary 
of the comments we received and our responses.
    Comment: A few commenters supported the proposal to calculate the 
full bundled payment rate by combining the drug component and the non-
drug components. Another commenter stated that clinical services, such 
as individual and group counseling, should be billed separately from 
the medication.
    Response: Section 1861(jjj) of the Act defines OUD treatment 
services to include certain opioid treatment medications furnished by 
an OTP, as well as other services such as substance use counseling and 
individual and group therapy. Section 1834(w) of the Act instructs the 
Secretary to make a bundled payment for the services that are furnished 
by an OTP to an individual during an episode of care. We do not believe 
the statute supports unbundling the medications from the other OUD 
treatment services furnished by OTPs during the same episode of care.
    After consideration of the public comments, we are finalizing our 
proposal to calculate the full bundled payment rate for services 
furnished by OTPs by combining the drug component and the non-drug 
components. We are codifying the methodology for determining the 
bundled payment rates for OUD treatment services at Sec.  410.67(d).
a. Review of Medicaid and TRICARE Programs
    Section 1834(w)(2) of the Act, added by section 2005(c) of the 
SUPPORT Act, provides that in developing the bundled payment rates for 
OUD treatment services furnished by OTPs, the Secretary may consider 
payment rates paid to the OTPs for comparable services under the state 
plans under title XIX of the Act (Medicaid) or under the TRICARE 
program under chapter 55 of title 10 of the United States Code 
(U.S.C.). The payments for comparable services under TRICARE and 
Medicaid programs are discussed below. In the proposed rule, we 
acknowledged that many private payers cover services furnished by OTPs, 
and welcomed comment on the scope of private payer OTP coverage and the 
payment rates private payers have established for OTPs furnishing 
comparable OUD treatment services. We also indicated that we might 
consider this information as part of the development of the final 
bundled payment rates for OUD treatment services furnished by OTPs.
(1) TRICARE
    In the ``TRICARE: Mental Health and Substance Use Disorder 
Treatment'' final rule, which appeared in the September 2, 2016 Federal 
Register (81 FR 61068) (hereinafter referred to as the 2016 TRICARE 
final rule), the Department of Defense (DOD) finalized its methodology 
for determining payments for services furnished to TRICARE 
beneficiaries by an OTP in the regulations at 32 CFR 199.14(a)(2)(ix). 
The payments are also described in Chapter 7, Section 5 and Chapter 1, 
Section 15 of the TRICARE Reimbursement Manual 6010.61-M, April 1, 
2015. As discussed in the 2016 TRICARE final rule, a number of 
commenters indicated that they believed the rates established by DOD 
are near market rates and acceptable (81 FR 61079).
    In the 2016 TRICARE final rule, DOD established separate payment 
methodologies for treatment in OTPs based on the particular medication 
being administered. DOD finalized a weekly all-inclusive per diem rate 
for OTPs when furnishing methadone for MAT. Under 32 CFR 
199.14(a)(2)(ix)(A)(3)(i), this weekly rate includes the cost of the 
drug and the cost of related non-drug services (that is, the costs 
related to intake/assessment, drug dispensing and screening and 
integrated psychosocial and medical treatment and supportive services), 
hereafter referred as the non-drug services. In the proposed rule (84 
FR 40524), we noted that the services included in the TRICARE weekly 
bundle are generally comparable to the definition of OUD treatment 
services in section 2005 of the SUPPORT Act. The weekly all-inclusive 
per diem rate for these services was determined based on preliminary 
review of industry billing practices (which included Medicaid and other 
third-party payers) for the dispensing of methadone, including an 
estimated daily drug cost of $3 and a daily estimated cost of $15 for 
the non-drug services. These daily costs were converted to an estimated 
weekly per diem rate of $126 ($18 per day x 7 days) in the 2016 TRICARE 
final rule. Under 32 CFR 199.14(a)(2)(iv)(C)(2), this rate is updated 
annually by the Medicare hospital inpatient prospective payment system 
(IPPS) update factor. The 2019 TRICARE weekly per diem rate for 
methadone treatment in an OTP is $133.15.\37\ Beneficiary cost-sharing 
consists of a flat copayment that may be applied to this weekly rate.
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    \37\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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    DOD also established payment rates for other medications used for 
MAT (buprenorphine and extended-release injectable naltrexone) to allow 
OTPs to bill for the full range of medications available. Under 32 CFR 
199.14(a)(2)(ix)(A)(3)(ii), DOD established a fee-for-service (FFS) 
payment methodology for buprenorphine and extended-release injectable 
naltrexone because they are more likely to be prescribed and 
administered in an office-based treatment setting but are still 
available for treatment furnished in an OTP. DOD stated in the 2016 
TRICARE final rule (81 FR 61080) that treatment with buprenorphine and 
naltrexone is more variable in dosage and frequency than with 
methadone. Therefore, TRICARE pays for these medications and the 
accompanying non-drug services separately on a FFS basis. Buprenorphine 
is paid based on 95 percent of average wholesale price (AWP) and the 
non-drug component is paid on a per visit basis at an estimated cost of 
$22.50 per visit. Extended-release injectable naltrexone is paid at the 
average sales price (ASP) plus a drug administration fee while the non-
drug services are also paid at an estimated per visit cost of $22.50. 
DOD also reserved discretion to establish the payment methodology for 
new drugs and biologicals that may become available for the treatment 
of SUDs in OTPs.
    DOD instructed that OTPs use the ``Alcohol and/or other drug use 
services, not otherwise specified'' H-code for billing the non-drug 
services when buprenorphine or naltrexone is used, and required OTPs to 
also include both the J-code and the National Drug Code (NDC) for the 
drug used, as well as the dosage and acquisition cost on the claim 
form.\38\ Drugs listed on Medicare's Part B ASP files are paid using 
the ASP.\39\ Drugs not appearing on the Medicare ASP file are paid at 
the lesser of billed

[[Page 62640]]

charges or 95 percent of the AWP.\40\ Using this methodology, TRICARE 
estimated a daily drug cost of $10 for buprenorphine and a monthly drug 
cost of $1,129 for extended-release injectable naltrexone.\41\
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    \38\ 81 FR 61080.
    \39\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
    \40\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
    \41\ 81 FR 61080.
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(2) Medicaid (Title XIX)
    States have the flexibility to administer the Medicaid program to 
meet their own needs within the Medicaid program parameters set forth 
in federal statute and regulations. All states cover and pay for some 
form of medications for MAT of OUD under their Medicaid programs. 
However, as of 2018, only 42 states covered methadone for MAT for OUD 
under their Medicaid programs.\42\ We note that section 1006(b) of the 
SUPPORT Act amended sections 1902 and 1905 of the Act to require that 
Medicaid State plans cover all drugs approved under section 505 of the 
FFDCA to treat OUD, including methadone, and all biological products 
licensed under section 351 of the Public Health Service Act to treat 
OUD, beginning October 1, 2020. This requirement sunsets on September 
30, 2025.
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    \42\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport_0.pdf.
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    In reviewing Medicaid payments for OUD treatment services furnished 
by OTPs in a few states, we found significant variation in the MAT 
coverage, OUD treatment services, and payment structure among the 
states. Thus, it is difficult to identify a standardized Medicaid 
payment amount for OTP services. A number of factors such as the unit 
of payment, types of services bundled within a payment code, and how 
MAT services are paid varied among the states. For example, for 
treatment of OUD using methadone for MAT, most OTPs bill under HCPCS 
code H0020 (Alcohol and/or drug services; methadone administration and/
or service (provision of the drug by a licensed program)) under the 
Medicaid program; however, the unit of payment varies by state from 
daily, weekly, or monthly. For example, the unit of payment in 
California is daily for methadone treatment,\43\ while the unit of 
payment in Maryland for methadone maintenance is weekly,\44\ and 
Vermont uses a monthly unit\45\ of payment of these OUD treatment items 
and services.
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    \43\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \44\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \45\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
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    For the other MAT drugs, all states cover buprenorphine and the 
buprenorphine-naloxone medications;\46\ however, fewer than 70 percent 
cover the implanted or extended-release injectable versions of 
buprenorphine.\47\ In addition, all states cover the extended-release 
injectable naltrexone. \48\ We also found that many states pay 
different rates based on the specific type of drug used for MAT.
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    \46\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \47\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \48\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
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    Non-drug items and services may be included in a bundled payment 
with the drug or paid separately, depending on the state, and can 
include dosing, dispensing and administration of the drug, individual 
and group counseling, and toxicology testing. In some states, certain 
services such as assessments, individual and group counseling, and 
toxicology testing can be billed separately. For example, some states 
(such as Maryland,\49\ Texas,\50\ and California \51\) separately 
reimburse for individual and group counseling services, while other 
states (such as Vermont \52\ and New Mexico \53\) include these 
services in the OUD bundled payment.
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    \49\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \50\ http://www.tmhp.com/News_Items/2018/11-Nov/11-16-18%20Substance%20Use%20Disorder%20Benefits%20to%20Change%20for%20Texas%20Medicaid%20January%201,%202019.pdf.
    \51\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \52\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
    \53\ http://www.hsd.state.nm.us/uploads/FileLinks/e7cfb008157f422597cccdc11d2034f0/MAT_Proposed_reimb_MAD_website_pdf.pdf. https://stre.samhsa.gov/system/files/medicaidfinancingmatreport.pdfnm.us/uploads/FileLinks/c78b68d063e04ce5adffe29376ff402e/12_10_MAT_OTC_Clinics_Supp_09062012__2_.pdf.
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b. Aspects of the Bundle
(1) Duration of Bundle
    Section 1834(w)(1) of the Act requires the Secretary to pay an OTP 
an amount that is equal to 100 percent of the bundled payment for OUD 
treatment services that are furnished by the OTP to an individual 
during an episode of care (as defined by the Secretary) beginning on or 
after January 1, 2020. We proposed that the duration of an episode of 
care for OUD treatment services would be a week (that is, a contiguous 
7-day period that may start on any day of the week). As noted in the 
proposed rule, this is similar to the structure of the TRICARE bundled 
payment to OTPs for methadone, which is based on a weekly bundled rate 
(81 FR 61079), as well as the payments by some state Medicaid programs. 
Given this similarity to existing coding structures, we stated that we 
believe a weekly duration for an episode of care would be most familiar 
to OTPs, and therefore, the least disruptive to adopt. We proposed to 
define an episode of care at Sec.  410.67(b) as a 1-week (contiguous 7-
day) period; however, we also solicited comments on whether we should 
consider a daily or monthly bundled payment.
    We also recognized that patients receiving MAT are often on this 
treatment regimen for an indefinite amount of time, and therefore, we 
did not propose any maximum number of weeks during an overall course of 
treatment for OUD.
    We received a number of public comments on the duration of the 
bundled payment. The following is a summary of the comments we received 
and our responses.
    Comment: Many commenters supported the proposal to define an 
episode of care as a 1-week (contiguous 7-day) period, while several 
commenters stated that a monthly episode of care may be more 
appropriate in some circumstances, such as during the maintenance phase 
of treatment, and a few commenters supported daily bundles because that 
approach is more consistent with the payment structure under their 
state Medicaid program. Many commenters were supportive of our decision 
not to propose any maximum number of weeks for a course of treatment 
for OUD.
    Response: While we recognize that the clinical needs of patients 
may differ depending on their stage of treatment, we are finalizing our 
proposal to define an episode of care as a 1-week (contiguous 7-day) 
period. OTPs are generally familiar with weekly episodes and we believe 
use of a weekly bundle will be less disruptive to the extent that an 
OTP already has processes in place to bill for weekly episodes. We 
recognize that patients receiving MAT are often on this treatment 
regimen for an indefinite amount of time, and therefore, we are not 
imposing any limit on the maximum number of weeks

[[Page 62641]]

during an overall course of treatment for OUD.
    After consideration of the public comments, we are finalizing our 
proposal to define an episode of care as a 1-week (contiguous 7-day) 
period at Sec.  410.67(b). We are not finalizing any limit on the 
maximum number of weeks during an overall course of treatment for OUD.
(a) Requirements for an Episode
    In the proposed rule (84 FR 40525), we noted that SAMHSA requires 
OTPs to have a treatment plan for each patient that identifies the 
frequency with which items and services are to be provided (Sec.  
8.12(f)(4)). We recognized that there is a range of service intensity 
depending on the severity of a patient's OUD and stage of treatment, 
and therefore, a ``full weekly bundle'' may consist of a very different 
frequency of services for a patient in the initial phase of treatment 
compared to a patient in the maintenance phase of treatment, but that 
we would still consider the requirements to bill for the full weekly 
bundle to be met if the patient is receiving the majority of the 
services identified in their treatment plan at that time. However, for 
the purposes of valuation, we assumed one substance use counseling 
session, one individual therapy session, and one group therapy session 
per week and one toxicology test per month. Given the anticipated 
changes in service intensity over time based on the individual 
patient's needs, we explained that we expect that treatment plans would 
be updated to reflect these changes or noted in the patient's medical 
record, for example, in a progress note. In cases where the OTP has 
furnished the majority (51 percent or more) of the services identified 
in the patient's current treatment plan (including any changes noted in 
the patient's medical record) over the course of a week, we proposed 
that it could bill for a full weekly bundle. We proposed to codify the 
payment methodology for full episodes of care (as well as partial 
episodes of care and non-drug episodes of care, as discussed below) in 
Sec.  410.67(d)(2).
    Comment: Several commenters stated that the frequency of services 
listed in the proposed rule for a typical case (we assumed one 
substance use counseling session, one individual therapy session, and 
one group therapy session per week and one toxicology test per month) 
would usually only occur during the initial phase of treatment/
stabilization.
    Response: We reiterate that we understand that the frequency of 
services will vary over time, and may be very different for a patient 
in the initial phase of treatment compared to a patient in the 
maintenance phase of treatment. We note that while we identified a set 
of services for purposes of calculating the payment rate for the weekly 
bundle, it is not a requirement for billing the bundled payment that 
all of those services be furnished in a given episode of care. Rather, 
as we discuss in more detail below, we are finalizing a policy under 
which the threshold to bill for an episode of care will be that at 
least one service was furnished to the patient during the week that 
corresponds to the episode of care.
(b) Partial Episode of Care
    As we explained in the proposed rule, we understand that there may 
be instances in which a beneficiary does not receive all of the 
services expected in a given week due to any number of issues, 
including, for example, an inpatient hospitalization during which a 
beneficiary would not be able to go to the OTP or inclement weather 
that impedes access to transportation. To provide more accurate payment 
to OTPs in cases where a beneficiary is not able to or chooses not to 
receive all items and services described in their treatment plan or the 
OTP is unable to furnish services, for example, in the case of a 
natural disaster, we proposed to establish separate payment rates for 
partial episodes that correspond with each of the full weekly bundles. 
In cases where the OTP has furnished at least one of the items or 
services (for example, dispensing one day of an oral MAT medication or 
one counseling session or one toxicology test) but less than 51 percent 
of the items and services included in OUD treatment services identified 
in the patient's current treatment plan (including any changes noted in 
the patient's medical record) over the course of a week, we proposed 
that it could bill for a partial weekly bundle. In cases in which the 
beneficiary does not receive a drug during the partial episode, we 
proposed that the code describing a non-drug partial weekly bundle must 
be used. For example, the OTP could bill for a partial episode in 
instances where the OTP is transitioning the beneficiary from one OUD 
medication to another and therefore the beneficiary is receiving less 
than a week of one type of medication. In those cases, two partial 
episodes could be billed, one for each of the medications, or one 
partial episode and one full episode, if all requirements for billing 
are met. We noted our intent to monitor this issue and to consider the 
need to make changes to this policy in future rulemaking to ensure that 
the billing for partial episodes is not being abused. We proposed to 
define a partial episode of care in Sec.  410.67(b) and to codify the 
payment methodology for partial episodes in Sec.  410.67(d). We 
solicited comments on our proposed approach to full and partial 
episodes, including the threshold that should be applied to determine 
when an OTP may bill for the full weekly bundle versus a partial 
episode. We also solicited comment on the minimum threshold that should 
be applied to determine when a partial episode could be billed (for 
example, at least one item or service, or an alternative threshold such 
as 10 or 25 percent of the items and services included in the OUD 
treatment services identified in the patient's current treatment plan 
(including any changes noted in the patient's medical record) over the 
course of a week). We also solicited comment regarding whether any 
other payers of OTP services allow for billing of partial bundles and 
what thresholds they use.
    We received public comments on our proposal to create separate 
coding and payment for partial episodes. The following is a summary of 
the comments we received and our responses.
    Comment: Many commenters noted that determining the threshold for 
when to bill the partial episode versus the full episode was 
impractical, stating it would be cumbersome to implement and would 
require far more frequent updating of the treatment plan than is 
typical, especially since the frequency of services delivered can vary 
significantly from week to week. Commenters also requested 
clarification on how various services would count toward the 51 percent 
threshold, and urged CMS to eliminate the partial bundled payment to 
simplify billing and reduce confusion that could lead to billing 
compliance issues. A few commenters stated that the total number of 
services associated with a patient's treatment plan is not documented 
in a way that would facilitate using the proposed threshold for billing 
for a full bundle, and therefore, it would not be feasible for OTPs to 
operationalize the proposed approach. Some commenters also noted that 
operationalizing this approach would require them to obtain additional 
administrative resources to track the services provided to each patient 
in relation to their treatment plan in order to determine when the 
threshold for billing for a full bundle is met. A few commenters stated 
that applying partial episodes to the TRICARE bundled rate is 
inconsistent with TRICARE's approach, which already accounts for 
differences in treatment intensity in a single unified payment rate. 
Others recommended that

[[Page 62642]]

CMS should not apply partial week payments, as the reduced resource 
costs for some episodes are already reflected in the payment rate for 
the full week bundle. A few commenters supported the concept of partial 
episodes, but requested clarification about the billing threshold.
    Response: Based on the concerns raised by the commenters, we are 
not finalizing partial episodes at this time. We understand that many 
OTPs would need to change their documentation patterns to 
operationalize the proposed threshold for determining when to bill a 
full episode versus a partial episode and that having to make such 
changes in a short amount of time could be burdensome and potentially 
create barriers to providing care. In the interest of combating the 
opioid crisis and in the best interest of beneficiaries, our goal is to 
minimize barriers to OTPs enrolling in Medicare and beginning to 
furnish services to Medicare beneficiaries. Accordingly, for CY 2020, 
we are finalizing only the proposal to establish full weekly bundled 
payments at Sec.  410.67(d)(2). The threshold to bill a full episode 
will be that at least one service was furnished (from either the drug 
or non-drug component) to the patient during the week that corresponds 
to the episode of care. We are finalizing this threshold at Sec.  
410.67(d)(3). We note that we will be monitoring for abuse given this 
lower threshold for billing for full weekly bundled payment. We also 
note that we remain interested in implementing a payment policy for 
partial episodes at some point in the future. We would establish the 
policies to govern partial episodes through notice and comment 
rulemaking, and we are interested in working with OTPs to explore how 
such a policy would best be applied.
(c) Non-Drug Episode of Care
    In addition to the bundled payments for full and partial episodes 
of care that are based on the medication administered for treatment 
(and include both a drug and non-drug component as described in detail 
below), we proposed to establish a non-drug episode of care to provide 
a mechanism for OTPs to bill for non-drug services, including substance 
use counseling, individual and group therapy, and toxicology testing 
that are rendered during weeks when a medication is not administered, 
for example, in cases where a patient is being treated with injectable 
buprenorphine or naltrexone on a monthly basis or has a buprenorphine 
implant. We proposed to codify this non-drug episode of care at Sec.  
410.67(d).
    We did not receive any comments on non-drug episodes of care, and 
are finalizing the policies governing the use of non-drug episodes of 
care in Sec.  410.67(d)(1)(iii).
(2) Drug and Non-Drug Components
    As discussed above, in establishing the bundled payment rates, we 
proposed to develop separate payment methodologies for the drug 
component and the non-drug (which includes the dispensing and 
administration of such medication, if applicable; substance use 
counseling; individual and group therapy; and toxicology testing) 
components of the bundled payment. Each of these components is 
discussed in this section.
(a) Drug Component
    As discussed previously, the cost of medications used by OTPs to 
treat OUD varies widely. Creating a single bundled payment rate that 
does not reflect the type of drug used could result in access issues 
for beneficiaries who might be best served by treatment using a more 
expensive medication. As a result, in the proposed rule (84 FR 40526), 
we stated our belief that the significant variation in the cost of 
these drugs would need to be reflected adequately in the bundled 
payment rates for OTP services to avoid impairing access to appropriate 
care.
    Section 1834(w)(2) of the Act states that the Secretary may 
implement the bundled payment to OTPs though one or more bundles based 
on a number of factors, including the type of medication provided (such 
as buprenorphine, methadone, extended-release injectable naltrexone, or 
a new innovative drug). Accordingly, consistent with the discretion 
afforded under section 1834(w)(2) of the Act, and after consideration 
of payment rates paid to OTPs for comparable services by other payers 
as discussed above, we proposed to base the OTP bundled payment rates, 
in part, on the type of medication used for treatment. Specifically, we 
proposed the following categories of bundled payments to reflect those 
drugs currently approved by the FDA under section 505 of the FFDCA for 
use in treatment of OUD:
     Methadone (oral).
     Buprenorphine (oral).
     Buprenorphine (injection).
     Buprenorphine (implant).
     Naltrexone (injection).
    In addition, we proposed to create a category of bundled payment 
describing a drug not otherwise specified to be used for new drugs (as 
discussed further below). We also proposed a non-drug bundled payment 
to be used when medication is not administered (as discussed further 
below) noting that we believe creating these categories of bundled 
payments based on the drug used for treatment would strike a reasonable 
balance between recognizing the variable costs of these medications and 
the statutory requirement to make a bundled payment for OTP services. 
We proposed to codify this policy of establishing the categories of 
bundled payments based on the type of opioid agonist and antagonist 
treatment medication in Sec.  410.67(d)(1).
    We received public comments related to our proposal to establish 
categories of OTP bundled payments based on the type of opioid agonist 
and antagonist treatment medication used during the episode of care. 
The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters submitted comments concerning our 
proposal to base the OTP bundled payment rates, in part, on the type of 
medication (that is, methadone (oral), buprenorphine (oral), 
buprenorphine (injection), buprenorphine (implant), naltrexone 
(injection)) used for treatment. A few commenters supported our 
proposal to use the five medication categories. Another commenter 
supported the medication categories but cautioned CMS to monitor and 
evaluate drug pricing and availability to ensure the payments are 
sufficient to cover the cost of medications. In contrast, another 
commenter stated that the medications should not be bundled and that 
the bundles, if used, were too broad. This commenter believed such an 
approach would inhibit the ability of the health care provider to 
choose the best treatment for a patient.
    Response: Section 1861(jjj)(1) of the Act defines OUD treatment 
services to include certain opioid treatment medications furnished by 
an OTP. Section 1834(w) of the Act instructs the Secretary to make a 
bundled payment for these services. We do not believe the statute 
supports unbundling the medications from the other OUD treatment 
services furnished by OTPs. We defined the five medication categories 
to represent the distinct types of covered OTP medications currently on 
the market based on primary active ingredient, method of 
administration, and cost. We believe these categories of bundled 
payments strike a reasonable balance between recognizing the variable 
costs of these medications and the statutory requirement to make a 
bundled payment for OTP services. We discuss our treatment of new drugs 
below.

[[Page 62643]]

    Comment: One commenter urged CMS to clarify whether the naltrexone 
bundled payment category referred to injectable or oral naltrexone.
    Response: The naltrexone drug product that is FDA-approved for the 
treatment of opioid dependence is an extended-release, intramuscular 
injection.\54\ The naltrexone bundled payment category refers to this 
injectable product.
---------------------------------------------------------------------------

    \54\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
---------------------------------------------------------------------------

    Comment: A commenter brought to our attention the fact that 
buprenorphine-only products are both FDA-approved and marketed for the 
treatment of opioid dependence by generic manufacturers, whereas in the 
proposed rule, we stated our understanding that all oral buprenorphine 
products also contained naloxone as an active ingredient. The commenter 
recommended that we clarify the definition of buprenorphine products to 
note the inclusion of these products as well.
    Response: Upon further inspection, we have identified marketed 
buprenorphine-only products. We have also reviewed the available 
pricing for both the buprenorphine-only and the buprenorphine with 
naloxone products and found them to be similar. We believe that 
including both types of products in the same drug category for payment 
purposes would not negatively impact patient access to either of these 
two versions of buprenorphine. Therefore, we are clarifying that the 
proposed ``Buprenorphine (oral)'' drug category includes both the 
buprenorphine-only and buprenorphine-naloxone products that are 
currently FDA-approved and marketed for the treatment of opioid 
dependence.
    After consideration of the public comments, we are finalizing our 
proposal to base the OTP bundled payment rates, in part, on the type of 
medication used for treatment. These categories reflect those drugs 
currently approved by the FDA under section 505 of the FFDCA for use in 
treatment of OUD: that is, methadone (oral), buprenorphine (oral), 
buprenorphine (injection), buprenorphine (implant), naltrexone 
(injection)). We will codify this policy of establishing the categories 
of bundled payments based on the type of opioid agonist and antagonist 
treatment medication in Sec.  410.67(d)(1).
i. New Drugs
    We anticipate that there may be new FDA-approved opioid agonist and 
antagonist treatment medications to treat OUD in the future. In the 
scenario where an OTP furnishes MAT using a new FDA-approved opioid 
agonist or antagonist medication for OUD treatment that is not 
specified in one of our existing codes, we proposed that OTPs would 
bill for the episode of care using the medication not otherwise 
specified (NOS) code (HCPCS code G2075). In such cases, we proposed to 
use the typical or average maintenance dose to determine the drug cost 
for the new bundle. We also proposed that pricing would be determined 
based on the relevant pricing methodology (described in section II.G.3. 
of this final rule) or invoice pricing in the event the information 
necessary to apply the relevant pricing methodology is not available. 
For example, in the case of injectable and implantable drugs, which are 
generally covered and paid for under Medicare Part B, we proposed to 
use the methodology in section 1847A of the Act (which bases most 
payments on ASP). For oral medications, which are generally covered and 
paid for under Medicare Part D, we proposed to use ASP-based payment 
when we receive manufacturer-submitted ASP data for these drugs. In the 
event that we do not receive manufacturer-submitted ASP pricing data, 
we considered several potential pricing mechanisms (discussed further 
below) to estimate the payment amounts for oral drugs typically paid 
for under Medicare Part D but that would become OTP drugs paid under 
Part B when used as part of MAT furnished in an OTP. We did not propose 
a specific pricing mechanism for the situation in which we do not 
receive manufacturer-submitted ASP pricing data, but solicited public 
comment on several potential approaches for estimating the acquisition 
cost and payment amounts for these drugs. If the information necessary 
to apply the alternative pricing methodology chosen for the oral drugs 
is also not available to price the new medication, we proposed to use 
invoice pricing until either ASP pricing data or the information 
necessary to apply the chosen alternate pricing methodology becomes 
available to price the medication. We proposed to codify this approach 
for determining the amount of the bundled payment for new medications 
in Sec.  410.67(d)(2). The medication NOS code would be used until we 
have the opportunity to consider through rulemaking establishing a 
unique bundled payment for episodes of care during which the new drug 
is furnished. We solicited comments on this proposed approach to the 
treatment of new drugs used for MAT in OTPs.
    We received public comments on the proposals related to new drugs. 
The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters generally supported coverage of new FDA-
approved medications for OUD. One commenter noted that a flexible 
approach to innovative therapies to treat OUD is critical to ensure 
that Medicare beneficiaries have access to all FDA-approved therapies 
that best meet their needs.
    Response: We believe that our proposal to allow providers to bill 
using a medication NOS code would offer OTPs the flexibility to provide 
beneficiaries with quick access to new FDA-approved medications for OUD 
until we have the opportunity to consider through rulemaking 
establishing a unique bundled payment for episodes of care during which 
the new drug is furnished.
    Therefore, we are finalizing our proposal to allow OTPs to bill for 
an episode of care using the medication not otherwise specified (NOS) 
code (HCPCS code G2075) in the scenario where an OTP furnishes MAT 
using a new FDA-approved opioid agonist or antagonist medication for 
OUD treatment that is not specified in one of our existing codes. In 
such cases, the typical or average maintenance dose would be used to 
determine the drug cost for the new bundle, which contractors would 
then add to the non-drug component payment amount that corresponds with 
the relevant payment for drug administration (oral, injectable, or 
implantable) to determine the total bundled payment for the episode of 
care. We are also finalizing our proposal that pricing would be 
determined based on the relevant pricing methodology as described in 
section II.G.3. of this final rule or through invoice pricing in the 
event the information necessary to apply the relevant pricing 
methodology is not available. We are codifying this approach for 
determining the amount of the bundled payment for episodes of care with 
new medications in Sec.  410.67(d)(2)(i)(C).
    As discussed above, we also solicited comments on how new 
medications that may be approved by the FDA in the future for use in 
the treatment of OUD with a novel mechanism of action (for example, not 
an opioid agonist and/or antagonist), such as medications approved 
under section 505 of the FFDCA to treat OUD and biological products 
licensed under section 351 of the Public Health Service Act to treat 
OUD, should be considered in the

[[Page 62644]]

context of OUD treatment services provided by OTPs. Additionally, we 
solicited comments on how such new drugs with a novel mechanism of 
action should be priced, and specifically whether pricing for these new 
non-opioid agonist and/or antagonist medications should be determined 
using the same pricing methodology proposed for new opioid agonist and 
antagonist treatment medications, described above or whether an 
alternative pricing methodology should be used.
    We did not receive any comments on the pricing of new drugs with a 
novel mechanism of action. We intend to monitor for the development of 
such new drugs for the treatment of OUD, and may consider this topic 
further in future rulemaking.
(b) Non-Drug Component
i. Counseling, Therapy, Toxicology Testing, and Drug Administration
    As discussed above, the bundled payment is for OUD treatment 
services furnished during the episode of care, which we proposed to 
define as the FDA-approved opioid agonist and antagonist treatment 
medications, the dispensing and administration of such medications (if 
applicable), substance use counseling by a professional to the extent 
authorized under state law to furnish such services, individual and 
group therapy with a physician or psychologist (or other mental health 
professional to the extent authorized under state law), and toxicology 
testing. The non-drug component of the OUD treatment services includes 
all items and services furnished during an episode of care except for 
the medication.
    Under the SAMHSA certification standards at Sec.  8.12(f)(5), OTPs 
must provide adequate substance abuse counseling to each patient as 
clinically necessary. We note that section 1861(jjj)(1)(C) of the Act, 
as added by section 2005(b) of the SUPPORT Act defines OUD treatment 
services as including ``substance use counseling by a professional to 
the extent authorized under state law to furnish such services.'' 
Therefore, professionals furnishing therapy or counseling services for 
OUD treatment must be operating within state law and scope of practice. 
These professionals could include licensed professional counselors, 
licensed clinical alcohol and drug counselors, and certified peer 
specialists that are permitted to furnish this type of therapy or 
counseling by state law and scope of practice. To the extent that the 
individuals furnishing therapy or counseling services are not 
authorized under state law to furnish such services, the therapy or 
counseling services would not be covered as OUD treatment services.
    Additionally, under the SAMHSA certification standards at Sec.  
8.12(f)(6), OTPs are required to provide adequate testing or analysis 
for drugs of abuse, including at least eight random drug abuse tests 
per year, per patient in maintenance treatment, in accordance with 
generally accepted clinical practice. These drug abuse tests (which are 
identified as toxicology tests in the definition of OUD treatment 
services in section 1861(jjj)(1)(E) of the Act) are used for 
diagnosing, monitoring and evaluating progress in treatment. The 
testing typically includes tests for opioids and other controlled 
substances. Urinalysis is primarily used for this testing; however, 
there are other types of testing such as hair or fluid analysis that 
could be used. We note that any of these types of toxicology tests 
would be considered to be OUD treatment services and would be included 
in the bundled payment for services furnished by an OTP.
    The non-drug component of the bundle also includes the cost of drug 
dispensing and/or administration, as applicable. Additional details 
regarding our proposed approach for pricing this aspect of the non-drug 
component of the bundle are included in our discussion of payment rates 
later in this section. We did not receive comments on our proposal to 
include counseling, therapy, toxicology testing, and drug 
administration in the non-drug component of the bundle.
ii. Other Services
    As discussed in the CY 2020 PFS proposed rule, we proposed to 
define OUD treatment services as those items and services that are 
specifically enumerated in section 1861(jjj)(1) of the Act, including 
services that are furnished via telecommunications technology, and 
solicited comment on any other items and services we might consider 
including as OUD treatment services under the discretion given to the 
Secretary in subparagraph (F) of that section to determine other 
appropriate items and services. We noted that if we were to finalize a 
definition of OUD treatment services that includes any other items or 
services, such as intake activities or periodic assessments as 
discussed above, we would consider whether any changes to the payment 
rates for the bundled payments would be necessary. As discussed above, 
we received comments that were supportive of creating add-on payment 
adjustments for intake activities and periodic assessments, and we are 
finalizing including intake activities and periodic assessment in the 
definition of OUD treatment services.
(3) Adjustment to Bundled Payment Rate for Additional Counseling or 
Therapy Services
    In addition to the items and services that we proposed to include 
in the bundles, we recognized that counseling and therapy are important 
components of MAT and that patients may need to receive counseling and/
or therapy more frequently at certain points in their treatment. In 
developing our policies for the proposed rule, we sought to ensure that 
patients have access to these needed services. Accordingly, we proposed 
to adjust the bundled payment rates through the use of an add-on code 
in order to account for instances in which effective treatment requires 
additional counseling or group or individual therapy to be furnished 
for a particular patient that substantially exceeds the amount 
specified in the patient's individualized treatment plan. As noted 
previously, we understand that there is variability in the frequency of 
services a patient might receive in a given week depending on the 
patient's severity and stage of treatment; however, in the proposed 
rule, we assumed that a typical case might include one substance use 
counseling session, one individual therapy session, and one group 
therapy session per week. As we explained in the proposed rule, we 
understand that the frequency of services will vary among patients and 
will change over time based on the individual patient's needs. We 
expect that the patient's treatment plan or the medical record will be 
updated to reflect when there are changes in the expected frequency of 
medically-necessary services based on the patient's condition and 
following such an update, the add-on code should no longer be billed if 
the frequency of the patient's counseling and/or therapy services is 
consistent with the treatment plan or medical record. In the case of 
unexpected or unforeseen circumstances that are time-limited, resolve 
quickly, and do not lead to updates to the treatment plan, we explained 
that we expect the medical necessity for billing the add-on code would 
be documented in the medical record. The proposed add-on code would 
reflect each additional 30 minutes of counseling or group or individual 
therapy furnished in a week of MAT, and could be billed in conjunction 
with the codes describing the full episode of care. For example,

[[Page 62645]]

there may be some weeks when a patient has a relapse or unexpected 
psychosocial stressors arise that warrant additional reasonable and 
necessary counseling services that were not foreseen at the time that 
the treatment plan was developed. We acknowledged that an unintended 
consequence of using the treatment plan to determine when billing of 
the add-on code would be permissible is a potential incentive for OTPs 
to document minimal counseling and/or therapy needs for a beneficiary, 
thereby resulting in increased opportunity for billing the add-on code. 
We indicated that we expect OTPs will ensure that treatment plans 
reflect the full scope of services expected to be furnished during an 
episode of care and will update treatment plans regularly to reflect 
changes. We noted that we intend to monitor this issue and would 
consider making changes to this policy through future rulemaking if 
necessary to ensure that this payment adjustment is not being billed 
inappropriately. We solicited comments on the add-on code and the 
threshold for billing. We proposed to codify this adjustment to the 
bundled payment rate for additional counseling or therapy services in 
Sec.  410.67(d)(3)(i).
    We received several comments on our proposed adjustment to the 
bundled payment rate for additional counseling or therapy services. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to create an add-on 
G-code to adjust the bundled payment rate for additional counseling or 
therapy services furnished. Several commenters stated that the number 
of therapy and counseling services described in the proposed rule 
usually only occurs during the initial stages of treatment and a few 
commenters stated that patients with that level of need in a given week 
may be referred for more intensive treatment, such as Intensive 
Outpatient (IOP) treatment. Some commenters noted the variation in 
payment rates for counseling across various state Medicaid programs and 
a few commenters suggested that we use HCPCS code G0396 as a reference 
code in valuing the payment rate for the counseling add-on code.
    Response: After consideration of the public comments, we are 
finalizing our proposal to establish an add-on code to describe an 
adjustment to the bundled payment when additional counseling or therapy 
services are furnished. This add-on payment is codified in the 
regulations at Sec.  410.67(d)(4)(i)(A). The payment rate we are 
finalizing for this add-on payment is discussed in more detail later in 
this final rule. 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. OTPs will be 
required to document the medical necessity for these services in the 
patient's medical record. Additionally, we note that we understand the 
frequency with which counseling and therapy services are furnished will 
vary over time for each individual patient and will often decrease over 
time as a patient stabilizes. Nevertheless, we believe it is important 
to acknowledge that some patients will require more intensive 
counseling and therapy services at certain times during their treatment 
and to establish a payment methodology under which OTPs may receive 
payment for furnishing these medically necessary services.
(4) Site of Service (Telecommunications)
    In recent years, we have sought to decrease barriers to access to 
care by furthering policies that expand the use of communication 
technologies. In the CY 2019 PFS final rule (83 FR 59482), we finalized 
new separate payments for communication technology-based services, 
including a virtual check-in and a remote evaluation of pre-recorded 
patient information. SAMHSA's federal guidelines (https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf) for OTPs refer to 
the CMS guidance on telemedicine and also state that OTPs are advised 
to proceed with full understanding of requirements established by state 
or health professional licensing boards. SAMHSA's federal guidelines 
for OTPs state that exceptional attention needs to be paid to data 
security and privacy in this evolving field. Telemedicine services 
should, under no circumstances, expand the scope of practice of a 
healthcare professional or permit practice in a jurisdiction (the 
location of the patient) where the provider is not licensed.
    We proposed to allow OTPs to furnish the substance use counseling, 
individual therapy, and group therapy included in the bundle via two-
way interactive audio-video communication technology, as clinically 
appropriate, in order to increase access to care for beneficiaries. We 
believed this would be an appropriate approach because, as discussed 
previously, we expected the telehealth services that will be furnished 
by OTPs will be similar to the Medicare telehealth services furnished 
under section 1834(m) of the Act, and the use of two-way interactive 
audio-video communication technology is required for these Medicare 
telehealth services under Sec.  410.78(a)(3). By allowing use of 
communication technology in furnishing these services, OTPs in rural 
communities or federally-designated geographic health professional 
shortage areas would be able to facilitate treatment through virtual 
care coming from an urban or other external site; however, we noted 
that the physicians and other practitioners furnishing these services 
would be required to comply with all applicable requirements related to 
professional licensing and scope of practice.
    We noted that section 1834(m) of the Act applies only to Medicare 
telehealth services furnished by a physician or other practitioner. 
Because OUD treatment services furnished by an OTP are not considered 
to be services furnished by a physician or other practitioner, we 
indicated that the restrictions of section 1834(m) of the Act would not 
apply. Additionally, we noted that counseling or therapy furnished via 
communication technology as part of OUD treatment services furnished by 
an OTP must not be separately billed by the practitioner furnishing the 
counseling or therapy because these services would already be paid 
through the bundled payment made to the OTP.
    We proposed to include language in Sec.  410.67(b) in the 
definition of OUD treatment services to allow OTPs to use two-way 
interactive audio-video communication technology, as clinically 
appropriate, in furnishing substance use counseling and individual and 
group therapy services, respectively. We solicited comment as to 
whether the proposal, including the furnishing of these services 
through communication technology, would be clinically appropriate. We 
also solicited public comment on other components of the bundle that 
may be clinically appropriate to be furnished via communication 
technology, while considering SAMHSA's guidance that OTPs should pay 
exceptional attention to data security and privacy.
    We received public comments on the proposal to include substance 
use counseling and individual and group therapy services furnished 
using telecommunications technology in the definition of OUD treatment 
services. The following is a summary of the comments we received and 
our responses.
    Comment: Many commenters supported the proposal to allow OTPs to 
use two-way interactive audio-video

[[Page 62646]]

communication technology, as clinically appropriate, in furnishing 
substance use counseling and individual and group therapy services, 
respectively. Several commenters noted that allowing the use of 
communication technology in furnishing these services has the potential 
to vastly expand OTPs' reach, particularly in underserved areas. A few 
commenters urged CMS to afford OTPs maximum flexibility in how 
telemedicine is deployed, such as allowing the provision of such 
services regardless of whether or not the counselor or patient is 
physically located at an OTP and noted that several states already 
support less restrictive telemedicine practices. One commenter 
recommended that CMS should also allow OTPs to furnish other important 
medical services to beneficiaries via telecommunications, including: 
Medication dose assessment and interactions, basic primary care, and 
HIV and hepatitis C risk reduction. A few commenters requested 
clarification as to whether a patient participating in individual and/
or group counseling could do so from their home or another location of 
their choosing as opposed to a designated satellite location.
    Response: We are finalizing our proposal to allow OTPs to use two-
way interactive audio-video communication technology, as clinically 
appropriate, in furnishing substance use counseling and individual and 
group therapy services. In response to the requests for clarification 
regarding where the beneficiary and practitioner can be located at the 
time the service is furnished, we note that section 2001 of the SUPPORT 
Act allows telehealth services for treatment of a diagnosed SUD or co-
occurring mental health disorder to be furnished to individuals at any 
telehealth originating site (other than a renal dialysis facility), 
including in a patient's home. Accordingly, consistent with this 
policy, we believe it is appropriate to permit beneficiaries to receive 
substance use counseling and individual group therapy services 
furnished by an OTP using telecommunications technology in their home 
or any other telehealth originating site, provided the requirements 
that apply to telehealth services payable under the PFS after July 1, 
2019, are met. In response to commenters who recommended that CMS 
should allow OTPs to furnish other medical services to beneficiaries 
via telecommunications, we note that SAMHSA and the DEA have 
regulations related to OUD services furnished via telecommunications 
that we would need further time to consider, but we may revisit this 
recommendation in developing our policies for future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to allow OTPs to use two-way interactive audio-video 
communication technology, as clinically appropriate, in furnishing 
substance use counseling and individual and group therapy services. We 
are also finalizing our proposal to include substance use counseling 
and individual and group therapy services furnished via two-way 
interactive audio-video communication technology in the definition of 
opioid use disorder treatment service in Sec.  410.67(b). We note that 
as OTP services are not PFS services, no originating site facility fee 
(HCPCS code Q3014) applies to OUD treatment services, and OTPs are not 
authorized to bill for the originating site facility fee.
(5) Coding
    We proposed to adopt a coding structure for OUD treatment services 
that would vary by the medication administered. To operationalize this 
approach, we proposed to establish G codes for weekly bundles 
describing treatment with methadone, buprenorphine oral, buprenorphine 
injectable, buprenorphine implants (insertion, removal, and insertion/
removal), extended-release injectable naltrexone, a non-drug bundle, 
and one for a medication not otherwise specified. We also proposed to 
establish partial episode G codes to correspond with each of those 
bundles, respectively. Additionally, we proposed to create an add-on 
code to describe additional counseling that is furnished beyond the 
amount specified in the patient's treatment plan. We also noted that 
were we to finalize including intake activities and periodic 
assessments in the definition of OUD treatment services, we welcomed 
feedback on whether we should consider modifying the payment associated 
with the bundle or creating add-on codes for services such as the 
initial physical examination, initial assessments and preparation of a 
treatment plan, periodic assessments or additional toxicology testing, 
and if so, what inputs we might consider in pricing such services, such 
as payment amounts for similar services under the PFS or CLFS. For 
example, we noted that to price the initial assessment, medical 
examination, and development of a treatment plan, we could crosswalk to 
the Medicare payment rate for a level 3 evaluation and management (E/M) 
visit for a new patient and to price the periodic assessments, we could 
crosswalk to the Medicare payment rate for a level 3 E/M visit for an 
established patient. To price additional toxicology testing, we could 
crosswalk to the Medicare payment for presumptive drug testing, such as 
that described by CPT code 80305. Additionally, we welcomed feedback on 
whether we should consider creating codes to describe bundled payments 
that include only the cost of the drug and drug administration as 
applicable in order to account for beneficiaries who are receiving 
interim maintenance treatment (as described previously in this section) 
or other situations in which the beneficiary is not receiving all of 
the services described in the full bundles.
    Regarding the non-drug bundle, we noted that this code would be 
billed for services furnished during an episode of care or partial 
episode of care when a medication is not administered. For example, 
when a patient receives a buprenorphine injection on a monthly basis, 
the OTP will only require payment for the medication during the first 
week of the month when the injection is given, and therefore, would 
bill the code describing the bundle that includes injectable 
buprenorphine during the first week of the month and would bill the 
code describing the non-drug bundle for the remaining weeks in that 
month for services such as substance use counseling, individual and 
group therapy, and toxicology testing.
    As discussed previously, we proposed that the codes describing the 
bundled payment for an episode of care or partial episode of care with 
a medication not otherwise specified should be used when the OTP 
furnishes MAT with a new opioid agonist or antagonist treatment 
medication approved by the FDA under section 505 of the FFDCA for the 
treatment of OUD. OTPs would use these codes until we have the 
opportunity to propose and finalize a new G code to describe the 
bundled payment for treatment using that drug and price it accordingly 
in the next rulemaking cycle. We noted that the code describing the 
weekly bundle for a medication not otherwise specified should not be 
used when the drug being administered is not a new opioid agonist or 
antagonist treatment medication approved by the FDA under section 505 
of the FFDCA for the treatment of OUD, and therefore, for which 
Medicare would not have the authority to make payment since section 
1861(jjj)(1)(A) of the Act requires that the medication must be an 
opioid agonist or antagonist treatment medication approved by the FDA 
under section 505 of the FFDCA for the treatment of OUD. Given the 
program integrity concerns regarding the

[[Page 62647]]

potential for misuse of a medication not otherwise specified code, we 
also welcomed comments as to whether this code was needed.
    See Table 18 for a list of the HCPCS codes for the weekly bundles 
that we are finalizing (G2067-G2075). We proposed that only an entity 
enrolled with Medicare as an OTP could bill these codes. Additionally, 
we proposed that OTPs would be limited to billing only these codes 
describing bundled payments, and may not bill for other codes, such as 
those paid under the PFS.
    We received many comments related to coding and payment for OTP 
services. The following is a summary of the comments we received and 
our responses.
    Comment: As described previously, many commenters supported the 
inclusion of intake activities, such as the initial physician 
examination, initial assessment and preparation of a treatment plan, as 
well as periodic assessments in the definition of OUD treatment 
services. Many commenters suggested that we create add-on codes to 
describe these services, and several commenters specifically suggested 
that we use CPT codes 99204 and 99214 as reference codes for pricing 
the intake and periodic assessment add-ons, respectively. A few 
commenters recommended that CMS work with OTPs and/or SAMHSA to 
determine whether an add-on for periodic assessments would sufficiently 
cover the needs of pregnant and postpartum women who seek care at OTPs.
    Response: As discussed above, we are finalizing including intake 
activities and periodic assessment in the definition of OUD treatment 
services. It is our understanding that these services are furnished 
much less frequently than the other services included in the weekly 
bundled payments; therefore, we are creating add-on G-codes to describe 
these services, which will allow us to make more targeted payments for 
these services. We note that the add-on code describing intake 
activities should only be billed for new patients (that is, patients 
starting treatment at the OTP). We agree with the commenters that the 
level 4 office/outpatient E/M visits 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. Therefore, we are pricing the 
add-on code describing intake activities using 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) as a reference code, which is assigned 
a CY 2019 non-facility rate of $166.86 under the PFS in addition to 
accounting for one toxicology test furnished at intake, using CPT code 
80305 (Drug test(s), presumptive, any number of drug classes, any 
number of devices or procedures; capable of being read by direct 
optical observation only (e.g., utilizing immunoassay [e.g., dipsticks, 
cups, cards, or cartridges]), includes sample validation when 
performed, per date of service) as a reference code, which is assigned 
a rate of $12.60 under the CLFS in CY 2019. Therefore, we summed those 
two amounts to calculate the total payment rate for the add-on code 
describing intake activities, which is $179.46. Similarly, we are 
pricing the add-on code describing periodic assessments using 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) as a 
reference code, which is assigned a CY 2019 non-facility rate of 
$110.28 under the PFS. The medical services described by these add-on 
codes could 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 and physician assistants. The other assessments, 
including psychosocial assessments could be furnished by practitioners 
who are eligible to do so under their state law and scope of licensure. 
Additionally, we note that the add-on code describing periodic 
assessments could 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 note 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. We also 
plan to monitor utilization of the periodic assessment add-on code 
given program integrity concerns about overutilization, and may 
consider further refinements in future rulemaking.
    Comment: Several commenters supported the creation of add-on codes 
to account for more frequent presumptive testing, including presumptive 
testing using instrumented chemistry analyzers, and for definitive 
testing. Several commenters highlighted the differences between 
presumptive and definitive tests, stating that CPT code 80305 describes 
a presumptive screen test by Dipstick or Point of Care rapid test cup, 
and noted that there is a significant difference in the payment rate 
for this code compared to the codes describing definitive drug testing. 
Several commenters requested that CMS set a rate that encompasses 
medically-appropriate testing frequencies, but also addresses the 
complexity of testing, noting that that the presumptive screening test 
uses limited technology and should not be relied upon by clinicians for 
providing true actionable and reliable information and stated that a 
bundled rate that includes only a crosswalk to a point-of-care rapid 
test will severely impact patient care. A few commenters noted that 
most basic drug tests will not detect Fentanyl and that failure to 
properly identify Fentanyl may place patients' lives at risk, and 
therefore, recommended that CMS consider referencing the current CLFS 
rates for codes HCPCS codes G0480-G0483, which describe definitive drug 
testing. A few commenters noted that point of care immunoassay testing 
is rarely able to detect methadone or buprenorphine and can never 
detect naltrexone and, if methadone or buprenorphine is detected, the 
immunoassay is unable to determine whether the patient is compliant or 
is adulterating the urine sample. In contrast, definitive testing is 
appropriate for detecting all of the drugs used for MAT therapy.
    Response: We find the commenters' arguments that both higher level 
presumptive tests and definitive tests

[[Page 62648]]

can be clinically appropriate in the treatment of OUD to be compelling. 
Further, we want to avoid creating financial disincentives that would 
prevent OTPs from furnishing medically-necessary care. Accordingly, we 
are building into the bundled payments both presumptive and definitive 
testing. We understand from commenters that while SAMHSA requires at 
least 8 toxicology screenings per year per patient, toxicology 
screening is frequently done more often, including up to weekly in new 
patients and that this is most frequently presumptive testing, but in 
more rare circumstances definitive testing is also performed. Thus, in 
consideration of what we believe might be an average case, we are 
assuming that beneficiaries will receive an average of two presumptive 
tests and one definitive test per month.
    We priced the presumptive test based on the CLFS rate for CPT code 
80305, which is $12.60, and then prorated that amount by dividing that 
rate by 2 to reflect the presumption that this type of testing would be 
furnished only twice a month. We priced the definitive test based on 
the CLFS rate for HCPCS code G0480, which is $114.43 and then prorated 
that amount by dividing that rate by 4 to reflect our presumption that 
this type of testing would be furnished once a month. Additionally, we 
note that we interpret the statute to require that all toxicology 
testing furnished by the OTP must be included in the bundled payment or 
adjustments to the bundled payment and could not be billed separately 
under the CLFS. We have elected to build the payment for these tests 
into the weekly bundled rates, rather than creating add-on codes, in 
order to avoid creating an incentive to furnish testing more frequently 
than needed. However, as OTPs begin to bill Medicare, if we find that 
there is an issue with beneficiaries receiving access to medically-
necessary definitive testing, we may consider making changes to how 
these tests are paid through future rulemaking.
    Comment: Several commenters stated that OTPs often provide case 
management and/or care management services and requested that CMS 
consider reimbursing for these services either as part of the standard 
bundle or as an adjustment to the bundled payment, as applicable. A few 
commenters stated that OTPs serve as a fixed point of responsibility in 
the provision of whole person-centered care and improving health 
outcomes through collaborative arrangements with health care providers 
outside of the OTP and that the goal of care management is to reduce 
health care costs, specifically preventable hospital admissions, 
readmissions, and avoidable emergency room visits. The commenters also 
stated that OTP staff also help patients with accessing food benefits, 
housing, and employment searches, which are critical components for 
sustained recovery, as part of case management.
    Response: We appreciate the feedback and note that we would like to 
work with OTPs to better understand how these services are furnished in 
the OTP setting and, as noted previously, we are interested in 
continued feedback and data on the specific items and services, 
including their frequency, furnished to beneficiaries by an OTP. We may 
consider making payment for case management/care management activities 
in future rulemaking.
    We note that the definition of OUD treatment services described in 
this final rule would need to be revised in future rulemaking to 
include any such additional items and services.
    Comment: A few commenters requested that CMS clarify whether the 
proposed billing codes could be used when a patient is undergoing 
detoxification in an OTP and some commenters requested a separate code 
describing a bundled payment for the costs associated with medications 
for medically-supervised management of opioid withdrawal, as well as 
counseling and toxicology testing. One commenter requested guidance to 
clarify how OTPs could bill for a ``naloxone challenge test'' prior to 
initiation of treatment with Vivitrol (naltrexone for extended-release 
injectable suspension).
    Response: We note that there is no specified dosage required for 
billing the bundled payments, so if a patient is tapering off methadone 
or buprenorphine while undergoing detoxification, the bundled payments 
describing those drugs may be used if the requirements for billing are 
satisfied and the non-drug bundle could be billed during any time that 
the patient is not being dispensed or administered a covered OUD 
treatment medication. We may consider for future rulemaking whether 
additional coding or payment changes are needed with respect to 
detoxification or the provision of naloxone.
    Comment: Several commenters requested clarification related to how 
take-home dosages of medication should be billed. A few commenters 
noted that the proposed definition of a partial episode does not 
account for patients who have earned take-home dose privileges and as a 
result may only attend the OTP once or twice in a month.
    Response: We agree with the commenters that additional coding is 
required to accurately account for the costs associated with providing 
a patient with take-home doses of medication. Accordingly, we are 
finalizing two codes to describe adjustments to the bundled payments, 
one for take-home supplies of methadone, which describes up to 7 
additional days of medication, and can be billed along with the 
respective weekly bundled payment in units of up to 3 (for a total of 
up to a one month supply), and one for take-home supplies of oral 
buprenorphine, which also describes up to 7 additional days of 
medication and can be billed along with the base bundle in units of up 
to 3 (for a total of up to a 1 month supply). We note that SAMHSA 
allows a maximum take-home supply of one month of medication; 
therefore, we do not expect the add-on codes describing take-home doses 
of methadone and oral buprenorphine to be billed any more than 3 times 
in one month (in addition to the weekly bundled payment). We also note 
that the add-on code for take-home doses of methadone can only be used 
with the methadone weekly episode of care code (HCPCS code G2067). 
Similarly, the add-on code for take-home doses of oral buprenorphine 
can only be used with the oral buprenorphine weekly episode of care 
code (HCPCS code G2068). We are pricing the add-on code describing 
take-home supplies of methadone, HCPCS code G2078, based on the payment 
rate for the drug component for the weekly bundle describing treatment 
with methadone ($35.28) and we are pricing the add-on code describing 
take home supplies of buprenorphine, HCPCS code G2079, based on the 
payment rate for the drug component for the weekly bundle describing 
treatment with oral buprenorphine ($86.26).
    Comment: Several commenters requested clarification related to how 
the bundled payment codes should be billed in a variety of situations. 
A few commenters specifically requested clarification on how ``guest 
dosing'' should be billed and others inquired as to whether prior 
authorization would be required.
    Response: In response to comments seeking clarification about the 
threshold to bill the partial vs. the full episodes, as noted above, we 
are finalizing only full episodes at this time and will consider 
partial episodes for future rulemaking. Additionally, as noted above, 
we are finalizing a number of add-on G codes to describe adjustments

[[Page 62649]]

to the bundle. Specifically, we are creating add-on codes for intake 
activities, periodic assessments, take-home supplies of methadone, take 
home supplies of oral buprenorphine, and additional counseling 
furnished. We note that some of the bundled payment codes describe a 
drug that is typically only administered once per month, such as the 
injectable drugs, or once in a 6-month period, in the case of the 
buprenorphine implants. In those cases, the code describing the bundled 
payment that includes the cost of the drug would be billed during the 
week that the drug is administered, and if at least once service is 
furnished in a subsequent week, the non-drug bundle would be billed. 
For example, in the case of a patient receiving injectable 
buprenorphine, we would expect that HCPCS code G2069 would be billed 
for the week during which the injection was administered and that HCPCS 
code G2074, which describes a bundle not including the drug, would be 
billed during any subsequent weeks that at least one non-drug service 
is furnished until the injection is administered again, at which time 
HCPCS code G2069 would be billed again for that week. We note that as 
HCPCS codes G2067-G2075 cover episodes of care of 7 contiguous days, we 
will not permit an OTP to bill any of these codes for the same 
beneficiary more than once per 7 contiguous day period. Additionally, 
consistent with FDA labelling, we do not generally expect the codes 
describing bundled payments including the injectable drugs (HCPCS codes 
G2069 and G2073) to be furnished more than once every 4 weeks. 
Similarly, consistent with FDA labelling, we do not generally expect 
the codes describing bundled payments including insertion of the 
buprenorphine implants (HCPCS codes G2070 and G2072) to be furnished 
more than once every 6 months.
    However, we do understand there are limited clinical scenarios when 
a beneficiary may be appropriately furnished OUD treatment services at 
more than one OTP within a 7 contiguous day period, such as for guest 
dosing or when a beneficiary transfers care between OTPs. We note that 
in these limited circumstances, each of the involved OTPs may bill the 
appropriate HCPCS codes that reflect the services furnished to the 
beneficiary. We expect that both OTPs involved would provide sufficient 
documentation in the patient's medical record to reflect the clinical 
situation and services provided. We will be monitoring the claims data 
to ensure that this flexibility is not being abused. Additionally, in 
instances in which a patient is switching from one drug to another, the 
OTP should only bill for one code describing a weekly bundled payment 
for that week and should determine which code to bill based on which 
drug was furnished for the majority of the week. In response to 
commenters who requested clarification regarding prior authorization, 
we note that we did not propose, and are not finalizing any prior 
authorization requirements for services furnished in OTPs, as our goal 
is not to restrict access to necessary care.
    The codes and long descriptors for the OTP bundled services and 
add-on services we are finalizing are:
     HCPCS code G2067: Medication assisted treatment, 
methadone; weekly bundle including dispensing and/or administration, 
substance use counseling, individual and group therapy, and toxicology 
testing, if performed (provision of the services by a Medicare-enrolled 
Opioid Treatment Program).
     HCPCS code G2068: Medication assisted treatment, 
buprenorphine (oral); weekly bundle including dispensing and/or 
administration, substance use counseling, individual and group therapy, 
and toxicology testing if performed (provision of the services by a 
Medicare-enrolled Opioid Treatment Program).
     HCPCS code G2069: Medication assisted treatment, 
buprenorphine (injectable); weekly bundle including dispensing and/or 
administration, substance use counseling, individual and group therapy, 
and toxicology testing if performed (provision of the services by a 
Medicare-enrolled Opioid Treatment Program).
     HCPCS code G2070: Medication assisted treatment, 
buprenorphine (implant insertion); weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing if performed (provision of the services 
by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code G2071: Medication assisted treatment, 
buprenorphine (implant removal); weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing if performed (provision of the services 
by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code G2072: Medication assisted treatment, 
buprenorphine (implant insertion and removal); weekly bundle including 
dispensing and/or administration, substance use counseling, individual 
and group therapy, and toxicology testing if performed (provision of 
the services by a Medicare-enrolled Opioid Treatment Program).
     HCPCS code G2073: Medication assisted treatment, 
naltrexone; weekly bundle including dispensing and/or administration, 
substance use counseling, individual and group therapy, and toxicology 
testing if performed (provision of the services by a Medicare-enrolled 
Opioid Treatment Program).
     HCPCS code G2074: Medication assisted treatment, weekly 
bundle not including the drug, including substance use counseling, 
individual and group therapy, and toxicology testing if performed 
(provision of the services by a Medicare-enrolled Opioid Treatment 
Program).
     HCPCS code G2075: Medication assisted treatment, 
medication not otherwise specified; weekly bundle including dispensing 
and/or administration, substance use counseling, individual and group 
therapy, and toxicology testing, if performed (provision of the 
services by a Medicare-enrolled Opioid Treatment Program).
     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 healthcare 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 (provision of the services by a 
Medicare-enrolled Opioid Treatment Program); List separately in 
addition to code for primary procedure.
     HCPCS code G2077: Periodic assessment; assessing 
periodically by qualified personnel to determine the most appropriate 
combination of services and treatment (provision of the services by a 
Medicare-enrolled Opioid Treatment Program); List separately in 
addition to code for primary procedure.
     HCPCS code G2078: Take-home supply of methadone; up to 7 
additional day supply (provision of the services by a Medicare-enrolled 
Opioid Treatment

[[Page 62650]]

Program); List separately in addition to code for primary procedure.
     HCPCS code G2079: Take-home supply of buprenorphine 
(oral); up to 7 additional day supply (provision of the services by a 
Medicare-enrolled Opioid Treatment Program); List separately in 
addition to code for primary procedure.
     HCPCS code G2080: Each additional 30 minutes of counseling 
or group or individual therapy in a week of medication assisted 
treatment, (provision of the services by a Medicare-enrolled Opioid 
Treatment Program); List separately in addition to code for primary 
procedure.
    Finally, we proposed that only an entity enrolled with Medicare as 
an OTP could bill these codes. Additionally, we proposed that OTPs 
would be limited to billing only these codes describing bundled 
payments, and may not bill for other codes, such as those paid under 
the PFS. We did not receive comments on these proposals, and are 
finalizing both these proposals.
(6) Payment Rates
    We proposed that the codes describing the OTP bundled services 
(HCPCS codes G2067-G2075) would be assigned flat dollar payment 
amounts, as listed in Table 18. As discussed previously, section 2005 
of the SUPPORT Act amended the definition of ``medical and other health 
services'' in section 1861(s) of the Act to provide for coverage of OUD 
treatment services furnished by an OTP and also added a new section 
1834(w) to the Act and amended section 1833(a)(1) of the Act to 
establish a bundled payment to OTPs for OUD treatment services 
furnished during an episode of care beginning on or after January 1, 
2020. Therefore, OUD treatment services and the payments for such 
services are wholly separate from physicians' services, as defined 
under section 1848(j)(3) of the Act, and for which payment is made 
under section 1848 of the Act. Because OUD treatment services are not 
considered physicians' services and are paid outside the PFS, we 
indicated that they would not be priced using relative value units 
(RVUs).
    Consistent with section 1834(w) of the Act, which requires the 
Secretary to make a bundled payment for OUD treatment services 
furnished by OTPs, we proposed to build the payment rates for OUD 
treatment services by combining the cost of the drug and the non-drug 
components (as applicable) into a single bundled payment as described 
in more detail below.
(a) Drug Component
    As part of determining a payment rate for the proposed bundles for 
OUD treatment services, a dosage of the applicable medication must be 
selected in order to calculate the costs of the drug component of the 
bundle. We proposed to use the typical or average maintenance dose to 
determine the drug costs for each of the bundles. As dosing for some, 
but not all, of these drugs varies considerably, this approach attempts 
to strike an appropriate balance between high- and low-dose drug 
regimens in the context of a bundled payment. Specifically, we proposed 
to calculate payment rates using a 100 mg daily dose for methadone, a 
10 mg daily dose for oral buprenorphine, a 100 mg monthly dose for the 
extended-release buprenorphine injection, four rods each containing 
74.2 mg of buprenorphine for the 6-month buprenorphine implant, and a 
380 mg monthly dose for extended-release injectable naltrexone. We 
solicited public comments on our proposal to use the typical 
maintenance dose in order to calculate the drug component of the 
bundled payment rate for each of the proposed codes. We also solicited 
comment on the specific typical maintenance dosage level that we have 
identified for each drug, and a process for identifying the typical 
maintenance dose for new opioid agonist or antagonist treatment 
medication approved by the FDA under section 505 of the FFDCA when such 
medications are billed using the medication NOS code, such as using the 
FDA-approved prescribing information or a review of the published, 
preferably peer-reviewed, literature. We noted that the bundled payment 
rates were intended to be comprehensive with respect to the drugs 
provided; therefore, we did not intend to include any other amounts 
related to drugs, other than for administration, as discussed below. 
This means, for example, that we would not pay for drug wastage, which 
we did not anticipate to be significant in the OTP setting.
    We received several comments on our proposal to use typical 
maintenance dosage levels to calculate payment rates.
    Comment: One commenter expressed concern over the proposal to use 
average maintenance doses to determine the drug cost component of the 
bundled payment. This commenter noted that TRICARE explicitly rejected 
this approach for buprenorphine and naltrexone due to significant 
variation in the dosage and frequency of administration for these 
drugs; and, instead, suggested an alternative methodology that would 
more appropriately account for variations in the clinical needs of 
patients.
    Response: While the TRICARE payment rates for OTP services were 
considered in determining the Medicare payment for OTP services, we 
note that section 1834(w)(2) of the Act expressly directs the Secretary 
to implement the Medicare OTP benefit using one or more payment 
bundles. We recognize that there may be some variation in the dosage 
and frequency of administration of these medications. Some 
beneficiaries may receive a larger than average dose, while other 
beneficiaries will receive a smaller than average dose; but payment 
based on the typical dose means that, across the Medicare beneficiaries 
served by the OTP, the payment amount should be reasonable and 
represent the average costs incurred in furnishing the drug component 
of the OUD treatment services. We believe the proposal to use the 
typical maintenance dosages is a reasonable approach to address the 
variable dosing of these medications within the statutory direction to 
implement this payment through one or more bundles.
    Comment: Most commenters agreed that the proposed 100 mg daily dose 
for methadone was reasonable. A couple of commenters also agreed with 
the proposed typical maintenance dosages of four rods each containing 
74.2 mg of buprenorphine for the 6-month buprenorphine implant and a 
380 mg monthly dose for extended-release injectable naltrexone. 
However, several commenters stated that the proposed typical 
maintenance dosage for oral buprenorphine of 10 mg is too low. A few 
commenters suggested that there is evidence indicating that higher 
doses of buprenorphine are associated with better treatment retention. 
Other commenters stated that OTP patients respond better to a higher 
dosing level of oral buprenorphine, in part, because they tend to have 
a longer history of opioid abuse. Commenters suggested potential 
alternative dosages ranging from 12-20 mg. Several commenters suggested 
setting the typical maintenance dosage for oral buprenorphine at 16 mg 
per day. One commenter noted this dosage is supported by SAMHSA's 
Treatment Improvement Protocol (TIP) 63 (located at https://store.samhsa.gov/system/files/sma18-5063fulldoc.pdf). In addition, 
while a few commenters stated that the 100 mg monthly dose for the 
extended-release buprenorphine injection was the appropriate 
maintenance dose, some commenters noted it would not adequately account 
for the first 2 months of treatment at the higher dose of 300 mg per 
month. Another commenter stated that there was

[[Page 62651]]

evidence indicating certain patients would require longer treatment 
with the higher dose of the extended-release buprenorphine injection 
and that the FDA label instructions allowed consideration of increasing 
the maintenance dose to 300 mg monthly for patients in which the 
benefits outweigh the risk. One commenter stated that CMS would need to 
better define how the average maintenance dose was calculated in order 
to allow for comment on the methodology.
    Response: We disagree with the commenter who stated that there was 
insufficient detail provided in the proposed rule in order to comment 
on the proposed average maintenance doses. As we described in the 
proposed rule, we identified the typical maintenance dose for each 
medication using the FDA-approved prescribing information or through a 
review of the published, preferably peer-reviewed, literature. We also 
included a reference in the proposed rule to each of the sources used 
to identify the typical maintenance doses.
    We note that, as the HCPCS codes for the extended-release 
buprenorphine injection (that is, Q9991: Buprenorphine XR 100 mg or 
less and Q9992: Buprenorphine XR over 100 mg) have the same payment 
rate; therefore, we do not believe that it is necessary to establish a 
second typical maintenance dose to calculate the payment rate for this 
drug. However, we agree that the typical maintenance dosage for oral 
buprenorphine should be set higher than the proposed 10 mg. The range 
offered by commenters was between 12 mg and 20 mg, with a 16 mg per day 
dose receiving the most support. We also note that SAMHSA's TIP 63 and 
the FDA labeling support a target dosage of 16 mg for maintenance 
treatment.\55\
---------------------------------------------------------------------------

    \55\ See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf.
---------------------------------------------------------------------------

    After consideration of the public comments, we are finalizing our 
proposal to use the typical maintenance dosages to calculate payment 
rates for the drug component of the weekly bundles (that is, a 100 mg 
daily dose for methadone, a 100 mg monthly dose for the extended-
release buprenorphine injection, four rods each containing 74.2 mg of 
buprenorphine for the 6-month buprenorphine implant, and a 380 mg 
monthly dose for extended-release injectable naltrexone) except that 
the payment rate for the drug component of the oral buprenorphine 
bundle will be calculated using a typical maintenance dose of 16 mg 
daily, rather than a 10 mg dose.
i. Potential Drug Pricing Data Sources
    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. We 
proposed to estimate an OTP's costs for the drug component of the 
bundles based on available data regarding drug costs rather than a 
provider-specific cost-to-charge ratio or another more direct 
assessment of facility or industry-specific drug costs. OTPs do not 
currently report costs associated with their services to the Medicare 
program, and we did not believe that a cost-to-charge ratio based on 
such reported information could be available for a significant period 
of time. Furthermore, we explained that we are unaware of any industry-
specific data that may be used to more accurately assess the prices at 
which OTPs acquire the medications used for OUD treatment. Therefore, 
we proposed to estimate an OTP's costs for the drugs used in MAT based 
on other available data sources, rather than applying a cost-to-charge 
ratio or another more direct assessment of drug acquisition cost; 
however, we also noted that we intended to continue to explore 
alternate ways to gather this information. As described in greater 
detail below, we proposed that the payment amounts for the drug 
component of the bundles be based on CMS pricing mechanisms currently 
in place. We solicited comment on other potential data sources for 
pricing OUD treatment medications either generally or specifically with 
respect to acquisition by OTPs. In the case of oral drugs that we 
proposed to include in the OTP bundled payments and for which we do not 
receive manufacturer-submitted ASP data, we explained that we were 
considering several potential approaches for determining the payment 
amounts for the drug component of the bundles. Although we did not 
propose a specific pricing mechanism, we solicited comments on several 
different approaches, and stated that we intended to develop a final 
policy for determining the payment amount for the drug component of the 
relevant bundles after considering the comments received.
    In considering the payment amount for the drug component of each of 
the bundled payments that include a drug, we began by breaking the 
drugs into two categories based on their current coverage and payment 
by Medicare. First, we discussed the injectable and implantable drugs, 
which are generally covered and paid for under Medicare Part B, and 
then discussed the oral medications, which are generally covered and 
paid for under Medicare Part D.\56\ Buprenorphine (injection), 
buprenorphine (implant), and naltrexone (injection) would fall into the 
former category and methadone and buprenorphine (oral) would fall into 
the latter category.
---------------------------------------------------------------------------

    \56\ Because, by law, methadone used in MAT cannot be dispensed 
by a pharmacy, it is not currently considered a Part D drug when 
used for MAT. Methadone used for this purpose can be dispensed only 
through an OTP certified by SAMHSA. However, methadone dispensed for 
pain may be considered a Part D drug and can be dispensed by a 
pharmacy.
---------------------------------------------------------------------------

ii. Part B Drugs
    Part B includes a limited drug benefit that encompasses drugs and 
biologicals described in section 1861(t) of the Act. Currently, covered 
Part B drugs fall into three general categories: Drugs furnished 
incident to a physician's services, drugs administered via a covered 
item of durable medical equipment, and other drugs specified by statute 
(generally in section 1861(s)(2) of the Act). Types of providers and 
suppliers that are paid for all or some of the Medicare-covered Part B 
drugs that they furnish include physicians, pharmacies, durable medical 
equipment suppliers, hospital outpatient departments, and end-stage 
renal disease (ESRD) facilities.
    The majority of Part B drug expenditures are for drugs furnished 
incident to a physician's service. Drugs furnished incident to a 
physician's service are typically injectable drugs that are 
administered in a non-facility setting (covered under section 
1861(s)(2)(A) of the Act) or in a hospital outpatient setting (covered 
under section 1861(s)(2)(B) of the Act). The statute (sections 
1861(s)(2)(A) and 1861(s)(2)(B) of the Act) limits ``incident to'' 
services to drugs that are not usually self-administered; self-
administered drugs, such as orally administered tablets and capsules 
are not paid for under the ``incident to'' provision. Payment for drugs 
furnished incident to a physician's service falls under section 1842(o) 
of the Act. In accordance with section 1842(o)(1)(C) of the Act, 
``incident to'' drugs furnished in a non-facility setting are paid 
under the methodology in section 1847A of the Act. ``Incident to'' 
drugs furnished in a facility setting also are paid using the 
methodology in section 1847A of the Act when it has been incorporated 
under the relevant payment system (for

[[Page 62652]]

example, the Hospital Outpatient Prospective Payment System 
(OPPS)).\57\
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    \57\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
---------------------------------------------------------------------------

    In most cases, payment using the methodology in section 1847A of 
the Act means payment is determined based on the ASP plus a 
statutorily-mandated 6 percent add-on. The payment for these drugs does 
not include costs for administering the drug to the patient (for 
example, by injection or infusion); payments for these physician and 
hospital services are made separately, and the payment amounts are 
determined under the PFS \58\ and the OPPS, respectively. The ASP 
payment amount determined under section 1847A of the Act reflects a 
volume-weighted ASP for all NDCs that are assigned to a HCPCS code. The 
ASP is calculated quarterly using manufacturer-submitted data on sales 
to all purchasers (with limited exceptions as articulated in section 
1847A(c)(2) of the Act, such as for sales at nominal charge and sales 
exempt from best price) with manufacturers' rebates, discounts, and 
price concessions reflected in the manufacturer's determination of ASP.
---------------------------------------------------------------------------

    \58\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
---------------------------------------------------------------------------

    Although the Part B drug benefit is generally considered to be 
limited in scope, it includes many categories of drugs and encompasses 
a variety of care settings and payment methodologies. In addition to 
the ``incident to'' drugs described above, Part B also covers and pays 
for certain oral drugs with specific benefit categories defined under 
section 1861(s) of the Act, including certain oral anti-cancer drugs 
and certain oral antiemetic drugs. In accordance with section 
1842(o)(1) of the Act or through incorporation under the relevant 
payment system as discussed above, most of these oral Part B drugs are 
also paid based on the ASP methodology described in section 1847A of 
the Act.
    However, at times Part B drugs are paid based on wholesale 
acquisition cost (WAC) as authorized under section 1847A(c)(4) of the 
Act \59\ or average manufacturer price (AMP)-based price substitutions 
as authorized under section 1847A(d) of the Act \60\. Also, in 
accordance with section 1842(o) of the Act, other payment methodologies 
may be applied to determine the payment amount for certain Part B 
drugs, for example, AWP-based payments (using current AWP) are made for 
influenza, pneumococcal pneumonia, and hepatitis B vaccines.\61\ We 
also use current AWP to make payment under the OPPS for very new drugs 
without an ASP.\62\ Contractors may also make independent payment 
amount determinations in situations where a national price is not 
available for physician and other supplier claims and for drugs that 
are specifically excluded from payment based on section 1847A of the 
Act (for example, radiopharmaceuticals as noted in section 303(h) of 
the Medicare Prescription Drug, Improvement and Modernization Act of 
2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003). In such cases, 
pricing may be determined based on compendia or invoices.\63\
---------------------------------------------------------------------------

    \59\ See 75 FR 73465-73466, the section titled Partial Quarter 
ASP data.
    \60\ See 77 FR 69140.
    \61\ Section 1842(o)(1)(A)(iv) of the Act.
    \62\ 80 FR 70426 and 80 FR 70442-3; Medicare Claims Processing 
Manual 100-04, Chapter 17, Section 20.1.3.
    \63\ Medicare Claims Processing Manual 100-04, Chapter 17, 
Section 20.1.3.
---------------------------------------------------------------------------

    While most Part B drugs are paid based on the ASP methodology, 
MedPAC has noted that the ASP methodology may encourage the use of more 
expensive drugs because the 6 percent add-on generates more revenue for 
more expensive drugs.\64\ The ASP payment amount also does not vary 
based on the price an individual provider or supplier pays to acquire 
the drug. The statute does not identify a reason for the additional 6 
percent add-on above ASP; however, as noted in the MedPAC report (and 
by sources cited in the report), the add-on is needed to account for 
handling and overhead costs and/or for additional mark-up in the 
distribution channels that are not captured in the manufacturer-
reported ASP.\65\
---------------------------------------------------------------------------

    \64\ See MedPAC Report to the Congress: Medicare and the Health 
Care Delivery System June 2015, pages 65-72.
    \65\ Ibid.
---------------------------------------------------------------------------

    We proposed to use the methodology in section 1847A of the Act 
(which bases most payments on ASP) to set the payment rates for the 
``incident to'' drugs. However, we proposed to limit the payment 
amounts for ``incident to'' drugs to 100 percent of the volume-weighted 
ASP for a HCPCS code instead of 106 percent of the volume-weighted ASP 
for a HCPCS code. We explained our belief that limiting the add-on 
would incentivize the use of the most clinically appropriate drug for a 
given patient. In addition, we noted that it was our understanding that 
many OTPs purchase directly from drug manufacturers, thereby limiting 
the markup from distribution channels. We also proposed to use the same 
version of the quarterly manufacturer-submitted data used for 
calculating the most recently posted ASP data files in preparing the CY 
2020 payment rates for OTPs. We noted that the quarterly ASP Drug 
Pricing Files include ASP plus 6 percent payment amounts.\66\ 
Accordingly, we adjusted these amounts consistent with our proposal to 
limit the payment amounts for these drugs to 100 percent of the volume-
weighted ASP for a HCPCS code. The proposed payment rates can be found 
in Table 15 of the CY 2020 PFS proposed rule (84 FR 40537). We proposed 
to codify the ASP payment methodology for the drug component of weekly 
bundles that include implantable or injectable medications at Sec.  
410.67(d)(2). We solicited public comment on the proposals, as well as 
on using alternative ASP-based payments to price these drugs, such as a 
rolling average of the past year's ASP payment rates.
---------------------------------------------------------------------------

    \66\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
---------------------------------------------------------------------------

    We received several comments on our proposals regarding pricing of 
Part B drugs. The following is a summary of the comments received and 
our responses.
    Comment: Several commenters expressed concern regarding the 
proposal to use the methodology in section 1847A of the Act (which 
bases most payments on ASP) to set the payment rates for the ``incident 
to'' drugs and to limit the payment amounts to 100 percent of the 
volume-weighted ASP for a code instead of 106 percent of the volume-
weighted ASP for a code. (We note that a similar proposal for setting 
the payment rates for the oral OTP drugs follows and that several of 
the comments we received did not specifically reference which group of 
drugs they were addressing; therefore, we have included a discussion of 
these comments under both sections.) A few commenters supported the 
proposal, reasoning that ASP provides a transparent and public 
benchmark that would allow monitoring for unexpected and unnecessary 
price changes by manufacturers.
    Several other commenters expressed concerns about the proposal to 
price the Part B injectable and implantable drugs used in the bundle 
using the ASP without the 6 percent add-on. Commenters noted that the 
add-on is a necessary part of the payment to account for items such as 
overhead costs and/or additional mark-ups in the traditional drug 
distribution channels that are not captured in the manufacturer-
reported ASP. A few commenters stated that the 6 percent

[[Page 62653]]

add-on would allow the OTP to recoup costs associated with rigorous 
storage and inventory tracking systems required by the DEA. These 
commenters also stated that the large OTPs, hospitals, and physician 
systems could skew ASP lower than the prices that smaller or rural OTPs 
could negotiate on their own. One commenter expressed concerns that 
OTPs might not be able to afford Part B drugs without the add-on to 
cover these costs, and suggested a cautious approach to ensure the 
success of these programs. A few commenters noted that the proposal to 
price Part B drugs using ASP without the 6 percent add-on would provide 
a disincentive for an OTP to utilize the most appropriate product for 
the patient in order to limit their cost of care. Some commenters 
objected to CMS' statement in the proposed rule that limiting the 6 
percent add-on would incentivize the use of the most clinically 
appropriate drug for a given patient asserting that the 6 percent add-
on does not provide an incentive to choose high-cost treatment 
inappropriately because physicians do not profit from administering 
Part B drugs under the ASP methodology. Several commenters also 
questioned CMS' legal authority to limit the payment amount for these 
drugs to 100 percent of the ASP.
    Response: We thank the commenters for their feedback on our 
proposal to set the payment amounts for ``incident to'' drugs at 100 
percent of the volume-weighted ASP. We agree that use of ASP provides a 
transparent and public benchmark for manufacturers' pricing as it 
reflects the manufacturers' actual sales prices to all purchasers (with 
limited exceptions) and is the only pricing methodology that includes 
off-invoice rebates and discounts as described in section 1847A(c)(3) 
of the Act. For this reason, we believe the ASP to be the most market-
based approach to set drug prices for the OTP bundled payments.
    As noted above, section 1834(w) of the Act grants the Secretary 
significant discretion to establish bundled payment rates for OUD 
treatment services. The statute does not dictate the use of any 
specific methodology, such as the methodology in section 1847A of the 
Act, in setting the payment rate for the drug component of the bundled 
payments. Therefore, we do not agree with the comments that indicated 
CMS has a legal obligation to include the 6 percent add-on when using 
ASP to determine the payment rate for the drug component of the bundled 
payments to OTPs for OUD treatment services.
    As noted in the proposed rule, we understand that many OTPs 
purchase medications directly from drug manufacturers, thereby limiting 
the markup from distribution channels. We received this information 
during a routine informational industry call with OTP advocates in 
preparation for drafting the proposed rule. We also note that this fact 
was not challenged by any of the commenters. Furthermore, we do not 
believe the record-keeping or storage requirements noted are unique to 
OTPs. In fact, the selection of drugs purchased by most OTPs is quite 
limited, which theoretically limits the utility of third-parties, such 
as wholesalers, and their associated costs and increases the purchase 
volume for OTPs and accompanying manufacturer discounts. We believe 
that this situation could lend itself to an OTP drug channel for 
purchasing at discounted rates either directly or through the use of 
buying groups as is the standard in the pharmacy industry today. 
Furthermore, we remain concerned that certain providers will look to 
differential drug costs to determine which therapies to offer. As a 
result, we believe that our proposed approach of paying for ``incident 
to'' drugs based on ASP offers the most appropriate balance between 
ensuring OTPs receive appropriate reimbursement for their drug 
acquisition costs, while also preserving the incentive to use the most 
clinically appropriate drug for the treatment of individual 
beneficiaries.
    After consideration of the public comments, we are finalizing our 
proposal to use the methodology in section 1847A of the Act (which 
bases most payments on ASP) to set the payment rates for the ``incident 
to'' drugs and to limit the payment amounts for these drugs to 100 
percent of the volume-weighted ASP for a drug category or code. We are 
codifying this policy in the regulations at Sec.  410.67(d)(2)(i)(A). 
However, we continue to be interested in feedback regarding drug 
acquisition costs for OTP providers, and in particular any drug 
acquisitions that exceed these rates after factoring in discounts, 
rebates, etc., and, if necessary, may revisit the payment methodology 
for ``incident to'' OTP drugs in future rulemaking to ensure that OTPs' 
drug acquisition costs are appropriately reimbursed.
iii. Oral Drugs
    We proposed to use ASP-based payment, which would be determined 
based on ASP data that have been calculated consistent with the 
provisions in 42 CFR part 414, subpart 800, to set the payment rates 
for the oral product categories when we receive manufacturer-submitted 
ASP data for these drugs. We stated that we believe using the ASP 
pricing data for oral OTP drugs currently covered under Part D \67\ 
would facilitate the computation of the estimated costs of these drugs. 
However, we acknowledged that we do not collect ASP pricing information 
under section 1927(b) of the Act for these drugs. We solicited public 
comment on whether manufacturers would be willing to submit ASP pricing 
data for OTP drugs currently covered under Part D on a voluntary basis.
---------------------------------------------------------------------------

    \67\ Please note that methadone is not currently considered a 
Part D drug when used for MAT. Methadone used for this purpose can 
be dispensed only through an OTP certified by SAMHSA. However, 
methadone dispensed for pain may be considered a Part D drug.
---------------------------------------------------------------------------

    We also proposed to limit the payment amounts for oral drugs to 100 
percent of the volume-weighted ASP for a HCPCS code instead of 106 
percent of the volume-weighted ASP for that HCPCS code. We explained 
our belief that limiting the 6 percent add-on would incentivize the use 
of the most clinically appropriate drug for a given patient. In 
addition, we explained our understanding that many OTPs purchase 
directly from drug manufacturers, thereby limiting the markup from 
distribution channels. We proposed to use the same version of the 
quarterly manufacturer-submitted data used for calculating the most 
recently posted ASP data files in preparing the CY 2020 payment rates 
for OTPs. We noted that the quarterly ASP Drug Pricing Files include 
ASP plus 6 percent payment amounts.\68\ Accordingly, we would adjust 
these amounts consistent with our proposal to limit the payment amounts 
for these drugs to 100 percent of the volume-weighted ASP for a HCPCS 
code. The proposed payment rates were provided in Table 15 of the 
proposed rule. We proposed to codify the ASP payment methodology for 
the drug component of weekly bundles that include an oral medication at 
Sec.  410.67(d)(2)(i)(B). We solicited public comment on these 
proposals, as well as on using alternative ASP-based payments to price 
these drugs, such as a rolling average of the past year's ASP payment 
rates.
---------------------------------------------------------------------------

    \68\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
---------------------------------------------------------------------------

    In the event that we do not receive manufacturer-submitted ASP 
pricing data, we also considered several potential alternative pricing 
mechanisms to estimate the payment amounts for oral drugs typically 
paid for under Medicare Part D but that would become OTP drugs paid 
under Part B when used as part of MAT in an OTP.

[[Page 62654]]

We did not propose a specific pricing mechanism for these drugs at this 
time, but solicited public comment on the following potential 
approaches for estimating the acquisition cost and payment amounts for 
these drugs and on alternative approaches. We noted that we would 
consider the comments received in developing our final policy for 
determining these drug prices.
Approach 1: The Methodology in Section 1847A of the Act
    One approach for estimating the cost of the drugs that are 
currently covered under Part D and for which ASP data are not available 
would be to use the methodology in section 1847A of the Act. Please see 
above for a discussion of the payment methodology in section 1847A of 
the Act. Under the methodology in section 1847A of the Act, when ASP 
data are not available, this option would price drugs using, for 
example, WAC or invoice pricing.
Approach 2: Medicare Part D Prescription Drug Plan Finder Data
    On January 28, 2005, we issued the ``Medicare Program; Medicare 
Prescription Drug Benefit'' final rule (70 FR 4194) which implemented 
the Medicare voluntary prescription drug benefit, as enacted by section 
101 of the MMA. Beginning on January 1, 2006, a prescription drug 
benefit program was available to beneficiaries with much broader drug 
coverage than was previously provided under Part B to include: Brand-
name prescription drugs and biologicals, generic drugs, biosimilars, 
vaccines, and medical supplies associated with the injection of 
insulin.\69\ This prescription drug benefit is offered to Medicare 
beneficiaries through Medicare Advantage Drug Plans (MA-PDs) and stand-
alone Prescription Drug Plans (PDPs). The prescription drug benefit 
under Medicare Part D is administered based on the ``negotiated 
prices'' of covered Part D drugs. Under Sec.  423.100 of the Part D 
regulations, the negotiated price of a Part D drug equals the amount 
paid by the Part D sponsor (or its pharmacy benefit manager) to the 
pharmacy at the point-of-sale for that drug. Typically, these Part D 
``negotiated prices'' are based on AWP minus a percentage for brand 
drugs or either the maximum allowable cost, which is based on 
proprietary methodologies used to establish the same payment for 
therapeutically equivalent products marketed by multiple labelers with 
different AWPs, or the Generic Effective Rate, which guarantees 
aggregate minimum reimbursement (for example, AWP-85 percent). The 
negotiated price under Part D also includes a dispensing fee (for 
example, $1-$2), which is added to the cost of the drug.
---------------------------------------------------------------------------

    \69\ See section 1860D-2(e) of the Act.
---------------------------------------------------------------------------

    Many of the beneficiaries who choose to enroll in Part D drug plans 
must pay premiums, deductibles, and copayments/co-insurance. The 
Medicare Prescription Drug Plan Finder is an online tool available at 
http://www.medicare.gov. This web tool allows beneficiaries to make 
informed choices about enrolling in Part D plans by comparing the 
plans' benefit packages, premiums, formularies, pharmacies, and pricing 
data. PDPs and MA-PDs are required to submit this information to CMS 
for posting on the Medicare Drug Plan Finder. The database structure 
provides the drug pricing and pharmacy network information necessary to 
accurately communicate plan information in a comparative format. The 
Medicare Prescription Drug Plan Finder displays information on 
pharmacies that are contracted to participate in the sponsors' network 
as either retail or mail order pharmacies.
    Another approach for estimating the cost of the drugs that are 
currently covered under Part D and for which ASP data are not available 
would be to use data retrieved from the online Medicare Prescription 
Drug Plan Finder. For example, the Part D drug prices for each drug 
used by an OTP as part of MAT could be estimated based on a national 
average price charged by all Part D plans and their network pharmacies. 
However, the prices listed in the Medicare Prescription Drug Plan 
Finder generally reflect the prices that are negotiated by larger 
buying groups, as larger pharmacies often have significant buying power 
and smaller pharmacies generally contract with a pharmacy services 
administrative organization (PSAO). As a result, we indicated that our 
primary concern with this pricing approach is that such prices may fail 
to reflect the drug prices that smaller OTP facilities may pay in 
acquiring these drugs and could therefore disadvantage these 
facilities. We explained that if we were to select this pricing 
approach for oral drugs for which ASP data are not available, we would 
anticipate setting the pricing for these drugs using the most recent 
Medicare Prescription Drug Plan Finder data available at the drafting 
of this CY 2020 PFS final rule. We noted that, for the Part B ESRD 
prospective payment system (PPS) outlier calculation, which provides 
ESRD facilities with additional payment in situations where the costs 
for treating patients exceed an established threshold under the ESRD 
PPS, we chose to adopt the ASP methodology in section 1847A of the Act, 
and the other pricing methodologies under section 1847A of the Act, as 
appropriate, when ASP data are not available, to price the renal 
dialysis drugs and biological products that were or would have been 
separately billable under Part B prior to implementation of the ESRD 
PPS,\70\ and the national average drug prices based on the Medicare 
Prescription Drug Plan Finder as the data source for pricing the renal 
dialysis drugs or biological products that were or would have been 
separately covered under Part D prior to implementation of the ESRD 
PPS.\71\
---------------------------------------------------------------------------

    \70\ 82 FR 50742 through 50745.
    \71\ 75 FR 49142.
---------------------------------------------------------------------------

    In the proposed rule, we stated that we believe all of the MAT 
drugs proposed for inclusion in the OTP benefit that are currently 
covered under Part D have clinical treatment indications beyond MAT 
such as for the treatment of pain.\72\ These drugs will continue to be 
covered under Part D for these other indications. Buprenorphine will 
continue to be covered under Part D for MAT as well. Consequently, Part 
D pricing information should continue to be available for these drugs 
and could be used in the computation of payment under the approach 
discussed above.
---------------------------------------------------------------------------

    \72\ For example, while methadone is not covered by Medicare 
Part D for MAT, methadone dispensed for pain may be considered a 
Part D drug.
---------------------------------------------------------------------------

    Because, by law, methadone used in MAT cannot be dispensed by a 
pharmacy, it is not currently considered a Part D drug when used for 
MAT. Methadone used for this purpose can be dispensed only through an 
OTP certified by SAMHSA. However, methadone dispensed for pain may be 
considered a Part D drug and can be dispensed by a pharmacy. 
Accordingly, we also solicited comment on the applicability of Part D 
payment rates for methadone dispensed by a pharmacy to methadone 
dispensed by an OTP for MAT.
Approach 3: Wholesale Acquisition Cost (WAC)
    Another approach for estimating the cost of the oral drugs that we 
proposed to include as part of the bundled payments, but for which ASP 
data are not available, would be to use WAC. Section 1847A(c)(6)(B) of 
the Act defines WAC as the manufacturer's list price for the drug to 
wholesalers or direct purchasers in the U.S., not including prompt pay 
or other discounts, rebates, or reductions in price, for the most 
recent month for

[[Page 62655]]

which the information is available, as reported in wholesale price 
guides or other publications of drug pricing data. As noted above in 
the discussion of Part B drugs, WAC is used as the basis for pricing 
some Part B drugs; for example, it is used when it is less than ASP in 
the case of single source drugs (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).
    Because WAC is the manufacturer's list price to wholesalers, we 
noted that we believe it is more reflective of the price paid by the 
end user than the AWP. As a result, we believe that this pricing 
mechanism would be consistent with pricing that currently occurs for 
drugs that are separately billable under Part B. However, we have 
concerns about the fact that WAC does not include prompt pay or other 
discounts, rebates, or reductions in price. We noted that if we were to 
select this option to estimate the cost of certain drugs, we would 
develop pricing using the most recent data files available at the time 
of drafting this CY 2020 PFS final rule.
Approach 4: National Average Drug Acquisition Cost (NADAC)
    Another approach for estimating the cost of the oral drugs that we 
proposed to include as part of the bundled payments, but for which ASP 
data are not available, would be to use Medicaid's NADAC survey. This 
survey provides another national drug pricing benchmark. CMS conducts 
surveys of retail community pharmacy prices, including drug ingredient 
costs, to develop the NADAC pricing benchmark. The NADAC was designed 
to create a national benchmark that is reflective of the prices paid by 
retail community pharmacies to acquire prescription and over-the-
counter covered outpatient drugs and is available for consideration by 
states to assist with their individual pharmacy payment policies.
    State Medicaid agencies reimburse pharmacy providers for prescribed 
covered outpatient drugs dispensed to Medicaid beneficiaries. The 
reimbursement formula consists of two parts: (1) Drug ingredient costs; 
and (2) a professional dispensing fee. In a final rule with comment 
period titled ``Medicaid Program; Covered Outpatient Drugs,'' which 
appeared in the February 1, 2016 Federal Register (81 FR 5169), we 
revised the methodology that state Medicaid programs use to determine 
drug ingredient costs, establishing an Actual Acquisition Cost (AAC) 
based determination, as opposed to a determination based on estimated 
acquisition costs (EAC). AAC is defined at 42 CFR 447.502 as the 
agency's determination of the pharmacy providers' actual prices paid to 
acquire drugs marketed or sold by specific manufacturers. As explained 
in the Covered Outpatient Drugs final rule with comment period (81 FR 
5175), we believe shifting from an EAC to an AAC based determination of 
ingredient costs is more consistent with the dictates of section 
1902(a)(30)(A) of the Act. In 2010, a working group within the National 
Association of State Medicaid Directors (NASMD) recommended the 
establishment of a single national pricing benchmark based on average 
drug acquisition costs. Pricing metrics based on actual drug purchase 
prices provide greater accuracy and transparency in how drug prices are 
established and are more resistant to manipulation. The NASMD requested 
that CMS coordinate, develop, and support this benchmark.
    Section 1927(f) of the Act provides, in part, that CMS may contract 
with a vendor to conduct monthly surveys with respect to prices for 
covered outpatient drugs dispensed by retail community pharmacies. We 
entered into a contract with Myers & Stauffer, LLC to perform a monthly 
nationwide retail price survey of retail community pharmacy covered 
outpatient drug prices (CMS-10241, OMB 0938-1041) and to provide states 
with weekly updates on pricing files, that is, the NADAC files. The 
NADAC survey process focuses on drug ingredient costs for retail 
community pharmacies. The survey collects acquisition costs for covered 
outpatient drugs purchased by retail pharmacies, which include invoice 
prices from independent and chain retail community pharmacies. The 
survey data provide information that CMS uses to assure compliance with 
federal requirements. In the proposed rule, we explained that we 
believe NADAC data could be used to set the prices for the oral drugs 
furnished by OTPs for which ASP data are not available. Survey data on 
invoice prices provide the closest pricing metric to ASP that we are 
aware of. However, we also noted that similar to the other available 
pricing metrics, we have concerns about the applicability of retail 
pharmacy prices to the acquisition costs available to OTPs since we 
have no evidence to suggest that these entities would be able to 
acquire drugs at a similar price point. We noted that if we were to 
select this option to estimate the cost of certain drugs, we would 
develop pricing using the most recent data files available at the time 
of drafting this CY 2020 PFS final rule.
Alternative Methadone Pricing: TRICARE
    We also considered an approach for estimating the cost of methadone 
using the amount calculated by TRICARE. As discussed above in this 
section of this final rule, the TRICARE rates for medications used in 
OTPs to treat OUD are spelled out in the 2016 TRICARE final rule (81 FR 
61068); in the regulations at 32 CFR 199.14(a)(2)(ix); and in Chapter 
7, Section 5 and Chapter 1, Section 15 of the TRICARE Reimbursement 
Manual 6010.61-M, April 1, 2015.
    In the 2016 TRICARE final rule, DOD established separate payment 
methodologies for OTPs based on the particular medication being 
administered for treatment.\73\ Based on TRICARE's review of industry 
billing practices, the initial weekly bundled rate for administration 
of methadone included a daily drug cost of $3, which is subject to an 
update factor.\74\
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    \73\ 81 FR 61079.
    \74\ 81 FR 61079.
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    We noted that this option would only be applicable for methadone 
because TRICARE has developed a FFS payment methodology for 
buprenorphine and naltrexone.\75\ In the 2016 TRICARE final rule, the 
DOD stated that the payments for buprenorphine and naltrexone are more 
variable in dosage and frequency for both the drug and non-drug 
services.\76\ Accordingly, TRICARE pays for drugs listed on Medicare's 
Part B ASP files, such as the injectable and implantable versions of 
buprenorphine using the ASP; drugs not appearing on the Medicare ASP 
file, such as oral buprenorphine, are priced at the lesser of billed 
charges or 95 percent of the AWP.\77\
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    \75\ 81 FR 61080.
    \76\ 81 FR 61080.
    \77\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
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    We stated that we believed that pricing methadone consistent with 
the TRICARE payment rate could provide a reasonable payment amount for 
methadone when ASP data are not available. As DOD noted in the 2016 
TRICARE final rule, ``a number of commenters indicated that they 
believed the rates DOD proposed for OTPs' services are near market 
rates and are acceptable.'' \78\
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    \78\ 81 FR 61080.
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    We proposed to codify this proposal to apply an alternative 
approach for determining the payment rate for oral drugs only if ASP 
data are not available in Sec.  410.67(d)(2)(i)(B). We solicited

[[Page 62656]]

public comment on the potential alternative approaches for estimating 
the cost of oral drugs that we proposed to include as part of the 
bundled payments but for which ASP data are not available, including 
any other alternate sources of data to estimate the cost of these oral 
MAT drugs. Payment rates based on these different options were set 
forth in Table 14 of the proposed rule. We stated that we would 
consider the comments received on these different approaches when 
deciding on the approach that we would use to determine the payment 
rates for oral drugs in the CY 2020 PFS final rule. We also solicited 
public comment on any other potential data sources for estimating the 
provider acquisition costs of OTP drugs currently paid under either 
Part B or Part D.
    We received several comments on our proposals regarding pricing of 
oral drugs. The following is a summary of the comments received and our 
responses.
    Comment: Several commenters submitted comments on the proposal to 
use ASP-based payment to set the payment rates for the oral product 
categories when we receive manufacturer-submitted ASP data for these 
drugs and to limit the payment amounts for oral drugs to 100 percent of 
the volume-weighted ASP instead of 106 percent of the volume-weighted 
ASP. (We note that a similar proposal for the injectable and 
implantable Part B drugs is discussed above and that several of the 
comments we received did not specifically reference which group of 
drugs they were concerning; therefore, we have included a discussion of 
these comments under both sections.) A few commenters supported the 
proposal, reasoning that ASP provides a transparent and public 
benchmark that would allow monitoring for unexpected and unnecessary 
price changes by manufacturers; and a couple of commenters encouraged 
us to require manufacturers to report these data.
    Several other commenters expressed concerns about the proposal to 
price the oral drugs used in the bundle using the ASP without the 6 
percent add-on. Commenters stated that the add-on is a necessary part 
of the payment to account for things such as overhead costs and/or 
additional mark-ups in the traditional drug distribution channels that 
are not captured in the manufacturer-reported ASP. A few commenters 
stated that the 6 percent add-on would allow the OTP to recoup costs 
associated with rigorous storage and inventory tracking systems 
required by the DEA. These commenters also stated that large OTPs, 
hospitals, and physician systems could skew ASP lower than the prices 
that smaller or rural OTPs could negotiate on their own. One commenter 
expressed concerns that OTPs might not be able to afford the oral drugs 
used in MAT without the add-on to cover these costs, and suggested that 
the Administration should be overly cautious to ensure success of these 
programs. Some commenters expressed concerns that this proposal would 
provide a disincentive for an OTP to utilize the most appropriate 
product for the patient to limit their cost of care. Several commenters 
also questioned CMS' legal authority to limit the payment amount for 
these drugs to 100 percent of the ASP.
    Response: We thank the commenters for their feedback on our 
proposal to use ASP-based payment to set the payment rates for the oral 
product categories when we receive manufacturer-submitted ASP data for 
these drugs and to limit the payment amounts for oral drugs to 100 
percent of the volume-weighted ASP instead of 106 percent of the 
volume-weighted ASP. We agree that use of ASP provides a transparent 
and public benchmark for manufacturers' pricing as it reflects the 
manufacturers' actual sales prices to all purchasers (with limited 
exceptions) and is the only pricing methodology that includes off-
invoice rebates and discounts as described in section 1847A(c)(3) of 
the Act. For this reason, we believe the ASP to be the most market-
based approach to set drug prices for the OTP benefit.
    As noted above, section 1834(w) of the Act grants the Secretary 
considerable discretion to establish bundled payment rates for OUD 
treatment services. The statute does not dictate use of any specific 
methodology, such as the methodology in section 1847A of the Act, in 
setting these payments. We used our discretion, granted by the Act, in 
proposing to modify the methodology in section 1847A of the Act to set 
payments to OTPs for oral drugs for which ASP data are available. 
Therefore, we do not agree with the comments that indicated CMS has a 
legal obligation to include the 6 percent add--when using ASP to 
determine payments to OTPs for oral drugs.
    As noted in the proposed rule, we understand that many OTPs 
purchase medications directly from drug manufacturers, thereby limiting 
the markup from distribution channels. We received this information 
during a routine informational industry call with OTP advocates in 
preparation for drafting the proposed rule. We also note that this fact 
was not challenged by any of the commenters. Furthermore, we do not 
believe the record-keeping or storage requirements noted are unique to 
OTPs. In fact, the selection of drugs purchased by most OTPs is quite 
limited, which theoretically limits the utility of third-parties, such 
as wholesalers, and their associated costs and increases the purchase 
volume for OTPs and accompanying manufacturer discounts. We believe 
that this situation could lend itself to an OTP drug channel for 
purchasing at discounted rates either directly or through the use of 
buying groups as is the standard in the pharmacy industry today. 
Furthermore, we remain concerned that certain providers will look to 
differential drug costs to determine which therapies to offer. As a 
result, we believe that our proposed approach of paying for oral drugs 
based on ASP, when available, offers an appropriate balance between 
ensuring OTPs receive appropriate reimbursement for their drug 
acquisition costs, while also preserving the incentive to use the most 
clinically appropriate drug for the treatment of individual 
beneficiaries.
    After consideration of the public comments, we are finalizing our 
proposal to use ASP-based payment to set the payment rates for the oral 
drugs and to limit the payment amounts for these drugs to 100 percent 
of the volume-weighted ASP when it is available. However, we continue 
to be interested in feedback regarding drug acquisition costs for OTP 
providers, and in particular any drug acquisitions that exceed these 
rates after factoring in discounts, rebates, etc., and if necessary, 
may revisit the payment methodology for oral OTP drugs in future 
rulemaking to ensure that OTPs' drug acquisition costs are 
appropriately reimbursed.
    Comment: A few commenters submitted comments on the potential 
pricing mechanisms described in the proposed rule to estimate the 
payment amounts for oral OTP drugs in the event that we do not receive 
manufacturer-submitted ASP pricing data. Some commenters supported 
establishing payments based on current Medicare law and practice, such 
as the rates provided under Part D, for other oral drugs. Another 
commenter advised against using methods such as AWP and WAC as these 
options can be manipulated by the manufacturers. This commenter also 
noted that NADAC and the Medicare Plan Finder prices may not be 
relevant to all OTP medications as they are retail-based price measures 
and OTPs are providers. One commenter suggested use of the methodology 
in section 1847A of the

[[Page 62657]]

Act, which would generally default to WAC-based payment if ASP is not 
reported. One commenter generally opposed the use of TRICARE rates, 
while another specifically stated that the current TRICARE payment rate 
for methadone, as presented in the proposed rule, is fair and should be 
used as a reference price for Medicare.
    Response: We agree with commenters that using current programmatic 
pricing mechanisms where available is preferable to a pricing 
methodology that is novel and unproven. As oral buprenorphine used for 
OUD is currently dispensed by retail pharmacies, we believe that a 
retail-based pricing method may be most relevant to this drug product 
and more reflective of actual costs than a list price. As noted above, 
the NADAC survey collects acquisition costs for covered outpatient 
drugs purchased by retail pharmacies, which include invoice prices from 
independent and chain retail community pharmacies. Pricing metrics 
based on actual drug purchase prices provide greater accuracy and 
transparency in how drug prices are established and are more resistant 
to manipulation. As the NADAC survey data on invoice prices provide the 
closest pricing metric to ASP that we are aware of, we believe, at this 
time, that NADAC data would be the best pricing benchmark to set the 
prices for non-methadone oral drugs (that is, currently only the oral 
buprenorphine products) furnished by OTPs for which ASP data are not 
available. We further agree that retail pricing benchmarks, such as 
NADAC and Part D Plan Finder data, may not be particularly relevant for 
methadone, because methadone is not dispensed by retail pharmacies for 
this indication and its use for OUD is limited to OTPs. As a result, we 
believe that use of the TRICARE rate for methadone, when ASP data are 
not available, is currently the most applicable reference price for 
Medicare payment of methadone used in the OTP setting.
    After consideration of the public comments, we are finalizing our 
proposal to use ASP-based payment to set the payment rates for the oral 
product categories when we receive manufacturer-submitted ASP data for 
these drugs and to limit the payment amounts for oral drugs to 100 
percent of the volume-weighted ASP. We have used the same version of 
the quarterly manufacturer-submitted data used for calculating the most 
recently posted ASP data files to determine the CY 2020 payment rates 
for OTPs. When ASP data are not available for the oral drugs used in 
OTPs, we are finalizing a policy under which we will use the TRICARE 
rate to set the payment for the drug component of the methadone bundle, 
and NADAC data to set the payment for the drug component of the oral 
buprenorphine bundle. Payment rates for these drugs are provided in 
Table 18. We note that, for purposes of determining payment for CY 
2020, we were able to calculate an ASP for methadone using manufacturer 
reported data. However, we did not receive ASP data from any of the 
buprenorphine oral manufacturers. Therefore, the drug component of the 
oral buprenorphine weekly bundle will be priced using NADAC survey 
data. We are finalizing this payment methodology for the oral drugs at 
Sec.  410.67(d)(2)(i)(B).
(b) Non-Drug Component
    To price the non-drug component of the bundled payments, we 
proposed to use a crosswalk to the non-drug component of the TRICARE 
weekly bundled rate for services furnished when a patient is prescribed 
methadone. As described above, in 2016, TRICARE finalized a weekly 
bundled rate for administration of methadone that included a daily drug 
cost of $3, along with a $15 per day cost for non-drug services (that 
is, the costs related to the intake/assessment, drug dispensing and 
screening and integrated psychosocial and medical treatment and 
supportive services). The daily projected per diem cost ($18/day) was 
converted to a weekly rate of $126 ($18/day x 7 days) (81 FR 61079). 
TRICARE updates the weekly bundled methadone rate for OTPs annually 
using the Medicare update factor used for other mental health care 
services rendered under TRICARE (that is, the Inpatient Prospective 
Payment System update factor) (81 FR 61079). The updated amount for CY 
2019 is $133.15 (of which $22.19 is the methadone cost and the 
remainder, $110.96, is for the non-drug services).\79\ In the proposed 
rule, we stated that we believed using the TRICARE weekly bundled rate 
would be a reasonable approach to setting the payment rate for the non-
drug component of the bundled payments to OTPs, particularly given the 
time constraints in developing a payment methodology prior to the 
January 1, 2020 effective date of this new Medicare benefit category. 
The TRICARE rate is an established national payment rate that was 
established through notice and comment rulemaking. As a result, OTPs 
and other interested parties had an opportunity to present information 
regarding the costs of these services. Furthermore, the TRICARE rate 
describes a generally similar bundle of services to those services that 
are included in the definition of OUD treatment services in section 
1861(jjj)(1) of the Act. We recognized that there are differences in 
the patient population for TRICARE compared with the Medicare 
beneficiary population. However, as OTP services have not previously 
been covered by Medicare, we noted that it is not clear what impact, if 
any, these differences would have on the cost of the services included 
in the non-drug component of the bundled payments. We proposed to 
codify the methodology for determining the payment rate for the non-
drug component of the bundled payments using the TRICARE weekly rate 
for non-drug services at Sec.  410.67(d)(2). As part of the proposal, 
we noted that we would plan to monitor utilization of non-drug services 
by Medicare beneficiaries and, if needed, would consider in future 
rulemaking ways we could tailor the TRICARE payment rate for these non-
drug services to the Medicare population, including dually eligible 
beneficiaries.
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    \79\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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    Because the TRICARE payment rate for the non-drug services included 
in its weekly bundled rate for methadone reflects the daily 
administration of methadone, as part of our proposed approach we 
indicated that we would adjust the TRICARE payment rate for non-drug 
services for most of the other bundled payments to more accurately 
reflect the cost of administering the other drugs used in MAT. For the 
oral buprenorphine bundled payment, we proposed to retain the same 
amount as the rate for the methadone bundled payment based on an 
assumption that this drug is also being dispensed daily. We stated that 
we understood that patients who have stabilized may be given 7-14 day 
supplies of oral buprenorphine at a time, but for the purposes of 
developing the proposed rates, we proposed to value this service to 
include daily drug dispensing to account for cases where daily drug 
dispensing is occurring. For the injectable drugs (buprenorphine and 
naltrexone), we proposed to subtract from the non-drug component, an 
amount that is comparable to the dispensing fees paid by several state 
Medicaid programs ($10.50) for a week of daily dispensing of methadone. 
This adjustment would account for the fact that these injectable drugs 
are not oral drugs that are dispensed daily; we proposed that we would 
then instead add the fee that Medicare pays for the

[[Page 62658]]

administration of an injection (which is currently $16.94 under the CY 
2019 non-facility Medicare payment rate for CPT code 96372). We 
proposed to update the amount of this adjustment annually using the 
same methodology that we were proposing to use to update the non-drug 
component of the bundled payments.
    Similarly, we proposed that the payment rates for the non-drug 
component of the codes for the weekly bundled payments for 
buprenorphine implants would be adjusted to add an amount for insertion 
and/or removal of the implants based on a direct crosswalk to the non-
facility payment rates under the Medicare PFS for the insertion, 
removal, or insertion and removal of these implants, which describe the 
physician work, PE, and malpractice costs associated with these 
procedures, and to remove the costs of daily drug dispensing 
(determined based on the dispensing fees paid by several state Medicaid 
programs for a week of daily dispensing of methadone, currently 
$10.50). For the code describing implant insertion, we proposed that we 
would use a crosswalk to the rate for HCPCS code G0516 (Insertion of 
non-biodegradable drug delivery implants, 4 or more (services for 
subdermal rod implant)); for the code describing implant removal, we 
proposed that we would use a crosswalk to the rate for HCPCS code G0517 
(Removal of non-biodegradable drug delivery implants, 4 or more 
(services for subdermal implants)); and for the code describing implant 
insertion and removal, we proposed that we would use a crosswalk to the 
rate for HCPCS code G0518 (Removal with reinsertion, non-biodegradable 
drug delivery implants, 4 or more (services for subdermal implants)). 
We note that in the proposed rule, we inadvertently misstated the 
amounts for HCPCS codes G0516, G0517, and G0518. The correct amounts 
for HCPCS codes G0516, G0517, and G0518 under the CY 2019 non-facility 
Medicare payment rate are $246.15, $265.61, and $465.26, respectively.
    To determine the payment rates for the code describing a non-drug 
bundled payment, we proposed to use a crosswalk to the reimbursement 
rate for the non-drug services included in the TRICARE weekly bundled 
rate for administration of methadone, adjusted to subtract the cost of 
methadone dispensing (using an amount that is comparable to the 
dispensing fees paid by several state Medicaid programs for a week of 
daily dispensing of methadone, which is currently $10.50).
    We proposed that the payment rate for the add-on code for each 
additional 30 minutes of counseling or group or individual therapy 
would be based on 30 minutes of substance use counseling and valued 
based on a crosswalk to the rates set by state Medicaid programs for 
similar services.
    We received a number of public comments on our proposed payment 
rates for the non-drug component of the bundled payment and the add-on 
code for additional counseling or therapy services. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters stated that the proposed rate for the non-
drug component of the bundled payment was insufficient. A few 
commenters expressed concern that establishing a Medicare rate that is 
lower than the rates set by some state Medicaid programs would 
destabilize the market. Some commenters recommended that the single 
full week TRICARE payment rate should be the floor used to pay for a 
basic Medicare OTP benefit assuming a similar level of service and that 
any additional services, such as extra counseling and/or therapy 
visits, should be reimbursed outside of the bundle, as CMS proposed for 
counseling sessions above the basic benefit and stated that if 
additional services are added to the basic benefit, the bundled payment 
should increase to reflect the additional services. Some commenters 
stated that the proposed rate reflects a market rate that is 
significantly discounted, noting that it is benchmarked on an insurance 
industry practice rooted in stigma and limited resources and expressed 
concern that it may inadvertently limit access to care at a time when 
the opioid overdose epidemic continues to cause significant mortality. 
Additionally, a few commenters noted that the TRICARE rate reflects the 
average cost of care for the typical TRICARE patient, but that they 
believed Medicare patients would generally require more services. A few 
commenters noted that the only difference between OTPs and office-based 
OUD treatment is the means of regulation and medication offered, and 
that therefore, the different settings should not be cause to pay 
differentially. Some commenters encouraged CMS to adjust the payment 
rates to account for severity of illness. Several commenters stated 
that the proposed rate for counseling is too low, which would make it 
difficult for providers to employ qualified practitioners. Several 
commenters urged CMS to use a building block methodology, which sums 
the Medicare payment rates for similar services furnished in the non-
facility setting, to calculate the payment rate for the non-drug 
component.
    Response: After consideration of the public comments, we are 
finalizing a payment rate for the non-drug component that is calculated 
based on a building block methodology using the Medicare payment rates 
for similar services furnished in the non-facility setting. We note 
that we considered a variety of different rates, including TRICARE and 
Medicaid, and decided ultimately to use Medicare rates for similar 
services. We appreciate commenters' feedback about the TRICARE rate, 
including the concern that it reflects an average cost of care for the 
TRICARE patient population, and note that by finalizing payment rates 
using the established rates for similar services under Medicare, we 
believe these rates will be more reflective of the resource costs 
involved in furnishing services to the Medicare patient population. We 
also acknowledge that establishing a methodology under which Medicare 
payments would be less than those made by state Medicaid programs could 
create unnecessary barriers to access to care. Additionally, we 
recognize that a differential in payment OUD treatment services 
furnished by OTPs and OUD treatment furnished in the office setting may 
set up a disparity that could disadvantage OTPs.
    The services that are included in the non-drug component of the 
weekly bundles are the same services that are included in the TRICARE 
rate, which are individual therapy, group therapy, substance use 
counseling, and toxicology testing. Therefore, we believe that a 
reasonable alternative approach is to finalize payment rates for the 
non-drug component of the bundled payments for CY 2020 that are 
determined using a building block methodology under which the payment 
rate for the same set of non-drug services is based on established 
rates for similar services under the Medicare PFS (non-facility rates), 
the Medicare CLFS, and state Medicaid programs.
    Specifically, the payment rate we are finalizing for the non-drug 
component reflects the Medicare payment rates for the following codes 
as reference codes for the services that are included in the TRICARE 
rate, (individual therapy, group therapy, substance use counseling, and 
toxicology testing): CPT code 90832 (Psychotherapy, 30 minutes with 
patient), in CY 2019 is currently assigned a non-facility rate of 
$68.47 under the PFS; CPT code 90853 (Group psychotherapy (other than 
of a multiple-family group)), which in CY 2019 is assigned a non-
facility rate of $27.39

[[Page 62659]]

under the PFS; HCPCS code G0396 (Alcohol and/or substance (other than 
tobacco) abuse structured assessment (e.g., audit, dast), and brief 
intervention 15 to 30 minutes), which in CY 2019 is assigned a non-
facility rate of $30.94 under the PFS when furnished by nonphysician 
practitioners (NPPs), as we believe this is a more accurate reflection 
of the practitioner type who would be furnishing substance use 
counseling in an OTP; CPT code 80305 (Drug test(s), presumptive, any 
number of drug classes, any number of devices or procedures; capable of 
being read by direct optical observation only (e.g., utilizing 
immunoassay [e.g., dipsticks, cups, cards, or cartridges]), includes 
sample validation when performed, per date of service), which in CY 
2019 is assigned a rate of $12.60 under the CLFS, and which we will 
prorate to account for two tests per month in the base bundled payment; 
and HCPCS code G0480 (Drug test(s), definitive, utilizing (1) drug 
identification methods able to identify individual drugs and 
distinguish between structural isomers (but not necessarily 
stereoisomers), including, but not limited to gc/ms (any type, single 
or tandem) and lc/ms (any type, single or tandem and excluding 
immunoassays (e.g., ia, eia, elisa, emit, fpia) and enzymatic methods 
(e.g., alcohol dehydrogenase)), (2) stable isotope or other universally 
recognized internal standards in all samples (e.g., to control for 
matrix effects, interferences and variations in signal strength), and 
(3) method or drug-specific calibration and matrix-matched quality 
control material (e.g., to control for instrument variations and mass 
spectral drift); qualitative or quantitative, all sources, includes 
specimen validity testing, per day; 1-7 drug class(es), including 
metabolite(s) if performed), which in CY 2019 is assigned a rate of 
$114.43 under the CLFS, and which we will prorate to account for one 
test per month in the base bundled payment, as discussed previously. 
The sum of these amounts is $161.71.
    We are also finalizing our proposal to adjust the non-drug 
component rate to account for different administration and dispensing 
costs of the drug that is used in the episode of care (either oral, 
injectable, or implantable). We note that in calculating the proposed 
rates, the TRICARE weekly bundled rate included administration of oral 
drugs, which we then adjusted accordingly for the other bundled 
payments by subtracting the amount for dispensing oral drugs and adding 
a different amount to account for administration of the injectable and 
implantable drugs. We are finalizing the rate we proposed for 
dispensing oral drugs using an approximation of the average dispensing 
fees under state Medicaid programs, which is $10.50, since there is no 
Medicare Part B rate for oral MAT drugs. For the injectable drugs 
(buprenorphine and naltrexone), we proposed to subtract from the non-
drug component an amount that is comparable to the dispensing fees paid 
by several state Medicaid programs ($10.50) for a week of daily 
dispensing of methadone, and to add the Medicare non-facility rate for 
administration of an injection. This adjustment was necessary to 
account for the fact that the TRICARE rate includes oral dispensing 
fees, whereas these injectable drugs are not oral drugs that are 
dispensed daily. However, because we are adopting a building block 
methodology in final rule to determine the payment rate for the non-
drug component of the weekly bundles, it is no longer necessary to 
subtract the oral dispensing fee; however, as we proposed, we will 
include the Medicare non-facility rate for administration of an 
injection in our determination of the payment rate for the non-drug 
component for weekly bundles that include injectable drugs. We are 
finalizing the rate we proposed for administration of an injection, 
based on CPT code 96372 (Therapeutic, prophylactic, or diagnostic 
injection (specify substance or drug); subcutaneous or intramuscular) 
as a reference code, is $16.94.
    For the codes describing the insertion, removal, or insertion and 
removal of the buprenorphine implants, we proposed to adjust the non-
drug component payment rate to remove the cost of daily administration 
of an oral drug and by adding the Medicare non-facility payment rate 
for the insertion, removal, or insertion and removal of the implants, 
respectively. Again, removal of the cost of daily administration of an 
oral drug is no longer necessary under our building block methodology; 
but, we are finalizing our proposal to include the rates for the 
insertion, removal, or insertion and removal of the buprenorphine 
implants, as applicable. The reference codes, which we proposed and are 
finalizing are: HCPCS codes G0516 (Insertion of non-biodegradable drug 
delivery implants, 4 or more (services for subdermal rod implant)), 
which in CY 2019 is assigned a non-facility rate of $246.15. G0517 
(Removal of non-biodegradable drug delivery implants, 4 or more 
(services for subdermal implants)), which in CY 2019 is assigned a non-
facility rate of $265.61 under the PFS, and G0518 (Removal with 
reinsertion, non-biodegradable drug delivery implants, 4 or more 
(services for subdermal implants)), which in CY 2019 is assigned a non-
facility rate of $465.26 under the PFS. Under the building block 
methodology we are adopting in this final rule, the total non-drug 
component payment for the non-drug bundle is $161.71, the total non-
drug component payment for oral drugs is $172.21, the total non-drug 
component payment for the injectable drugs is $178.65, the total non-
drug component payment for the buprenorphine implant insertion is 
$407.86, the total non-drug component payment for the buprenorphine 
implant removal is $427.32, and the total non-drug component payment 
for the buprenorphine implant insertion and removal is $626.97. See 
Table 18 for a full listing of the final payment rates that we are 
establishing in this final rule, which reflect the sum of the drug 
component and non-drug component for each bundled payment. We believe 
the rates we are finalizing are reflective of an average case, but we 
recognize that the number of services furnished for patients who have 
stabilized and are in the maintenance phase of treatment, may be 
significantly less. However, we note that while the reference codes 
listed above were considered for the purpose of valuation of the non-
drug component of the weekly bundled payments, it is not a requirement 
for billing these codes (HCPCS codes G2067-G2075) that all of the 
services described by these reference codes would necessarily be 
furnished during each week that the bundled payment is billed. Rather, 
the threshold to bill for the bundled payment is that at least one 
service in the bundle is furnished during that week, which could be 
administration of the drug, individual therapy, group therapy, 
substance use counseling, or toxicology testing.
    In response to commenters who stated that the proposed rate for the 
counseling add-on code was too low, we note that we are finalizing a 
rate of $30.94, which is based on the CY 2019 PFS non-facility rate for 
HCPCS code G0396 (Alcohol and/or substance (other than tobacco) abuse 
structured assessment (e.g., audit, dast), and brief intervention 15 to 
30 minutes), when furnished by NPPs, and is higher than the proposed 
amount for this add-on code. Additionally, we believe that the 
availability of this add-on code will allow OTPs to receive 
reimbursement for additional counseling services furnished to patients 
with more needs, thereby accounting for varying levels of severity of 
illness. We will be

[[Page 62660]]

monitoring the claims data to ensure that use of this add-on code is 
not being abused.
i. Medication Not Otherwise Specified
    In the proposed rule, we stated that we would expect the non-drug 
component for the medication not otherwise specified bundled payment 
(HCPCS code G2075) to be consistent with the pricing methodology for 
the other bundled payments and therefore, to be based on a crosswalk to 
the TRICARE rate, adjusted for any applicable administration and 
dispensing fees. For example, for oral medications, we would use the 
rate for the non-drug services included in the TRICARE methadone 
bundle, based on an assumption that the drug is also being dispensed 
daily. For the injectable medications, we similarly stated that we 
would adjust the TRICARE payment rate for non-drug services using the 
same methodology we proposed for the bundled payments with injectable 
medications (to subtract an amount for daily dispensing and add the 
non-facility Medicare payment rate for administration of the 
injection). For implantable medications, we stated that we would also 
use the same methodology we proposed for the bundled payments with 
implantable medications, with the same crosswalked non-facility 
Medicare payment rates (for insertion, removal, and insertion and 
removal). We solicited comments on how the price of the non-drug 
component of such bundled payments should be determined, in particular 
the dispensing and/or administration fees, including whether the 
methodology we proposed for determining the payment rate for the non-
drug component of an episode of care that includes a new opioid agonist 
and antagonist medication (which is based on whether the drug is oral, 
injectable, or implantable) would be appropriate to use for these new 
drugs.
    We did not receive any comments on our proposal relating to pricing 
the non-drug component for medication not otherwise specified bundled 
payments. Consistent with our original proposal, we intend to determine 
the payment for the non-drug component of the medication not otherwise 
specified bundle based on whether the drug is oral, injectable, or 
implantable. However, this payment would be determined using the 
building block payment methodology that we are adopting in this final 
rule to determine the non-drug component of the bundled payments for 
medications that have the same mode of administration.
(c) Partial Episode of Care
    For the codes describing partial episodes for methadone and oral 
buprenorphine, we proposed that the payment rates for the non-drug 
component would be calculated by taking one half of the payment rate 
for the non-drug component for the corresponding weekly bundles. We 
chose one half as the best approximation of the median cost of the 
services furnished during a partial episode consistent with our 
proposal to make a partial episode bundled payment when the majority of 
services described in a beneficiary's treatment plan are not furnished 
during a specific episode of care. However, we solicited comment on 
other methods that could be used to calculate these payment rates. We 
proposed that the payment rates for the drug component of these partial 
episode bundles would be calculated by taking one half of the payment 
rate for the drug component of the corresponding weekly bundles.
    For the codes describing partial episodes for injectable 
buprenorphine and naltrexone, we proposed that the payment rates for 
the drug component would be the same as the payment rate for the drug 
component of the full weekly bundle so that the OTP would be reimbursed 
for the cost of the drug that is given at the start of the episode. For 
the non-drug component, we proposed that the payment rate would be 
calculated as follows: The TRICARE non-drug component payment rate 
($110.96), adjusted to remove the cost of daily administration of an 
oral drug ($10.50), then divided by two; that amount would be added to 
the fee that Medicare pays for the administration of an injection 
(which is currently $16.94 under the CY 2019 non-facility Medicare 
payment rate for CPT code 96372).
    For the codes describing partial episodes for the buprenorphine 
implant insertion, removal, and insertion and removal, we proposed that 
the payment rates for the drug component would be the same as the 
payment rate for the corresponding weekly bundle. For the non-drug 
component, we proposed that the payment rate would be calculated as 
follows: The TRICARE non-drug component payment rate ($110.96), 
adjusted to remove the cost of daily administration of an oral drug 
($10.50), then divided by two; that amount would be added to the 
Medicare non-facility payment rate for the insertion, removal, or 
insertion and removal of the implants, respectively (based on the non-
facility rates for HCPCS codes G0516, G0517, and G0518, which are 
currently $246.15, $265.61, and $465.26, respectively).
    For the code describing a non-drug partial episode of care, we 
proposed that the payment rate would be calculated by taking one half 
of the payment rate for the corresponding weekly bundle.
    We proposed that the payment rate for the code describing partial 
episodes for a medication not otherwise specified would be calculated 
based on whether the medication is oral, injectable or implantable, 
following the methodology described above for the corresponding type of 
partial episode. We solicited comments on how partial episodes of care 
using new drugs with a novel mechanism of action (that is, non-opioid 
agonist and/or antagonist treatment medications) should be priced. For 
example, we could use the same approach described previously for 
pricing new opioid agonist and antagonist medications not otherwise 
specified, which is to follow the methodology based on whether the drug 
is oral, injectable or implantable.
    We did not receive comments on our proposed methodology for 
determining payment rates for partial episodes. However, as discussed 
above, after consideration of the public comments, we are not 
finalizing our proposal to create partial episodes at this time, and 
thus will not be finalizing our proposed methodology for pricing 
partial episodes.
BILLING CODE 4120-01-P

[[Page 62661]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.024


[[Page 62662]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.025

BILLING CODE 4120-01-C
(8) Place of Service (POS) Code for Services Furnished at OTPs
    In the proposed rule, we explained that we would be creating a new 
POS code specific to OTPs since there are no existing POS codes that 
specifically describe OTPs. We indicated that claims for OTP services 
would include this place of service code. We also noted that POS codes 
are available for use by all payers. We did not propose to make any 
differential payment based on the use of this new POS code.
    The following is a summary of the comments we received regarding 
the discussion of creating a new POS and our responses.
    Comment: Several commenters supported the plan to create a new POS 
code that would specifically describe OTPs. A few commenters stated 
that if non-OTP pharmacies were to dispense MAT drugs covered by an OTP 
bundle, it is not clear how the OTP POS code will be transmitted to 
Part D plans or pharmacies so that they will know whether an enrollee 
is also enrolled in an OTP. Another commenter stated that while POS 
codes currently distinguish inpatient from outpatient OUD treatment, 
they do not distinguish between a Medicare-enrolled OTP and a non-
Medicare-enrolled OTP and recommended that CMS should consider multiple 
value sets for POS codes to help retail pharmacies dispense 
prescriptions and process claims appropriately.
    Response: We have created a new place of service code, which will 
be described as Place of Service code 58 (Non-residential Opioid 
Treatment Facility--a location that provides treatment for OUD on an 
ambulatory basis. Services include methadone and other forms of MAT). 
We expect that POS code 58 will be noted on claims

[[Page 62663]]

submitted for the HCPCS G codes describing OTP services. Additionally, 
we note that the G codes describing the OTP bundled payments and add-on 
codes can only be billed by OTPs and cannot be billed by other 
providers. We note that POS codes are not specific to Medicare use and 
may be used by other payers.
    In response to the comments about non-OTP pharmacies dispensing MAT 
drugs included in an OTP bundle, we encourage pharmacies and 
prescribing OTPs be in close communication in order to ensure proper 
billing procedures are followed and to prevent duplicative payments. 
The presence of POS code 58 on retail pharmacy claims will not mean 
that the pharmacy should process MAT claims any differently than they 
do now. We appreciate the suggestion to create multiple value sets for 
POS codes, and will take that under consideration.
c. Duplicative Payments Under Parts B or D
    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. In 
the proposed rule, we noted that many of the individual items or 
services provided by OTPs that would be included in the bundled payment 
rates under the proposed policies may also be appropriately available 
to beneficiaries through other Medicare benefits. Although we 
recognized the potential for significant program integrity concerns 
when similar items or services are payable under separate Medicare 
benefits, we also stated that we believe it is important that any 
efforts to prevent duplicative payments not inadvertently restrict 
Medicare beneficiaries' access to other Medicare benefits even for the 
time period they are being treated by an OTP. For example, a 
beneficiary receiving counseling or therapy as part of an OTP bundle of 
services may also be receiving medically reasonable and necessary 
counseling or therapy as part of a physician's service during the same 
time period. Similarly, there could be circumstances where Medicare 
beneficiaries with OUD could receive treatment and/or medication from 
non-OTP entities that would not result in duplicative payments, 
presuming that both the OTP and the other entity appropriately 
furnished separate medically-necessary services or items. Consequently, 
we explained that we do not believe that provision of the same kinds of 
services by both an OTP and a separate provider or supplier would 
itself constitute a duplicative payment.
    We explained our belief that duplicative payments would result from 
the submission of claims to Medicare leading to payment for drugs 
furnished to a Medicare beneficiary and the associated dispensing fees 
on a certain date of service to both an OTP and another provider or 
supplier under a different benefit. In these circumstances, we would 
consider only one of the claims to be paid for appropriately. 
Accordingly, for purposes of implementing section 1834(w)(1) of the 
Act, we proposed to consider payment for medications delivered, 
administered or dispensed to the beneficiary as part of the OTP bundled 
payment to be a duplicative payment if delivery, administration or 
dispensing of the same medications was also separately paid under 
Medicare Parts B or D. We proposed to codify this policy at Sec.  
410.67(d)(4). We acknowledged that some OTPs may negotiate arrangements 
whereby community pharmacies supply MAT-related medications to OTPs. 
However, we stated that if the OTP provides medically-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. For example, 
the MAT drugs billed by an OTP as part of a bundled payment should not 
be reported to or paid under a Part D plan. We stated that we expect 
that OTPs will take reasonable steps to ensure that the items and 
services furnished under their care are not reported or billed under a 
different Medicare benefit. We also noted that CMS intends to monitor 
for duplicative payments, and would take appropriate action as needed 
when such duplicative payments are identified. Therefore, we proposed 
that in cases where a payment for drugs used as part of an OTP's 
treatment plan is identified as being a duplicative payment because the 
same costs were paid under a different Medicare benefit, CMS will 
generally recoup the duplicative payment made to the OTP as the OTP 
would be in the best position to know whether or not the drug that is 
included as part of the beneficiary's treatment plan is furnished by 
the OTP or by another provider or supplier given that the OTP is 
responsible for managing the beneficiary's overall OUD treatment. We 
proposed to codify this policy at Sec.  410.67(d)(4). We noted that 
this general approach would not preclude CMS or other auditors from 
conducting appropriate oversight of duplicative payments made to the 
other provider or suppliers, particularly in cases of fraud and/or 
abuse.
    We received a few comments on our proposed policy to address 
duplicative payments. The following is a summary of the comments we 
received and our responses.
    Comment: A few commenters supported the proposal that the OTP 
should be accountable for ensuring duplicative payments are not made on 
the basis that OTPs are in the best position to know whether a drug 
included in the patient's treatment plan is furnished by the OTP.
    Response: We thank the commenters for their feedback and support.
    Comment: One commenter stated that the new Medicare bundled 
payments to OTPs should not impact payment for MAT prescriptions 
rightfully transmitted to a retail pharmacy unless the prescription is 
from an OTP. The commenter stated that having to determine whether a 
MAT drug presented to a retail pharmacy should be covered under the new 
Part B OTP bundle or Part D could introduce a delay in access to 
treatment. The commenter stated that retail pharmacies should continue 
to process any MAT prescription under Part D, as they do today. The 
commenter also stated that prescribers who administer implantable or 
injectable MAT drugs outside of a SAMHSA-certified OTP would continue 
to bill these drugs to Part B. Additionally, the commenter questioned 
if the Medicare bundled payments to OTPs will include MAT drugs that 
are prescribed within an OTP by a licensed prescriber, but dispensed 
outside of it.
    Response: With regard to the commenter's question concerning MAT 
drugs prescribed within an OTP but dispensed outside of it, there is no 
issue of duplicative payment if the OTP has an arrangement with the 
pharmacy whereby CMS pays the OTP a bundled payment rate and the OTP 
reimburses the pharmacy through an independent arrangement (in which 
case the pharmacy would not bill the Part D plan, as it would be 
reimbursed by the OTP). However, if such an arrangement does not exist, 
and the pharmacy intends to submit a Part D claim, then the OTP should 
not bill for an episode of care that includes a drug component but 
instead should bill for a non-drug episode of care (HCPCS code G2074). 
Similarly, we note that if the drug administration for a Part B MAT 
drug occurs outside the OTP and the OTP is not also billing for a 
weekly bundle that includes that Part B drug, then the administering 
provider can bill Part B.

[[Page 62664]]

    Comment: One commenter stated that while they agree with our 
proposal to recoup duplicative payments from OTPs, CMS should monitor 
for any unintended impacts to access or other challenges that may 
result. The commenter stated that CMS must not create a situation in 
which beneficiaries cannot access needed care because they are 
receiving OUD treatment through an OTP bundle.
    Response: We have explicitly acknowledged that we do not believe a 
beneficiary receiving the same kinds of services from both an OTP and 
another provider or supplier would necessarily constitute a duplicative 
payment. We reiterate, however, that we do have an expectation that 
OTPs will take reasonable steps to ensure that the items and services 
furnished under their care are not reported or billed under a different 
Medicare benefit. For example, OTPs could actively coordinate care and 
facilitate information exchange between other prescribers, dispensers 
and plans who prescribe, administer, dispense, or pay for medications 
for OUD treatment. We also note that OTPs and other health care 
providers must comply with all applicable laws and regulations, such as 
the Health Insurance Portability and Accountability Act and the 
Substance Abuse Confidentiality Regulations (42 CFR part 2). We intend 
to conduct monitoring to ensure that our policies regarding duplicative 
payment do not have any such unintended consequences as described by 
the commenter.
    Comment: A few commenters stated that drugs dispensed outside the 
OTP should not be included in the OTP bundle. One commenter stated that 
community pharmacies currently face challenges in knowing whether a 
prescription is from an inpatient OTP or whether the inpatient OTP is 
prescribing outpatient therapy for a patient who is being discharged. 
The commenter stated that the best way to avoid duplicate payments from 
occurring is to limit the OTP bundled payment to drugs dispensed by an 
OTP facility; similarly the commenter stated that if take-home 
medications are included in the OTP bundle, they should also be 
dispensed by the OTP.
    Response: We disagree that only medications provided at the OTP 
should be included in the bundled payment. As indicated above, we are 
aware that some OTPs have arrangements with pharmacies whereby the OTP 
reimburses the pharmacy through an independent arrangement. In this 
case, it is appropriate for the OTP to bill for the weekly bundled 
payment that corresponds to the medication provided to the beneficiary. 
We also note that if questions arise regarding the purpose of the 
prescription, as described by the commenter, the pharmacy should 
contact the prescribing OTP for any necessary clarifications.
    Comment: A few commenters stated that more information is needed to 
better understand how CMS will monitor and protect against duplicative 
billing/payment. The commenters recommended that CMS update the 
guidance in the Medicare Program Integrity Manual to better outline the 
process through which duplicative payments will be monitored and 
corrected.
    Response: We will consider issuing further guidance either through 
future rulemaking or subregulatory guidance, as suggested.
    Comment: One commenter disagreed that OTPs should be financially 
accountable for duplicative payments. The commenter stated that OTPs 
may not have access to prescribing information for every physician or 
clinician the beneficiary sees outside of the OTP, nor do reporting 
mechanisms exist for this information in order for OTPs to quickly and 
efficiently review prior to engaging patients in time-sensitive 
deployment of OUD treatment.
    Response: We reiterate that we have explicitly acknowledged that we 
do not believe that payments for the same kinds of services from both 
an OTP and a separate provider or supplier would necessarily result in 
a duplicative payment. We also emphasize that we have narrowly defined 
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 medications (that 
is, same drug, dosage and formulation) is also separately paid under 
Medicare Part B or Part D for the same beneficiary with the same date 
of service. As noted earlier, we do not intend to prevent the 
appropriate billing under Medicare Part B or Part D for individual 
items or services that could be provided by OTPs as part of an episode 
of care and included in the bundled payment rate, but that may also be 
appropriately available to beneficiaries through other Medicare 
benefits.
    Comment: One commenter supported the proposal to hold OTPs 
accountable for duplicative payments, but stated that CMS should issue 
a non-enforcement or hold harmless grace period for CY 2020 for audits 
and other consequences such as Star Ratings related to the new OUD 
treatment services benefit.
    Response: We appreciate the feedback and note that section 
1834(w)(1) of the Act expressly requires that we take steps to ensure 
that no duplicative payments are made. Moreover, as explained above, we 
have narrowly defined duplicative payment, so we do not believe that a 
grace period would be necessary for CY 2020.
    After consideration of the public comments, we clarifying that our 
final policy on duplicative payments refers to payment for the same 
medication for the same beneficiary on the same date of service. Thus 
we are finalizing our proposal that in cases where a payment for drugs 
used as part of an OTP's treatment plan is identified as being a 
duplicative payment because a claim for the same medications for the 
same beneficiary on the same date of service was paid under a different 
Medicare benefit, CMS will generally recoup the duplicative payment 
made to the OTP. We have updated the text at Sec.  410.67(d)(5) to 
reflect this clarification.
d. Cost Sharing
    Section 2005(c) of the SUPPORT Act amended section 1833(a)(1) of 
the Act, relating to payment of Part B services, by adding a new 
subparagraph (CC), which specifies with respect to OUD treatment 
services furnished by an OTP during an episode of care that the amount 
paid shall be equal to the amount payable under section 1834(w) of the 
Act less any copayment required as specified by the Secretary. Section 
1834(w) of the Act, which was also added by section 2005(c) of the 
SUPPORT Act, requires that the Secretary pay an amount that is equal to 
100 percent of a bundled payment under this part for OUD treatment 
services. Given these two provisions, we believe that there is 
flexibility for CMS to set the copayment amount for OTP services either 
at zero or at an amount above zero. Therefore, we proposed to set the 
copayment at zero for a time-limited duration (for example, for the 
duration of the national opioid crisis), as we believe this would 
minimize barriers to patient access to OUD treatment services. Setting 
the copayment at zero would also ensure OTP providers receive the full 
Medicare payment amount for Medicare beneficiaries if secondary payers 
are not available or do not pay the copayment, especially for those 
dually eligible for Medicare and Medicaid.\80\ We solicited

[[Page 62665]]

public comment on our proposal to set the copayment at zero for a time-
limited duration, such as for the duration of the national opioid 
crisis, and any other metrics CMS might consider using to determine 
when to start requiring a copayment. In developing our approach, we 
also considered other alternatives, such as setting the copayment at a 
fixed fee calculated based on 20 percent of the payment rate for the 
bundle, consistent with the standard copayment requirement for other 
Part B services, or applying a flat dollar copayment amount similar to 
TRICARE's copayment; however, we recognized that setting the copayment 
for OUD services at an amount greater than zero could create a barrier 
to access to treatment for many beneficiaries. We proposed to codify 
the proposed copayment amount of zero at Sec.  410.67(e). We solicited 
feedback on our proposal to set the copayment amount for OTP services 
at zero, and on the alternatives considered, including whether we 
should consider any of these alternatives for CY 2020 or future years.
---------------------------------------------------------------------------

    \80\ For those dually eligible individuals in the Qualified 
Medicare Beneficiary program (7.7 million of the 12 million dually 
eligible individuals in 2017), state Medicaid programs cover the 
Medicare Part A and Part B deductible and coinsurance. However, 
section 4714 of the Balanced Budget Act of 1997 (Pub. L. 105-33) 
provides discretion for states to pay Medicare cost-sharing only if 
the Medicaid payment rate for the service is above the Medicare paid 
amount for the service. Since most states opt for this discretion, 
and most Medicaid rates are lower than Medicare's, states often do 
not pay the provider for the Medicare cost-sharing amount. Providers 
are further prohibited from collecting the Medicare cost-sharing 
amount from the beneficiary, effectively having to take a discount 
compared to the amount received for other Medicare beneficiaries.
---------------------------------------------------------------------------

    Separately, we noted that the Part B deductible would apply for OUD 
treatment services, as mandated for all Part B services by section 
1833(b) of the Act.
    We received public comments on the proposals related to cost 
sharing for the bundled payments for OUD treatment services. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters supported the proposal to set the 
copayment at zero for a time limited duration. A few commenters 
encouraged CMS to consider setting the copayment at zero permanently, 
noting that individuals who require the services of an OTP will have 
difficulty making copayments for a variety of reasons, regardless of 
whether there is an opioid epidemic across the nation. One commenter 
noted that if a patient received OUD treatment services outside of an 
OTP, they would pay 20 percent Part B coinsurance under Medicare at 
other health care settings or Part D plan cost sharing for any 
pharmacy-dispensed prescription drugs which may disadvantage other 
established Medicare provider types. This commenter also noted that 
OTPs may not be available to patients in all geographic localities, 
which would seem to be unfair.
    Response: We appreciate the support for our proposal. After 
consideration of the public comments, we are finalizing our proposal to 
set the copayment at zero for a time limited duration, as we believe 
this would minimize barriers to patient access to OUD treatment 
services. Setting the copayment at zero also ensures OTPs receive the 
full Medicare payment amount for Medicare beneficiaries if secondary 
payers are not available or do not pay the copayment, especially for 
those beneficiaries who are dually eligible for Medicare and Medicaid. 
However, as we explained in the proposed rule, we are interested in 
setting the copayment at zero for a time limited duration (for example, 
until such time as the Secretary does not renew the national public 
health emergency declaration for the continued consequence of the 
opioid crisis affecting our nation), and intend to address the 
copayment in future rulemaking at such a time we deem appropriate. 
Although we appreciate the concern that OUD treatment services 
furnished in other settings require beneficiary cost sharing, we 
believe it is important, especially in light of the opioid epidemic, to 
minimize barriers to patient access to OUD treatment services in such 
instances that we are able to and note that section 2005 of the SUPPORT 
Act does not provide authority to waive cost sharing for OUD treatment 
services furnished in other settings.
    Comment: One commenter requested that OTPs be allowed to receive 
Medicare bad debt payments for any uncollected Part B deductible 
payments, noting that OTP providers are unlikely to be successful in 
collecting deductibles for many patients in this population. Another 
commenter expressed concern that the application of the Part B 
deductible to OUD treatment services furnished by OTPs might 
particularly affect dually eligible beneficiaries currently receiving 
OTP care as they are likely to visit an OTP provider in January, before 
they hit their annual Part B deductible. This could put them in the 
position of owing over $100 in January.
    Response: We note that bad debts arising from covered services paid 
under a reasonable charge-based methodology or a fee schedule are not 
reimbursable under the Medicare program (42 CFR 413.89(i)). 
Additionally, we note that the majority of dually eligible individuals 
are Qualified Medicare Beneficiaries (QMBs), a program in which 
Medicaid covers the Medicare Part A (if any) and Part B premiums and 
other Medicare cost-sharing. States may pay for deductibles, 
coinsurance, and copayments for Medicare services furnished by Medicare 
providers to QMBs to the extent consistent with the Medicaid State 
Plan. States have the option to reduce or eliminate the state's 
Medicare cost sharing payments by adopting policies that limit payment 
to the lesser of (a) the Medicare cost sharing amount, or (b) the 
difference between the Medicare payment and the Medicaid rate for the 
service, consistent with the methodology identified in the state plan. 
When Medicaid rates are lower this can result in the provider receiving 
reduced or even no payment for the deductible. Regardless of the amount 
paid by the state for the deductible, coinsurance, and copayments, 
sections 1848(g)(3) and 1866(a)(1)(A) of the Act prohibit Medicare 
providers from billing QMBs for Medicare Parts A and B cost sharing 
amounts. States may also choose to cover Medicare cost-sharing for 
certain other full-benefit dually eligible individuals.
    As discussed in more detail below, once a provider is enrolled in 
Medicare, Medicare will crossover the deductible portion of the claim 
to state Medicaid agencies, and the state will adjudicate the claim. 
However, as noted above, states often use different HCPCS billing codes 
for OTP services than Medicare does; in these cases, we note that the 
state's claims processing system may reject the claim and will notify 
the provider, who can re-code and resubmit the claim directly to the 
state.
    In summary, we are finalizing our proposal to set the copayment for 
OUD treatment services furnished by OTPs at zero for a time limited 
duration, as we believe this would minimize barriers to patient access 
to OUD treatment services. We are codifying this beneficiary cost-
sharing amount at Sec.  410.67(e).
4. Adjustments to Bundled Payment Rates for OUD Treatment Services
    The costs of providing OUD treatment services will likely vary over 
time and depending on the geographic location where the services are 
furnished. Below we discuss our proposed adjustments to the bundled 
payment rates to account for these factors.

[[Page 62666]]

a. Locality Adjustment
    Section 1834(w)(2) of the Act, as added by section 2005(c) of the 
SUPPORT Act provides that the Secretary may implement the bundled 
payment for OUD treatment services furnished by OTPs through one or 
more bundles based on the type of medications, the frequency of 
services, the scope of services furnished, characteristics of the 
individuals furnished such services, or other factors as the Secretary 
determines appropriate. The cost for the provision of OUD treatment 
services, like many other healthcare services covered by Medicare, will 
likely vary across the country based upon the differing cost in a given 
geographic locality. To account for such geographic cost differences in 
the provision of services, in a number of payment systems, Medicare 
routinely applies geographic locality adjustments to the payment rates 
for particular services. Because we believe OUD treatment services 
furnished by OTPs will also be subject to varying cost based upon the 
geographic locality where the services are furnished, in the proposed 
rule we proposed to apply a geographic locality adjustment to the 
bundled payment rate for OUD treatment services. We discussed our 
proposed approach with respect to both the drug component (which 
reflects payment for the drug) and the non-drug component (which 
reflects payment for all other services furnished to the beneficiary by 
the OTP, such as drug administration, counseling, toxicology testing, 
etc.) of the bundled payment.
(1) Drug Component
    Because our proposed approaches for pricing the MAT drugs included 
in the bundles all reflected national pricing, and because there is no 
GAF applied to the payment of Part B drugs under the ASP methodology, 
we did not believe that it would be necessary to adjust the drug 
component of the bundled payment rates for OTP services based upon 
geographic locality. Therefore, we proposed not to apply a geographic 
locality adjustment to the drug component of the bundled payment rate 
for OTP services. We did not receive any comments on this proposal and 
are finalizing as proposed not to make any geographic adjustment to the 
drug component of the bundled payment rates.
(2) Non-Drug Component
    Unlike the national pricing of drugs, the costs for the services 
included in the non-drug component of the OTP bundled payment for OUD 
treatment services are not constant across all geographic localities. 
For example, OTPs' costs for rent or employee wages could vary 
significantly across different localities and could potentially result 
in disparate costs for the services included in the non-drug component 
of OUD treatment services. Because the costs of furnishing the services 
included in the non-drug component of the OTP bundled payment for OUD 
treatment services will vary based upon the geographic locality in 
which the services are provided, in the proposed rule we stated that we 
believed it would be appropriate to apply a geographic locality 
adjustment to the non-drug component of the bundled payments. We 
believed that the geographic variation in the cost of the non-drug 
services provided by OTPs would be similar to the geographic variation 
in the cost of services furnished in physician offices. Therefore, to 
account for the differential costs of OUD treatment services across the 
country, we proposed to adjust the non-drug component of the bundled 
payment rates for OUD treatment services using an approach similar to 
the established methodology used to geographically adjust payments 
under the PFS based upon the location where the service is furnished. 
The PFS currently provides for an adjustment to the payment for PFS 
services based upon the fee schedule area in which the service is 
provided through the use of Geographic Practice Cost Indices (GPCIs), 
which measure the relative cost differences among localities compared 
to the national average for each of the three fee schedule components 
(work, PE, and malpractice).
    Although we proposed to adjust the non-drug component of the 
payments for OUD treatment services using an approach similar to the 
established methodology used to adjust PFS payment for geographic 
locality, because GPCIs provide for the application of geographic 
locality adjustments to the three distinct components of PFS services, 
and we proposed the OTP bundled payment as a flat rate payment for all 
OUD treatment services furnished during an episode of care, we 
explained that a single factor would be required to apply the 
geographic locality adjustment to the non-drug component of the OTP 
bundled payment rate. Therefore, to apply a geographic locality 
adjustment to the non-drug component of the OTP bundled payment for OUD 
treatment services through a single factor, we proposed to use the 
Geographic Adjustment Factor (GAF) at Sec.  414.26. Specifically, we 
proposed to use the GAF to adjust the payment for the non-drug 
component of the OTP bundled payment to reflect the costs of furnishing 
the non-drug component of OUD treatment services in each of the PFS fee 
schedule areas. The GAF is calculated using the GPCIs under the PFS, 
and is used to account for cost differences in furnishing physicians' 
services in differing geographic localities. The GAF is calculated for 
each fee schedule area as the weighted composite of all three GPCIs 
(work, PE, and malpractice) for that given locality using the national 
GPCI cost share weights. In developing the proposal, we also considered 
geographically adjusting the payment for the non-drug component of the 
OTP bundled payment using only the PE GPCI value for each fee schedule 
area. However, because the non-drug component of OUD treatment services 
is comprised of work, PE, and malpractice expenses, we proposed using 
the GAF as we believe the weighted composite of all three GPCIs 
reflected in the GAF would be the more appropriate GAF to reflect 
geographic variations in the cost to OTPs of furnishing OUD treatment 
services.
    The GAF, which is determined under Sec.  414.26, is discussed 
earlier in section II.D.1. of this final rule and the specific GAF 
values for each payment locality are posted in Addendum D to this final 
rule. In developing the proposed geographic locality adjustment for the 
non-drug component of the OUD treatment services payment rate, we also 
considered other potential locality adjustments, such as the Inpatient 
Prospective Payment System (IPPS) hospital wage index. However, we 
proposed using the GAF as we believed the services provided in an OTP 
more closely resemble the services provided at a physician office than 
the services provided in other settings, such as inpatient hospitals. 
We proposed to codify using the GAF to adjust the non-drug component of 
the OTP bundled payments to reflect the cost differences in furnishing 
these services in differing geographic localities at Sec.  
410.67(d)(3)(ii). We solicited public comment on the proposal to adjust 
the non-drug component of the OTP bundled payments for geographic 
variations in the costs of furnishing OUD treatment services using the 
GAF. We also solicited comments on any factors, other than the GAF, 
that could be used to make this payment adjustment.
    Additionally, we noted that the majority of OTPs operate in urban 
localities. In light of this fact, we

[[Page 62667]]

explained that we were interested in receiving information on whether 
rural areas have appropriate access to treatment for OUD. We were 
particularly interested in any potential limitations on access to care 
for OUD in rural areas and whether there are additional adjustments to 
the proposed bundled payments that should be made to account for the 
costs incurred by OTPs in furnishing OUD treatment services in rural 
areas. We solicited comment for future consideration on this issue and 
potential solutions we could consider adopting to address this 
potential issue through future rulemaking.
    We received a few comments on the proposed locality adjustment. The 
following is a summary of the comments we received and our responses.
    Comment: One commenter supported using the GAF to geographically 
adjust the non-drug component of the bundled payment.
    Response: We thank the commenter for their support and feedback.
    Comment: One commenter stated that CMS should create a 17 percent 
rural add-on payment to be applied to the bundled payment rate in low-
population density areas where it is difficult to find doctors, nurses, 
and counselors to treat OUD patients. The commenter noted that Medicare 
provides a 17 percent rural add-on for inpatient psychiatric facilities 
which often treat substance abuse cases.
    Response: We appreciate the suggestion and may consider whether to 
propose a rural add-on payment in future rulemaking. In the interim, we 
note that the current Medicare PFS locality structure contains 34 
states with a statewide payment locality, which means that, in these 
states, the geographic adjustment is the same in all areas, whether 
urban or rural, thus reducing rural/urban payment differentials within 
a state. We intend to monitor this issue, and as previously stated, may 
revisit the issue of a rural add-on payment in the future.
    After consideration of the public comments, we are finalizing our 
proposal to adjust the non-drug component of the OTP bundled payments 
using the GAF in Sec.  410.67(d)(4)(ii). Additionally, although we did 
not explicitly address the application of a geographic adjustment in 
the context of the add-on payment adjustments for non-drug services in 
the proposed rule, we believe that the same logic regarding the 
differential costs for those services would apply and should be 
recognized. As such, we are also finalizing that the add-on payment 
adjustments for non-drug services will be geographically adjusted as 
described above.
b. Annual Update
    Section 1834(w)(3) of the Act, as added by section 2005(c) of the 
SUPPORT Act, requires that the Secretary provide an update each year to 
the OTP bundled payment rates. To fulfill this statutory requirement, 
we proposed to apply a blended annual update, comprised of distinct 
updates for the drug and non-drug components of the bundled payment 
rates, to account for the differing rate of growth in the prices of 
drugs relative to other services. We proposed that this blended annual 
update for the OTP bundled payment rates would first apply for 
determining the CY 2021 OTP bundled payment rates. The specific details 
of the proposed updates for the drug and non-drug components 
respectively are discussed in this section.
(1) Drug Component
    As stated above, we proposed to establish the pricing of the drug 
component of the OTP bundled payment rates for OUD treatment services 
based on CMS pricing mechanisms currently in place. To recognize the 
potential change in costs of the drugs used in MAT from year to year 
and to fulfill the requirement to provide an annual update to the OTP 
bundled payment rates, we proposed to update the payment for the drug 
component based upon the changes in drug costs reported under the 
pricing mechanism used to establish the pricing of the drug component 
of the applicable bundled payment rate, as discussed earlier. For 
example, if we were to price the drug component of the bundled payment 
rate for episodes of care using ASP data, the pricing of the drug 
component for these OTP bundled payments would be updated using the 
most recently available ASP data at the time of ratesetting for the 
applicable calendar year. In the proposed rule, we also discussed a 
number of alternative data sources that could be used to price oral 
drugs in the drug component of OTP bundled payments in cases when we do 
not receive manufacturer-submitted ASP pricing data. As an example, if 
we were to use NADAC data, as discussed as one of the alternatives, to 
determine the payment for the drug component of the bundled payment for 
oral drugs in cases when we do not have manufacturer-submitted ASP 
pricing data, this payment rate would be updated using the most 
recently available NADAC data at the time of ratesetting for the 
applicable calendar year.
    In developing the proposal to annually update the pricing of the 
drug component of the OUD treatment services payment rate, we also 
considered other methodologies, including applying a single uniform 
update factor to the drug and non-drug components of the proposed 
payment rates. We ultimately determined not to propose the use of a 
single uniform update factor, because we believed that it was important 
to apply an annual update to the payment rates that recognizes the 
differing rate of growth of drug costs compared to the rate of growth 
in the cost of the other services. In addition, we also considered 
annually updating the pricing of the drug component of the OUD 
treatment services payment rate via an established update factor such 
as the Producer Price Index (PPI) for chemicals and allied products, 
analgesics (WPU06380202). The PPI for chemicals and allied products, 
analgesics is a subset of the PPI produced by the Bureau of Labor 
Statistics (BLS), which measures the average change over time in the 
selling prices received by domestic producers for their output. 
Ultimately we decided against proposing to update the pricing of the 
drug component of the OUD treatment services payment rate via an 
established update factor such as the PPI in favor of our proposed 
approach because we believed the proposed approach would update the 
pricing of the drug component of the OUD treatment services payment 
rate in the manner that would be most familiar to stakeholders. We 
solicited public comment on the proposed approach to updating the drug 
component of the bundled payment rates. We also solicited comment on 
possible alternate methodologies for updating the drug component of the 
payment rate for OUD treatment services, such as use of the PPI for 
chemicals and allied products, analgesics.
    We did not receive any comments on the proposed approach to update 
the drug component of the bundled payment rates, and are finalizing our 
proposal to use the most recently available data from the applicable 
pricing mechanism finalized for drug pricing, as described above, to 
annually update the drug component of the bundled payment. We are 
codifying this policy at Sec.  410.67(d)(2)(i), which provides that 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.

[[Page 62668]]

(2) Non-Drug Component
    To account for the potential changing costs of the services 
included in the non-drug component of the bundled payment rates for OUD 
treatment services, we proposed to update the non-drug component of the 
bundled payment for OUD treatment services based upon the Medicare 
Economic Index (MEI). The MEI is defined in section 1842(i)(3) of the 
Act and the methodology for computing the MEI is described in Sec.  
405.504(d). The MEI is used to update the payment rates for physician 
services under section 1842(b)(3) of the Act, which states that 
prevailing charge levels beginning after June 30, 1973, may not exceed 
the level from the previous year except to the extent that the 
Secretary finds, on the basis of appropriate economic index data, that 
such a higher level is justified by year-to-year economic changes. The 
MEI is a fixed-weight input price index that reflects the physicians' 
own time and the physicians' PEs, with an adjustment for the change in 
economy-wide, private nonfarm business multifactor productivity. The 
method for calculating the MEI was last revised in the CY 2014 PFS 
final rule with comment period (78 FR 74264). In developing the 
proposed update factor for the non-drug component of the OUD treatment 
services payment rate, we also considered other potential update 
factors, such as the BLS Consumer Price Index for All Items for Urban 
Consumers (CPI-U) (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm) and the IPPS hospital market basket reduced 
by the multifactor productivity adjustment. The CPI-U is a measure of 
the average change over time in the prices paid by urban consumers for 
a market basket of consumer goods and services. However, we concluded 
that a healthcare-specific update factor, such as the MEI, would be 
more appropriate for OTPs than the CPI-U, which measures general 
inflation, as the MEI would more accurately reflect the change in the 
prices of goods and services included in the non-drug component of the 
OTP bundled payments.
    Similarly, we believed the MEI would be more appropriate than the 
IPPS market basket to update the non-drug component of the bundled 
payment rates as the services provided by an OTP more closely resemble 
the services provided at a physician office than the services provided 
by an inpatient hospital. Accordingly, we proposed to update the 
payment amount for the non-drug component of each of the bundled 
payment rates for OUD treatment services furnished by OTPs based upon 
the most recently available historical annual growth in the MEI 
available at the time of rulemaking. We proposed to codify this 
proposal at Sec.  410.67(d)(3)(iii).
    We received one comment on the annual update for the non-drug 
component of the bundled payment rate. The following is a summary of 
the comment we received and our response.
    Comment: One commenter disagreed with using the MEI to increase the 
non-drug component payment and stated that the MEI focuses more 
narrowly on physician practices. The commenter stated that an OTP's 
cost structures are more similar to hospital outpatient departments 
than physician offices. The commenter stated that over time, updating 
rates by the MEI, which closely mirrors general inflation, will create 
access to care issues as federal and state mandated OTP costs grow 
faster than Medicare reimbursements. The commenter also stated that 
TRICARE utilizes the IPPS annual update factor and if CMS' goal is to 
align payment with the TRICARE model, it should act consistently and 
also adopt its annual adjustment policy.
    Response: We clarify that CMS' goal is not to align payment with 
the TRICARE model. As indicated above, section 1834(w)(2) of the Act 
provides that the Secretary may consider the rates paid to OTPs for 
comparable services under Medicaid or under TRICARE. As we discussed in 
the CY 2020 PFS proposed rule, we considered payments for those 
comparable services in the development of our payment rates. However, 
we note that we also solicited comment on the scope of private payer 
OTP coverage and the payment rates private payers have established for 
OTPs furnishing comparable OUD treatment services for consideration.
    We appreciate the commenter's concern about using the MEI to update 
the non-drug component of the OTP bundled payment rate. Ideally, we 
would develop a market basket that reflects the detailed cost 
structures of OTP facilities; however, these data are not currently 
available. Therefore, we have to use a price index that best 
approximates the cost of the medical services being provided by the OTP 
facilities. Although TRICARE uses the IPPS annual update factor, we 
believe the MEI is a more appropriate index to use to update the non-
drug component of the OTP bundled payment rate based on both conceptual 
and compositional reasons.
    From a conceptual standpoint, we believe physicians' services 
furnished in the office setting more closely align to the OUD treatment 
services furnished by OTPs as they both encompass minimally invasive 
medical care such as assessment, counseling, and administering of 
medications. The MEI measures the market price changes in the inputs 
used to furnish physicians' services, and represents both the medical 
and non-medical costs associated with providing this care. In contrast, 
hospitals engage in complex inpatient and outpatient medical services, 
such as surgical procedures and emergency room trauma, which are 
significantly different to the services furnished in OTP facilities. 
The IPPS market basket reflects these complex services and the non-
medical costs associated with managing these large facilities, such as 
non-medical labor-related services (including but not limited to legal, 
accounting, financial, and installation and maintenance repair 
services), which account for almost 25 percent of the IPPS market 
basket.
    From a compositional standpoint, the MEI more closely aligns with 
the services associated with the OTP payment system. In particular, the 
MEI does not reflect drug costs (which will be updated separately for 
OTPs, as discussed previously) as these costs are not reimbursed under 
the Medicare PFS, for which the MEI was originally developed. The IPPS 
market basket, however, is an operating market basket that reflects 
drug costs because these costs are included in the IPPS operating base 
payment rate. Additionally, the MEI includes PE associated with all 
operations, including any capital or leasing costs. The IPPS market 
basket, on the other hand, excludes capital costs because under the 
IPPS, capital costs are reimbursed separately and the IPPS capital 
payment rates are updated using the IPPS capital market basket, which 
reflects the complex capital acquisition and financing methods of IPPS 
hospitals. Finally, the MEI reflects an adjustment for expected 
productivity improvements associated with the provision of care (the 
MEI uses the change in economy-wide private non-farm business 
multifactor productivity), which, given the similarity in the nature of 
services furnished in the physician office and OTP settings, OTPs would 
also be anticipated to be able to achieve. The IPPS market basket does 
not include a productivity adjustment as that adjustment is applied 
separately as part of the payment rate update. These compositional 
differences account for many of the differences between the growth 
rates of the MEI and the IPPS market basket that the commenter 
identified as a concern. Because the

[[Page 62669]]

differences in growth rates between the IPPS market basket and the MEI 
are due to these compositional differences, we disagree with the 
commenter that there is a concern with using the MEI to update the non-
drug component of the bundled payment rates. That is, we believe the 
MEI is an appropriate price index to serve as a proxy for changes in 
market costs associated with providing OTP services, as it reflects 
both the medical and non-medical costs of providing noninvasive medical 
care in a non-inpatient facility.
    After consideration of the public comments, we are finalizing the 
proposal to update the non-drug component of the bundled payment for 
OUD treatment services based upon the MEI. These policies are codified 
in Sec.  410.67(d)(4)(iii). Additionally, although we did not 
explicitly address the application of the annual update to the add-on 
payment adjustments for non-drug services in the proposed rule, we 
believe that the same logic regarding the potential changing costs of 
the services included in the non-drug component of the bundled payment 
rates is applicable. As such, we are finalizing that the add-on payment 
adjustments for non-drug services will be subject to the annual update 
as described above.
    In addition to comments on our proposals and the related issues on 
which we specifically requested public input, we received a number of 
other public comments related to our implementation of this new 
Medicare benefit for OUD treatment services furnished in an OTP. 
Several comments focused on various aspects of how the OTP proposals 
intersect with Medicaid, those beneficiaries dually eligible for 
Medicare and Medicaid, Medicare Advantage, and certain requirements 
related to compliance, quality measurement, and Electronic Health 
Records. While these issues were not addressed specifically in the 
proposed rule, we believe it is important to clarify how the OTP 
policies interface with existing policies under these other programs. 
The following is a summary of the comments we received and our 
responses.
    Comment: Most commenters expressed concerns that in the states that 
currently cover OTP services under Medicaid, the transition from 
Medicaid to Medicare as primary payer for those OTP services for dually 
eligible individuals could result in disruptions to dually eligible 
individuals' OTP treatment, as well as for OTP providers. Several 
commenters noted the tight timeframes for OTP providers to enroll in 
Medicare. For those OTPs currently serving dually eligible individuals 
under Medicaid, any enrollment backlog may create cash flow problems 
for these providers, as Medicaid is the payer of last resort, which 
normally means Medicaid stops paying for a benefit once Medicare starts 
to cover it. They also noted that the timing of the final regulation 
would result in less than 60 days to implement needed changes to 
billing systems. Commenters requested flexibilities during this 
transition, including a transition period in which OTP providers could 
still bill Medicaid, with well-publicized transition timelines for a 
grace period during which improperly submitted claims could be 
corrected.
    Response: We appreciate the concerns expressed by commenters. As 
discussed in more detail below, Medicaid must pay for OTP services for 
dually eligible individuals if the service is covered by the Medicaid 
state plan and the OTP provider is enrolled in Medicaid and not yet 
enrolled in Medicare.
    We will issue guidance to states on strategies to promote 
continuity of care for dually eligible individuals during this 
transition period while upholding their responsibilities under Medicaid 
as the payer of last resort. We will remind states that Medicaid must 
pay for services delivered to these beneficiaries by OTP providers who 
are not yet enrolled in Medicare. Recognizing that many OTP providers 
may not yet be enrolled in Medicare on January 1, 2020, we will 
recommend that states not impose systems edits to automatically reject 
claims, (under the assumption that the OTP is Medicare-enrolled and 
therefore Medicare is the appropriate primary payer for the dually 
eligible individual) for OTP services furnished to dually eligible 
individuals at the start of the year. We will encourage states to reach 
out to their Medicaid-enrolled OTP providers to advise them to enroll 
as quickly as possible in Medicare. To support continuity of care, we 
will ask states to offer OTPs options during the interim until Medicare 
approves the provider enrollment, including billing Medicaid for 
payment (with the understanding that Medicaid will later recoup the 
Medicaid payments made, back to the effective date of Medicare provider 
enrollment, and the provider will bill Medicare instead for those 
claims), or to hold claims and bill Medicare once the OTP provider is 
Medicare-enrolled. As requested by the commenters, we will also include 
in our outreach to OTP providers information about these transition 
options.
    Comment: One commenter who supported a transition period requested 
that the transition period be extended in cases where OTP providers 
need to be credentialed and contract with a large number of Medicare 
Advantage plans, or when Medicaid Managed Care Organizations are 
involved in covering the Medicare cost-sharing. Commenters noted that 
unlike Medicare, where there is a single provider enrollment process, 
it will take significantly longer for OTP providers to become network 
providers with multiple Medicare Advantage plans, potentially delaying 
their ability to provide services to dually eligible enrollees of those 
plans.
    Response: We share the concern around ensuring continuity of care 
for dually eligible individuals who are currently obtaining treatment 
from an OTP provider through Medicaid and are enrolled in a Medicare 
Advantage managed care plan. The factors impacting transition are 
different in Medicare Advantage from those discussed below for Original 
Medicare. Under section 1852(a) of the Act and 42 CFR 422.100, Medicare 
Advantage (MA) plans must cover the Medicare OTP benefit because it is 
a Part B benefit. MA plans may meet this obligation by contracting with 
OTP providers or making other arrangements with non-contracted OTP 
providers. Under current MA program requirements, MA plans may furnish 
OTP access for their enrollees either by establishing direct contracts 
with OTPs or by arranging access on a non-contract basis. If an MA plan 
furnishes access to OTPs by contracting with one or more OTPs the MA 
plan is not necessarily required to contract with all OTP providers in 
the area, but must ensure that the contracts with OTPs it does have 
furnish sufficient access and availability to OTP services for its 
enrollees and are also consistent with the community pattern of care 
based on the service area where the MA plan is being offered. If an MA 
plan allows its enrollees to obtain OTP services on a non-contract 
basis the MA plan must ensure that its enrollees are able to access OTP 
services that are available within the community pattern of care. (see 
Sec.  422.112). If a dually eligible individual enrolled in the plan is 
currently in treatment with an OTP provider with which the plan does 
not contract, the plan should create a transition process under which 
the individual can continue to see their current OTP provider while the 
plan works with the individual to transition to a network provider. 
Allowing the individual to continue to see their current provider 
during this transition will ensure continuity of care for this 
vulnerable population.
    Comment: One commenter specifically requested that dually

[[Page 62670]]

eligible individuals receiving services from an OTP provider not 
enrolled in Medicare be able to continue to receive treatment from that 
provider, and further requested this apply to dually eligible 
individuals not yet in treatment but who have no Medicare OTP providers 
in their area.
    Response: As noted above, Medicaid must still cover OTP services 
for dually eligible individuals whose provider is not yet enrolled in 
Medicare. This flexibility promotes continuity of care for dually 
eligible individuals already receiving OTP services under Medicaid now, 
as well as providing beneficiaries access to Medicaid-enrolled OTP 
providers when there are no Medicare-enrolled OTP providers in their 
area.
    Comment: Some commenters requested clarification on how OTP 
providers would bill for dually eligible individuals once Medicare 
starts covering these services on January 1, 2020, including the 
process for the Part B deductible to be paid by Medicaid.
    Response: Once Medicare starts covering OTP services, a Medicare-
enrolled OTP provider would bill Medicare for OUD treatment services 
furnished to dually eligible individuals under Original Medicare. For 
Original Medicare, if the dually eligible beneficiary has not yet met 
their annual Medicare Part B deductible, Medicare will automatically 
``crossover'' the claim to Medicaid to adjudicate for payment of the 
deductible. In addition, please see responses to comments below for a 
discussion of the process when a state is using different billing codes 
than Medicare, and when an OTP provider is not yet enrolled in 
Medicare.
    For OTP providers serving dually eligible individuals enrolled in 
Medicare Advantage, there is no automated crossover process. For cost 
sharing applicable to the OTP benefit under the MA plan, MA plans are 
required by Sec.  422.504(g)(1) to specify in their contracts with 
providers that such dually eligible enrollees will not be held liable 
for Medicare Part A and Part B cost sharing when the State is 
responsible for paying such amounts, and to inform providers of 
Medicare and Medicaid benefits, and rules for enrollees eligible for 
Medicare and Medicaid. We understand most MA plans have not entered 
into coordination of benefit agreements with state Medicaid agencies. 
In these instances, the MA plan would not have any means to forward 
claims for cost sharing directly to state Medicaid programs for 
payment; and so an OTP provider would need to bill Medicaid directly 
for the cost sharing that the provider may not collect from the 
enrollee; this may also mean that the OTP provider has to re-code the 
claim if the state uses different billing codes than the Medicare 
Advantage plan uses.
    Comment: One commenter specifically requested that the timeframe 
for state Medicaid agencies to update their respective fee schedules 
match the Medicare payment methodology to prevent denials when Medicare 
sends the crossover claim to Medicaid for the deductible.
    Response: State Medicaid programs often use different codes and pay 
differently than Medicare. There is no requirement to match the 
Medicare payment methodology, but states do need to be able to process 
claims for the beneficiary's cost-sharing liability for most dually 
eligible individuals. If the state uses different billing codes, its 
claims processing system may initially deny the crossover claim, and 
send a remittance advice to the provider notifying the provider of the 
denial. The OTP provider should then re-code the claim using the 
Medicaid billing codes and resubmit to Medicaid for processing.
    Comment: A few commenters suggested that CMS offer an expedited 
process for receiving a Medicare denial, to provide Medicaid with proof 
that Medicare will not cover the OTP services. A few other commenters 
also suggested CMS make available an up-to-date-listing of Medicare 
enrolled OTP providers in each state.
    Response: We agree it is important to support OTP providers and 
states by providing the information needed to facilitate the process 
for an OTP provider to bill Medicaid for services furnished to a dually 
eligible individual, when that is permitted. Medicaid will often accept 
a Medicare claims denial as proof that Medicare will not cover the 
service, and will process the claim for Medicaid coverage. However, 
Medicare can only process a claim from a Medicare-enrolled provider, 
and thus can only issue a claims denial to a Medicare-enrolled 
provider.
    As we note in our response to a prior comment, Medicaid must pay 
for OUD treatment services furnished by an OTP to a dually eligible 
individual when the service is covered by the Medicaid state plan and 
the OTP provider is enrolled in Medicaid, but is not enrolled in 
Medicare. We agree with the suggestion to make publicly-available and 
update a list of Medicare-enrolled OTP providers so OTPs and states 
have evidence that a given provider is not Medicare-enrolled. We 
anticipate this information will also have value for Medicare 
beneficiaries seeking OUD treatment services in OTPs. We also note that 
states already have access to the CMS Provider Enrollment, Chain, and 
Ownership System (PECOS) provider enrollment system, and can confirm 
provider enrollment or lack thereof through queries to that system.
    Comment: Several commenters expressed concern about the 
intersection of Medicaid's ``Upper Payment Limit'' (UPL) policy with 
the proposed Medicare payment rates for OTP services. The commenters 
noted that most states that cover OTP services have payment rates that 
are higher than the proposed Medicare payment rates, and expressed a 
concern that Medicaid's UPL policy requires Medicaid rates to be lower 
than Medicare's. Commenters noted that unless Medicare significantly 
increases its proposed rates, state Medicaid agencies would be forced 
to lower theirs to comply with the UPL. Commenters requested that CMS 
increase the Medicare rates for services furnished by OTPs to exceed 
the Medicaid rate in every state, or not apply the UPL requirements to 
the Medicaid OTP services.
    Response: We appreciate the concern expressed by the commenters. 
However, the UPL requirements do not directly impact payment rates for 
individual services such as the OUD treatment services furnished by 
OTPs in the way commenters describe, and states have policy options to 
address UPL-related concerns. As background, state Medicaid agencies 
can opt to cover OTP services under the Medicaid clinic benefit or the 
Medicaid rehabilitation benefit. The Medicaid clinic benefit is subject 
to a UPL based on estimated Medicare payments, but states demonstrate 
compliance with this requirement at an aggregate level across the range 
of services covered under the clinic benefit as a whole for a given 
year. States are not required to set Medicaid payment lower than 
Medicare at a service or code-level basis. Within the UPL requirements, 
states have significant flexibility in how they may pay for individual 
services or codes or make payments to clinics that specialize in 
providing certain types of care. As a result, states offering OTP 
services under the clinic benefit would not be required to reduce their 
payment rates to be less than Medicare for OTP services. We will issue 
guidance reminding states that the UPL policy for the clinic benefit 
applies at the aggregate level, and will work with states to determine 
how to comply with the UPL if they currently cover OTP under the clinic 
benefit. For states that offer OTP services under the rehabilitation 
benefit, we note there is no UPL for that benefit, so the Medicare

[[Page 62671]]

payment rate for OTP services does not impact Medicaid payment for 
those states. As a result, there is no need to adjust the Medicare 
payment rates for OUD treatment services furnished by OTPs that we are 
adopting in this final rule to address this concern.
    Comment: One commenter suggested CMS provide guidance to states on 
what the Medicare OTP benefit does and does not cover, to facilitate 
Medicaid covering specific OTP services for dually eligible individuals 
that Medicare does not cover.
    Response: We acknowledge that states may have a more expansive 
benefit for services provided by OTPs than Medicare's, and that in 
those situations, states may continue to cover specific OTP services 
that Medicare does not. To support a smooth transition, we will provide 
guidance to states to describe the Medicare OTP benefit and remind them 
that Medicaid may still cover specific OTP services not covered under 
the Medicare OTP benefit.
    Comment: Several commenters suggested that CMS conduct significant 
outreach on coordination of benefits; that is, how Medicare will be 
primary payer and Medicaid will be secondary payer for dually eligible 
individuals. One commenter further suggested that OTP providers should 
receive training and technology to facilitate screening patients for 
Medicare, as well as Medicaid, eligibility and enrollment.
    Response: We agree with the need for significant outreach to OTP 
providers regarding coordination of benefits, and are collaborating 
with SAMHSA--which certifies OTP providers--to do so. We will explore 
options around providing technical assistance on connecting eligible 
clients to Medicare and Medicaid coverage.
    Comment: One commenter suggested that as part of supporting the 
transition from Medicaid to Medicare coverage of OTP services, CMS 
issue guidance to remind states to continue transportation coverage for 
full benefit dually eligible individuals receiving services under the 
Medicare OTP benefit.
    Response: As noted elsewhere, Medicare is the primary payer for 
services that are payable by both Medicare and Medicaid. However, 
Medicare has a limited non-emergency ambulance transportation benefit. 
If a full benefit dually eligible individual is obtaining a Medicaid-
coverable benefit for which Medicare is the primary payer, the state 
must assure, in certain circumstances, transportation to the medical 
service (in the limited instances in which Medicaid does not cover a 
service Medicare covers, it is optional for states to cover 
transportation). As a result, when states cover OTP services, and when 
the applicable criteria are met, Medicaid must assure non-emergency 
medical transportation for full benefit dually eligible individuals 
obtaining Medicare-covered OTP services.
    Comment: Several commenters supported the proposal to initially set 
the copayment for OTP services zero, but requested that this policy be 
made permanent for dually eligible individuals.
    Response: We will consider issues on future copayment rates, and on 
keeping the zero copayment for dually eligible individuals, as part of 
any future rulemaking on the cost-sharing requirements for the benefit 
as a whole.
    Comment: A commenter raised concerns regarding the January 1, 2020 
implementation date for the OTP benefit due to implementation barriers. 
The commenter stated that MAOs need final payment codes, payment 
information and clarity regarding any benefit caps or other benefit 
limits. The commenter further stated that MAOs need additional time to 
finalize contracting systems and to develop operational details for the 
benefit.
    Response: Although we understand the concern, we do not plan to 
delay the implementation of this benefit due to the acute need for the 
OUD treatment services furnished by OTPs. We will work closely with 
MAOs to ensure timely implementation of this benefit. Plans must 
provide enrollees with a level of access to Medicare-covered OTP 
services that is consistent with prevailing community patterns of care 
in the areas where the network is being offered (Sec.  422.112(a)(10)). 
We note that, for CY 2020, Medicare Advantage plans may contract with 
an OTP provider so long as the requirements for such providers (such as 
licensure, certification, and other qualifications, etc.) under Titles 
XVIII and XI of the Act are met. Allowing the individual to continue to 
see their current provider during this transition will ensure 
continuity of care for this vulnerable population.
    Comment: One commenter recommended that CMS issue a non-enforcement 
or ``hold harmless'' grace period against plans for Part B vs. Part D 
determinations for 2020, with respect to audits and other consequences 
such as Star Ratings related to the new OUD treatment services benefit.
    Response: We do not believe it is appropriate for CMS to issue a 
``hold harmless'' period regarding the implementation of the new OTP 
benefit. As we have noted in other responses, we believe there is an 
urgency in making this benefit available to people struggling with 
opioid use disorder. CMS will work closely with organizations to ensure 
a smooth implementation of this benefit. With regard to the Part B 
versus Part D determination, we remind Medicare Advantage plans that 
Sec.  422.112(b)(7) requires plans that also cover Part D drugs to 
coordinate coverage and have a process in place to ensure provision of 
the covered drug to an enrollee in a timely fashion. CMS clarifies that 
buprenorphine prescribed by DATA 2000 providers outside of OTPs can 
continue to be covered under Part D. The DATA 2000 and OTP programs are 
designed to meet the needs of those needing opioid dependency treatment 
in different ways. Therefore, because buprenorphine is still covered 
under Part D when furnished outside an OTP, sponsors should not need to 
implement new point of service Part B versus Part D pharmacy edits for 
a buprenorphine claim. In addition, any substantive changes to the Star 
Ratings measure specifications must be adopted through rulemaking per 
Sec. Sec.  422.164 and 423.184.
    Comment: A commenter recommended that CMS delay the implementation 
of the OTP benefit until January 1, 2021, because MA plans did not have 
an opportunity to account for the new benefit in their 2020 year bids.
    Response: In the CY 2020 Call Letter released April 1, 2019 
available at the following web link: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf, 
CMS issued guidance to MAOs regarding section 2005 of the SUPPORT Act 
and implementing the OTP benefit. In the Call Letter, CMS reminded 
plans that opioid use disorder treatment services furnished by OTPs 
would be covered as a Medicare Part B benefit beginning January 1, 
2020. We also stated that MA organizations should prepare their bids 
using available information and reiterated that MA plans must provide 
all medically necessary Part A and Part B covered services to enrollees 
consistent with section 1852 of the Act and the regulations in part 
422. As such, MA plans were given the opportunity to account for the 
new benefit in their 2020 bids and did so when bids were submitted on 
June 3, 2019.
    Comment: A commenter expressed concerns that there may be 
insufficient number of OTPs available in 2020 who are SAMSHA accredited 
with a Medicare provider agreement to contract with MA plans.
    Response: We note that MA plans will be required to furnish access 
to OTP

[[Page 62672]]

services consistent with what is available to Original Medicare 
beneficiaries residing in the same geographic area. (see Sec.  422.112) 
While OTPs will currently not be a specialty included in our evaluation 
of MA networks, all plan covered services must be furnished consistent 
with community patterns of care (see Sec.  422.112(a)(10)). This means 
that a plan's enrollees, who are receiving services from an OTP, cannot 
be required to travel significantly farther than the distance Original 
Medicare beneficiaries are required to travel in order to access 
services from the OTP. MA plans are not required to furnish 
transportation to the OTP facilities as part of the OTP benefit. 
However, MA plans can furnish transportation to health care services as 
a supplemental benefit. In addition, as noted elsewhere, Medicaid must 
assure, in certain circumstances, non-emergency transportation for a 
dually eligible individual to obtain a Medicaid-coverable benefit for 
which Medicare is primary payer.
    Comment: A commenter stated that, in order to administer this new 
benefit, guidance is needed on which services must be covered by an MA 
plan without cost-sharing and the timelines for coverage without cost-
sharing (for example, no more than 12 months of active treatment). The 
commenter further stated that since OUD treatment is complex and can 
vary from patient to patient, it is important that plans understand 
whether there should be no cost-sharing on all components or if there 
are specific nuances in how to apply the requirement.
    Response: MA plans can offer the OTP benefit consistent with the 
bids which were submitted for CY 2020, including proposed cost-sharing. 
We note that MA plans must assure that, in instances in which they 
impose cost-sharing for the OTP benefit, providers do not bill a 
Qualified Medicare Beneficiary for such cost-sharing. (see Sec.  
422.504(g)(1).)
    Comment: A commenter requested clarification as to whether OTPs 
will be billing Medicare Part B--that is, the FFS Medicare program--for 
services furnished to Medicare Advantage enrollees.
    Response: No. OTPs that furnish Medicare covered medically 
necessary services to MA enrollees will be paid by the enrollees' MA 
plans. MA plans are required to furnish or cover all benefits that are 
covered by Medicare Part A and Part B, excluding hospice, for their 
enrollees. As previously noted, MA plans are required to contract with, 
or arrange on a non-contract basis for, enrollee access to medically 
necessary OTP services consistent with the community pattern of care. 
MA plans may have direct contracts with OTPs in which they negotiate 
the terms and conditions of payment for the Medicare-covered services 
furnished by the OTP. An OTP treating an MA enrollee that does not have 
a contract with the enrollee's MA plan should contact the MA plan to 
confirm coverage and payment.
    Comment: A commenter requested additional information about CMS' 
expectations of how the OTP benefit will be made available to Medicare 
Advantage enrollees.
    Response: In the CY 2020 Call Letter released on April 1, 2019, CMS 
issued guidance to MA organizations regarding section 2005 of the 
SUPPORT Act and implementing the OTP benefit. In the CY 2020 Call 
Letter, CMS reminded plans that opioid use disorder treatment services 
furnished by OTPs would be covered as a Medicare Part B benefit by 
plans beginning January 1, 2020. We also stated that MA organizations 
should prepare their bids using available information and reiterated 
that MA plans must provide all medically necessary Part A and Part B 
covered services to enrollees consistent with section 1852 of the Act 
and the regulations in part 422.
    For dually eligible individuals who may already be receiving OTP 
services through Medicaid, MA plans should ensure continuity of care 
for their enrollees any time there is a transition from a non-
contracted to a contracted provider. In addition, as noted above, MA 
plans must assure that in instances in which they impose cost-sharing 
on the OTP benefit, providers do not bill a Qualified Medicare 
Beneficiary for such cost-sharing.
    Comment: A commenter asks that CMS not allow MA plans to utilize 
prior authorization (PA) or step therapy for treatment of opioid 
withdrawal symptoms.
    Response: MA plans may use step therapy for Part B drugs when 
medically appropriate and consistent with the requirements in Sec.  
422.136. We also note that when an MA plan processes a coverage request 
that involves prior authorization or other utilization management 
requirements, such as step therapy for Part B drugs, the plan's 
determination on whether to grant approval of a service or a drug for 
an enrollee constitutes an organization determination under part 422, 
subpart M, and is subject to appeal. Specifically, as described at 
Sec.  422.568, the MA organization must notify the enrollee of its 
determination as expeditiously as the enrollee's health condition 
requires. CMS is considering strategies we can use to monitor the 
implementation of the OTP benefit by MA plans and any issues that may 
impede access to medically necessary treatment of opioid use disorder, 
including what data might be available to evaluate plan performance.
    Comment: A commenter questioned how MA-PD and Prescription Drug 
Plan sponsors will know what beneficiaries are eligible for this 
benefit. The commenter proposes that an option would be to provide an 
indicator in the CMS Medicare Advantage and Prescription Drug data 
System (MARx), with start and end dates, for beneficiary eligibility 
for OTP services.
    Response: All beneficiaries needing treatment for opioid addiction 
are eligible for this benefit. We appreciate the data suggestion and 
will take it into consideration in our on-going implementation of the 
OTP benefit.
    Comment: A commenter questioned how Medicare's managed care plan 
partners are supposed to reflect the use of this new benefit in their 
required data submissions.
    Response: We will furnish guidance to MA organizations and cost 
plans on this topic at a later date.
    Comment: A commenter requested that since OTPs are currently 
providing OUD services to Medicare beneficiaries, and that the provider 
enrollment process would not start until the new Part B benefit is 
available (January 1, 2020), will CMS allow for payments to OTPs for 
services delivered in the 30 days prior to their successful enrollment.
    Response: As we noted in a previous response, MA plans cannot 
contract or furnish the Part B OTP services through any OTP that is 
SAMSHA accredited if that OTP has not yet enrolled in Medicare but the 
MA plan may cover or furnish services provided by such a provider as a 
supplemental benefit (Sec.  422.204(b)(3). Allowing the individual to 
continue to see their current provider during this transition will 
ensure continuity of care for this vulnerable population. Furthermore, 
in some situations, the MA plan may be required by Sec.  422.112(a)(3) 
to provide out-of-network access for the OTP benefit and we remind MA 
organizations of their obligations under part 422 regulations to 
furnish all Part A and Part B benefits, excluding hospice, to their 
enrollees.
    Comment: A commenter noted that the Annual Notice of Change and 
Evidence of Coverage (ANOC and EOC) documents can play an essential 
role in updating beneficiaries as to new benefits, but the timing for

[[Page 62673]]

implementation of the OTP benefit in 2020 makes this impractical, and 
instead suggested that CMS undertake a robust public education campaign 
aimed directly at beneficiaries.
    Response: The SUPPORT Act became law in October 2018 and CMS issued 
guidance to MA organizations in the CY 2020 Draft Call Letter (issued 
in January 2019) and the CY 2020 Final Call Letter (issued in April 
2019) about the requirement to cover the OTP benefit, so MA 
organizations had sufficient time to plan to include the necessary 
information in ANOCs and EOCs for 2020. Medicare Advantage plans are 
required to include the new OTP benefit in their 2020 ANOC/EOC. We are 
also implementing a comprehensive education campaign regarding the new 
OTP benefit. Our public education campaign will feature CMS information 
channels, education resources and outreach leveraging media/stakeholder 
networks to raise awareness and engage Medicare beneficiaries. 
Specifically it will include earned media (for example, drop-in article 
for local/community newspapers), social media (for example, tweets and 
Facebook posts), beneficiary publications, and outreach to beneficiary 
partners including State Health Insurance Assistance Programs (SHIPs) 
across the country, in addition to information available from 1-800-
MEDICARE and our consumer website, http://www.medicare.gov.
    Comment: One commenter requested more information about the 
compliance criteria, quality metrics, and electronic health record 
(EHR) requirements that will be used to evaluate OTPs, and whether OTPs 
will be subject to the requirements of the Quality Payment Program.
    Response: We did not propose any compliance criteria, quality 
metrics, or EHR requirements for OTPs. As OTPs are not one of the 
eligible clinician types for the Quality Payment Program, they are not 
able to participate in MIPS or to be a Qualifying APM Participant (QP). 
However, OTPs may be able to participate in a Center for Medicare and 
Medicaid Innovation payment model, depending on the eligible 
participants identified for that specific model, and then would be 
subject to the requirements of that specific model, which could include 
quality or EHR-related requirements.
    After a thorough review of the above policy considerations 
reflected in the public comments we received, we are finalizing the 
proposed provisions to implement the new OTP benefit under section 2005 
of the SUPPORT Act, with modifications as described above, at Sec.  
410.67, part 489 and part 498.

H. Bundled Payments Under the PFS for Substance Use Disorders

1. Background and Provision
    In the CY 2019 PFS proposed rule (83 FR 35730), we solicited 
comment on creating a bundled episode of care payment for management 
and counseling treatment for substance use disorders. We received 
approximately 50 comments on this topic, most of which were supportive 
of creating a separate bundled payment for these services. Some 
commenters recommended focusing the bundle on services related to 
medication assisted treatment (MAT) used in treatment for opioid use 
disorder (OUD). Several commenters also recommended that we establish 
higher payment amounts for patients with more complex needs who require 
more intensive services and management, and also expressed concern that 
an episode of care that limited the duration of treatment would not be 
conducive to treating OUD, given the chronic nature of this disorder. 
Other commenters recommended that we establish separate bundled 
payments for treatment of substance use disorders that does, and does 
not, involve MAT.
    In response to the public comments, we proposed to establish 
bundled payments for the overall treatment of OUD, including 
management, care coordination, psychotherapy, and counseling 
activities. We noted that, 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. Additionally, payment for medically necessary 
toxicology testing would not be included in the proposed OUD bundle, 
and would continue to be billed separately under the Clinical Lab Fee 
Schedule. We also proposed to implement the new Medicare Part B benefit 
added by section 2005 of the SUPPORT Act for coverage of certain 
services furnished by Opioid Treatment Programs (OTPs) beginning in CY 
2020. We believe the bundled payment under the PFS for OUD treatment 
described below will create an avenue for physicians and other health 
professionals to bill for a bundle of services that is similar to the 
new bundled OUD treatment services benefit, but not furnished by an 
OTP. By creating a separate bundled payment for these services under 
the PFS, we hope to incentivize increased provision of counseling and 
care coordination for patients with OUD in the office setting, thereby 
expanding access to OUD care. We note that use of these codes is 
limited to only beneficiaries diagnosed with OUD; however, we may 
consider other potential bundles describing services for other 
substance use disorders in future rulemaking.
    To implement this new bundled payment, we proposed to create two 
HCPCS G-codes to describe monthly bundles of services that include 
overall management, care coordination, individual and group 
psychotherapy and counseling for office-based OUD treatment. Although 
we considered proposing weekly-reported codes to describe a bundle of 
services that would align with the proposed OTP bundle, we believe that 
monthly-reported codes will better align with the practice and billing 
of other types of care management services furnished in office settings 
and billed under the PFS (for example, behavioral health integration 
(BHI) services). We believe monthly-reported codes would be less 
administratively burdensome for practitioners, and more likely to be 
consistent with care management and prescribing patterns in the office 
setting (as compared with an OTP) given the increased use of long-
acting MAT drugs (such as injectable naltrexone or implanted 
buprenorphine) in the office setting compared to the OTP setting. We 
note that these codes should not be billed for beneficiaries who are 
receiving treatment at an OTP, as we believe that would be duplicative 
since the bundled payments made to OTPs cover similar services for the 
treatment of OUD. Based on feedback we received through the comment 
solicitation, we proposed to create a code to describe the initial 
month of treatment, which would include intake activities and 
development of a treatment plan, as well as assessments to aid in 
development of the treatment plan in addition to care coordination, 
individual therapy, group therapy, and counseling; a code to describe 
subsequent months of treatment including care coordination, individual 
therapy, group therapy, and counseling; and an add-on code that could 
be billed in circumstances when effective treatment requires additional 
resources for a particular patient that substantially exceed the 
resources included in the base codes. In other words, the add-on code 
would address extraordinary circumstances that are not contemplated by 
the bundled code. We acknowledge that the course of treatment for OUD 
is variable, and in some instances, the first several months of 
treatment may be more resource intensive. We solicited comment on 
whether we should consider creating a separately billable

[[Page 62674]]

code or codes to describe additional resources involved in furnishing 
OUD treatment-related services after the first month, for example, when 
substantial revisions to the treatment plan are needed, and what 
resource inputs we might consider in setting values for such codes.
    We believe that, in general, bundled payments create incentives to 
provide efficient care by mitigating incentives tied to volume of 
services furnished, and that these incentives can be undermined by 
creating separate billing mechanisms to account for higher resource 
costs for particular patients. However, we share some of the concerns 
raised by commenters that an OUD bundle should not inadvertently limit 
the appropriate amount of OUD care furnished to patients with varying 
medical needs. In consideration of this concern, we proposed to create 
an add-on code to make appropriate payment for additional resource 
costs in order to mitigate the risks that the bundled OUD payment might 
limit clinically-indicated patient care for patients that require 
significantly more care than is in the range of what is typical for the 
kinds of care described by the base codes. However, we are also 
interested in comments regarding ways we might better stratify the 
coding for OUD treatment to reflect the varying needs of patients 
(based on complexity or frequency of services, for example) while 
maintaining the full advantage of the bundled payment, including 
increased efficiency and flexibility in furnishing care.
    We anticipate that these services 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. Additionally, unlike the codes that describe care furnished 
using the psychiatric collaborative care model (CPT codes 99492, 99493, 
and 99494), which require consultation with a psychiatric consultant, 
we did not propose to require consultation with a specialist as a 
condition of payment for these codes, but we note that consultation 
with a specialist could be counted toward the minutes required for 
billing HCPCS codes G2086, G2087, and G2088.
    The codes and descriptors for the services are:
     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).
    For the purposes of valuation for HCPCS codes G2086 and G2087, we 
are assuming two individual psychotherapy sessions per month and four 
group psychotherapy sessions per month; however, we understand that the 
number of therapy and counseling sessions furnished per month will vary 
among patients and also fluctuate over time based on the individual 
patient's needs. Consistent with the methodology for pricing other 
services under the PFS, HCPCS codes G2086, G2087, and G2088 are valued 
based on what we believe to be a typical case, and we understand that 
based on variability in patient needs, some patients will require more 
resources, and some fewer. In order to maintain the advantages inherent 
in developing a payment bundle, we proposed that the add-on code (HCPCS 
code G2088) can only be billed when the total time spent by the billing 
professional and the clinical staff furnishing the OUD treatment 
services described by the base code exceeds double the minimum amount 
of service time required to bill the base code for the month. We 
believe it is appropriate to limit billing of the add-on code to 
situations where medically necessary OUD treatment services for a 
particular patient exceed twice the minimum service time for the base 
code because, as noted above, the add-on code is intended to address 
extraordinary situations where effective treatment requires additional 
resources that substantially exceed the resources included in the base 
codes. For example, the needs of a particular patient in a month may be 
unusually acute, well beyond the needs of the typical patient; or there 
may be some months when psychosocial stressors arise that were 
unforeseen at the time the treatment plan was developed, but warrant 
additional or more intensive therapy services for the patient. We 
proposed that when the time requirement is met, HCPCS code G2088 could 
be billed as an add-on code during the initial month or subsequent 
months of OUD treatment. Practitioners should document the medical 
necessity for the use of the add-on code in the patient's medical 
record. We solicited comment on the proposal.
    We proposed to value HCPCS codes G2086, G2087, and G2088 using a 
building block methodology that sums the work RVUs and direct PE inputs 
from codes that describe the component services we believe would be 
typical, consistent with the approach we have previously used in 
valuing monthly care management services that include face-to-face 
services within the payment. For HCPCS code G2086, we developed 
proposed inputs using a crosswalk to CPT code 99492 (Initial 
psychiatric collaborative care management, first 70 minutes in the 
first calendar 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: Outreach to and engagement in 
treatment of a patient directed by the treating physician or other 
qualified health care professional; initial assessment of the patient, 
including administration of validated rating scales, with the 
development of an individualized treatment plan; review by the 
psychiatric consultant with modifications of the plan if recommended; 
entering patient in a registry and tracking patient follow-up and 
progress using the registry, with appropriate documentation, and 
participation in weekly caseload consultation with the psychiatric 
consultant; and provision of brief interventions using evidence-based 
techniques such as behavioral activation, motivational interviewing, 
and other focused treatment strategies.), which is assigned a work RVU 
of 1.70, plus CPT code 90832 (Psychotherapy, 30 minutes with patient), 
which is assigned a work RVU of 1.50 (assuming two over the course of 
the month), and CPT code 90853 (Group psychotherapy (other than of a 
multiple-family group)), which is assigned a work RVU of 0.59 (assuming 
four over the course of a month), for a work RVU of 7.06. The required 
minimum number of minutes described in HCPCS code G2086 is also based 
on a crosswalk to CPT code 99492. Additionally, for HCPCS code G2086, 
we proposed to use a crosswalk to the direct PE inputs associated with 
CPT code 99492, CPT code 90832 (times two), and CPT code 90853 (times 
four). We believe that the work and PE described by these crosswalk 
codes is analogous to the services described in HCPCS code G2086 
because HCPCS code G2086 includes similar care

[[Page 62675]]

coordination activities as described in CPT code 99492 and bundles in 
the psychotherapy services described in CPT codes 90832 and 90853.
    We proposed to value HCPCS code G2087 using a crosswalk to 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 and are prepared for 
discharge from active treatment), which is assigned a work RVU of 1.53, 
plus CPT code 90832, which is assigned a work RVU of 1.50 (assuming two 
over the course of the month), and CPT code 90853, which is assigned a 
work RVU of 0.59 (assuming four over the course of a month), for a work 
RVU of 6.89. The required minimum number of minutes described in HCPCS 
code G2087 is also based on a crosswalk to CPT codes 99493. For HCPCS 
code G2087, we proposed to use a crosswalk to the direct PE inputs 
associated with CPT code 99493, CPT code 90832 (times two), and CPT 
code 90853 (times four). We believe that the work and PE described by 
these crosswalk codes is analogous to the services described in HCPCS 
code G2087 because HCPCS code G2087 includes similar care coordination 
activities as described in CPT code 99493 and bundles in the 
psychotherapy services described in CPT codes 90832 and 90853.
    We proposed to value HCPCS code G2088 using a crosswalk to CPT code 
99494 (Initial or subsequent psychiatric collaborative care management, 
each additional 30 minutes in a calendar 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 (List separately in addition to code for primary 
procedure)), which is assigned a work RVU of 0.82. The required minimum 
number of minutes described in HCPCS code G2087 is also based on a 
crosswalk to CPT codes 99493. For HCPCS code G2088, we proposed to use 
a crosswalk to the direct PE inputs associated with CPT code 99494. We 
believe that the work and PE described by this crosswalk code is 
analogous to the services described in HCPCS code G2088 because HCPCS 
code G2088 includes similar care coordination activities as described 
in CPT code 99494.
    We understand that many beneficiaries with OUD have comorbidities 
and may require medically-necessary psychotherapy services for other 
behavioral health conditions. In order to avoid duplicative billing, we 
proposed that, when furnished to treat OUD, CPT codes 90832, 90834, 
90837, and 90853 may not be reported by the same practitioner for the 
same beneficiary in the same month as HCPCS codes G2086, G2087, and 
G2088. We solicited comments on the proposal.
    We proposed that practitioners reporting the OUD bundle must 
furnish a separately reportable initiating visit in association with 
the onset of OUD treatment, since the bundle requires a level of care 
coordination that cannot be effective without appropriate evaluation of 
the patient's needs. This is similar to the requirements for chronic 
care management (CCM) services (CPT codes 99487, 99489, 99490, and 
99491) and BHI services (CPT codes 99484, 99492, 99493, and 99494) 
finalized in the CY 2017 PFS final rule (81 FR 80239). The initiating 
visit would establish the beneficiary's relationship with the billing 
practitioner, ensure the billing practitioner assesses the beneficiary 
to determine clinical appropriateness of MAT in cases where MAT is 
being furnished, and provide an opportunity to obtain beneficiary 
consent to receive care management services (as discussed further 
below). We proposed that the same services that can serve as the 
initiating visit for CCM services and BHI services can serve as the 
initiating visit for the services described by HCPCS codes G2086-G2088. 
For new patients or patients not seen by the practitioner within a year 
prior to the commencement of CCM services and BHI services, the billing 
practitioner must initiate the service during a ``comprehensive'' E/M 
visit (levels 2 through 5 E/M visits), annual wellness visit (AWV) or 
initial preventive physical exam (IPPE). The face-to-face visit 
included in transitional care management (TCM) services (CPT codes 
99495 and 99496) also qualifies as a ``comprehensive'' visit for CCM 
and BHI initiation. We proposed that these visits could similarly serve 
as the initiating visit for OUD services.
    We proposed that the counseling, therapy, and care coordination 
described in the OUD treatment codes could be provided by professionals 
who are qualified to provide the services under state law and within 
their scope of practice ``incident to'' the services of the billing 
physician or other practitioner. We also proposed that the billing 
clinician would manage the patient's overall care, as well as supervise 
any other individuals participating in the treatment, similar to the 
structure of the BHI codes describing the psychiatric collaborative 
care model finalized in the CY 2017 PFS final rule (81 FR 80229), in 
which services are reported by a treating physician or other qualified 
health care professional and include the services of the treating 
physician or other qualified health care professional, as well as the 
services of other professionals who furnish services incident to the 
services of the treating physician or other qualified health care 
professional. Additionally, we proposed to add these codes to the list 
of designated care management services for which we allow general 
supervision of the non-face-to-face portion of the required services. 
Consistent with policies for other separately billable care management 
services under the PFS, because these proposed OUD treatment bundles 
include non-face-to-face care management components, we proposed that 
the billing practitioner or clinical staff must document in the 
beneficiary's medical record that they obtained the beneficiary's 
consent to receive the services, and that, as part of the consent, they 
informed the beneficiary that there is cost sharing associated with 
these services, including potential deductible and coinsurance amounts, 
for both in-person and non-face-to-face services that are provided.
    We proposed to allow any of the individual therapy, group therapy 
and counseling services included in HCPCS codes G2086, G2087, and G2088 
to be furnished via telehealth, as clinically appropriate, in order to 
increase access to care for beneficiaries. As discussed in section 
II.F. of this final rule regarding

[[Page 62676]]

Telehealth Services, like certain other non-face-to-face PFS services, 
the components of HCPCS codes G2086 through G2088 describing care 
coordination are commonly furnished remotely using telecommunications 
technology, and do not require the patient to be present in-person with 
the practitioner when they are furnished. As such, these services are 
not considered telehealth services for purposes of Medicare, and we do 
not need to consider whether the non-face-to-face aspects of HCPCS 
codes G2086 through G2088 are similar to other telehealth services. If 
the non-face-to-face components of HCPCS codes G2086 through G2088 were 
separately billable, they would not need to be on the Medicare 
telehealth list to be covered and paid in the same way as services 
delivered without the use of telecommunications technology.
    Section 2001(a) of the SUPPORT Act amended section 1834(m) of the 
Act, adding a new paragraph (7) that removes the geographic limitations 
for telehealth services furnished on or after July 1, 2019, to an 
individual with a substance use disorder (SUD) diagnosis for purposes 
of treatment of such disorder or co-occurring mental health disorder. 
The new paragraph at section 1834(m)(7) of the Act also allows 
telehealth services for treatment of a diagnosed SUD or co-occurring 
mental health disorder to be furnished to individuals at any telehealth 
originating site (other than a renal dialysis facility), including in a 
patient's home. As discussed in section II.F. of this final rule, 
Telehealth Services, we proposed to add HCPCS codes G2086, G2087, and 
G2088 to the list of Medicare Telehealth services. Because certain 
required services (such as individual psychotherapy or group 
psychotherapy services) that are included in the proposed OUD bundled 
payment codes would be furnished to treat a diagnosed SUD, and would 
ordinarily require a face-to-face encounter, they could be furnished 
more broadly as telehealth services as permitted under section 
1834(m)(7) of the Act.
    For these services described above (HCPCS codes G2086, G2087, and 
G2088), we solicited comment on how these potential codes, descriptors, 
and payment rates align with state Medicaid coding and payment rates 
for the purposes of state payment of cost sharing for Medicare-Medicaid 
dually eligible individuals. Additionally, we understand that treatment 
for OUD can vary, and that MAT alone has demonstrated efficacy. In 
cases where a medication such as buprenorphine or naltrexone is used to 
treat OUD alone, without therapy or counseling, we note that existing 
applicable codes can be used to furnishing and bill for that care (for 
example, using E/M visits, in lieu of billing the bundled OUD codes 
proposed here).
    As discussed in section II.G. of this final rule, Medicare Coverage 
for Certain Services Furnished by Opioid Treatment Programs, we 
proposed to set the copayment at zero for OUD services furnished by an 
OTP, given the flexibility in section 1834(w)(1) of the Act for us to 
set the copayment amount for OTP services either at zero or at an 
amount above zero. We note that we do not have the statutory authority 
to eliminate the deductible and coinsurance requirements for the 
bundled OUD treatment services under the PFS. We acknowledge the 
potential impact of coinsurance on patient health care decisions and 
intend to monitor its impact if these proposals were to be finalized.
    Finally, we recognize that historically, the CPT Editorial Panel 
has frequently created CPT codes describing services that we originally 
established using G-codes and adopted them through the CPT Editorial 
Panel process. We note that we would consider using any newly available 
CPT coding to describe services similar to those described here in 
future rulemaking, as early as CY 2021. We would consider and adopt any 
such CPT codes through subsequent rulemaking.
    Additionally, we understand that in some cases, OUD can first 
become apparent to practitioners in the emergency department setting. 
We recognize that there is not specific coding that describes diagnosis 
of OUD or the initiation of, or referral for, MAT in the emergency 
department setting. We solicited comment on the use of MAT in the 
emergency department setting, including initiation of MAT and the 
potential for either referral or follow-up care, as well as the 
potential for administration of long-acting MAT agents in this setting, 
in order to better understand typical practice patterns to help inform 
whether we should consider making separate payment for such services in 
future rulemaking. We solicited feedback from stakeholders and the 
public on other potential bundles describing services for other 
substance use disorders for our consideration in future rulemaking.
    We received public comments on the proposed bundled payments under 
the PFS for substance use disorders. The following is a summary of the 
comments we received and our responses.
    Comment: Many commenters expressed support for this proposal and a 
few noted that the PFS bundle would provide an opportunity to increase 
access to OUD treatment for beneficiaries who live in areas without an 
OTP, but also encouraged CMS to seek opportunities to more closely 
align the benefit across OTP and PFS settings before it is introduced 
and to monitor for any unintended responses to payment incentives, 
noting differences in the number of psychotherapy sessions included.
    Response: We agree with the commenters regarding the importance of 
alignment in these services when furnished in different settings and 
note that we are finalizing several changes to the coding and payment 
for services furnished in an OTP (see section II.G of this final rule), 
which we believe more closely align the payments made by Medicare for 
OUD services across settings. For example, we are finalizing using a 
building block methodology to calculate the payment rate for the OTP 
bundled payments using Medicare rates, including the rates for CPT 
codes 90832 and 90853, which were also used to calculate the payment 
rates HCPCS codes G2086, G2087, and G2088. Additionally, we are 
finalizing an adjustment to the OTP bundled payments to account for 
intake activities, similar to activities included in HCPCS code G2086, 
which describes the initial month of treatment. In response to the 
comments related to monitoring for unintended responses to payment 
incentives, we note that we will be monitoring utilization of HCPCS 
codes G2086, G2087, and G2088 and their interaction with other 
services, as well as the codes describing bundled payments for services 
furnished at OTPs.
    Comment: A few commenters commended CMS on several aspects of this 
proposal and urged that the proposed codes and valuations be finalized, 
and also recommended that CMS consider establishing bundled payment 
amounts that recognize services for different levels of patient need 
and different types of practice arrangements, including consultation 
with specialists.
    Response: We thank the commenters for their statements of support. 
We are finalizing the payment amounts for HCPCS codes G2086, G2087, and 
G2088 as proposed. We also appreciate the commenters' views on coding 
for these services, and will consider whether it would be appropriate 
to create codes describing different levels of patient need and 
different practice arrangements for possible future rulemaking.

[[Page 62677]]

    Comment: A few commenters recommended that CMS adjust the payment 
methodology for these services to account for patient complexity/
severity using the American Society of Addiction Medicine (ASAM) 
Criteria or other equivalent criteria and to account for different 
types of practice arrangements and emerging technologies. These 
commenters also recommended that we lower the threshold for billing the 
add-on code to allow it to be billed when the OUD treatment services 
described by the base code exceeds 125-150 percent of the minimum time 
required to bill the base code for the month. Additionally, the 
commenters recommended that CMS urge health care practitioners to 
consult with physician addiction specialists, as appropriate, when 
treating patients with moderate to severe OUD.
    Response: After considering public comments, we are finalizing our 
proposal without modification that HCPCS code G2088 can be billed when 
the total time spent by the billing professional and the clinical staff 
furnishing the OUD treatment services described by the base code 
exceeds double the minimum amount of service time required to bill the 
base code for the month. We continue to believe it is appropriate to 
limit billing of the add-on code to situations where medically 
necessary OUD treatment services for a particular patient exceed twice 
the minimum service time for the base code because, as noted above, the 
add-on code is intended to address extraordinary situations where 
effective treatment requires additional resources that substantially 
exceed the resources included in the base codes. Additionally, we agree 
with the commenter's recommendation that practitioners furnishing OUD 
treatment services should consult with addiction specialists, as 
clinically appropriate.
    Comment: Many commenters requested that CMS allow additional 
psychotherapy services to be furnished for patients receiving treatment 
for OUD or another SUD. A few commenters expressed concern that a 
practitioner would not be able to bill separately for psychotherapy 
services furnished to beneficiaries with OUD and a co-occurring mental 
health condition, noting that in rural areas there may not be enough 
behavioral health providers for a patient to be seen by separate 
practitioners for SUD and mental health diagnoses.
    Response: It is not our intention to limit access to medically 
necessary services through the creation of bundled payment for OUD 
treatment services. We clarify that while the psychotherapy services 
described by CPT codes 90832 (Psychotherapy, 30 minutes with patient), 
90834 (Psychotherapy, 45 minutes with patient), 90837 (Psychotherapy, 
60 minutes with patient), and 90853 (Group psychotherapy (other than of 
a multiple-family group)) cannot be reported by the same practitioner 
for the same beneficiary in the same month as the codes describing this 
bundled episode of care, practitioners can bill for additional 
psychotherapy furnished for the treatment of OUD using the add-on code 
(HCPCS code G2088). In cases where psychotherapy services are furnished 
for co-occurring diagnoses, any of the psychotherapy codes could be 
billed, as medically reasonable and necessary. We note that 
practitioners should determine which of the patient's diagnoses they 
are treating is the primary one being treated during that session in 
order to decide whether it is appropriate to bill separately for 
psychotherapy services furnished for co-occurring diagnoses. After 
reflecting on these and other comments, we also believe it is important 
to modify our proposal to establish a requirement that at least one 
psychotherapy service must be furnished in order to bill for HCPCS 
codes G2086 or G2087. Since the new G codes incorporate the resource 
costs involved in furnishing psychotherapy services into the payment 
rate, we believe it is appropriate that a minimum of at least one 
psychotherapy service be furnished in order to bill for HCPCS codes 
G2086 or G2087. We note that not all OUD treatment necessarily require 
provision of regular psychotherapy services for all patients, for 
example for patients receiving MAT over a long period of time. In these 
cases, we note that existing coding describing care management services 
(CPT codes 99484, 99492, 99493, and 99494) and E/M services can be 
billed for treatment of substance use disorders, including OUD, so we 
do not believe that this requirement will inhibit access to OUD 
services.
    Comment: A few commenters expressed concern that the proposed G 
codes will inappropriately limit access to a variety of evidence-based, 
non-opioid pain management therapies.
    Response: We note that the proposed bundled payment codes would not 
preclude practitioners from furnishing or billing for other non-opioid 
pain management treatments.
    In summary, after consideration of the comments, we are finalizing 
HCPCS codes G2086, G2087, and G2088 with modifications to establish a 
requirement that at least one psychotherapy service must be furnished 
in order to bill for HCPCS codes G2086 or G2087. We are clarifying that 
practitioners can bill for additional psychotherapy furnished for the 
treatment of OUD using the add-on code (HCPCS code G2088) and, in cases 
where psychotherapy services furnished are furnished for co-occurring 
diagnoses, for any of the psychotherapy codes, as medically reasonable 
and necessary.
2. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers 
(FQHCs)
    In the CY 2018 PFS final rule (82 FR 53169 through 53180), we 
established payment for General Care Management (CCM) services using 
HCPCS G0511 which is an RHC and FQHC-specific G code for at least 20 
minutes of CCM, complex CCM, or general behavioral health services. 
Payment for this code is currently set at the average of the non-
facility, non-geographically adjusted payment rates for CPT codes 
99490, 99487, 99491, and 99484. The types of chronic conditions that 
are eligible for care management services include mental health or 
behavioral health conditions, including substance use disorders.
    In the CY 2018 PFS final rule with comment period (82 FR 53169 
through 53180), we also established payment for psychiatric 
Collaborative Care Services (CoCM) using HCPCS code G0512, which is an 
RHC and FQHC specific G-code for at least 70 minutes in the first 
calendar month, and at least 60 minutes in subsequent calendar months 
of psychiatric CoCM services. Payment for this code is set at the 
average of the non-facility, non-geographically adjusted rates for CPT 
codes 99492 and 99493. The psychiatric CoCM model of care may be used 
to treat patients with any behavioral health condition that is being 
treated by the billing practitioner, including substance use disorders.
    RHCs and FQHCs can also bill for individual psychotherapy services 
using CPT codes 90791, 90792, 90832, 90834, 90837, 90839, or 90845, 
which are billable visits under the RHC all-inclusive rate (AIR) and 
FQHC Prospective Payment System (PPS) when furnished by an RHC or FQHC 
practitioner. If a qualified mental health service is furnished on the 
same day as a qualified primary care service, the RHC or FQHC can bill 
for 2 visits.
    RHCs and FQHCs are engaged primarily in providing services that are 
furnished typically in a physician's office or an outpatient clinic. As 
a result of the bundled payment under the PFS for OUD treatment 
furnished by physicians, we reviewed the applicability of RHCs and 
FQHCs

[[Page 62678]]

furnishing and billing for similar services. Specifically, we 
considered establishing a new RHC and FQHC specific G code for OUD 
treatment with the payment rate set at the average of the non-facility, 
non-geographically adjusted payment rates for G2086 and G2087, 
beginning on January 1, 2020. The requirements to bill the services 
would be similar to the requirements under the PFS for G2086 and G2087, 
including that an initiating visit with a primary care practitioner 
must occur within one year before OUD services begin, and that consent 
be obtained before services are furnished.
    However, because RHCs and FQHCs that choose to furnish OUD services 
can continue to report these individual codes when treating OUD, and 
can also offer their patients comprehensive care coordination services 
using HCPCS codes G0511 and G0512, we stated that we did not believe 
that adding a new and separate code to report a bundle of OUD services 
was necessary. Therefore, we did not propose to add a new G code for a 
bundle of OUD services.
    We received public comments on our decision not to add a new G code 
for a bundle of OUD services furnished by RHCs and FQHCs. The following 
is a summary of the comments we received and our responses.
    Comment: Commenters requested that we create a new G code for RHCs 
and FQHCs to bill for a bundle of OUD services. None of these comments 
were from an RHC or FQHC or a representative of RHCs or FQHCs.
    Response: As we have noted, RHCs and FQHCs that provide OUD 
services to their patients can bill for individual psychotherapy 
services using a range of CPT codes that are billable visits under the 
RHC all-inclusive rate (AIR) and FQHC Prospective Payment System (PPS) 
when furnished by an RHC or FQHC practitioner. These codes can be 
billed on the same day as a qualified primary care visit, and RHCs and 
FQHCs can also bill for care management services and receive a payment 
in addition to their AIR or PPS payment. We did not receive any 
comments that lead us to conclude that a separate G code for RHCs and 
FQHCs to bill for OUD services is necessary, or any comments on how 
such a code would not be duplicative of existing billing mechanisms.
    After considering the comments, we are finalizing our proposal not 
to establish a separate G code for OUD payments to RHCs and FQHCs. If 
we become aware that a separate code would be beneficial to RHCs and 
FQHCs that choose to furnish these services, we will again consider 
this.

I. Physician Supervision for Physician Assistant (PA) Services

1. Background
    Section 4072(e) of the Omnibus Budget Reconciliation Act of 1986 
(Pub. L. 99-509, October 21, 1986), added section 1861(s)(2)(K)(i) of 
the Act to establish a benefit for services furnished by a physician 
assistant (PA) under the supervision of a physician. We have 
interpreted this physician supervision requirement in the regulation at 
Sec.  410.74(a)(2)(iv) to require PA services to be furnished under the 
general supervision of a physician. This general supervision 
requirement was based upon another longstanding regulation at Sec.  
410.32(b)(3)(i) that defines three levels of supervision for diagnostic 
tests, which are general, direct and personal supervision. Of these 
three supervision levels, general supervision is the most lenient. 
Specifically, the general supervision requirement means that PA 
services must be furnished under a physician's overall direction and 
control, but the physician's presence is not required during the 
performance of PA services.
    In the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we 
published a request for information (RFI) on CMS flexibilities and 
efficiencies. In response to this RFI, commenters including PA 
stakeholders informed us about recent changes in the practice of 
medicine for PAs, particularly regarding physician supervision. These 
commenters also reached out separately to CMS with their concerns. They 
stated that PAs are now practicing more autonomously, like nurse 
practitioners (NPs) and clinical nurse specialists (CNSs), as members 
of medical teams that often consist of physicians, nonphysician 
practitioners (NPPs) and other allied health professionals. This 
changed approach to the delivery of health care services involving PAs 
has resulted in changes to scope of practice laws in some states for 
PAs regarding physician supervision. According to these commenters, 
some states have already updated their requirements for PAs related to 
physician supervision, some states have made changes and are now silent 
about their physician supervision requirements, while other states have 
not yet changed their PA scope of practice in terms of their physician 
supervision requirements. Overall, these commenters believe that as 
states continue to make changes to their physician supervision 
requirements for PAs, the Medicare requirement for general supervision 
of PA services may become increasingly out of step with current medical 
practice, imposing a more stringent standard than state laws governing 
physician supervision of PA services. Furthermore, as currently 
defined, stakeholders have suggested that the supervision requirement 
is often misinterpreted or misunderstood in a manner that restricts 
PAs' ability to practice to the full extent of their education and 
expertise. The stakeholders have suggested that the current regulatory 
definition of physician supervision as it applies to PAs could 
inappropriately restrict the practice of PAs in delivering their 
professional services to the Medicare population.
    We note that we have understood our current policy to require 
general physician supervision for PA services to fulfill the statutory 
physician supervision requirement; and we believe that general 
physician supervision gives PAs flexibility to furnish their 
professional services without the need for a physician's physical 
presence or availability. Nonetheless, we appreciate the concerns 
articulated by stakeholders. To more fully understand the current 
landscape for medical practice involving PA services and how the 
current regulatory definition may be problematic, we invited public 
comments on specific examples of changes in state law and state scope 
of practice rules that enable PAs to practice more broadly such that 
those rules are in tension with the Medicare requirement for general 
physician supervision of PA services that has been in place since the 
inception of the PA benefit category under Medicare law.
    Given the commenters' understanding of ongoing changes underway to 
the state scope of practice laws regarding physician supervision of PA 
services, commenters on our CY 2018 RFI have requested that CMS 
reconsider its interpretation of the statutory requirement that PA 
services must be furnished under the supervision of a physician to 
allow PAs to operate similarly to NPs and CNSs, who are required by 
section 1861(s)(2)(K)(ii) of the Act to furnish their services ``in 
collaboration'' with a physician. In general, we have interpreted 
collaboration for this purpose at Sec. Sec.  410.75(c)(3) and 
410.76(c)(3) of our regulations to mean a process in which an NP or CNS 
(respectively) works with one or more physicians to deliver health care 
services within the scope of the practitioner's expertise, with medical 
direction and appropriate supervision as provided by state law in which 
the services are performed. The commenters stated that allowing PA 
services to be furnished using such a collaborative

[[Page 62679]]

process would offer PAs the flexibility necessary to deliver services 
more effectively under today's health care system in accordance with 
the scope of practice in the state(s) where they practice, rather than 
being limited by the system that was in place when PA services were 
first covered under Medicare Part B over 30 years ago.
2. Summary of Proposal and Final Provisions
    After considering the comments we received on the RFI, as well as 
information we received regarding the scope of practice laws in some 
states regarding supervision requirements for PAs, we proposed to 
revise the regulation at Sec.  410.74 that establishes physician 
supervision requirements for PAs. Specifically, we proposed to revise 
Sec.  410.74(a)(2) to provide that the statutory physician supervision 
requirement for PA services at section 1861(s)(2)(K)(i) of the Act 
would be met when a PA furnishes their services in accordance with 
state law and state scope of practice rules for PAs in the state in 
which the services are furnished, with medical direction and 
appropriate supervision as required by state law in which the services 
are performed. In the absence of state law governing physician 
supervision of PA services, the physician supervision required by 
Medicare for PA services would be evidenced by documentation in the 
medical record of the PA's approach to working with physicians in 
furnishing their services. Consistent with current rules, such 
documentation would need to be available to CMS, upon request. This 
change would substantially align the regulation on physician 
supervision for PA services at Sec.  410.74(a)(2) with our current 
regulations on physician collaboration for NP and CNS services at 
Sec. Sec.  410.75(c)(3) and 410.76(c)(3). We continue to engage with 
key stakeholders on this issue and receive information on the expanded 
role of NPPs as members of the medical team. As we are informed about 
transitions in state law and scope of practice governing physician 
supervision, as well as changes in the way that PAs practice, we 
acknowledge the state's role and autonomy to establish, uphold, and 
enforce their state laws and PA scope of practice requirements to 
ensure that an appropriate level of physician oversight occurs when PAs 
furnish their professional services to Medicare Part B patients. Our 
policy on this issue largely defers to state law and scope of practice 
and enables states the flexibility to develop requirements for PA 
services that are unique and appropriate for their respective state, 
allowing the states to be accountable for the safety and quality of 
health care services that PAs furnish.
    We received public comments on the proposed physician supervision 
PA services provisions. The following is a summary of the comments we 
received and our responses.
    Comment: The majority of commenters supported our proposal overall, 
to the extent that it considers state law and scope of practice rules 
for the state in which the services are furnished, to largely conform 
our interpretation of the statutory physician supervision requirement 
for PA services as interpreted under regulations at Sec.  410.74(a)(2) 
with the statutory physician collaboration requirement for NP and CNS 
services as interpreted under regulations at Sec. Sec.  410.75(c)(3) 
and 410.76(c)(3). Commenters indicated that aligning the physician 
supervision requirement for PA services with the physician 
collaboration requirement for NPs and CNSs would reduce practical 
differences in PA and NP/CNS utilization for employers, employees, 
States and even Medicare patients. They stated that deferring to state 
law and scope of practice rules for supervision of PA services will 
enable PAs to practice at the top of their education and expertise, and 
therefore, assist the State in which they practice with meeting its 
healthcare workforce needs, particularly in states that include remote 
rural and underserved areas. These commenters noted that PAs are 
authorized to provide medical and surgical care in all 50 States and 
the District of Columbia, and are committed to increasing access to 
high quality care for all, as well as continuity of care under the 
changing landscape of healthcare in the U.S. Commenters from 20 States 
provided evidence of changes in their state laws or scope of practice 
rules to move away from references to ``physician supervision'' of PAs, 
and in some cases replacing it with the term, ``physician 
collaboration'' to describe the PA-physician relationship. Commenters 
reported such changes in laws and rules for PA supervision in Arizona, 
California, Colorado, Connecticut, Florida, Idaho, Illinois, 
Massachusetts, Michigan, Missouri, Montana, Nevada, North Dakota, 
Oregon, Oklahoma, Rhode Island, South Carolina, Texas, Utah, and 
Virginia. PA commenters practicing in Kansas, Vermont and Wisconsin 
indicated that their state laws and scope of practice rules are 
currently undergoing similar changes that should be effective in 2020 
or shortly thereafter. Additionally, these commenters supported CMS' 
efforts to reduce practice burdens on PAs and to develop regulations 
for the Medicare program that closely align with the transition in 
state laws and scope of practice rules for PAs regarding physician 
supervision. These commenters also noted that the changes being made to 
state laws and scope of practice rules were recommended by the December 
2018 Federal government report on healthcare competition entitled, 
``Reforming America's Healthcare System Through Choice and 
Competition'' available at https://www.hhs.gov/sites/default/files/Reforming-Americas-Healthcare-System-Through-Choice-and-Competition.pdf. The commenters directed our attention to the specific 
recommendation in the report that states should consider eliminating 
requirements for rigid collaborative practice and supervision 
agreements that are not justified by legitimate health and safety 
concerns to ensure continuity of care for American healthcare 
consumers.
    Response: We appreciate the commenters' recognition of our efforts 
to reduce burden on PA practice given the changes in their professional 
practice since the inception of the Medicare Part B benefit category 
for PAs under Medicare law. We also appreciate the commenters' support 
of our proposal to consider state law and scope of practice rules 
governing PA supervision as an appropriate measure by which to ensure 
that the physician supervision requirement for PA services under 
Medicare statute at section 1861(s)(K)(i) of the Act is met. We 
particularly appreciate the feedback from commenters citing changes 
that have already been made to state laws and scope of practice rules 
to address evolution in PA practice. These comments are very helpful to 
inform our broader understanding of the current healthcare landscape 
for PAs, and to ensure that the statutory PA physician supervision 
requirement continues to be met.
    Comment: Many commenters who supported our proposal to the extent 
that it relates to state law and scope of practice rules for physician 
supervision of PA services disagreed with our proposal to address 
situations where states are silent about their scope of practice 
requirements for physician supervision of PA services. Specifically, 
these commenters urged us to require that, in the absence of state law 
governing physician supervision of PA services, PAs should be required 
to document at the practice level, rather than in the medical record, 
the working relationship that they have with physicians. The commenters 
expressed

[[Page 62680]]

concern that requiring PAs to document their approach in the medical 
record for every patient that they treat would be a tremendous 
administrative burden that would have a significantly adverse impact on 
the PA's ability to deliver care. A few commenters suggested that there 
should not be a requirement for PAs to document the relationship with 
any supervising or collaborating physician in every patient chart 
because such documentation is already provided as part of the practice 
protocols for PAs that are maintained by the individual State boards of 
medicine. Furthermore, some commenters recommended that, in the absence 
of state law addressing physician supervision of PA services, 
documentation at the practice of the working relationship that PAs have 
with physicians should be required to address situations where PAs deal 
with issues outside their scope of practice.
    Response: We are clarifying that it is not our intention to create 
an overly burdensome and unnecessary administrative documentation 
requirement governing PA physician supervision that results in a 
hindrance to PA practice. We believe that, in the absence of state law, 
if there is documentation at the practice which demonstrates the 
working relationship that PAs have with physicians in furnishing their 
professional services, then this would be adequate to ensure that the 
statutory requirement for PA physician supervision is met. However, we 
believe that in the absence of state law and scope of practice rules 
governing physician supervision of PAs, the relationship that PAs have 
with physicians in their practice should be required and documented at 
the practice for all services that PAs furnish, not solely for services 
outside their scope of practice.
    Comment: One commenter suggested that the PA physician supervision 
requirement and the NP and CNS physician collaboration requirement 
should be totally removed so that these health care professionals are 
not tethered to a physician in any way. This commenter further 
suggested that the removal of a physician supervision requirement would 
enable PAs to be able to bill the Medicare program directly for their 
services like NPs and CNSs, rather than having their services billed by 
their employer as they currently are.
    Response: The Medicare statute sets forth the requirements for 
physician supervision of PA services and the requirement for physician 
collaboration for NP and CNS services. As such, we do not have 
authority to remove those requirements. Additionally, our regulation at 
Sec.  410.150(b)(15), which is based on the statutory requirements of 
section 1842(b)(6)(C)(i) of the Act governing payment for PA services 
requires that a PA's employer or independent contractor must bill the 
Medicare program for PA services. Accordingly, we are not making 
changes to requirements for Medicare Part B payment for PA professional 
services in this final rule.
    Comment: Some commenters opposed the proposal overall, and 
particularly the standard CMS proposed to address the PA physician 
supervision requirement in the absence of state law and scope of 
practice rules. These commenters stressed that by just substituting 
``physician supervision'' with ``physician collaboration,'' the 
proposal fails to meet the statutory physician supervision requirement 
and instead relies on unnecessary variations in standards of care based 
on differences in state law that are inappropriate for a federal 
program. These commenters stated that the PA educational curricula are 
not tailored to developing the responsibilities of PAs to perform all 
medical services and procedures such as ordering appropriate diagnostic 
tests and performing highly technical radiology procedures without 
physician oversight and direction. They believe that physician 
involvement, either through the physical presence of a physician or 
availability via telecommunications technology, was necessary to ensure 
that optimal patient care is not compromised. Additionally, these 
commenters alluded to high-profile lawsuits against provider 
organizations in the last year involving PA documentation and billing 
policy where audits revealed documentation and signature challenges for 
electronic medical records (EMR) systems in determining whether 
physician supervision had occurred, and in distinguishing work 
furnished by a physician, PA or other supplier involved in a patient's 
care. They suggested that these same obstacles could potentially apply 
to our proposed medical record documentation standard for PAs to 
demonstrate, in the absence of state law, the relationship that they 
have with physicians when furnishing their services. Overall, these 
commenters stated that the current requirement we established in 
regulation for a general level of physician supervision to meet the 
statutory physician supervision requirement for PA services is 
appropriately consistent with state laws, and enables physicians to 
maintain the ultimate responsibility for managing patient care without 
preempting state law and scope of practice rules or inadvertently 
eliminating any physician oversight of PA services. Accordingly, these 
commenters urged CMS to maintain the current regulatory standard for 
general physician supervision of PA services as a clearer standard for 
physician supervision across-the-board for the Medicare program, and 
consistent with statutory requirements.
    Response: We appreciate the concerns that these commenters raised 
about our proposal and acknowledge that the statutory requirement for 
physician supervision of PA services remains in effect. Further, we 
believe it is appropriate for the Medicare program to recognize and 
consider the role of states in regulating medical practice and their 
autonomy to establish, uphold, and enforce their laws and PA scope of 
practice requirements that are uniquely appropriate for their 
respective states, just as we ensure that there is appropriate 
physician supervision of PA services, consistent with the requirement 
under Medicare law. Additionally, we believe that the commenters' 
concerns about obstacles for EMR systems to determine whether physician 
supervision occurred will be mitigated by our decision, as described 
above, to require in the absence of state law addressing physician 
supervision of PA services that PAs must document at the practice, 
rather than in the medical record, their relationship with physicians 
when furnishing their professional services.
    Comment: Some of the commenters who opposed our proposal to require 
that PAs must document how they handle physician supervision of their 
services in the absence of state law recommended that we remove the 
documentation standard as proposed and replace it with a standard that 
imposes a requirement that PAs work within a health care team led by a 
physician, given that they believe no state allows PAs to practice 
independently without any physician supervision or collaboration.
    Response: We appreciate this suggestion about how to ensure that 
physician supervision of PA services occurs in states that are silent 
about this requirement in their laws or scope of practice requirements 
for PA professional services. However, we disagree with the commenters' 
suggestion that, where state law or scope of practice requirements do 
not address physician supervision of PA services, we should not adopt 
the proposed requirement that PAs document their approach to working 
with physicians. We believe it is

[[Page 62681]]

important to continue to ensure that the statutory requirement for 
physician supervision of PA services is met. We also disagree with the 
commenters' suggestion that we should impose specific requirements that 
PAs must practice as part of a physician-led health care team. Based on 
information provided by other commenters, it seems clear that the way 
PAs practice is evolving, and that state laws and scope of practice 
rules are being modified to embrace that change. We believe our role 
and responsibility is to ensure continued compliance with Medicare 
statutory requirements without placing undue limitations on changes in 
PA medical practice. As such, we will recognize and consider state law 
and scope of practice rules principally to ensure that physician 
supervision occurs without mandating under our regulations that PAs 
work within a health care team led by a physician.
    Comment: Commenters posed various questions about PA services that 
are outside the scope the proposals we included in the CY 2020 PFS 
proposed rule. These comments pertained to issues such as PA 
supervision requirements for both SAMHSA-designated physicians and PAs 
when furnishing medically-assisted treatment (MAT) services to patients 
with opioid use disorder; physician supervision requirements for PAs 
when furnishing services in PA-directed rural health clinics; hospice 
physician supervision requirements for PAs and the presence of hospice 
Medical Directors; extending the same considerations for PA physician 
supervision requirements to pharmacists when furnishing their services 
incident to the professional services of physicians; and, the Medicare 
payment implications under this proposal for PA services.
    Response: We did not propose changes to the regulations regarding 
PA services other than the provision that generally addresses the 
statutory requirement for physician supervision of PA services. 
Therefore, we are not addressing these other issues in this final rule.
    After considering the public comments, we are finalizing our 
proposal on PA physician supervision, with modifications as described 
above, to require under Sec.  410.74(a)(2) the following:
     That a PA must furnish their professional services in 
accordance with state law and state scope of practice rules for PAs in 
the state in which the PA's professional services are furnished. Any 
state laws or state scope of practice rules that describe the required 
practice relationship between physicians and PAs, including explicit 
supervisory or collaborative practice requirements, describe a form of 
supervision for purposes of section 1861(s)(2)(K)(i) of the Act.
     For states with no explicit state law or scope of practice 
rules regarding physician supervision of PA services, physician 
supervision is a process in which a PA has a working relationship with 
one or more physicians to supervise the delivery of their health care 
services. Such physician supervision is evidenced by documenting at the 
practice level the PA's scope of practice and the working relationships 
the PA has with the supervising physician/s when furnishing 
professional services.

J. Review and Verification of Medical Record Documentation

1. Background
    In an effort to reduce mandatory and duplicative medical record 
evaluation and management (E/M) documentation requirements, we 
finalized an amended regulatory provision at 42 CFR part 415, subpart 
D, in the CY 2019 PFS final rule (83 FR 59653 through 59654). 
Specifically, Sec.  415.172(a) requires as a condition of payment under 
the PFS that the teaching physician (as defined in Sec.  415.152) must 
be present during certain portions of services that are furnished with 
the involvement of residents (individuals who are training in a 
graduate medical education program). Section 415.174(a) provides for an 
exception to the teaching physician presence requirements in the case 
of certain E/M services under certain conditions, but requires that the 
teaching physician must direct and review the care provided by no more 
than four residents at a time. Sections 415.172(b) and 415.174(a)(6), 
respectively require that the teaching physician's presence and 
participation in services involving residents must be documented in the 
medical record. We amended these regulations to provide that a 
physician, resident, or nurse may document in the patient's medical 
record that the teaching physician presence and participation 
requirements were met. As a result, for E/M visits furnished beginning 
January 1, 2019, the extent of the teaching physician's participation 
in services involving residents may be demonstrated by notes in the 
medical records made by a physician, resident, or nurse.
    For the same burden reduction purposes, we issued Change Request 
(CR) 10412, Transmittal 3971 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3971CP.pdf on February 2, 
2018, which revised a paragraph in our manual instructions on 
``Teaching Physician Services'' at Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 100.1.1B., to reduce duplicative 
documentation requirements by allowing a teaching physician to review 
and verify (sign/date) notes made by a student in a patient's medical 
record for E/M services, rather than having to re-document the 
information, largely duplicating the student's notes. We issued 
corrections to CR 10412 through Transmittal 4068 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4068CP.pdf and re-issued the CR on May 31, 2018. Pub. 100-04, Medicare 
Claims Processing Manual, Chapter 12, Section 100 contains a list of 
definitions pertinent to teaching physician services.
    Following these amendments to our regulations and manual, certain 
stakeholders raised concerns about the definitions in this section, 
particularly those for teaching physician, student, and documentation; 
and when considered in conjunction with the interpretation of the 
manual provision at Pub. 100-04, Medicare Claims Processing Manual, 
Chapter 12, Section 100.1.1B., which addresses documentation of E/M 
services involving students. While there is no regulatory definition of 
student, the manual instruction defines a student as an individual who 
participates in an accredited educational program (for example, a 
medical school) that is not an approved graduate medical education 
(GME) program. The manual instructions also specify that a student is 
never considered to be an intern or a resident, and that Medicare does 
not pay for services furnished by a student (see Section 100.1.1B. for 
a discussion concerning E/M service documentation performed by 
students).
    As stated in the CY 2020 PFS proposed rule, we are aware that 
nonphysician practitioners (NPPs) who are authorized under Medicare 
Part B to furnish and be paid for all levels of E/M services are 
seeking similar relief from burdensome E/M documentation requirements 
that would allow them to review and verify medical record notes made by 
their students, rather than having to re-document the information. 
These NPPs include nurse practitioners (NPs), clinical nurse 
specialists (CNSs), and certified nurse-midwives (CNMs), collectively 
referred to hereafter for purposes of this discussion as advanced 
practice registered nurses (APRNs), as well as physician assistants 
(PAs). Subsequent to the publication of the CY

[[Page 62682]]

2019 PFS final rule (83 FR 59653 through 59654), through feedback from 
listening sessions hosted by CMS' Documentation Requirements 
Simplification workgroup, we began to hear concerns from a variety of 
stakeholders about the requirements for teaching physician review and 
verification of documentation added to the medical record by other 
individuals. Physician and NPP stakeholders expressed concern about the 
scope of the changes to Sec. Sec.  415.172(b) and 415.174(a)(6) which 
authorize only a physician, resident, or nurse to include notes in the 
medical record to document E/M services furnished by teaching 
physicians, because they believed that students and other members of 
the medical team should be similarly permitted to provide E/M medical 
record documentation. In addition to students, these stakeholders 
indicated that ``other members of the medical team'' could include 
individuals who the teaching physician, other physicians, PA and APRN 
preceptors designate as being appropriate to document services in the 
medical record, which the billing practitioner would then review and 
verify, and rely upon for billing purposes.
    Subsequent to the publication of the student documentation manual 
instruction change at section 100.1.1B of the Medicare Claims 
Processing Manual, representatives of PAs and APRNs requested 
clarification about whether PA and APRN preceptors and their students 
were subject to the same E/M documentation requirements as teaching 
physicians and their medical students. These stakeholders suggested 
that the reference to ``student'' in the manual instruction on E/M 
documentation provided by students is ambiguous because it does not 
specify ``medical student''. These stakeholders also suggested that the 
definition of ``student'' in section 100 of this manual instruction is 
ambiguous because PA and APRN preceptors also educate students who are 
individuals who participate in an accredited educational program that 
is not an approved GME program. Accordingly, these stakeholders 
expressed concern that the uncertainty throughout the health care 
industry, including among our contractors, concerning the student E/M 
documentation review and verification policy under these manual 
guidelines results in unequal treatment as compared to teaching 
physicians. The stakeholders stated that depending on how the manual 
instruction is interpreted, PA and APRN preceptors may be required to 
re-document E/M services in full when their students include notes in 
the medical records, without having the same option that teaching 
physicians do to simply review and verify medical student 
documentation.
2. Proposed Provisions and Summaries of and Responses to Public 
Comments
    After considering the concerns expressed by these stakeholders, we 
noted in the CY 2020 PFS proposed rule that we believe it would be 
appropriate to provide broad flexibility to the physicians, PAs and 
APRNs (regardless of whether they are acting in a teaching capacity) 
who document and who are paid under the PFS for their professional 
services. Therefore, we proposed to establish a general principle to 
allow the physician, the PA, or the APRN who furnishes and bills for 
their professional services to review and verify, rather than re-
document, information included in the medical record by physicians, 
residents, nurses, students or other members of the medical team. We 
explained that this principle would apply across the spectrum of all 
Medicare-covered services paid under the PFS. We noted that because the 
proposal is intended to apply broadly, we proposed to amend regulations 
for teaching physicians, physicians, PAs, and APRNs to add this new 
flexibility for medical record documentation requirements for 
professional services furnished by physicians, PAs and APRNs in all 
settings.
    Specifically, to reflect our simplified and standardized approach 
to medical record documentation for all professional services furnished 
by physicians, PAs and APRNs paid under the PFS, we proposed to amend 
Sec. Sec.  410.20 (Physicians' services), 410.74 (PA services), 410.75 
(NP services), 410.76 (CNS services) and 410.77 (CNM services) to add a 
new paragraph entitled, ``Medical record documentation.'' We noted that 
this paragraph would specify that, when furnishing their professional 
services, the clinician may review and verify (sign/date) notes in a 
patient's medical record made by other physicians, residents, nurses, 
students, or other members of the medical team, including notes 
documenting the practitioner's presence and participation in the 
services, rather than fully re-documenting the information. We also 
noted that, while the proposed change addresses who may document 
services in the medical record, subject to review and verification by 
the furnishing and billing clinician, it would not modify the scope of, 
or standards for, the documentation that is needed in the medical 
record to demonstrate medical necessity of services, or otherwise for 
purposes of appropriate medical recordkeeping.
    We also proposed to make conforming amendments to Sec. Sec.  
415.172(b) and 415.174(a)(6) to also allow physicians, residents, 
nurses, students, or other members of the medical team to enter 
information in the medical record that can then be reviewed and 
verified by a teaching physician without the need for re-documentation.
    We received public comments on the proposed Review and Verification 
of Medical Record Documentation provisions. The following is a summary 
of the comments we received and our responses.
    Comment: Many commenters supported the premise for this 
documentation proposal which they stated almost unanimously would 
relieve burdensome documentation requirements for PAs, NP, CNSs, and 
CNMs who are authorized providers under Medicare Part B in that it 
would minimize ``note bloat'' and clinician burnout, and would allow 
clinicians to focus their limited time instead on patient care. The 
commenters stated that enabling physicians other than teaching 
physicians, PAs and APRNs who furnish and bill for their professional 
services to review and verify, rather than re-document information 
included in the medical record by physicians, residents, nurses, 
students or other members of the medical team is forward-thinking, 
reflective of the professional healthcare setting and, it eliminates 
disparities in clinical training opportunities so that a student's 
experience ranks more than shadowing. The commenters noted that 
recognizing PA and APRN preceptors in the same manner as teaching 
physicians regarding student medical record documentation would advance 
access to quality care for Medicare beneficiaries particularly in rural 
and underserved areas by granting clinical training opportunities to PA 
and APRN students. Additionally, these commenters expressed support for 
this documentation proposal because they believed it would remove the 
disparity in burden reduction between physicians and clinicians such as 
PAs and APRNs and, instead would lead to parity for all suppliers of 
Medicare services paid under the PFS. The commenters also noted that 
another advantage of these documentation requirements is that they will 
lead to electronic health records (EHRs) being less cluttered with 
repetitive notes of little additional clinical use, making more 
meaningful

[[Page 62683]]

information easier for physicians and clinicians to identify while 
offering greater certainty to medical team members and Medicare 
Administrative Contractors (MACs) alike.
    Response: We appreciate the insight provided by commenters about 
how the broad flexibility under our proposal would enhance the clinical 
training opportunities and experience for other physicians, PAs, APRNs 
and their students while still maintaining the integrity of the 
information documented in the medical record as it is reviewed and 
verified by the billing practitioner.
    Comment: A commenter supported the merit of the broad flexibility 
provided under the medical record documentation proposal and suggested 
that we could improve our proposal by including certified registered 
nurse anesthetists (CRNAs) and their students under this proposal 
because CRNAs are also included under the nursing industry's ``APRN'' 
umbrella. The commenter pointed out that the proposal currently 
includes NPs, CNSs and CNMs, which are three out of the four categories 
of APRNs. However, this commenter stated that CRNAs should also be 
included under this proposal, because not only are CRNAs considered 
APRNs, they are also authorized by Medicare to furnish and bill for E/M 
services and all medically necessary services within their state scope 
of practice. CRNAs regularly complete comprehensive E/M documentation 
for patients, which is also well within their scope of practice. 
Accordingly, the commenter believed that since this criterion was a 
factor in proposing the medical record documentation policy for PAs, 
NPs, CNSs and CNMs, CRNAs should be included under this policy.
    Response: We appreciate the commenter bringing to our attention 
that CRNAs are another type of clinical nurse that the nursing industry 
recognizes as an APRN, and that the commenter believed should be 
included under this medical record documentation proposal. The 
regulations at Sec.  410.69 interpret the statutory CRNA benefit 
category at section 1861(bb)(1) of the Act to authorize Medicare Part B 
payment to CRNAs for anesthesia services and related care that CRNAs 
are legally authorized to perform by the state in which the services 
are furnished. We also acknowledge that some states license CRNAs to 
furnish E/M services as part of the ``related care'' services 
authorized under their Medicare Part B benefit category. Upon further 
reflection, we agree that it is appropriate to include CRNAs and their 
students, as well as other members of their health care team, for 
purposes of the medical record documentation proposal.
    Comment: Several commenters suggested that CMS specifically name 
the types of students that it intends to include as those who are 
eligible to make notes in the medical record documentation in order to 
avoid unnecessary confusion by obscuring the intended scope of students 
as ``other members of the medical team.'' These commenters stated that 
explicitly naming the types of clinicians and students for which the 
documentation they add can be reviewed and verified by the billing 
professional would eliminate misinterpretation on the part of health 
systems, care providers, and educators, and would improve both clinical 
training opportunities and, ultimately, patient care.
    Response: We acknowledge that uncertainty in the healthcare 
industry and for MACs about the specific types of students who were 
allowed to make notes in the medical record which teaching physicians 
could review and verify without re-documenting was a factor we 
considered in proposing to revise the documentation requirements in the 
CY 2020 PFS proposed rule. We find the comment to be persuasive 
regarding the need for us to be more explicit regarding the flexibility 
we intend to establish for other physicians, PAs and APRNs and their 
students. Given that the initial impetus for our proposal was to 
address potential confusion about our reference in a manual provision 
to ``students,'' we would not want to generate any further potential 
for confusion with this policy. In making our proposal, we referred not 
only to medical students, but more broadly to students in the 
disciplines of the clinicians who are authorized to bill the Medicare 
program for a broad spectrum of health care services, including all 
level E/M services. We agree with the commenters that it is important 
to be clear about the scope of this policy and, therefore, we will 
modify our proposal to explicitly list the types of students for which 
the medical records documentation policy applies rather than using a 
generic reference to ``students.'' Therefore, at Sec. Sec.  410.20, 
410.69, 410.74, 410.75, 410.76 and 410.77, we will modify our proposed 
amendments to the regulation to specify the types of students who may 
make notes in the medical record that may then be reviewed and 
verified, rather than re-documented, by the billing clinician.
    Comment: Several commenters suggested that CMS specify that 
physicians, PAs, and APRNs may sign off on only those notes in the 
medical record made by someone of their same provider type or 
discipline. For example, a PA may only review and verify information 
included in a patient's chart by another PA or PA student. One of these 
commenters stated that CMS should withhold any documentation 
requirement changes until the agency establishes guidelines in future 
rulemaking that clarify the circumstances under which a clinician would 
be permitted to review and verify medical record documentation. 
Conversely, a few of these same commenters questioned the proposal and 
stated that it is unclear whether a PA or APRN can sign off on any 
resident or student documentation regardless of their credential level. 
For example, a PA would be able to attest and bill for work that was 
performed by a senior resident who is training to become a medical 
doctor. A few of these commenters warned that scope of practice laws 
may impose documentation requirements that lead to physicians and 
clinicians only reviewing documentation of their own student types and 
not that of other disciplines. Furthermore, the commenters stated that 
the teaching physician services requirements do not permit PAs and 
APRNs to formally act as teaching physicians.
    Response: We did not propose any limitations that would restrict a 
billing professional to only reviewing and verifying documentation in 
the medical record entered by health care team members practicing or 
training within their same specialty or discipline. We believe that 
this type of limitation on our proposal would defeat our intended 
purpose to provide broad flexibility, establishing a generalized 
principle for medical record documentation for all professional 
services paid under the Medicare PFS in all settings. Therefore, we 
disagree with the commenters' recommendation, and are not finalizing 
restrictions on the scope of medical record documentation entered by 
members of the medical team that can be reviewed and verified by the 
billing professional. Additionally, our documentation proposal does not 
address any applicable billing or payment requirements for the work or 
services that others furnish in connection with the professional 
services that are billed by teaching physicians, other physicians, PAs 
or APRNs. Rather, our proposal is limited to addressing who is 
authorized, for purposes of the Medicare program, to review and verify 
documentation in the medical record entered by certain individuals, 
without having to re-document the information.

[[Page 62684]]

    Comment: Similarly, several commenters representing physicians 
supported making the proposed changes to medical record documentation 
requirements for physicians only, and not for PAs and APRNs. They 
stated that only physicians submitting a claim for services are 
responsible and appropriately trained to review and verify 
documentation in the medical record provided by physicians, residents, 
nurses, students, or other members of the medical team across the 
spectrum of all Medicare-covered services paid under the PFS. They 
maintained that safeguards must be in place to ensure the medical 
record includes accurate documentation of clinical findings, 
treatments, and ongoing care plans by all members of the medical team.
    Response: We note that the billing professional, in submitting a 
claim to Medicare for services paid under the PFS, is responsible for 
the accuracy of the information included on that claim. While we 
appreciate the perspective of these commenters, stakeholders and other 
commenters have made it clear to us that the role of PAs and APRNs has 
changed to the point that our current regulations present an unintended 
burden for billing practitioners, unnecessarily requiring them to re-
document information entered into the medical record by physicians, 
residents, nurses, students, and other members of the medical team when 
it would be sufficient for them to simply review and verify it. 
Therefore, we are not establishing a requirement in this final rule 
that only a billing physician may review and verify documentation in 
the medical record added by physicians, residents, nurses, students, 
and other members of the medical team.
    Comment: Commenters requested clarification about whether multiple 
students and residents can enter documentation into the medical record 
on the same day and during the same office visit. One commenter stated 
that, currently, MACs or auditing agencies will deny PA or APRN 
services when furnished on the same day as a service billed by a 
physician regardless of the physician's specialty.
    Response: We appreciate the information and suggestion provided by 
these commenters. We did not propose a limitation on how many members 
of the medical team can enter information in the medical record for a 
given date of service or patient encounter, and do not believe such a 
limitation is warranted. We did not address the scope of services that 
can be billed for a patient on the same date of service. Therefore, 
this aspect of the comment is outside the scope of the proposed rule 
and we will not address it in this final rule.
    Comment: Several commenters encouraged CMS to re-examine the 
current requirements regarding documentation of the billing 
practitioner's physical presence and participation in certain E/M 
services and procedures. The commenters stated that this physical 
presence and participation requirement results in significant burden 
for teaching physicians and PA and APRN preceptors when their students 
are participating in patient care. These commenters stated that while 
physical presence and participation of physicians and practitioners in 
the clinic is critical for safe patient care, presence in the 
examination room during documentation is onerous and unnecessary. The 
commenters also noted that this requirement greatly diminishes the 
learning experience for students, as they do not develop the ability to 
think or operate independently, formulate diagnoses, and generate 
treatment plans, producing less experienced graduate clinicians who are 
not as prepared as they could be to provide care on their own.
    Response: We did not propose any changes to requirements pertaining 
to the documentation of physical presence and participation for certain 
E/M services and procedures at Sec. Sec.  415.172 and 415.174, and we 
are not addressing these requirements in this final rule.
    Comment: A commenter questioned whether this proposal recognizes 
``scribes'' other than a medical assistant or a registered nurse for 
purposes of entering notes in a patient's medical record. The commenter 
defined a scribe as an independent individual assisting a single care 
provider, and expressed concern that utilizing clinical support staff 
as a scribe to document services will lead to dissatisfaction of 
employees and loss of clinical support staff, which would adversely 
affect the shortage in clinical support staff that already exists. 
Likewise, a commenter suggested that CMS should explicitly include 
dieticians and nutritionists among the other members of the medical 
team who are eligible to enter notes in the medical record.
    Response: We proposed broad flexibility for teaching physicians, 
other physicians, PAs and APRNs to use their discretion in identifying, 
for each particular case, the individuals who are serving as members of 
the medical team, potentially including scribes, dieticians, 
nutritionists, or other members of their medical team. Although we are 
modifying our proposal to clarify the scope of students that may be 
considered members of the medical team for purposes of this 
documentation policy as explained above, we intentionally did not 
propose to specify who can be included as a member of the medical team.
    Comment: One commenter questioned whether their assumption is 
correct that this proposal applies to all types of services (that is, 
procedures, E/M services, and diagnostic services).
    Response: The commenter's assumption is accurate; our proposed 
medical record documentation policy would apply broadly to all services 
of physicians, PAs and APRNs, regardless of the type of service (E/M, 
procedure, diagnostic test) or the setting in which the service is 
furnished.
    Comment: We received a number of comments that were outside the 
scope of the CY 2020 PFS proposed rule.
    Response: We appreciate and will consider these comments for other 
purposes including possible future rulemaking.
    After considering the comments, we are finalizing our proposal with 
a couple of modifications. We are explicitly naming PA and NP, CNS, CNM 
and CRNA students as APRN students, along with medical students, as the 
types of students who may document notes in a patient's medical record 
that may be reviewed and verified rather than re-documented by the 
billing professional; and revising Sec. Sec.  410.20, 410.69, 410.74, 
410.75, 410.76, 410.77, 415.172 and 415.174 to reflect this change. 
Additionally, similar to the revisions we are making to the regulations 
at Sec. Sec.  410.20, 410.69, 410.74, 410.75, 410.76, 410.77, 415.172 
and 415.174, we are amending our regulation at Sec.  410.69 to add a 
new paragraph (5) under the definition of CRNA to include CRNAs as a 
category of APRNs for purposes of this policy, and to include CRNA 
students under the reference to APRN students.

K. Care Management Services

1. Background
    In recent years, we have updated PFS payment policies to improve 
payment for care management and care 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 
distinguish between services that are face-to-face; represent a single 
encounter, monthly service or both; are timed services; represent 
primary care versus specialty care; address specific conditions; and 
represent the work of the billing

[[Page 62685]]

practitioner, their clinical staff, or both (see Table 19). Additional 
information regarding recent new codes and associated PFS payment rules 
is available on our website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
[GRAPHIC] [TIFF OMITTED] TR15NO19.026

    Based on our review of the Medicare claims data we estimate that 
approximately 3 million unique beneficiaries (9 percent of the Medicare 
fee-for-service (FFS) population) receive these services annually, with 
higher use of chronic care management (CCM), transitional care 
management (TCM), and advance care planning (ACP) services. We believe 
gaps remain in coding and payment, such as for care management of 
patients having a single, serious, or complex chronic condition. In 
this final rule, we continue our ongoing work in this area through code 
set refinement related to TCM services and CCM services, in addition to 
new coding for principal care management (PCM) services, and addressing 
chronic care remote physiologic monitoring (RPM) services.
2. Transitional Care Management (TCM) Services
    Utilization of TCM services has increased each year since CMS 
established coding and began paying separately for TCM services. There 
were almost 300,000 TCM professional claims during 2013, the first year 
of TCM services, and almost 1.3 million professional claims during 
2018, the most recent year of complete claims data. However, a recent 
analysis of TCM claims data by Bindman and Cox \81\ found that use of 
TCM services is low when compared to the number of Medicare 
beneficiaries with eligible discharges. Bindman and Cox noted that the 
beneficiaries who received TCM services demonstrated reduced 
readmission rates, lower mortality, and decreased health care costs. 
Based upon these findings, we believe that increasing utilization of 
medically necessary TCM services could positively affect patient 
outcomes.
---------------------------------------------------------------------------

    \81\ Bindman, AB, Cox DF. Changes in health care costs and 
mortality associated with transitional care management services 
after a discharge among Medicare beneficiaries [published online 
July 30, 2018]. JAMA Intern Med, doi:10.1001/
jamainternmed.2018.2572.
---------------------------------------------------------------------------

    In developing the proposal designed to increase utilization of TCM 
services, we considered factors that could contribute to low 
utilization. Bindman and Cox identified two likely contributing 
factors: The administrative burdens associated with billing TCM 
services and the payment amount to physicians for furnishing these 
services.
    We focused initially on the requirements for billing TCM services. 
In reviewing TCM billing requirements, we noted that we had established 
in the CY 2013 PFS final rule with comment period a list of 57 HCPCS 
codes that could not be billed during the 30-day period covered by TCM 
services by the same practitioner reporting TCM (77 FR 68990). This 
list mirrored reporting restrictions put in place by the CPT Editorial 
Panel for the TCM codes. At the time we established separate payment 
for the TCM CPT codes, we agreed with the CPT Editorial Panel that the 
services described by the 57 codes could be overlapping and duplicative 
with TCM in their definition and scope. Additionally, many of the codes 
were not separately payable or covered under the PFS so even if they 
had been reported for PFS payment, they would not have been paid 
separately (see, for example, 77 FR 68985).

[[Page 62686]]

    In response to those initial concerns, we adopted billing 
restrictions to avoid duplicative billing and payment for covered 
services. In our recent analysis of the services associated with the 57 
codes, we found that the majority of codes on the list are either 
bundled, noncovered by Medicare, or invalid for Medicare payment 
purposes. Table 20 provides detailed information regarding the subset 
of these codes that would be separately payable under the PFS (Status 
Indicator ``A'') and, as such, are the focus of CY 2020 policy for TCM. 
Fourteen (14) codes on the list represent active codes that are paid 
separately under the PFS and that upon reconsideration, we believe do 
not substantially overlap with TCM services and should be separately 
payable alongside medically necessary TCM. For example, CPT code 99358 
(Prolonged E/M service before and/or after direct patient care; first 
hour; non-face-to-face time spent by a physician or other qualified 
health care professional on a given date providing prolonged service) 
would allow the physician or other qualified healthcare professional 
extra time to review records and manage patient support services after 
the face-to-face visit required as part of TCM services.
    After review of the services described by the 14 HCPCS codes, we 
determined that the 14 codes, when medically necessary, may complement 
TCM services rather than substantially overlap or duplicate services. 
We also believed removing the billing restrictions associated with the 
14 codes might increase use of TCM services.
[GRAPHIC] [TIFF OMITTED] TR15NO19.027

    Thus, with the goal of increasing medically appropriate use of TCM 
services, we proposed to revise our billing requirements for TCM by 
allowing TCM codes to be billed concurrently with any of these 14 
codes. In the proposed rule, we solicited comment on four questions 
related to current billing policies. They included:
     Does overlap of services exist, and if so, which services 
should be

[[Page 62687]]

restricted from being billed concurrently with TCM?
     Does overlap depend upon whether the same or a different 
practitioner reports the services; we note that CPT reporting rules 
generally apply at the practitioner level?
     Should our policy differ based upon whether the same or 
different practitioner reports the services?
     Does the newest CPT code in the chronic care management 
services family (CPT code 99491 for CCM by a physician or other 
qualified health professional, established in 2019) overlap with TCM or 
should it be reportable and separately payable in the same service 
period?
    The second part of our analysis examined how current payment rates 
for TCM might negatively affect the appropriate utilization of TCM 
services, an idea proposed by Bindman and Cox. Although we sought 
comment previously about factors affecting utilization of CCM and TCM 
services, we received too few comments related specifically to TCM to 
know if payment affected use of the service.
    As part of a regular RUC review of new technologies or services 
during 2018, 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) and 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) were 
resurveyed. For this RUC resurvey, several years of claims data were 
available and clinicians had more experience to inform their views 
about the work required to furnish TCM services. Based upon the results 
of the 2018 RUC survey of the TCM codes, the RUC recommended a slight 
increase in work RVUs for both codes. We believe the results from the 
new survey better reflect the work involved in furnishing TCM services 
as care management services. Thus, also for CY 2020, we proposed the 
RUC-recommended work RVU of 2.36 for CPT code 99495 and the RUC-
recommended work RVU of 3.10 for CPT code 99496. We did not propose any 
PE refinements to the TCM codes.
    We received public comments to our proposed policies and questions. 
The following is a summary of the comments we received.
    Comment: With regard to the questions about billing requirements, 
most commenters wrote in support of our proposal to remove billing 
restrictions associated with the 14 codes that, at present, cannot be 
billed concurrently with TCM. A few commenters indicated that overlap, 
if it does exist, is minimal. Some commenters cautioned that our 
suggested change to billing might cause increased confusion for payers 
other than Medicare and suggested that CMS instead work with the CPT 
Editorial Panel to review and possibly revise the restrictions. In 
response to our questions about overlap in services, commenters 
reported that overlap is not dependent upon whether the same or a 
different practitioner reports the services. Commenters added that 
policy should not be based upon what practitioner reports the services. 
Finally, commenters expressed support for allowing CPT code 99491 
(Chronic care management services, provided personally by a physician 
or other qualified healthcare professional, at least 30 minutes of 
professional time per calendar month) to be reportable and separately 
payable in the same service period as TCM.
    Response: We thank the many commenters for their comments regarding 
ways to increase utilization of TCM services. Our goal in proposing to 
remove the current billing restrictions was to increase appropriate 
utilization of TCM services, particularly in light of the potential 
benefits noted by Bindman and Cox. Since publication of the CY 2020 PFS 
proposed rule, we have identified two chronic care management codes, 
CPT codes 99490 and 99491 that are not listed in the TCM section of the 
CPT manual as being restricted from concurrent billing. However, in the 
care management section of the 2019 CPT Manual, prefatory language 
indicates that neither CPT code 99495 nor 99496 (see, page 50) can be 
billed during the same month as CPT code 99490. Given our proposal to 
remove current billing restrictions, we believe that both CPT codes 
99490 and the new 99491 should be added to the list of care management 
codes that can be billed concurrently with TCM when relevant and 
medically necessary.
    We continue to believe that revising the billing requirements and 
allowing TCM codes to be billed concurrently with codes currently 
restricted will help to achieve our goal and may result in other payers 
implementing similar changes. Additionally, this change may lead the 
CPT Editorial Panel to consider revising the current prohibitions on 
billing TCM with certain codes.
    Comment: Commenters uniformly recommended that CMS finalize the 
increased valuations for the two TCM codes. Commenters expressed 
support for the agency's goal of increasing utilization of medically 
necessary TCM services given the potential benefits the services 
provide to patients as noted by Bindman and Cox.
    Response: We believe that adopting the RUC-recommended increase in 
valuation of the work RVUs will support our goal of increasing 
medically necessary TCM services.
    After considering public comments on our questions and proposals, 
and in light of our goal of increasing utilization of TCM services, we 
are finalizing our proposal to allow concurrent billing of the care 
management codes currently restricted from being billed with TCM. This 
includes allowing concurrent billing of TCM with the 14 codes specified 
in Table 20, as well as CPT codes 99490 and 99491, which we have 
identified as codes that also fit this policy. We are finalizing for 
both TCM codes the proposed increases in work RVUs and the RUC-
recommended direct PE inputs. We look forward to working with the 
public and other stakeholders to potentially further refine our billing 
policies through future notice and comment rulemaking.
3. Chronic Care Management (CCM) Services
    CCM services are comprehensive care coordination services per 
calendar month, furnished by a physician or nonphysician practitioner 
(NPP) managing overall care and their clinical staff, for patients with 
two or more serious chronic conditions. There are currently two general 
subsets of codes: One for non-complex chronic care management (starting 
in 2015, with a new code for 2019) and a set of codes for complex 
chronic care management (starting in 2017). Tables 21 and 22 list the 
applicable current codes (abbreviated) and provide a high-level summary 
of the CCM service elements. We refer readers to the following website 
for more comprehensive information regarding the CCM codes and the 
existing requirements for billing them to the PFS, available on our 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.

[[Page 62688]]

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[GRAPHIC] [TIFF OMITTED] TR15NO19.029

    Early data show that, in general, CCM services are increasing 
patient and practitioner satisfaction, saving costs and enabling solo 
practitioners to remain in independent practice.\82\ Utilization has 
reached approximately 75 percent of the level we initially assumed 
under the PFS when we began paying for CCM services separately under 
the PFS. While these are positive results, we believe that CCM services 
(especially complex CCM services) continue to be underutilized. In 
addition, we note that, at the February 2019 CPT Editorial Panel 
meeting, certain specialty associations requested refinements to the 
existing CCM codes, and consideration of their proposal was postponed. 
Also, we have heard from some stakeholders suggesting that the time 
increments for non-complex CCM performed by clinical staff should be 
changed to recognize finer increments of time, and that certain 
requirements related to care planning are unclear. Based on our 
consideration of this ongoing feedback, we believe some of the 
refinements requested by specialty associations and other stakeholders 
may be necessary to improve payment accuracy, reduce unnecessary burden

[[Page 62689]]

and help ensure that beneficiaries who need CCM services have access to 
them. Accordingly, we proposed the following changes to the CCM code 
set for CY 2020.
---------------------------------------------------------------------------

    \82\ https://innovation.cms.gov/Files/reports/chronic-care-mngmt-finalevalrpt.pdf.
---------------------------------------------------------------------------

a. Non-Complex CCM Services by Clinical Staff (CPT Code 99490, HCPCS 
Codes GCCC1 and GCCC2)
    Currently, the clinical staff CPT code for non-complex CCM, CPT 
code 99490 (Chronic care management services, at least 20 minutes of 
clinical staff time directed by a physician or other qualified health 
care professional, per calendar month, with the following required 
elements: Multiple (two or more) chronic conditions expected to last at 
least 12 months, or until the death of the patient; chronic conditions 
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; comprehensive care plan 
established, implemented, revised, or monitored.) describes 20 or more 
minutes of clinical staff time spent performing chronic care management 
activities under the direction of a physician/qualified health care 
professional (QHP). When we initially adopted this code for payment 
and, in feedback we have since received, a number of stakeholders 
suggested that CMS undervalued the PE RVU because we assumed that the 
minimum time for the code (20 minutes of clinical staff time) would be 
typical (see, for example, 79 FR 67717 through 67718). In the CY 2017 
PFS final rule with comment period, we continued to consider whether 
the payment amount for CPT code 99490 is appropriate, given the amount 
of time typically spent furnishing CCM services (81 FR 80243 through 
80244). We adopted the complex CCM codes for payment beginning in CY 
2017, in part, to pay more appropriately for services furnished to 
beneficiaries requiring longer service times (see below). Some 
stakeholders continue to recommend that we should create an add-on code 
for non-complex CCM performed by clinical staff, such that these 
services would be defined and valued in 20-minute increments of time 
with additional payment for each additional 20 minutes of clinical 
staff time spent performing care management activities.
    We agreed that coding changes that identify additional time 
increments may improve payment accuracy for non-complex CCM. 
Accordingly, we proposed to adopt two new G codes with new increments 
of clinical staff time instead of the existing single CPT code (CPT 
code 99490). The first G code would have described the initial 20 
minutes of clinical staff time, and the second G code would have 
described each additional 20 minutes thereafter. We intended these 
would be temporary G codes, to be used for PFS payment instead of CPT 
code 99490 until the CPT Editorial Panel can consider revisions to the 
current CPT code set. We said we would consider adopting any CPT 
code(s) once the CPT Editorial Panel completes its work. We 
acknowledged that imposing a transitional period during which G codes 
would be used under the PFS in lieu of the CPT codes is potentially 
disruptive, and solicited comment on whether the benefit of proceeding 
with the proposed G codes outweighs the burden of transitioning to 
their use in the intervening year(s) before a decision by the CPT 
Editorial Panel.
    We proposed that the base code would be HCPCS code GCCC1 (Chronic 
care management services, initial 20 minutes of clinical staff time 
directed by a physician or other qualified health care professional, 
per calendar month, with the following required elements: multiple (two 
or more) chronic conditions expected to last at least 12 months, or 
until the death of the patient; chronic conditions place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline; and comprehensive care plan established, 
implemented, revised, or monitored. (Chronic care management services 
of less than 20 minutes duration, in a calendar month, are not reported 
separately)). We proposed a work RVU of 0.61 for HCPCS code GCCC1, 
which we crosswalked from CPT code 99490. We believed these codes would 
have a similar amount of work since they would have the same intra-
service time of 15 minutes.
    We proposed an add-on HCPCS code GCCC2 (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). (Use 
GCCC2 in conjunction with GCCC1). (Do not report GCCC1, GCCC2 in the 
same calendar month as GCCC3, GCCC4, 99491)). We proposed a work RVU of 
0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107 
(Incisional biopsy of skin (e.g., wedge) (including simple closure, 
when performed); each separate/additional lesion (List separately in 
addition to code for primary procedure)), which has a work RVU of 0.54, 
which we believed would accurately reflect the work associated with 
each additional 20 minutes of CCM services. Both codes would have the 
same intraservice time of 15 minutes. We noted that the nature of the 
PFS relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, 
codes need not share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk. In this case, 
we believed CPT code 11107 shared a similar work intensity to proposed 
HCPCS code GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2 
would share the same intraservice time, add-on codes may have lower 
intensity than the base codes because they describe the continuation of 
an already initiated service.
    We solicited public comment on whether we should limit the number 
of times HCPCS code GCCC2 could be reported in a given service period 
for a given beneficiary. It was not clear how often more than 40 
minutes of clinical staff time is currently spent or is medically 
necessary. In addition, once 60 minutes of clinical staff time is 
spent, many or most patients might also require complex medical 
decision-making, and such patients would already be described under 
existing coding for complex CCM. We believed a limit (such as allowing 
the add-on code to be reported only once per service period per 
beneficiary) may be appropriate in order to maintain distinctions 
between complex and non-complex CCM, as well as appropriately limit 
beneficiary cost sharing and program spending to medically necessary 
services. We noted that complex CCM already describes (in part) 60 or 
more minutes of clinical staff time in a service period. We solicited 
comment on whether and how often beneficiaries who do not require 
complex CCM (for example, do not require the complex medical decision 
making that is part of complex CCM) would need 60 or more minutes of 
non-complex CCM clinical staff time and thereby warrant more than one 
use of HCPCS code GCCC2 within a service period.
    Comment: Several commenters supported the proposed add-on HCPCS 
code GCCC2, and recommended that there be a limit on its use 
(frequency) to keep non-complex CCM distinct from complex CCM. These 
commenters stated that patients requiring multiple uses of the add-on 
service likely require the moderate to high medical decision making of 
complex CCM. Other commenters stated that, while they have patients who 
do not require the complex

[[Page 62690]]

medical decision making that is part of complex CCM, care management 
for these patients is time-consuming and would require 60 or more 
minutes of non-complex CCM clinical staff time within a service period. 
These commenters suggested that limiting the frequency of reporting 
HCPCS code GCCC2 to twice during a service period allows for accurate 
payments, while preventing inappropriate use of the code. The Medicare 
Payment Advisory Commission (MedPAC) expressed support for the proposed 
add-on code for non-complex CCM because it would better reflect the 
resources involved in furnishing care management services and increase 
payment accuracy for CCM. Other commenters stated that G codes would 
help to facilitate earlier implementation and would ease transition to 
any updates made to CPT codes.
    However, a number of commenters were not supportive of the 
introduction of temporary G codes within the CCM code set, believing it 
would produce administrative burden and cause confusion. These 
commenters stated that in September 2019 the CPT Editorial Panel was 
considering an application for similar changes to refine the code set. 
These commenters urged us to work with the CPT Editorial Panel 
regarding changes to the CCM code set and its revaluation. A few 
commenters suggested that CMS could achieve its burden reduction goals 
by continuing to recognize CPT codes 99490, 99487, and 99489 and also 
provide CMS-specific guidance for those codes for purposes of billing 
Medicare.
    Response: We are not finalizing our proposal to create HCPCS codes 
GCCC1 (or GCCC3 or GCCC4, see below) in consideration of commenters' 
concerns that the introduction of temporary G codes replacing most of 
the CCM code set would create administrative burden, especially in 
light of the CPT Editorial Panel's currently ongoing work in this area. 
However we are finalizing GCCC2 (the add-on for non-complex CCM 
clinical staff time), henceforth referred to as G2058, because this 
code addresses what we believe is an important gap in the current code 
set that should be addressed more immediately, and that finalizing only 
this single G code rather than the full range of proposed G codes will 
allow payment for these services while creating significantly less 
administrative burden. 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 G2058. We are 
sympathetic to commenters' concerns that the introduction of temporary 
replacement G codes across the CCM code set may introduce substantial 
confusion or administrative burden, but we believe a single new G code 
to pay more for additional 20-minute increments of non-complex CCM 
clinical staff time is important to pursue now. We are finalizing the 
work RVU for G2058 as proposed.
    We agree with commenters that there should be a frequency limit on 
the reporting of HCPCS code G2058 to maintain the distinction between 
complex and non-complex CCM and, in response to comments, we are 
finalizing that HCPCS code G2058 will be reportable a maximum of two 
times within a given service period for a given beneficiary. We believe 
the availability of this G code will further our policy goals to 
improve payment accuracy for care management services and allow 
practitioners and their teams to spend more time with their patients.
    Comment: A few commenters suggested that CMS should revalue the 
work RVUs for the CCM codes given that we proposed to increase the work 
RVUs for TCM, and CCM was originally valued based upon the RVUs for 
TCM.
    Response: We appreciate these suggestions but, given the ongoing 
work of the CPT Editorial Panel regarding these codes, we will consider 
potential revaluation of this code set in the context of any future 
changes or recommendations that may be made by the CPT Editorial Panel 
or the RUC.
b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes 
GCCC3 and GCCC4)
    There are two CPT codes for complex CCM:
     CPT code 99487 (Complex chronic care management services, 
with the following required elements: Multiple (two or more) chronic 
conditions expected to last at least 12 months, or until the death of 
the patient; chronic conditions place the patient at significant risk 
of death, acute exacerbation/decompensation, or functional decline; 
establishment or substantial revision of a comprehensive care plan; 
moderate or high complexity medical decision making; 60 minutes of 
clinical staff time directed by physician or other qualified health 
care professional, per calendar month. (Complex chronic care management 
services of less than 60 minutes duration, in a calendar month, are not 
reported separately); and
     CPT code 99489 (each additional 30 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).
    Complex CCM describes care management for patients who require not 
only more clinical staff time, but also complex medical decision-making 
and establishment or substantial revision of the care plan. 
Specifically, the CPT codes for complex CCM include in the code 
descriptors a requirement for establishment or substantial revision of 
the comprehensive care plan. The code descriptors for complex CCM also 
include moderate to high complexity medical decision-making (moderate 
to high complexity medical decision-making is an explicit part of the 
services).
    We proposed to adopt two new G codes that would be used for billing 
under the PFS instead of CPT codes 99487 and 99489, and that would not 
include the service component of substantial care plan revision. We 
believed it is not necessary to explicitly include substantial care 
plan revision because patients requiring moderate to high complexity 
medical decision making implicitly need and receive substantial care 
plan revision. The service component of substantial care plan revision 
is potentially duplicative with the medical decision making service 
component and, therefore, we believed it is unnecessary as a means of 
distinguishing eligible patients. Instead of CPT code 99487, we 
proposed to adopt HCPCS code GCCC3 (Complex chronic care management 
services, with the following required elements: Multiple (two or more) 
chronic conditions expected to last at least 12 months, or until the 
death of the patient; chronic conditions place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline; comprehensive care plan established, implemented, 
revised, or monitored; moderate or high complexity medical decision 
making; 60 minutes of clinical staff time directed by physician or 
other qualified health care professional, per calendar month. (Complex 
chronic care management services of less than 60 minutes duration, in a 
calendar month, are not reported separately)). We proposed a work RVU 
of 1.00 for HCPCS code GCCC3, which is a crosswalk to CPT code 99487.
    Instead of CPT code 99489, we proposed to adopt HCPCS code GCCC4 
(each additional 30 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). 
(Report GCCC4 in conjunction with GCCC3). (Do not report GCCC4 for care

[[Page 62691]]

management services of less than 30 minutes additional to the first 60 
minutes of complex chronic care management services during a calendar 
month)). We proposed a work RVU of 0.50 for HCPCS code GCCC4, which is 
a crosswalk to CPT code 99489.
    We intended these would be temporary G codes to remain in place 
until the CPT Editorial Panel can consider revising the current code 
descriptors for complex CCM services. We stated that we would consider 
adopting any new or revised complex CCM CPT code(s) once the CPT 
Editorial Panel completes its work. We acknowledged that imposing a 
transitional period during which G codes would be used under the PFS in 
lieu of the CPT codes is potentially disruptive. We solicited comment 
on whether the benefit of proceeding with the proposed G codes 
outweighs the burden of transitioning to their use in the intervening 
year(s) before a decision by the CPT Editorial Panel.
    Comment: While expressing general support for the proposed changes 
to these codes to remove the element of substantial care plan revision, 
several commenters expressed concerns that the temporary introduction 
of G codes would produce administrative burden and cause confusion. 
These commenters stated that in September 2019 the CPT Editorial Panel 
was considering an application for similar changes to refine the code 
set and clarify care planning. These commenters urged us to work with 
the CPT Editorial Panel regarding changes to the CCM code set and its 
revaluation. However, other commenters stated that G codes would help 
to facilitate earlier implementation and would ease transition to any 
updates made to CPT codes. A few commenters suggested that CMS could 
achieve its burden reduction goals by continuing to recognize CPT codes 
99490, 99487, and 99489 and also provide CMS-specific guidance for 
those codes for purposes of billing Medicare.
    Response: We are not finalizing our proposal to create HCPCS codes 
GCCC3 and GCCC4 in light of concerns raised by commenters, especially 
in light of the CPT Editorial Panel's currently ongoing work in this 
area and the concerns expressed by those that we expect would likely 
provide these services. Instead, given the support for our proposed 
care planning changes, for CY 2020 we will continue to recognize CPT 
codes 99487 and 99489, but with a different care planning element for 
purposes of billing Medicare. Beginning in CY 2020, for PFS billing 
purposes for CPT codes 99487 and 99489, we will interpret the code 
descriptor ``establishment or substantial revision of a comprehensive 
care plan'' to mean that a comprehensive care plan is established, 
implemented, revised, or monitored. This will allow for consistency in 
the care planning service element of complex CCM and non-complex CCM 
services provided by clinical staff. While we usually create G codes 
with alternative code descriptors when our payment policy varies from 
what is included in a CPT code descriptor(s), the change we proposed 
for the complex CCM care plan code descriptor is a relatively minor 
modification to the CPT code descriptor that we believe can be 
accomplished without the use of G codes. We look forward to reviewing 
any refinements or other recommendations for these services that may 
come from the CPT Editorial Panel and the RUC, and will consider such 
recommendations through our rulemaking process.
c. Typical Care Plan
    In 2013, in working with the physician community to develop and 
propose the CCM codes for PFS payment, the medical community 
recommended and CMS agreed that adequate care planning is integral to 
managing patients with multiple chronic conditions. We stated our 
belief that furnishing care management to beneficiaries with multiple 
chronic conditions requires complex and multidisciplinary care 
modalities that involve, among other things, regular physician 
development and/or revision of care plans and integration of new 
information into the care plan (78 FR 43337). In the CY 2014 PFS final 
rule with comment period (78 FR 74416 through 74418), consistent with 
recommendations CMS received in 2013 from the AMA's Complex Chronic 
Care Coordination Workgroup, we finalized a CCM scope of service 
element for a patient-centered plan of care with the following 
characteristics: It is a comprehensive plan of care for all health 
problems and typically includes, but is not limited to, the following 
elements: Problem list; expected outcome and prognosis; measurable 
treatment goals; cognitive and functional assessment; symptom 
management; planned interventions; medical management; environmental 
evaluation; caregiver assessment; community/social services ordered; 
how the services of agencies and specialists unconnected to the 
practice will be directed/coordinated; identify the individuals 
responsible for each intervention, requirements for periodic review; 
and when applicable, revisions of the care plan.
    The CPT Editorial Panel also incorporated and adopted this language 
in the prefatory language for Care Management Services codes (page 49 
of the 2019 CPT Codebook) including CCM services.
    As we continue to consider the need for potential refinements to 
the CCM code set, we have heard that there is still some confusion in 
the medical community regarding what a care plan typically includes. We 
re-reviewed this language for CCM, and we believe there may be aspects 
of the typical care plan language we adopted for CCM that are redundant 
or potentially unduly burdensome. In our CY 2020 PFS proposed rule, we 
noted that because these are ``typical'' care plan elements, these 
elements do not comprise a set of strict requirements that must be 
included in a care plan for purposes of billing for CCM services; the 
elements are intended to reflect those that are typically, but perhaps 
not always, included in a care plan as medically appropriate for a 
particular beneficiary. Nevertheless, we proposed to eliminate the 
phrase ``community/social services ordered, how the services of 
agencies and specialists unconnected to the practice will be directed/
coordinated, identify the individuals responsible for each 
intervention'' and insert the phrase ``interaction and coordination 
with outside resources and practitioners and providers.'' We believed 
simpler language could describe the important work of interacting and 
coordinating with resources external to the practice. While it is 
preferable, when feasible, to identify who is responsible for 
interventions, it may be difficult to maintain an up-to-date listing of 
responsible individuals especially when they are outside of the 
practice, for example, when there is staff turnover or assignment 
changes.
    We proposed new language to read: The comprehensive care plan for 
all health issues typically includes, but is not limited to, the 
following elements:
     Problem list.
     Expected outcome and prognosis.
     Measurable treatment goals.
     Cognitive and functional assessment.
     Symptom management
     Planned interventions.
     Medical management.
     Environmental evaluation
     Caregiver assessment
     Interaction and coordination with outside resources and 
practitioners and providers.
     Requirements for periodic review.
     When applicable, revision of the care plan.

[[Page 62692]]

    We welcomed feedback on our proposal, including language that would 
best guide practitioners as they decide what to include in their 
comprehensive care plan for CCM recipients.
    Comment: Commenters largely supported CMS' proposed definition of 
the typical care plan, and stated that it was simpler than the current 
definition and also comprehensive.
    Response: We thank the commenters for their support and are 
finalizing our proposed changes to the typical care plan for all CCM. 
We are eliminating the phrase ``community/social services ordered, how 
the services of agencies and specialists unconnected to the practice 
will be directed/coordinated, identify the individuals responsible for 
each intervention'' and inserting the phrase ``interaction and 
coordination with outside resources and practitioners and providers.'' 
The new language will read: ``The comprehensive care plan for all 
health issues typically includes, but is not limited to, the following 
elements:
     Problem list.
     Expected outcome and prognosis.
     Measurable treatment goals.
     Cognitive and functional assessment.
     Symptom management
     Planned interventions.
     Medical management.
     Environmental evaluation
     Caregiver assessment
     Interaction and coordination with outside resources and 
practitioners and providers.
     Requirements for periodic review.
     When applicable, revision of the care plan.''
    We anticipate that this change will reduce burden and simplify the 
important work of interacting and coordinating with resources external 
to the practice.
4. Principal Care Management (PCM) Services
    A gap we identified in coding and payment for care management 
services is care management for patients with only one chronic 
condition. The current CCM codes require patients to have two or more 
chronic conditions. These codes 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. We have heard from a number of stakeholders, especially 
those in specialties that use the office/outpatient E/M code set to 
report the majority of their services, that there can be significant 
resources involved in care management for a single high risk disease or 
complex chronic condition that is not well accounted for in existing 
coding (FR 78 74415). This issue has also been raised by the 
stakeholder community in proposal submissions to the Physician-Focused 
Payment Model Technical Advisory Committee (PTAC), which are available 
at https://aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee. Therefore, we proposed separate coding and payment 
for Principal Care Management (PCM) services, which describe care 
management services for one serious chronic condition. A qualifying 
condition will typically be expected to last between 3 months and 1 
year, or until the death of the patient, may have led to a recent 
hospitalization, and/or place the patient at significant risk of death, 
acute exacerbation/decompensation, or functional decline.
    Although we did not propose any restrictions on the specialties 
that could bill for PCM, we expect that most of these services will be 
billed by specialists who are focused on managing patients with a 
single complex chronic condition requiring substantial care management. 
We expect that, in most instances, initiation of PCM will be triggered 
by an exacerbation of the patient's complex chronic condition or recent 
hospitalization such that disease-specific care management is 
warranted. We anticipate that in the majority of instances, PCM 
services will be billed when a single condition is of such complexity 
that it cannot be managed as effectively in the primary care setting, 
and instead requires management by another, more specialized, 
practitioner. For example, a typical patient may present to their 
primary care practitioner with an exacerbation of an existing chronic 
condition. Although the primary care practitioner may be able to 
provide care management services for this one complex chronic 
condition, it is also possible that the primary care practitioner and/
or the patient could instead decide that another clinician should 
provide relevant care management services. In this case, the primary 
care practitioner will still oversee the overall care for the patient 
while the practitioner billing for PCM services will provide care 
management services for the specific complex chronic condition. The 
treating clinician may need to provide a disease-specific care plan or 
may need to make frequent adjustments to the patient's medication 
regimen. The expected outcome of PCM is for the patient's condition to 
be stabilized by the treating clinician so that overall care management 
for the patient's condition can be returned to the patient's primary 
care practitioner. If the beneficiary only has one complex chronic 
condition that is overseen by the primary care practitioner, then the 
primary care practitioner will also be able to bill for PCM services. 
We proposed that PCM services include coordination of medical and/or 
psychosocial care related to the single complex chronic condition, 
provided by a physician or clinical staff under the direction of a 
physician or other qualified health care professional.
    We anticipate that many patients will have more than one complex 
chronic condition. If a clinician is providing PCM services for one 
complex chronic condition, management of the patient's other conditions 
will continue to be managed by the primary care practitioner while the 
patient is receiving PCM services for a single complex condition. It is 
also possible that the patient could receive PCM services from more 
than one clinician if the patient experiences an exacerbation of more 
than one complex chronic condition simultaneously.
    For CY 2020, we proposed to make separate payment for PCM services 
via two new G codes: HCPCS code 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) and HCPCS code 
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

[[Page 62693]]

medication regimen, and/or the management of the condition is unusually 
complex due to comorbidities). HCPCS code G2064 would be reported when, 
during the calendar month, at least 30 minutes of physician or other 
qualified health care provider 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.
    For HCPCS code G2064, we proposed a crosswalk to the work value 
associated with CPT code 99217 (Observation care discharge day 
management (This code is to be utilized to report all services provided 
to a patient on discharge from outpatient hospital ``observation 
status'' if the discharge is on other than the initial date of 
``observation status.'' To report services to a patient designated as 
``observation status'' or ``inpatient status'' and discharged on the 
same date, use the codes for Observation or Inpatient Care Services 
[including Admission and Discharge Services, 99234-99236 as 
appropriate])) as we believe these values most accurately reflect the 
resource costs associated when the billing practitioner performs PCM 
services. CPT code 99217 has the same intraservice time as HCPCS code 
G2064 and the physician work is of similar intensity. Therefore, we 
proposed a work RVU of 1.28 for HCPCS code G2064.
    For HCPCS code G2065, we proposed a crosswalk to the work and PE 
inputs associated with CPT code 99490 (clinical staff non-complex CCM) 
as we believe these values reflect the resource costs associated with 
the clinician's direction of clinical staff who are performing the PCM 
services, and the intraservice times and intensity of the work for the 
two codes will be the same. Therefore, we proposed a work RVU of 0.61 
for HCPCS code G2065.
    Although we proposed separate coding and payment for PCM services 
performed by clinical staff with the oversight of the billing 
professional and services furnished directly by the billing 
professional, we solicited comment on whether both codes are necessary 
to appropriately describe and bill for PCM services. We note that we 
are basing this coding structure on the codes for CCM services with CPT 
code 99491 reflecting care management by the billing professional and 
CPT code 99490 reflecting care management by clinical staff directed by 
a physician or other qualified health care professional.
    We acknowledged that we concurrently proposed revisions for both 
complex and non-complex CCM services. Were we not to finalize the 
changes for both complex and non-complex CCM services, we stated our 
belief that the overall structure and description of the CCM services 
remain close enough to serve as a model for the coding structure and 
description of services for the proposed PCM services. We solicited 
public comment on whether it would be appropriate to create an add-on 
code for additional time spent each month (similar to HCPCS code GCCC2 
discussed above) when PCM services are furnished by clinical staff 
under the direction of the billing practitioner.
    Comment: Most commenters supported separate payment for PCM 
services, noting the gap in payment for care management and 
coordination for a patient's single complex or chronic condition. Other 
commenters were supportive of the policy goal but expressed concerns 
that the work described by PCM is duplicative of work being furnished 
as part of CCM and encouraged CMS to work with the CPT editorial panel 
to develop coding for this service.
    Response: We appreciate the support for both the policy goal of 
appropriate payment for care management services conducted for a 
patient's single complex or chronic condition and for separate payment 
for PCM services. We look forward to reviewing and considering 
recommendations from the CPT Editorial Panel and the RUC, should they 
develop and value CPT codes describing this or similar services, 
through our rulemaking process.
    Comment: A few commenters stated that HCPCS code G2064 was 
undervalued and should have a work RVU of 1.45, which is the same work 
RVU as CPT code 99491 (Chronic care management services, provided 
personally by a physician or other qualified health care professional, 
at least 30 minutes of physician or other qualified health care 
professional time, per calendar month, with the following required 
elements: Multiple (two or more) chronic conditions expected to last at 
least 12 months, or until the death of the patient; chronic conditions 
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; comprehensive care plan 
established, implemented, revised, or monitored). CPT code 99491 
describes the work associated with care management performed by the 
billing practitioner, in contrast to CPT code 99490, which describes 
the work associated with supervision of care management performed by 
clinical staff. Commenters pointed out that CPT codes 99491 and 99490 
served as the model for HCPCS codes G2064 and G2065. Commenters stated 
that CPT code 99491 was a more accurate crosswalk for HCPCS code G2064 
because both codes describe the work associated with care management 
and coordination performed by the billing practitioner, and G2065 
describes the work associated with supervising care management done by 
clinical staff and was valued the same as CPT code 99490. Commenters 
also pointed out that, although PCM services describe care management 
associated with a single condition, the fact that this condition has 
most likely experienced an exacerbation or has caused the patient to 
recently be hospitalized, results in greater intensity than the work 
associated with managing multiple chronic conditions, some of which may 
be more stable.
    Response: After considering these comments, we agree that the work 
RVU we proposed for code G2064 (1.28 RVUs) should be valued through a 
crosswalk to CPT code 99491, and we agree with the points made by 
commenters regarding the intensity of care management for a single 
condition, especially when that condition has likely experienced an 
exacerbation. We also agree that the relativity between CPT codes 99490 
and 99491 should be preserved in HCPCS codes G2064 and G2065. 
Therefore, we are finalizing an RVU of 1.45 for HCPCS code G2064.
    Comment: A few commenters supported creation of an add-on code for 
additional time spent engaged in PCM services beyond the initial 30 
minutes, similar to HCPCS code G2060 discussed above.
    Response: We thank commenters for their input. Given that this is a 
new service, we believe it would be more appropriate to monitor uptake 
and stakeholder response, and we will consider whether to establish a 
separate add-on code for additional time spent furnishing PCM services 
beyond the initial 30 minutes for possible future rulemaking.
    Although we believe that PCM services describe a situation where a 
patient's condition is severe enough to require care management for a 
single complex chronic condition beyond what is described by CCM or 
performed in the primary care setting, we are concerned that a possible 
unintended consequence of making separate payment for care management 
for a single chronic condition is that a patient with multiple

[[Page 62694]]

chronic conditions could have their care managed by multiple 
practitioners, each only billing for PCM, which could potentially 
result in fragmented patient care, overlaps in services, and 
duplicative services. Although we did not propose additional 
requirements for the PCM services, we did consider alternatives such as 
requiring that the practitioner billing PCM must document ongoing 
communication with the patient's primary care practitioner to 
demonstrate that there is continuity of care between the specialist and 
primary care settings, or requiring that the patient have had a face-
to-face visit with the practitioner billing PCM within the prior 30 
days to demonstrate that they have an ongoing relationship. We 
solicited comment on whether requirements such as these are necessary 
or appropriate, and whether there should be additional requirements to 
prevent potential care fragmentation or service duplication.
    We received public comments on whether requirements such as these 
are necessary or appropriate, and whether there should be additional 
requirements to prevent potential care fragmentation or service 
duplication. The following is a summary of the comments we received and 
our responses.
    Comment: Many commenters' shared CMS' concerns. Some commenters 
recommended that CMS not finalize separate payment for PCM services, 
stating that this would move away from patient-specific, continuous, 
comprehensive value based care management and coordination toward a 
more disease specific care management, resulting in fragmented care and 
service duplication. A few commenters with concerns about care 
fragmentation suggested that CMS first implement PCM through a 
demonstration. Others supported requiring the billing practitioner 
document ongoing communication and care coordination with any other 
practitioners overseeing care of the patient, such as primary care 
practitioners, pharmacists, hospitalists, or social workers, as 
applicable. These commenters stated that this would be sufficient to 
maintain coordination and continuity of care in the instance where 
multiple practitioners are involved in furnishing care to the 
beneficiary. A few commenters also suggested that CMS not allow billing 
of PCM services by multiple practitioners for the same indication. 
Still other commenters stated that it was not necessary to include any 
requirements pertaining to care fragmentation or service duplication, 
and that such requirements would be a barrier to uptake.
    Response: While we share commenters' concerns regarding care 
fragmentation and service duplication, we do not believe they rise to 
the level that separate payment should not be adopted for these 
services. The type of care management services that we believe are 
appropriately described by the PCM codes involve work intensively 
focused on managing a single condition and, with very few exceptions, 
could not be replaced by a single practitioner billing CCM services for 
management of multiple chronic conditions. However, we also believe it 
necessary to put in place some requirements so as to avoid a situation 
where each of a patient's individual conditions are being managed 
separately by different practitioners who all bill for PCM services. 
Therefore, we are finalizing a requirement that ongoing communication 
and care coordination between all practitioners furnishing care to the 
beneficiary must be documented by the practitioner billing for PCM in 
the patient's medical record.
    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 proposed that the full CCM scope of service requirements 
apply to PCM, including documenting the patient's verbal consent in the 
medical record. We solicited comment on whether there are required 
elements of CCM services that the public and stakeholders believe 
should not be applicable to PCM, and should be removed or altered.
    A high level summary of these requirements is available in Table 23 
and available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement .pdf. 
Both the initiating visit and the patient's verbal consent are 
necessary as not all patients who meet the criteria to receive 
separately billable PCM services may want to receive these services. 
The beneficiary should be educated as to what PCM services are and any 
cost sharing that may apply. Additionally, as practitioners have 
informed us that beneficiary cost sharing is a significant barrier to 
provision of other care management services, we solicited comment on 
how best to educate practitioners and beneficiaries on the benefits of 
PCM services.

[[Page 62695]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.030

    We received public comments on whether there are required elements 
of CCM services that the public and stakeholders believe should not be 
applicable to PCM, and should be removed or altered. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters supported application of the required 
elements of CCM to PCM with a number of refinements, although a few 
urged CMS not to add overly burdensome billing requirements. Commenters 
requested that CMS clarify that elements of CCM, such as the 
``systematic needs assessment,'' ``receipt of preventive services,'' 
and a ``comprehensive care plan'' must be furnished only for the 
specific chronic condition for which the billing practitioner is 
treating the patient. Some commenters pointed out that a 
``comprehensive care plan'' was not needed when a practitioner is 
engaged in care management and coordination of a single complex or 
chronic condition, and instead suggested it be changed to ``disease-
specific care plan.'' Other commenters suggest that we remove this 
language entirely. Commenters expressed concern with requiring that the 
EHR be certified to a particular standard. Commenters generally 
recommended that an initiating visit be furnished within a window of 
time to demonstrate that a relationship has been established between 
the beneficiary and the practitioner furnishing PCM. Commenters 
supported the retention of the requirement that there be the capacity 
for in-person care management. Commenters also recommended that verbal 
and or written consent be documented in the medical record so that the 
patient is aware of the service and any applicable cost sharing, 
although some stated that this was a burdensome requirement given that 
they may not know in advance which beneficiaries will require PCM 
services.
    Response: We thank commenters for all their input. We agree with 
commenters that a ``disease-specific'' care plan is more appropriate 
than a comprehensive care plan, as the practitioner will be providing 
care coordination and management for a single condition, and as such, 
the care plan may be more limited. We also agree that certain aspects 
of CCM, such as ``systematic needs assessment'' and ``receipt of 
preventive services'' should only be furnished as applicable to the 
condition being treated and should not be a requirement to bill for PCM 
services. Table 24 shows the elements of CCM, as revised in response to 
comments, that will be required for PCM.

[[Page 62696]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.031

    With regard to the certified EHR, we continue to believe that use 
of certified EHR technology is vital to ensure that practitioners are 
capable of providing the full scope of PCM services, such as timely 
care coordination and continuity of care (see our prior discussion of 
this issue at 79 FR 67723). The use of certified EHR technology helps 
ensure that members of the care team have timely access to the 
patient's most updated health information. Also, we believe that use of 
certified EHR technology among physicians and other practitioners will 
increase as we move forward to implement the Quality Payment Program, 
including MIPS and Advanced Alternative Payment Models, as well as 
other value-based payment initiatives. Accordingly, we are not 
modifying the proposed use of certified EHR technology as an element of 
PCM services.
    We received public comments on how best to educate practitioners 
and beneficiaries on the benefits of PCM services. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters recommended that CMS issue guidance for billing 
and coding criteria, clinical situations in which PCM may be billed, 
and what defines a complex condition.
    Response: We look forward to continued engagement with the public 
to revise and refine PCM services as they are implemented. We encourage 
stakeholders to submit questions and information to CMS so that we 
might consider changes or clarification for future rulemaking.
    Additionally, we proposed to add HCPCS code G2065 to the list of 
designated care management services for which we allow general 
supervision as described in our regulation at Sec.  410.26(b)(5).
    Comment: Commenters supported adding HCPCS code G2065 to the list 
of designated care management services for which we allow general 
supervision.
    Response: We thank commenters for their support and are finalizing 
as proposed.
    Due to the potential for duplicative payment, we proposed that PCM 
could not be billed by the same practitioner for the same patient 
concurrent with certain other care management services, such as CCM, 
behavioral health integration services, and monthly capitated ESRD 
payments. We also proposed that PCM will not be billable by the same 
practitioner for the same patient during a surgical global period, as 
we believe those resource costs will already be included in the 
valuation of the global surgical code.
    We also solicited comment on any potential for duplicative payment 
between the PCM services and other services, such as interprofessional 
consultation services (CPT codes 99446-99449 (Interprofessional 
telephone/internet/electronic health record assessment and management 
service provided by a consultative physician, including a verbal and 
written report to the patient's treating/requesting physician or other 
qualified health care professional), CPT code 99451 (Interprofessional 
telephone/

[[Page 62697]]

internet/electronic health record assessment and management service 
provided by a consultative physician, including a written report to the 
patient's treating/requesting physician or other qualified health care 
professional, 5 minutes or more of medical consultative time), and CPT 
code 99452 (Interprofessional telephone/internet/electronic health 
record referral service(s) provided by a treating/requesting physician 
or other qualified health care professional, 30 minutes) or remote 
patient monitoring (CPT code 99091 (Collection and interpretation of 
physiologic data (e.g., ECG, blood pressure, glucose monitoring) 
digitally stored and/or transmitted by the patient and/or caregiver to 
the physician or other qualified health care professional, qualified by 
education, training, licensure/regulation (when applicable) requiring a 
minimum of 30 minutes of time, each 30 days), 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), and CPT code 99457 (Remote physiologic 
monitoring treatment management services, 20 minutes or more of 
clinical staff/physician/other qualified health care professional time 
in a calendar month requiring interactive communication with the 
patient/caregiver during the month).
    Comment: Commenters generally supported restricting the number of 
care management services billable by the same practitioner for the same 
patient, stating that this was necessary to avoid service duplication. 
A few commenters also stated that services such as interprofessional 
consultation and chronic care RPM should not be separately billable in 
the same month as PCM by the same practitioner for the same 
beneficiary. Others disagreed, stating the RPM and interprofessional 
consultations describe distinct services not accounted for in the work 
of PCM. RPM in particular was described by these commenters as being 
complimentary to PCM services, rather than duplicative.
    Commenters requested clarification as to potential overlap between 
PCM and CCM and some commenters suggested that PCM could be billed 
concurrent with CCM for the same beneficiary, if billed by different 
practitioners. Commenters also requested that CMS clarify any potential 
overlap between PCM and HCPCS code GPC1X (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. (Add-on 
code, list separately in addition to office/outpatient evaluation and 
management visit, new or established).
    Response: We do not believe there will be a duplication of care 
management between PCM and other care management services solely as a 
result of separate payment for the new PCM codes, particularly with the 
revised list of required elements which better distinguish PCM services 
from CCM. However, we also agree with commenters that PCM services 
should not be furnished with other care management services by the same 
practitioner for the same beneficiary, nor should PCM services be 
furnished at the same time as interprofessional consultations for the 
same condition by the same practitioner for the same patient. However, 
we are convinced by stakeholders who stated that RPM services are 
distinct from PCM and could be billed concurrently by the same 
practitioner for the same beneficiary provided that the time is not 
counted twice. We will also be monitoring billing of these services. We 
will appreciate continued input and engagement on these issues with the 
public and stakeholder community, and may make refinements to these 
policies in future rulemaking.
    With regard to the relationship between PCM services and HCPCS code 
GPC1X, we do not believe there is any overlap. We note that PCM 
describes ongoing care management services and is billed monthly, 
whereas HCPCS code GPC1X is an adjustment to an office/outpatient E/M 
visit (which are separately billable alongside PCM) to capture 
additional resource costs associated with performing either a primary 
care visit or a visit that is part of ongoing care of a patients 
single, serious, or complex condition.
    Comment: A commenter requested that RHCs and FQHCs be allowed to 
furnish and report PCM services.
    Response: We thank the commenter for the suggestion. While we did 
not propose a new mechanism for RHCs and FQHCs to report PCM services 
specifically, we recognize that the requirements for the new PCM codes 
are similar to the requirements for the services described by HCPCS 
code G0511, which is the RHC/FQHC-specific general care management 
code, and will consider adding PCM to G0511 in future rulemaking.
5. Chronic Care Remote Physiologic Monitoring Services
    Chronic care remote physiologic monitoring (RPM) services involve 
the collection, analysis, and interpretation of digitally collected 
physiologic data, followed by the development of a treatment plan, and 
the managing of a patient under the treatment plan. The current CPT 
code 99457 is a treatment management code, billable after 20 minutes or 
more of clinical staff/physician/other qualified professional time with 
a patient in a calendar month.
    In September 2018, the CPT Editorial Panel revised the CPT code 
structure for CPT code 99457 effective beginning CY 2020. The new code 
structure retains CPT code 99457 as a base code that describes the 
first 20 minutes of the treatment management services, and uses a new 
add-on code to describe subsequent 20 minute intervals of the service. 
The new code descriptors for CY 2020 are: CPT code 99457 (Remote 
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month; initial 20 minutes) and 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; additional 20 minutes).
    In considering the work RVUs for the new add-on CPT code 99458, we 
first considered the value of its base code. We previously valued the 
base code at 0.61 work RVUs. Given the value of the base code, we did 
not agree with the RUC-recommended work RVU of 0.61 for CPT code 99458. 
Instead, we proposed a work RVU of 0.50 for the add-on code, which we 
believed was supported by CPT code 88381 (Microdissection (i.e., sample 
preparation of microscopically identified target); manual) and which 
has the same intraservice and total times of 20 minutes with an XXX 
global period and work RVU of 0.53, as well as the survey value at the 
25th percentile. We proposed the RUC-recommended direct PE inputs for 
CPT code 99458.
    Finally, we proposed that RPM services could be furnished under 
general supervision. Because care management services include 
establishing, implementing, revising, or monitoring treatment plans, as 
well as providing support services, and because

[[Page 62698]]

RPM services include establishing, implementing, revising, and 
monitoring a specific treatment plan for a patient related to one or 
more chronic conditions that are monitored remotely, we believed that 
CPT codes 99457 and 99458 should be included as designated care 
management services. Designated care management services can be 
furnished under general supervision. Section 410.26(b)(5) of our 
regulations states that designated care management services can be 
furnished under the general supervision of the ``physician or other 
qualified health care professional (who is qualified by education, 
training, licensure/regulation and facility privileging)'' (see also 
2019 CPT Codebook, page xii) when these services or supplies are 
provided incident to the services of a physician or other qualified 
healthcare professional. The physician or other qualified healthcare 
professional supervising the auxiliary personnel need not be the same 
individual treating the patient more broadly. However, only the 
supervising physician or other qualified healthcare professional may 
bill Medicare for incident to services.
    We received public comments on the proposed valuation of the RPM 
add-on CPT code 99458 and our proposal to designate CPT codes 99457 and 
99458 as care management services. The following is a summary of the 
comments we received in response to our two proposals, as well as our 
responses.
    Comment: We received numerous comments regarding our valuation of 
the new RPM code, CPT code 99458. Commenters uniformly disagreed with 
our proposed work RVU of 0.50 writing that there are no efficiencies to 
be gained when continuing the same treatment management service for an 
additional 20 minutes. Some commenters questioned our use of CPT code 
88381 (Microdissection (i.e., sample preparation of microscopically 
identified target); manual) as a reference code, a code that does not 
resemble the work and the intensity of the work furnished during a care 
management session.
    Response: We thank the many commenters for their insights into the 
work required for CPT codes 99457 and 99458.
    Comment: Commenters uniformly agreed with our proposal to designate 
CPT codes 99457 and 99458 as care management services so that the 
services can be furnished under general supervision.
    Response: We agree with commenters that the add-on code requires 
the same work time and intensity as the RPM base code. Therefore, we 
are finalizing the RUC-recommended work RVU 0.61 for CPT code 99458. We 
are also finalizing the RUC-recommended direct PE. In addition, we are 
finalizing our proposal to designate both CPT code 99457 and CPT code 
99458 care management codes as defined in Sec.  410.26(b)(5) of our 
regulations.
    Comment: Several commenters expressed concerns about the ambiguity 
of the code descriptors for the RPM codes. Commenters requested that 
CMS define what is meant by ``physiologic parameters'', ``digitally 
transmitted data'' (as opposed to patient-reported data), ``medical 
device,'' and ``interactive communication''. Several commenters asked 
if we could expand the list of practitioners allowed to furnish RPM 
services, while others requested that we clarify who can furnish and 
bill for the RPM services. One commenter stated that the prefatory 
language for the codes should state explicitly that an established 
patient-practitioner relationship must exist prior to billing for RPM 
services. Another commenter recommended that we provide guidance 
related to billing and documentation for RPM. Some commenters 
questioned whether the codes could be used for patients that without 
chronic conditions.
    Response: We appreciate the many questions raised by commenters 
about the set of RPM codes and understand the frustration commenters 
expressed with the current code descriptors. Therefore, given the 
numerous questions raised by commenters, we plan to consider these and 
other questions related to RPM in future rulemaking.
    Comment: We received a few comments asking whether RPM is a 
billable service in RHCs and FQHCs.
    Response: RHCs are paid an all-inclusive rate (AIR) when a 
medically necessary, face-to-face visit is furnished by an RHC 
practitioner. FQHCs are paid the lesser of their charges or the FQHC 
PPS rate when a medically-necessary, face-to-face visit is furnished by 
an FQHC practitioner. Both the RHC AIR and the FQHC PPS rate include 
all services and supplies furnished incident to the visit. Services 
such as RPM are not separately billable because they are already 
included in the RHC AIR or FQHC PPS payment.
6. Comment Solicitation on Consent for Communication Technology-Based 
Services
    In the CY 2019 PFS final rule, we finalized separate payment for a 
number of services that could be furnished via telecommunications 
technology. 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)), 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)), CPT codes 99446-99449 (Interprofessional telephone/
internet/electronic health record assessment and management service 
provided by a consultative physician, including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional), CPT code 99451 (Interprofessional 
telephone/internet/electronic health record assessment and management 
service provided by a consultative physician, including a written 
report to the patient's treating/requesting physician or other 
qualified health care professional, 5 minutes or more of medical 
consultative time), and CPT code 99452 (Interprofessional telephone/
internet/electronic health record referral service(s) provided by a 
treating/requesting physician or other qualified health care 
professional, 30 minutes).
    As discussed in that rule, (83 FR 59490 through 59491), while a few 
commenters suggested that it would be less burdensome to obtain a 
general consent for multiple services at once, we stipulated that 
verbal consent must be documented in the medical record for each 
service furnished so that the beneficiary is aware of any applicable 
cost sharing. This is similar to the requirements for other non-face-
to-face care management services under the PFS.
    We have continued to hear from stakeholders that requiring advance 
beneficiary consent for each of these services is burdensome. For HCPCS 
codes G2010 and G2012, stakeholders have stated that it is difficult 
and burdensome to obtain consent at the outset of each of what are 
meant to be brief check-in services. For CPT codes 99446-99449, 99451 
and 99452, practitioners have informed us that it is

[[Page 62699]]

particularly difficult for the consulting practitioner to obtain 
consent from a patient they have never seen. Given our longstanding 
goals to reduce burden and promote the use of communication technology-
based services (CTBS), we sought comment in the CY 2020 PFS proposed 
rule on whether a single advance beneficiary consent could be obtained 
for a number of communication technology-based services. During the 
consent process, the practitioner will make sure the beneficiary is 
aware that utilization of these services will result in a cost sharing 
obligation. We solicited comment on the appropriate interval of time or 
number of services for which consent could be obtained, for example, 
for all these services furnished within a 6-month or 1-year period, or 
for a set number of services, after which a new consent will need to be 
obtained. We also solicited comment on the potential program integrity 
concerns associated with allowing advance consent and how best to 
minimize those concerns.
    We received public comments on the appropriate interval of time or 
number of services for which consent could be obtained and the 
potential program integrity concerns associated with allowing advance 
consent and how best to minimize those concerns. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported requiring a generalized consent 
for multiple communication technology-based services or 
interprofessional consultations. Most commenters suggested that a year 
was an appropriate interval for which consent should be obtained, 
although some commenters suggested other time intervals, such as every 
6 months, quarterly, or no requirement at all.
    A few commenters suggested that there should be separate consent 
processes for services that involve an interaction with the patient, 
such as HCPCS codes G2010 to report the remote evaluation of recorded 
video and/or images for an established patient and G2012 to report 
brief communication technology-based service for an established 
patient, and services that do not involve direct interaction with the 
patient, such as CPT codes 99446 through 99449, 99451 and 99452, which 
describe services such as electronic assessment and management by a 
consultative physician.
    Other commenters raised more general concerns with beneficiary cost 
sharing, pointing out that beneficiaries may not be accustomed to being 
charged cost sharing for non-face-to-face services. These commenters 
urged CMS to eliminate cost sharing for these services.
    Response: We appreciate commenters' support for allowing a single 
consent to be obtained for multiple CTBS or interprofessional 
consultation services over an interval of time, rather than requiring 
consent to be obtained prior to each service. Given the commenters' 
support, we are finalizing a policy to permit a single consent to be 
obtained for multiple CTBS or interprofessional consultation services. 
Based on feedback from commenters, we believe an appropriate interval 
for the single consent is one year, and we are finalizing that the 
single consent must be obtained at least annually. We will continue to 
consider whether a separate consent should be obtained for services 
that involve direct interaction between the patient and practitioner, 
and those that do not involve interaction such as interprofessional 
services; and we may address this issue in potential future rulemaking.
    We also appreciate commenters' continued concerns about the burden 
associated with cost sharing for CTBS and interprofessional 
consultation services. Although we do not have statutory authority to 
eliminate cost sharing for these services, we appreciate the continued 
input from the public as to how best to educate both practitioners and 
beneficiaries to reduce instances of unexpected bills.
7. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers 
(FQHCs)
    RHCs and FQHCs are paid for general care management services using 
HCPCS code G0511, which is an RHC and FQHC-specific G-code for 20 
minutes or more of CCM services, complex CCM services, CCM furnished by 
a physician or other qualified health care professional, or general 
behavioral health services, and we are allowing G0511 to also be billed 
when the requirements for PCM are met. Payment for this service is set 
at the average of the national, non-facility payment rates for CPT 
codes 99490, 99487, 99491, and 99484. We proposed to use the non-
facility payment rates for HCPCS codes GCCC1 and GCCC3 instead of the 
non-facility payment rates for CPT codes 99490 and 99487, respectively, 
if these changes were finalized for practitioners billing under the 
PFS; as indicated above, these codes were not finalized. We note that 
we did not propose any changes in the valuation of these codes.
    Comment: Regarding the use HCPCS codes GCCC1 and GCCC3, commenters 
noted they would be supportive of this change if they were finalized 
for practitioners billing under the PFS for RHCs and FQHCs.
    Response: Since HCPCS codes GCCC1 and GCCC3 are not being finalized 
for use under the PFS, we are not finalizing this change for RHCs and 
FQHCs. Therefore, payment for HCPCS G0511 will continue to set based on 
the average of the national, non-facility payment rates for CPT codes 
99490, 99487, 99491, and 99484.

L. Coinsurance for Colorectal Cancer Screening Tests

    Section 1861(pp) of the Act defines ``colorectal cancer screening 
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act, 
``screening flexible sigmoidoscopy'' and ``screening colonoscopy'' are 
two of the recognized procedures. Among other things, section 
1861(pp)(1)(D) of the Act authorizes the Secretary to include other 
tests or procedures in the definition, and modifications to the tests 
and procedures described under this subsection, ``with such frequency 
and payment limits, as the Secretary determines appropriate, in 
consultation with appropriate organizations.'' Section 1861(s)(2)(R) of 
the Act includes these colorectal cancer screening tests in the 
definition of the medical and other health services that fall within 
the scope of Medicare Part B benefits described in section 1832(a)(1) 
of the Act. Section 1861(ddd)(3) of the Act includes these colorectal 
cancer screening services within the definition of ``preventive 
services.'' In addition, section 1833(a)(1)(Y) of the Act provides for 
payment for preventive services recommended by the United States 
Preventive Services Task Force (USPSTF) with a grade of A or B under 
the PFS at 100 percent of the lesser of the actual charge or the fee 
schedule amount for these colorectal cancer screening tests, and under 
the OPPS at 100 percent of the OPPS payment amount. As such, there is 
no beneficiary responsibility for coinsurance for recommended 
colorectal cancer screening tests as defined in section 1861(pp)(1) of 
the Act.
    Under these statutory provisions, we have issued regulations 
governing payment for colorectal cancer screening tests at 42 CFR 
410.152(l)(5). We pay 100 percent of the Medicare payment amount 
established under the applicable payment methodology for the setting 
for providers and suppliers, and beneficiaries are not required to pay 
Part B coinsurance.
    In addition to screening tests, which typically are furnished to 
patients in the absence of signs or symptoms of illness

[[Page 62700]]

or injury, Medicare also covers various diagnostic tests (Sec.  
410.32). In general, diagnostic tests must be ordered by the physician 
or practitioner who is treating the beneficiary, and who uses the 
results of the diagnostic test in the management of the patient's 
specific medical problem. Under Part B, Medicare may cover flexible 
sigmoidoscopies and colonoscopies as diagnostic tests when those tests 
are reasonable and necessary as specified in section 1862(a)(1)(A) of 
the Act. When these services are furnished as diagnostic tests rather 
than as screening tests, patients are responsible for the Part B 
coinsurance (normally 20 percent) associated with these services.
    We define ``colorectal cancer screening tests'' in our regulation 
at Sec.  410.37(a)(1) to include ``flexible screening sigmoidoscopies'' 
and ``screening colonoscopies, including anesthesia furnished in 
conjunction with the service.'' Under our current policies, we exclude 
from the definition of colorectal screening services colonoscopies and 
sigmoidoscopies that begin as a screening service, but where a polyp or 
other growth is found and removed as part of the procedure. The 
exclusion of these services from the definition of colorectal cancer 
screening services is based upon separate provisions of the statute 
dealing with the detection of lesions or growths during procedures (62 
FR 59048, 59082, October 31, 1997). Section 1834(d)(2)(D) of the Act 
provides that if, during the course of a screening flexible 
sigmoidoscopy, a lesion or growth is detected which results in a biopsy 
or removal of the lesion or growth, payment under Medicare Part B shall 
not be made for the screening flexible sigmoidoscopy but shall be made 
for the procedure classified as a flexible sigmoidoscopy with such 
biopsy or removal. Similarly, section 1834(d)(3)(D) of the Act that 
provides if, during the course of a screening colonoscopy, a lesion or 
growth is detected which results in a biopsy or removal of the lesion 
or growth, payment under Medicare Part B shall not be made for the 
screening colonoscopy but shall be made for the procedure classified as 
a colonoscopy with such biopsy or removal.
    Because we interpret sections 1834(d)(2)(C)(ii) and 
1834(d)(3)(C)(ii) of the Act to require us to pay for these tests as 
diagnostic tests, rather than as screening tests, the 100 percent 
payment rate for recommended preventive services under section 
1833(a)(1)(Y) of the Act, as codified in our regulation at Sec.  
410.152(l)(5), would not apply to those diagnostic procedures. As such, 
beneficiaries are responsible for the usual coinsurance that applies to 
the services (20 or 25 percent of the cost of the services depending on 
the setting).
    Under section 1833(b) of the Act, before making payment under 
Medicare Part B for expenses incurred by a beneficiary for covered Part 
B services, beneficiaries must first meet the applicable deductible for 
the year. Section 4104 of the Affordable Care Act (that is, the Patient 
Protection and Affordable Care Act (Pub L. 111-148, enacted March 23, 
2010), and the Health Care and Education Reconciliation Act of 2010 
(Pub. L. 111-152, enacted March 30, 2010), collectively referred to as 
the ``Affordable Care Act'') amended section 1833(b)(1) of the Act to 
make the deductible inapplicable to expenses incurred for certain 
preventive services that are recommended with a grade of A or B by the 
USPSTF, including colorectal cancer screening tests as defined in 
section 1861(pp) of the Act. Section 4104 of the Affordable Care Act 
also added a sentence at the end of section 1833(b)(1) of the Act 
specifying that the exception to the deductible shall apply with 
respect to a colorectal cancer screening test regardless of the code 
that is billed for the establishment of a diagnosis as a result of the 
test, or for the removal of tissue or other matter or other procedure 
that is furnished in connection with, as a result of, and in the same 
clinical encounter as the screening test. Although the Affordable Care 
Act addressed the applicability of the deductible in the case of a 
colorectal cancer screening test that involves biopsy or tissue 
removal, it did not alter the coinsurance provision in section 1833(a) 
of the Act for such procedures. Although public commenters encouraged 
the agency to also eliminate the coinsurance in these circumstances, 
the agency found that the statute did not provide for elimination of 
the coinsurance (75 FR 73170, 73431, November 29, 2010).
    Beneficiaries have continued to contact us noting their 
``surprise'' that a coinsurance (20 or 25 percent depending on the 
setting) applies when they expected to receive a colorectal screening 
procedure to which coinsurance does not apply, but instead received 
what Medicare considers to be a diagnostic procedure because polyps 
were discovered and removed. Similarly, physicians have also expressed 
concerns about the reactions of beneficiaries when they are informed 
that they will be responsible for coinsurance if polyps are discovered 
and removed during what they expected to be a screening procedure to 
which coinsurance does not apply. Other stakeholders and some members 
of Congress have regularly expressed to us that they consider the 
agency's policy on coinsurance for colorectal screening procedures 
during which tissue is removed to be a misinterpretation of the law.
    Over the years, we have released a wide variety of publicly 
available educational materials that explain the Medicare preventive 
services benefits as part of our overall outreach activities to 
Medicare beneficiaries. These materials contain a complete description 
of the Medicare preventive services benefits, including information on 
colorectal cancer screening, and also provide relevant details on the 
applicability of cost sharing. These materials are available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243319.html. We believe that the 
information in these materials can be instrumental in continuing to 
educate physicians and beneficiaries about cost sharing obligations in 
order to mitigate instances of ``surprise'' billing. In the CY 2020 PFS 
proposed rule (84 FR 40556), we solicited comment on whether we should 
consider establishing a requirement that the physician who plans to 
furnish a colorectal cancer screening notify the patient in advance 
that a screening procedure could result in a diagnostic procedure if 
polyps are discovered and removed, and that coinsurance may apply. 
Specifically, we solicited comment on whether we should require the 
physician, or their staff, to provide a verbal notice with a notation 
in the medical record, or whether we should consider a different 
approach to informing patients of the copay implications, such as a 
written notice with standard language that we would require the 
physician, or their staff, to provide to patients prior to a colorectal 
cancer screening. We also solicited comment on what mechanism, if any, 
we should consider using to monitor compliance with a notification 
requirement if we decide to finalize one for CY 2020 or through future 
rulemaking.
    We received over 1,600 public comments on the requirements for 
coinsurance for colorectal cancer screening tests.
    Comment: Many comments were on coverage and statutory issues, such 
as coverage for colorectal cancer screening more frequently and not 
requiring coinsurance for diagnostic colonoscopy.
    Response: These comments are out of scope.

[[Page 62701]]

    Comment: Many commenters were on professionals providing 
information to individuals receiving a screening colonoscopies. Several 
commenters noted that Medicare could do a better job of educating 
beneficiaries about when screening colonoscopies become diagnostic 
colonoscopies, and therefore, coinsurance applies. In addition to not 
understanding that when removal of a polyp, lesion or growth is 
discovered a screening colonoscopy becomes a diagnostic one, some 
commenters misunderstood that a screening colonoscopy can only occur 
every 10 years for most individuals, or the appropriate frequency for a 
high risk individual. Many commenters were confused that a diagnostic 
colonoscopy occurs after a positive Cologuard[supreg] or fetal occult 
blood tests rather than a screening colonoscopy.
    Response: As a result of our review of the public comments, we 
intend to undertake a comprehensive review of all of our outreach 
materials, such as the Medicare & You Handbook and Medicare Preventive 
Services, to see if Medicare policies on payment and coverage for 
screening colonoscopies can be made clearer. We believe this would be a 
service to Medicare beneficiaries.

M. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate 
Therapy
a. Background
    In the CY 2019 PFS proposed and final rules (83 FR 34850; 83 FR 
59654 and 59661), we discussed the statutory requirements of section 
50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
123, February 9, 2018). Beginning January 1, 2018, section 50202 of the 
BBA of 2018 repealed the Medicare outpatient therapy caps and the 
therapy cap exceptions process, while retaining the cap amounts as 
limitations and requiring medical review to ensure that therapy 
services are furnished when appropriate. Section 50202 of the BBA of 
2018 amended section 1833(g) of the Act by adding a new paragraph 
(7)(A) requiring that after expenses incurred for the beneficiary's 
outpatient therapy services for the year have exceeded one or both of 
the previous therapy cap amounts, all therapy suppliers and providers 
must continue to use an appropriate modifier on claims. We implemented 
this provision by continuing to require use of the existing KX 
modifier. By using the KX modifier on the claim, the therapy supplier 
or provider is attesting that the services are medically necessary and 
that supportive justification is documented in the medical record. As 
with the incurred expenses for the prior therapy cap amounts, there is 
one amount for physical therapy (PT) and speech language pathology 
(SLP) services combined, and a separate amount for occupational therapy 
(OT) services. These KX modifier threshold amounts are indexed annually 
by the Medicare Economic Index (MEI). After the beneficiary's incurred 
expenditures for outpatient therapy services exceed the KX modifier 
threshold amount for the year, claims for outpatient therapy services 
without the KX modifier are denied.
    Section 50202 of the BBA of 2018 also added a new paragraph 7(B) to 
section 1833(g) of the Act which retained the targeted medical review 
(MR) process for 2018 and subsequent years, but established a lower 
threshold amount of $3,000 rather than the $3,700 threshold amount that 
had applied for the original manual MR process established by section 
3005(g) of the Middle Class Tax Relief and Jobs Creation Act of 2012 
(MCTRJCA) (Pub. L. 112-96, February 22, 2012). The manual MR process 
with a threshold amount of $3,700 was replaced by the targeted MR 
process with the same threshold amount through amendments made by 
section 202 of the Medicare Access and CHIP Reauthorization Act of 2015 
(MACRA) (Pub. L. 114-10, April 16, 2015).
    With the latest amendments made by the BBA of 2018, for CY 2018 
(and each successive calendar year until 2028, at which time it is 
indexed annually by the MEI), the MR threshold is $3,000 for PT and SLP 
services and $3,000 for OT services. For purposes of applying the 
targeted MR process, we use a criteria-based process for selecting 
providers and suppliers that includes factors such as a high percentage 
of patients receiving therapy beyond the medical review threshold as 
compared to peers. For information on the targeted medical review 
process, please visit https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
    In the CY 2019 PFS final rule (83 FR 59661), when discussing our 
tracking and accrual process for outpatient therapy services in the 
section on the KX Threshold Amounts, we noted that we track each 
beneficiary's incurred expenses for therapy services annually by 
applying the PFS-based payment amount for each service less any 
applicable multiple procedure reduction for CMS-designated ``always 
therapy'' services. We also stated that we use the PFS rates to accrue 
expenses for therapy services provided in critical access hospitals 
(CAHs) as required by section 1833(g)(6)(B) of the Act, added by 
section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. 
L. 112-240, January 2, 2013). As discussed below, we mistakenly 
indicated that this statutory requirement was extended by subsequent 
legislation, including section 50202 of the BBA of 2018.
b. Summary of Proposed Regulatory Revisions
    While we explained and implemented the changes required by section 
50202 of the BBA of 2018 in CY 2019 PFS rulemaking (83 FR 34850; 83 FR 
59654 and 59661), we did not codify those changes in regulation text. 
In the CY 2020 PFS proposed rule, we proposed to revise the regulations 
at Sec. Sec.  410.59 (outpatient occupational therapy) and 410.60 
(physical therapy and speech-language pathology) to incorporate the 
changes made by section 50202 of the BBA of 2018. Specifically, we 
proposed to add a new paragraph (e)(1)(v) to Sec. Sec.  410.59 and 
410.60 to clarify that the specified amounts of annual per-beneficiary 
incurred expenses are no longer applied as limitations but as threshold 
amounts above which services require, as a condition of payment, 
inclusion of the KX modifier; and that use of the KX modifier confirms 
that the services are medically necessary as justified by appropriate 
documentation in the patient's medical record. We proposed to amend 
paragraph (e)(2) in Sec. Sec.  410.59 and 410.60 to specify the therapy 
services and amounts that are accrued for purposes of applying the KX 
modifier threshold, including the continued accrual of therapy services 
furnished by CAHs directly or under arrangements at the PFS-based 
payment rates. We also proposed to amend paragraph (e)(3) in Sec. Sec.  
410.59 and 410.60 for the purpose of applying the medical review 
threshold to clarify the threshold amounts and the applicable years for 
both the manual MR process originally established through section 
3005(g) of MCTRJCA and the targeted MR process established by the 
MACRA, and including the changes made through section 50202 of the BBA 
of 2018 as discussed previously.
    In the CY 2019 PFS final rule (83 FR 59661), we incorrectly stated 
that section 1833(g)(6)(B) of the Act continues to require that we 
accrue expenses for therapy services furnished by CAHs at the PFS rate 
because the provision, originally added by section 603(b) of the ATRA, 
was extended by subsequent legislation, including section 50202 of the 
BBA of 2018. The

[[Page 62702]]

requirement in section 1833(g)(6)(B) of the Act was actually time-
limited to services furnished in CY 2013. To apply the therapy caps 
(and now the KX modifier thresholds) after the expiration of the 
requirement in 1833(g)(6)(B) of the Act, we needed a process to accrue 
the annual expenses for therapy services furnished by CAHs and, in the 
CY 2014 PFS final rule with comment period, we elected to continue the 
process prescribed in section 1833(g)(6)(B) of the Act (78 FR 74405 
through 74410).
    We received public comments on the proposed revisions to regulation 
text to codify the changes required by section 50202 of the BBA of 
2018. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters appreciated our proposal to clarify and 
codify the requirements as outlined in section 50202 of the BBA of 
2018.
    Response: We thank commenters for their support.
    After considering the comments, we are finalizing as proposed the 
changes in regulation text to reflect the requirements of section 50202 
of the BBA of 2018.
2. Payment for Outpatient PT and OT Services Furnished by Therapy 
Assistants
a. Background
    Section 53107 of the BBA of 2018 added a new subsection 1834(v) to 
the Act to require in paragraph (1) that, for services furnished on or 
after January 1, 2022, payment for outpatient physical and occupational 
therapy services for which payment is made under sections 1848 or 
1834(k) of the Act which are furnished in whole or in part by a therapy 
assistant must be paid at 85 percent of the amount that is otherwise 
applicable. Section 1834(v)(2) of the Act further required that we 
establish a modifier to identify these services by January 1, 2019, and 
that claims for outpatient therapy services furnished in whole or in 
part by a therapy assistant must include the modifier effective for 
dates of service beginning on January 1, 2020. Section 1834(v)(3) of 
the Act required that we implement the subsection through notice and 
comment rulemaking.
    In the CY 2019 PFS proposed and final rules (83 FR 35850 through 
35852 and 83 FR 59654 through 50660, respectively), we established two 
modifiers--one to identify services furnished in whole or in part by a 
physical therapist assistant (PTA) and the other to identify services 
furnished in whole or in part by an occupational therapy assistant 
(OTA). The modifiers are defined as follows:
     CQ Modifier: Outpatient physical therapy services 
furnished in whole or in part by a physical therapist assistant.
     CO Modifier: Outpatient occupational therapy services 
furnished in whole or in part by an occupational therapy assistant.
    In the CY 2019 PFS final rule, we clarified that the CQ and CO 
modifiers are required to be used when applicable for services 
furnished on or after January 1, 2020, on the claim line of the service 
alongside the respective GP or GO therapy modifier to identify services 
furnished under a PT or OT plan of care. The GP and GO therapy 
modifiers, along with the GN modifier for speech-language pathology 
(SLP) services, have been used since 1998 to track and accrue the per-
beneficiary incurred expenses amounts to different therapy caps, now KX 
modifier thresholds, one amount for PT and SLP services combined and a 
separate amount for OT services. We also clarified in the CY 2019 PFS 
final rule that the CQ and CO modifiers will trigger application of the 
reduced payment rate for outpatient therapy services furnished in whole 
or in part by a PTA or OTA, beginning for services furnished in CY 
2022.
    In response to public comments on the CY 2019 PFS proposed rule, we 
did not finalize our proposed definition of ``furnished in whole or in 
part by a PTA or OTA'' as a service for which any minute of a 
therapeutic service is furnished by a PTA or OTA. Instead, we finalized 
a de minimis standard under which a service is considered to be 
furnished in whole or in part by a PTA or OTA when more than 10 percent 
of the service is furnished by the PTA or OTA.
    We also explained in the CY 2019 PFS proposed and final rules (83 
FR 35850 through 35852 and 83 FR 59654 through 59660, respectively) 
that the CQ and CO modifiers would not apply to claims for outpatient 
therapy services that are furnished by, or incident to the services of, 
physicians or nonphysician practitioners (NPPs) including nurse 
practitioners, physician assistants, and clinical nurse specialists. 
This is because our regulations for outpatient physical and 
occupational therapy services require that an individual furnishing 
outpatient therapy services incident to the services of a physician or 
NPP must meet the qualifications and standards for a therapist. As 
such, only therapists and not therapy assistants can furnish outpatient 
therapy services incident to the services of a physician or NPP (83 FR 
59655 through 59656); and, the new PTA and OTA modifiers cannot be used 
on the line of service of the professional claim when the rendering NPI 
identified on the claim is a physician or an NPP. We also intend to 
revise our manual provisions at Pub. 100-02, Medicare Benefit Policy 
Manual (MBPM), Chapter 15, section 230, as appropriate, to reflect 
requirements for the new CQ and CO modifiers that will be used to 
identify services furnished in whole or in part by a PTA or OTA 
starting in CY 2020. We anticipate amending these manual provisions for 
CY 2020 to reflect the policies we adopt through the CY 2020 PFS notice 
and comment rulemaking process.
    In PFS rulemaking for CY 2019, we identified certain situations 
when the therapy assistant modifiers do apply. The modifiers are 
applicable to:
     Therapeutic portions of outpatient therapy services 
furnished by PTAs/OTAs, as opposed to administrative or other non-
therapeutic services that can be performed by others without the 
education and training of OTAs and PTAs.
     Services wholly furnished by PTAs or OTAs without physical 
or occupational therapists.
     Evaluative services that are furnished in part by PTAs/
OTAs (keeping in mind that PTAs/OTAs are not recognized to wholly 
furnish PT and OT evaluation or re-evaluations).
    We also identified some situations when the therapy assistant 
modifiers do not apply. They do not apply when:
     PTAs/OTAs furnish services that can be done by a 
technician or aide who does not have the training and education of a 
PTA/OTA.
     Therapists exclusively furnish services without the 
involvement of PTAs/OTAs.
    Finally, we noted that we would be further addressing application 
of the modifiers for therapy assistant services and the 10 percent de 
minimis standard more specifically in PFS rulemaking for CY 2020, 
including how the modifiers are applied in different scenarios for 
different types of services.
b. Applying the CQ and CO Modifiers
    We interpreted the references in section 1834(v)(1) and (2) of the 
Act to outpatient physical therapy ``service'' and outpatient 
occupational therapy ``service'' to mean a specific procedure code that 
describes a PT or OT service. This interpretation makes sense because 
section 1834(v)(2) of the Act requires the use of a modifier to 
identify on each request for payment, or bill submitted for an 
outpatient therapy service furnished in whole or in part by a PTA/OTA. 
For purposes of billing, each outpatient therapy service is identified 
by a procedure code.

[[Page 62703]]

    To apply the de minimis standard under which a service is 
considered to be furnished in whole or in part by a PTA or OTA when 
more than 10 percent of the service is furnished by the PTA or OTA, we 
proposed to make the 10 percent calculation based on the respective 
therapeutic minutes of time spent by the therapist and the PTA/OTA, 
rounded to the nearest whole minute. The minutes of time spent by a 
PTA/OTA furnishing a therapeutic service can overlap partially or 
completely with the time spent by a physical or occupational therapist 
furnishing the service. We proposed that the total time for a service 
would be the total time spent by the therapist (whether independent of, 
or concurrent with, a PTA/OTA) plus any additional time spent by the 
PTA/OTA independently furnishing the therapeutic service. When deciding 
whether the therapy assistant modifiers apply, we proposed that if the 
PTA/OTA participates in the service concurrently with the therapist for 
only a portion of the total time that the therapist delivers a service, 
the CQ/CO modifiers apply when the minutes furnished by the therapy 
assistant are greater than 10 percent of the total minutes spent by the 
therapist furnishing the service. If the PTA/OTA and the therapist each 
separately furnish portions of the same service, we proposed that the 
CQ/CO modifiers would apply when the minutes furnished by the therapy 
assistant are greater than 10 percent of the total minutes--the sum of 
the minutes spent by the therapist and therapy assistant--for that 
service. We proposed to apply the CQ/CO modifier policies to all 
services that would be billed with the respective GP or GO therapy 
modifier. We believed this was appropriate because it is the same way 
that CMS currently identifies physical therapy or occupational therapy 
services for purposes of accruing incurred expenses for the thresholds 
and targeted review process.
    For purposes of deciding whether the 10 percent de minimis standard 
is exceeded, we offered two different ways to compute this. The first 
is to divide the PTA/OTA minutes by the total minutes for the service--
which is (a) the therapist's total time when PTA/OTA minutes are 
furnished concurrently with the therapist, or (b) the sum of the PTA/
OTA and therapist minutes when the PTA/OTA's services are furnished 
separately from the therapist; and then to multiply this number by 100 
to calculate the percentage of the service that involves the PTA/OTA. 
We proposed to round to the nearest whole number so that when this 
percentage is 11 percent or greater, the 10 percent de minimis standard 
is exceeded and the CQ/CO modifier is applied. The other method is 
simply to divide the total time for the service (as described above) by 
10 to identify the 10 percent de minimis standard, and then to add one 
minute to identify the number of minutes of service by the PTA/OTA that 
would be needed to exceed the 10 percent standard. For example, where 
the total time of a service is 60 minutes, the 10 percent standard is 
six (6) minutes, and adding one minute yields seven (7) minutes. Once 
the PTA/OTA furnishes at least 7 minutes of the service, the CQ/CO 
modifier would be required to be added to the claim for that service. 
As noted above, we proposed to round the minutes and percentages of the 
service to the nearest whole integer. For example, when the total time 
for the service is 45 minutes, the 10 percent calculation would be 4.5 
which would be rounded up to 5, and the PTA/OTA's contribution would 
need to meet or exceed 6 minutes before the CQ/CO modifier is required 
to be reported on the claim. See Table 25 for minutes needed to meet or 
exceed using the ``simple'' method with typical times for the total 
time of a therapy service.
[GRAPHIC] [TIFF OMITTED] TR15NO19.032

    We also clarified that the 10 percent de minimis standard, and 
therefore, the CQ/CO modifiers are not applicable to services in which 
the PTA/OTA did not participate. To the extent that the PTA/OTA and the 
physical therapist/occupational therapist (PT/OT) separately furnish 
different services that are described by procedure codes defined in 15-
minute increments, billing examples and proposed policies are included 
below in Scenario Two.
    We proposed to address more specifically the application of the 10 
percent de minimis standard in various clinical scenarios to decide 
when the CQ/CO modifiers apply. We acknowledged that application of the 
10 percent de minimis standard can work differently depending on the 
types of services and scenarios involving both

[[Page 62704]]

the PTA/OTA and the PT/OT. Therapy services are typically furnished in 
multiple units of the same or different services on a given treatment 
day, which can include untimed services (not billable in multiple 
units) and timed services that are defined by codes described in 15-
minute intervals. The majority of the untimed services that therapists 
bill for fall into three categories: (1) Evaluative procedures, (2) 
group therapy, and (3) supervised modalities. We discuss each of these 
in greater detail below. Only one (1) unit can be reported in the claim 
field labeled ``units'' for each procedure code representing an untimed 
service. The preponderance of therapy services, though, are billed 
using codes that are described in 15-minute increments. These services 
are typically furnished to a patient on a single day in multiple units 
of the same and/or different services. Under our current policy, the 
total number of units of one or more timed services that can be added 
to a claim depends on the total time for all the 15-minute timed codes 
that were delivered to a patient on a single date of service. A summary 
of our proposals for applying the CQ/CO modifiers using the 10 percent 
de minimis standard, along with applicable billing scenarios, are 
outlined below by category. In each of these scenarios, we assumed that 
the PTA/OTA minutes are for therapeutic services.
     Evaluations and re-evaluations: CPT codes 97161 through 
97163 for physical therapy evaluations for low, moderate, and high 
complexity level, and CPT code 97164 for physical therapy re-
evaluation; and CPT codes 97165 through 97167 for occupational therapy 
evaluations for low, moderate, and high complexity level, and CPT 97168 
for occupational therapy re-evaluation. These PT and OT evaluative 
procedures are untimed codes and cannot be billed in multiple units--
one unit is billed on the claim. As discussed in CY 2019 PFS rulemaking 
(83 FR 35852 and 83 FR 59656) and noted above, PTAs/OTAs are not 
recognized to furnish evaluative or assessment services, but to the 
extent that they furnish a portion of an evaluation or re-evaluation 
(such as completing clinical labor tasks for each code) that exceeds 
the 10 percent de minimis standard, the appropriate therapy assistant 
modifier (CQ or CO) must be used on the claim. We note that it is 
possible for the PTA/OTA to furnish these minutes either concurrently 
or separately from the therapist. For example, when the PTA/OTA assists 
the PT/OT concurrently for a 5-minute portion of the 30 minutes that a 
PT or OT spent furnishing an evaluation (for example, CPT code 97162 
for moderate complexity PT evaluation or CPT code 97165 for a low 
complexity OT evaluation--each have a typical therapist face-to-face 
time of 30 minutes), the respective CQ or CO modifier is applied to the 
service because the 5 minutes surpasses the 10 percent de minimis 
standard. In other words, 10 percent of 30 minutes is 3 minutes, and 
the CQ or CO modifier applies if the PTA/OTA furnishes more than 3 
minutes, meaning at least 4 minutes, of the service. If the PTA/OTA 
separately furnishes a portion of the service that takes 5 minutes (for 
example, performing clinical labor tasks such as obtaining vital signs, 
providing self-assessment tool to the patient and verifying its 
completion), and then the PT/OT separately (without the PTA/OTA) 
furnishes a 30 minute face-to-face evaluative procedure--bringing the 
total time of the service to 35 minutes (the sum of the separate PTA/
OTA minutes, that is, 5 minutes, plus the 30-minute therapist service), 
the CQ or CO modifier would be applied to the service because the 5 
minutes of OTA/PTA time exceeds 10 percent of the 35 total minutes for 
the service. In other words, 10 percent of 35 minutes is 3.5 minutes 
which is rounded up to 4 minutes. The CQ or CO modifier would apply 
when the PTA/OTA furnishes 5 or more minutes of the service, as 
discussed above and referenced in Table 25.
     Group Therapy: CPT code 97150 (requires constant 
attendance of therapist or assistant, or both). CPT code 97150 
describes a service furnished to a group of 2 or more patients. Like 
evaluative services, this code is an untimed service and cannot be 
billed in multiple units on the claim, so one unit of the service is 
billed for each patient in the group. For the group service, the CQ/CO 
modifier would apply when the PTA/OTA wholly furnishes the service 
without the therapist. The CQ/CO modifier would also apply when the 
total minutes of the service furnished by the PTA/OTA (whether 
concurrently with, or separately from, the therapist), exceed 10 
percent of the total time, in minutes, of the group therapy service 
(that is, the total minutes of service spent by the therapist (with or 
without the PTA/OTA) plus any minutes spent by the PTA/OTA separately 
from the therapist). For example, the modifiers would apply when the 
PTA/OTA participates concurrently with the therapist for 5 minutes of a 
total group therapy service time of 40-minutes (based on the time of 
the therapist); or when the PTA/OTA separately furnishes 5 minutes of a 
total group time of 40 minutes (based on the sum of minutes of the PTA/
OTA (5) and therapist (35)).
     Supervised Modalities: CPT codes 97010 through 97028, and 
HCPCS codes G0281, G0183, and G0329. Modalities, in general, are 
physical agents that are applied to body tissue in order to produce a 
therapeutic change through various forms of energy, including but not 
limited to thermal, acoustic, light, mechanical or electric. Supervised 
modalities, for example vasopneumatic devices, paraffin bath, and 
electrical stimulation (unattended), do not require the constant 
attendance of the therapist or supervised therapy assistant, unlike the 
modalities defined in 15-minute increments that are discussed in the 
below category. When a supervised modality, such as whirlpool (CPT code 
97022), is provided without the direct contact of a PT/OT and/or PTA/
OTA, that is, it is furnished entirely by a technician or aide, the 
service is not covered and cannot be billed to Medicare. Supervised 
modality services are untimed, so only one unit of the service can be 
billed regardless of the number of body areas that are treated. For 
example, when paraffin bath treatment is provided to both of the 
patient's hands, one unit of CPT code 97018 can be billed, not two. For 
supervised modalities, the CQ or CO modifier would apply to the service 
when the PTA/OTA fully furnishes all the minutes of the service, or 
when the minutes provided by the PTA or OTA exceed 10 percent of total 
minutes of the service. For example, the CQ/CO modifiers would apply 
when either (1) the PTA/OTA concurrently furnishes 2 minutes of a total 
8-minute service by the therapist furnishing paraffin bath treatment 
(HCPCS code 97018) because 2 minutes is greater than 10 percent of 8 
minutes ((0.8 minute, or 1 minute after rounding); or (2) the PTA/OTA 
furnishes 3 minutes of the service separately from the therapist who 
furnishes 5 minutes of treatment for a total time of 8 minutes (total 
time equals the sum of the PT/OT minutes plus the separate PTA/OTA 
minutes) because 3 minutes is greater than 10 percent of 8 total 
minutes (0.8 minute rounded to 1 minute).
     Services defined by 15-minute increments/units: These 
timed codes are included in the following current CPT code ranges: CPT 
codes 97032 through 97542--including the subset of codes for modalities 
in the series CPT codes 97032 through 97036; and, codes for procedures 
in the series CPT codes 97110-97542; CPT codes 97750-97755

[[Page 62705]]

for tests and measurements; and CPT codes: 97760-97763 for orthotic 
management and training and prosthetic training. Based on CPT 
instructions for these codes, the therapist (or their supervised 
therapy assistant, as appropriate) is required to furnish the service 
directly in a one-on-one encounter with the patient, meaning they are 
treating only one patient during that time. Examples of modalities 
requiring one-on-one patient contact include electrical stimulation 
(attended), CPT code 97032, and ultrasound, CPT code 97035. Examples of 
procedures include therapeutic exercise, CPT code 97110, neuromuscular 
reeducation, CPT 97112, and gait training, CPT code 97116.
    Our policy for reporting of service units with HCPCS codes for both 
untimed services and timed services (that is, only those therapy 
services defined in 15-minute increments) is explained in section 20.2 
of Chapter 5 of the Medicare Claims Processing Manual (MCPM). To bill 
for services described by the timed codes (hereafter, those codes 
described per each 15-minutes) furnished to a patient on a date of 
service, the therapist or therapy assistant needs to first identify all 
timed services furnished to a patient on that day, and then total all 
the minutes of all those timed codes. Next, the therapist or therapy 
assistant needs to identify the total number of units of timed codes 
that can be reported on the claim for the physical or occupational 
therapy services for a patient in one treatment day. Once the number of 
billable units is identified, the therapist or therapy assistant 
assigns the appropriate number of unit(s) to each timed service code 
according to the total time spent furnishing each service. For example, 
to bill for one 15-minute unit of a timed code, the qualified 
professional (the therapist or therapy assistant) must furnish at least 
8 minutes and up to 22 minutes of the service; to bill for 2 units, at 
least 23 minutes and up to 37 minutes, and to bill for 3 units, at 
least 38 minutes and up to 52 minutes. We note that these minute ranges 
are applicable when one service, or multiple services, defined by timed 
codes are furnished by the qualified professional on a treatment day. 
We understand that the therapy industry often refers to these billing 
conventions as the ``eight-minute rule.'' The idea is that when a 
therapist or therapy provider bills for one or more units of services 
that are described by timed codes, the therapist's direct, one-on-one 
patient contact time would average 15 minutes per unit. This idea is 
also the basis for the work values we have established for these timed 
codes. Our current policies for billing of timed codes and related 
documentation do not take into consideration whether a service is 
furnished ``in whole or in part'' by a PTA/OTA, or otherwise address 
the application of the CQ/CO modifier when the 10 percent de minimis 
standard is exceeded, for those services in which both the PTA/OTA and 
the PT/OT work together to furnish a service or services.
    To support the number of 15-minute timed units billed on a claim 
for each treatment day, we require that the total timed-code treatment 
time be documented in the medical record, and that the treatment note 
must document each timed service, whether or not it is billed, because 
the unbilled timed service(s) can impact billing. The minutes that each 
service is furnished can be, but are not required to be, documented. We 
also require that each untimed service be documented in the treatment 
note in order to support these services billed on the claim; and, that 
the total treatment time for each treatment day be documented--
including minutes spent providing services represented by the timed 
codes (the total timed-code treatment time) and the untimed codes. To 
minimize burden, we are not proposing changes to these documentation 
requirements in this proposed rule.
    Beginning January 1, 2020, in order to provide support for 
application of the CQ/CO modifier(s) to the claim as required by 
section 1834(v)(2)(B) of the Act and our regulations at Sec. Sec.  
410.59(a)(4) and 410.60(a)(4), we proposed to add a requirement that 
the treatment notes explain, via a short phrase or statement, the 
application or non-application of the CQ/CO modifier for each service 
furnished that day. We would include this documentation requirement in 
subsection in Chapter 15, MBPM, section 220.3.E on treatment notes. 
Because the CQ/CO modifiers also apply to untimed services, our 
proposed revision to the documentation requirement for the daily 
treatment note would extend to those codes and services as well. For 
example, when PTAs/OTAs assist PTs/OTs to furnish services, the 
treatment note could state one of the following, as applicable: (a) 
``Code 97110: CQ/CO modifier applied - PTA/OTA wholly furnished'' or, 
(b) ``Code 97150: CQ/CO modifier applied - PTA/OTA minutes = 15%'' or 
``Code 97530: CQ/CP modifier not applied - PTA/OTA minutes less than 
10% standard.'' For those therapy services furnished exclusively by 
therapists without the use of PTAs/OTA, the PT/OT could note one of the 
following: ``CQ/CO modifier NA'', or ``CQ/CO modifier NA - PT/OT fully 
furnished all services.'' Given that the minutes of service furnished 
by or with the PTA/OTA and the total time in minutes for each service 
(timed and untimed) are used to decide whether the CQ/CO modifier is 
applied to a service, we sought comment on whether it would be 
appropriate to require documentation of the minutes as part of the CQ/
CO modifier explanation as a means to avoid possible additional burden 
associated with a contractor's medical review process conducted for 
these services. We solicited comment from therapists and therapy 
providers about current burden associated with the medical review 
process based on our current policy that does not require the times for 
individual services to be documented. Based on comments received, if we 
were to adopt a policy to include documentation of the PTA/OTA minutes 
and total time (TT) minutes, the CQ/CO modifier explanation could read 
similar to the following: ``Code 97162 (TT = 30 minutes): CQ/CO 
modifier not applied - PTA/OTA minutes (3) did not exceed the 10 
percent standard.''
    To recap, under our policy, therapists or therapy assistants would 
apply the therapy assistant modifiers to the timed codes by first 
following the usual process to identify all procedure codes for the 15-
minute timed services furnished to a beneficiary on the date of 
service, add up all the minutes of the timed codes furnished to the 
beneficiary on the date of service, decide how many total units of 
timed services are billable for the beneficiary on the date of service 
(based on time ranges in the chart in the manual), and assign billable 
units to each billable procedure code. The therapist or therapy 
assistant would then need to decide for each billed procedure code 
whether or not the therapy assistant modifiers apply.
    As previously explained, the CQ/CO modifier does not apply if all 
units of a procedure code were furnished entirely by the therapist; 
and, where all units of the procedure code were furnished entirely by 
the PTA/OTA, the appropriate CQ/CO modifier would apply. When some 
portion of the billed procedure code is furnished by the PTA/OTA, the 
therapist or therapy assistant would need to look at the total minutes 
for all the billed units of the service, and compare it to the minutes 
of the service furnished by the PTA/OTA as described above in order to 
decide whether the 10 percent de minimis standard is exceeded. If the 
minutes of the service furnished by the

[[Page 62706]]

PTA/OTA are more than 10 percent of the total minutes of the service, 
the therapist or therapy assistant would assign the appropriate CQ or 
CO modifier. We would make clarifying technical changes to chapter 5, 
section 20.2 of the MCPM to reflect the policies adopted through in 
this rulemaking related to the application or non-application of the 
therapy assistant modifiers. We anticipated that we would add examples 
to illustrate when the applicable therapy assistant modifiers must be 
applied, similar to the examples provided below.
    In the CY 2020 PFS proposed rule, we provided detailed examples of 
clinical scenarios to illustrate how the 10 percent de minimis standard 
would be applied under our proposals when therapists and their 
assistants work together concurrently or separately to treat the same 
patient on the same day (84 FR 40562 through 40564).
c. Regulatory Provisions
    In accordance with section 1834(v)(2)(B) of the Act, we proposed to 
amend Sec. Sec.  410.59(a)(4) and 410.60(a)(4) for outpatient physical 
and occupational therapy services, respectively, and Sec.  410.105(d) 
for physical and occupational therapy services furnished by 
comprehensive outpatient rehabilitation facilities (CORFs) as 
authorized under section 1861(cc) of the Act, to establish as a 
condition of payment that claims for services furnished in whole or in 
part by an OTA or PTA must include a prescribed modifier; and that 
services will not be considered furnished in part by an OTA or PTA 
unless they exceed 10 percent of the total minutes for that service, 
beginning for services furnished on and after January 1, 2020. To 
implement section 1834(v)(1) of the Act, we proposed to amend 
Sec. Sec.  410.59(a)(4) and 410.60(a)(4) for outpatient physical and 
occupational therapy services, respectively, and at Sec.  410.105(d) 
for physical and occupational therapy services furnished by CORFs to 
specify that claims from physical and occupational therapists in 
private practice paid under section 1848 of the Act and from providers 
paid under section 1834(k) of the Act for physical therapy and 
occupational therapy services that contain a therapy assistant 
modifier, are paid at 85 percent of the otherwise applicable payment 
amount for the service for dates of service on and after January 1, 
2022. As specified in the CY 2019 PFS final rule, we also noted that 
the CQ or CO modifier is to be applied alongside the corresponding GP 
or GO therapy modifier that is required on each claim line of service 
for physical therapy or occupational therapy services. Beginning for 
dates of service and after January 1, 2020, claims missing the 
corresponding GP or GO therapy modifier will be rejected/returned to 
the therapist or therapy provider so they can be corrected and 
resubmitted for processing.
    As discussed in the CY 2019 PFS proposed and final rules (see 83 FR 
35850 and 83 FR 59654), we established that the reduced payment rate 
under section 1834(v)(1) of the Act for the outpatient therapy services 
furnished in whole or in part by therapy assistants is not applicable 
to outpatient therapy services furnished by CAHs, for which payment is 
made under section 1834(g) of the Act. We clarified that we do not 
interpret section 1834(v) of the Act to apply to outpatient physical 
therapy or occupational therapy services furnished by CAHs, or by other 
providers for which payment for outpatient therapy services is not made 
under section 1834(k) of the Act based on the PFS rates.
    We received almost 9,000 public comments on the proposed payment 
provisions for outpatient PT and OT services furnished in whole or in 
part by therapy assistants. The following is a summary of the comments 
we received and our responses.
    Comment: Many commenters objected to our proposal that the time for 
the therapeutic service furnished ``in part'' by the PTA/OTA that 
counts towards the 10 percent standard includes both the minutes spent 
concurrently with and separately from the therapist. These commenters 
also expressed concerns that this unfairly discounts services that are 
fully furnished by therapists in which the therapy assistant supports 
them while providing a service. Some of these commenters stated that 
section 53107 of the BBA of 2018 does not permit the application of the 
assistant modifier for a PT or OT service furnished by the respective 
physical or occupational therapist and that CMS exceeded its authority 
in proposing to do so.
    Many commenters stated that when a therapy assistant and therapist 
furnish care to a patient at the same time, it is apparent the patient 
requires both professionals; and, that this clinical scenario either 
represents a highly skilled procedure or one where such services are 
required for safety reasons. Commenters stated their belief that 
applying the therapy assistant modifiers to discount payment for these 
services is not justified.
    Many commenters stated they objected to the use of the term 
``concurrent'' when applying the 10 percent standard for purposes of 
outpatient therapy services because it conflicts with the definition of 
``concurrent'' as it applies to the SNF Part A patient. The SNF Minimum 
Data Set Resident Assessment Instrument (MDS-RAI) manual guidance 
defines ``concurrent'' to include the number of minutes of therapy when 
the therapist or assistant is treating two residents at the same time. 
Some commenters also disagreed with our use of the term ``concurrent'' 
because that term is not currently defined for outpatient therapy 
services in statute, regulation, or in our manuals to ``reflect when 
two clinicians (therapist and therapist assistant) are providing care 
to a beneficiary at the same time.'' These commenters recommended that 
CMS adopt the term ``team'' instead, based on a reference to a document 
on the CMS therapy services website titled ``11 Part B Billing 
Scenarios,'' because they stated it describes care being delivered to 
one patient at the same time by two professionals as ``team-based 
therapy.''
    Other commenters suggested that instead of ``concurrent,'' that we 
use the term ``in tandem'' to describe the cases where a therapist and 
a therapy/therapist assistant are jointly furnishing services to a 
patient at the same time. One commenter recommended that CMS reconsider 
its definition of ``concurrent'' therapy and align it with the 
definition in Part A.
    Some commenters supported our proposal including a few commenters 
that agreed there should be a payment differential for the services 
furnished by a therapy assistant; and, several stated they fully 
supported of all of the proposals. A few commenters shared their 
concerns that they have observed therapy assistants practicing outside 
their scope of practice and their level of training--such as managing a 
patient's plans of care, some without any therapist supervision.
    Many commenters urged CMS to restructure the proposal to recognize 
as services furnished in whole or in part by therapy assistants only 
those minutes that the therapy assistant spends independently with the 
patient when the therapist is absent.
    Response: After a review of commenters' concerns and our current 
policies, we are persuaded to reconsider our interpretation of what 
time counts as services furnished in whole or in part by therapy 
assistants, including for purposes of applying the 10 percent standard. 
We agree with commenters that we should not count the time when a 
therapist and a therapist assistant furnish services to the same 
patient at the same time. We believe this

[[Page 62707]]

interpretation is appropriate because we agree with commenters that 
when a therapist and therapist assistant furnish services together, the 
therapist is fully furnishing the service. Also, any time that the 
therapy assistant furnishes services alone or independent of the 
therapist is time that the therapist can be credited for furnishing 
services to a different patient. We also note the commenters' incorrect 
use of the term ``clinicians'' to refer to the both the therapist and 
the therapy assistant. We clarify that the term clinician refers only 
the physical or occupational therapist and that a therapy assistant is 
considered a qualified professional when furnishing services under the 
supervision of a therapist. For purposes of Medicare, therapy 
assistants are limited in the services they may furnish and may not 
supervise other therapy caregivers (see MBPM, Chapter 15, section 230.1 
and 230.2).
    We agree with commenters that using the term ``concurrent'' could 
be confusing because it is used for the SNF Part A patient to represent 
the number of minutes that a therapist or therapy assistant is treating 
two patients at the same time. Given that we are not finalizing the 
proposal to count the minutes of service furnished by the assistant 
together with the therapist, we no longer have a need to use the 
``concurrent'' term. Regarding the suggestion that we use the term 
``team'' instead of concurrent, we also do not define in our manuals 
the term ``team'' because we believe it is ambiguous. We have only used 
the term ``team'' in the ``Team'' billing scenario in one of the ``11 
Billing Scenarios'' where it is used in an example in which the 
physical therapist and occupational therapist furnish all the minutes 
of a 30-minute service together--only the physical therapist or 
occupational therapist can bill for each 15 minute unit, but not both.
    We find the commenters' concerns persuasive and are revising our 
proposed policy so that the time spent by a PTA/OTA furnishing a 
therapeutic service ``concurrently,'' or at the same time, with the 
therapist will not count for purposes of assessing whether the 10 
percent standard has been met. Instead, we are finalizing a policy that 
only the minutes that the PTA/OTA spends independent of the therapist 
will count towards the 10 percent de minimis standard. We are revising 
our regulation text at Sec. Sec.  410.59 (outpatient occupational 
therapy), 410.60 (physical therapy), and 410.105 (for PT and OT CORF 
services) accordingly. In the CY 2020 PFS proposed rule, we provided 
detailed examples of clinical scenarios to illustrate how the 10 
percent de minimis standard would be applied under our proposals when 
therapists and their assistants work together concurrently or 
separately to treat the same patient on the same day (84 FR 40562 
through 40564). We intend to provide further detail regarding examples 
of clinical scenarios to illustrate our final policies regarding the 
applicability of the therapy assistant modifiers through information 
that we will post on the cms.gov website.
    Comment: Commenters opposed our proposal to apply the 10 percent 
time standard, for billing purposes, to all the billed units of a 
service defined by a single procedure code, and urged CMS to not 
finalize the proposal. These commenters requested that instead CMS 
finalize a policy that assesses the 10 percent standard for each 15-
minute unit of each procedure code. Commenters noted that the proposal 
was contrary to the response to comments in the CY 2019 PFS final rule 
(83 FR 59659) in which we provided an example of how our systems would 
allow them to bill for 15-minute units of a timed service on 2 separate 
claim lines--one with an assistant modifier and the other without. Some 
commenters stated that the proposal would not allow proper payment when 
a therapist fully furnishes 30 minutes of a timed service, then hands 
off to a therapy assistant who fully performs another 15 minutes of the 
same service. Many commenters stated that the proposed policy does not 
reflect congressional intent because it would discount the therapists' 
services, rather than therapy assistants' services.
    Response: We acknowledge that we provided a hypothetical billing 
example in the CY 2019 PFS final rule suggesting that our policy would 
allow the number of 15-minute units of a code furnished by the PT/OT 
and the PTA/OTA to be listed separately on two different claim lines, 
and that the example differed from the proposal we developed for the CY 
2020 PFS proposed rule. As the commenters noted, we proposed, for 
billing purposes, that each outpatient therapy service that is subject 
to the 10 percent de minimis standard would be identified on the claim 
by a single procedure code, for both untimed codes and codes described 
in 15-minute-unit increments. After consideration of the public 
comments on our proposal and further reflection on our manual 
requirements to document timed codes, we find the commenters' concerns 
persuasive and, for purposes of billing, we are finalizing a revised 
definition of a service to which the de minimis standard is applied to 
include untimed codes and each 15-minute unit of codes described in 15-
minute increments as a service. Accordingly, we are revising our final 
policy in response to comments to allow the separate reporting, on two 
different claim lines, of the number of 15-minute units of a code to 
which the therapy assistant modifiers do not apply, and the number of 
15-minute units of a code to which the therapy assistant modifiers do 
apply. In the CY 2020 PFS proposed rule, we provided detailed examples 
of clinical scenarios to illustrate how the 10 percent de minimis 
standard would be applied under our proposals (84 FR 40562 through 
40564). The revised policy we are finalizing here will apply generally 
in the same way as illustrated in those examples, except for the 
difference in the minutes of time that are counted toward the 10 
percent standard (not counting the minutes furnished together by a 
therapist and therapy assistant), the application of the 10 percent 
standard to each billed unit of a timed code rather than to all billed 
units of a timed code, and the billing on two separate claim lines of 
the units of a timed code to which the therapy assistant modifiers do 
and do not apply. We intend to provide further detail regarding 
examples of clinical scenarios to illustrate our final policies 
regarding the applicability of the therapy assistant modifiers through 
information that we will post on the cms.gov website.
    Comment: Nearly all commenters opposed our proposal to require that 
the treatment notes explain, in a short phrase or statement, the 
application or non-application of the therapy assistant modifier for 
each therapy service furnished. Many of these commenters stated that 
the statute does not require documentation to explain why a modifier 
was or was not applied for each code. Most commenters stated that the 
proposed documentation requirements associated with the de minimis 
standard for the therapy assistant modifiers are exceedingly burdensome 
and conflict with the Administration's ``Patients over Paperwork 
Initiative.'' The commenters stated that it is unreasonable to impose a 
new documentation requirement on therapists and therapy providers that 
is duplicative of current requirements. Many commenters stated that the 
Medicare Benefit Policy Manual (MBPM) already includes extensive 
documentation requirements, and that the Medicare Claims Processing 
Manual (MCPM) includes extensive detail on how to count minutes for 
therapy services.
    Many commenters stated that if a therapist or therapy provider has 
a

[[Page 62708]]

mechanism to provide evidence as to whether a specific service was 
furnished independently by a therapist or an assistant, or was 
furnished ``in part'' by an assistant, in sufficient detail to permit a 
medical record reviewer to determine whether the de minimis threshold 
was met, they should not also be required to separately document this 
information in a narrative note. A few of the commenters opposing the 
addition of narrative phrases for each service stated that we should 
revise our current subregulatory guidance to include a statement such 
as the following: ``The provider should have a mechanism in place to 
provide evidence whether a specific service was furnished independently 
by a therapist or an assistant, or was furnished ``in part'' by an 
assistant in sufficient detail to permit the determination of whether 
the ``de minimis'' threshold was met.'' Another commenter stated that 
it is expected and appropriate for the documentation in the medical 
record to specify whether a certain service was furnished independently 
by a therapist or an assistant or was furnished ``in part'' by an 
assistant in enough detail to permit a medical record reviewer to 
determine whether the de minimis threshold was met.
    Many commenters stated that they believe our proposed documentation 
requirement to explain in the medical record the use or non-use of the 
modifiers would serve as another tool for medical reviewers to use 
against therapy providers to justify a technical denial even though the 
medical record may otherwise contain sufficient documentation to 
justify the use or non-use of the CQ/CO modifier.
    Many commenters submitted comments that were specific to our 
request for comment on documentation of the minutes for services 
furnished by the PTA/OTA as a means to avoid possible additional burden 
associated with a contractor's medical review process conducted for 
these services. Nearly all of the commenters stated they opposed adding 
a requirement to include a narrative phrase in the treatment note and 
requiring documentation of the minutes as duplicative of existing 
documentation requirements. One commenter, also not in favor of 
requiring the addition of narrative phrases to the medical record 
because they do not believe such phrases provide value to patient care 
or providers, stated that the therapy provider should document the 
number of minutes provided solely by the assistant and that this should 
be adequate to support the use and nonuse of the CO/CQ modifiers--
citing an example that included ``CPT 97110--Assistant provided 8 
minutes, Therapist provided 24 minutes'' and ``CPT 97530--Assistant 
provided 22 minutes, Therapist provided 0 minutes.''
    Several commenters supported the proposed documentation 
requirements. One commenter stated they have already begun taking steps 
to support billing compliance via their electronic health record that 
creates a selection to attach the appropriate PTA/OTA modifier and 
includes the creation of a ``smart phrase'' which the therapist can 
document to support compliance of billing and review.
    Response: We appreciate the comments regarding our documentation 
proposal. After consideration of the comments and a review of our 
manual provisions, we find many of the commenters' suggestions 
persuasive. We agree that the addition of narrative phrases for each 
service may be duplicative of existing documentation requirements in 
the MBPM, chapter 15, section 220 and in Chapter 5, MCPM. Although a 
few commenters supported the addition of narratives, we also took note 
of the many commenters who told us that therapists and therapy 
providers should not be required to include a narrative for each 
service explaining the application or non-application of the therapy 
assistant modifiers when the medical record contains evidence as to 
whether a specific service was furnished independently by a therapist 
or an assistant, or was furnished ``in part'' by an assistant, in 
sufficient detail to permit a medical record reviewer to determine 
whether the de minimis threshold was met.
    As a result, we are not finalizing the proposed documentation 
requirement to explain in the treatment note, in a short phrase or 
statement, the application or non-application of the therapy assistant 
modifier for each therapy service furnished; nor are we finalizing a 
requirement that the therapist and therapy assistant minutes be 
included in the documentation. Instead, we remind therapists and 
therapy providers that correct billing requires sufficient 
documentation in the medical record to support the codes and units 
reported on the claim, including those reported with and without an 
assistant modifier.
    Further, we clarify that we would expect the documentation in the 
medical record to be sufficient to know whether a specific service was 
furnished independently by a therapist or a therapist assistant, or was 
furnished ``in part'' by a therapist assistant, in sufficient detail to 
permit the determination of whether the 10 percent standard was 
exceeded.
    Comment: Many commenters expressed concern that the application of 
the therapy assistant modifiers is likely to result in drastic 
underpayments for outpatient therapy services beginning in 2022, which 
they believe would severely restrict beneficiary access to vital 
therapy services, particularly in rural and underserved areas. Other 
commenters specifically requested that CMS exempt rural areas from the 
therapy assistant modifier policy.
    Response: While we appreciate the concerns raised about the 
potential effects of the therapy assistant modifier policy, we do not 
believe that section 1834(v) of the Act permits us to exempt the 
application of the PTA/OTA modifier policies in rural and underserved 
areas. We intend to monitor the implementation of the therapy assistant 
modifiers, including any changes to access to outpatient therapy 
services.
    Comment: One commenter stated their concerns about the correct 
ordering of modifiers on claims for therapy services to assure correct 
payment, but without adding to therapists' or therapy providers' 
administrative burden. They based their concerns on a CMS longstanding 
FAQ, which states that modifiers that impact payment should be in the 
first position, and are seeking clarification as to whether the CQ or 
CO modifier would need to be in the first position on claims for PT 
services (modifier GP) and OT services (modifier GO) where one of those 
new modifiers applies. The commenters stated that if the CQ or CO 
modifier is required to be in the first position, that would need to be 
done manually because therapists and therapy providers are not able to 
program their chargemasters to accommodate every possible modifier 
combination to meet Medicare and non-Medicare reporting requirements.
    Response: We appreciate the commenter's comments. We note that we 
do not have central standard systems edits in place to reject or return 
claims for PT or OT services if the CQ or CO modifier is not in the 
first modifier position. However, some CMS contractors processing 
professional claims may have systems logic in place that would do so. 
We recently issued instructions to our contractors to reorder modifiers 
for PT and OT services so that claims with the therapy assistant 
modifiers are not returned. This reordering will be effective for 
claims containing CQ and CO modifiers with dates of service on and 
after January 1, 2020.

[[Page 62709]]

3. Therapy KX Modifier Threshold Amounts
    The KX modifier thresholds, as discussed above in this section, 
were established through section 50202 of the Bipartisan Budget Act 
(BBA) of 2018. Formerly referred to as therapy caps, these KX modifier 
thresholds are a permanent provision of the law, meaning that the 
statute does not specify an end date. These per-beneficiary amounts 
under section 1833(g) of the Act (as amended by section 4541 of the 
Balanced Budget Act of 1997) (Pub. L. 105-33, August 5, 1997) are 
updated each year based on the MEI. Specifically, these amounts are 
calculated by updating the previous year's amount by the MEI for the 
upcoming calendar year and rounding to the nearest $10.00. Increasing 
the CY 2019 KX modifier threshold amount of $2,040 by the CY 2020 MEI 
of 1.9 percent and rounding to the nearest $10.00 results in a CY 2020 
KX threshold amount of $2,080 for PT and SLP services combined and 
$2,080 for OT services.
    Section 50202 of the Bipartisan Budget Act of 2018 also added 
section 1833(g)(7)(B) of the Act which retains the targeted medical 
review process, but at a lower threshold amount of $3,000 (until CY 
2028) as detailed above in this section. Accordingly, for CY 2020, the 
MR threshold is $3,000 for PT and SLP services combined and $3,000 for 
OT services. Some, but not all claims exceeding the MR threshold amount 
are subject to review, under the established targeted review process. 
For information on the targeted manual medical review process, go to 
https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-CompliancePrograms/Medical-Review/TherapyCap.html.
    We track each beneficiary's incurred expenses for therapy services 
annually and counts them toward the KX modifier and MR thresholds by 
applying the PFS rate for each service less any applicable multiple 
procedure payment reduction (MPPR) amount for services of CMS-
designated ``always therapy'' services. As explained previously in this 
section, we apply the PFS-rate accrual process to outpatient therapy 
services furnished by critical access hospitals (CAHs) even though they 
may be paid on a cost basis (effective January 1, 2014).
    When the expenses incurred for the beneficiary's outpatient therapy 
services for the year have exceeded one or both of the KX modifier 
thresholds, therapy suppliers and providers use the KX modifier on 
claims for subsequent medically necessary services. By using the KX 
modifier, the therapist and therapy provider attest that the services 
above the KX modifier thresholds are reasonable and necessary and that 
documentation of the medical necessity for the services is in the 
beneficiary's medical record. Claims for outpatient therapy services 
that exceed the KX modifier thresholds but do not include the KX 
modifier are denied.

N. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since the inception of the PFS, 
it has also been a priority to revalue services regularly to make sure 
that the payment rates reflect the changing trends in the practice of 
medicine and current prices for inputs used in the PE calculations. 
Initially, this was accomplished primarily through the 5-year review 
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year 
review process, revisions in RVUs were proposed and finalized via 
rulemaking. In addition to the 5-year reviews, beginning with CY 2009, 
CMS and the RUC identified a number of potentially misvalued codes each 
year using various identification screens, as discussed in section 
II.E. of this final rule, Potentially Misvalued Services under the PFS. 
Historically, when we received RUC recommendations, our process had 
been to establish interim final RVUs for the potentially misvalued 
codes, new codes, and any other codes for which there were coding 
changes in the final rule with comment period for a year. Then, during 
the 60-day period following the publication of the final rule with 
comment period, we accepted public comment about those valuations. For 
services furnished during the calendar year following the publication 
of interim final rates, we paid for services based upon the interim 
final values established in the final rule. In the final rule with 
comment period for the subsequent year, we considered and responded to 
public comments received on the interim final values, and typically 
made any appropriate adjustments and finalized those values.
    In the CY 2015 PFS final rule with comment period (79 FR 67547), we 
finalized a new process for establishing values for new, revised and 
potentially misvalued codes. Under the new process, we include proposed 
values for these services in the proposed rule, rather than 
establishing them as interim final in the final rule with comment 
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the 
new process was applicable to all codes, except for new codes that 
describe truly new services. For CY 2017, we proposed new values in the 
CY 2017 PFS proposed rule for the vast majority of 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

[[Page 62710]]

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 
included the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs generally 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.
    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

[[Page 62711]]

the PFS. In addition to these, we sometimes use the relationship 
between the old time values and the new time values for particular 
services to identify alternative work RVUs based on changes in time 
components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider these work RVUs as potential 
options relative to the values developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we believe that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC's recommendation has appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned methodologies to identify potential work RVUs, including 
the methodologies intended to account for the changes in the resources 
involved in furnishing the procedure.
    Several stakeholders, including the RUC, have expressed general 
objections to our use of these methodologies and deemed our actions in 
adjusting the recommended work RVUs as inappropriate; other 
stakeholders have also expressed general concerns with CMS refinements 
to RUC-recommended values in general. In the CY 2017 PFS final rule (81 
FR 80272 through 80277), we responded in detail to several comments 
that we received regarding this issue. In the CY 2017 PFS proposed rule 
(81 FR 46162), we requested comments regarding potential alternatives 
to making adjustments that would recognize overall estimates of work in 
the context of changes in the resource of time for particular services; 
however, we did not receive any specific potential alternatives. As 
described earlier in this section, crosswalks to key reference or 
similar codes are one of the many methodological approaches we have 
employed to identify potential values that reconcile the RUC-recommend 
work RVUs with the recommended time values when the RUC-recommended 
work RVUs did not appear to account for significant changes in time.
    We received several comments regarding our methodologies for work 
valuation in response to the CY 2020 PFS proposed rule and those 
comments are summarized below.
    Comment: Several commenters disagreed with our reference to older 
work time sources, and stated that their use led to the proposal of 
work RVUs based on flawed assumptions. Commenters stated that codes 
with ``CMS/Other'' or ``Harvard'' work time sources, used in the 
original valuation of certain older services, were not surveyed, and 
therefore, were not resource-based. Commenters also stated that it was 
invalid to draw comparisons between the current work time and work RVUs 
of these services to the newly surveyed work time and work RVUs as 
recommended by the RUC.
    Response: We agree that it is important to use the recent data 
available regarding work times, and we note that when many years have 
passed between when time is measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important element in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had routinely been overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, given 
the process under which codes are often valued by comparisons to codes 
with similar times. It also would undermine the validity of the 
allocation of indirect PE RVUs to physician specialties across the PFS. 
Instead, we believe that it is crucial that the code valuation process 
take place with the understanding that the existing work times, used in 
the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available and that we are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the use of time ratio 
methodologies for work valuation. Commenters stated that this use of 
time ratios is not a valid methodology for valuation of physician 
services. Commenters stated that treating all components of physician 
time (preservice, intraservice, postservice and post-operative visits) 
as having identical intensity is incorrect, and inconsistently applying 
it to only certain services under review creates inherent payment 
disparities in a payment system which is based on relative valuation. 
Commenters stated that in many scenarios, CMS selects an arbitrary 
combination of inputs to apply rather than seeking a valid clinically 
relevant relationship that would preserve relativity. Commenters urged 
CMS to determine the work valuation for each code based not only on 
surveyed work times, but also the intensity and complexity of the 
service and relativity to other similar services, rather than basing 
the work value entirely on time.
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for information provided by surveys that suggests the amount of 
time involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. When our review of 
recommended values reveals that changes in the resource of time have 
been unaccounted for in a recommended RVU, then we believe we have the 
obligation to account for that change in establishing work RVUs since

[[Page 62712]]

the statute explicitly identifies time as one of the two elements of 
the work RVUs.
    We recognize that it would not be appropriate to develop work RVUs 
solely based on time given that intensity is also an element of work, 
but in applying the time ratios, we are using derived intensity 
measures based on current work RVUs for individual procedures. We 
clarify again that we do not treat all components of physician time as 
having identical intensity. If we were to disregard intensity 
altogether, the work RVUs for all services would be developed based 
solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. For example, among the codes reviewed in this 
current CY 2020 PFS final rule, CPT codes 52442 (Cystourethroscopy, 
with insertion of permanent adjustable transprostatic implant; each 
additional permanent adjustable transprostatic implant) and 92627 
(Evaluation of auditory function for surgically implanted device(s) 
candidacy or post-operative status of a surgically implanted device(s); 
each additional 15 minutes) share the identical work time of 15 minutes 
but have very different work RVUs of 1.01 and 0.33 respectively. In 
addition, CPT codes 11983 (Removal with reinsertion, non-biodegradable 
drug delivery implant), 64446 (Injection(s), anesthetic agent(s) and/or 
steroid; sciatic nerve, continuous infusion by catheter (including 
catheter placement)), and 78804 (Rp L.T.I.D. w/flow when performed, 
wholebody 2 or more days) all share the same intraservice work time of 
15 minutes and total work time of 40 minutes but each code has a 
different work RVU. These examples demonstrate that we do not value 
services purely based on work time; instead, we incorporate time as one 
of multiple different factors employed in our review process. 
Furthermore, we reiterate that we use time ratios to identify 
potentially appropriate work RVUs, and then use other methods 
(including estimates of work from CMS medical personnel and crosswalks 
to key reference or similar codes) to validate these RVUs. For more 
details on our methodology for developing work RVUs, we direct readers 
to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277).
    We also want to clarify for the commenters that our review process 
is not arbitrary in nature. Our reviews of recommended work RVUs and 
time inputs generally include, but have not been limited to, a review 
of information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the federal 
government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). With regards to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Several commenters discouraged the use of valuation based 
on work RVU increments. Commenters stated that this methodology 
inaccurately treats all components of the physician time as having 
identical intensity and would lead to incorrect work valuations. 
Commenters stated that CMS should carefully consider the clinical 
information justifying the changes in physician work intensity provided 
by the RUC and other stakeholders.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We have no evidence to suggest that the use 
of an incremental difference between codes conflicts with the statute's 
definition of the work component as the resources in time and intensity 
required in furnishing the service. We do consider clinical information 
associated with physician work intensity provided by the RUC and other 
stakeholders as part of our review process, although we remind readers 
again that we do not agree that codes must share the same site of 
service, patient population, or utilization level to serve as an 
appropriate crosswalk.
    In response to comments, in the CY 2019 PFS final rule (83 FR 
59515), we clarified that terms ``reference services'', ``key reference 
services'', and ``crosswalks'' as described by the commenters are part 
of the RUC's process for code valuation. These are not terms that we 
created, and we do not agree that we necessarily must employ them in 
the identical fashion for the purposes of discussing our valuation of 
individual services that come up for review. However, in the interest 
of minimizing confusion and providing clear language to facilitate 
stakeholder feedback, we will seek to limit the use of the term, 
``crosswalk,'' to those cases where we are making a comparison to a CPT 
code with the identical work RVU. We also occasionally make use of a 
``bracket'' for code valuation. A ``bracket'' refers to when a work RVU 
falls between the values of two CPT codes, one at a higher work RVU and 
one at a lower work RVU.
    We look forward to continuing to engage with stakeholders and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes; and will continue to 
welcome feedback from all interested parties regarding valuation of 
services for consideration through our rulemaking process. We refer 
readers to the detailed discussion in this section of the valuation 
considered for specific codes. Table 26 contains a list of codes and 
descriptors for which we are finalizing work RVUs; this includes all 
codes for which we received RUC recommendations by February 10, 2019. 
The work RVUs, work time and other payment information for all CY 2020 
payable codes are available on the CMS website under downloads for the 
CY 2020 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs to Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially

[[Page 62713]]

misvalued codes. We review the RUC-recommended direct PE inputs on a 
code by code basis. Like our review of recommended work RVUs, our 
review of recommended direct PE inputs generally includes, but is not 
limited to, a review of information provided by the RUC, HCPAC, and 
other public commenters, medical literature, and comparative databases, 
as well as a comparison with other codes within the PFS, and 
consultation with physicians and health care professionals within CMS 
and the federal government, as well as Medicare claims data. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other public commenters and the 
rationale for the recommendations. When we determine that the RUC's 
recommendations appropriately estimate the direct PE inputs (clinical 
labor, disposable supplies, and medical equipment) required for the 
typical service, are consistent with the principles of relativity, and 
reflect our payment policies, we use those direct PE inputs to value a 
service. If not, we refine the recommended PE inputs to better reflect 
our estimate of the PE resources required for the service. We also 
confirm whether CPT codes should have facility and/or nonfacility 
direct PE inputs and refine the inputs accordingly.
    Our review and refinement of the RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 27 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final 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 27 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 2020 are displayed in 
the CY 2020 direct PE input files, available on the CMS website under 
the 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. The inputs displayed there have been 
used in developing the CY 2020 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 final rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), for more 
information regarding the collaborative work of CMS and the

[[Page 62714]]

RUC in improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. However, some recommendations include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2020, we received invoices for several new supply and 
equipment items. Tables 28 and 29 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this final 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 28 and 29 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 
2020 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. 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 2020
(1) Tissue Grafting Procedures (CPT Codes 15769, 15771, 15772, 15773, 
and 15774)
    CPT code 20926 (Tissue grafts, other (e.g., paratenon, fat, 
dermis)), was identified through a review of services with anomalous 
sites of service when compared to Medicare utilization data. The CPT 
Editorial Panel subsequently replaced CPT code 20926 with five codes in 
the Integumentary section to better describe tissue grafting 
procedures.
    We proposed the RUC-recommended work RVUs of 6.68 for CPT code 
15769 (Grafting of autologous soft tissue, other, harvested by direct 
excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15771 
(grafting of autologous fat harvested by liposuction technique to 
trunk, breasts, scalp, arms, and/or legs; 50cc or less injectate), 2.50 
for CPT code 15772 (grafting of autologous fat harvested by liposuction 
technique to trunk, breasts, scalp, arms, and/or legs; each additional 
50cc injectate, or part thereof (list separately in addition to code 
for primary procedure)), 6.83 for CPT code 15773 (grafting of 
autologous fat harvested by liposuction technique to face, eyelids, 
mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25cc or less 
injectate), and 2.41 for CPT code 15774 (grafting of autologous fat 
harvested by liposuction technique to face, eyelids, mouth, neck, ears, 
orbits, genitalia, hands, and/or feet; each additional 25cc injectate, 
or part thereof (list separately in addition to code for primary 
procedure)).
    We proposed the RUC-recommended direct PE inputs for this code 
family without refinement.
    We received public comments on the proposed valuation of the codes 
in the Tissue Grafting Procedures family. The following is a summary of 
the comments we received and our responses.

[[Page 62715]]

    Comment: A commenter stated that they supported our proposal to use 
the RUC-recommended work RVUs for these codes.
    Response: We appreciate the support for our proposal from the 
commenter. After consideration of the public comments, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
Tissue Grafting Procedures family as proposed.
(2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983, 
20700, 20702, 20704, 20701, 20703, and 20705)
    CPT codes 11980-11983 were identified as potentially misvalued 
since the majority specialty found in recent claims data differs from 
the two specialties that originally surveyed the codes. The current 
valuation of CPT code 11980 (Subcutaneous hormone pellet implantation 
(implantation of estradiol and/or testosterone pellets beneath the 
skin)) was reaffirmed by the RUC as the physician work had not changed 
since the last review. The CPT Editorial Panel revised the other three 
existing codes in the family and created six additional add-on codes to 
describe orthopaedic drug delivery. These codes were surveyed and 
reviewed for the October 2018 RUC meeting.
    CPT code 11980 (Subcutaneous hormone pellet implantation 
(implantation of estradiol and/or testosterone pellets beneath the 
skin)) with the current work value of 1.10 RVUs and 12 minutes of 
intraservice time, and 27 minutes of total time, was determined to be 
unchanged since last reviewed and was recommended by the RUC to be 
maintained. We concur. We did not propose any direct PE refinements to 
CPT code 11980. CPT code 11981 (Insertion, non-biodegradable drug 
delivery implant) has a current work RVU of 1.48, with 39 minutes of 
total physician time. The specialty society survey recommended a work 
RVU of 1.30, with 31 minutes of total physician time and 5 minutes of 
intraservice time. The RUC recommended a work RVU of 1.30 (25th 
percentile), with 30 minutes of total physician time and 5 minutes of 
intraservice time. For comparable reference CPT codes to CPT code 
11981, the RUC and the survey respondents had selected CPT code 55876 
(Placement of interstitial device(s) for radiation therapy guidance 
(e.g., fiducial markers, dosimeter), prostate (via needle, any 
approach), single or multiple (work RVU = 1.73, 20 minutes intraservice 
time and 59 total minutes)) and CPT code 57500 (Biopsy of cervix, 
single or multiple, or local excision of lesion, with or without 
fulguration (separate procedure) (work RVU = 1.20, 15 minutes 
intraservice time and 29 total minutes)). The RUC further offered for 
comparison, CPT code 67515 (Injection of medication or other substance 
into Tenon's capsule (work RVU = 1.40 (from CY 2018), 5 minutes 
intraservice time and 21 minutes total time)), CPT code 12013 (Simple 
repair of superficial wounds of face, ears, eyelids, nose, lips and/or 
mucous membranes; 2.6 cm to 5.0 cm (work RVU = 1.22 and 27 total 
minutes)) and CPT code 12004 (Simple repair of superficial wounds of 
scalp, neck, axillae, external genitalia, trunk and/or extremities 
(including hands and feet); 7.6 cm to 12.5 cm) (work RVU = 1.44 and 29 
total minutes)). In addition, we offered CPT code 67500 (Injection of 
medication into cavity behind eye) (work RVU = 1.18 and 5 minutes 
intraservice time and 33 total minutes) for reference. Given that the 
CPT code 11981 incurs a 23 percent reduction in the new total physician 
time and with reference to CPT code 67500, we proposed a work RVU of 
1.14, and accepted the survey-recommended 5 minutes for intraservice 
time and 30 minutes of total time. We did not propose any direct PE 
refinements to CPT code 11981.
    CPT code 11982 (Removal, non-biodegradable drug delivery implant) 
has a current work RVU of 1.78, with 44 minutes of total physician 
time. The specialty society survey recommended a work RVU of 1.70 RVU, 
with 10 minutes of intraservice time and 34 minutes of total physician 
time. The RUC also recommended a work RVU of 1.70, with 10 minutes of 
intraservice time and 33 minutes of total physician time. The RUC 
confirmed that removal (CPT code 11982), requires more intraservice 
time to perform than the insertion (CPT code 11981). For comparable 
reference codes to CPT code 11982, the RUC and the survey respondents 
had selected CPT code 54150 (Circumcision, using clamp or other device 
with regional dorsal penile or ring block) (work RVU = 1.90, 15 minutes 
intraservice time and 45 total minutes)) and CPT code 12004 (Simple 
repair of superficial wounds of scalp, neck, axillae, external 
genitalia, trunk and/or extremities (including hands and feet); 7.6 cm 
to 12.5 cm) (work RVU = 1.44, with 17 minutes intraservice time and 29 
minutes total time)). We offered CPT code 64486 (Injections of local 
anesthetic for pain control and abdominal wall analgesia on one side) 
(work RVU = 1.27, 10 minutes intraservice time and 35 total minutes)) 
for reference. Given that the CPT code 11982 incurs a 25 percent 
reduction in the new total physician time and with reference to CPT 
code 64486, we proposed a work RVU of 1.34, and accepted the RUC-
recommended 10 minutes for intraservice time and 33 minutes of total 
time. We did not propose any direct PE refinements to CPT code 11982.
    CPT code 11983 (Removal with reinsertion, non-biodegradable drug 
delivery implant) has a current work RVU of 3.30, with 69 minutes of 
total physician time. The specialty society survey recommended a work 
RVU of 2.50 RVU, with 15 minutes of intraservice time and 41 minutes of 
total physician time. The RUC also recommended a work RVU of 2.10, with 
15 minutes of intraservice time and 40 minutes of total physician time. 
The RUC confirmed that CPT code 11983 requires more intraservice time 
to perform than the insertion CPT code 11981. For comparable reference 
codes to CPT code 11983, the RUC and the survey respondents had 
selected CPT code 55700 (Biopsy, prostate; needle or punch, single or 
multiple, any approach) (work RVU = 2.50, 15 minutes intraservice time 
and 35 total minutes)), CPT code 54150 (Circumcision, using clamp or 
other device with regional dorsal penile or ring block) (work RVU = 
1.90, 15 minutes intraservice time and 45 total minutes)) and CPT code 
52281 (Cystourethroscopy, with calibration and/or dilation of urethral 
stricture or stenosis, with or without meatotomy, with or without 
injection procedure for cystography, male or female) (work RVU = 2.75 
and 20 minutes intraservice time and 46 minutes total time)). We 
offered CPT code 62324 (Insertion of indwelling catheter and 
administration of substance into spinal canal of upper or middle back) 
(work RVU = 1.89, 15 minutes intraservice time and 43 total minutes)) 
for reference. Given that the CPT code 11983 incurs a 42 percent 
reduction in new total physician time and with reference to CPT code 
62324, we proposed a work RVU of 1.91, and accepted the RUC-recommended 
15 minutes for intraservice time and 40 minutes of total time. We did 
not propose any direct PE refinements to CPT code 11983.
    The new proposed add-on CPT codes 20700-20705 are intended to be 
typically reported with CPT codes 11981-11983, with debridement or 
arthrotomy procedures done primarily by orthopedic surgeons. The 
specialty society's survey for CPT code 20700 (Manual preparation and 
insertion of drug delivery device(s), deep (e.g., subfascial)) found a 
2.00 work RVU value at the median and a 1.50 work

[[Page 62716]]

RVU value at the 25th percentile, with 20 minutes of intraservice time 
and 30 minutes of total physician time, for the preparation of the 
antibiotic powder and cement, rolled into beads and threaded onto 
suture for insertion into the infected bone. The RUC recommended a work 
RVU of 1.50, with 20 minutes of intraservice time and 27 minutes of 
total physician time. The RUC's reference CPT codes included CPT code 
11047 (Debridement, bone (includes epidermis, dermis, subcutaneous 
tissue, muscle and/or fascia, if performed); each additional 20 sq cm, 
or part thereof) (work RVU = 1.80, and 30 minutes intraservice time)), 
CPT codes 64484 (Injection(s), anesthetic agent and/or steroid, 
transforaminal epidural, with imaging guidance (fluoroscopy or CT); 
lumbar or sacral, each additional level) (work RVU = 1.00 and 10 
minutes intraservice time)), and CPT code 36227 (Selective catheter 
placement, external carotid artery, unilateral, with angiography of the 
ipsilateral external carotid circulation and all associated 
radiological supervision and interpretation) (work RVU = 2.09 and 20 
minutes intraservice time)). Our review of similar add-on CPT codes 
yielded CPT code 64634 (Destruction of upper or middle spinal facet 
joint nerves with imaging guidance) (work RVU = 1.32 and 20 minutes 
intraservice time)). We proposed for CPT code 20700, a work RVU of 
1.32, and accept the RUC-recommended 20 minutes of intraservice time 
and 27 minutes of total time.
    The specialty society's survey for CPT code 20702 (Manual 
preparation and insertion of drug delivery device(s), intramedullary) 
found a 3.25 work RVU value at the median and a 2.50 work RVU value at 
the 25th percentile, with 25 minutes of intraservice time and 32 
minutes of total physician time, for the preparation of the 
``antibiotic nail'' ready for insertion into the intramedullary canal 
with fluoroscopic guidance. The RUC recommended a work RVU of 2.50, 
with 25 minutes of intraservice time and 32 minutes of total physician 
time. The RUC's reference CPT codes included CPT code 11047 
(Debridement, bone (includes epidermis, dermis, subcutaneous tissue, 
muscle and/or fascia, if performed); each additional 20 sq cm, or part 
thereof) (work RVU = 1.80, and 30 minutes intraservice time)), CPT code 
57267 (Insertion of mesh or other prosthesis for repair of pelvic floor 
defect, each site (anterior, posterior compartment), vaginal approach 
(work RVU = 4.88 and 45 minutes intraservice time)), and CPT code 36227 
(Selective catheter placement, external carotid artery, unilateral, 
with angiography of the ipsilateral external carotid circulation and 
all associated radiological supervision and interpretation (work RVU = 
2.09 and 15 minutes intraservice time)). We find that the reference CPT 
code 11047, with 30 minutes of intraservice time, is suitable, but we 
adjust our proposed work RVU of 1.70 to account for the 25 minutes, 
instead of our reference code's 30 minutes of intraservice time (and 
the 32 minutes of total time), for CPT code 20702.
    The specialty society's survey for CPT code 20704 (Manual 
preparation and insertion of drug delivery device(s), intra-articular) 
found a 4.00 work RVU value at the median and a 2.60 work RVU value at 
the 25th percentile, with 30 minutes of intraservice time and 37 
minutes of total physician time, for the preparation of the antibiotic 
cement inserted into a pre-fabricated silicone mold, when after setting 
up, will be cemented to the end of the bone (with the joint). The RUC 
recommended a work RVU of 2.60, with 30 minutes of intraservice time 
and 37 minutes of total physician time. The RUC's reference CPT codes 
included CPT code 11047 (Debridement, bone (includes epidermis, dermis, 
subcutaneous tissue, muscle and/or fascia, if performed); each 
additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes 
intraservice time)), CPT code 57267 (Insertion of mesh or other 
prosthesis for repair of pelvic floor defect, each site (anterior, 
posterior compartment), vaginal approach (work RVU = 4.88 and 45 
minutes intraservice time)), and CPT code 36227 (Selective catheter 
placement, external carotid artery, unilateral, with angiography of the 
ipsilateral external carotid circulation and all associated 
radiological supervision and interpretation (work RVU = 2.09 and 20 
minutes intraservice time)). We find that the reference CPT code 11047, 
with 30 minutes of intraservice time, is a suitable guide and we 
proposed the work RVU of 1.80 with the RUC-recommended 30 minutes of 
intraservice time and 37 minutes of total time, for CPT code 20704.
    The specialty society's survey for CPT code 20701 (Removal of drug 
delivery device(s), deep (e.g., subfascial)) found a 1.75 work RVU 
value at the median and a 1.13 work RVU value at the 25th percentile, 
with 15 minutes of intraservice time and 18 minutes of total physician 
time. The work includes a marginal dissection to expose the drug 
delivery device and to remove it. The RUC recommended a work RVU of 
1.13, with 18 minutes of total physician time and 15 minutes of 
intraservice time. The RUC's reference CPT codes included CPT code 
11047 (Debridement, bone (includes epidermis, dermis, subcutaneous 
tissue, muscle and/or fascia, if performed); each additional 20 sq cm, 
or part thereof (work RVU = 1.80, and 30 minutes intraservice time)), 
CPT code 64484 (Injection(s), anesthetic agent and/or steroid, 
transforaminal epidural, with imaging guidance (fluoroscopy or CT); 
lumbar or sacral, each additional level (work RVU = 1.00 and 10 minutes 
intraservice time)), and CPT code 64480 (Injection(s), anesthetic agent 
and/or steroid, transforaminal epidural, with imaging guidance 
(fluoroscopy or CT); cervical or thoracic, each additional level (work 
RVU = 1.20 and 15 minutes intraservice time)). We proposed the RUC-
recommended work RVU of 1.13 with 15 minutes of intraservice time and 
18 minutes of total time for 20701.
    The specialty society's survey for CPT code 20703 (Removal of drug 
delivery device(s), intramedullary) found a 2.50 work RVU value at the 
median and a 1.80 work RVU value at the 25th percentile, with 20 
minutes of intraservice time and 23 minutes of total physician time. 
The work includes a marginal dissection, in addition to what was in the 
base procedure, to loosen and expose the drug delivery device and to 
remove it, any remaining drug delivery device shards that may have 
broken off. The RUC recommended a work RVU of 1.80, with 20 minutes of 
intraservice time and 23 minutes of total physician time. The RUC's 
reference CPT codes included CPT code 11047 (Debridement, bone 
(includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, 
if performed); each additional 20 sq cm, or part thereof (work RVU = 
1.80, and 30 minutes intraservice time)), CPT codes 37253 
(Intravascular ultrasound (noncoronary vessel) during diagnostic 
evaluation and/or therapeutic intervention, including radiological 
supervision and interpretation; each additional noncoronary vessel 
(work RVU = 1.44 and 20 minutes intraservice time)), and CPT code 36227 
(Selective catheter placement, external carotid artery, unilateral, 
with angiography of the ipsilateral external carotid circulation and 
all associated radiological supervision and interpretation (work RVU = 
2.09 and 15 minutes intraservice time)). We proposed the RUC-
recommended work RVU of 1.80 with 20 minutes of intraservice time and 
23 minutes of total time for 20703.
    The specialty society's survey for CPT code 20705 (Removal of drug 
delivery

[[Page 62717]]

device(s), intra-articular) found a 3.30 work RVU value at the median 
and a 2.15 work RVU value at the 25th percentile, with 25 minutes of 
intraservice time and 28 minutes of total physician time. The work 
includes the removal of the intra-articular drug delivery device that 
is cemented to both sides of the joint without removing too much bone 
in the process. The RUC recommended a work RVU of 2.15, with 25 minutes 
of intraservice time and 28 minutes of total physician time. The RUC's 
reference CPT codes included CPT code 11047 (Debridement, bone 
(includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, 
if performed); each additional 20 sq cm, or part thereof (work RVU = 
1.80, and 30 minutes intraservice time)), CPT code 36476 (Endovenous 
ablation therapy of incompetent vein, extremity, inclusive of all 
imaging guidance and monitoring, percutaneous, radiofrequency; 
subsequent vein(s) treated in a single extremity, each through separate 
access sites (work RVU = 2.65 and 30 minutes intraservice time)), and 
CPT code 36227 (Selective catheter placement, external carotid artery, 
unilateral, with angiography of the ipsilateral external carotid 
circulation and all associated radiological supervision and 
interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We 
proposed the RUC-recommended work RVU of 2.15 with 25 minutes of 
intraservice time and 28 minutes of total time for 20705.
    We received public comments on the proposed valuation of the codes 
in the Drug Delivery Implant Procedures family. The following is a 
summary of the comments we received and our responses.
    Comment: In an overall comment to code valuations, but also 
pertinent to this section, one commenter stated that they are 
increasingly concerned that CMS is eschewing the bedrock principles of 
valuation within the RBRVS (namely, magnitude estimation, survey data 
and clinical expertise) in favor of arbitrary mathematical formulas and 
in their opinion, make a distinction in the different types of 
physician time, which are ``CMS/Other'' time source, ``Harvard'' time 
source, and ``RUC'' time source (from physician surveys).
    Response: As we have discussed in previous rules, we agree that it 
is important to use the most recent data available regarding time, and 
we note that when many years have passed between when physician times 
are measured, significant discrepancies can occur. However, we also 
continue to believe that our operating assumption regarding the 
validity of the existing time values as a point of comparison is 
critical to the integrity of the current relative value system.
    The physician times and intensities currently associated with 
codes, play important roles in PFS ratesetting in their comparativeness 
to each other, in establishing work RVUs. If we were to operate under 
the assumption that previously recommended work times had routinely 
been overestimated, this would undermine the relativity of the work 
RVUs on the PFS. Given that the process under which codes are often 
valued by comparison to codes with similar times, we acknowledge the 
distinction between ``CMS/Other'' times, ``Harvard'' times, and ``RUC'' 
physician surveyed times, but we cannot apply different validation 
weights to any of these labels. They are all physician times data 
collected over many years. We understand that some time values may not 
have been reviewed or re-surveyed in a number of years, but that alone 
is not an indicator of how accurate or inaccurate a time value may be. 
We believe that over the years as more codes are being reviewed and 
examined, that collectively the entire fee schedule of procedure codes 
should all naturally align themselves into a very reliable and more 
accurate system reflecting every code's relativity to one another (in 
their work RVUs, in their procedure times, and in their work 
intensities).
    We believe that it is crucial that the code valuation process with 
existing work times and work RVUs in the PFS ratesetting processes are 
accurate. We recognize that adjusting work RVUs for changes in 
physician times is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we always try to apply various methodologies to 
identify several potential work values for individual codes. CMS CPT 
code review not only examines the relationships between work, time, and 
intensity, but we also look at magnitude and rank order anomalies 
particularly in families or groups of codes that are closely related, 
but may differ slightly in degrees found in their clinical descriptions 
and possibly in the typical beneficiary populations that each code 
might serve. Among these codes, we try to keep the differences in 
times, work, and intensity properly distant between each other. In some 
cases, where there are marked improvements in medical techniques and 
technological assistance, we may see better efficiencies in physician's 
work, and thus decreases in physician's times, but we also recognize 
that some improvements may introduce greater complexity and either a 
greater intensity and/or increase in physician times.
    We reiterate that we believe it would be irresponsible to ignore or 
discount ``CMS/Other'' times or ``Harvard'' times in our data system 
and that we need to consider all times and all intensities and all 
procedure code's clinically relevant relatedness (or non-relatedness) 
to each other, in establishing more refined work RVUs for PFS services. 
Also note that ``RUC'' physician times are not always necessarily AMA 
RUC surveyed times. CMS may have adjusted AMA RUC surveyed times in our 
annual review of all HCPCS codes, as well as times that the AMA labels 
as ``Harvard'' or ``CMS/Other'' physician times.
    Comment: One commenter stated the current source of time for CPT 
code 11981 is CMS/Other. The commenter also stated the crosswalk or 
methodology used in the original valuation of this service is unknown 
and not resource-based; therefore, it is invalid to compare the current 
time and work to the surveyed time and work. The commenter noted this 
code's source of time is CMS/Other, implying that the time was merely 
crosswalked or selected by a single CMS staffer some time ago, and CMS 
should not compare the valid survey time to the initial CMS/Other time 
because the initial CMS/Other source data is flawed and has no validity 
for comparison.
    Response: The current physician time for CPT code 11981 is 39 
minutes of total time and the current work RVUs is 1.48. The AMA RUC's 
new recommended times are 5 minutes intra-service time and 30 minutes 
total time (surveyed total time was 31 minutes). We accept the AMA RUC 
newly surveyed-recommended times. The AMA RUC selected multiple 
reference CPT codes 55876, 57500, 67515, 12013, and 12004 that they 
believe to be comparable to CPT code 11981. We selected the reference 
CPT code 67500, with 5 minutes intra-time and 33 minutes total time, 
which we believe to be a better reference code and is clearly 
comparable to the accepted recommended times for CPT code 11981. CPT 
code 67500 was last reviewed in 2005 and the time source was from the 
``RUC'' who no doubt surveyed this code at that time, so CPT code 
67500's time source is not ``CMS/Other'', which we do not believe is 
material to selecting a reference code for physician work and time. As 
discussed above, we believe there is no comparison flaw in time or work 
RVUs, based on the AMA RUC's distinction labeling of ``RUC'' times, 
``CMS/Other

[[Page 62718]]

times'', or ``Harvard'' times. We believe that it is crucial that the 
code valuation process take place with the understanding that all 
existing work times, used in the PFS ratesetting processes, are 
accurate. Our reference CPT code 67500's work RVU is 1.18.
    Comment: Some commenters stated that CPT code 11981 is not 
clinically related to our reference code of CPT code 67500, as it 
relates to both the physician description of work and the typical 
patient population treated with this service.
    Response: As part of our review, we look for comparable codes that 
are similar in physician service times, work RVUs, work intensity, and 
clinical similarity. As discussed above, we believe there is no 
comparison flaw in time or work RVUs, based on the AMA RUC's 
distinction labeling of ``RUC'' times, ``CMS/Other times'', or 
``Harvard'' times. We believe that it is crucial that the code 
valuation process take place with the understanding that all existing 
work times, used in the PFS ratesetting processes, are accurate. We 
continue to believe that CPT code 67500 is the better reference code 
for us to use to establish an appropriate valuation for CPT code 11981. 
Both codes require 5 minutes intra-service time and CPT code 11981 
takes 30 minutes total time while CPT code 67500 takes a similar amount 
of 33 minutes of total time.
    While the commenters object to CMS' reference CPT code of 67500 as 
being clinically related to CPT code 11981, the commenter's additional 
selected CPT reference codes of 67515, 12013, and 12004, are also very 
different from CPT code 11981. There appears to be a discrepancy in the 
AMA RUC's CPT (referencing) code 67515 (Injection of medication or 
other substance into Tenon's capsule, work RVU = 1.40, 5 minutes intra-
service time and 21 minutes total time). CMS' data indicates a 
different work RVU and physician times for this code. For CPT code 
67515, we have on record for work RVU = 0.75, 3 minutes intra-service 
time and 13 minutes total time.
    The AMA RUC CPT (referencing) codes 12013 and 12004 appears to be 
at least partially valued on the length of a wound repair (2.6 cm to 
5.0 cm or 7.6 cm to 12.5 cm), and assuming that the longer the wound 
repair is, the more work and physician time is required to perform the 
procedure. CPT code 11981 does not have this ``size length'' 
characteristic, so we question if CPT codes 12013 or 12004 more or less 
are a valid comparison referencing codes to CPT code 11981 where there 
is not this ``size length'' characteristic. As we have stated, the 
clinical relatedness of codes are not always exact, nor always 
available.
    Comment: The RUC survey respondents offered CPT code 55876 
(Placement of interstitial device(s) for radiation therapy guidance 
(e.g., fiducial markers, dosimeter), prostate (via needle, any 
approach), single or multiple (work RVU = 1.73, 20 minutes intra-
service time and 59 total minutes)) and 57500 (Biopsy of cervix, single 
or multiple, or local excision of lesion, with or without fulguration 
(separate procedure) (work RVU = 1.20, 15 minutes intra-service time 
and 29 total minutes)) as referencing codes to CPT code 11981.
    The AMA RUC recommendation offered CPT code 67515 (Injection of 
medication or other substance into Tenon's capsule (work RVU = 1.40, 5 
minutes intra-service time and 21 minutes total time)), MPC codes 12013 
(Simple repair of superficial wounds of face, ears, eyelids, nose, lips 
and/or mucous membranes; 2.6 cm to 5.0 cm (work RVU = 1.22, 15 minutes 
intra-service time and 27 total minutes)) and 12004 (Simple repair of 
superficial wounds of scalp, neck, axillae, external genitalia, trunk 
and/or extremities (including hands and feet); 7.6 cm to 12.5 cm (work 
RVU = 1.44 15 minutes intra-service time and 29 total minutes)). The 
AMA RUC offer these reference codes to have similar physician work and 
total time to CPT code 11981.
    Response: All of the commenter's reference comparison CPT codes 
have far more intra-service time than CPT code 11981 intra-service time 
of 5 minutes, except for CPT code 67515, but this code appears to only 
have 3 minutes of intra-service time and 0.75 work RVUs. CMS' CPT 
(reference) code of 67500 appears to have the closest physician times 
to CPT code 11981 and their work RVUs should be similar.
    After consideration of the public comments for CPT code 11981, we 
are finalizing the proposed work RVU as 1.14.
    Comment: Several commenters stated the current source of time for 
CPT code 11982 is CMS/Other. Commenters also stated the crosswalk or 
methodology used in the original valuation of this service is unknown 
and not resource-based; therefore, it is invalid to compare the current 
time and work to the surveyed time and work. Commenters noted this 
code's source of time is CMS/Other, implying that the time was merely 
crosswalked or selected by a single CMS staffer some time ago. CMS 
should not compare the valid survey time to the initial CMS/Other time 
because the initial CMS/Other source data is flawed and has no validity 
for comparison.
    Response: The current physician times for CPT code 11982 are 44 
minutes of total time and the current work RVUs is 1.78. The AMA RUC's 
new recommended times are 10 minutes intra-service time and 33 minutes 
total time (surveyed total time was 34 minutes). CMS accepts the AMA 
RUC newly surveyed recommended times and used CPT reference code 64486, 
with 10 minutes intra-service time and 35 minutes total time, which are 
clearly comparable to the accepted recommended times for CPT code 
11982. CPT code 64486 was introduced by CPT in 2014 and the time source 
was from the ``RUC'' who no doubt surveyed this code at that time, so 
CPT code 64486's time source is not ``CMS/Other'', which we do not 
believe is material to selecting a reference code for physician work 
and time. As part of our review, we look for comparable codes that are 
similar in physician service times, work RVUs, work intensity, and 
clinically relatedness. As discussed above, we believe there is no 
comparison flaw in time or work RVUs, based on the AMA RUC's 
distinction labeling of ``RUC'' times, ``CMS/Other times'', or 
``Harvard'' times. We believe that it is crucial that the code 
valuation process take place with the understanding that all existing 
work times, used in the PFS ratesetting processes, are accurate and 
there is no comparison flaw. Our reference CPT code 64486's work RVU is 
1.27.
    Comment: Commenters stated that CPT code 11982 is essentially not 
clinically related to our reference code of CPT code 64486, in 
physician description of work and the typical patient population that 
they treat.
    Response: As part of our review, we look for comparable codes that 
are similar in physician service times, work RVUs, work intensity, and 
are clinically related. As discussed above, we believe there is no 
comparison flaw in time or work RVUs, based on the AMA RUC's 
distinction labeling of ``RUC'' times, ``CMS/Other times'', or 
``Harvard'' times. We believe that it is crucial that the code 
valuation process take place with the understanding that all existing 
work times, used in the PFS ratesetting processes, are accurate. CPT 
codes 11982 and 64486 are not clinically related, but their work times 
and work RVUs are similar. The commenter's selected reference CPT codes 
of 54150 and 12004, can also be said to be very similar to CPT code 
11982 as well. CPT (referencing) code 54150 appears to apply only to 
the male patient population, where CPT code 11982

[[Page 62719]]

applies to both the male and female population. CPT (referencing) code 
12004 appears to be at least partially valued on the length of a wound 
repair (7.6 cm to 12.5 cm), assuming that the longer the wound repair 
is, the more work and physician time is required to perform the 
procedure, but CPT code 11982 does not have this ``size length'' 
characteristic. As previously stated, clinical relatedness between 
codes are not always exact, nor always available for exact comparison 
and we continue to believe that CMS' reference CPT code 64486 is 
equally as valid as the AMA RUC's reference CPT codes.
    Comment: The AMA RUC and the survey respondents offered CPT code 
54150 (Circumcision, using clamp or other device with regional dorsal 
penile or ring block (work RVU = 1.90, 15 minutes intra-service time 
and 45 total minutes)) and CPT code 12004 (Simple repair of superficial 
wounds of scalp, neck, axillae, external genitalia, trunk and/or 
extremities (including hands and feet); 7.6 cm to 12.5 cm (work RVU = 
1.44, with 17 minutes intra-service time and 29 minutes total time)) as 
comparable reference codes to CPT code 11982.
    Response: Both AMA RUC reference codes have more intra-service 
times than CPT code 11982, so accordingly, they have more work RVUs. We 
believe CPT code 11982 with 10 minutes of intra-service time should 
have a work RVU value that is less than the AMA RUC reference codes and 
less than their recommended 1.70 RVUs. CPT code 64486 physician times 
are very similar to CPT code 11982's physician times and their work 
RVUs should be similar.
    After consideration of the public comments for CPT code 11982, we 
are finalizing its work RVU, as proposed, to 1.34 RVUs.
    Comment: One commenter stated the current source of time for CPT 
code 11983 is CMS/Other and the crosswalk or methodology used in the 
original valuation of this service is unknown and not resource-based; 
therefore, it is invalid to compare the current time and work to the 
surveyed time and work. The commenter further stated this code's source 
of time is CMS/Other, implying that the time was merely crosswalked or 
selected by a single CMS staffer some time ago. CMS should not compare 
the valid survey time to the initial CMS/Other time because the initial 
CMS/Other source data is flawed and has no validity for comparison.
    Response: The current physician times for CPT code 11983 are 49 
minutes of total time and the current work RVUs is 3.30. The AMA RUC's 
new recommended times are 15 minutes intra-service time and 40 minutes 
total time (surveyed total time was 41 minutes). We accept the AMA RUC 
newly surveyed recommended times and used CPT code 62324, with 15 
minutes intra-service time and 43 minutes total time, which are 
comparable to the AMA RUC recommended times for CPT code 11983. CPT 
code 62324 was introduced by CPT in 2017 and the time source was from 
the ``RUC'' who no doubt surveyed this code at that time, so CPT code 
62324's time source is not ``CMS/Other'', which we do not believe is 
material to selecting a reference code for physician work and time. As 
part of our review, we look for comparable codes that are similar in 
physician service times, work RVUs, work intensity, and clinically 
similarity. As discussed above, we believe there is no comparison flaw 
in time or work RVUs, based on the AMA RUC's distinction labeling of 
``RUC'' times, ``CMS/Other times'', or ``Harvard'' times. We believe 
that it is crucial that the code valuation process take place with the 
understanding that all existing work times, used in the PFS ratesetting 
processes, are accurate. We continue to believe that CPT code 62324 is 
the better reference code to CPT code 11983. Our reference CPT code 
62324's work RVU is 1.89.
    Comment: Commenters stated that the intensity of the work required 
to perform CPT code 11983 is not comparable to CMS' reference to 
injection of anesthetic code 62324 and yet in their original AMA RUC 
survey for CPT code 11983, the commenter stated the survey respondents 
indicated that CPT code 11983 (originally 15 minutes intra-service 
time, 69 minutes total time, and 3.30 work RVUs) overall requires the 
same or more intensity and complexity to perform as CPT code 55700 (15 
minutes of intra-service time, 35 minutes of total time, and 2.50 work 
RVUs). The RUC noted that since CPT code 11983 has such a low intra-
service time and is a 000-day service comparing the intra-service per 
unit of time (IWPUT) is not a useful comparison.
    Response: The commenters stated that CPT (CMS reference) code 62324 
(15 minutes intra-service time, 43 minutes total time and their work 
RVU is 1.89) is less intensive than CPT code 11983 and thus their work 
RVUs are not comparable. But, the original selected surveyees' 
reference CPT code of 55700 (15 minutes intra-service time, 35 minutes 
total time and work RVU is 2.50) has been stated as the same or less 
intensive than CPT code 11983. Therefore, we question if that is true. 
If CPT code 55700 (2.50 work RVUs) is the same or less intensive than 
CPT code 11983, CPT code 11983's proposed work RVU should be 2.50 or 
greater. The RUC recommended work RVU for CPT code 11983 is 2.10. This 
is less than 2.50. The survey median yielded 2.50. Further, the AMA RUC 
asserts that the work RVU for CPT code 11983 should be higher than 1.89 
(62324) and also higher than 2.50 (55700) but recommends a proposed 
work RVU of 2.10. The AMA RUC noted that since CPT code 11983 has such 
a low intra-service time and is a 000-day service, comparing the intra-
service per unit of time (IWPUT) is not a useful comparison. (The AMA 
RUC also referenced CPT code 54150 (work RVU is 1.90) and CPT code 
52281 (work RVU is 2.75) as potential reference codes.
    As part of our review, we look for comparable codes that are 
similar in physician service times, work RVUs, work intensity, and are 
clinical related. As discussed above, we believe there is no comparison 
flaw in time or work RVUs, based on the AMA RUC's distinction labeling 
of ``RUC'' times, ``CMS/Other times'', or ``Harvard'' times. We believe 
that it is crucial that the code valuation process take place with the 
understanding that all existing work times, used in the PFS ratesetting 
processes, are accurate and there is no comparison flaw. As for the 
question of our selection of CPT code 62324 being more or less 
clinically related to CPT code 11983, as we have previously stated in 
this regard, perfect clinical relatedness is not always available in 
selecting a reference code. The same is true with the AMA RUC selection 
of reference code(s).
    After consideration of the public comments for CPT code 11983, we 
are finalizing the work RVU, as proposed, of 1.91 RVUs.
    Comment: One commenter stated that CMS may have a typo in the text 
of the proposed rule because the CY 2020 PFS proposed rule Physician 
Time file indicated the same time as the RUC recommended with a total 
of 27 minutes for CPT code 20700.
    Response: The commenter is correct that there was a typo in the 
text concerning CPT code 20700 (206X0) where in one sentence the total 
physician time was stated as 27 minutes and then in a subsequent 
sentence it was stated as 20 minutes. The typo has been corrected. Upon 
further review of the AMA RUC recommendations and CMS own examination, 
we believe that our proposed RVU value of 1.32 work RVUs on balance is 
not entirely supportable, and we are instead adopting the AMA RUC 
recommended

[[Page 62720]]

value of 1.50 work RVUs for CPT code 20700.
    Comment: Concerning the paragraph on CPT code 20702 (206X1), 
commenters noted that there were two typos in the proposed rule for the 
CMS reference CPT code 11047. The commenter stated that the RUC total 
time recommended for CPT code 20702 (206X1) is 32 minutes not 38 
minutes and the total time for CMS reference code 11047 is 31 minutes 
not 32 minutes, but both are listed correctly in the CY 2020 PFS 
proposed rule Physician Time file.
    Response: The commenter is correct that there was a typo in the 
text concerning CPT code 20702 (206X1) where in one sentence the total 
physician time was stated as 38 minutes when it was actually 32 
minutes. The 38 minutes was from the survey total time for this code, 
and it was inadvertently used. The typo has been corrected. Upon 
further review of the AMA RUC recommendations and CMS' own examination, 
we believe that our proposed value of 1.70 work RVUs on balance is not 
entirely supportable, and we are instead adopting the AMA RUC 
recommended value of 2.50 work RVUs for CPT code 20702.
    Comment: One commenter noted that there is a typo in the text of 
the proposed rule for CPT code 20704 (206X2). The commenter stated the 
RUC recommended 5 minutes evaluation pre-service time, 30 minutes 
intra-service time and 2 minutes post-service time, totaling 37 minutes 
for CPT code 20704 (206X2), not 45 minutes. The physician time for CPT 
code 20704 (206X2) is listed correctly in the CY 2020 PFS proposed rule 
Physician Time file.
    Response: The commenter is correct that there was a typo in the 
text concerning CPT code 20704 (206X2) where in one sentence the total 
physician time was stated as 45 minutes when it was actually 37 
minutes. The 45 minutes was this from this CPT code's surveyed total 
time and the actual AMA RUC recommended total time was 37 minutes. The 
typo has been corrected. Upon further review of the AMA RUC 
recommendations and CMS' own examination, we believe our proposed value 
of 1.80 work RVUs on balance is not entirely supportable and we are 
instead adopting the AMA RUC recommended value of 2.60 work RVUs for 
CPT code 20704.
    After consideration of the public comments, we are accepting the 
AMA RUC's surveyed times for CPT codes 11981, 11982, and 11983, 
however, we do not agree with the AMA RUC recommended work RVUs, and we 
are finalizing our proposed work RVUs of 1.14 for CPT code 11981, 1.34 
for CPT code 11982, and 1.91 for CPT code 11983. For CPT codes 20700 to 
20705, we agree with and are finalizing the AMA RUC's recommended work 
RVUs of 1.50 for CPT code 20700, 1.13 for CPT code 20701, 2.50 for CPT 
code 20702, 1.80 for CPT code 20703, 2.60 for CPT code 20704, and 2.15 
for CPT code 20705. We recognize that the manual preparation and 
insertion of drug delivery device(s) should take more time than their 
removal code counterparts, and while we accepted the work RVUs for the 
removal codes, on the whole, they did not make as much sense in their 
relativity to each other, with our proposed work RVUs for the 
insertions. The AMA RUC recommended insertion work RVUs are a better 
fit with the removal work RVUs.
(3) Bone Biopsy Trocar-Needle (CPT Codes 20220 and 20225)
    In October 2017, CPT code 20225 (Biopsy, bone, trocar, or needle; 
deep (e.g., vertebral body, femur)) was identified as being performed 
by a different specialty than the one that originally surveyed this 
service. CPT code 20220 (Biopsy, bone, trocar, or needle; superficial 
(e.g., ilium, sternum, spinous process, ribs)) was added as part of the 
family, and both codes were surveyed and reviewed for the January 2019 
RUC meeting.
    We disagree with the RUC-recommended work RVU of 1.93 for CPT code 
20220 and we proposed a work RVU of 1.65 based on a crosswalk to CPT 
code 47000 (Biopsy of liver, needle; percutaneous). CPT code 47000 
shares the same intraservice time of 20 minutes with CPT code 20220 and 
has slightly higher total time at 55 minutes as compared to 50 minutes. 
It is also one of the top reference codes selected by the survey 
respondents. In our review of CPT code 20220, we noted that the 
recommended intraservice time is decreasing from 22 minutes to 20 
minutes (9 percent reduction), and that the recommended total time is 
increasing from 49 minutes to 50 minutes (2 percent increase). However, 
the RUC-recommended work RVU is increasing from 1.27 to 1.93, which is 
an increase of 52 percent. Although we do not imply that the decrease 
in time as reflected in survey values must equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work are time and intensity, changes in surveyed 
work time should be appropriately reflected in the proposed work RVUs.
    In the case of CPT code 20220, we believe that it was more accurate 
to propose a work RVU of 1.65, based on a crosswalk to CPT code 47000, 
to account for the decrease in the surveyed intraservice work time. We 
believe that the work carried out by the practitioner in CPT code 47000 
is potentially more intense than the work performed in CPT code 20220, 
as the reviewed code is a superficial bone biopsy as opposed to the 
non-superficial biopsy taking place on an internal organ (the liver) 
described by CPT code 47000. We also note that the survey respondents 
considered CPT code 47000 to have similar intensity to CPT code 20220: 
50 percent or more of the survey respondents rated the two codes as 
``identical'' under the categories of Mental Effort and Judgment, 
Physical Effort Required, and Psychological Stress, along with a 
plurality of survey respondents rating the two codes as identical in 
the category of Technical Skill Required. We believe that this provides 
further support for our belief that CPT code 20220 should be 
crosswalked to CPT code 47000 at the same work RVU of 1.65.
    We disagree with the RUC-recommended work RVU of 3.00 for CPT code 
20225 and we proposed a work RVU of 2.45 based on a crosswalk to CPT 
code 30906 (Control nasal hemorrhage, posterior, with posterior nasal 
packs and/or cautery, any method; subsequent). CPT code 30906 shares 
the same intraservice time of 30 minutes and has 1 fewer minute of 
total time as compared to CPT code 20225. When reviewing this code, we 
observed a pattern similar to what we had seen with CPT code 20220. We 
note that the recommended intraservice time for CPT code 20225 is 
decreasing from 60 minutes to 30 minutes (50 percent reduction), and 
the recommended total time is decreasing from 135 minutes to 64 minutes 
(53 percent reduction); however, the RUC-recommended work RVU is 
increasing from 1.87 to 3.00, which is an increase of about 60 percent. 
As we noted earlier, we do not believe that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, and we did not propose a linear 
decrease in the work valuation based on these time ratios. Indeed, we 
agree with the RUC recommendation that the work RVU of CPT code 20225 
should increase over the current valuation. However, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be appropriately reflected in changes to the 
work RVUs, and we do not believe that it would be accurate to propose 
the recommended work RVU of 3.00 given

[[Page 62721]]

the significant decreases in surveyed work time.
    Instead, we believe that it would be more accurate to propose a 
work RVU of 2.45 for CPT code 20225 based on a crosswalk to CPT code 
30906. We note that this proposed work RVU is a very close match to the 
intraservice time ratio between the two codes in the family; we 
proposed a work RVU of 1.65 for CPT code 20220 with 20 minutes of 
intraservice work time, and a work RVU of 2.45 for CPT code 20225 with 
30 minutes of intraservice work time. (The exact intraservice time 
ratio calculates to a work RVU of 2.47.) We believe that the proposed 
work RVUs maintain the relative intensity of the two codes in the 
family, and better preserve relativity with the rest of the codes on 
the PFS.
    For the direct PE inputs, we proposed to replace the bone biopsy 
device (SF055) supply with the bone biopsy needle (SC077) in CPT code 
20225. We note that this code currently makes use of the bone biopsy 
needle, and there was no rationale provided in the recommended 
materials to explain why it would now be typical for the bone biopsy 
needle to be replaced by the bone biopsy device. We proposed to 
maintain the use of the current supply item. We are also proposing to 
adopt a 90 percent utilization rate for the use of the CT room (EL007) 
equipment in CPT code 20225. We previously finalized a policy in the CY 
2010 PFS final rule (74 FR 61754 through 61755) to increase the 
equipment utilization rate to 90 percent for expensive diagnostic 
equipment priced at more than $1 million, and specifically cited the 
use of CT and MRI equipment which would be subject to this utilization 
rate.
    We received public comments on the proposed valuation of the codes 
in the Bone Biopsy Trocar-Needle family. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 1.65 for CPT code 20220 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.93. Commenters stated that a 
superficial bone biopsy as described in CPT code 20220 is more intense 
to perform than a liver biopsy as described in the CMS crosswalk code 
(47000), and that the typical indication for CPT code 20220, a 
potentially infectious or malignant lesion, requires a biopsy with an 
11-gauge Jamshidi bone biopsy needle. Commenters stated that accurate 
placement and increased risk of adjacent structures results in a 
greater intensity of physician work relative to CPT code 47000.
    Response: We appreciate the additional information from the 
commenters regarding the relative intensity of CPT codes 20220 and 
47000. In light of this additional information, we agree with the 
commenters that the superficial bone biopsy service described by CPT 
code 20220 has a higher intensity than the liver biopsy service 
described by CPT code 47000. Although we stated that the crosswalk code 
was ``potentially more intense'' in the proposed rule, we ultimately 
proposed a higher intensity for CPT code 20220 than CPT code 47000 at 
our work RVU of 1.65. Based on the information provided by the survey 
respondents, who considered CPT code 47000 to have similar intensity to 
CPT code 20220, we continue to disagree with the RUC-recommended work 
RVU of 1.93, which would assign a significantly higher intensity to CPT 
code 20220. We continue to believe that it was more accurate to propose 
a work RVU of 1.65, based on the aforementioned crosswalk to CPT code 
47000, which assigns both codes a similar intensity, accounts for the 
decrease in the surveyed intraservice work time, and incorporates the 
information provided by the survey respondents.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 2.45 for CPT code 20225 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 3.00. Commenters stated that 
crosswalking a deep bone biopsy performed on patients with a 
destructive malignant lesion to CPT code 30906, a service used for 
controlling an established patient's nosebleed, was inappropriate. 
Commenters noted that the proposed intensity of CPT code 20225 was 
lower than the intensity of the crosswalk code.
    Response: We disagree with the commenters that there is a 
meaningful difference in intensity between CPT code 20225 and our 
crosswalk CPT code 30906. These two codes share the same intraservice 
time of 30 minutes and differ by only 1 minute of total time, 64 
minutes as compared to 63 minutes. The intensity of these two codes 
differs by less than one half of one percentage point, and it would be 
difficult for two procedures to match more closely on intensity (which 
is itself a derived number not measured directly) without sharing the 
same work times. We also disagree with the commenters that the choice 
of CPT code 30906 is an inappropriate crosswalk on clinical grounds. 
CPT code 30906 is far from a simple ``nosebleed'', instead describing a 
service in which the typical patient requires repeated treatment for 
control of nasal hemorrhages using anesthesia and extensive cautery. 
Like CPT code 20225, CPT code 30906 is a significant 0-day global 
procedure that requires 30 minutes of intraservice work time. We 
continue to believe that it was more accurate to propose a work RVU of 
2.45 for CPT code 20225, based on the aforementioned crosswalk to CPT 
code 30906, which we believe better maintains the relative intensity of 
the two codes in the family, and better preserves relativity with the 
rest of the codes on the PFS.
    Comment: Several commenters stated the crosswalk or methodology 
used in the original valuation of CPT code 20220 is unknown and not 
resource-based, and therefore, it was invalid for CMS to compare the 
current time and work to the surveyed time and work. Commenters stated 
that referencing physician times and derived intensities created almost 
30 years ago under the Harvard study as a method to critique RUC 
recommendations was not appropriate. Commenters also stated that when 
CPT code 20225 was last evaluated in 1995, work times were evaluated 
with much less rigor, and that the near zero intensity of CPT code 
20225 indicated a severely anomalous relationship between the current 
work value and current physician time.
    Response: We disagree with the commenter that it was invalid to 
compare the current time and work to the surveyed time and work. We 
believe that it is crucial that the code valuation process take place 
with the understanding that the existing work times, used in the PFS 
ratesetting processes, are accurate. We recognize that adjusting work 
RVUs for changes in time is not always a straightforward process and 
that the intensity associated with changes in time is not necessarily 
always linear, which is why we apply various methodologies to identify 
several potential work values for individual codes. However, we 
reiterate that we believe it would be irresponsible to ignore changes 
in time based on the best data available and that we are statutorily 
obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of old 
work time values that were established many years ago and have not 
since been reviewed in our methodology, we refer readers to our 
discussion of the subject in the Methodology for Establishing Work RVUs 
section of this rule (section II.N.2. of this final rule), as well as a 
longer discussion in the CY 2017 PFS final rule (81 FR 80273 through 
80274).

[[Page 62722]]

    Comment: Several commenters disagreed with the CMS proposal to 
replace the bone biopsy device (SF055) supply with the bone biopsy 
needle (SC077) in CPT code 20225. Commenters stated that the bone 
biopsy device was necessary to perform this procedure and that the 
omission of this supply item when this service was last reviewed in 
2004 was an oversight. Commenters stated that in the vast majority of 
cases, deep bone biopsies are performed percutaneously using a bone 
biopsy drill device that allows for access to sclerotic bony lesions in 
a manner that a bone biopsy needle cannot, and that failing to 
accurately include the devices typically used to perform this service 
in a nonfacility setting would likely result in the procedures being 
pushed to a more expensive facility setting.
    Response: Although we appreciate the additional information about 
the bone biopsy device provided by the commenters, we disagree that its 
use would be typical for CPT code 20225. As we stated in the proposed 
rule, CPT code 20225 currently makes use of the bone biopsy needle and 
there was no rationale provided in the recommended materials to explain 
why it would now be typical for the bone biopsy needle to be replaced 
by the bone biopsy device. We believe it unlikely that the lack of a 
bone biopsy device in the current direct PE inputs for CPT code 20225 
was an accidental omission, given that it has been omitted from the 
direct PE inputs for the past 15 years--had this been an oversight, we 
would expect that there would have been a previous attempt to address 
it. We also note that the clinical description of work for CPT code 
20225 makes no mention of a bone biopsy drill, but does repeatedly 
mention the use of a needle for the bone biopsy. Based on this 
evidence, we continue to believe that the continued use of the bone 
biopsy needle supply would be typical for the procedure.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Bone Biopsy Trocar-
Needle family as proposed.
(4) Trigger Point Dry Needling (CPT Codes 20560 and 20561)
    For CY 2020, the CPT Editorial Panel approved two new codes to 
report dry needling of musculature trigger points. These codes were 
surveyed and reviewed by the HCPAC for the January 2019 RUC meeting.
    We disagree with the HCPAC-recommended work RVU of 0.45 for CPT 
code 20560 (Needle insertion(s) without injection(s), 1 or 2 muscle(s)) 
and we proposed a work RVU of 0.32 based on a crosswalk to CPT code 
36600 (Arterial puncture, withdrawal of blood for diagnosis). CPT code 
36600 shares the identical intraservice time, total time, and intensity 
with CPT code 20560, which makes it an appropriate choice for a 
crosswalk. In our review of CPT code 20560, we compared the procedure 
to the top reference code chosen by the survey participants, CPT code 
97140 (Manual therapy techniques (e.g., mobilization/manipulation, 
manual lymphatic drainage, manual traction), 1 or more regions, each 15 
minutes). This therapy procedure has 50 percent more intraservice time 
than CPT code 20560, as well as higher total time; however, the 
recommended work RVU of 0.45 was higher than the work RVU of 0.43 for 
the top reference code from the survey. We did not agree that CPT code 
20560 should be valued at a higher rate, and therefore, we proposed a 
work RVU of 0.32 based on the aforementioned crosswalk to CPT code 
36600.
    We disagree with the HCPAC-recommended work RVU of 0.60 for CPT 
code 20561 (Needle insertion(s) without injection(s), 3 or more 
muscle(s)) and we proposed a work RVU of 0.48 based on a crosswalk to 
CPT codes 97113 (Therapeutic procedure, 1 or more areas, each 15 
minutes; aquatic therapy with therapeutic exercises) and 97542 
(Wheelchair management (e.g., assessment, fitting, training), each 15 
minutes). Both of these codes share the same work RVU of 0.48 and the 
same intraservice time of 15 minutes as CPT code 20561, with CPT code 
97113 having two fewer minutes of total time and CPT code 97542 having 
two additional minutes of total time. We note that this proposed work 
RVU is an exact match of the intraservice time ratio between the two 
codes in the family; we proposed a work RVU of 0.32 for CPT code 20560 
with 10 minutes of intraservice work time, and a work RVU of 0.48 for 
CPT code 20561 with 15 minutes of intraservice work time. We also 
considered crosswalking the work RVU of CPT code 20561 to the top 
reference code from the survey, CPT code 97140, at a work RVU of 0.43. 
However, we chose to employ the crosswalk to CPT codes 97113 and 97542 
at a work RVU of 0.48 instead, due to the fact that the survey 
respondents indicated that CPT code 20561 was more intense than CPT 
code 97140.
    We also proposed to designate CPT codes 20560 and 20561 as ``always 
therapy'' procedures, and we solicited comments on this designation. We 
proposed the RUC-recommended direct PE inputs for all codes in the 
family.
    We received public comments on the proposed valuation of the codes 
in the Trigger Point Dry Needling family. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 0.32 for CPT code 20560 and stated that CMS should instead 
finalize the HCPAC-recommended work RVU of 0.45. Commenters stated that 
CMS disregarded all factors that go into work valuation apart from 
time, as well as minimized the understanding of the service on the part 
of the survey respondents. Commenters stated that the survey 
respondents recognized that CPT code 20560 is more intense and complex 
to perform than the top reference code, CPT code 97140, because it is 
an invasive procedure rather than non-invasive manual therapy. 
Commenters stated that 70 percent of the survey respondents that 
selected this key reference code indicated that CPT code 20560 requires 
more mental effort and judgment and 84 percent indicated that more 
physiological stress is involved. Commenters stated that noninvasive 
techniques do not have the same risks or skill requirement as 
procedures described by 20560, and that a higher level of education for 
the qualified health care professional is required in addition to a 
higher level of skill and focus during and following the procedure when 
performing CPT code 20560.
    Response: In response to the first issue raised by the commenters 
regarding work valuation based on time values, we recognize that it 
would not be appropriate to develop work RVUs solely based on time 
given that intensity is also an element of work. We clarify again that 
we do not treat all components of physician time as having identical 
intensity. If we were to disregard intensity altogether, the work RVUs 
for all services would be developed based solely on time values and 
that is definitively not the case, as indicated by the many services 
that share the same time values but have different work RVUs. For more 
details on our methodology for developing work RVUs, we refer readers 
to our discussion of the subject in the Methodology for Establishing 
Work RVUs section of this rule (section II.N.2 of this final rule), as 
well as a longer discussion in the CY 2017 PFS final rule (81 FR 80272 
through 80277).
    We also disagree with the commenters that CPT code 20560 is more 
intense and complex to perform than the top

[[Page 62723]]

reference code, CPT code 97140. Although it is true that a majority of 
survey respondents stated that CPT code 20560 requires more mental 
effort/judgment and additional physiological stress, 74 percent of the 
same survey respondents also stated that CPT code 20560 required less 
physical effort than CPT code 97140, which would suggest that the 
reviewed code instead has a lower intensity. We do not agree that the 
survey responses provide sufficient support for assigning a higher work 
RVU to CPT 20560 than CPT code 97140, especially given that this top 
reference code has 50 percent more intraservice time. We similarly do 
not agree that the intensity of the non-invasive manual therapy 
procedure described by CPT code 97140 is inherently lower on clinical 
grounds than the invasive procedure described by CPT code 20560. The 
manual therapy procedure described by CPT code 97140 has its own 
distinct type of skill requirements since there is more extensive 
direct contact between the practitioner and the patient than in CPT 
code 20560. We continue to believe that CPT code 20560 should not be 
valued at a higher rate than CPT code 97140, and therefore, we proposed 
a work RVU of 0.32 based on the aforementioned crosswalk to CPT code 
36600.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 0.48 for CPT code 20561 and stated that CMS should instead 
finalize the HCPAC-recommended work RVU of 0.60. Commenters stated that 
CMS started with the work RVU they assigned to CPT code 20560 and then 
selected crosswalk codes that matched the intraservice time ratio 
between the codes in the family. Commenters stated that this is an 
erroneous methodology and, if finalized, would create a rank order 
anomaly between this and other similar services.
    Response: We clarify that we did not use an intraservice time ratio 
to determine the work valuation of CPT code 20561. As we stated in the 
proposed rule, we proposed a work RVU of 0.48 based on a crosswalk to 
CPT codes 97113 and 97542 as both of these codes share the same work 
RVU of 0.48 and the same intraservice time of 15 minutes as CPT code 
20561, with CPT code 97113 having 2 fewer minutes of total time and CPT 
code 97542 having 2 additional minutes of total time. We believe that 
the close match between the surveyed work time for CPT code 20561 and 
the work times of these two codes indicated that these three services 
should be valued similarly, and we disagree that the proposed work RVU 
would create a rank order anomaly due to the close relationship between 
the work times of these codes. We noted in the proposed rule that the 
proposed work RVU of 0.48 for CPT code 20561 is an exact match of the 
intraservice time ratio between the two codes in the family; however, 
we cited this fact as supporting evidence and not as the primary basis 
for valuation. Although we did not use a time ratio for work valuation 
in this case, we continue to believe that the use of time ratios is one 
of several appropriate methods for identifying potential work RVUs for 
particular PFS services. For more details on our methodology for 
developing work RVUs, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80272 through 80277).
    Comment: Several commenters provided the same rationale for CPT 
code 20561 in relation to the top reference code from the survey, CPT 
code 97140, as they had made for CPT code 20560. Commenters stated that 
the survey respondents recognized that CPT code 20561 is more intense 
and complex to perform than the top reference code, CPT code 97140, 
because it is an invasive procedure rather than non-invasive manual 
therapy. Commenters stated that 71 percent of the survey respondents 
that selected this key reference code indicated that CPT code 20560 
requires more mental effort and judgment and 88 percent indicated that 
more physiological stress is involved. Commenters stated that 
noninvasive techniques do not have the same risks or skill requirement 
as procedures described by 20561, and that a higher level of education 
for the qualified health care professional is required in addition to a 
higher level of skill and focus during and following the procedure when 
performing CPT code 20561.
    Response: We continue to disagree with the commenters that CPT code 
20561 is more intense and complex to perform than the top reference 
code, CPT code 97140, for many of the same reasons that we cited in our 
response to the same comments regarding CPT code 20560. As we observed 
for the first code in the family, 69 percent of the same survey 
respondents also stated that CPT code 20561 required less physical 
effort than CPT code 97140, which would again suggest that the reviewed 
code instead has a lower intensity. Unlike CPT code 20560, we agree 
that CPT code 20561 should have a higher work RVU than CPT code 97140, 
which is why we proposed a work RVU of 0.48 for the procedure. To the 
extent that the commenters are stating that CPT code 20561 should have 
a higher work RVU than CPT code 97140, we agree with the commenters and 
we proposed a work RVU accordingly. We do not agree with the commenters 
that CPT code 20561 should be valued nearly 50 percent higher than CPT 
code 97140 given their nearly identical work times and similar overall 
intensity.
    Comment: One commenter agreed with the CMS proposal to designate 
CPT codes 20560 and 20561 as ``always therapy'' procedures. The 
commenter stated that acupuncturists would also use additional 
modalities and procedures in their scope along with these codes, and 
that these would not typically be billed independently.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: Many commenters disagreed with the CMS proposal to 
designate CPT codes 20560 and 20561 as ``always therapy'' procedures. 
Commenters stated that these services may be performed by a wide range 
of professionals and that it may not be appropriate to bill the service 
under a therapy plan of care. Commenters also stated that assigning a 
designation of ``always therapy'' to these codes would be inconsistent 
with CMS' designation of other CPT codes as ``sometimes therapy'' codes 
that could be appropriately provided either as therapy services or non-
therapy services. Other commenters objected to the proposal by stating 
that dry needling codes should be placed in the surgical section of the 
CPT codebook, and that due to the invasive nature of these procedures 
using needles, they should only be performed by licensed medical 
physicians or licensed acupuncturists. Commenters urged CMS to change 
the designation of CPT codes 20560 and 20561 to ``sometimes therapy'' 
procedures.
    Response: We appreciate the feedback from the commenters in 
providing additional information about which providers will bill these 
services, and the fact that it may not be appropriate to bill these 
service under a therapy plan of care. After consideration of the 
comments, we are not finalizing our proposal to designate CPT codes 
20560 and 20561 as ``always therapy'' procedures. We believe that a 
``sometimes therapy'' designation would be more appropriate if we were 
to designate these codes as therapy procedures.
    Comment: One commenter stated that if CPT codes 20560 and 20561 are 
covered services under Medicare then

[[Page 62724]]

an acupuncturist should be a qualified health care professional and 
should be recognized by Medicare to provide this service. The commenter 
described some of the clinical benefits associated with acupuncture and 
stated again that acupuncturists should be recognized by Medicare to 
provide dry needling.
    Response: We appreciate the feedback from the commenter regarding 
the practice of acupuncture. However, we did not make a proposal 
regarding the classification of acupuncturists, and therefore, this 
comment is out of scope.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Trigger Point Dry 
Needling family as proposed. We are not finalizing these codes as 
``always'' or ``sometimes'' therapy services because dry needling 
services are non-covered unless otherwise specified through a national 
coverage determination (NCD). Please refer to the NCD Manual, Section 
30.3 at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part1.pdf.
(5) Closed Treatment Vertebral Fracture (CPT Code 22310)
    This service was identified through a screen of services with a 
negative IWPUT and Medicare utilization over 10,000 for all services or 
over 1,000 for Harvard valued and CMS/Other source codes.
    For CPT code 22310 (Closed treatment of vertebral body fracture(s), 
without manipulation, requiring and including casting or bracing), we 
disagreed with the recommended work-RVU of 3.75, stating that we did 
not think that this reduction in work RVU from the current value of 
3.89 was commensurate with the RUC-recommended 33-minute reduction in 
intraservice time and 105-minute reduction in total time. We noted that 
while we understand that the RUC considers the current Harvard study 
time values for this service to be invalid estimations, we believed 
that a further reduction in work RVUs is warranted given the 
significance of the RUC-recommended reduction in physician time. We 
proposed a work RVU of 3.45 with a crosswalk to CPT code 21073 
(Manipulation of temporomandibular joint(s) (TMJ), therapeutic, 
requiring an anesthesia service (i.e., general or monitored anesthesia 
care)), which has an identical intraservice time and similar total time 
as those proposed by the RUC for CPT code 22310 to more accurately 
account for the decrease in the surveyed work time.
    For the direct PE inputs, we proposed to refine the equipment time 
for the power table (EF031) to conform to our established policies for 
non-highly technical equipment.
    We received public comments on the proposed valuation of the codes 
in the Closed Treatment Vertebral Fracture family. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters stated that CMS is inappropriately 
comparing accurate survey time to Harvard time, which the commenter 
stated holds zero validity for comparison. The commenters further 
stated that our proposed value fails to acknowledge that the Harvard 
work value was much higher based on the Harvard study physician work 
times than the current work value of the service. One commenter noted 
that in the June 1991 proposed rule, the work RVU for 22310, based on 
the Harvard study, was 6.31, then, in the November 1991 final rule for 
the 1992 PFS, the work RVU was reduced to 1.95, and then in 1997, 
hospital and office visits were assigned by algorithm for practice 
expense (PE) purposes. The commenter stated that the entire history of 
value of this code is fraught with misestimations of time and the 
current work RVU of 3.89 has nothing to do with the Harvard study.
    Response: We believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available and that we are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    We recognize that this code has undergone revisions and that the 
work value has changed significantly from the Harvard value. If we 
accept the commenter's contention that the current work RVU is 
unrelated to the original Harvard work RVU, and we compare the time 
values to the original 1991 Harvard work value of 6.31, our proposed 
work RVU continues to appear to be appropriate. A ratio of the change 
in intraservice time to the original RVU of 6.31 is 3.50; a ratio of 
the change in total time to the original work RVU of 6.31 is 2.38. 
These ratios suggest that our proposed RVU of 3.45 is a more accurate 
valuation than the RUC's recommended RVU of 3.75. We continue to 
believe that a crosswalk to CPT code 21073, which describes 
manipulation under general or monitored care under anesthesia with 
manipulation of the TMJ, is appropriate. CPT code 22310 involves closed 
treatment without manipulation and the application of a brace, while 
CPT code 21073 involves anesthesia and manipulation; we believe the 
similar work and time of CPT code 21073 validates our work RVU of 3.45 
for CPT Code 22310.
    Comment: Several commenters stated that they agreed with our 
proposal to refine the equipment time for the power table (EF031) to 
conform to our established policies for non-highly technical equipment.
    Response: We appreciate the support for our proposal from the 
commenters.
    After consideration of the public comments, we are finalizing our 
work RVU of 3.45 as proposed. We are also finalizing the direct PE 
inputs as proposed.
(6) Tendon Sheath Procedures (CPT Codes 26020, 26055, and 26160)
    The RUC identified these services through a screen of services with 
a negative IWPUT and Medicare utilization over 10,000 for all services 
or over 1,000 for Harvard valued and CMS/Other source codes. For CPT 
code 26020 (Drainage of tendon sheath, digit and/or palm, each), we do 
not agree with the RUC-recommended work RVU of 7.79 based on the survey 
median. While we agree that the survey data validate an increase in 
work RVU, we see no compelling reason that this service would be 
significantly more intense to furnish than services of similar time 
values. Therefore, we proposed a work RVU of 6.84 which is the survey 
25th percentile. As further support for this value, we note that it 
falls between the work RVUs of CPT code 28122 (Partial excision 
(craterization, saucerization, sequestrectomy, or diaphysectomy) bone 
(e.g., osteomyelitis or bossing); tarsal or metatarsal bone, except 
talus or calcaneus), with a work RVU of 6.76, and CPT code 28289 
(Hallux rigidus correction with cheilectomy, debridement and capsular 
release of the first metatarsophalangeal joint; without implant), with 
a work RVU of 6.90; both codes have intraservice time values that are 
identical to, and total time values

[[Page 62725]]

that are similar to, the RUC-recommended time values for CPT code 
26020.
    For CPT code 26055 (Tendon sheath incision (e.g., for trigger 
finger)), we do not agree with the RUC recommendation to increase the 
work RVU to 3.75 despite a reduction in physician time. Instead, we 
proposed to maintain the current work RVU of 3.11; we are supporting 
this based on a total time increment methodology between the CPT code 
26020 and CPT code 26055. The total time ratio between the recommended 
time of 119 minutes and the recommended 262 minutes for code 26020 
equals 45 percent, and 45 percent of our proposed RVU of 6.84 for CPT 
code 26020 equals a work RVU of 3.10, which we believe validates the 
current work RVU of 3.11. We proposed the RUC-recommended work RVU of 
3.57 for CPT code 26160 (Excision of lesion of tendon sheath or joint 
capsule (e.g., cyst, mucous cyst, or ganglion), hand or finger). We 
note that our proposed work RVUs validate the RUC's contention that CPT 
code 26160 is slightly more intense to perform than CPT code 26055.
    For the direct PE inputs, we proposed to refine the quantity of the 
impervious staff gown (SB027) supply from 2 to 1 for CPT codes 26055 
and 26160. We believe that the second impervious staff gown supply is 
duplicative due to the inclusion of this same supply in the surgical 
cleaning pack (SA043). The recommended materials state that a gown is 
worn by the practitioner and one assistant, which are provided by one 
standalone gown and a second gown in the surgical cleaning pack.
    We received public comments on the proposed valuation of the codes 
in the Tendon Sheath Procedures family. The following is a summary of 
the comments we received and our responses.
    Comment: A few commenters stated that, for CPT code 26020, our 
supporting reference codes, CPT code 28122 and CPT code 28289, are 
inappropriate in that they have lower total time values than the 
surveyed total time of CPT code 26020, and that this reflects that 
these two reference codes typically involve a patient who is discharged 
within 23 hours of the procedure and are less intense. The commenter 
stated that the RUC's recommendation of the median survey value for CPT 
code 26020 is necessary because even at the survey median, the 
intraoperative intensity (0.027), is so low that there are no 
comparator codes with a lower work RVU. This commenter also stated that 
the survey 25th percentile work RVU would vastly underestimate the 
physician work, resulting in an intraoperative intensity of 0.006--or 
essentially zero.
    Response: For CPT code 26020, we continue to believe that the RUC's 
recommended work RVU of 7.79 is disproportionately high, as it 
represents a 35 percent increase in work despite a 5 minute increase in 
intraservice time and a 30 minute increase in total time. We believe 
our proposal to value CPT code 26020 with the survey 25th percentile, 
which represents a roughly 26 percent increase is more proportionate. 
Further, we note that our proposed value recognizes the work inherent 
in this procedure, including the requisite inpatient monitoring, as it 
lies within the top quartile of all 90-day global period codes with an 
intraservice time of 45 minutes. We recognize that the relatively high 
total time value for this code results in a relatively low intensity 
value, however we continue to believe that our value appears to be 
consistent with other relatively low-intensity procedures of similar 
times. The intensity value that results from our proposed work RVU is 
extremely close to that which results from the RUC's recommended work 
RVU, and therefore, we continue to think that our value adequately 
reflects the work inherent in the procedure.
    Comment: One commenter stated that our proposal to maintain the 
current work RVU for CPT code 26055 indicates that we inappropriately 
noted that the reduction in time should exactly correlate with a 
reduction in work RVU. The current times are based on a 2005 survey but 
the current work RVU is based on the Harvard study. The commenter 
stated that CMS should not compare the old times relative to the work 
RVU. The commenter disagreed with use of an incremental methodology to 
value CPT code 26055, as it inaccurately treats all components of the 
physician time as having identical intensity. In addition, the 
commenter stated maintaining the current work RVU for CPT code 26055 
results in an inappropriately low intensity of 0.011 which does not 
reflect an open surgical procedure typically performed in a facility 
under moderate sedation and is not much higher than the assigned value 
for pre-service scrub/dress/wait time.
    Response: We do not believe that our proposal assumes that the 
reduction in time for this service should exactly correlate with a 
reduction in work RVU; a proportionate reduction based solely on time 
would result in a lower RVU than that proposed. As discussed elsewhere 
in this rule, we believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. We 
believe the use of an incremental difference between codes is a valid 
methodology for setting values, especially in valuing services within a 
family of revised codes where it is important to maintain appropriate 
intra-family relativity. Historically, we have frequently utilized an 
incremental methodology in which we value a code based upon its 
incremental difference between another code or another family of codes. 
We note that the RUC has also used the same incremental methodology on 
occasion when it was unable to produce valid survey data for a service. 
We have no evidence to suggest that the use of an incremental 
difference between codes conflicts with the statute's definition of the 
work component as the resources in time and intensity required in 
furnishing the service. For more details on our methodology for 
developing work RVUs, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80272 through 80277). We continue to 
believe that our proposed work RVU maintains the proportionate 
relationship with CPT code 26020.
    We continue to believe that comparisons to similar procedures of 
similar time values indicate that our proposed value accurately 
reflects the intensity inherent in the procedure.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the quantity of the impervious staff gown (SB027) supply from 2 
to 1 for CPT codes 26055 and 26160 and stated that this gown was not 
duplicative. Commenters stated that two gowns are required in the 
procedure room (for the practitioner and a clinical staff member) and a 
separate gown is required, typically for a second clinical staff 
individual, for the cleaning of instruments in a separate room. 
Commenters stated that the US Department of Labor, Occupational Safety 
and Health Administration (OSHA) regulations require that all personal 
protective equipment must be removed prior to leaving the work area, 
which includes removing the impervious staff gown worn during the 
procedure, and therefore, necessitating the inclusion of another gown 
as a supply input.
    Response: We appreciate the additional information provided by the 
commenters regarding the number of impervious staff gowns typically 
used in these procedures. As a result of this additional information, 
we are not

[[Page 62726]]

finalizing our proposed refinement to reduce the quantity of the 
impervious staff gown (SB027) supply from 2 to 1 for CPT codes 26055 
and 26160. We are instead finalizing the RUC-recommended direct PE 
inputs for all three codes in the family.
    After consideration of the public comments, we are finalizing our 
proposed work RVUs of 6.84 for CPT code 26020, 3.11 for CPT code 26055, 
and 3.57 for CPT code 26160. We are finalizing the RUC-recommended 
direct PE inputs for all three codes in the family as stated 
previously.
(7) Closed Treatment Fracture--Hip (CPT Code 27220)
    This service was identified through a screen of services with a 
negative IWPUT and Medicare utilization over 10,000 for all services or 
over 1,000 for Harvard valued and CMS/Other source codes. For CPT code 
27220 (Closed treatment of acetabulum (hip socket) fracture(s); without 
manipulation), we disagree with the RUC-recommended work RVU of 6.00 
based on the survey median value, because we do not believe that this 
reduction in work RVU from the current value of 6.83 is commensurate 
with the RUC-recommended a 19-minute reduction in intraservice time and 
an 80-minute reduction in total time. While we understand that the RUC 
considers the current Harvard study time values for this service to be 
invalid estimations, we believe that a further reduction in work RVUs 
is warranted given the significance of the RUC-recommended reduction in 
physician time. We believe that it would be more accurate to propose 
the survey 25th percentile work RVU of 5.50, and we are supporting this 
value with a crosswalk to CPT code 27267 (Closed treatment of femoral 
fracture, proximal end, head; without manipulation) to account for the 
decrease in the surveyed work time.
    For the direct PE inputs, we proposed to refine the equipment time 
for the power table (EF031) to conform to our established policies for 
non-highly technical equipment.
    We received public comments on the proposed valuation of the Closed 
Treatment Fracture--Hip code. The following is a summary of the 
comments we received and our responses.
    Comment: A few commenters disagreed with our proposal, stating that 
it relies on a comparison of accurate survey time to Harvard time, the 
latter of which they stated holds zero validity for comparison.
    Response: We believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available and that we are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80273 through 80274).
    Comment: One commenter stated that reducing the work RVU of this 
service based on a comparison to the current work value does not 
adequately take into account that the current value reflects 
adjustments made to the original Harvard work RVU in various rule 
cycles over many years to account for increases in the E/M services 
included in the global period of this service. A downward adjustment to 
the work RVU would essentially reverse increases that have been made to 
account for this post-operative work.
    Response: We disagree that reducing the work RVU ignores the value 
of the E/M services included in the global period; while the Harvard 
work values for services such as this one have been adjusted upward in 
previous years to account for these services, we nevertheless have 
included the surveyed work time in our analysis of this code; and this 
surveyed time includes post-operative work. Our proposed work RVU was 
not based solely on the reduction in time. We note that our crosswalk 
code, CPT code 27267 (Closed treatment of femoral fracture, proximal 
end, head; without manipulation) includes a similar amount of 
postoperative work, and therefore, we believe that our value adequately 
reflects this work.
    Comment: The RUC commented that our proposed work RVU will 
inappropriately value this service equally to the work RVU of the 
survey key reference service, CPT code 27267, and the latter has 
significantly less pre-service time, and is thus not an appropriate 
crosswalk. Furthermore, our proposed value does not adequately correct 
the negative IWPUT resulting from the current value, stating that the 
resulting IWPUT of 0.008 is essentially zero.
    Response: We continue to believe that CPT code 27267 is an 
appropriate crosswalk; both procedures involve closed treatment of hip 
without manipulation. While the derived intensity value that results 
from our proposed value of 5.50 is lower than that which results from 
the RUC's value, it is only negligibly so, with a difference of 0.033 
in IWPUT.
    Comment: A commenter stated that they agreed with our proposal to 
refine the equipment time for the power table (EF031) to conform to our 
established policies for non-highly technical equipment.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing as 
proposed a work RVU of 5.50 for CPT code 27220. We are also finalizing 
the direct PE inputs as proposed.
(8) Arthrodesis--Sacroiliac Joint (CPT Code 27279)
    In the CY 2018 PFS final rule (82 FR 53017), CPT code 27279 
(Arthrodesis, sacroiliac joint, percutaneous or minimally invasive 
(indirect visualization), with image guidance, includes obtaining bone 
graft when performed, and placement of transfixing device) was 
nominated for review by stakeholders as a potentially misvalued 
service. We stated that CPT code 27279 is potentially misvalued, and 
that a comprehensive review of the code values was warranted. This code 
was subsequently reviewed by the RUC. According to the specialty 
societies, the previous 2014 survey of CPT code 27279, was based on 
flawed methodology that resulted in an underestimation of 
intraoperative intensity. When CPT code 27279 was surveyed in 2014, 
there was a low rate of response. Due to the dearth of survey data and 
the RUC's agreement with the specialty society at the time that the 
survey respondents had somewhat overvalued the work involved in 
performing this service, the RUC used a crosswalk to CPT code 62287 
(Decompression procedure, percutaneous, of nucleus pulposus of 
intervertebral disc, any method utilizing needle based technique to 
remove disc material under fluoroscopic imaging or other form of 
indirect visualization, with discography and/or epidural injection(s) 
at the treated level(s), when performed, single or multiple levels, 
lumbar) to recommend a work RVU of 9.03. The

[[Page 62727]]

specialty societies indicated that with increased and broader 
utilization of this technique, the 2018 survey is a more robust 
assessment of physician work and intensity and provides more data with 
which to make a crosswalk recommendation. According to the RUC, there 
is no compelling evidence that the physician work, intensity or 
complexity has changed for this service.
    We proposed to maintain the current work RVU of 9.03 as recommended 
by the RUC. A stakeholder stated that maintaining this RVU would 
constitute the continued undervaluation of this service, and that this 
would incentivize use of a more intensive and invasive procedure, CPT 
code 27280 (Arthrodesis, open, sacroiliac joint, including obtaining 
bone graft, including instrumentation, when performed), as well as 
incentivize this service to be inappropriately furnished on an 
inpatient basis. This stakeholder has requested that, in the interest 
of protecting patient access, we implement payment parity between the 
two services by proposing to crosswalk the work RVU of CPT code 27279 
to that of CPT code 27280, which has a work RVU of 20.00. While we 
proposed the RUC-recommended work RVU, we solicited public comment on 
whether an alternative valuation of 20.00 would be more appropriate. 
This alternative valuation would recognize relative parity between 
these two services in terms of the work inherent in furnishing them.
    We proposed the RUC-recommended direct PE inputs for CPT code 
27279.
    We received public comments on the proposed valuation of the 
Arthrodesis--Sacroiliac Joint code. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter questioned how the most recent stakeholder 
comment was obtained, since the RUC recommendations are not public 
until after the publication of the proposed rule. The commenter stated 
that the recent stakeholder comment could not have been received by CMS 
via the formal comment process, and questioned if the comment was 
communicated via the passing of verbal comment between individuals at 
the RUC meeting or someone gained confidential information 
inappropriately. The commenter stated the reason this service was 
reviewed in 2019 is because it was nominated by a stakeholder that it 
may be undervalued.
    Response: This communication between the agency and a stakeholder 
was not inappropriate. When considering potential valuation for 
services on the PFS, we may take into account information provided to 
us by stakeholders including specialty societies that may have 
participated in the RUC process but did not agree with what was 
submitted as part of the RUC's recommendations. In any event, we 
reiterate that the stakeholder's argument that the service is 
undervalued refers to the current valuation of the service.
    Comment: The RUC restated that it had determined that there is not 
compelling evidence to revalue this procedure as the intensity required 
to perform CPT code 27279 has not changed. With no convincing rationale 
that the physician work, intensity or complexity has changed for this 
service, the RUC recommended to maintain the work RVU of 9.03 for CPT 
code 27279. The RUC did not believe that CPT code CPT code 27279 should 
be valued with a direct crosswalk to CPT code 27280, stating that the 
latter is vastly different than CPT code 27279 because it is an open 
procedure that includes instrumentation, requires double the amount of 
intra-service time to perform, and is more intense and complex to 
perform.
    Many commenters stated that the work RVU of CPT code 27279 is 
undervalued, and stated that the service is complex and intense and 
involves significant risk and preoperative work. Commenters presented 
study results that demonstrate the advantages of this procedure over 
the open procedure, stating that it is minimally invasive and has 
vastly improved outcomes. Some commenters cited studies that they noted 
demonstrate cost-effectiveness metrics and patient reported outcome 
improvements that are better than nearly all orthopaedic and spinal 
procedures, and more cost-efficient than ongoing nonoperative care. 
Commenters stated that, while the procedure described by CPT code 27279 
is less invasive than the open procedure; it nevertheless is similar in 
terms of intensity, as it requires significant pre and postoperative 
care, image guidance, and monitoring. A commenter cited risk associated 
with placement of the guide wires which may result in damage to vital 
structures including spinal nerve roots, blood vessels, and viscera. 
Similarly, commenters cited risks inherent in spinal procedures such as 
bleeding, infection, and pseudoarthrosis. One commenter discussed 
insertion of pins and pegs that run the risk of violating the sacral 
foraminas creating radiculopathies. In addition, a commenter mentioned 
the potential for postoperative hematomas. Other risks cited include 
considerable risk of nerve damage, vascular compressions and iatrogenic 
fractures caused by misplacement of the guide wires, broaches and large 
implants. According to a commenter, the anatomy involved in this 
procedure is more complex than for a discectomy or decompression 
laminectomy. Commenters stated that the procedure is significantly more 
intense than the crosswalk code that its current value was originally 
based on, CPT code 62287 (Decompression procedure, percutaneous, of 
nucleus pulposus of intervertebral disc, any method utilizing needle 
based technique to remove disc material under fluoroscopic imaging or 
other form of indirect visualization, with discography and/or epidural 
injection(s) at the treated level(s), when performed, single or 
multiple levels, lumbar). The commenters stated that this procedure 
requires special skill given the complexity of the anatomy and 
extensive preoperative time.
    Commenters offered various suggestions for a more appropriate 
valuation for CPT code 27279; many commenters stated that 27279 is more 
appropriately valued with a work RVU of 20.00, as it is comparable in 
time and intensity to CPT code 27280. One commenter suggested a work 
RVU of 14.23 which resulted from a regression analysis of surveys. 
Other suggested crosswalk codes offered by commenters include CPT codes 
63030 (Laminotomy (hemilaminectomy), with decompression of nerve 
root(s), including partial facetectomy, foraminotomy and/or excision of 
herniated intervertebral disc; 1 interspace, lumbar), with a work RVU 
of 13.18, 63047 (Laminectomy, facetectomy and foraminotomy (unilateral 
or bilateral with decompression of spinal cord, cauda equina and/or 
nerve root[s], [e.g., spinal or lateral recess stenosis]), single 
vertebral segment; lumbar), with a work RVU of 15.37, 22551 
(Arthrodesis, anterior interbody, including disc space preparation, 
discectomy, osteophytectomy and decompression of spinal cord and/or 
nerve roots; cervical below C2), with a work RVU of 25.00, 27245 
(Treatment of intertrochanteric, peritrochanteric, or subtrochanteric 
femoral fracture; with intramedullary implant, with or without 
interlocking screws and/or cerclage) with a work RVU of 18.18, 27130 
(Arthroplasty, acetabular and proximal femoral prosthetic replacement 
(total hip arthroplasty), with or without autograft or allograft), with 
a work RVU of 20.72, 22612 (Arthrodesis, posterior or posterolateral 
technique, single level; lumbar (with lateral transverse technique, 
when performed)) with a

[[Page 62728]]

work RVU of 23.53, 63040 (Laminotomy (hemilaminectomy), with 
decompression of nerve root(s), including partial facetectomy, 
foraminotomy and/or excision of herniated intervertebral disc, 
reexploration, single interspace; cervical) with an RVU of 20.31, 63042 
(Laminotomy (hemilaminectomy), with decompression of nerve root(s), 
including partial facetectomy, foraminotomy and/or excision of 
herniated intervertebral disc, reexploration, single interspace; 
lumbar) with an RVU of 18.76, 63045 (Laminectomy, facetectomy and 
foraminotomy (unilateral or bilateral with decompression of spinal 
cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral 
recess stenosis]), single vertebral segment; cervical) with a work RVU 
of 17.95, and 63046 (Laminectomy, facetectomy and foraminotomy 
(unilateral or bilateral with decompression of spinal cord, cauda 
equina and/or nerve root[s], [e.g., spinal or lateral recess 
stenosis]), single vertebral segment; thoracic) with a work RVU of 
17.25.
    Response: Commenters have provided extensive evidence that leads us 
to believe that the current work RVU understates the inherent intensity 
of the procedure. We agree with the RUC's longstanding contention that 
survey data is critical in determining appropriate valuation of 
services. The fact that this code is valued based on a crosswalk from 
2014 rather than on updated survey data raised concerns. The RUC's 
survey data, as well as extensive stakeholder comment indicates to us 
that this service continues to be undervalued.
    We agree with the RUC that CPT code 27279 would not be accurately 
valued identically to the analogous open procedure CPT code 27280, as 
the latter is substantially more complex and requires twice the amount 
of intraservice time to perform. Therefore, finalizing an equivalent 
value for these two services would introduce a rank-order anomaly. 
While we are persuaded by extensive public comment that this service as 
currently valued does not adequately reflect the work inherent in 
performing the procedure, we note that all of the crosswalk codes 
recommended by commenters involve significantly more physician time 
than that required for CPT code 27279, and values crosswalked to these 
codes would not maintain appropriate rank-order between CPT codes 27279 
and 27280, and would in many instances result in a valuation that is 
higher than that of the open procedure, CPT code 27280. We believe it 
is preferable to value this service in close adherence to the surveyed 
time values. After consideration of the comments, we are finalizing a 
work RVU of 12.13 with a direct crosswalk to CPT code 57288 (Sling 
operation for stress incontinence (e.g., fascia or synthetic)), which 
describes an open procedure of similar intensity. This procedure has an 
identical intraservice time value and similar total time value. We 
believe that the description of this service and its work and time 
values indicate that it is a strong crosswalk and a work RVU of 12.13 
is a more accurate valuation for this service. We believe a value 
crosswalked to this service more accurately reflects the work inherent 
in performing the procedure while accounting for the surveyed work 
time.
    After consideration of the public comments, we are finalizing a 
work RVU of 12.13 for this service. We are also finalizing the direct 
PE inputs as proposed.
(9) Pericardiocentesis and Pericardial Drainage (CPT Code 33016, 33017, 
33018, and 33019)
    CPT code 33015 (Tube pericardiostomy) was identified as potentially 
misvalued on a Relativity Assessment Workgroup (RAW) screen of codes 
with a negative IWPUT and Medicare utilization over 10,000 for all 
services or over 1,000 for Harvard valued and CMS or other source 
codes. In September 2018, the CPT Editorial Panel deleted four existing 
codes and created four new codes to describe pericardiocentesis 
drainage procedures to differentiate by age and to include imaging 
guidance.
    We proposed to refine the work RVU for all four codes in the 
family. We disagree with the RUC-recommended work RVU of 5.00 for CPT 
code 33016 (Pericardiocentesis, including imaging guidance, when 
performed) and proposed a work RVU of 4.40 based on a crosswalk to CPT 
code 43244 (Esophagogastroduodenoscopy, flexible, transoral; with band 
ligation of esophageal/gastric varices). CPT code 43244 shares the same 
intraservice time of 30 minutes with CPT code 33016 and has a slightly 
longer total time of 81 minutes as compared to 75 minutes for the 
reviewed code. In our review of CPT code 33016, we noted that the 
recommended intraservice time as compared to the current initial 
pericardiocentesis procedure (CPT code 33010) is increasing from 24 
minutes to 30 minutes (25 percent), and the recommended total time is 
remaining the same at 75 minutes; however, the RUC-recommended work RVU 
is increasing from 1.99 to 5.00, which is an increase of 151 percent. 
Although we did not imply that the decrease in time as reflected in 
survey values must equate to a one-to-one or linear increase in the 
valuation of work RVUs, we believe that since the two components of 
work are time and intensity, modest increases in time should be 
appropriately reflected with a commensurate increase the work RVUs. We 
also conducted a search in the RUC database among 0-day global codes 
with 30 minutes of intraservice time and comparable total time of 65-85 
minutes. Our search identified 49 codes and all 49 of these codes had a 
work RVU lower than 5.00. We do not believe that it would serve the 
interests of relativity to establish a new maximum work RVU for this 
range of time values.
    As a result, we believe that it is more accurate to propose a work 
RVU of 4.40 for CPT code 33016 based on a crosswalk to CPT code 43244 
to account for these modest increases in the surveyed work time as 
compared to the predecessor pericardiocentesis codes. We are aware that 
CPT code 33016 is bundling imaging guidance into the new procedure, 
which was not included in the previous pericardiocentesis codes. 
However, we do not believe that the recoding of the services in this 
family has resulted in an increase in their intensity, only a change in 
the way in which they will be reported, and therefore, we do not 
believe that it would serve the interests of relativity to propose the 
RUC-recommended work values for all of the codes in this family. We 
also note that, through the bundling of some of these frequently 
reported services, it is reasonable to expect that the new coding 
system will achieve savings via elimination of duplicative assumptions 
of the resources involved in furnishing particular servicers. For 
example, a practitioner would not be carrying out the full preservice 
work twice for CPT codes 33010 and 76930, but preservice times were 
assigned to both codes under the old coding. We believe the new coding 
assigns more accurate work times, and thus, reflects efficiencies in 
resource costs that existed but were not reflected in the services as 
they were previously reported. If the addition of imaging guidance had 
made the new CPT codes significantly more intense to perform, we 
believe that this would have been reflected in the surveyed work times, 
which were largely unchanged from the predecessor codes.
    We disagree with the RUC-recommended work RVU of 5.50 for CPT code 
33017 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including fluoroscopy

[[Page 62729]]

and/or ultrasound guidance, when performed; 6 years and older without 
congenital cardiac anomaly) and proposed a work RVU of 4.62 based on a 
crosswalk to CPT code 52234 (Cystourethroscopy, with fulguration 
(including cryosurgery or laser surgery) and/or resection of; SMALL 
bladder tumor(s) (0.5 up to 2.0 cm)). CPT code 52234 shares the same 
intraservice time of 30 minutes with CPT code 33017 and has 2 
additional minutes of total time at 79 minutes as compared to 77 
minutes for the reviewed code. In our review of CPT code 33017, we 
noted many of the same issues that we had raised with CPT code 33016, 
in particular with the increase in the work RVU greatly exceeding the 
increase in the surveyed work times as compared to the predecessor 
pericardiocentesis codes. We searched the RUC database again for 0-day 
global codes with 30 minutes of intraservice time and comparable total 
time of 67-87 minutes. Our search identified 43 codes and again all 43 
of these codes had a work RVU lower than 5.50. As we stated with regard 
to CPT code 33016, we do not believe that it would serve the interests 
of relativity to establish a new maximum work RVU for this range of 
time values. We believe that it is more accurate to propose a work RVU 
of 4.62 for CPT code 33017 based on a crosswalk to CPT code 52234 based 
on the same rationale that we detailed with regards to CPT code 33016.
    We disagree with the RUC-recommended work RVU of 6.00 for CPT code 
33018 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including fluoroscopy and/or ultrasound guidance, when 
performed; birth through 5 years of age, or any age with congenital 
cardiac anomaly) and proposed a work RVU of 5.00 based on the survey 
25th percentile value. In our review of CPT code 33018, we noted many 
of the same issues that we had raised with CPT codes 33016 and 33017, 
in particular with the increase in the work RVU greatly exceeding the 
increase in the surveyed work times as compared to the predecessor 
pericardiocentesis codes. The recommended work RVU of 6.00 was based on 
a crosswalk to CPT code 31603 (Tracheostomy, emergency procedure; 
transtracheal), which shares the same intraservice time of 30 minutes 
with CPT code 33018 and very similar total time. While we agree that 
CPT code 31603 is a close match to the surveyed work times for CPT code 
33018, we do not believe that it is the most accurate choice for a 
crosswalk due to the fact that CPT code 31603 is a clear outlier in 
work valuation. We searched for 0-day global codes in the RUC database 
with 30 minutes of intraservice time and a comparable 90-120 minutes of 
total time. There were 21 codes that met this criteria, and the 
recommended crosswalk to CPT code 31603 had the highest work RVU of any 
of these codes at the recommended 6.00. Furthermore, there was only one 
other code with a work RVU above 5.00, another tracheostomy procedure 
described by CPT code 31600 (Tracheostomy, planned (separate 
procedure)) at a work RVU of 5.56. None of the other codes had a work 
RVU higher than 4.69, and the median work RVU of the group comes out to 
only 4.00. The two tracheostomy procedures have work RVUs more than a 
full standard deviation above any of the other codes in this group of 
0-day global procedures.
    We do not mean to suggest that the work RVU for a given service 
must always fall in the middle of a range of codes with similar time 
values. We recognize that it would not be appropriate to develop work 
RVUs solely based on time given that intensity is also an element of 
work. Were we to disregard intensity altogether, the work RVUs for all 
services would be developed based solely on time values and that is 
definitively not the case, as indicated by the many services that share 
the same time values but have different work RVUs. However, we also do 
not believe that it would serve the interests of relativity by 
crosswalking the work RVU of CPT code 33018 to tracheostomy procedures 
that are higher than anything else in this group of codes, procedures 
that we believe to be outliers due to the serious risk of patient 
mortality associated with their performance. We believe that it is this 
patient risk which is responsible for the otherwise anomalously high 
intensity in CPT codes 31600 and 31603. Therefore, we proposed a work 
RVU of 5.00 for CPT code 33018 based on the survey 25th percentile, 
which we believe more accurately captures both the time and intensity 
associated with the procedure.
    We disagree with the RUC-recommended work RVU of 5.00 for CPT code 
33019 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including CT guidance) and proposed a work RVU of 4.29 
based on the survey 25th percentile value. In our review of CPT code 
33019, we noted many of the same issues that we had raised with CPT 
codes 33016-33018, in particular with the increase in the work RVU 
greatly exceeding the increase in the surveyed work times as compared 
to the predecessor pericardiocentesis codes. We searched for 0-day 
global codes in the RUC database with 30 minutes of intraservice time 
(slightly higher than the 28 minutes of intraservice time in CPT code 
33019) and a comparable 70-100 minutes of total time. Our search 
identified 45 codes and again all 45 of these codes had a work RVU 
lower than 5.00, which led us to believe that the recommended work RVU 
for CPT code 33019 was overvalued. We also compared CPT code 33019 to 
the most similar code in the family, CPT code 33017, and noted that the 
survey respondents indicated that CPT code 33019 should have a lower 
work RVU at both the survey 25th percentile and survey median values. 
Therefore, we proposed a work RVU of 4.29 for CPT code 33019 based on 
the survey 25th percentile value. We are supporting this proposal with 
a reference to CPT code 31254 (Nasal/sinus endoscopy, surgical with 
ethmoidectomy; partial (anterior)), a recently-reviewed code with an 
intraservice work time of 30 minutes, a total time of 84 minutes, and a 
work RVU of 4.27.
    The RUC did not recommend and we did not propose any direct PE 
inputs for the codes in this family.
    We received public comments on the proposed valuation of the codes 
in the Pericardiocentesis and Pericardial Drainage family. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters stated the crosswalk or methodology 
used in the original valuation of CPT code 33015 is unknown and not 
resource-based, and therefore, it was invalid for CMS to compare the 
current time and work to the surveyed time and work of the newly 
created codes in the family. Commenters also stated since CPT codes 
33010 and 33015 were last valued, there has been a change in the 
patient population; patients who receive these services have become 
more complex, acute, and heterogeneous. Commenters stated that several 
of these deleted codes being bundled into the new codes have negative 
intensities, which indicated a very anomalous relationship between the 
current work RVUs and the current work times.
    Response: We disagree with the commenter that it was invalid to 
compare the current time and work to the surveyed time and work. We 
believe it is crucial that the code valuation process take place with 
the understanding that the existing work times used in the PFS 
ratesetting processes are accurate. We recognize that adjusting work 
RVUs for changes in time is not always a straightforward

[[Page 62730]]

process and that the intensity associated with changes in time is not 
necessarily always linear. That is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 4.40 for CPT code 33016 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 5.00. Commenters stated that 
CPT code 33016 is one of the more intense procedures that 
interventional cardiologists perform, with two of the most common 
complications being either lacerating the coronary artery or puncturing 
the right ventricle, either of which can be fatal. Commenters stated 
that the reduction in intensity for CPT code 33016 proposed by CMS 
would establish this service out of rank order with other services in 
the PFS, including the proposed crosswalk code. Commenters stated that 
the upper endoscopy service described by CPT code 43244 involves less 
work and less risk than performing CPT code 33016, even considering 
that the typical patient for CPT code 43244 presents with hematemesis, 
and therefore, it is not an appropriate crosswalk.
    Response: We agree with the commenters that CPT code 33016 is a 
highly intense procedure with life-threatening risks to the patient. 
This is the reason we crosswalked the work RVU to CPT code 43244, a 
similarly high intensity Esophagogastroduodenoscopy procedure that 
involves inserting a flexible upper endoscope through the mouth and 
esophagus into the proximal stomach, then insufflating the stomach with 
air after suctioning its liquid contents to perform an examination of 
the entire stomach in the forward and retroflexed position. We note as 
well that our proposed work RVU of 4.40 for CPT code 33016 results in a 
higher intensity for the code than for CPT code 43244. We agree with 
the commenters that CPT code 33016 should have the higher intensity 
between the two codes, which is what we proposed.
    We also mentioned in the proposed rule that we had conducted a 
search in the RUC database among 0-day global codes with 30 minutes of 
intraservice time and comparable total time of 65-85 minutes. We 
mentioned that our search identified 49 codes and all 49 of these codes 
had a work RVU lower than the recommended 5.00. We add that out of 
those 49 codes identified by our search, only 3 of them had a work RVU 
higher than the proposed 4.40: CPT code 37191 (Insertion of 
intravascular vena cava filter, endovascular approach including 
vascular access, vessel selection, and radiological supervision and 
interpretation, intraprocedural roadmapping, and imaging guidance 
(ultrasound and fluoroscopy), when performed) at a work RVU of 4.46, 
CPT code 45385 (Colonoscopy, flexible; with removal of tumor(s), 
polyp(s), or other lesion(s) by snare technique) at a work RVU of 4.57, 
and CPT code 52234 (Cystourethroscopy, with fulguration (including 
cryosurgery or laser surgery) and/or resection of; SMALL bladder 
tumor(s) (0.5 up to 2.0 cm)) at a work RVU of 4.62. Our proposed 
valuation for CPT code 33016 recognizes the dangerous nature of the 
procedure and places it above the 90th percentile of the distribution 
of codes with similar work times. However, as we stated in the proposed 
rule, we do not believe that it would serve the interests of relativity 
to establish a new maximum work RVU that goes beyond this range of time 
values. We do not believe that the recoding of the services in this 
family has resulted in an increase in their intensity, only a change in 
the way in which they will be reported, and through the bundling of 
some of these frequently reported services, it is reasonable to expect 
that the new coding system will achieve savings via elimination of 
duplicative assumptions of the resources involved in furnishing 
particular servicers. We believe the new coding assigns more accurate 
work times, and thus, reflects efficiencies in resource costs that 
existed but were not reflected in the services as they were previously 
reported. If the addition of imaging guidance had made the new CPT 
codes significantly more intense to perform, we believe that this would 
have been reflected in the surveyed work times, which were largely 
unchanged from the predecessor codes.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 4.62 for CPT code 33017 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 5.50. Commenters stated that 
CPT code 52234 was not an appropriate crosswalk code as it is a planned 
procedure, whereas code 33017 is typically emergent and more intense as 
the patient has acute hemodynamic instability.
    Response: We disagree with the commenters that CPT code 52234 is 
not an appropriate crosswalk code on the grounds that it is a planned 
procedure. We continue to believe that the nature of the PFS relative 
value system is that all services are appropriately subject to 
comparisons to one another. Although codes that describe clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk. 
To the extent that commenters stated that CPT code 33017 is a more 
intense procedure than CPT code 52234, we agree with the commenters, 
which is why we proposed a higher intensity for CPT code 33017 in the 
proposed rule.
    Comment: Several commenters stated that the proposed work RVU 
increment between CPT codes 33016 and 33017 (0.22) does not align with 
the relative increased difficulty and additional work involved in 
performing CPT code 33017. Commenters stated that CPT code 33017 
includes all work of CPT code 33016, with the addition of suturing an 
indwelling catheter in place, as well as the work of managing that 
catheter, and is an emergent procedure as opposed to a planned 
procedure. Commenters stated that the intensity of the proposed value 
for CPT code 33017 is only 5 percent higher than CPT code 33016, and 
that this would be insufficient.
    Response: We agree with the commenters that CPT code 33017 is a 
more intense procedure than CPT code 33016, which is why we proposed a 
higher intensity for this emergent procedure. However, we do not agree 
with the commenters that this greater intensity justifies the RUC-
recommended work increment of 0.50 work RVUs between the two 
procedures. We believe that if CPT code 33017 typically required a 
significant amount of additional work in comparison to CPT code 33016, 
it would have been reflected in the surveyed work times for the two 
procedures. Instead, the surveyed work times are nearly identical 
between the two procedures, with the same intraservice time and only 2 
additional minutes of total time for CPT code 33017, 77 minutes in 
comparison to 75 minutes. Absent evidence of additional work time from 
the survey respondents,

[[Page 62731]]

we continue to believe that the proposed work RVU and proposed 
intensity for CPT code 33017 accurately capture the increased 
difficulty of the procedure in comparison to CPT code 33016.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 5.00 for CPT code 33018 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 6.00. Commenters stated that 
the typical patient for CPT code 33018 is a small child, and that since 
there is less space for fluid to accumulate in a small child, the 
target-zone is smaller for the needle, and therefore, the procedure is 
more intense than the other codes in the family. Commenters stated that 
the proposed intensity of CPT code 33018 is nearly identical to the 
proposed intensity for CPT code 33016, a relatively less intense 
service to perform, which would create a rank order anomaly within the 
family with respect to intensity.
    Response: We appreciate the additional information from the 
commenters highlighting the pediatric nature of the patient population 
for CPT code 33018, and the potential for a rank order anomaly within 
the family with respect to intensity at the proposed work valuation. We 
agree with the commenters that CPT code 33018 should have the highest 
intensity among the four codes in this family.
    Therefore, we are finalizing a work RVU of 5.40 for CPT code 33018 
based on the RUC-recommended incremental relationship between this code 
and CPT code 33016 (a difference of 1.00 RVUs), which we are applying 
to our proposed value for the latter code. This work RVU will result in 
CPT code 33018 having the highest intensity out of the four codes in 
the family, in recognition of the additional difficulty and complexity 
of its pediatric patient population. We considered finalizing the RUC-
recommended work RVU of 6.00 for CPT code 33018, which is based on a 
crosswalk to the emergency tracheostomy procedure described by CPT code 
31603. However, we continue to have reservations about the use of this 
code as a crosswalk, as we believe that CPT code 31603 is a clear 
outlier in work valuation. As we stated in the proposed rule, the 
recommended crosswalk to CPT code 31603 had the highest work RVU among 
all of the codes in the RUC database with similar work time values, 
with only one other code in this group (CPT code 31600, another 
emergency tracheostomy procedure) having a work RVU higher than 4.69. 
These two tracheostomy procedures have work RVUs more than a full 
standard deviation above any of the other codes in this group of 0-day 
global procedures, and we believe these two codes to be outliers due to 
the serious risk of patient mortality associated with their 
performance. We believe that it is more accurate to use the RUC-
recommended incremental relationship between this code and CPT code 
33016 and finalize a work RVU of 5.40 for CPT code 33018, which 
recognizes the increased intensity of the procedure without 
crosswalking it to an outlier code with much greater risk of patient 
mortality.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 4.29 for CPT code 33019 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 5.00. Commenters stated that 
the proposed work RVU for CPT code 33019 would create a rank order 
anomaly with respect to CPT code 33016. Commenters stated that although 
both procedures have distinct attributes, they both involve an 
identical amount of physician work.
    Response: We disagree with the commenters that CPT codes 33016 and 
33019 involve the identical amount of work. The survey respondents 
clearly did not believe that these two codes shared the same amount of 
work, as the surveys produced distinctly different work RVUs at the 
25th percentile (5.00 against 4.29), the median (6.00 against 5.00), 
and the 75th percentile (7.85 against 5.44) for CPT codes 33016 and 
33019, respectively. The survey respondents also recorded different 
intraservice times (30 minutes against 28 minutes) and total times (75 
minutes against 84 minutes) for the two procedures. We believe that the 
survey data clearly demonstrates that CPT code 33019 should be valued 
at a lower work RVU than 33016, and we continue to believe that it was 
more accurate to propose a work RVU of 4.29 based on the survey 25th 
percentile.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Pericardiocentesis and Pericardial 
Drainage family as proposed, with the exception of CPT code 33018 where 
we are instead finalizing a work RVU of 5.40. We are also finalizing 
our proposal to have no direct PE inputs for these codes.
(10) Pericardiotomy (CPT Codes 33020 and 33025)
    The RUC identified services with a negative IWPUT and Medicare 
utilization over 10,000 for all services or over 1,000 for Harvard 
valued and CMS/Other source codes. CPT code 33020 (Pericardiotomy for 
removal of clot or foreign body (primary procedure)) and CPT code 33025 
(Creation of pericardial window or partial resection for drainage) were 
surveyed for April 2018.
    We disagreed with the RUC-recommended work RVU of 14.31 (25th 
percentile survey value) for CPT code 33020 and proposed a work RVU of 
12.95. Our proposed work RVU is based on a crosswalk to CPT code 58700 
(Salpingectomy, complete or partial, unilateral or bilateral (separate 
procedure)), which has an identical work RVU of 12.95, identical 60 
minutes intraservice time, and near identical total time values as CPT 
code 33020.
    In our review of CPT code 33020, we noted that the RUC-recommended 
intraservice time is decreasing from 85 minutes to 60 minutes (29 
percent reduction), and that the RUC- recommended total time is 
decreasing from 565 minutes to 321 minutes (43 percent reduction). 
However, the RUC-recommended work RVU is only decreasing from 14.95 to 
14.31, which is a reduction of less than 5 percent. Although we did not 
imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we 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 33020, we 
believed that it would be more accurate to propose a work RVU of 12.95, 
based on a crosswalk to CPT code 58700 to account for these decreases 
in surveyed work times.
    For CPT code 33025, the RUC recommended a work RVU of 13.20 (survey 
25th percentile value). Although we disagreed with the RUC-recommended 
work RVU of 13.20, based on RUC survey results and the time resources 
involved in furnishing these two procedures we agreed that the relative 
difference in work RVUs between CPT codes 33020 and 33025 is equivalent 
to the RUC-recommended incremental difference of 1.11 less work RVUs. 
Therefore, we proposed a work RVU of 11.84 based on a reference to CPT 
code 34712 (Transcatheter delivery of enhanced fixation devices(s) to 
the endograft (e.g., anchor, screw, tack) and all associated 
radiological supervision and interpretation), which has a work RVU of 
12.00, identical intraservice time of 60 minutes, and similar total 
time as CPT code 33025.
    In reviewing CPT code 33025, we noted that the RUC-recommended 
intraservice time is decreasing from 66

[[Page 62732]]

minutes to 60 minutes (9 percent reduction), and that the RUC-
recommended total time is decreasing from 410 minutes to 301 minutes 
(27 percent reduction). However, the RUC-recommended work RVU is only 
decreasing from 13.70 to 13.20, which is a reduction of less than 5 
percent. Although we did not imply that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we 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 33025, we believed that it would be more accurate 
to propose a work RVU of 11.84, based on less the incremental 
difference of 1.11 work RVUs between CPT codes 33020 and 33025 and a 
crosswalk to CPT code 34712 to account for these decreases in surveyed 
work times.
    We proposed the RUC-recommended direct PE inputs for all the codes 
in this family.
    We received public comments on the proposed valuation of the codes 
in the Pericardiotomy family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter noted that CMS misstated which code was 
identified via the RUC screen.
    Response: We thank the commenter for bringing this to our 
attention. We have clarified how these codes came under review to 
reflect, as written in the RUC recommendations, that the RUC identified 
services with a negative IWPUT and Medicare utilization over 10,000 for 
all services or over 1,000 for Harvard valued and CMS/Other source 
codes. The RUC recommended that these services be surveyed for April 
2018.
    Comment: Several commenters disagreed with the CMS-proposed work 
RVU of 12.95 for CPT code 33020 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 14.31. Commenters stated the 
typical patient for CPT code 33020 is acutely ill and has typically 
encountered some type of trauma resulting in the need for intensive 
short-term care prior to and immediately following the procedure. A 
commenter further noted that CPT code 33020 requires more physician 
work and is more intense than the CMS cross walk, CPT code 58700, 
because during both the pre-service and intra-service time, continual 
monitoring of the patient's hemodynamics is required because of the 
risk of imminent cardiac tamponade.
    Response: We appreciate the additional information from the 
commenters regarding the relative intensity of CPT codes 33020 and 
58700. In light of this additional information, we agree with the 
commenters that CPT code 33020 has a higher intensity than CPT code 
58700.
    Comment: Several commenters stated that the incremental methodology 
used in valuing these services was flawed; commenters did not agree 
that it was appropriate to reduce the work RVU for CPT code 33025 from 
the value proposed by the RUC, relative to the RUC's recommended 
difference in work between this code and CPT code 33020. Commenters 
also noted that it is imperative to employ RUC survey data to value 
these codes, and that using an incremental approach in lieu of survey 
data, strong crosswalks, and input from the practitioners providing 
these services was unjustified.
    Response: We appreciate the commenters' concerns regarding our use 
of time ratio methodologies in the code valuation process for 
establishing work RVUs. We have responded to concerns about our 
methodology earlier in this section of this final rule. For more 
details on our methodology for developing work RVUs, we refer readers 
to our discussion of the subject in the ``Methodology for Establishing 
Work RVUs'' section of this rule (section II.N.2. of this final rule), 
as well as a longer discussion in the CY 2017 PFS final rule (81 FR 
80272 through 80277).
    After consideration of the public comments, we are not finalizing 
the proposed work RUVs for CPT codes 33020 and 33025, and instead are 
finalizing the RUC-recommended RVUs for the codes in the Pericardiotomy 
family. We are finalizing the direct PE inputs as proposed.
(11) Transcatheter Aortic Valve Replacement (TAVR) (CPT Codes 33361, 
33362, 33363, 33364, 33365, and 33366)
    In October 2016, the RUC's RAW reviewed codes that had been flagged 
in the period from October 2011 to April 2012, using 3 years of 
available Medicare claims data (2013, 2014 and preliminary 2015 data). 
The RUC workgroup concluded that the technology for these transcatheter 
aortic valve replacement (TAVR) services was evolving, as the typical 
site of service had shifted from being provided in academic centers to 
private centers, and the RUC recommended that CPT codes 33361-33366 be 
resurveyed for physician work and PE. These six codes were surveyed and 
reviewed at the April 2018 RUC meeting using a survey methodology that 
reflected the unique nature of these codes. CPT codes 33361-33366 are 
currently the only codes on the PFS where the -62 co-surgeon modifier 
is required 100 percent of the time.
    We proposed the RUC-recommended work RVU for all six of the codes 
in this family. We proposed a work RVU of 22.47 for CPT code 33361 
(Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic 
valve; percutaneous femoral artery approach), a work RVU of 24.54 for 
CPT code 33362 (Transcatheter aortic valve replacement (TAVR/TAVI) with 
prosthetic valve; open femoral artery approach), a work RVU of 25.47 
for CPT code 33363 (Transcatheter aortic valve replacement (TAVR/TAVI) 
with prosthetic valve; open axillary artery approach), a work RVU of 
25.97 for CPT code 33364 (Transcatheter aortic valve replacement (TAVR/
TAVI) with prosthetic valve; open iliac artery approach), a work RVU of 
26.59 for CPT code 33365 (Transcatheter aortic valve replacement (TAVR/
TAVI) with prosthetic valve; transaortic approach (e.g., median 
sternotomy, mediastinotomy)), and a work RVU of 29.35 for CPT code 
33366 (Transcatheter aortic valve replacement (TAVR/TAVI) with 
prosthetic valve; transapical exposure (e.g., left thoracotomy)).
    Although we have some concerns that the RUC-recommended work RVUs 
for these six codes do not match the decreases in surveyed work time, 
we recognize that the technology described by the TAVR procedures is in 
the process of being adopted by a much wider audience, and that there 
will be greater intensity on the part of the practitioner when this 
particular new technology is first being adopted. However, we intend to 
continue examining whether these services are appropriately valued, in 
light of the proposed national coverage determination proposing to use 
TAVR for the treatment of symptomatic aortic valve stenosis that we 
posted on March 26, 2019. We will also consider any further 
improvements to the valuation of these services, as their use becomes 
more commonplace, through future notice and comment rulemaking. The 
text of the proposed national coverage determination is available on 
the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=293.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the

[[Page 62733]]

Transcatheter Aortic Valve Replacement family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter stated that they appreciate recognition of the 
complexities of this evolving technology by CMS and agreed with the 
proposal of the RUC-recommended work RVUS for all six of these codes.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: Several commenters disagreed with the proposed work RVUs. 
Commenters disagreed with the proposed reduction in work RVUs for CPT 
codes 33361-33366 on the basis that the proposed values were too low 
and did not accurately reflect the actual work time and intensity 
required to perform all aspects of the procedures. Commenters stated 
that the amount of effort spent is not decreasing, and RVUs are shared 
equally between the surgeon and cardiologist. A commenter stated that 
the number of Medicare beneficiaries receiving TAVR was increasing 
rapidly due to FDA approval of an expanded TAVR indication in low 
surgical risk patients and a revised National Coverage Determination 
(NCD) published by CMS. This commenter stated that the RUC-recommended 
and CMS-proposed valuations do not include the time and PE costs 
associated with physicians' TAVR-related data requirements, and the 
commenter recommended delaying the adoption of the new work RVUs.
    Response: We disagree with the commenters that the proposed work 
RVUs for CPT codes 33361-33366 were too low and that the implementation 
of these work RVUs should be delayed. The work surveys conducted by the 
RUC indicated that the typical intraservice work time decreased 
substantially for each code in the family since the last time of review 
in 2012. For example, CPT code 33361 decreased from a previous 
intraservice work time of 135 minutes to a newly surveyed intraservice 
work time of 90 minutes. Although we do not imply that the decrease in 
time as reflected in survey values must equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work are time and intensity, significant 
decreases in time should be appropriately reflected in decreases to 
work RVUs. This was the rationale for the RUC's recommendation of 
decreased work RVUs for the six codes in the family, which we shared in 
proposing these valuations. We also do not agree that an increase in 
utilization for the TAVR codes would necessarily be sufficient 
rationale for delaying their implementation, as there are many other 
services experiencing a high rate of growth for which we have not 
proposed a delay in valuation.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Transcatheter 
Aortic Valve Replacement family as proposed.
(12) Aortic Graft Procedures (CPT Codes 33858, 33859, 33863, 33864, 
33871, and 33866)
    In 2017, CPT created a new add-on code, CPT code 33866 (Aortic 
hemiarch graft including isolation and control of the arch vessels, 
beveled open distal aortic anastomosis extending under one or more of 
the arch vessels, and total circulatory arrest or isolated cerebral 
perfusion (List separately in addition to code for primary procedure)). 
For CY 2019, we finalized the RUC's recommended work RVU for this code 
as proposed, and indicated that we would consider any coding changes or 
RUC recommendations in future rulemaking (83 FR 59528). CPT revised the 
code set to develop distinct codes for ascending aortic repair for 
dissection and ascending aortic repair for other ascending aortic 
disease such as aneurysms and congenital anomalies, creating two new 
codes, as well as revaluating the two other codes in the family.
    For CPT code 33858 (Ascending aorta graft, with cardiopulmonary 
bypass, includes valve suspension, when performed; for aortic 
dissection), we disagree with the RUC-recommended work RVU of 65.00, 
because the RUC is recommending an increase in work RVU that is not 
commensurate with a reduction in physician time, and because we do not 
believe that the RUC's recommendation that this service be increased to 
a value that would place it among the highest valued of all services of 
similar physician time is appropriate; we believe a comparison to other 
services of similar time indicates that the RUC's recommended increase 
overstates the work. Instead, we proposed to increase the work RVU to 
63.40 based on a crosswalk to CPT code 61697 (Surgery of complex 
intracranial aneurysm, intracranial approach; carotid circulation).
    For CPT code 33859 (Ascending aorta graft, with cardiopulmonary 
bypass, includes valve suspension, when performed; for aortic disease 
other than dissection (e.g., aneurysm)), we disagree with the RUC-
recommended work RVU of 50.00, because we do not believe it adequately 
reflects the recommended decrease in physician time, and because we do 
not believe this service should be assigned a value that is among the 
highest of all 90-day global services with similar physician time 
values. Instead, we proposed a work RVU of 45.13 based on a crosswalk 
to CPT code 33468 (Tricuspid valve repositioning and plication for 
Ebstein anomaly), which is a code with an identical intraservice time 
and similar total time value.
    For CPT code 33863 (Ascending aorta graft, with cardiopulmonary 
bypass, with aortic root replacement using valved conduit and coronary 
reconstruction (e.g., Bentall)), according to the RUC, the survey 
respondents underestimated the intraservice time of the procedure and 
the RUC recommended a work RVU of 59.00 based on the 75th percentile of 
survey responses for intraservice time. We believe the use of the 
survey 75th percentile value to be problematic, as the intraservice 
time values should generally reflect the survey median. We are 
requesting that this code be resurveyed to determine more accurate 
physician time values, and we proposed to maintain the current RVU of 
58.79 for CY 2020.
    For CPT code 33864 (Ascending aorta graft, with cardiopulmonary 
bypass with valve suspension, with coronary reconstruction and valve-
sparing aortic root remodeling (e.g., David Procedure, Yacoub 
procedure)), we do not agree with the RUC-recommended work RVU of 
63.00, because we believe this increase is not justified given that the 
intraservice time is not changing from its current value, and the 
physician total time value is decreasing. Therefore, we proposed to 
maintain the current work RVU of 60.08 for this service.
    For CPT code 33871 (Transverse aortic arch graft, with 
cardiopulmonary bypass, with profound hypothermia, total circulatory 
arrest and isolated cerebral perfusion with reimplantation of arch 
vessel(s) (e.g., island pedicle or individual arch vessel 
reimplantation)), we disagree with the RUC's recommended work RVU of 
65.75. While we agree that an increase in work RVU is justified, as 
discussed above, we believe that the use of the 75th percentile of 
physician intraservice work time is problematic, and believe such a 
significant increase in work RVU is not validated. Therefore, we 
proposed a less significant increase to 60.88 using the RUC-recommended 
difference in work value between CPT code 33859 and the code in 
question, CPT code 33871 (a difference of 15.75). As further support 
for this value, we note that it falls between CPT codes 33782 (Aortic 
root translocation with ventricular septal defect and pulmonary 
stenosis

[[Page 62734]]

repair (i.e., Nikaidoh procedure); without coronary ostium 
reimplantation), which has a work RVU of 60.08, and CPT code 43112 
(Total or near total esophagectomy, with thoracotomy; with 
pharyngogastrostomy or cervical esophagogastrostomy, with or without 
pyloroplasty (i.e., McKeown esophagectomy or tri-incisional 
esophagectomy)), which has a work RVU of 62.00. Both of these 
bracketing reference codes have similar intraservice and total time 
values.
    For CPT code 33866 (Aortic hemiarch graft including isolation and 
control of the arch vessels, beveled open distal aortic anastomosis 
extending under one or more of the arch vessels, and total circulatory 
arrest or isolated cerebral perfusion (List separately in addition to 
code for primary procedure)), we proposed the RUC-recommended work RVU 
of 17.75.
    For the direct PE inputs, we proposed to refine the clinical labor 
to align with the number of post-operative visits. Thus, we proposed to 
add 12 minutes of clinical labor time for ``Discharge day management'' 
for CPT codes 33859, 33863, 33864, and 33871, as each of these codes 
include a 99238 discharge visit within their global periods that should 
be reflected in the clinical labor inputs.
    We received public comments on the proposed valuation of the codes 
in the Aortic Graft Procedures family. The following is a summary of 
the comments we received and our responses.
    Comment: One commenter disagreed with our proposed value for CPT 
Code 33858, and stated that our proposal ignores that deleted CPT code 
33860 is a more general code than CPT code 33858, as 33860 is both used 
for emergent procedures (e.g., repairs for aortic dissection) and for 
planned procedures (e.g., repair for aortic diseases other than 
dissection), whereas CPT code 33858 is only the portion of CPT code 
33860's volume that is emergent. Therefore, the commenter suggested 
that we should not compare physician times for the two codes as they 
describe different intensities. This commenter stated that CMS 
inappropriately rejected the RUC recommendation and instead picked an 
arbitrary low-volume crosswalk, last reviewed almost 15 years ago, with 
a work RVU only 2.5 percent less than the RUC recommendation. 
Furthermore, the commenter stated that this selected crosswalk is not 
an appropriate comparator, as CPT code 33858 involves three critical 
care visits, whereas the crosswalk code 61697 does not include any 
critical care.
    Response: As we explained in the CY 2020 PFS proposed rule (84 FR 
40575), our determination that the RUC's value overstates the work was 
based on an analysis of all codes with 90-day global periods. Our use 
of a crosswalk based on physician time is consistent with longstanding 
valuation methodology. We note that crosswalk CPT code 61697 has an 
intraservice time value that is identical to that of CPT code 33858, 
and a total time value that is over 20 percent higher than that of CPT 
code 33858; thus, we believe that the critical care component is 
adequately reflected in this value. The vignettes for CPT code 33858 
and our crosswalk code, CPT code 61697, both describe complicated 
procedures for acutely ill patients; both involve significant vascular 
structures and are performed on urgent or emergent bases. Our 
examination of time values indicated that the RUC's work RVU was 
somewhat overstated, and we continue to believe that CPT code 61697 
provides an appropriate crosswalk.
    Comment: For CPT Code 33859, a commenter questioned our statement 
that we did not believe that the RUC-recommended work RVU adequately 
reflects the recommended decrease in physician time, stating that the 
change in total time from 931 minutes to 778 minutes is in close 
proportion to the change in value from the current value of 59.46 for 
the deleted code to the RUC recommendation of 50.00. This commenter 
stated that our proposed value for CPT 33871 is also flawed as it is 
based on an increment to CPT 33859.
    Response: We disagree that the RUC's recommended reduction in work 
RVU is closely proportionate to the decrease in time. We disagree that 
physician time ratios indicate that the RUC-recommended value is 
closely proportionate to the time decrease. We note that, while the 
commenter cites the total time ratio, the intraservice time ratio 
indicate that the RUC's recommended value is somewhat overstated. Our 
crosswalk code CPT code 33468 and CPT code 33859 both involve bypass 
procedures, and have similar time values; CPT code 33468 has more total 
time than CPT code 33859. We continue to believe, given the time values 
and intensity involved in the two procedures, that CPT code 33468 is a 
strong crosswalk. For CPT code 33871, we note that our reference code 
CPT code 43112 has almost the same intraservice time value and 196 more 
minutes of total time, and further validates our proposed work RVU.
    Comment: For CPT codes 33863 and 33871, a commenter stated that our 
rationales, which in part included an assumption on our part that the 
physician intraservice times were overstated in that they are the 75th 
percentile survey values, neglected to acknowledge or account for the 
STS Database intra-service times for these codes, which in the 
commenter's view support the RUC's recommended intra-service times. The 
commenter suggested that our request that these services be resurveyed 
ignores the RUC's rationale regarding the STS database times.
    Response: We note that we did not ignore the STS database time 
data, and our proposed values for CPT codes 33863 and 33871 rely on 
times from this database, and we are finalizing the time values as 
recommended for these codes. We primarily rely on survey data for time 
values, however we continue to remain interested in a range of data 
sources and how to integrate these data sources into our ratesetting 
process.
    Comment: A commenter disagreed with our proposal to maintain the 
current work RVU for CPT code 33864, and stated that our proposed value 
for CPT code 33864 would not have appropriate relativity compared to 
our proposed value for CPT code 33863, and that the former service 
involves more difficult and intense work than the latter. The commenter 
stated that CPT code 33864 involves replacing the aortic root and 
ascending aorta, but unlike CPT code 33863, attempts to preserve the 
patient's own native aortic valve--a procedure far more complex and 
skill-intensive than aortic valve replacement reflected in CPT code 
33863. The increment of the RUC recommendations between these two 
services is 4.00 RVUs, whereas the increment for the CMS-proposed 
values is only 1.29 RVUs, which is not sufficient to account for the 
difference in work between these two services.
    Response: We agree that CPT code 33864 is a more intense procedure 
than CPT code 33863, which is why we proposed a higher intensity for 
this procedure. However, we do not agree with the commenters that this 
greater intensity justifies the RUC-recommended work increment of 4.00 
work RVUs between the two procedures. We believe that if CPT code 33864 
typically required a significant amount of additional work in 
comparison to CPT code 33863, that work would have been reflected in 
the surveyed work times for the two procedures. Instead, the surveyed 
work times are identical between the two procedures. Absent evidence of 
additional work time from the survey respondents, we continue to 
believe that the proposed work RVU and proposed intensity for CPT code 
33864 accurately

[[Page 62735]]

capture the increased difficulty of the procedure in comparison to CPT 
code 33863.
    Comment: One commenter stated that they agreed with the proposed 
direct PE clinical labor refinements for these codes.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing work 
RVUs of 63.40 for 33858, 45.13 for 33859, 58.79 for CPT code 33863, 
60.08 for CPT code 33864, 60.88 for CPT code 33871, and the RUC-
recommended work RVU of 17.75 for CPT code 33866 as proposed. We are 
also finalizing the direct PE inputs as proposed.
(13) Iliac Branched Endograft Placement (CPT Codes 34717 and 34718)
    For CY 2018, the CPT Editorial Panel created a family of 20 new and 
revised codes that redefined coding for endovascular repair of the 
aorta and iliac arteries. The iliac branched endograft technology has 
become more mainstream over time, and two new CPT codes were created to 
capture the work of iliac artery endovascular repair with an iliac 
branched endograft. These two new codes were surveyed and reviewed for 
the January 2019 RUC meeting.
    We proposed the RUC-recommended work RVU of 9.00 for CPT code 34717 
(Endovascular repair of iliac artery at the time of aorto-iliac artery 
endograft placement by deployment of an iliac branched endograft 
including pre-procedure sizing and device selection, all ipsilateral 
selective iliac artery catheterization(s), all associated radiological 
supervision and interpretation, and all endograft extension(s) 
proximally to the aortic bifurcation and distally in the internal 
iliac, external iliac, and common femoral artery(ies), and treatment 
zone angioplasty/stenting, when performed, for rupture or other than 
rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous 
malformation, penetrating ulcer, traumatic disruption), unilateral) and 
the RUC-recommended work RVU of 24.00 for CPT code 34718 (Endovascular 
repair of iliac artery, not associated with placement of an aorto-iliac 
artery endograft at the same session, by deployment of an iliac 
branched endograft, including pre-procedure sizing and device 
selection, all ipsilateral selective iliac artery catheterization(s), 
all associated radiological supervision and interpretation, and all 
endograft extension(s) proximally to the aortic bifurcation and 
distally in the internal iliac, external iliac, and common femoral 
artery(ies), and treatment zone angioplasty/stenting, when performed, 
for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, 
arteriovenous malformation, penetrating ulcer), unilateral).
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Iliac Branched Endograft Placement family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVU for both codes in the family.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Iliac Branched 
Endograft Placement family as proposed.
(14) Exploration of Artery (CPT Codes 35701, 35703, and 35703)
    CPT code 35701 (Exploration not followed by surgical repair, 
artery; neck (e.g., carotid, subclavian)) was identified via a screen 
for services with a negative IWPUT and Medicare utilization over 10,000 
for all services or over 1,000 for Harvard valued and CMS/Other source 
codes. In September 2018, the CPT Editorial Panel revised one code, 
added two new codes, and deleted three existing codes in the family to 
report major artery exploration procedures and to condense the code set 
due to low frequency.
    We proposed the RUC-recommended work RVU for all three codes in the 
family. We proposed a work RVU of 7.50 for CPT code 35701, a work RVU 
of 7.12 for CPT code 35702 (Exploration not followed by surgical 
repair, artery; upper extremity (e.g., axillary, brachial, radial, 
ulnar)), and a work RVU of 7.50 for CPT code 35703 (Exploration not 
followed by surgical repair, artery; lower extremity (e.g., common 
femoral, deep femoral, superficial femoral, popliteal, tibial, 
peroneal)).
    For the direct PE inputs, we proposed to refine the clinical labor, 
supplies, and equipment to match the number of office visits contained 
in the global periods of the codes under review. We proposed to refine 
the clinical labor time for the ``Post-operative visits (total time)'' 
(CA039) activity from 36 minutes to 27 minutes for CPT codes 35701 and 
35702, and from 63 minutes to 27 minutes for CPT code 35703. Each of 
these CPT codes contains a single postoperative level 2 office visit 
(CPT code 99212) in its global period, and 27 minutes of clinical labor 
is the time associated with this office visit. We proposed to refine 
the equipment time for the exam table (EF023) to the same time of 27 
minutes for each code to match the clinical labor time. Finally, we are 
also proposing to refine the quantity of the minimum multi-specialty 
visit pack (SA048) from 2 to 1 for CPT code 35703 to match the single 
postoperative visit in the code's global period. We believe that the 
additional direct PE inputs in the recommended materials were an 
accidental oversight due to revisions that took place at the RUC 
meeting following the approval of the PE inputs for these codes.
    We received public comments on the proposed valuation of the codes 
in the Exploration of Artery family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter stated that they supported the proposed work 
RVUs and thanked CMS for correcting the PE to reflect the number of 
office visits contained in the global period.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Exploration of 
Artery family as proposed.
(15) Intravascular Ultrasound (CPT Codes 37252 and 37253)
    In the CY 2015 PFS proposed rule, a stakeholder requested that CMS 
establish non-facility PE RVUs for CPT codes 37250 and 37251. CMS 
sought comment regarding the setting and valuation of these services. 
The CPT Editorial Panel deleted CPT codes 37250 ((Ultrasound evaluation 
of blood vessel during diagnosis or treatment) and 37251 (Ultrasound 
evaluation of blood vessel during diagnosis or treatment) and created 
new bundled codes 37252 (Intravascular ultrasound (noncoronary vessel) 
during diagnostic evaluation and/or therapeutic intervention, including 
radiological supervision and interpretation; initial noncoronary 
vessel) and 37253 (Intravascular ultrasound (noncoronary vessel) during 
diagnostic evaluation and/or therapeutic intervention, including 
radiological supervision and interpretation; each additional 
noncoronary vessel) to describe intravascular ultrasound (IVUS). CMS 
finalized the RUC recommended work RVUs for intravascular ultrasound.
    When CPT codes 37252 and 37253 were reviewed at the January 2015 
RUC meeting, they were assumed to be work neutral compared to 
predecessor codes

[[Page 62736]]

CPT codes 37250 and 37251, meaning they would not result in an overall 
increase in work spending, and that they would result in an overall 
savings of work RVUs that would be redistributed to the Medicare 
conversion factor. Services are considered work neutral if, despite 
changes in coding, the overall amount of work RVUs for a set of 
services is held constant from one year to the next.
    The RUC determined that, between CY 2015 and CY 2016, the overall 
work spending for these services went up by 44 percent as compared to 
the predecessor codes, thus disrupting the projected work neutrality. 
Observed utilization also doubled. In April 2018, the RUC reviewed this 
code family and found that the utilization of these services was 
underestimated, considering that the newer bundled codes included 
radiological supervision and interpretation.
    Consequently, the RUC recommended that these services be surveyed 
for October 2018. The RUC indicated that the specialty societies should 
research why there was such an increase in the utilization. 
Accordingly, the specialty society surveyed these add-on codes, and the 
survey results indicated the intraservice and total work times, along 
with the work RVU should remain the same despite the RUC's 
underestimation of utilization for these codes.
    We disagreed with the RUC-recommended work RVU of 1.80 for CPT code 
37252 and proposed a work RVU of 1.55 based on a crosswalk to CPT code 
19084. CPT code 19084 is a recently reviewed code with 20 minutes of 
intraservice time and 25 minutes of total time. In reviewing CPT code 
37252, we note, as mentioned above, that in CY 2015 the specialty 
society expected that bundling this service would achieve work 
neutrality, meaning that new coding would not result in an overall 
increase in work spending. However, since 2015, observed utilization 
for CPT code 37252 has greatly exceeded estimated utilization. 
Therefore, we proposed for CY 2020 work RVUs based on crosswalk codes 
that would have resulted in restored work neutrality for the 
intravascular ultrasound code family.
    For CPT code 37253, we disagreed with the RUC-recommended work RVU 
of 1.44 and we proposed a work RVU of 1.19. Although we disagreed with 
the RUC-recommended work RVU, we note the relative difference in work 
between CPT codes 37252 and 37253 is an interval of 0.36 RVUs. 
Therefore, we proposed a work RVU of 1.19 for CPT code 37253, based on 
the recommended interval of 0.36 fewer RVUs than our proposed work RVU 
of 1.55 for CPT code 37252.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Intravascular Ultrasound family. The following is a summary of 
the comments we received and our responses.
    Comment: A few commenters disagreed with our proposed values for 
these codes and urged us to accept the RUC-recommended values. One 
commenter stated the increased utilization for these codes may be for a 
host of reasons, some of which include increased complexity of 
interventions being performed in the arterial, venous, and aortic 
spaces. This commenter stated that a large proportion of the 
utilization of this service is by a few physicians, and if we reduce 
the RVUs as proposed, many physicians and patients may be affected. The 
commenter stated that an attempt to enforce work neutrality may result 
in harm to a large group of patients while only a small group of 
physicians are responsible, and recommended that this issue should be 
addressed at a local level. The commenter stated that if CMS has 
continuing concerns about overutilization or outliers for CPT codes 
37252 and 37253, the Agency can use LCDs and the RAC process. Another 
commenter disagreed with use of an incremental methodology to value CPT 
code 37253, suggesting that it inaccurately treats all components of 
the physician time as having identical intensity.
    Response: We are persuaded that reducing work RVUs that would have 
resulted in work neutrality for these codes may not be appropriate, and 
that valuation in this instance should be determined irrespective of 
utilization. Comments indicate that the increase in utilization for 
these services may have occurred for a variety of reasons including 
those related to potential inappropriate billing by some practitioners. 
We would not ordinarily expect volume for a revised code family to 
change exponentially between the old and revised code sets, however we 
are persuaded by commenters that this is more appropriately addressed 
in this instance through an analysis of claims to determine potentially 
inappropriate billing by some practitioners. In response to public 
comment, we are finalizing the RUC-recommended work RVUs of 1.80 for 
CPT Code 37252 and 1.44 for CPT code 37253.
    After consideration of the public comments, we not finalizing our 
proposed work RVUs, and we are instead finalizing the RUC-recommended 
work RVUs for CPT Codes 37252 and 37253. We are also finalizing the 
direct PE inputs as proposed.
(16) Stab Phlebectomy of Varicose Veins (CPT Codes 37765 and 37766)
    These services were identified in February 2008 via the High Volume 
Growth screen, for services with a total Medicare utilization of 1,000 
or more that have increased by at least 100 percent from 2004 through 
2006. The RUC subsequently recommended monitoring and reviewing changes 
in utilization over multiple years. In October 2017, the RUC 
recommended that this service be surveyed for April 2018. We proposed 
the RUC-recommended work RVUs of 4.80 for CPT code 37765 (Stab 
phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions) and 
6.00 for CPT code 37766 (Stab phlebectomy of varicose veins, 1 
extremity; more than 20 incisions). We proposed the RUC-recommended 
direct PE inputs for all codes in the family.
    We received public comments on the proposed valuation of the codes 
in the Stab Phlebectomy of Varicose Veins family. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters stated that they supported our proposal of the 
RUC-recommended work RVU and direct PE inputs for both codes in the 
family.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: A few commenters stated that our proposals for these codes 
will result in unreasonable reductions in payment.
    Response: We continue to believe that the RUC's recommended 
decreases in work RVUs are proportionate to the decreases in surveyed 
work times for these services.
    Comment: A commenter stated that the RUC-recommended physician 
survey times are inaccurate, and the commenter requested that we 
consider data collected by the American Vein and Lymphatic Society as 
additional physician work time data.
    Response: We welcome the submission of any additional data or 
information that would allow us to consider these codes for further 
review at a future time.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs as proposed. We are also finalizing the 
direct PE inputs as proposed.

[[Page 62737]]

(17) Biopsy of Mouth Lesion (CPT Code 40808)
    CPT code 40808 (Biopsy, vestibule of mouth) was identified via a 
screen for services with a negative IWPUT and Medicare utilization over 
10,000 for all services or over 1,000 for Harvard valued and CMS/Other 
source codes.
    We disagree with the RUC's recommended work RVU of 1.05 with a 
crosswalk to CPT code 11440 (Excision, other benign lesion including 
margins, except skin tag (unless listed elsewhere), face, ears, 
eyelids, nose, lips, mucous membrane; excised diameter 0.5 cm or less), 
as we believe this increase in work RVU is not commensurate with the 
RUC-recommended 5-minute reduction in intraservice time and a 10-minute 
reduction in total time. While we understand that the RUC considers the 
current time values for this service to be invalid estimations, we do 
not see compelling evidence that would indicate that an increase in 
work RVU that would be concurrent with a reduction in physician time is 
appropriate. Therefore, we proposed to maintain the current work RVU of 
1.01, and note that implementing the current work RVU with the RUC-
recommended revised physician time values would correct the negative 
IWPUT anomaly.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes. As we detailed 
when discussing this issue in the CY 2019 PFS final rule (83 FR 59463 
through 59464), CPT code 40808 does not include the old clinical labor 
task ``Patient clinical information and questionnaire reviewed by 
technologist, order from physician confirmed and exam protocoled by 
radiologist'' on a prior version of the PE worksheet, nor does the code 
contain any clinical labor for the CA007 activity (``Review patient 
clinical extant information and questionnaire''). CPT code 40808 does 
not appear to be an instance where an old clinical labor task was split 
into two new clinical labor activities, and 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. We also note that there is no effect on the 
total clinical labor direct costs in these situations, since the same 3 
minutes of clinical labor time is still being furnished.
    We are also proposing to refine the equipment time for the 
electrocautery-hyfrecator (EQ110) to conform to our established 
policies for non-highly technical equipment.
    We received public comments on the proposed valuation of the codes 
in the Biopsy of Mouth Lesion family. The following is a summary of the 
comments we received and our responses.
    Comment: One commenter disagreed with our rationale, stating that 
it ignores that the RUC reviewed and accepted compelling evidence that 
the original valuation was based on flawed methodology when it was 
reviewed in 1995, resulting in a negative IWPUT. The value of the 
service was maintained without taking into consideration the times 
newly assigned to the service in 1995. That resulted in the physician 
time and work value having a distorted relationship. The commenter 
stated that, contrary to the assertion made in the proposed rule, this 
compelling evidence makes a strong case that the work was formerly 
misvalued. The commenter asserted that if a work value was assigned by 
CMS in 1995 without CMS appropriately being informed by physician time 
data, then the work value assigned prior to the RUC's 2018 analysis 
used an inappropriate methodology. The commenter also stated that the 
IWPUT derived from the RUC recommendation is only 0.0194, while the 
IWPUT of CMS' alternate proposal, 0.0153, would be less than twice the 
intensity assigned to pre-service scrub/dress/wait time and 
inappropriately low for the intra-service time of this service or for 
that matter, the clear majority of all services in the Medicare PFS.
    Response: We are persuaded by the comments regarding the 
problematic nature of using the source physician time, as well as the 
derived intensity, to revalue this code, and agree with the commenter 
that the RUC-recommended work RVU of 1.05 for CPT code 40808 is 
appropriate.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Confirm order, protocol exam'' 
(CA014) activity to 0 minutes. Commenters stated that 1 minute was 
required to order the pathology and complete the request form, 
including patient history, location, differential diagnosis, and staff 
processing time. Another commenter stated that they supported the 
proposal to refine the clinical labor time for the ``Prepare room, 
equipment and supplies'' (CA013) activity to 3 minutes, but noted that 
an additional minute is required for the CA014 activity to order the 
specimen for pathology to review.
    Response: We continue to disagree with the commenters that 1 minute 
should be assigned for the CA014 clinical labor activity in CPT code 
40808. As we stated in the proposed rule, CPT code 40808 does not 
include the old clinical labor task ``Patient clinical information and 
questionnaire reviewed by technologist, order from physician confirmed 
and exam protocoled by radiologist'' on a prior version of the PE 
worksheet, nor does the code contain any clinical labor for the CA007 
activity or appear to be an instance where an old clinical labor task 
was split into two new clinical labor activities. We continue to 
believe that in these cases the 3 total minutes of clinical staff time 
would be more accurately described by the CA013 activity code, and 
commenters did not supply any rationale as to why this would not be the 
case. We also note once again that there is no effect on the total 
clinical labor direct costs from these refinements, since the same 3 
minutes of clinical labor time is still being furnished.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 1.05 for CPT code 40808 rather than our 
proposed value of 1.01. We are also finalizing the direct PE inputs as 
proposed.
(18) Transanal Hemorrhoidal Dearterialization (CPT Codes 46945, 46946, 
and 46948)
    We proposed the RUC-recommended work RVU for all three codes in the 
family. We proposed a work RVU of 3.69 for CPT code 46945 
(Hemorrhoidectomy, internal, by ligation other than rubber band; single 
hemorrhoid column/group, without imaging guidance), a work RVU of 4.50 
for CPT code 46946 (2 or more hemorrhoid columns/groups, without 
imaging guidance), and a work RVU of 5.57 for CPT code 46948 
(Hemorrhoidectomy, internal, by transanal hemorrhoidal 
dearterialization, 2 or more hemorrhoid columns/groups, including 
ultrasound guidance, with mucopexy when performed).
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Transanal Hemorrhoidal Dearterialization family. The following 
is a summary of the comments we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVU for both codes in the family.

[[Page 62738]]

    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Transanal 
Hemorrhoidal Dearterialization family as proposed.
(19) Preperitoneal Pelvic Packing (CPT Codes 49013 and 49014)
    In May 2018, the CPT Editorial Panel approved the addition of two 
codes for preperitoneal pelvic packing, removal and/or repacking for 
hemorrhage associated with pelvic trauma. These new codes were surveyed 
and reviewed for the October 2018 RUC meeting.
    We disagree with the RUC-recommended work RVU of 8.35 for CPT code 
49013 (Preperitoneal pelvic packing for hemorrhage associated with 
pelvic trauma, including local exploration) and proposed a work RVU of 
7.55 based on a crosswalk to CPT code 52345 (Cystourethroscopy with 
ureteroscopy; with treatment of ureteropelvic junction stricture (e.g., 
balloon dilation, laser, electrocautery, and incision)). We are also 
proposing to reduce the immediate postservice work time from 60 minutes 
to 45 minutes, which results in a total work time of 140 minutes for 
this procedure. We believe that the survey respondents overstated the 
immediate postservice work time that would typically be required to 
perform CPT code 49013, which we investigated by comparing this new 
service against the existing 0-day global codes on the PFS. We found 
that among the roughly 1100 codes with 0-day global periods, only 21 
codes had an immediate postservice work time of 60 minutes or longer. 
The 21 codes that fell into this category had significantly higher 
intraservice work times than CPT code 49013, with an average 
intraservice work time of 111 minutes as compared to the 45 minutes of 
intraservice work time in CPT code 49013. Generally speaking, it is 
extremely rare for a service to have more immediate postservice work 
time than intraservice work time, and in fact only 28 out of the 
roughly 1100 codes with 0-day global periods had more immediate 
postservice work time than intraservice work time. While we agree that 
each service on the PFS is its own unique entity, these comparisons to 
other 0-day global codes suggest that the survey respondents 
overestimated the amount of immediate postservice work time that would 
typically be associated with CPT code 49013.
    As a result, we believe that it would be more accurate to reduce 
the immediate postservice work time to 45 minutes and to propose a work 
RVU of 7.55 based on a crosswalk to CPT code 52345. This crosswalk code 
shares an intraservice work time of 45 minutes and a similar total time 
of 135 minutes after taking into account the reduced immediate 
postservice work time that we proposed for CPT code 49013. We searched 
the RUC database for 0-day global procedures with 45 minutes of 
intraservice work time, and at the recommended work RVU of 8.35, CPT 
code 49013 would establish a new maximum value, higher than all of the 
79 other codes that fall into this category. We recognize that CPT code 
49013 describes a preperitoneal pelvic packing service associated with 
pelvic trauma, and that this is a difficult and intensive procedure 
that rightly has a higher work RVU than many of these other 0-day 
global codes. However, we believe that it better maintains relativity 
to propose a crosswalk to CPT code 52345 at a work RVU of 7.55, which 
would still assign this code the second-highest work RVU among all 0 
day global codes with 45 minutes of intraservice work time, as opposed 
to proposing the survey median work RVU of 8.35 at a rate higher than 
anything in the current RUC database.
    We disagree with the RUC-recommended work RVU of 6.73 for CPT code 
49014 (Re-exploration of pelvic wound with removal of preperitoneal 
pelvic packing including repacking, when performed) and proposed a work 
RVU of 5.70 based on the 25th percentile survey value. We believe that 
the survey 25th percentile work RVU more accurately describes the work 
of re-exploring this type of pelvic wound, and by proposing the survey 
25th percentile we are maintaining the general increment in RVUs 
between the two codes in the family (a difference of 1.62 RVUs as 
recommended by the RUC as compared to 1.85 RVUs as proposed here). We 
are supporting this valuation with a reference to CPT code 39401 
(Mediastinoscopy; includes biopsy(ies) of mediastinal mass (e.g., 
lymphoma), when performed), a recently reviewed code from CY 2015 which 
shares the same intraservice time of 45 minutes, a slightly higher 
total time of 142 minutes and a lower work RVU of 5.44.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Preperitoneal Pelvic Packing family. The following is a summary 
of the comments we received and our responses.
    Comment: Many commenters disagreed with the CMS proposed work RVU 
of 7.55 for CPT code 49013 and stated that CMS should instead finalize 
the RUC-recommended work RVU of 8.35. Commenters stated that the 
typical patient for CPT code 49013 is a critically injured emergent 
patient and that the procedure typically is performed as expeditiously 
as possible to avoid a hemorrhagic death of the patient. Commenters 
stated that CPT code 52345 is an elective outpatient operation, not an 
emergent procedure, and therefore, it was inarguable that the intensity 
of work for CPT code 49013 is considerably greater despite the two 
procedures sharing the same intraservice work time. Commenters 
disagreed with the CMS comparison of the postoperative time for code 
49013 to other 0-day global procedures, stating that this took place 
without consideration of the type of work that is required for this 
code. Commenters stated that there are less than 800 0-day global codes 
that have been reviewed by the RUC, and that almost 240 of those 
procedures are endoscopy services performed electively under moderate 
sedation, while another 125 of those procedures include simple 
injections, biopsies, casting/strapping services, trimming nails, 
simple repair of wounds, and osteopathic and chiropractic services. 
Commenters stated that it was inappropriate and incorrect to equate 
code 49013 to these types of 0-day global codes for purposes of 
reviewing postoperative time.
    Commenters also disagreed with the CMS-proposed immediate 
postservice work time of 45 minutes and stated that CMS should instead 
finalize the RUC-recommended work time of 60 minutes. Commenters stated 
that the immediate postservice work time of CPT code 49013 includes all 
postoperative care until midnight on the day of the procedure, a period 
where the patient will still be unstable and critical and their 
hemodynamic status will need to be monitored very closely. Commenters 
stated that due to the rare emergency nature of the procedure 60 
minutes of postoperative time in the operating room, recovery unit, and 
intensive care unit on the day of this procedure would be typical. 
Commenters also pointed to the survey data for CPT code 49013, in which 
over 65 percent of all survey respondents indicated 50 minutes or more 
of postoperative time and of the 28 respondents with recent (12 month) 
experience, 60 percent indicated 60 minutes or more of postoperative 
work time. Commenters stated that there was no evidence to the contrary 
that these experienced providers overestimated the time they spend 
postoperatively on the day of the procedure.

[[Page 62739]]

    Response: We appreciate the additional feedback from the commenters 
regarding the typical patients undergoing CPT code 49013 and the nature 
of the postoperative care that they will typically receive. Based on 
the additional information supplied by the commenters, we are not 
finalizing our refinements to the work RVU or postoperative work time 
for this code.
    Comment: Many commenters disagreed with the CMS proposed work RVU 
of 5.70 for CPT code 49014 and stated that CMS should instead finalize 
the RUC-recommended work RVU of 6.73. Commenters stated that the 
typical patient undergoing CPT code 49014 will likely still be 
critically ill and unstable having survived significant pelvic trauma 
24 to 48 hours prior to the procedure. Commenters disagreed with the 
CMS comparison to CPT code 39401, which describes a diagnostic biopsy 
procedure that is typically performed as an outpatient procedure on a 
stable patient. Commenters stated that the intensity of removing the 
preperitoneal pelvic pads one by one while ensuring the patient remains 
hemodynamically stable, as described by CPT code 49014, is much greater 
than taking mediastinal biopsies as described by CPT code 39401. One 
commenter provided a table that outlined several recently reviewed 0-
day global codes with similar intraoperative time and intensity as code 
49014, and stated that these codes supported the RUC-recommended work 
RVU of 6.73.
    Response: We appreciate the additional feedback from the commenters 
regarding the typical patients undergoing CPT code 49014. Based on the 
additional information supplied by the commenters, we are not 
finalizing our refinement to the work RVU for this code.
    After consideration of the public comments, we are not finalizing 
our proposed refinements to the work RVUs or the work times for the 
codes in the Preperitoneal Pelvic Packing family. We are instead 
finalizing the RUC-recommended work RVU of 8.35 for CPT code 49013 and 
the RUC-recommended work RVU of 6.73 for CPT code 49014. We are also 
finalizing the RUC-recommended immediate postservice work time of 60 
minutes for CPT code 49013. We are finalizing the RUC-recommended 
direct PE inputs for both codes in the family as proposed.
(20) Cystourethroscopy Insertion Transprostatic Implant (CPT Codes 
52441 and 52442)
    In 2005, the AMA RUC began the process of flagging services that 
represent new technology or new services as they were presented to the 
AMA/Specialty Society RVS Update Committee. This service was reviewed 
at the October 2018 RAW meeting, and the RAW indicated that the 
utilization is increasing and questioned the time required to perform 
these services. These two codes were surveyed and reviewed for the 
January 2019 RUC meeting.
    We disagree with the RUC-recommended work RVU of 4.50 (current 
value) for CPT code 52441 (Cystourethroscopy, with insertion of 
permanent adjustable transprostatic implant; single implant) and 
proposed a work RVU of 4.00. This proposed work RVU is based on a 
crosswalk from recently reviewed CPT code 58562 (Hysterscopy, surgical; 
with removal of impacted foreign body), which has a work RVU of 4.00, 
and an identical 25 minutes of intraservice time as CPT code 52441.
    We disagree with the RUC-recommended work RVU of 1.20 (current 
value) for CPT code 52442 (Cystourethroscopy, with insertion of 
permanent adjustable transprostatic implant; each additional permanent 
adjustable transprostatic implant (List separately in addition to code 
for primary procedure)) and proposed a work RVU of 1.01. This proposed 
work RVU is based on a crosswalk from CPT code 36218 (Selective 
catheter placement, arterial system; additional second order, third 
order, and beyond, thoracic or brachiocephalic branch, within a 
vascular family (List in addition to code for initial second or third 
order vessel as appropriate)), which has a work RVU of 1.01, and an 
identical 15 minutes of intraservice time as CPT code 52442.
    The RUC survey showed a reduction in time, and the work should 
reflect these changes.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family without refinement.
    We received public comments on the proposed valuation of the codes 
in the Cystourethroscopy Insertion Transprostatic Implant family. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 4.00 for CPT code 52441 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 4.50. One commenter stated the 
RUC recommendation for code 52441 was understated, but would support 
the RUC recommendation at this time. Commenters stated that the CMS 
proposal completely disregards all factors that go into the work value 
apart from time and, if finalized, would create a rank order anomaly 
relative to other urological procedures. Commenters stated that 
although the intraservice time for CPT code 52441 has decreased from 30 
minutes to 25 minutes, the physician work for the procedure is now more 
intense.
    Response: We recognize that adjusting work RVUs for changes in time 
is not always a straightforward process and that the intensity 
associated with changes in time is not necessarily always linear, which 
is why we apply various methodologies to identify several potential 
work values for individual codes. However, we reiterate that we believe 
it would be irresponsible to ignore changes in time based on the best 
data available and that we are statutorily obligated to consider both 
time and intensity in establishing work RVUs for PFS services. We 
continue to believe that recently reviewed CPT code 58562 with an 
identical 25 minutes of intraservice time is a strong crosswalk and a 
work RVU of 4.00 is a more accurate valuation for code 52441.
    Comment: A few commenters disagreed with our comparison of code 
52441 to code 58562 because they are unrelated procedures, and also 
stated that removal of an intrauterine foreign body is not the same 
procedure as placement of a transprostatic implant and does not require 
as much skill and decision.
    Response: We disagree with the commenters that CPT code 58562 is 
not an appropriate crosswalk code on the grounds that it is an 
unrelated procedure. We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 1.01 for CPT code 52442 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.20. One commenter stated the 
RUC recommendation for code 52442 was understated and suggested the 
work RVU should be increase to 2.09 using a

[[Page 62740]]

crosswalk to code 36227 (Selective catheter placement, external carotid 
artery, unilateral, with angiography of the ipsilateral external 
carotid circulation and all associated radiological supervision and 
interpretation (List separately in addition to code for primary 
procedure)). Commenters stated that although the intraservice time for 
CPT code 52442 has decreased from 25 minutes to 15 minutes, the 
physician work for the procedure is now more intense. Commenters stated 
that the CMS proposal for code 52442 completely disregards all factors 
that go into the work value apart from time and, if finalized, would 
create a rank order anomaly relative to other urological procedures.
    Response: We disagree that CPT code 36227 is a better comparator to 
code 52442. Code 36227 is significantly more intense than the reviewed 
code 52442 because it involves catheter insertion into the external 
carotid artery, and we do not believe that it would be an appropriate 
comparison code. We agree with the commenters that intensity has 
increased for code 52442. This is the reason why we crosswalked the 
work RVU of code 36218 to code 52442. Code 36218 has the same 
intraservice time of 15 minutes and a higher intensity than code 52442. 
According to the RUC database, the intensity of work per unit of time 
(IWPUT) is greater for code 36218 than for code 52442. We continue to 
believe that CPT code 36218 with an identical 15 minutes of 
intraservice time is a strong crosswalk and a work RVU of 1.01 is a 
more accurate valuation for code 52442.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the 
Cystourethroscopy Insertion Transprostatic Implant family of codes (CPT 
codes 52441 and 52442) as proposed.
(21) Orchiopexy (CPT Code 54640)
    The CPT Editorial Panel revised existing CPT code 54640 to describe 
an additional approach for orchiopexy (scrotal) and to clearly indicate 
that hernia repair is separately reportable. This code was surveyed and 
reviewed for the January 2019 RUC meeting.
    We proposed to maintain the current work RVU of 7.73 as recommended 
by the RUC. We proposed the RUC-recommended direct PE inputs for CPT 
code 54640 without refinement.
    We received public comments on the proposed valuation of CPT code 
54640 for Orchiopexy. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs and direct PE inputs for Orchiopexy (CPT code 
54640).
(22) Radiofrequency Neurotomy Sacroiliac Joint (CPT Codes 64451, 64625)
    In September 2018, the CPT Editorial Panel created two new codes to 
describe injection and radiofrequency ablation of the sacroiliac joint 
with image guidance for somatic nerve procedures. We proposed the RUC-
recommended work RVU of 1.52 for CPT code 64451 (Injection(s), 
anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac 
joint, with image guidance (i.e., fluoroscopy or computed tomography)) 
and the RUC-recommended work RVU of 3.39 for CPT code 64625 
(Radiofrequency ablation, nerves innervating the sacroiliac joint, with 
image guidance (i.e., fluoroscopy or computed tomography)).
    For the direct PE inputs, we proposed to refine the quantity of the 
``needle, 18-26g 1.5-3.5in, spinal'' (SC028) supply from 3 to 1 for CPT 
code 64451. There are no spinal needles in use in the reference code 
associated with CPT code 64451, and there was no explanation in the 
recommended materials explaining why three such needles would be 
typical for this procedure. We agree that the service being performed 
in CPT code 64451 would require a spinal needle, but we do not believe 
that the use of three such needles would be typical.
    We proposed to refine the quantity of the ``cannula (radiofrequency 
denervation) (SMK-C10)'' (SD011) supply from 4 to 2 for CPT code 64625. 
We do not believe that the use of 4 of these cannula would be typical 
for the procedure, as the reference code currently used for destruction 
by neurolytic agent contains only a single cannula. We believe that the 
nerves would typically be ablated one at a time using this cannula, as 
opposed to ablating four of them simultaneously as suggested in the 
recommended direct PE inputs. We also searched in the RUC database for 
other CPT codes that made use of the SD011 supply, and out of the seven 
codes that currently use this item, none of them include more than 2 
cannula. As a result, we proposed to refine the supply quantity to 2 
cannula to match the highest amount contained in an existing code on 
the PFS. We are also refining the equipment time for the 
``radiofrequency kit for destruction by neurolytic agent'' (EQ354) 
equipment from 164 minutes to 82 minutes. The RUC's equipment time 
recommendation was predicated on the use of 4 of the SD011 supplies for 
41 minutes apiece, and we are refining the equipment time to reflect 
our supply refinement to 2 cannula. It was unclear in the recommended 
materials as to whether the radiofrequency kit equipment was in use 
simultaneously or sequentially along with the cannula supplies, and 
therefore, we are soliciting comments on the typical use of this 
equipment.
    Finally, we proposed to refine the equipment time for the 
technologist PACS workstation (ED050) equipment to match our standard 
equipment time formulas, which results in an increase of 5 minutes of 
equipment time for both codes.
    We received public comments on the proposed valuation of the codes 
in the Radiofrequency Neurotomy Sacroiliac Joint family. The following 
is a summary of the comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the quantity of the ``needle, 18-26g 1.5-3.5in, spinal'' (SC028) 
supply from 3 to 1 for CPT code 64451. Commenters stated that this code 
describes four separate injections of three sacral levels, and that 
four separate needles are required to inject the dorsal rami of L5 and 
the lateral branches of S1, S2 and S3. Commenters clarified that 
although the original RUC recommendation indicated that only 3 needles 
are needed for CPT code 64451, this was an error and the recommendation 
should in fact be 4 needles. Commenters stated that standard practice 
is to place the four needles, then simultaneously inject, and that if 
one needle were to be used there would be additional time required to 
account for the sequential fashion of the injections.
    Response: We appreciate the additional information provided by the 
commenters regarding the SC028 spinal needle supply, especially the 
clarification that the use of four needles would be typical for the 
procedure. This was particularly helpful in resolving the discrepancy 
between the original recommendation of three needles and the four 
injections taking place. Although we continue to have reservations as 
to whether four simultaneous injections would be typical for this 
procedure, we are finalizing a supply quantity of 4 spinal needles for 
CPT code 64451 as recommended by the commenters.

[[Page 62741]]

    Comment: Several commenters disagreed with the CMS proposal to 
refine the quantity of the ``cannula (radiofrequency denervation) (SMK-
C10)'' (SD011) supply from 4 to 2 for CPT code 64625. Commenters stated 
that, in a similar fashion to CPT code 64451, the radiofrequency 
ablation of the nerves innervating the sacroiliac joint in CPT code 
64625 requires four cannulas for simultaneous ablation of the four 
nerves. Commenters stated that these cannula are placed and then guided 
simultaneously to allow for fewer fluoroscopic images and a safer total 
radiation dose for the patient and staff. Commenters also noted that 
the comparison codes referenced in the proposed rule involved an 
ablation of a single nerve, and that while this was an excellent base 
comparison, CPT code 64625 reflects four times that work. Commenters 
requested that CMS finalize the RUC-recommended supply quantity of 4 
cannulas.
    Response: We appreciate the additional information provided by the 
commenters regarding the SD011 cannula supply, especially the reminder 
that the other comparison codes containing a cannula supply involved 
the ablation of a single nerve instead of four nerves. As we stated 
with regard to the spinal needle supple for CPT code 64451, we continue 
to have reservations as to whether four simultaneous ablations would be 
typical for this procedure; however, we are finalizing a supply 
quantity of 4 cannula for CPT code 64625 as recommended by the 
commenters.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the equipment time for the ``radiofrequency kit for destruction 
by neurolytic agent'' (EQ354) equipment from 164 minutes to 82 minutes. 
Commenters stated that four kits are used for 41 minutes each totaling 
164 minutes, as the 41 minutes (times 4) occurs simultaneously. 
Commenters stated again that four cannulas and four kits are needed for 
the simultaneous ablation of four nerves.
    Response: Since we did not finalize our proposal to refine the 
quantity of the SD011 cannula supply from 4 to 2 for CPT code 64625, we 
are also not finalizing our refinement to the EQ354 equipment time. We 
will instead finalize the RUC-recommended equipment time of 164 minutes 
for the radiofrequency kit.
    Comment: Several commenters stated that the proposed reduction in 
RVUs for knee genicular nerve ablation and sacroiliac joint ablation 
will effectively reduce access for Medicare beneficiaries to reasonable 
and sensible treatments for chronic knee and low back pain 
respectively. The commenters detailed the clinical benefits of these 
procedures and requested that the proposed reduction in RVUs for knee 
and sacroiliac joint ablation not be enacted, as the commenters stated 
that doing so would jeopardize their ability to responsibly treat a 
large number of patients.
    Response: We appreciate the feedback from the commenters detailing 
their experience with these procedures and their clinical importance to 
Medicare beneficiaries. We agree that it is extremely important to 
ensure reasonable and fair payment for each service in order to 
maintain access to care. In the particular case of the codes in the 
Radiofrequency Neurotomy Sacroiliac Joint family, we agreed with the 
RUC recommendations for work valuation and proposed the recommended 
work RVUs without refinement. We believe that this valuation will 
ensure that providers are properly compensated for these services.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Radiofrequency Neurotomy Sacroiliac 
Joint family as proposed. We are finalizing the RUC-recommended direct 
PE inputs for both codes in the family, with the exception of a 
refinement from 3 to 4 spinal needles (SC028) for CPT code 64451 and 
the proposed equipment time refinements for the technologist PACS 
workstation (ED050) equipment to match our standard equipment time 
formulas.
(23) Lumbar Puncture (CPT Codes 62270, 62328, 62272, and 62329)
    In October 2017, these services were identified as being performed 
by a different specialty than the specialty that originally surveyed 
this service. In January 2018, the RUC recommended that these services 
be referred to CPT to bundle image guidance. At the September 2018 CPT 
Editorial Panel meeting, the Panel created two new codes to bundle 
diagnostic and therapeutic lumbar puncture with fluoroscopic or CT 
image guidance and revised the existing diagnostic and therapeutic 
lumbar puncture codes so they would only be reported without 
fluoroscopic or CT guidance.
    For CPT code 62270 (Spinal puncture, lumbar, diagnostic), we 
disagree with the RUC-recommended work RVU of 1.44 and we proposed a 
work RVU of 1.22 based on a crosswalk to CPT code 40490 (Biopsy of 
lip). CPT code 40490 has the same intraservice time of 15 minutes and 2 
additional minutes of total time. In reviewing CPT code 62270, we noted 
that the recommended intraservice time is decreasing from 20 minutes to 
15 minutes (25 percent reduction), and the recommended total time is 
decreasing from 40 minutes to 32 minutes (20 percent reduction); 
however, the RUC-recommended work RVU is increasing from 1.37 to 1.44, 
which is an increase of just over 5 percent. Although we do not imply 
that the decrease in time as reflected in survey values must equate to 
a one-to-one or linear decrease in the valuation of work RVUs, we 
believe that since the two components of work are time and intensity, 
significant decreases in time should be appropriately reflected in 
decreases to work RVUs. In the case of CPT code 62270, we believed that 
it was more accurate to propose a work RVU of 1.22 based on a crosswalk 
to CPT code 40490 to account for these decreases in the surveyed work 
time.
    For CPT code 62328 (Spinal puncture, lumbar, diagnostic; with 
fluoroscopic or CT guidance), we disagree with the RUC-recommended work 
RVU of 1.95 and we proposed a work RVU of 1.73. Although we disagree 
with the RUC-recommended work RVU, we note that the relative difference 
in work between CPT codes 62270 and 62328 is equivalent to an interval 
of 0.51 RVUs. Therefore, we proposed a work RVU of 1.73 for CPT code 
62328, based on the recommended interval of 0.51 additional RVUs above 
our proposed work RVU of 1.22 for CPT code 62270.
    For CPT code 62272 (Spinal puncture, therapeutic, for drainage of 
cerebrospinal fluid (by needle or catheter), we disagree with the RUC-
recommended work RVU of 1.80 and we proposed a work RVU of 1.58. 
Although we disagree with the RUC-recommended work RVU, we note that 
the relative difference in work between CPT codes 62270 and 62328 is 
equivalent to the RUC-recommended interval of 0.36 RVUs. Therefore, we 
proposed a work RVU of 1.58 for CPT code 62272, based on the 
recommended interval of 0.36 additional RVUs above our proposed work 
RVU of 1.22 for CPT code 62270.
    For CPT code 62329 (Spinal puncture, therapeutic, for drainage of 
cerebrospinal fluid (by needle or catheter); with fluoroscopic or CT 
guidance), we disagree with the RUC-recommended work RVU of 2.25 and we 
proposed a work RVU of 2.03. Although we disagree with the RUC-
recommended work RVU, we note that the relative difference in work 
between CPT codes 62270 and 62329 is equivalent to the recommended 
interval of 0.81 RVUs. Therefore, we proposed a

[[Page 62742]]

work RVU of 2.03 for CPT code 62329, based on the recommended interval 
of 0.81 additional RVUs above our proposed work RVU of 1.22 for CPT 
code 62270.
    We proposed the RUC-recommended direct PE inputs for all four codes 
in the family without refinement.
    We received public comments on the proposed valuation of the codes 
in the Lumbar Puncture family. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters disagreed with the CMS-proposed work 
RVU of 1.22 for CPT code 62270 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.44. Commenters stated that 
the proposed crosswalk to CPT code 40490 was inappropriate and was 
chosen based only on a time comparison without consideration to the 
intensity of the work. Commenters stated that CPT code 62270 had a very 
different and more intensive patient population that the proposed 
crosswalk to CPT code 40490, with the crosswalk code typically 
performed in a physician office as an elective procedure while code CPT 
code 62270 is typically performed on seriously ill patients in the 
emergency room or inpatient hospital setting. Commenters stated that 
CPT code 62270 is a more intense and complex procedure because it 
involves insertion of a needle to at least a depth of 6-7 cm in the 
average sized patient while navigating around spine anatomy such as 
subcutaneous soft tissues, paraspinal muscles, spinous process, 
interspinous ligament, transverse process, epidural space and dura to 
access the cerebrospinal space. Commenters also stated that these two 
procedures were not clinically similar, as CPT code 40490 is a 
superficial biopsy of a visible lesion whereas CPT code 62270 requires 
the physician to guide a needle from the skin, through the soft 
tissues, between the posterior elements of the lumbar spine, and into 
the thecal sac within the spinal canal in a patient that is presenting 
with neurologic symptoms necessitating an emergent procedure.
    Response: We disagree with the commenters that CPT code 40490 was 
an inappropriate choice to use as a crosswalk for work valuation, and 
we did not choose this code based only on a time comparison without 
respect to intensity. We recognize that it would not be appropriate to 
develop work RVUs solely based on time given that intensity is also an 
element of work. We clarify again that we do not treat all components 
of physician time as having identical intensity. Were we to disregard 
intensity altogether, the work RVUs for all services would be developed 
based solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. For more details on our methodology for developing 
work RVUs, we refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this rule (section 
II.N.2. of this final rule), as well as a longer discussion in the CY 
2017 PFS final rule (81 FR 80272 through 80277).
    In more general terms, we continue to believe that the nature of 
the PFS relative value system is such that all services are 
appropriately subject to comparisons to one another. Although codes 
that describe clinically similar services are sometimes stronger 
comparator codes, we do not agree that codes must share the same site 
of service, patient population, or utilization level to serve as an 
appropriate crosswalk. We also note that the RUC-recommended crosswalk 
code used to determine the recommended work RVU of 1.44, CPT code 
12004, is itself not clinically similar to CPT code 62270. While both 
procedures include an initial injection, they are otherwise clinically 
distinct from one another, with CPT code 12004 describing repair of 
superficial wounds while CPT code 62270 describes a spinal puncture for 
the purpose of obtaining cerebrospinal fluid samples. We do not 
understand the critique of CPT code 40490 as a clinically dissimilar 
code on the part of the commenters when the recommended work RVU of 
1.44 is also based on a clinically dissimilar code.
    For the specific case of CPT code 40490, while it is true that this 
is not an emergent procedure, the service nonetheless requires tissue 
excision and carries a substantial risk of serious bleeding from the 
patient. To the extent that commenters stated that CPT code 62270 is a 
more intense procedure than CPT code 40490, we agree with the 
commenters, which is why we proposed a higher intensity for CPT code 
62270 in the proposed rule. We also note that CPT code 40490 was not 
the only crosswalk code that we could have chosen for work valuation. 
We also considered CPT code 12013 (Simple repair of superficial wounds 
of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6 cm to 
5.0 cm), an MPC code with the same 15 minutes of intraservice time, 27 
minutes of total time, and the same work RVU of 1.22. If the commenters 
have reason to believe that wound repair procedures such as CPT code 
12004 are more appropriate choices as crosswalks on clinical grounds, 
we emphasize that we also could have chosen CPT code 12013 (another 
wound repair procedure) for our crosswalk and still derived the same 
work RVU of 1.22.
    Comment: Several commenters disagreed with the CMS-proposed work 
RVUs for CPT codes 62328, 62272, and 62329. Commenters stated that CMS 
should instead finalize the RUC-recommended work RVUs for these 
procedures. Commenters stated that the incremental methodology used in 
valuing these services was flawed; commenters did not agree that it was 
appropriate to reduce the work RVU for CPT code 62270 from the value 
proposed by the RUC, while also recalibrating the work RVUs for CPT 
codes 62328, 62272, and 62329 relative to the RUC's recommended 
difference in work between these code and CPT code 62270. Commenters 
stated that patients for CPT code 62328 have typically failed a bedside 
lumbar puncture or have prior history of spine surgery that requires 
imaging to facilitate access into the cerebrospinal fluid space, and 
therefore, calculating a step-up in value from CPT code 62270 does not 
accurately capture the work differences. Commenters stated that it is 
imperative to employ RUC survey data to value these codes, and that 
using an incremental approach in lieu of survey data, strong 
crosswalks, and input from the practitioners providing these services 
was unjustified.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We have no evidence to suggest that the 
consideration of an incremental difference between codes for the work 
component would be an inaccurate methodology to use for identifying the 
work resources in time and intensity involved in furnishing the 
service. For more details on our methodology for developing work RVUs, 
we refer readers to our discussion of the subject in the Methodology 
for Establishing Work RVUs section of this rule (section II.N.2. of 
this final rule), as well as a longer discussion in the CY 2017 PFS 
final rule (81 FR 80272 through 80277).

[[Page 62743]]

    Comment: Several commenters stated the crosswalk or methodology 
used in the original valuation of CPT code 62272 is unknown and not 
resource-based, and therefore, it was invalid for CMS to compare the 
current time and work to the surveyed time and work. Commenters stated 
that referencing physician times and derived intensities created almost 
30 years ago under the Harvard study as a method to critique RUC 
recommendations was not appropriate.
    Response: We believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily-obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80273 through 80274). We also note that for the specific 
case of CPT code 62272, our proposed work RVU of 1.58 was based on the 
use of an incremental methodology and was unrelated to the existing 
work time values.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Lumbar Puncture 
family as proposed.
(24) Electronic Analysis of Implanted Pump (CPT Codes 62367, 62368, 
62369, and 62370)
    CPT code 62368 (Electronic analysis of programmable, implanted pump 
for intrathecal or epidural drug infusion (includes evaluation of 
reservoir status, alarm status, drug prescription status); with 
reprogramming) was identified by the RUC on a list of services which 
were originally surveyed by one specialty but are now typically 
performed by a different specialty. It was reviewed along with three 
other codes in the family for PE only at the April 2018 RUC meeting. 
The RUC did not recommend work RVUs for these codes and we did not 
propose to change the current work RVUs.
    For the direct PE inputs, we proposed to remove the minimum multi-
specialty visit pack (SA048) from CPT code 62370 as a duplicative 
supply due to the fact that this code is typically billed with an E/M 
or other evaluation service.
    We received public comments on the proposed valuation of the codes 
in the Electronic Analysis of Implanted Pump family. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported the proposal to remove the 
minimum multi-specialty visit pack (SA048) from CPT code 62370 as a 
duplicative supply.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposed reduction 
in the nonfacility PE RVUs for the Electronic Analysis of Implanted 
Pump family of codes. The commenters detailed the use of implantable 
infusion pumps for the treatment of spasticity and chronic intractable 
pain and stated that they had concerns that the proposed physician 
payment reductions could threaten access to this important alternative 
therapy. The commenters stated that CMS provided commentary in the 
proposed rule about removing the minimum multi-specialty visit pack 
(SA048) from CPT code 62370 but there was no rationale given for a 
reduction of this magnitude applying across the entire family of codes. 
The commenters stated that they did not believe that a reduction in 
clinical labor time for these services was warranted, and restated that 
reducing the clinical labor time and cutting payment to physician 
offices for these codes, without a basis for doing so, was 
inappropriate.
    Response: We clarify for the commenters that we proposed to remove 
the minimum multi-specialty visit pack (SA048) only from CPT code 
62370, as a duplicative supply due to the fact that this code is 
typically billed with an E/M or other evaluation service. We did not 
propose to remove the SA048 visit pack from CPT code 62369 as this code 
is not typically billed with an E/M service. Aside from this singular 
refinement, we proposed the RUC-recommended direct PE inputs without 
refinement for the four codes in the family. We agree with the RUC that 
the typical clinical labor time required to perform these services has 
decreased significantly since they were last reviewed in 2011, 
particularly in light of the fact that three of the four codes are 
typically billed with a same day E/M service.
    Comment: A commenter stated that the RUC and CMS applied 
significant reductions to clinical labor inputs for CPT codes 62367 and 
62368 because these services are billed more than 50 percent of the 
time with E/M office visit services. The commenter stated that while 
this may be the case, the underlying rationale--that clinical staff 
times are redundant--does not apply to these services. The commenter 
stated that neuromodulation physician offices provide these services to 
patients every day, and the time spent by clinical staff is not 
duplicative and is not captured by any accompanying E/M codes.
    Response: In cases where a service is typically furnished to a 
beneficiary on the same day as an E/M service, we believe that there is 
overlap between the two services in some of the activities furnished 
during the preservice evaluation and postservice time. Our longstanding 
adjustments have reflected a broad assumption that at least one-third 
of the work time in both the preservice evaluation and postservice 
period is duplicative of work furnished during the E/M visit, and we 
believe that the clinical labor tasks are similarly duplicative. For 
example, we do not believe that clinical labor tasks such as ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) and ``Prepare room, equipment and supplies'' 
(CA013) would typically be performed in CPT code 62367 given that 
clinical labor time is already allocated for these identical tasks in 
the E/M codes. We also note that the commenter did not provide a 
rationale as to why this clinical labor time would not be duplicative. 
We continue to agree with the RUC-recommended clinical labor times that 
we proposed for the four codes in this family.
    Comment: A commenter stated that the clinical labor time assigned 
to CPT codes 62369 and 62370 for clinical staff time during the 
procedure (the intraservice time) should not be set as the same time as 
the time assigned for physician intraservice work. The commenter stated 
that the clinical staff spends significant amounts of time before and 
after the physician provides his/her services, including tracking 
patient refill dates, reviewing charts, writing prescriptions, and 
transmitting them to a pharmacy. The commenter stated that when 
medications are received, these need to be recorded and double-locked 
per Drug Enforcement Agency (DEA) regulations, and then when taken out 
and dispensed the staff

[[Page 62744]]

must inform and assist the patient in collecting their signatures. The 
commenter stated that this clinical labor occurs for every patient 
encounter and should be recognized in the RVUs assigned to these 
services.
    Response: We agree with the commenter that these are important 
tasks that must be carried out for each patient and they should be 
recognized in the valuation of these services. However, we note for the 
commenter that most of these clinical labor tasks are already included 
in the typically billed same day E/M code for CPT code 62370, which has 
clinical labor time allocated for these very same activities, such as 
checking tab test results, reviewing document history, and coordinating 
home care. In the case of CPT code 62369, which is not typically billed 
with a same day E/M code, clinical labor for performing these tasks has 
been retained in the proposed direct PE inputs.
    After consideration of the public comments, we are finalizing the 
direct PE inputs for the codes in the Electronic Analysis of Implanted 
Pump family as proposed. We did not propose and we are not finalizing 
any changes to the current work RVUs.
(25) Somatic Nerve Injection (CPT Codes 64400, 64408, 64415, 64416, 
64417, 64420, 64421, 64425, 64430, 64435, 64445, 64446, 64447, 64448, 
64449, and 64450)
    In May 2018, the CPT Editorial Panel approved the revision of 
descriptors and guidelines for the codes in this family and the 
deletion of three CPT codes to clarify reporting (that is, separate 
reporting of imaging guidance, number of units and a change from a 0-
day global to ZZZ for one of the CPT codes in this family). This family 
of services describe the injection of an anesthetic agent(s) and/or 
steroid into a nerve plexus, nerve, or branch; reported once per nerve 
plexus, nerve, or branch as described in the descriptor regardless of 
the number of injections performed along the nerve plexus, nerve, or 
branch described by the code.
    CPT codes 64400 (Injection(s), anesthetic agent(s); trigeminal 
nerve, each branch (i.e., ophthalmic, maxillary, mandibular)), 64408 
(Injection(s), anesthetic agent(s), and/or steroid; vagus nerve), 64415 
(Injection(s), anesthetic agent(s) and/or steroid; brachial plexus), 
64416 (Injection(s), anesthetic agent(s) and/or steroid; brachial 
plexus, continuous infusion by catheter (including catheter 
placement)), 64417 (Injection(s), anesthetic agent(s) and/or steroid; 
axillary nerve), 64420 (Injection(s), anesthetic agent(s) and/or 
steroid; intercostal nerve, single level), 64421 (Injection(s), 
anesthetic agent(s) and/or steroid; intercostal nerves, each additional 
level (List separately in addition to code for primary procedure)), 
64425 (Injection(s), anesthetic agent(s) and/or steroid; ilioinguinal, 
iliohypogastric nerves), 64430 (Injection(s), anesthetic agent(s) and/
or steroid; pudendal nerve), 64435 (Injection(s), anesthetic agent(s) 
and/or steroid; paracervical (uterine) nerve), 64445 (Injection(s), 
anesthetic agent(s) and/or steroid; sciatic nerve), 64446 
(Injection(s), anesthetic agent(s) and/or steroid; sciatic nerve, 
continuous infusion by catheter (including catheter placement)), 64447 
(Injection(s), anesthetic agent(s); femoral nerve), 64448 
(Injection(s), anesthetic agent(s) and/or steroid; femoral nerve, 
continuous infusion by catheter (including catheter placement)), 64449 
(Injection(s), anesthetic agent(s) and/or steroid; lumbar plexus, 
posterior approach, continuous infusion by catheter (including catheter 
placement)), and 64450 (Injection(s), anesthetic agent(s); other 
peripheral nerve or branch) were reviewed for work and PE at the 
October 2018 RUC meeting. The PE for CPT code 64450 was re-reviewed 
during the RUC January 2019 meeting.
    During the October 2018 RUC presentation for this family of 
services, the specialty societies stated that CPT codes 64415, 64416, 
64417, 64446, 66447, and 64448 were reported with CPT code 76942 
(Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, 
injection, localization device), imaging supervision and 
interpretation) more than 50 percent of the time. Specifically, 76 
percent with CPT code 64415, 85 percent with CPT code 64416, 68 percent 
with CPT code 64417, 77 percent with CPT code 64446, 77 percent with 
CPT code 66447, and 79 percent with CPT code 64448. It was also noted 
in the RUC recommendations that this overlap was accounted for in the 
RUC recommendations submitted for these services. Furthermore, the RUC 
recommendations sated that the RUC referred CPT codes 64415, 64416, 
64417, 64446, 64447 and 64448 to be bundled with ultrasound guidance, 
CPT code 76942 to the CPT Editorial Panel for CPT 2021.
    In reviewing this family of services, our proposed work and PE 
values for CPT codes 64415, 64416, 64417, 64446, 64447 and 64448 did 
not consider the overlap of imaging, as noted in the RUC 
recommendations. We noted that the RUC recommendations did not include 
values to support the valuation for the bundling of imaging in their 
work or PE recommendations and that the CPT code descriptors do not 
state that imaging is included.
    For CY 2020, we proposed the RUC-recommended work RVUs for CPT 
codes 64417 (work RVU of 1.27), 64435 (work RVU of 0.75), 64447 (work 
RVU of 1.10), and 64450 (work RVU of 0.75), the RUC reaffirmed work RVU 
of 0.94 for CPT code 64405 (Injection, anesthetic agent; greater 
occipital nerve), which is the current work RVU finalized in the CY 
2019 PFS final rule (83 FR 59542), and the RUC reaffirmed work RVU of 
1.10 for CPT code 64418 (Injection, anesthetic agent; suprascapular 
nerve), which is the current work RVU value finalized in the CY 2018 
PFS final rule (82 FR 53054). Although we proposed the RUC-reaffirmed 
work RVUs for these two codes, as submitted in the RUC recommendations, 
we noted that comparable codes in this family of services have lower 
work RVUs. Thus, these two codes may have become misvalued since their 
last valuation, as they were not resurveyed under this code family 
during the October 2018 RUC meeting.
    In continuing our review of this code family, we disagreed with the 
RUC-recommended work RVU of 1.00 for CPT code 64400 and proposed a work 
RVU of 0.75, to maintain rank order in this code family. Our proposed 
work RVU is based on a crosswalk to another code in this family, CPT 
code 64450, which has an identical work RVU of 0.75 and near identical 
intraservice and total time values to CPT code 64400.
    We noted that the RUC-recommended intraservice time decreased from 
37 to 6 minutes (84 percent reduction) and the RUC-recommended total 
time decreased from 69 to 20 minutes (71 percent reduction) for CPT 
code 64400. However, the RUC-recommended work RVU only decreased by 
0.11, a 10 percent reduction. We did not believe the RUC-recommended 
work RVU appropriately accounts for the substantial reductions in the 
surveyed work times for the procedure. Although we did not imply that 
the decrease in time as reflected in survey values must always equate 
to a one-to-one or linear decrease in the valuation of work RVUs, we 
believe that since the two components of work and time are 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. In the case of CPT 
code 64400, we believe that it would be more accurate to propose a work 
RVU of 0.75

[[Page 62745]]

based on a crosswalk to CPT code 64450, which has an identical work RVU 
of 0.75 and near identical intraservice and total times to CPT code 
64400. We further noted that our proposed work RVU maintains rank order 
in this code family among comparable codes.
    For CPT code 64408, we disagreed with the RUC-recommended work RVU 
of 0.90 and proposed a work RVU of 0.75, to maintain rank order in this 
code family. Our proposed work RVU is based on a crosswalk to another 
code in this family, CPT code 64450, which has an identical work RVU of 
0.75, and near identical intraservice and total time values to CPT code 
64408.
    We noted that the RUC-recommended intraservice time decreased from 
16 to 5 minutes (69 percent reduction) and RUC-recommended total time 
decreased from 36 to 20 minutes (44 percent reduction) for CPT code 
64408. Although the RUC-recommended work RVU decreased by 0.51, a 36 
percent reduction, we do not believe the RUC-recommended work RVU 
appropriately accounted for the substantial reductions in the surveyed 
work times for the procedure. Although we did not imply that the 
decrease in time as reflected in survey values must always equate to a 
one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work and time are 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. In the case of CPT code 
64408, we believe that it would be more accurate to propose a work RVU 
of 0.75, based on a crosswalk CPT code 64450, to account for these 
decrease in the surveyed work times. We further noted that our proposed 
work RVU maintains rank order in this code family among comparable 
codes.
    For CPT code 64415, we disagreed with the RUC-recommended work RVU 
of 1.42 and proposed a work RVU of 1.35, based on our total time ratio 
methodology and further supported by a reference to CPT code 49450 
(Replacement of gastrostomy or cecostomy (or other colonic) tube, 
percutaneous, under fluoroscopic guidance including contrast 
injections(s), image documentation and report), which has a work RVU of 
1.36 and similar intraservice and total time values to CPT code 64415.
    We noted that the RUC-recommended intraservice time decreased from 
15 to 12 minutes (20 percent reduction) and RUC-recommended total time 
decreased from 44 to 40 minutes (9 percent reduction). However, the 
RUC-recommended work RVU only decreased by 0.06, which is a 4 percent 
reduction. We did not believe the RUC-recommended work RVU 
appropriately accounted for the substantial reductions in the surveyed 
work times for the procedure. Although we did not imply that the 
decrease in time as reflected in survey values must always equate to a 
one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work and time are 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. In the case of CPT code 
64415, we believed that it would be more accurate to propose a work RVU 
of 1.35, based on our time ratio methodology and a reference to CPT 
code 49450, to account for these decrease in the surveyed work times.
    For CPT code 64416, we disagreed with the RUC-recommended work RVU 
of 1.81 and proposed a work RVU of 1.48, based on our total time ratio 
methodology and further supported by a bracket of CPT code 62270 
(Spinal puncture, lumbar, diagnostic), which has a work RVU of 1.37, 
identical intraservice, and similar total time to CPT code 64416 and 
CPT code 91035 (Esophagus, gastroesophageal reflux test; with mucosal 
attached telemetry pH electrode placement, recording, analysis and 
interpretation), which has a work RVU of 1.59, identical intraservice, 
and near identical total time values to CPT code 64416.
    We noted that while the RUC-recommended intraservice time remained 
unchanged, the RUC-recommended total time decreased from 60 to 49 
minutes (18 percent reduction). However, the RUC recommended 
maintaining the current work RVU of 1.81. We do not believe the RUC-
recommended work RVU appropriately accounted for the substantial 
reductions in the surveyed total time for the procedure. Although we 
did not imply that the decrease in time as reflected in survey values 
must always equate to a one-to-one or linear decrease in the valuation 
of work RVUs, we believed that since the two components of work and 
time are 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. In the case of CPT code 64416, we believed that it would be more 
accurate to propose a work RVU of 1.48, based on our time ratios 
methodology and supported by a bracket to CPT code 62270 and CPT code 
91035, to account for these decreases in the surveyed work times.
    For CPT code 64420, we disagreed with the RUC-recommended work RVU 
of 1.18 and proposed a work RVU of 1.08, based on our time ratio 
methodology and further supported by a reference to CPT code 12011 
(Simple repair of superficial wounds of face, ears, eyelids, nose, lips 
and/or mucous membranes; 2.5 cm or less), which has a work RVU of 1.07 
and similar intraservice and total time values to CPT code 64420.
    We noted that the RUC-recommended intraservice time decreased from 
17 to 10 minutes (41 percent reduction) and the RUC-recommended total 
time decreased from 37 to 34 minutes (8 percent reduction). However, 
the RUC recommended to maintaining the current work RVU of 1.18. We do 
not believe the RUC-recommended work RVU appropriately accounted for 
the substantial reductions in the surveyed work times for the 
procedure. Although we did not imply that the decrease in time as 
reflected in survey values must always equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work and time are 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. In the case of CPT code 64420, we 
believed that it would be more accurate to propose a work RVU of 1.08 
based on our times ratio methodology and a crosswalk to CPT code 12011, 
to account for these decreases in the surveyed work times.
    For CPT code 64421, we disagreed with the RUC-recommended work RVU 
of 0.60 and proposed a work RVU of 0.50, based on our intraservice time 
ratio methodology and to maintain rank order among comparable codes in 
the family. Our proposed work RVU is further supported by a crosswalk 
to CPT code 15276 (Application of skin substitute graft to face, scalp, 
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or 
multiple digits, total wound surface area up to 100 sq cm; each 
additional 25 sq cm wound surface area, or part thereof (List 
separately in addition to code for primary procedure)), which has a 
work RVU of 0.50 and identical intraservice and total times to CPT code 
64421.
    We noted that our time ratio methodology suggests the code is 
better valued at 0.50. Furthermore, we note the RUC-recommended work 
RVU of 0.60 creates a rank order anomaly in the code

[[Page 62746]]

family. In the case of CPT code 64421, we believed that it would be 
more accurate to propose a work RVU of 0.50, based on our time ratio 
methodology and a crosswalk to CPT code 15276, to maintain rank order 
among comparable codes in the family.
    For CPT code 64425, we disagreed with the RUC-recommended work RVU 
of 1.19 and proposed a work RVU of 1.00, to maintain rank order among 
comparable codes in the family, based on a bracket of CPT code 12001 
(Simple repair of superficial wounds of scalp, neck, axillae, external 
genitalia, trunk and/or extremities (including hands and feet); 2.5 cm 
or less) which has a work RVU of 0.84 and near identical intraservice 
and total time values to CPT code 64425 and CPT code 30901 (Control 
nasal hemorrhage, anterior, simple (limited cautery and/or packing) any 
method), which has a work RVU of 1.10 and near identical intraservice 
and total times to CPT code 64425. CPT code 64425 has 11 minutes of 
intraservice time and 25 minutes of total time.
    We noted that the RUC-recommended work RVU of 1.19 creates a rank 
order anomaly in the code family. In the case of CPT code 64425, we 
believed that it would be more accurate to propose a work RVU of 1.00, 
based on a bracket of CPT codes 12001 and 30901 to maintain rank order 
among comparable codes in the family.
    For CPT code 64430, we disagreed with the RUC-recommended work RVU 
of 1.15 and proposed a work RVU of 1.00, to maintain rank order among 
comparable codes in the family, based on a bracket of CPT code 45330 
(Sigmoidoscopy, flexible; diagnostic, including collection of 
specimen(s) by brushing or washing, when performed (separate 
procedure)), which has a work RVU of 0.84 and near identical 
intraservice and total time values to CPT code 64430 and CPT code 31576 
(Laryngoscopy, flexible; with biopsy(ies)), which has a work RVU of 
1.89 and near identical intraservice and total time values to CPT code 
64430.
    We noted that the RUC-recommended intraservice time decreased from 
17 to 10 minutes (41 percent reduction) and the RUC-recommended total 
time increased from 39 to 43 minutes (10 percent increase). While the 
RUC-recommended work RVU is decreasing by 0.31, a 21 percent reduction, 
we do not believe the RUC-recommended work RVU appropriately accounted 
for the substantial reductions in the surveyed intraservice work time 
for the procedure. Although we did not imply that the decrease in time 
as reflected in survey values must always equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work and time are 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. In the case of CPT code 64430, we 
believed that it would be more accurate to propose a work RVU of 1.00, 
based on a bracket of CPT codes 45300 and 31576 to account for these 
decreases in surveyed work times and to maintain rank order among 
comparable codes in this family.
    For CPT code 64445, we disagreed with the RUC-recommended work RVU 
of 1.18 and proposed a work RVU of 1.00, based on our time ratio 
methodology and to maintain rank order among comparable codes in the 
family. Our proposed work RVU is based on a bracket of CPT code 12001 
(Simple repair of superficial wounds of scalp, neck, axillae, external 
genitalia, trunk and/or extremities (including hands and feet); 2.5 cm 
or less), which has a work RVU of 0.84 and near identical intraservice 
and total times to CPT code 64445 and CPT code 30901 (Control nasal 
hemorrhage, anterior, simple (limited cautery and/or packing) any 
method), which has a work RVU of 1.10 and near identical intraservice 
and total time values to CPT code 64445.
    We noted that the RUC-recommended intraservice time decreased from 
15 to 10 minutes (33 percent reduction) and the RUC-recommended total 
time decreased from 48 to 24 minutes (50 percent reduction). While the 
RUC-recommended work RVU is decreasing by 0.30, a 21 percent reduction, 
we do not believe the RUC-recommended work RVU appropriately accounted 
for the substantial reductions in the surveyed intraservice work time 
for the procedure. Although we did not imply that the decrease in time 
as reflected in survey values must always equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work and time are 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. In the case of CPT code 64445, we 
believed that it would be more accurate to propose a work RVU of 1.00, 
based on a bracket of CPT codes 12001 and 30901 to account for these 
decreases in surveyed work times and to maintain rank order among 
comparable codes in the family.
    For CPT code 64446, we disagreed with the RUC-recommended work RVU 
of 1.54 and proposed a work RVU of 1.36 based on our intraservice time 
ratios methodology and further supported by a reference to CPT code 
51710 (Change of cystostomy tube; complicated), which has a near 
identical work RVU of 1.35 and near identical intraservice and total 
time values to CPT code 64446.
    We noted that RUC-recommended intraservice time decreased from 20 
to 15 minutes (25 percent reduction) and the RUC-recommended total time 
decreased from 64 to 40 minutes (38 percent reduction). While the RUC-
recommended work RVU is decreasing by 0.27, a 15 percent reduction, we 
do not believe the RUC-recommended work RVU appropriately accounted for 
the substantial reductions in the surveyed intraservice work time for 
the procedure. Although we did not imply that the decrease in time as 
reflected in survey values must always equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work and time are 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. In the case of CPT code 64446, we 
believed that it would be more accurate to propose a work RVU of 1.36, 
based on our time ratios methodology and a reference to CPT code 51710 
to account for these decreases in surveyed times and to maintain rank 
order among comparable codes in the family.
    For CPT code 64448, we disagreed with the RUC-recommended work RVU 
of 1.55 and proposed a work RVU of 1.41, based our intraservice time 
ratio methodology and a reference to CPT code 27096 (Injection 
procedure for sacroiliac joint, anesthetic/steroid, with image guidance 
(fluoroscopy or CT) including arthrography when performed), which has a 
work RVU of 1.48 and near identical intraservice time and identical 
total time values to CPT code 64448.
    We noted that RUC-recommended intraservice time decreased from 15 
to 13 minutes (13 percent reduction) and the RUC-recommended total time 
decreased from 55 to 38 minutes (62 percent reduction). While the RUC-
recommended work RVU is only decreasing by 0.08, which is only a 5 
percent reduction. We do not believe the RUC-recommended work RVU 
appropriately accounted for the substantial reductions in the surveyed 
intraservice work time for the procedure. Although we did not imply 
that the decrease in time as reflected in survey values must always 
equate to a

[[Page 62747]]

one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work and time are 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. In the case of CPT code 
64448, we believed that it would be more accurate to propose a work RVU 
of 1.41, based on our time ratios methodology and a crosswalk to CPT 
code 27096 to account for these decreases in surveyed times and to 
maintain rank order among comparable codes in the family.
    For CPT code 64449, we disagreed with the RUC-recommended work RVU 
of 1.55 and proposed a work RVU of 1.27, based our intraservice time 
ratio methodology and a reference to CPT code 11755 (Biopsy of nail 
unit (e.g., plate, bed, matrix, hyponychium, proximal and lateral nail 
folds) (separate procedure)), which has a work RVU of 1.25 and near 
identical intraservice and total times to CPT code 64449.
    We noted that RUC-recommended intraservice time decreased from 20 
to 14 minutes (30 percent reduction) and the RUC-recommended total time 
decreased from 60 to 38 minutes (37 percent reduction). While the RUC-
recommended work RVU is decreasing by 0.26, a 14 percent reduction, we 
do not believe the RUC-recommended work RVU appropriately accounted for 
the substantial reductions in the surveyed intraservice work time for 
the procedure. Although we did not imply that the decrease in time as 
reflected in survey values must always equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work and time are 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. In the case of CPT code 64449, we 
believe that it would be more accurate to propose a work RVU of 1.27, 
based on our time ratios methodology and a reference to CPT code 11755 
to account for these decreases in surveyed times and to maintain rank 
order among comparable codes in the family.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Confirm availability of prior images/studies'' (CA006) 
activity for CPT code 64450. This code does not currently include this 
clinical labor time, and unlike the new code, CPT code 64XX1, in the 
Genicular Injection and RFA code family, in which the PE for CPT code 
64450 was resurveyed at the January 2019 RUC for PE, CPT code 64450 
does not include imaging guidance in its code descriptor. When CPT code 
64450 is performed with imaging guidance, it would be billed together 
with a separate imaging code that already includes clinical labor time 
for confirming the availability of prior images. As a result, it would 
be duplicative to include this clinical labor time in CPT code 64450. 
We are also proposing to refine the clinical labor time for the 
``Assist physician or other qualified healthcare professional--directly 
related to physician work time (100 percent)'' (CA018) activity from 10 
to 5 minutes for CPT code 64450, to match the intraservice work time 
and proposing to refine the equipment times in accordance with our 
standard equipment time formulas for CPT code 64450.
    Additionally, we proposed to refine the clinical labor time for the 
``provide education/obtain consent'' (CA011) from 3 minutes to 2 
minutes, for CPT codes 64400, 64408, 64415, 64417, 64420, 64425, 64430, 
64435, 64445, 64447 and 64450, to conform to the standard for this 
clinical labor task. We are also proposing to refine the equipment time 
in accordance with our standard equipment time formula for these codes. 
We note that there were no RUC-recommended direct PE inputs provided 
for CPT codes 64416, 64446, and 64448.
    We received public comments on the proposed valuation of the codes 
in the Somatic Nerve Injection family. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters stated that they supported our proposal 
of the RUC-recommended work RVUs for CPT codes 64417, 64435, 64447, and 
64450 and the RUC- reaffirmed work RVUs for CPT codes 64405 and 64418.
    Response: We appreciate the support for our proposals from 
commenters. As noted above, although we proposed the RUC-reaffirmed 
work RVUs for 64405 and 64418, as submitted in the RUC recommendations, 
we reiterate that comparable codes in this family of services have 
lower work RVUs. Thus, we are considering whether these two codes may 
have become misvalued since their last valuation, as they were not 
resurveyed under this code family during the October 2018 RUC meeting.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT codes 64415, 64416, 64446, 64448, 64449. Commenters stated that 
CMS should instead finalize the RUC-recommended work RVUs for these 
procedures. Commenters stated that CMS based the proposed values for 
these services on what the commenters referred to as the ``CMS time 
ratio methodology''; however, the agency did not elaborate on which 
time ratio specifically. Commenters speculated on the time ratio 
methodology they believed CMS applied to value the codes where the time 
ratio methodology used was not explicitly stated.
    Several commenters disagreed with the use of time ratio 
methodologies for work valuation of these services. Commenters stated 
that this use of time ratios is not a valid methodology for valuation 
of physicians' services. Commenters stated that treating all components 
of physician time (preservice, intraservice, postservice and post-
operative visits) as having identical intensity is incorrect, and 
inconsistently applying time ratio methodologies to only certain 
services under review creates inherent payment disparities in a payment 
system which is based on relative valuation. Commenters suggested that, 
in many scenarios, CMS selects an arbitrary combination of inputs to 
apply rather than seeking a valid clinically relevant relationship that 
would preserve relativity. Commenters urged CMS to determine the work 
valuation for each code based not only on surveyed work times, but also 
the intensity and complexity of the service and relativity to other 
similar services, rather than basing the work value entirely on time.
    Response: We have stated the specific time ratio methodology used 
to determine the proposed work RVU for each of the codes in this family 
where it was not explicitly stated in this final rule.
    We disagree with the commenters and continue to believe that the 
use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for information provided by surveys which suggests that the 
amount of time involved in furnishing the service has changed 
significantly. We have responded to concerns about our methodology 
earlier in this section. For additional information regarding the use 
of old work time values that were established many years ago and have 
not since been reviewed in our methodology, we refer readers to our 
discussion of the subject in the Methodology for Establishing Work RVUs 
section of this rule (section II.N.2. of this final rule), as well as a 
longer discussion in the CY 2017 PFS final rule (81 FR 80273 through 
80274). Based on

[[Page 62748]]

the aforementioned crosswalks, brackets, or references for CPT codes 
64415, 64416, 64446, 64448, 64449 codes, we continue to believe that 
the proposed values for these codes better maintain the relative 
intensity of the codes in the family, and better preserves relativity 
with the rest of the codes on the PFS.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT codes 64420 and 64421. Commenters stated that CMS should 
instead finalize the RUC-recommended work RVUs for these procedures. 
Commenters stated that CMS based the proposed values for these services 
on what the commenters referred to as the ``CMS time ratio 
methodology'', however, the Agency did not elaborate on which time 
ratio specifically. Commenters speculated the time ratio methodology 
they believed CMS applied to value these codes.
    Several commenters disagreed with the use of time ratio 
methodologies for work valuation of these services. Commenters stated 
that this use of time ratios is not a valid methodology for valuation 
of physician services. Commenters stated that treating all components 
of physician time (preservice, intraservice, postservice and post-
operative visits) as having identical intensity is incorrect, and 
inconsistently applying it to only certain services under review 
creates inherent payment disparities in a payment system which is based 
on relative valuation. Commenters noted that in many scenarios, CMS 
selects an arbitrary combination of inputs to apply rather than seeking 
a valid clinically relevant relationship that would preserve 
relativity. Commenters urged CMS to determine the work valuation for 
the each code based not only on surveyed work times, but also the 
intensity and complexity of the service and relativity to other similar 
services, rather than basing the work value entirely on time.
    Several commenters disagreed with our reference to older work time 
sources, and noted that their use led to the proposal of work RVUs 
based on flawed assumptions. Commenters stated that codes with ``CMS/
Other'' or ``Harvard'' work time sources, used in the original 
valuation of certain older services, were not surveyed, and therefore, 
were not resource-based. Commenters stated that it was invalid to draw 
comparisons between the current work times and work RVUs of these 
services to the newly surveyed work time and work RVUs as recommended 
by the RUC.
    Response: In this final rule we have stated the specific time ratio 
methodology used to determine the CMS proposed work RVU for each of the 
codes in this family where it was not explicitly stated.
    We disagree with the commenters and continue to believe that the 
use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We have responded to concerns about our 
methodology earlier in this section. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80273 through 80274).
    We agree that it is important to use the recent data available 
regarding work times, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. We 
have responded to concerns about our methodology earlier in this 
section. For additional information regarding the use of old work time 
values that were established many years ago and have not since been 
reviewed in our methodology, we refer readers to our discussion of the 
subject in the Methodology for Establishing Work RVUs section of this 
rule (section II.N.2. of this final rule), as well as a longer 
discussion in the CY 2017 PFS final rule (81 FR 80273 through 80274). 
Based on the aforementioned crosswalks, brackets, or references for 
these codes, which continue to believe the proposed values better 
maintains the relative intensity of the codes in the family, and better 
preserves relativity with the rest of the codes on the PFS.
    Comment: A commenter noted that CMS did not state the current times 
for CPT code 64425. Several commenters disagreed with the proposed work 
RVUs for CPT Codes 64400, 64408, 64425, and 64430). Commenters stated 
that CMS should instead finalize the RUC-recommended work RVUs for 
these procedures. Commenters disagreed with our reference to the older 
work time sources, and suggested that the use of those sources led to 
the proposal of work RVUs based on flawed assumptions. Commenters 
stated that codes with ``CMS/Other'' or ``Harvard'' work time sources, 
used in the original valuation of certain older services, in this case, 
were not surveyed, and therefore, were not resource-based. Commenters 
noted that it was invalid to draw comparisons between the current work 
times and work RVUs of these services to the newly surveyed work time 
and work RVUs as recommended by the RUC for the services.
    Response: We have included the times for CPT code 64425 in the 
discussion above on this code in this final rule, to note that this 
code has 11 minutes of intraservice time and 25 minutes of total time. 
We appreciate the commenters' concerns regarding our reference to older 
work time sources and their use in the code valuation process for 
establishing work RVUs for these services. We agree that it is 
important to use the recent data available regarding work times, and we 
recognize that when many years have passed since time was last 
measured, significant discrepancies can occur. However, we also believe 
that our operating assumption regarding the validity of the existing 
values as a point of comparison is critical to the integrity of the 
relative value system as currently constructed. We have responded to 
concerns about our methodology earlier in this section. For additional 
information regarding the use of old work time values that were 
established many years ago and have not since been reviewed in our 
methodology, we refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this rule (section 
II.N.2. of this final rule), as well as a longer discussion in the CY 
2017 PFS final rule (81 FR 80273 through 80274). Based on the 
aforementioned crosswalks, brackets, or references for these codes, 
which continue to believe the proposed values better maintains the 
relative intensity of the codes in the family, and better preserves 
relativity with the rest of the codes on the PFS.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT codes 64415, 64416, 64446, 64448, and 64449. Commenters stated 
that CMS should instead finalize the RUC-recommended work RVUs for 
these procedures.
    Several commenters disagreed with the use of time ratio 
methodologies for work valuation of these services. Commenters stated 
that this use of time ratios is not a valid methodology for

[[Page 62749]]

valuation of physician services. Commenters stated that treating all 
components of physician time (preservice, intraservice, postservice and 
post-operative visits) as having identical intensity is incorrect, and 
inconsistently applying it to only certain services under review 
creates inherent payment disparities in a payment system which is based 
on relative valuation. Commenters suggested that in many scenarios, CMS 
selects an arbitrary combination of inputs to apply rather than seeking 
a valid clinically relevant relationship that would preserve 
relativity. Commenters urged CMS to determine the work valuation for 
each code based not only on surveyed work times, but also the intensity 
and complexity of the service and relativity to other similar services, 
rather than basing the work value entirely on time.
    Response: We disagree with the commenters that the use of time 
ratios is not a valid valuation methodology, and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We have responded to concerns about our 
methodology earlier in this section. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80273 through 80274). Based on the aforementioned 
crosswalks, brackets, or references for these codes, which continue to 
believe the proposed values better maintains the relative intensity of 
the codes in the family, and better preserves relativity with the rest 
of the codes on the PFS.
    Comment: Several commenters disagreed with the proposed work RVU of 
1.00 for CPT code 64445. Commenters stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.10 for this procedure. A 
commenter stated that the CMS proposed value of 1.00 seemingly was 
selected using a method with no precedent.
    Response: We disagree with the commenter's suggestion that the CMS-
proposed value was selected using an unprecedented method. As stated in 
the CY 2020 PFS proposed rule (84 FR 40582), the proposed work RVU was 
selected to maintain rank order among comparable codes in the family. 
The proposed work RVU was further supported by a bracket to CPT codes 
12001 and 30901. 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). For additional information 
on our methodology, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80273 through 80274). Based on the 
aforementioned brackets, which continue to believe the proposed value 
better maintains the relative intensity of the codes in the family, and 
better preserves relativity with the rest of the codes on the PFS.
    Comment: A few commenters disagreed with the proposed direct PE 
refinements to refine the clinical labor time for the ``provide 
education/obtain consent'' (CA011) from 3 minutes to 2 minutes, for CPT 
codes 64400, 64408, 64415, 64417, 64420, 64425, 64430, 64435, 64445, 
64447 and 64450, to conform to the standard for this clinical labor 
task. The also disagreed with the proposal to refine the equipment time 
in accordance with our standard equipment time formula for these codes. 
Commenters stated that the RUC does not have a standard time for this 
task. This time is required because of the potential complications 
associated with injections and the need to review aftercare 
instructions.
    Response: We disagree with the commenters that 3 minutes would be 
typically needed for the clinical staff to provide education and obtain 
consent in these procedures. We have typically assigned 2 minutes for 
this clinical labor activity unless we had a specific rationale for a 
higher amount of clinical labor time, and we continue to believe that 
this standard amount of clinical labor time would be the most accurate 
value for CPT codes 64400, 64408, 64415, 64417, 64420, 64425, 64430, 
64435, 64445, 64447 and 64450. Furthermore, we note that these codes 
have 2 minutes of ``Review home care instructions, coordinate visits/
prescriptions'' (CA035).
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Somatic Nerve 
Injection family as proposed.
(26) Genicular Injection and RFA (CPT Codes 64640, 64454, and 64624)
    In May 2018, the CPT Editorial Panel approved the addition of two 
codes to report injection of anesthetic and destruction of genicular 
nerves by neurolytic agent. In October 2018, the RUC discussed issues 
surrounding the survey of this family of services and supported the 
specialty societies' request for CPT codes 64640 (Destruction by 
neurolytic agent; other peripheral nerve or branch), 64454 
(Injection(s), anesthetic agent(s) and/or steroid; genicular nerve 
branches including imaging guidance, when performed), and 64624 
(Destruction by neurolytic agent genicular nerve branches including 
imaging guidance, when performed) to be resurveyed and presented at the 
January 2019 RUC meeting, based on their concern that many survey 
respondents appeared to be confused about the number of nerve branch 
injections involved with these three codes. The RUC resurveyed these 
services at the January 2019 RUC meeting.
    For CY 2020, we proposed the RUC-recommended work RVUs for two of 
the three codes in this family. We proposed the RUC-recommended work 
RVU of 1.98 (25th percentile survey value) for CPT code 64640 and the 
RUC-recommended work RVU of 1.52 (25th percentile survey value) for CPT 
code of 64454.
    For CPT code 64624, we disagreed with the RUC-recommended work RVU 
of 2.62, which is higher than the 25th percentile survey value, a work 
RVU 2.50, and proposed a work RVU of 2.50 (25th percentile survey 
value) based on a reference to CPT code 11622 (Excision, malignant 
lesion including margins, trunk, arms, or legs; excised diameter 1.1 to 
2.0 cm), which has a work RVU of 2.41 and near identical intraservice 
and total times to CPT code 64624.
    In our review of CPT code 64624, we examined the intraservice time 
ratio for the new code, CPT code 64624, in relation to an existing code 
in this family of services, CPT code 64640. CPT code 64624 has a RUC-
recommended work RVU of 2.62, 25 minutes of intraservice time, and 74 
minutes of total time. CPT code 64640 has a RUC-recommended work RVU of 
1.98, 20 minutes of intraservice time, and 64 minutes of total time. To 
derive our proposed work RVU of 2.50, we calculated the intraservice 
time ratio

[[Page 62750]]

between these two codes, which is a calculated value of 1.25, and 
applied this ratio times the RUC-recommended work RVU of 1.98 for CPT 
code 64650, which resulted in a calculated value of 2.48. This value is 
nearly identical to the January 2018 RUC 25th percentile survey value 
for CPT code 64624, a work RVU of 2.50. Our proposed work RVU of 2.50 
is further supported by a reference to CPT code 11622.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Confirm availability of prior images/studies'' (CA006) 
activity for CPT code 64640. This code does not currently include this 
clinical labor time, and unlike the new code in the family (CPT code 
64624), CPT code 64640 does not include imaging guidance in its code 
descriptor. When CPT code 64640 is performed with imaging guidance, it 
would be billed together with a separate imaging code that already 
includes clinical labor time for confirming the availability of prior 
images. As a result, it would be duplicative to include this clinical 
labor time in CPT code 64640. We proposed to refine the clinical labor 
time for the ``Assist physician or other qualified healthcare 
professional--directly related to physician work time (100 percent)'' 
(CA018) activity from 25 to 20 minutes for CPT code 64640, to match the 
intraservice work time. We are also proposed to refine the equipment 
times in accordance with our standard equipment time formulas for CPT 
code 64640.
    We proposed the RUC-recommended direct PE inputs for CPT code 64454 
without refinement.
    For CPT code 64624, we proposed to refine the quantity of the 
``cannula (radiofrequency denervation) (SMK-C10)'' (SD011) supply from 
3 to 1. We did not believe that the use of 3 of this supply item would 
be typical for the procedure. We noted that the RUC recommendations for 
another code in this family, CPT code 64640 only contains 1 of this 
supply item. We believed that the nerves would typically be ablated one 
at a time using this cannula, as opposed to ablating three of them 
simultaneously as suggested in the recommended direct PE inputs. We 
also searched in the RUC database for other CPT codes that made use of 
the SD011 supply, and out of the seven codes that currently use this 
item, none of them include more than 2 cannula. As a result, we 
proposed to refine the supply quantity to 2 cannula to match the 
highest amount contained in an existing code on the PFS. We proposed to 
refine the equipment time for the ``radiofrequency kit for destruction 
by neurolytic agent'' (EQ354) equipment from 141 minutes to 47 minutes. 
The equipment time recommendation was predicated on the use of 3 of the 
SD011 supplies for 47 minutes apiece, and we proposed to refine the 
equipment time to reflect our supply refinement to 1 cannula. It was 
unclear in the RUC recommendation materials as to whether the 
radiofrequency kit equipment was in use simultaneously or sequentially 
along with the cannula supplies, and therefore, we are soliciting 
comments on the typical use of this equipment.
    We received public comments on the proposed valuation of the codes 
in the Genicular Injection and RFA family. The following is a summary 
of the comments we received and our responses.
    Comment: A commenter stated that for both of the new codes, CPT 
codes 64454 and 64624, they were concerned that CMS proposed to reduce 
values recommended by the CPT Relative Value Scale Update Committee 
(RUC) based primarily upon a comparison to CPT code 64640.
    Response: We note that we proposed a different work RVU for one of 
the two new codes in this family, not both, as noted by the commenter. 
We proposed a work RVU of 2.50 for CPT code 64454, based upon an 
intraservice time ratio between that code and CPT code 64640. We 
proposed the RUC-recommended work RVU of 1.52 for CPT code 64454.
    Comment: A commenter stated that they supported our proposal of the 
RUC-recommended work RVUs for the CPT codes 64640 and 64454, two of the 
three codes in this family.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 2.50 for CPT code 64624 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 2.62. A commenter stated that 
CPT code 64624 describes the destruction of three different nerve 
branches at three locations to provide analgesia for the respective 
knee and should not be crosswalked to CPT code 11642 (Excision, 
malignant lesion including margins, face, ears, eyelids, nose, lips; 
excised diameter 1.1 to 2.0 cm) which describes excision of a malignant 
lesion. This commenter further noted that the RUC direct crosswalk, CPT 
code 11642 requires the same time as CMS' proposed crosswalk code 
11622. However, CPT code 11622 requires less physician work because it 
is an excision on the trunk, arms or legs, whereas CPT code 11642 is an 
excision on the face, ears, eyelids, nose, lips, which is a more 
delicate area in which precision is required and it is more intense and 
complex to complete. CPT code 64624 likewise is more intense, complex 
and requires precision to avoid irreversible damage.
    Response: We note that the commenter stated the RUC's crosswalk in 
reference to what code CPT code 64424 should not be crosswalked to, 
perhaps the commenter meant to note the CMS reference code, CPT code 
11622. We agree with the commenter that CPT code 64624 should not be 
crosswalked to CPT code 11622, which is why we proposed this code as a 
reference, and not a direct crosswalk. Furthermore, we disagree that 
RUC crosswalk, CPT code 11642, requires the same times as CMS' proposed 
crosswalk, 11622.
    We disagree with the commenters that there is a meaningful 
difference in intensity between CPT reference code, CPT code 11622 and 
RUC's crosswalk CPT 11642. These two codes share the identical work 
times, the same intraservice time of 30 minutes and same total time, 68 
minutes. We continue to believe that it was more accurate to propose a 
work RVU of 2.50 for CPT code 64624, based on the reference to CPT code 
11622, further supported by the survey 25th percentile value, a work 
RVU of 2.50. We believe the proposed value better maintains the 
relative intensity of the two codes in the family, and better preserves 
relativity with the rest of the codes on the PFS.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the quantity of the ``cannula (radiofrequency denervation) (SMK-
C10)'' (SD011) supply from 3 to 1 for CPT code 64624. Commenters stated 
that, as with the sacroiliac joint code, CPT code 64624 does require 
simultaneous ablation of the three genicular nerves. Commenters further 
noted that this is standard practice, and therefore, was the way the 
survey respondents would have completed the survey.
    Response: We appreciate the additional information provided by the 
commenters regarding the SD011 cannula supply. We continue to have 
reservations as to whether three simultaneous ablations would be 
typical for this procedure; however, we are finalizing a supply 
quantity of 3 cannula (SD011) for CPT code 64624 as recommended by 
commenters.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the equipment time for the ``radiofrequency kit for destruction 
by neurolytic agent'' (EQ354) equipment from 141 minutes to 47 minutes. 
Commenters stated that three kits are

[[Page 62751]]

used for 47 minutes each totaling 141 minutes, as the 47 minutes (times 
3) occurs simultaneously. Commenters stated again that three cannulas 
and three kits are needed for the simultaneous ablation of three 
nerves.
    Response: Since we did not finalize our proposal to refine the 
quantity of the SD011 cannula supply from 3 to 1 for CPT code 64624, we 
are also not finalizing our refinement to the equipment time for EQ354. 
We will instead finalize the RUC-recommended equipment time of 141 
minutes for the radiofrequency kit (EQ354).
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Genicular Injection and RFA family as 
proposed. We are also finalizing the RUC-recommended direct PE inputs 
for the codes in this family, with the exception of finalizing a supply 
quantity of 3 of SD011 and 141 minutes for EQ354 for CPT code 64624, as 
recommended by commenters.
(27) Cyclophotocoagulation (CPT Codes 66711, 66982, 66983, 66984, 
66987, and 66988)
    In October 2017, CPT codes 66711 (Ciliary body destruction; 
cyclophotocoagulation, endoscopic) and 66984 (Extracapsular cataract 
removal with insertion of intraocular lens prosthesis (1 stage 
procedure), manual or mechanical technique (e.g., irrigation and 
aspiration or phacoemulsification) were identified as codes reported 
together 75 percent of the time or more. The RUC reviewed action plans 
to determine whether a code bundle solution should be developed for 
these services. In January 2018, the RUC recommended to refer to CPT to 
bundle 66711 with 66984 for CPT 2020. In May 2018, the CPT Editorial 
Panel revised three codes and created two new codes, CPT codes 66987 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; with endoscopic cyclophotocoagulation) 
and 66988 (Extracapsular cataract removal with insertion of intraocular 
lens prosthesis (1 stage procedure), manual or mechanical technique 
(e.g., irrigation and aspiration or phacoemulsification); with 
endoscopic cyclophotocoagulation) to differentiate cataract procedures 
performed with and without endoscopic cyclophotocoagulation.
    The codes discussed above and CPT codes 66982 (Extracapsular 
cataract removal with insertion of intraocular lens prosthesis (1-stage 
procedure), manual or mechanical technique (e.g., irrigation and 
aspiration or phacoemulsification), complex, requiring devices or 
techniques not generally used in routine cataract surgery (e.g., iris 
expansion device, suture support for intraocular lens, or primary 
posterior capsulorrhexis) or performed on patients in the amblyogenic 
developmental stage) and 66983 (Intracapsular cataract extraction with 
insertion of intraocular lens prosthesis (1 stage procedure)) were 
reviewed at the January 2019 RUC meeting.
    For CY 2020, we proposed the RUC-recommended work RVU of 10.25 for 
CPT code 66982, the RUC recommendation to contractor-price CPT code 
66983, and the RUC-recommended work RVU of 7.35 for CPT code 66984. We 
disagreed with the RUC recommendations for CPT codes 66711, 66987, and 
66988.
    For CPT code 66711, we disagreed with the RUC-recommended work RVU 
of 6.36 and proposed a work RVU of 5.62, based on crosswalk to CPT code 
28285 (Correction, hammertoe (e.g., interphalangeal fusion, partial or 
total phalangectomy), which has an identical work RVU of 5.62, and 
similar intraservice and total times.
    In our review of CPT code 66711, we noted that the recommended 
intraservice time is decreasing from 20 minutes to 10 minutes (33 
percent reduction), and that the recommended total time is decreasing 
from 192 minutes to 191 minutes (0.5 percent reduction). While the RUC-
recommended work RVU is decreasing from 7.93 to 6.36, which is a 20 
percent reduction, we do not believe it appropriately accounts for the 
decreases in survey time. Time ratio methodology suggest that CPT code 
66711 is better valued at a work RVU of 5.29, thus it is overvalued 
with consideration to the decreases in survey times. Although we did 
not imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we 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 66711, we 
believed that it would be more accurate to propose a work RVU of 5.62, 
based on our time ratio methodology and a crosswalk to CPT code 28285 
to account for these decreases in surveyed work times.
    For CPT code 66987, the RUC recommended a work RVU of 13.15, we 
disagreed with the RUC-recommended work RVU and proposed contractor-
pricing for this code. In reviewing this code, we noted that the RUC 
recommendation survey values did not support the RUC-recommended work 
RVU of 13.15 and furthermore, the RUC recommendations did not include a 
crosswalk to support the RUC-recommended work RVU. The RUC 
recommendations noted a lack of potential crosswalk codes due to the 
complete lack of similarly intense major surgical procedures comparable 
in the amount of skin-to-skin time, operating room time and amount of 
post-operative care. We note that the RUC-recommended work RVU of 13.15 
is higher than similarly timed codes on the PFS. Given that lack of 
both survey data and a crosswalk to support the RUC-recommended work 
RVU for this new code, and that the RUC-recommended work RVU of 13.15 
is higher than similarly timed codes on the PFS, we believed it is was 
appropriate to propose contractor-pricing for CPT code 66987. We also 
noted that the RUC recommended contractor-pricing for another code in 
this family, CPT code 66983, which we proposed to contractor-price for 
CY 2020.
    For CPT code 66988, the RUC recommended a work RVU of 10.25, we 
disagreed with the RUC-recommended work RVU and proposed contractor-
pricing for this code. In reviewing this code, we noted that the RUC 
recommendation survey values do not support the RUC-recommended work 
RVU of 10.25. Furthermore, we were concerned with the RUC recommended 
crosswalk, CPT code 67110 (Repair of retinal detachment; by injection 
of air or other gas (e.g., pneumatic retinopexy), which is the same 
crosswalk used to support the RUC-recommended work RVU of 10.25 for 
another code in this family, CPT code 66982. CPT code 67110 has 30 
minutes of intraservice time and 196 minutes of total time. Although 
CPT code 67110 has the identical intraservice time to CPT codes 66982 
and 66988, we note that CPT code 67110 has 196 minutes of total time, 
which is 21 minutes less than the 175 minutes of total time of CPT code 
66982, and 6 minutes less than the 202 minutes of total time of CPT 
Code 66988. However, the RUC is recommending the same work RVU of 10.25 
for CPT codes 66982 and 66988, supported by the same crosswalk to CPT 
code 67110.

[[Page 62752]]

    Given that lack of survey data and our concern for the RUC-
recommended crosswalk to support the RUC-recommended work RVU of 10.25 
for CPT code 66988, we believed it was appropriate to propose 
contractor-pricing for CPT code 66988. We also noted that the RUC 
recommended contractor-pricing for another code in this family, CPT 
code 66983, which we are prosed for CY 2020.
    We proposed to remove all the direct PE inputs for CPT codes 66987 
and 66988, given our proposal to contractor-price these codes. We 
proposed the RUC-recommended direct PE inputs for the other codes in 
this family.
    We received public comments on the proposed valuation of the codes 
in the Cyclophotocoagulation family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter noted that for CPT code 66711, the intra-
service time is decreasing from 30 minutes to 20 minutes, not 20 
minutes to 10 minutes, as stated by CMS in the proposed rule.
    Response: We apologize for the typo and in this final rule 
corrected the intraservice time value for CPT code 66711 in the 
discussion above on this code, to reflect a decrease in intraservice 
time from 30 minutes to 20 minutes.
    Comment: Several commenters stated support for our proposal of the 
RUC-recommended work RVU for CPT code 66982, the RUC recommendation to 
contractor-price CPT code 66983, and the RUC-recommended work RVU for 
CPT code 66984.
    Comment: Several commenters stated support for our proposal of the 
RUC-recommended work RVU for CPT code 66982, the RUC recommendation to 
contractor-price CPT code 66983, and the RUC-recommended work RVU for 
CPT code 66984.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Several commenters disagreed with the use of time ratio 
methodologies for work valuation for CPT code 66711. Commenters stated 
that this use of time ratios is not a valid methodology for valuation 
of physician services. Commenters stated that treating all components 
of physician time (preservice, intraservice, postservice and post-
operative visits) as having identical intensity is incorrect, and 
inconsistently applying it to only certain services under review 
creates inherent payment disparities in a payment system which is based 
on relative valuation. Commenters stated that in many scenarios, CMS 
selects an arbitrary combination of inputs to apply rather than seeking 
a valid clinically relevant relationship that would preserve 
relativity. Commenters urged CMS to determine the work valuation for 
the each code based not only on surveyed work times, but also the 
intensity and complexity of the service and relativity to other similar 
services, rather than basing the work value entirely on time.
    Response: We appreciate the commenters' concerns regarding CMS' use 
of time ratio methodologies in the code valuation process for 
establishing work RVUs. We have responded to concerns about our 
methodology earlier in this section of this final rule. For additional 
information regarding the use of use of time ratios in our methodology, 
we refer readers to our discussion of the subject in the Methodology 
for Establishing Work RVUs section of this rule (section II.N.2), as 
well as a longer discussion in the CY 2017 PFS final rule (81 FR 80273 
through 80274).
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 5.62 for CPT code 66711 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 6.36. Commenters stated that 
although CPT code 66711 has a similar total time value to the CMS 
crosswalk CPT code 28285, CPT code 66711 requires more physician work 
and is much more intense, and complex working in the eye than on a toe. 
Correction of hammertoe as described by CPT code 28285, is a low-risk 
procedure on a small appendage, while CPT 66711, endoscopic ciliary 
photoablation (ECP) is a high-risk procedure on a diseased eye with 
risk of loss of vision.
    It was noted in the RUC's comment letter that they expressed 
difficulty in finding a valid crosswalk to recommend the appropriate 
work RVU for CPT code 66711. The RUC further noted that they conducted 
a thorough search of all other potential crosswalk codes and ran into a 
lack of potential crosswalk codes due to the lack of similarly intense 
major surgical procedures with a comparable amount of skin-to-skin 
time, OR time and amount of post-operative care. They noted that the 
most appropriate crosswalk for CPT 66711 is CPT code 67210 Destruction 
of localized lesion of retina (e.g., macular edema, tumors), 1 or more 
sessions; photocoagulation (work RVU = 6.36 and 15 minutes intra-
service time). CPT code 66711 is more intense and complex to perform 
than 67210 on all measures examined (mental effort/judgment, technical 
skill/physical effort and psychological stress); both codes use laser 
ablation of tissue making it the most clinically relatable service for 
comparison.
    Response: We disagree with the commenters that there is a 
meaningful difference in intensity between CPT code 66711 and the CMS 
crosswalk CPT code 28285. These two codes share an identical 
intraservice time of 30 minutes and differ by only 2 minutes of total 
time, 192 minutes for CPT code 66711, compared to 190 minutes for CPT 
code 28285. Given the minimal difference in intensity between these two 
codes, it would be difficult for two procedures to match more closely 
on intensity (which is itself a derived number not measured directly) 
without sharing the same work times. Like CPT code 66711, the CMS 
crosswalk, CPT code 28285, is a significant 090-day global procedure 
that requires 30 minutes of intraservice work time. We continue to 
believe that it is more accurate to propose a work RVU of 5.62 for CPT 
code 66711, based on the aforementioned crosswalk to CPT code 28285, 
which we believe better preserves relativity with the rest of the codes 
on the PFS. Furthermore, the CMS crosswalk code (CPT code 28285) was 
found after a thorough search of valid crosswalks to recommend the 
appropriate work RVU for CPT code 66711, which we reiterate is 
significant 090-day global procedure that requires 30 minutes of 
intraservice work time, the same as CPT code 66711.
    Comment: Several commenters disagreed with the CMS proposal to 
contractor-price CPT code 66987 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 13.15. Several commenters 
stated that contractor-pricing would be burdensome. One commenter noted 
that contractor-pricing would be burdensome because CPT code 66987 and 
CPT code 66987 (CMS proposed contractor-pricing) would be reported over 
7,000 times per year.
    Response: We thank commenters for their feedback. We note that the 
RUC-recommended contractor-pricing for another code in this family, CPT 
code 66983, and did not make a general or specific reference to burden 
related to contractor-pricing. Furthermore, we note that when services 
are furnished to a Medicare beneficiary, the provider files the 
Medicare claim with the contractor that has jurisdiction over the 
claims furnished by the provider. We are not persuaded by commenter's 
assertion that contractor-pricing for CPT code 66987 would lead to an 
increase in burden.
    Comment: The RUC's comment letter noted that they had challenges of 
surveying these intense 090-day global services with short intra-
service time due a lack of similar reference services. One commenter 
stated that CMS recommend contractor-pricing for CPT code 66987, 
despite survey data that

[[Page 62753]]

supports the RUC-recommended value for this code.
    Response: As stated in the proposed rule, the RUC-recommended work 
RVU of 13.50, lacked support from survey data and a crosswalk to 
support the value. Furthermore, the RUC-recommended a work RVU of 
13.50, but the survey 25 percentile value was 13.50, and the RUC-
recommended work RVU is higher than similarly timed codes on the PFS. 
Therefore, we believe it is more appropriate to contractor-price this 
code until more data can be collected, for consideration in future 
rulemaking.
    Comment: Several commenters disagreed with the CMS proposal to 
contractor-price CPT code 66988 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 10.25. Several commenters 
stated that contractor-pricing would be burdensome. One commenter noted 
that contractor-pricing would be burdensome because CPT code 66988 and 
CPT code 66987 (CMS proposed contractor-pricing) would be reported over 
7,000 times per year.
    Response: We thank commenters for their feedback. We note that the 
RUC-recommended carrier-pricing for another code in this family, CPT 
code 66983, and did not make general or specific reference to burden 
related to contractor-pricing. Furthermore, we note that when services 
are furnished to a Medicare beneficiary, the provider files the 
Medicare claim with the contractor that has jurisdiction over the 
claims furnished by the provider. We are not persuaded by the 
commenter's discussion that contractor-pricing for CPT code 66988 would 
lead to an increase in burden.
    Comment: One commenter stated that CMS recommended contractor-
pricing for CPT code 66988, despite survey data that supports the RUC-
recommended value for this code.
    Response: As stated in the proposed rule, the RUC-recommended work 
RVU of 10.25, lacked support from survey data and a crosswalk to 
support the value. Furthermore, the RUC-recommended a work RVU of 10.25 
but the survey 25 percentile value was 11.08. Furthermore, CMS noted 
concerns with the RUC's crosswalk (CPT code 67710) to support their 
work RVU for this code. To reiterate, although CPT code 67110 has the 
identical intraservice time to CPT codes 66982 and 66988, we note that 
CPT code 67110 has 196 minutes of total time, which is 21 minutes less 
than the 175 minutes of total time of CPT code 66982, and 6 minutes 
less than the 202 minutes of total time of CPT Code 66988. However, the 
RUC is recommended the same work RVU of 10.25 for CPT codes 66982 and 
66988, supported by the same crosswalk to CPT code 67110, which we 
found concerning. Therefore, we believe it is more appropriate to 
contractor-price this code until more data can be collected, for 
consideration in future rulemaking.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the 
Cyclophotocoagulation family as proposed.
(28) X-Ray Exam--Sinuses (CPT Codes 70210 and 70220)
    CPT code 70210 (Radiologic examination, sinuses, paranasal, less 
than 3 views) and CPT code 70220 (Radiologic examination, sinuses, 
paranasal, complete, minimum of 3 views) were identified as potentially 
misvalued through a screen for Medicare services with utilization of 
30,000 or more annually. These two codes were first reviewed by the RUC 
in April 2018, but were subsequently surveyed by the specialty 
societies and reviewed again by the RUC in January 2019.
    For CPT code 70210, we disagreed with the RUC-recommended work RVU 
of 0.20, and proposed to maintain the current work RVU of 0.17 
supported by a bracket of CPT code 73501 (Radiologic examination, hip, 
unilateral, with pelvis when performed; 1 view), which has a work RVU 
of 0.18, and CPT code 73560 (Radiologic examination, knee; 1 or 2 
views), which has a work RVU of 0.16.
    The RUC's recommendation is consistent with 25th percentile of 
survey results and is based on a comparison of the survey code with the 
two key reference services. The first key reference service, CPT code 
71046 (Radiologic examination, chest; 2 views), has a work RVU of 0.22, 
4 minutes of intraservice time, and 6 minutes of total time. The RUC 
noted that the survey code has 1 minute less intraservice and total 
time compared with the first key reference service (CPT code 71046), 
which accounts for the slightly lower work RVU for the survey code. The 
RUC also compared CPT code 70210 to CPT code 70355 (Orthopantogram 
(e.g., panoramic X-ray)), with a work RVU of 0.20, 5 minutes of 
intraservice time, and 6 minutes of total time. Although the 
intraservice and total times are lower for CPT code 70210 than for CPT 
code 70355, the work is slightly more intense for the survey code, 
according to the RUC, justifying an identical work RVU of 0.20 for CPT 
code 70210. We disagreed with the RUC's recommendation to increase the 
work RVU for CPT code 70210 from the current value (0.17) to 0.20 for 
two main reasons. First, the total time (5 minutes) for this code has 
not changed from the current total time and without a corresponding 
explanation for an increase in valuation despite maintaining the same 
total time, we were not convinced that the work RVU for this code 
should increase. In addition, we noted that based on a general 
comparison of CPT codes with identical intraservice time and total time 
(approximately 23 comparison codes, excluding those currently under 
review), a work RVU of 0.20 would establish a new upper threshold among 
this cohort. Therefore, we proposed to maintain the work RVU of 0.17 
for CPT code 70210.
    For CPT code 70220, we proposed the RUC-recommended work RVU of 
0.22.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the X-Ray Exam--Sinuses family. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters stated that they supported our proposal 
for the direct PE inputs for the codes in this family and our proposal 
for the RUC-recommended work RVU for CPT code 70220.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT code 70210. Commenters stated that CMS should instead finalize 
the RUC-recommended work RVUs for this procedure. A commenter stated 
that the best ``corresponding explanation for an increase in valuation 
despite maintaining the same total time'' is that the current time and 
value have no validity for comparison since they are CMS/Other, and 
were assigned using an unknown methodology. In addition, although total 
times happen to match, CMS/Other times did not break out pre-service, 
intra-service, and post-service times which have different intensities. 
Therefore, the value recommendation is based on the survey, which is 
supported by the survey times, the comparison with other axial x-ray 
codes, and the survey times.
    Response: We appreciate the commenters' concerns regarding CMS' 
interpretation of older work time sources and their use in the code 
valuation process for establishing work RVUs for these services. We 
agree that it is important to use the recent data

[[Page 62754]]

available regarding work times, and we note that when many years have 
passed between when time is measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. We have responded to concerns about our methodology 
earlier in this section. For additional information regarding the use 
of old work time values that were established many years ago and have 
not since been reviewed in our methodology, we refer readers to our 
discussion of the subject in the Methodology for Establishing Work RVUs 
section of this rule (section II.N. of this final rule), as well as a 
longer discussion in the CY 2017 PFS final rule (81 FR 80273 through 
80274). Based on the aforementioned crosswalks, brackets, or references 
for these codes, which continue to believe the proposed values better 
maintains the relative intensity of the codes in the family, and better 
preserves relativity with the rest of the codes on the PFS.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the X-Ray Exam--Sinuses 
as proposed.
(29) X-Ray Exam--Skull (CPT Codes 70250 and 70260)
    CPT code 70250 (Radiologic examination, skull, less than 4 views) 
was identified as potentially misvalued through a screen of Medicare 
services with utilization of 30,000 or more annually. CPT code 70260 
(Radiologic examination, skull; complete, minimum of 4 views) was 
included as part of the same family. These two codes were first 
reviewed by the RUC in April 2018, but were subsequently surveyed by 
the specialty societies and reviewed by the RUC again in January 2019.
    For CPT code 70250 we disagreed with the RUC-recommended work RVU 
of 0.20 and proposed a work RVU of 0.18 supported by crosswalk to CPT 
code 73501 (Radiologic examination, hip, unilateral, with pelvis when 
performed; 1 view), which has a work RVU of 0.18, 3 minutes of 
intraservice time, and 5 minutes of total time,
    The RUC-recommended work RVU is bracketed by the top key reference 
service, CPT code 71046 (Radiologic examination, chest; 2 views) with 4 
minutes of intraservice time, 6 minutes total time, and a work RVU of 
0.22; and key reference service, CPT code 73562 (Radiologic 
examination, knee; 3 views), with intraservice time of 4 minutes, total 
time of 6 minutes, and a work RVU of 0.18. The RUC noted that while the 
survey code has less time than CPT code 71046, the work is slightly 
more intense due to anatomical and contextual complexity. The survey 
code is also more intense compared with the second key reference 
service, CPT code 73562, according to the RUC, because of the higher 
level of technical skill involved in an X-ray of the skull (axial 
skeleton) compared with an X-ray of the knee (appendicular skeleton). 
The RUC further indicated that a comparison between the survey code and 
CPT codes with a work RVU of 0.18 would not be appropriate given the 
higher level of complexity associated with an X-ray of the skull than 
with other CPT codes that have similar times. We disagreed with the 
RUC-recommended work RVU of 0.20 for CPT code 70250. We note that the 
total time for furnishing the service has decreased by 2 minutes while 
the description of the work involved in furnishing the service has not 
changed. This suggests that a value closer to the total time ratio 
(TTR) calculation (work RVU of 0.17) would be more appropriate. In 
addition, a search of CPT codes with 3 minutes of intraservice time and 
5 minutes of total time indicates that the maximum work RVU for codes 
with these times is 0.18, meaning that a work RVU of 0.20 would 
establish a new relative high work RVU for codes with these times. 
Therefore, we proposed a work RVU of 0.18 for CPT code 70250.
    We disagreed with the RUC recommended a work RVU of 0.29 for CPT 
code 70260 and proposed a work RVU of 0.28 based on an increment 
between this code and CPT code 70250. Moreover, since we proposed a 
lower work RVU for the base code for this family (work RVU of 0.18 for 
CPT code 70250), we believe a lower work RVU for CPT code 70260 is 
warranted. To identify an alternative value, we calculated the 
increment between the current work RVU for CPT code 72050 (work RVU of 
0.24) and the current work RVU for CPT code 72060 (work RVU of 0.34) 
and applied it to the CMS proposed work RVU for CPT code 70250 (0.18 + 
0.10) to calculate a proposed work RVU of 0.28.
    The survey times for furnishing the service are 4 minutes of 
intraservice time and 7 minutes total time, compared with the current 
intraservice time and total time of 7 minutes. However, in developing 
their recommendation, the RUC reduced the total time for this code from 
7 minutes to 6 minutes. Although the RUC's recommended work RVU 
reflects the 25th percentile of survey results, the survey 25th 
percentile is based on an additional minute of total time compared with 
the RUC's total time for this CPT code.
    We believe that applying this increment is a better reflection of 
the work time and intensity involved in furnishing CPT code 70260, and 
therefore, we proposed a work RVU of 0.28 for this service.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the X-Ray Exam--Skull family. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT codes 70250 and 70260. Commenters stated that CMS should 
instead finalize the RUC-recommended work RVUs for these procedures. 
Commenters disagreed with our reference to older work time sources, and 
noted that their use led to the proposal of work RVUs based on flawed 
assumptions. Commenters stated that codes with ``CMS/Other'' or 
``Harvard'' work time sources, used in the original valuation of 
certain older services, in this case, were not surveyed, and therefore, 
were not resource-based. Commenters noted that it was invalid to draw 
comparisons between the current work times and work RVUs of these 
services to the newly surveyed work time and work RVUs as recommended 
by the RUC for the services.
    Response: We appreciate the commenters' concerns regarding CMS' 
interpretation of older work time sources and their use in the code 
valuation process for establishing work RVUs for these services. We 
agree that it is important to use the recent data available regarding 
work times, and we note that when many years have passed between when 
time is measured, significant discrepancies can occur. However, we also 
believe that our operating assumption regarding the validity of the 
existing values as a point of comparison is critical to the integrity 
of the relative value system as currently constructed. We have 
responded to concerns about our methodology earlier in this section. 
For additional information regarding the use of old work time values 
that were established many years ago and have not since been reviewed 
in our methodology, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80273 through 80274). Based on the 
aforementioned crosswalks, brackets, or references for

[[Page 62755]]

these codes, which continue to believe the proposed values better 
maintains the relative intensity of the codes in the family, and better 
preserves relativity with the rest of the codes on the PFS.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU for CPT 70260. Commenters stated that CMS should instead finalize 
the RUC-recommended work RVU for this procedure. Commenters stated that 
the incremental methodology used in valuing these services was flawed; 
commenters did not agree that it was appropriate to reduce the work RVU 
for CPT code 72202 from the value proposed by the RUC, while also 
recalibrating the work relative to the RUC's recommended difference in 
work between this code and CPT code 72200. Commenters noted that it is 
imperative to employ RUC survey data to value these codes, and that 
using an incremental approach in lieu of survey data, strong 
crosswalks, and input from the practitioners providing these services 
was unjustified.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We have no evidence to suggest that the use 
of an incremental difference between codes conflicts with the statute's 
definition of the work component as the resources in time and intensity 
required in furnishing the service. For more details on our methodology 
for developing work RVUs, we refer readers to our discussion of the 
subject in the Methodology for Establishing Work RVUs section of this 
rule (section II.N.2. of this final rule), as well as a longer 
discussion in the CY 2017 PFS final rule (81 FR 80272 through 80277).
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the X-Ray Exam--Skull 
family as proposed.
(30) X-Ray Exam--Neck (CPT Code 70360)
    CPT code 70360 (Radiologic examination; neck, soft tissue) was 
identified as potentially misvalued through a screen of CPT codes with 
annual Medicare utilization of 30,000 or more. CPT code 70360 was first 
reviewed by the RUC in April 2018 but was subsequently surveyed by the 
specialty societies and reviewed by the RUC again in January 2019.
    For CPT code 70360 we disagreed with the RUC recommended work RVU 
of 0.20 and recommended a work RVU of 0.18, supported by a crosswalk to 
CPT code 73552 (Radiologic examination, femur; minimum 2 views), which 
has similar time values and work RVU of 0.18. To support their 
recommendation, the RUC cited the survey key reference service, CPT 
code 71046 (Radiologic examination, chest; 2 views), with a work RVU of 
0.22, 4 minutes of intraservice time, and 6 minutes of total time. They 
noted that the key reference code has 1 minute higher intraservice and 
total time, accounting for the slightly higher work RVU compared with 
the survey code, CPT code 70360. The RUC also cited the second highest 
key reference service, CPT code 73562 (Radiologic examination, knee; 3 
views) with a work RVU of 0.18, intraservice time of 4 minutes, and 
total time of 6 minutes. They noted that, while the survey code has 
lower intraservice time (3 minutes) and total time (5 minutes) compared 
with CPT code 73562, the survey code is more complex than the key 
reference service, thereby supporting a higher work RVU for the survey 
code (CPT code 70360) of 0.20. We do not agree with the RUC that the 
work RVU for CPT code 70360 should increase from 0.17 to 0.20. The 
total time for the CPT code, as recommended by the RUC (5 minutes), is 
unchanged from the existing total time. Without a corresponding 
discussion of why the current work RVU is insufficient, disagreed that 
there should be an increase in the work RVU. Furthermore, although the 
RUC's recommendation is consistent with the 25th percentile of survey 
results for the work RVU, the total time from the survey results was 6 
minutes, not the RUC-recommended time of 5 minutes. We looked at CPT 
codes with similar (incorrectly stated as identical in the CY 2020 PFS 
proposed rule) times to the survey code for a crosswalk, we identified 
CPT code 73552 (Radiologic examination, femur; minimum 2 views), which 
has a work RVU of 0.18. We believe this is a more appropriate valuation 
for CPT code 70360 and proposed a work RVU for this CPT code of 0.18.
    We proposed the RUC-recommended direct PE inputs for CPT code 
70360.
    We received public comments on the proposed valuation of the codes 
in the X-Ray Exam--Neck family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter noted that CMS' statement that they ``looked 
at CPT codes with identical times to the survey code for a crosswalk'' 
and identified 73552. However, the times for the two codes are not, in 
fact, identical. The intra-service time differs by a full minute which 
is a key component of a valid crosswalk.
    Response: We thank the commenter for bringing this to our 
attention. We apologize for the confusion and corrected this typo in 
this final rule to reflect that the times are similar.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT code 70360). Commenters stated that CMS should instead finalize 
the RUC-recommended work RVUs for this procedure. Commenters disagreed 
with our reference to older work time sources, and noted that their use 
led to the proposal of work RVUs based on flawed assumptions. 
Commenters stated that codes with ``CMS/Other'' or ``Harvard'' work 
time sources, used in the original valuation of certain older services, 
in this case, were not surveyed, and therefore, were not resource-
based. Commenters noted that it was invalid to draw comparisons between 
the current work times and work RVUs of these services to the newly 
surveyed work time and work RVUs as recommended by the RUC for the 
services.
    Response: We appreciate the commenters' concerns regarding CMS' 
interpretation of older work time sources and their use in the code 
valuation process for establishing work RVUs for these services. We 
agree that it is important to use the recent data available regarding 
work times, and we note that when many years have passed between when 
time is measured, significant discrepancies can occur. However, we also 
believe that our operating assumption regarding the validity of the 
existing values as a point of comparison is critical to the integrity 
of the relative value system as currently constructed. We have 
responded to concerns about our methodology earlier in this section. 
For additional information regarding the use of old work time values 
that were established many years ago and have not since been reviewed 
in our methodology, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80273 through 80274). Based on the 
aforementioned crosswalks, brackets, or references for these codes, 
which continue to believe

[[Page 62756]]

the proposed values better maintains the relative intensity of the 
codes in the family, and better preserves relativity with the rest of 
the codes on the PFS
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for the code in the X-Ray Exam--Neck 
family as proposed.
(31) X-Ray Exam--Spine (CPT Codes 72020, 72040, 72050, 72052, 72070, 
72072, 72074, 72080, 72100, 72110, 72114, and 72120)
    CPT codes 72020 (Radiologic examination spine, single view, specify 
level) and 72072 (Radiologic examination, spine; thoracic, 3 views) 
were identified through a screen of CMS/Other Source codes with 
Medicare utilization greater than 100,000 services annually. The code 
family was expanded to include 10 additional CPT codes to be reviewed 
together as a group: CPT code 72040 (Radiologic examination, spine, 
cervical; 2 or 3 views), CPT code 72050 (Radiologic examination, spine, 
cervical; 4 or 5 views), CPT code 72052 (Radiologic examination, spine 
cervical; 6 or more views), CPT code 72070 (Radiologic examination 
spine; thoracic, 2 views), CPT code 72074 (Radiologic examination, 
spine; thoracic, minimum of 4 views), CPT code 72080 (Radiologic 
examination, spine; thoracolumbar junction, minimum of 2 views), CPT 
code 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views), 
CPT code 72110 (Radiologic examination, spine, lumbosacral; minimum of 
4 views), CPT code 72114 (Radiologic examination, spine, lumbosacral; 
complete, including bending views, minimum of 6 views), and CPT code 
72120 (Radiologic examination, spine, lumbosacral; bending views only, 
2 or 3 views). This family of CPT codes was originally valued by the 
specialty societies using a crosswalk methodology approved by the RUC 
Research Subcommittee. However, after we expressed concern about the 
use of this approach for valuing work and PE, the specialty society 
agreed to survey these codes and the RUC reviewed them again in January 
2019.
    For the majority of CPT codes in this family, the RUC recommended a 
work RVU that is slightly different (higher or lower) than the current 
work RVU. Three CPT codes in this family are maintaining the current 
work RVU. We proposed the RUC-recommended work RVU for all 12 CPT codes 
in this family as follows: A work RVU of 0.16 for CPT code 72020, a 
work RVU of 0.22 for CPT code 72040, a work RVU of 0.27 for CPT code 
72050, a work RVU of 0.30 for CPT code 72052, a work RVU of 0.20 for 
CPT code 72070, a work RVU of 0.23 for CPT code 72072, a work RVU of 
0.25 for CPT code 72074, a work RVU of 0.21 for CPT 72080, a work RVU 
of 0.22 for CPT code 72100, a work RVU of 0.26 for CPT code 72110, a 
work RVU of 0.30 for CPT code 72114, and a work RVU of 0.22 for CPT 
code 72120.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the X-Ray Exam--Spine family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the codes in this family.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the X-Ray Exam--Spine 
family as proposed.
(32) CT-Orbit-Ear-Fossa (CPT Codes 70480, 70481, and 70482)
    In October 2017, the RAW requested that AMA staff develop a list of 
CMS/Other codes with Medicare utilization of 30,000 or more. CPT code 
70480 (Computed tomography (CT), orbit, sella, or posterior fossa or 
outer, middle, or inner ear; without contrast material) was identified. 
In addition, the code family was expanded to include two related CT 
codes, CPT code 70481 (Computed tomography, orbit, sella, or posterior 
fossa or outer, middle, or inner ear; with contrast material) and CPT 
code 70482 (Computed tomography, orbit, sella, or posterior fossa or 
outer, middle, or inner ear; without contrast material followed by 
contrast material(s) and further sections). In 2018, the RUC 
recommended this code family be surveyed.
    For CPT code 70840, we disagreed with the RUC-recommended work RVU 
of 1.28 and proposed instead a work RVU of 1.13. We proposed a lower 
work RVU because 1.13 represents the commensurate 12 percent decrease 
in work time reflected in survey values. We referenced the work RVUs of 
CPT codes 72128 (Computed tomography, chest, spine; without dye) and 
71250 (Computed tomography, thorax without dye) both of which have the 
same intraservice time (that is, 15 minutes) as CPT code 70840 but 
longer total times (that is, 25 minutes versus 22 minutes). We believe 
that CPT code 72128 with a work RVU of 1.0 and CPT code 71250 with a 
work RVU of 1.16 more accurately reflect the relative work values of 
CPT code 70840.
    We also disagreed with the RUC-recommended work RVU of 1.13 for CPT 
code 70481. Instead, we proposed a work RVU of 1.06 for CPT code 70481. 
As with CPT code 70840, we proposed a lower work RVU for CPT code 70481 
because a work RVU of 1.06 is commensurate with the 23 percent decrease 
in surveyed total time from 26 to 20 minutes. We believe CPT code 76641 
(Ultrasound, breast, unilateral) with a work RVU of 0.73 and CPT code 
70460 (Computed Tomography, head or brain, without contrast) with a 
work RVU of 1.13 serve as appropriate references for our proposed work 
RVU for CPT code 70841. Although CPT codes 76641 and 70460 have longer 
total times at 22 minutes and lower intraservice times at 12 minutes, 
we believe they better reflect the relative work value of CPT code 
70481 with a proposed work RVU of 1.06, total time of 20 minutes, and 
intraservice time of 13 minutes.
    For the third code in the family, CPT code 70482, we proposed the 
RUC-recommended work RVU of 1.27.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the CT-Orbit-Ear-Fossa family. The following is a summary of the 
comments we received and our responses.
    Comment: Commenters expressed support for our proposal to accept 
the RUC-recommended work RVU for CPT code 70482. However, they 
disagreed with our proposal to lower the work RVUs commensurate with 
decreases in time for CPT codes 70480 and 70481. Commenters uniformly 
requested that we reconsider the work RVUs because the work associated 
with the CPT code 70482 is more anatomically complex than the code we 
proposed as reference. Additionally, commenters indicated that this 
particular family of CT codes does not reflect the typical step-up in 
time and work as is the case for most radiology code families. 
Commenters noted too that the RUC-recommended values fell at the survey 
25th percentile or below as is typical of work valuations.
    Response: We thank the commenters for their insights into the 
services associated with CPT codes 70480, 70481, and 70482. We were 
persuaded by their comments and will finalize the three codes with the 
RUC-recommended work RVUs.
    Comment: Commenters disagreed with the proposal of the RUC-
recommended direct PE inputs for CPT

[[Page 62757]]

codes 70480-70482, which would lower CT equipment time by approximately 
one-third. The commenters stated that based on their experience in 
actual imaging center practice CT equipment time should be based on the 
actual, total CT technologist time, rather than the RUC-recommended PE 
inputs that are not supported by standard operating procedures. 
Commenters stated that that once the patient is greeted and gowned, he/
she will be escorted into the CT room where the technologist will 
perform the other procedure-related activities such as confirming the 
exam to be performed against the order, determining the correct exam 
protocol, etc.
    Response: We disagree with the commenters that the RUC-recommended 
and CMS proposed CT equipment times for the codes in this family are 
inaccurate. We continue to 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 and are typically available for other 
patients even when one member of clinical staff may be occupied with a 
preservice or postservice task related to the procedure. For a more 
detailed description of this topic, we refer readers to the CY 2015 PFS 
final rule with comment period (79 FR 67639 through 67640).
    After consideration of the public comments, we are finalizing the 
RUC-recommended values for all three codes in the CT-Orbit-Ear-Fossa 
family: CPT codes 70480 with work RVU 1.28, 70481 with work RVU 1.13, 
and 70482 with work RVU 1.27. We also are finalizing the RUC-
recommended direct PE inputs for all three codes.
(33) CT Spine (CPT Codes 72125, 72126, 72127, 72128, 72129, 72130, 
72131, 72132, and 72133)
    CPT code 72132 (Computed tomography, lumbar spine; with contrast 
material) was identified as potentially misvalued on a screen of CMS/
Other codes with Medicare utilization of 30,000 or more. Eight other 
spine CT codes were identified as part of the family, and they were 
surveyed and reviewed together at the April 2018 RUC meeting.
    We proposed the RUC-recommended work RVU for eight of the nine 
codes in the family. We proposed a work RVU of 1.22 for CPT code 72126 
(Computed tomography, cervical spine; with contrast material), a work 
RVU of 1.27 for CPT code 72127 (Computed tomography, cervical spine; 
without contrast material, followed by contrast material(s) and further 
sections), a work RVU of 1.00 for CPT code 72128 (Computed tomography, 
thoracic spine; without contrast material), a work RVU of 1.22 for CPT 
code 72129 (Computed tomography, thoracic spine; with contrast 
material), a work RVU of 1.27 for CPT code 72130 (Computed tomography, 
thoracic spine; without contrast material, followed by contrast 
material(s) and further sections), a work RVU of 1.00 for CPT code 
72131 (Computed tomography, lumbar spine; without contrast material), a 
work RVU of 1.22 for CPT code 72132 (Computed tomography, lumbar spine; 
with contrast material), and a work RVU of 1.27 for CPT code 72133 
(Computed tomography, lumbar spine; without contrast material, followed 
by contrast material(s) and further sections).
    We disagree with the RUC-recommended work RVU of 1.07 for CPT code 
72125 (Computed tomography, cervical spine; without contrast material) 
and we proposed a work RVU of 1.00 to match the other without contrast 
codes in the family. The cervical spine CT procedure described by CPT 
code 72125 shares the identical surveyed work time as the thoracic 
spine CT procedure described by CPT code 72128 and the lumbar spine CT 
procedure described by CPT code 72131, and we believe that this 
indicates that these three CPT codes should share the same work RVU of 
1.00. Our proposed work RVU would also match the pattern established by 
the rest of the codes in this family, in which the contrast procedures 
(CPT codes 72126, 72129, and 72132) share a proposed work RVU of 1.22 
and the without/with contrast procedures (CPT codes 72127, 72130, and 
72133) share a proposed work RVU of 1.27.
    We recognize that the RUC has stated that they believe CPT code 
72125 to be a more complex study than CPT codes 72128 and 72131 because 
the cervical spine is subject to an increased number of injuries and 
there are a larger number of articulations to evaluate. This was the 
basis for their recommendation that this code should be valued slightly 
higher than the other without contrast codes. However, if CPT code 
72125 has a more difficult patient population and requires a larger 
number of articulations to evaluate as compared to CPT codes 72128 and 
72131, we do not understand why this was not reflected in the surveyed 
work times, which were identical for the three procedures. We believe 
that if the intensity of the procedure were higher due to these 
additional difficulties, it would be reflected in a longer surveyed 
work time. In addition, the survey respondents selected a higher work 
RVU for CPT code 72131 than CPT code 72125 at both the survey 25th 
percentile (1.20 to 1.18) and survey median values (1.39 to 1.28), 
which does not suggest that CPT code 72125 should be valued at a higher 
rate.
    We also note that the surveyed intraservice work time for CPT code 
72125 is decreasing from 15 minutes to 12 minutes, and we believe that 
this provides additional support for a slight reduction in the work RVU 
to match the other without contrast codes in the family. We recognize 
that adjusting work RVUs for changes in time is not always a 
straightforward process and that the intensity associated with changes 
in time is not necessarily always linear, which is why we apply various 
methodologies to identify several potential work values for individual 
codes. However, we reiterate that we believe it would be irresponsible 
to ignore changes in time based on the best data available and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of prior work time values in our methodology, we 
refer readers to our discussion of the subject in the CY 2017 PFS final 
rule (81 FR 80273 through 80274).
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the CT Spine family. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 1.00 for CPT code 72125 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.07. Commenters stated that 
CPT code 72125 is a more complex service compared to CPT codes 72128 
and 72131 because the cervical spine is subject to an increased number 
of injuries and there are a larger number of articulations to evaluate 
including the joints at the craniocervical junction, facet and 
uncovertebral joints.
    Response: We disagree with the commenters that CPT code 72125 is a 
more complex service compared to CPT codes 72128 and 72131. We 
acknowledged that the RUC had provided this rationale in their 
recommendations for CPT code 72125, and we cited the data from the 
survey respondents that led us to believe that this was not the case. 
We did not receive a response from the commenters

[[Page 62758]]

addressing our use of the survey data, and therefore, we continue to 
believe that CPT code 72125 should not be valued higher than CPT codes 
72128 and 72131.
    Comment: Several commenters referenced how the codes in this family 
had been valued during previous reviews, stating that CMS had 
previously refined the work RVU of CPT codes 72128 and 72131 to 1.00 
while finalizing the RUC-recommended work RVU of 1.07 for CPT code 
72125. Commenters stated that because CMS reduced the work RVU for 
these codes but kept the RUC-recommended work RVUs, there was 
incongruence between their work times in the RUC database and the 
existing work RVUs. Commenters also stated that CPT codes with the same 
or similar times can, and should, have varying RVUs; even though the 
times for these codes are the same, commenters stressed that the 
intensity of work for CPT code 72125 is higher than CPT codes 72128 or 
72131 due to more anatomical complexity in the cervical spine and the 
risk of injury to the patient.
    Response: We appreciate the additional information provided by the 
commenters regarding the previous review of these codes in an earlier 
rule cycle. However, since all nine codes in the family were re-
surveyed and produced new survey data, we believe that it is more 
appropriate to base their valuation on the current survey results, as 
opposed to the historical survey results. We continue to believe that 
if the intensity of CPT code 72125 were higher than CPT codes 72128 or 
72131 due to the additional difficulties mentioned by the commenters, 
it would be reflected in a longer surveyed work time. We also note 
again that the survey respondents selected a higher work RVU for CPT 
code 72131 than CPT code 72125 at both the survey 25th percentile (1.20 
to 1.18) and survey median values (1.39 to 1.28), which does not 
suggest that CPT code 72125 should be valued at a higher rate. We did 
not receive any comments explaining why the survey respondents valued 
CPT code 72125 lower than CPT code 72131 yet it should be valued at a 
higher rate.
    In more general terms, we agree with the commenters that CPT codes 
with the same or similar times can, and should, have varying RVUs. We 
recognize that it would not be appropriate to develop work RVUs solely 
based on time given that intensity is also an element of work. We 
clarify again that we do not treat all components of physician time as 
having identical intensity. Were we to disregard intensity altogether, 
the work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
For more details on our methodology for developing work RVUs, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80272 through 80277). In the specific case of CPT code 
72125, we believe that it should share the same work RVU of 1.00 with 
CPT codes 72128 and 72131 not solely because these three codes share 
the same work times, but also because it matches the pattern 
established by the rest of the codes in this family, in which the 
contrast procedures (CPT codes 72126, 72129, and 72132) share a 
proposed work RVU of 1.22 and the without/with contrast procedures (CPT 
codes 72127, 72130, and 72133) share a proposed work RVU of 1.27.
    Comment: Several commenters disagreed with the proposal of the RUC-
recommended direct PE inputs for CPT codes 72125-72133, which would 
lower CT equipment time by approximately one-third. The commenters 
stated that, based on their experience in actual imaging center 
practice, CT equipment time should be based on the actual, total CT 
technologist time, rather than the RUC-recommended PE inputs that are 
not supported by standard operating procedures. Commenters stated that 
that once the patient is greeted and gowned, he/she will be escorted 
into the CT room where the technologist will perform the other 
procedure-related activities such as confirming the exam to be 
performed against the order, determining the correct exam protocol, 
etc.
    Response: We disagree with the commenters that the RUC-recommended 
and CMS proposed CT equipment times for the codes in this family were 
inaccurate. We continue to 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 and are typically available for other 
patients even when one member of clinical staff may be occupied with a 
preservice or postservice task related to the procedure. For a more 
detailed description of this topic, we refer readers to the CY 2015 PFS 
final rule with comment period (79 FR 67639 through 67640).
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the CT Spine family as 
proposed.
(34) X-Ray Exam--Pelvis (CPT Codes 72170 and 72190)
    CPT code 72190 (Radiologic examination, pelvis; complete, minimum 
of 3 views) was identified as potentially misvalued through a screen of 
CMS/Other codes with Medicare utilization of 30,000 or more annually. 
CPT code 72170 (Radiologic examination, pelvis; 1 or 2 views) was added 
as part of the family. The RUC originally reviewed these two codes 
after specialty societies employed a crosswalk methodology to value 
work and PE. However, after we expressed concern about the use of this 
approach, the specialty society agreed to survey the codes and the RUC 
reviewed them again at the meeting in January 2019.
    The RUC recommended a work RVU of 0.17 for CPT code 72170, which 
maintains the current value. For CPT code 72190, the RUC recommended a 
work RVU of 0.25, which is slightly higher than the current value (work 
RVU of 0.21). We proposed the RUC-recommended work RVUs for these two 
codes in this family.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the codes in this family.
    Response: We appreciate the support for our proposals from the 
commenter. After consideration of the public comments, we are 
finalizing the work RVUs and direct PE inputs for the codes in the X-
Ray Exam--Pelvis family as proposed.
(35) X-Ray Exam--Sacrum (CPT Codes 72200, 72202, and 72220)
    CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum 
of 2 views) was identified on a screen of CMS/Other source codes with 
Medicare utilization greater than 100,000 annually. CPT codes 72200 
(Radiologic examination, sacroiliac joints; less than 3 views) and 
72202 (Radiologic examination, sacroiliac joints; 3 or more views) were 
also included for review as part of the same family of codes. These 
three codes were originally valued by the specialty societies using a 
crosswalk methodology approved by the RUC Research Subcommittee. 
However, after we expressed concern about the use of this approach for 
valuing work and PE, the specialty society agreed to survey these codes 
and the RUC reviewed them again in January 2019.

[[Page 62759]]

    For CPT code 72200, we disagreed with the RUC recommended work RVU 
of 0.20, and proposed a work RVU of 0.17, which maintains the current 
value. We were concerned that the large variation in specialty 
societies' survey times is indicative of differences in patient 
population, practice workflow, or even possibly some ambiguity 
associated with the survey vignette. Furthermore, we did not agree that 
there is sufficient justification for an increase in work RVU for this 
service. To support their recommendation, the RUC compared the survey 
code to the key reference service, CPT code 73522 (Radiologic 
examination, hips, bilateral, with pelvis when performed; 3-4 views), 
with a work RVU of 0.29, 5 minutes of intraservice time and 7 minutes 
of total time. The intraservice and total times for the key reference 
service are 1 minute higher than the survey code (4 minutes 
intraservice time, 6 minutes total time for CPT code 72200) and the 
survey code is less intense, according to the RUC, thereby supporting a 
slightly lower work RVU of 0.20 for CPT code 72200. The RUC's second 
key reference service is CPT code 73562 (Radiologic examination, knee; 
3 views), with 4 minutes of intraservice time, 6 minutes of total time, 
and a work RVU of 0.18. The RUC noted that this second key reference 
service is less intense to furnish than the survey code, which 
justifies a slightly lower work RVU despite identical intraservice time 
(4 minutes) and total time (6 minutes). The RUC further supported their 
recommendation with a bracket to CPT code 93042 (Rhythm ECG, 1-3 leads; 
interpretation and report only), which has a work RVU of 0.15, and CPT 
code 70355 (Orthopantogram (e.g., panoramic x-ray)), which has a work 
RVU of 0.20 (which is identical to the RUC-recommended work RVU for CPT 
code 72200 but has one additional minute of intraservice time). 
Although the RUC-recommended work RVU of 0.20 is consistent with the 
work RVU estimated by the TTR and reflects the 25th percentile of 
survey results, we do not agree that there is sufficient justification 
for an increase in work RVU for this service. We also note that the 
25th percentile of the survey results work RVU of 0.20 proposed by the 
RUC is based on the overall survey total time, which is 8 minutes, 
rather than the RUC-recommended 6 minutes. We found no corresponding 
explanation for the variability in survey times, leading us to question 
why there should be an increase in work RVU from the current value. 
Therefore, we proposed to maintain the current work RVU of 0.17 for CPT 
code 72200.
    For CPT code 72202, we disagreed with the RUC-recommended work RVU 
of 0.26, and proposed a work RVU of 0.23 based on our increment 
methodology. Our proposed value is supported by a bracket to CPT code 
73521 (Radiologic examination, hips, bilateral, with pelvis when 
performed; 2 views), which has a work RVU of 0.22 and similar time 
values, and CPT code 74021 (Radiologic examination, abdomen; 3 or more 
views), which has a work RVU 0.27, and identical time values, to CPT 
code 72202. Although we disagreed with the RUC-recommended work RVU of 
0.20 for CPT code 72200 (the prior code in this family), based on RUC 
survey results and the time resources involved in furnishing CPT codes 
72200 and 72202, we agreed that the relative difference in work RVUs 
between CPT codes 72200 and 72202 is equivalent to the RUC-recommended 
incremental difference of 0.06 additional work RVUs. The RUC supported 
their recommendation with two key reference services. The first is CPT 
code 73522 (Radiologic examination, hips, bilateral, with pelvis when 
performed; 3-4 views) with 5 minutes intraservice time, 7 minutes total 
time, and a work RVU of 0.29. They noted that this code has an 
additional minute for intraservice and total time compared with the 
survey code, reflecting the additional views associated with evaluating 
bilateral hip joints. The RUC's second key reference service is CPT 
code 73562 (Radiologic examination, knee; 3 views) with 4 minutes 
intraservice time, 6 minutes total time, and a work RVU of 0.18. The 
RUC notes that the survey code has the same times but requires more 
intensity and includes an additional view compared with the reference 
service, which the RUC notes justifies a higher work RVU for the survey 
code.
    We disagreed with the RUC's recommended work RVU for CPT code 
72202. Given that there is no change in the total time required to 
furnish the service and there is no corresponding description of an 
increase in the intensity of the work relative to the existing value, 
we do not believe an increase in the work RVU for this service is 
warranted. Therefore, based on those concerns and our incremental 
methodology, supported by a bracket to CPT codes 73521 and 74021, we 
proposed a work RVU of 0.23 for CPT code 72202.
    For CPT code 72220 we disagreed with the RUC-recommended work RVU 
0.20 and proposed to maintain the current work RVU of 0.17. We note 
that there is no change in the total time required to furnish the 
service. We also note that a work RUC-recommended RVU of 0.20 for CPT 
code 72220 would place it near the maximum work RVU for CPT codes with 
identical intraservice time (3 minutes) and total time (5 minutes). The 
RUC's key reference service from the survey results is CPT code 73522 
(Radiologic examination, hips, bilateral, with pelvis when performed, 
2-4 views), has a work RVU of 0.29, 5 minutes intraservice time, and 7 
minutes total time. The RUC noted that their recommended work RVU for 
CPT code 72220 has a lower value than the top key reference code (CPT 
code 73522) because of the shorter time and lower intensity involved in 
furnishing the survey code. The RUC's second highest key reference 
service, CPT code 73562 (Radiologic examination, knee; 3 views) has a 
work RVU of 0.18 with 4 minutes of intraservice time and 6 minutes of 
total time. The RUC noted that this second key reference service has a 
lower work RVU than the survey code despite having a slightly higher 
intraservice time and total time because it involves an X-ray of just 
one knee.
    We disagree with the RUC's recommended increase in the work RVU for 
CPT code 72220 from 0.17 to 0.20. We note that there is no change in 
the total time required to furnish the service and that the RUC-
recommended work RVU would place it near the maximum work RVU for CPT 
codes with identical intraservice time (3 minutes) and total time (5 
minutes). Therefore, based on those concerns we proposed to maintain 
the current work RVU of 0.17 for CPT code 72220.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the X-Ray Exam--Sacrum family. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters stated that they supported the proposal 
of the RUC-recommended direct PE inputs for the code in the family.
    Response: We appreciate the support for our proposal for the direct 
PE inputs from the commenters.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT codes 72200 and 72220. Commenters stated that CMS should 
instead finalize the RUC-recommended work RVUs for these procedures. 
Commenters disagreed with our reference to older work time sources, and 
noted that their use led to the proposal of work RVUs based on flawed

[[Page 62760]]

assumptions. Commenters stated that codes with ``CMS/Other'' or 
``Harvard'' work time sources, used in the original valuation of 
certain older services, in this case, were not surveyed, and therefore, 
were not resource-based. Commenters noted that it was invalid to draw 
comparisons between the current work times and work RVUs of these 
services to the newly surveyed work time and work RVUs as recommended 
by the RUC for the services.
    Response: We appreciate the commenters' concerns regarding CMS' 
interpretation of older work time sources and their use in the code 
valuation process for establishing work RVUs for these services. We 
agree that it is important to use the recent data available regarding 
work times, and we note that when many years have passed between when 
time is measured, significant discrepancies can occur. However, we also 
believe that our operating assumption regarding the validity of the 
existing values as a point of comparison is critical to the integrity 
of the relative value system as currently constructed. We have 
responded to concerns about our methodology earlier in this section. 
For additional information regarding the use of old work time values 
that were established many years ago and have not since been reviewed 
in our methodology, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80273 through 80274). Our proposal to 
maintain the current work RVUs for CPT codes 72200 (a work RVU of 0.17) 
and 72220 (a work RVU of 0.17) and a work RVU of 0.23 for CPT code 
72202 is supported by the aforementioned bracket to CPT codes 73521 and 
74021. We continue to believe the proposed values better maintains the 
relative intensity of the codes in the family, and better preserves 
relativity with the rest of the codes on the PFS.
    Comment: A commenter stated that CMS' note in the proposed rule 
regarding the reduction in time is misleading. A commenter disagreed 
with the CMS proposed work RVU for CPT code 72202. One commenter stated 
that CMS should instead finalize the RUC-recommended work RVU for this 
procedure, stating that the incremental methodology used in valuing 
these services was flawed; the commenter did not agree that it was 
appropriate to reduce the work RVU for CPT code 72202 from the value 
proposed by the RUC, while also recalibrating the work relative to the 
RUC's recommended difference in work between this code and CPT code 
72200. A commenter noted that it is imperative to employ RUC survey 
data to value this service, and that using an incremental approach in 
lieu of survey data, strong crosswalks, and input from the 
practitioners providing these services was unjustified.
    Response: We apologize for the confusion noted by commenters who 
stated that the reduction in time for CPT code 72200 was misleading. In 
this final rule we have clarified our note on the reductions in time in 
the discussion above on this code. We believe the use of an incremental 
difference between codes is a valid methodology for setting values, 
especially in valuing services within a family of revised codes where 
it is important to maintain appropriate intra-family relativity. Thus, 
we applied the use of an incremental difference between CPT codes 72202 
and 72200 to develop the proposed work RVU for CPT code. Historically, 
we have frequently utilized an incremental methodology in which we 
value a code based upon its incremental difference between another code 
or another family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We have no evidence to suggest that the use 
of an incremental difference between codes conflicts with the statute's 
definition of the work component as the resources in time and intensity 
required in furnishing the service. For more details on our methodology 
for developing work RVUs, we refer readers to our discussion of the 
subject in the Methodology for Establishing Work RVUs section of this 
rule (section II.N.2. of this final rule), as well as a longer 
discussion in the CY 2017 PFS final rule (81 FR 80272 through 80277).
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the X-Ray Exam--Sacrum 
family as proposed.
(36) X-Ray Exam--Clavicle-Shoulder (CPT Codes 73000, 73010, 73020, 
73030, and 73050)
    CPT code 73030 (Radiologic examination, shoulder; complete, minimum 
of 2 views) was identified as potentially misvalued through a screen of 
services with more than 100,000 utilization annually. CPT codes 73000 
(Radiologic examination; clavicle, complete), 73010 (Radiologic 
examination; scapula, complete), 73020 (Radiologic examination, 
shoulder; 1 view), and 73050 (Radiologic examination, acromioclavicular 
joints, bilateral, with or without weighted distraction) were included 
for review as part of the same family. We proposed the RUC-recommended 
work RVUs for all five codes in this family. We proposed a work RVU of 
0.16 for CPT code 73000, a work RVU of 0.17 for CPT code 73010, a work 
RVU of 0.15 for CPT code 73020, a work RVU of 0.18 for CPT code 73030, 
and a work RVU of 0.18 for CPT code 73050.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the codes in this family.
    Response: We appreciate the support for our proposals from the 
commenter. After consideration of the public comments, we are 
finalizing the work RVUs and direct PE inputs for the codes in the X-
Ray Exam--Clavicle-Shoulder family as proposed.
(37) CT Lower Extremity (CPT Codes 73700, 73701, and 73702)
    CPT code 73701 (Computed tomography, lower extremity; with contrast 
material(s)) was identified as potentially misvalued on a screen of 
CMS/Other codes with Medicare utilization of 30,000 or more. Two other 
lower extremity CT codes were identified as part of the family, and 
they were surveyed and reviewed together at the April 2018 RUC meeting.
    We proposed the RUC-recommended work RVU for all three codes in 
this family. We proposed a work RVU of 1.00 for CPT code 73700 
(Computed tomography, lower extremity; without contrast material), a 
work RVU of 1.16 for CPT code 73701 (Computed tomography, lower 
extremity; with contrast material(s)), and a work RVU of 1.22 for CPT 
code 73702 (Computed tomography, lower extremity; without contrast 
material, followed by contrast material(s) and further sections).
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the CT Lower Extremity family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVUs for the codes in the family.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: Several commenters disagreed with the proposal of the RUC-
recommended direct PE inputs for CPT

[[Page 62761]]

codes 73700-73702, which would lower CT equipment time by approximately 
one-third. The commenters stated that, based on their experience in 
actual imaging center practice, CT equipment time should be based on 
the actual, total CT technologist time, rather than the RUC-recommended 
PE inputs that are not supported by standard operating procedures. 
Commenters stated that that once the patient is greeted and gowned, he/
she will be escorted into the CT room where the technologist will 
perform the other procedure-related activities such as confirming the 
exam to be performed against the order, determining the correct exam 
protocol, etc.
    Response: We disagree with the commenters that the RUC-recommended 
and CMS proposed CT equipment times for the codes in this family are 
inaccurate. We continue to 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 and are typically available for other 
patients even when one member of clinical staff may be occupied with a 
preservice or postservice task related to the procedure. For a more 
detailed description of this topic, we refer readers to the CY 2015 PFS 
final rule with comment period (79 FR 67639 through 67640).
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the CT Lower Extremity 
family as proposed.
(38) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
    CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090 
(Radiologic examination; forearm, 2 views) were identified on a screen 
of CMS/Other source codes with Medicare utilization greater than 
100,000 services annually. CPT code 73080 (Radiologic examination, 
elbow; complete, minimum of 3 views) was included for review as part of 
the same code family. All three CPT codes in this family were 
originally valued by the specialty societies using a crosswalk 
methodology approved by the RUC research committee. However, after we 
expressed concern about the use of this approach for valuing work and 
PE, the specialty society agreed to survey the codes and the RUC 
reviewed them again at the meeting in January 2019. We proposed the 
RUC-recommended work RVU for all three codes in this family. We 
proposed a work RVU of 0.16 for CPT code 73070, a work RVU of 0.17 for 
CPT code 73080, and a work RVU of 0.16 for CPT code 73090.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the codes in this family.
    Response: We appreciate the support for our proposals from the 
commenter. After consideration of the public comments, we are 
finalizing the work RVUs and direct PE inputs for the codes in the X-
Ray Elbow-Forearm family as proposed.
(39) X-Ray Heel (CPT Code 73650)
    CPT code 73650 (Radiologic examination; calcaneous, minimum of 2 
views) was identified on a screen of CMS/Other source codes with 
Medicare utilization greater than 100,000 services annually. CPT code 
73650 was originally valued by the specialty societies using a 
crosswalk methodology approved by the RUC Research Subcommittee. 
However, after we expressed concern about the use of this approach for 
valuing work and PE, the specialty society agreed to survey the code 
and the RUC reviewed it again in January 2019. For CPT code 73650, we 
proposed the RUC-recommended work RVU of 0.16.
    We proposed the RUC-recommended direct PE inputs for CPT code 
73650.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the code in this family.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the code in the X-Ray Heel family as 
proposed.
(40) X-Ray Toe (CPT Code 73660)
    CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) 
was identified on a screen of CMS/Other source codes with Medicare 
utilization greater than 100,000 services annually. CPT code 73660 was 
originally valued by the specialty societies using a crosswalk 
methodology approved by the RUC Research Subcommittee. However, after 
we expressed concern about the use of this approach for valuing work 
and PE, the specialty society agreed to survey the code and the RUC 
reviewed it again in January 2019. We proposed the RUC-recommended work 
RVU of 0.13 for CPT code 73660.
    We proposed the RUC-recommended direct PE inputs for CPT code 
73660.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the code in this family.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the code in the X-Ray Toe family as 
proposed.
(41) Upper Gastrointestinal Tract Imaging (CPT Codes 74210, 74220, 
74230, 74221, 74240, 74246, and 74248)
    These services were identified through a list of list of CMS/Other 
codes with Medicare utilization of 30,000 or more. The CPT Editorial 
Panel subsequently revised this code set in order to conform to other 
families of radiologic examinations.
    We proposed the RUC-recommended work RVUs of 0.59 for CPT code 
74210 (Radiologic examination, pharynx and/or cervical esophagus, 
including scout neck radiograph(s) and delayed image(s), when 
performed, contrast (e.g., barium) study), 0.60 for CPT code 74220 
(Radiologic examination, esophagus, including scout chest radiograph(s) 
and delayed image(s), when performed; single-contrast (e.g., barium) 
study), 0.70 for CPT code 74221 (Radiologic examination, esophagus, 
including scout chest radiograph(s) and delayed image(s), when 
performed; double-contrast (e.g., high-density barium and effervescent 
agent) study), 0.53 for CPT code 74230 (Radiologic examination, 
swallowing function, with cineradiography/videoradiography, including 
scout neck radiograph(s) and delayed image(s), when performed, contrast 
(e.g., barium) study), 0.80 for CPT code 74240 (Radiologic examination, 
upper gastrointestinal tract, including scout abdominal radiograph(s) 
and delayed image(s), when performed; single-contrast (e.g., barium) 
study) 0.90 for CPT code 74246 (Radiologic examination, upper 
gastrointestinal tract, including scout abdominal radiograph(s) and 
delayed image(s), when performed; double-contrast (e.g., high-density 
barium and effervescent agent) study, including glucagon, when 
administered), and 0.70 for CPT code 74248 (Radiologic examination, 
upper gastrointestinal tract, including scout abdominal radiograph(s) 
and delayed image(s), when performed; with small intestine follow-
through study, including multiple serial images (List separately in 
addition to code for primary procedure)). We are also proposing the 
reaffirmed work RVU of 0.59 for CPT code 74210 (Radiologic examination, 
pharynx and/or cervical esophagus,

[[Page 62762]]

including scout neck radiograph(s) and delayed image(s), when 
performed, contrast (e.g., barium) study) and the reaffirmed work RVU 
of 0.53 for CPT code 74230 (Radiologic examination, swallowing 
function, with cineradiography/videoradiography, including scout neck 
radiograph(s) and delayed image(s), when performed, contrast (e.g., 
barium) study).
    For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we noted that 
no rationale was given for the RUC-recommended times for these codes, 
and we requested comment on the appropriateness of the RUC-recommended 
clinical labor times for this activity of 13 minutes, 13 minutes, 15 
minutes, 15 minutes, 19 minutes, 22 minutes, and 15 minutes for CPT 
codes 74210, 74220, 74221, 74230, 74240, and 74246, respectively. In 
addition, for CPT code 74230, we proposed to refine the clinical labor 
times for the ``Prepare room, equipment and supplies'' (CA013) and 
``Prepare, set-up and start IV, initial positioning and monitoring of 
patient'' (CA016) activity codes to the standard values of 2 minutes 
each, as well as to refine the equipment times to reflect these changes 
in clinical labor.
    We received public comments on the proposed valuation of the codes 
in the Upper Gastrointestinal Tract Imaging family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter supported our proposal to use the RUC-
recommended work RVUs for these codes.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: A commenter stated that, contrary to our statement that no 
rationale was provided for the times recommended for the ``perform 
procedure/service--NOT directly related to physician work time'' 
(CA021) clinical labor activity, the RUC had included detailed 
information on the RUC-recommended clinical labor in the PE SOR, and 
the commenter reiterated the rationale.
    Response: We thank the commenter for the clarification.
    Comment: A commenter disagreed with our refinements to the RUC-
recommended minutes for the ``Prepare, set-up and start IV, initial 
positioning and monitoring of patient'' (CA016) activity. This 
commenter stated patients require extra time for positioning because by 
CMS' own policy rules these patients need two diagnoses to qualify for 
the exam, the most common being prior cerebral infarct and pneumonia. 
The patients are elderly, debilitated, and have multiple comorbidities. 
They are being positioned upright between a table and fluoroscopy tube 
with minimal allowance for deviation because the field of view (their 
oropharynx and larynx) are a small target.
    A commenter disagreed with our proposed refinement to the number of 
minutes allocated to the ``Prepare room, equipment and supplies'' 
(CA013) activity, stating that this exam's requirements exceed a normal 
radiographic exam. The commenter stated that multiple consistencies of 
barium must be prepared, including thin liquid, nectar thick liquid, 
honey-thick liquid, purees, mixed solids, and solids and that the 
varying barium consistencies are delivered by teaspoon, straw, and cup. 
The commenter stated that all of these items must be prepared prior to 
beginning the exam.
    Response: We appreciate the additional information provided by 
commenters regarding these clinical labor activities. Based on the 
information provided by the commenters, we are not finalizing our 
proposed refinements to the CA013 and CA016 clinical labor activities, 
and we are instead finalizing the RUC-recommended times.
    After consideration of the public comments, we are finalizing as 
proposed the RUC-recommended work RVUs, as well as the RUC-recommended 
direct PE inputs.
(42) Lower Gastrointestinal Tract Imaging (CPT Codes 74250, 74251, 
74270, and 74280)
    These services were identified through a list of list of CMS/Other 
codes with Medicare utilization of 30,000 or more. We proposed the RUC-
recommended work RVUs of 0.81 for CPT code 74250 (Radiologic 
examination, small intestine, including multiple serial images and 
scout abdominal radiograph(s), when performed; single-contrast (e.g., 
barium) study), 1.17 for CPT code 74251 (Radiologic examination, small 
intestine, including multiple serial images and scout abdominal 
radiograph(s), when performed; double-contrast (e.g., high-density 
barium and air via enteroclysis tube) study, including glucagon, when 
administered), 1.04 for 74270 (Radiologic examination, colon, including 
scout abdominal radiograph(s) and delayed image(s), when performed; 
single-contrast (e.g., barium) study), and 1.26 for CPT code 74280 
(Radiologic examination, colon, including scout abdominal radiograph(s) 
and delayed image(s), when performed; double-contrast (e.g., high 
density barium and air) study, including glucagon, when administered).
    For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we noted that 
no rationale was given for the recommended times for these codes, and 
we requested comment on the appropriateness of the RUC-recommended 
clinical labor times for this activity of 19 minutes, 30 minutes, 25 
minutes, and 36 minutes for CPT codes 74250, 74251, 74270, and 74280, 
respectively. In addition, we proposed to refine the equipment time for 
the room, radiographic-fluoroscopic (EL014) for CPT code 74250 to 
conform to our established standard for highly technical equipment and 
to match the rest of the codes in the family.
    We received public comments on the proposed valuation of the codes 
in the Lower Gastrointestinal Tract Imaging family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter supported our proposal to use the RUC-
recommended work RVUs for these codes.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: A commenter stated that, contrary to our statement that no 
rationale was provided for the times recommended for the ``perform 
procedure/service--NOT directly related to physician work time'' 
(CA021) clinical labor activity, the RUC had included detailed 
information on the RUC-recommended clinical labor in the PE SOR, and 
the commenter reiterated the rationale.
    Response: We thank the commenter for the clarification. We are 
finalizing the RUC-recommended times as proposed for this clinical 
labor activity.
    After consideration of the public comments, we are finalizing as 
proposed the RUC-recommended work RVUs, as well as our proposed direct 
PE refinements.
(43) Urography (CPT Code 74425)
    The service described by CPT code 74425 (Urography, antegrade 
(pyelostogram, nephrostogram, loopogram), radiological supervision and 
interpretation) was combined with services describing genitourinary 
catheter procedures by the CPT Editorial Panel in CY 2016, resulting in 
CPT codes 50431 (Injection procedure for antegrade nephrostogram and/or 
ureterogram, complete diagnostic procedure including imaging guidance

[[Page 62763]]

(e.g., ultrasound and fluoroscopy) and all associated radiological 
supervision and interpretation; existing access) and 50432 (Placement 
of nephrostomy catheter, percutaneous, including diagnostic 
nephrostogram and/or ureterogram when performed, imaging guidance 
(e.g., ultrasound and/or fluoroscopy) and all associated radiological 
supervision and interpretation). CPT code 74425 was not deleted at the 
time, but the RUC agreed with the specialty societies that 2 years of 
Medicare claims data should be available for analysis before the code 
was resurveyed for valuation to allow for any changes in the 
characteristics and process involved in furnishing the service 
separately from the genitourinary catheter procedures. The specialty 
society surveyed CPT code 74425 and reviewed the results with the RUC 
in October 2018.
    The results of the specialty society surveys indicated a large 
increase in the amount of time required to furnish the service and, 
correspondingly, to the work RVU. The total time for CPT code 74425 
based on the survey results was 34 minutes, an increase of 25 minutes 
over the current total time of 9 minutes. In reviewing the survey 
results, the RUC revised the total time for this CPT code to 24 
minutes, with a recommended work RVU of 0.51. The reason for the large 
increase in time, according to the RUC, is a change in the typical 
patient profile in which the typical patient is one with an ileal 
conduit through which nephrostomy tubes have been placed for post-
operative obstruction. Based on the described change in patient 
population and increased time required to furnish the service, we 
proposed the RUC-recommended work RVU of 0.51 for CPT code 74425.
    We proposed the RUC-recommended direct PE inputs for CPT code 
74425.
    We received public comments on the proposed valuation of the codes 
in the Urography family. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters stated that they supported our 
proposals for the work RVUs and direct PE inputs for the code in this 
family
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the code in the Urography family as 
proposed.
(44) Abdominal Aortography (CPT Codes 75625 and 75630)
    In October 2017, the RAW requested that AMA staff compile a list of 
CMS/Other codes with Medicare utilization of 30,000 or more. In January 
2018, the RUC recommended to survey these services for the October 2018 
RUC meeting. Subsequently, the specialty society surveyed these codes.
    We disagree with the RUC-recommended work RVU of 1.75 for CPT code 
75625 (Aortography, abdominal, by serialography, radiological 
supervision and interpretation). In reviewing CPT code 75625, we note 
that the key reference service, CPT Code 75710 (Angiography, extremity, 
unilateral, radiological supervision and interpretation), has 10 
additional minutes of intraservice time, 10 additional minutes of total 
time and the same work RVU, which would indicate the RUC-recommended 
work RVU of 1.75 appears to be overvalued. When we compared the 
intraservice time ratio between the RUC-recommended time of 30 minutes 
and the reference code intraservice time of 40 minutes we found a ratio 
of 25 percent. 25 percent of the reference code work RVU of 1.75 equals 
a work RVU of 1.31. When we compared the total service time ratio 
between the RUC-recommended time of 60 minutes and the reference code 
total service time of 70 minutes we found a ratio of 14 percent. 14 
percent of the reference code work RVU of 1.75 equals a work RVU of 
1.51. Therefore, we believe an accurate value would lie between 1.31 
and 1.52 RVUs. In looking for a comparative code, we have identified 
CPT code 38222. CPT Code 38222 is a recently reviewed CPT code with the 
identical intraservice and total times. As a result, we believe that it 
is more accurate to propose a work RVU of 1.44 based on a crosswalk to 
CPT code 38222.
    In case of CPT code 75630 (Aortography, abdominal plus bilateral 
iliofemoral lower extremity, catheter, by serialography, radiological 
supervision and interpretation), we proposed the RUC-recommended value 
of 2.00 RVUs.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Abdominal Aortography family. The following is a summary of the 
comments we received and our responses.
    Comment: Commenters supported our proposal to value CPT code 75630 
with the RUC-recommended work RVU.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: A few commenters stated that our proposed value for CPT 
code 75625 is invalid, as it relies on a reference to the current 
value, and the crosswalk or methodology used in the original valuation 
of this service is unknown and not resource-based; therefore, it is 
invalid to compare the current time and work to the surveyed time and 
work.
    Response: We believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available and that we are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: A commenter stated that CPT code 38222 provides a poor 
crosswalk to support our proposed value for CPT code 75625 because it 
is performed by physicians from a different specialty, it does not 
involve imaging and exposure to radiation, it does not require intra-
arterial access or monitoring of hemodynamic parameters, and it is a 
much lower risk procedure.
    Response: Our determination that the RUC's recommended value 
somewhat overstates the inherent work is based in part on an analysis 
of all codes of similar physician time values; we believe the survey 
data validates an increase in work, but this analysis of all codes of 
similar times indicates that the increase should not be of the 
magnitude recommended by the RUC. We note that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another, and that codes do not need to 
share the same specialty. Although codes that describe clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk. 
After consideration of the public comments, we are finalizing our 
proposed work RVUs and direct PE inputs for these codes.

[[Page 62764]]

(45) Angiography (CPT Codes 75726 and 75774)
    We proposed the RUC-recommend work RVU for both codes in this 
family. We proposed a work RVU of 2.05 for CPT code 75726 (Angiography, 
visceral, selective or supraselective (with or without flush 
aortogram), radiological supervision and interpretation), a work RVU of 
1.01 for CPT code 75774 (Angiography, selective, each additional vessel 
studied after basic examination, radiological supervision and 
interpretation (List separately in addition to code for primary 
procedure).
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Angiography family. The following is a summary of the comments 
we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVUs for the codes in the family.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Angiography family 
as proposed.
(46) X-Ray Exam Specimen (CPT Code 76098)
    CPT code 76098 (Radiological examination, surgical specimen) was 
reviewed by the RUC based on a request from the American College of 
Radiology (ACR) to determine whether CPT code 76098 was undervalued 
because of the assumption that the service is typically furnished 
concurrently with a placement of localization device service (CPT codes 
19281 (Placement of breast localization device(s) (e.g., clip, metallic 
pellet, wire/needle, radioactive seeds), percutaneous; first lesion, 
including mammographic guidance), 19282 (Placement of breast 
localization device(s) (e.g., clip, metallic pellet, wire/needle, 
radioactive seeds), percutaneous; each additional lesion, including 
mammographic guidance (List separately in addition to code for primary 
procedure), 19283 (Placement of breast localization device(s) (e.g., 
clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; 
first lesion, including stereotactic guidance), 19284 (Placement of 
breast localization device(s) (e.g., clip, metallic pellet, wire/
needle, radioactive seeds), percutaneous; each additional lesion, 
including stereotactic guidance (List separately in addition to code 
for primary procedure)) 19285 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds), percutaneous; first lesion, including ultrasound guidance), 
19286 (Placement of breast localization device(s) (e.g., clip, metallic 
pellet, wire/needle, radioactive seeds), percutaneous; each additional 
lesion, including ultrasound guidance (List separately in addition to 
code for primary procedure), 19287 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds), percutaneous; first lesion, including magnetic resonance 
guidance), and 19288 (Placement of breast localization device(s) (e.g., 
clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; 
each additional lesion, including magnetic resonance guidance (List 
separately in addition to code for primary procedure)) each 
representing a different imaging modality). In a letter to the RUC, ACR 
expressed concern about the appropriateness of a codes valuation 
process in which physician time and intensity for a code are reduced to 
account for overlap with codes that are furnished to a patient on the 
same day. During the April 2018 RUC meeting, the specialty societies 
requested a work RVU of 0.40 for CPT code 76098, with intraservice time 
of 5 minutes and total time of 15 minutes. Currently, this service has 
a work RVU of 0.16, with 5 minutes of total time and no available 
intraservice time. In April 2018, the RUC and the specialty society 
agreed that additional analysis of the data was warranted in 
consideration of the relatively large change in survey time and work 
RVU for this service. The RUC agreed to review CPT code 76098 again in 
October 2018.
    The RUC recommended a work RVU of 0.31 for CPT code 76098, based on 
the October 2018 meeting, which represents an increase over the current 
value (0.16), but a decrease relative to the specialty society's 
original request of 0.40. The intraservice time for this CPT code is 5 
minutes, and the total time is 11 minutes. Based on the parameters we 
typically use to review and evaluate RUC recommendations, which rely 
heavily on survey data, we agree that a work RVU of 0.31 for a CPT code 
with 5 minutes intraservice and 11 minutes total time is consistent 
with other CPT codes with similar times and levels of intensity. We 
proposed the RUC-recommended work RVU of 0.31 for CPT code 76098.
    We share the ACR's interest in establishing or clarifying 
parameters that indicate when CPT codes that are furnished concurrently 
by the same provider should be valued to account for the overlap in 
physician work time and intensity, and even PE. We are broadly 
interested in stakeholder feedback and suggestions about what those 
parameters might be and whether or how they should affect code 
valuation.
    We proposed the RUC-recommended direct PE inputs for CPT code 
76098.
    We received public comments on the proposed valuation of the codes 
in the X-Ray Exam Specimen family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter stated appreciation that CMS proposed the RUC-
recommended value for CPT code 76098, but wanted to clarify some of the 
statements in the proposed rule regarding how the code came up for 
review and their concerns regarding the billed together data. They 
noted that CPT code 76098 was reviewed by the RUC in April 2018 as part 
of the CMS/Other utilization >30,000 screen. At that time, RUC members 
questioned whether 76098 is typically performed with another code on 
the same patient, same date of service, and by the same provider. 
Billed together data showed that no single other code was typically 
performed with CPT code 76098, but if multiple codes (in this case all 
CPT codes representing placement of needle localization device by any 
imaging modality) were combined, then the billed together threshold was 
met. A commenter expressed concern about whether or not it is 
appropriate to combine multiple similar codes when determining billed 
together status. The ACR noted that adding individual billed together 
rates will result in double counting when three or more of those codes 
are billed together, rendering the data inaccurate unless this overlap 
is accounted for. Additionally, the ACR expressed concern that this 
method of determining billed together status reflects a change in RUC 
procedure and should be validated through the Research Subcommittee 
before establishing precedent. As further noted by the commenter, since 
this was a complex, multi-code issue, the RUC decided to revisit this 
issue at the October 2018 RUC meeting where AMA staff could present 
their research on this matter. In October 2018, the RUC agreed that CPT 
code 76098 is typically performed with one type of needle localization 
on the same day (any of CPT codes 19281-19288), and 4 minutes of pre-
service time was removed from the survey time to account for overlap in 
work.
    Response: We appreciate the support for our proposals from the 
commenter, and the additional information to clarify

[[Page 62765]]

how CPT code 76098 came up for review and noting their concerns 
regarding the billed together data.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the code in the X-Ray Exam Specimen 
family as proposed.
(47) 3D Rendering (CPT Code 76376)
    CPT code 76376 (3D rendering with interpretation and reporting of 
computed tomography, magnetic resonance imaging, ultrasound, or other 
tomographic modality with image postprocessing under concurrent 
supervision; not requiring image postprocessing on an independent 
workstation) was identified as potentially misvalued on a screen of 
codes with a negative intraservice work per unit of time (IWPUT), with 
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes 
and over 1,000 for Harvard valued and CMS/Other source codes. It was 
surveyed and reviewed at the April 2018 RUC meeting.
    We proposed the RUC-recommended work RVU of 0.20 for CPT code 
76376. We are also proposing the RUC-recommended direct PE inputs for 
CPT code 76376.
    We received public comments on the proposed valuation of the codes 
in the 3D Rendering family. The following is a summary of the comments 
we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVU for CPT code 76376.
    Response: We appreciate the support for our proposal from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 76376 as proposed.
(48) Ultrasound Exam--Chest (CPT Code 76604)
    CPT code 76604 (Ultrasound, chest (includes mediastinum), real time 
with image documentation) was identified as potentially misvalued on a 
screen of CMS/Other codes with Medicare utilization of 30,000 or more. 
It was surveyed and reviewed for the April 2018 RUC meeting.
    We proposed the RUC-recommended work RVU of 0.59 for CPT code 
76604. We are also proposing the RUC-recommended direct PE inputs for 
CPT code 76604.
    We received public comments on the proposed valuation of the codes 
in the Ultrasound Exam--Chest family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVU for CPT code 76604.
    Response: We appreciate the support for our proposal from the 
commenter.
    Comment: Several commenters disagreed with the RUC-recommended and 
CMS proposed replacement of the general ultrasound room (EL015) with a 
portable ultrasound unit (EQ250) for CPT code 76604. The commenters 
stated that their members reported using console-based ultrasound 
systems, which reflect a higher cost than portable ultrasound units, 
and stated that the direct PE inputs for CPT code 76604 should 
accurately reflect the cost of equipment being used by radiologic 
practices and freestanding imaging centers. Commenters stated that they 
only uses console-based ultrasound systems because of their greater 
processing power, advanced features, better image quality, and 
suitability for a wider range of clinical scenarios including 
obstetrics, breast, vascular, abdominal, and chest.
    Response: While we agree with the commenters that the direct PE 
inputs for CPT code 76604 should accurately reflect equipment usage, we 
disagree that the use of the ultrasound room would be typical for this 
procedure. We agree with the RUC recommendations that the practice 
patterns for CPT code 76604 have changed over time, and that it is no 
longer typical for patients to require the use of a full ultrasound 
room for this examination given the widespread availability of highly 
quality portable ultrasound equipment. We believe that the typical 
patient would be treated using these portal ultrasounds for their chest 
examination.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 76604 as proposed.
(49) X-Ray Exam--Bone (CPT Codes 77073, 77074, 77075, 77076, and 77077)
    CPT codes 77073 (Bone length studies (orthoroentgenogram, 
scanogram)), 77075 (Radiologic examination, osseous survey; complete 
(axial and appendicular skeleton)), and 77077 (Joint survey, single 
view, 2 or more joints) were identified as potentially misvalued on a 
screen of CMS/Other codes with Medicare utilization of 30,000 or more. 
CPT codes 77074 (Radiologic examination, osseous survey; limited (e.g., 
for metastases)) and 77076 (Radiologic examination, osseous survey, 
infant) were reviewed as part of the same family.
    We proposed the RUC-recommended work RVU for all five CPT codes in 
this family. We proposed a work RVU of 0.26 for CPT code 77073, a work 
RVU of 0.44 for CPT code 77074, a work RVU of 0.55 for CPT code 77075, 
a work RVU of 0.70 for CPT code 77076, and a work RVU of 0.33 for CPT 
code 77077.
    We proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    Comment: A commenter was supportive of our proposals for the work 
RVUs and direct PE inputs for the codes in this family.
    Response: We appreciate the support for our proposals from the 
commenter. After consideration of the public comments, we are 
finalizing the work RVUs and direct PE for the codes in the X-Ray 
Exam--Bone family as proposed.
(50) SPECT-CT Procedures (CPT Codes 78800, 78801, 78802, 78803, 78804, 
78830, 78831, 78832, and 78835)
    The CPT Editorial Panel revised five codes, created four new codes 
and deleted nine codes to better differentiate between planar 
radiopharmaceutical localization procedures and SPECT, SPECT-CT and 
multiple area or multiple day radiopharmaceutical localization/
distribution procedures.
    For CPT code 78800 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar 
limited single area (e.g., head, neck, chest pelvis), single day of 
imaging), we disagree with the RUC recommendation to assign a work RVU 
of 0.70 based on the survey 25th percentile to this code, because we 
believe that it is inconsistent with the RUC-recommended reduction in 
physician time. We proposed a work RVU of 0.64 based on the following 
total time ratio: The RUC-recommended 27 minutes divided by the current 
28 minutes multiplied by the current work RVU of 0.66, which results in 
a work RVU of 0.64. We note that this value is bracketed by the work 
RVUs of CPT code 93287 (Peri-procedural device evaluation (in person) 
and programming of device system parameters before or after a surgery, 
procedure, or test with analysis, review and report by a physician or 
other qualified health care professional; single, dual, or multiple 
lead implantable defibrillator system), with a work RVU of 0.45, and 
CPT code 94617 (Exercise test for bronchospasm, including pre- and 
post-spirometry, electrocardiographic recording(s), and pulse 
oximetry), with a work RVU of 0.70. Both of these supporting crosswalks 
have intraservice time values

[[Page 62766]]

of 10 minutes, and they have similar total time values.
    For CPT code 78801 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar, 
2 or more areas (e.g., abdomen and pelvis, head and chest), 1 or more 
days of imaging or single area imaging over 2 or more days), we 
disagree with the RUC recommendation to maintain the current work RVU 
of 0.79 despite a 22-minute reduction in intraservice time. We believe 
a reduction from the current value is warranted given the recommended 
reduction in physician time, and also to be consistent with other 
services of similar time values. We proposed a work RVU of 0.73 based 
on the RUC-recommended incremental relationship between this code and 
CPT code 78800 (a difference of 0.09 RVU), which we apply to our 
proposed value for the latter code. As support for our proposed work 
RVU of 0.73, we note that it falls between the work RVUs of CPT code 
94617 (Exercise test for bronchospasm, including pre- and post-
spirometry, electrocardiographic recording(s), and pulse oximetry) with 
a work RVU of 0.70, and CPT code 93280 (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; dual lead pacemaker system) with a 
work RVU of 0.77.
    For CPT code 78802 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar, 
whole body, single day of imaging), we disagree with the RUC 
recommendation to maintain the current work RVU of 0.86, as we believe 
that it is inconsistent with a reduction in time values, and because we 
do not agree that a work RVU that is among the highest of other 
services of similar intraservice time values is appropriate. We 
proposed a work RVU of 0.80 based on the RUC-recommended incremental 
relationship between this code and CPT code 78800 (a difference of 0.16 
RVU), which we apply to our proposed value for the latter code. As 
support for our proposed work RVU of 0.80, we note that it falls 
between the work RVUs of CPT code 92520 (Laryngeal function studies 
(i.e., aerodynamic testing and acoustic testing)) with a work RVU of 
0.75, and CPT code 93282 (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; single lead transvenous implantable 
defibrillator system) with a work RVU of 0.85.
    For CPT code 78804 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); planar, 
whole body, requiring 2 or more days of imaging), we disagree with the 
RUC recommendation to maintain the current work RVU of 1.07, as we 
believe that it is inconsistent with a reduction in time values, and 
because this work RVU appears to be valued highly relative to other 
services of similar time values. We proposed a work RVU of 1.01 based 
on the RUC-recommended incremental relationship between this code and 
CPT code 78800 (a difference of 0.37 RVU), which we apply to our 
proposed value for the latter code. As support for our proposed work 
RVU of 1.01, we reference CPT code 91111 (Gastrointestinal tract 
imaging, intraluminal (e.g., capsule endoscopy), esophagus with 
interpretation and report), which has a work RVU of 1.00 and similar 
physician time values.
    For CPT code 78803 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT), single area (e.g., head, neck, chest pelvis), 
single day of imaging), we disagree with the RUC recommendation to 
increase the work RVU to 1.20 based on the survey 25th percentile to 
this code, because we believe that it is inconsistent with the RUC-
recommended reduction in physician time. We proposed to maintain the 
current work RVU of 1.09. We support this value with a reference to CPT 
code 78266 (Gastric emptying imaging study (e.g., solid, liquid, or 
both); with small bowel and colon transit, multiple days), which has a 
work RVU of 1.08, and similar time values.
    For CPT code 78830 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT) with concurrently acquired computed tomography (CT) 
transmission scan for anatomical review, localization and 
determination/detection of pathology, single area (e.g., head, neck, 
chest or pelvis), single day of imaging), we disagree with the RUC 
recommendation to assign a work RVU of 1.60 based on the survey 25th 
percentile to this code, as this would value this code more highly than 
services of similar time values. To maintain relativity among services 
in this family, we proposed a work RVU of 1.49 for CPT code 78830 based 
on the RUC-recommended incremental relationship between CPT code 78830 
and CPT code 78803 (a difference of 0.40 RVU), which we apply to our 
proposed value for the latter code. As support for our proposed work 
RVU of 1.49, we note that it is bracketed by the work RVUs of CPT codes 
72195 (Magnetic resonance (e.g., proton) imaging, pelvis; without 
contrast material(s)) with a work RVU of 1.46, and 95861 (Needle 
electromyography; 2 extremities with or without related paraspinal 
areas) with a work RVU of 1.54. The physician time values of these 
services bracket those recommended for CPT code 778X0.
    For CPT code 78831 (Radiopharmaceutical localization of tumor, 
inflammatory process or distribution of radiopharmaceutical agent(s), 
(includes vascular flow and blood pool imaging when performed); 
tomographic (SPECT), minimum 2 areas (e.g., pelvis and knees, abdomen 
and pelvis), single day of imaging, or single area of imaging over 2 or 
more days), we disagree with the RUC recommendation to assign a work 
RVU of 1.93 based on the survey 50th percentile to this code, as this 
would value this code more highly than services of similar time values. 
To maintain relativity among services in this family, we proposed a 
work RVU of 1.82 based on the RUC-recommended incremental relationship 
between this code and CPT code 78803 (a difference of 0.73 RVU), which 
we apply to our proposed value for the latter code. As support for our 
proposed work RVU of 1.82, we note that it is bracketed by the work 
RVUs of the CPT codes which are members of the same code families 
referenced for the previous CPT code, 78830: CPT codes 72191 (Computed 
tomographic angiography, pelvis, with contrast material(s), including 
noncontrast images, if performed, and image postprocessing) with a work 
RVU of 1.81, and 95863 (Needle electromyography; 3 extremities with or 
without related paraspinal areas) with a work RVU of 1.87. The 
physician time values of these services bracket those recommended for 
CPT code 778X1.
    For CPT code 78832 (Radiopharmaceutical localization of

[[Page 62767]]

tumor, inflammatory process or distribution of radiopharmaceutical 
agent(s), (includes vascular flow and blood pool imaging when 
performed); tomographic (SPECT) with concurrently acquired computed 
tomography (CT) transmission scan for anatomical review, localization 
and determination/detection of pathology, minimum 2 areas (e.g., pelvis 
and knees, abdomen and pelvis), single day of imaging, or single area 
of imaging over 2 or more days imaging), we disagree with the RUC 
recommendation to assign a work RVU of 2.23 based on the survey 50th 
percentile to this code, as this would value this code more highly than 
services of similar time values. To maintain relativity among services 
in this family, we proposed a work RVU of 2.12 based on the RUC-
recommended incremental relationship between this code and CPT code 
78803 (a difference of 1.03 RVU), which we apply to our proposed value 
for the latter code. As support for our proposed work RVU of 2.12, we 
reference CPT code 70554 (Magnetic resonance imaging, brain, functional 
MRI; including test selection and administration of repetitive body 
part movement and/or visual stimulation, not requiring physician or 
psychologist administration), which has a work RVU of 2.11 and 
physician intraservice and total time values that are identical to 
those recommended for this service.
    For CPT code 78835 (Radiopharmaceutical quantification 
measurement(s) single area), we disagree with the RUC recommendation to 
assign a work RVU of 0.51 based on the survey 25th percentile to this 
code, because we want to maintain relativity and proportionality among 
codes of this family. We based our values for the other codes in this 
family on their relative relationship to either CPT code 78800 or 
78832, depending on the type of service described by the code. For CPT 
code 78830, which describes a single day of imaging and is thus 
analogous to CPT code 78835 in terms of units of service, our analysis 
indicates a reduction from the RUC value of approximately 7 percent is 
appropriate. Therefore, we apply a similar reduction of 7 percent to 
the RUC-recommended work RVU of 0.51 to arrive at an RVU of 0.47. We 
support this value by noting that it is bracketed by add-on CPT codes 
77001 (Fluoroscopic guidance for central venous access device 
placement, replacement (catheter only or complete), or removal 
(includes fluoroscopic guidance for vascular access and catheter 
manipulation, any necessary contrast injections through access site or 
catheter with related venography radiologic supervision and 
interpretation, and radiographic documentation of final catheter 
position) (List separately in addition to code for primary procedure)) 
with a work RVU of 0.38, and 77002 (Fluoroscopic guidance for needle 
placement (e.g., biopsy, aspiration, injection, localization device) 
(List separately in addition to code for primary procedure)), with a 
work RVU of 0.54. Both of these reference CPT codes have intraservice 
time values that are similar to, and total time values that are 
identical to, those recommended for CPT code 78835.
    For the direct PE inputs, we are refining the number of minutes of 
clinical labor allocated to the activity ``Prepare, set-up and start 
IV, initial positioning and monitoring of patient'' to the 2-minute 
standard for CPT codes 78800, 78801, 78802, 78804, 78803, 78830, 78831, 
and 78832, as no rationale was provided for these codes to have times 
above the standard for this activity. We are also refining the 
equipment time formulas to reflect this clinical labor refinement for 
these codes. For CPT codes 78800, 78801, 78802, 78804, 78803, 78830, 
78831, and 78832, we proposed to refine the equipment times to match 
our standard equipment time formula for the professional PACS 
workstation. For the supply item SM022 ``sanitizing cloth-wipe 
(surface, instruments, equipment),'' we proposed to refine these 
supplies to quantities of 5 each for CPT codes 78801, 78804, and 78832 
to conform with other codes in the family.
    We received public comments on the proposed valuation of the codes 
in the SPECT-CT Procedures family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter disagreed with our proposal which revalues 
these codes based on a total time ratio to value CPT code 78800 and 
increments between CPT code 78800 and CPT codes 78801, 78802, and 
78804, and maintains the current value for CPT code 78803 and uses 
increments between the latter code and CPT codes 78830, 78831, and 
78832. According to this commenter, our proposal is inappropriate, as 
it relies on an invalid total time ratio methodology to value CPT code 
78800, and this time ratio methodology contradicts our stated position 
that we do not consider decrease in time as reflected in survey values 
equates to a one-to-one or linear decrease in the valuation of work 
RVUs.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. For more details on our methodology for 
developing work RVUs, we refer readers to our discussion of the subject 
in Section 2, Methodology for Establishing Work RVUs (section II.N.2. 
of this final rule), as well as a longer discussion in the CY 2017 PFS 
final rule (81 FR 80272 through 80277).
    Comment: One commenter stated that the methodology used in the 
original valuation of CPT codes 78800, 78801, and 78803 is unknown and 
not resource-based; therefore, it is invalid to compare the current 
time and work to the surveyed time and work. This code's source of time 
is Harvard, implying that the time was merely extrapolated and not 
measured directly. The commenter noted that CMS' continued practice of 
referencing physician times and derived intensities created almost 30 
years ago under the Harvard study as a method to critique RUC 
recommendations is not appropriate. The commenter also stated that the 
Harvard study employed much less rigor when determining physician time 
relative to the modern RUC/CMS process.
    Response: We believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available and that we are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: For CPT Code 78835, a commenter stated that our 
application of a percentage reduction to a RUC recommendation is 
inappropriate and

[[Page 62768]]

not resourced based. The work of add-on code 78835 is a separate 
tangential service where the physician interprets and reviews a 
processed quantitated dataset and quality control information. Although 
78835 is an add-on code for SPECT-CT, the commenter stated that the 
work of the add-on code differs markedly from the work of supervising 
and interpreting the SPECT-CT images themselves. The physicians not 
only reviews and interprets the dataset, but also commonly will redraw 
and reprocess to ensure reproducibility as they compare to prior images 
or datasets. The commenter stated that decisions are often discussed 
with referring physicians for improvement or decline of patients' area 
of interest status, and therefore, this is a very intense service as 
patient management will rely heavily on the quantitative comparisons.
    Response: We continue to believe that applying a percentage 
reduction to the RUC-recommended value in this instance is an 
appropriate method of maintaining relativity among these services. Our 
proposed valuation for this service is consistent with other add-on 
codes of similar time, and maintains relative value with the other 
codes in the code family. In addition, we note that the intensity 
measure which results from our proposed value is essentially identical 
to that derived from the RUC-recommended value; the difference is only 
0.002 of IWPUT. For these reasons, we believe that our proposed work 
RVU adequately captures the inherent intensity, and we note that the 
intensity value that results from our work RVU is virtually identical 
to that which results from the RUC value.
    Comment: Commenters disagreed with our refinement to the clinical 
labor minutes allocated for the CA016 activity, and stated that the 
additional minute(s) above the standard PE 2 minutes is to account for 
the additional handling of the radiotracers or setting up the patient 
in the camera.
    Response: We appreciate the additional information provided by the 
commenter, and in response to public comment, we are not finalizing our 
proposed refinements to the minutes allocated to the CA016 activity, 
and we are instead finalizing the RUC-recommended time inputs for this 
activity for all of the codes in the family.
    Comment: A commenter disagreed with our proposed refinements to the 
SM022 supply item, used to clean the nuclear medicine equipment room 
and the room to receive and measure the radiotracers. The commenter 
stated that, if the imaging is typically over 2 days, then 10 items are 
needed. Also, if there are two radiotracers, then 10 not 5 of the wipes 
are needed because some of the wipes are used on camera and the area 
where the patient is given the injection(s) and others are used for the 
place where you receive and then go back to draw up the radiotracers.
    Response: In response to public comment, we are not finalizing our 
proposed refinement, and instead are adopting the RUC-recommended 
quantities of the SM022 supply item.
    Comment: One commenter sent invoices to update the price for the 
``gamma camera system, single-dual head SPECT CT'' (ER097) equipment. 
The commenter stated that an average and typical negotiated price is 
$750,000 for this piece of equipment and that the CMS price for ER097 
was undervaluing these services. The commenter urged CMS to update this 
equipment input price so that the reviewed procedures would be assessed 
appropriately and remain relative in valuation to other planar, SPECT, 
PET or PET-CT nuclear medicine services.
    Response: We appreciate the submission of additional invoices from 
the commenter for use in pricing the ER097 gamma camera system. We are 
finalizing an increase in the price of this equipment item from the 
proposed $464,428.95 to $703,443.37 based on the submission of five 
invoices. Because the invoices for the ER097 gamma camera system were 
submitted as part of a revaluation or comprehensive review of a code 
family, this updated pricing will be fully implemented immediately for 
CY 2020 rather than being phased in over the 4-year supply and 
equipment pricing transition. (For additional details on this policy 
finalized in CY 2019, see 83 FR 59474 in the CY 2019 PFS final rule.)
    After consideration of the public comments, we are finalizing our 
proposed work RVUs and direct PE refinements, with the exception of the 
CA016 clinical labor activity and SM022 supply item, for which we are 
finalizing the RUC-recommended labor times and quantities.
(51) Myocardial PET (CPT Codes 78459, 78429, 78491, 78430, 78492, 
78431, 78432, 78433, and 78434)
    CPT code 78492 (Myocardial imaging, positron emission tomography 
(PET), perfusion; multiple studies at rest and/or stress) was 
identified via the High Volume Growth screen with total Medicare 
utilization over 10,000 that increased by at least 100 percent from 
2009 through 2014. The CPT Editorial Panel revised this code set to 
reflect newer technology aspects such as wall motion, ejection 
fraction, flow reserve, and technology updates for hardware and 
software. The CPT Editorial Panel deleted a Category III code, added 
six Category I codes, and revised the three existing codes to 
separately identify component services included for myocardial imaging 
using positron emission tomography.
    For CPT code 78491 (Myocardial imaging, positron emission 
tomography, perfusion study (including ventricular wall motion(s), and/
or ejection fractions(s), when performed); single study, at rest or 
stress (exercise or pharmacologic)), we disagreed with the RUC-
recommended work RVU of 1.56, which is the survey 25th percentile 
value, as we believed that the 30-minute reduction in intraservice time 
and 15-minute reduction in physician total time does not validate an 
increase in work RVU, and we believed that the significance of the 
reductions in recommended physician time values warranted a reduction 
in work RVU. We proposed a work RVU of 1.00 based on the following 
total time ratio: The recommended 30 minutes divided by the current 45 
minutes multiplied by the current work RVU of 1.50, which results in a 
work RVU of 1.00. As further support for this value, we note that it 
falls between CPT code 78278 (Acute gastrointestinal blood loss 
imaging), with a work RVU of 0.99, and CPT code 10021 (Fine needle 
aspiration biopsy, without imaging guidance; first lesion), with a work 
RVU of 1.03.
    For CPT code 78430 (Myocardial imaging, positron emission 
tomography, perfusion study (including ventricular wall motion(s), and/
or ejection fractions(s), when performed); single study, at rest or 
stress (exercise or pharmacologic), with concurrently acquired computed 
tomography transmission scan), we disagreed with the RUC recommendation 
of 1.67 based on the survey 25th percentile, as we did not agree this 
service would be appropriately valued with an RVU that is among the 
highest of all services of similar times with this global period. We 
proposed a work RVU of 1.11 by applying the RUC-recommended increment 
between CPT code 78491 and this code, an increment of 0.11, to our 
proposed value of 1.00 for CPT code 78491, thus maintaining the RUC's 
recommended incremental relationship between these codes. As further 
support for this value, we noted that it falls between CPT codes 95977 
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s], interleaving, amplitude, pulse 
width, frequency [Hz], on/off cycling, burst, magnet mode, dose 
lockout, patient selectable parameters,

[[Page 62769]]

responsive neurostimulation, detection algorithms, closed loop 
parameters, and passive parameters) by physician or other qualified 
health care professional; with complex cranial nerve neurostimulator 
pulse generator/transmitter programming by physician or other qualified 
health care professional)), with a work RVU of 0.97, and 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), with a work RVU of 1.25; 
both of these codes have similar physician time values.
    For CPT code 78459 (Myocardial imaging, positron emission 
tomography (PET), metabolic evaluation study (including ventricular 
wall motion(s), and/or ejection fraction(s), when performed) single 
study), we disagreed with the RUC recommendation to increase the work 
RVU to 1.61 based on the survey 25th percentile. We believed that the 
magnitude of the recommended reductions in physician time (a 50-minute 
reduction in intraservice time and a 32-minute reduction in total time) 
suggests that this value is overestimated; furthermore, we note that 
the RUC's recommendation is among the highest for all XXX-global period 
codes, or codes for which the global period concept does not apply, 
with similar time values. We proposed a work RVU of 1.05 by applying 
the RUC-recommended increment between this code and CPT code 78491, a 
difference of 0.05, which we applied to our proposed value for the 
latter code. We support our RVU of 1.05 by referencing two CPT codes: 
10021 (Fine needle aspiration biopsy, without imaging guidance; first 
lesion), and 36440 (Push transfusion, blood, 2 years or younger), both 
of which have work RVUs of 1.03, as well as identical intraservice and 
similar total time values.
    We disagreed with the RUC's recommended valuation of 1.76 for CPT 
code 78429 (Myocardial imaging, positron emission tomography (PET), 
metabolic evaluation study (including ventricular wall motion(s), and/
or ejection fraction(s), when performed) single study; with 
concurrently acquired computed tomography transmission scan), which is 
based on the survey 25th percentile, because we believed a work RVU 
that is greater than those of all other services of similar 
intraservice time values is not appropriate. We proposed a work RVU of 
1.20 for CPT code 78429. We proposed to value CPT code 78429 with an 
incremental methodology, which preserves the RUC-recommended 
relationship among the codes in this family; the RUC recommends an 
increment of 0.20 between CPT code 78429 and CPT code 78491. We 
proposed to apply this increment to our proposed value of 1.00 for CPT 
code 78491 to arrive at our value of 1.20.
    We disagreed with the RUC's recommendation of 1.80 for CPT code 
78492 (Myocardial imaging, positron emission tomography, perfusion 
study (including ventricular wall motion(s), and/or ejection 
fractions(s), when performed); multiple studies at rest and stress 
(exercise or pharmacologic)) given the magnitude of the recommended 
reduction in physician time values (a 35-minute reduction in 
intraservice time and a 17-minute reduction in total time), and also 
given the fact that the RUC's recommended value would be the highest of 
all codes of this intraservice time and global period. We proposed a 
work RVU of 1.24 based on the RUC-recommended incremental difference 
between 78491 and 78492 of 0.24, which we add to our proposed value for 
78491 for a work RVU of 1.24. As further support for this value, we 
referenced CPT code 95908 (Nerve conduction studies; 3-4 studies), with 
a work RVU of 1.25, similar physician time values.
    We disagreed with the RUC's recommendation of 1.90 for CPT code 
78431 (Myocardial imaging, positron emission tomography, perfusion 
study (including ventricular wall motion(s), and/or ejection 
fractions(s), when performed); multiple studies at rest and stress 
(exercise or pharmacologic), with concurrently acquired computed 
tomography transmission scan) which is based on a crosswalk to CPT code 
64617 (Chemodenervation of muscle(s); larynx, unilateral, percutaneous 
(e.g., for spasmodic dysphonia), includes guidance by needle 
electromyography, when performed), because the fact that this work RVU 
is greater than those of all other services of similar intraservice 
time values suggested that it is an overestimate. Instead we proposed a 
work RVU of 1.34 for CPT code 78431, based on an incremental 
methodology. We apply the RUC-recommended increment between 78491 and 
CPT code 78431, a difference of 0.34, to our proposed value of 1.00 for 
CPT code 78491, for a value of 1.34. We supported this value by 
referencing CPT code 77261 (Therapeutic radiology treatment planning; 
simple), with a work RVU of 1.30, and CPT code 94003 (Ventilation 
assist and management, initiation of pressure or volume preset 
ventilators for assisted or controlled breathing; hospital inpatient/
observation, each subsequent day), with a work RVU of 1.37. These codes 
have similar physician time values.
    We disagreed with the RUC's recommendation of 2.07 for CPT code 
78432 (Myocardial imaging, positron emission tomography, combined 
perfusion with metabolic evaluation study (including ventricular wall 
motion(s), and/or ejection fraction(s), when performed), dual 
radiotracer (e.g., myocardial viability)), because we believed the fact 
that this work RVU is greater than those of all other services of 
similar intraservice time values suggests that it is an overestimate. 
We proposed a work RVU of 1.51 for CPT code 78432, based on an 
incremental methodology. We applied the RUC-recommended increment 
between 78491 and CPT code 78432, a difference of 0.51, to our proposed 
value of 1.00 for CPT code 78491, for a value of 1.51. We support this 
value by referencing CPT code 10005 (Fine needle aspiration biopsy, 
including ultrasound guidance; first lesion), with a work RVU of 1.46, 
and similar physician time values.
    Similarly for CPT code 78433 (Myocardial imaging, positron emission 
tomography, combined perfusion with metabolic evaluation study 
(including ventricular wall motion(s), and/or ejection fraction(s), 
when performed), dual radiotracer (e.g., myocardial viability); with 
concurrently acquired computed tomography transmission scan), we 
disagreed with the RUC's recommendation of 2.26 based on a crosswalk to 
CPT code 71552 (Magnetic resonance (e.g., proton) imaging, chest (e.g., 
for evaluation of hilar and mediastinal lymphadenopathy); without 
contrast material(s), followed by contrast material(s) and further 
sequences), because we believed the fact that this work RVU is among 
the highest among services of similar intraservice time values suggests 
that it is an overestimate. We proposed a work RVU of 1.70 by applying 
the RUC-recommended increment between CPT code 78433 and CPT code 
78491, which is a difference of 0.70, to our proposed value for CPT 
code 78491 for a value of 1.70. We supported this value by referencing 
CPT codes 95924 (Testing of autonomic nervous system function; combined 
parasympathetic and sympathetic adrenergic function testing with at 
least 5 minutes of passive tilt) and 74182 (Magnetic resonance (e.g., 
proton) imaging, abdomen; with contrast material(s)), both of which 
have work RVUs of 1.73.

[[Page 62770]]

    For CPT code 78434 (Absolute quantitation of myocardial blood flow 
(AQMBF), positron emission tomography, rest and pharmacologic stress 
(List separately in addition to code for primary procedure)), we 
disagreed with the RUC recommendation to assign a work RVU of 0.63 to 
this code based on the survey 25th percentile, because we believed a 
comparison to other codes with a global period of ZZZ (add-on codes) 
suggests that this is somewhat overvalued, and because we want to 
maintain relativity and proportionality to other codes in this series. 
We based our values for the other codes in this family on their 
relative relationships to CPT code 78491; for that code our analysis 
indicates that a reduction from the RUC value of roughly \1/3\ is 
appropriate, based on a ratio of the decrease in total time to the 
current work RVU. Therefore, we apply a similar reduction of \1/3\ to 
the RUC-recommended work RVU of 0.63 to arrive at an RVU of 
approximately 0.42. Applying a reduction that is similar to the 
reduction we believe is warranted from the RUC value for CPT code 78491 
to CPT code 78434 will maintain consistency in value among these 
services We believed this work RVU is validated by noting that it is 
bracketed by CPT codes 15272 (Application of skin substitute graft to 
trunk, arms, legs, total wound surface area up to 100 sq cm; each 
additional 25 sq cm wound surface area, or part thereof (List 
separately in addition to code for primary procedure)), with a work RVU 
of 0.33, and 11105 (Punch biopsy of skin (including simple closure, 
when performed); each separate/additional lesion (List separately in 
addition to code for primary procedure)), with a work RVU of 0.45. A 
work RVU of 0.42 is thus consistent with ZZZ global period codes of 
similar physician times.
    For the direct PE inputs, for several of the equipment items, we 
proposed to refine the equipment times to conform to our established 
policies for non-highly, as well as for highly technical equipment. 
(For the highly technical equipment standard, please see the discussion 
in the CY 2013 PFS final rule, 77 FR 69028.) In addition, we proposed 
to refine the equipment times to conform to our established policies 
for PACS Workstation. For the new equipment items ER110: ``PET 
Refurbished Imaging Cardiac Configuration'' and ER111: ``PET/CT Imaging 
Camera Cardiac Configuration,'' we proposed to assume that a 90 percent 
equipment utilization rate is typical, as this would be consistent with 
our equipment utilization assumptions for expensive diagnostic imaging 
equipment. For the supply item SM022 ``sanitizing cloth-wipe (surface, 
instruments, equipment),'' we proposed to refine these supplies to 
quantities of 5 each for CPT codes 78432 and 78433 to conform with 
other codes in the family. We proposed that we will not price the 
``Software and hardware package for Absolute Quantitation'' as a new 
equipment item, due to the fact that the submitted invoices included a 
service contract and a combined software/hardware bundle with no 
breakdown on individual pricing. Based on our lack of specific pricing 
data, we believe that this software is more accurately characterized as 
an indirect PE input that is not individually allocable to a particular 
patient for a particular service.
    We received public comments on the proposed valuation of the codes 
in the Myocardial PET family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter noted that the values published in the text of 
the 2020 PFS proposed rule do not match those posted in Table 20: 
Proposed CY 2020 Work RVUs for New, Revised and Potentially Misvalued 
Codes and in Addendum B.
    Response: We regret that we have posted inaccurate values in the 
proposed rule Addenda and in Table 20. Our proposed work RVUs are 
accurately reflected in the text of the proposed rule.
    Comment: A few commenters disagreed with our proposed work RVUs for 
CPT codes 78459, 78429, 78491, 78430, 78492, 78431, 78432, and 78433, 
stating that our use of a time ratio to value CPT code 78491 is 
invalid, as it treats all components of physician time (pre-service, 
intra-service, post-service and post-operative visits) as having 
identical intensity. Similarly, the commenter stated that our use of 
increments to value CPT codes 78459, 78429, 78430, 78492, 78431, 78432, 
and 78433 is inappropriate as it treats all components of the physician 
time as having identical intensity. The commenter stated that our 
proposed values for these codes vastly underestimate the physician work 
required to perform these services.
    These commenters stated that our proposed valuations for these 
codes take no account of the fact that the physician work involved with 
these services has changed, and that substantial changes in 
instrumentation, hardware and software have occurred since these codes 
were created.
    Response: As discussed in the Methodology for Establishing Work 
RVUs section of this rule (section II.N.2. of this final rule), we 
continue to believe that time ratios are one of several appropriate 
methodologies for valuing services. However, we are persuaded that 
examining the changes in physician time for these services alone may 
not adequately reflect increases in intensity due to changes in 
technology for these services. We are persuaded by the comments that 
suggest that these codes describe services that have changed 
substantially over time. After consideration of the public comment, and 
in the interest of payment stability and protecting patient access for 
these services, we are not finalizing the proposed work RVUs for these 
services and instead are adopting the RUC-recommended work RVUs for 
these services.
    Comment: Many commenters stated that moving from contractor pricing 
to active pricing for the technical component (TC) of these services 
using inputs as proposed will result in drastic reductions in payment 
rates for these services. These commenters stated that our proposal 
will result in a roughly 80 percent reduction in payments for the TC, 
and that this reduction will effectively eliminate access to Myocardial 
PET. Commenters stated that the RUC recommended direct PE inputs 
understate technical costs. Commenters discussed the importance of this 
service as a non-invasive diagnostic tool which they stated is superior 
to conventional nuclear cardiology and reduces the need for coronary 
angiography and coronary interventions. Commenters offered detailed 
evidence on the efficacy of PET and its usefulness in reducing 
mortalities and morbidities; this evidence includes a study which 
demonstrates that in patients being evaluated for suspected coronary 
artery disease, Cardiac PET results in a 50 percent reduction in the 
use of coronary arteriography and CABG and a 30 percent reduction in 
direct patient management costs, while maintaining excellent patient 
outcomes and minimizing indirect costs. Commenters noted other studies 
demonstrate the effectiveness of PET as a diagnostic tool when compared 
to other modalities for diagnosis of myocardial ischemia.
    Commenters representing Cardiologists expressed support for the RUC 
process, however, they noted that they are alarmed at the proposed 75-
80 percent reduction in the TC payment and stated it is not consistent 
with the amounts necessary to continue to operate a Cardiac PET 
facility. Further, they argued that the inputs used to calculate 
payment were incomplete and

[[Page 62771]]

inaccurate, which combined to trigger an unsustainable proposal. These 
commenters requested that we work with physicians, industry, and 
cardiologist representatives to improve the accuracy of all inputs used 
to generate the proposed CY 2020 RVUs, and they requested that CMS 
maintain payment at current levels pending an appropriate revision.
    Response: As stressed by many commenters, adopting active pricing 
for the TC of these codes will result in significant reductions in 
payment. We believe there is substantial work to be done to assure the 
new valuations for the TCs of these codes accurately reflect the 
technical inputs. In the interest of maintaining payment stability and 
protecting patient access to these important services, we are delaying 
the adoption of active pricing for these codes until such time as more 
accurate sets of inputs can be developed, and we are maintaining 
contractor pricing for the TC of these services. CMS will continue to 
review the inputs, and encourage the public to submit additional 
information on the most accurate resource-based payment for these 
services by our annual February 10th deadline for consideration in 
future rulemaking.
    Comment: One commenter disagreed with our proposed refinements to 
the SM022 supply item, used to clean the nuclear medicine equipment 
room and the room to receive and measure the radiotracers. The 
commenter stated that, if the imaging is typically over 2 days, then 10 
items are needed. Also, if there are two radiotracers, then 10 not 5 of 
the wipes are needed because some of the wipes are used on camera and 
the area where the patient is given the injection(s) and others are 
used for the place where you receive and then go back to draw up the 
radiotracers.
    Response: In response to public comment, we are not finalizing the 
proposed refinement and instead are finalizing the RUC-recommended 
quantities of the SM022 supply item.
    Comment: Several commenters submitted invoices to update the price 
for the ``PET Refurbished Imaging Cardiac Configuration'' (ER110) and 
the ``PET/CT Imaging Camera Cardiac Configuration'' (ER111) equipment 
items. The commenters urged CMS to update these equipment prices in 
response to the additional data included on the invoices.
    Response: We appreciate the submission of additional invoices from 
the commenters for use in pricing the ER110 and ER111 equipment items. 
We are finalizing an increase in the price of the ER110 ``PET 
Refurbished Imaging Cardiac Configuration'' equipment from the proposed 
$425,000 to $527,615.63 based on additional pricing data, from one 
submitted invoice to an average of ten invoices. We are finalizing an 
increase in the price of the ER111 ``PET/CT Imaging Camera Cardiac 
Configuration'' equipment from the proposed $1,232,226.44 to 
$1,364,960.59 based on additional pricing data, from an average of four 
submitted invoices to an average of eight invoices. We note that we 
also received an additional invoice for the ER111 equipment at a price 
of $3,206,811.30; however, due to the fact that this invoice was nearly 
triple the price of the other eight invoices, we did not include it in 
the overall average as it appears to be an outlier that is not 
representative of typical pricing.
    Comment: Several commenters disagreed with the CMS proposal to 
refrain from establishing a price for the ``Software and hardware 
package for Absolute Quantitation'' as a new equipment item. Commenters 
stated that it was unreasonable for CMS to propose that the software 
should be removed, as historically all nuclear medicine hardware must 
have software to run them or they do not work. Commenters stated that 
practitioners must have both the hardware and software to analyze 
myocardial blood flow and that separating the software and hardware 
would render this system inoperable. One commenter urged CMS to price 
the software and hardware package for absolute quantitation as 
recommended while other commenters submitted additional invoices and 
asked CMS to use them for pricing.
    Response: We stated in the proposed rule that we would not price 
the ``Software and hardware package for Absolute Quantitation'' as a 
new equipment item due to the fact that the submitted invoices included 
a service contract and a combined software/hardware bundle with no 
breakdown on individual pricing. We appreciate the submission of 
additional invoices from the commenters with more specific pricing 
information for this equipment without the inclusion of a service 
contract, which we continue to believe is a form of indirect PE. 
Therefore, we are finalizing the creation of ``Software and hardware 
package for Absolute Quantitation'' as a new equipment item (ER113) at 
a price of $44,652.33 based on the submission of six new invoices from 
the commenters.
    Comment: One commenter stated that the pricing for the new PET 
Generator Infusion Cart (ER109) was incorrect. The commenter stated 
that the invoices used to establish the proposed price for the ER109 
equipment were instead for the purchase of the ``generator'' that comes 
loaded with the radioactive rubidium 82. The commenter explained that 
the infusion cart is the machine that houses the rubidium generator and 
draws the rubidium tracer doses, and that the generator is a separate 
equipment item. The commenter provided four invoices for the purchase 
of the infusion cart itself, as well as several invoices for the 
monthly rental fee of an infusion cart.
    Response: We appreciate the additional information provided by the 
commenter with regards to the PET generator and infusion cart, 
including the invoices for the monthly rental fee of an infusion cart. 
Based on the information provided by the commenter, we are finalizing a 
change to the name of the ER109 equipment item, which were are changing 
from ``PET Generator Infusion Cart'' to ``PET Infusion Cart'' to more 
accurately reflect the equipment in question. We are finalizing the 
price of the ER109 infusion cart at $74,225.47 based on the submission 
of four new invoices from the commenters. In light of the clarification 
provided by the commenters, we are also creating a new ER114 equipment 
item named ``PET Generator (Rubidium)'' to cover the cost of the 
generator. The price of the ER114 equipment remains unchanged from the 
proposed price of $47,052.80, which had mistakenly been applied to the 
ER109 infusion cart in the proposed rule, and we will assign the same 
equipment time to the ER114 generator as proposed for the ER109 
infusion cart in CPT codes 78430, 78431, 78432, 78433, 78434, 78491, 
and 78492. We note as well for future reference that although we 
appreciated the submission of the rental invoices, we are unable to use 
invoices for a monthly rental fee to determine the typical purchase 
price for equipment. We believe that invoices for a monthly rental fee 
would not be representative of the purchase price for equipment, in the 
same fashion that the rental fee for a car differs from its purchase 
price.
    Comment: One commenter supplied additional invoices for costs 
associated with Myocardial PET procedures that the commenter believed 
should be considered in pricing. The commenter stated that it was 
typical for building infrastructure improvements like enhanced load-
bearing supports, lead-lining in the walls, and separate cooling 
systems to be necessary to install and maintain a PET machine. The 
commenter stated that payment rates that failed to account for the 
startup and maintenance costs necessary to provide high-quality imaging 
services to sick

[[Page 62772]]

patients would further disadvantage practices that provide Myocardial 
PET.
    Response: We disagree with the commenter that these additional 
invoices constitute forms of direct PE. The commenter submitted two 
invoices for a ``Lead PET Cabinet'' which would be used for storage 
purposes. Under our PE methodology as detailed in the CY 2010 final 
rule with comment period (74 FR 61743-61748), this is considered to be 
an administrative cost which falls under indirect PE, similar to the 
expenses associated with office rent, as it is not a cost directly 
associated with the furnishing of the procedure. The commenter also 
submitted three invoices for a ``PET Service Contract'', which, as the 
name suggests, constitutes a service contract that we would also 
consider to be an administrative expense and a form of indirect PE. The 
details of this contract specify that it included ``maintenance, 
testing, and quality control'' for PET equipment; however, our 
equipment pricing formula already includes maintenance costs, and if we 
were to pay separately for this service contract, we would be paying 
duplicatively for this equipment. We agree with the commenter that 
there are significant costs associated with running a practice that 
furnishes services involving capital-intensive imaging equipment. 
However, under our PE methodology these costs are included under 
indirect PE in the form of administrative and office rent expenses, and 
it would be inaccurate and duplicative to include them as a separate 
direct PE cost.
    Comment: Several commenters disagreed with the CMS proposal to 
assume that a 90 percent equipment utilization rate would be typical 
for the new ``PET Refurbished Imaging Cardiac Configuration'' (ER110) 
and ``PET/CT Imaging Camera Cardiac Configuration'' (ER111) equipment 
items. Commenters stated that they had collected data from the number 
of patients imaged with this equipment each day, which showed an 
overall average of 4.5 patients imaged per facility per day. Commenters 
stated that this work flow data equated to the equipment remaining in 
use for 5-6 hours each day, which was far lower than what a 90 percent 
utilization rate would suggest. Commenters noted that these PET 
services existed in 2010 when CMS made the decision to apply the 90 
percent utilization rate only to CT and MRI services, and they were 
unaware of any changes in CMS policy or any statutory requirement to 
assume a 90 percent utilization rate for PET imaging. Commenters stated 
that experts that perform cardiac PET and PET-CT in the physician 
office and independent diagnostic testing facility (IDTF) settings 
confirmed that a 50 percent utilization would be a more accurate 
utilization rate and urged CMS to adopt the default utilization rate of 
50 percent.
    Response: We appreciate the submission of additional information 
from the commenters, particularly the work flow study data that 
indicated that the PET equipment typically remains in use for 5-6 hours 
per day. Based on the information from the commenters, we are not 
finalizing our proposal to assume a 90 percent utilization rate for the 
ER110 and ER111 equipment items, and we will instead finalize the 
default 50 percent utilization rate assumption for both equipment 
items.
    Comment: A commenter stated that they were concerned about a rapid 
transition from contractor pricing to relative values that are 
significantly lower than current rates. The commenter stated that CMS 
should use the most current paid (2018) contractor claims for CPT codes 
78459, 78491 and 78492 to establish a weighted average technical rate 
for each code, and then use its authority to phase in changes in 
payment so as not to disrupt services. The commenter acknowledged that 
it could be argued as to whether or not the phase-in provision applied 
to CPT codes 78459, 78491 and 78492, but urged CMS to phase in these 
codes and limit them to no more than a 20 percent reduction for the 
technical or global in any one year so as to not jeopardize patient 
access to care.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that are not new or revised 
codes, if the total RVUs for a service for a year would otherwise be 
decreased by an estimated 20 percent or more as compared to the total 
RVUs for the previous year, the applicable adjustments in work, PE, and 
MP RVUs shall be phased-in over a 2-year period. We proposed to exempt 
CPT codes 78459, 78491 and 78492 from the phase-in of significant RVU 
reductions required by section 1848(c)(7) of the Act due to the fact 
that they are moving from contractor-priced status to active pricing 
status; we believe that this constitutes a ``revised'' code for 
purposes of section 1848(c)(7) of the Act. We have also previously 
finalized a policy through rulemaking stating that significant coding 
revisions within a family of codes can change the relationships among 
codes to the extent that it changes the way that all services in the 
group are reported, even if some individual codes retain the same 
number or, in some cases, the same descriptor. Excluding codes from the 
phase-in when there are significant revisions to the code family also 
helps to maintain the appropriate rank order among codes in the family, 
avoiding years for which RVU changes for some codes in a family are in 
transition while others were fully implemented. We believe that either 
the shift from contractor-priced status to active pricing status or 
inclusion as part of a code family undergoing major revisions 
constitutes a ``revised'' code for purposes of section 1848(c)(7) of 
the Act. For additional information regarding the phase-in of 
significant RVU reductions, we direct readers to the CY 2016 PFS final 
rule with comment period (80 FR 70927 through 70929).
    After consideration of the public comments, we are not finalizing 
our proposed work RVUs, and are instead finalizing the RUC-recommended 
work RVUs. We are not finalizing our proposal to assign PE RVUs using 
direct PE inputs, and we are instead maintaining contractor pricing for 
the TC of these services.
(52) Cytopathology, Cervical-Vaginal (CPT Code 88141, HCPCS Codes 
G0124, G0141, and P3001)
    CPT code 88141 (Cytopathology, cervical or vaginal (any reporting 
system), requiring interpretation by physician), HCPCS code G0124 
(Screening cytopathology, cervical or vaginal (any reporting system), 
collected in preservative fluid, automated thin layer preparation, 
requiring interpretation by physician), HCPCS code G0141 (Screening 
cytopathology smears, cervical or vaginal, performed by automated 
system, with manual rescreening, requiring interpretation by 
physician), and HCPCS code P3001 (Screening Papanicolaou smear, 
cervical or vaginal, up to three smears, requiring interpretation by 
physician) were identified as potentially misvalued on a list of CMS or 
other source codes with Medicare utilization of 30,000 or more.
    In the CY 2000 PFS final rule (64 FR 59408), we finalized a policy 
that it was more appropriate to evaluate the work, PE, and MP RVUs for 
HCPCS codes P3001, G0124, and G0141 identical or comparable to the 
values of CPT code 88141.
    For CY 2020, the RUC recommended a work RVU of 0.42 for CPT code 
88141 and HCPCS codes G0124, G0141, and P3001, based on the current 
value. We disagreed with the RUC-recommended work RVU and proposed a 
work RVU of 0.26 for all four codes in this family, based on our 
intraservice time ratio methodology and a crosswalk to CPT code 93313 
(Echocardiography, transesophageal, real-time with image

[[Page 62773]]

documentation (2D) (with or without M-mode recording); placement of 
transesophageal probe only), which has an identical work RVU of 0.26, 
identical intraservice and total work times values to CPT code 88141 
and HCPCS codes G0124, and G0141, and similar intraservice and total 
time values to HCPCS code P3001.
    In reviewing this family of codes, we noted that the intraservice 
and total work times for CPT code 88141 and HCPCS codes G0124, and 
G0141 are decreasing from 16 minutes to 10 minutes (38 percent 
reduction) and the intraservice and total work times for HCPCS code 
P3001 are decreasing from 16 minutes to 12 minutes (25 percent 
reduction). However, the RUC recommended a work RVU of 0.42 for all 
four codes in this family, based on the maintaining the current work 
RVU. Although we did not imply that the decrease in time as reflected 
in survey values must equate to a one-to-one or linear decrease in the 
valuation of work RVUs, we 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 88141 and HCPCS codes G0124, G0141, and P3001, we believed that it 
would be more accurate to propose a work RVU of 0.26, based on our 
intraservice time ratio methodology and a crosswalk to CPT code 93313 
to account for these decreases in the surveyed work times.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Perform regulatory mandated quality assurance activity'' 
(CA033) activity from 7 minutes to 5 minutes for all four codes in the 
family. We believed that these quality assurance activities would not 
typically take 7 minutes to perform, given that similar federally 
mandated Mammography Quality Standards Act (MQSA) activities were 
recommended and finalized at a time of 4 minutes for CPT codes 77065-
77067 in CY 2017 (81 FR 80314-80316), and other related regulatory 
compliance activities were recommended and finalized at a time of 5 
minutes for CPT codes 78012-78014 in CY 2013 (77 FR 69037). To preserve 
relativity between services, we proposed a clinical labor time of 5 
minutes for the codes in this family based on this prior allocation of 
clinical labor time.
    We are also proposed to remove the 1-minute of clinical labor time 
for the ``File specimen, supplies, and other materials'' (PA008) 
activity from all four codes under the rationale that this task is a 
form of indirect PE. As we stated in the CY 2017 PFS final rule (81 FR 
80324), we agree that filing specimens is an important task, and we 
agree that these would take more than zero minutes to perform. However, 
we continue to believe that these activities are correctly categorized 
under indirect PE as administrative functions, and therefore, we do not 
recognize the filing of specimens as a direct PE input, and we do not 
consider this task as typically performed by clinical labor on a per-
service basis.
    We proposed to refine the equipment time for the compound 
microscope (EP024) equipment to 10 minutes for all four codes in the 
family to match the work time of the procedures. The recommended 
materials for this code family state that the compound microscope is 
utilized by the pathologist, and therefore, we believe that the 10-
minute work time of the procedures would be the most accurate equipment 
time to propose.
    We received public comments on the proposed valuation of the codes 
in the Cytopathology, Cervical-Vaginal family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter disagreed with the proposed work RVUs for CPT 
Code 88141, and HCPCS codes G0124, G0141, and P3001. This commenter 
stated that it is clear that CMS misinterpreted the RUC's 
recommendations because lowering the work value of code P3001, using 
what the commenter referred to as the ``CMS' 25 percent time ratio 
methodology,'' would equate to a work RVU of 0.32, not 0.26 as 
proposed. This commenter also urged CMS to discontinue its arbitrary 
use of invalid time components, invalid methodologies using time 
ratios, and other irrational uses of data to value physician services.
    Response: We note that we correctly interpreted the RUC's 
recommendations, and correctly applied a time ratio methodology to 
develop the proposed work RVUs for the codes in this family. We also 
considered an existing policy set forth in the CY 2000 PFS final rule 
(64 FR 59408), for these services to develop our proposed values. The 
RUC recommended maintaining the existing work RVU for all four codes in 
this family, which is a work RVU of 0.42. In our review of the codes in 
this family, the intraservice time ratio for CPT code 88141, suggest 
CPT code 88141 is better valued at a work RVU of 0.26. We note, that in 
an existing policy related to these four codes, discussed in the CY 
2000 PFS final rule (64 FR 59408), we finalized a policy that it was 
more appropriate to evaluate the work, PE, and MP RVUs for HCPCS codes 
P3001, G0124, and G0141 identical or comparable to the values of CPT 
code 88141. Thus, we proposed an identical work RVU of 0.26 for all 
four codes in this family, such that the proposed work RVU for HCPCS 
codes P3001, G0124, and G0141 are valued identical to CPT code 88141. 
We note that the RUC recommended that we maintain the same work RVU for 
all four codes in this family, and did not recommend a different work 
RVU for HCPCS P3001.
    We also clarify for the commenters that our review process is not 
arbitrary in nature. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the federal 
government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). With regards to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Several commenters disagreed with the proposed work RVUs 
for CPT Code 88141, and HCPCS codes G0124, G0141, and P3001. Commenters 
stated that CMS should instead finalize the RUC-recommended work RVUs 
for these procedures. Commenters disagreed with our reference to older 
work time sources, and noted that their use led to the proposal of work 
RVUs based on flawed assumptions. Commenters stated that codes with 
``CMS/Other'' or ``Harvard'' work time sources, used in the original 
valuation of certain older services, were not

[[Page 62774]]

surveyed, and therefore, were not resource-based. Commenters noted that 
it was invalid to draw comparisons between the current work times and 
work RVUs of these services to the newly surveyed work time and work 
RVUs as recommended by the RUC for the services.
    Response: We appreciate the commenters' concerns regarding CMS' 
interpretation of older work time sources and their use in the code 
valuation process for establishing work RVUs for these services. We 
agree that it is important to use the recent data available regarding 
work times, and we note that when many years have passed between when 
time is measured, significant discrepancies can occur. However, we also 
believe that our operating assumption regarding the validity of the 
existing values as a point of comparison is critical to the integrity 
of the relative value system as currently constructed. We have 
responded to concerns about our methodology earlier in this section. 
For additional information regarding the use of old work time values 
that were established many years ago and have not since been reviewed 
in our methodology, we refer readers to our discussion of the subject 
in the Methodology for Establishing Work RVUs section of this rule 
(section II.N.2. of this final rule), as well as a longer discussion in 
the CY 2017 PFS final rule (81 FR 80273 through 80274). Based on the 
aforementioned crosswalks, we continue to believe the proposed values 
better preserve relativity with the rest of the codes on the PFS.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Perform regulatory mandated 
quality assurance activity'' (CA033) activity from 7 minutes to 5 
minutes for all four codes in the family. Commenters stated that 
laboratories which process and interpret gynecologic cytology are 
extensively regulated, and the commenters listed a series of different 
exercises that must take place in slide reexamination. Commenters 
stated that cytotechnologists are required to record the number of 
slides examined, the type of preparation, and the amount of time spent 
in slide examination. Commenters also stated that pap tests are highly 
litigated and perhaps relatively poorly paid procedures, and that the 
need for extensive QA and QC procedures and risk of litigation is a 
serious disincentive for providing this service.
    Response: We appreciate the additional information provided by the 
commenters regarding the types of quality assurance activities that 
take place during these procedures. However, commenters did not address 
our rationale for proposing this refinement to the CA033 clinical labor 
activity, which was the previous finalization of 4 minutes for similar 
federally mandated MQSA activities in CPT codes 77065-77067 and 5 
minutes for CPT codes 78012-78014. We did not receive information from 
the commenters regarding how the quality assurance activities taking 
place in the codes in this family would be different from the similar 
quality assurance activities finalized in previous rulemaking, or 
provide a rationale for why additional time would typically be required 
for the reviewed codes. We continue to believe that a clinical labor 
time of 5 minutes is the most accurate valuation for the CA033 clinical 
labor activity to preserve relativity between services based on this 
prior allocation of clinical labor time.
    Comment: Several commenters disagreed with the CMS proposal to 
remove the 1-minute of clinical labor time for the ``File specimen, 
supplies, and other materials'' (PA008) activity from all four codes 
under the rationale that this task is a form of indirect PE. Commenters 
stated that these tasks must be performed for each individual patient 
case and that the results are manually entered in most facilities. 
Commenters stated that the laboratory technician carefully reviews, 
double checks the information, and enters the reporting results into 
the laboratory information system. Commenters stated that 1 minute for 
this task was very typical and appropriate for this service.
    Response: As we stated in the CY 2017 PFS final rule (81 FR 80324) 
and again in the proposed rule, we agree that filing specimens is an 
important task, and we agree that it would take more than zero minutes 
to perform. However, we continue to believe that these activities are 
correctly categorized under indirect PE as administrative functions, 
and therefore, we do not recognize the filing of specimens as a direct 
PE input, and we do not consider this task as typically performed by 
clinical labor on a per-service basis.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the equipment time for the compound microscope (EP024) equipment 
to 10 minutes for all four codes in the family to match the work time 
of the procedures. Commenters stated that the microscope is utilized by 
the pathologist for the entire physician time, and, in addition, the 
cytotechnologist uses a different microscope for at least 4 minutes to 
assist in the performance of regulatory mandated quality assurance 
activities. Commenters urged CMS to finalize the RUC-recommended PE 
recommendations for CPT codes 88141, G0124, G0141, and P3001.
    Response: We appreciate the additional information provided by the 
commenters regarding the use of the compound microscope by the 
cytotechnologist in these procedures. Based on the information provided 
by the commenters, we are not finalizing our proposed refinement to the 
equipment time for the compound microscope (EP024) equipment. We are 
instead finalizing the RUC-recommended equipment time for all four 
codes in the family.
    After consideration of the public comments we are finalizing the 
work RVUs for the codes in this family as proposed. We are also 
finalizing our direct PE refinements as proposed, with the exception of 
the compound microscope (EP024) equipment time as detailed above.
(53) Biofeedback Training (CPT Codes 90912 and 90913)
    CPT code 90911 (Biofeedback training, perineal muscles, anorectal 
or urethral sphincter, including EMG and/or manometry) was identified 
as potentially misvalued on a RAW screen of codes with a negative IWPUT 
and Medicare utilization over 10,000 for all services or over 1,000 for 
Harvard valued and CMS or other source codes. In September 2018, the 
CPT Editorial Panel replaced this code with two new codes to describe 
biofeedback training initial 15 minutes of one-on-one patient contact 
and each additional 15 minutes of biofeedback training.
    We proposed the RUC-recommended work RVU of 0.90 for CPT code 90912 
(Biofeedback training, perineal muscles, anorectal or urethral 
sphincter, including EMG and/or manometry when performed; initial 15 
minutes of one-on-one patient contact), as well as the RUC-recommended 
work RVU of 0.50 for CPT code 90913 (Biofeedback training, perineal 
muscles, anorectal or urethral sphincter, including EMG and/or 
manometry when performed; each additional 15 minutes of one-on-one 
patient contact). For the direct PE inputs, we proposed to refine the 
equipment time for the power table (EF031) equipment in CPT code 90912 
to conform to our established policies for non-highly technical 
equipment.
    We are also proposing to designate CPT codes 90912 and 90913 as 
``sometimes therapy'' procedures which means that an appropriate 
therapy modifier is always required when this service is furnished by 
therapists. For

[[Page 62775]]

more information we direct readers to the Therapy Code List section of 
the CMS website at https://www.cms.gov/Medicare/Billing/TherapyServices/AnnualTherapyUpdate.html.
    We received public comments on the proposed valuation of the codes 
in the Biofeedback Training family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVU for both codes in the family. Another 
commenter agreed with the proposal to designate both procedures as 
``sometimes therapy'', as they are performed in a physician's office 
and will not require the use of the modifier for physical therapy, 
occupational therapy, or speech-language pathology plan of care.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Biofeedback 
Training family as proposed. We are also finalizing the proposal to 
designate CPT codes 90912 and 90913 as ``sometimes therapy'' 
procedures.
(54) Corneal Hysteresis Determination (CPT Code 92145)
    In 2005, the AMA RUC began the process of flagging services that 
represent new technology or new services as they were presented to the 
AMA/Specialty Society RVS Update Committee. The AMA RUC reviewed this 
service at the October 2018 RAW meeting, and indicated that the 
utilization is continuing to increase for this service. This code was 
surveyed and reviewed for the January 2019 RUC meeting.
    We proposed the work RVU of 0.10 as recommended by the RUC. We also 
proposed the RUC-recommended direct PE inputs for CPT code 92145 
without refinement.
    We received public comments on the proposed valuation of CPT code 
92145 for Corneal Hysteresis Determination. The following is a summary 
of the comments we received and our responses.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs and direct PE inputs for Corneal Hysteresis 
Determination (CPT code 92145).
(55) Computerized Dynamic Posturography (CPT Codes 92548 and 92549)
    CPT code 92548 (Computerized dynamic posturography) was identified 
via the negative IWPUT screen. CPT revised one code and added another 
code to more accurately describe the current clinical work and 
equipment necessary to provide this service.
    We do not agree with the RUC's recommended work RVUs of 0.76 for 
CPT code 92548 (Computerized dynamic posturography sensory organization 
test (CDP-SOT), 6 conditions (i.e., eyes open, eyes closed, visual 
sway, platform sway, eyes closed platform sway, platform and visual 
sway), including interpretation and report), or 0.96 for CPT code 92549 
(Computerized dynamic posturography sensory organization test (CDP-
SOT), 6 conditions (i.e., eyes open, eyes closed, visual sway, platform 
sway, eyes closed platform sway, platform and visual sway), including 
interpretation and report; with motor control test (MCT) and adaptation 
test (ADT)). For CPT code 92548, we agree that an increase in work RVU 
is warranted; however, we believe the surveyed time values suggest an 
increase of a less significant magnitude than that recommended. We 
proposed a work RVU of 0.67 based on the intraservice time ratio: we 
divide the RUC-recommended intraservice time value of 20 by the current 
value of 15 and multiply the product by the current work RVU of 0.50 
for a ratio of 0.67. As a supporting crosswalk, we note that our value 
is greater than the work RVU of 0.60 for CPT code 93316 
(Transesophageal echocardiography for congenital cardiac anomalies; 
placement of transesophageal probe only), which has identical 
intraservice and total times.
    We proposed to maintain relativity between these two codes by 
valuing CPT code 92549 by applying the RUC-recommended incremental 
difference between the two codes, a difference of 0.20, to our proposed 
value of 0.67 for CPT code 93316; therefore, we proposed a work RVU of 
0.87 for CPT code 92549. As further support for this value, we note 
that it falls between the work RVUs of CPT codes 95972 (Electronic 
analysis of implanted neurostimulator pulse generator/transmitter 
(e.g., contact group[s], interleaving, amplitude, pulse width, 
frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, 
patient selectable parameters, responsive neurostimulation, detection 
algorithms, closed loop parameters, and passive parameters) by 
physician or other qualified health care professional; with complex 
spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator 
pulse generator/transmitter programming by physician or other qualified 
health care professional), with a work RVU of 0.80, and CPT code 38207 
(Transplant preparation of hematopoietic progenitor cells; 
cryopreservation and storage), with a work RVU of 0.89.
    We proposed the RUC-recommended direct PE inputs for these codes 
without refinement.
    We received public comments on the proposed valuation of the codes 
in the Computerized Dynamic Posturography family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter objected to our proposed work RVUs for these 
codes, stating that they relied inappropriately on a time ratio to 
value CPT code 92548, and that use of a time ratio represents a flawed 
methodology. Furthermore, the commenter stated that we incorrectly 
referred to our supporting reference CPT code 93316 as a ``crosswalk,'' 
as this code does not have a work RVU equivalent to what we are 
proposing for CPT code 92548.
    Response: We regret that the values posted in Addendum B and in 
table 20 of the proposed rule do not match those in the text of 
proposed rule. We reiterate that we proposed work RVUs of 0.67 for CPT 
code 92548 and 0.87 for CPT code 92549 as discussed above, as well as 
in the text of the proposed rule (84 FR 40596). We agree that CPT code 
93316 is more appropriately termed a reference code rather than a 
crosswalk. We continue to believe that the use of time ratios is one of 
several appropriate methods for identifying potential work RVUs for 
particular services, and we refer readers to the ''Methodology for 
Establishing Work RVUs'' (section II.N.2. of this final rule) for a 
fuller discussion.
    Comment: A commenter stated that our valuation of CPT code 92549, 
which is based on the RUC-recommended incremental relationship between 
this code and CPT code 92548 is an invalid methodology.
    Response: We continue to believe that an analysis that includes 
RUC-recommended incremental relationships between codes is an 
appropriate methodology for estimating accurate relative value among 
services. We believe that use of the increment, as well as reference to 
bracketing CPT codes 95972 and 38207, the latter of which has higher 
time values than CPT 92549, validates our proposed work RVU.

[[Page 62776]]

    Comment: Several commenters requested that CMS phase in the 
proposed cuts for CPT codes 92548 and 92549 under the authority 
provided by the ``Protecting Access to Medicare Act of 2014'' (Pub. L. 
113-93) which requires a 2-year phase-in of payment reductions that 
exceed 20 percent. The commenters stated that these codes define 
services that are not new, rather they were clarified by CPT as noted 
by the retention of the same CPT code. Commenters stated that the 
services are now more clearly defined, in the interest of program 
integrity, but the services themselves have not changed.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that are not new or revised 
codes, if the total RVUs for a service for a year would otherwise be 
decreased by an estimated 20 percent or more as compared to the total 
RVUs for the previous year, the applicable adjustments in work, PE, and 
MP RVUs shall be phased-in over a 2-year period. CPT code 92549 is 
exempt from the phase-in of significant RVU reductions required by 
section 1848(c)(7) of the Act because it is a new code, and the statute 
explicitly states that the phase-in does not apply to new codes. We 
proposed to exempt CPT code 92548 from the phase-in due to the fact 
that it is part of the same family of codes that included new CPT code 
92549. We have previously finalized this policy through rulemaking, 
stating that significant coding revisions within a family of codes can 
change the relationships among codes to the extent that it changes the 
way that all services in the group are reported, even if some 
individual codes retain the same number or, in some cases, the same 
descriptor. Excluding codes from the phase-in when there are 
significant revisions to the code family also helps to maintain the 
appropriate rank order among codes in the family, avoiding years for 
which RVU changes for some codes in a family are in transition while 
others were fully implemented. In addition, the code descriptor for CPT 
code 92548 was significantly changed by CPT as part of this review, 
which we believe meets the criteria of ``revised'' as detailed in the 
statute. For additional information regarding the phase-in of 
significant RVU reductions, we direct readers to the CY 2016 PFS final 
rule with comment period (80 FR 70927 through 70929).
    After consideration of the public comments, we are finalizing our 
proposed work RVUs and the RUC-recommended direct PE inputs.
(56) Auditory Function Evaluation (CPT Codes 92626 and 92627)
    CPT code 92626 (Evaluation of auditory function for surgically 
implanted device(s), candidacy or post-operative status of a surgically 
implanted device(s); first hour) appeared on the RAW 2016 high volume 
growth screen. In 2017, it was identified through a CMS request. CPT 
code 92627 (Evaluation of auditory function for surgically implanted 
device(s), candidacy or post-operative status of a surgically implanted 
device(s); each additional 15 minutes) the add-on code for CPT code for 
92626, also was included in the CMS request to review audiology 
services.
    For CY 2020, we proposed the HCPAC-recommended work RVU of 1.40 for 
CPT code 92626, which is identical to its current RVU. We also proposed 
the HCPAC-recommended work RVU of 0.33 for the add-on code, CPT code 
92627. We proposed the RUC-recommended direct PE inputs for both codes.
    We received several comments on the proposed valuations of the 
Auditory Function Evaluation codes. All commenters expressed support 
for our recommended RVU values for the 2020 final rule. After 
consideration of the public comments, we are finalizing the proposed 
work RVUs and direct PE inputs for CPT codes 92926 and 92927.
(57) Septostomy (CPT Codes 92992 and 92993)
    CPT codes 92992 (Atrial septectomy or septostomy; transvenous 
method, balloon (e.g., Rashkind type) (includes cardiac 
catheterization)) and 92993 (Atrial septectomy or septostomy; blade 
method (Park septostomy) (includes cardiac catheterization)) were 
nominated as potentially misvalued services. These services are 
typically performed on children, a non-Medicare population, and are 
currently contractor-priced. These codes were surveyed and reviewed for 
the January 2019 RUC meeting.
    We proposed to maintain contractor pricing for CPT codes 92992 and 
92993, as recommended by the RUC. These codes will be referred to the 
CPT Editorial Panel for revision and potential deletion. We also 
proposed a change from 90-day to 0-day global period status for these 
two procedures, also as recommended by the RUC.
    We received public comments on the proposed valuation of the codes 
in the Septostomy family. The following is a summary of the comments we 
received and our responses.
    Comment: A commenter stated that they supported the proposals to 
maintain contractor pricing for CPT codes 92992 and 92993 and to change 
from 90-day to 0-day global period status for these two procedures.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing 
contractor pricing for CPT codes 92992 and 92993 as proposed, as well 
as a change from 90-day to 0-day global period status for these two 
procedures.
(58) Ophthalmoscopy (CPT Codes 92201 and 92202)
    CPT code 92225 was identified as potentially misvalued on a screen 
of codes with a negative IWPUT, with 2016 estimated Medicare 
utilization over 10,000 for RUC reviewed codes and over 1,000 for 
Harvard valued and CMS/Other source codes. In February 2018, the CPT 
Editorial Panel deleted CPT codes 92225 and 92226 and created two new 
codes to specify what portion of the eye is examined for a service 
beyond the normal comprehensive eye exam.
    We proposed the RUC-recommended work RVUs of 0.40 for CPT code 
92201 (Ophthalmoscopy, extended, with retinal drawing and scleral 
depression of peripheral retinal disease (e.g., for retinal tear, 
retinal detachment, retinal tumor) with interpretation and report, 
unilateral or bilateral) and 0.26 for CPT code 92202 (Ophthalmoscopy, 
extended, with drawing of optic nerve or macula (e.g., for glaucoma, 
macular pathology, tumor) with interpretation and report, unilateral or 
bilateral).
    We proposed the RUC-recommended direct PE inputs for this code 
family without refinement.
    We received public comments on the proposed valuation of the codes 
in the Ophthalmoscopy family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter supported our proposal to use the RUC-
recommended work RVU for this code.
    Response: We appreciate the support for our proposal from the 
commenters.
    After consideration of the public comments, we are finalizing work 
RVUs as proposed. We are also finalizing the direct PE inputs as 
proposed.
(59) Remote Interrogation Device Evaluation (CPT Codes 93297, 93298, 
93299, and HCPCS code G2066)
    When the RUC previously reviewed the CPT code 93299 at the January 
2017 RUC meeting, the specialty society submitted PE inputs for CPT 
code 93299 (Interrogation device evaluation(s), (remote) up to 30 days; 
implantable cardiovascular physiologic monitor system or subcutaneous 
cardiac rhythm

[[Page 62777]]

monitor system, remote data acquisitions(s), receipt of transmissions 
and technician review, technical support and distribution of results); 
the PE Subcommittee and RUC accepted the society recommendations. In 
the CY 2018 PFS final rule (82 FR 53064), we did not finalize our 
proposal to establish national pricing for CPT code 93299 and the code 
remained contractor-priced.
    At the October 2018 RUC meeting, the RUC re-examined CPT code 
93299. CPT codes 93297 (Interrogation device evaluation(s), (remote) up 
to 30 days; implantable cardiovascular physiologic monitor system, 
including analysis of 1 or more recorded physiologic cardiovascular 
data elements from all internal and external sensors, analysis, 
review(s) and report(s) by a physician or other qualified health care 
professional) and 93298 (Interrogation device evaluation(s), remote up 
to 30 days; subcutaneous cardiac rhythm monitor system, including 
analysis or recorded heart rhythm data, analysis, review(s) and 
report(s) by a physician or other qualified health care professional) 
were added to this family of services. These three codes were reviewed 
for PE only.
    CPT codes 93297 and 93298 are work-only codes and CPT code 93299 is 
meant to serve as the catch-all for both 30-day remote monitoring 
services. The RUC is unclear why the code family was designed this way, 
noting it may have been a way to allow for the possibility that the 
technical work would be provided by vendors, but they noted that this 
is not how the service is currently provided. They stated that in the 
decade since these codes were created, it has become clear that 
implantable cardiovascular monitor (ICM) and implantable loop recorder 
(ILR) services are very different services and the PE cannot be 
appropriately captured for both services in a single technical code. 
They noted that CPT codes 93297-93299 will be placed on the new 
technology/new services list and be re-reviewed by the RUC in 3 years 
to ensure correct calculation and utilization assumptions. It was noted 
in the RUC recommendations that the specialty society intended to 
submit a coding proposal to the CPT Editorial Panel to delete CPT code 
93299, as it will no longer be necessary to have a separate code for PE 
if CPT codes 93297 and 93298 are allocated direct PE in CY 2020.
    In our review of these services, we noted that the RUC 
recommendations did not provide a detailed description of the clinical 
labor tasks being performed or detailed information on the typical use 
of the supply and equipment used when furnishing these services. These 
details are important in order for us to review if the RUC-recommended 
PE inputs are appropriate to furnish these services. The RUC submitted 
PE inputs (which were not previously included) for the work-only CPT 
codes 93297 and 93298, but did not include details to substantiate 
these recommended PE inputs for any of the three codes in this family.
    Additionally, we were concerned with the appropriateness of the 
RUC's reference code, CPT code 93296 (Interrogation device 
evaluation(s) (remote), up to 90 days; single, dual, or multiple lead 
pacemaker system, leadless pacemaker system, or implantable 
defibrillator system, remote data acquisition(s), receipt of 
transmissions and technician review, technical support and distribution 
of results). CPT code 93296 is for remote monitoring over a 90-day 
period, but was used as a reference to derive the RUC-recommended 
direct PE inputs for CPT codes 93297-93299, which are for remote 
monitoring over a 30-day period.
    For the CY 2020 direct PE inputs, we proposed to remove the 
clinical labor time for ``Perform procedure/service--not directly 
related to physician work time'' (CA021); to remove the requested 
quantity for the supply ``Paper, laser printing (each sheet)'' (SK057); 
and to refine the equipment times in accordance with our standard 
equipment time formulas for CPT codes 93297 and 93298.
    Although we did not propose to allocate direct PE inputs for CPT 
codes 93297 and 93298, we sought additional comment on the 
appropriateness of CPT code 93296 as the reference code, details on the 
clinical labor tasks, and more information on the typical use of the 
supply and equipment used to furnish these services. For example, it 
was unclear in the RUC recommendations how many patients are monitored 
concurrently. As an additional example, it was unclear in the RUC 
recommendations as to what tasks are involved when clinical staff 
engage with the patient throughout the month to perform education about 
the device and re-education protocols after the initial enrollment.
    The CPT Editorial Panel is deleting CPT code 93299 for CY 2020. We 
note this differs from the RUC recommendations for this code from the 
October 2018 meeting, which stated that the specialty society intended 
to submit a coding proposal to the CPT Editorial Panel to delete CPT 
code 93299, as it would no longer be necessary to have a separate code 
for PE, if CPT codes 93297 and 93298 are allocated direct PE for CY 
2020. Given that we proposed to not allocate direct PE inputs for CPT 
code 93297 and 93298 for CY 2020 and CPT code 93299 is being deleted 
for CY 2020, we proposed to create a G-code to describe the services 
previously furnished under CPT code 93299. We proposed to create HCPCS 
code G2066 (Interrogation device evaluation(s), (remote) up to 30 days; 
implantable cardiovascular physiologic monitor system, implantable loop 
recorder system, or subcutaneous cardiac rhythm monitor system, remote 
data acquisition(s), receipt of transmissions and technician review, 
technical support and distribution of results), to describe the 
services previously furnished under CPT code 93299, effective for CY 
2020.
    We received public comments on the proposed valuation of the codes 
in the Remote Interrogation Device Evaluation family. The following is 
a summary of the comments we received and our responses.
    Comment: One commenter stated strong support for CMS' proposal to 
not recommend the RUC recommended direct PE inputs for CPT codes 93297 
and 93298, and to create a contractor-priced G-code to replace CPT code 
93299, which has been eliminated by the AMA CPT. This commenter further 
noted that they understood the interest in creating nationally priced 
CPT codes that reflect the differences in expenses between ILR and ICM 
monitoring services, the agreed that the RUC recommendations, which 
were developed without input from IDTFs like theirs and are not 
substantiated and should not be implemented. They urged that any future 
revaluation of this code family provide for input by all providers 
IDTFs that perform the service.
    Response: We thank the commenter for their support of our proposal.
    Comment: A commenter stated they agreed with our proposal and 
recommended that they all be finalized including a proposal to 
establish HCPCS code G2066 effective January 1, 2020. The commenter 
stated that as a threshold matter, that the descriptors for CPT codes 
93297 and 93298 were not changed. They still describe only the 
professional component (PC) and do not describe the TC. Without a 
change in descriptor, adding PE inputs to these professional codes is 
very confusing, especially to IDTFS, such as theirs, who are not 
allowed to bill for professional services.
    Response: We thank the commenter for their support of our proposal.
    Comment: A commenter noted they were perplexed that CMS stated the 
RUC recommendations did not provide a detailed description of the 
clinical

[[Page 62778]]

labor tasks being performed or detailed information on the typical use 
of the supply and equipment used when furnishing these services.
    Response: We thank the commenter for the additional information. We 
note that while the RUC's recommendations contained some of the same 
information provided in the commenter's letter, it did not contain the 
same level of granularity provided in the commenter's letter. As an 
example, in our review of the time data, we note that both documents 
(RUC recommendations and commenter's letter) stated that over the 
course of a month a technologist interacts with the patient 1.63 times 
a month to process device-generated notifications for 17 minutes. 
However, the commenter's letter provided more details and noted that if 
a device generates an alert it will be communicated to the 
manufacturer's servers. This would imply that 17 minutes for this task 
is not always warranted, specifically if no alerts are communicated to 
the manufacturer's servers. This was unclear to us because the RUC 
recommendations did not contain the level of details as the commenter's 
letter.
    Comment: One commenter noted that CMS sought additional information 
on the appropriateness of CPT code 93296 as the reference code. The 
commenter noted that the current recommendation uses CPT code 93296 as 
a simple reference code and suggested that it is appropriate because it 
is a similar service insofar as it is a remote interrogation of an 
electrophysiology device with similarities in terms of information 
workflow, but the recommended inputs are based on new data that was not 
available when the codes were last valued and the recommended PE inputs 
are in no way a crosswalk to the inputs of CPT code 93296.
    Response: We appreciate the feedback, but continue to question the 
appropriateness of this crosswalk because 93299 is a service for up to 
30 days and CPT code 93296 is for up to 90 days of remote monitoring.
    Comment: Several commenters did not support our proposals, stating 
that CMS should allocate the RUC-recommended direct PE inputs for CPT 
codes 93297 and 93298, and that the creation of HCPCS code GTTT1 
(G2066) is unnecessary since CPT code 93299 is being deleted by the CPT 
Editorial Panel for CY 2020.
    Response: We disagree with the commenters that the creation of 
HCPCS code G2066 is unnecessary because, CPT code 93299 is being 
deleted for CY 2020. We reiterate that the RUC recommendations noted 
CPT code 93299 would be deleted if CMS allocated direct PE inputs for 
CPT codes 93297 and 93298 and that the specialty society intended to 
submit an application to the CPT Editorial Panel to have CPT code 
93299. Further, it was noted in RUC recommendations that the RUC 
recommended that CPT code 93299 be referred to CPT for deletion. Thus, 
based on the information submitted to CMS, our understanding is that 
the intent to delete CPT code was predicated on CMS allocating direct 
PEs to CPT codes 93297 and 93298. There was no indication in the RUC 
recommendations that an application to delete CPT code 93299 had been 
submitted and that it would be deleted for CY 2020. Furthermore, CPT 
code 93299 was reviewed at the October 2018 RUC, and related 
recommendations provided to CMS. CMS did not propose to allocate direct 
PE for those codes, thus it was necessary to create a HCPCS code G2066) 
to describe the services previously furnished under CPT code 93299, 
effective for CY 2020.
    After consideration of the public comments, we are finalizing our 
proposals for the codes in the Remote Interrogation Device Evaluation 
family.
(60) Duplex Scan Arterial Inflow-Venous Outflow (CPT Codes 93985 and 
93986)
    In September 2018, the CPT Editorial Panel recommended replacing 
one HCPCS code (G0365) with two new codes to describe the duplex scan 
of arterial inflow and venous outflow for preoperative vessel 
assessment prior to creation of hemodialysis access for complete 
bilateral and unilateral study. We proposed the RUC-recommended work 
RVU of 0.80 for CPT code 93985 (Duplex scan of arterial inflow and 
venous outflow for preoperative vessel assessment prior to creation of 
hemodialysis access; complete bilateral study), as well as the RUC-
recommended work RVU of 0.50 for CPT code 93986 (Duplex scan of 
arterial inflow and venous outflow for preoperative vessel assessment 
prior to creation of hemodialysis access; complete unilateral study).
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
from 4 minutes to 2 minutes for both codes in the family. Two minutes 
is the standard time for this clinical labor activity, and 2 minutes is 
also the time assigned for this activity in the reference code, CPT 
code 93990 (Duplex scan of hemodialysis access (including arterial 
inflow, body of access and venous outflow)). There was no rationale 
provided in the recommended materials indicating why this additional 
clinical labor time would be typical for the procedures, and therefore, 
we proposed to refine to the standard time of 2 minutes. We are also 
proposing to adjust the equipment times to conform to this change in 
the clinical labor time.
    We received public comments on the proposed valuation of the codes 
in the Remote Interrogation Device Evaluation family. The following is 
a summary of the comments we received and our responses.
    Comment: A commenter stated that they supported the proposal of the 
RUC-recommended work RVU for both codes in the family. Two commenters 
also stated that they supported the proposed direct PE refinements.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Duplex Scan 
Arterial Inflow-Venous Outflow family as proposed.
(61) Myocardial Strain Imaging (CPT Code 93356)
    The CPT Editorial Panel deleted one Category III code and created 
one new Category I add-on code CPT code 93356 to describe the work of 
myocardial strain imaging performed in supplement to transthoracic 
echocardiography services. We proposed the RUC-recommended work RVU of 
0.24.
    We proposed the RUC-recommended direct PE inputs for CPT code 
93356. However, we note that no rationale was given for the RUC-
recommended 12 minutes of clinical labor time for the activity CA021 
``Perform procedure/service,'' and we requested comment on the 
appropriateness of this allocated time value.
    We received public comments on the proposed valuation of the codes 
in the Myocardial Strain Imaging family. The following is a summary of 
the comments we received and our responses.
    Comment: A commenter supported our proposal to use the RUC-
recommended work RVU for this code.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: A commenter stated that, contrary to our statement that no 
rationale was provided for the times recommended for the ``perform 
procedure/service--NOT directly related to physician work time'' 
(CA021) clinical labor activity, the RUC had included detailed 
information on the RUC-recommended clinical labor in the PE SOR, and 
the commenter reiterated the rationale.

[[Page 62779]]

    Response: We thank the commenter for the clarification.
    After consideration of the public comments, we are finalizing our 
proposals for this code.
(62) Lung Function Test (CPT Code 94200)
    The RUC recommended this service for survey because it appeared on 
a list of CMS/Other codes with Medicare utilization of 30,000 or more. 
According to the RUC, this service is typically reported with an E/M 
service and another pulmonary function test, and the RUC-recommended 
times would appropriately account for any overlap with other services. 
The RUC stated that the intraservice time involves reading and 
interpreting the test to determine if a significant interval change has 
occurred and then generating a report, which supports the 5 minutes of 
physician work indicated in the survey. The RUC did not agree with the 
specialty society that communication of the report required an 
additional 2 minutes of physician time over the postservice time 
included in the other services reported on the same day. The RUC 
reduced the postservice time from 2 minutes to 1 minute because the 
service requires minimal time to enter the results into the medical 
record and communicate the results to the patient and the referring 
physician. Based in part on these reductions in physician time, the RUC 
recommended a reduction in work RVU from the current value with a 
crosswalk to CPT code 95905 (Motor and/or sensory nerve conduction, 
using preconfigured electrode array(s), amplitude and latency/velocity 
study, each limb, includes F-wave study when performed, with 
interpretation and report).
    For CPT code 94200 (Maximum breathing capacity, maximal voluntary 
ventilation), we proposed the RUC-recommended work RVU of 0.05. A 
stakeholder stated that the RUC's recommended work RVU understates the 
costs inherent in performing this service, and that the survey 25th 
percentile value of 0.10 is more accurate for this service. While we 
proposed the RUC-recommended 0.05, we solicited public comment on this 
stakeholder-recommended potential alternative value.
    We proposed the RUC-recommended direct PE inputs for CPT code 94200 
without refinement.
    We received public comments on the proposed valuation of the codes 
in the Lung Function Test family. The following is a summary of the 
comments we received and our responses.
    Comment: A commenter questioned how the most recent stakeholder 
comment was obtained, since the RUC recommendations are not public 
until after the publication of the proposed rule. The commenter stated 
that the recent stakeholder comment could not have been received by CMS 
via the formal comment process, and questioned whether the comment was 
communicated via the passing of verbal comments between individuals at 
the RUC meeting or someone inappropriately gained confidential 
information.
    Response: As noted for the Arthrodesis--Sacroiliac Joint code (CPT 
Code 27279), such communication between the agency and a stakeholder 
was not inappropriate. When considering potential valuation for 
services on the PFS, we may take into account information provided to 
us by stakeholders including specialty societies that may have 
participated in the RUC process but did not agree with what was 
submitted as part of the RUC's recommendations. For instance, in CY 
2019 rulemaking, for the Psychological and Neuropsychological Testing 
family of codes, we noted that a stakeholder that represents the 
psychologist and neuropsychologist community stated that the RUC's 
recommendations for those services would have resulted in significant 
reductions in payment (FR 83 35770).
    Comment: The RUC reiterated that it considered the survey 25th 
percentile, but ultimately decided that it would overvalue the work 
involved in performing this service given the survey intra-service time 
of 5 minutes, and they instead recommended a work RVU of 0.05.
    Response: After consideration of the public comments, we are 
finalizing the RUC-recommended work RVU of 0.05 as proposed. We are 
finalizing the direct PE inputs for CPT code 94200 as proposed.
(63) Long-Term EEG Monitoring (CPT Codes 95700, 95705, 95706, 95707, 
95708, 95709, 95710, 95711, 95712, 95713, 95714, 95715, 95716, 95717, 
95718, 95719, 95720, 95721, 95722, 95723, 95724, 95725, and 95726)
    In January 2017, the RUC identified CPT code 95951 via the high 
volume growth screen, which considers if the service has total Medicare 
utilization of 10,000 or more and if utilization has increased by at 
least 100 percent from 2009 through 2014. The RUC recommended that this 
service be referred to the CPT Editorial Panel for needed changes, 
including code deletions, revision of code descriptors, and the 
addition of new codes to this family. In May 2018, the CPT Editorial 
Panel approved the revision of one code, deletion of five codes, and 
addition of 23 new codes for reporting long-term EEG professional and 
technical services. We are using the phrase ``professional component'' 
codes to refer to CPT codes 95717-95726 and ``technical component'' 
codes to refer to CPT codes 95700-95716.
    We proposed the RUC-recommended work RVU for six of the 
professional component (PC) codes in this family. We proposed a work 
RVU of 3.86 for CPT code 95721 (Electroencephalogram, continuous 
recording, physician or other qualified health care professional review 
of recorded events, complete study; greater than 36 hours, up to 60 
hours of EEG recording, without video), a work RVU of 4.70 for CPT code 
95722 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, complete 
study; greater than 36 hours, up to 60 hours of EEG recording, with 
video), a work RVU of 4.75 for CPT code 95723 (Electroencephalogram, 
continuous recording, physician or other qualified health care 
professional review of recorded events, complete study; greater than 60 
hours, up to 84 hours of EEG recording, without video), a work RVU of 
6.00 for CPT code 95724 (Electroencephalogram, continuous recording, 
physician or other qualified health care professional review of 
recorded events, complete study; greater than 60 hours, up to 84 hours 
of EEG recording, with video), a work RVU of 5.40 for CPT code 95725 
(Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, complete 
study; greater than 84 hours of EEG recording, without video) and a 
work RVU of 7.58 for CPT code 95726 (Electroencephalogram, continuous 
recording, physician or other qualified health care professional review 
of recorded events, complete study; greater than 84 hours of EEG 
recording, with video).
    We also proposed adopting the RUC-recommended work RVU of 0.00 for 
the 13 technical component (TC) codes in the family: CPT code 95700 
(Electroencephalogram (EEG) continuous recording, with video when 
performed, set-up, patient education, and take down when performed, 
administered in-person by EEG technologist, minimum of 8 channels), CPT 
code 95705 (Electroencephalogram (EEG) without video, review of data, 
technical description by EEG technologist, 2-12 hours; unmonitored),

[[Page 62780]]

CPT code 95706 (Electroencephalogram (EEG) without video, review of 
data, technical description by EEG technologist, 2-12 hours; with 
intermittent monitoring and maintenance), CPT code 95707 
(Electroencephalogram (EEG) without video, review of data, technical 
description by EEG technologist, 2-12 hours; with continuous, real-time 
monitoring and maintenance), CPT code 95708 (Electroencephalogram (EEG) 
without video, review of data, technical description by EEG 
technologist, each increment of 12-26 hours; unmonitored), CPT code 
95709 (Electroencephalogram (EEG) without video, review of data, 
technical description by EEG technologist, each increment of 12-26 
hours; with intermittent monitoring and maintenance), CPT code 95710 
(Electroencephalogram (EEG) without video, review of data, technical 
description by EEG technologist, each increment of 12-26 hours; with 
continuous, real-time monitoring and maintenance), CPT code 95711 
(Electroencephalogram with video (VEEG), review of data, technical 
description by EEG technologist, 2-12 hours; unmonitored), CPT code 
95712 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, 2-12 hours; with 
intermittent monitoring and maintenance), CPT code 95713 
(Electroencephalogram with video (VEEG), review of data, technical 
description by EEG technologist, 2-12 hours; with continuous, real-time 
monitoring and maintenance), CPT code 95714 (Electroencephalogram with 
video (VEEG), review of data, technical description by EEG 
technologist, each increment of 12-26 hours; unmonitored), CPT code 
95715 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, each increment of 12-26 
hours; with intermittent monitoring and maintenance), and CPT code 
95716 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, each increment of 12-26 
hours; with continuous, real-time monitoring and maintenance).
    We disagreed with the RUC-recommended work RVU of 2.00 for CPT code 
95717 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, 2-12 
hours of EEG recording; without video) and we proposed a work RVU of 
1.85 based on a crosswalk to CPT code 93314 (Echocardiography, 
transesophageal, real-time with image documentation (2D) (with or 
without M-mode recording); image acquisition, interpretation and report 
only). CPT code 93314 is a recently-reviewed code with 2 additional 
minutes of intraservice time and 4 additional minutes of total time as 
compared to CPT code 95717. When considering the work RVU for CPT code 
95717, we looked to the second reference code chosen by the survey 
participants, CPT code 95957 (Digital analysis of electroencephalogram 
(EEG) (e.g., for epileptic spike analysis)). This code has 2 additional 
minutes of intraservice time and 9 additional minutes of total time as 
compared to CPT code 95717, yet has a work RVU of 1.98, lower than the 
recommended work RVU of 2.00. These time values suggested that CPT code 
95717 would be more accurately valued at a work RVU slightly below the 
1.98 of CPT code 95957. We also looked at the intraservice time ratio 
between CPT code 95717 and some of its predecessor codes. The 
intraservice time ratio with CPT code 95953 (Monitoring for 
localization of cerebral seizure focus by computerized portable 16 or 
more channel EEG, electroencephalographic (EEG) recording and 
interpretation, each 24 hours, unattended) suggests a similar potential 
work RVU of 1.91 (28 minutes divided by 45 minutes times a work RVU of 
3.08). Based on this information, we proposed a work RVU of 1.85 for 
CPT code 95717 based on the aforementioned crosswalk to CPT code 93314.
    We disagreed with the RUC-recommended work RVU of 2.50 for CPT code 
95718 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, analysis 
of spike and seizure detection, interpretation, and report, 2-12 hours 
of EEG recording; with video (VEEG)) and we proposed a work RVU of 
2.35. Although we disagreed with the RUC-recommended work RVU, we 
concurred with the RUC that the relative difference in work between CPT 
codes 95717 and 95718 is equivalent to the recommended interval of 0.50 
RVUs. Therefore, we proposed a work RVU of 2.35 for CPT code 95718, 
based on the recommended interval of 0.50 additional RVUs above our 
proposed work RVU of 1.85 for CPT code 95717. We supported this work 
RVU with a reference to CPT code 99310 (Subsequent nursing facility 
care, per day, for the evaluation and management of a patient, which 
requires at least 2 of the 3 key components), which shares the same 
intraservice time of 35 minutes and the identical work RVU of 2.35. CPT 
code 99310 is a lower intensity procedure but has increased total work 
time as compared to CPT code 95718.
    We disagreed with the RUC-recommended work RVU of 3.00 for CPT code 
95719 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, analysis 
of spike and seizure detection, each increment of greater than 12 
hours, up to 26 hours of EEG recording, interpretation and report after 
each 24-hour period; without video), and we proposed a work RVU of 2.60 
based on a crosswalk to CPT code 99219 (Initial observation care, per 
day, for the evaluation and management of a patient, which requires 3 
key components). CPT code 99219 shares the same intraservice time of 40 
minutes and has a slightly higher total time as compared to CPT code 
95719. We also noted that the observation care described by CPT code 
99219 shares some clinical similarities to the long term EEG monitoring 
described by CPT code 95719, although we noted, as always, that the 
nature of the PFS relative value system is such that all services are 
appropriately subject to comparisons to one another, and that codes do 
not need to share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk.
    In addition, we believed that the proposed crosswalk to CPT code 
99219 at a work RVU of 2.60 more accurately captures the intensity of 
CPT code 95719. At the recommended work RVU of 3.00, the intensity of 
CPT code 95719 is anomalously high in comparison to the rest of the 
family, higher than any of the other PC codes. We did not have reason 
to believe that the 24-hour EEG monitoring done without video, as 
described in CPT code 95719, would be notably more intense than the 
other codes in the same family. Furthermore, the recommendations for 
this code family specifically state that the codes that describe video 
EEG monitoring are more intense than the codes that describe non-video 
EEG monitoring. However, at the recommended work RVU for CPT code 
95719, this non-video form of EEG monitoring had the highest intensity 
in the family. At our proposed work RVU of 2.60, the intensity of CPT 
code 95719 is no longer anomalously high in comparison to the rest of 
the family, and also remains lower than the intensity of the 24 hour 
EEG monitoring with video procedure described by CPT code 95720.

[[Page 62781]]

    We disagreed with the RUC-recommended work RVU of 3.86 for CPT code 
95720 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, analysis 
of spike and seizure detection, each increment of greater than 12 
hours, up to 26 hours of EEG recording, interpretation and report after 
each 24-hour period; with video (VEEG)), and we proposed a work RVU of 
3.50 based on the survey 25th percentile value. The RUC-recommended 
work RVU of 3.86 was based on a crosswalk to CPT code 99223 (Initial 
hospital care, per day, for the evaluation and management of a patient, 
which requires 3 key components), a code that shares the same 
intraservice time of 55 minutes but has 15 additional minutes of total 
time as compared to CPT code 95720, at 90 minutes as compared to 75 
minutes. We disagreed with the use of this crosswalk, as the 15 minutes 
of additional total time in CPT code 99223 resulted in a higher work 
valuation that overstates the work RVU of CPT code 95720. These 15 
additional minutes of preservice and postservice work time in the 
recommended crosswalk code have a calculated work RVU of 0.34 under the 
building block methodology; subtracting out this work RVU of 0.34 from 
the crosswalk code's work RVU of 3.86 resulted in an estimated work RVU 
of 3.52, which is nearly identical to the survey 25th percentile work 
RVU of 3.50. Similarly, if we were to calculate a total time ratio 
between CPT code 95720 and the recommended crosswalk code 99223, it 
would produce a noticeably lower work RVU of 3.22 (75 minutes divided 
by 90 minutes times a work RVU of 3.86). Based on this rationale, we 
did not believe that it would serve the interests of relativity to 
propose a work RVU of 3.86 based on the recommended crosswalk.
    Instead, we proposed a work RVU of 3.50 for CPT code 95720 based on 
the survey 25th percentile value. We noted that among the predecessor 
codes for this family, CPT code 95956 (Monitoring for localization of 
cerebral seizure focus by cable or radio, 16 or more channel telemetry, 
electroencephalographic (EEG) recording and interpretation, each 24 
hours, attended by a technologist or nurse) had a higher intraservice 
time of 60 minutes and a higher total time of 105 minutes at a work RVU 
of 3.61. This prior valuation of CPT code 95956 does not support the 
RUC-recommended work RVU of 3.86 for CPT code 95720, but does support 
the proposed work RVU of 3.50 at the slightly lower newly surveyed work 
times. We also noted that at the recommended work RVU of 3.86, the 
intensity of CPT code 95720 was anomalously high in comparison to the 
rest of the family, the second-highest intensity as compared to the 
other PC codes. We did not have reason to believe that the 24 hour EEG 
monitoring done with video as described in CPT code 95720 would be 
notably more intense than the other codes in the same family. At our 
proposed work RVU of 3.50, the intensity of CPT code 95720 is no longer 
anomalously high in comparison to the rest of the family, while still 
remaining slightly higher than the intensity of the 24 hour EEG 
monitoring performed without video procedure described by CPT code 
95719.
    For the direct PE inputs, we proposed to make a series of 
refinements to the clinical labor times of CPT code 95700. Many of the 
clinical labor times for this CPT code were derived using a survey 
process and were recommended to CMS at the survey median values. This 
was in contrast to the typical process that the RUC uses to make 
recommendations for direct PE inputs, where the inputs are usually 
based on either standard times or carried over from reference codes. We 
believe that when surveys are used to recommended direct PE inputs, we 
must apply a similar process of scrutiny to that used in assessing the 
work RVUs that are recommended based on a survey methodology. We have 
long expressed our concerns over the validity of the survey results 
used to produce work RVU recommendations, such as in the CY 2011 PFS 
final rule (75 FR 73328), and we have noted that over the past decade 
the AMA RUC has increasingly chosen to recommend the survey 25th 
percentile work RVU over the survey median value, potentially 
responding to the same concerns that we have identified.
    As a result, we believe that when assessing the survey of direct PE 
inputs used to produce many of the recommendations for CPT code 95700, 
it would be more accurate to propose the survey 25th percentile direct 
PE inputs as opposed to the recommended survey median direct PE inputs. 
Therefore, we proposed to refine the clinical labor time for the 
``Provide education/obtain consent'' (CA011) activity from 13 minutes 
to 7 minutes and to refine the clinical labor time for the ``Review 
home care instructions, coordinate visits/prescriptions'' (CA035) 
activity from 10 minutes to 7 minutes. In both of these cases, the 
recommended clinical labor times based on the survey median values are 
more than double the standard time for these activities. Although we 
agreed that additional clinical labor time would be required to carry 
out these activities for CPT code 95700, we did not believe that the 
survey median times would be typical. We proposed the survey 25th 
percentile times of 7 minutes for each activity as we believe that this 
time would be more typical for obtaining consent and reviewing home 
care instructions.
    We also proposed to refine the clinical labor time for the 
``Complete pre-procedure phone calls and prescription'' (CA005) 
activity from 10 minutes to 3 minutes for CPT code 95700. This is 
another situation where we proposed the survey 25th percentile clinical 
labor time of 3 minutes instead of the survey median clinical labor 
time of 10 minutes. However, we also note that many of the tasks that 
fell under the CA005 activity code as described in the PE 
recommendations appear to constitute forms of indirect PE, such as 
collecting supplies for setup and loading equipment and supplies into 
vehicles. Collecting supplies and loading equipment are administrative 
tasks that are not individually allocable to a particular patient for a 
particular service, and therefore, constitute indirect PE under our 
methodology. Due to the fact that many of the tasks described under the 
CA005 activity code are forms of indirect PE, we believed that the RUC-
recommended survey median clinical labor time of 10 minutes overstated 
the amount of direct clinical labor taking place. We believed that it 
was more accurate to propose the survey 25th percentile clinical labor 
time of 3 minutes for this activity code to reflect the non-
administrative tasks performed by the clinical staff.
    We also proposed to refine the quantity of the non-sterile gloves 
(SB022) supply from 3 to 2 for CPT code 95700. We note that the current 
reference code, CPT code 95953, uses 2 of these pairs of gloves and the 
survey also stated that 2 pairs of gloves were typical for the 
procedure. Although the recommended materials state that a pair of 
gloves is needed to set up the equipment, to take down the equipment, 
and a third is required for electrode changes, we did not agree that 
the use of a third pair of gloves would be typical given their usage in 
the reference code and in the responses from the survey.
    We note that we did not propose to refine many of the other 
clinical labor times for CPT code 95700, which remain at the survey 
median clinical labor times. Due to the nature of the continuous 
recording EEG service taking place, we agree that the survey median 
clinical labor times of 12 minutes for the ``Prepare room, equipment 
and supplies'' (CA013) activity, 45 minutes

[[Page 62782]]

for the ``Prepare, set-up and start IV, initial positioning and 
monitoring of patient'' (CA016) activity, and 22 minutes for the 
``Clean room/equipment by clinical staff'' (CA024) activity would be 
typical for this procedure. We reiterate that we assess the direct PE 
inputs for each procedure individually based on our methodology of what 
would be reasonable and medically necessary for the typical patient.
    For CPT codes 95705-95716, we proposed to refine the clinical labor 
time for the ``Coordinate post-procedure services'' (CA038) activity 
from either 11 minutes to 5 minutes or from 22 minutes to 10 minutes as 
appropriate for the CPT code in question. The recommended materials for 
these procedures state that the tasks taking place constitute ``Merge 
EEG and Video files (partially automated program), confirm transfer of 
data, delete from laptop/computer if necessary''. We believe that many 
of the tasks detailed here are administrative in nature, consisting of 
forms of data entry, and therefore, would be considered types of 
indirect PE. We note that when CPT code 95812 (Electroencephalogram 
(EEG) extended monitoring; 41-60 minutes) was recently reviewed for CY 
2017, we finalized the recommended clinical labor time of 2 minutes for 
``Transfer data to reading station & archive data'', a task which we 
believe to be highly similar. Due to the longer duration of the 
procedures in CPT codes 95705-95716, we proposed clinical labor times 
of 5 minutes and 10 minutes for the CA038 activity for these CPT codes. 
We are also refining the equipment time for the Technologist PACS 
workstation (ED050) to match the clinical labor time proposed for the 
CA038 activity.
    For the four continuous monitoring procedures, CPT codes 95707, 
95710, 95713, and 95716, we proposed to refine the equipment time for 
the ambulatory EEG review station (EQ016) equipment. The recommended 
equipment time for the ambulatory EEG review station was equal to four 
times the ``Perform procedure/service'' (CA021) clinical labor time 
plus a small amount of extra prep time. We did not agree that it would 
be typical to assign this much equipment time, as it is our 
understanding that one ambulatory EEG review station can be hooked up 
to as many as four monitors at a time for continuous monitoring. 
Therefore, we did not believe that each monitor would require its own 
review station, and therefore, the equipment time should not be equal 
to four times the clinical labor of the ``Perform procedure/service'' 
(CA021) activity. As a result, we proposed to refine the ambulatory EEG 
review station equipment time from 510 minutes to 150 minutes for CPT 
code 95707, from 1480 minutes to 400 minutes for CPT code 95710, from 
514 minutes to 154 minutes for CPT code 95713, and from 1495 minutes to 
415 minutes for CPT code 95716.
    For the 10 professional component procedures, CPT codes 95717-
95726, we again proposed to refine the equipment time for the 
ambulatory EEG review station (EQ016) equipment. We believe that the 
use of the ambulatory EEG review station is analogous in these 
procedures to the use of the professional PACS workstation (ED053) in 
other procedures, and we proposed to refine the equipment times for 
these 10 procedures to match our standard equipment time formula for 
the professional PACS workstation. Therefore, we proposed an equipment 
time for the ambulatory EEG review station equal to half the preservice 
work time (rounded up) plus the intraservice work time for CPT codes 
95717 through 95726. We believed that this equipment time was more 
accurate than the recommended equipment time, which was equal to the 
total work time of the procedures, as the work descriptors for CPT 
codes 95717-95726 make no mention of the ambulatory EEG review station 
in the postservice work period.
    Finally, we proposed to price the new ``EEG, digital, prolonged 
testing system with remote video, for patient home use'' (EQ394) 
equipment at $26,410.95 based on an invoice submission. We did not use 
a second invoice submitted for the new equipment for pricing, as it 
contained a disaggregated list of equipment components and it was not 
clear if they represented the same equipment item as the first invoice.
    We received public comments on the proposed valuation of the codes 
in the Long-Term EEG Monitoring family. The following is a summary of 
the comments we received and our responses. Due to the large number of 
comments we received for this code family, we will first summarize the 
comments related to general code valuation, followed by the comments 
related to specific work RVUs, and finally the comments related to 
direct PE inputs.
    Comment: Many commenters expressed concern with the proposed values 
for the codes in the Long Term EEG Monitoring family. Commenters stated 
that the proposed values would jeopardize beneficiary access to these 
tests, which are vitally important to patients with epilepsy and other 
seizure disorders. Commenters listed some of the benefits resulting 
from advances in technology that now make it possible for patients to 
receive long-term EEGs in their home, particularly for patients in 
rural and medically underserved communities. Commenters stated that if 
the proposed values were finalized, many Medicare beneficiaries will be 
forced to be admitted to a hospital to receive the same testing they 
could have received in their home, driving up costs to both the 
beneficiary and the federal government. These commenters requested that 
CMS withdraw the proposed reductions in values for in-home EEG tests 
and continue paying at rates established by regional Medicare 
Administrative Contractors (MACs) in their respective jurisdictions. 
Commenters stated that CMS has taken this approach in the past for 
services such as the Transcranial Magnetic Stimulation family (CPT 
codes 90867, 90868, 90869), which do not fit into the standard 
valuation methodology, and that continuing to use contractor pricing 
for a period of 3 to 4 years would allow health care providers and MACs 
to gain experience with the new codes.
    Response: We appreciate the feedback from the commenters on the 
importance of maintaining access to these services. We agree with the 
commenters that it is critical for payment for services furnished to 
Medicare beneficiaries be accurately valued, and we share their desire 
to ensure that patients in rural and medically underserved communities 
will continue to receive care, especially in light of the rapidly 
growing utilization of EEG monitoring procedures. These services were 
flagged for review due to a high volume growth screen, which considers 
if the service has total Medicare utilization of 10,000 or more and if 
utilization has increased by at least 100 percent from 2009 through 
2014. Based on the identification of these services in the high volume 
growth screen, the CPT Editorial Panel updated the coding by revising 
code descriptions, deleting codes, and adding new codes, with the goal 
of incorporating the current use of video in EEG tests, better 
differentiating inpatient and ambulatory monitoring services, and 
reflecting the rapid increase in utilization for these services.
    We estimate that utilization for the new Long Term EEG Monitoring 
code set will exceed 500,000 services annually in CY 2020, and, 
generally speaking, we believe it is more accurate for the purposes of 
relativity to establish national pricing for services that will have 
high utilization as opposed to leaving them contractor-priced. However, 
we have carefully considered commenters' concerns regarding the 
accuracy of the proposed inputs, especially in the context of the

[[Page 62783]]

accessibility and payment stability concerns also raised by the 
commenters, and we have decided that the proposed payment for the TC 
Long Term EEG Monitoring codes (CPT codes 95700-95716) should be 
withdrawn in favor of contactor-pricing for CY 2020 in order to allow 
additional time for stakeholder feedback. We are seeking additional 
information from stakeholders that will address the concerns about the 
resource inputs involved in furnishing these services in the context of 
the accessibility and need for payment stability raised by the 
commenters. We will further consider establishing national values for 
these codes through future rulemaking.
    Comment: Several commenters stated that the PE methodology CMS used 
to establish values for TC services was inappropriate for these codes, 
and the recommendations from the RUC for PE inputs were so flawed as to 
be unusable. Commenters stated that the PE information submitted by the 
RUC to CMS was deeply flawed, as it was collected from physicians and 
EEG technologists who are employed by hospitals or physician offices 
and unfamiliar with home studies. Several commenters stated that the 
RUC recommendations did not include as PE inputs the significant fees 
for software, data usage, and cell phones which are necessary to 
establish and maintain the monitoring connections in the patient's 
home. Commenters also stated that the RUC-recommended work times were 
not reasonable for these procedures, as practitioners needed to go 
through video data and patient logs, as well as type up a detailed 
report and review patient history. Some commenters were critical of the 
RUC's survey methodology, stating that the work surveys were biased or 
flawed and suffered from a low response rate. Commenters stated that 
surveys are notoriously inaccurate and physicians rarely if ever use 
surveys to determine patients' care due to biases that result from a 
low response rate. These commenters were critical of the RUC's survey 
methodology in general and stated that the relatively small number of 
survey respondents were not representative of wider practice patterns.
    Response: We appreciate the feedback from the commenters regarding 
the work RVUs, work times, and direct PE inputs recommended by the RUC. 
In the CY 2011 PFS final rule with comment period (75 FR 73328 through 
73329), we discussed a variety of methodologies and approaches that we 
use to develop work RVUs, including survey data, building blocks, 
crosswalks to key reference or similar codes, and magnitude estimation. 
We emphasize that we do not believe that the RUC is the exclusive 
source of information used in valuation of PFS services, and we are 
supportive of the submission of additional data that can aid in the 
process of determining the resources that are typically used to furnish 
these services. However, in the absence of alternative data to value 
new services, we believe that the recommendations from the RUC are a 
key source to use for valuation of work and direct PE, and therefore, 
these recommendations have an important role in our review process and 
in our responsibility to assign relative value units used to determine 
payment rates under the PFS. Because we did not receive data from the 
commenters to support alternate valuations from the RUC 
recommendations, not only do we believe it is appropriate to consider 
the RUC recommendations, we do not believe it would be appropriate to 
ignore the RUC recommendations for work RVUs and direct PE inputs for 
the Long Term EEG Monitoring family of codes. However, we urge 
interested stakeholders to consider submitting robust data regarding 
direct PE resource inputs and costs involved in furnishing these and 
other services for our consideration for future rulemaking.
    Comment: Several commenters acknowledged that there has been an 
increase (greater than 100 percent) in EEG utilization from 2009-2014, 
and stated that it was critical for CMS to study why this increase has 
occurred. Commenters stated that utilization has increased for these 
services due to the effect of the Affordable Care Act on epilepsy care, 
the increased need for EEG monitoring in the ICU, the importance of 
long-term monitoring for accurate diagnoses for patients with seizures, 
and due to the presence of outlier cases. Commenters stated that 
millions of patients have obtained insurance over the last few years 
and many of the previously uninsured were poor and lower income, and 
therefore, the population of newly insured patients with psychiatric 
diagnoses has increased. Commenters stated that an abundance of data 
has emerged over the last 10 years demonstrating that more intensive 
continuous EEG monitoring in the ICU is needed to detect seizures that 
the prevalence of seizures that were previously undetected is very high 
in critically ill patients, and that patients with untreated seizures 
and non-convulsive status epilepticus have significantly poorer 
outcomes. Commenters stated that if physicians truly were able to more 
efficiently interpret EEG, this increased efficiency would not be a 
reasonable justification for changing payment. Commenters stated that 
if a worker is more productive most businesses would encourage this, 
and the worker would not be punished for more efficient work.
    Response: We appreciate the additional information supplied by the 
commenters regarding the potential causes behind increasing utilization 
of these services. We note that while observed increases in utilization 
contributed to review of these services under the misvalued code 
initiative, we establish RVUs based on the resources involved in 
furnishing services. We remind commenters that section 1848(c)(2)(C)(i) 
of the Act specifically defines the work component as the relative 
resources, incorporating time and intensity, required in furnishing the 
service. As such, if the work time for a service has decreased as a 
result of improvements in technology or practice patterns, those things 
should be reflected in the work valuation.
    Comment: Several commenters stated that there were potential rank 
order anomalies in the proposed valuation of the codes in this family. 
Commenters stated that the TC of CPT code 95819 (Electroencephalogram 
(EEG); including recording awake and asleep), considered a routine EEG 
of 20-40 minutes recording, was valued higher than several of the new 
Long Term EEG Monitoring codes, including CPT codes 95711, 95712, 
95714, 95708, and 95706. Commenters also stated that CPT code 95710, 
which does not include video, was valued higher than CPT code 95716, 
which does include video. Commenters questioned why the more resource 
intensive service with video would be valued less than the same service 
without video.
    Response: We do not agree with the commenters that the identified 
codes represent rank order anomalies. CPT code 95819 has significantly 
more clinical labor time (154 minutes) than CPT codes 95711, 95712, 
95714, 95708, and 95706. We remind readers that this is due to the fact 
that the new TC Long Term EEG Monitoring codes do not include direct PE 
inputs for setting up or taking down the monitoring equipment, which 
are separately reported under CPT code 95700. These direct PE inputs 
associated with setup and takedown are included in CPT code 95819, 
which, along with its greater assignment of clinical labor time, 
explains why it has a higher valuation that these procedures.
    With regard to CPT codes 95710 and 95716, we agree that, generally 
speaking, the version of the procedure

[[Page 62784]]

that includes video would be valued higher than the version of the 
procedure that does not include video. We note that this is the pattern 
for all of the other video/non-video pairings in this code family, such 
as CPT codes 95705 and 95711, CPT codes 95706 and 95712, CPT codes 
95707 and 95713, CPT codes 95708 and 95714, and CPT codes 95709 and 
95715. We also note that the proposed direct costs for CPT code 95710 
are lower than the proposed direct costs for CPT code 95716. However, 
the total payment rate referred to by the commenter (that is, the total 
sum RVU for these codes) also includes the indirect PE portion of the 
payment and, under our ratesetting methodology, CPT code 95710 received 
a slightly higher indirect PE allocation as compared to CPT code 95716. 
This was due to the different utilization crosswalks that we proposed 
for the two codes, in which CPT code 95710 was crosswalked from 
services that would currently be reported using CPT code 95953 while 
CPT code 95716 was crosswalked from services that would currently be 
reported using CPT code 95951. Because CPT code 95953 has a slightly 
higher indirect PE allocation as compared to CPT code 95951, under the 
proposed new coding for CY 2020, CPT code 95710 would also have a 
slightly higher indirect PE allocation and receive slightly more 
indirect PE in comparison to CPT code 95716. We remind readers that 
indirect PE makes up a significant amount of the PE RVUs and, as such, 
the total payment for services; and procedures with greater direct PE 
costs do not always have a larger PE RVU. We also note that the 
proposed differential between these two new CPT codes was one half of 
one percent, which we do not believe to be a statistically significant 
amount, and that all of the TC codes in this family will be contractor-
priced for CY 2020.
    Comment: Several commenters stated that the phase-in of significant 
relative value unit reductions applies to codes that are not new or 
revised, which would exclude the long-term EEG monitoring codes. 
However, commenters still urged CMS to apply the phase-in to this 
family of codes due to the proposed payment reductions.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that are not new or revised 
codes, if the total RVUs for a service for a year would otherwise be 
decreased by an estimated 20 percent or more as compared to the total 
RVUs for the previous year, the applicable adjustments in work, PE, and 
MP RVUs shall be phased-in over a 2-year period. We did not propose to 
apply the phase-in of significant RVU reductions required by section 
1848(c)(7) of the Act to the codes in the Long Term EEG Monitoring 
family due to the fact that they are all new codes created by the CPT 
Editorial Panel, which are statutorily excluded from the phase-in 
provision. For additional information regarding the phase-in of 
significant RVU reductions, we direct readers to the CY 2016 PFS final 
rule with comment period (80 FR 70927 through 70929).
    Comment: Several commenters stated that the primary issues related 
to the undervaluation of the 2-12 hour EEG TC services (CPT codes 
95705-95707 and 95711-95713) appeared to be a result of a 
misunderstanding of where and how these services are provided. 
Commenters stated that these codes were valued as if they typically 
will be performed in a physician's office setting, when in fact EEG TC 
services are typically performed in the home setting regardless of 
duration. Commenters stated that the proposed valuation was fatally 
flawed as a result, and stated that CMS should refrain from finalizing 
the proposed valuation and temporarily authorize contractor pricing 
pending revaluation that takes into consideration data to be provided 
from IDTFs.
    Response: We disagree with the commenters that the 2-12 hour EEG TC 
codes would typically be performed in the home setting regardless of 
duration. The RUC reviewed and developed recommendations for these 
codes with the understanding that they were typically performed in the 
office setting. We emphasize that we do not believe that the RUC is the 
exclusive source of information used in valuation of PFS services, and 
we are supportive of the submission of additional data that can aid in 
the process of determining the resources that are typically used to 
furnish these services. However, in the absence of alternative data 
used to value new services, we believe that the recommendations from 
the RUC, generally speaking, are the most accurate source to use when 
it comes to determining the typical site of service for new codes. 
Because we did not receive data from the commenters to support their 
contention that the patient's home would be the typical setting for 
these codes, we do not believe that it would be appropriate to ignore 
the RUC recommendations regarding the related direct PE inputs. 
However, we urge interested stakeholders to consider submitting robust 
data regarding site of service for these and other services.
    The following comments address the proposed work valuation of 
individual codes in the family.
    Comment: Several commenters stated that the PC codes in the family 
(CPT codes 95717-95726) should be viewed as two distinct subsets when 
considering rank order for the family, as they represent two distinct 
patient populations. Commenters stated that when viewing the family of 
codes in this manner, the RUC-recommended work RVUs do not create a 
rank order anomaly for the family and recognize both the time and 
intensity of the services. Commenters stated that CPT codes 95717-95720 
are typically facility-based services, provided to hospital inpatients 
and outpatients, in which the work is more complex and intense as the 
typical patients are undergoing pre-surgical evaluations and/or being 
withdrawn from anti-seizure medications to induce seizures. Commenters 
stated that CPT codes 95721-95726 will be provided to patients 
primarily tested in their homes, in which the practitioner does not 
access the data until the conclusion of the study. Commenters urged CMS 
to accept the RUC-recommended work RVUs for all of these PC codes.
    Response: We disagree with the commenters that the PC codes in the 
family (CPT codes 95717-95726) should be viewed as two distinct subsets 
when considering rank order for the family. We believe that all ten of 
these new codes were created together by the CPT Editorial Panel, 
surveyed together by the specialty societies, and reviewed together by 
the RUC. We do not believe that it would serve the purpose of 
maintaining relativity to consider the first four codes separate from 
the last six codes, any more than it would be appropriate to consider 
only the video or only the non-video codes separate from their 
counterparts. We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate basis of 
comparison.
    Comment: Many commenters disagreed with the CMS proposed work RVU 
of 1.85 for CPT code 95717 and stated that CMS should instead finalize 
the RUC-recommended work RVU of 2.00. Commenters stated that the CMS 
crosswalk code (CPT code 93314) was a poor reference point in general, 
as CMS finalized a work RVU for this crosswalk

[[Page 62785]]

code much lower than its RUC-recommended value of 2.80. Commenters also 
stated that the proposed work RVU of 1.85 would not maintain 
appropriate relativity to other services in this family, particularly 
CPT code 95813 (Electroencephalogram (EEG) extended monitoring; 61-119 
minutes), for which CMS finalized the RUC-recommended work RVU of 1.63 
in CY 2018. Commenters stated that the proposed value would 
inappropriately assign CPT code 95717 an intensity that is 10 percent 
lower than CPT code 95813.
    Response: We appreciate the additional information provided by the 
commenters with respect to CPT code 95813. Based on the information 
provided by the commenters, we are not finalizing our proposed work RVU 
of 1.85, and we will instead finalize the RUC-recommended work RVU of 
2.00 for CPT code 95717.
    Comment: Many commenters disagreed with the CMS-proposed work RVU 
of 2.35 for CPT code 95718 and stated that CMS should instead finalize 
the RUC-recommended work RVU of 2.50. Commenters stated that since the 
CMS rationale for rejecting the RUC recommendation for CPT code 95717 
was flawed as described above, it should not be used as the basis to 
derive a new value for CPT code 95718. Commenters stated that the CMS 
reference code (CPT code 99310) was a poor comparator as it is 
typically performed by a nonphysician and involves highly disparate 
work. Commenters stated that the proposed value would not maintain 
appropriate relativity to other services in this family, particularly 
CPT code 95813, by inappropriately assigning CPT code 95718 a lower 
intensity.
    Response: As we stated in the proposed rule, we concurred with the 
RUC that the relative difference in work between CPT codes 95717 and 
95718 is equivalent to the recommended interval of 0.50 RVUs. Since we 
are finalizing the RUC-recommended work RVU of 2.00 for CPT code 95717 
based on feedback from commenters, we will also finalize the RUC-
recommended work RVU of 2.50 for CPT code 95718 to maintain this 
incremental difference between the two codes.
    Comment: Many commenters disagreed with the CMS proposed work RVU 
of 2.60 for CPT code 95719 and stated that CMS should instead finalize 
the RUC-recommended work RVU of 3.00. Commenters stated that the 
proposed crosswalk code (CPT code 99219) was inappropriate as 
observation care involves relatively less intensity than the typical 
long-term EEG described by the survey code. Commenters stated that 
although both services involve identical intraservice time and similar 
total time, CPT code 95719 is a more intense service performed on a 
sicker patient population. Commenters also stated that the proposed 
value would not maintain appropriate relativity to other services in 
this family, particularly CPT code 95813, by inappropriately assigning 
CPT code 95719 a lower intensity.
    Response: We appreciate the additional information provided by the 
commenters with respect to CPT code 95813. Based on the information 
provided by the commenters, we are not finalizing our proposed work RVU 
of 2.60, and we will instead finalize the RUC-recommended work RVU of 
3.00 for CPT code 95719.
    Comment: Many commenters disagreed with the CMS proposed work RVU 
of 3.50 for CPT code 95720 and stated that CMS should instead finalize 
the RUC-recommended work RVU of 3.86. Commenters stated that CMS 
incorrectly referenced CPT code 95956 as a predecessor code for CPT 
code 95720, rather than CPT code 95951. Commenters stated that CPT code 
95956 is the predecessor code for CPT code 95719, which has no video 
recording, and therefore, has a lower work RVU. Commenters stated that 
CMS appreciated the difference in work when video is recorded but used 
the wrong predecessor code for CPT code 95720.
    Response: We disagree with the commenters that we referred to an 
incorrect predecessor code for CPT code 95720 in the proposed rule. We 
noted in the proposed rule that among the predecessor codes for this 
family, CPT code 95956 had a higher intraservice time of 60 minutes and 
a higher total time of 105 minutes at a work RVU of 3.61. We did not 
state that CPT code 95956 was a direct predecessor code for CPT 95720, 
as we were aware that it did not include video recording, and 
therefore, we did not include CPT code 95956 in the proposed 
utilization crosswalk for CPT code 95720. We continue to believe that 
it is appropriate to make comparisons between the codes that are 
currently used to report Long Term EEG Monitoring and the newly created 
codes that will be used for these services going forward.
    Comment: Commenters also disagreed with the CMS criticism of the 
RUC-recommended crosswalk to CPT code 99223. Commenters stated that CMS 
seemed to be asserting that all crosswalks must have near identical 
work intensity instead of simply involving the same overall amount of 
work. Commenters stated that crosswalks with near identical times do 
not always exist, which was the case for this service, which sometimes 
necessitates selecting a crosswalk with somewhat disparate total time 
which has a different level of work intensity though the same overall 
amount of work. Commenters stated that although CPT code 99223 involved 
more total time, CPT code 95720 is a more intense service to perform 
given the difficulty involved in making an appropriate reading/
diagnosis and a more intensive patient population in which the typical 
patient is a candidate for epilepsy surgery.
    Response: We agree with the commenters that codes selected as 
crosswalks do not necessarily need to share the identical work times. 
However, since we are we are obligated under the statute to consider 
both time and intensity in establishing work RVUs for PFS services, we 
believe that, generally speaking, it is more accurate to use codes with 
similar work time values when determining which codes should be used 
for crosswalks. In the particular case of CPT code 95720, we believed 
that the 15 minutes of additional total time in CPT code 99223 as 
compared to CPT code 95720 resulted in a higher work valuation that 
overstated the work RVU of CPT code 95720.
    Comment: Commenters also stated that the proposed work RVU for CPT 
code 95720 would not maintain appropriate relativity to other services 
in this family, particularly CPT code 95813, by inappropriately 
assigning CPT code 95720 a lower intensity. Commenters disagreed with 
the proposed work valuation of CPT code 95720 and stated that this code 
would indeed be notably more intense than the other codes in the same 
family given that the typical patient for that code is a candidate for 
epilepsy surgery. Commenters stated that CMS failed to take account for 
the typical patient for this service in determining the work valuation.
    Response: We appreciate the additional information provided by the 
commenters with respect to CPT code 95813 and the typical patients for 
this code. Based on the information provided by the commenters, we are 
not finalizing our proposed work RVU of 3.50, and we will instead 
finalize the RUC-recommended work RVU of 3.86 for CPT code 95720. 
Therefore, we are finalizing the RUC-recommended work RVU for all ten 
of the PC codes in this family.
    The following comments address the proposed direct PE inputs for 
the Long Term EEG Monitoring family of codes.

[[Page 62786]]

    Comment: Many commenters were concerned that the RVUs associated 
with the TC Long Term EEG Monitoring services (CPT codes 95700-95716) 
would be reduced substantially from their predecessor codes, 
specifically as compared to CPT code 95951 and 95956. Commenters stated 
that these reductions would be unsustainable for these technical 
services, as the proposed values and resulting payment rates simply 
would not cover the costs.
    Response: We are aware of the concerns raised by the commenters 
about the proposed values, and, as mentioned previously, we are 
finalizing contractor pricing for the TC Long Term EEG Monitoring 
services (CPT codes 95700-95716). Due to the high utilization of these 
services, we believe that they should eventually be transitioned to 
national pricing and, therefore, we are detailing and responding to 
many of the issues raised by stakeholders that relate to valuation of 
the TC codes. We believe that this discussion will assist in the 
eventual national pricing of these services through further rulemaking.
    We note that there were many significant changes made to this code 
family when the previous Long Term EEG Monitoring codes were deleted 
and replaced with new codes, and we believe that it is important to 
explain for the commenters why the new TC codes do not correspond 
directly to the previous coding. Services will be reported differently 
under the new coding, and therefore, direct RVU comparisons between the 
old codes and the new codes are not necessarily accurate.
    We note for readers that the new coding has been split into 
separate TC-only codes (CPT codes 95700-95716) and PC-only codes (CPT 
codes 95717-95726). Comparisons to the global component of the prior 
codes for Long Term EEG Monitoring, which included both PCs and TCs, 
would not be accurate due to this different coding structure. We also 
note that the new TC-only codes include a separate code for setting up 
and taking down the EEG equipment (CPT code 95700), whereas the prior 
coding contained these steps along with the monitoring itself in a 
single code. The new monitoring codes must be considered together with 
the setup code 95700 to be comparable to the previous coding.
    We also believe that it is important to note that the new coding is 
more granular than the previous coding, and includes separate codes for 
2-12 hours of monitoring (8 hours typical) along with codes for 12-26 
hours of monitoring (24 hours typical). The previous codes only 
described Long Term EEG Monitoring in 24 hour increments, and it is 
natural to assume that the resources associated with providing 8 hours 
of monitoring would be less than those associated with 24 hours of 
monitoring. Many commenters compared the RVUs for new TC codes such as 
CPT codes 95712 and 95713, which have 8 hours of monitoring in the 
typical case, to CPT code 95951, which assumes 24 hours of monitoring 
is typical. The PE methodology under the PFS is a resource-based 
system, and if the typical case for some of the new TC services 
involves 8 hours of monitoring, we believe that this should be 
reflected in the RVUs for those services.
    We note as well that the coding has become more granular in 
describing different types of monitoring. The prior Long Term EEG 
Monitoring coding only made a distinction between attended versus 
unattended monitoring, whereas the new coding includes a third category 
for intermittent monitoring. We would expect the RVUs for CPT codes 
95706, 95709, 95712, and 95715 to decrease as compared to the prior 
coding that assumed monitoring would be continuous throughout the 
duration of the procedures.
    Finally, we also note that changes in practice patterns for these 
services has affected them since their last time of review. CPT code 
95956 (Monitoring for localization of cerebral seizure focus by cable 
or radio, 16 or more channel telemetry, electroencephalographic (EEG) 
recording and interpretation, each 24 hours, attended by a technologist 
or nurse) contained 1440 minutes of clinical labor time (24 hours times 
60 minutes) associated with monitoring in its direct PE inputs, 
assuming that the patient would be individually monitored for the 
entirety of the 24 hour period. However, based on the recommendations 
from the RUC, we understand that it is now typical for the clinical 
labor technician to monitor 4 patients at a time, even during the 
continuous monitoring procedures. This is reflected in the recommended 
clinical labor inputs for CPT codes 95710 and 95716, which contain 360 
minutes of clinical labor (1,440 divided by 4) instead of the 1,440 
minutes in the previous coding. The shorter duration continuous 
monitoring codes similarly contain 120 minutes (8 hours times 60 
minutes divided by 4) of clinical labor time to reflect the fact that 
monitoring 4 patients at a time is the typical practice, and the 
intermittent monitoring codes contain even less clinical labor time to 
reflect the fact that monitoring 12 patients at a time is typical 
practice. (Obviously the unattended monitoring codes do not contain any 
clinical labor at all for this activity as there is no technician 
monitoring the patient in these cases.)
    The net result is that there is significantly less clinical labor 
associated with the new Long Term EEG Monitoring codes as compared to 
the prior coding set, and this was reflected in their proposed payment 
rates. We believe that it is important to propose the most accurate 
values possible under our relative value system, and if it has become 
the typical practice pattern for the technician to monitor 4 patients 
at a time, we believe that this should be reflected in the RVUs for 
these services. We do not believe that it would be accurate or serve 
the interests of relativity to continue to assign the prior 1,440 
minutes of clinical labor time for the new TC codes if this no longer 
reflects current monitoring practice patterns. We emphasize again that 
we are finalizing contractor pricing for the TC codes, but we believe 
that if we were to adopt active pricing, the valuation must be 
resource-based and grounded in current practice patterns.
    Comment: Several commenters disagreed with the CMS proposal of the 
survey 25th percentile direct PE inputs as opposed to the recommended 
survey median direct PE inputs for CPT code 95700. Commenters stated 
that the 25th percentile clinical labor times are a completely 
different measure than the 25th percentile work RVU, and the RUC makes 
recommendations on direct PE inputs only, not the PE RVUs which would 
be the equivalent of the work RVUs. Commenters also stated that the 
median survey times for work are what is most commonly recommended by 
the RUC, not the 25th percentile survey work times, which was even more 
reason to employ the survey median times from the PE survey. Commenters 
stated that PE surveys are especially difficult to conduct and require 
a great deal of resources from the specialty societies involved, and 
the commenters encouraged CMS to finalize the RUC-recommended direct PE 
inputs for CPT code 95700.
    Response: We appreciate the feedback from the commenters regarding 
the use of the direct PE survey employed for CPT code 95700. We concur 
with the commenters that the use of a survey methodology to determine 
direct PE inputs is not identical to the surveys used for work 
valuation, which is why we stated in the proposed rule that we believed 
in applying ``a similar process of scrutiny'' and not the same process. 
We remind the commenters that we did not propose the 25th percentile 
value for all of the direct PE inputs, instead

[[Page 62787]]

choosing the survey value for each input that we believed to be most 
accurate based on the information that we had available. For example, 
we agreed in the proposed rule that the survey median clinical labor 
times of 12 minutes for the ``Prepare room, equipment and supplies'' 
(CA013) activity, 45 minutes for the ``Prepare, set-up and start IV, 
initial positioning and monitoring of patient'' (CA016) activity, and 
22 minutes for the ``Clean room/equipment by clinical staff'' (CA024) 
activity would be typical for CPT code 95700. We believe that proposing 
the survey median value from the direct PE survey in all cases would be 
no more accurate than proposing the survey 25th percentile value in all 
cases. We reiterate that we assess the direct PE inputs for each 
procedure individually based on our methodology of what would be 
reasonable and medically necessary for the typical patient.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Complete pre-procedure phone 
calls and prescription'' (CA005) activity from 10 minutes to 3 minutes 
for CPT code 95700. Commenters stated that instructions for video-EEG 
monitoring are lengthy and complicated, including the purpose of the 
test, patient preparation (hair care prior to test for electrode gel 
application, appropriate clothing), limitations on activities during 
the test, details of the location of testing, and type of equipment the 
patient will take home or be monitored with. Commenters stated that 
education typically takes 10 minutes.
    Response: We disagree with the commenters that 10 minutes of 
clinical labor time would be typical for this activity. We note that 
the description of tasks provided by the commenters for the CA005 
activity does not match the description of this activity code provided 
in the recommended materials for CPT code 95700, which instead listed 
calling the patient to confirm they have completed all pre-procedure 
activities, sanitizing and preparing any equipment that needs to be 
sanitized prior to each procedure, and collecting supplies to complete 
setup. The patient education tasks described by the commenters are 
contained in the CA011 activity code (``Provide education/obtain 
consent''), not the CA005 activity code. We continue to believe that 
many of the tasks described under the CA005 activity code are forms of 
indirect PE, and as we stated in the proposed rule, we believe that the 
RUC-recommended survey median clinical labor time of 10 minutes 
overstates the amount of direct clinical labor taking place. We 
continue to believe that it was more accurate to propose the survey 
25th percentile clinical labor time of 3 minutes for this activity code 
to reflect the non-administrative tasks performed by the clinical 
staff.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Provide education/obtain 
consent'' (CA011) activity from 13 minutes to 7 minutes. Commenters 
stated that the proposed 7 minutes was not ``more typical'' for this 
service, as long-term EEG monitoring is a service often performed on 
patients associated with neuropsychological impairment. Commenters 
stated that this condition means that the cognitive status of the 
patient may be challenged, making it more difficult to provide 
education, obtain consent, and review instructions. Commenters stated 
that people experiencing seizures who require a long-term EEG may be 
confused, sleepy, or forgetful, and making certain that patients are 
aware of the care instructions is important and can be a time-consuming 
endeavor. Commenters included a series of studies involving epilepsy 
research and requested that CMS finalize the RUC-recommended value of 
13 minutes to reflect the patient mix undertaking these procedures.
    Response: We appreciate the additional information provided by the 
commenters, including the studies included with their comments. We 
agree that there is a need for additional clinical labor time for 
patient education and consent in these procedures due to the patient 
population concerns identified by the commenters. This is the reason 
why we proposed 7 minutes for the CA011 activity code, which is more 
than triple the typical time of 2 minutes assigned to most other 
procedures for this task. We continue to believe that the proposed time 
of 7 minutes would be more typical for obtaining consent and reviewing 
patient education.
    Comment: Several commenters disagreed with the CMS proposal of the 
RUC-recommended clinical labor time of 45 minutes for the ``Prepare, 
set-up and start IV, initial positioning and monitoring of patient'' 
(CA016) activity. Commenters stated that this time was undervalued and 
it was missing clinical labor time for applying the 10-20 system for 
electrode placement, following universal infection control policies, 
assessing skin breakdown risk at the electrode application site, using 
appropriate electrode application technique for at-risk patients, 
placing recording reference and ground electrodes in digital recording 
systems, and securing the headbox/transmitter system to protect against 
disconnection during patient movement. Commenters stated that the time 
that the EEG technologists takes to disconnect electrodes from the 
patient also appeared to be missing from the valuation of CPT code 
95700 and needed to be included. The commenters stated that their EEG 
technologists averaged 128 minutes per patient for the activities 
covered in CPT code 95700, not the proposed 45 minutes.
    Response: We disagree with the commenters that the tasks described 
in the CA016 activity code would typically require 128 minutes, almost 
triple the RUC-recommended time that we proposed. The same steps 
described by the commenter--such as preparing the patient, applying the 
electrodes, and testing the equipment--were part of the direct PE 
survey undertaken by the RUC, which returned a median time of 45 
minutes and a 25th percentile time of 22 minutes. Although we agree 
with the commenter on the importance of these tasks, we do not believe 
that it would be typical for them to take 128 minutes given the survey 
data compiled by the RUC. We also note for the commenters that we did 
propose clinical labor time associated with disconnecting electrodes 
from the patient and taking down the monitoring equipment. This 
clinical labor time is listed under the CA024 clinical labor activity 
(``Clean room/equipment by clinical staff''), and we proposed the RUC-
recommended 22 minutes for these tasks.
    Comment: Several commenters disagreed with the CMS proposal of the 
RUC-recommended clinical labor time for the ``Perform procedure/
service--NOT directly related to physician work time'' (CA021) activity 
across the TC Long Term EEG Monitoring family of codes. Commenters 
stated that the RUC survey data included more clinical labor time for 
the 2-12 hour EEG codes than for the longer duration 12-26 hour EEG 
codes, with a disproportionate amount of time given to the monitoring 
codes of shorter duration. Commenters provided several examples, such 
as CPT code 95706 having 57 minutes of clinical labor time as compared 
against CPT code 95709 having 50 minutes of clinical labor time. 
Commenters stated that the proposed clinical labor times were clearly 
in error and must be corrected in a final rule.
    Response: We disagree with the commenters that the proposed 
clinical labor times were in error. The CA021 clinical labor times for 
the shorter 2-12 hour EEG codes have additional clinical labor time for 
maintenance activities, as

[[Page 62788]]

recommended by the RUC, which are not included for the longer 12-26 
hour EEG codes due to the fact that these maintenance activities were 
stated not to be typically performed for the longer codes. We believe 
that many of these maintenance activities would not typically take 
place for the longer 12-26 hour EEG codes due to the fact that they 
will typically take place in the patient's home as opposed to the 
office setting. More importantly, we note that there are two 
technicians associated with each of the TC Long Term EEG Monitoring 
codes, one technician associated with monitoring tasks and another 
technician associated with non-monitoring tasks. We believe that 
looking at the clinical labor for only one of these two technicians 
presents an inaccurate picture of the coding structure. To use the same 
comparison between CPT codes 95706 and 95709 raised by the commenters, 
the second technician--the one present during the actual monitoring--
has a clinical labor time of 40 minutes for the shorter 2-12 hour code 
(95706) and 120 minutes for the longer 12-26 hour code (95709), exactly 
as one would expect to see. We believe that it is highly misleading to 
look at only one of the two technicians in suggesting that the clinical 
labor times are in error and need correcting.
    Comment: Several commenters stated that the proposed estimates for 
the non-monitoring clinical labor times associated with the continuous 
monitoring long term EEG codes were inaccurate. Commenters stated that 
the non-monitoring tasks involved in the provision of the services 
described in these codes are extensive, including: Reviewing patient 
clinical history, confirming the camera is displaying properly, 
reviewing patient events from prior monitoring, reviewing EEG recording 
for quality, checking electrode impedances for quality, documenting 
findings and notes, ensuring the patient is still in camera view, 
conducting maintenance during the patient session including contacting 
on-call maintenance support, repairing or replacing electrodes, 
counseling or instructing the patient if electrodes stop recording or a 
patient event occurs, communicating with the physician/QHP for events 
or triggers, reviewing and preparing data and video reports for the 
physician, analyzing and annotating the EEG test noting spike generator 
locations, and sending all data to the physician for reading. The 
commenters stated that the clinical labor time recommended by the RUC 
and proposed by CMS is substantially lower than what is required and 
fails to capture the time involved for all of the tasks outlined above.
    Response: We disagree with the commenters that the proposed 
clinical labor time for these non-monitoring clinical labor activities 
would not be typical for these codes. We proposed the RUC-recommended 
clinical labor time for the service period of all four continuous 
monitoring EEG codes, which does include clinical labor time associated 
with the very same tasks listed by the commenter. For example, we 
proposed the RUC-recommended 72 minutes of clinical labor time for the 
CA021 (``Perform procedure/service--NOT directly related to physician 
work time'') activity for CPT code 95713, which included 10 minutes of 
clinical labor time for reviewing patient clinical history, current 
medications, and prior monitoring. Our proposal also included 34 
minutes of clinical labor time for reviewing and preparing data, 
annotating the EEG, noting spike generator locations, documenting 
technologist initial notes, and sending all data to the practitioner 
for reading. We note that the very same clinical labor tasks described 
by the commenters were recommended by the RUC and proposed by CMS to 
include substantial (over 60 minutes) clinical labor time for these 
activities. We clarify for the commenters that the proposed clinical 
labor did include time for maintenance activities, with the non-
monitoring technician repositioning or reattaching the electrodes as 
needed throughout the procedure time. In the absence of data from the 
commenters to support these significantly higher clinical labor times, 
we continue to believe that our proposed times are the most accurate 
values.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Coordinate post-procedure 
services'' (CA038) activity from either 11 minutes to 5 minutes or from 
22 minutes to 10 minutes as appropriate for the CPT code in question. 
Commenters stated that CMS used a comparison to the clinical labor time 
for CPT code 95812 in making this refinement, however CPT code 95812 
describes a 41-60 minute study as opposed to long term EEG monitoring. 
Commenters stated that selecting the relevant EEG data to be archived 
and then archiving it would take considerably longer due to the longer 
duration of the reviewed codes. Commenters urged CMS to finalize the 
RUC-recommended clinical labor times instead of the proposed values.
    Response: We appreciate the additional information provided by the 
commenters regarding the shorter duration of CPT code 95812. Based on 
the feedback from the commenters, we would not finalize our proposed 
refinements and would instead finalize the RUC-recommended clinical 
labor time for the ``Coordinate post-procedure services'' (CA038) 
activity at either 11 minutes or 22 minutes as appropriate for the CPT 
code in question if we were to adopt national pricing. We would also 
finalize the equipment time for the Technologist PACS workstation 
(ED050) to match the clinical labor time for the CA038 activity if we 
were to adopt active pricing.
    Comment: A commenter disagreed with both the RUC-recommended and 
CMS-proposed clinical labor times for CPT code 95700. The commenter 
stated that this code does not specify whether the service is being 
performed in a physician's office or the patient's home, and this lack 
of differentiation makes it difficult to provide an accurate picture of 
the service. The commenter stated that the proposed clinical staff time 
for CPT code 95700 of 96 minutes was approximately half of the time 
actually required to do a set up in the patient's home and does not 
include any time for the take down. The commenter stated that in the 
home setting the procedure set up is typically 3 hours and take down is 
one hour. The commenter also stated that the proposed clinical labor 
for CPT code 95700 did not include any travel time, which is usually 
between 1 and 3 hours in each direction. The commenter stated that 
additional clinical labor time should be added to reflect this setup 
and takedown time along with 3 hours of clinical labor time to reflect 
travel.
    Response: We disagree with the commenter that several additional 
hours of clinical labor time should be added to CPT code 95700. 
Although we do not believe that the RUC is the exclusive source of 
information used in valuation of PFS services, in the absence of 
alternative data used to value new services, we believe that the direct 
PE recommendations from the RUC are the key source to use for 
valuation. We believe that the direct PE survey used by the RUC for CPT 
code 95700 represents the best information available for this service, 
and given that we did not receive data from the commenter to support 
alternate valuations, we believe that the clinical labor times that we 
proposed, based on either the median or 25th percentile values from the 
RUC's direct PE survey, represent the most accurate times. We also note 
for the commenter that we did propose clinical labor time associated 
with disconnecting electrodes from the patient and taking down the 
monitoring

[[Page 62789]]

equipment. This clinical labor time is listed under the CA024 clinical 
labor activity (``Clean room/equipment by clinical staff''), and we 
proposed the RUC-recommended 22 minutes for these tasks.
    With regard to the driving times mentioned by the commenter, we did 
not propose clinical labor time for these activities because we 
consider them to be a type of office expense, and therefore, a form of 
indirect PE. Transportation costs are not individually allocable to a 
particular patient for a particular service, and therefore, constitute 
indirect PE under our methodology.
    Comment: A commenter disagreed with both the RUC-recommended and 
proposed clinical labor times for CPT codes 95715 and 95716. The 
commenter stated that the clinical labor inputs failed to include time 
for tasks such as maintenance and pruning, and the proposed clinical 
labor assumed that the maximum number of patients are being monitored 
at all times. The commenter stated that the clinical labor inputs also 
do not include time for data pruning, a critical component of EEG 
monitoring that allows the neurologist to more efficiently read the 
test results. The commenter stated that approximately 4 hours of 
clinical labor time should be added to these codes to reflect these 
missing inputs.
    Response: We disagree with the commenter that this additional 
clinical labor time would be typical for CPT codes 95715 and 95716. We 
proposed the RUC-recommended clinical labor time for the service period 
of both codes, which does include clinical labor time associated with 
data management. For example, we proposed the RUC-recommended 70 
minutes of clinical labor time for the CA021 (``Perform procedure/
service--NOT directly related to physician work time'') activity for 
CPT code 95715, which included 60 minutes of clinical labor time for 
reviewing and preparing data, annotating the EEG, noting spike 
generator locations, documenting technologist initial notes, and 
sending all data to the practitioner for reading. The recommended 
materials stated that this data preparation would typically take place 
during the patient session, as opposed to separate from it, and we have 
no reason to belief that this would not be the case.
    Comment: Several commenters stated that it was inappropriate for 
CMS to assume that IDTFs typically operate at maximum efficiency, 
providing continuous monitoring to 4 patients at the same time and 
intermittent monitoring to 12 patients at the same time. Commenters 
stated that the RUC survey that was the basis for the proposed 
duration-of-monitoring assumptions indicated that it is more typical 
for continuous monitoring to be provided to three patients at the same 
time. Commenters stated that they anticipated that the time associated 
with monitoring would increase under the new CPT nomenclature, since 
the new nomenclature provides an incentive for increased physician 
involvement in the monitoring process, which likely would increase 
physician-technologist communication and coordination. Commenters also 
stated that some facilities will not have enough EEG machines to 
monitor 12 patients at a time under intermittent monitoring.
    Response: We continue to believe that 4 patients would typically be 
monitored at a time under continuous monitoring and that 12 patients 
would typically be monitored at a time during intermittent monitoring. 
While it is true that the RUC survey initially suggested that 3 
patients would be monitored at a time during continuous monitoring, the 
RUC updated its clinical labor times to reflect an assumption of 4 
patients being monitored simultaneously based on a consensus opinion 
that this more accurately reflected the typical practice pattern. With 
regard to the specific issue raised by the commenters, we agree that 
some facilities may not have enough EEG machines to monitor 12 patients 
at a time, but, conversely, some facilities may be able to monitor more 
than 12 patients at a time. Our methodology is based on the typical 
case and is not intended to cover every possible situation that may 
occur across all providers. The typical case for long term EEG 
monitoring was recommended to us and we believe to be 4 patients at a 
time for continuous monitoring and 12 patients at a time for 
intermittent monitoring.
    Comment: Several commenters disagreed with both the RUC-recommended 
and proposed supplies for CPT code 95700. Commenters stated that there 
were many additional supplies that should also be included in this 
code, such as 28 disposable electrodes, 9-volt lithium batteries, a 
battery tester, foam electrodes, a HIPAA-compliant lockbox, utility 
scissors, disinfecting Cavi-wipes, protective skin barrier wipes, 
disposable sterile sheet pads, Purell hand sanitizer, cotton-tip 
applicators, disposable Hefty bags, and patient safety labels. 
Commenters provided invoices for some of these supplies and requested 
that CMS add them to the direct PE inputs for CPT code 95700.
    Response: We disagree with the commenters that these additional 
supplies should be added to the direct PE inputs for CPT code 95700. 
Aside from proposing to refine the quantity of the non-sterile gloves 
(SB022) supply from 3 to 2, due to the fact that we believed the third 
pair of gloves to be duplicative, we proposed the RUC-recommended 
supplies for this code. We believe that these recommended supplies, 
based on the direct PE survey for CPT code 95700, represent the most 
accurate data associated with this procedure. We continue to believe 
that the use of disposable electrodes would not be typical for CPT code 
95700, as the recommended materials specifically stated that reusable 
electrodes would instead be typical. Many of the other supplies listed 
by the commenters were never included as supplies in the predecessor 
EEG monitoring codes, or they represent office expenses that we would 
consider to be indirect PE, such as the lockbox used for storage or the 
trash bags used for disposal. We continue to believe that the direct PE 
survey used by the RUC for CPT code 95700 represents the best supply 
information available for this service.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the equipment time for the Technologist PACS workstation (ED050) 
to match the clinical labor time proposed for the CA038 activity. 
Commenters stated that the work performed on the PACS station for long 
term EEG monitoring was different than other PACs stations, as the PAC 
station is where the EEG recording data and video data is processed, 
clipped, and ultimately saved. Commenters stated that given the 
duration of long term EEG recordings, the RUC-recommended equipment 
times for the technologist PACS workstation are more accurate and 
representative of the work performed.
    Response: We disagree with the commenters that the technologist 
PACS workstation (ED050) equipment time is used differently for long 
term EEG monitoring procedures as compared to the use of the same 
workstation in other services. The fact that EEG recording data is 
processed and clipped on the technologist PACS workstation does not 
provide a rationale for additional equipment time, as similar 
activities take place in other services as well. We do not understand 
why the workstation would be in use for double the amount of clinical 
labor assigned to the CA038 (``Coordinate post-procedure services'') 
activity code, as the RUC recommended, and we continue to believe that 
the equipment time should, generally

[[Page 62790]]

speaking, match the clinical labor time in which the equipment item is 
in use.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the equipment time for the ambulatory EEG review station (EQ016) 
equipment for the four continuous monitoring procedures, CPT codes 
95707, 95710, 95713, and 95716. Commenters stated that it was not 
typical for a review station to be hooked up to four monitors, as CMS 
stated in the proposed rule, and instead 2-3 monitors would be typical. 
Commenters stated that it would be more appropriate to assign EQ016 
minutes by multiplying CA021 clinical labor time 2 or 3 times plus prep 
time, rather than the refined times proposed by CMS.
    Response: We appreciate the additional information provided by the 
commenter stating that it would be typical for a review station to be 
hooked up to 2-3 monitors at a time. Based on the information from the 
commenters, we are refining the equipment times for the ambulatory EEG 
review station (EQ016) equipment to reflect the belief that having a 
review station connected to 3 monitors at a time is the typical case. 
This results in the equipment times increasing slightly for all four 
CPT codes, such as CPT code 95707 increasing from the proposed 150 
minutes to a new time of 190 minutes. Therefore, we would finalize 
EQ016 equipment times of 190 minutes for CPT code 95707, 520 minutes 
for CPT code 95710, 194 minutes for CPT code 95713, and 535 minutes for 
CPT code 95716 if we were to adopt active pricing for these codes.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the equipment time for the ambulatory EEG review station (EQ016) 
equipment in the PC codes (CPT codes 95717-95726) based on the belief 
that the use of the ambulatory EEG review station is analogous in these 
procedures to the use of the professional PACS workstation (ED053) in 
other procedures. Commenters stated that the EEG review station is used 
during the postservice work period and should be included in the PE 
inputs for all of the PC codes. Commenters stated that often the 
referring physician calls the physician providing the service to ask 
questions about the recording, and the providing physician will pull up 
the record on an EEG review station and go over the questions and 
provide responses with the inquiring physician. Commenters stated that 
this is similar to when a physician asks a radiologist about an MRI or 
CT report, as the radiologist opens the radiology review station to 
view the images while discussing with the referring physician the 
questions and answers.
    Response: We continue to disagree with the commenters about 
assigning the full work time to the ambulatory EEG review station 
(EQ016) equipment in the PC codes. We appreciate the analogy provided 
by the commenters to the use of a review station for an MRI or CT 
report; as we wrote in the proposed rule, we believe that the use of 
the ambulatory EEG review station is analogous in these procedures to 
the use of the professional PACS workstation (ED053) in other 
procedures, and we do not assign equipment time for the professional 
PACS workstation in MRI or CT procedures based on review by the 
practitioner in the postservice work period. We continue to believe 
that it better serves the purpose of relativity to propose an equipment 
time for the ambulatory EEG review station equal to half the preservice 
work time (rounded up) plus the intraservice work time for CPT codes 
95717 through 95726. We also continue to note that the work descriptors 
for CPT codes 95717-95726 make no mention of the ambulatory EEG review 
station in the postservice work period. Perhaps this equipment is used 
``often'' as the commenters stated but that does not necessarily mean 
that its use is typical for the procedures.
    Comment: A commenter disagreed with the proposed price of 
$26,410.95 for the equipment, ``EEG, digital, prolonged testing system 
with remote video, for patients home use'' (EQ394). The commenter 
submitted two invoices indicating slightly higher pricing for this 
equipment item and requested that CMS incorporate them into the 
equipment price.
    Response: We appreciate the submission of additional invoices from 
the commenter. Based on this information, we are finalizing an increase 
in the price of ``EEG, digital, prolonged testing system with remote 
video, for patients home use'' (EQ394) equipment from the proposed 
$26,410.95 to $29,496.98 based on the submission of three total 
invoices.
    Comment: A commenter disagreed with the proposed equipment items 
for CPT codes 95715 and 95716. The commenter stated that these codes 
assume use of an EEG review station, ambulatory (EQ016) equipment item 
at a price of $7,950 but the actual equipment used is more 
sophisticated and is better described as an EEG monitoring system 
(EQ019) equipment item at a price of $33,389.29.
    Response: We disagree with the commenter that the EEG monitoring 
system (EQ019) equipment would be more typical for these procedures 
than the proposed EEG review station, ambulatory (EQ016) equipment. The 
EQ019 equipment is a specialized item utilized by only two CPT codes, 
91132 and 91133, which are both transcutaneous diagnostic 
Electrogastrography procedures. By contrast, the EQ016 equipment is 
currently utilized in CPT code 95950, an actual EEG code that serves as 
a direct predecessor for many of the new long term EEG monitoring 
codes. We agree with the RUC that the use of the EQ016 equipment would 
be typical for these procedures.
    Comment: A commenter stated that the bedroom furniture (EF003) 
equipment was included only in CPT codes 95706, 95707, 95712, and 
95713, the EEG codes for 2-12 hours monitoring duration. The commenter 
stated that the need for furniture does not discontinue if the patient 
requires longer term monitoring, and requested that CMS add the EF003 
equipment to CPT codes 95709, 95710, 95715, and 95716.
    Response: As we noted elsewhere in the comment responses, the 2-12 
hour EEG monitoring codes were reviewed by the RUC and recommended to 
CMS with the understanding that they were typically performed in the 
office setting, whereas the 12-26 hour EEG monitoring codes were 
reviewed by the RUC and then recommended to CMS with the understanding 
that they were typically performed in the home setting. Although we 
agree with the commenter that the patient would typically be resting on 
some kind of furniture in the longer EEG monitoring codes, there is no 
equipment cost in these codes because the furniture would be located in 
the patient's own home and not in the office setting.
    Comment: Several commenters disagreed with both the RUC-recommended 
and CMS-proposed equipment items. These commenters stated that the 
proposed equipment reflects three different systems for EEG/vEEG 
recording, ranging in cost from $7,950 to $46,750, even though the same 
type of system is used for all of the monitoring described in the new 
EEG TC codes. Commenters stated that the proposed inputs reflected no 
additional equipment cost for video equipment and had an 
unrealistically long useful life. Commenters stated that the proposed 
inputs failed to recognize the software that is necessary to facilitate 
physician monitoring of testing in real time, as anticipated by new CPT 
codes 95717-95720.
    Response: We disagree with the commenters regarding these equipment 
issues. We proposed the use of different

[[Page 62791]]

equipment items to reflect the fact that the monitoring for the TC 
codes is captured by different types of equipment depending on the type 
of monitoring and the site of service. For example, the ``EEG, digital, 
prolonged testing system with remote video, for patients home use'' 
(EQ394) equipment is designed to be used to capture video recordings 
that take place in the patient's home. In contrast, the ``EEG monitor, 
digital, portable'' (EQ014) equipment does not contain a video 
component, and we proposed to include it only in the non-video codes in 
this family. Under our resource-based methodology, it would not be 
accurate to assign the same equipment to each TC code in the family 
given that they describe different services with differing equipment 
needs. Similarly, we disagree with the statement from the commenters 
that the proposed inputs reflected no additional equipment cost for 
video equipment. As we noted, we proposed different and more expensive 
equipment types for the codes in the family that use video equipment as 
opposed to those that do not.
    We also disagree with the commenters that we proposed 
unrealistically long useful life durations for the equipment. The only 
new equipment item used in this family of codes is the EQ394 equipment, 
for which we proposed a useful life of 7 years. This matches the same 
useful life of 7 years which has long been established for the EQ014, 
EQ015, and EQ017 equipment items, all of which involve EEG monitoring 
and all of which are utilized by codes in this family. We believe that 
the new EQ394 equipment would share this same useful life assumption 
with the other previously existing types of EEG monitoring equipment. 
We also disagree with the commenters that the direct PE inputs lack the 
necessary software to facilitate physician monitoring of testing in 
real time. The equipment items utilized for video monitoring, EQ017 and 
EQ394, both include basic software in their purchase prices, which 
helps to explain why they are priced at a higher rate than the non-
video EQ014 monitoring equipment.
    Comment: Several commenters suggested that the proposed equipment 
times were understated. Commenters stated that the monitoring system 
equipment times appeared to reflect only 8 hours of actual monitoring 
time (480 minutes) for the 2-12 hour codes and 24 hours (1,440 minutes) 
for the 12-26 hour codes. The commenter stated that the proposed 
equipment times only reflected the time for their direct use to monitor 
patients, and failed to reflect the time necessary for the delivery and 
return of equipment, set up, disconnect, or cleaning of equipment.
    Response: We disagree with the commenter that the proposed 
equipment times were understated. We note that the ``EEG monitor, 
digital, portable'' (EQ014) equipment did include proposed equipment 
time associated with patient setup and disconnecting of equipment in 
CPT code 95700. The other equipment items did not require this kind of 
set up, disconnecting, and cleaning time (such as the Technologist PACS 
workstation and ambulatory EEG review station). We also note for the 
commenters that time allocated for delivery and return of equipment is 
an office expense that we consider to be a form of indirect PE under 
our methodology.
    Comment: Several commenters stated that the review station requires 
use of equipment that is not otherwise recognized in the proposed rule, 
including a high spec laptop PC, wide screen monitors, advanced review 
software, high bandwidth internet connectivity, software for security 
purposes, and data storage that is HIPAA compliant. Commenters stated 
that CMS failed to recognize substantial IT, software and server costs, 
including uploading and storing for large patient data files. One 
commenter included an invoice for a storage area network (SAN) 
displaying a paid purchase price of $15,992.40 while another commenter 
submitted an invoice for a portable external hard drive at a price of 
$51.89.
    Response: These types of equipment listed by the commenters are 
administrative expenses that we are considered forms of indirect PE 
under our methodology. Although we agree that providers will have a 
need for laptops, monitors, internet connectivity, data storage, and 
software security systems, these expenses are not unique to individual 
procedures and constitute forms of general office expenses. We note as 
an example that we do not assign separate direct PE for higher 
electricity costs to diagnostic imaging procedures as compared to 
cognitive evaluation procedures; these expenses are part of the office 
costs of running a practice, not specific to individual procedures. We 
continue to believe that these costs are appropriately captured via the 
indirect PE methodology as opposed to being included as a separate 
direct PE input.
    Comment: A commenter stated that there appeared to be a discrepancy 
in the RUC survey results sent to CMS. The commenter stated that, under 
clinical labor codes (CA021) for patient/family education and for 
internal communication, time was provided for each code, however there 
was no time allotted for these clinical labor activities. The commenter 
stated that these activities are necessary for the conduct of long-term 
EEG services and asked CMS to clarify which data point was used within 
the proposed rule.
    Response: We remind the commenter that CMS does not publish the RUC 
recommendations, and we cannot speak as to whether or not they may 
contain errors. We review and make our own assessment of the RUC 
recommendations. We remind readers that the direct PE inputs for CY 
2020 are displayed in the CY 2020 direct PE input files, available on 
the CMS website under the 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.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for all of the codes in the Long Term EEG 
Monitoring family. We are finalizing the direct PE inputs as proposed 
for the PC-only codes in the family (CPT codes 95717-95726) and 
finalizing the assignment of contractor pricing for the TC-only codes 
in the family (CPT codes 95700-95716). As we have summarized above, 
commenters have raised some significant concerns regarding the 
usefulness of these codes in establishing appropriate values for these 
services. Also as we have noted in the preceding discussion, we 
continually seek updated information, including and especially 
empirical data, regarding the resources involved in furnishing PFS 
services.
    In the context of the concerns raised regarding the applicability 
of the new code set in various settings of care and by the services 
furnished to patients with varying needs, we are persuaded by 
commenters that we should maintain the stability inherent in contractor 
pricing despite consideration of RUC-recommended direct PE inputs for 
these TC services. While many of the same concerns apply to the PC 
component of these services, we note that the professional component of 
these services are currently valued using recommendations originally 
furnished by the RUC. Consequently, we believe it is appropriate to 
maintain national payment rates for the professional component of these 
services. However, we continue to seek information regarding these 
services and how the changes in valuation and coding might affect 
appropriate access to care for beneficiaries. For example, we would 
consider establishing G-codes specific for services in particular 
settings of care

[[Page 62792]]

in future rulemaking should such access concerns become apparent.
(64) Health and Behavioral Assessment and Intervention (CPT Codes 
96156, 96158, 96159, 96164, 96165, 96167, 96168, 96170, and 96171)
    The 2001 Health and Behavior Assessment and Intervention (HBAI) RUC 
valuations were based on the old CPT code 90801 (Psychiatric diagnostic 
interview evaluation), a 60-minute service. The RUC originally 
recommended the Health and Behavior Assessment and Intervention 
procedures to be 15-minute services, approximately equal to one-quarter 
of the value of CPT code 90801, which we finalized without refinements. 
While the RUC may have assumed that these services would typically be 
reported in four, 15-minute services per single patient encounter, in 
actual claims data, there is wide variation in the number of services 
provided and submitted. The RUC reconsidered their rationale for the 
original RUC-recommended valuation of this family of codes in September 
2018. 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; re-
assessment), 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)).
    The nine replacement HBAI CPT codes include CPT code 96156 (Health 
behavior assessment, including re-assessment (i.e., health-focused 
clinical interview, behavioral observations, clinical decision 
making)), CPT code 96158 (Health behavior intervention, individual, 
face-to-face; initial 30 minutes), CPT code 96159 (Health behavior 
intervention, individual, face-to-face; each additional 15 minutes 
(list separately in addition to code for primary service)), CPT code 
96164 (Health behavior intervention, group (2 or more patients), face-
to-face; initial 30 minutes), CPT code 96165 (Health behavior 
intervention, group (2 or more patients), face-to-face; each additional 
15 minutes (list separately in addition to code for primary service)), 
CPT code 96167 (Health behavior intervention, family (with the patient 
present), face-to-face; initial 30 minutes), CPT code 96168 (Health 
behavior intervention, family (with the patient present), face-to-face 
each additional 15 minutes (list separately in addition to code for 
primary service)), CPT code 96170 (Health behavior intervention, family 
(without the patient present), face-to-face; initial 30 minutes), 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 proposed the RUC-recommended work RVUs for each of the codes in 
this family as follows.
     For CPT code 96156, we proposed a work RVU of 2.10.
     For CPT code 96158, we proposed a work RVU of 1.45.
     For CPT code 96159, we proposed a work RVU of 0.50.
     For CPT code 96164, we proposed a work RVU of 0.21.
     For CPT code 96165, we proposed a work RVU of 0.10.
     For CPT code 96167, we proposed a work RVU of 1.55.
     For CPT code 96168, we proposed a work RVU of 0.55.
     For CPT code 96170, we proposed a work RVU of 1.50 (but 
this code will be non-covered by Medicare).
     For CPT code 96171, we proposed a work RVU of 0.54 (but 
this code will be non-covered by Medicare).
    We proposed the RUC-recommended direct PE inputs for all of the CPT 
codes in this family without refinement.
    We received public comments on the proposed valuation of the codes 
in the Health and Behavioral Assessment and Intervention family. The 
following is a summary of the comments we received and our responses.
    Comment: The total number of comments for the HBAI CPT codes are 
from Psychologist who are uniformly pleased to see that CMS has 
accepted all of the AMA RUC's recommended increases for the Health 
Behavior Assessment and Intervention (HBAI) services and that the 
American Psychological Association further urges CMS to make payable 
CPT code 96170 and 96171, both Family Intervention services without the 
patient being present.
    Response: As with the original HBAI non-covered codes, where the 
patient is not present during the service, that will remain true with 
the new replacement CPT code 96170 and 96171 where they will retain 
their non-covered status.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Health and 
Behavioral Assessment and Intervention code family as proposed.
(65) Cognitive Function Intervention (CPT Codes 97129 and 97130)
    In 2017, we received HCPAC recommendations for new CPT code 97127 
(Development of cognitive skills to improve attention, memory, problem 
solving, direct patient contact, 1) that described the services under 
CPT code 97532 (Development of cognitive skills to improve attention, 
memory, problem solving, direct patient contact, each 15 minutes). CPT 
code 97532 was scheduled to be deleted and replaced by the new untimed 
code CPT code 97127. In the CY 2018 PFS final rule (82 FR 53074 through 
53076), however, we suggested that CPT code 97127 as an untimed/per day 
code did not appropriately account for the variable amounts of time 
spent with a patient depending upon the discipline and/or setting and 
thus assigned the code a procedure status of ``I'' (Invalid). In place 
of CPT code 97127, we established a new HCPCS G code, G0515 
(Development of cognitive skills to improve attention, memory, problem 
solving, direct patient contact, each 15 minutes), with a work RVU of 
0.44. HCPCS code G0515 maintained the descriptor and values from the 
former CPT code 97532.
    In September 2018, the CPT Editorial Panel revised CPT code 97129 
(Therapeutic interventions that focus on cognitive function (e.g., 
attention, memory, reasoning, executive function, problem solving and/
or pragmatic functioning) and compensatory strategies to manage the 
performance of an activity (e.g., managing time or schedules, 
initiating, organizing and sequencing tasks), direct (one-to-one) 
patient contact; initial 15 minutes) and created an add-on code, CPT 
code 97130 (Therapeutic interventions that focus on cognitive function 
(e.g., attention, memory, reasoning, executive function, problem 
solving and/or pragmatic functioning) and compensatory strategies to 
manage the performance of an activity (e.g., managing time or 
schedules, initiating, organizing and

[[Page 62793]]

sequencing tasks), direct (one-to-one) patient contact; each additional 
15 minutes (list separately in addition to code for primary 
procedure)).
    We proposed the RUC-recommended work RVUs of 0.50 for CPT code 
97129 and 0.48 for CPT code 97130. We also proposed the RUC-recommended 
direct PE inputs for all codes in the family. Additionally, we proposed 
to designate CPT codes 97129 and 97130 as sometime therapy codes 
because the services might be appropriately furnished by therapists 
under the outpatient therapy services benefit (includes physical 
therapy, occupational therapy, or speech-language pathology) or outside 
the therapy benefit by physicians, NPPs, and psychologists.
    We received public comments on the proposed valuation of CPT codes 
97129 and 97130. The following is a summary of the comments we received 
and our response.
    Comment: Commenters uniformly requested that we adopt the new 
cognitive function intervention codes at the values we proposed.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: A commenter stated that CMS did not indicate whether HCPCS 
code G0515 (Cognitive skills development, each 15 minutes) will be 
deleted. The commenter requested that CMS delete HCPCS code G0515 given 
the proposal of new CPT codes describing the treatment of cognitive 
impairments.
    Response: We proposed to delete HCPCS code G0515 and replace it 
with new CPT codes 97129 and 97130, as detailed in our CY 2019 Analytic 
Crosswalk to CY 2020 public use file issued along with the proposed 
rule. We can confirm for the commenter that HCPCS code G0515 will be 
deleted for CY 2020.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Cognitive Function 
Intervention family as proposed. We are also finalizing our proposal to 
designate both codes as sometime therapy codes.
(66) Open Wound Debridement (CPT Codes 97597 and 97598)
    CPT code 97598 (Debridement (e.g., high pressure waterjet with/
without suction, sharp selective debridement with scissors, scalpel and 
forceps), open wound, (e.g., fibrin, devitalized epidermis and/or 
dermis, exudate, debris, biofilm), including topical application(s), 
wound assessment, use of a whirlpool, when performed and instruction(s) 
for ongoing care, per session, total wound(s) surface area; each 
additional 20 sq cm, or part thereof) was identified by the RUC on a 
list of services that were originally surveyed by one specialty but are 
now typically performed by a different specialty. It was reviewed along 
CPT code 97597 (Debridement (e.g., high pressure waterjet with/without 
suction, sharp selective debridement with scissors, scalpel and 
forceps), open wound, (e.g., fibrin, devitalized epidermis and/or 
dermis, exudate, debris, biofilm), including topical application(s), 
wound assessment, use of a whirlpool, when performed and instruction(s) 
for ongoing care, per session, total wound(s) surface area; first 20 sq 
cm or less) at the October 2018 RUC meeting.
    We disagree with the RUC-recommended work RVU of 0.88 for CPT code 
97597 and we proposed a work RVU of 0.77 based on a crosswalk to CPT 
code 27369 (Injection procedure for contrast knee arthrography or 
contrast enhanced CT/MRI knee arthrography). CPT code 27369 is a 
recently-reviewed code with the same intraservice time of 15 minutes 
and a total time of 28 minutes, 1 minute fewer than CPT code 97597. In 
reviewing this code, we noted that the recommended intraservice time is 
increasing from 14 minutes to 15 minutes (7 percent), and the 
recommended total time is increasing from 24 minutes to 29 minutes (21 
percent); however, the RUC-recommended work RVU is increasing from 0.51 
to 0.88, which is an increase of 73 percent. Although we did not imply 
that the decrease in time as reflected in survey values must equate to 
a one-to-one or linear increase in the valuation of work RVUs, we 
believe that since the two components of work are time and intensity, 
modest increases in time should be appropriately reflected with a 
commensurate increase the work RVUs. In the case of CPT code 97597, we 
believed that it is more accurate to propose a work RVU of 0.77 based 
on a crosswalk to CPT code 27369 to account for these modest increases 
in the surveyed work time. We also note that even at the proposed work 
RVU of 0.77 the intensity of this procedure as measured by IWPUT is 
increasing by more than 50 percent over the current value.
    We proposed the RUC-recommended work RVU of 0.50 for CPT code 
97598. We are also proposing the RUC-recommended direct PE inputs for 
all codes in the family.
    We received public comments on the proposed valuation of the codes 
in the Open Wound Debridement family. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 0.77 for CPT code 97597 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 0.88. Commenters stated that 
the work RVU of 0.77 for the proposed CMS crosswalk code, CPT code 
27369, was derived by CMS using a reverse building block methodology 
from the RUC-recommended work RVU of 0.96. Commenters stated that the 
use of the reverse building block methodology to develop a work RVU for 
CPT code 27369 was faulty, and therefore, this code was not an 
appropriate choice to serve as a crosswalk for CPT code 97597.
    Response: We disagree with the commenters that CPT code 27369 was 
an inappropriate choice to serve as a crosswalk. 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 the use of building block methodologies (see the 
CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) 
for more information). Components that we use in the building block 
approach may include preservice, intraservice, or postservice time and 
post-procedure visits. We use the building block methodology to 
construct, or deconstruct, the work RVU for a CPT code based on 
component pieces of the code, and building block methodologies have 
long been used in developing work RVUs under the PFS. More importantly, 
the work valuation of CPT code 27369 was finalized at 0.77 in the CY 
2019 PFS final rule (83 FR 59525) and additional discussion of this 
code's work RVU is out of scope for this rule. We continue to believe 
that it is more accurate to propose a work RVU of 0.77 for CPT code 
97597 based on a crosswalk to CPT code 27369 to account for the modest 
increases in the procedure's surveyed work time.
    Comment: Several commenters stated that due to flawed methodologies 
in the survey process, CPT code 97597 was incorrectly valued in 2010, 
and therefore, it was invalid for CMS to compare the current time and 
work to the surveyed time and work of the newly created codes in the 
family. Commenters also stated that since CPT code 97597 was last 
valued there has been a change in the patient population, and 
therefore, the RUC-recommended increase in work time and work RVU was 
not commensurate with the flawed current work times and work RVU.

[[Page 62794]]

    Response: We believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available and that we are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.N.2. of this 
final rule), as well as a longer discussion in the CY 2017 PFS final 
rule (81 FR 80273 through 80274).
    Comment: A commenter disagreed with the proposed valuation of CPT 
code 97597 based on a comparison to CPT codes 99212 and 99213, stating 
that the methodology employed for this code family was contradictory to 
how the Agency reviewed other codes in this same proposed rule for 
similar services. The commenter stated that CMS proposed a work RVU of 
0.75 for CPT code 99212 compared with a proposed work RVU of 0.77 for 
CPT code 97597, a difference of only 3 percent, even though the total 
time for CPT code 97597 is 61 percent greater. The commenter stated 
that a similar comparison could also be made using CPT code 99213 
(proposed work RVU = 1.30, total time = 30 minutes) which requires a 
low level of medical decision-making similar to CPT code 97597. The 
commenter stated that when considering work per unit time, the proposed 
work RVU for CPT code 97597 significantly undervalues the physician 
work compared to CPT codes 99212 and 99213.
    Response: We recognize that it would not be appropriate to develop 
work RVUs solely based on time given that intensity is also an element 
of work. We clarify again that we do not treat all components of 
physician time as having identical intensity. Were we to disregard 
intensity altogether, the work RVUs for all services would be developed 
based solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. For more details on our methodology for developing 
work RVUs, we refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this rule (section 
II.N.2. of this final rule), as well as a longer discussion in the CY 
2017 PFS final rule (81 FR 80272 through 80277). For the specific case 
of CPT code 97597, we note again that the proposed work RVU was not 
based on a time ratio or a building block methodology, but instead 
based on a crosswalk to CPT code 27369. This was only one of several 
different codes that we could have chosen for a crosswalk; we also 
considered CPT code 36470 (Injection of sclerosant; single incompetent 
vein (other than telangiectasia)) and CPT code 43756 (Duodenal 
intubation and aspiration, diagnostic, includes image guidance; single 
specimen (e.g., bile study for crystals or afferent loop culture)), 
both of which have similar time values and work RVUs of 0.75 and 0.77 
respectively. We disagree with the commenters that CPT codes 99212 and 
99213 are appropriate choices for comparisons, as they do not share the 
same 0 day global period as CPT code 97597.
    Comment: Several commenters stated that they supported the proposal 
of the RUC-recommended work RVU for CPT code 97598 and the RUC-
recommended direct PE inputs for both codes.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Open Wound 
Debridement family as proposed.
(67) Negative Pressure Wound Therapy (CPT Codes 97607 and 97608)
    In the CY 2013 final rule with comment period, we created two HCPCS 
codes to provide a payment mechanism for negative pressure wound 
therapy services furnished to beneficiaries using equipment that is not 
paid for as durable medical equipment: G0456 (Negative pressure wound 
therapy, (for example, vacuum assisted drainage collection) using a 
mechanically powered device, not durable medical equipment, including 
provision of cartridge and dressing(s), topical application(s), wound 
assessment, and instructions for ongoing care, per session; total 
wound(s) surface area less than or equal to 50 square centimeters) and 
G0457 (Negative pressure wound therapy, (for example, vacuum assisted 
drainage collection) using a mechanically-powered device, not durable 
medical equipment, including provision of cartridge and dressing(s), 
topical application(s), wound assessment, and instructions for ongoing 
care, per session; total wound(s) surface area greater than 50 sq. cm). 
For CY 2015, the CPT Editorial Panel created CPT codes 97607 (Negative 
pressure wound therapy, (e.g., vacuum assisted drainage collection), 
utilizing disposable, non-durable medical equipment including provision 
of exudate) and 97608 (Negative pressure wound therapy, (e.g., vacuum 
assisted drainage collection), utilizing disposable, non-durable 
medical equipment including provision of exudate) to describe negative 
pressure wound therapy with the use of a disposable system. In 
addition, CPT codes 97605 (Negative pressure wound therapy (e.g., 
vacuum assisted drainage collection), utilizing durable medical 
equipment (DME), including topical application(s), wound assessment, 
and instruction(s) for ongoing care, per session; total wound(s) 
surface area less than or equal to 50 square centimeters) and 97606 
(Negative pressure wound therapy (e.g., vacuum assisted drainage 
collection), utilizing durable medical equipment (DME), including 
topical application(s), wound assessment, and instruction(s) for 
ongoing care, per session; total wound(s) surface area greater than 50 
square centimeters) were revised to specify the use of durable medical 
equipment. Based upon the revised coding scheme for negative pressure 
wound therapy, we deleted the G-codes. Due to concerns that we had with 
these services, we contractor priced CPT codes 97607 and 97608 
beginning in CY 2015 (79 FR 67670). In the CY 2016 PFS final rule (80 
FR 71005), in response to comment expressing disappointment with CMS' 
decision to contractor price these codes, we noted that there were 
obstacles to developing accurate payment rates for these services 
within the PE RVU methodology, including the indirect PE allocation for 
the typical practitioners who furnish these services and the diversity 
of the products used in furnishing these services.
    We have received repeated requests from stakeholders, including in 
comments received in response to the CY 2019 PFS final rule, to assign 
an active status to these codes, meaning we would assign rates to the 
codes rather than allowing them to be contractor priced. In that rule, 
(83 FR 59473), we noted that we received a request that CMS should 
assign direct cost inputs and PE RVUs to CPT codes 97607 and 97608, and 
we indicated that we would

[[Page 62795]]

take this feedback from commenters under consideration for future 
rulemaking.
    In response to stakeholder feedback, we evaluated the codes and 
determined there was adequate volume to assign an active status. We 
proposed to assign an active status to CPT codes 97607 and 97608 and we 
proposed the work RVUs as recommended by the RUC that we received for 
CY 2015 when the CPT Editorial Panel created these codes. Thus, we 
proposed a work RVU of 0.41 for CPT code 97607 and a work RVU of 0.46 
for CPT code 97608. Similarly, we proposed the RUC-recommended direct 
PE inputs originally for CY 2015 with the following refinement: For the 
clinical labor activity ``check dressings & wound/home care 
instructions/coordinate office visits/prescriptions,'' we are refining 
the clinical labor time to the standard 2 minutes for this task. In 
addition, the direct inputs for these codes include the new supply 
item, ``kit, negative pressure wound therapy, disposable'' (SA131). A 
search of publicly available commercial pricing data indicates that a 
unit price of approximately $100 is appropriate, and therefore, we 
proposed this price for this supply item. In the proposed rule, we 
sought invoices to more accurately price this kit.
    We received public comments on the proposed valuation of the codes 
in the Negative Pressure Wound Therapy family. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter expressed support for our proposed work and 
direct PE values and appreciated CMS changing the payment status to 
active. Another commenter stated that they did not object to the 
proposed direct PE refinements and stated that these refinements 
matched the changes in time as compared with CPT codes 97605 and 97608.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Several commenters supported the proposal to establish a 
national fee schedule amount for application of single-use disposable 
negative pressure wound therapy billed with CPT codes 97607 and 97608. 
However, the commenters disagreed with the proposed price of $100 for 
the disposable negative pressure wound therapy kit (SA131) supply. One 
commenter stated that although single-use disposable negative pressure 
wound therapy device costs can vary, the average price paid by office-
based physicians is $273.55 for these PICO single-use negative pressure 
wound therapy devices. The commenter submitted five invoices to support 
this price for the SA131 supply, and requested that CMS update the 
proposed price. Another commenter agreed that the proposed price does 
not reflect the actual invoiced prices by manufacturers or suppliers/
distributors on the market today, and submitted additional paid 
invoices showing the average supply cost for the disposable negative 
pressure wound therapy kit being between $208 and $494 depending on the 
type of disposable negative pressure wound therapy deployed.
    Response: We appreciate the submission of additional invoices on 
the part of the commenter. However, when we reviewed the pricing for 
the SA131 supply, we continued to find disposal negative pressure wound 
therapy kits available for purchase online for roughly $100. We 
compared the kits on the submitted invoices to the kits available for 
purchase online, and as far as we can determine, they appear to 
describe the same product, with both kits containing a dressing of the 
same size and a disposable pump. In light of the additional pricing 
information supplied by the commenters, we are finalizing an increase 
in the price of the disposable negative pressure wound therapy kit 
(SA131) supply, but only to the lower end of the invoice prices 
submitted by the commenters. We are finalizing a price of $208 for the 
SA131 supply based on the lower end of the average supply cost provided 
by the commenters, as there appear to be kits that are readily 
available at both higher and lower prices. We believe that the $208 
price point will serve as a proxy for the typical purchase price of 
these kits.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Negative Pressure 
Wound Therapy family as proposed.
(68) Ultrasonic Wound Assessment (CPT Code 97610)
    In 2005, the AMA RUC began the process of flagging services that 
represent new technology or new services as they were presented to the 
Committee. CPT code 97610 (Low frequency, non-contact, non-thermal 
ultrasound, including topical application(s), when performed, wound 
assessment, and instruction(s) for ongoing care, per day) was flagged 
for CPT 2015 and reviewed at the October 2018 RAW meeting. The 
Workgroup indicated that the utilization is continuing to increase for 
this service, and recommended that it be resurveyed for physician work 
and PE for the January 2019 RUC meeting.
    We proposed the RUC-recommend work RVU of 0.40 for CPT code 97610. 
We also proposed the RUC-recommended direct PE inputs for CPT code 
97610.
    We received public comments on the proposed valuation of the codes 
in the Ultrasonic Wound Assessment family. The following is a summary 
of the comments we received and our responses.
    Comment: A commenter supported our proposal for this code.
    Response: We appreciate the support from the commenter.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU and direct PE inputs as proposed.
(69) Online Digital Evaluation Service (E-Visit) (CPT Codes 98970, 
98971, and 98972)
    In September 2018, the CPT Editorial Panel deleted two codes and 
replaced them with six new non-face-to-face codes to describe patient-
initiated digital communications that require a clinical decision that 
otherwise typically would have been provided in the office. The HCPAC 
reviewed and made recommendations for CPT code 98970 (Qualified 
nonphysician healthcare professional online digital evaluation and 
management service, for an established patient, for up to seven days, 
cumulative time during the 7 days; 5-10 minutes), CPT code 98971 
(Qualified nonphysician healthcare professional online digital 
evaluation and management service, for an established patient, for up 
to seven days, cumulative time during the 7 days; 11-20 minutes), and 
CPT code 98972 (Qualified nonphysician qualified healthcare 
professional online digital evaluation and management service, for an 
established patient, for up to seven days, cumulative time during the 7 
days; 21 or more minutes). CPT codes 99421-99423 are for practitioners 
who can independently bill E/M services while CPT codes 98970-98972 are 
for practitioners who cannot independently bill E/M services.
    The statutory requirements that govern the Medicare benefit are 
specific regarding which practitioners may bill for E/M services. As 
such, when codes are established that describe E/M services that fall 
outside the Medicare benefit category of the practitioners who may bill 
for that service, we have typically created parallel HCPCS G-codes with 
descriptors that refer to the performance of an ``assessment'' rather 
than an ``evaluation''. We acknowledge

[[Page 62796]]

that there are qualified non-physician health care professionals who 
will likely perform these services. Therefore, for CY 2020, we proposed 
separate payment for online digital assessments via three HCPCS G-codes 
that mirror the RUC recommendations for CPT codes 98970-98972. The 
proposed HCPCS G codes and descriptors are as follows:
     HCPCS code G2061 (Qualified nonphysician healthcare 
professional online assessment, for an established patient, for up to 
seven days, cumulative time during the 7 days; 5-10 minutes);
     HCPCS code G2062 (Qualified nonphysician healthcare 
professional online assessment service, for an established patient, for 
up to seven days, cumulative time during the 7 days; 11-20 minutes); 
and
     HCPCS code G2063 (Qualified nonphysician qualified 
healthcare professional assessment service, for an established patient, 
for up to seven days, cumulative time during the 7 days; 21 or more 
minutes).
    For CY 2020, we proposed a work RVU of 0.25 for CPT code G2061, 
which reflects the RUC-recommended work RVU for CPT code 98970. For 
HCPCS codes G2062 and G2063, we believe that the 25th percentile work 
RVU associated with CPT codes 98971 and 98972 respectively, better 
reflects the intensity of performing these services, as well as the 
methodology used to value the other codes in the family, all of which 
use the 25th percentile work RVU. Therefore, we proposed a work RVU of 
0.44 for HCPCS code G2062 and a work RVU of 0.69 for HCPCS code G2063.
    We proposed the direct PE inputs associated with CPT codes 98970, 
98971, and 98972 for G2061, G2062, and G2063 respectively.
    We received public comments on the proposed valuation of the codes 
in the Online Digital Evaluation Service (e-Visit) family. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters were supportive of separate payment for 
these services, although a number expressed reservations with the use 
of HCPCS G-codes and encouraged CMS to work with the CPT editorial 
panel to make refinements to the CPT code descriptors. Some commenters 
stated that the proposed values for HCPCS codes GPPP2 and GPPP3 
undervalued the work associated with these services and encouraged CMS 
to adopt the RUC recommended work RVUs of 0.50 and 0.80, respectively. 
Commenters stated that these codes were valued to be identical to the 
work RVUs associated with the corresponding physician codes, 99422 and 
99423.
    Commenters from specialty societies representing audiologist and 
speech language pathologists, who are ineligible to bill for HCPCS 
codes G2061-G2063 due to restrictions on their benefit category, 
nevertheless encouraged CMS to allow them to bill for these services.
    Response: We thank commenters for submitting their comments. We 
note that a drafting error was made in the code descriptors for HCPCS 
codes G2061-G2063. The following are the correct descriptors:
     HCPCS code 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);
     HCPCS code 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
     HCPCS code 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).
    We continue to believe that the work associated when these services 
are furnished by a nonphysician practitioner (NPP) will typically be 
less than when furnished by a physician, due to the acuity of the 
patient. Therefore, we maintain that HCPCS codes G2062 and G2063 are 
accurately valued at 0.44 and 0.69, respectively and are finalizing 
those values as proposed. We would also like to reiterate that there 
are many practitioners for whom these services fall outside the scope 
of their benefit category and as such, may not receive separate payment 
for these services under Medicare.
    After consideration of the public comments we are finalizing as 
proposed.
(70) Emergency Department Visits (CPT Codes 99281, 99282, 99283, 99284, 
and 99285)
    In the CY 2018 PFS final rule, we finalized a proposal to nominate 
CPT codes 99281-99285 as potentially misvalued based on information 
suggesting that the work RVUs for emergency department visits may not 
appropriately reflect the full resources involved in furnishing these 
services (FR 82 53018.) These five codes were surveyed and reviewed for 
the April 2018 RUC meeting. For CY 2020 we proposed 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 propose any direct PE 
inputs for the codes in this family.
    We received public comments on the proposed valuation of the codes 
in the Emergency Department Visits family. The following is a summary 
of the comments we received and our responses.
    Comment: Commenters from a major specialty society representing 
emergency department physicians suggested that, in order to maintain 
relativity with the newly revalued office/outpatient E/M visits, that 
CMS increase the work RVU to 1.60 for CPT code 99283, 2.74 for CPT code 
99284, and 4.00 for CPT code 99285. Other commenters supported 
finalizing as proposed.
    Response: We thank commenters for submitting their comments. As 
discussed in section II. P. of this final rule, Payment for Evaluation 
and Management Services, we are considering updating other E/M visits 
to maintain relativity with the revalued office/outpatient E/M code set 
as part of CY 2021 PFS rulemaking.
    After consideration of the public comments, we are finalizing as 
proposed. We are also finalizing our proposal to have no direct PE 
inputs for these codes.
(71) Self-Measured Blood Pressure Monitoring (CPT Codes 99473, 99474, 
93784, 93786, 93788, and 93790)
    In September 2018, the CPT Editorial Panel created two new codes 
and revised four other codes to describe self-measured blood pressure 
monitoring services and to differentiate self-measured blood pressuring 
monitoring services from ambulatory blood pressure monitoring services. 
The first of the two new codes that describe self-measured blood 
pressure monitoring is CPT code 99473 (Self-measured blood pressure 
using a device validated for clinical accuracy; patient education/
training and device calibration) and is a PE only code. The second code 
is 99474 (Self-measured blood pressure using a device validated for 
clinical accuracy; separate self-measurements of two readings, one 
minute apart, twice daily over a 30-day period (minimum of 12 
readings), collection of data reported by the patient and/or caregiver 
to the physician or other qualified health care professional, with 
report of average

[[Page 62797]]

systolic and diastolic pressures and subsequent communication of a 
treatment plan to the patient).
    The remaining four codes, which monitor ambulatory blood pressure, 
include CPT code 93784 (Ambulatory blood pressure monitoring, utilizing 
report-generating software, automated, worn continuously for 24 hours 
or longer; including recording, scanning analysis, interpretation and 
report), CPT code 93786 (Ambulatory blood pressure monitoring, 
recording only), CPT code 93788 (Ambulatory blood pressure monitoring, 
scanning analysis with report), and CPT code 93790 (Ambulatory blood 
pressure monitoring, review with interpretation and report). CPT code 
93784 is a composite code that is the sum of CPT codes 93786, 93788, 
and 93790. CPT codes 93786 and 93788 are PE only codes.
    We proposed the RUC-recommended work RVU of 0.18 for CPT code 
99474, the RUC-recommended work RVU of 0.38 for CPT code 93784, and the 
RUC-recommended work RVU of 0.38 for CPT code 93790. We proposed the 
RUC-recommended work RVU of 0.00 for CPT codes 93786, 93788, and 99473. 
We also proposed the RUC-recommended direct PE inputs for all codes in 
the family.
    We received public comments on the proposed valuation of the codes 
in the Self-Measured Blood Pressure Monitoring family. The following is 
a summary of the comments we received and our response.
    Comment: Commenters expressed uniform support for the creation of 
self-measured blood pressure monitoring codes, as well as the proposed 
valuation of the codes.
    Response: We are finalizing the work RVUs and direct PE inputs as 
proposed for CPT codes 99474, 93784, and 93790, as well as for CPT 
codes 93786, 93788, and 99473.
(72) Online Digital Evaluation Service (e-Visit) (CPT Codes 99421, 
99422, and 99423)
    In September 2018, the CPT Editorial Panel deleted two codes and 
replaced them with six new non-face-to face codes to describe patient-
initiated digital communications that require a clinical decision that 
otherwise typically would have been provided in the office. The RUC 
reviewed and made recommendations for 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), and 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).
    For CY 2020, we proposed the RUC-recommended work RVUs of 0.25 for 
CPT code 99421, 0.50 for CPT code 99422, and 0.80 for CPT code 99423. 
We proposed the RUC-recommended direct PE inputs for all codes in the 
family.
    We received public comments on the proposed valuation of the codes 
in the Online Digital Evaluation Service (e-Visit) family. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters supported separate payment for these and the 
proposed values.
    Response: We thank commenters for submitting their comments.
    After consideration of the public comments we are finalizing as 
proposed.
(73) Radiation Therapy Codes (HCPCS Codes G6001, G6002, G6003, G6004, 
G6005, G6006, G6007, G6008, G6009, G6010, G6011, G6012, G6013, G6014, 
G6015, G6016 and G6017)
    For CY 2015, CPT revised the radiation therapy code set for 
following identification of some of the codes as potentially misvalued 
and the affected specialty society's contention that the provision of 
radiation therapy could not be accurately reported under the existing 
code set. In the CY 2015 PFS final rule, we finalized that we were 
delaying implementation of this revised code set, citing concerns with 
our potentially having finalized a substantial coding revision on an 
interim final basis. In addition, we stated that substantial work 
needed to be done to assure the new valuations for these codes 
accurately reflect the coding changes. We finalized that we would 
maintain inputs at CY 2014 levels by creating G-codes as necessary to 
allow practitioners to continue to report services to CMS in CY 2015 as 
they did in CY 2014 and for payments to be made in the same way. 
Following the publication of the CY 2015 PFS final rule, the Patient 
Access and Medicare Protection Act (Pub. L. 114-115, December 28, 2015) 
was enacted, which included the provision that the code definitions, 
the work relative value units and the direct inputs for the PE RVUs for 
radiation treatment delivery and related imaging services (identified 
in 2016 by HCPCS G-codes G6001 through G6015) for the fee schedule 
established under this subsection for services furnished in 2017 and 
2018 shall be the same as such definitions, units, and inputs for such 
services for the fee schedule established for services furnished in 
2016. In CY 2018, Congress extended this ``freeze'' in coding 
descriptions and inputs through CY 2019 as a provision of the 
Bipartisan Budget Act of 2018. For CY 2020, in the interest of payment 
stability, we proposed to continue using these G-codes, as well as 
their current work RVUs and direct PE inputs. We are also proposing 
that, for CY 2020, our PE methodology will continue to include a 
utilization rate assumption of 60 percent for the equipment item: 
ER089, ``IMRT Accelerator.''
    We received public comments on the proposed valuation of the codes 
in the Radiation Therapy Codes family. The following is a summary of 
the comments we received and our responses.
    Comment: Commenters stated that they support our proposals for 
these services.
    Response: We appreciate the support for our proposal. After 
consideration of the public comments, we are finalizing our proposal to 
continue making payment for these services using HCPCS G-codes G6001 
through G6017 with their current work RVUs and direct PE inputs.
    Comment: A few commenters stated that we should develop RVUs for 
HCPCS code G6017 (Intra-fraction localization and tracking of target or 
patient motion during delivery of radiation therapy (e.g., 3d 
positional tracking, gating, 3d surface tracking)), each fraction of 
treatment, which is a contractor priced code or its predecessor code 
CPT code 77387 (Guidance for localization of target volume for delivery 
of radiation treatment, includes intrafraction tracking, when 
performed), which has an inactive status. The commenters also requests 
that we publish RVUs for CPT code 77387 based on the RUC-recommended 
inputs submitted in 2014 despite this code having an inactive status 
for the benefit of third party payers to mitigate confusion and 
inconsistency.
    Response: We continue to believe that, given the introduction of 
the Radiation Oncology Payment Model, it is preferable to maintain the 
current payment rates for these codes for CY 2020 in the interest of 
stability and to prevent disruption. We will, however, take this 
information into consideration for future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal for these services.

[[Page 62798]]

(74) Immunization Administration Services (HCPCS Codes G0008, G0009, 
and G0010)
    Recent epidemics, including the measles crisis earlier this year, 
emphasize the importance of consistent beneficiary access to 
vaccinations that are vital to public health. Medicare has established 
coding and payment for immunization administration services, including 
HCPCS codes G0008 (Admin influenza virus vac), G0009 (Admin 
pneumococcal vaccine), and G0010 (Admin hepatitis b vaccine) that allow 
for the vaccination of Medicare beneficiaries. While we did not make 
any specific proposals in the CY 2020 PFS proposed rule to change 
payment for these administration services, we did receive comments 
noting a decrease in payment for these services. These comments noted 
the linked crosswalk between CPT code 96372 (Therapeutic, prophylactic, 
or diagnostic injection (specify substance or drug) subcutaneous or 
intramuscular) and a number of the immunization services, and the 
impact that a proposed reduction to 96372 would have on payment for 
some practices that offer immunization services. We recognize that it 
is in the public interest to ensure appropriate payment to physicians 
and other practitioners for provision of the immunization 
administration services that are used to deliver vaccines and plan to 
review the valuations for these services to ensure appropriate payment. 
In the interim, given our concern about public access to vaccines and 
in light of recent public health events, we are maintaining the CY 2019 
national payment amount for immunization administration services for CY 
2020.
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O. Response to the Comment Solicitation on Opportunities for Bundled 
Payments Under the PFS

    Under the PFS, Medicare typically makes a separate payment for each 
individual service furnished to a beneficiary consistent with section 
1848 of the Act, which requires CMS to establish payment for 
physicians' services based on the relative resources involved in 
furnishing the service. The statute defines ``services'' broadly, with 
reference to the uniform procedure coding system established by CMS for 
the purpose of Medicare FFS payments, called the Healthcare Common 
Procedure Coding System (HCPCS). There are sets of HCPCS codes that 
represent health care procedures, supplies, medical equipment, 
products, and services. The majority of physicians' services for which 
payment is made under the PFS are described using HCPCS Level I codes 
and descriptors that are the AMA's Current Procedural Terminology (CPT) 
code set. CPT codes generally describe an individual item or service, 
while some codes describe a combination of services (a procedure and 
imaging guidance, for example) bundled together. Some HCPCS codes 
explicitly encompass multiple services (global surgery codes, for 
example), and the PFS payment for some services is reduced when a 
combination of services is furnished to the same patient on the same 
day (through multiple procedure payment reduction policies). However, 
payment for most services under the PFS is made based on rates 
established for individual services, each described by a CPT code. 
Identifying and developing appropriate payment policies that aim to 
achieve better care and improved health for Medicare beneficiaries is a 
priority for CMS. Consistent with that goal, we are interested in 
exploring new options for establishing PFS payment rates or adjustments 
for services that are furnished together. For purposes of this 
discussion, we will refer to the circumstances where a set of services 
is grouped together for purposes of ratesetting and payment as 
``bundled payment.''
    One of the mechanisms through which we support innovative payment 
and service delivery models, for Medicare and other beneficiaries, is 
through CMS' Center for Medicare and Medicaid Innovation (the 
Innovation Center). The Innovation Center is currently testing models 
in which payment for physicians' services is bundled on a per-
beneficiary population basis, or is based on episodes of care that 
usually begin with a triggering

[[Page 62844]]

event and extend for a specified period of time thereafter. An example 
of a model in which payment is made on a per-beneficiary population 
basis is Comprehensive Primary Care Plus (CPC+), in which participating 
practices receive prospective per-beneficiary care management fees and 
Comprehensive Primary Care Payments for certain primary care services 
such as chronic care management and E/M services. An example of an 
episode payment model is the Oncology Care Model (OCM), in which 
participating physician practices receive a per-beneficiary Monthly 
Enhanced Oncology Services payment for care management and care 
coordination surrounding chemotherapy administration to cancer 
patients.
    As noted in the CY 2020 PFS proposed rule, we are actively 
exploring the extent to which these basic principles of bundled 
payment, such as establishing per-beneficiary payments for multiple 
services or condition-specific episodes of care, can be applied within 
the statutory framework of the PFS. As such, we solicited comment on 
opportunities to expand the concept of bundling to recognize 
efficiencies among physicians' services paid under the PFS and better 
align Medicare payment policies with CMS' broader goal of achieving 
better care for patients, better health for our communities, and lower 
costs through improvement in our health care system. We believe that 
the statute, while requiring CMS to pay for physicians' services based 
on the relative resources involved in furnishing the service, allows 
considerable flexibility for developing payments under the PFS.
    We received public comments on the solicitation on opportunities 
for bundled payments under the PFS.
    Comment: We received many comments in response to this 
solicitation. Some commenters expressed general support for the concept 
of bundled payments while urging caution on the design and 
implementation, suggesting that specialty societies and the CPT 
Editorial Panel are positioned to identify opportunities for bundled 
payments. Other commenters stated that bundled payments are not within 
the statutory authority of the PFS and stated that CMS continue to use 
the Innovation Center to test these concepts.
    Response: We thank the commenters for all the information 
submitted. We will review the many public comments we received on this 
topic and consider this issue further for potential future rulemaking.

P. Payment for Evaluation and Management (E/M) Visits

1. Background
a. E/M Visits Coding Structure
    Physicians and other practitioners who are paid under the PFS bill 
for common office visits for evaluation and management (E/M) services 
under 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 have three key components 
within their code descriptors: history of present illness (History), 
physical examination (Exam), and medical decision-making (MDM).\83\
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    \83\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
---------------------------------------------------------------------------

    The CPT code descriptors recognize counseling, care coordination, 
and the nature of the presenting problem as additional service 
components, but these are contributory factors in determining which 
code to report.\84\ Per the CPT code descriptors, counseling and/or 
care coordination are provided consistent with the nature of the 
problem and the patient's and/or family's needs. Counseling and care 
coordination are not required at every patient encounter and can be 
accounted for in separate coding.\85\
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    \84\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
    \85\ 2019 CPT Codebook, Evaluation and Management, pp. 4-56.
---------------------------------------------------------------------------

    As finalized in the CY 2019 PFS final rule, the amount of time 
spent by the billing practitioner is not a determining factor in code 
level selection unless: (1) Counseling and care coordination dominate 
the visit, in which case time becomes the key factor in determining 
visit level; and/or (2) the service is a prolonged (or beginning in 
2021, ``extended'') (83 FR 59630) E/M visit. Typical times for each 
level of E/M visit are included in each of the CPT code descriptors, 
are used for PFS rate setting purposes, and provide a reference point 
for the reporting of prolonged visits. Separate add-on codes describe, 
and can be reported for, visits that take prolonged (or beginning in 
2021, ``extended'') (83 FR 59630) amounts of time.
    There are 3 to 5 E/M visit code levels, depending upon site of 
service and the extent of the three components of history, exam, and 
MDM. For example, there are 3 to 4 levels of E/M visit codes in the 
inpatient hospital and nursing facility settings based on a relatively 
narrow range of complexity in those settings. In contrast, there are 5 
levels of E/M visit codes in the office or other outpatient setting 
based on a broader range of complexity in those settings.
    PFS payment rates for E/M visit codes generally increase with the 
level of visit billed, although in the CY 2019 PFS final rule (83 FR 
59638), for reasons discussed below, we finalized the assignment of a 
single payment rate for levels 2 through 4 office/outpatient E/M visits 
beginning in CY 2021. As for all services under the PFS, the payment 
rates for E/M visits are based on the work (time and intensity), PE, 
and malpractice expense resources required to furnish the typical case 
of the service.
    In total, E/M visits comprise approximately 40 percent of allowed 
charges for PFS services, and office/outpatient E/M visits comprise 
approximately 20 percent of allowed charges for PFS services. Within 
the E/M services 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 services for physicians and other practitioners who do 
not routinely furnish procedural interventions or diagnostic tests. 
Generally, these practitioners include both primary care practitioners 
and certain specialists such as neurologists, endocrinologists and 
rheumatologists. Certain specialties, such as podiatry, tend to furnish 
lower level E/M visits more often than higher level E/M visits. Some 
specialties, such as dermatology and otolaryngology, tend to bill more 
E/M visits on the same day as they bill minor procedures.
b. E/M Documentation Guidelines
    For CY 2019 and 2020, when coding and billing E/M visits to 
Medicare, practitioners may use one of two versions of the E/M 
Documentation Guidelines for a patient encounter, commonly referenced 
based on the year of their release: the ``1995'' or ``1997'' E/M 
Documentation Guidelines (hereafter, the 1995 and 1997 Guidelines).\86\ 
These Guidelines specify the medical record information within each of 
the three key components (such as number of body systems reviewed) that 
serves as support

[[Page 62845]]

for billing a given level of E/M visit. The 1995 and 1997 Guidelines 
are very similar to the guidelines for E/M visits that currently reside 
within the AMA's CPT codebook for E/M visits. For example, the core 
structure of what comprises or defines the different levels of history, 
exam, and medical decision-making in the 1995 and 1997 Guidelines are 
the same as those in the CPT codebook. However, the 1995 and 1997 
Guidelines include extensive examples of clinical work that comprise 
different levels of medical decision-making that do not appear in the 
AMA's CPT codebook. Also, the 1995 and 1997 Guidelines do not contain 
references to preventive care that appear in the AMA's CPT codebook. We 
provide an example of how the 1995 and 1997 Guidelines distinguish 
between level 2 and level 3 E/M visits in Table 32.
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    \86\ See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; 
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the 
Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.
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BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
    According to both Medicare claims processing manual instructions 
and CPT coding rules, when counseling and/or coordination of care 
accounts for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time) 
the duration of the visit can be used as an alternative basis to select 
the appropriate E/M visit level (Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2019 CPT Codebook Evaluation and Management 
Services Guidelines, page 10). Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.1.B states, ``Instruct physicians to 
select the code for the service based upon the content of the service. 
The duration of the visit is an ancillary factor and does not control 
the level of the service to be billed unless more than 50 percent of 
the face-to-face time (for non-inpatient services) or more than 50 
percent of the floor time (for inpatient services) is spent providing 
counseling or coordination of care as described in subsection C.'' 
Subsection C states that ``the physician may document time spent with 
the patient in conjunction with the medical decision-making involved 
and a description of the coordination of care or counseling provided. 
Documentation must be in sufficient detail to support the claim.''

[[Page 62846]]

The example included in subsection C further states, ``The code 
selection is based on the total time of the face-to-face encounter or 
floor time, not just the counseling time. The medical record must be 
documented in sufficient detail to justify the selection of the 
specific code if time is the basis for selection of the code.''
    Both the 1995 and 1997 Guidelines address time, stating that, ``In 
the case where counseling and/or coordination of care dominates (more 
than 50 percent of) the physician/patient and/or family encounter 
(face-to-face time in the office or other outpatient setting or floor/
unit time in the hospital or nursing facility), time is considered the 
key or controlling factor to qualify for a particular level of E/M 
services.'' The Guidelines go on to state that, ``If the physician 
elects to report the level of service based on counseling and/or 
coordination of care, the total length of time of the encounter (face-
to-face or floor time, as appropriate) should be documented and the 
record should describe the counseling and/or activities to coordinate 
care.'' \87\ Additional manual provisions regarding E/M visits are 
housed separately within Medicare's internet-Only Manuals, and are not 
contained within the 1995 or 1997 Guidelines.
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    \87\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997 
guidelines.
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    In accordance with section 1862(a)(1)(A) of the Act, which requires 
services paid under Medicare Part B to be reasonable and necessary for 
the diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member, medical necessity is a 
prerequisite to Medicare payment for E/M visits. Pub. 100-04, Medicare 
Claims Processing Manual, Chapter 12, Section 30.6.1.B states, 
``Medical necessity of a service is the overarching criterion for 
payment in addition to the individual requirements of a CPT code. It 
would not be medically necessary or appropriate to bill a higher level 
of E/M service when a lower level of service is warranted. The volume 
of documentation should not be the primary influence upon which a 
specific level of service is billed. Documentation should support the 
level of service reported.''
c. Summary of Changes to Coding, Payment and Documentation of Office/
Outpatient E/M Visits Finalized for CY 2021 in the CY 2019 PFS Final 
Rule
    In the CY 2019 PFS final rule (83 FR 59452 through 60303), we 
finalized a number of coding, payment, and documentation changes under 
the PFS for office/outpatient E/M visits (CPT codes 99201-99215) to 
reduce administrative burden, improve payment accuracy, and update this 
code set to better reflect the current practice of medicine. In 
summary, we finalized the following policy changes for office/
outpatient E/M visits under the PFS effective January 1, 2021:
     Reduction in the payment variation for office/outpatient 
E/M visit levels by paying a single rate (also referred to as a blended 
rate) for office/outpatient E/M visit levels 2 through 4 (one rate for 
established patients and another rate for new patients), while 
maintaining the payment rate for office/outpatient E/M visit level 5 in 
order to better account for the care and needs of complex patients. 
Practitioners will still report the appropriate code for the level of 
service they furnished, since we did not replace these CPT codes with 
HCPCS G codes and will continue to use typical times associated with 
each individual CPT code when time is used to document the office/
outpatient E/M visit.
     Permitting practitioners to choose to document office/
outpatient E/M level 2 through 5 visits using MDM or time, or the 
current framework based on the 1995 or 1997 Guidelines.
     As a corollary to the uniform payment rate for level 2-4 
E/M visits, when using MDM or the current framework to document the 
office/outpatient E/M visit, a minimum supporting documentation 
standard associated with level 2 office/outpatient E/M visits will 
apply. For these cases, Medicare will require information to support a 
level 2 office/outpatient E/M visit code for history, exam, and/or MDM.
     When time is used to document, practitioners will document 
the medical necessity of the office/outpatient E/M visit and that the 
billing practitioner personally spent the required amount of time face-
to-face with the beneficiary. The required face-to-face time will be 
the typical time for the reported code, except for extended or 
prolonged visits where extended or prolonged times will apply.
     Implementation of HCPCS add-on G codes that describe the 
additional resources inherent in visits for primary care and particular 
kinds of non-procedural specialized medical care (HCPCS codes GPC1X and 
GCG0X, respectively). These codes were finalized in order to reflect 
the differential resource costs associated with performing certain 
types of office/outpatient E/M visits. These codes will only be 
reportable with office/outpatient E/M level 2 through 4 visits.
     Adoption of a new ``extended visit'' add-on G code (HCPCS 
code GPRO1) for use only with office/outpatient E/M level 2 through 4 
visits, to account for the additional resources required when 
practitioners need to spend extended time with the patient for these 
visits. The existing prolonged E/M codes can continue to be used with 
levels 1 and 5 office/outpatient E/M visits.
    We stated that we believed these policies would allow practitioners 
greater flexibility to exercise clinical judgment in documentation so 
they can focus on what is clinically relevant and medically necessary 
for the beneficiary. We believed these policies will reduce a 
substantial amount of administrative burden (83 FR 60068 through 60070) 
and result in limited specialty-level redistributive impacts (83 FR 
60060). We stated our intent to continue engaging in further 
discussions with the public over the next several years to potentially 
further refine our policies for 2021. We finalized the coding, payment, 
and documentation changes to reduce administrative burden, improve 
payment accuracy, and update the code set to better reflect the current 
practice of medicine.
2. Continued Stakeholder Feedback
    In January and February 2019, we hosted a series of structured 
listening sessions on the forthcoming changes that CMS finalized for 
office/outpatient E/M visit coding, documentation and payment for CY 
2021. These sessions provided an opportunity for CMS to gain further 
input and information from the wide range of affected stakeholders on 
these important policy changes. Our goal was to continue to listen and 
consider perspectives from individual practicing clinicians, specialty 
associations, beneficiaries and their advocates, and other interested 
stakeholders to prepare for implementation of the office/outpatient E/M 
visit policies that we finalized for CY 2021.
    In these listening sessions, although stakeholders supported our 
intention to reduce burdensome, clinically outdated documentation 
requirements, they noted that in response to the office/outpatient E/M 
visit policies CMS finalized for CY 2021, the AMA/CPT established the 
Joint AMA CPT Workgroup on E/M to develop an alternative solution. This 
workgroup developed an alternative approach, similar to the one we 
finalized, for office/outpatient E/M coding and documentation. That 
approach was approved by the CPT Editorial Panel in February 2019, with 
an effective date of January 1, 2021 and is available on the

[[Page 62847]]

AMA's website at https://www.ama-assn.org/cpt-evaluation-and-management. Given the CPT coding changes that will take effect in 2021, 
the AMA RUC also conducted a resurvey and revaluation of the office/
outpatient E/M visit codes, and provided us with its recommendations.
    Effective January 1, 2021, the CPT Editorial Panel adopted 
revisions to the office/outpatient E/M code descriptors, and 
substantially revised both the CPT prefatory language and the CPT 
interpretive guidelines that instruct practitioners on how to bill 
these codes. The AMA has approved an accompanying set of interpretive 
guidelines governing and updating what determines different levels of 
MDM for office/outpatient E/M visits. Some of the changes made by the 
CPT Editorial Panel parallel our finalized policies for CY 2021, such 
as the choice of time or MDM in determination of code level. Other 
aspects differ, such as the number of code levels retained, presumably 
for purposes of differential payment; the times, and inclusion of all 
time spent on the day of the visit; and elimination of options such as 
the use of history and exam or time in combination with MDM, to select 
code level.
    Many stakeholders have continued to express objections to our 
assignment of a single payment rate to level 2-4 office/outpatient E/M 
visits stating that this inappropriately incentivizes multiple, shorter 
visits and seeing less complex patients. Many stakeholders also stated 
that the purpose and use of the HCPCS add-on G codes that we 
established for primary care and non-procedural specialized medical 
care remain ambiguous, expressed concern that the codes are potentially 
contrary to current law prohibiting specialty-specific payment, and 
asserted that Medicare's coding approach is unlikely to be adopted by 
other payers.
    In meetings with stakeholders since we issued the CY 2019 PFS final 
rule, some stakeholders suggested that only time should be used to 
select the service level because time is easy to audit, simple to 
document, and better accounts for patient complexity, in comparison to 
the CPT Editorial Panel revised MDM interpretive guidance. These 
stakeholders stated that the implementation of the CPT Editorial Panel 
revised MDM interpretive guidance will result in the likely increase in 
the selection of levels 4 and 5, relative to current typical coding 
patterns. They suggested that to more accurately distinguish varying 
levels of patient complexity, either the visit levels should be 
recalibrated so that levels 4 and 5 no longer represent the most often 
billed visit, or a sixth level should be added. In these meetings, some 
stakeholders also stated that the office/outpatient E/M codes fail to 
capture the full range of services provided by certain specialties, 
particularly primary care and other specialties that rely heavily on 
office/outpatient E/M services rather than procedures, systematically 
undervaluing primary care visits and visits furnished in the context of 
non-procedural specialty care, thereby creating payment disparities 
that have contributed to workforce shortages and beneficiary access 
challenges across a range of specialties. They reiterated that office/
outpatient E/M visit codes have not been extensively examined since the 
creation of the PFS and recommended that CMS conduct an extensive 
research effort to revise and revalue office/outpatient E/M services 
through a major research initiative akin to that undertaken when the 
PFS was first established.
    The AMA believes its approach will accomplish greater burden 
reduction, is more clinically intuitive and reflects the current 
practice of medicine, and is more likely to be adopted by all payers 
than the policies CMS finalized for CY 2021. The AMA has posted an 
estimate of the burden reduction associated with the policies approved 
at CPT on the AMA's website at https://www.ama-assn.org/cpt-evaluation-and-management.
3. CY 2021 PFS Final Policies for Office/Outpatient Visits
a. Overview
    In the CY 2020 PFS proposed rule, we discussed our proposal to 
adopt the CPT coding for office/outpatient E/M visits effective January 
1, 2021, noting that the CPT coding changes will necessitate changes to 
CMS' policies for CY 2021, due to forthcoming changes in code 
descriptors. In addition, we addressed revaluation of the codes, 
proposing new values for the codes as revised by CPT, that would also 
take effect on January 1, 2021. We proposed to assign separate payment 
rather than a blended rate, to each of the office/outpatient E/M visit 
codes (except CPT code 99201, which CPT is deleting) and the new 
prolonged visit add-on CPT code (CPT code 99XXX). We proposed to delete 
the HCPCS add-on code we finalized last year for CY 2021 for extended 
visits (GPRO1), and to no longer pay separately for CPT codes 99358-9 
(prolonged E/M visit without direct patient contact) in association 
with office/outpatient E/M visits. We proposed to simplify, consolidate 
and revalue the HCPCS add-on codes we finalized last year for CY 2021 
for primary care (GPC1X) and non-procedural specialized medical care 
(GCG0X), and to allow the consolidated single code to be reported with 
all office/outpatient E/M visit levels (not just levels 2 through 4). 
All of these changes would be effective January 1, 2021. We noted that 
our proposed policies would further our ongoing effort to reduce 
administrative burden, improve payment accuracy, and update the office/
outpatient EM visit code set to better reflect the current practice of 
medicine.
    We received many thousands of comments in response to these 
proposals. The following is a summary of the comments and our response.
b. Public Comments and Responses
(1) Office/Outpatient E/M Visit Coding and Documentation
    For CY 2021, for office/outpatient E/M visits (CPT codes 99201-
99215), we proposed generally to adopt the new coding, prefatory 
language, and interpretive guidance framework that has been issued by 
the AMA/CPT (see https://www.ama-assn.org/cpt-evaluation-and-management) because we believed it would accomplish greater burden 
reduction than the policies we finalized for CY 2021 and would be more 
intuitive and consistent with the current practice of medicine. We 
noted that this includes deletion of CPT code 99201 (Level 1 office/
outpatient visit, new patient), which the CPT Editorial Panel decided 
to eliminate as CPT codes 99201 and 99202 are both straightforward MDM 
and only differentiated by history and exam elements.
    Under this new framework, history and exam would no longer be used 
to select the level of code for office/outpatient E/M visits. Instead, 
an office/outpatient E/M visit would 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 would no longer apply, and these components would only be 
performed when, and to the extent, medically necessary and clinically 
appropriate. Level 1 visits would only describe or include visits 
performed by clinical staff for established patients, and the concept 
of medical decision making would not apply to CPT code 99211.
    For levels 2 through 5 office/outpatient E/M visits, the code level 
reported would be decided based on either the level of MDM (as 
redefined in

[[Page 62848]]

the new AMA/CPT guidance framework) 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). Because we would no longer assign a 
blended payment rate (discussed below), we would no longer adopt the 
minimum supporting documentation associated with level 2 office/
outpatient E/M visits, which we had finalized in the CY 2019 PFS final 
rule (83 FR 59634) as a corollary to the uniform payment rate for level 
2-4 office/outpatient E/M visits when using MDM or the current 
framework to document the office/outpatient E/M visit. We would adopt 
the new time ranges within the CPT codes as revised by the CPT 
Editorial Panel.
    Comment: Commenters were generally supportive of our proposals to 
eliminate the blended payment rate and instead adopt the revised CPT 
coding and levels for separate payment, including the choice of 
selecting visit level on the basis of time or MDM. The commenters 
agreed that these proposals would reduce administrative burden, improve 
payment accuracy, and better reflect the current practice of medicine. 
However, a number of commenters disagreed with the new MDM guidelines 
and believe they need further refinement before implementation. A few 
commenters believed the revised guidelines represent a critical first 
step and supported them as such, but were concerned that they fail to 
capture all the inputs for the visit (especially physical exam) and the 
complexity (intensity) of the patient with multiple issues; may 
continue to result in undesired cutting and pasting in the medical 
record; and fail to properly differentiate levels (particularly level 2 
versus 3, and level 3 versus 4). These commenters were concerned that 
the revised MDM criteria may not prevent upcoding or prevent the 
accumulation of meaningless or repetitive information in the medical 
record just for billing purposes, and suggested that CMS work with the 
Office of the National Coordinator for Health Information Technology 
(ONC) on ways to accomplish ``behind-the-scenes'' documentation in 
support of the data review associated with MDM.
    One commenter supported using time as the basis for choosing the E/
M code, but expressed concern about using MDM as one of the primary 
factors to determine E/M levels. This commenter viewed time as the most 
important factor, and was concerned about MDM levels failing to account 
for the complexity of neurologic patients and difficulty attaining the 
highest level of E/M code using MDM alone. This commenter suggested 
there will be an increase in reporting of levels 4 and 5 office/
outpatient E/M visits under the new construct that may necessitate 
recalibrating the visit levels.
    A few commenters suggested that when time is used to determine 
visit level selection that it should be based on time spent during the 
24-hour period that includes the face-to-face visit, in recognition of 
those practitioners who see patients during evening clinic hours. 
Similarly, when MDM is used to determine visit level, some commenters 
expressed concern that MDM cannot be concluded until practitioners 
receive test results, which may not occur until after the date of the 
encounter.
    Response: We agree that the MDM guidelines as revised by the AMA/
CPT represent a good first step in reducing burden and updating the 
different levels of MDM for the current practice of medicine, as well 
as the coming 2021 definitional changes in this code set. We agree with 
the majority of commenters that time and MDM are each important 
measures of office/outpatient E/M visit complexity that practitioners 
should have the option to use to select visit level, and that history 
and physical exam only need to be performed and documented as medically 
appropriate. Therefore, we are finalizing our proposal to adopt the MDM 
guidelines as revised by CPT and allow the use of time or MDM to select 
office/outpatient E/M visit level beginning January 1, 2021. We share 
some of the commenters' concerns about potential resulting shifts in 
visit levels billed and among specialties, and intend to monitor the 
claims data to assess any resulting changes. We will continue to 
consider whether future refinements to the office/outpatient E/M visit 
code set, its valuation, and supporting documentation may be needed. We 
refer readers to our comment/response below on the prolonged service 
codes regarding the applicable time period for the primary office/
outpatient E/M visit code and prolonged service code(s). Finally, the 
AMA/CPT has indicated it will undertake educational efforts on its new 
guidelines that we expect might clarify outstanding questions such as 
the application of test results received on subsequent dates when MDM 
is used to select visit level.
    Comment: A few commenters stated that CPT's new documentation 
guidelines for the revised office/outpatient E/M code set that would 
permit code selection based on either MDM or time did not accurately 
represent MDM activities for urgent care practitioners who report 
office/outpatient E/Ms in the urgent care setting. These commenters 
were concerned that the revised MDM criteria fail to account for the 
complexity of the patient with multiple issues and would result in 
inaccurate visit level selection, and recommended that CMS allow urgent 
care practitioners to use either the 1995 and 1997 Guidelines or CPT's 
new documentation guidelines for the revised office/outpatient E/M code 
set and allow data to be gathered to monitor it over time.
    Response: We appreciate these concerns, but we believe that 
allowing practitioners to use either the 1995 and 1997 Guidelines or 
CPT's new documentation guidelines for the revised office/outpatient E/
M code set would create further burden. In the CY 2019 PFS proposed 
rule, we proposed to allow practitioners a choice between the 1995 and 
1997 Guidelines, MDM alone, or time alone to document office/outpatient 
E/M services. In response to this proposal, commenters stated that 
``such a policy would introduce too much variation in medical record 
format and content, or too many potential frameworks against which an 
auditor might review a claim'' (83 FR 59633). Because we believe that 
CPT's new documentation guidelines for the revised office/outpatient E/
M code set accomplishes greater burden reduction than the policies we 
finalized for CY 2021 in the CY 2019 PFS final rule, we are finalizing 
our proposal to adopt the MDM guidelines as revised by CPT and allow 
the use of time or MDM to select office/outpatient E/M visit level. We 
share some of the commenters' concerns about potential resulting shifts 
in visit levels billed and among specialties, and intend to monitor the 
claims data to assess any resulting changes. We will continue to 
consider whether future refinements to the office/outpatient E/M visit 
code set, its valuation, and supporting documentation may be needed.
    We interpreted the revised CPT prefatory language and reporting 
instructions to mean that there would be a single add-on CPT code for 
prolonged office/outpatient E/M visits (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 15 minutes (List separately in addition to codes 99205, 99215 for 
office or other outpatient Evaluation and Management services)) that 
would only be reported when time is used for code level

[[Page 62849]]

selection and the time for a level 5 office/outpatient visit (the floor 
of the level 5 time range) is exceeded by 15 minutes or more on the 
date of service. We demonstrated how prolonged office/outpatient E/M 
visit time would be reported:
[GRAPHIC] [TIFF OMITTED] TR15NO19.079

    Comment: Commenters supported the proposal to adopt CPT code 99XXX 
to report all prolonged time spent on the day of the visit. Several 
commenters sought to clarify that day or date of visit means the 24-
hour period for the date of service of the reported office/outpatient 
E/M visit code.
    Response: We are finalizing our proposal to adopt CPT code 99XXX to 
report all prolonged time spent on the date of the primary office/
outpatient E/M visit code, which is the 24-hour period for the date of 
service reported for the primary office/outpatient E/M visit code.
    We also proposed to adopt our interpretation of the revised CPT 
prefatory language and reporting instructions, that CPT codes 99358-9 
(Prolonged E/M without Direct Patient Contact) would no longer be 
reportable in association or ``conjunction'' with office/outpatient E/M 
visits. In other words, when using time to select office/outpatient E/M 
visit level, any additional time spent by the reporting practitioner on 
a prior or subsequent date of service (such as reviewing medical 
records or test results) could not count toward the required times for 
reporting CPT codes 99202-99215 or 99XXX, or be reportable using CPT 
codes 99358-9. This interpretation would be consistent with the way the 
office/outpatient E/M visit codes were resurveyed, where the AMA/RUC 
instructed practitioners to consider all time spent 3 days prior to, or 
7 days after, the office/outpatient E/M visit (see below for a 
discussion of revaluation proposals). Moreover we noted that CPT codes 
99358 and 99359 describe time spent beyond the ``usual'' time (CPT 
prefatory language), and it was not clear what would comprise ``usual'' 
time given the new time ranges for the office/outpatient E/M visit 
codes and new CPT code 99XXX (prolonged office/outpatient E/M visit).
    New CPT prefatory language specifies, ``For prolonged services on a 
date other than the date of a face-to-face encounter, including office 
or other outpatient services (99202, 99203, 99204, 99205, 99211, 99212, 
99213, 99214, 99215), see 99358, 99359 . . . Do not report 99XXX in 
conjunction with . . . 99358, 99359''. We did not believe CPT code 
99211 should be included in this list of base codes since it will only 
include clinical staff time. Also, given that CPT codes 99358, 99359 
can currently be used to report practitioner time spent on any date 
(the date of the visit or any other day), and it was not clear whether 
CPT changed this rule, the CPT reporting instruction ``see 99358, 
99359'' seemed circular. The new prefatory language seemed unclear 
regarding whether CPT codes 99358, 99359 could be reported instead of, 
or in addition to, CPT code 99XXX, and whether the prolonged time would 
have to be spent on the visit date, within 3 days prior or 7 days after 
the visit date, or outside of this new 10-day window relevant for the 
base code.
    We solicited public input on the proposal and whether it would be 
appropriate to interpret the CPT reporting instructions for CPT codes 
99358-99359 as proposed, as well as how this interpretation may impact 
valuation. We stated our belief that CPT codes 99358 and 99359 may need 
to be redefined, resurveyed and revalued. After internal review, we 
believed that when time is used to select visit level, having one add-
on code (CPT code 99XXX) instead of multiple add-on codes for 
additional time may be administratively simpler and most consistent 
with our goal of documentation burden reduction.
    HCPCS code GPRO1 (extended office/outpatient E/M time) would no 
longer be needed because the time described by this code would instead 
be described by a level 3, 4 or 5 office/outpatient E/M visit base code 
and, if applicable, the single new add-on CPT code for prolonged 
office/outpatient E/M visits (CPT code 99XXX). Therefore, we proposed 
to delete HCPCS code GPRO1 for CY 2021. We proposed to adopt the AMA/
CPT prefatory language that lists qualifying activities that could be 
included when time is used to select the visit level. Alternatively, if 
MDM is used to choose the visit level, time would not be relevant to 
code selection.
    Comment: Some commenters sought clarification on apparent overlap 
between CPT codes 99358-99359 and 99XXX, and recommended that CPT 
review this. Some commenters specified that there should continue to be 
a way to code and bill separately for prolonged time spent on a day 
other than the visit, such as for medical record review in advance of a 
new patient visit. In their public comment, the AMA/RUC noted that CPT 
codes 99358-99359 are not frequently reported, and recommended that the 
CPT/RUC Workgroup on E/M should review the issues raised in our

[[Page 62850]]

proposed rule regarding CPT codes 99358-99359 and ensure that the codes 
and guidelines are clarified, as needed, prior to any future RUC 
survey.
    Response: Since Medicare began separately paying for CPT codes 
99358-99359 in 2017 under the PFS, their PFS utilization has increased 
more than ten-fold from approximately 10,000 claim lines in 2016 to 
approximately 126,000 claim lines in 2018. While this remains a small 
percentage of E/M visit claims, utilization may further increase once 
all office/outpatient E/M visits can be reported on the basis of time 
alone and new activities such as documenting clinical information are 
explicitly counted as qualifying time. We continue to believe that the 
new CPT prefatory language on these codes is difficult to follow and 
interpret. For example, it states, ``for prolonged time without direct 
patient contact on the date of office or other outpatient services, use 
99xxx. Codes 99358, 99359 may also be used for prolonged services on a 
date other than the date of a face-to-face encounter.'' But for CPT 
code 99xxx it states not to report 99xxx in conjunction with 99358, 
99359 which could mean not to report 99358-99359 if 99xxx is reported, 
even on a separate day. Additionally, CPT would allow reporting at the 
midpoint of time for CPT codes 99358-99359 but not 99XXX, and these 
codes have discrepant time increments (one hour for CPT codes 99358-9 
reportable after the midpoint, and 15 minutes for CPT code 99XXX not 
reportable after the midpoint).
    Under the new CPT framework allowing the use of time to select 
visit level and the new list of qualifying activities, there is a new 
Medicare program vulnerability and potential increased beneficiary cost 
sharing associated with the inability to assess what visit(s) prolonged 
service codes reported on a date other than the visit are associated 
with and, accordingly, to assess whether the prolonged time was 
reasonable and necessary. If more than one visit was furnished (for 
example, if a beneficiary has an inpatient visit or another outpatient 
visit by the same practitioner within a wide time range of a given 
office/outpatient visit), it would not be clear which visit the 
prolonged time reported under CPT codes 99358-99359 is associated with 
for evaluating medical necessity and increments of time in relation to 
the base/companion code.
    We continue to believe it would be administratively simpler and 
improve payment accuracy and program integrity to have only a single 
add-on code specific to prolonged office/outpatient E/M visits that is 
clearly linked to the companion E/M office/outpatient visit code. We 
believe that under the new coding framework, CPT codes 99358-99359 are 
potentially misvalued, need to be revised for clarity and present new 
program integrity challenges. Therefore, we are finalizing our proposal 
that CPT codes 99358-99359 will not be payable in association with 
office/outpatient E/M visits beginning in CY 2021. We will consider 
future changes made to these codes by the CPT Editorial Panel or the 
RUC for possible future rulemaking. We note that a number of other 
codes such as CCM, TCM, and other care management codes may be used to 
report time spent outside the direct patient contact on dates other 
than the office/outpatient visit, if the reporting requirements for 
those services are met. While these care management codes are not 
identical to the prolonged visit codes, they can be used to report a 
number of similar activities.
    Comment: Commenters supported the proposal to delete HCPCS code 
GPRO1 for CY 2021 and to adopt the AMA/CPT prefatory language that 
lists qualifying activities that could be included when time is used to 
select the visit level. Alternatively, if MDM is used to choose the 
visit level, time would not be relevant to code selection.
    Response: We are finalizing as proposed that GPRO1 will be deleted. 
Also, the new CPT prefatory language listing qualifying activities that 
can be included when time is used to select the visit level will apply 
for purposes of PFS payment. Alternatively, if MDM is used to choose 
the visit level, time will not be relevant to code selection.
    Comment: Several commenters expressed concern regarding the use of 
physician and nonphysician practitioner (NPP) time and documentation as 
it pertains to a split/shared encounter when a beneficiary sees both 
the physician and NPP at one visit. One commenter questioned whether, 
when considering the use of an add-on code for time, the documented 
time would be limited to only one practitioner's time spent providing 
the service, or the time could include a combination of more than one 
physician and/or clinician providing the service. Another commenter 
stated that the CPT guidelines are inconsistent with the Medicare 
guidelines for split/shared E/M services. The commenter stated that per 
CMS guidelines, ``split/shared'' office visit E/M services only apply 
to established patients, while the new CPT introductory guidelines for 
the new patient office visit codes 99202-99205, specifically describe 
``incident to'' work and time of both the physician and QHP for 
selecting a level of code. The commenter requested CMS clarify its 
incident-to policy rules relative to the revised CPT guidelines for new 
patient office visit codes.
    One commenter requested that CMS consider the impact to the split/
shared services guidelines as it incorporates documentation from a 
physician and a NPP. The commenter stated that policies set forth by 
the Medicare Administrative Contractors (MACs) require specific 
documentation of the second practitioner's participation in the 
delivery of the service in the medical record to support medical 
necessity for their participation and inquired how the impact of time 
and medical decision making changes impact these other regulations. The 
commenter detailed their concerns with the current proposal as it 
relates to split/shared services and asked whether CMS would clarify or 
redefine the documentation requirements for physician assistants (PAs) 
advanced practice registered nurses (APRNs), or physicians for these 
types of services. The commenter further requested clarification on how 
best to select appropriate E/M levels when practitioners use time to 
support their levels of service and two practitioner types are involved 
in furnishing care to the same patient on the same day. The commenter 
also asked whether CMS is considering a change in payment for PAs and 
APRNs, if so, whether it would be at the same rate for physician, and 
if not, how these new proposed documentation changes define the billing 
practitioner.
    Response: We did not make any proposals specific to split/shared 
services in the CY 2020 PFS proposed rule. We thank the public 
commenters for raising these issues. We will review and take into 
account the public comments received on this topic and will consider 
the issues raised in the comments for possible future rulemaking.
    Comment: Several commenters expressed concern that practitioners 
who report E/M services in multiple settings (for example, hospital 
inpatient services, emergency department services) would be required to 
document and create billing protocols under one set of rules for 
office/outpatient E/M visits and another set of rules for other E/M 
settings. These commenters recommended that CMS should apply CPT's new 
documentation guidelines for the revised office/outpatient E/M code set 
to all E/M services in all settings.
    Response: Although we did not make any proposals in this regard for 
CYs 2020 or 2021, we appreciate the

[[Page 62851]]

information submitted. We will review and take into account the public 
comments received on this topic and will consider the issues raised in 
the comments for possible future rulemaking.
(2) Office/Outpatient E/M Visit Revaluation (CPT Codes 99201 Through 
99215)
    We received valuation recommendations from the AMA RUC for the 
revised office/outpatient E/M visit codes (CPT codes 99201 through 
99215) following completion of its survey and revaluation process for 
these codes. Although these codes do not take effect until CY 2021, we 
believed that it was appropriate to follow our usual process of 
addressing the valuation of the revised office/outpatient E/M visit 
codes through rulemaking after we receive the RUC recommendations. 
Additionally, establishing values for the new codes through rulemaking 
this year will allow more time for clinicians to make any necessary 
process and systems adjustments before they begin using the codes. In 
recent years, we have considered how best to update and revalue the 
office/outpatient E/M visit codes as they represent a significant 
proportion of PFS expenditures.
    MedPAC has had longstanding concerns that office/outpatient E/M 
services are undervalued in the PFS, and in its March 2019 Report to 
Congress, further asserted that the office/outpatient E/M code set has 
become passively devalued as values of these codes have remained 
unchanged, while the coding and valuation for other types of services 
under the fee schedule have been updated to reflect changes in medical 
practice (see pages 120 through 121 at http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch4_sec.pdf?sfvrsn=0).
    In April 2019, the RUC provided us the results of its review, and 
recommendations for work RVUs, PE inputs and physician time (number of 
minutes) for the revised office/outpatient E/M visit code set. Please 
note that these changes in coding and values are for the revised 
office/outpatient E/M visit code set and a new 15-minute prolonged 
services code. That code set is effective beginning in CY 2021, and the 
values would go into effect with those codes as of January 1, 2021.
    We proposed to adopt the RUC-recommended work RVUs for all of the 
office/outpatient E/M visit codes and the new prolonged services add-on 
code. Specifically, we proposed a work RVU of 0.93 for CPT code 99202 
(Office or other outpatient visit for the evaluation and management of 
a new patient, which requires a medically appropriate history and/or 
examination and straightforward medical decision making. When using 
time for code selection, 15-29 minutes of total time is spent on the 
date of the encounter), a work RVU of 1.6 for CPT code 99203 (Office or 
other outpatient visit for the evaluation and management of a new 
patient, which requires a medically appropriate history and/or 
examination and low level of medical decision making. When using time 
for code selection, 30-44 minutes of total time is spent on the date of 
the encounter), a work RVU of 2.6 for CPT code 99204 (Office or other 
outpatient visit for the evaluation and management of a new patient, 
which requires a medically appropriate history and/or examination and 
moderate level of medical decision making. When using time for code 
selection, 45-59 minutes of total time is spent on the date of the 
encounter), a work RVU of 3.5 for CPT code 99205 (Office or other 
outpatient visit for the evaluation and management of a new patient, 
which requires a medically appropriate history and/or examination and 
high level of medical decision making. When using time for code 
selection, 60-74 minutes of total time is spent on the date of the 
encounter. (For services 75 minutes or longer, see Prolonged Services 
99XXX)), a work RVU of 0.18 for 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)), a work RVU of 0.7 for CPT code 99212 (Office or other 
outpatient visit for the evaluation and management of an established 
patient, which requires a medically appropriate history and/or 
examination and straightforward medical decision making. When using 
time for code selection, 10-19 minutes of total time is spent on the 
date of the encounter), a work RVU of 1.3 for CPT code 99213 (Office or 
other outpatient visit for the evaluation and management of an 
established patient, which requires a medically appropriate history 
and/or examination and low level of medical decision making. When using 
time for code selection, 20-29 minutes of total time is spent on the 
date of the encounter), a work RVU of 1.92 for CPT code 99214 (Office 
or other outpatient visit for the evaluation and management of an 
established patient, which requires a medically appropriate history 
and/or examination and moderate level of medical decision making. When 
using time for code selection, 30-39 minutes of total time is spent on 
the date of the encounter), a work RVU of 2.8 for CPT code 99215 
(Office or other outpatient visit for the evaluation and management of 
an established patient, which requires a medically appropriate history 
and/or examination and high level of medical decision making. When 
using time for code selection, 40-54 minutes of total time is spent on 
the date of the encounter. (For services 55 minutes or longer, see 
Prolonged Services 99XXX)) and a work RVU of 0.61 for 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 15 minutes (List separately in addition to codes 
99205, 99215 for office or other outpatient Evaluation and Management 
services)).
    Regarding the RUC recommendations for PE inputs for these codes, we 
proposed to remove equipment item ED021 (computer, desktop, with 
monitor), as we do not believe that this item would be allocated to the 
use of an individual patient for an individual service; rather, we 
believe this item is better characterized as part of indirect costs 
similar to office rent or administrative expenses as per our standard 
process for refining PE for this and other services.
    The information we reviewed on the RUC valuation exercise was based 
on an extensive survey the RUC conducted of more than 50 specialty 
societies. For purposes of valuation, survey respondents were asked to 
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. This is different from the 
way codes are usually surveyed by the RUC for purposes of valuation, 
where pre-, intra-, and post-service time were surveyed, but not within 
a specific timeframe. The 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 RUC's 
approach sometimes resulted in two conflicting sets of times: The 
component times as surveyed and the total time as surveyed. Although we 
proposed to adopt the RUC-recommended times as explained below, we 
solicited comment on how

[[Page 62852]]

CMS should address the discrepancies in times, which have implications 
both for valuation of individual codes and for PFS ratesetting in 
general, as the intra-service times and total times are used as 
references for valuing many other services under the PFS and that the 
programming used for PFS ratesetting requires that the component times 
sum to the total time. Specifically, we solicited comment on which 
times should CMS use, and how we should resolve differences between the 
component and total times when they conflict. Table 34 illustrates the 
surveyed times for each service period and the surveyed total time. It 
also shows the actual total time if summed from the component times.
[GRAPHIC] [TIFF OMITTED] TR15NO19.080

    Table 35 summarizes the current office/outpatient E/M visit code 
set, and the new prolonged services code physician work RVUs and total 
time compared to what CMS finalized in CY 2019 for CY 2021, and the 
RUC-recommended work RVU and total time.
[GRAPHIC] [TIFF OMITTED] TR15NO19.081

    The RUC recommendations reflect a rigorous and robust survey 
approach, including surveying over 50 specialty societies, demonstrate 
that office/outpatient E/M visits are generally more complex, for most 
clinicians. In the CY 2019 PFS final rule, we finalized for CY 2021 a 
significant reduction in the payment variation in office/outpatient E/M 
visit levels by paying a single blended rate for E/M office/outpatient 
visit levels 2 through 4 (one for established and another for new 
patients). We also maintained the separate payment rates for E/M 
office/outpatient level 5 visits in order to better account for the 
care and needs of particularly complex patients. We believed that the 
single blended payment rate for E/M office/outpatient visit levels 2-4 
better accounted for the resources associated with the typical visit. 
After reviewing the RUC recommendations, in conjunction with the 
revised code descriptors and documentation guidelines for CPT codes 
99202 through 99215, we believe codes and recommended values would more 
accurately account for the time and intensity of office/outpatient E/M 
visits than either the current codes and values or the values we 
finalized in the CY 2019 PFS final rule for CY 2021. Therefore, we 
proposed to establish separate values for Levels 2-4 office/outpatient 
E/M visits for both new and

[[Page 62853]]

established patients rather than continue with the blended rate. We 
proposed to accept the RUC-recommended work and time values for the 
revised office/outpatient E/M visit codes without refinement for CY 
2021. With regard to the RUC's recommendations for PE inputs, we 
proposed to remove equipment item ED021 (computer, desktop, with 
monitor), as this item is included in the overhead costs. Note that 
these changes to codes and values would go into effect January 1, 2021.
    We received public comments on the proposed Office/Outpatient E/M 
Visit Revaluation provisions. The following is a summary of the 
comments we received and our responses.
    Comment: The majority of commenters supported revision of CMS' 
finalized policies, including blended payment rate for levels 2-4 and 
CMS' proposed adoption of the RUC recommended values for CPT codes 
99202-99215, and 99xxx, deleting CPT code 99201, and maintaining 
separate payment for the remaining codes.
    A few commenters expressed concern with the RUC-recommended values, 
stating that the standard for compelling evidence had not been met, 
that the survey instrument was flawed, and that the survey respondents 
may not have understood the survey method or the new coding guidance 
itself. These commenters urged CMS to delay implementation of the RUC-
recommended times and RVUs until the public is more familiar with the 
new coding system, at which time the codes could be resurveyed by the 
RUC.
    Response: With regard to the concerns raised regarding the RUC 
survey process and revaluation effort, we recognize that valuation of 
codes is an iterative process and that estimates may need to be 
updated. Due to the robust nature of the survey and the consensus of 
the RUC participants, we believe that the combination of adopting the 
CPT's revised code set and accepting the RUC-recommended values will 
represent a significant improvement in the description and payment of 
office and outpatient E/M visits over the current coding and values. We 
believe the RUC process and resultant recommendations provide a 
sufficient basis on which to set values for CY 2021; and that this is 
especially so given that there is sufficient time to consider any 
additional information developed before the new code set and values 
take effect. We note that the updated values are not effective until CY 
2021, and will consider additional information pertaining to valuation 
of these services if submitted prior to the February 10, 2020 deadline 
for submission of RUC and/or stakeholder valuation recommendations to 
be considered for CY 2021 rulemaking.
    Comment: Most commenters did not support the classification of 
equipment item ED021 (computer, desktop, with monitor) as an indirect 
PE, stating that the computer was an important part of furnishing the 
service, used for documentation or to view test results, and was not 
available for other uses while a visit was being furnished. A few 
commenters suggested that the office/outpatient E/M visit codes should 
include as direct PE 2 minutes for identifying and obtaining imaging, 
lab, or other test results.
    Response: We continue to believe that ED021 is best characterized 
as an indirect PE. Although desktop computers may be used perform not 
only administrative tasks, but also a number of clinical tasks such as 
recording information about the patient obtained during evaluation or 
accessing the patient's history during the visit, we continue to 
believe that the majority of the functionality of a desktop computer is 
not individually allocable to a particular patient for a particular 
service. We also note that there are a number of services similar to an 
office visit, such as CPT code 99483 (Assessment of and care planning 
for a patient with cognitive impairment, requiring an independent 
historian, in the office or other outpatient, home or domiciliary or 
rest home, with all of the following required elements: Cognition-
focused evaluation including a pertinent history and examination; 
Medical decision making of moderate or high complexity; Functional 
assessment (e.g., basic and instrumental activities of daily living), 
including decision-making capacity; Use of standardized instruments for 
staging of dementia (e.g., functional assessment staging test [FAST], 
clinical dementia rating [CDR]); Medication reconciliation and review 
for high-risk medications; Evaluation for neuropsychiatric and 
behavioral symptoms, including depression, including use of 
standardized screening instrument(s); Evaluation of safety (e.g., 
home), including motor vehicle operation; Identification of 
caregiver(s), caregiver knowledge, caregiver needs, social supports, 
and the willingness of caregiver to take on caregiving tasks; 
Development, updating or revision, or review of an Advance Care Plan; 
Creation of a written care plan, including initial plans to address any 
neuropsychiatric symptoms, neuro-cognitive symptoms, functional 
limitations, and referral to community resources as needed (e.g., 
rehabilitation services, adult day programs, support groups) shared 
with the patient and/or caregiver with initial education and support. 
Typically, 50 minutes are spent face-to-face with the patient and/or 
family or caregiver) and CPT code 99490 (Chronic care management 
services, at least 20 minutes of clinical staff time directed by a 
physician or other qualified health care professional, per calendar 
month, with the following required elements: Multiple (two or more) 
chronic conditions expected to last at least 12 months, or until the 
death of the patient; chronic conditions place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline; comprehensive care plan established, implemented, 
revised, or monitored) that do not include equipment item ED021 as a 
direct PE input despite specifically requiring information be entered 
into an EHR or other tasks that would typically be completed using a 
desktop computer. Beyond the classification of the desktop computer as 
an indirect PE, we believe that the PE inputs as recommended to CMS by 
the RUC are accurate, and as such, we do not agree that additional time 
is needed for identifying and obtaining imaging, lab, or other test 
results.
    Comment: Many commenters recommended that, for purposes of 
ratesetting and the CMS time file, CMS should consider total time to be 
the median total time as recommended by the RUC.
    Response: We thank the commenters for their suggestions. Currently, 
for ratesetting and the CMS time file, the total time for the office/
outpatient E/M code set is the sum of pre-, intra-, and post-service 
times. If we were to consider the median total time as recommended by 
commenters and the RUC, then the pre-, intra-, and post-services times 
would no longer, in some instances, sum to the total. As we noted in 
the proposed rule, this has implications both for valuation of 
individual codes and for PFS ratesetting in general, as the intra-
service times and total times are used as references for valuing many 
other services under the PFS and that the programming used for PFS 
ratesetting requires that the component times sum to the total time. We 
will continue to consider this issue in future rulemaking.
    Comment: Many commenters expressed concerns about the 
redistributive impact of revaluing of the office/outpatient E/M visit 
code set, particularly for practitioners who do not routinely bill 
office/outpatient E/M visits. Commenters suggested a number of 
strategies CMS could use to mitigate

[[Page 62854]]

the negative redistributive impact, such as phasing the changes in over 
4 or 5 years, capping increases or decreases, conducting claims-based 
analysis, and working with Congress to ensure that these changes would 
not negatively impact the CY 2021 conversion factor.
    Response: As these office/outpatient E/M visit codes make up around 
20 percent of total PFS expenditures, we understand commenters' 
concerns with the magnitude of the redistributive adjustment necessary 
to budget neutralize the increased values. Given that these revised 
codes and values do not take effect until CY 2021, and we do not know 
the magnitude of redistribution resulting from other policies we may 
adopt through rulemaking before then, we believe it would be premature 
to finalize a strategy in this final rule as these values would not be 
effective until CY 2021. However, we intend to consider these concerns 
and address them in future rulemaking.
    Based on our review of public comments, we are finalizing valuation 
for CPT codes 99202 through 99215, as proposed for implementation 
beginning in CY 2021.
(3) Simplification, Consolidation and Revaluation of HCPCS Codes GCG0X 
and 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 believe that the revalued office/outpatient E/M visit code set 
itself still does not appropriately reflect differences in resource 
costs between certain types of office/outpatient E/M visits. In the CY 
2019 PFS proposed rule, we articulated that, based on stakeholder 
comments, clinical examples, and our review of the literature on 
office/outpatient E/M services, there are three types of office/
outpatient E/M visits that differ from the typical office/outpatient E/
M visit and are not appropriately reflected in the current office/
outpatient E/M visit code set and valuation. These three types of 
office/outpatient E/M visits can be distinguished by the mode of care 
provided and, as a result, have different resource costs. The three 
types of office/outpatient E/M visits that differ from the typical 
office/outpatient E/M service are: (1) Separately identifiable office/
outpatient E/M visits furnished in conjunction with a global procedure; 
(2) primary care office/outpatient E/M visits for continuous patient 
care; and (3) certain types of specialist office/outpatient E/M visits. 
We proposed, but did not finalize, the application of a multiple 
procedure payment reduction (MPPR) to the first category of visits, to 
account for overlapping resource costs when office/outpatient E/M 
visits were furnished on the same day as a 0-day global procedure. To 
address the shortcomings in the E/M code set in appropriately 
describing and reflecting resource costs for the other two types of 
office/outpatient E/M visits, we proposed and finalized the two HCPCS G 
codes: HCPCS code GCG0X (Visit complexity inherent to evaluation and 
management associated with non-procedural specialty care including 
endocrinology, rheumatology, hematology/oncology, urology, neurology, 
obstetrics/gynecology, allergy/immunology, otolaryngology, 
interventional pain management, cardiology, nephrology, infectious 
disease, psychiatry, and pulmonology (Add-on code, list separately in 
addition to level 2 through 4 office/outpatient evaluation and 
management visit, new or established) which describes the inherent 
complexity associated with certain types of specialist visits and GPC1X 
(Visit complexity inherent to evaluation and management associated with 
primary medical care services that serve as the continuing focal point 
for all needed health care services (Add-on code, list separately in 
addition to level 2 through 4 office/outpatient evaluation and 
management visit, new or established), which describes additional 
resources associated with primary care visits.
    Although we finalized two separate codes, we valued both HCPCS 
codes GCG0X and GPC1X via a crosswalk to 75 percent of the work and 
time value of CPT code 90785 (Interactive complexity (List separately 
in addition to the code for primary procedure)). Interactive complexity 
is an add-on code that may be billed when a psychotherapy or 
psychiatric service requires more work due to the complexity of the 
patient, and we believed that 75 percent of its work and time values 
accurately captured the additional resource costs of primary care 
office/outpatient E/M visits and certain types of specialty office/
outpatient E/M visits when billed with the single, blended payment rate 
for office/outpatient E/M visit levels 2-4.
    In the CY 2019 PFS final rule, we stated that, due to the variation 
among the types of visits performed by certain specialties, we did not 
believe that the broad office/outpatient E/M visit code set captured 
the resource costs associated with furnishing primary care and certain 
types of specialist visits (FR 83 59638). As we stated above, we 
believe that the revised office/outpatient E/M visit code set and RUC-
recommended values more accurately reflect the resources associated 
with a typical visit. However, we believe the typical visit described 
by the revised code set still does not adequately describe or reflect 
the resources associated with primary care and certain types of 
specialty visits.
    As such, we believe that there is still a need for add-on coding 
because the revised office/outpatient E/M visit code set does not 
recognize that there are additional resource costs inherent in 
furnishing some kinds of office/outpatient E/M visits. However, based 
on previous public comments and ongoing engagement with stakeholders, 
we understand the need for the add-on code(s) and descriptor(s) to be 
easy to understand and report when appropriate, including in terms of 
medical record documentation and billing. We also clarify that the add-
on coding is not intended to reflect any difference in payment based on 
the billing practitioner's specialty, but rather the recognition of 
different per-visit resource costs based on the kinds of care the 
practitioner provides, regardless of their specialty. Therefore, we 
proposed to simplify the coding by consolidating the two add-on codes 
into a single add-on code and revising the single code descriptor to 
better describe the work associated with visits that are part of 
ongoing, comprehensive primary care and/or visits that are part of 
ongoing care related to a patient's single, serious, or complex chronic 
condition.
    We proposed to revise the descriptor for HCPCS code GPC1X and 
delete HCPCS code GCG0X. The proposed descriptor for GPC1X appears in 
Table 36. We solicited comment regarding the proposed changes, 
particularly the proposed new code descriptor for GPC1X and whether or 
not more than one code, similar to the policy finalized last year, 
would be necessary or beneficial.
    We have also reconsidered the appropriate valuation for this HCPCS 
add-on G-code in the context of the revised office/outpatient E/M visit 
code set and proposed values. Upon further review and in light of the 
other changes to the office/outpatient E/M visit code set, we believe 
that valuing the add-on code at 75 percent of CPT code 90785 would 
understate the additional inherent intensity associated with furnishing 
primary care and certain types of specialty visits. As CPT code 90785 
also describes additional work associated with certain psychotherapy or 
psychiatric visits, we believe its work

[[Page 62855]]

and time values are the most appropriate crosswalk for the revised 
HCPCS code GPC1X. Therefore, we proposed to value HCPCS code GPC1X at 
100 percent of the work and time values for CPT code 90785, and 
proposed a work RVU of 0.33 and a physician time of 11 minutes. We also 
proposed that this HCPCS add-on G code could be billed as applicable 
with every level of office/outpatient E/M visit, and that we would 
revise the code descriptor to reflect that change. See Table 36 for the 
changes to the code descriptor. We note that if the CPT Editorial Panel 
makes any further changes to the office/outpatient E/M visit codes and 
descriptors, or creates one or more CPT codes that duplicate this add-
on code, or if the RUC and/or stakeholders or other public commenters 
recommend values for these or other related codes, we would consider 
them through subsequent rulemaking.
[GRAPHIC] [TIFF OMITTED] TR15NO19.082

    We received public comments on the proposed Simplification, 
Consolidation and Revaluation of HCPCS codes GCG0X and GPC1X. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters who rely upon the level 4 and 5 office/
outpatient E/M visits to report the majority of their services were 
very supportive of the consolidation and redefinition of HCPCS codes 
GCG0X and GPC1X. Commenters agreed with CMS in that, although the 
revalued office/outpatient E/M visit codes better account for the 
intensity associated with furnishing these services, there are 
additional resources associated with primary care and certain types of 
non-procedural specialty care that are not captured by the revalued 
codes. Commenters also stated that the revised descriptor was clearer 
in that it did not allude to certain specialties specifically, but 
described the work associated with primary care or ongoing care related 
to a patient's single, serious, or complex chronic condition. 
Commenters generally supported CMS' proposal to change the level of 
visits billable with HCPCS code GPC1X from level 2-4 new or established 
patient visits to all visit levels, although a few commenters stated 
that it would only be billable with the level 4 and 5 visits because 
the clinical vignettes associated with those services describe patients 
with single, serious or complex chronic problem whereas the vignettes 
associated with the lower level office/outpatient E/M visit codes do 
not. Commenters also supported the increased work RVU.
    Response: We thank the commenters for their support and generally 
agree with these comments. We note that clinical vignettes are meant to 
describe a typical patient for purposes of code valuation. Given the 
wide variety of visit types billable with the office/outpatient E/M 
visit code set, we do not believe that the value associated with the 
typical patient accounts for the additional resources associated with 
primary care or ongoing care related to a patient's single, serious, or 
complex chronic condition, regardless of the visit level. Therefore, we 
do not agree that billing HCPCS code GPC1X should be restricted to 
higher level office/outpatient E/M visits.
    Comment: A few commenters recommended that the code descriptor for 
GPC1X be modified as follows (additions italicized): ``Visit complexity 
inherent to evaluation and management associated with medical care 
services that serve as the first contact and continuing focal point for 
all needed health care services in coordination with others as needed 
and/or with medical care services that are part of ongoing care related 
to a patient's single, serious, or complex chronic condition(s). (Add-
on code, list separately in addition to office/outpatient evaluation 
and management visit, new, or established.).'' These commenters stated 
that these revisions better capture the work associated with primary 
care visits. Commenters also requested clarification on what CMS 
considers to be a ``complex'' or ``serious'' condition, and stated that 
CMS should issue detailed guidance and clinical scenarios wherein the 
billing of the GPC1X would be appropriate.
    Response: We agree with commenters that the revisions have the 
potential to improve the accuracy of the code descriptor as it pertains 
to the primary care services described by HCPCS code GPC1X. We look 
forward to continued engagement with the public in the development of 
guidance and, in making this or similar refinements to the code through 
future rulemaking.
    Comment: Other commenters disagreed with CMS' proposal. Many of 
these commenters, including the RUC, stated that they were supportive 
of separate payment for an add-on code that would account for 
additional work associated with ``outlier'' cases of particular 
clinical intensity but urged CMS to work with CPT and RUC to define and 
value the service.
    Other commenters expressed concern regarding the necessity of HCPCS 
code GPC1X entirely. A few stated that, given the revaluation of the 
office/outpatient E/M visit codes, separate payment for certain types 
of primary care or specialty visits was duplicative and unnecessary. 
Some commenters also noted that the additional utilization associated 
with HCPCS code GPC1X further contributed to the redistributive effect 
of budget neutrality (BN)

[[Page 62856]]

adjustment related to revaluing the office/outpatient E/M visit codes, 
particularly for those specialties who do not routinely furnish office 
visits.
    Response: HCPCS code GPC1X does not describe outlier visits, but 
visits associated with primary care or care services that are part of 
ongoing care related to a patient's single, serious, or complex chronic 
condition(s), which we maintain is qualitatively different from the 
work accounted for in the revalued office/outpatient E/M visits. As 
stated previously, we will consider strategies to mitigate the 
redistributive effects of BN adjustment associated with revaluing of 
the office/outpatient E/M visit code set as part of future rulemaking.
    After considering the comments, we are finalizing the code 
descriptor for GPC1X as proposed. We are finalizing valuation as 
proposed. GPC1X will be implemented in CY 2021.
(4) Valuation of CPT Code 99xxx (Prolonged Office/Outpatient E/M)
    We proposed to delete to the HCPCS add-on code we finalized last 
year for CY 2021 for extended office/outpatient E/M visits (GPRO1) and 
adopt the new CPT code 99XXX. The RUC also provided a recommendation 
for new 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 15 minutes (List separately in 
addition to codes 99205, 99215 for office or other outpatient 
Evaluation and Management services). The RUC recommended 15 minutes of 
physician time and a work RVU of 0.61. Further, we proposed to accept 
the RUC recommended values for CPT code 99XXX without refinement.
    We solicited comment on these proposals, as well as any additional 
information stakeholders can provide on the appropriate valuation for 
these services.
    We received public comments on the proposed valuation of CPT code 
99xxx. The following is a summary of the comments we received and our 
responses.
    Comment: Most commenters supported the proposed value for CPT code 
99XXX. A few commenters recommended a work RVU of 1.17, consistent with 
the valuation of the HCPCS G-code for additional time finalized in last 
year's rulemaking, GPRO1.
    Response: We note that 99XXX describes 15 minutes of additional 
time, whereas GPR01 described 30 minutes of additional time. Therefore, 
we continue to believe that 0.61 is a more accurate work RVU for 99XXX.
    After considering the comments, we are finalizing valuation for CPT 
code 99XXX as proposed.
(5) Implementation Timeframe
    We proposed that these policy changes for office/outpatient E/M 
visits would be effective starting January 1, 2021. We believed this 
would allow sufficient time for physician and practitioner education 
and further feedback; changes in clinical workflows, EHRs and any other 
impacted systems; and corresponding changes that may be made by other 
payers. In summary, we proposed to adopt the following policies for 
office/outpatient E/M visits effective January 1, 2021:
     Separate payment for the five levels of office/outpatient 
E/M visit CPT codes, as revised by the CPT Editorial Panel effective 
January 1, 2021 and resurveyed by the AMA RUC, with minor refinement. 
This would include deletion of CPT code 99201 (Level 1 new patient 
office/outpatient E/M visit) and adoption of the revised CPT code 
descriptors for CPT codes 99202-99215;
     Elimination of the use of history and/or physical exam to 
select among code levels;
     Choice of time or MDM to decide the level of office/
outpatient E/M visit (using the revised CPT interpretive guidelines for 
MDM);
     Payment for prolonged office/outpatient E/M visits using 
the new CPT code 99xxx, deletion of HCPCS code GPRO1 (extended office/
outpatient E/M visit) that we previously finalized for 2021, and no 
longer recognizing CPT codes 99358-9 for separate payment in 
association with office/outpatient E/M visits;
     Revise the descriptor for HCPCS code GPC1X and delete 
HCPCS code GCG0X; and
     Increase in value for HCPCS code GCG1X and allow it to be 
reported with all office/outpatient E/M visit levels.
    We received public comments on the proposed implementation 
timeframe. The following is a summary of the comments we received and 
our responses.
    Comment: Commenters generally supported the proposed implementation 
date of CY 2021, stating that this implementation date would allow 
adequate time to educate practitioners and their staff, revise 
electronic health records, and transition clinical workflows, 
institutional processes and policies, and other aspects of practitioner 
work that would be impacted by these policy changes. Several commenters 
suggested that CMS should implement changes for CY 2020 instead of CY 
2021. A few commenters suggested that CMS should phase in 
implementation more gradually, ranging between 18 months to allow 
electronic health record systems vendors more time to prepare, and 4 or 
5 years to mitigate the redistributive impact of the valuation changes.
    Response: Given that the CPT coding changes will take effect in 
2021, we are finalizing these proposals for January 1, 2021, which is 
also the implementation timeframe we finalized last year. We believe 
the delayed implementation to CY 2021 will allow practitioners and 
electronic health records vendors time to prepare. As stated 
previously, given that we do not know the magnitude of redistribution 
resulting from other policies we may adopt through rulemaking before 
these changes take effect, we believe it would be premature to finalize 
a strategy in this final rule for addressing redistributive impacts. 
However, we intend to consider concerns expressed by commenters and 
address them in future rulemaking.
(6) Global Surgical Packages
    In addition to their recommendations regarding physician work, 
time, and PE for office/outpatient E/M visits, the AMA RUC also 
recommended adjusting the office/outpatient E/M visits for procedures 
with post-operative visits included in 10- or 90-day global periods to 
reflect the changes made to the values for office/outpatient E/M 
visits. The valuation of most procedures with 10- and 90-day global 
periods reflect a certain number of post-operative visits that are 
assumed to typically be furnished by the same practice and specialty as 
the procedure itself during the global period. While the work involved 
in these post-operative visits is often valued with reference to RVUs 
for separately-billed E/M visits, bundled post-operative visit RVUs do 
not directly contribute a certain number of RVUs to the valuation of 
procedures with 10- or 90-day global periods.
    In the CY 2015 PFS final rule, we discussed the challenges of 
accurately accounting for the number of visits included in the 
valuation of 10- and 90-day global packages (79 FR 67548, 67582). We 
finalized a policy to change all global periods to 0-day global 
periods, and to allow separate payment for post-operative E/M visits. 
Our concerns were based on a number of key points including: The lack 
of sufficient data on the number of visits typically

[[Page 62857]]

furnished during the global periods, questions about whether we will be 
able to adjust values on a regular basis to reflect changes in the 
practice of medicine and health care delivery, and concerns about how 
our global payment policies could affect the services that are actually 
furnished. In finalizing a policy to transform all 10- and 90-day 
global codes to 0-day global codes in CY 2017 and CY 2018, 
respectively, to improve the accuracy of valuation and payment for the 
various components of global packages, including pre- and post-
operative visits and the procedure itself, we stated that we were 
adopting this policy because it is critical that PFS payment rates be 
based upon RVUs that reflect the relative resources involved in 
furnishing the services. We also stated our belief that transforming 
all 10- and 90-day global codes to 0-day global packages would:
     Increase the accuracy of PFS payment by setting payment 
rates for individual services that more closely reflect the typical 
resources used in furnishing the procedures;
     Avoid potentially duplicative or unwarranted payments when 
a beneficiary receives post-operative care from a different 
practitioner during the global period;
     Eliminate disparities between the payment for E/M services 
in global periods and those furnished individually;
     Maintain the same-day packaging of pre- and post-operative 
physicians' services in the 0-day global packages; and
     Facilitate the availability of more accurate data for new 
payment models and quality research.
    Section 523(a) of the MACRA added section 1848(c)(8)(A) of the Act, 
which prohibited the Secretary from implementing the policy described 
above, which would have transformed all 10-day and 90-day global 
surgery packages to 0-day global packages. Section 1848(c)(8)(B) of the 
Act, which was also added by section 523(a) of the MACRA, required us 
to collect data to value surgical services. Section 1848(c)(8)(B)(i) of 
the Act requires us to develop a process to gather information needed 
to value surgical services from a representative sample of physicians, 
and requires that the data collection begin no later than January 1, 
2017. The collected information must include the number and level of 
medical visits furnished during the global period and other items and 
services related to the surgery and furnished during the global period, 
as appropriate. Section 1848(c)(8)(B)(iii) of the Act specifies that 
the Inspector General shall audit a sample of the collected information 
to verify its accuracy. Section 1848(c)(8)(C) of the Act, which was 
also added by section 523(a) of the MACRA, requires that, beginning in 
CY 2019, we must use the information collected as appropriate, along 
with other available data, to improve the accuracy of valuation of 
surgical services under the PFS.
    Resource-based valuation of individual physicians' services is a 
critical foundation for Medicare payment to physicians. It is essential 
that the RVUs under the PFS be based as closely and accurately as 
possible on the actual resources used in furnishing specific services 
to make appropriate payment and preserve relativity among services. For 
global surgical packages, this requires using objective data on all of 
the resources used to furnish the services that are included in the 
package. Not having such data for some components may significantly 
skew relativity and create unwarranted payment disparities within the 
PFS. The current valuations for many services valued as global packages 
are based upon the total package as a unit rather than by determining 
the resources used in furnishing the procedure and each additional 
service/visit and summing the results. As a result, we do not have the 
same level of information about the components of global packages as we 
do for other services. To value global packages accurately and relative 
to other procedures, we need accurate information about the resources--
work, PEs and malpractice--used in furnishing the procedure, similar to 
what is used to determine RVUs for all services. In addition, we need 
the same information on the postoperative services furnished in the 
global period (and pre-operative services the day before for 90-day 
global packages).
    In response to the MACRA amendments to section 1848(c)(8) of the 
Act, CMS required practitioners who work in practices that include 10 
or more practitioners in Florida, Kentucky, Louisiana, Nevada, New 
Jersey, North Dakota, Ohio, Oregon, and Rhode Island to report using 
CPT 99024 on post-operative visits furnished during the global period 
for select procedures furnished on or after July 1, 2017. The specified 
procedures are those that are furnished by more than 100 practitioners 
and either are nationally furnished more than 10,000 times annually or 
have more than $10 million in annual allowed charges.
    RAND analyzed the data collected from the post-operative visits 
through this claim- based reporting for the first year of reporting, 
July 1, 2017 through June 30, 2018. They found that only 4 percent of 
procedures with 10-day global periods had any post-operative visits 
reported. While 71 percent of procedures with 90-day global periods had 
at least one associated post-operative visit, only 39 percent of the 
total post-operative visits expected for procedures with 90-day global 
periods were reported. (A complete report on this is available at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.)
    In addition to the claims-based data collection, RAND collected 
data on the level of visits. They began with an attempt to collect data 
via a survey from all specialties as described in the 2017 final rule. 
Given the low rate of response from practitioners, we narrowed the 
scope and focused on three high-volume procedures with global periods 
that were common enough to likely result in a robust sample size: (1) 
Cataract surgery; (2) hip arthroplasty; and (3) complex wound repair. A 
total of 725 physicians billing frequently for cataract surgery, hip 
arthroplasty, and complex wound repair reported on the time, 
activities, and staff involved in 3,469 visits. Our findings on 
physician time and work from the survey were broadly similar to what we 
expected based on E/M visits in the Time File for cataract surgery and 
hip replacement and somewhat different for complex wound repair. It 
should be noted that the time and work values used for this comparison 
were for 2018 E/M visits. (For the complete report, see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.)
    The third report in the series looks at ways we could consider 
revaluing procedures using the collected data. To provide us with 
estimates to frame a discussion, RAND modeled how valuation for 
procedures would change by adjusting work RVUs, physician time, and 
direct PE inputs based on the difference between the number of post-
operative visits observed via claims-based reporting and the expected 
number of post-operative visits used during valuation. RAND looked at 
three types of changes: (1) Updated work RVUs based on the observed 
number of post-operative visits measured four ways (median, 75th 
percentile, mean, and modal observed visits); (2) Allocated PE RVUs 
reflecting direct PE inputs updated to reflect the median number of 
reported post-operative visits; and (3) Modeled total RVUs reflecting 
(a) updated work RVUs, (b) updated physician time, and (c) updated

[[Page 62858]]

direct PE inputs, and including allocated PE and malpractice RVUs. This 
report is designed to inform further conversations about how to revalue 
global procedures. (For the complete report, see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.) We provided the public and stakeholders 
the data we had available with the proposed rule, and asked that they 
provide input on an appropriate approach to using these data to revalue 
global surgical procedures. We will continue to study and consider 
alternative ways to address the values for these services.
    We received public comments on the impact of the new E/M coding and 
valuations on global surgical packages and on the reports and other 
information on revaluing global surgical packages that we made 
available with the proposed rule. The following is a summary of the 
comments we received and our responses.
    Comment: Most commenters objected to not using the proposed new E/M 
coding and valuations to revise the values for global surgery packages. 
The commenters stated that failure to use the new E/M coding and values 
for global services will disrupt the relativity in the PFS, create 
specialty differences and could violate the MACRA section 523(a) 
statutory requirements. Most commenters objected to our not proposing 
to adopt the AMA RUC recommendations to apply revised values for E/M 
office visits in global surgery procedures. They stated that not 
adopting the RUC recommendations interferes with relativity because we 
proposed to apply the RUC-recommended E/M values to stand-alone E/M 
services, but not to the E/M services that are included in global 
surgical packages. Commenters noted that in the past, CMS has aligned 
changes in valuation of stand-alone office visits with valuation of the 
office visits in the surgical global period so that each time the value 
for separately billed office visits was changed, corresponding changes 
were made to the value of visits for all global surgery packages. In 
addition, some commenters stated that, by failing to adopt all of the 
RUC-recommended work and time values for the revised office visit E/M 
codes, including the recommended adjustments to the 10- and 90-day 
global codes, CMS is implementing these values in an arbitrary and 
piecemeal fashion. Some commenters stated that applying the RUC-
recommended E/M values to stand-alone E/M services, but not to the E/M 
services that are included in the global surgical package, would result 
in disruption to the relativity between codes across the Medicare PFS. 
A number of commenters also stated that failing to adjust the global 
codes to reflect adjustments to separately billable E/M services is 
tantamount to paying some physicians less for providing the same E/M 
services, in violation of the law.
    Response: Relativity is an important concept we consider heavily 
when establishing values for services under the PFS. To maintain 
relativity in the past, we had adjusted values for global surgery 
procedures when we updated values for E/M visits because we did not 
have information to suggest that it might not be appropriate to do so. 
However, there are now important, unresolved questions regarding how 
post-operative visits included in global surgery codes should be valued 
relative to stand-alone E/M visit analogues. Specifically, it is 
unclear whether it would be appropriate to use a building-block 
approach to increase the valuation for global surgical packages in a 
way that could disrupt potentially more accurate estimates of total 
work for procedures with global periods from magnitude estimation. 
Furthermore, given the information described above on E/M services 
furnished as part of global surgery services, we have questions about 
the appropriate number of E/M services reflected in the values for 
global surgery procedures. If the number of E/M services for global 
codes is not appropriate, adopting the AMA RUC-recommended values for 
E/M services in global surgery codes would exacerbate rather than 
ameliorate any potential relativity issues. Therefore, we are not 
adopting the RUC recommendation to apply revised values for E/M 
services to the global surgery codes at this time.
    Section 1848(c)(8)(C) of the Act, as added by section 523a of the 
MACRA, requires CMS to use the information collected as appropriate, 
along with other available data, to improve the accuracy of valuation 
of surgical services under the PFS. We believe it is important to avoid 
contributing further to the potential misvaluation of global surgical 
procedures. Reflexively adding revised E/M work RVUs to values for 
global codes as recommended by the RUC and other commenters could 
potentially result in inappropriate shifts in relativity under the PFS, 
and the associated BN adjustment could result in potentially 
inappropriate adjustments to payment rates for services without global 
periods, such as separately-billed E/M visits. Given that the 
information we have gathered to date as required by section 
1848(c)(8)(B)(i) of the Act, as well as the conclusions of past OIG 
studies, suggests that the values for E/M services typically furnished 
in global surgery periods are overstated in the current valuations for 
global surgery codes, we do not believe it would be appropriate to 
amplify the effects of any such overvaluation by increasing the values 
of included E/M services while we continue to look into the information 
and develop appropriate solutions.
    Comment: Commenters raised concerns about the generalizability of 
the claims data we collected on post-operative visits since it was only 
collected from practices with 10 or more practitioners in 9 states. One 
commenter stated that the AMA 2018 Physician Practice Benchmark Survey 
indicated that 54 percent of physicians are in practices with fewer 
than 10 physicians. They added that, for surgical specialties, 64 
percent of physicians are in practices with fewer than 10 physicians. 
Commenters expressed a related concern that the definition of 
``practice'' used in the reporting of post-operative visits caused 
confusion and decreased reporting. Further, commenters expressed 
concern that some physicians may not have been aware of the reporting 
requirement, and therefore, some post-operative visits were not 
reported. One commenter noted that using CPT 99024 to report post-
operative visits contradicts specialty society coding education, and 
some practices encountered difficulties reporting the zero-charge CPT 
99024 as attempts to report the code in many practices and EHR systems 
are blocked by the software.
    Response: We believe that the newly-collected post-operative visit 
data significantly improves our understanding of which bundled post-
operative visits are actually furnished during global periods, beyond 
estimates provided by the AMA RUC and specialty society surveys. CMS 
chose to limit reporting to a random sample of 9 states and to exclude 
practices with less than 10 practitioners because of concerns from the 
physician community about reporting burden, which might be particularly 
high for smaller practices. Some commenters have now suggested that the 
scope of our required reporting may be inadequate. We can consider for 
the future whether requiring reporting for smaller practices and 
throughout the country would give us better data. We also note that, 
although we have authority to do so, we chose not to penalize 
practitioners who did not report, but we could also reevaluate this 
decision if the current reporting rates are insufficient.

[[Page 62859]]

    Comment: Commenters disagreed with the conclusion in the RAND 
report that only 39 percent of expected post-operative visits following 
procedures with 90-day global periods and only 4 percent of expected 
post-operative visits following procedure with 10-day global periods 
were actually performed. Commenters objected to counting all non-
occurring visits as ``no'' visits as some visits were not reported. 
Relatedly, commenters raised many concerns with the methodology used in 
the RAND analyses. These include:
     Revaluations from the RUC have made the data outdated.
     Potential flaws in the way procedures were matched to 
reported 99024 codes.
     Disagreement with the definition of ``robust reporters'' 
used in the sensitivity analyses.
     Possible bias from the use of half-visits from the time 
file.
     Reporting of procedures with 10-day global periods are 
dominated by HCPCS codes 17000, 17004 and 17110, which are not 
representative of all procedures.
     Inclusion of separately-billed E/M services to provide 
post-operative care could account for the gap between observed and 
expected visits.
    Response: The RAND results focus on the share of expected post-
operative visits that were reported to CMS. It is true that the absence 
of a reported visit does not necessarily mean that a post-operative 
visit did not occur. However, apart from required reporting, we have no 
way to know whether a visit occurred. For some specialties, including 
hand surgery, orthopedic surgery, vascular surgery, ophthalmology, 
neurosurgery, urology, plastic and reconstructive surgery, dermatology 
and general surgery, 85 percent or more of practitioners who were 
expected to report post-operative visits relating to global surgical 
services reported at least some visits. We can only assume the visits 
that are furnished are being reported.
    The RAND report includes results from many sensitivity analyses 
that aim to address several methodological concerns raised by some 
commenters, and particularly concerns related to potentially incomplete 
reporting. While different sensitivity approaches slightly increase or 
decrease the number of reported post-operative visits we would expect 
to see, none results in findings that differ substantially from the 
report's main conclusions that a small share of expected post-operative 
visits for procedures with 10-day global periods, and less than half of 
expected post-operative visits for procedure with 90-day global 
periods, appear to actually occur. RAND will be issuing a report in 
response to each of these methodological concerns later this year. This 
report will also be posted on the CMS website.
    Comment: MedPAC supported CMS' decision to not adopt the RUC's 
recommendation that CMS adjust the work RVUs for postoperative E/M 
visits that are part of surgical codes with 10-day and 90-day global 
periods. MedPAC cited evidence that 10-day and 90-day global surgical 
codes are overvalued. Several other commenters agreed that we should 
not adjust values for the global surgery codes to reflect revised 
values for E/M visits. For example, one commenter stated, ``[W]e 
believe it would be imprudent to adjust the E/M component [of global 
surgery codes] because of any changes to the values of stand-alone 
office/outpatient visit codes 99201-99215 and we support CMS' decision 
in this regard.'' Another commenter expressed support for CMS' 
``efforts to collect this information and ensure an appropriate number 
and type of E/M codes bundled with the 10-day and 90-day globals.''
    Response: We agree that it would be imprudent at this point to 
adjust the values for surgical codes with 10- and 90-day global periods 
to reflect the values for stand-alone E/M visits.
    After considering the comments, we are not making changes in the 
values of global surgery procedures to reflect changes we are making in 
this final rule beginning in CY 2021 to coding and values for stand-
alone E/M services. We anticipate continuing to assess and develop an 
approach to revaluing global surgery procedures, including the 
associated post-operative visits. We appreciate all the comments on the 
three RAND reports and we will study them as we go forward. For the 
specialty societies that expressed concern that our current method does 
not accurately account for the data, we welcome submissions on other 
methods of gathering the data or ways to tabulate the results.
c. Comment Solicitation on Revaluing the Office/Outpatient E/M Visit 
Within TCM, Cognitive Impairment Assessment/Care Planning and Similar 
Services
    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, 
such as transitional care management services (CPT codes 99495, 99496); 
cognitive impairment assessment and care planning (CPT code 99483); 
certain ESRD monthly services (CPT codes 90951 through 90961); the 
Initial Preventive Physical Exam (G0438) and the Annual Wellness Visit 
(G0439). We stated that, in future rulemaking, we may consider 
adjusting the RVUs for these services and we sought public input on 
such a policy. We noted that, unlike the global surgical codes, many 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 valuation commensurate 
with any changes to the values for the revised codes for office/
outpatient E/M visits. While some of these services do not involve an 
included E/M visit, 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.
    We also sought comment on whether or not the public believes it 
would be necessary or beneficial to make systematic adjustments to 
other related PFS services to maintain relativity between these 
services and office/outpatient E/M visits. We were particularly 
interested in whether it would be beneficial or necessary to make 
corresponding adjustments to E/M codes describing visits in other 
settings, such as home visits, or to codes describing more specific 
kinds of visits, like counseling visits. For example, CPT code 99348 
(Home visit for the evaluation and management of an established 
patient, which requires at least 2 of these 3 key components: An 
expanded problem focused interval history; An expanded problem focused 
examination; Medical decision making of low complexity. Counseling and/
or coordination of care with other physicians, other qualified health 
care professionals, or agencies are provided consistent with the nature 
of the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are of low to moderate severity. Typically, 25 
minutes are spent face-to-face with the patient and/or family) is 
commonly used to report home visits, and like CPT code 99214, the code 
describes approximately 45 minutes of time with the patient and has a 
work RVU of 1.56. Under the proposal to increase the work RVU of CPT 
code 99214 from 1.5 to 1.92, the proportional value of CPT code 99348 
would decrease relative to the work RVU for CPT code 99214. To maintain 
the same proportional value to CPT code 99214, the work RVU for CPT 
code 99348 would need to increase from 1.56 to

[[Page 62860]]

2.00. We understand that certain other services, such as those that 
describe ophthalmological examination and evaluation, as well as 
psychotherapy visit codes, are used either in place of or in 
association with office/outpatient visit codes.
    For example, CPT code 92012 (Ophthalmological services: Medical 
examination and evaluation, with initiation or continuation of 
diagnostic and treatment program; intermediate, established patient) 
currently has a work RVU of 0.92. Under the proposal to increase the 
work RVU of CPT code 99213 from 0.97 to 1.30, the proportional value of 
CPT code 92012 would decrease relative to the work RVU for CPT code 
99213, as both codes describe around 30 minutes of work. To maintain 
the same proportional value to CPT code 99213, the work RVU for CPT 
code 92012 would need to increase from 0.92 to 1.23. Similarly, 
behavioral health professionals report several codes to describe 
psychiatric diagnostic evaluations and visits they furnish. When 
furnished with an E/M service, practitioners report psychotherapy add-
on codes instead of stand-alone psychotherapy codes that would 
otherwise be reported. Because the overall work RVUs for the combined 
service, including the value for the office/outpatient visit code, 
would increase under the proposal, we are interested in comments 
regarding whether or not it would be appropriate to reconsider the 
value of the psychotherapy codes, as well as the psychiatric diagnostic 
evaluations relative to the proposed values for the office/outpatient 
visit codes. Under the proposed revaluation of the office/outpatient E/
M visits, the proportional value of CPT code 90834 (Psychotherapy, 45 
minutes with patient) would decrease relative to work RVUs for CPT code 
99214 plus CPT code 90836. The current 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. Under the proposed revaluation of the 
office/outpatient E/M visits, the combined work RVU for CPT codes 99214 
and 90836 would be 3.82 (1.90 + 1.92). To maintain the proportionate 
difference between these services, the work RVU for CPT code 90834 
would increase from 2.00 to 2.25. Based on these three examples, we 
sought public comment on whether we should make similar adjustments to 
E/M codes in different settings, and other types of visits, such as 
counseling services.
    Comment: Many commenters supported some degree of revaluation of 
non-global surgical codes that include one or more bundled office/
outpatient visits (such as TCM and the ESRD MCPs), E/M visits in other 
settings (such as inpatient or home visits), other E/M services (such 
as care planning for patients with cognitive impairment), and/or non-E/
M office visits (such as the ophthalmology visit codes.)
    Some commenters suggested specific revaluations. Commenters 
recommended that CMS revalue the ophthalmological visits to maintain 
relativity with the office/outpatient E/M services. This commenter 
recommended a new RVU of 0.88 for CPT code 92002, an RVU of 2.05 for 
CPT code 92004, and RVU of 1.23 for CPT code 92012, and an RVU of 1.82 
for CPT code 92014. Commenters also suggested a work RVU of 1.60 for 
CPT code 99283, and RVU of 2.74 for CPT code 99284, and an RVU of 4.00 
for CPT code 99285 to maintain relativity between these services and 
the office/outpatient E/M visits.
    Other commenters suggested making a single adjustment to the E/M 
visits in other settings to maintain relativity between these services 
and the revalued office/outpatient E/M visits. Many of these commenters 
also requested that CMS make similar revisions to the code definitions 
and documentation requirements for those services. Commenters also 
supported updating the payment rates for the ESRD MCP codes, noting 
that a similar adjustment had not been made to those codes when the 
office/outpatient E/M visits were revalued in the past.
    Response: We thank commenters for their thorough recommendations 
and look forward to considering these recommendations for future 
rulemaking.

III. Other Provisions of the Proposed Regulations

A. Changes to the Ambulance Physician Certification Statement 
Requirement

    Under our ongoing initiative to identify Medicare regulations that 
are unnecessary, obsolete, or excessively burdensome on health care 
providers and suppliers, we proposed to revise Sec. Sec.  410.40 and 
410.41. Importantly, in the proposed rule (84 FR 40680), we first 
clarified that these requirements apply to ambulance providers, as well 
as suppliers. We stated that the revisions would give certain clarity 
to ambulance providers and suppliers regarding the physician or non-
physician certification statement and add staff who may sign 
certification statements when the ambulance provider or supplier is 
unable to obtain a signed statement from the attending physician.
1. Exceptions to Certification Statement Requirement
    Under section 1861(s)(7) of the Act, ambulance services are covered 
where the use of other methods of transportation is contraindicated by 
the individual's condition, but only to the extent provided in 
regulations. Currently, Sec.  410.40(d) specifies the medical necessity 
requirements for both nonemergency, scheduled, repetitive ambulance 
services and nonemergency ambulance services that are either 
unscheduled or that are scheduled on a non-repetitive basis. In the 
final rule with comment period that appeared in the January 25, 1999 
Federal Register (64 FR 3637) (hereinafter referred to as the ``January 
25, 1999 final rule with comment period''), we stated that a physician 
certification statement (PCS) must be obtained as evidence that the 
attending physician has determined that other means of transportation 
are contraindicated and that the transport is medically necessary (64 
FR 3639). In the final rule with comment period that appeared in the 
February 27, 2002 Federal Register (67 FR 9100) (hereinafter referred 
to as the ``February 27, 2002 final rule with comment period''), we 
added that a certification statement (hereinafter referred to as ``non-
physician certification statement'') could be obtained from other 
authorized staff should the attending physician be unavailable. (67 FR 
9111)
    We stated in the proposed rule (84 FR 40680) that currently there 
are no circumstances, other than those specified at Sec.  
410.40(d)(3)(ii) and (iv), granting exceptions to the need for a PCS or 
non-physician certification statement, and that we have received 
feedback from ambulance providers, suppliers, and their industry 
representatives (``stakeholders'') that various situations exist where 
the need for a PCS or non-physician certification is excessive, or at 
least redundant to similar existing documentation requirements. Two of 
the most prominent circumstances identified by the stakeholders include 
interfacility transports (IFTs), commonly referred to as hospital-to-
hospital transports, and specialty care transports (SCTs), and 
stakeholders have requested that we incorporate additional exceptions 
into the regulatory framework.
    As we discussed in the proposed rule (84 FR 40680 through 40681), 
upon reviewing the need for a PCS and non-physician certification 
statement, stakeholders' concerns, and our commitment to reducing the 
burden placed on providers and suppliers, we have determined that 
instead of

[[Page 62861]]

incorporating additional exceptions, our efforts would be better served 
by minorly altering the structure of the existing regulatory framework. 
We stated in the proposed rule that these changes are intended to 
maximize flexibility for ambulance providers and suppliers to obtain 
the requisite certification statements and maintain the focus on the 
determination that other means of transportation are contraindicated 
and that the transport is medically necessary.
    To accomplish this, we proposed to add a new paragraph (a) in Sec.  
410.40 in which we would define both PCSs, as well as non-physician 
certification statements. Therefore, we proposed to redesignate 
existing paragraph (a) ``Basic rules'' as paragraph (b) and redesignate 
the remaining paragraphs, respectively. Most significantly, paragraph 
(d) ``Medical necessity requirements'' will be redesignated as 
paragraph (e).
    We stated in the proposed rule (84 FR 40681) that for paragraph 
(a), the two definitions, PCSs and non-physician certification 
statements, would clarify that: (1) The focus is on the certification 
of the medical necessity provisions contained in newly redesignated 
paragraph (e)(1); and (2) the form of the certification statement is 
not prescribed, thus affording maximum flexibility to ambulance 
providers and suppliers. We stated that since the two definitions would 
incorporate the requirement to obtain a certification of medical 
necessity, we proposed a conforming change to newly redesignated 
paragraph (e)(2) to remove the language requiring that an order 
certifying medical necessity be obtained.
    As we stated in the proposed rule, we have repeatedly been told by 
stakeholders that there are ample opportunities for ambulance providers 
and suppliers to convey the information required in the certification 
statement. Stakeholders have mentioned, for example, that for 
transports such as IFTs and SCTs other requirements of federal, state, 
or local law require them to obtain other documentation, such as 
Emergency Medical Treatment & Labor Act (EMTALA) forms and medical 
transport forms, that serve the same purpose as the PCS or non-
physician certification statement. There is every likelihood that other 
ambulance transports require similarly styled documentation that 
likewise could serve the same purpose.
    To be clear, our regulations have never prescribed the precise form 
or format of this required documentation. As we discussed in the 
proposed rule, to satisfy the requirements of section 1861(s)(7) of the 
Act, ambulance providers' and suppliers' focus should be on clearly 
documenting the threshold determination that other means of 
transportation are contraindicated and that the transport is medically 
necessary. We stated that the precise form or format by which that 
information is conveyed has never been prescribed. We further stated 
that our aim here is to ensure that ambulance providers and suppliers 
understand they have flexibility in the form by which they convey the 
requirements of proposed Sec.  410.40(e), so long as that threshold 
determination is clearly expressed.
    We stated in the proposed rule that the definition of non-physician 
certification statement in Sec.  410.40(a) would incorporate the 
existing requirements that apply when an ambulance provider or supplier 
is unable to obtain a signed PCS from the attending physician and, 
instead, obtains a non-physician certification statement, including: 
(1) That the staff have personal knowledge of the beneficiary's 
condition at the time the ambulance transport is ordered or the service 
is furnished; (2) the employment-related requirements; and (3) the 
specific staff that can sign in lieu of the attending physician. We 
stated that included within the definition of non-physician 
certification statement, and as further discussed below, is an 
expansion of the list of staff who may sign when the attending 
physician is unavailable. In light of the staff being listed as part of 
the definition of non-physician certification statement at Sec.  
410.40(a), we proposed a corresponding change to proposed and newly 
redesignated paragraph (e)(3)(iii) to remove the reference to the staff 
currently listed within the paragraph. Moreover, in paragraphs 
(e)(3)(i) and (iv), we proposed changes to refer to the newly 
redesignated paragraph (e), and in paragraph (e)(3)(v), we proposed 
changes to refer to the newly defined terms in paragraph (a), 
specifically the physician or non-physician certification statement. 
Lastly, we also proposed a corresponding change to Sec.  410.41(c)(1) 
to add that ambulance providers or suppliers must indicate on the 
claims form that, ``when applicable, a physician certification 
statement or non-physician certification statement is on file.''
    In the CY 2013 PFS final rule with comment period (77 FR 69161), we 
stated that the Secretary is the final arbiter of whether a service is 
medically necessary for Medicare coverage. We stated in the proposed 
rule that we believe that the proposed changes would better enable 
contractors to establish the medical necessity of these transports by 
focusing more on the threshold medical necessity determination as 
opposed to the form or format of the documentation used. We further 
stated that we did not anticipate that this clarification will alter 
the frequency of claim denials.
    In 2018, 68.9 percent of improper payments in non-emergency 
transport was due to insufficient documentation. Although we know the 
ambulance certification statement is a source of documentation error, 
we are unable to determine if clarifying that there is no specific form 
or format for the certification statement will lead to significantly 
fewer denials. Similarly, we are unable to determine whether adding to 
the list of non-physicians that may sign a certification statement will 
lead to significantly fewer denials. The impact primarily will afford 
providers increased flexibility in completing the form. We believe that 
claims denied for technical documentation issues currently are likely 
appealed and overturned in the supplier/provider's favor if the 
ambulance transport was indeed medically necessary. Therefore, although 
we believe the clarifications could result in fewer claims being 
denied, it is unlikely to be a statistically significant change.
2. Addition of Staff Authorized To Sign Non-Physician Certification 
Statements
    In the January 25, 1999 final rule with comment period (64 FR 
3637), we finalized language at Sec.  410.40 to require ambulance 
providers or suppliers, in the case of nonemergency unscheduled 
ambulance services (Sec.  410.40(d)(3)) to obtain a PCS. In that rule, 
we explained that: (1) Nonemergency ambulance service is a Medicare 
service furnished to a beneficiary for whom a physician is responsible, 
therefore, the physician is responsible for the medical necessity 
determination; and (2) the PCS will help to ensure that the claims 
submitted for ambulance services are reasonable and necessary, because 
other methods of transportation are contraindicated (64 FR 3641). We 
further stated that we believed the requirement would help to avoid 
Medicare payment for unnecessary ambulance services that are not 
medically necessary even though they may be desirable to beneficiaries. 
However, in that final rule with comment period, we also addressed the 
ability of ambulance providers or suppliers to obtain a written order 
from the beneficiary's attending physician within 48 hours after the 
transport to avoid unnecessary delays. We agreed with stakeholders that 
while it is

[[Page 62862]]

reasonable to expect that an ambulance supplier could obtain a 
pretransport PCS for routine, scheduled trips, it is less reasonable to 
impose such a requirement on unscheduled transports, and that it was 
not necessary that the ambulance suppliers have the PCS in hand prior 
to furnishing the service. To avoid unnecessary delays for unscheduled 
transports, we finalized the requirement that required documentation 
can be obtained within 48 hours after the ambulance transportation 
service has been furnished.
    In the February 27, 2002 final rule with comment period (67 FR 
9111), we noted that we had been made aware of instances in which 
ambulance suppliers, despite having provided ambulance transports, 
were, through no fault of their own, experiencing difficulty in 
obtaining the necessary PCS within the required 48-hour timeframe. We 
stated that the 48-hour period remained the appropriate period of time, 
but created alternatives for ambulance providers and suppliers unable 
to obtain a PCS. We finalized an alternative at Sec.  410.40(d)(3)(iii) 
where ambulance providers and suppliers unable to obtain a PCS from the 
attending physician could obtain a signed certification (not a 
physician certification statement) from certain other staff. At that 
time, we identified several staff members, including a physician 
assistant (PA), nurse practitioner (NP), clinical nurse specialist 
(CNS), registered nurse (RN), and a discharge planner as staff members 
able to sign such a non-physician certification statement. The only 
additional constraints are: (1) That the staff be employed by the 
beneficiary's attending physician or by the hospital or facility where 
the beneficiary is being treated and from which the beneficiary is 
transported; and (2) that the staff have personal knowledge of the 
beneficiary's condition at the time the ambulance transport is ordered 
or the service is furnished.
    We stated in the proposed rule (84 FR 40682) that in the 
intervening years, we have received feedback from stakeholders that 
other staff, such as licensed practical nurses (LPNs), social workers, 
and case managers, should be included in the list of staff that can 
sign a certification statement. Similar to the currently designated 
staff, we stated that we now believe that LPNs, social workers, and 
case managers who have personal knowledge of a beneficiary's condition 
at the time ambulance transport is ordered and the service is furnished 
have a skill set largely equal or similar to the other staff members. 
Thus, we proposed as part of the new definition of non-physician 
certification statement at Sec.  410.40(a)(2)(iii) to add LPNs, social 
workers, and case managers to the list of staff who may sign a 
certification statement when the ambulance provider or supplier is 
unable to obtain a signed PCS from the attending physician. As with the 
staff currently listed in Sec.  410.40(d)(3)(iii), LPNs, social 
workers, and case managers would need to be employed by the 
beneficiary's attending physician or the hospital or facility where the 
beneficiary is being treated and from which the beneficiary is 
transported, and have personal knowledge of the beneficiary's condition 
at the time the ambulance transport is ordered or the service is 
furnished. We also requested comments on whether other staff should be 
included in this regulation, and requested that commenters identify 
such staff's licensure and position and the reason it would be 
appropriate for such staff to sign a certification statement.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported our changes to the ambulance 
certification requirements, including the addition of licensed 
practical nurses, social workers, and case managers to the list of non-
physician staff who are authorized to sign a certification statement 
when a statement cannot be obtained from the attending physician. One 
commenter noted that CMS should monitor the new provisions closely to 
ensure that enforcement is fair, consistent, and expected and the new 
approach is not abused.
    Response: We agree that the new provisions must be fairly and 
consistently applied. Through our contractors, we will focus on 
ensuring a fair and consistent application of the new requirements so 
that the requirements are not subject to abuse.
    Comment: One commenter recommended that a licensed non-physician 
staff member should be authorized to sign a certification statement for 
all emergency and nonemergency cases and that adding an additional 
layer of bureaucracy does not increase quality, but does increase cost.
    Response: We do not currently require a certification statement for 
emergency ambulance transport, and did not propose to add such a 
requirement for emergency ambulance transport as it would, among other 
things, increase documentation burden and costs. We continue to believe 
that requiring a certification statement for non-emergency ambulance 
transports is necessary. Of note, the certification assists our efforts 
in combating fraud, waste and abuse.
    Comment: One commenter supported the ``proposal to eliminate the 
PCS as a requirement for hospital-to-hospital transports,'' and 
requested confirmation that CMS will not burden ambulance service 
providers and suppliers with having to obtain the other documents, for 
example, transfer forms and/or EMTALA forms, that can be used in lieu 
of the PCS and to clarify that if a PCS is not required for 
interfacility transports, then ambulance service providers and 
suppliers will not be required to obtain a certificate of mailing (or 
proof of mailing).
    Response: To be clear, we did not propose the elimination of the 
PCS as a requirement for hospital-to-hospital transports. Rather, we 
clarified that the precise form or format of the certification 
statement is not prescribed, thus increasing ambulance suppliers' and 
providers' flexibility to comply with the certification statement 
requirements. Also, the steps we have taken to clarify the regulations 
do not obviate a provider's or supplier's responsibility to submit 
required documentation upon request to Medicare review contractors, 
which may request documentation from the supplier or provider to 
evaluate eligibility, coverage, medical necessity, and other 
reimbursement-related factors.
    Comment: One commenter questioned if CMS would consider the 
completion of a non-physician certification statement by nursing staff 
in the emergency department as compliant with the regulatory 
requirements, if the treating physician is unavailable due to treatment 
of another patient in the Emergency Department.
    Response: The scope of this rule is to clarify the requirements 
associated with the form and content of the physician certification 
statement and the non-physician certification statement along with 
adding additional staff members who may, under the appropriate 
circumstances, sign a non-physician certification statement. Although 
this scenario could be acceptable should the criteria set forth in the 
regulations be met, specific fact-based scenarios should be discussed 
with the appropriate Medicare Administrative Contractor.
    Comment: One commenter recommended CMS make additional changes, 
including modernizing and streamlining the 855B Ambulance Enrollment 
form, eliminating the duplicative requirements for patient

[[Page 62863]]

signatures, and modernizing the revocation process for suppliers' and 
providers' ability to bill Medicare.
    Response: These recommendations are outside the scope of the 
proposed changes.
    Comment: One commenter noted that the changes will do very little 
to lessen the unnecessary burden that the PCS requirement imposes on 
ambulance providers and suppliers every day and that CMS, instead, 
should ``eliminate this useless exercise in chasing paper'' and alleged 
that the PCS carries ``no weight.'' This same commenter recommended 
that CMS add several additional staff members who can sign the non-
physician certification statement, including licensed vocational nurses 
(LVNs), advanced practice registered nurses (APRNs), paramedics not 
functioning as an employee of the ambulance provider or supplier 
furnishing the ambulance services for which payment is claimed, 
physical therapists, occupational therapists, psychiatrists and 
psychologists.
    Response: Although we understand the commenter's concern regarding 
burden, we disagree that the certification statements are a useless 
exercise or that they carry no weight. We specifically noted within the 
proposed rule that the changes were intended to maximize flexibility 
for ambulance providers and suppliers to obtain the requisite 
certification statements and maintain the focus on the determination 
that other means of transportation are contraindicated and that the 
transport is medically necessary. We believe the clarifications are in 
line with our intended outcome and the certification statements serve 
an important role in preventing and combating fraud, waste and abuse. 
The clarifications to the certification statement requirements will, in 
fact, reduce burden by clearly conveying that redundant certification 
statements need not be submitted and as a result of other non-physician 
staff members being authorized to sign non-physician certification 
statements. Moreover, while we appreciate the information regarding 
other staff members who could sign a non-physician certification, we 
are not adding additional staff members at this time. Of note, 
psychiatrists, as physicians are already included as staff who can sign 
the physician certification statement. For the remaining suggested 
positions, we appreciate the suggestions regarding additional staff who 
could sign the non-physician certification and will consider the 
suggestions in future rulemaking.
    Comment: One commenter suggested CMS correct what the commenter 
believed is an inaccurate statement regarding the prior existence or 
use of the term ``non-physician certification statement in that CMS had 
not previously used that term. The same commenter also recommended 
several other modifications to promote consistency and readability 
within the regulations, including: (1) Deleting superfluous language in 
Sec.  410.40(e)(3)(i) related to the certifying of medical necessity 
since the phrase is already included as part of the newly proposed 
definition of PCS in paragraph (a); (2) that CMS should change the 
words ``procedure codes'' to ``modifiers'' in proposed Sec.  
410.41(c)(1) as the term ``modifiers'' more accurately refers to origin 
and destination indicators; and (3) that CMS add references to both 
suppliers and providers in Sec.  410.41(c) and (c)(2), that refer to 
both physician certification statements and non-physician certification 
statements in (c)(1) and change the word ``or'' to ``a'' in newly 
proposed Sec.  410.40(e)(3)(iii) preceding the phrase ``non-physician 
certification statements must be obtained.''
    Response: We appreciate the commenter's observation that we did not 
previously use the term ``non-physician certification statement,'' but 
we merely used the term to facilitate our efforts to more clearly 
convey the distinction we are attempting to account for within the 
regulations, namely that a certification statement can--in certain 
limited circumstances--be signed by a staff member who is not a 
physician. We believe that use of the term non-physician certification 
statement is particularly relevant since we are adding even more 
positions to the list of personnel who can sign these statements. We 
believe that the clarified terminology allows better process 
accountability so a physician's signature is not mistaken with other 
personnel only sometimes eligible to sign, which should aid in 
combatting potential fraud and abuse. Additionally, with regard to (1) 
deleting superfluous language in Sec.  410.40(e)(3)(i) related to the 
certifying of medical necessity since the phrase is already included as 
part of the newly proposed definition of PCS in paragraph (a), we agree 
this language is no longer necessary in light of the definition and are 
deleting it. Regarding item (2) that we should change the words 
``procedure codes'' to ``modifiers'' in proposed Sec.  410.41(c)(1) as 
the term ``modifiers'' more accurately refers to origin and destination 
indicators, we appreciate the commenter's suggestion and may propose 
alternative language to address this in future rulemaking. Finally, we 
agree and are implementing the recommendations in (3) that we add 
references to both suppliers and providers in Sec.  410.41(c) and 
(c)(2) and noted an additional need for reference to both in Sec.  
410.40(e)(3)(iv), refer to both the physician certification statement 
and non-physician certification statement in Sec.  410.41(c)(1), and 
change the word ``or'' to ``a'' in newly proposed Sec.  
410.40(e)(3)(iii) preceding the phrase ``non-physician certification 
statements must be obtained.''
    After consideration of the comments received, for the reasons set 
forth in the proposed rule and in this final rule, we are finalizing 
our proposed revisions to Sec. Sec.  410.40 and 410.41 with the 
modifications discussed above. In addition, we are making conforming/
technical changes to update cross-references in Sec. Sec.  409.27 and 
414.605, as necessitated by the redesignation of paragraphs in Sec.  
410.40.

B. Establishment of a Medicare Ground Ambulance Data Collection System

1. Background
    Section 1861(s)(7) of the Act establishes an ambulance service as a 
Medicare Part B service where the use of other methods of 
transportation is contraindicated by the individual's condition, but 
only to the extent provided in regulations. Since April 1, 2002, 
payment for ambulance services has been made under the ambulance fee 
schedule (AFS), which the Secretary established under section 1834(l) 
of the Act. Payment for an ambulance service is made at the lesser of 
the actual billed amount or the AFS amount, which consists of a base 
rate for the level of service, a separate payment for mileage to the 
nearest appropriate facility, a GAF, and other applicable adjustment 
factors as set forth at section 1834(l) of the Act and Sec.  414.610 of 
the regulations. In accordance with section 1834(l)(3) of the Act and 
Sec.  414.610(f), the AFS rates are adjusted annually based on an 
inflation factor. The AFS also incorporates two permanent add-on 
payments and three temporary add-on payments to the base rate and/or 
mileage rate. The two permanent add-on payments are: (1) A 50 percent 
increase in the standard mileage rate for ground ambulance transports 
that originate in rural areas where the travel distance is between 1 
and 17 miles; and (2) a 50 percent increase to both the base and 
mileage rate for rural air ambulance transports. The three temporary 
add-on payments are: (1) A 3 percent increase to the base and mileage 
rate for ground ambulance transports that originate in rural areas; (2) 
a 2 percent increase to

[[Page 62864]]

the base and mileage rate for ground ambulance transports that 
originate in urban areas; and (3) a 22.6 percent increase in the base 
rate for ground ambulance transports that originate in ``super rural'' 
areas. Our regulations relating to coverage of and payment for 
ambulance services are set forth at 42 CFR part 410, subpart B, and 42 
CFR part 414, subpart H.
2. Statutory Requirement for Ground Ambulance Providers and Suppliers 
To Submit Cost and Other Information
    Section 50203(b) of the BBA of 2018 added a new paragraph (17) to 
section 1834(l) of the Act, which requires ground ambulance providers 
of services and suppliers to submit cost and other information. 
Specifically, section 1834(l)(17)(A) of the Act requires the Secretary 
to develop a data collection system (which may include use of a cost 
survey) to collect cost, revenue, utilization, and other information 
determined appropriate by the Secretary for providers and suppliers of 
ground ambulance services. Such system must be designed to collect 
information: (1) Needed to evaluate the extent to which reported costs 
relate to payment rates under the AFS; (2) on the utilization of 
capital equipment and ambulance capacity, including information 
consistent with the type of information described in section 1121(a) of 
the Act; and (3) on different types of ground ambulance services 
furnished in different geographic locations, including rural areas and 
low population density areas described in section 1834(l)(12) of the 
Act (super rural areas).
    Section 1834(l)(17)(B)(i) of the Act requires the Secretary to 
specify the data collection system by December 31, 2019, and to 
identify the ground ambulance providers and suppliers that would be 
required to submit information under the data collection system, 
including the representative sample defined at clause (ii).
    Under section 1834(l)(17)(B)(ii) of the Act, not later than 
December 31, 2019, for the data collection for the first year and for 
each subsequent year through 2024, the Secretary must determine a 
representative sample to submit information under the data collection 
system. The sample must be representative of different types of ground 
ambulance providers and suppliers (such as those providers and 
suppliers that are part of an emergency service or part of a government 
organization) and the geographic locations in which ground ambulance 
services are furnished (such as urban, rural, and low population 
density areas), and not include an individual ground ambulance provider 
or supplier in the sample for 2 consecutive years, to the extent 
practicable.
    Section 1834(l)(17)(C) of the Act requires that for each year, a 
ground ambulance provider or supplier identified by the Secretary in 
the representative sample as being required to submit information under 
the data collection system for a period for the year must submit to the 
Secretary the information specified under the system in a form and 
manner, and at a time specified by the Secretary.
    Section 1834(l)(17)(D) of the Act requires that beginning January 
1, 2022, the Secretary apply a 10 percent payment reduction to payments 
made under section 1834(l) of the Act for the applicable period to a 
ground ambulance provider or supplier that is required to submit 
information under the data collection system and does not sufficiently 
submit such information. The term ``applicable period'' is defined 
under section 1834(l)(17)(D)(ii) of the Act to mean, for a ground 
ambulance provider or supplier, a year specified by the Secretary not 
more than 2 years after the end of the period for which the Secretary 
has made a determination that the ground ambulance provider or supplier 
has failed to sufficiently submit information under the data collection 
system. A hardship exemption to the payment reduction is authorized 
under section 1834(l)(17)(D)(iii) of the Act, which provides that the 
Secretary may exempt a ground ambulance provider or supplier from the 
payment reduction for an applicable period in the event of significant 
hardship, such as a natural disaster, bankruptcy, or other similar 
situation that the Secretary determines interfered with the ability of 
the ground ambulance provider or supplier to submit such information in 
a timely manner for the specified period. Lastly, section 
1834(l)(17)(D)(iv) of the Act requires the Secretary to establish an 
informal review process under which a ground ambulance provider or 
supplier may seek an informal review of a determination that the 
provider or supplier is subject to the payment reduction.
    Section 1834(l)(17)(E)(i) of the Act allows the Secretary to revise 
the data collection system as appropriate and, if available, taking 
into consideration the report (or reports) that the Medicare Payment 
Advisory Commission (MedPAC) will submit to Congress. Section 
1834(l)(17)(E)(ii) of the Act specifies that, to continue to evaluate 
the extent to which reported costs relate to payment rates under 
section 1834(l) of the Act and other purposes as the Secretary deems 
appropriate, the Secretary shall require ground ambulance providers and 
suppliers to submit information for years after 2024, but in no case 
less often than once every 3 years, as determined appropriate by the 
Secretary.
    As required by section 1834(l)(17)(F) of the Act, not later than 
March 15, 2023, and as determined necessary by MedPAC, MedPAC must 
assess, and submit to Congress a report on, information submitted by 
providers and suppliers of ground ambulance services through the data 
collection system, the adequacy of payments for ground ambulance 
services and geographic variations in the cost of furnishing such 
services. The report must contain the following:
     An analysis of information submitted through the data 
collection system;
     An analysis of any burden on ground ambulance providers 
and suppliers associated with the data collection system;
     A recommendation as to whether information should continue 
to be submitted through such data collection system or if such system 
should be revised by the Secretary, as provided under section 
1834(l)(17)(E)(i) of the Act; and
     Other information determined appropriate by MedPAC.
    Section 1834(l)(17)(G) of the Act requires the Secretary to post 
information on the results of the data collection on the CMS website, 
as determined appropriate by the Secretary.
    Section 1834(l)(17)(H) of the Act requires the Secretary to 
implement the provisions of section 1834(l)(17) of the Act through 
notice and comment rulemaking.
    Section 1834(l)(17)(I) of the Act provides that the Paperwork 
Reduction Act (Title 44, Chapter 35 of the U.S. Code) does not apply to 
collection of information required under section 1834(l)(17) of the 
Act.
    Section 1834(l)(17)(J) of the Act provides that there shall be no 
administrative or judicial review under sections 1869 or 1878 of the 
Act, or otherwise, of the data collection system or identification of 
respondents.
    We note that while the requirements of section 1834(l)(17) of the 
Act are specific to ground ambulance organizations, many stakeholders 
have expressed interest to us in making this type of information 
available for other providers and suppliers of ambulance services. For 
example, air ambulance organizations have suggested they are interested 
in making this information available. We recognize that the

[[Page 62865]]

regulation of air ambulances spans multiple federal agencies, and note 
that section 418 of the FAA Reauthorization Act of 2018 (Pub. L. 115-
254, enacted October 5, 2018) requires the Secretary of Transportation, 
in consultation with the Secretary of HHS, to establish an advisory 
committee that includes HHS; DOT; insurance regulators; patient and 
consumer advocacy groups; physicians specializing in emergency, trauma, 
cardiac, or stroke; various segments of the air ambulance industry; and 
others. This committee will review options to improve the disclosure of 
charges and fees for air medical services, better inform consumers of 
insurance options for those services, and better inform and protect 
consumers of these services. We welcomed comments on the state of the 
air ambulance industry and how CMS can work within its statutory 
authority to ensure that appropriate payments are made to air ambulance 
organizations serving the Medicare population.
    We received 58 public comments on our proposals to establish a 
ground ambulance data collection system, including 11 public comments 
on air ambulance payments from air ambulance organizations, air and 
ground ambulance organizations, an international trade association that 
represents providers of emergency air medical services and critical 
care ground medical transport services, an insurance company and a 
national heart association. The following is a summary of the comments 
we received and our response.
    Comments: Many commenters stated that they appreciate that CMS 
proposed to establish a data collection system for ground ambulance 
providers and suppliers, but noted that ground ambulance transportation 
is only a part of the overall emergency medical services ecosystem. 
Some commenters described the vital role of air medical services in 
providing timely critical care responses to high-acuity life-or- death 
incidents, and stated that air medical service providers and suppliers 
are the critical link to tertiary care in severe medical emergencies.
    Several commenters stated that the current payment rates for air 
ambulance services are inadequate and that, except for the annual 
ambulance inflation factor (AIF), CMS has not adjusted the AFS since it 
was established in 2002. They stated that prior to 2006, CMS had 
exercised its authority to make periodic adjustments to the AFS based 
on the actual costs of providing air medical transportation, and that 
Medicare payments have failed to keep pace with costs of providing air 
medical services. One commenter stated that ensuring that Medicare 
beneficiaries continue to have access to air medical transportation 
when they need it the most should be a priority for the Medicare 
program, and another commenter suggested that the Medical or 
Transportation Consumer Price Index (CPI) should be used to update air 
ambulance payments. Other commenters noted that the Medicare payment 
rate has an impact on Medicaid payment rates, as well as payment rates 
from private payors. Commenters described the various factors that are 
increasing the cost of providing air medical services, particularly in 
rural areas.
    According to several commenters, air ambulance providers and 
suppliers have access to detailed cost information and are willing to 
share this information with CMS. Several stated that there is an 
existing study entitled ``Air Medical Services Cost Study Report'' 
(March 24, 2017; Xcenda) that provides accurate information on the 
costs of providing air ambulance services, and that this study could be 
used to determine appropriate payment for air ambulance providers and 
suppliers under the Medicare program.
    Some commenters encouraged CMS to continue to explore ways to 
collect the same cost, revenue, and utilization data from air ambulance 
providers and suppliers that it has proposed to collect from ground 
ambulance providers and suppliers. Some commenters stated that ground 
and air ambulance services are increasingly contributing to growing 
healthcare expenditures and that they appreciate CMS' efforts to better 
understand the associated services and costs.
    Several commenters urged CMS to exercise its existing authority to 
develop, with stakeholder input, a data collection process that would 
provide CMS with current cost data that could be used to rebase the 
AFS. The commenters also stated that this would result in more adequate 
Medicare payment rates for air ambulance services, and that this would 
also address inadequate payment from commercial insurers.
    Response: We agree that it is essential that Medicare beneficiaries 
have adequate access to ambulance services, especially in rural areas, 
and we appreciate the comments regarding the adequacy of the Medicare 
air ambulance rates and the suggestions regarding updating those rates. 
We note that section 1834(l)(17) of the Act, which is the authority for 
establishing a ground ambulance services data collection system, 
applies only to providers and suppliers of ground ambulance services. 
Accordingly, we do not have the statutory authority to implement a data 
collection system for air ambulance services at this time.
3. Research To Inform the Development of a Ground Ambulance Data 
Collection System
    To inform the development of a ground ambulance data collection 
system, including a representative sampling plan, our contractor 
developed recommendations regarding the methodology for collecting 
cost, revenue, utilization and other information from ground ambulance 
providers and suppliers (also collectively referred to in this final 
rule as ``ground ambulance organizations'') and a sampling plan 
consistent with sections 1834(l)(17)(A) and (B) of the Act. Our 
contractor also developed recommendations for the collection and 
reporting of data with the least amount of burden possible to ground 
ambulance organizations. The recommendations took into consideration 
the following:
     An environmental scan consisting of a review of existing 
peer-reviewed literature, government and association reports, and 
targeted web searches. The purpose of the environmental scan was to 
collect information on costs and revenues of ground ambulance 
transportation services, identify background information regarding the 
differences among ground ambulance organizations including state and 
local requirements that may impact the costs of providing ambulance 
services, and describe financial challenges facing the ambulance 
industry. Five previously fielded ambulance cost collection tools were 
also identified and analyzed and are described below.
     Interviews with ambulance providers and suppliers, billing 
companies, and other stakeholders to determine all major cost, revenue, 
and utilization components, and differences in these components across 
ground ambulance organizations. These discussions provided valuable 
information on the process for developing a data collection system, 
including how to best elicit valid responses and limit burden on 
respondents, as well as the timing of the data collection.
     Analyses of Medicare claims and enrollment data, including 
all fee-for-service (FFS) Medicare claims with dates of service in 
2016, the most recent complete year of claims data for ground ambulance 
services.
    Our contractor also analyzed the following five data collection 
tools that currently collect or have collected data from ground 
ambulance organizations:

[[Page 62866]]

     The Moran Company Statistical and Financial Data Survey 
(the ``Moran survey'').\88\ In 2012, American Ambulance Association 
(AAA) commissioned a study with the goal of developing a data 
collection tool and making recommendations for collecting data to 
determine the costs of delivering ground ambulance services to Medicare 
beneficiaries. The result was the Moran survey, which is a two-step 
data collection method in which all ambulance providers and suppliers 
first complete a short survey with basic descriptive information on 
their characteristics, and second, a representative sample of ambulance 
providers and suppliers report more specific cost information.
---------------------------------------------------------------------------

    \88\ The Moran Company (2014). Detailing ``Hybrid Data 
Collection Method'' for the Ambulance Industry: Beta Test Results of 
the Statistical & Financial Data Survey & Recommendations, [Online]. 
Available at https://s3.amazonaws.com/americanambulance-advocacy/AAA+Final+Report+Detailing+Hybrid+Data+Collection+Method.pdf.
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     Ground Emergency Medical Transportation (GEMT) Cost Report 
form and instructions from California's Medicaid program.\89\ The GEMT 
Cost Report form and instructions is used by some states to determine 
whether ambulance providers and suppliers should receive supplemental 
payments from state Medicaid programs to cover shortfalls between 
revenue and costs. This data collection tool is geared toward 
government entities, as private ambulance providers and suppliers do 
not qualify for the supplemental payments.
---------------------------------------------------------------------------

    \89\ State of California--Health and Human Services Agency 
Department of Health Care Services Ground Emergency Medical 
Transportation (2013). Ground Emergency Medical Transportation 
Services Cost Report General Instructions for Completing Cost Report 
Forms, [Online]. Available at http://www.dhcs.ca.gov/provgovpart/documents/gemt/gemt_cstrptinstr.pdf.
---------------------------------------------------------------------------

     The Emergency Medical Services Cost Analysis Project 
(EMSCAP) framework.\90\ The National Highway Traffic Safety 
Administration funded EMSCAP in 2007 to develop a framework for 
determining the cost for an EMS system at the community level. 
Subsequently, EMSCAP researchers used this framework to develop a cost 
workbook and pilot test the tool on three communities representing 
rural, urban, and suburban areas. EMS services within the three 
communities included volunteer, paid, and combination EMS agencies, 
both fire department and third service-based. Third service-based 
refers to services provided by a local government that include a fire 
department, police department and a separate EMS, forming an emergency 
trio.
---------------------------------------------------------------------------

    \90\ Lerner, E.B., Nichol, G., Spaite, D.W., Garrison, H.G., & 
Maio, R.F. (2007). A comprehensive framework for determining the 
cost of an emergency medical services system. Available at https://www.mcw.edu/departments/emergency-medicine/research/emergency-medical-services-cost-analysis-project.
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     A 2012 Government Accountability Office (GAO) ambulance 
survey.\91\ To examine ground ambulance suppliers' costs for 
transports, in 2012 GAO administered a web-based survey to a random 
sample of 294 eligible ambulance suppliers. GAO collected data on their 
2010 costs, revenues, transports, and organizational characteristics. 
Although the GAO survey collected data for each domain at the summary 
level, it also prompted respondents to take into account multiple 
factors when calculating their summary costs.
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    \91\ U.S. Government Accountability Office (2012). Survey of 
Ambulance Services. Available at https://www.gao.gov/assets/650/649018.pdf.
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     The Rural Ambulance Service Budget Model.\92\ This tool 
was developed by a task force of the Rural EMS and Trauma Technical 
Assistance Center with funds from the Health Resources and Services 
Administration (HRSA) in the early 2000s. The purpose was to provide 
assistance to rural ambulance entities in establishing an annual budget 
and to calculate the value of services donated by other entities, as 
well as services donated by the ambulance entity's staff to the 
community. The tool was last updated in 2010 and has been cited as a 
resource for rural ground ambulance organizations by state and national 
government agencies. However, use of the tool is not required by any of 
these agencies.
---------------------------------------------------------------------------

    \92\ Health Resources and Services Administration. The Rural 
Ambulance Service Budget Model, [Online]. Available at https://www.ruralcenter.org/resource-library/rural-ambulance-service-budget-model.
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    As discussed in the proposed rule, our contractor's analysis of 
these tools revealed that while there was overlap of the broad cost 
categories collected (for example, labor, vehicles, and facilities 
costs) via these tools, there were significant differences in the more 
specific data collected within these broad categories. Overall, there 
was a large amount of variability regarding whether the tools allowed 
for detailed accounting of costs and whether the tools used respondent-
defined or survey-defined categories for reporting. The five tools also 
differed in terms of their instructions, format, and design in terms of 
how a portion of organizations' total costs were allocated to ground 
ambulance costs, the timeframe for reporting, and the flexibility of 
reporting.
    Based on these activities, our contractor prepared a report 
entitled, ``Medicare Ground Ambulance Data Collection System--Sampling 
and Data Collection Instrument Considerations and Recommendations'' 
(referred to as ``the CAMH \93\ report'') which is referenced 
throughout this final rule. It is available at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html and provides more 
detail on the research, findings and recommendations concerning the 
data collection instrument and sampling.
---------------------------------------------------------------------------

    \93\ CMS Alliance to Modernize Healthcare.
---------------------------------------------------------------------------

    We received comments on our research, including testing, to inform 
the data collection system. The following is a summary of the comments 
we received and our responses.
    Comment: While commenters were generally very supportive of the 
proposed data collection system, several commenters stated that testing 
is a critical step in the development of any survey and they were 
disappointed that we did not test the data collection instrument and 
sampling methodology prior to making our proposals. To address these 
concerns, the commenters recommended that CMS assess the quality and 
consistency of submitted data throughout the first year of data 
reporting, and consider revisions to the data collection instrument 
either during or after the first year of data collection to address any 
issues that are identified. They also asked that CMS work with 
stakeholders to provide any needed clarifications for subsequent 
collection years and make any adjustments necessary to assure that a 
statistically appropriate representative sample is obtained. A 
commenter recommended that CMS not wait for rulemaking cycles to 
clarify definitions or make other minor changes to the system, and that 
doing so would slow down the process and make the first years of data 
less useful. Many commenters urged CMS to provide substantial education 
to ground ambulance organizations and develop definitions and 
instruction manuals to ensure that accurate and usable data is obtained 
from all types of services as quickly as possible.
    Response: While the data collection system and instrument was not 
widely tested prior to making our proposals, we conducted an extensive 
environmental scan as described above, consulted with as many 
stakeholders as possible throughout the tight timeframe between when 
the law was enacted and the statutory deadline for specifying the data 
collection system. This included meeting with all the major 
associations representing ground ambulance

[[Page 62867]]

providers and suppliers, and conducting interviews with randomly 
selected ground ambulance organizations as described in our 
contractor's report. Given the extensive effort that has gone into 
preparing the data collection instrument and sampling plan, as well as 
the overall positive feedback we received from commenters to the 
proposed rule, we believe the data collection instrument and sampling 
plan will achieve the requirements of the statute. We also plan to 
conduct extensive stakeholder outreach and develop educational 
materials to help respondents report accurate information, and will 
make revisions to the data collection instrument and sampling plan as 
expeditiously as possible to address any issues that are identified.
4. Final Policies for the Data Collection Instrument
a. Format
    In the proposed rule, we discussed several options we considered 
for collecting the data including a survey, a cost report spreadsheet 
similar to the GEMT, and the Medicare Cost Report (MCR). During 
interviews with ambulance providers and suppliers, some participants 
stated that they would prefer that data collection be done through a 
cost report spreadsheet, rather than a survey, such as the GEMT and 
other similar data collection tools utilized by state Medicaid 
programs. They noted that data cost collection spreadsheets such as the 
GEMT are used in some states where supplemental payments are made to 
ground ambulance organizations based on costs and revenue reported via 
a cost reporting template. Although these tools are valuable to the 
ambulance suppliers that utilize them for Medicaid payment purposes, we 
noted that only a small number of states make use of these tools for 
the purpose of providing supplemental payments and that they are 
generally geared toward government run entities that provide a broad 
range of emergency medical services and not just ground ambulance 
services. We stated that for these reasons, we did not believe that 
these tools could be used by all ground ambulance organizations for 
Medicare payment purposes without significant revision.
    During stakeholder outreach, other ambulance providers and 
suppliers stated their preference for survey-based reporting such as 
the Moran survey, because they believe survey reporting is less 
burdensome and allows more flexibility for reporting. We agreed that 
survey reporting can be designed to provide greater flexibility of 
reporting with reduced reporting burden. However, the Moran survey 
recommended excluding small ground ambulance organizations with limited 
capacity or those which relied heavily on volunteer services, which we 
stated would exclude a large percentage of ground ambulance 
organizations from our sample, would not take into account the unique 
differences of government run ground ambulance entities, and could not 
be used by all ground ambulance organizations without significant 
revisions. Some ambulance organizations that favored using the Moran 
survey also recommended using cost reporting guidelines that are 
similar to the CMS requirements for the MCR. In the proposed rule, we 
stated that although we agree that standardization is important for 
data analysis, many smaller ground ambulance organizations have stated 
they would have difficulty complying with complex cost reporting 
guidelines. We stated that we believed that requiring ground ambulance 
organizations to complete and submit an MCR for the purpose of the data 
collection required in section 1834(l)(17) of the Act would be 
unnecessarily resource intensive and burdensome.
    In the proposed rule, we also considered using multiple instruments 
or staged data collection as recommended in the Moran Report, where we 
would first collect organizational characteristic data from all ground 
ambulance organizations, use that information for sampling purposes, 
and then collect cost and revenue information from a sample of 
ambulance providers and suppliers. Using this approach, we stated we 
would need 100 percent participation from all ground ambulance 
organizations in reporting the organizational characteristic data in 
order for the data to be used for sampling purposes. We did not propose 
this approach because we believed multiple data collections would 
increase respondent burden and may not align with sections 
1834(l)(17)(A) and (B) of the Act which requires CMS to collect data 
from a random sample and prohibits data collection from the same ground 
ambulance organizations in 2 consecutive years to the extent 
practicable.
    In the proposed rule, we stated that we did not believe that any of 
the existing or previously used data collection instruments described 
above would be sufficient to adequately capture the data required by 
section 1834(l) of the Act. Therefore, we proposed to collect ground 
ambulance organization data using a survey that we developed 
specifically for this purpose, referred to as the data collection 
instrument, via a secure web-based system. We stated that we believed 
that the data collection instrument should be usable by all ground 
ambulance organizations, regardless of their size, scope of operations 
and services offered, and structure and proposed that the data 
collection instrument include screening questions and skip patterns 
that direct ground ambulance organizations to only view and respond to 
questions that apply to their specific type of organization. We stated 
that we also believed that the data collection instrument we proposed 
is easier to navigate and less time consuming to complete than a cost 
report spreadsheet. We also stated that the secure web-based survey 
would be available before the start of the first data reporting period 
to allow time for users to register, receive their secure login 
information, and receive training from CMS on how to use the system. 
Finally, we proposed to codify these policies at Sec.  414.626.
    We received comments on the format of the data collection 
instrument. The following is a summary of the comments we received and 
our responses.
    Comment: Many commenters stated that they support our proposal to 
collect ground ambulance data using a survey developed specifically for 
this purpose and not use existing GEMT workbooks or Medicaid cost 
reports because they do not believe that either would provide the 
necessary information for CMS and MedPAC to use when addressing the 
questions that Congress set forth in the statute. They also expressed 
support for our approach to the development of a web-enabled data 
collection system and the principles that guided the development of the 
data collection instrument. In particular, they noted our goal of 
developing a system that will balance respondent burden against the 
need to collect the data required by the statute, provide flexibility 
to collect data from diverse ambulance organizations, and enable the 
calculation of per-transport costs for comparison to Medicare payment 
rates. They encouraged us to collect the data in a manner that allows 
for as much analysis as possible, such as the comparison of per- 
transport costs across subgroups of ambulance organizations, and 
analyses estimating the marginal cost of a particular type of 
transport. These commenters stated that they believe the proposed data 
collection system and draft Medicare ground ambulance data collection 
instrument provide a solid foundation for future evaluation.
    Some commenters stated that while they would have preferred a 
spreadsheet

[[Page 62868]]

for the data collection instrument, they agree that the proposed web-
based survey with skip logic and other embedded tools to help ground 
ambulance organizations navigate the data collection instrument will be 
helpful. They asked that CMS consider ways that web-based tools can 
leverage the technology to provide additional clarity around the data 
submission. For example, they stated that it may be useful to include 
standardized definitions or address common questions by incorporating 
links to specific questions to the terms/answers and to have 
definitions or allocation rules ``pop-up'' on the screen when a user 
starts a new question. One commenter requested that the data collection 
system allow enough time for the respondent to complete the 
information, to save partially completed data, and easily come back to 
where they left off to edit or continue entering the data. Commenters 
stated that they would welcome the chance to walk through the data 
collection system, as well as the data collection instrument once it is 
coded and share ideas about how the web-based nature of it can be 
refined. They would also like to work with CMS to find ways that may 
allow for easier data entry, including auto-population of certain 
fields and an application programming interface (API) import method 
from commonly used accounting software.
    While nearly all commenters expressed support for the proposed 
format of the data collection instrument, some commenters were 
concerned that due to the complexity of the data collection instrument, 
the response rate will be low and that the submitted data may be 
inaccurate, particularly for smaller ground ambulance organizations. 
One commenter recommended that low-volume ambulance organizations (for 
example, those providing 600 or fewer all-payer ground transports per 
year) should only be required to complete a much shorter version of the 
proposed data collection instrument in order to increase the response 
rate. This commenter suggested that for low-volume ambulance 
organizations, only the minimum information needed to calculate the 
organization's cost per transport, such as the organization's total 
annual budget, total number and type of transports regardless of payer, 
average number of miles per transport, type of organization, non-profit 
vs. for-profit status, use of shared space, and percent of labor hours 
from volunteers, should be collected.
    Response: We thank the commenters for the overwhelming support of 
the proposed format of the data collection instrument and will 
implement many of the suggestions commenters provided to ensure the 
data collection system is user friendly and provides as many avenues 
for analysis as possible.
    We understand the concern that upon first glance, the data 
collection instrument may appear complex, as well as the concern that 
it may suffer from a low response rate. However, we expect that 
ambulance organizations will find that the use of screening questions 
and skip patterns that direct them to only view and respond to 
questions that apply to their specific type of organization will be 
easier to navigate and less time consuming to complete than a cost 
report spreadsheet. We believe that the data collection instrument will 
be usable by all ground ambulance organizations regardless of their 
size or other characteristics, and do not believe it is necessary or 
beneficial to have a limited data collection instrument for low-volume 
ambulance organizations to complete. Our belief is that all ground 
ambulance organizations that are chosen to participate in the sample 
will work with CMS and their ambulance associations to receive the 
assistance they need to report the data required, not just because they 
will receive a 10 percent payment reduction for failure to report the 
data, but also because they believe their data is important so that 
those analyzing the data can accurately assess whether or not Medicare 
payment rates are adequate. We specifically designed the data 
collection instrument to leave as many doors open as possible for data 
analysis while also considering the burden associated with every 
question.
    Comment: Some commenters expressed concern that information on key 
organizational characteristics (such as organization type and use of 
volunteer labor) are being collected as part of this data collection 
effort, rather than in a separate data collection process that would 
occur before the collection of cost and revenue data. They stated this 
two-stage approach to data collection is needed to stratify the sample 
and ensure a representative sample.
    Response: We recognize the desire that many commenters shared to 
have all of the organizational characteristic data prior to selecting 
samples to ensure that CMS has what commenters believe would be a 
complete set of data to use to stratify the sample. As stated in the 
proposed rule, we believe that Medicare claims and enrollment data 
provide CMS with enough data to appropriately stratify the sample. We 
also continue to believe that multiple data collections would increase 
respondent burden and that the commenters' suggestion to collect data 
from all ground ambulance organizations in the first data collection 
and then select a random sample to collect data from some ground 
ambulance organizations in that same year or the year after may not 
align with sections 1834(l)(17)(B) of the Act, which requires CMS to 
collect data from a random sample and prohibits data collection from 
the same ground ambulance organizations in 2 consecutive years, to the 
extent practicable. Furthermore, we believe that collecting data on 
organizational characteristics as part of one data collection effort 
will enable skip patterns within the survey to limit the number of 
questions organizations with certain characteristics will need to 
answer.
    After consideration of the comments, we are finalizing our proposal 
to collect ground ambulance organization data using a single survey-
based data collection instrument delivered via a secure web-based 
system. We made a few technical changes to our proposals to codify 
these policies at Sec.  414.626 including adding a definition for 
Medicare Ground Ambulance Data Collection Instrument. We are finalizing 
our proposals to codify these policies at Sec.  414.626.
b. Scope of Cost, Revenue, and Utilization Data
    Section 1834(l)(17)(A) of the Act requires CMS to develop a data 
collection system to collect data related to cost, revenue, 
utilization, and other information determined appropriate by the 
Secretary for ground ambulance organizations. Section 1834(1)(17)(A)(i) 
of the Act further specifies that the information collected through the 
system should be sufficient to evaluate the extent to which reported 
costs relate to payment rates.
    In the proposed rule we stated that we considered several options 
regarding the scope of collecting data on ground ambulance cost, 
revenue, and utilization. One option was to require ground ambulance 
organizations to report on their: (1) Total costs related to ground 
ambulance services; (2) total revenue from ground ambulance services; 
and (3) total ground ambulance service utilization. We stated that this 
approach considers all ground ambulance costs, revenue, and 
utilization, regardless of whether the service was billable to Medicare 
or related to a Medicare beneficiary and that the advantage of this 
approach is that ground ambulance organizations already track 
information at their

[[Page 62869]]

organizational level on total costs, revenue, and utilization for their 
own internal budgeting and planning. We stated that this method was 
also used to calculate an organization-level average cost per transport 
in two previous studies described below:
    In a 2012 study entitled, ``Ambulance Providers: Costs and Medicare 
Margins Varied Widely; Transports of Beneficiaries has Increased'',\94\ 
the GAO performed an analysis to assess how Medicare payments, 
including the temporary add-on payments, compared to costs reported 
using a survey. The GAO collected information via a survey on 
organizations' total costs, including operating and capital costs, 
without restriction to costs associated with Medicare transports or 
costs incurred in responding to calls for service from Medicare 
beneficiaries. GAO then divided reported total costs by the reported 
number of transports (regardless of whether Medicare paid for the 
transport) to calculate an average cost per transport for each 
organization, and reported summary statistics across these averages, 
including a median cost per transport of $429. However, to simplify 
data collection and analysis, the analysis was limited to ambulance 
suppliers that did not share operational costs with a fire department, 
hospital, or other entity. GAO stated that its calculations assumed 
that this average cost per transport was constant for all of an 
organization's transports regardless of whether or not the patient 
transported was a Medicare beneficiary. This approach implicitly loads 
the costs associated with activities that did not result in a 
transport, such as responses by a ground ambulance where the patient 
could not be located, refused transport, or was treated on the scene, 
into the estimated cost per transport.
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    \94\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
---------------------------------------------------------------------------

    The second study, ``Report to Congress Evaluation of Hospitals' 
Ambulance Data on Medicare Cost Reports and Feasibility of Obtaining 
Cost Data from All Ambulance Providers and Suppliers,'' \95\ was 
conducted by HHS as required under the American Taxpayer Relief Act of 
2012 (ATRA) (Pub. L 112-240, enacted January 2, 2013). This report used 
data from Medicare cost reports as its data source, rather than a 
survey, and included only ambulance providers, rather than ambulance 
providers and suppliers. It described substantially higher costs per 
transports for ambulance providers compared to the estimate from GAO, 
with a median of approximately $1,750 per transport. It did not compare 
reported total costs to Medicare revenue tallied in claims data with 
and without the temporary add-on payments. Neither the GAO nor the HHS 
report compared costs and AFS payment rates for specific Healthcare 
Common Procedure Coding System (HCPCS) codes because the available cost 
data in both studies did not support that level of analysis.
---------------------------------------------------------------------------

    \95\ This report is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Report-To-Congress-September-2015.pdf.
---------------------------------------------------------------------------

    Another option we discussed in the proposed rule was considering 
only those costs that are relevant to ground ambulance services 
furnished to Medicare beneficiaries. We stated that collecting costs 
associated with specific services (such as Medicare transports) and 
excluding other services (such as Medicaid transports or responses that 
did not result in transport) would require either a much more intensive 
and costly data collection approach (such as time and motion studies) 
or assumptions on which portions of total costs were related to the 
specific activity. We also stated that we believed this approach would 
be overly burdensome and complex for ground ambulance organizations, 
especially those who provide other services in addition to ground 
ambulance services.
    A third option we considered for the proposed rule was to only 
consider those costs that are related to the specific ground ambulance 
transport services that are paid under the AFS. We stated that this 
would require ground ambulance organizations to report costs, revenue, 
and utilization related to specific levels of services reported with 
HCPCS codes, but not costs, revenue, and utilization for other services 
such as responses that did not result in a transport (which is not 
covered under the AFS). In the proposed rule we stated that we believe 
this option would be overly burdensome and complex.
    We stated that in discussions with ambulance providers and 
suppliers, we were informed that ground ambulance organizations most 
often track organization-level total costs, revenue, and utilization 
across all activities and services furnished to all patients. We were 
told that most would find it difficult to report costs, revenue, and 
utilization associated with services furnished exclusively to Medicare 
beneficiaries or associated with Medicare services covered under the 
AFS.
    Therefore, we proposed the first option, which would require ground 
ambulance organizations to report on their: (1) Total costs related to 
ground ambulance services; (2) total revenue from ground ambulance 
services; and (3) total ground ambulance service utilization. We stated 
that this approach considers all ground ambulance costs, revenue, and 
utilization, regardless of whether the service was billable to Medicare 
or related to a Medicare beneficiary to collect total cost, total 
revenue, and total utilization data.
    Although we proposed to collect a ground ambulance organization's 
total costs and total revenues, we stated we were aware that many 
ground ambulance organizations share operational costs with fire 
departments, other public service organizations, air ambulance 
services, hospitals, and other entities. We stated that for these 
organizations, only a portion of certain capital and operational costs 
contribute to total ground ambulance costs, and only a portion of 
revenue is from ground ambulance services. We also stated we were aware 
that some ground ambulance suppliers deploy emergency medical 
technicians (EMTs) in fire trucks, which will make it difficult to 
determine whether the fire truck costs should be factored into the 
total ground ambulance costs, and if so, how that will be calculated.
    In the proposed rule, we stated that one option to address these 
challenges is to limit data collection to ground ambulance 
organizations that do not share operational costs with fire 
departments, hospitals, or other entities, as GAO did for their 2012 
report. We stated that we did not believe this approach meets the 
requirement in section 1834(l)(17)(B)(ii) of the Act for a 
representative sample because many ambulance suppliers and all 
ambulance providers share operational costs with fire, police, health 
care delivery or other activities. We also considered including 
providers' and suppliers' total costs and revenues across all 
activities and stated that while this would simplify cost and revenue 
data reporting, the resulting data would not be limited to ground 
ambulance activities, and therefore, would result in biased estimates 
of ground ambulance costs or require significant assumptions to 
estimate ground ambulance costs alone.
    To more accurately define total costs and total revenues related to 
ground ambulance services for those ground ambulance organizations that 
provide other services in addition to ground ambulance services, we 
proposed an approach where the data collection instrument instructions 
would separately address three further refined proposed categories of 
total ground ambulance costs and revenues:

[[Page 62870]]

     Cost and revenue components completely unrelated to ground 
ambulance services. In the proposed rule, we stated these costs and 
revenues would be unrelated to this data collection and not reported. 
We gave examples that included administrative staff without ground 
ambulance responsibilities, health care delivery outside of ground 
ambulance, community paramedicine, community education and outreach, 
and fire and police public safety response.
     Cost and revenue components partially related to ground 
ambulance services. We stated these costs and revenue would be reported 
in full, but respondents would report additional information that could 
be used to allocate a portion of the costs to ground ambulance 
services. We stated that depending on how the data would be utilized, 
certain costs could be included or excluded from an analysis after data 
are collected. We provided examples to include EMTs who are also 
firefighters and facilities with both ground ambulance and fire 
department functions. (We stated that we considered an alternative 
where respondents would allocate costs and report only costs associated 
with ground ambulance services but believed that would pose an 
additional burden on the respondent to calculate allocated amounts, and 
would result in an allocation process that is less transparent and 
standardized).
     Cost and revenue components entirely related to ground 
ambulance services. We stated that these costs are reported in full. We 
gave an example to include EMTs with only ground ambulance 
responsibilities and ground ambulance vehicles.
    In the proposed rule, we stated that we believe that this approach 
will enable us to collect the data necessary to evaluate the adequacy 
of payments for ground ambulance services, the utilization of capital 
equipment and ambulance capacity, and the geographic variation in the 
cost of furnishing such services. We stated that the data could be 
analyzed in the same manner as the data in the GAO report, for example, 
calculating an average per-transport cost for each organization and 
calculating Medicare margins with and without add-on payments, or could 
provide the basis for other analyses to link reported costs to AFS 
rates. We stated that an analysis could use reported total costs and 
information on the volume of transports by levels of services to 
estimate a cost for each HCPCS code reported for the AFS, or 
regression-based approaches to estimate the marginal cost of furnishing 
each HCPCS code on the AFS. We stated that we believed that under our 
approach, the collected data will be available to estimate total costs 
and revenue relevant to ground ambulance services.
    We received comments on scope of cost, revenue, and utilization 
data.
    Comment: Many commenters stated that they support CMS' approach to 
collect data on total costs related to ground ambulance services, total 
revenue from ground ambulance services, and total ground ambulance 
service utilization. They stated that they support this approach 
because it will provide the most accurate and complete view of ground 
ambulance costs, revenue, and utilization.
    Commenters also expressed support of CMS' proposal to collect data 
in such a way that will allow the allocation of a share of 
organizations' total costs to ground ambulance services in cases where 
an organization also provides other services or activities. Commenters 
stated that separating ground ambulance costs from non-ground ambulance 
costs is essential for the data collection system to comply with the 
intent of the Congress when it established the new program. They also 
stated that they agree that the data collection instrument should 
provide clear instructions to separately address these costs while in 
many cases allowing them to be reported and that the clear definition 
of these terms will be critically important to ensure the consistent 
application of these categories.
    Finally, one commenter expressed concern that several categories of 
``hidden'' or ``opportunity'' costs were not captured in the data 
collection instrument. These include, but are not limited to: 
volunteers using their own cars to respond to calls; the time/money 
volunteers lose in responding to calls, and position vacancies that 
organizations cannot fill or needed capital equipment or buildings that 
they cannot purchase due budget constraints. The commenter noted these 
``hidden costs'' artificially lower the cost of running an ambulance 
service for some organizations.
    Response: We agree that it is critical to collect data in such a 
way that ground ambulance costs can be separated from an organization's 
total costs in cases where an organization performs ground ambulance 
and other activities. The approach that we proposed would collect 
information in such a way that analysts (rather than the respondent) 
would be able to allocate many costs to ground ambulance services.
    We also do not agree with the commenter who suggested that we 
collect information on what they described as ``hidden'' costs. The 
statute requires us to collect information on actual costs, not on 
costs that would have occurred under certain circumstances. We believe 
that the proposed data collection instrument will provide the necessary 
data required by the statute, and collecting information on other costs 
or potential costs would be out of scope for this data collection.
    After consideration of the comments, we are finalizing our 
proposals to collect data on total costs related to ground ambulance 
services, total revenue from ground ambulance services, and total 
ground ambulance service utilization. We are also finalizing our 
proposals regarding allocation of a share of organizations' total costs 
and revenues unrelated to, partially related to, and entirely related 
to ground ambulance services.
c. Final Data Collection Elements
    In the proposed rule, we shared the proposed data collection 
instrument on the CMS website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html. We provided an overview of the 
elements of the data collection instrument we proposed in Table 37, 
including information on costs, revenues, utilization (which we define 
for the purposes of the data collection instrument as service volume 
and service mix), as well as the characteristics of ground ambulance 
organizations.
    In the proposed rule we stated that to help structure the data 
collection instrument, we organized costs by category (for example, 
labor, vehicles, and facilities), which we stated was the approach used 
in the GEMT and the AAA/Moran survey.

[[Page 62871]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.083

(1) Collecting Data on Ground Ambulance Provider and Supplier 
Characteristics
    We are required to collect information regarding the geographic 
location of ground ambulance organizations to meet the requirement at 
section 1834(l)(17)(A)(iii) of the Act that the collected data include 
information on services furnished in different geographic locations, 
including rural areas and low population density areas. In the proposed 
rule, we stated that we recognized that there are differences between 
and among ground ambulance organizations on several key 
characteristics, including geographic location; ownership (for-profit 
or non-profit, government or non-government, etc.); service volume, 
organization type (including whether costs are shared with fire or 
police response or health care delivery operations); EMS 
responsibilities; and staffing models. We stated that our research 
indicated that:
     There are differences in costs per transport by ground 
ambulance organizations with a different ownership status;
     EMS level of service and staffing models often have an 
important impact on costs, with higher EMS levels of service (for 
example, quicker response times) and static staffing models (that is, 
mainatining a constant response capability 24 hours a day, 7 days a 
week, 365 days a year) involving higher fixed costs; and
     Utilization varies significantly across ambulance 
providers and suppliers of different characteristics.
    Due to this variation in characteristics and the effect it has on 
costs and revenues, we stated that we believed it is important for 
ground ambulance organizations to report additional characterictics to 
adequately analyze the differences in costs and revenue among different 
types of ambulance providers and suppliers. We also stated that we 
believed collecting this information directly through the data 
collection instrument will improve data quality with minimal burden on 
the respondents because the data collection instrument was designed to 
tailor later sections and questions based on respondents' 
characteristics through programmed ``skip patterns''. We stated we 
considered relying exclusively on the Medicare enrollment form CMS 855A 
for ground ambulance providers or CMS 855B for ground ambulance 
suppliers to capture this information, but believed that data accuracy 
would be more robust if reported directly by respondents for the 
specific purpose of this data collection.
    We proposed to collect information on ownership and organization 
type through a sequence of questions in Section 2 of the data 
collection instrument. We stated that some of the questions in this 
section were adapted in part from prior surveys (such as the GAO and 
Moran surveys) with changes as necessary to fit scenarios reported 
during interviews with ground ambulance organizations. The first 
question related to organizational characteristics, question 6, asked 
about the organizations' ownership status and aligned closely with a 
similar question on the Medicare enrollment form CMS 855B for ambulance 
suppliers. Question 7 asked whether the respondent's organization used 
any volunteer labor. While this question could have been asked later in 
the data collection instrument around the collection of labor data, we 
stated we opted to include it here because many ground ambulance 
organizations informed CMS that they view the use of volunteer labor as 
a defining organizational characteristic, on par with ownership status, 
and that a volunteer labor question was expected by respondents at this 
early point in the data collection instrument. Question 8 asked

[[Page 62872]]

respondents to select a category that best describes their ambulance 
organization. We stated that the response options for this item are 
mutually exclusive and align with the ambulance provider and supplier 
taxonomy described in the CAMH report. The next two questions, 9 and 
10, more directly asked whether the respondent has shared operational 
costs with an entity of another type, including a fire department, 
hospital, or other entity. We stated that we proposed these questions 
in addition to the organization type question to account for situations 
where a respondent might primarily identify as an organization of one 
type (with implications for shared operational costs) but then might 
have shared operational costs with another entity type. We stated that 
responses to questions 9 and 10 play an important role in skip logic 
later in the data collection instrument regarding questions and 
response options relevant only to ground ambulance organizations with 
shared operational costs with an entity of another type.
    We stated that other questions regarding organizational 
characteristics are necessary to tailor later parts of the data 
collection instrument to the respondent. These included questions in 
Section 2 of the data collection instrument on whether the respondent's 
ambulance organization:
     Is part of a broader corporation or other entity billing 
under multiple National Provider Identifiers (NPIs) (question 2).
     Routinely responds to emergency calls for service 
(question 11).
     Operates land, water, and air ambulances (questions 12-
14).
     Has a staffing model that is static (that is, consistent 
staffing over the course of a day/week) or dynamic (that is, staffing 
varies over the course of a day/week) or combined deployment (certain 
times of the day have a fixed number of units, and other times are 
dynamic depending on need) (question 15).
     Provides continuous (also known as ``24/7/365'') emergency 
services) (question 16).
     Provides paramedic or other emergency response staff to 
meet ambulances from other organizations in the course of a response 
(questions 17 and 18).
    In our interviews with ambulance providers and suppliers, some 
participants indicated that their staffing model is an organizational 
characteristic that would likely be associated with costs per transport 
and that organizations that need to maintain fixed staffing levels over 
time (for example, to maintain an emergency response capability to 
serve a community) would likely have higher costs than those that do 
not.
    Section 1834(l)(17)(A)(iii) of the Act requires collecting data 
from ambulance providers and suppliers in different geographic 
locations, including rural areas and low population density areas. In 
the proposed rule, we stated that the area served by ambulance 
organizations is an important characteristic and we proposed to collect 
information on the geographic area served by each ambulance 
organization in Section 3 of the data collection instrument.
    In the proposed rule, we stated that many ground ambulance 
organizations have a primary service area in which they are responsible 
for a certain type of service (for example, ALS-1 emergency response 
within the borders of a county, town, or other municipality) and may 
have secondary services areas for a variety reasons, such as providing 
mutual or auto aid, or providing a different service in a secondary 
area (for example, non-emergency transports state-wide). For the 
proposed rule, we considered several alternatives to collect 
information on service area. One option was to utilize Medicare claims 
data, but we stated that this would limit the information to Medicare 
billed transports only and would also not differentiate between primary 
and other service areas. Another option was to allow respondents to 
write in a description of their primary and other service areas, but we 
stated this would require converting written responses to a format that 
can be used for analysis. A third option was for respondents to report 
the ZIP codes that constitute their primary and other service area. We 
stated this approach aligns with the Medicare enrollment process 
requirement to submit ZIP codes where the ground ambulance organization 
operates and that it would also collect ZIP code-based information on 
service area that can be easily linked to the ZIP Code to Carrier 
Locality file \96\ that lists each ZIP code and its designation as 
urban; rural; or super-rural. We stated that this file is used by the 
MACs to determine if the temporary add-on payments should apply to a 
transport under the AFS. We also stated the main limitation of this 
approach is that ZIP codes would not always align to service areas, 
because ZIP codes routinely cross town, county, and other boundaries 
that are likely relevant for defining ground ambulance organizations' 
service areas.
---------------------------------------------------------------------------

    \96\ Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html.
---------------------------------------------------------------------------

    We proposed to require ground ambulance organizations that are 
selected during sampling to identify their primary service area by 
either: (1) Providing a list of ZIP codes that constitute their primary 
service area; or (2) selecting a primary service area using pre-
populated drop-down menus at the county and municipality level in 
question 1, Section 3 of the data collection instrument. We also 
proposed to require respondents to specify whether they have a 
``secondary'' service area, which we stated are areas where services 
are regularly provided under mutual aid, auto-aid, or other agreements 
in Section 3, question 4 of the data collection instrument and if so, 
to identify the secondary service area using ZIP codes or other regions 
as described above for the primary service area (Section 3, question 
5). We stated that mutual aid agreements are joint agreements with 
neighboring areas in which they can ask each other for assistance and 
that auto-aid arrangements allow a central dispatch to send the closest 
ambulance to the scene. We did not propose to collect information on 
areas served only in exceptional circumstances, such as areas rarely 
served under mutual or auto-aid agreements or deployments in response 
to natural disasters or mass casualty events because we stated we 
believe reporting on rarely-served areas will involve significant 
additional burden and will add to complexity of the data collection 
instrument without generating data that will be useful for analysis.
    In the proposed rule, we stated that the proposed approach 
distinguishes between primary and secondary service areas and will 
allow subsequent questions on the balance of transports in a 
respondent's primary versus secondary service area and whether average 
trip time and response times are substantively longer in the secondary 
versus primary service area. We stated that we believed this approach 
results in data that can be easily analyzed and eliminates the need to 
ask certain other questions (such as the population and square mileage 
of the respondent's service area) because this information can be 
inferred using the reported geographic service area boundaries.
    We proposed to ask the following questions in Sections 3 and 4 of 
the data collection instrument, service area and subsequent emergency 
response time, because the responses to these questions are closely 
related to the area served by the organization:

[[Page 62873]]

     Whether the respondent is the primary emergency ambulance 
organization for at least one type of service in their primary service 
area (Section 3, question 2).
     Average trip time in primary and secondary service areas 
(Section 3, questions 3 and 6).
     Average response time (for organizations responding to 
emergency calls for service) for primary and secondary service areas 
(Section 4, questions 1-2).
     Whether the organization is required or incentivized to 
meet response time targets by contract or other arrangement (for 
organizations responding to emergency calls for service) (Section 4, 
question 3).
    In the proposed rule, we stated that average trip and response time 
are necessary to understand how geographic distance between the ground 
ambulance organization's facilities and patients affects costs. In 
interviews, ground ambulance organizations recommended the collection 
of average trip time in addition to mileage because some rural and 
remote areas may have relatively long average trip times even though 
mileage may be more modest due to terrain, the quality of roads, and 
other factors. We stated that we believed that collecting information 
on average response time would allow the analysis of whether 
communities with different response time expectations and targets have 
systematically different costs.
    We received comments on collecting data on ground ambulance 
provider and supplier characteristics. The following is a summary of 
the comments we received and our responses.
    Comments: Many commenters stated that they are pleased that CMS has 
recognized the importance of taking into account organizational 
characteristics in designing the data collection instrument. They 
stated that even though the organizational characteristics in Section 2 
of the data collection instrument differ from those initially 
recommended by the AAA based on its work with the Moran Company, they 
believe that in its totality the data collection instrument covers the 
key organizational characteristics that policy-makers will need to use 
to accurately determine the cost of providing ground ambulance 
services. Commenters made several specific recommendations. One 
commenter recommended that CMS add questions asking whether the 
respondent has sole source contracts or local jurisdictional 
requirements and suggested that we add categorical response options 
(specifically, less than and greater than 20 percent) to the existing 
question on the use volunteer labor because these characteristics may 
be systematically related to reported costs and revenue.
    Commenters also asked CMS to consider several specific clarifying 
changes to the data collection instrument including: (1) Clarifying how 
respondents should respond to question 1 in Section 2 if they have 
multiple service types under the same NPI; (2) defining NPI; (3) 
distinguishing between response options for independent/proprietary 
organization types; (4) specifying which organization name should be 
reported; (5) defining the term ``public/private partnership;'' (6) 
adding an ``other'' organization type; (7) clarifying the term 
`volunteer' and which volunteer personnel are in-scope when reporting 
volunteer labor; and (8) clarifying how to classify 501(c)(4) 
organizations.
    Many commenters requested that because the questions in Section 4, 
emergency response time, are similar to those in Section 3 of the data 
collection instrument, they would like CMS to provide the same 
clarification to these questions that they highlighted for Section 3 of 
the data collection instrument.
    One commenter requested clarification on whether the average trip 
time is calculated across all calls or just specific types such as 
emergency, scheduled, etc. One commenter recommended that average 
response time be defined as starting when the call for service is 
answered to when the first EMS unit arrives on location. The commenter 
stated this definition is best because it measures response times as 
experienced by the public/patient. One commenter requested 
clarification on Section 4, Question 3 which asks whether organizations 
are penalized for exceeding response time targets, if their local area 
imposes these standards. The commenter requested clarification on 
whether any performance penalties should be included in the answer to 
this question or only response time penalties.
    Several commenters also recommended asking ground ambulance 
organizations to provide 90th percentile response time rather than 
average response time. They believe 90th percentile response time is a 
more accurate indicator of ambulance services capabilities and quality. 
They stated that average time has too wide a range for error, since 
roughly half of responses are quicker/slower than average. They further 
stated that using average response time also tends to flatten the data, 
which means that the fastest and slowest organizations do not stand out 
as much.
    Response: We appreciate commenters' points that much of the 
information collected via the data collection instrument will be useful 
in describing variation across ground ambulance organizations. Many of 
the specific characteristics that commenters suggested adding to the 
initial section of the data collection instrument are already included 
in the survey. For example, Section 3 of the proposed data collection 
instrument asks if the organization is the only EMS provider in most or 
all of their service area, Section 4 asks about response time targets, 
and Section 7 asks for detailed information related to volunteer labor. 
We added screening questions to the initial section of the data 
collection instrument only when they were necessary to inform skip 
patterns, and reserved asking other questions until later sections. The 
information collected via the survey can be used to conduct analyses 
for various subgroups of organizations, for example those that are and 
are not the only EMS provider in part or all of their service area.
    We thank commenters for pointing out several opportunities to 
clarify the instructions and items in the proposed data collection 
instrument. We believe that based on the wording of question 1, Section 
2, organizations with more than one service line under the same NPI 
(such as both air and ground ambulance) should answer ``yes'' to 
question 1 in Section 2. We agree that the term national provider 
identifier should be defined at its first use in the data collection 
instrument. When distinguishing between different types of proprietary/
independent ground ambulance organizations, we intended option (e) to 
reflect primarily EMS responsibilities and option (f) to reflect 
primary responsibilities that are non-emergency. For the legal name, we 
are requesting that organizations use their legal name, which should 
match the name used on their Medicare enrollment form 855B in most 
cases. For this reason, we encourage all ambulance organizations to 
confirm that their information is up-to-date in the Medicare enrollment 
database, the Provider Enrollment Chain and Ownership System (PECOS). A 
public/private partnership is a formal contractual arrangement between 
a government and an entity chartered for the express purpose of 
providing the service. We believe that the response options for the 
ownership type item (question 6 in Section 2) are comprehensive and no 
additional ``other'' option is necessary. The volunteer labor question 
refers to any

[[Page 62874]]

volunteers, including non-medical personnel. Any staff member who is 
paid could not be counted twice, once as a paid staff member and once 
as a non-paid staff member or volunteer. So in the example of a paid 
administrator who serves as a volunteer responder, they should be 
counted in the administrator category since that is the category in 
which they are paid. Volunteers may receive some forms of compensation 
but are not considered full or part time employees if they are not paid 
a minimum wage in return for full or part-time labor. Finally, 
501(c)(4) organizations are considered to be for-profit organizations.
    We agree that most ground ambulance organizations that respond to 
emergency calls for service already track response times and that 
different organizations may use different methodologies for tracking. 
We also agree that it is important to define the term ``average 
response time'' to ensure respondents are reporting times measured in a 
consistent way but we are concerned that specifying one definition or 
another may result in additional burden for organizations that 
currently track response time using another definition. We believe that 
several summary statistics would be useful for analysis, including an 
estimate of central tendency (like the mean) and an estimate focusing 
more on outliers (like the 90th percentile). We are also clarifying 
that response time target penalties do not include performance or any 
other type of penalties.
    As a result of these comments, we will change two of the options in 
Question 8 to (e) Independent/proprietary organization primarily 
providing EMS services and (f) Independent/proprietary organization 
providing non-emergency services. We will also add information on the 
use of volunteers to clarify that it refers to all volunteer staff, not 
only response personnel. We will add the text ``that best fits your 
organization'' to Section 2, question 6, and we will define NPI on the 
first use of that acronym. We will also add new items on whether or not 
the organization uses the response time definition in the data 
collection instrument or another definition, new instructions to 
clarify that respondents should report response times as they currently 
measure them, and a new item for the 90th percentile response time. We 
will revise the data collection instrument to add an initial yes/no 
question asking whether the organization measures response time 
specifically as the time from when the call for service is answered to 
when the first EMS unit arrives on the scene. If the respondent answers 
yes, we would then ask for response time summary statistics. If the 
respondent answers no, we would ask them to specify what definition 
they use.
    Comment: Many commenters were pleased that the proposed data 
collection instrument includes questions on their service area because 
of the impact of the service area on their costs. They described that 
in some rural areas, ambulance organizations may have to commit 
vehicles for several hours for a single response if their service areas 
cover hundreds of miles. In urban areas, an ambulance organization may 
face a similar challenge of having a vehicle committed to a single 
response as it navigates traffic congestion and overcrowded emergency 
rooms. Commenters were also appreciative that we proposed using ZIP 
code level data, because as the census data changes, so do the ZIP 
codes designated as urban, rural, and super-rural. They stated that 
this information is essential to understand the costs of ambulance 
organizations providing services in these areas, especially to assess 
the add-ons and adequacy of current ambulance fee schedule rates. These 
commenters stated that they appreciate the data elements related to 
average trip time since having standardized assessment of these 
elements is also important. They stated that while they had divided the 
average duration of a transport into three categories, they support the 
more detailed division in the proposed data collection instrument.
    One commenter sought clarification on what CMS means by ``primary 
service area'' and ``secondary service area''. They inferred that the 
intent of these distinctions is to allow the end users of the data to 
be able to allocate the costs appropriately as related to urban, rural, 
or super-rural areas by proportioning the costs of respondents based on 
where they provide the most services. They stated that they believe 
that this approach makes sense as a way to parse out the complexities 
that an ambulance organization might provide services in more than one 
geographic designated (for example, urban, rural, super-rural) and that 
using the ZIP codes rather than the current Medicare definitions of 
urban, rural, and super-rural will provide consistency in reporting, as 
the 2020 Census may shift the CMS definitions again. The commenter 
suggested that, if this assumption is in fact correct, that CMS define 
the term ``primary service area'' as the area where more than half of 
its services are provided. The same commenter asked that CMS provide a 
standard definition to what it means by ``the primary emergency 
service.'' They stated that while many ambulance organizations will 
likely know whether they are the only provider of emergency services in 
an area or not, they may not know the volume of services provided by 
other organizations if there are others providing these services. They 
also stated that it could also be helpful to know whether CMS will 
audit the answers to this question and what will be done with the 
respondents' data if more than one ambulance organization answers that 
it is the primary emergency ambulance provider for the same set of ZIP 
codes. Another commenter requested clarification on whether the 
secondary service area could include the whole state, or when an 
organization handles a transfer of a patient to higher level care for 
another organization.
    Response: We thank the commenters for these detailed questions and 
appreciate the opportunity to provide additional clarification. Each 
ambulance organization will determine what it considers to be its 
primary service area, usually based on whether it has primary EMS or 
responsibilities within a specific jurisdiction or if it has 
contractual or other arrangements to provide a certain level of service 
with a particular region (as opposed to an area where it renders aid to 
other ambulance organizations). We expect that in most cases, well over 
50 percent of an organization's transports will occur in the primary 
service area. Given the lack of information about ambulance 
organization service areas, we believe it will be useful to collect 
respondents' subjective assessment of their own primary and secondary 
service areas, and do not believe that a specific threshold would be 
relevant for all respondents. For example, there are likely cases where 
an organization's primary service area by contract accounts for half or 
less than half of its paid transports if it serves an area with high 
levels of mutual or auto-aid agreements. While there are other 
approaches to collect more detailed information on service areas and 
the arrangements (both formal and informal), responsibilities, levels 
of service offered, and service volume in different parts of an 
organization's service area, we believe that the burden involved in 
collecting this more detailed information would be considerable. 
Commenters highlighted several examples of cases where it might be 
difficult to identify whether they have a secondary service area. If an 
organization operates an emergency service for one jurisdiction but 
then

[[Page 62875]]

operates a non-emergency service in the rest of the state, both may be 
considered primary since the ground ambulance organization has the 
primary responsibility for serving both areas. Also, we would not 
expect that all ground ambulance organizations will have a secondary 
service area.
    We also do not agree with the suggestion to describe primary 
service areas as those with only one emergency ambulance provider 
because that would exclude organizations that are the primary emergency 
ambulance provider in areas where other organizations respond to calls 
through mutual or auto-aid arrangements on an occasional, but perhaps 
not an exceptional basis. We understand that ambulance organizations 
vary in how they define their service areas, and we expect that ground 
ambulance organizations will report their service area information 
accurately. We believe the existing question provides us with the 
detail we need to understand the service area of the responding ground 
ambulance organization.
    After consideration of the comments, we clarified that responses to 
questions related to the primary and secondary service area should be 
based on the respondents' best judgment regarding the definition of 
their organization's primary service area and, if applicable, secondary 
service area. We further clarified the primary and secondary service 
area definitions through the new examples in the data collection 
instrument instructions and making additional edits pertaining to the 
service area.
    Comment: Several commenters suggested adding a question to Section 
3 of the data collection instrument that would ask if the ground 
ambulance organizations uses EMS employees from another agency, such as 
a fire department or law enforcement agency, either to provide initial 
patient care/assessment or continue providing patient care during 
transportation to a hospital or other destination. If the respondent 
answers no, they would skip to Section 4. If the respondent answered 
yes, they would be asked the percentage of patient transports that are 
EMS employees from another response agencies providing initial patient 
care/assessment or continuing to provide patient care during 
transportation, and if the ground ambulance organization reimburses 
this non-transporting agency for the patient care/assessment services 
they provide.
    Commenters stated that they believe it would be beneficial for CMS 
to gain an understanding of how frequently ground ambulance agencies 
rely upon a fire department or law enforcement agency for additional 
EMS personnel to provide patient care. They stated that while they 
understand that we are focused mostly on obtaining data related to 
individual patient transportation, they believe it is important to 
consider the entire EMS response system because that is key to 
evaluating the efficiency and effectiveness of ambulance organizations 
that rely upon a third-party agencies (such as a fire department or law 
enforcement agency) to meet their response-time goals.
    These same commenters also asked that CMS include a question in 
Section 4 of the data collection instrument that asks if a ground 
ambulance organization responds to calls for service in conjunction 
with a non-transporting EMS agency, such as a fire department or law 
enforcement agency. If the respondent answers no, they would skip to 
Section 5 of the data collection instrument. If the respondent answers 
yes, they would then be asked for additional information including: The 
percentage of responses in which a non-transporting agency responds 
initially to the patient; the percentage of transports where an initial 
responding EMS provider from another agency continue providing patient 
care during transport to a destination; if they have a formal agreement 
with the non-transporting agency to provide these services; and if they 
reimburse the non-transporting agency for these services. Commenters 
also stated that often ground ambulance organizations may rely upon a 
non-transporting fire department or law enforcement agency for the 
initial response to a call for service in order to ``stop the clock'' 
and that they believe CMS should include this set of questions to 
determine how often transporting agencies rely upon a non-transporting 
agency for initial response and whether the transporting agency is 
reimbursing the non-transporting fire department or law enforcement 
agency for this critical response role. Other commenters also suggested 
that the survey needs to better capture these situations where non-
transporting agencies also respond.
    Response: The commenters raise an important issue that medical care 
provided to beneficiaries in emergency settings by the EMS system as a 
whole consist of more than simply transporting beneficiaries. Costs may 
differ for organizations in these situations in important ways; 
therefore, we agree with the commenters to add one question to the 
survey that incorporates whether the agency responds to calls with 
another agency.
    After consideration of the comments we added a question in Section 
2 of the data collection instrument asking whether the organization 
responds to calls for service in conjunction with a non-transporting 
EMS agency, such as a fire department or law enforcement agency. We 
also added a follow-up question for respondents answering ``yes'' to 
collection information on (a) the share of ground ambulance responses 
during which a non-transporting EMS agency provides staff contributing 
to the response, and (b) the broad roles of these staff (including EMT-
Paramedic, other EMT, and other.
(2) Collecting Data on Ground Ambulance Utilization
    CMS is required to collect information on the utilization of ground 
ambulance services. In the proposed rule we stated that while we could 
collect information on the volume of ground ambulance services that can 
be billed to Medicare, this approach would not provide information 
needed to determine total utilization of ground ambulance 
organizations. We stated another option would be to utilize Medicare 
claims data for estimates of ground ambulance transport volume and 
separately collect information on services not payable by Medicare 
(such as responses that did not result in a transport), but that this 
approach would also not provide complete information on total transport 
volume, since other services, such as responses that do not result in a 
transport, would not be included.
    Based on information provided during interviews with ground 
ambulance organizations, we identified several distinct utilization 
categories, such as total responses and ground ambulance responses. In 
the proposed rule, we stated that this is particularly important for 
fire-based and police-based organizations that may have a significant 
volume of fire and police responses that do not involve a ground 
ambulance. We stated that the number of responses that did not result 
in a transport can be separately tallied. We also stated that other 
important utilization categories are ground ambulance transports (that 
is, responses during which a patient is loaded in a ground ambulance), 
which can be measured in terms of total transports (that is, all ground 
ambulance transports regardless of payor) or paid transports (that is, 
transports for which the ambulance provider or supplier was paid in 
part or in full). Additionally, we stated that another utilization 
category would include information on ambulance providers and suppliers 
that furnish paramedic intercept services or

[[Page 62876]]

provide paramedic-level staff in the course of a BLS response where 
another organization provides the ground ambulance transport.
    In the proposed rule, we stated we believed it is important to 
collect utilization data related to all services, not just transports, 
because other services that contribute to the total volume of responses 
have direct implications for costs and that collecting utilization 
information related to transports without collecting information on 
other services would omit important cost information. We stated that 
some utilization measures, such as the ratio of ground ambulance to 
total responses, may be one basis for allocating certain costs reported 
elsewhere in the data collection instrument. We stated that another 
example would be the difference between total and paid transport, as 
this would provide information on services that were provided to 
patients but for which no payment is received.
    To best capture the full range of utilization data, we proposed a 
two-pronged approach to collect data on the volume and the mix of 
services. First, we proposed to collect total volume of services for 
each of the categories listed below in Section 5 of the data collection 
instrument:
     Total responses, including those where a ground ambulance 
was not deployed (question 1).
     Ground ambulance responses, that is, responses where a 
ground ambulance was deployed (question 2).
     Ground ambulance responses that did not result in a 
transport (question 4).
     Ground ambulance transports (question 5).
     Paid ground ambulance transports, that is, ground 
ambulance transports where the ambulance provider or supplier was paid 
for a billed amount in part or in full (question 6).
     Standby events (question 7).
     Paramedic intercept services as defined by Medicare 
(question 8).
     Other situations where paramedic staff contributes to a 
response where another organization provides the ground ambulance 
transport (question 9).
    The CAMH report describes several cases where an ambulance provider 
or suppliers' mix of services within one of the utilization categories 
described above could affect costs or revenue. Most importantly, within 
billed transports, variation in the mix of specific ground ambulance 
services (for example, ALS versus BLS services) will affect both costs 
(because ALS transports require more and more costly inputs) and 
revenue (because ALS services are generally paid at a higher rate). We 
stated that ground ambulance organizations with a higher share of 
responses that are emergency responses may also face higher fixed 
costs, and that the costs for organizations furnishing larger shares of 
water ambulance transports are likely different than costs from 
organizations that do not furnish water ambulance transports. We stated 
that there is a subset of ground ambulance organizations that 
specialize in non-emergency transports or inter-facility transports, 
which suggests that this business model may result in different per-
transport costs compared to EMS-focused ambulance providers and 
suppliers.
    Second, to account for this significant variation, we proposed to 
collect the following information related to service mix:
     The share of responses that were emergency versus non-
emergency (Section 6, question 1).
     The share of transports that were land versus water (asked 
only of organizations reporting that they operate water ambulances; 
Section 6 question 2).
     The share of transports by service level (Section 6 
question 3).
     The share of transports that were inter-facility 
transports (Section 6 question 4).
    We did not propose that respondents report on their mix of services 
in primary and secondary service areas (as defined above) separately 
because this would double the length of this section of the data 
collection instrument and require complex calculations or use of 
assumptions by respondents that do not separately track services by 
area. Instead, we proposed that respondents report the share of total 
ground ambulance responses that were in a secondary rather than primary 
service area in a single item (Section 5 question 3). We also did not 
propose to collect detailed information regarding the mix of services 
for total transports (versus paid transports) and paid transports 
(versus total transports) because collecting information on the mix of 
services for total and paid transports separately would double the 
reporting burden in this section and because we believed, based on 
discussions with stakeholders, that it is reasonable to assume that the 
distribution of transports across categories would be the same.
    We received comments on collecting data on ground ambulance 
utilization and service mix. The following is a summary of the comments 
we received and our responses.
    Comment: Many commenters stated that they were pleased that CMS 
proposed to collect utilization data on all services, not just 
transports, in Section 3 of the data collection instrument. These 
commenters stated that they agree with CMS that these data are 
important because other services that contribute to the total volume of 
responses have direct implications for costs. They also stated that 
given the importance of this information to determining and evaluating 
the costs of providing ground ambulance services, they asked that CMS 
add ``low,'' ``medium,'' and ``high'' response options to allow the 
data to be separated by the volume of services provided by each 
respondent. They stated that while that information might be obtained 
by adding the various questions in Section 5 of the data collection 
instrument, adding such a question would allow for evaluators to have a 
more straight-forward and consistent method of taking this critical 
factor into account. They stated that by setting the definition of low, 
medium, and high volume, CMS would be standardizing the way in which 
these terms are used by anyone seeking to use the data to develop 
policy and that standardization is critically important when policies 
such as low-volume adjusters are being considered.
    Several commenters requested clarifications on the definitions of 
``ground ambulance,'' ``response,'' and ``transport, including removing 
the Medicare definition of `medically necessary' from the definition of 
transports because it is not uniform across payers. For items related 
to service mix, one commenter suggested using the Medicare manual 
definitions of specific ground ambulance services to avoid confusion. 
Commenters also suggested clarifications to the definition of 
``interfacility transport.''
    Another commenter suggested several points of clarification on 
responses and transports. The commenter stated that it was not clear 
how to count responses for situations when multiple ambulances may be 
dispatched to the scene, but not all of them transport beneficiaries. 
They suggested that responses should actually be the number of 
ambulances sent to the scene. This same commenter also requested 
clarification on whether responses where a police car is first on the 
scene and then cancels the ambulance should be counted in responses, 
and whether community paramedicine visits should be counted.
    One commenter requested clarification about how to treat transfers 
that are `emergency.' The commenter noted that in rural areas, 
transfers can

[[Page 62877]]

be considered emergency calls when a patient needs to be transported to 
a higher level of care. They requested clarification on how an 
emergency transfer should be counted in the responses and transports. 
This commenter also requested clarification on how ground ambulance 
organizations who receive some local tax funding to offset the patients 
who do not pay should report unpaid transports since in this scenario 
all patients' transports are partially paid.
    Many commenters noted that, while they believe it is important to 
collect information on responses that do not result in transports, they 
believed some ground ambulance organizations do not currently track 
this information. These commenters suggested that CMS add new response 
options to allow respondents to either estimate the share of responses 
where the patient is not transported or to report that this information 
is not available.
    Several commenters noted that they incur significant costs for 
ground ambulance where the patient is pronounced dead at the scene. 
These commenters asked that CMS add several items to the data 
collection instrument to collect information on the share of responses 
that involve a patient pronounced dead on-scene and the time and costs 
involved in these responses.
    Response: We appreciate the detailed comments to our proposals, but 
do not agree that respondents should be presented with an option to 
report service volume in terms of categorical ``low,'' ``medium,'' and 
``high'' response options. Data collected using this categorical 
approach would considerably decrease the precision of estimated per-
transport costs. We also believe that it would be challenging to 
combine data from ground ambulance organizations reporting specific 
counts of services with those opting to use the categorical response 
options. Reported counts of services can easily be described in terms 
of categories when the data is analyzed.
    We agree that it is appropriate to use Medicare manual definitions 
for ground ambulance services, although some of the verbatim 
descriptions may need to be abridged due to their length. We appreciate 
commenters' concerns that the specific Medicare definition of ground 
ambulance transport may not apply to transports paid by certain other 
payers. While we would generally prefer to use the Medicare definition 
of ground ambulance transports, we believe that the burden of asking 
respondents to distinguish between transports paid by other payers that 
would or would not have met Medicare requirements would be unreasonable 
compared to incremental benefit of using this narrower definition. We 
agree that the definition of interfacility transport in the data 
collection instrument needs to be clarified and revised. We agree that 
the commenters' specific clarifications to the definitions of several 
service categories will be helpful to respondents.
    In the data collection instrument, the term `ground ambulance 
response' is defined as ``a response by a fully equipped and staffed 
ground ambulance, scheduled or unscheduled, with or without a 
transport, and with or without payment. If more than one vehicle is 
sent to the scene, the instructions are to count this as one 
response.'' For example, if three ambulances are sent to one incident, 
and only one ambulance transports a patient, then this example is 
counted as one response and one transport. Similarly, responses where 
another EMS vehicle arrives and cancels the ambulance would not be 
counted in the responses. While there may be some discrepancy between 
the number of responses, paid transports and responses that do not 
result in a transport, we do not agree with the suggestion to allow for 
multiple ambulances sent to one scene to be counted as multiple 
responses since we do not encourage ground ambulance organizations to 
send more than one ambulance on every call.
    Emergency transfers would be counted in the number of emergency 
responses in Section 6, Question 1, and under their corresponding level 
of service in Question 3. Paid transports should only include those 
where a health insurer or patient paid for some or all of the billed 
charge. Any payments that are offset by tax revenue should not be 
counted in this section since tax revenue is reported separately in the 
revenue section.
    We agree with commenters that it is important to collect 
information on the number of responses that do not result in a 
transport, and understand that some ground ambulance organizations many 
not currently track this information. Due to the importance of this 
information for determining cost, we do not believe that adding the 
response options to report that the information is not available or to 
allow respondents to estimate the share of responses where the patient 
is not transported is appropriate.
    The proposed data collection instrument asks respondents to report 
the share of responses that do not result in a transport for any 
reason, including that the death of the patient. We are collecting 
information on all ground ambulance costs, regardless of whether the 
patient was transported. Given our overarching goal of minimizing 
burden while collecting the data necessary, we believe that existing 
items collecting information on the number of responses that did not 
result in a transport are sufficient.
    After consideration of the comments, we used the Medicare manual 
definitions of Medicare ground ambulance services, clarified the 
definitions of other response and transport categories, and removed the 
Medicare medical necessity requirement from the definition of ``ground 
ambulance transport.'' We also refined the definition of 
``interfacility transport'' in the data collection instrument to 
include transports where ``the origin and destination are one of the 
following: A hospital or skilled nursing facility that participates in 
the Medicare program or a hospital-based facility that meets Medicare's 
requirements for provider-based status. We also added an additional 
question to the data collection instrument that specifically asks for 
interfacility transports that are covered under Medicare Part A where 
the ambulance provider or supplier would seek payment from SNF, 
hospital, or hospice.
    Finally, we clarified the instructions for the definitions of 
response and transports, incorporating the example of an emergency 
transfer.
(3) Collecting Data on Costs
    Section 1834(l)(17)(A) of the Act requires CMS to collect cost 
information from ground ambulance organizations. This section describes 
the data in each cost category that we proposed to collect, as well as 
alternatives that we considered.
    In the proposed rule we stated that the costs reported separately 
in the categories of costs we proposed to collect would sum to an 
organization's total ground ambulance costs. In addition to ground 
ambulance costs, we proposed to ask all respondents in the data 
collection instrument to report their total annual costs (that is, 
operating and capital expenses), inclusive of costs unrelated to ground 
ambulance services, in a single survey item (Section 12, question 1). 
For ground ambulance organizations that do not have costs from other 
activities (such as from operating a fire or police department), the 
reported total costs are a way to cross-check costs reported in 
individual cost categories throughout the data collection instrument, 
and we can compare the reported total to the sum of costs across 
categories. In the proposed rule, we stated that such a

[[Page 62878]]

cross-check may also be appropriate for ground ambulance organizations 
with costs from other activities, as the sum of costs across ground 
ambulance cost categories should always be less than the ground 
ambulance organization's reported total costs. We stated that we 
believed that this cross-check will improve data quality and is 
consistent with existing survey-based data collection tools and that 
this approach would provide a better understanding of the overall size 
and scope of ground ambulance organizations, including activities other 
than providing ground ambulance services and that relatively larger 
organizations may have lower ground ambulance costs due to due to 
economies of scale and scope.
    To avoid reporting the same costs multiple times, we included 
instructions and reminders throughout the data collection instrument to 
avoid double-counting of costs. We stated that from a design 
perspective, we believe it is less important where a particular cost is 
reported on the data collection instrument and more important that the 
cost is reported only once.
    We made two proposals that have important implications for 
reporting in all cost sections in the data collection instrument. 
First, in the case where a sampled organization is part of a broader 
organization (such as when a single parent company operates different 
ground ambulance suppliers), we proposed to ask the respondents to 
report an allocated portion of the relevant ground ambulance labor, 
facilities, vehicle, supply/equipment, and other costs from the broader 
parent organization level in separate questions in several places in 
the cost sections of the data collection instrument (Section 7.2 
question 3, Section 8.2 question 2, Section 8.3 question 2, Section 9.2 
question 5, Section 9.3 question 6, Section 10.2 question 4, and 
Section 11 questions 2 and 5). This scenario is discussed in more 
detail in the sampling section below. In exploratory analyses, we found 
that a small share of NPIs were part of broader parent organizations. 
Due to the rarity of this scenario and the complexity of calculations 
required, we proposed to allow the respondent to report an allocated 
amount directly for these questions using an allocation approach they 
regularly use for this purpose. We stated that while a specific 
allocation approach would yield more uniform and transparent data, we 
believed that these benefits were not worth the additional respondent 
burden.
    Second, we proposed to include a general instruction stating that 
in cases where costs are paid by another entity with which the 
respondent has an ongoing business relationship, the respondent must 
collect and report these costs to ensure that the data reported 
reflects all costs relevant to ground ambulance services. We provided 
examples including when a municipality pays rent, utilities, or 
benefits directly for a government or non-profit ambulance 
organization, or when hospitals provide supplies and/or medications to 
ground ambulance operations at no cost. During interviews with ground 
ambulance organizations, we were told that there are many nuanced 
arrangements that fit this broad scenario. In the proposed rule, we 
stated that although we recognized this would be an additional step for 
some ground ambulance organizations, we are concerned that the lack of 
reported cost data in one of these major categories could significantly 
affect calculated total cost.
    Because some ambulances, other vehicles, and buildings are donated 
to ground ambulance organizations, we stated that we considered asking 
respondents to report fair market values for these vehicles and 
buildings. We stated our concern that the lack of reported cost data in 
one of these major categories could affect calculated total cost, as 
well as our understanding that it is not always clear what cost is 
appropriate to report. To avoid the subjectivity and burden involved in 
asking respondents to report fair market value, we proposed that 
respondents report which ambulances, other vehicles, and buildings have 
been donated, but not an estimate of the fair market value of those 
donations. We stated we believe fair market values could be imputed 
using publicly available sources of data to facilitate comparison of 
data between organizations that have donations and those that do not. 
For the same reasons, we also proposed not to collect an estimate of 
fair market value for donated equipment, supplies, and costs collected 
in the ``other costs'' section of the data collection instrument. We 
stated that for those ground ambulance organizations with costs that 
were paid by another entity with which the respondent has an ongoing 
business relationship, such as a ground ambulance organization that is 
part of or owned by a government entity, respondents would obtain the 
cost information directly from that entity since we would not consider 
these to be donated items.
    We received general comments on collecting data on ground ambulance 
costs. The following is a summary of the comments we received and our 
responses.
    Comment: Commenters were supportive of the categories of costs that 
we proposed for the data collection system. Commenters stated that they 
support collecting total ground ambulance costs across all cost data 
elements, without limiting the costs to those associated with 
transports and as a result, the cost of readiness will be embedded in 
the response for each cost category and then be automatically allocated 
across the services provided. However, one commenter suggested 
including an explicit question to measure readiness costs: Total trip 
time multiplied by total responses divided by total scheduled ambulance 
unit hours (total ambulance labor hours reported for a week divided by 
2 as typically there are 2 personnel on an ambulance).
    Commenters were also supportive of the proposal to have respondents 
report total annual costs that include the operating and capital 
expenses inclusive of costs unrelated to ground ambulance services in a 
single survey question, as well as CMS' efforts to eliminate double-
counting of costs. Several commenters requested clarification that the 
total cost and total revenues section include non-ground ambulance 
related costs/revenues.
    Commenters stated that they in general support the allocation rules 
as proposed. Several commenters recommended collecting costs paid by 
another entity in the data collection instrument and for inclusion in 
any analysis of Medicare margins so that the costs will not be 
artificially low and provided the example of including the labor 
provided by non-transporting organizations at the scene. Another 
commenter was concerned it may be difficult to obtain costs paid for by 
other entities for which they have an ongoing business relationship 
such as a municipality paying for dispatch services.
    Commenters supported CMS' proposal to ask reporting ground 
ambulance organizations that are part of broader parent organizations 
(for example a broader for-profit corporation billing Medicare for 
ground ambulance services under multiple NPIs) to submit information 
related to an allocated share of their parent organization's costs. One 
commenter specifically recommended that CMS use the term ``central 
office'' rather than ``parent organization'' in the data collection 
instrument and suggested that CMS specify a specific allocation 
methodology that respondents must follow in this scenario to avoid 
concerns of differences in how these costs are reported across 
organizations. Another commenter asked that CMS take the

[[Page 62879]]

reported estimates of allocated parent organization costs in good 
faith, without the threat of audits as the data may be difficult for 
organizations to report, particularly in the initial years of data 
collection.
    One commenter requested that respondents be asked to estimate the 
fair market value of any ambulances, other vehicles, and buildings that 
have been donated, rather than relying on CMS or MedPAC to impute these 
values. The commenter stated they believe respondents could be given 
the option of identifying the estimated value as of the year the item 
was donated (and the year it was donated), if that is less burdensome 
than estimating the current value. They thought that respondents would 
be in a much better position to accurately estimate these values than 
CMS or MedPAC.
    One commenter stated that many small ground ambulance organizations 
do not keep track of data on depreciation and was concerned that any of 
the sections asking for depreciation would be difficult to fill out for 
some ground ambulance organizations.
    Response: The survey is designed to collect information on total 
costs, which implicitly captures all costs related to readiness, and 
therefore, we do not believe it necessary to include a separate 
question that requires ground ambulance organizations to calculate a 
readiness cost.
    We believe that while some commenters noted the lack of a standard 
approach to the allocation of costs between ambulance organizations and 
their parent organization or central office could potentially lead to 
differences in how these costs are reported, we do not believe that 
developing a specific, standardized allocation method for these costs 
is necessary, as we expect only a small share of reporting ground 
ambulance organizations to allocate parent organization costs in this 
way.
    The questions for total costs and total revenue currently specify 
that services not related to ground ambulance services should be 
included, but we agree with the commenter suggesting the addition of a 
question on fees paid to other non-transporting organizations for their 
services, when there is an agreement in place to pay for these 
services. However, as we discuss elsewhere in these comments, we 
continue to believe that requiring ground ambulance organizations to 
report on the estimated costs of labor, supplies, vehicles, etc. for 
non-transport vehicles that are `in-kind' donations would be extremely 
burdensome for ground ambulance organizations that do not currently pay 
for these services. However, if a cost that is borne directly by the 
ground ambulance organization or another entity that owns, operates, or 
manages the ground ambulance organization, then that cost is required 
to be reported.
    We acknowledge that certain items such as depreciation will be 
difficult for some agencies to estimate and we will provide additional 
instructions on how to estimate depreciation in the survey 
instructions. However, we disagree with the commenter regarding 
collecting fair market value from respondents because we want to reduce 
any subjectivity and burden involved in asking respondents to report 
fair market value. We continue to believe fair market values could be 
imputed using publicly available sources of data to facilitate 
comparison of data between organizations that have donations and those 
that do not. We believe the data collected on the survey will allow end 
users to infer approximate costs for donated items.
    After consideration of the comments, we added a question to the 
`other costs' section for funds paid to other organizations for 
services (such as non-transporting organizations providing medical 
personnel).
(i.) Collecting Data on Staffing and Labor Costs
    As we discussed in the proposed rule, ambulance organizations told 
us in interviews that labor is one the largest contributors to total 
ground ambulance costs (especially medical staff such as EMTs, 
paramedics, and medical directors). They told us that they use a broad 
mix of labor types and hiring arrangements, and that there is 
significant variation in tracking staffing and labor cost inputs that 
are needed to calculate costs. We were also informed by ambulance 
organizations that data on the number of ground ambulance staff and 
associated labor costs were often available at one of three levels: The 
individual employee level; aggregated by category such as EMT-Basic or 
Medical Director; or aggregated across all staff. Additionally, we were 
told by ambulance providers and suppliers that ground ambulance 
organizations typically face challenges in tracking ground ambulance 
staff and costs by category when staff had multiple ground ambulance 
responsibilities (for example, EMTs with supervisory responsibilities, 
EMTs who are also firefighters, etc.).
    In the proposed rule we stated that we agree that labor costs are 
an important component of total costs and believed that it is necessary 
to collect information on both staffing levels, that is, the quantity 
of labor used, and the labor costs resulting from these labor inputs. 
Without information on staffing levels, we stated we would not be able 
to gauge whether differences in labor costs are due to compensation or 
different levels of staffing. We further stated that collecting 
information on staffing levels allows the use of imputed labor rates 
from other sources (such as the Bureau of Labor Statistics). We also 
acknowledged the practical need to balance the burden involved in 
reporting extremely detailed staffing and labor costs information 
against the usefulness of detailed data for explaining variation in 
ground ambulance costs. Therefore, we proposed to collect information 
in the data collection instrument on the number of staff and labor 
costs for several detailed categories of response staff in Section 7 of 
the data collection instrument. This includes medical staff such as 
EMT-basic, EMT-intermediate, and EMT-paramedic, a single category for 
paid administrative and facilities staff (for example, executives, 
billing staff, and maintenance staff), and a single category for 
medical directors. We stated we believed this approach involves less 
respondent burden compared to reporting on each individual staff 
member. If more detailed categories were used for reporting staffing 
levels and costs, we stated we believed the burden involved in 
assigning paid administrative and facilities staff with multiple roles 
to individual categories or apportioning their labor and costs to 
separate categories would increase.
    We stated that the main limitation of our approach is that we would 
not collect detailed information on specific paid administration and 
facilities labor categories. Therefore, we also proposed to collect 
some information that would help explain variation in labor costs by 
asking whether the ground ambulance organization has some staff in more 
specific paid administration and facilities categories such as billing, 
dispatch, and maintenance staff (Section 7, question 1). We stated this 
question serves as a screening question to determine which response 
options appear to the respondent in several other questions in this 
section of the data collection instrument. We also proposed to ask for 
information on why individual labor categories are not used (Section 7, 
question 1) and if there is at least one individual with 20 hours a 
week or more of effort devoted to specific activities such as training 
and quality assurance (Section 7.2, question 2).

[[Page 62880]]

Reporting Staffing Levels
    In reporting staffing levels in the data collection instrument, we 
stated that we considered several approaches. One approach we 
considered was asking the respondent to report only the number of staff 
(that is, counts of people). Under this approach, a part-time employee 
would count as ``1'' to the number of staff even if they worked a small 
number of hours per week. We stated we believed this approach would 
result in less accurate reporting of labor inputs, especially from 
organizations relying heavily on part-time staff or staff with 
responsibilities unrelated to ground ambulance services. We also 
considered allowing respondents to report full-time-equivalent (FTE) 
staff on a 40-hour per week basis, but ground ambulance organizations 
informed us that reporting FTEs would be burdensome. As a third 
approach, we considered asking respondents to report ground ambulance 
staffing levels in terms of hours over a reporting year. We stated that 
reporting labor hours over the entire reporting year allows for more 
accurate reporting of staff working part-time and may involve less 
burden for respondents that already tally annual labor hours (for 
example, via payroll records), but would likely be difficult for those 
who do not already track labor hours in this manner. As a fourth 
approach, we considered asking respondents to report ground ambulance 
staffing levels in terms of hours worked during a typical week. We 
stated that reporting staffing levels in terms of hours worked either 
over a reporting year or during a typical week allows detailed 
accounting of part-time staff and staff with ground ambulance and other 
responsibilities and involves fewer calculations and adjustments than 
reporting FTEs. We also stated that reporting in terms of hours over a 
typical week has the additional advantage of simplifying reporting for 
staff that start or stop work during the 12-month reporting period. We 
further stated that the main limitation of reporting staffing levels in 
terms of hours over a typical week is that the week that the respondent 
selects for reporting may not be generalizable to other weeks in the 
reporting period.
    In the interest of minimizing reporting burden, we proposed to 
collect information on the number of staff in terms of hours worked 
over a typical week (Sections 7.1 and 7.2). The instructions in the 
data collection instrument asked respondents to ``select a week for 
reporting that is typical, in terms of seasonality, in the volume of 
services that you offer (if any) and staffing levels during the 
reporting year.''
Scope of Reported Labor Costs
    For the purposes of collecting information on labor costs, we 
proposed to define labor costs to include compensation, benefits (for 
example, healthcare, paid time off, retirement contributions, etc.), 
stipends, overtime pay, and all other compensation to staff. We 
referred to these costs as fully-burdened costs. We stated that some 
ambulance providers and suppliers track compensation but not benefits 
because another entity, such as a municipality, pays for benefits, and 
that the ability of these ambulance organizations to report fully 
burdened costs may be limited. We stated that despite this limitation 
and due to the importance of labor costs as a component of total ground 
ambulance costs that we believed information on fully burdened costs 
(Sections 7.1 and 7.2) must be reported so that all relevant ground 
ambulance transport costs are collected. We stated that ground 
ambulance organizations selected to report data may need to implement 
new tracking systems or request information from other entities (such 
as municipalities) to be able to report fully-burdened labor costs.
Volunteer Labor
    In the proposed rule, we stated that ground ambulance organizations 
have also informed us that a significant share of ambulance 
organizations rely in part or entirely on volunteer labor and that the 
systems and data available to track the number of volunteers and the 
time that they devote to ground ambulance services varies. We proposed 
to collect information on the total number of volunteers and the total 
volunteer hours in a typical week using the same EMT/response staff and 
administrative and facilities staff categories used elsewhere in the 
data collection instrument (Section 7.3, questions 1-5). We stated the 
although some suggested that assigning a value to volunteer labor hours 
may be important, the data collection instrument collects information 
only on the amount of volunteer labor (measured in hours in a typical 
week) and not a market value for that labor. We also stated that we 
believed reported hours can be converted, if necessary, to market rates 
using data from other sources. We proposed to collect the total 
realized costs associated with volunteer labor such as stipends, 
honorariums, and other benefits to ensure all costs associated with 
ground ambulance transport are collected (Section 7.3, question 6).
Allocation and Reporting Staff With Other Non-Ground Ambulance 
Responsibilities
    Since firefighter/EMTs are common in many ambulance suppliers, we 
proposed to ask respondents that share costs with a fire or police 
department to report total hours in a typical week for paid EMT/
response staff with fire/police duties only (Section 7.1). In the 
proposed rule, we stated we believed this information could be used to 
subtract a portion of associated labor costs when calculating ground 
ambulance labor costs. We stated we believed our approach is more 
consistent and involves less burden than asking respondents to perform 
their own allocation calculations necessary to report only the hours or 
full-time equivalents related to ground ambulance services.
    As already noted, many ground ambulance organizations have staff 
with responsibilities beyond ground ambulance and fire/police response. 
To account for these scenarios, we proposed to ask respondents to 
report the total hours in a typical week unrelated to ground ambulance 
or fire/police response duties (which are addressed separately as 
described in Section 7.1), as the costs associated with this labor can 
be subtracted by those analyzing the data when calculating ground 
ambulance labor costs. We stated we believed this approach provides 
both transparency and consistency in the data with minimal burden, and 
may avoid scenarios where all of the costs associated with staff with 
limited ground ambulance responsibilities contribute to total ground 
ambulance costs.
    We received comments on collecting data on collecting labor costs. 
The following is a summary of the comments we received and our 
responses.
    Comment: All commenters supported the collecting of information on 
staffing and labor costs. They stated that they agree that labor is a 
major driver of the cost of ground ambulance services; thus, despite 
the fact that it may be difficult for some organizations to report full 
labor-related costs, they should be encouraged to do so to allow CMS 
and others to understand the full cost of labor, including 
compensation, benefits (for example, healthcare, paid time off, 
retirement contributions, etc.), stipends, overtime pay, and all other 
compensation to staff.
    Commenters also stated that understanding and accounting for 
volunteer hours is an important

[[Page 62881]]

component of ground ambulance costs and that they agree with our 
proposals to collect information on the total number of volunteers and 
the total volunteer hours in a typical week using the same EMT/response 
staff and administrative and facilities staff categories used elsewhere 
in the proposed data collection instrument, as well as the decision to 
collect only hours and allow those analyzing the information from the 
data collection instrument to use appropriate proxies for placing a 
value on the cost of volunteer labor. Additionally, they stated that 
they support the CMS proposal to have respondents who also provide fire 
or public safety services to report the hours of their EMTs in a manner 
that will allow those using the data to subtract the portion of the 
associated labor costs that is not attributable to ground ambulance 
labor costs. They stated that the data collection system must ensure 
that the costs used to assess Medicare payment rates are specific to 
the provision of ground ambulance services and not mixed with the costs 
associated with other services that an organization might provide.
    Several commenters made specific recommendations related to the 
definitions used in this section of the data collection instrument. 
Some commenters were concerned that the instruction to exclude staff 
and labor costs related to staff with responsibilities in ``healthcare 
delivery unrelated to ground ambulance'' could be interpreted to 
include EMT and other response staff arriving on the scene via a 
vehicle other than a ground ambulance. Another commenter asked that CMS 
clarify the scope for costs related to volunteer labor ``stipends and/
or benefits''.
    Several commenters made specific recommendations related to 
improving the instructions for this section of the survey. One 
commenter expressed concern that CMS may be biasing certain reported 
staffing and cost information by asking respondents to categorize staff 
based on their roles or certification at the start of the reporting 
period. Other commenters requested clarification on how to report 
information for staff who work in both response and administrative 
roles. One commenter requested clarification on how respondents should 
select a ``typical week'' over which staffing levels should be reported 
and recommended replacing the typical week approach with an approach 
based on dividing hours worked annually by 52. The same commenter also 
requested clarification on how the labor costs associated with medical 
directors should be reported and recommended separate reporting on 
staffing and costs for medical directors who are employees and those 
who are contractors. Another commenter requested clarification about 
the reporting of hours for volunteers who might be on call with pagers.
    Some commenters suggested adding additional items to capture more 
information on how labor from partner organizations (that is, other 
entities sending response and other staff to respond to calls for 
service) contribute to overall responses. One commenter specifically 
suggested that CMS ask for counts of total staff for different types of 
responses so that CMS can better understand different staffing and 
deployment models.
    Several commenters stated that throughout the proposed rule, CMS 
mentioned their intention to calculate the value of services performed 
by volunteer personnel by benchmarking their number of hours served 
against the average wage data collected by the Bureau of Labor 
Statistics. They stated that the Bureau of Labor Statistics' current 
processes for gathering wage information for EMS personnel is 
inaccurate as it pertains to cross-trained firefighter/EMTs and 
firefighter/paramedics. Another commenter suggested using another 
database called Independent Sector to determining the value of 
volunteer labor.
    Response: We thank commenters for their support. We considered 
several alternatives when developing our proposals for collecting 
information on staffing and labor costs, including approaches that 
would have allowed respondents to split reported hours and labor costs 
across multiple staff categories for individual staff with multiple 
responsibilities. While these alternatives could collect more detailed 
information, they would all increase response burden substantially. The 
proposed instructions ensure that all compensation costs are reported, 
and no compensation costs are double counted. The instructions 
accomplish this by aiming to direct respondents to assign each 
individual staff member to only one labor category. While CMS 
recognizes the instructions are lengthy, the aim is to minimize 
necessary calculations and complex data tracking by the respondent.
    It appears that several commenters mistakenly assumed that we 
proposed to collect compensation costs over a typical week rather than 
over the entire annual reporting period. While we did propose to 
collect information on staffing levels over a typical week, the data 
collection instrument collects compensation costs only on an annual 
basis. Collecting annual compensation minimizes some of the concerns 
raised by commenters related to under or over-estimating labor costs in 
a particular category. The distinction between reporting staffing 
levels during a typical week and labor costs over the entire year may 
have introduced unnecessary complication, and therefore, we are 
removing the instruction to report staffing levels during a typical 
week and instead will ask respondents to report staffing levels in 
terms of hours over the entire annual reporting period.
    The proposed data collection instrument instructions ask 
respondents to report costs associated with contracted medical director 
services in Section 11 of the data collection instrument as an ``other 
cost.'' We agree with commenters that separating questions related to 
medical directors is confusing particularly given the fact that 
contracted medical directors are so common.
    In reporting the hours associated with volunteer labor, it was not 
our intention to capture hours on-call while volunteers are at other 
locations or jobs. We intended to capture the hours in service, which 
includes the time from which they receive a call or a page to the time 
they are finished with their call, as well as time spent in the station 
house performing duties as if they were being paid.
    We agree that it would be possible to collect information that 
would help explain differences in staffing and deployment models, 
although collecting this information would add additional burden on 
respondents. The current labor questions collect what we believe is the 
most relevant information to assess how differences in labor inputs 
drive total costs--more specifically, the data collection instrument 
collects information on the total staff and total compensation. We 
agree that it is important to understand the extent to which other 
organizations contribute to responses, for example by providing 
paramedic or other staff to responses that are not paid by the 
organization submitting data. While the proposed data collection 
instrument collects costs related to these arrangements when a payment 
is made, the proposed data collection instrument does not otherwise 
collect information on when such arrangements exist, which we agree 
would be helpful information to include in the data collection 
instrument.
    Comment: One commenter stated that using the Bureau of Labor 
Statistics is one method of valuing volunteer labor but provided an 
alternative method for

[[Page 62882]]

valuing volunteer labor using Independent Sector data. Another 
commenter stated that the BLS' current processes for gathering wage 
information for EMS personnel is inaccurate as it pertains to cross-
trained firefighter/EMTs and firefighter/paramedics. Commenters also 
stated that the definition of stipends and benefits for volunteer labor 
should be broadened to include all forms of compensation from the 
ground ambulance organization such as insurance, stipends, or other 
forms of compensation.
    Response: We did not specify the use BLS or any other source of 
wage data to determine the valuation of volunteer labor in the proposed 
rule in order to provide flexibility in valuing volunteer labor when 
analyzing the data. The data collection instrument collects information 
on volunteer hours and total compensation of any type from the ground 
ambulance organization so we agree that the definition of ``stipends 
and/or benefits'' should be broadened to include all forms of 
compensation from the ground ambulance organization such as insurance, 
stipends, or other forms of compensation.
    After consideration of the comments, we are removing the 
instruction to report staffing levels during a typical week and instead 
will ask respondents to report staffing levels in terms of hours over 
the entire annual reporting period. This will result in reporting 
instructions that are more similar for staffing levels and labor costs. 
We are not changing the instructions that ask respondents to categorize 
each staff member in only one category. While alternative approaches 
could collect more accurate and detailed information, we believe these 
alternatives would involve significant additional burden. We are adding 
new items to the labor section asking (1) whether another organization 
provides staff in certain labor categories (including paramedic, other 
EMT, and other) to responses where the sampled ground ambulance 
organization would transport the patient, and (2) what share of 
responses involve labor from other organizations in these categories. 
We believe these additions will help CMS understand when reported labor 
costs may be lower due to contributions to responses from other 
organizations.
    To minimize confusion and potential double-counting of costs 
associated with medical directors, we are moving the specific question 
related to contracted medical director service costs from the other 
costs section, Section 11, to the labor section, Section 7, in the data 
collection instrument. We are editing the definition of ``stipends and/
or benefits'' in relation to volunteer compensation to include all 
compensation provided by the ground ambulance organization. 
Organizations should only report the costs they pay for a medical 
director, not an estimated true cost for the value of that medical 
director's labor. We will also clarify the instructions surrounding the 
calculation of volunteer hours to include time spent in service for all 
volunteers. We are also editing the instructions in this section to 
clarify that staff participating in ground ambulance responses should 
be included regardless of how they arrive on the scene.
(ii.) Collecting Data on Facility Costs
    Facility costs may include rent, mortgage payments, depreciation, 
property taxes, utilities, insurance, and maintenance, and the 
associated costs vary widely across ambulance providers and suppliers. 
Some ground ambulance organizations own facilities while for others, 
rent, mortgage, or leasing is an important component of total 
operational costs. Some ground ambulance organizations share facilities 
with other operations (such as fire and rescue services), and 
individual ground ambulance organizations often operate out of several 
facilities of different types, sizes, and share of space related to 
ground ambulance operations.
    In the proposed rule, we considered requiring respondents to report 
facility costs aggregated across all facilities. We stated we believed 
this approach would minimize burden on the respondent by eliminating 
the need to break costs down by facility but that it may also increase 
the risk for inconsistencies in how respondents report total facilities 
costs. We stated that under this approach, respondents whose ground 
ambulance organizations share operational costs with a fire department 
or other entity would need to calculate and report an estimate of 
facilities costs that was relevant only to ground ambulance services.
    We also considered requiring respondents to report all costs on a 
per-facility basis. We stated we believed this approach would allow the 
most flexibility in reporting complex facility arrangements from ground 
ambulance organizations operating out of multiple facilities. We 
further stated that this approach may also involve more burden, 
particularly for larger organizations, to report costs on a facility-
by-facility basis, and many organizations do not track costs such as 
maintenance or utilities on a per-facility basis.
    We proposed a hybrid approach involving both per-facility and 
aggregate reporting of different information. We stated that first 
respondents report the total number of facilities (Section 8., 
questions 1-2) and then indicate for each facility whether they paid 
rent, mortgage, or neither during the reporting period, total square 
footage, and share of square footage related to ground ambulance 
services (Section 8.1, question 3); second, respondents report their 
per-facility rent, mortgage, or annual depreciation (Section 8.2); and 
third, respondents report facilities-related insurance, maintenance, 
utilities, and property taxes aggregated across all facilities (Section 
8.3).
    We stated that we believe this approach allows for the collection 
of the information needed to calculate a total facilities cost related 
to ground ambulance services while avoiding a burden on respondents to 
calculate allocated facility costs. We stated that total insurance, 
maintenance, utility, and property tax costs can be allocated using 
reported square footage and shares of square footage related to ground 
ambulance services. We further stated that the approach requires 
respondents to provide both the square footage of each facility, and 
the share of square footage for the facility that is related to ground 
ambulance operations. We stated that we expect some ground ambulance 
organizations would have this information available and others would 
need to collect this square footage information to report along with 
facilities costs, but did not believe this information would will be 
difficult to collect.
    We received comments on collecting data on facility costs. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters stated that they support the proposals 
related to facility costs and had no additional suggestions. One 
commenter requested further guidance on how ground ambulance 
organizations should interpret the percentage of their facility square 
footage directly attributable to ground ambulance services. They asked 
if CMS is just looking for the space used to park the ambulance and 
store EMS supplies, how ground ambulance organizations should 
categorize common spaces, and what portion of the chief's office should 
be designated as being attributable to ground ambulance services.
    Response: We are not specifying a particular methodology for 
calculating the percent of square footage attributable to ground 
ambulance services, in order to reduce the burden on organizations who 
might have a particular method in place already. The

[[Page 62883]]

instructions in Section 8 of the data collection instrument ask for the 
total square footage of the facility and the percentage of the facility 
related to ground ambulance services. The entire square footage of the 
facility should be reported in the first case.
    After consideration of the comments, we provided additional 
examples for clarification on how a ground ambulance organization 
should report the percentage of the facility attributed to ground 
ambulance services in the data collection instrument.
(iii.) Collecting Data on Vehicle Costs
    Section 1834(l)(17)(A)(ii) of the Act requires CMS to collect 
information on ``the utilization of capital equipment and ambulance 
capacity.'' We proposed to collect information on the number of ground 
ambulances and other vehicles related to providing ground ambulance 
services, as well as the costs associated with these vehicles to meet 
these requirements.
    In the proposed rule, we stated that ambulance organizations 
operate ground ambulances, as well as other vehicles to support their 
ground ambulance operation, and some may have a variety of other 
vehicles that are associated with ground ambulance responses. We 
provided the example of a fire truck staffed with fire personnel cross-
trained as EMTs that may respond with a ground ambulance to an 
emergency call. We stated that other vehicles might be used in 
responses and may be referred to as a non-transporting EMS vehicle, a 
quick response vehicle, a fly-car, or an SUV that carries a paramedic 
to meet a BLS ambulance from another organization during the course of 
a response.
    We considered two alternatives for collecting vehicle costs in the 
proposed rule. One alternative was to only include the costs for 
ambulances and exclude other certain non-ambulance response vehicles 
from reported costs. We stated that we believe that excluding other 
certain non-ambulance response vehicles from reported costs could 
potentially result in underreporting of total ground ambulance costs, 
particularly among those providers or suppliers that rely heavily on 
these vehicles to support their ground ambulance services. Another 
alternative we considered was to include the costs of all vehicles that 
are used as part of ambulance services, such as quick response vehicles 
that are used to supplement ambulances.
    For all vehicles, vehicle costs can be reported either in aggregate 
or on a per-vehicle basis. We stated that we believe that while 
reporting vehicle costs in aggregate may involve less burden for some 
respondents, those respondents that do not track aggregated costs would 
still require a tool to enter information on per-vehicle basis. 
Furthermore, we stated we believed that aggregated costs for vehicles 
other than ground ambulances offer analysts with fewer alternatives to 
allocate a share of vehicle costs to ground ambulance services.
    We proposed to collect data on vehicle costs in the data collection 
instrument in two parts: Ground ambulance vehicles (Section 9.1); and 
all other vehicles related to ground ambulance operations (Section 
9.2). For ground ambulance vehicles, we proposed to collect information 
on the number of vehicles, total miles traveled, and per-vehicle 
information on annual depreciated value (and remounting costs if 
applicable) for owned vehicles, and annual lease payments for rented 
vehicles (Section 9.1, questions 1-4). We considered proposing to 
collect the necessary information to calculate annual depreciated value 
using a standardized approach. However, we proposed to allow 
respondents with owned vehicles to use their own accounting approach to 
calculate annual depreciated value per vehicle. We stated we believed 
that allowing flexibility for respondents to use their standard 
approach for this calculation would result in more accurate data and 
less reporting burden.
    We also proposed to use a similar approach to collect per-vehicle 
information for owned and leased vehicles of any other type that 
contribute to ground ambulance operations, including fire trucks, quick 
response vehicles, all-terrain vehicles, etc. (Section 9.2, questions 
1-5). We stated that the proposed instructions in Section 9.2 of the 
data collection instrument specified that reported vehicles must 
support ground ambulance services. We proposed to collect the type of 
each vehicle in broad categories in addition to the annual depreciated 
value or lease payment amount for each vehicle.
    In addition to the above costs, we also proposed to collect 
aggregate costs associated with licensing, registration, maintenance, 
fuel, insurance costs for all vehicles combined (ambulance and non-
ambulance) (Section 9.3, questions 1-5). We stated we believe that 
these costs are often aggregated within providers' and suppliers' 
records and that reporting in aggregate form may reduce respondent 
burden with minimum risk for reporting error.
    When estimating total ground ambulance vehicle costs for ground 
ambulance organizations that share operational costs with fire and 
police response or other non-ground ambulance activities, we stated 
that a share of vehicle costs reported via the data collection 
instrument will need to be allocated as vehicle costs related to ground 
ambulance services. One alternative we considered to do this was simply 
to ask respondents about the share of costs associated with ground 
ambulance services as we thought this would be the least burdensome 
approach; however, we stated that we believed data collected in this 
manner would not allow for estimation of costs associated with non-
ground ambulance vehicles that support ambulance services. We 
considered another alternative where (1) the ratio of ground ambulance 
to total responses would be used to allocate costs associated with non-
ambulance vehicles, (2) the total number of vehicles would be used to 
allocate aggregate costs associated with licensing, registration, 
maintenance, and fuel costs, and (3) depreciated annual costs and/or 
lease payment amounts would be used to allocate insurance costs. We 
stated that the main limitation of this approach is that maintenance 
and fuel costs could vary significantly across vehicle categories. We 
provided the example that maintenance and fuel costs may be 
significantly different for ground ambulance than for other types of 
vehicles. As a result, we proposed a modification of this alternative 
where we also ask respondents to list percent of total maintenance and 
fuel costs attributable to each type of vehicle (that is, ground 
ambulances, fire trucks, land rescue vehicles, water rescue vehicle, 
other vehicles that respond to emergencies such as quick response 
vehicles, and other vehicles; Section 9.3, questions 4 and 5). We 
proposed to also ask respondents to report total mileage for ground 
ambulance (land and water separately) and total mileage for other 
vehicles related to ground ambulance responses (land and water 
separately) as a potential alternative means to allocate fuel and 
maintenance costs.
    We received comments on collecting data on vehicle costs. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters stated that they generally support the 
approach to collect vehicle cost data. Many commenters stated that they 
agree it will be easier for ground ambulance organizations to track 
their total vehicle costs and report that information than try to 
allocate the vehicle costs between ``loaded'' (or response) hours/miles 
and the costs incurred when the vehicles are not being used to respond 
directly to a

[[Page 62884]]

request for service (for example, a 911 call). They stated that this 
approach would work across the major cost centers outlined in the 
proposed rule. They stated that they understand that CMS has sought to 
strike a balance between asking for detailed information and not 
imposing an overwhelming burden on ground ambulance organizations. They 
stated that while they believe it may overstate the costs to aggregate 
those associated with licensing, registration, maintenance, fuel, 
insurance costs for all vehicles combined, both ambulance and non-
ambulance, they appreciate the interest in reducing the burden on 
respondents when reporting such information. They stated that they also 
support differentiating between vehicles that function as ground 
ambulances and those that do not. They requested clarification on 
whether the definition of a ground ambulance refers to the CMS 
definition or to the definitions that apply in the respondent's state 
or locality. One commenter suggested adding more general examples of 
non-ambulance vehicles.
    One commenter requested clarification about how to handle the 
reporting of fire trucks specifically, in cases where a fire truck with 
EMS personnel may be sent to the scene as part of a response. This fire 
truck could be owned by the organization filling out the survey, or 
another non-transporting fire truck from a different organization. This 
same commenter also requested clarification on how to report insurance 
costs when these may be paid by another agency, such as a state agency 
that purchases insurance on behalf of all of the vehicles in its fleet.
    Response: We agree that it is important to balance burden on 
respondents with the level of detail of vehicle data reported in this 
section. While some data, for example licensing, registration, 
maintenance, fuel, insurance costs, could be collected in more detail 
in relation to ground ambulance services, we believe that alternatives 
to collect more detailed data would involve significant additional 
burden. Our intention is for organizations to report the ambulances 
that qualify as such in their jurisdiction. We expect that most of 
these ground ambulances would meet CMS' definition of a ground 
ambulance.
    It is our intention in the vehicles section to collect data on the 
costs of vehicles associated with the reporting organization only. This 
may include fire trucks if the fire trucks are sent to the scene with 
EMS personnel. If there are no firefighters co-trained as EMS 
personnel, then these fire trucks are not related to ground ambulance 
service and should not be included. If an organization is assisted by 
another organization at the scene (such as from a different fire 
department), the costs associated with these vehicles would not be 
included. We state elsewhere in these comments that we will add an 
additional question to the miscellaneous costs that allows 
organizations to report fees paid to other non-transporting 
organizations for their services. We believe that it would be too much 
additional burden to ask organizations to assess the costs of providing 
services for organizations other than their own.
    For insurance, fuel or other vehicle-related costs, we ask that 
organizations ask the agency providing these items for an estimate of 
their cost.
    After consideration of the comments, we added more general examples 
of non-ambulance vehicles, such as sport utility vehicles and pickup 
trucks used to support ground ambulance services, which should be 
included in reporting in this section. We also clarified in the data 
collection instrument that respondents should report on all ground 
ambulance vehicles that meet local and state requirements.
(iv.) Collecting Data on Equipment and Supply Costs
    In our interviews with ground ambulance organizations, we were told 
that not all ground ambulance organizations would be able to report 
detailed item-by-item equipment and supply information, and that some 
organizations have far more sophisticated inventory tracking systems 
than others that would allow them to report detailed information within 
a category.
    In the proposed rule, we stated we considered alternative 
approaches related to reporting equipment and supply costs that varied 
primarily on the level of detail for reporting. We considered extremely 
detailed data reporting as it would be potentially useful to identify 
variability in costs across organizations. However, as noted above, we 
stated that many ground ambulance organizations may not keep detailed 
records of all their individual equipment and supply costs. Taking 
those factors into account, we proposed to request total costs in a 
small number of equipment and supply categories rather than itemized 
information for all equipment and supply categories (Section 10). We 
stated these would include:
     Capital medical equipment.
     Medications.
     All other medical equipment, supplies, and consumables.
     Capital non-medical equipment.
     Uniforms.
     All other non-medical equipment and supplies.
    We also considered whether to have respondents report both medical 
and non-medical equipment and supplies together. We stated that we 
believed that the majority of medical supplies are more likely to be 
related to ground ambulance services than non-medical supplies for 
organizations with shared services, and therefore, we proposed to 
collect this information separately.
Reporting of Capital Versus Non-Capital Equipment
    To meet the requirement in section 1834(l)(17)(A)(ii) of the Act to 
collect information to facilitate the analysis of ``the utilization of 
capital equipment,'' we proposed to separately collect information on 
capital equipment expenses (rather than equipment-related operating 
expenses). Capital equipment (both medical and non-medical) yield 
utility over time, which we stated can vary depending on the expected 
service life of the specific good. We stated that in addition to the 
cost of purchasing or leasing durable goods equipment, depreciation and 
maintenance costs must be considered in the total cost calculations. 
Since ground ambulance organizations often track capital equipment on 
an itemized level, separating items of significantly different age and 
cost is necessary to calculate depreciation. Therefore, to minimize 
burden by aligning reporting with the accounting approaches used by 
respondents, we proposed to ask for capital (Section 10.1, question 1; 
Section 10.2, question 1) and non-capital costs (Section 10.1, 
questions 2-3; Section 10.2, questions 2-3) separately so that 
respondents could report annual depreciated costs for capital equipment 
and total annual costs otherwise. We also proposed to allow respondents 
to report annual maintenance and service costs for capital equipment 
because ground ambulance organizations have stated during interviews 
that these costs can be significant compared to purchase costs or 
annual depreciated costs. Finally, we proposed to allow respondents to 
use their own standard accounting practice to categorize equipment as 
capital or non-capital. We stated that while we believe it would be 
possible to ask respondents to use a standard approach, we believed 
this would require respondents with another practice to recalculate 
annual depreciated cost and potentially increase respondent burden and 
reporting errors.

[[Page 62885]]

Allocation of Shared Costs
    During interviews with ground ambulance organizations, it was noted 
that although the vast majority of equipment and supplies are for 
ground ambulance services, some costs are shared with hospitals or 
clinics. We stated that we believed separate reporting on medical and 
non-medical equipment and supplies would facilitate allocation (Section 
10.1, versus Section 10.2). For organizations that indicate the use of 
shared services, we proposed to ask separately what share of medical 
and non-medical equipment and supply costs are related to ground 
ambulance services (Section 10.1, questions 1c, 2a; Section 10.2, 
questions 1c, 2a, 3a). We stated the share of non-medical equipment and 
supplies used for ambulance services may vary for respondents with 
operations beyond ambulance services. While other allocation methods 
(such as the share of responses that are ground ambulance responses) 
may be appropriate to allocate equipment and supply costs, asking 
respondents to provide their estimate of the share of equipment and 
supply costs related to ambulance services reduces assumptions made 
about how best to apply allocation across the various equipment and 
supplies reported.
    We received comments on collecting data on equipment and supply 
costs. The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters expressed a desire to work with CMS to 
develop additional categories for the cost of equipment, consumables, 
and supplies for future surveys that would allow policy-makers to 
address high-cost products or patients who require services resulting 
in higher costs. They stated that they support the differentiation 
between capital and non- capital equipment, as well as the proposed 
allocation rules, and questioned whether nebulizers, which are devices 
for producing a fine spray of liquid for inhaling a drug, should be 
considered capital equipment. Another commenter stated that some 
organizations may not separately report medication costs from other 
supplies and equipment, and questioned why this was important to 
separate.
    Response: While there are many other potential equipment and supply 
categories that could have been added separately to this section, in 
the interest of balancing the level of detail collected in the data 
collection instrument with burden, we decided to limit this section to 
only a small number of specific types of supplies and equipment (such 
as drugs) for which we proposed to collect costs separately. We believe 
that the data collected through the data collection instrument may 
point to opportunities for additional refinement in this section in 
future years of data collection. For example, rather than collect 
information on all drugs in aggregate, reporting by category of drug or 
even for individual drugs may provide useful information. Still, given 
the fact that information on ground ambulance costs is limited, we 
believe the appropriate first step is to collect higher-level cost 
information. We also agree with the commenters that items such as 
nebulizers should be considered non-capital equipment as they are 
typically a single usage device when used by ground ambulance providers 
and suppliers. In the process of developing the survey, we heard from 
many organizations about the increasing cost of medications and as a 
result, we requested these items to be reported separately. We 
recognize that some organizations may not be able to separate their 
drug costs from other medical consumables, so this question is optional 
on the survey.
    After consideration of the comments, we removed the example of 
nebulizers from the capital equipment section.
(v.) Collecting Data on Other Costs
    In addition to core costs for ambulance providers and suppliers 
that are associated with labor, vehicles, facilities, and equipment or 
supplies, ground ambulance organizations have indicated that these 
entities incur costs associated with contracted services (for example, 
for billing, vehicle maintenance, accounting, dispatch or call center 
services, facilities maintenance, and IT support), as well as other 
miscellaneous costs (for example, administrative expenses, fees and 
taxes) to support ground ambulance services.
    In the proposed rule, we considered including contracted services 
as part of the labor section, since many of the contracted services 
related to costs that would otherwise be labor-related if the tasks 
were performed by employed staff. However, we were concerned that 
ground ambulance organizations might report this information in 
multiple data collection instrument sections (for example, both labor 
and miscellaneous costs). As a result, we separated contracted services 
into their own categories. While we considered allowing respondents to 
report in the aggregate any other miscellaneous costs associated with 
ground ambulance services because we stated we believed this approach 
may be less burdensome for organizations that track miscellaneous costs 
in aggregate, we stated we believed this would introduce a large amount 
of reporting bias and inconsistency in reporting across organizations. 
In the proposed rule, we made several proposals related to reporting 
contracted services and miscellaneous costs as described below.
Reporting Contracted Services
    For contracted services, we proposed that respondents indicate 
whether their organization utilizes contracted services to support a 
variety of tasks (Section 11, question 1), the associated total annual 
cost for these services, and the percentage of costs attributable to 
ground ambulance services. The data collection instrument provided 
instructions to ensure that respondents do not report on contracted 
costs multiple times.
Reporting of Miscellaneous Costs
    For other miscellaneous costs not otherwise captured in prior 
sections of the data collection instrument, we proposed that 
respondents be able to report additional costs first using an extensive 
list of other potential cost categories (Section 11, question 2) and 
then use write-in fields if necessary. We stated that providing a pre-
populated check list would help ensure the consistency and completeness 
of reporting across respondents.
Allocation of Miscellaneous Shared Costs
    Information from ground ambulance organizations indicates that 
there are a number of miscellaneous costs associated with the overall 
operation of organizations that are shared across services. To account 
for these shared costs, we proposed that respondents report an 
allocation factor for each contracted service, (Section 11, question 
1), as well as for each reported miscellaneous expense (Section 11, 
questions 3-4) as described in the data collection instrument. We 
considered the alternative of asking for an overall share of 
miscellaneous costs associated with ground ambulance services or 
utilizing information gathered about the share of ground ambulance 
responses versus total responses to determine an overall allocation 
factor. We stated that while this would present less burden on 
respondents, the share of miscellaneous costs and share of contracted 
services varies widely across organizations with shared services.
    We received comments on collecting data on other costs. The 
following is a summary of the comments we received and our responses.

[[Page 62886]]

    Comment: Many commenters supported the proposed data elements for 
other costs, but as noted with regard to labor, they requested 
clarification as to the allocation of medical director fees to ensure 
there is no double-counting between the two sections.
    Several commenters stated that Section 11, Question 3 (advertising 
expenses) of the data collection instrument directs respondents to 
provide information on a variety of general and miscellaneous costs. 
They stated they believe CMS should clarify what is meant by the 
``Advertising'' category of expenses because it is unclear whether this 
is generic advertising to the public or if this would be inclusive of 
advertising conducted in order to recruit volunteer personnel. 
Additionally, they thought CMS should clarify which advertising 
expenses this includes (print, television, radio, online/social media, 
trade show exhibitions, promotional items such as shirts and stickers, 
etc.).
    Another commenter suggested that CMS collect information about 
unpaid transports (excluding charitable care) and/or uncompensated 
health care services when no transport is involved. They stated that 
they recognize that Section 5 in the data collection instrument asks 
about the volume of paid transports. They stated that it is not clear 
that information about the actual costs associated with unpaid 
transports could be determined through the other questions at this time 
but that this information is essential to understand how the 
limitations in the current Medicare benefit have a negative impact on 
overall Medicare costs. They also stated that this information would 
also help policy-makers assess how unpaid services could be addressed 
in the future. They stated that they believe that this information 
should be distinguished from bad debt or charitable care, because the 
former implies the inability to collect coinsurance amounts, while the 
latter indicates services provided to those without insurance or funds 
to pay for the services. This unpaid category would be focused on 
transports or services provided to patients with insurance, but for 
which the insurance company refuses to pay.
    One commenter suggested that costs for franchise fees needed to be 
collected in the survey because franchise fees are costs some 
organizations pay local governments to operate within the jurisdiction. 
The same commenter advised that dispatch costs would be difficult to 
capture for rural organizations because dispatch services are generally 
run by a central entity such as county government. Finally, one 
commenter requested clarification on what was included in `total costs' 
and `total revenues' as to whether this included total costs and 
revenues from organizations with shared services.
    Response: As noted in our response to comments in the labor 
section, we are moving the reporting of contracted medical director 
services to the labor section to avoid potential confusion and double-
counting. More generally, the proposed data collection instrument 
included an instruction in the contracted labor section to not report 
funds that had already been reported elsewhere in the survey. We agree 
with the comment suggesting clarifications to the definition of 
advertising. While the proposed data collection instrument collects 
some information relevant to uncompensated care, we did not intend to 
directly collect respondents' estimates of uncompensated care. The data 
collection instrument does collect information on the total costs borne 
by the ground ambulance organization, including costs related to 
transports for which no or partial payment is received. The data 
collection instrument also collects information on the total number of 
transports for which payment is received versus total transports.
    In response to the suggestion to add a question to collect 
information on franchise fees, we wanted to highlight that this data 
item is already being collected in the section on other costs, which 
reads as follows: ``Fees paid to local jurisdictions required as 
condition of providing ground ambulance service.''
    We intended the total costs and total revenues to incorporate the 
full totals for each question. This means that for organizations with 
shared services, they would report their full operating and capital 
costs, and revenues, even for the portions of their business unrelated 
to ground ambulance service. For example, a fire department also 
operating an ambulance service would answer this question with their 
total cost and total revenue across the whole organization. For 
organizations without shared services, their total costs will match 
those reported in the data collection instrument. For organizations 
with shared services, their total costs will be higher than those 
reported in the data collection instrument.
    After consideration of the comments, we clarified the definition of 
advertising to include any type of advertising (even for recruiting 
purposes) in any medium (print, radio, internet, etc.). We also added 
additional clarification to the questions for total costs and total 
revenues.
d. Data Collection on Revenue
    Section 1834(l)(17)(A) of the Act requires the development of a 
data collection system to collect revenue information for ground 
ambulance provider and suppliers. Payments from Medicare and other 
health care payers are important components of total revenue for some 
ambulance providers and suppliers. Most ambulance providers and 
suppliers also have other sources of revenue in addition to payments 
for billed services. Based on review of existing literature and 
discussions with ground ambulance organizations, these primary sources 
of revenue include, but are not limited to: Patient out-of-pocket 
payments; direct public financing of fire, EMS, or other agencies; 
subsidies, grants, and other revenue from local, state, or federal 
government sources; revenue from providing services under contract; and 
fundraising and donations. In the proposed rule we stated that we view 
total revenue as the sum of payments from health care payers and all 
other sources of revenue, including those listed above.
    We stated that while collecting information on total revenue is 
essential to understanding variations in how EMS services are financed 
across the country, this information is not collected by Medicare or by 
any other entity of which we are aware. Similar to other sections of 
the data collection instrument, we stated that we also considered what 
level of data to request in this section. We proposed to ask for total 
revenue in aggregate (Section 13, question 1) and total revenue from 
paid ground ambulance transports for Medicare and, if possible, broken 
down by payer category for other payers (Section 13, questions 2-5). We 
proposed this level of detail because we believe understanding payer 
mix would be helpful to assess Medicare's contributions to total 
revenue. We stated that based on information provided by ambulance 
providers and suppliers, there is variation in how patient-paid amounts 
were recorded in ambulance billing systems. We proposed to ask 
respondents whether revenue by payer includes corresponding patient 
cost sharing or whether cost-sharing amounts are included in a self-pay 
category. For other revenue (for example, contracts from facilities and 
membership fees (such as those associated with community members that 
enroll in ambulance clubs), we proposed to request information on 
additional revenue in predetermined categories and using write-in 
fields if necessary (Section 13, question 5).

[[Page 62887]]

    Allocation of Shared Revenues. Ground ambulance organizations vary 
widely in the types of other revenue sources (as noted in Section 13, 
question 6) they receive and their share of allocated costs. For this 
reason, we proposed to have respondents report the share of revenue for 
each category that is attributable to ground ambulance services 
(Section 13). Similar to miscellaneous costs, we considered the 
alternative of asking for an overall share of other revenue sources 
associated with ground ambulance services or utilizing information 
gathered about the share of ground ambulance responses versus total 
responses to determine an overall allocation factor. While this would 
present less burden on respondents, we stated that we did not believe 
it would adequately capture the revenue only associated with ground 
ambulance services, especially for organization with shared services.
    To collect information on uncompensated care, including charity 
care and bad debt, we proposed to collect information on both total and 
paid transports. We stated these two measures of volume can be used to 
provide insight into the share of transports that are not paid. The 
data collection instrument broadly collects information on total costs 
(including costs incurred in furnishing services that are ultimately 
paid and not paid) and total transports (again including transports 
that are both paid and not paid). We stated that the collected data 
could be used to estimate per-transport costs that can be estimated by 
dividing total costs by total transports, so we do not believe it is 
necessary to directly collect information on uncompensated care in the 
revenue section of the data collection instrument.
    We invited comments on collecting revenue. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported the collection of ground 
ambulance revenue from different types of payers, as well as the 
collection of other sources of revenue. These commenters asked that CMS 
divide Medicaid revenue by traditional Medicaid and Medicaid managed 
care, similar to the separate lines for Medicare fee-for-service and 
Medicare Advantage and recommend that CMS define the term ``ambulance 
club,'' which they stated is not a standard term.
    Several commenters asked CMS to add a revenue category to Section 
13, Question 5 in the data collection instrument to collect in-kind 
contributions (including labor, supplies, medications, etc.) provided 
by another agency which responds to calls for emergency service in 
conjunction with the ground ambulance organization completing the data 
collection instrument. Commenters would like respondents to select yes 
or no, enter the dollar amount, and enter a percentage. They stated 
that fire departments often provide EMS care to patients, including at 
the ALS level, even when another agency provides the actual ground 
transportation services to a patient and when this occurs, the fire 
department's ALS personnel often continue providing patient care inside 
the third-party ambulance during transportation to the hospital. They 
stated that this continuation of patient care by fire department 
personnel constitutes a significant savings to the third-party 
transportation company as they do not incur the costs associated with 
the fire department employee(s) such as salary, benefits, and 
insurance. They also stated that in many cases, the fire department 
never receives reimbursement for these costs by the third-party ground 
ambulance agency. They stated that since the data collection instrument 
only will apply to Medicare-enrolled ground ambulance agencies that 
they believe that the data collection instrument should count these 
services as in-kind contributions to the third-party ambulance agency. 
Commenters further stated that ground agencies selected for sampling by 
CMS each year can easily gain this information by requesting it from 
the agencies which commonly respond to calls for emergency service with 
the third-party ground ambulance agency.
    Several commenters stated that Section 11, Question 5 seeks 
information from respondents on several revenue categories which may 
apply to an ambulance supplier or provider. They stated that since the 
goal of the data collection instrument is to assess the adequacy of 
CMS' reimbursements for the cost of providing patient care, they 
believed that the inclusion of tax revenue for public agencies could 
lead to the inclusion of unrelated data. They stated that operating 
revenue that is derived from taxation and provided to public agencies 
represents the level of service expected by a community but is not 
expected to be a dollar-for-dollar coverage of patient care costs and 
that these funds should supplement, not supplant, CMS' reimbursements 
to public agencies for the care that they provide to Medicare 
beneficiaries. They also stated that they believed that tax-derived 
subsidies should be reported by respondents when these funds are 
included in a larger contract between a local government and a private 
entity. They stated that in these cases, these subsidies are 
intertwined with the overall structure and terms of the contract but 
that they do support the requirement for respondents to report when 
revenue is received by any agency (public or private) through an EMS-
specific tax and as a result, they recommend that CMS adopt changes to 
Section 13, question 5.
    Another commenter suggested that donations to organizations that 
support volunteers should be considered in the revenue section. This 
same commenter also requested clarification as to whether patient self-
pay includes the uninsured or uncovered transports.
    Response: We agree that it would be informative to distinguish 
between traditional FFS Medicaid and Medicaid managed care revenue and 
will add that option to the instrument. We use the term `ambulance 
club' to describe a membership organization where local residents pay a 
regular fee for ambulance service not provided by their local 
governments. We do not agree with the commenter suggesting to collect 
information on the in-kind subsidies provided by other, non-
transporting agencies who assist the reporting organization at the 
scene or while transporting patients. We believe this additional 
question will add substantial burden for organizations who must collect 
it, as this requires valuing the other organization's labor, supplies, 
vehicles, facilities, etc., and this information will be captured in 
the cost sections if there is a contract between the organizations for 
reimbursement.
    The data collection instrument is designed to capture the costs of 
operating a ground ambulance service, consistent with our statutory 
requirements and we do not believe that including donations to other 
organizations would be appropriate to include. Donations, payment, or 
benefits made by other entities that support staff or other services 
that are out of scope for this data collection are also out of scope 
when reporting revenue. The patient self-pay revenue section is 
intended to capture payments patients made to the ambulance 
organization for a transport that was covered or not covered by their 
health insurer.
    We are required to collect information on revenue received by 
ground ambulance organizations. Therefore, we do not agree that tax 
revenue for public agencies should be excluded from the data collection 
instrument because omitting questions related to this source

[[Page 62888]]

of revenue from that data collection instrument would result in an 
incomplete picture of revenue across different types of ground 
ambulance organizations. The data collection instrument collects 
information separately on tax revenue for public agencies and from 
contracts between local governments and ground ambulance organizations.
    After consideration of the comments, we clarified the meaning of an 
ambulance club and added an option to separately report Medicaid 
Managed care revenue. We also added an option to separately report 
contract revenue from local governments, as well as tax revenue from 
local governments, and clarified that self-pay refers to non-covered 
transports.
    After consideration of the comments regarding the data collection 
instrument, we are finalizing our proposals regarding the format, 
scope, costs and revenue with several modifications or clarifications 
as described in the sections above.
5. Final Policies for Sampling
    Section 1834(l)(17)(B)(i) of the Act requires that CMS identify the 
ground ambulance providers and suppliers organizations that would be 
required to submit information under the data collection system, 
including the representative sample. Section 1834(l)(17)(B)(ii)(II) of 
the Act requires the representative sample must be representative of 
the different types of providers and suppliers of ground ambulance 
services (such as those providers and suppliers that are part of an 
emergency service or part of a government organization) and the 
geographic locations in which ground ambulance services are furnished 
(such as urban, rural, and low population density areas). Under section 
1834(l)(17)(B)(ii)(III) of the Act, the Secretary cannot include an 
individual ambulance provider and supplier in 2 consecutive years, to 
the extent practicable. In the proposed rule, we stated that in 
addition to meeting the requirements set forth in the statute, 
including developing a reprentative sample, our proposals around 
sampling aim to balance our need for statistical precision with 
reporting burden. We also stated that our we developed our proposals 
with the intention of obtaining statistical precision with the least 
amount of reporting burden.
    Eligible Organizations. In the proposed rule, we stated that a 
sampling frame drawing on all ground ambulance organizations in the 
United States and its territories that provide ground ambulance 
services (that is, not just those enrolled in Medicare or billing 
Medicare in a given year) may be of interest conceptually, but that we 
have not identified a data source listing all ambulance providers and 
suppliers that could be used as the source for a broader sampling 
frame. Since sections 1834(l)(17)(A) of the Act requires the Secretary 
to collect cost, revenue, and utilization information from providers of 
services and suppliers of ground ambulance services (which are Medicare 
specific terms with specific meaning) with the purpose of determining 
the adequacy of payment rates and section 1834(l)(17)(D) of the Act 
requires the Secretary to reduce payments to ground ambulance 
organizations that do not sufficiently report, we stated we believe 
that the intent of the statute is to collect information under the data 
collection system from ground ambulance organizations that bill 
Medicare. Therefore, we proposed to sample ground ambulance 
organizations that are enrolled in Medicare and that billed for at 
least one Medicare ambulance transport in the most recent year for 
which we have a full year of claims data prior to sampling. Since 
ground ambulance organizations have a full year to submit their claims 
to Medicare after the date of service, claims data for a calendar year 
are generally not considered complete until the end of the following 
calendar year. We stated that as a result, we would use 2017 Medicare 
claims and enrollment data to determine the sample for the 2020 data 
collection period because 2018 Medicare claims data could not be 
considered complete in late 2019 when the sample for the 2020 data 
collection period would be selected.
    Sampling at the NPI level: Section 1834(l)(17) of the Act 
prohibits, to the extent practicable, sampling the same ambulance 
provider or supplier in 2 consecutive years. Although we stated we 
considered sampling at a broader parent organization level for those 
that bill Medicare under more than one NPI, we stated we found it was 
difficult to tease out of the Medicare enrollment data all the 
complexities of the business relationships and identify all NPIs that 
may be affiliated with the same parent organization. Therefore, we 
proposed to select the sample at the NPI level and to include the 
specific NPI selected to report information. Furthermore, we proposed 
to collect the name of the ground ambulance organization and the name 
and contact information of the person responsible for completing the 
data collection instrument for the purposes of confirming that the data 
submitted aligns with the intended NPI (Section 2, questions 3 and 4).
    Organizations using volunteer labor: Some stakeholders have 
suggested that ground ambulance organizations relying on volunteer 
labor above a certain threshold (for example, more than 10 percent of 
volunteer labor) should be exempt from sampling. Others have suggested 
that ground ambulance organizations using volunteer labor should not be 
excluded because those organizations that use volunteer labor are 
likely to be smaller and that a large share of ambulance suppliers 
(particilarly those in rural and super rural areas) would be exempt 
from sampling, and therefore, our sample would not be representative as 
required by section 1834(l)(17)(B)(ii) of the Act. We acknowledged that 
analysis of the data may require additional steps to combine data 
submitted from ground ambulance organzations that do and do not rely on 
volunteers since reported labor costs would be significantly lower for 
ground ambulance organizations that use volunteer labor compared to 
those that do not. We stated that ground ambulance organizations that 
use volunteer labor might have some costs related to their volunteer 
labor, such as stipends, but may not have others, such as an hourly 
wage. Therefore, we proposed to collect information on paid and unpaid 
volunteer hours during a typical week using the same EMT/response staff 
categories used elsewhere in the data collection instrument. We stated 
we believed reported hours could be converted to market rates using 
data from other sources, such as the Bureau of Labor Statistics' wage 
data. Ambulance providers and supplies that rely on volunteer labor 
reported that it is becoming increasingly difficult to find volunteers 
and they are having to hire paid staff in their place, especially for 
the more costly labor categories, such as paramedics. Therefore, we 
proposed that ambulance providers and suppliers that use any amount of 
volunteer labor be included in sampling. We invited comments as to 
whether organanizations that rely on volunteer labor should be exempt 
from sampling.
    Sampling file. We proposed several organizational characteristics 
for the specific strata (volume of Medicare billed transports, service 
area population density, ownership, provider versus supplier status, 
and the share of transports that are non-emergency) that we stated 
could be obtained from available Medicare data. We proposed to develop 
sampling files using the most recent full year of data available. For 
the first sample notified in 2019 and

[[Page 62889]]

reporting in 2020, we proposed to use 2017 claims and enrollment data. 
Another alternative we considered was using 2018 data, however we did 
not propose this because such data may not be complete for all 2018 
service dates at the time the sample for the initial year of data 
reporting is selected. We invited comments on our proposal to use the 
most recent full year of available Medicare data for sampling purposes, 
as described above.
    Implications of historical sampling files. In the proposed rule we 
stated that we expect there may be instances in which some ground 
ambulance organizations that were in operation at the time they were 
selected for the sample may cease operations by the time data reporting 
begins and that we expect that some new ground ambulance organizations 
would start operating between the time the sample was created and when 
reporting begins. Since we proposed to collect a full 12 continous 
months of data, these organizations would not have the data we proposed 
to collect. Therefore, we proposed that ground ambulance providers and 
suppliers organizations selected for the sample that were not operating 
for the full 12 continuous months of the data collection period would 
be exempt from reporting for the applicable data collection period; 
however, for newer ground ambulance organizations, they would be 
eligible for sampling and reporting in future years when they have a 
full continuous 12 months of data.
    We stated that we believed the above scenerios are inevitable given 
the significant amount of time between sampling and data reporting and 
invited comments on our approach regarding exempting ground ambulance 
organizations who do not have a full 12-month continuous period of 
data.
    Sampling rate: We proposed that 25 percent of ground ambulance 
organizations be sampled from all strata (as described below) in each 
of the first 4 years of reporting without replacement; that is, if an 
organization is sampled in Year 1, it would not be eligible for 
sampling again in the subsequent 3 years of data collection. We 
proposed a 25 percent sampling rate because we stated if a lower 
sampling rate is used, estimates of cost, revenue, and utilization from 
the data collected via the data collection instrument for subgroups of 
ground ambulance suppliers will be of inadequate precision as described 
in the following section. We stated that our analyses illustrated that 
using a 50 percent sampling rate would yield only marginal gains in 
precision over a sampling NPIs at a 25 percent rate while doubling the 
response burden. We stated that in our view, these gains are not 
sufficient to merit the increased burden that would be imposed by 
implementing a higher sampling rate. We stated that our proposal was 
informed by analyses regarding the alternative sampling rates in 
Chapter 7 of the CAMH report. We invited comments on the sampling rate 
of 25 percent each year.
    We also proposed to notify ground ambulance organizations that have 
been selected for the representative sample by listing such ground 
ambulance organizations on the CMS website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html and provide 
written notification to each selected ground ambulance organization via 
email or U.S. mail. We stated that notification on the CMS website 
would be provided at least 30 days prior to the time the selected 
ambulance organization would will be required to begin collecting data. 
For purposes of CY 2020, we stated that we would post such information 
on the website when the CY 2020 PFS final rule is issued. We also 
proposed to codify the representative sample requirements in Sec.  
414.626(c).
    Approach for Sampling: In the proposed rule, we considered several 
alternatives for developing a stratified sampling approach to 
facilitate data collection from specific types of ground ambulance 
oragnizations. Section 1834(l)(17)(B)(ii)(II) of the Act requires that 
the sample be representative of the different types of providers and 
suppliers of ground ambulance services, such as those providers and 
suppliers that are part of an emergency service or part of a government 
organization and the geographic locations in which ground ambulance 
services are funished (such as urban, rural, and low population density 
areas). One approach we considered was sampling ground ambulance 
organizations in proportion to their volume of Medicare-billed ground 
ambulance services. Under this approach, we stated that organizations 
with more billed Medicare ground ambulance transports would be more 
likely to be sampled than organizations with fewer billed Medicare 
ground ambulance transports. The analysis of our 2016 data described in 
the CAMH report shows that a small number of ground ambulance 
organizations provided a large share of total Medicare transports. We 
stated that the top 10 percent of ground ambulance organizations by 
volume accounted for nearly 70 percent of total Medicare ground 
ambulance transports and the bottom 50 percent of ambulance providers 
and suppliers by volume accounted for only 3 percent of total Medicare 
ground ambulance transports. Under this approach, we stated that the 
ambulance providers and suppliers in the top 10 percent by volume would 
be much more likely to be sampled compared to those in the bottom 50 
percent by volume. We also stated that while this approach would 
efficiently collect data on the majority of Medicare ground ambulance 
transports, we do not believe that this approach would comport with the 
requirements in section 1834(l)(17)(B)(ii)(II) of the Act to develop a 
representative sample of ground ambulance organizations based on the 
characteristics (such as ownership and geographic location) of 
ambulance providers and suppliers. Therefore, we stated that we do not 
believe that data we would be collecting using this approach would meet 
the requirements in section 1834(l)(17)(B)(ii)(II) of the Act.
    Other alternatives for a sampling methodology we considered 
included simple and stratified random samples of ground ambulance 
organizations. We stated a simple random sample would include a fixed 
share of all ground ambulance organizations, regardless of any 
differences in characterstics, in each year's sample. Unlike sampling 
in proportion to Medicare-billed ground ambulance services, we stated a 
simple random sample by definition provides a representative sample. A 
stratified random sample first stratifies all ground ambulance 
organizations based on selected characteristics and then a sample is 
seleced at random from the strata. We stated the rate at which these 
organizations are sampled would be the same for organizations in the 
same stratum; however, that the sampling rate may vary across strata. 
So long as the sampling rate is not zero within any stratum and so long 
as appropriate weighting adjustments are used, we stated the sample 
would be considered representative.
    As discussed in the proposed rule, stratified random sampling has 
several advantages in that it is easy to implement and it meets the 
requirement that the sample be representative and it also can be used 
to target sampling of ambulance organziations with specific 
characteristics, such as ownership and geographic location, to 
specifically meet the requirements in section 1834(l)(17)(B)(ii)(II) of 
the Act that the sample be representative of the different types of 
providers and suppliers of ground ambulance services, such as those 
providers and suppliers that are part of an emergency service or part 
of

[[Page 62890]]

a government organization and the geographic locations in which ground 
ambulance services are funished (such as urban, rural, and low 
population density areas). We stated that it is also possible to 
oversample from less prevelant strata using this approach in order to 
facilitate more precise estimates for certain groups or comparisons 
between subgroups. Furthermore, unlike a simple random sample, we 
stated the flexibility to vary sampling rates across strata allows the 
ability to account for anticipated and unanticipated rates of 
nonresponse.
    We stated that we believe that use of a stratified random sample 
would comport with the statutory requirements. Therefore, we proposed a 
stratified random sample approach. Specifically, we proposed to sample 
from each strata at the same rate (25 percent, as described above). We 
stated we believe that data collected from a sample of this type can be 
adjusted via statistical weighting to be representative of all ground 
ambulance organizations billing Medicare for ground ambulance services 
even if response rates vary across the characteristics used for 
stratification.
    For the purposes of estimating the number of responses from the 
sampled ground ambulance organizations, we stated we assumed that all 
ground ambulance providers and suppliers organizations sampled will 
report, because: (1) Reporting is a requirement; (2) there is a 10 
percent payment reduction for failure to sufficiently report; and (3) 
we believed every ground ambulance organization would want its data 
accounted for in the evaluation of the extent to which reported costs 
relate to payment rates.
    Variables for Stratification: Section 1834(l)(17)(B)(ii)(II) of the 
Act requires that the sample be representative of the different types 
of providers and suppliers of ground ambulance services, such as those 
providers and suppliers that are part of an emergency service or part 
of a government organization, and the geographic locations in which 
ground ambulance services are funished (such as urban, rural, and low 
population density areas). We proposed a stratified sampling approach 
under which we would first sample based on a set of charactericistcs of 
ground ambulance organizations that are described below (that is, 
strata) and then assess response rates based on those characteristics. 
Based on our analysis of information provided by ground ambulance 
organizations, we stated we believed there are several important 
characteristics that vary among ground ambulance organizations that 
have implications for their costs and revenues and that could serve as 
strata for the purposes of sampling:
     Provider versus supplier status. The GAO (2012) \97\ and 
HHS (2015) \98\ reports found much higher per-transport costs for 
ambulance providers than those of ambulance suppliers. We stated this 
suggests that the ground ambulance cost structures for ambulance 
providers and suppliers are fundamentally different.
---------------------------------------------------------------------------

    \97\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
    \98\ This report is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Report-To-Congress-September-2015.pdf.
---------------------------------------------------------------------------

     Service area population density. Ground ambulance 
organizations operate in urban, rural, and super-rural settings. As 
described in the CAMH report, rural and super-rural organizations tend 
to be smaller, transport patients at greater distances, are more likely 
to be government owned, and rely more heavily on volunteer labor. We 
stated the population density of the area in which a ground ambulance 
organization is operating is expected to affect costs and revenues in a 
number of ways. Organizations serving rural and super-rural areas 
generally are likely to face lower demand for services, and thus, 
deliver a smaller number of transports. In addition, in rural and 
super-rural areas the average distance traveled per transport tends to 
be greater. We further stated that payment rates will also 
differentially impact revenue by population density because the 
Medicare AFS accounts for mileage and, in addition, rural and super-
rural providers and suppliers receive higher temporary add-on payments.
     Volume of transports. If there are economies of scale, 
organizations providing a larger volume of services typically would 
face lower per-transport costs. We stated our analysis found the 
majority of ground ambulance organizations have a low volume of 
transports, but there are a small number of organizations with a very 
high volume of transports. Additionally we stated that suppliers 
providing a large volume of transports are more likely to be for-profit 
organizations.
     Ownership. For-profit (non-government), non-profit (non-
government), and government ground ambulance organizations have 
different business models and mixes of services, leading to different 
costs. We stated conceptually, for-profit organizations maximize profit 
and operate only in markets and service lines with positive margins and 
that non-profit and government ground ambulance organizations more 
broadly provide emergency service to communities and may be organized 
and operated in a way that does not maximize profits. The 2012 GAO 
report found ground ambulance organizations with more limited 
government support are more likely to have incentives to keep costs 
lower. They found that for each 2 percent decline in the average length 
of government subsidy there was a 2 percent decline in the average cost 
per transport. As a result, we stated we expect that costs will differ 
based on ownership.
     Types of services provided. One key distinction in the 
types of services provided is between emergency transports and non-
emergency (for example, scheduled or inter-facility) transports. We 
stated that for-profit suppliers are more likely than others to 
specialize in non-emergency scheduled transports. We stated that 
another key distinction is between the level of service provided (for 
example BLS versus ALS).
     Staffing. The level of staff training (for example, EMTs 
versus paramedics) and the number of staff deployed is driven in part 
by the type and volume of calls, the availability and proximity of the 
nearest providers, and resources available in that community. We stated 
that some suppliers use static staffing models that use set staff 
schedules, whereas others use a dynamic, or flexible, staffing model 
that calls upon staff if there is a surge in demand.
     Use of volunteer labor. Volunteer labor tends to be more 
common among small, government-based ambulance suppliers operating in 
rural and super-rural settings.
     Response times. In many cases, response times are related 
to the population density of the area in which they operate, with rural 
areas having response times more than double those of urban areas. We 
stated that rural and super-rural ambulance providers and suppliers 
generally travel greater distances to get to patients and transport 
them to a hospital or the nearest appropriate facility. We also stated 
that variation in response times within urban areas might also occur, 
for example if there is significant emergency department crowding, or 
in extreme cases diversion that requires the ambulance to travel 
further to another hospital or wait with the patient until a bed is 
available and that this extra time affects the availability of the 
ambulance and the staff for subsequent trips, potentially increasing 
response times.
    We stated we were not aware of any existing data source that lists 
all ground

[[Page 62891]]

ambulance organzations or one that encompasses all the characteristics 
that impact costs and revenues described above. We stated that Medicare 
claims and enrollment data is the only source of data for which we were 
aware that has all the providers and suppliers that bill Medicare in a 
given year. We stated that several of the organizational 
characteristics we discuss above (including provider versus supplier 
status, ownership, service area population density, Medicare billed 
transport volume, and type of services provided) are available from 
Medicare data while others, such as the use of volunteer labor, 
staffing model, and response times are not.
    We proposed to stratify the sample based on provider versus 
supplier status, ownership (for-profit, non-profit, and government), 
service area population density (transports originating in primarily 
urban, rural, and super rural zip codes), and Medicare billed transport 
volume categories. Based on our analysis of the number and distribution 
of ground ambulance organizations' transports in 2016, we proposed 
volume categories of 1 to 200, 201 to 800, 801 to 2500, and 2501 or 
more paid Medicare transports. The volume categories aim to divide 
ground ambulance organizations into roughly similar-sized groups, while 
separating ground ambulance organizations with very high volume (that 
is, greater than 2500 Medicare transports per year) into a separate 
category. We stated we would expect that these highest-volume ground 
ambulance organizations may face different costs than lower-volume 
organizations due to economies of scale.
    We proposed to focus on these four characteristics due to data 
availability, and our analyses that show these to be key defining 
characteristics of ground ambulance organizations (which are also 
described in the CAMH report). We stated that service area population 
density and Medicare billed transport volume have a direct impact on 
ground ambulance revenue, which is one of the categories of data that 
we are required to collect by section 1834(l)(17)(A) of the Act. We 
stated that through Medicare claims and enrollment data, we believe we 
have enough information to stratify ground ambulance organizations on 
these four characteristics. This stratification approach results in 36 
groupings of ground ambulance suppliers (defined by combinations of the 
three ownership categories, three service area population density 
categories, and four Medicare billed transport volume categories) and 
the same number of groupings for ambulance providers.
    In some of these groupings, there are only a handful of ground 
ambulance organizations providing ground ambulance services with a 
specific set of the four characteristics. We stated this could result 
in situations where few or no ground ambulance organizations with the 
specific set of characteristics were sampled. To minimize this risk and 
avoid situations where we are sampling from strata that contain only a 
few ambulance providers and suppliers in the entire population, we 
proposed to stratify ground ambulance providers, which account for only 
6 percent of ground ambulance organizations combined, based on service 
area population density only. We proposed to use this characteristic to 
stratify providers rather than another characteristic because section 
1834(l)(17)(A) of the Act specifically requires the Secretary to 
develop a data collection system to collect information on ground 
ambulance services furnished in different geographic locations, 
including rural areas and low population density areas described in 
section 1834(l)(12) of the Act (super rural areas).
    We also proposed to collapse the two highest Medicare ground 
ambulance transport volume categories (801-2500 and 2501 and more 
transports) into a single category (801 and more transports) for for-
profit ground ambulance suppliers that primarily service super-rural 
areas due to the small number of ground ambulance organizations in 
these two volume categories. We stated the proposed sampling rate of 25 
percent aims to meet a threshold that will provide an adequate degree 
of precision for estimates within each strata subgroup (that is, 
provider versus supplier status, ownership (for-profit, non-profit, and 
government), service area population density (transports originating in 
primarily urban, rural, and super rural zip codes), and Medicare billed 
transport volume categories). The specific threshold is 200 expected 
responses in each subgroup. This number of expected responses will 
ensure that small to medium differences in means between groups (that 
is, affect size) can be detected.
    We stated that a 25 percent sampling rate is expected to result in 
more than 200 responses in each subgroup except for ground ambulance 
providers (where we expect 153 responses with a 25 percent sampling 
rate) and that a 25 percent sampling rate will result in more than 200 
expected responses for other organizations not represented in the 
strata, including organizations providing primarily non-emergency 
transports and transports to and from dialysis facilities. We stated 
that we also expect that a 25 percent sampling rate will result in more 
than 200 responses for organizations that rely primarily on volunteer 
labor, as well as for those who do not.
    We invited comments on all our proposals for sampling including our 
proposals on eligible organizations, methods for sampling, sampling at 
the NPI level, sampling of organizations using volunteer labor, 
sampling files, and sampling rates. We also invited comments on our 
proposals to collect data from ground ambulance organizations that bill 
Medicare, and the use of a stratified random sample.
    We received comments on our proposals for sampling as described in 
this section. The following is a summary of the comments we received 
and our responses.
    Comment: Commenters were generally very supportive of our proposals 
and agreed that the data collection effort must cover ground ambulance 
organizations of all types (government, for-profit, not-for-profit, 
provider-based, and volunteer) regardless of size and service area 
(urban, rural and super rural). They stated that all ground ambulance 
organizations must be represented in the samples to allow for 
stakeholders and policy-makers to understand the true cost of providing 
ambulance services in the geographically diverse areas of the country. 
Some commenters also believe that this information is important to 
support the permanent inclusion of the urban, rural, and super-rural 
add-ons into the AFS payment. Commenters noted that while it may be 
more difficult for some smaller or rural/super-rural ground ambulance 
organizations to provide such data, their data are essential for 
policy-makers to evaluate the ambulance benefit in its entirety.
    One commenter stated that, while they believe it is important for 
organizations that rely on volunteer labor to be included in the 
sampling, they encourage CMS to consider exempting from sampling ground 
ambulance organizations with very low volumes of Medicare-billed 
transports where the payment reduction for not reporting data would be 
less than the cost of reporting data. One commenter advocated for 
excluding organizations with workforces consisting of 50 percent or 
more volunteer labor because of the administrative burden associated 
with reporting. Another commenter expressed concern that the penalties 
for not reporting would endanger the

[[Page 62892]]

financial health for small, rural ambulance organizations.
    Response: We recognize that there may be some ground ambulance 
organizations that have limited resources that affect their ability to 
report the required information, and that for these ground ambulance 
organizations, a 10 percent payment reduction in Medicare payments 
could result in significant financial hardship. However, we believe 
that it is critical that ground ambulance organizations of all types 
submit data so that we can all understand better the costs of 
furnishing ground ambulance services, including ground ambulance 
services furnished in very low-volume or in rural and super-rural 
areas. This is particularly important because several payment policies 
such as current add-on payments specifically apply to ground ambulance 
services in rural and super-rural areas, and therefore, we do not agree 
that small ground ambulance organizations should be excluded from 
sampling. While some very low volume ground ambulance organizations may 
conclude that the payment reduction will be less than the estimated 
costs of collecting and reporting data, we believe it is important to 
offer all ground ambulance organizations the opportunity to submit data 
and participate in this important national data collection activity. If 
we were to systematically exclude any category of ground ambulance 
organizations, for example organizations with very low volumes of 
Medicare-billed ground ambulance services, there would be gaps in our 
understanding of important segments of ground ambulance organizations 
and their role in the country's emergency response system. We note that 
section 1834(l)(17)(A)(D)(iii) of the Act authorizes the Secretary to 
exempt a ground ambulance provider or supplier from the 10 percent 
payment reduction for an applicable period in the event of significant 
hardship, such as bankruptcy, which is discussed in detail below in 
this rule.
    Comment: Many commenters stated that they support a stratified 
sampling approach and believe the proposed approach should allow the 
end users of the data to ensure a representative sample and facilitate 
analysis of subgroups of ground ambulance organizations, but would have 
preferred that CMS first obtain information about organization type, 
utilization patterns, and other relevant organizational characteristics 
to support a stratified random sample before collecting cost, revenue 
and other data. They believed CMS would have been better positioned to 
ensure that, when it fields the data collection instrument it is 
obtaining a representative sample of all types, sizes, and geographic 
distribution of ground ambulance services if they had first collected 
organizational data from all ground ambulance organizations. Commenters 
asked that CMS work closely with stakeholders during the first years of 
the system to identify and resolve any problems that arise. They also 
stated that prior research echoed the need for a stratified sample due 
to variation in the level of transport costs resulting from various 
business models present in the industry.
    Response: As we have stated above, we do not believe that it is 
necessary to first collect only organizational characteristic data from 
all ground ambulance organizations prior to collecting cost, revenue 
and utilization data. We believe that CMS' claims and enrollment data 
are sufficient for the purposes of selecting stratified samples of 
ground ambulance organizations.
    Comment: Many commenters stated that they agree that selecting 25 
percent of ground ambulance services (defined at the National Provider 
Identifier level) is appropriate for each of the 4 years of the system. 
They quoted prior research that has indicated that a sample of 
approximately 15-25 percent of the ambulance industry should be 
sufficient to ensure cost data are representative of the industry 
overall and for subgroups of ground ambulance organizations, reliable 
in establishing ambulance payment rates, and a significant improvement 
on the data used to establish the current payment rates. They also 
stated that prior efforts to sample ambulance cost data have generated 
varying results and in order to generate a representative sample CMS 
needs a larger sample than has been conducted in the past. They stated 
that business models of ambulance providers and suppliers vary in terms 
of their service areas, types of services, and most importantly their 
volume of transports. To account for this variation, the commenters 
recommended that the sample should support analysis for 14 different 
subgroups of ground ambulance organizations: Super-rural (majority of 
transport pick-ups in super rural zip codes), rural (majority of 
transport pick-ups in rural zip codes), urban (majority of transport 
pick-ups in urban zip codes), for-profit, not-for-profit, government 
entity (not including fire/public safety), volunteer-based, hospital-
based, fire/public safety-based, low transport volume (less than 600 
transports per year), medium transport volume (600 to 5000 transports 
per year), high transport volume (more than 5000 transports per year, 
Advanced Life Support (ALS) transport-focused (greater the 90 percent 
of transports are ALS), and Basic Life Support (BLS) transport-focused 
(greater than 90 percent of transports are BLS). These commenters 
stated that it may be necessary to sample 100 to 200 of each type of 
providers and suppliers. They stated that they believe that response 
rates are not likely to be a problem in collecting the data due to the 
reduction Congress has tied to non-responders.
    Response: Our proposal to sample 25 percent of all ground ambulance 
organizations in each of the 4 years is based on our analysis which 
shows that this approach will ensure we have enough data for analysis 
and that the sample is a representative of all ground ambulance 
organizations in each of the years of data collection. We believe that 
this approach is consistent with the statutory requirements regarding 
data collection. As we noted in the proposed rule, we believe those 
analyzing the data will want to calculate estimates for subgroups of 
the ground ambulance organizations in the sample, for instance ground 
ambulance providers operating primarily in super-rural areas that are 
government owned or for profit ground ambulance providers operating in 
urban areas. We also noted that we believe that 200 responses per 
subgroup will be necessary in order to calculate estimates of 
sufficient precision within different subgroups of ambulance 
organizations. Furthermore, we noted that a sample of 25 percent of 
ground ambulance organizations will result in data collected from more 
than 200 ground ambulance organizations in nearly all of the subgroups 
that we noted may be of interest to those analyzing the data. Lastly, 
we said that response rates lower than 25 percent would result in fewer 
than 200 sampled ground ambulance in additional subgroups of ground 
ambulance organizations and that estimates from data summarized from 
fewer than 200 respondents in a particular type or category will be 
less precise than necessary to determine the adequacy of payments.
    Comment: One commenter suggested that CMS select a sample of 
respondents that is in proportion of their volume of Medicare-billed 
ambulance services. For example, if 94 percent of Medicare ground 
ambulance claims are submitted by independent ambulance suppliers, then 
ideally 94 percent of each year's survey sample would consist of 
independent ambulance suppliers. Similarly, the 50 percent of 
organizations that make up only 3 percent of Medicare ground ambulance 
claims would make up only 3 percent of

[[Page 62893]]

the sample. They also suggested that to allow MedPAC to produce the 
most accurate analysis for their Congressional report by the March 15, 
2023, statutory deadline, MedPAC would need to receive data from a 
robust sample of ambulance organizations by March 2022. Therefore, they 
believe the first year's survey sample should be large enough to 
produce statistically reliable results using that year's data alone. In 
addition, they stated that all high-volume ambulance organizations (for 
example, the 10 percent of organizations that provide 70 percent of 
Medicare ground transports) should be surveyed within the first 2 years 
of data collection with 50 percent of these organizations surveyed in 
the first year and the other 50 percent surveyed in the second year.
    Response: We do not agree that ground ambulance organizations 
should be sampled solely in proportion to their volume of Medicare 
ground ambulance service claims. While such an approach would collect 
information sooner from the small number of ground ambulance 
organizations that account for the majority of Medicare ground 
ambulance transports, it would shift the focus of the data collection 
effort almost entirely towards these large organizations at the expense 
of including smaller organizations. Our analysis indicates that the top 
3 percent of organizations in terms of Medicare ground ambulance 
transport volume (all with more than 10,000 transports per year) 
account for 39 percent of total Medicare transports while the bottom 42 
percent (all with fewer than 200 transports per year) account for only 
2 percent of total Medicare transports. We believe that under our 
approach, each ground ambulance organization has an equal probability 
of being included in the sample. We also agree with other commenters 
that stressed the importance of a broad and inclusive approach to 
collecting data from all types of ground ambulance organizations, and 
sampling solely in proportion to volume would dramatically decrease the 
contributions of some types of ground ambulance organizations to the 
data collection effort.
    We believe that the 25 percent sample proposed and supported by 
almost all commenters will yield sufficient data for analysis of the 
data after each year of data collection. While sampling at higher rates 
for some or all types of ground ambulance organizations in earlier 
years would result in additional data in the first year, we do not 
believe that the additional data is necessary to conduct an accurate 
analysis of the data. We disagree with the recommendation to sample 
ground ambulance organizations with the highest Medicare volume at 
higher rates in the initial years of data collection due to the 
concerns previously discussed about sampling solely in proportion to 
volume. We are also concerned that sampling larger ground ambulance 
organizations more heavily in the first 2 years of data collection will 
deter smaller ground ambulance from reporting because they will 
perceive that their data will not be used in the analysis.
    After consideration of the comments, we are finalizing our sampling 
proposals to implement a 25 percent stratified sample in each of the 
first 4 years of data collection. We are also finalizing our proposal 
to codify the representative sample requirements at Sec.  414.626(c).
6. Collecting and Reporting of Information Under the Data Collection 
System
    For each data collection year, section 1834(l)(17)(C) of the Act 
requires ground ambulance organizations identified as part of the 
representative sample to submit information specified under the system, 
with respect to a period for the year (referred to as the ``data 
collection period''), in a form and manner and at a time (referred to 
as the ``data reporting period'') specified by the Secretary. In this 
section, we proposed to define the data collection period and the data 
reporting period. In determining when the data collection and reporting 
periods should fall, our objectives were to: (1) Allow selected ground 
ambulance organizations sufficient time to collect and report the 
required information; and (2) collect the data for analysis in the 
least burdensome manner.
    We considered annual (that is, 12-month) data collection periods 
and shorter data collection periods (for example, a 6-month period). We 
proposed a 12-month data collection period because a shorter period 
could result in biased data due to seasonality in costs, revenue, or 
utilization among ground ambulance organizations.
    As we stated previously, ambulance providers and suppliers 
constitute a diverse group of organizations with varied annual 
accounting practices. Accordingly, we proposed to define the data 
collection period as a continuous 12-month period of time, which is 
either the calendar year aligning with the data collection year, or 
when an organization uses another fiscal year for accounting purposes 
and the organization elects to collect and report data over this period 
rather than the calendar year, the 12-month period that is their fiscal 
year that begins during the data collection year. We proposed this data 
collection period based on feedback from ground ambulance organizations 
that stated that they prefer to collect data based on an annual 
accounting period (either calendar year or fiscal year) already used by 
the organization, and that requiring all organizations to report on the 
same 12-month period (for example, calendar year) could involve 
significant additional burden in terms of data collection and 
reporting. We believe that providing flexibility in collecting 
information under the data collection system would reduce the burden on 
ground ambulance organizations.
    Therefore, we proposed that the first data collection period be 
January 1, 2020 through December 31, 2021, with organizations reporting 
on a calendar year basis collecting data from January 1, 2020 through 
December 31, 2021, and organizations reporting on a fiscal year basis 
collecting data over a continuous 12-month period of time from the 
start of the fiscal year beginning in calendar year 2020. Upon being 
notified that they are selected as part of the sample, ground ambulance 
organizations must notify CMS of their annual accounting period within 
30 days according to the instructions in the notification letter, so 
that CMS is aware of when their data collection and data reporting 
periods would begin. We proposed that respondents would additionally 
confirm the data collection period when reporting data via the data 
collection instrument (section 2, question 5).
    We also proposed that ground ambulance organizations would have up 
to 5 months to report to CMS (data reporting period) the data following 
the end of its 12-month data collection period. For example, if a 
ground ambulance organization is selected as part of the representative 
sample for the CY 2020 data collection year, and notifies CMS that its 
annual accounting period is based on a calendar year, the data 
collection period for this ground ambulance organization would begin on 
January 1, 2020 and end on December 31, 2020, and the data reporting 
period would be January 1, 2021 through May 31, 2021. A ground 
ambulance organization selected for CY 2020 that notifies CMS that its 
annual accounting period is based on a fiscal year basis with a fiscal 
year beginning on June 1, 2020 would have a data collection period from 
June 1, 2020 through May 31, 2021 and a data reporting period from June 
1, 2021 through October 1, 2021. Since a 5-month reporting period is 
enough time for entities that file cost reports with Medicare to 
complete and submit their data, we believe it should

[[Page 62894]]

also provide adequate time for ground ambulance organizations to report 
information under the data collection system to CMS. This will allow 
providers and suppliers time to validate the information and certify 
the accuracy of their data required under the data collection before 
reporting it to CMS.
    We proposed to codify the data collection and reporting 
requirements for selected ground organizations at Sec.  414.626(b).
    Tables 38 and 39 illustrate various examples of data collection 
periods and the data reporting periods that were proposed. Please note 
that an individual ground ambulance organization would only be selected 
to participate in one data collection and reporting period, and that 
the specific data collection and reporting period dates might vary for 
each organization and be different than the dates noted in Tables 38 
and 39.

 Table 38--Example of a Data Collection and Reporting Period for a Ground Ambulance Organization With a Calendar
                                             Year Accounting Period
----------------------------------------------------------------------------------------------------------------
                            Year                               Data collection period     Data reporting period
----------------------------------------------------------------------------------------------------------------
1...........................................................     01/01/2020-12/31/2020     01/01/2021-05/31/2021
2...........................................................     01/01/2021-12/31/2021     01/01/2022-05/31/2022
3...........................................................     01/01/2022-12/31/2022     01/01/2023-05/31/2023
4...........................................................     01/01/2023-12/31/2023     01/01/2024-05/31/2024
----------------------------------------------------------------------------------------------------------------


     Table 39--Example of a Data Collection and Reporting Period for a Ground Ambulance Organization With an
                                 Accounting Period Not Based on a Calendar Year
----------------------------------------------------------------------------------------------------------------
                            Year                               Data collection period     Data reporting period
----------------------------------------------------------------------------------------------------------------
1...........................................................     06/01/2020-05/31/2021     06/01/2021-10/31/2021
2...........................................................     06/01/2021-05/31/2022     06/01/2022-10/31/2022
3...........................................................     06/01/2022-05/31/2023     06/01/2023-10/31/2023
4...........................................................     06/01/2023-05/31/2024     06/01/2024-10/31/2024
----------------------------------------------------------------------------------------------------------------

    We invited comments on our proposal to use a 12-month data 
collection period. We also invited comments on our proposal to give 
sampled ground ambulances the flexibility to collect data on either a 
calendar year basis or on the basis of the ground ambulance 
organization's fiscal year. In addition, we invited comments on our 
proposal to allow a ground ambulance organization 5 months to report 
the data collected during data collection period to CMS through the 
data collection system. We stated that any ongoing collection of data 
after the initial 4-year period would be addressed in future 
rulemaking.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter requested that we issue a technical 
correction to the proposed rule to correct the year for the first data 
collection period and the reporting calendar year.
    Response: We thank the commenter for bringing this error to our 
attention and note that we inadvertently stated in one place in the 
proposed rule that the first data collection period would be January 1, 
2020 through December 31, 2021 (84 FR 40699). We note that we correctly 
stated the dates of the first data collection period throughout the 
remainder of the proposed rule and confirm again here that the correct 
dates of the first data collection period are January 1, 2020 through 
December 31, 2020.
    Comment: All commenters supported our proposal to allow ground 
ambulance organizations to report based on either a calendar year or 
their organization's fiscal year. We received no comments on the data 
collection period, and no comments on the proposal to allow a ground 
ambulance organization 5 months to report the data collected during 
data collection period.
    Response: We appreciate the commenters' support of these proposals.
    Comment: One commenter noted that internal systems of ground 
ambulance providers and suppliers will have to be changed during 2020 
and that parameters will need to be edited in order to obtain quality 
data in a reasonable time.
    Response: While we understand that system changes may be necessary 
for some ground ambulance organizations who are sampled in the first 
data collection period, we believe that most ground ambulance 
organizations will be able to complete the data collection requirements 
within the specified timeframe.
    After consideration of the comments, we are finalizing the data 
collection period as a continuous 12-month period of time, which is 
either the calendar year aligning with the data collection year, or the 
organization's 12-month fiscal year that begins during the data 
collection year when an organization uses fiscal year for accounting 
purposes and elects to collect and report data over this period rather 
than the calendar year. We are also finalizing our proposal to allow a 
ground ambulance organization 5 months to report the data collected 
during data collection period. We are also finalizing our proposals to 
codify the data collection and reporting requirements for selected 
ground ambulance organizations at Sec.  414.626(b).
7. Payment Reduction for Failure To Report
a. General Information and Applicable Period
    Section 1834(l)(17)(D)(i) of the Act requires that beginning 
January 1, 2022, subject to clause (ii), the Secretary reduce the 
payments made to a ground ambulance organization under section 
1834(l)(17) of the Act for the applicable period by 10 percent if the 
ground ambulance organization is required to submit data under the data 
collection system with respect to a data collection period and does not 
sufficiently submit such data. Section 1834(l)(17)(D)(ii) of the Act 
defines the applicable period as a year specified by the Secretary not 
more than 2 years after the end of the period for which the Secretary 
has made a determination that the ground ambulance provider or supplier 
failed to sufficiently submit information under the data collection 
system.
    As previously discussed, we proposed to define the data collection 
and data reporting periods based on the ground ambulance organization's 
annual accounting period (either calendar year

[[Page 62895]]

or fiscal year). The timeline for the determination of the 10 percent 
reduction to payments would depend on: (1) The 12-month data collection 
period based on the organization's accounting period; (2) the end of 
the data reporting period that corresponds with the selected data 
collection period; and (3) the time it would take CMS to review the 
data to determine whether it had been sufficiently submitted. We 
proposed that we would make a determination that the ground ambulance 
organization is subject to the 10 percent payment reduction no later 
than the date that is 3 months following the date that the ambulance 
organization's data reporting period ends. This timeframe will allow 
CMS to assess whether the required data was sufficiently submitted.
    For example, if a ground ambulance organization is selected in the 
first sampling year and it reports to CMS that its annual accounting 
period is an October 1 through September 30th fiscal year, then its 
data collection period would be October 1, 2020 through September 30, 
2021, and the data reporting period that would apply to the ground 
ambulance organization would be from October 1, 2021--February 28 (or 
29, if a leap year), 2022. We would make a determination regarding the 
sufficiency of that ground ambulance organization's reporting no later 
than June 1, 2022. With this timeframe, we would propose to apply the 
10 percent reduction in payments, if applicable, for ambulance services 
provided by that ground ambulance organization between January 1, 2023 
and December 31, 2023, because under section 1834(l)(17)(D)(iii) of the 
Act, the applicable period must be one year in length. As another 
example, if a ground ambulance organization's annual accounting period 
is the calendar year, its data collection period would be January 1, 
2020 through December 31, 2020, the data reporting period that would 
apply to the ground ambulance organization would be from January 1, 
2021-May 31, 2021, and we would make a determination regarding the 
sufficiency of that ambulance organization's reporting no later than 
August 31, 2021. With this timeframe, we would propose to apply the 10 
percent reduction in payments, if applicable, for ambulance services 
provided between January 1, 2022 and December 31, 2022. The payment 
reduction would always be applied to ground ambulance transports 
provided during the calendar year that begins following the date that 
we determine that the ground ambulance organization is subject to the 
payment reduction.
    We proposed that if we find the data reported is not sufficient, we 
would notify the ground ambulance organization that it will be subject 
to the 10 percent payment reduction for ambulance services provided 
during the next calendar year. We would interpret ``sufficient'' to 
mean that the data reported by the ground ambulance organization is 
accurate and includes all required data requested on the data 
collection instrument.
    We proposed to apply the 10 percent payment reduction for the 
appropriate calendar year as described above to ambulance fee schedule 
payments as described in Sec.  414.610. The payment reduction will 
apply to claims for dates of service during the applicable calendar 
year and will be applied to the final ambulance fee schedule payment, 
after all other adjustments have been applied under Sec.  414.610(c). 
We proposed to codify the payment reduction by adding a new paragraph 
(c)(9) in Sec.  414.610.
b. Hardship Exemption
    Section 1834(l)(17)(A)(D)(iii) of the Act authorizes the Secretary 
to exempt a ground ambulance provider or supplier from the 10 percent 
payment reduction for an applicable period in the event of significant 
hardship, such as a natural disaster, bankruptcy, or other similar 
situation that the Secretary determines interfered with the ability of 
the ground ambulance provider or supplier to submit such information in 
a timely manner for the specified period.
    We recognize that there may be some ground ambulance organizations 
that have limited resources that affect their ability to report the 
required information, and that for these ground ambulance 
organizations, a 10 percent payment reduction in Medicare payments 
could result in significant financial hardship.
    An example of this situation could be a ground ambulance 
organization that is located in a super rural area with such limited 
resources that it cannot report the required information without 
significantly increasing the possibility that it would need to file for 
bankruptcy.
    Another example could be a ground ambulance organization that is 
located in an area that had recently experienced a natural disaster 
such as widespread flooding that caused the closure of a local 
emergency room or other facilities. Due to the increased demand for 
services and rerouting of patients, this ground ambulance organization 
might be unable to collect and report information in a timely manner.
    We proposed that ground ambulance organizations that have 
experienced these or other similar situations could request a hardship 
exemption, and we would consider granting an exemption if the ground 
ambulance organization could demonstrate that the significant hardship 
interfered with its ability to submit the required data under the data 
collection system.
    To request a hardship exemption, we proposed that a ground 
ambulance organization submit to CMS a completed request form, which 
can be found on the Ambulance Services Center website (https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html), and 
that the following information be included:
     Ambulance Provider or Supplier Name;
     NPI Number;
     Ambulance Provider or Supplier Location Address;
     CEO and any other designated personnel contact 
information, including name, email address, telephone number and 
mailing address (must include a physical address, a post office box 
address is not acceptable);
     Reason for requesting a hardship exemption;
     Evidence of the impact of the hardship exemption (such as 
photographs, newspaper, other media articles, financial data, 
bankruptcy filing, etc.); and
     Date when the ground ambulance organization would be able 
to begin submitting information under the data collection system.
    We proposed that the completed hardship exemption request form be 
signed and dated by the Chief Executive Officer (CEO) or designee of 
the ambulance company, and be submitted as soon as possible, and not 
later than 90 calendar days after the date that the ground ambulance 
organization was notified that it will be subject to the 10 percent 
payment reduction as a result of not sufficiently submitting 
information under the data collection system. We proposed that the 
request form be submitted to the Ambulance ODF mailbox at 
[email protected]. Following receipt of the request form, we 
proposed to provide: (1) A written acknowledgement that the request has 
been received; and (2) a written response to the CEO and any designated 
personnel using the contact information provided in the request within 
30 days of the date that we received the request. We also proposed to 
codify the hardship exemption requirement at Sec.  414.626(d).

[[Page 62896]]

c. Informal Review
    Section 1834(l)(17)(D)(iv) of the Act requires the Secretary to 
establish a process under which a sampled ground organization may seek 
an informal review of a determination that it is subject to the 10 
percent reduction. To request an informal review, we proposed that a 
ground ambulance organization must submit the following information:
     Ground Ambulance Organization Name;
     NPI Number;
     CEO and any other designated personnel contact 
information, including name, email address, telephone number and 
mailing address (must include a physical address, a post office box 
address is not acceptable);
     Ground ambulance organization's selected data collection 
period and data reporting period; and
     A statement of the reasons why the ground ambulance 
organization does not agree with CMS' determination and any supporting 
documentation.
    We proposed that the informal review request must be signed by the 
CEO/designee of the ground ambulance organization and be submitted 
within 90 calendar days of the date that the ground ambulance 
organization received notice regarding the 10 percent reduction in 
payments. We proposed 90 calendar days to submit an informal review 
request to allow time for the ground ambulance organization to gather 
the information needed to support the request for informal review. We 
proposed that the request be submitted to the Ambulance ODF mailbox at 
[email protected]. Following receipt of the request for informal 
review, we will provide: (1) A written acknowledgement using the 
contact information provided in the request, to the CEO and any 
additional designated personnel, notifying them that the ambulance 
provider or supplier's request has been received; and (2) a written 
response to the CEO and any designated personnel using the contact 
information provided in the request within 30 days. We solicited 
comments on our informal review process. We also proposed to codify the 
informal review process in Sec.  414.626(e).
    We invited comments regarding all the proposals on the payment 
reduction for failure to report, including the applicable period, 
hardship exemption, and informal review.
    We received comments on the proposals for the hardship exemption 
and informal review, and no comments on the applicable period. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters supported our proposals regarding the 
hardship exemption and informal review. One commenter noted that the 
majority of patients in rural/super rural areas are Medicare 
beneficiaries and that in these areas, the ground ambulance 
organization may have a small call volume. The commenter stated that 
the ground ambulance organization may not understand how to complete 
the survey, and the financial impact of the 10 percent reduction would 
impact the ground ambulance organization's ability to stay in business. 
One commenter requested clarification on the length and timing of the 
10 percent reduction for failure to report.
    Response: We appreciate the support of the commenters. We will 
provide education and outreach to ground ambulance organizations that 
are selected to participate in the ground ambulance data collection 
system and will work directly with the affected organizations to the 
extent possible. As previously noted, the payment reduction would 
always be applied to ground ambulance transports provided during the 
calendar year for a one year period that begins following the date that 
we determine that the ground ambulance organization is subject to the 
payment reduction.
    Comment: Some commenters supported the proposed process for 
applying for a hardship exemption. One commenter stated that the form 
and timeline seem appropriate and sufficient to allow ambulance 
organizations to seek the exemption. One commenter asked that CMS 
provide automatic hardship exemptions when a deadline falls during the 
period of natural disaster, such as a hurricane.
    Response: We appreciate the support of the commenters on the 
proposed process for hardship exemption. While we understand that a 
natural disaster may affect the ground ambulance organization's ability 
to collect or submit the required data, we are unable to provide an 
automatic hardship exemption. Unless the ground ambulance organization 
applies for the exemption, we would have no way of knowing which ground 
ambulance organizations are affected or to what extent the disaster has 
affected them. All ground ambulance organizations that are selected to 
participate in the data collection system have up to 5 months to report 
the data collected during the data collection period, and we encourage 
them not to wait for the deadline to report. We understand it may be 
difficult to meet a deadline during a natural disaster and we will work 
with the affected ground ambulance organization to the extent possible.
    Comment: A commenter requested clarification regarding when the 
hardship exemption form will be available and when the organization can 
apply for the exemption. Another commenter requested information on how 
the hardship exemption request will be evaluated.
    Response: The hardship exemption request form will be available on 
our website when this final rule is published. A ground ambulance 
organization that has been selected to report cost, revenue, 
utilization, and other information under the ground ambulance data 
collection system may apply for a hardship exemption during their data 
collection period if they have experienced a hardship that prevents 
them from submitting the required information. Again, we remind 
organizations that they have 5 months to report their data and should 
try to submit it as soon as possible to avoid this type of situation. 
All hardship exemption requests will be evaluated based on the 
information submitted that clearly shows that they are unable to submit 
the required data due to a significant hardship, such as a natural 
disaster, bankruptcy, or other similar situation.
    Comment: Some commenters supported the informal review process that 
we proposed to adopt and asked that we permit ground ambulance 
organizations to address any problems with their submitted data 
originally during a defined time period and without having to incur a 
payment reduction. The commenters stated that this correction would be 
prudent because of the lack of testing of the data collection 
instrument.
    Response: We will work with the affected organization to the extent 
possible to correct any mistakes or omissions in the data they 
submitted in order to avoid incurring a payment reduction.
    After consideration of the comments, we are finalizing all of our 
proposals regarding on the payment reduction for failure to report, 
including the applicable period, hardship exemption, and informal 
review. We are also finalizing our proposal to codify the payment 
reduction by adding a new paragraph (c)(9) in Sec.  414.610, our 
proposal to codify the hardship exemption requirement at Sec.  
414.626(d) and our proposal to codify the informal review process at 
Sec.  414.626(e). In the proposed rule, we inadvertently stated that 
the informal review process would

[[Page 62897]]

be codified at Sec.  414.610(e) (84 FR 40701).
    Hardship exemption and informal review requests should be submitted 
to the Ambulance ODF mailbox at: [email protected]. Questions on 
the ground ambulance data collection system should be sent to 
[email protected].
8. Public Availability
    Section 1834(l)(17)(G) of the Act requires that the results of the 
data collection be posted on the CMS website, as determined appropriate 
by the Secretary. We proposed to post on our website a report that 
includes summary statistics, respondent characteristics, and other 
relevant results in the aggregate so that individual ground ambulance 
organizations are not identifiable.
    We also proposed that the data above will be made available to the 
public through posting on our website at least every 2 years. The 2-
year timeframe would allow CMS time to analyze the data that is being 
reported, factoring in the various accounting periods of the first 
group of sampled ground ambulance organizations (which have early 
accounting periods in the CY 2020 data collection year).
    We proposed to post summary results by the last quarter of 2022, 
because we believe we may have most or all of the data requested by 
then. We invited comments on our proposals regarding the type of 
information that should be posted from the data collected and the 
timeline in which the results of the data collection should be posted 
on our website.
    We invited comments regarding our proposals for public availability 
of the data.
    We received comments on our proposals regarding the type of 
information that should be posted from the data collected, the timeline 
in which the results of the data collection should be posted on our 
website, and the public availability of the data.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter stated that the report should be more 
detailed than the proposed summary statistics, respondent 
characteristics, and other relevant results in the aggregate. One 
commenter recommended that the data collected through the data 
collection system be made publicly available in various formats such as 
Public Use Files (PUF) accessible through the web, or other formats 
that will facilitate the use of the data for other purposes.
    One commenter stated it is important that stakeholders have access 
to the data collection in a manner that is similar to the publicly 
available data obtained through traditional Medicare cost reporting. 
Some commenters encouraged CMS to incorporate the ambulance cost data 
into the standard Healthcare Cost Report Information System (HCRIS) as 
an additional subsystem to the ground ambulance data collection system.
    One commenter recommended that CMS follow the standard HCRIS file 
format and schedule for releasing ambulance cost data, including 
releasing two types of data files. This commenter recommended that the 
ambulance cost report PUF contain a subset of the data variables 
reported by ambulance suppliers and providers and may enable users to 
calculate provider margins and assess ambulance transport volume. The 
commenter requested data be available in multiple formats and also 
stated that CMS should follow the standard file formats as it releases 
these files to reduce the burden on researchers. The commenter also 
recommended that all ambulance cost report variables be defined with 
Medicare's Provider Reimbursement Manual. Lastly, the commenter stated 
that the individual ground ambulance organizations should not be 
identifiable in the results of the data collection on our website.
    Response: We thank the commenters for their recommendations 
regarding the posting of the results of the data collection on the CMS 
website. We are exploring several mechanisms for posting of the report 
to our website. As such, we will consider the use of HCRIS and other 
PUFs to make the data publicly available. We intend to post as much 
data as possible, including summary statistics describing the data 
reported by subgroups of respondents, while protecting the 
confidentiality of the respondents.
    Comment: One commenter stated that the information should be 
published more frequently than once every 2 years.
    Response: We believe that the 2-year timeframe would allow us time 
to analyze the reported data, factoring in the various accounting 
periods. We will make the data available more frequently if possible.
    Comment: Several commenters supported our proposal to make the data 
collected through the data collection system publicly available. One 
commenter stated that the data collected through the data collection 
system will be exceptionally valuable for agencies, payors, policy 
makers and other stakeholders and they recommend that the data be 
publicly available. One commenter stated that it is important that 
stakeholders have access to the data to be able to evaluate the 
adequacy of the payment system, not just MedPAC or other policymakers.
    One commenter preferred that these data be shared publicly to 
provide more transparency in ambulance service rates. One commenter 
stated that given that this is the early stages of the development of 
the ambulance data collection system and the lack of testing, CMS might 
consider restricting access to the data in the first few years to only 
key stakeholders. This commenter stated that key stakeholders may be 
able to assist the agency with validating the initial data submitted by 
ambulance suppliers and providers.
    Response: We appreciate the support of the commenters on our public 
availability proposals. We agree that making the data publically 
available is the most transparent approach and we anticipate that the 
data we make publicly available will be meaningful to all interested 
persons or organizations.
    We did not receive any comments regarding our proposal to post 
summary results by the last quarter of 2022. After consideration of the 
comments, we are finalizing our proposals for public availability of 
the data including to post on our website a report that includes 
summary statistics, respondent characteristics, and other relevant 
results in the aggregate so that individual ground ambulance 
organizations are not identifiable. The data above will be made 
available to the public through posting on our website at least every 2 
years and we will post summary results by the last quarter of 2022.
9. Limitations on Review
    Section 1834(l)(17)(J) of the Act provides that there shall be no 
administrative or judicial review under sections 1869 or 1878 of the 
Act, or otherwise, of the data collection system or identification of 
respondents. We proposed to codify the limitations on review at Sec.  
414.626(g). We did not receive any comments on this proposal and are 
finalizing it as proposed.

C. Expanded Access to Medicare Intensive Cardiac Rehabilitation (ICR)

    Section 51004 of the Bipartisan Budget Act of 2018 (BBA of 2018) 
(Pub. L. 115-123, enacted February 9, 2018) amended section 
1861(eee)(4)(B) of the Act directing CMS to add covered conditions for 
intensive cardiac rehabilitation (ICR). This final rule expands 
coverage through revisions to Sec.  410.49(b)(1).

[[Page 62898]]

1. Background
    Cardiac rehabilitation (CR) was developed in the 1950s from the 
concept of early mobilization after acute myocardial infarction (heart 
attack).\99\ The standard of care prior to the widespread adoption of 
CR was bed-rest and inactivity after acute myocardial infarction.\100\ 
In the 1970s, cardiac rehabilitation developed into highly structured, 
physician supervised, electrocardiographically-monitored exercise 
programs. However, the programs consisted almost solely of exercise 
alone.\101\ Forman (2000) stated that ``over subsequent years the 
objectives of cardiac rehabilitation broadened beyond exercise into a 
composite of cardiac risk modification. Lipid, blood pressure, and 
stress reduction, smoking cessation, diet change, and weight loss were 
coupled to goals of exercise training.''
---------------------------------------------------------------------------

    \99\ Pashkow, FJ. Issues in Contemporary Cardiac Rehabilitation: 
A Historical Perspective. JACC 1993 Mar 1;21(3):822-34.
    \100\ Forman DE. Cardiac rehabilitation and secondary prevention 
programs for elderly cardiac patients. Clin Geriatr Med. 2000 
Aug;16(3):619-29.
    \101\ Ades PA. A controlled trial of cardiac rehabilitation in 
the home setting using electrocardiographic and voice 
transtelephonic monitoring. Am Heart J. 2000 Mar;139(3):543-8.
---------------------------------------------------------------------------

    ICR, also commonly referred to as a ``lifestyle modification'' 
program, typically involves the same elements as traditional CR 
programs, but are furnished in highly structured environments in which 
sessions of the various components may be combined for longer periods 
of CR and also may be more rigorous.
    Section 144(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (MIPPA) (Pub. L. 110-275, enacted July 15, 2008) 
amended Title XVIII to add new section 1861(eee) of the Act to provide 
coverage of CR and ICR under Medicare Part B. The statute specified 
certain conditions for these services and an effective date of January 
1, 2010, for coverage of these services. Conditions of coverage for CR 
and ICR consistent with the statutory provisions of section 144(a) of 
the MIPPA were codified in Sec.  410.49 through the CY 2010 PFS final 
rule with comment period (74 FR 61872-61879 and 62004-62005). These 
programs were designed to improve the health care of Medicare 
beneficiaries with cardiovascular disease.
    Under Sec.  410.49(b), Medicare Part B covers CR and ICR program 
services for beneficiaries who have experienced one or more of the 
following: (1) An acute myocardial infarction within the preceding 12 
months; (2) a coronary artery bypass surgery; (3) current stable angina 
pectoris; (4) heart valve repair or replacement; (5) percutaneous 
transluminal coronary angioplasty (PTCA) or coronary stenting; or (6) a 
heart or heart-lung transplant. For CR only, other cardiac conditions 
may be added as specified through a national coverage determination 
(NCD). Effective February 18, 2014, we expanded coverage of CR in NCD 
20.10.1, Cardiac Rehabilitation Programs for Chronic Heart Failure 
(Pub. 100-03 20.10.1), to beneficiaries with stable, chronic heart 
failure, defined as patients with left ventricular ejection fraction of 
35 percent or less and New York Heart Association (NYHA) class II to IV 
symptoms despite being on optimal heart failure therapy for at least 6 
weeks. Stable patients are defined as patients who have not had recent 
(<= 6 weeks) or planned (<= 6 months) major cardiovascular 
hospitalizations or procedures.
2. Statutory Authority
    Section 51004 of the BBA of 2018, entitled ``Expanded Access to 
Medicare Intensive Cardiac Rehabilitation Programs,'' amended section 
1861(eee)(4)(B) of the Act. The amendment directs us to expand the list 
of covered conditions for ICR beyond the 6 conditions specified in 
section 144(a) of the MIPPA and codified in Sec.  410.49(b)(1).
3. Discussion of Statutory Requirements
    Section 1861(eee)(4)(B) of the Act requires that, in addition to 
the 6 conditions specified in section 144(a) of the MIPPA, ICR be 
covered for beneficiaries with (1) stable, chronic heart failure 
(defined as patients with left ventricular ejection fraction of 35 
percent or less and New York Heart Association (NYHA) class II to IV 
symptoms despite being on optimal heart failure therapy for at least 6 
weeks); or (2) any additional condition for which the Secretary has 
determined that a cardiac rehabilitation program shall be covered, 
unless the Secretary determines, using the same process used to 
determine that the condition is covered for a cardiac rehabilitation 
program, that such coverage is not supported by the clinical evidence.
    The statute explicitly states cardiac rehabilitation; therefore, 
this final rule is specific to CR and ICR for cardiac conditions. As 
such, this final rule cannot exceed the limits of the statute to apply 
CR and ICR other conditions (for example, cancer, metabolic syndrome, 
diabetes, peripheral artery disease, etc.).
4. Proposals for Implementation
    We proposed to amend Sec.  410.49(b) to expand the covered 
conditions for ICR. We proposed to amend Sec.  410.49(b)(vii) to add 
coverage of ICR for patients with stable, chronic heart failure defined 
as patients with left ventricular ejection fraction of 35 percent or 
less and New York Heart Association (NYHA) class II to IV symptoms 
despite being on optimal heart failure therapy for at least 6 weeks. We 
also proposed to specify in Sec.  410.49(b)(vii) that coverage for CR 
was effective February 18, 2014 as per the NCD for Cardiac 
Rehabilitation for Chronic Heart Failure (Pub. 100-03 20.10.1) which 
was finalized on February 18, 2014 as discussed above, and that 
coverage for ICR was effective on enactment of the BBA of 2018 
(February 9, 2018).
    We also proposed to add new Sec.  410.49(b)(viii) to include 
coverage of ICR, in addition to CR, for other cardiac conditions as 
specified through an NCD. Under the existing Sec.  410.49(b)(vii), 
coverage for CR may be established for other cardiac conditions through 
an NCD, and this final rule will extend this criterion to ICR, as well 
unless coverage for ICR is not supported by clinical evidence. As such, 
NCDs modifying the covered conditions would apply to both CR and ICR so 
long as clinical evidence supports coverage for CR and coverage for 
ICR.
    It is important to note that conditions that may be considered for 
expanded coverage are limited to cardiac conditions and may not include 
other conditions (for example, cancer, metabolic syndrome, diabetes, 
peripheral artery disease, etc.).
5. Comments
    We received public comments on this proposal and some were outside 
the scope.
    Comment: Several commenters supported this proposal. In particular, 
they supported the alignment of the CR and ICR covered conditions and 
utilization of the NCD process to expand ICR covered conditions in the 
future. Many of these commenters suggested that our proposal was 
consistent with the underlying statute.
    Response: We appreciate the commenter's support to codify in 
regulations the provisions of section 51004 of the BBA.
    Comment: Several commenters submitted comments on this proposal 
that were outside of the scope of the proposed rule. For example, these 
comments touched upon authorizing other health care providers to order 
and supervise CR; extending coverage of CR

[[Page 62899]]

to non-cardiac related conditions; and altering existing NCDs.
    Response: We appreciate the commenters' interest in the CR and ICR 
topics. However, because these comments were outside of the scope of 
the proposed rule, we are not responding to them in this final rule.
    In summary, we are finalizing modifications to Sec.  410.49(b) to 
implement the coverage changes specific to ICR. This includes expanding 
coverage of ICR to beneficiaries with chronic heart failure as 
discussed above and providing for modifications to covered cardiac 
conditions for ICR, in addition to CR, as specified through an NCD.

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

1. Background
    Sections 1903(a)(3)(F) and (t) of the Act provide the statutory 
basis for the incentive payments made to Medicaid EPs and eligible 
hospitals for the adoption, implementation, upgrade, and meaningful use 
of 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 42 
CFR 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 2019 PFS final rule (83 FR 59452, 59703 through 59704), 
we established for 2019 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 section III.I.3.h.(2)(b)(i) of this final rule, we amend the list of 
available eCQMs for the CY 2020 performance period. To keep eCQM 
specifications current and minimize complexity, we proposed to align 
the eCQMs available for Medicaid EPs in 2020 with those available for 
MIPS eligible clinicians for the CY 2020 performance period. 
Specifically, we proposed that the eCQMs available for Medicaid EPs in 
2020 would consist of the list of quality measures available under the 
eCQM collection type on the final list of quality measures established 
under MIPS for the CY 2020 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 reduce health care provider reporting burden (83 FR 
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 as they report for MIPS. 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 anticipated 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 
2020. We expected that this proposal would have only a minimal impact 
on states, by requiring minor adjustments to state systems for 2020 to 
maintain current eCQM lists and specifications.
    For 2020, we proposed to again require (as we did for 2019) 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 2019, we proposed that for 2020, 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 requirements for the MIPS 
quality performance category for eligible clinicians using the eCQM 
collection type. We also proposed that if no outcome or high priority 
measures are relevant to a Medicaid EP's scope of practice, the 
clinician may report on any six eCQMs that are relevant, as was the 
policy in 2019.
    In the CY 2019 PFS final rule (83 FR 59702 and 59704), 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 in 2019. We proposed to 
use the same three methods for identifying high priority eCQMs for the 
Medicaid Promoting Interoperability Program for 2020:
     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

[[Page 62900]]

adults enrolled in Medicaid (Adult Core Set) (hereinafter together 
referred to as ``Core Sets'') that are also included on the MIPS list 
of eCQMs.
    Sections 1139A and 1139B of the Act require the Secretary to 
identify and publish core sets of health care quality measures for 
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries. 
These measure sets are required by statute to be updated annually and 
are voluntarily reported by states to CMS. These Core Sets are composed 
of measures that specifically focus on populations served by the 
Medicaid and CHIP programs and are of particular importance to their 
care. The MIPS eCQM list includes several, but not all, of the measures 
in the Core Sets. Because the Core Sets are released at the beginning 
of each year, it is not possible to update the list of high-priority 
eCQMs with those added to the current year's Core Sets.
    The eCQMs that would be available for Medicaid EPs to report in 
2020, that are both part of the Core Sets and on the MIPS list of 
eCQMs, and that we proposed would be considered high priority measures 
were: 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, subject to CMS' 
review and approval, 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 2019. As noted above, we proposed to use 
the same three methods for identifying high priority eCQMs for the 
Medicaid Promoting Interoperability Program for 2020. We invited 
comments as to whether any of these methods should be altered or 
removed, or whether any additional methods should be considered for 
2021.
    We received public comments on aligning the available eCQMs for the 
Medicaid Promoting Interoperability Program with those available under 
the eCQM collection type for the MIPS CY 2020 performance period, the 
requirement that Medicaid EPs must submit any six eCQMs relevant to an 
EP's scope of practice, including one outcome measure (or if an outcome 
measure is not available or relevant, one high priority measure), and 
the three methods we proposed for identifying high priority measures. 
The following is a summary of the comments we received and our 
responses.
    Comment: All comments we received on these topics were supportive 
of our proposals.
    Response: We thank commenters for their support.
    After considering public comments, we are finalizing these policies 
as proposed. The eCQMs available for Medicaid EPs in 2020 will consist 
of the list of quality measures available under the eCQM collection 
type on the final list of quality measures established under MIPS for 
the CY 2020 performance period. In 2020, Medicaid EPs will be required 
to report on any six eCQMs that are relevant to their scope of 
practice, regardless of whether they report via attestation or 
electronically. For a reporting period in CY 2020, Medicaid EPs will 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). 
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. eCQMs identified via any of the three methods discussed above 
will be high priority measures for EPs participating in the Medicaid 
Promoting Interoperability Program in 2020.
    We also proposed that the 2020 eCQM reporting period for Medicaid 
EPs who have demonstrated meaningful use in a prior year would be a 
minimum of any continuous 274-day period within CY 2020. This 274-day 
eCQM reporting period corresponds to the 9-month period from January 1, 
2020 to September 30, 2020. We explained that under our proposal, 
Medicaid EPs would not be required to use that exact reporting period, 
but would be able to use any continuous 274-day period within CY 2020. 
We also explained that Medicaid EPs could also use a longer eCQM 
reporting period in CY 2020, up to the full calendar year. We noted 
that states would be required to allow sufficient time for EPs to 
attest for program year 2020 beyond January 1, 2021 so that EPs may, 
should they choose to do so, select EHR and eCQM reporting periods that 
take place at any time within the 2020 calendar year through December 
31, 2020.
    We proposed this eCQM reporting period for 2020 to improve state 
flexibility in the penultimate year of the Medicaid Promoting 
Interoperability Program, and to facilitate an orderly end of the 
program in 2021. In the CY 2019 PFS final rule, we established that the 
eCQM reporting period for Medicaid EPs in 2021 will be a minimum of any 
continuous 90-day period within CY 2021, and also established that the 
end date for this period must fall before October 31, 2021, to help 
ensure that states can issue all Medicaid Promoting Interoperability 
payments to EPs by the December 31, 2021 statutory deadline (83 FR 
59704 through 59706). When proposing that policy, we received comments 
that asked us to consider an eCQM reporting period shorter than a full 
year in 2020. Commenters on the CY 2019 PFS proposals stated that a 
full-year reporting period may create significant backlogs of 2020 and 
2021 attestations in 2021 that may create difficulty for states to 
issue payments by the statutory deadline (83 FR 59705). We continue to 
believe that a full year reporting period creates more useful data for 
quality measurement and improvement because it would give states a 
broader picture of the care rendered by a health care provider and 
patient outcomes. However, we agree that a full-year eCQM reporting 
period in 2020 would unnecessarily burden states as they will need to 
issue incentive payments and implement systems changes for 2021 in a 
timely manner.
    We explained that this proposal would allow states to accept 
attestations for program year 2020 as early as October 1, 2020 from 
Medicaid EPs who choose to use an eCQM reporting period early in the 
year, and thus could give states additional time to prepare for 2021 
and the end of the Medicaid Promoting Interoperability Program. We 
explained that even though states would also still have to allow EPs to 
submit attestations for 2020 in 2021, we believe that allowing some EPs 
to attest sooner could accelerate states' pre-payment verification and 
payment process. We explained that we considered whether to propose a 
Medicaid EP eCQM reporting period for 2020 from January 1, 2020 through 
September 30, 2020, with no flexibility for EPs to select an

[[Page 62901]]

alternative 274-day eCQM reporting period. We also considered whether 
to propose a date prior to December 31, 2020 by which all Medicaid EP 
EHR and eCQM reporting periods for 2020 must end. While either of these 
alternatives might have further helped to ensure that all states would 
have additional time to prepare for 2021, we decided not to propose 
either of them because we wanted to preserve as much flexibility as 
possible for Medicaid EPs. However, we solicited comment, especially 
from states and Medicaid EPs, about whether either of these 
alternatives might be preferable to our proposal.
    We noted that states submit their attestation deadlines to CMS each 
year as part of their SMHPs. We did not believe that this proposal 
would create any additional burden on EPs or health IT vendors, as 
CEHRT should be able to report eCQM data with respect to any period of 
time.
    We proposed that, in 2020, the eCQM reporting period for Medicaid 
EPs demonstrating meaningful use for the first time, which was 
established in the final rule entitled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program-Stage 3 and 
Modifications to Meaningful Use in 2015 Through 2017'' (80 FR 62762, 
62892) (hereinafter known as the ``Stage 3 final rule''), would remain 
any continuous 90-day period within the calendar year, as in previous 
years.
    The following is a summary of the comments we received about the 
proposed eCQM reporting period for CY 2020, and our responses.
    Comment: All commenters supported the principle of our proposal to 
shorten the eCQM reporting period for CY 2020. Some commenters noted 
that eCQMs are developed for a full-year reporting period, and that any 
reporting period shorter than a year (regardless of length) will 
inherently introduce data quality issues, but agreed that shortening 
the reporting period in order to facilitate 2020 and 2021 payments was 
an overriding concern. However, most commenters opposed a 274-day 
reporting period for CY 2020, and instead urged us to establish a 90-
day eCQM reporting period for CY 2020. No commenters supported a fixed 
reporting period (for example, from January 1, 2020 to September 30, 
2020); most commenters objected to a fixed reporting period on the 
grounds that allowing EPs to select their own reporting period would 
increase their flexibility to meet the program requirements.
    The comments suggesting that we instead establish a 90-day eCQM 
reporting period for 2020 came from a variety of stakeholders, 
including provider organizations, health IT vendors, and state Medicaid 
agencies. These commenters presented several rationales in support of a 
90-day eCQM reporting period. First, many of these commenters noted 
that we have never used an EHR or eCQM reporting period other than a 
full year or 90 days for EPs, so establishing a one-time 274-day eCQM 
reporting period for 2020 would be confusing to EPs. A couple of 
commenters suggested that a 90-day reporting period was much simpler, 
but that a reporting period based on the calendar quarter or even a 
full year would be less confusing for EPs than a 274-day reporting 
period. Second, one commenter suggested that a 90-day eCQM reporting 
period might actually produce data that could be more useful for 
longitudinal analytics than a 274-day reporting period, because a 90-
day reporting period would align with the already-established 90-day 
eCQM reporting period for 2021. Third, some of these commenters 
asserted that a 90-day eCQM reporting period would reduce the 
administrative and reporting burden for EPs because it would be aligned 
with the eCQM reporting period for MIPS eligible clinicians. These 
commenters thought that there would be a 90-day reporting period for 
eligible clinicians in MIPS who choose the eCQM collection type.
    We also received comments discussing whether CEHRT should be able 
to report eCQMs for any length of time. One health IT vendor agreed 
that CEHRT should be able to report eCQMs for any length of time, while 
another commenter stated that its systems would require additional 
coding to produce eCQM data for a 274-day reporting period.
    Response: After considering these comments, we agree with the 
commenters that finalizing a 274-day eCQM reporting period only for CY 
2020 may cause confusion for Medicaid EPs. The Medicaid Promoting 
Interoperability Program has always used reporting periods of a full 
year or 90 days for EPs. We believe that finalizing a 90-day eCQM 
reporting period for 2020, as recommended by commenters, instead of the 
274-day eCQM reporting period we proposed, is more likely to reduce 
burden on EPs, health IT vendors, states, and other stakeholders, as 
compared to a full-year period or the 274-day eCQM reporting period we 
proposed.
    A 90-day eCQM reporting period in 2020 will reduce burden on 
Medicaid EPs because it will provide EPs with additional time during 
which they can attest (depending on when their state accepts 
attestations for 2020). It could reduce burden on states by enabling 
states to take EP attestations earlier during 2020, which could help 
states perform the necessary prepayment process and issue incentive 
payments for 2020 over a longer period of time while they prepare for 
the final year of the program in 2021. While certain health IT vendors 
submitted comments that generally confirmed our understanding that 
CEHRT should be able to run reports for any period of time, as outlined 
in the proposed rule, one commenter noted that there may be some CEHRT 
products that would need additional coding for a new reporting period 
length versus the previously-used 90-day eCQM reporting period. Thus, 
finalizing a 90-day eCQM reporting period could also reduce burden on 
at least some health IT vendors. Furthermore, this policy would allow 
EPs to use the same 90-day period for their Medicaid Promoting 
Interoperability Program EHR reporting period and eCQM reporting 
period.
    As noted above, we continue to believe that a full year eCQM 
reporting period would lead to better data quality than a shorter 
period. We also agree that any eCQM reporting period shorter than a 
full year is inherently going to introduce data quality issues, whether 
it is a 274-day or 90-day period. However, we acknowledge that a 90-day 
eCQM reporting period in 2020 would match the already-established 90-
day eCQM reporting period for 2021, and thus might provide better data 
for comparison than a 274-day period. Ultimately, we concluded that the 
risk of any possible data quality degradation due to a shorter 
reporting period might be somewhat mitigated by using a period that can 
be compared across program years 2020 and 2021. We also concluded that, 
generally, the potential data quality issues associated with a shorter 
eCQM reporting period are outweighed by the benefits to all 
stakeholders of a shorter period for 2020.
    While we generally agreed with the commenters recommending we 
establish a 90-day eCQM reporting period, the comments recommending 
that we do so specifically in order to align with MIPS reporting were 
based on a mistaken assumption. We are establishing a full-year 
reporting period for the MIPS quality performance category, in section 
III.K.3.c.(1) of this final rule, as we did for 2018 and 2019. While a 
90-day eCQM reporting period in 2020 for the Medicaid Promoting 
Interoperability Program would not be aligned with this MIPS reporting 
period, we believe that, for the reasons

[[Page 62902]]

discussed above and in the proposed rule preamble, a period shorter 
than a full year would provide helpful flexibility to Medicaid EPs and 
states, and that these benefits outweigh any potential burdens created 
by the lack of alignment. No commenters suggested to us that aligning 
the eCQM reporting period for 2020 with the full year reporting period 
for MIPS eligible clinicians who use the eCQM collection type 
outweighed the benefits of the shorter reporting period that we 
proposed.
    After considering the comments, we are finalizing a continuous 90-
day eCQM reporting period for all Medicaid EPs in 2020. EPs may select 
any continuous 90-day period within the calendar year. The reporting 
period is a minimum, and we encourage EPs to report on a longer period 
if they are able to do so.
    Under this policy, EPs may be able to attest to meaningful use as 
early as April 1, 2020. We encourage states to begin taking 
attestations as early as possible in 2020, as that would allow states 
as much time as possible to process and make 2020 payments before they 
have to prepare for the 2021 program year. Just as we proposed in 
connection with the 274-day eCQM reporting period, we expect states to 
provide EPs the opportunity to use any 90-day period in 2020 under the 
finalized policy, up to and including a period that ends December 31, 
2020. Therefore, states must allow sufficient time for EPs to attest 
into CY 2021. As noted in the proposed rule and above, states submit 
their attestation deadlines to CMS for approval each year as part of 
their SMHPs.
3. Objective 1: Protect Patient Health Information in 2021
    In the Stage 3 final rule (80 FR 62762, 62832), we established 
Meaningful Use Objective 1 as ``Protect electronic protected health 
information (ePHI) created or maintained by the CEHRT through the 
implementation of appropriate technical, administrative, and physical 
safeguards.'' As specified at Sec.  495.24(d)(1)(i)(B), to meet that 
objective, EPs must meet the associated measure to conduct or review a 
security risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including addressing the security (including encryption) 
of data created or maintained by CEHRT in accordance with requirements 
under 45 CFR 164.312(a)(2)(iv) and 164.306(d)(3), implement security 
updates as necessary, and correct identified security deficiencies as 
part of the provider's risk management process.
    In the Stage 3 final rule, we explained that this measure must be 
completed in the same calendar year as the EHR reporting period. This 
may occur before, during, or after the EHR reporting period, though if 
it occurs after the EHR reporting period it must occur before the 
provider attests to meaningful use of CEHRT or before the end of the 
calendar year, whichever comes first (80 FR 62831). In practice, this 
means that EPs do not attest to meaningful use of CEHRT before 
completing this measure.
    As discussed above, states must issue all Medicaid Promoting 
Interoperability Program incentive payments by the statutory deadline 
of December 31, 2021. States can establish state-specific deadlines for 
Medicaid EPs to attest to the state regarding meaningful use of CEHRT 
in CY 2021. However, due to changes CMS made in prior rulemaking to the 
Medicaid Promoting Interoperability Program EHR and eCQM reporting 
periods for 2021, all states must set attestation deadlines on or 
before October 31, 2021. See 42 CFR 495.4 (definition of ``EHR 
reporting period'') and 495.332(f)(3) and (4), and 83 FR 59704 through 
59705. Because all EPs are expected to attest to meaningful use of 
CEHRT before the end of CY 2021, Medicaid EPs would no longer have the 
option of completing the security risk analysis at the end of the 
calendar year, and would likely have to complete it well before 
December 2021. For example, in a state with an attestation deadline of 
October 1, 2021, a Medicaid EP would have to conduct the security risk 
analysis by September 30, 2021. Stakeholders have offered us feedback 
that most security risk analyses are conducted on a clinic or practice 
level, which may include EPs and non-EPs. As we noted in the Stage 3 
final rule, ``[a]n organization may conduct one security risk analysis 
or review which is applicable to all EPs within the organization, 
provided it is within the same calendar year and prior to any EP 
attestation for that calendar year. However, each EP is individually 
responsible for their own attestation and for independently meeting the 
objective. Therefore, it is incumbent on each individual EP to ensure 
that any security risk analysis or review conducted for the group is 
relevant to and fully inclusive of any unique implementation or use of 
CEHRT relevant to their individual practice'' (80 FR 62794).
    If an EP or practice typically conducts the security risk analysis 
at the end of each year, the CY 2021 timeline for attesting to 
meaningful use of CEHRT may create burden for all Medicaid EPs and for 
non-EP health care providers within the same organization as Medicaid 
EPs, and may not be optimal for protecting information security, 
because it could disrupt the intervals between security risk analyses. 
As we explained in the Stage 3 final rule, a security risk analysis is 
not a discrete item in time, but a comprehensive analysis covering the 
full period of time for which it is applicable; and the annual review 
of such an analysis is similarly comprehensive. In other words, the 
analysis and review, no matter when they are conducted, should not be 
just a ``point in time'' exercise, and instead should cover a span of 
the entire year, including a review planning for future system changes 
within the year or a review of prior system changes within the year (80 
FR 62831). However, EPs that typically conduct the security risk 
analysis in December of each calendar year might conduct one security 
risk analysis in December 2020, and then have to conduct another one 
well before December 2021, if the analysis must be completed before the 
EP attests to meaningful use of CEHRT for CY 2021. We believe that 
security risk analyses are most effective for data security when 
conducted on a regular schedule. In addition, practice locations may 
have ongoing contracts or processes in place to perform a security risk 
analysis at the same time each year. We do not wish to create burden 
for EPs and non-EPs related to changing those processes to meet the CY 
2021 Medicaid Promoting Interoperability Program attestation timelines.
    Therefore, we proposed to allow Medicaid EPs to conduct a security 
risk analysis at any time during CY 2021, even if the EP conducts the 
analysis after the EP attests to meaningful use of CEHRT to the state. 
A Medicaid EP who has not completed a security risk analysis for CY 
2021 by the time he or she attests to meaningful use of CEHRT for CY 
2021 would be required to attest that he or she will complete the 
required analysis by December 31, 2021. Under this proposal, states 
could require Medicaid EPs to submit evidence that the security risk 
analysis has been completed as promised, even after the incentive 
payment has been issued. In addition, states could require EPs to 
attest that if a security risk analysis is not completed by December 
31, 2021, they will voluntarily rescind their attestation to meaningful 
use of CEHRT and return the incentive payment. We explained that if 
this proposal is finalized, we would work with states to develop post-
payment verification and audit processes that meet CMS due diligence 
requirements,

[[Page 62903]]

including those in Sec. Sec.  495.318 and 495.368, and generally to 
ensure that incentive payments are made properly. We reminded states 
that as a condition of receiving enhanced federal financial 
participation, they are required to demonstrate to the satisfaction of 
HHS that they are conducting adequate oversight of the program, 
including routine tracking of meaningful use attestations (See Sec.  
495.318(b)). We also reminded states that they must submit a 
description of the methodology used to verify that EPs have 
meaningfully used CEHRT for CMS approval as part of their SMHP. (See 
Sec.  495.332(c)). In the final rule titled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program'' (75 FR 44313), 
CMS explained that states are expected to ``look behind'' provider 
attestations, and that this would require audits both pre- and post-
payment (75 FR 44515). These requirements and expectations would not 
change under this proposal.
    The following is a summary of the comments we received on our 
proposed changes, and our responses.
    Comment: The majority of commenters stated their support for our 
proposal to allow Medicaid EPs to conduct a security risk analysis 
(SRA) at any time during CY 2021, even if the EP conducts the analysis 
after the EP attests to meaningful use of CEHRT to the state. These 
commenters stated that allowing EPs to complete the security risk 
analysis after their attestation will provide flexibility to EPs while 
allowing states sufficient time to process incentive payments in the 
final year of the program.
    Response: It is our intention to allow for maximum flexibility for 
Medicaid EPs to attest before their state's 2021 deadline, while 
maintaining their annual SRA schedule.
    Comment: A few commenters, including state Medicaid agencies, 
opposed our proposal to allow EPs to conduct their SRA after the EP 
attests to meaningful use of CEHRT to the state. These commenters 
expressed concern about program integrity risk, as well as the burden 
on state Medicaid agencies to ensure that these EPs are able to 
demonstrate that they met the program requirements. In addition, the 
commenters were concerned that the proposed policy might result in a 
greater number of recouped payments as a result of EPs not actually 
meeting the requirements.
    Response: We believe safeguards are available to mitigate program 
integrity risk, such as requiring Medicaid EPs to submit evidence of 
their SRA once it is complete. Because the final incentive payments 
must be issued by December 31, 2021, we are limited in our ability to 
provide flexibility to Medicaid EPs given that all states must set 
attestation deadlines on or before October 31, 2021. Our policy is 
motivated by a desire to reduce overall burden on Medicaid EPs. We 
acknowledge there is some potential additional burden associated with 
increased monitoring by state Medicaid agencies and an increased risk 
of recoupments from what we believe would likely be a small minority of 
EPs. However, we believe this additional burden is clearly outweighed 
by the reduced burden on what we anticipate would be the vast majority 
of Medicaid EPs that are afforded flexibility to conduct the SRA at any 
point in the calendar year that aligns with their operational needs. 
Additionally, as noted above, states are already required to conduct 
adequate oversight of the Medicaid Promoting Interoperability Program, 
and we intend to work with states to develop post-payment verification 
and audit processes that meet CMS due diligence requirements, and 
generally to ensure that incentive payments are made properly. We have 
established at Sec.  495.322(b) that 90 percent federal financial 
participation will be available for state administrative expenditures 
related to Medicaid Promoting Interoperability Program audits and 
appeals that are incurred on or before September 30, 2023.
    After considering public comments, we are finalizing this policy as 
proposed, and will allow Medicaid EPs to conduct a security risk 
analysis at any time during CY 2021, even if the EP conducts the 
analysis after the EP attests to meaningful use of CEHRT to the state. 
A Medicaid EP who has not completed a security risk analysis for CY 
2021 by the time he or she attests to meaningful use of CEHRT for CY 
2021 will be required to attest that he or she will complete the 
required analysis by December 31, 2021.
4. Clarification
    In the CY 2019 PFS final rule (83 FR 59702), in the list of high 
priority eCQMs that are available for Medicaid EPs to report in 2019 
because they are both part of the Core Sets and on the MIPS list of 
eCQMs, we inadvertently listed ``Initiation and Engagement of Alcohol 
and Other Drug Dependence Treatment'' as ``CMS4.'' It should have read 
``CMS137, `Initiation and Engagement of Alcohol and Other Drug 
Dependence Treatment.' ''

E. Medicare Shared Savings Program

    As required under section 1899 of the Act, we established the 
Medicare Shared Savings Program (Shared Savings Program) to facilitate 
coordination and cooperation among health care providers to improve the 
quality of care for Medicare fee-for-service (FFS) beneficiaries and 
reduce the rate of growth in expenditures under Medicare Parts A and B. 
Eligible groups of providers and suppliers, including physicians, 
hospitals, and other health care providers, may participate in the 
Shared Savings Program by forming or participating in an Accountable 
Care Organization (ACO). Please refer to the CY 2020 PFS proposed rule 
for a summary of policies finalized in prior rules (84 FR 40705).
    As a general summary, in the CY 2020 PFS proposed rule, we:
     Discussed aligning the Shared Savings Program quality 
measure set with proposed changes to the Web Interface measure set 
under MIPS per previously-finalized policy;
     Proposed a change to the claims-based measures;
     Solicited comment on aligning the Shared Savings Program 
quality score with the MIPS quality performance category score; and
     Proposed a technical change to correct a cross-reference 
within a provision of the Shared Savings Program's regulations on the 
skilled nursing facility (SNF) 3-day rule waiver, to conform with 
amendments to Sec.  425.612 that were adopted in the final rule for the 
Shared Savings Program that appeared in the December 31, 2018 Federal 
Register (Medicare Program: Medicare Shared Savings Program; 
Accountable Care Organizations--Pathways to Success; final rule) (83 FR 
67816) (hereinafter referred to as the ``December 2018 final rule'').
1. Quality Measurement
a. Background
    Section 1899(b)(3)(C) of the Act states that the Secretary shall 
establish quality performance standards to assess the quality of care 
furnished by ACOs and seek to improve the quality of care furnished by 
ACOs over time by specifying higher standards, new measures, or both. 
In the final rule establishing the Shared Savings Program that appeared 
in the November 2, 2011 Federal Register (Medicare Program; Medicare 
Shared Savings Program; Accountable Care Organizations; final rue (76 
FR 67802) (hereinafter referred to as the ``November 2011 final 
rule''), we established a quality measure set spanning four domains: 
patient experience of care, care coordination/patient safety, 
preventive health, and at-risk population (76 FR 67872 through 67891). 
Since the Shared Savings

[[Page 62904]]

Program was established, we have updated the measures that comprise the 
quality performance measure set for the Shared Savings Program through 
the annual 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. 
For performance years starting in 2019, 23 quality measures will be 
used to determine ACO quality performance (83 FR 59707 through 59715). 
The information used to determine ACO performance on these quality 
measures will be 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) will be 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, such as Levels A-D of 
the BASIC Track) of the Shared Savings Program that is not an Advanced 
APM, as well as those participating in an ACO in a track (or payment 
model within a track) 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. CMS Web Interface and Claims-Based Measures
    Since the Shared Savings Program was first established in 2012, we 
have updated the quality measure set to reduce reporting burden and 
focus on more meaningful, outcome-based measures. The most recent 
updates to the Shared Savings Program quality measure set were made in 
the CY 2019 PFS final rule (83 FR 59711). In the CY 2019 PFS final 
rule, we explained that in developing the proposed changes to the 
quality measure set for 2019, we had considered the agency's efforts to 
streamline quality measures, reduce regulatory burden and promote 
innovation as part of the agency's Meaningful Measures initiative (see 
CMS Press Release, CMS Administrator Verma Announces New Meaningful 
Measures Initiative and Addresses Regulatory Reform; Promotes 
Innovation at LAN Summit, October 30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). We also noted that under the 
Meaningful Measures initiative, we have committed to assessing only 
those core issues that are most vital to providing high-quality care 
and improving patient outcomes, with the aim of focusing on high-
priority measures, reducing unnecessary burden on providers, and 
putting patients first. The changes made in the CY 2019 PFS final rule 
reduced the Shared Savings Program quality measure set from 31 to 23 
measures. Currently, more than half of the 23 Shared Savings Program 
quality measures are outcome and high-priority measures, including:
     Patient-experience of care measures collected through the 
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
     Outcome measures supporting effective communication and 
care coordination, such as unplanned admission and readmission 
measures.
     Intermediate outcome measures that address the effective 
treatment of chronic disease, such as hemoglobin A1c control for 
patients with diabetes.
    As we stated in the CY 2019 PFS final rule (83 FR 59713), we seek 
to align the Shared Savings Program quality measure set with changes 
made to the CMS Web Interface measures under the Quality Payment 
Program. In the 2017 PFS final rule, we stated that we do not believe 
it is beneficial to propose CMS Web interface measures for ACO quality 
reporting separately (81 FR 80499). Therefore, to avoid confusion and 
duplicative rulemaking, we adopted a policy that any future changes to 
the CMS Web interface measures would be proposed and finalized through 
rulemaking for the Quality Payment Program, and that such changes would 
be applicable to ACO quality reporting under the Shared Savings 
Program. In accordance with the policy adopted in the CY 2017 PFS final 
rule (81 FR 80501), we did not make any specific proposals related to 
changes in CMS Web Interface measures reported under the Shared Savings 
Program in the CY 2020 PFS proposed rule (84 FR 40706). Rather, we 
referred readers to Appendix 1, Table C (Existing Quality Measures 
Finalized for Removal Beginning with the 2022 MIPS Payment Year) and 
Table Group A (New Quality Measures Finalized for Addition Beginning 
with the 2022 MIPS Payment Year) of the proposed rule for a complete 
discussion of the proposed changes to the CMS Web Interface measures 
for performance year 2020 (2022 MIPS Payment Year). As discussed in 
section III.I.3.B.1 of this final rule, no changes are being finalized 
to the CMS Web Interface measures set for performance year 2020. As a 
result, ACOs will continue to be responsible for reporting the 
following measure for performance year 2020 for purposes of the Shared 
Savings Program:
     ACO-14 Preventive Care and Screening Influenza 
Immunization
    As explained in the proposed rule, we will maintain the measure 
with the ``substantive'' change described in Appendix 1, Table D-A 81 
(Previously Finalized Quality Measures with Substantive Changes 
Finalized for the 2022 Payment Year and Future Years) of this final 
rule. As discussed in Table D-A 81 of this final rule, we have reviewed 
the ``substantive'' change and we do not believe this change to the 
measure would require that we revert the measure to pay-for-reporting 
for the 2020 performance year. We have determined that we can create a 
historical benchmark using data reported for the measure in past years 
as updating the numerator instructions that allow the use of the Live 
Attenuated Influenza Vaccine (LAIV) does not significantly impact ACO-
14; but rather, allows for shared decision making between the patient 
and the eligible clinician over the best method of administration, 
while aligning with the current performance period's CDC/ACIP 
guidelines without negatively affecting clinicians providing LAIV.
    Additionally, in section III.I.3.B.(1) of the CY 2020 PFS proposed 
rule, we proposed to add the following measure to the CMS Web Interface 
for purposes of the Quality Payment Program:
     ACO-47 Adult Immunization Status: We refer readers to 
Appendix 1, Table Group A.3 of this final rule for a discussion of 
comments received on this proposal. Based on the policies being 
finalized for purposes of MIPS in Appendix 1, Table Group A.3 of this 
final rule, Shared Savings Program ACOs will not be responsible for 
reporting the Adult Immunization Status measure (ACO-47) for 
performance year 2020.
    In section III.J.3.c.(1)(d) of the CY 2020 PFS proposed rule, we 
discussed our determination, based on extensive stakeholder feedback, 
that the 2018 CMS Web Interface measure numerator guidance for the 
Preventive Care and Screening: Tobacco Use: Screening and Cessation 
Intervention (ACO-17) measure was inconsistent with the intent of the 
CMS Web Interface version

[[Page 62905]]

of this measure as modified in the CY 2018 Quality Payment Program 
final rule (82 FR 54164) and unduly burdensome on clinicians. We 
explained that, due to this numerator guidance, we were unable to rely 
on historical data to benchmark the measure. Therefore, for the 2018 
performance year we explained that we were designating the measure pay-
for-reporting in accordance with Sec.  425.502(a)(5).
    Additionally, in section III.J.3.c.(1)(d) of the CY 2020 PFS 
proposed rule, we proposed to update the CMS Web Interface measure 
numerator guidance for purposes of the Quality Payment Program. We 
noted that to the extent that this change would constitute a change to 
the Shared Savings Program measure set after the start of the 2019 
performance period, we believed that, consistent with section 
1871(e)(1)(A)(ii) of the Act, it would be contrary to the public 
interest not to modify the measure as proposed in Table DD because the 
guidance was inconsistent with the intent of the CMS Web Interface 
version of this measure, as modified in the CY 2018 Quality Payment 
Program final rule, and unduly burdensome on clinicians. We noted that 
if this modification were finalized as proposed, then consistent with 
our discussion in the CY 2018 PFS final rule, we expected that we would 
be able to use historical data reported on the measure to establish an 
appropriate 2019 benchmark that aligns with the updated specifications 
(82 FR 53214 and 53215) and the measure would be pay-for-performance 
for performance years starting in 2019 and all subsequent years.
    While we did not make any specific proposals under the Medicare 
Shared Savings Program related to the Preventive Care and Screening: 
Tobacco Use: Screening and Cessation Intervention (ACO-17) measure for 
performance years starting in 2019, we did receive public comments on 
the proposed update to the numerator guidance for the Preventive Care 
and Screening: Tobacco Use: Screening and Cessation Intervention (ACO-
17) measure for performance years starting in 2019. The following is a 
summary of the comments we received and our response.
    Comment: Commenters unanimously supported the proposed update to 
the numerator guidance for the Preventive Care and Screening: Tobacco 
Use: Screening and Cessation Intervention (ACO-17) measure as discussed 
in Table DD in Appendix 1 of this final rule (Previously Finalized 
Quality Measures with Substantive Changes finalized for the 2021 MIPS 
Payment Year). However, commenters unanimously opposed CMS designating 
the measure to pay-for-performance for performance years starting in 
2019. Several commenters expressed concerns that notice of this change 
for 2019 is coming late in the performance year, which they stated did 
not allow sufficient time for vendors and/or ACOs to update workflows 
and reports before the start of CMS Web Interface reporting and could 
have a negative impact on performance. As a result of these stated 
concerns, the commenters opposed reverting this measure to pay-for-
performance and suggested it remain pay-for-reporting for 2019. Many 
commenters suggested that CMS keep the measure as pay-for-reporting for 
2018 and 2019 consistent with our policy that newly introduced measures 
will be pay-for-reporting for 2 years, and another commenter expressed 
concern with the lack of clarity in the specifications which they 
stated would support maintaining the measure in a pay-for-reporting 
status for 2019 and 2020.
    Response: We refer readers to Table DD.1 (Previously Finalized 
Quality Measures with Substantive Changes finalized for the 2021 MIPS 
Payment Year) for more details on the updated numerator guidance and 
measure specifications for ACO-17. We note that we did not make a 
proposal to make ACO-17 pay-for-performance for 2019; rather, we noted 
in the proposed rule that we were reverting the measure back to the 
version finalized in the CY 2018 PFS final rule and explained that we 
would have the data to create a benchmark for performance years 
starting in 2019, and thus the measure would be pay for performance. At 
that time, we had concluded that the ``substantive'' changes to this 
measure adopted in the CY 2018 PFS final rule would not require CMS to 
revert the measure to pay-for-reporting because we would still be able 
to use historical data reported on the measure to establish an 
appropriate benchmark that aligned specifications (82 FR 53214 and 
53215). However, we understand commenters' concerns about changes to 
the specifications during the performance period and how these changes 
could potentially impact workflow.
    We have been persuaded by commenters that scoring ACO-17 for 
performance years starting in 2019 could disadvantage clinicians who 
had planned to implement the measure with the revised numerator 
guidance that was in place for 2018. Reverting this measure to the 
version finalized for 2018 is considered a substantive change, as 
reflected in the CY 2018 Quality Payment Program final rule (82 FR 
54164). The regulations at Sec.  425.502(a)(5) grant CMS discretion to 
redesignate a measure as pay for reporting when there is a 
determination under the Quality Payment Program that the measure has 
undergone a substantive change. Accordingly, we are exercising that 
discretion to revert ACO-17 to pay for reporting for performance years 
starting in 2019. We believe that this will allow time for ACOs (and 
their vendors) to take the steps necessary to report the measure 
consistent with the specifications in performance year 2020. 
Accordingly, we are finalizing that ACO-17 will be pay-for-reporting 
for performance years starting in 2019, but will revert to pay-for-
performance for performance year 2020.
    In the CY 2020 PFS proposed rule, we noted that AHRQ, which is the 
measure steward for ACO-43--Ambulatory Sensitive Condition Acute 
Composite (AHRQ Prevention Quality Indicator (PQI) #91) (version with 
additional Risk Adjustment), made an update to the measure that will 
require a change to the measure specifications for performance year 
2020.\102\ Currently, ACO-43 assesses the risk adjusted rate of 
hospital discharges for acute PQI conditions with a principal diagnosis 
of dehydration, bacterial pneumonia, and urinary tract infection. The 
updated measure will only include two conditions, bacterial pneumonia 
and urinary tract infection. This measure is a composite measure and 
the rate of hospital discharges is approximately equal to the sum of 
the rates of hospital discharges for each of its components. Therefore, 
the removal of dehydration will likely decrease the composite rate by 
approximately the rate of dehydration discharges. Based on this 
substantive change, we proposed to redesignate ACO-43 as pay-for-
reporting for 2020 and 2021 consistent with our policy under Sec.  
425.502(a)(4), which provides that a newly introduced measure is set at 
the level of complete and accurate reporting for the first two 
reporting periods the measure is required. However, we also considered 
creating a benchmark using historical data for bacterial pneumonia and 
urinary tract infection and keeping the measure pay-for-performance. As 
this is a claims-based measure, we have access to historical data for 
both bacterial pneumonia and urinary tract infection so we would be 
able to create a historical benchmark for the revised

[[Page 62906]]

measure. However, we also explained our belief that changes to measures 
can impact how ACOs, their ACO participants, and ACO provider/suppliers 
allocate their resources and redesign their care process to improve 
quality of care for their beneficiaries. As a result, we noted that our 
proposal to revert the measure to pay-for-reporting for 2 years would 
give ACOs time to refine care processes and educate clinicians while 
also gaining experience with the refined composite measure and an 
understanding of performance under revised benchmarks prior to the 
start of a pay for performance year.
---------------------------------------------------------------------------

    \102\ https://www.qualityindicators.ahrq.gov/News/Retirement%20Notice_v2019_Indicators.pdf.
---------------------------------------------------------------------------

    We received public comments on this proposal and the alternative 
approach considered. The following is a summary of the comments we 
received and our response.
    Comment: Commenters unanimously supported our proposal to revert 
the revised version of ACO-43--Ambulatory Sensitive Condition Acute 
Composite (AHRQ Prevention Quality Indicator (PQI) #91) (version with 
additional Risk Adjustment) to pay-for-reporting for 2020 and 2021. The 
commenters agreed with CMS that this will give ACOs time to refine care 
processes and educate clinicians, while also gaining experience with 
the revised composite measure. One commenter stated that with only one 
of the two sub-measures (pneumonia) tested and endorsed at the facility 
level, it is not known how well the two components together represent 
the quality of the care provided by ACOs. The commenter suggested that 
CMS ensure the composite is tested at the ACO level and reviewed by 
NQF.
    Response: We acknowledge the commenter's concern with regard to not 
knowing how well the revised two component measure will represent the 
quality of the care provided by the ACO; reverting the measure to pay-
for-reporting for 2 years allows us to review/analyze performance data 
for the revised measure before incorporating the measure performance 
into the Shared Savings Program quality score.
    After considering the comments received we are finalizing our 
proposal that ACO-43--Ambulatory Sensitive Condition Acute Composite 
(AHRQ Prevention Quality Indicator (PQI) #91) (version with additional 
Risk Adjustment) will be pay-for-reporting for 2020 and 2021 consistent 
with our policy under Sec.  425.502(a)(4), which provides that a newly 
introduced measure is set at the level of complete and accurate 
reporting for the first two reporting periods the measure is required.
    Table 40 shows the Shared Savings Program quality measure set for 
performance year 2020 and subsequent performance years that will result 
from the finalized policies in section III.I.3.B.(1) of this final 
rule.
BILLING CODE 4120-01-P

[[Page 62907]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.084


[[Page 62908]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.085

BILLING CODE 4120-01-C
    The net result of the final policies in section III.I.3.b.(1) of 
this final rule will be a set of 23 measures on which ACOs' quality 
performance will be assessed for performance year 2020 and subsequent 
performance years. The 4 domains will include the following numbers of 
quality measures (See Table 41):
     Patient/Caregiver Experience of Care-10 measures.
     Care Coordination/Patient Safety-4 measures.
     Preventive Health-6 measures.
     At Risk Populations-3 measures.
    Table 41 provides a summary of the number of measures by domain and 
the total points and domain weights that will be used for scoring 
purposes.
[GRAPHIC] [TIFF OMITTED] TR15NO19.086

c. Solicitation of Comment on Aligning the Shared Savings Program 
Quality Score With the MIPS Quality Score
    As discussed above, our principal goal in selecting quality 
measures for the Shared Savings Program 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. The Shared 
Savings Program quality measure set currently consists of 23 measures 
spanning four domains that are submitted by the ACO through the CMS Web 
Interface, calculated by us for ACOs from administrative claims data, 
and collected via a patient experience of care survey referred to as 
the CAHPS for ACOs Survey. The number of measures within the four 
domains has changed over time to reflect changes in clinical practice, 
move towards more outcome and high-priority measures, align with other 
quality reporting programs, and reduce burden; however, the overall 
structure of four equally weighted measure domains has remained 
consistent in determining ACOs' quality performance since the Shared 
Savings Program was established in 2012. 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. Currently, the quality performance 
standard is based on an ACO's performance year rather than financial 
track. The quality performance standard is 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. In the second or 
subsequent years of the 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 the 30th

[[Page 62909]]

percentile 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)).
    ACOs are rewarded for their quality performance on a sliding scale 
on which higher levels of quality performance translate to higher rates 
of shared savings and, depending on the track under which an ACO is 
participating, may result in lower rates of shared losses. In addition, 
ACOs that demonstrate significant quality improvement on measures in a 
domain are eligible to receive a quality improvement reward (Sec.  
425.502(e)(4)). Specifically, for each domain, ACOs can be awarded up 
to four additional points for quality performance improvement on the 
quality measures within the domain. These bonus points are added to the 
total points that an ACO achieves for the quality measures within that 
domain, but the total number of points cannot exceed the maximum total 
points for the domain.
    In the CY 2018 Quality Payment Program final rule, we finalized a 
policy for the 2018 performance period and subsequent performance 
periods that the quality performance category under the MIPS APM 
Scoring Standard for MIPS eligible clinicians participating in a Shared 
Savings Program ACO will be assessed based on measures collected 
through the CMS Web Interface and the CAHPS for ACOs survey measures 
(82 FR 53688 through 53706). We assign the same MIPS quality 
performance category score to each Tax Identification Number (TIN)/
National Provider Identifier (NPI) in a Shared Savings Program ACO 
based on the ACO's total quality score derived from the measures 
reported via the CMS Web Interface and the CAHPS for ACOs survey. 
Eligible clinicians in a Shared Savings Program ACO will receive full 
credit for the improvement activities performance category in 2020 
based on their performance of improvement activities required under the 
Shared Savings Program. In addition, ACO participants report on the 
Promoting Interoperability performance category at the group or solo 
practice level for eligible clinicians subject to the Promoting 
Interoperability performance category. Data for the Promoting 
Interoperability performance category is reported by ACO participants 
at the TIN level and is then weighted and aggregated to get a single 
ACO score for the performance category that applies to all eligible 
clinicians participating in the ACO. These three categories in the APM 
scoring standard are weighted as follows: Quality is 50 percent, 
Improvement Activities is 20 percent; and Promoting Interoperability is 
30 percent. Eligible Clinicians participating in the Shared Savings 
Program are not assessed under 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 is weighted at zero percent.
    Eligible clinicians who reassign their billing rights to an ACO 
Participant TIN in an Advanced APM (Track 2, Track 1+ ACO Model, BASIC 
Track Level E, and ENHANCED Track (formerly known as Track 3)) and who 
are included on the Advanced APM Participation List on at least one of 
three snapshot dates (March 31, June 30, and August 31) during the 
performance year may become Qualifying APM Participants (QPs) for the 
year, if they meet payment or patient count thresholds. If these 
eligible clinicians attain QP status for the performance year via their 
participation in the Shared Savings Program ACO, they would receive an 
APM incentive payment and would not be subject to the MIPS reporting 
requirements or payment adjustment for the related payment year. 
However, they would be required to report quality for purposes of the 
Shared Savings Program financial reconciliation.
    As we explained in the CY 2020 PFS proposed rule (83 FR 40710), we 
recognize that ACOs and their participating providers and suppliers 
have finite resources to dedicate to engaging in efforts to improve 
quality and reduce costs for their assigned beneficiary population. 
Although CMS has worked to align policies under the Shared Savings 
Program with the Quality Payment Program, we recognize that some 
differences in program methodologies for the Shared Savings Program and 
MIPS remain and could potentially create conflicts for MIPS eligible 
clinicians in an ACO who are attempting to strategically transform 
their respective practices to earn shared savings under the terms of 
the Shared Savings Program and a positive payment adjustment under 
MIPS. Currently, under the Shared Savings Program, ACOs in performance 
years other than the first performance year of their first agreement 
period are allocated up to two points for quality measures that are 
pay-for-performance, according to where their performance falls, 
relative to benchmark deciles. Incomplete reporting of any CMS Web 
Interface measure will result in zero points for all CMS Web Interface 
measures and the ACO will fail to meet the quality performance standard 
for the performance year. Similarly, if a CAHPS for ACOs Survey is not 
administered and/or no data is transmitted to CMS, zero points will be 
earned for all Patient/Caregiver Experience measures and the ACO will 
fail to meet the quality standard for the performance year. The quality 
measure set for the Shared Savings Program also includes certain 
claims-based measures that are not part of the MIPS quality performance 
category, and we currently calculate performance rates on these claims-
based measures for purposes of determining an ACO's overall quality 
score under the Shared Savings Program.
    In contrast, when a group submits measures for the MIPS quality 
performance category via the CMS Web Interface, each measure is 
assessed against its benchmark to determine how many points the measure 
earns. For the 2019 MIPS performance period, a group can receive 
between 3 and 10 points for each MIPS measure (not including bonus 
points) that meets the data completeness and case minimum requirements 
by comparing measure performance to established benchmarks. If a group 
fails to meet the data completeness requirement on one of the CMS Web 
Interface measures, it receives zero points for that measure; however, 
all other CMS Web Interface measures that meet the data completeness 
requirement are assessed against the measure benchmarks, and the points 
earned across all measures are included in the quality performance 
category score. Currently, the only administrative claims-based measure 
used in MIPS is the All-Cause Readmission measure, which is only 
calculated for groups with 16 or more eligible clinicians. These 
differences between the Shared Savings Program quality measure set and 
the MIPS quality measure set highlight the different quality 
measurement approaches for which Shared Savings Program ACOs must 
simultaneously evaluate, prioritize, and target resources that may be 
better directed toward patient care if the quality measurement 
approaches under the Shared Savings Program and MIPS were more closely 
aligned.
    As we stated in the proposed rule, we believe that using a single 
methodology to measure quality performance under both the Shared 
Savings Program and the MIPS would allow ACOs to better focus on 
increasing the value of healthcare, improving care, and engaging 
patients, and reduce burden as ACOs would be able to track to a smaller 
measure set under a unified scoring methodology. Accordingly, we 
solicited comment on how to potentially align the Shared Savings 
Program

[[Page 62910]]

quality reporting requirements and scoring methodology more closely 
with the MIPS quality reporting requirements and scoring methodology.
    We received public comments on how to potentially align the Shared 
Savings Program quality reporting requirements and scoring methodology 
more closely with the MIPS quality reporting requirements and scoring 
methodology. The following is a summary of the comments we received and 
our response.
    Comment: Several commenters supported the concept of aligning the 
Shared Savings Program quality score with the MIPS quality performance 
category scoring methodology in the interest of reducing program 
complexity and reporting burden. One commenter suggested that CMS 
consider alignment opportunities and approaches holistically rather 
than compartmentalized within programs; as MIPS Value Pathways (MVPs) 
are also intended to reduce burden and confusion and align metrics, the 
commenters encouraged CMS to explore opportunities to systematically 
address changes to both the Shared Savings Program and MIPS in a 
coordinated fashion. Another commenter was generally supportive of 
alignment between Medicare programs but expressed concern that ACOs are 
already navigating a complete overhaul of the program under the new 
policies established in the December 2018 Pathways to Success final 
rule (83 FR 67816). The commenter stated that quality reporting and 
scoring is one of the few areas of consistency in the Shared Savings 
Program and now is not the time to overhaul these quality requirements 
in the midst of all the other changes to which ACOs are adjusting.
    The majority of commenters were opposed to the approach of aligning 
the Shared Savings Program quality score with the MIPS quality 
performance category score. Commenters stated that ACOs are focused on 
the total population they serve and accountable for total costs of 
caring for their aligned beneficiary population. The commenters stated 
that ACOs should have a separate quality measure set and methodology 
for scoring quality, thus keeping the MIPS quality performance category 
score separate from the assessment of the quality performance of ACOs 
under the Shared Savings Program. Several commenters suggested that CMS 
should test the use of a more limited number of quality measures with 
low reporting burdens, including eCQMs and claims-based measures 
designed specifically for ACOs, which they believed would be 
appropriate for organizations committed to population health and 
accountable for total cost of care for the patients they serve. Several 
commenters noted that aligning the Shared Savings Program quality score 
with the MIPS quality performance category score would increase burden 
and require resources that would be better directed to improve patient 
care but did not elaborate on why they believed this approach would be 
more burdensome. Another commenter stated that while they appreciate 
the sentiment to keep quality measurement and scoring simple and 
aligned across programs, the measures used in APMs, such as the Shared 
Savings Program, should lead and not follow MIPS because the quality 
measure sets used in MIPS continue to be populated with specialty 
driven measures, which the commenter believed do not encourage 
transition to APMs. Another commenter stated that the goals of the two 
programs may not lend themselves to perfect alignment as the MIPS 
program is specialty and provider specific, making episodic measures 
more meaningful, whereas ACOs are responsible for beneficiaries' total 
cost of care over the course of the entire performance year and it 
stands to follow that eligible clinicians participating in ACOs should 
be accountable for total health measures.
    Several commenters that opposed the concept of alignment of the 
Shared Savings Program quality score with the MIPS quality performance 
category score also stated that a significant restructuring of the 
Shared Savings Program quality performance requirements would introduce 
more confusion for ACOs that are transitioning into new pathway tracks, 
as well as uncertainty, as CMS has also proposed extensive revisions to 
MIPS as the program transitions to MIPS Value Pathways. Another 
commenter stated they disagreed with replacing the Shared Savings 
Program quality score with the MIPS quality performance category score 
until such a time that CMS can ensure that the measures and patient 
populations included are aligned across both programs. The commenter 
stated that MIPS uses a retrospective approach to assign patients to 
individual clinicians or practices, whereas, the commenter stated, 
Shared Savings Program uses a prospective approach to assign 
beneficiaries to ACOs. Because of these differences, the commenter 
believed replacing the Shared Savings Program quality score with the 
MIPS quality performance category score would lead to inconsistent and 
incorrect comparisons.
    Response: As we plan for future updates and changes to the Shared 
Savings Program quality reporting requirements and scoring methodology, 
we will consider this feedback in the development of our proposals.
    In particular, we requested comments on replacing the Shared 
Savings Program quality score with the MIPS quality performance 
category score, for ACOs in Shared Savings Program tracks (or payment 
models levels within a track) that do not meet the definition of an 
Advanced APM (currently, Track 1 and BASIC Track Levels A, B, C and D). 
We explained that allowing for a single quality performance score for 
both programs would eliminate the need for ACOs to focus their 
resources for quality improvement on maximizing performance under two 
separate quality reporting requirements with distinct scoring 
methodologies. Currently, for ACOs in tracks (or payment models within 
a track) that do not meet the definition of an Advanced APM, the MIPS 
quality performance category score is calculated based on the measures 
reported by the ACO via the CMS Web Interface and the CAHPS for ACO 
survey measures. For Shared Savings Program quality scoring purposes, 
we indicated that we could utilize the MIPS quality performance 
category score, converted to a percentage of points earned out of the 
total points available, as the ACO's quality score for purposes of 
financial reconciliation under the Shared Savings Program. Since the 
release of the proposed rule, we have updated the MIPS Quality 
performance category scores for 2018, and we note that for performance 
year 2018, the weighted mean MIPS quality performance category score 
for ACOs in Shared Savings Program tracks (or payment models within a 
track) that do not meet the definition of an Advanced APM was 48.16 and 
the weighted median MIPS quality performance score for these ACOs was 
50.00, out of a possible 50 points assigned for the quality performance 
category.
    ACOs in tracks (or payment models within a track) that meet the 
definition of an Advanced APM whose eligible clinicians are QPs for the 
year and thus are excluded from the MIPS reporting requirements, do not 
receive a quality performance category score under MIPS. Instead the 
quality data the ACO reports to the CMS Web Interface is used along 
with the ACO's CAHPS data and the administrative claims-based measures 
calculated by us, solely for the purpose of scoring the quality 
performance of the

[[Page 62911]]

ACO under the Shared Savings Program quality scoring methodology. As an 
alternative, given that we currently collect the necessary data from 
these ACOs, we explained that we could also calculate a quality score 
for these ACOs under the MIPS scoring methodology, and use this score 
to assess the quality performance of the ACO for purposes of the Shared 
Savings Program. Using this score would also inform eligible clinicians 
participating in these ACOs of their MIPS quality score in the event 
that they lose QP status and are scored under the MIPS APM scoring 
standard.
    Utilizing a MIPS quality performance category score to assess the 
quality performance for purposes of the Shared Savings Program of ACOs 
in tracks (or payment models within a track) that qualify as an 
Advanced APM would not change whether 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. Rather, under this approach we would utilize the 
same scoring methodology to determine quality performance for Shared 
Savings Program ACOs that are participating in Advanced APMs as would 
be used to assess the quality performance of ACOs in Shared Savings 
Program tracks (or payment models within a track) that do not meet the 
definition of an Advanced APM, creating further alignment of 
performance results and further synergies between the Shared Savings 
Program and MIPS.
    We welcomed public comments on the approach of using the MIPS 
quality performance category score to assess quality performance for 
purposes of the Shared Savings Program quality performance standard for 
ACOs that are in tracks (or payment models within a track) that qualify 
as Advanced APMs, and therefore, do not receive a MIPS quality 
performance category score if their eligible clinicians meet QP or 
Partial QP thresholds and are excluded from MIPS, as well as potential 
alternative approaches for scoring Shared Savings Program quality 
performance in a way that more closely aligns with MIPS. The following 
is a summary of the comments we received and our response.
    Comment: We received few comments specifically on the approach of 
using the MIPS quality performance category score to assess quality 
performance for purposes of the Shared Savings Program quality 
performance standard for ACOs that are in tracks (or payment models 
within a track) that qualify as Advanced APMs. Some commenters 
supported the approach, stating that increased alignment with the MIPS 
scoring methodology would provide more comparable data and lessen the 
burden for eligible clinicians. Another commenter supported the 
approach of using MIPS quality scores as the Shared Savings Program 
quality performance score, stating that this approach would simplify 
the process for eligible clinicians participating in the Shared Savings 
Program, including eligible clinicians participating in Advanced APMs 
that do not meet the criteria to be a QP and reduce the complexity and 
burden of reporting.
    One commenter did not support the approach of using the MIPS 
quality performance category score to assess quality performance for 
purposes of the Shared Savings Program quality performance standard for 
ACOs that are in tracks (or payment models within a track) that qualify 
as Advanced APMs because they support the current methodology, which 
they believed focuses on the total cost of care, not just the physician 
service component.
    Response: As we plan for future updates and changes to the Shared 
Savings Program quality scoring methodology, we will consider this 
feedback in the development of our proposals.
    In addition, we also solicited comment on simplifying MIPS by 
implementing a new MIPS Value Pathway framework, which may include 
implementing a core measure set using administrative claims-based 
measures that can be broadly applied to communities or populations and 
developing measure sets around specialty areas or public health 
conditions to standardize and provide more cohesive reporting and 
participation. We refer readers to section III.I.3.a.(3) of this final 
rule for more information on these approaches and a summary of the 
comments received.
    Currently, for ACOs in tracks (or payment models within a track) 
that do not meet the definition of an Advanced APM, the MIPS quality 
performance category score is calculated based on the measures reported 
by the ACO via the CMS Web Interface and the CAHPS for ACO survey 
measures. In section III.I.3.b.(1)(ii) of the proposed rule, we 
proposed to add the MIPS All-Cause Unplanned Admission for Patients 
with Multiple Chronic Conditions (MCC) measure to the MIPS quality 
performance category. We noted that if this measure were to be added to 
MIPS quality performance category, implementation of the measure would 
be delayed until the 2021 performance period for MIPS. We explained 
that if the MCC measure were to be included in the MIPS quality 
performance category, we would also consider including the MIPS claims-
based measures (MCC and MIPS All-Cause Readmission measure) in the MIPS 
APM scoring standard for ACOs in tracks (or payment models within a 
track) that are not Advanced APMs and in the MIPS quality performance 
category equivalent score for ACOs in tracks that are Advanced APMs, in 
order to fully align the quality scoring methodology under the Shared 
Savings Program with the MIPS scoring methodology to reduce the burden 
on ACOs and their eligible clinicians of tracking to multiple quality 
reporting requirements and quality scoring methodologies. We would then 
use this score for purposes of assessing quality performance under the 
Shared Savings Program for all ACOs. We noted that these MIPS claims-
based measures are similar to those currently used to assess ACO 
quality under the Shared Savings Program. The MIPS MCC and ACO MCC are 
similar because they both target patients with multiple chronic 
conditions but the cohort, outcome, and risk model for the MIPS MCC 
measure would vary from the ACO MCC measure. The cohort for the ACO MCC 
includes eight conditions whereas the MIPS MCC measure includes nine 
conditions, where the additional condition is 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. We 
referred readers to Appendix 1 Table AA (New Quality Measures for 
Addition for the 2023 Payment Year and Future Years) of the proposed 
rule for more detailed information on the MIPS MCC measure. Both the 
MIPS and Shared Savings Program versions of the All-Cause Readmission 
measure were developed to fully align with the original hospital 
measure of Hospital-Wide Readmission. The MIPS and Shared Savings 
Program versions of the All Cause Readmission measure are essentially 
re-specifications of the same hospital measure and are updated annually 
to maintain that alignment. Because of this, the measures have a very 
similar, or identical, definition for included patients, outcome 
definition, and risk adjustment model. The primary difference between 
the measures is only the entity that is accountable--either an ACO or a 
MIPS-eligible clinician--but the specifications are otherwise aligned. 
We noted that we welcomed comment on potentially including all of the 
MIPS claims-based measures in the MIPS

[[Page 62912]]

quality performance category score (instead of the 3 claims-based 
measures that are currently included in the Shared Savings Program 
quality score), and using this score (converted to a percentage of 
points earned out of the total points available) in place of the 
current Shared Savings Program quality score to assess quality 
performance for all ACOs for purposes of the Shared Savings Program. We 
noted that we would also continue to assess ACOs on the CAHPS for ACOs 
survey but quality performance would be calculated by MIPS based on the 
methodology used for scoring the CAHPS for MIPS survey and included in 
the MIPS quality performance category score. The scoring and 
benchmarking approach for the CAHPS for MIPS is to assign points based 
on each summary survey measure (SSM) and then average the points for 
all the scored SSMs to calculate the overall CAHPS score. In contrast, 
ACOs currently, receive up to 2 points for each of the 10 SSMs for a 
total of 20 points.
    We received several public comments on potentially including the 
CMS Web Interface, CAHPS for ACO survey and the two MIPS claims-based 
measures in the MIPS quality performance category score for ACOs and 
using this score in place of the current Shared Savings Program quality 
score to assess quality performance for all ACOs for purposes of the 
Shared Savings Program. The following is a summary of the comments we 
received and our response.
    Comment: One commenter supported the use of a sparing list of 
meaningful measures that reduce the burden of reporting and applauded 
CMS' efforts to seek out opportunities for greater harmonization and 
streamlining within FFS Medicare and across programs. Another commenter 
urged CMS to review the measures it includes in the Shared Savings 
Program measure set, as well as other Medicare Programs and models, 
because the current measures are not clinically appropriate or 
applicable to a frail, seriously ill, or home-limited patient 
population. The commenter stated they were concerned that even though 
they were delivering high-quality and clinically appropriate care to 
this medically complex patient population, they are penalized under 
these initiatives. However, the majority of commenters opposed to this 
approach. One commenter stated that the All Cause Unplanned Admissions 
for Patients with Multiple Chronic Conditions would be difficult for 
ACOs to manage due to all the included conditions. The commenter added 
that ACOs do not receive enough actionable data in the quality reports 
provided by CMS to fully understand their performance on the measure. 
The commenter suggested providing the number of patients included in 
the numerator and in the denominator and identifying the actual 
patients that were included would give providers more actionable 
information. A few commenters expressed concern that any consideration 
of aligning the Shared Savings Program quality scoring methodologies 
with the MIPS quality score when CMS is also beginning significant 
modifications to the MIPS program introduces a great deal of 
uncertainty regarding how the quality scoring methodology may also 
change in the future; therefore, they do not believe the MIPS All-Cause 
Readmission and MCC claims-based measures would be appropriate for 
ACOs. Another commenter stated that they do not believe the MIPS 
administrative claims-based measures are a better alternative to the 
administrative claims-based measures ACOs are currently subject to. The 
commenter noted that ACOs are responsible for the total cost of care 
for their aligned beneficiary populations; therefore, CMS must use a 
different approach in evaluating the quality of care furnished ACOs as 
compared to individuals or groups reporting quality measures in MIPS, 
who are not participating in total cost of care.
    Response: As we plan for future updates and changes to the Shared 
Savings Program quality scoring methodology, we will consider this 
feedback in the development of our proposals.
    In addition, we solicited comment on determining the threshold for 
minimum attainment in the Shared Savings Program using the MIPS APM 
quality performance category scoring. As noted previously in this 
section, ACOs in the first performance year of their first agreement 
period are considered to have met the quality performance standard, and 
therefore, to be eligible to share in savings or minimize shared 
losses, if applicable, when they completely and accurately report all 
quality measures. ACOs in all other performance years are required to 
completely and accurately report and meet the minimum attainment level 
on at least one measure in each domain, to be determined to have met 
the quality performance standard and to be eligible to share in 
savings. For these ACOs, minimum attainment is defined as a score that 
is at or above 30 percent or the 30th percentile of the performance 
benchmark. The 30th percentile for the Shared Savings Program is the 
equivalent of the 4th decile performance benchmark under MIPS APM 
quality performance category scoring. We indicated that as we look to 
more closely align with MIPS quality performance category scoring in 
future years, we were considering how to determine whether ACOs have 
met the minimum attainment level. For example, minimum attainment could 
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 that is 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 quality scores under 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, ACOs with quality scores under the 4th 
decile of all MIPS quality performance category scores would be subject 
to compliance actions and possible termination. We acknowledged that a 
requirement that ACOs achieve an overall MIPS quality performance 
category score (or equivalent score) that meets or exceeds the 4th 
decile across all MIPS quality performance category scores would be a 
higher standard than the current requirement that ACOs meet the 30th 
percentile on one measure per Shared Savings Program quality domain; 
however, 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. We 
believe that increasing the minimum attainment level would incentivize 
improvement in the quality of care provided to the beneficiaries 
assigned to an ACO. Furthermore, consistent with section 1899(b)(3)(C) 
of the Act, it is appropriate to require a higher standard of care in 
order for ACOs to continue to share in any savings they achieve. Given 
the maturity of the Shared Savings Program, we are also considering 
setting a higher threshold, such as the median or mean quality 
performance category score across all MIPS quality category scores, for 
determining eligibility to share in savings under the Shared Savings 
Program for all ACOs, other than those ACOs in their first performance 
year of their first agreement period. We welcomed comment on these 
potential approaches or other approaches for determining Shared Savings 
Program

[[Page 62913]]

quality minimum attainment using MIPS data.
    We also solicited comment on how to potentially utilize the MIPS 
quality performance category score to adjust shared savings and shared 
losses under the Shared Savings Program, as applicable. Currently, for 
all Shared Savings Program ACOs and Track 1+ Model ACOs, the ACO's 
quality score is multiplied with the maximum sharing rate of the track 
to determine the final sharing rate, and therefore, the amount of 
shared savings, if applicable. For some ACOs under two-sided models, 
specifically ACOs in Track 2 and the ENHANCED track, the ACO's quality 
score is also used in determining the amount of shared losses owed, if 
applicable. Under Track 2 and the ENHANCED track, the loss sharing rate 
is determined as 1 minus the ACO's final sharing rate based on quality 
performance, up to a maximum of 60 percent or 75 percent, respectively. 
Under the Track 1+ Model and two-sided models of the BASIC track 
(Levels C, D and E), the amount of shared losses is determined based on 
a fixed 30 percent loss sharing rate, regardless of the ACO's quality 
score. Thus, a higher quality score results in the ACO receiving a 
higher proportion of shared savings in all Shared Savings Program 
tracks and the Track 1+ Model, or greater mitigation of shared losses 
in Track 2 and the ENHANCED track. We stated that we could apply the 
MIPS quality performance category score to determine ACOs' shared 
savings and shared losses, if applicable, in the same manner. For 
instance, as an alternative to the current approach to determining 
shared savings payments for Shared Savings Program ACOs, we could 
establish a minimum attainment threshold, such as a score at or above 
the 4th decile of all MIPS quality performance category scores or the 
median or mean quality performance category score, that if met would 
allow ACOs to share in savings based on the full sharing rate of their 
track. We welcomed comment on these or other potential approaches for 
utilizing the MIPS quality performance category score or an alternative 
score in determining shared savings or shared losses under the Shared 
Savings Program.
    In addition, we discussed an option considered under which we would 
determine the MIPS quality performance category score for all Shared 
Savings Program ACOs as it is currently calculated for non-ACO group 
reporters using the CMS Web Interface. That is, ACOs would receive a 
score for each of the measures they report and zero points for those 
measures they do not report. This would be a change from the current 
methodology under which ACOs must report all Web Interface measures to 
complete quality reporting. We noted that currently, for ACOs in the 
first year of their first agreement period, minimum attainment is set 
at the level of complete and accurate reporting of all measures. If we 
were to adopt the MIPS quality performance category score as the Shared 
Savings Program quality score, we would consider no longer imposing a 
different quality standard for ACOs in the first year of their first 
participation agreement versus ACOs in later performance years. Given 
that the Shared Savings Program is evolving and many Medicare quality 
programs including MIPS are incentivizing performance rather than 
reporting, we noted that we are considering no longer transitioning 
from pay-for-reporting to pay-for-performance during an ACO's first 
agreement period in the Shared Savings Program. We stated that we 
believe requiring all ACOs regardless of time in the program to be 
assessed on quality performance would be an appropriate policy since 
nearly 100 percent of ACOs consistently satisfactorily report all 
quality measures. We welcomed comment on this alternative for 
determining the MIPS quality performance category score.
    We received public comments on determining the threshold for 
minimum attainment in the Shared Savings Program using the MIPS APM 
quality performance category scoring and the approach of scoring ACOs 
for each measure they report and zero points for those measures they do 
not report. The following is a summary of the comments we received and 
our response.
    Comment: One commenter noted that using the MIPS scoring 
methodology for ACOs would result in a somewhat higher standard than is 
currently used because ACOs would need to meet a minimum overall 
threshold rather than a threshold on one measure in each domain to be 
eligible to share in savings. However, the commenter noted that ACOs 
would benefit by being able to earn a quality score even if they fail 
to report one measure. The commenter stated the benefits of this 
approach outweigh the drawbacks and supported the option of aligning 
the Shared Savings Program quality scoring methodology with the current 
methodology used for MIPS. This commenter also stated that under this 
alternate approach ACOs should be able to proceed directly to pay-for-
performance, particularly since failure on one measure would no longer 
result in overall failure in quality performance.
    The majority of commenters opposed the approach of determining the 
threshold for minimum attainment in the Shared Savings Program using 
the MIPS APM quality performance category scoring. Several commenters 
stated that they did not support the option of using a MIPS quality 
scoring approach that would hold ACOs to a higher standard to be 
eligible to share in savings, if earned, by requiring a quality 
performance score at or above the fourth decile across all MIPS quality 
performance category scores in order to meet the minimum attainment 
level. These commenters also stated that they were concerned the MIPS 
quality scoring methodologies could result in narrow bands for measures 
with clustered performance, resulting in inequitable scores for very 
small differences in performance especially when extrapolated from a 
small sample size. They offered an example under which small 
differences in measure performance rates might result in measure point 
changes that could add up quickly and may not reflect substantive 
differences in actual quality of care. The commenters stated their 
belief that percentile rankings are more meaningful because they 
provide the larger context and help appropriately adjust the actual 
scores. Another commenter stated that if the goal is to align the 
Shared Savings Program and MIPS quality scoring approaches, then it 
would make little sense to hold ACOs to a higher attainment standard 
than other MIPS clinicians; they suggested setting the minimum 
attainment standard for ACOs at the 3rd decile rather than the 4th 
decile. Another commenter opposed increasing the minimum attainment 
standard under the Shared Savings Program stating their belief that the 
current Shared Savings Program quality scoring methodology is 
sufficient to incentivize high quality care. The commenter also stated 
that ACOs enter the program with differing levels of performance on the 
Shared Savings Program quality measures and different levels of 
experience documenting quality metrics in a manner required by the 
program. In addition, the commenter expressed the belief that it takes 
time to implement new workflows to maximize performance, so increasing 
the minimum attainment level could act as a deterrent to new entrants 
joining the program or ACOs remaining in the program and working to 
improve care. Several commenters expressed concerns about the concept 
of removing the pay-

[[Page 62914]]

for-reporting year currently provided to ACOs in their first year of 
their first agreement, stating that this change would have significant 
repercussions for new ACOs. The commenters noted that providing ACOs in 
their first year with 12 months to assess performance, understand 
measure specifications, and implement workflow and IT changes necessary 
to capture data and document quality performance as specified by the 
measure steward is a vast undertaking requiring significant resources. 
In addition, the commenters stated this time is crucial to educate 
clinicians and support staff to incorporate processes to implement the 
quality measure requirements into their practice and establish buy-in 
and support among staff.
    Response: As we plan for future updates and changes to the Shared 
Savings Program quality scoring methodology, we will consider this 
feedback in the development of our proposals.
    Lastly, we solicited comment on using the MIPS quality improvement 
scoring methodology rather than the Shared Savings Program Quality 
Improvement Reward to reward ACOs for quality improvement. Under the 
Shared Savings Program, we currently allow ACOs not in their first 
performance year in the program to earn a Quality Improvement Reward in 
each of the four quality domains. In contrast, under MIPS, improvement 
points are generally awarded as part of the MIPS quality performance 
category score if a MIPS eligible clinician (1) has a quality 
performance category achievement percent score for the previous 
performance period and the current performance period; (2) fully 
participates in the quality performance category for the current 
performance period; and (3) submits data under the same identifier for 
the 2 consecutive performance periods. As a result, if we were to adopt 
an approach under which we use the MIPS quality performance category 
score for the Shared Savings Program quality score, quality improvement 
points earned under MIPS would be included in that score, and we would 
not have a need to add additional points to it. We welcomed public 
comment on this or other approaches to considering improvement as part 
of using the MIPS quality performance category or an equivalent score, 
to determine quality performance under the Shared Savings Program.
    We received no public comments on using the MIPS quality 
improvement scoring methodology rather than the Shared Savings Program 
Quality Improvement Reward to reward ACOs for quality improvement.
2. Technical Change To Correct Reference in SNF 3-Day Rule Waiver 
Provision
    In the December 2018 final rule, we made a number of amendments to 
Sec.  425.612 (83 FR 68080). As part of these amendments, we 
redesignated paragraphs (a)(1)(v)(A) through (C) of Sec.  425.612 as 
paragraphs (a)(1)(v)(C) through (E). In making these amendments, we 
inadvertently omitted a necessary update to a cross-reference to one of 
these provisions. Accordingly, we propose to remove the phase 
``paragraph (a)(1)(v)(B)'' from Sec.  425.612(a)(1)(v)(E), and in its 
place add the phrase ``paragraph (a)(1)(v)(D)''.
    We received no public comments on this proposal, and are finalizing 
the technical change as proposed.

F. Open Payments

1. Background
a. Open Payments Policies
    The Open Payments program is a statutorily-mandated program that 
promotes transparency by providing information to the public about the 
financial relationships between the pharmaceutical and medical device 
industry, and certain types of health care providers. Section 1128G of 
the Act requires manufacturers of covered drugs, devices, biologicals, 
or medical supplies (referred to as ``applicable manufacturers''), as 
well as group purchasing organizations (GPOs), to annually submit 
information for the preceding calendar year about certain payments or 
other transfers of value made to ``covered recipients,'' currently 
defined as physicians and teaching hospitals.
    Payments or other transfers of value that must be reported include 
such things as research, honoraria, gifts, travel expenses, meals, 
grants, and other compensation. The type of information required to be 
reported includes, but is not limited to, the date and amount of the 
payment or other transfer of value, identifying information about the 
covered recipient, and details about products associated with the 
transaction. When a payment or other transfer of value is related to 
marketing, education, or research specific to a covered drug, device, 
biological or medical supply, the name of that covered drug, device, 
biological or medical supply also must be reported. The estimated 
burden of these reporting requirements, as outlined under OMB control 
number 0938-1237, is just over 1 million hours over the course of 1 
year.
    Section 1128G of the Act establishes certain minimum dollar 
thresholds for required reporting, with two bases for reporting: 
Individual and aggregate payments; or transfers of value. To determine 
if small individual payments or other transfers of value made to a 
covered recipient exceed the aggregate threshold and must be reported, 
applicable manufacturers and applicable GPOs must aggregate all 
individual payments made across all payment categories within a given 
reporting year. The statutory threshold established in 2013 was $10 for 
individual payments, and $100 for aggregated payments, and this amount 
has increased with the consumer price index each year. For CY 2019, the 
annual reporting thresholds for individual payments or other transfers 
of value is $10.79 and the aggregate amount is $107.91.
    The Open Payments program yields information to the general public 
that may influence their health care decision-making and choice of 
providers, as well as information that researchers may use to look into 
potential correlations between financial relationships and provider 
behaviors. More than 64 million records have been disclosed under the 
Open Payments program since August 2013, enabling significant 
transparency into covered exchanges of value. We have been committed to 
stakeholder engagement in an effort to limit burden in the Open 
Payments program reporting processes and improve clarity for the 
public. Additional background about the program and guidance, including 
frequently asked questions, about how the program works and what type 
of information is required to be reported is available at www.cms.gov/OpenPayments.
    In the February 8, 2013 Federal Register (78 FR 9458), we issued 
regulations implementing section 1128G of the Act to create the Open 
Payments program. Section 1128G of the Act requires applicable 
manufacturers and applicable GPOs to submit information annually about 
certain payments or other transfers of value made to covered recipients 
during the course of the preceding calendar year. Additionally, section 
1128G of the Act defines covered drugs, devices, biologicals, or 
medical supplies as those covered under Medicare, a State plan under 
Medicaid, or the Children's Health Insurance Program (CHIP) (or a 
waiver of either such state plan), and requires applicable 
manufacturers and applicable GPOs to disclose any ownership or 
investment

[[Page 62915]]

interests in such entities held by physicians or physician's immediate 
family members, as well as information on any payments or other 
transfers of value provided to such physician owners or investors. 
Under section 1128G(e)(10)(A) of the Act, the term ``payment or other 
transfer of value'' refers to a transfer of anything of value, though 
some exclusions apply.
    In the CY 2015 PFS final rule with comment period (79 FR 67548), we 
revised the regulations by standardizing reporting in the Open Payments 
program. Specifically, we: (1) Deleted the definition of ``covered 
device''; (2) removed the special rules for payments or other transfers 
of value related to continuing education programs; (3) clarified the 
marketed name reporting requirements for devices and medical supplies; 
and (4) required stock, stock options, and any other ownership 
interests to be reported as distinct forms of payment.
    In the CY 2017 PFS proposed rule (81 FR 46395), we solicited 
information from the public on a wide variety of information regarding 
the Open Payments program. Since the implementation of the program and 
changes made in the CY 2015 PFS final rule with comment period, various 
commenters have provided us feedback. Consequently, we identified areas 
in the rule that might benefit from revision and solicited public 
comments to inform future rulemaking. We sought comment on whether the 
nature of payment categories listed at Sec.  403.904(e)(2) are 
adequately inclusive to facilitate reporting of all payments or 
transfers of value, as well as ways to streamline or make the reporting 
process more efficient while facilitating our role in oversight, 
compliance, and enforcement, along with posing other program-specific 
questions. A summary of solicited comments was published in the CY 2017 
PFS final rule (81 FR 80428-80429).
    On October 24, 2018, the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment for Patients and Communities Act 
(SUPPORT Act) (Pub. L. 115-270) was signed into law. Section 6111 of 
the SUPPORT Act amended the definition of ``covered recipient'' under 
section 1128G(e)(6) of the Act with respect to information required to 
be submitted on or after January 1, 2022, to include physician 
assistants (PA), nurse practitioners (NP), clinical nurse specialists 
(CNS), certified registered nurse anesthetists (CRNA), and certified 
nurse midwives (CNM), in addition to the previously listed covered 
recipients of physicians and teaching hospitals. In the CY 2020 PFS 
proposed rule, we proposed to codify the Open Payments provisions from 
the SUPPORT Act, proposed to address public comments received from the 
CY 2017 PFS proposed rule by simplifying the process for reporting data 
by adjusting the nature of payment categories, and proposed changes to 
standardize data on reported covered drugs, devices, biologicals, or 
medical supplies.
b. Legal Authority
    Three principal legal authorities from the Social Security Act 
ground our provisions:
     Sections 1102 and 1871 of the Act, which provide general 
authority for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.
     Section 1861 of the Act, which defines providers and 
suppliers.
     Section 1128G of the Act, as amended by section 6111 of 
the SUPPORT Act, which requires applicable manufacturers of drugs, 
devices, biologicals, or medical supplies covered under Medicare or a 
State plan under Medicaid or CHIP to report annually to the Secretary 
certain payments or other transfers of value to physicians and teaching 
hospitals, and to PAs, NPs, CNSs, CRNAs, and CNMs for information 
required to be submitted under section 1128G of the Act on or after 
January 1, 2022.
c. Provisions of the Proposed Regulations and Analysis of and Responses 
to Public Comments
    In the CY 2020 PFS proposed rule, we proposed to revise several 
Open Payments regulations at 42 CFR part 403. We proposed that the 
following provisions be effective for data collected beginning in CY 
2021 and reported in CY 2022: (1) Expanding the definition of a covered 
recipient to include the categories specified in the SUPPORT Act; (2) 
expanding the nature of payment categories; and (3) standardizing data 
on reported covered drugs, devices, biologicals, or medical supplies. 
We also proposed a correction to the national drug codes (NDCs) 
reporting requirements for drugs and biologicals that, once finalized 
will be effective 60 days following the publication of the final rule. 
We believe this will give all stakeholders sufficient time to prepare 
for these requirements.
(1) Expanding the Definition of a Covered Recipient
    Section 1128G of the Act requires applicable manufacturers and 
applicable GPOs to report annually information about certain payments 
or other transfers of value made to covered recipients, as well as 
ownership or investment interests held by physicians or their immediate 
family members in such entities. (Section 1128G(e)(7) of the Act 
exempts physicians who are employed by the reporting manufacturer, such 
that manufacturers do not report payments to their own employees.) As 
we noted previously, section 6111 of the SUPPORT Act expanded the 
definition of covered recipients from physicians and teaching hospitals 
to include PAs, NPs, CNSs, CRNAs, and CNMs; it likewise expanded to 
these individuals the same exception for manufacturer-employment. The 
SUPPORT Act requires these changes to be in effect for information 
required to be submitted on or after January 1, 2022. In short, the 
statute requires applicable manufacturers to report transfers of value 
pertaining to these additional provider types in the same way they have 
been required to report transfers of value to physicians and teaching 
hospitals. Since the information is reported to CMS in the calendar 
year following the year in which it was collected, this means that the 
data would be collected by the industry during CY 2021.
    We proposed to revise Sec.  403.902 to align with the statutory 
requirements in sections 1128G(e)(6)(A) and (B) of the Act. 
Specifically, we proposed to revise the definition of ``covered 
recipient'' in Sec.  403.902 to include PAs, NPs, CNSs, CRNAs, and 
CNMs. In addition, we proposed at Sec.  403.902 to reference the 
definitions of these additional provider types as defined in sections 
1861(aa)(5)(A), (aa)(5)(B), (bb) (2), and (gg)(2) of the Act.
    We also proposed to update certain provisions in part 403, subpart 
I to include provider and supplier types other than physicians as 
specified in sections 1128G(e)(6)(A) and (B) of the Act. Specifically, 
we proposed the following revisions:
     In Sec.  403.902, to add the definitions of ``certified 
nurse midwife,'' ``certified registered nurse anesthetist,'' ``clinical 
nurse specialist,'' ``non-teaching hospital covered recipient,'' 
``nurse practitioner,'' and ``physician assistant.''
     In Sec.  403.902, to revise the definition of ``covered 
recipient'' by adding physician assistant, nurse practitioner, clinical 
nurse specialist, certified registered nurse anesthetist, or certified 
nurse-midwife'' after the phrase ``Any physician.''
     In Sec.  403.904(c)(1), (f)(1)(i)(A), and (h)(7), to 
replace the term ``physician'' with the phrase ``non-teaching 
hospital.''

[[Page 62916]]

     In Sec.  403.904(c)(3), to replace the term ``physician'' 
in the title with the phrase ``non-teaching hospital,'' add the phrase 
``non-teaching hospital'' after ``In the case of a,'' and remove the 
phrase ``who is a physician'' from the text.
     In Sec.  403.904 (c)(3)(ii) and (iii), (f)(1)(i)(A)(1), 
(f)(1)(i)(A)(3) and (5), and (f)(1)(v), to change the term 
``physician'' to the phrase ``non-teaching hospital covered 
recipient.''
     In Sec.  403.904(h)(13), to remove the phrase ``who is a 
physician'' and add the phrase ``non-teaching hospital'' after ``In the 
case of.''
     In Sec.  403.904(f)(1), to remove the phrase ``(either 
physicians or teaching hospitals).''
     In Sec.  403.908(g)(2)(ii), to change the words 
``physicians and teaching hospitals'' to the term ``Covered 
recipients.''
    The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters expressed support for the expansion of the 
definition of covered recipients.
    Response: We thank the commenters for their support.
    Comment: Some commenters asked about the definitions of covered 
recipients. A subset asked how the definition of the new covered 
recipient categories will be consistent across jurisdictions and 
recommended partnering with stakeholders to ensure appropriate 
solutions. Another asked that definitions be consistent throughout CMS 
guidance documents.
    Response: While we appreciate these questions, the definitions for 
the additional covered recipients are delineated within the SUPPORT Act 
and will be the same across all jurisdictions or regions. The SUPPORT 
Act directly references the definitions of the service providers within 
existing statute (section 1861 of the Act). Since our proposal was 
designed to implement the provisions of the SUPPORT Act with regard to 
the definition of covered recipients, we believe providing the 
definitions within the statute is sufficient, and at Sec.  403.902, we 
proposed to add these definitions verbatim from the statute. We will 
continue to work with stakeholders to determine the challenges that the 
industry may face and to work through the best solutions available to 
implement a robust program. We are committed to providing sufficient 
guidance to reporting entities regarding how to properly identify 
covered recipients when submitting data for the new categories prior to 
implementing this change. As we update our technical assistance and 
guidance, we will continue to provide clarifications requested through 
our outreach and education. The Open Payments help desk will continue 
to be available for direct questions. A summary of comments received 
pertaining to the validation of data on the new covered recipient 
categories is provided below.
    Comment: One commenter asked whether updated templates will be 
provided for data submission.
    Response: We expect to update the submission templates based on 
changes made in this rule, and they will be made available prior to the 
start of data collection for CY 2021 data, which will be submitted in 
CY 2022. While we assume that this question related to the covered 
recipient provision, the answer holds true for the other Open Payments 
provisions as well.
    Comment: Some commenters suggested that CMS extend Open Payment 
deadlines. Other commenters requested delays for reporting data, noting 
that it may not be possible to arrange and capture all the new 
information about the new covered recipients in CY 2021 by the CY 2022 
annual reporting deadline. Another requested extending the time period 
for review, dispute, and correction.
    Response: As mentioned earlier, this rule was designed specifically 
to implement the provisions of the SUPPORT Act regarding covered 
recipients in the Open Payments program. Therefore, the effective 
date(s) we proposed are based on the statute, and we do not have the 
authority to alter the statutory requirement.
    Comment: Some commenters suggested that it would facilitate prompt 
and complete reporting if CMS would provide technical support for 
implementation of the new provisions.
    Response: We will continue to provide technical support through 
direct outreach, outreach to associations, the issuance of guidance, 
informational webinar sessions, and direct assistance via the program 
help desk. We intend to continue to operate as a responsible business 
partner in this manner.
    Comment: Some commenters raised concerns with ensuring the 
integrity of the reported data from submission through the review and 
dispute process, to the subsequent publication of the data given the 
new covered recipient provider types.
    Response: The Open Payments program has a system in place for 
reporting entities to include unique identifying information about 
covered recipients, such as an NPI or state license number, when 
submitting a record. We understand that accurately identifying mid-
level practitioners will entail additional challenges. As we have in 
the past, we will work with stakeholders to understand the challenges 
the new covered recipient categories may impose, and collaborate on 
practical solutions that ensure accuracy and availability of necessary 
data. We will also provide technical assistance to reporting entities 
to help them accurately report on the additional covered recipients. 
The review and dispute process is set forth in regulation at Sec.  
403.908(g) and upholds the reporting standards that are in the statute 
at 42 U.S.C. 1320a-7h (c)(1)(C) and (D). We follow the guidelines in 
the regulation to ensure timely publication of data, and we do not have 
the authority to modify a statutory provision. We will provide outreach 
and technical support through the issuance of guidance, informational 
webinar sessions, and direct assistance via the program help desk as it 
has throughout the implementation of the Open Payments program. 
Furthermore, we annually revise and republish reports with any data 
that has been updated throughout the year. In addition to our direct 
outreach to covered recipients, we encourage industry groups to 
reiterate the opportunities that covered recipients have to review and 
verify data that have been reported under their name.
    Comment: One commenter asked CMS to simplify the two-step 
registration process for covered recipients. Another commenter 
suggested that additional disclaimers should be provided with the Open 
Payments data noting that payments or transfers of value do not 
necessarily imply wrongdoing. One commenter suggested that CMS require 
each reporting entity to have a direct point of contact for covered 
recipients to contact to help resolve disputed claims. Another 
commenter suggested that NPIs be collected and included in the Open 
Payments datasets, noting that this would assist in matching and cross-
referencing data. Two other commenters recommended expanding the Open 
Payments program. One suggested it cover all forms of potential 
conflicts of interest in the medical community; another suggested it 
cover venture capital companies that purchase physician practices.
    Response: While we appreciate these suggestions, they are outside 
the scope of this rule.
    After consideration of these comments, we are finalizing our 
proposed revisions to Sec. Sec.  403.902, 403.904, and 403.908.

[[Page 62917]]

(2) Nature of Payment Categories
    Under current statutory and regulatory requirements, applicable 
manufacturers and applicable GPOs must characterize the nature of 
payments made to covered recipients by selecting the ``Nature of 
Payment'' category that most closely describes the reported payment. 
Some of the ``Nature of Payment'' categories, as specified at Sec.  
403.904(e)(2), are specifically required by section 1128G(a)(1)(A)(vi) 
of the Act, while the statute also allows the Secretary to define any 
other nature of payment or other transfer of value.
    Based upon information we obtained from the public comments 
solicited in the CY 2017 PFS proposed rule (81 FR 46395), stakeholders 
have identified debt forgiveness, long term medical supply or device 
loan, and acquisitions (among others) as useful categories to add to 
comply with the general reporting requirement under section 
1128G(a)(1)(A) of the Act. Therefore, and so as to add clarity to the 
types of payments or transfers of value made by applicable manufactures 
and applicable GPOs to covered recipients, we proposed to revise the 
``Nature of Payment'' categories in Sec.  403.904(e)(2) by 
consolidating two duplicative categories and by adding the three new 
categories described below.
    First, the categories that we proposed to consolidate include two 
separate categories for continuing education programs. Section 
1128G(a)(1)(A)(vi)(XIII) of the Act requires manufacturers to report 
direct compensation for serving as faculty or a speaker for medical 
education programs. The current Sec.  403.904(e)(2)(xiv) and (xv) 
distinguish between accredited/certified and unaccredited/non-certified 
continuing education programs. Although we defined separate categories 
at the inception of the Open Payments program, we no longer believe 
that the distinction in this category is necessary. In revised Sec.  
403.904(e)(2)(xv), we proposed to consolidate these categories and make 
the regulatory wording match the statutory language ``medical education 
programs,'' which we believe would streamline the reporting 
requirements while not detracting from the underlying context of the 
data.
    In addition, we proposed three additional categories that would 
operate prospectively and would not require the updating of previously 
reported payments or other transfers of value that may fall within 
these new categories.
    The three new categories are as follows:
     Debt Forgiveness (Sec.  403.904(e)(2)(xi)): This will be 
used to categorize transfers of value related to forgiving the debt of 
a covered recipient, a physician owner, or the immediate family of the 
physician who holds an ownership or investment interest.
     Long-Term Medical Supply or Device Loan (new Sec.  
403.904(e)(2)(xiv)): Section 403.904 currently contains an exclusion 
from reporting for the loan of a covered device, or the provision of a 
limited quantity of medical supplies for a short-term trial period, not 
to exceed a loan period of 90 days, or a quantity of 90 days of average 
use, respectively. This new category will be used to characterize the 
loans of covered devices or the provision of medical supplies for 
longer than 90 days. (Note: We proposed to combine current paragraphs 
on continuing education programs Sec.  403.904(e)(2)(xiv) and (xv) to 
replace paragraph (e)(2)(xv) as noted in the consolidating continuing 
education programs above.)
     Acquisitions (Sec.  403.904(e)(2)(xviii)): This addition 
will provide a category for characterizing buyout payments made to 
covered recipients in relation to the acquisition of a company in which 
the covered recipient has an ownership interest.
    We also proposed to add the definition of ``long-term medical 
supply or device loan'' to Sec.  403.902 as ``the loan of supplies or a 
device for 91 days or longer.'' For consistency within the definitions 
section, we proposed to redesignate Sec.  403.904(h)(5), which contains 
the definition of ``short-term medical supply or device loan'' to Sec.  
403.902. As a result, we proposed a new Sec.  403.904(h)(5) to be 
``short-term medical supply or device loan.''
    We received several comments regarding our proposed revisions to 
the nature of payment categories. The following is a summary of the 
comments we received and our responses.
    Comment: Some commenters supported the nature of payment changes.
    Response: We thank the commenters for their support.
    Comment: One commenter disagreed with the consolidation of the 
faculty or speaker compensation for continuing education programs 
because they believe that the difference between accredited/certified 
and unaccredited/non-certified is significant in potential manufacturer 
influence. Another commenter suggested that honoraria for continuing 
medical education presenters should be excluded.
    Response: By aligning to the terminology provided in the statute, 
we are streamlining data reporting. We do not believe that the change 
to ``medical education programs''--without differentiating whether they 
are accredited/certified--will detract from the context of the data 
(that is, being paid by a manufacturer to be on the faculty or speak at 
medical educational programs). Generally speaking, direct or indirect 
payments or other transfers of value for serving as a faculty or 
speaker at a medical education program would be reportable under Open 
Payments unless an exclusion applies.
    Comment: Two commenters suggested that clarification be provided on 
what would be covered in the consolidated nature of payment category 
``medical education programs'' to ensure programs for the expanded 
group of covered recipients are covered in the same way as physicians.
    Response: We consider this term to be broad enough to encompass 
various types of education programs, regardless of whether separate 
covered recipient groups may describe them with different names. We 
will keep this feedback in mind as we develop our operational guidance 
on the implementation of this provision.
    Comment: Some commenters requested additional information and 
guidance on what types of payments and transfers of value would fall 
within the nature of payment categories.
    Response: As part of the rulemaking process, we provided 
definitions for the new categories in the proposed rule to be codified 
at Sec.  403.902. As part of the Open Payments operations, further 
technical assistance and operational guidance will be provided. We will 
provide technical support through direct outreach, outreach to 
associations, the issuance of guidance, informational webinar sessions, 
as well as direct assistance via the program help desk as we have 
offered consistently throughout the implementation of the Open Payments 
program.
    Comment: Some commenters recommended revising the definition of the 
nature of payment category ``education'' to exclude materials such as 
medical journal articles.
    Response: Although we appreciate this suggestion, it is outside the 
scope of this rule.
    After considering the aforementioned comments discussed here and in 
the covered recipients provision regarding our proposed changes to the 
nature of payment provision, we are finalizing the changes proposed in 
Sec. Sec.  403.902 and 403.904.
(3) Standardizing Data on Reported Covered Drugs, Devices, Biologicals, 
or Medical Supplies
    When applicable manufacturers or applicable GPOs report payments or

[[Page 62918]]

transfers of value related to specific drugs and biologicals, we 
currently require names and NDCs to be reported to the Open Payments 
program. Since there was a lack of federally-recognized medical device 
identifiers (DIs) when we started the Open Payments program, we have 
not required analogous reporting for the manufacturers of such devices. 
However, the Food and Drug Administration (FDA) established and 
continues to implement a system for the use of standardized unique 
device identifiers (UDIs) for medical devices and has issued 
regulations at 21 CFR part 801, subpart B, and 21 CFR part 830, 
requiring, among other things, that a UDI be included on the label of 
most devices distributed in the United States. (See 78 FR 58785, 
September 24, 2013.) Based upon the FDA's UDI regulatory requirements 
and the requirement by the HHS Office of the National Coordinator for 
Health Information Technology (ONC) that UDIs form part of the Common 
Clinical Data Set (45 CFR part 170), we believe that the use of UDIs 
and DIs, a subcomponent of the UDI, have become more standardized. 
Moreover, the HHS Office of Inspector General (OIG) included a 
recommendation for Open Payments to require more specific information 
about devices in an August 2018 report (OEI-03-15-00220).\103\
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    \103\ The HHS OIG report OEI-03-15-002200 is available at 
https://oig.hhs.gov/oei/reports/oei-03-15-00220.pdf.
---------------------------------------------------------------------------

    With the standardization and typical use of UDIs and based upon 
OIG's recommendation, we proposed that the DI component, the mandatory 
fixed portion of the UDI assigned to a device, if any, should be 
incorporated into Open Payments reporting that applicable manufacturers 
or applicable GPOs provide. We did not propose to require a full UDI. 
We believe the step that we proposed would substantially aid in 
enhancing the quality of the Open Payments data because the identifiers 
could be used to validate submitted device information. This effort 
will also enhance the usefulness of Open Payments data to the public by 
providing more precise information about the medical supplies and 
devices associated with a transaction. Specifically, we proposed to 
revise Sec.  403.904(c)(8) to require applicable manufacturers and 
applicable GPOs to provide the DIs (if any) to identify reported 
devices in a comprehensive fashion meaningful to the users of Open 
Payments data and reorganize the section accordingly.
    We also sought to further clarify the reporting requirements with 
regard to drugs and biologicals. Since the outset of the Open Payments 
program, NDCs have been required for both research and non-research 
payments. In Sec.  403.904(f)(1)(iv), we require that NDCs be reported 
for drugs and biologicals used in research. However, in the CY 2015 PFS 
final rule with comment period (79 FR 67548), the non-research payment 
NDC requirement was erroneously removed when changes were made to the 
rule text regarding marketed names. We proposed to correct this error 
in order to reiterate that NDCs are required for both research and non-
research payments and to make the change effective 60 days from 
publishing the final rule.
    We proposed to revise Sec.  403.904(c)(8) to require DIs (if any) 
to identify reported devices in a comprehensive fashion meaningful to 
the users of Open Payments data and reorganize the section accordingly. 
We also proposed to reincorporate language that specifically required 
reporting of NDCs.
    As a result of the changes to Sec.  403.904(c)(8), we also proposed 
technical changes to Sec.  403.904(f)(1)(iv) and to add mirrored 
definitions from 21 CFR 801.3 for ``device identifier'' and ``unique 
device identifier'' to Sec.  403.902.
    We received comments regarding our proposed revisions to 
standardize data on reported covered drugs, devices, biologicals, or 
medical supplies. The following is a summary of the comments we 
received and our responses.
    Comment: Some commenters provided their support for adding DIs to 
the data being reported. Commenters believe that this will make the 
data more useful to the public.
    Response: We thank the commenters for their support.
    Comment: Some commenters suggested removing or delaying the 
addition of DIs to the data being collected. The commenters raised 
concerns about scenarios in which multiple DIs could be associated with 
one transaction or a device may be associated with multiple 
identifiers. Commenters stated that reporting would be cumbersome to 
manufacturers and that the subsequent data may be confusing to the 
public.
    Response: We look forward to discussing the details of 
implementation solutions with stakeholders. As noted in the proposed 
rule, part of the value of collecting DIs is that we believe such a 
step would substantially aid in enhancing the quality of the Open 
Payments data because the DIs can be used to validate submitted device 
information, such as the marketed or brand name. Our intention is to 
provide meaningful data to the public; therefore, we hope stakeholders 
will continue to contribute to our process as we move to update our 
data systems. As part of the Open Payments operations technical 
assistance, we will provide guidance, explanations, and examples of how 
to report DIs, as well as how to report when there are multiple DIs, to 
industry on our website and through other outreach efforts. We will 
also provide technical support through direct outreach, outreach to 
industry groups, the issuance of guidance, informational webinar 
sessions, and direct assistance via the program help desk. As noted in 
the proposed rule, we proposed that this provision be effective for 
data collected beginning in CY 2021 and reported in CY 2022, and we 
believe that this will give all stakeholders sufficient time to prepare 
for these requirements.
    Comment: One commenter recommended that the following additional 
data items be collected from reporting entities and made available: (1) 
Whether it is a manufacturer or GPO; (2) If it is a manufacturer, what 
it produces; and (3) If it is a GPO, whether it is a physician owned 
distributor (POD). Another commenter recommended that CMS assess 
penalties on PODs that do not comply with the statute by accurately and 
completely reporting payments or transfers of value to covered 
recipients. Finally, one commenter suggested that DIs be added to all 
claims data.
    Response: While we appreciate these suggestions, they are outside 
the scope of this rule.
    Comment: One commenter suggested increasing the monetary threshold 
for reporting.
    Response: While we appreciate this suggestion, it is outside the 
scope of this rule. Additionally, we note that the monetary threshold 
is set in statute at 42 U.S.C. 1320a-7h(e)(10)(B)(i), and therefore, we 
do not have the authority to make the suggested change.
    After considering the other Open Payments comments and the above 
comments on standardizing data, we are finalizing the changes proposed 
in Sec. Sec.  403.902 and 403.904.

G. Solicitation of Public Comments Regarding Notification of Infusion 
Therapy Options Available Prior To Furnishing Home Infusion Therapy

    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

[[Page 62919]]

or subcutaneously through a pump that is an item of durable medical 
equipment in the beneficiary's home, 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. For example, a physician may 
verbally discuss the treatment options with the patient during the 
visit and annotate the treatment decision in the medical record before 
establishing the infusion plan. Some physicians may also provide 
options in writing to the patient in the hospital discharge papers or 
office visit summaries, as well as retain a written patient attestation 
that all options were provided and considered. The frequency of 
discussing these options could vary based on a routine scheduled visit 
or according to the individual's clinical needs.
    We solicited comments in the CY 2020 PFS proposed rule (84 FR 
40716), as well as 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.
    The following is a summary of the comments received on both 
solicitations.
    Comment: Several commenters supported the proposed examples of the 
physician verbally discussing the infusion therapy options and 
annotating the resulting decision in the medical record and initial 
plan of care. Many commenters stated that written materials may be a 
helpful supplement to a verbal conversation, but written materials 
should not be the sole means of beneficiary notification. They 
emphasized that infusion therapy options should be verbally discussed 
so the patient, and any family caregiver, may have an opportunity to 
get immediate answers to questions that may not be addressed in written 
materials. Many commenters encouraged CMS to consider minimizing the 
paperwork burden and confusion that written documents or patient 
attestations could impose on physicians and patients.
    Commenters recommended that the conversation should include how the 
infusion therapy options differ in terms of effectiveness, safety, 
time, comfort, convenience, location, frequency, and out-of-pocket 
costs. Some commenters specifically noted that beneficiaries are 
subject to the standard 20 percent coinsurance with this new Part B 
benefit; and the ordering physician should be aware of the patient's 
insurance status, and therefore, assist them in making informed 
decisions about their care.
    Some commenters recommended the policy should allow for other 
professionals, such as social workers, home health nurses, and other 
staff to assist the treating physician with this notification in order 
to remove unnecessary administrative burden for clinicians. Commenters 
also requested the notification policy include requirements that are 
simple and easy for physicians to implement, and would retain the 
current flexibility for physicians to use multiple notification 
mechanisms as directly suggested by beneficiaries, advocates and 
stakeholders.
    One commenter requested that CMS follow similar procedures for 
other electronically prompted beneficiary notifications. Another 
commenter recommended that CMS develop a single standardized format for 
this notice to avoid benefit denials and delays in therapy. Another 
commenter suggested that CMS establish a training program for 
physicians, hospitals and contractors prior to implementation.
    One commenter requested that CMS permit sufficient time for 
physicians to research the available home infusion therapy options. 
Another commenter requested that CMS create a web page where a 
beneficiary or referring clinician can research if there is a home 
infusion therapy supplier in the beneficiary's geographic location that 
is capable of delivering these services, and that the supplier is 
enrolled and approved by Medicare.
    Two commenters requested that this notification be required only 
when the drug regimen is available and appropriate for home infusion 
therapy. They suggested that notification should not be required if 
there are certain safety risks associated with infusion therapy in that 
patient's home or if the home infusion therapy option is not available 
in the patient's geographic area.
    Regarding the frequency of notification, one commenter suggested 
that only one streamlined notice be required at the start of therapy 
because many therapies have a duration for the life of the beneficiary. 
Two commenters specified that notification of options should be 
discussed and documented in the patient record whenever a new infusion 
therapy treatment is deemed necessary by the physician and anytime 
thereafter if there are changes in patient condition or circumstances 
that would affect the patient's choices.
    Response: We appreciate the commenters' support and recommendations 
and will take the comments into consideration as we continue developing 
future policy through notice-and-comment rulemaking effective for home 
infusion therapy services beginning CY 2021 and for subsequent years.

H. Medicare Enrollment of Opioid Treatment Programs and Enhancements to 
General Enrollment Policies Concerning Improper Prescribing and Patient 
Harm

1. Enrollment of Opioid Treatment Programs
a. Legislative and Regulatory Background
    As previously explained in this final rule, the SUPPORT Act was 
designed to alleviate the nationwide opioid crisis by: (1) Reducing the 
abuse and supply of opioids; (2) helping individuals recover from 
opioid addiction and supporting the families of these persons; and (3) 
establishing innovative and long-term solutions to the crisis. Section 
2005 of the SUPPORT Act attempts to fulfill these objectives, in part, 
by establishing a new Medicare benefit category for opioid treatment 
programs (OTPs). Section 2005(d) of the SUPPORT Act amended section 
1866(e) of the Act by adding a new paragraph (3) thereto that 
classified OTPs as Medicare providers (though only for the furnishing 
of opioid use disorder treatment services). This will enable OTPs that 
meet all applicable statutory and regulatory requirements to bill and 
receive payment under the Medicare program for furnishing such services 
to Medicare beneficiaries.
b. Definition of and Certain Requirements for OTPs
    As already mentioned, an OTP is currently defined in 42 CFR 8.2 as 
a

[[Page 62920]]

program or practitioner engaged in opioid treatment of individuals with 
an opioid agonist treatment medication registered under 21 U.S.C. 
823(g)(1). Section 2005(b) of the SUPPORT Act added a new section 
1861(jjj)(2) to the Act defining an OTP as an entity that meets, among 
other things, the definition of an OTP in Sec.  8.2 (or any successor 
regulation). Section 1861(jjj)(2) of the Act also outlines certain 
additional requirements that an OTP must meet to qualify as such. These 
requirements include the following:
(1) Accreditation
    Consistent with new section 1861(jjj)(2)(C) of the Act, as added by 
section 2005(b) of the SUPPORT Act (and also required under 42 CFR 
8.11(a)(2)), an OTP must have a current, valid accreditation by an 
accrediting body or other entity approved by the Substance Abuse and 
Mental Health Services Administration (SAMHSA), the federal agency that 
oversees OTPs. A core purpose of OTP accreditation is to ensure that an 
OTP meets: (1) Certain minimum requirements for furnishing medication-
assisted treatment (MAT); and (2) the applicable accreditation 
standards of SAMHSA-approved accrediting bodies, of which there 
presently are six. The accreditation process includes, but is not 
limited to, an accreditation survey, which involves an onsite review 
and evaluation of an OTP to determine compliance with applicable 
federal standards.
(2) Certification
    A second requirement addressed in section 1861(jjj)(2)(B) of the 
Act, as added by section 2005(b) of the SUPPORT Act, is also outlined 
in current regulations referenced in Sec.  8.11(a). Along with 
accreditation, an OTP must have a current, valid certification by 
SAMHSA for such a program. The prerequisites for certification (as well 
as the certification process itself) are addressed in Sec.  8.11 and 
include, but are not restricted to, the following:
     Current and valid accreditation (as described previously);
     Adherence to the federal opioid treatment standards 
described in Sec.  8.12; and
     Compliance with all pertinent state laws and regulations, 
as stated in Sec.  8.11(f)(1).
    Under Sec.  8.11(a)(3), certification is generally for a maximum 3-
year period, though this may be extended by 1 year if an application 
for accreditation is pending. SAMHSA may revoke or suspend an OTP's 
certification if any of the applicable grounds identified in Sec.  
8.14(a) or (b), respectively, exist. According to SAMHSA statistics, 
there are currently about 1,677 active OTPs; of these, approximately 
1,585 have full certifications and 92 have provisional certifications.
(3) OTP Enrollment
    Section 2005(b) of the SUPPORT Act, which added a new section 
1861(jjj)(2)(A) to the Act, requires that an OTP be enrolled in the 
Medicare program under section 1866(j) of the Act to: (1) Qualify as an 
OTP; and (2) bill and receive payment from Medicare for opioid use 
disorder treatment services. Per section 1861(jjj)(2)(A) of the Act, 
and as discussed in more detail in this section III.H. of this final 
rule, we proposed a number of requirements in the CY 2020 PFS proposed 
rule that OTPs must meet to enroll in Medicare.
c. Current Medicare Enrollment Process
(1) Background
    Section 1866(j)(1)(A) of the Act requires the Secretary to 
establish a process for the enrollment of providers and suppliers in 
the Medicare program. The overarching purpose of the enrollment process 
is to help ensure that providers and suppliers that seek to bill the 
Medicare program for services or items furnished to Medicare 
beneficiaries are qualified to do so under federal and state laws. The 
process is, to an extent, a ``gatekeeper'' that prevents unqualified 
and potentially fraudulent individuals and entities from being able to 
enter and inappropriately bill Medicare. CMS and our Medicare 
Administrative Contractors (MACs; hereafter occasionally referred to as 
``contractors'') carefully and closely screen and review Medicare 
enrollment applicants to verify that they meet all applicable legal 
requirements.
    CMS has taken various steps via regulation to outline a process for 
enrolling providers and suppliers in the Medicare program. For 
instance, in the April 21, 2006 Federal Register (71 FR 20754), we 
published the ``Medicare Program; Requirements for Providers and 
Suppliers to Establish and Maintain Medicare Enrollment'' final rule 
that set forth certain requirements in 42 CFR part 424, subpart P 
(currently Sec. Sec.  424.500 through 424.570) that providers and 
suppliers must meet to obtain and maintain Medicare billing privileges. 
We cited therein sections 1102 and 1871 of the Act as general authority 
for our establishment of these requirements, which were designed for 
the efficient administration of the Medicare program. Subsequent to the 
April 21, 2006 final rule, we published additional provider enrollment 
regulations. These were intended not only to clarify or strengthen 
certain components of the enrollment process but also to enable us to 
take further action against problematic providers and suppliers.
(2) Form CMS-855--Medicare Enrollment Application
    Under Sec.  424.510, a provider or supplier must complete, sign, 
and submit to its assigned MAC the appropriate Form CMS-855 (OMB 
Control No. 0938-0685) application in order 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; \104\ Provider Enrollment, Chain, and Ownership System), 
captures information about the provider or supplier that is needed for 
CMS or its MACs to determine whether the provider or supplier meets all 
Medicare requirements. Data collected on the Form CMS-855 is carefully 
reviewed and verified by CMS or its MACs and includes, but is not 
limited to:
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    \104\ https://www.hhs.gov/foia/privacy/sorns/09700532/index.html.
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     General identifying information (for example, legal 
business name, tax identification number).
     Licensure and/or certification data.
     Any final adverse actions (as that term is defined in 
Sec.  424.502) of the provider or supplier, such as felony convictions, 
exclusions by the HHS Office of Inspector General (OIG), or state 
license suspensions or revocations.
     Practice locations and other applicable addresses of the 
provider or supplier.
     Information regarding the provider's or supplier's owning 
and managing individuals and organizations and any final adverse 
actions those parties may have.
    After receiving a provider's or supplier's application for initial 
enrollment, reviewing and confirming the information thereon, and 
determining whether the provider or supplier meets all applicable 
Medicare requirements, CMS or the MAC will either: (1) Approve the 
application and grant billing privileges to the provider or supplier 
(or, depending upon the provider or supplier type involved, simply 
recommend approval of the application and refer it to the state agency 
or to the CMS regional office, as

[[Page 62921]]

applicable); or (2) deny enrollment under Sec.  424.530.
d. OTP Enrollment Provisions
(1) Legal Basis and Necessity
    In proposing requirements and procedures with which OTPs must 
comply to enroll and remain enrolled in Medicare, we relied on the 
authority granted to us not only under section 1861(jjj)(2)(A) of the 
Act but also under several other statutory provisions. First, section 
1866(j) of the Act provides specific authority with respect to the 
enrollment process for providers and suppliers. Second, sections 1102 
and 1871 of the Act furnish general authority for the Secretary to 
prescribe regulations for the efficient administration of the Medicare 
program.
    We believe, and it has been our longstanding experience, that the 
provider enrollment process is invaluable in helping to ensure that: 
(1) All potential providers and suppliers are carefully reviewed for 
compliance with all applicable requirements; (2) problematic providers 
and suppliers are kept out of Medicare; and (3) beneficiaries are 
protected from unqualified providers and suppliers. Indeed, without 
this process, the Medicare program and Medicare beneficiaries could be 
endangered, and billions of Trust Fund dollars could be paid to 
unqualified or fraudulent parties.
    However, we noted in the proposed rule that our general concerns 
were not restricted to the mere need and desire to establish provider 
enrollment requirements for OTPs. While provider enrollment is a 
crucial component of CMS' overall broader program integrity efforts, it 
is not the only one. We emphasized that in establishing and 
implementing an overall Medicare OTP process per the SUPPORT Act and 
implementing an overall program integrity strategy, our objectives 
would extend to matters such as: (1) Monitoring OTP billing patterns; 
(2) ensuring the proper payment of OTP claims; (3) performing OTP 
audits as required by law; (4) making certain that OTP beneficiaries 
receive quality care; and (5) taking action (enrollment-related or 
otherwise) against non-compliant or abusive OTP providers. In other 
words, it should not be assumed for purposes of the OTP process that 
the term ``program integrity'' is limited to the provider enrollment 
concept, for it applies to many other types of payment safeguards as 
well.
(2) OTP Enrollment Requirements--Proposed Provisions in the CY 2020 PFS 
Proposed Rule
    We proposed the following OTP enrollment provisions:
(a) Addition of Sec.  424.67 and General OTP Requirement To Enroll
    We proposed to establish a new Sec.  424.67 that would include most 
of our OTP enrollment provisions. In paragraph (a) thereof, we proposed 
that for a program or eligible professional (as that term is defined in 
section 1848(k)(3)(B) of the Act) to receive Medicare payment for the 
provision of opioid use disorder treatment services, the provider must 
qualify as an OTP (as that term is defined in Sec.  8.2) and enroll in 
the Medicare program under the provisions of part 424, subpart P, as 
well as the provisions of Sec.  424.67.
(b) OTPs--Procedures and Compliance
    In paragraph (b) of Sec.  424.67, we proposed several specific 
enrollment requirements that OTPs must meet that either clarify or 
supplement those contained in subpart P.
(i) OTPs: Form CMS-855B
    In Sec.  424.67(b)(1), we proposed that an OTP must complete in 
full and submit the Form CMS-855B application (``Medicare Enrollment 
Application: Clinics/Group Practices and Certain Other Suppliers'') 
(OMB Control No.: 0938-0685) and any applicable supplement or 
attachment thereto (which would be submitted to OMB under control 
number 0938-0685) to its applicable Medicare contractor. The supplement 
or attachment would capture certain information that is: (1) Unique to 
OTPs but not obtained via the Form CMS-855B; and (2) necessary to 
enable CMS to effectively screen their applications and confirm their 
qualifications.
    As part of this general requirement concerning Form CMS-855 
completion, we proposed two subsidiary requirements as part of the 
aforementioned supplement/attachment.
    First, in Sec.  424.67(b)(1)(i), we proposed that the OTP must 
maintain and submit to CMS (via the applicable supplement/attachment) a 
list of all physicians and other eligible professionals (as the term 
``eligible professional'' is defined in section 1848(k)(3)(B) of the 
Act) who are legally authorized to prescribe, order, or dispense 
controlled substances on behalf of the OTP. The list must include the 
physician's or other eligible professional's first and last name and 
middle initial, Social Security Number, National Provider Identifier, 
and license number (if applicable). We believed that this requirement 
would enable us to: (1) Confirm that these individuals are qualified to 
perform the activities in question; and (2) screen their prescribing 
practices, the latter being an especially important consideration in 
light of the nationwide opioid epidemic.
    Second, we proposed in Sec.  424.67(b)(1)(ii) that the OTP must 
certify via the Form CMS-855B 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 Sec.  
424.67(b) and (d) (discussed below).
(ii) OTPs: Application Fee
    Under Sec.  424.514, prospective and revalidating institutional 
providers that are submitting an enrollment application generally must 
pay the required application fee. (For CY 2019, the fee amount is 
$586.) Section 424.502 defines an institutional provider as any 
provider or supplier that submits a paper Medicare enrollment 
application using the Form CMS-855A, Form CMS-855B (not including 
physician and nonphysician practitioner (NPP) organizations, which are 
exempt from the fee requirement if they are enrolling as a physician or 
NPP organization), Form CMS-855S, Form CMS-20134, or an associated 
internet-based PECOS enrollment application. Since an OTP, as a 
specialized facility, would be required to complete the Form CMS-855B 
to enroll in Medicare as an OTP (and would not be enrolling as a 
physician or non-physician organization), we believed that an OTP would 
meet the definition of an institutional provider under Sec.  424.502. 
Therefore, we proposed to clarify in new Sec.  424.67(b)(2) that the 
OTP must pay an application fee consistent with Sec.  424.514.
(c) OTPs: Categorical Risk Designation
    Section 424.518 outlines enrollment screening categories and 
requirements based on a CMS assessment of the level 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 poses, the greater the level of scrutiny with 
which CMS will screen and review providers or suppliers within that 
category.
    There are three categories of screening in Sec.  424.518: High, 
moderate, and limited, with the ``high'' category being the strictest 
level of screening. We proposed to include newly enrolling OTPs within 
this ``high'' classification. This means that the OTP would be

[[Page 62922]]

subject to the same screening procedures that apply to all other 
enrolling providers and suppliers (regardless of the risk category into 
which they fall) as well as the following:
     A site visit.
     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.
     A fingerprint-based criminal history record check of the 
Federal Bureau of Investigation's 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.
    We generally explained that a high categorical risk designation was 
appropriate because we have no historical information on OTPs (either 
from an enrollment, billing, or claims payment perspective) upon which 
we can fairly estimate the degree of risk they may pose.
    Given the foregoing, we proposed:
     To state in new Sec.  424.67(b)(3) that newly enrolled OTP 
providers would be screened at the high categorical risk level in 
accordance with the requirements of Sec.  424.518(c).
     To add a new paragraph (iv) to Sec.  424.518(c)(1) that 
would add newly enrolled OTPs to the types of providers and suppliers 
screened at the high categorical risk level.
     To add a new paragraph (xii) to Sec.  424.518(b)(1) 
whereby OTPs that are revalidating their current Medicare enrollment 
(under Sec.  424.515) would be screened at the moderate categorical 
risk level (which involves a site visit but does not include the 
fingerprint submission requirement of the high categorical risk level). 
This would be consistent with our approach towards several other 
provider and supplier types (for example, home health agencies) that 
are screened at the high categorical risk level when newly enrolling 
and at the moderate level when revalidating.
     Consistent with the addition of new Sec.  
424.518(b)(1)(xii), we proposed to require that, upon revalidation, the 
OTP must successfully complete the moderate categorical risk level 
screening required under Sec.  424.518(b) in order to remain enrolled 
in Medicare. This provision would be designated as new Sec.  
424.67(d)(1)(iii).
(d) OTPs: Certification
    Consistent with both section 1861(jjj)(2)(B) of the Act and Sec.  
8.11, we proposed in new Sec.  424.67(b)(4)(i) that to enroll in 
Medicare, an OTP must have in effect a current, valid certification by 
SAMHSA for such a program. However, under Sec.  424.67(b)(4)(ii), we 
proposed that we would not accept a provisional certification under 
Sec.  8.11(e) in lieu of the certification described in Sec.  8.11(a). 
We believed that the OTP certification requirement in section 
1861(jjj)(2)(B) of the Act refers to full SAMHSA certification rather 
than provisional certification.
(e) OTPs: Managing Employees
    Consistent with sections 1124 and 1124A of the Act, an enrolling 
provider or supplier must disclose all of its managing employees on the 
Form CMS-855 application. Thus, we proposed in new Sec.  424.67(b)(5) 
that all OTP's staff who meet the regulatory definition of managing 
employee in Sec.  424.502 must be reported on the Form CMS-855 
application and/or any applicable supplement. Such individuals would 
include, but not be limited to, the OTP's medical director and program 
sponsor (both as described in Sec.  8.2).
(f) Standards Specific to OTPs
    In light of the previously mentioned concerns about the nationwide 
opioid crisis and the need for drugs to be prescribed and, moreover, 
dispensed, in a careful, reasonable manner, we also proposed certain 
enrollment standards unique to the services that OTPs provide.
    In new Sec.  424.67(b)(6)(i), we proposed that an OTP must not 
employ or contract with a prescribing or ordering physician or other 
eligible professional or with any individual legally authorized to 
dispense narcotics who, within the preceding 10 years, has been 
convicted (as that term is defined in 42 CFR 1001.2) of a federal or 
state felony that we deem detrimental to the best interests of the 
Medicare program and its beneficiaries, based on the same categories of 
detrimental felonies, as well as case-by-case detrimental 
determinations, codified at Sec.  424.535(a)(3). This provision would 
apply irrespective of whether the individual in question is: (1) 
Currently dispensing narcotics at or on behalf of the OTP; or (2) a W-2 
employee of the OTP.
    In new Sec.  424.67(b)(6)(ii), we proposed that the OTP must not 
employ or contract with any personnel (regardless of whether the 
individual is a W-2 employee of the OTP) who is revoked from Medicare 
under Sec.  424.535 or any other applicable section in Title 42, or who 
is on the preclusion list under Sec.  422.222 or Sec.  423.120(c)(6). 
(See https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html for 
background information on the preclusion list).
    In Sec.  424.67(b)(6)(iii), we proposed that the OTP must not 
employ or contract with any personnel (regardless of whether the 
individual is a W-2 employee of the OTP) who has a prior adverse action 
imposed by a state oversight board, including, but not limited to, a 
reprimand, fine, or restriction, for a case or situation involving 
patient harm that CMS deems detrimental to the best interests of the 
Medicare program and its beneficiaries. We would consider the factors 
specified at Sec.  424.535(a)(22) (discussed in more detail below) in 
each case of patient harm that potentially applies to this provision.
    The overriding rationale for these provisions is our view that OTP 
personnel who have engaged in problematic behavior present a potential 
threat to the OTP's patients and to the Trust Funds.
(g) Provider Agreement
    As previously mentioned, section 2005(d) of the SUPPORT Act amended 
section 1866(e) of the Act by adding a new paragraph (3) classifying 
OTPs as Medicare providers, though only with respect to the furnishing 
of opioid use disorder treatment services. Under section 1866(a)(1) of 
the Act, all Medicare providers (as that term is defined in section 
1866(e) of the Act) must enter into a provider agreement with the 
Secretary. (Section 1866(a)(1) of the Act outlines required terms of 
the provider agreement, such as allowed charges for furnished 
services.)
    Consistent with these requirements, we proposed two new provisions. 
In new Sec.  424.67(b)(7)(i), we proposed that an OTP must, in 
accordance with the provisions of 42 CFR part 489, sign (and adhere to 
the terms of) a provider agreement with CMS in order to participate and 
enroll in Medicare. In new Sec.  424.67(b)(7)(ii), we proposed that an 
OTP's appeals under part 498 of a Medicare revocation (under Sec.  
424.535) and of a termination of its provider agreement (under Sec.  
489.53) must be filed jointly and, as applicable, considered jointly by 
CMS under part 498.
    Regarding this latter provision, we believe that having dual, 
separate appeals processes for OTPs would impose unnecessary 
administrative burdens on OTPs and CMS. A single appeals process would, 
in our view, be more efficient. We did, however, solicit comment on 
this proposed consolidated appeals process, including suggestions of 
alternative processes and the

[[Page 62923]]

potential operational components thereof.
(h) OTPs: Other Applicable Requirements
    To ensure that the OTP meets all other applicable requirements for 
enrollment, we proposed at Sec.  424.67(b)(8) that the OTP must comply 
with all other applicable enrollment requirements specified in Sec.  
424.67 and in part 424, subpart P.
(i) OTPs: Denial of Enrollment and Appeals Thereof
    We proposed to state in new Sec.  424.67(c) that CMS may deny an 
OTP's enrollment application on either of the following grounds:
     The provider does not have in effect a current, valid 
certification by SAMHSA as required under Sec.  424.67(b)(4) or fails 
to meet any other applicable requirement in Sec.  424.67.
     Any of the reasons for denial of a prospective provider's 
or supplier's enrollment application in Sec.  424.530 applies.
    We also proposed that an OTP may appeal the denial of its 
enrollment application under part 498.
    The purposes of these provisions were to, respectively, ensure: (1) 
The OTP's compliance with Sec.  424.67 and all other applicable 
enrollment requirements; and (2) that the OTP has the same appeal 
rights as all other provider and supplier types.
(j) OTPs: Continued Compliance, Standards, and Reasons for Revocation
    For reasons identical to those behind our addition of Sec.  
424.67(c), we proposed several provisions in new Sec.  424.67(d).
    In paragraph (d)(1), we proposed to state that, upon and after 
enrollment, an OTP:
     Must remain validly certified by SAMHSA as required under 
Sec.  8.11.
     Remains subject to, and must remain in full compliance 
with, the provisions of part 424, subpart P, as well as those in Sec.  
424.67. This includes, but is not limited to, the provisions of Sec.  
424.67(b)(6), the revalidation provisions in Sec.  424.515, and the 
deactivation and reactivation provisions in Sec.  424.540.
    In paragraph (d)(2), we proposed that CMS may revoke an OTP's 
enrollment if:
     The provider does not have a current, valid certification 
by SAMHSA or fails to meet any other applicable requirement or standard 
in Sec.  424.67, including, but not limited to, the OTP standards in 
Sec. Sec.  424.67(b)(6) and (d)(1).
     Any of the revocation reasons in Sec.  424.535 applies.
    Finally, in new paragraph (d)(3), we proposed that an OTP may 
appeal the revocation of its enrollment under part 498.
(k) OTPs: Prescribing Individuals
    In new Sec.  424.67(e)(1) (and with respect to payment to OTP 
providers for furnished drugs), we proposed that the prescribing or 
medication ordering physician's or other eligible professional's 
National Provider Identifier must be listed on Field 17 (the ordering/
referring/other field) of the Form CMS-1500 (Health Insurance Claim 
Form; 0938-1197) (or the digital equivalent thereof)). We believed that 
this requirement would help us: (1) Ensure that the physician or other 
eligible professional in question is qualified to prescribe drugs on 
behalf of the OTP; and (2) monitor the prescribing individual in 
relation to each claim. This requirement would have to be met in order 
for an OTP claim for a prescribed drug to be paid. To avoid the 
impression, however, that this is the only requirement necessary for 
claim payment, we proposed to further clarify in new paragraph (e)(2) 
that all other applicable requirements in Sec.  424.67, part 424, and 
part 8 must also be met.
(l) OTPs: Relationship to 42 CFR Part 8
    To help ensure that OTPs understand their continuing need to comply 
with the provisions in Part 8 (several of which are referenced above) 
and to clarify that the provisions in Sec.  424.67 are generally 
restricted to the enrollment process, we proposed to state in new Sec.  
424.67(f) that Sec.  424.67 shall not be construed as: (1) Supplanting 
any of the provisions in part 8; or (2) eliminating an OTP's obligation 
to maintain compliance with all applicable provisions in part 8.
(m) Effective and Retrospective Date of OTP Billing Privileges
    Section 424.520 outlines the effective date of billing privileges 
for provider and supplier types that are eligible to enroll in 
Medicare. Paragraph (d) thereof sets forth the applicable effective 
date for physicians, NPPs, physician and NPP organizations, and 
ambulance suppliers. This effective date is the later of: (1) The date 
of filing of a Medicare enrollment application that was subsequently 
approved by a Medicare contractor; or (2) the date that the supplier 
first began furnishing services at a new practice location. Similarly, 
Sec.  424.521(a) states that physicians, NPPs, physician and NPP 
organizations, and ambulance suppliers may retrospectively bill for 
services when the supplier 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 (Pub. L. 100-707, enacted November 23, 1988), 
42 U.S.C. 5121-5206 (Stafford Act), precluded enrollment in advance of 
providing services to Medicare beneficiaries.
    To clarify the effective date of billing privileges for OTPs and to 
account for circumstances that could prevent an OTP's enrollment prior 
to the furnishing of Medicare services, we proposed to include newly 
enrolling OTPs within the scope of Sec. Sec.  424.520(d) and 
424.521(a).
    We also sought public feedback on additional means of preventing 
fraud, waste, and abuse in OTP settings; for instance, we noted that we 
would appreciate suggestions--based on stakeholder experience in the 
OUD and OTP arenas--from which we could develop further regulatory 
authority to take action against problematic OTPs.
(3) Summary of the Public Comments on OTP Enrollment Provisions and the 
CMS Responses
    We received comments concerning our proposed OTP enrollment 
provisions from approximately 15 stakeholders. The comments are 
summarized below, followed respectively by our responses thereto.
    Comment: Several commenters stated that our proposed assignment of 
newly enrolling OTPs to the high categorical risk level was reasonably 
prudent due to our: (1) Stated lack of historical information on OTPs; 
and (2) safety concerns. One commenter added that CMS might wish to 
reconsider this risk level assignment once sufficient experience with 
the OTP enrollment process has been attained.
    Response: We appreciate the commenters' support. While we cannot 
commit to any future risk level reclassification for initially 
enrolling OTPs, we will closely monitor OTP enrollment over the coming 
years and, if warranted, consider potential regulatory revisions that 
serve the best interests of the Medicare program and its beneficiaries.
    Comment: One commenter stated that there could be heightened risk 
in OTP facilities compared to other settings, for the services provided 
involve the

[[Page 62924]]

prescribing and dispensing of controlled substances and a complex 
subset of patients dealing with addiction. However, the commenter 
cautioned CMS against overly restrictive policies that may hinder 
patient care or physician practices. Another commenter encouraged CMS 
to streamline and minimize the cost associated with the OTP enrollment 
process.
    Response: In establishing our OTP enrollment proposals, we strived 
to protect the Medicare program, the Trust Funds, and beneficiaries 
while (1) avoiding the imposition of unnecessary and excessively 
burdensome and costly requirements and (2) ensuring patient access to 
care as much as possible; that is, our aim was to propose requirements 
consistent with program and patient safety without needlessly burdening 
OTPs. We believe this approach will prove successful in appropriately 
balancing the needs addressed by the commenters.
    Comment: Several commenters expressed support for the proposed 
assignment of enrolled OTPs to the moderate level of categorical 
screening and the proposed changes to Sec. Sec.  424.520 and 424.521 
regarding retroactive billing.
    Response: We appreciate the commenters' support.
    Comment: One commenter that is currently enrolling their locations 
under the ``Clinic/Group Practice'' category on the Form CMS-855B 
questioned whether CMS will be creating a new ``OTP Provider'' category 
on the form. If so, the commenter asked whether clinics that currently 
have a Medicare number will have to re-enroll as an OTP.
    Response: We are in the process of revising the Form CMS-855B as 
part of this rule to include a new category for OTPs. Since OTPs are a 
provider type that is distinct from clinics/group practices, with 
different requirements and conditions for enrollment, a currently 
enrolled clinic/group practice will need to separately enroll as an OTP 
if it wishes to bill for OTP services.
    Comment: Several commenters stated that a provisional certification 
should be sufficient to satisfy the certification requirement at 
proposed Sec.  424.67(b)(4), at least for the 12-month period before 
full certification is granted. The commenters stated that: (1) This 
would expand access to OTP care; (2) provisional certification is 
indeed a type of SAMHSA certification that has been used for many years 
to enable new OTPs to treat patients temporarily; and (3) failure to 
accept provisional certification represents a barrier to treatment that 
is inconsistent with congressional intent.
    Response: As mentioned previously, section 1861(jjj)(2)(B) of the 
Act states that an OTP must have in effect a certification by SAMHSA. 
We interpret this requirement to mean full SAMHSA certification rather 
than provisional certification because the statute does not specify 
that provisional certification is acceptable in lieu of full 
certification. We also note that provisional certification under Sec.  
8.11(e) applies to OTPs that do not have a current SAMHSA certification 
but have applied for accreditation with an accreditation organization. 
Yet section 1861(jjj)(2)(C) of the Act requires actual accreditation 
rather than the mere application for accreditation. Therefore, since 
the latter cannot be accepted for enrollment purposes, we do not 
believe a provisional certification (which, again, pertains to non-
accredited parties) can, either.
    Comment: One commenter questioned whether an organization with 
multiple programs and clinics will be able to apply (via the Form CMS-
855B) for a single provider number and bill for services furnished by 
each program under this number.
    Response: Separately certified and accredited OTPs must be 
separately enrolled. Multiple OTPs cannot be grouped under a single 
enrollment.
    Comment: Several commenters requested verification that OTP 
enrollment will be done at the provider level under the program's NPI 
and will not require the enrollment or credentialing of physicians and 
practitioners employed by the OTP. The commenters stated that if the 
latter were required: (1) It could pose a significant burden on OTPs; 
and (2) practitioners who could not become enrolled would lose their 
employment with the OTP, which could hinder the OTP's ability to 
furnish care. The commenters also requested clarification as to how 
such a requirement would impact other practices and settings where the 
physician or practitioner may work.
    Response: The OTP facility itself will be enrolled. The physicians 
and practitioners will not have to enroll as part of the OTP's 
enrollment.
    Comment: Several comments sought clarification regarding: (1) 
Whether there is a specific timeframe in which OTPs will have to 
enroll; and (2) when OTPs can begin submitting applications for 
enrollment.
    Response: OTPs may submit applications immediately, and we 
encourage them to do so to begin billing on and after the OTP benefit 
commencement date of January 1, 2020.
    Comment: Several commenters stated that SAMHSA's existing 
certification and accreditation requirements are sufficient to ensure 
an OTP's quality of service and that no additional conditions for 
Medicare enrollment should be required. As evidence of such, the 
commenters cited a statement in the proposed rule that the 
certification and accreditation requirements are ``sufficient to ensure 
the health and safety of individuals being furnished services by OTPs, 
as well as the effective and efficient furnishing of such services.'' 
Accordingly, the commenters stated that no requirements beyond 
certification and accreditation should be necessary, especially given 
that OTPs are already heavily regulated.
    Response: We disagree with the commenters. The statement cited by 
the commenters was never meant to imply that OTP enrollment would or 
should consist merely of the submission of a copy of the OTP's SAMHSA 
certification and accreditation, without any need for completion of the 
Form CMS-855B and CMS' verification of the information thereon. As 
already mentioned, section 1861(jjj)(2)(A) of the Act requires that an 
OTP be enrolled in Medicare under section 1866(j) of the Act; moreover, 
section 1866(j)(1)(A) of the Act requires the Secretary to establish a 
process for the enrollment of providers and suppliers in the Medicare 
program. Consistent with (and even prior to) section 1866(j) of the 
Act, we established a thorough enrollment process designed to ensure 
that all providers and suppliers meet Medicare requirements. We believe 
the commenters are, in effect, asking for an exemption from this 
process for OTPs. CMS cannot consent to this. All providers and 
suppliers are required to adhere to our enrollment requirements, which 
have been longstanding, and there is nothing in section 1861(jjj)(2)(A) 
of the Act to indicate that OTPs were meant to be exempt. We further 
note that the SAMHSA certification and accreditation processes, while 
extremely crucial safeguards, do not involve reviews of whether the OTP 
meets Medicare requirements. However, our existing enrollment process 
does, which is why the latter is needed.
    Comment: Several commenters opposed our assignment of OTPs to the 
high-risk screening level on several grounds. The commenters stated 
that CMS should already have sufficient data from state Medicaid 
agencies regarding OTP risk, meaning that our contention that we lack 
historical information concerning OTPs is without merit. Commenters 
also stated that OTPs are

[[Page 62925]]

already subject to significant regulation and oversight at the federal, 
state, and even local levels. Adding another level of supervision via 
high-risk screening would, they stated, be costly, redundant, and 
unnecessarily burdensome for OTPs, so much so that it could delay the 
enrollment of OTPs and thus deny prompt care to patients. The 
commenters also asserted that a high-risk screening designation creates 
an unwarranted stigma about OTPs and methadone treatment without 
factual support.
    Response: Notwithstanding the commenters' statements concerning 
Medicaid, we do not have any historical information on OTPs in the 
context of Medicare participation. Medicaid and Medicare are two 
distinct programs with differing requirements. As such, and given the 
type of services performed at OTPs in light of the opioid epidemic, we 
believe that a robust scrutiny of newly enrolling OTPs is important. 
Indeed, we believe that it is important for all newly-recognized 
Medicare provider and types (due to Medicare's general lack of history 
associated with them) to be closely reviewed. Nevertheless, we 
appreciate and understand the commenters' concerns, and we recognize 
that many SAMHSA-certified OTPs have been in operation well before the 
enactment of the SUPPORT Act on October 24, 2018. Consequently, we are 
revising our proposed provisions such that newly enrolling OTPs that 
have been fully and continuously certified by SAMHSA since October 23, 
2018, will be assigned to the moderate risk level of categorical 
screening. Those that have not been fully and continuously certified by 
SAMHSA since that date will be subject to the originally proposed high-
risk level of categorical screening. (All revalidating OTPs will remain 
at the moderate level as proposed.)
    We believe this approach will help balance the need to reduce the 
overall burden on the OTP community with the importance of ensuring 
that newer, more recently established OTPs (that, perhaps, have a 
shorter history of sustained performance) are appropriately screened. 
We also emphasize that neither our proposed nor our final risk 
categories were or are meant to stigmatize the OTP community. Rather, 
our objective is to ensure that OTPs, like all Medicare-enrolling 
providers and suppliers, are appropriately screened.
    Comment: Several commenters stated that the requirement that OTPs 
not employ or contract with professionals convicted of a felony within 
the last 10 years or with a prior adverse action with the state 
oversight board is discriminatory. The commenters stated that many 
individuals working in substance use disorder treatment entered the 
field because they themselves are in recovery. Commenters stated that 
individuals should not be discriminated against: (1) For crimes they 
may have committed while still in an active disease state; or (2) if 
they have satisfactorily met requirements of the state's recovering 
professionals program.
    Response: We respectfully disagree that this requirement is 
discriminatory, and it was in no manner intended to be. Our sole 
concern was to safeguard the Medicare program and its beneficiaries 
from individuals who could present a threat. We further note that there 
is precedent for the requirement in question. Under Sec. Sec.  
424.530(a)(3) and 424.535(a)(3), CMS may deny or revoke enrollment if 
the provider, supplier, or any owner or managing employee of the 
provider or supplier was, within the preceding 10 years, convicted of a 
federal or state felony that CMS determines is detrimental to the best 
interests of the Medicare program and its beneficiaries. A similar 
provision at Sec.  424.205(e)(1)(v) exists for the Medicare Diabetes 
Prevention Program (MDPP) coaches, who are prohibited from furnishing 
MDPP services if they have been convicted (within the previous 10 
years) of one of the federal or state felonies outlined in that 
provision. Given this, and, more importantly, the very sensitive nature 
of controlled substances and medication-assisted treatment, we believe 
that the OTP employment provision in question is appropriate and 
necessary.
    Nonetheless, we stress that this is a discretionary provision, in 
the sense that the felony in question must be one that CMS determines 
to be detrimental to the best interests of the Medicare program and its 
beneficiaries based on our review of the factors in Sec.  
424.535(a)(3). We understand the commenters' concerns, and it should 
not be assumed that every felony conviction and the circumstances 
surrounding it will meet the standard described in the previous 
sentence.
    Comment: Several commenters stated that our reference in the 
proposed rule to patient brokers and excessive stays in sober homes 
represents a poor and possibly discriminatory illustration of an OTP's 
risk potential.
    Response: The statement that the commenter cited was not intended 
to denigrate OTPs. It was merely an example we have seen of 
disconcerting provider behavior in the context of drug treatment.
    Comment: Regarding the proposed list of prescribing, ordering, or 
dispensing physicians and other eligible professionals, one commenter 
stated that the term ``eligible professional'' (as defined in section 
1848(k)(3)(B) of the Act) does not include pharmacists. The commenter 
stated that some pharmacists may be legally authorized to prescribe, 
order, or dispense medications. Thus, limiting the list to physicians 
and other eligible professionals could imply that pharmacists cannot 
perform these functions. The commenter recommended that CMS modify this 
requirement to include pharmacists within the category of individuals 
who should be reported on the aforementioned list.
    Response: We agree and will revise Sec.  424.67(b)(1)(i) to include 
pharmacists within the scope of the list requirement, though this 
should not be construed as implying that a pharmacist qualifies as an 
eligible professional under section 1848(k)(3)(B) of the Act.
    Comment: One commenter questioned whether per diem nursing staff 
(such as registered nurses) will need to be listed on the Form CMS-855B 
OTP supplement.
    Response: As the previous commenter noted and as indicated in our 
response, the individuals listed under Sec.  424.67(b)(1)(i) are 
physicians, other eligible professionals, and pharmacists. Individuals, 
such as registered nurses, who do not fall within these categories need 
not be listed. (The definition of ``eligible professionals'' in section 
1848(k)(3)(B) of the Act, though, does include practitioners described 
in section 1842(b)(18)(C) of the Act, and the definition of 
``practitioners'' includes nurse practitioners, clinical nurse 
specialists, and certified registered nurse anesthetists, among other 
individuals.) However, we note that individuals to whom Sec.  
424.67(b)(1)(i) applies can be either employees or contracted personnel 
so long as they are legally authorized to prescribe, order, or dispense 
controlled substances on the OTP's behalf. We believe ``per diem'' 
staff fall within the classification of contracted personnel, for while 
they are not employees, they are acting on behalf of the OTP per a 
contractual arrangement. Therefore, they would have to be listed. We 
will revise the regulatory text of Sec.  424.67(b)(1)(i) to clarify 
that the individual need not be a W-2 employee of the OTP.
    Comment: One commenter requested clarification regarding whether 
physicians or other eligible professionals participating in

[[Page 62926]]

continuous improvement activities (such as a quality assessment or peer 
review) without a state or federal government action against them would 
be denied participation in an OTP or other Medicare program.
    Response: Engagement in the continuous improvement activities the 
commenter describes does not, in and of itself: (1) Constitute grounds 
for denial or revocation of Medicare enrollment; or (2) invoke the 
prohibitions in Sec.  424.67(b)(6).
(4) Final OTP Enrollment Provisions
    After considering the comments received, we are finalizing our 
provisions as proposed with several exceptions.
    Section 424.67(b)(1)(i) is expanded to apply to all physicians, 
other eligible professionals, and pharmacists who are legally 
authorized to prescribe, order, or dispense controlled substances on 
behalf of the OTP (regardless of whether the individual is a W-2 
employee of the OTP).
    In Sec.  424.67(b)(3), we are revising this paragraph to state that 
applicants must successfully complete the assigned categorical risk 
level screening required under, as applicable, Sec.  424.518(b) and 
(c). This is intended to accommodate the two aforementioned levels of 
screening for newly enrolling OTPs.
    Proposed Sec.  424.518(b)(1)(xii), which stated that revalidating 
OTPs would be subject to the moderate risk level of categorical 
screening, will be re-designated as new Sec.  424.518(b)(1)(xiii). 
Consistent with our prior discussion on this issue, prospective OTPs 
that have been fully and continuously certified by SAMHSA since October 
23, 2018 will be included in revised Sec.  424.518(b)(1)(xii).
    In Sec.  424.518(c)(1)(iv), which outlines providers and suppliers 
in the high-risk level of categorical screening, we are revising this 
provision to include prospective (newly enrolling) OTPs that have not 
been fully and continuously certified by SAMHSA since October 23, 2018.
    We did not receive requested public feedback on additional means of 
preventing OTP fraud, waste, and abuse from which we could consider 
future regulatory action. However, we always welcome such suggestions.
2. Revision and Addition to Denial and Revocation Reasons in Sec. Sec.  
424.530 and 424.535
a. Improper Prescribing
    Under existing Sec.  424.535(a)(14), CMS may revoke a physician's 
or other eligible professional's enrollment if he or she has a pattern 
or practice of prescribing Part D drugs that:
     Is abusive and/or represents a threat to the health and 
safety of Medicare beneficiaries; or
     Fails to meet Medicare requirements.
    This revocation reason is designed to address situations where 
prescribers of Part D drugs engaged in prescribing activities that were 
or could be harmful to Medicare beneficiaries and the Trust Funds or 
were otherwise inconsistent with Medicare policies. Since the 
provision's inception, we have revoked the enrollments of physicians 
and practitioners who have engaged in a variety of improper prescribing 
practices. However, given the nationwide opioid epidemic, we remain 
concerned about such behavior. Therefore, we proposed that Sec.  
424.535(a)(14) should no longer be restricted to Part D drugs but must 
extend to all Medicare drugs, including Part B drugs; specifically, the 
term ``Part D drugs'' in the opening paragraph of Sec.  424.535(a)(14) 
would be changed to ``Part B or D drugs.'' We noted that this proposal 
would affect prescriptions of any Part B or D drugs, not merely those 
prescriptions given to beneficiaries using OTPs.
b. Patient Harm
    As referenced previously, and due to the importance of ensuring 
patient safety in all provider and supplier settings (not merely those 
involving OTPs), we also proposed to add Sec.  424.535(a)(22) as a new 
revocation reason; this would be coupled with a concomitant new denial 
reason in Sec.  424.530(a)(15). These two paragraphs would permit us to 
revoke or deny, as applicable, a physician's or other eligible 
professional's (as that term is defined in section 1848(k)(3)(B) of the 
Act) enrollment if he or she has been subject to prior action from a 
state oversight board, federal or state health care program, 
Independent Review Organization (IRO) determination(s), or any other 
equivalent governmental body or program that oversees, regulates, or 
administers the provision of health care with underlying facts 
reflecting improper physician or other eligible professional conduct 
that led to patient harm. In determining whether a revocation or denial 
on this ground is appropriate, CMS would consider the following 
factors:
     The nature of the patient harm.
     The nature of the physician's or other eligible 
professional's conduct.
     The number and type(s) of sanctions or disciplinary 
actions that have been imposed against the physician or other eligible 
professional by a state oversight board, IRO, federal or state health 
care program, or any other equivalent governmental body or program that 
oversees, regulates, or administers the provision of health care. Such 
actions include, but are not limited to in scope or degree:
    ++ License restriction(s) pertaining to certain procedures or 
practices,
    ++ Required compliance appearances before state oversight board 
members,
    ++ Required participation in rehabilitation or mental/behavioral 
health programs,
    ++ Required abstinence from drugs or alcohol and random drug 
testing,
    ++ License restriction(s) regarding the ability to treat certain 
types of patients (for example, cannot be alone with members of a 
different gender after a sexual offense charge),
    ++ Administrative/monetary penalties, or
    ++ Formal reprimand(s).
     If applicable, the nature of the IRO determination(s).
     The number of patients impacted by the physician's or 
other eligible professional's conduct and the degree of harm thereto or 
impact upon.
     Any other information that CMS deems relevant to its 
determination.
    As noted in the proposed rule and in previous rulemaking efforts, 
we remain concerned about instances of physician or other eligible 
professional misconduct, and we believe our authority under sections 
1102, 1866(j)(1)(A), and 1871 of the Act to take action to stem such 
behavior should be expanded to include the scenarios identified in 
Sec.  424.530(a)(15) and Sec.  424.535(a)(22). State oversight boards, 
such as medical boards and other administrative bodies, have found 
certain physicians and other eligible professionals to have engaged in 
professional misconduct and/or negligent or abusive behavior involving 
patient harm. In addition, IRO determinations have offered valuable, 
independent analyses and findings of provider misconduct that we should 
have the opportunity to use to promote the best interests of Medicare 
beneficiaries. We outlined our belief that our proposed revocation and 
denial authorities would improve overall patient care by preventing 
certain problematic physicians and other eligible professionals from 
treating Medicare patients.
    We stated in the proposed rule that Sec. Sec.  424.530(a)(15) and 
424.535(a)(22) would apply to physicians and other eligible 
professionals in OTP and non-OTP settings. In addition, to clarify the 
scope of the term ``state oversight board'' in the context of 
Sec. Sec.  424.530(a)(15) and 424.535(a)(22), we

[[Page 62927]]

proposed to define this term in Sec.  424.502. Specifically, we 
proposed (for purposes of Sec. Sec.  424.530(a)(15) and 424.535(a)(22) 
only) to define ``state oversight board'' to mean any state 
administrative body or organization, such as (but not limited to) a 
medical board, licensing agency, or accreditation body, that directly 
or indirectly oversees or regulates the provision of health care within 
the state.
    We solicited comment not only on our definition of ``state 
oversight board'' but also on our proposed revocation and denial 
authorities.
c. Summary of the Public Comments on Improper Prescribing and Patient 
Harm and the CMS Responses
    We received comments concerning our improper prescribing and 
patient harm provisions from approximately 30 stakeholders. The 
comments are summarized below, followed by our responses.
    Comment: Several commenters opposed not only our proposed revision 
of Sec.  424.535(a)(14) but also the existing version of (a)(14). The 
commenters expressed concern that some types of prescribers and 
specialties would be unfairly targeted and prevented from legitimate 
prescribing. The commenters added that what may be considered excessive 
prescribing for the general population could be clinically appropriate 
given a patient's individual circumstances and conditions (particularly 
in pain management and palliative care). Other commenters stated that 
while it is important to monitor highly egregious prescribers, CMS must 
ensure that physicians who are prescribing appropriately, even at 
higher doses (beyond certain guidelines or recommended thresholds), are 
not unnecessarily sanctioned or disciplined. Erroneous sanctions, they 
claimed, could have negative impacts on patient care, deny access to 
new and innovate forms of treatment, and spur clinicians to restrict 
their prescribing practices based on potential revocation concerns.
    Response: Since the commencement of our enforcement of existing 
Sec.  424.535(a)(14), we have not targeted particular physician or 
practitioner specialties and have been extremely careful in our 
application of the criteria outlined in this provision. The commenters 
are correct that certain situations could warrant different levels of 
prescribing, and the flexibility afforded by the factors in Sec.  
424.535(a)(14) has allowed us to thoroughly consider and address such 
differing scenarios. We stress that this will not change with our 
expansion of Sec.  424.535(a)(14) to include Part B drugs.
    We have received no indication that the application of Sec.  
424.535(a)(14) has generally caused physicians and other eligible 
professionals to significantly reduce their levels of prescribing or 
caused barriers to Part D drugs. Given this, we do not foresee such 
problems with the addition of Part B drugs.
    Comment: Several commenters stated that Sec.  424.535(a)(14) 
duplicates current safety mechanisms and revocation reasons, overly 
burdens prescribers, and effectively represents CMS engaging in second-
guessing the clinical determinations of medical professionals.
    Response: We respectfully disagree. We currently have no revocation 
authority other than Sec.  424.535(a)(14) to directly address abusive 
prescribing practices. In addition, we have applied Sec.  
424.535(a)(14) very sparingly and only in demonstrably egregious 
instances of improper prescribing. Therefore, the only persons who have 
been burdened are the extremely few who have engaged in such practices, 
while the overwhelming preponderance of the remaining 2 million Part D 
prescribers have been unaffected. Also, the fact that only severe cases 
have triggered Sec.  424.535(a)(14) indicates that CMS gives great 
deference to the prescribing decisions of the provider community as a 
whole.
    Comment: Many commenters opposed our additions of Sec. Sec.  
424.530(a)(15) and 424.535(a)(22) and urged us to withdraw them. 
Commenters stated that these provisions are overly vague, do not 
furnish sufficient guidance to physicians and other eligible 
professionals as to what the expectations are, and create excessive 
uncertainty and burden for these individuals. Commenters also stated 
that Sec.  424.535(a)(22) would unfairly impose harsh and 
disproportionate sanctions on providers for potentially minor 
violations. Another commenter expressed particular concern about young 
and inexperienced physicians who could be punished by CMS for modest 
transgressions. Additional commenters stated that a Medicare revocation 
under Sec.  424.535(a)(22) would trigger an automatic Medicaid 
enrollment termination as well as termination from private payer 
programs, which could devastate the individual's medical practice.
    Commenters further stated that Sec.  424.535(a)(22) would 
negatively affect Medicare beneficiaries' access to health services 
because: (1) A revoked provider's patients would have to seek care 
elsewhere; and (2) the number of available physicians and other 
eligible professionals (including, perhaps, the group practices with 
which they are affiliated) will be unnecessarily reduced, leading to 
provider shortages. Commenters added that this could be especially 
problematic in remote and underserved areas and with specialized 
services. They stated that the patient harm that CMS seeks to deter 
could actually increase through a restriction of available care.
    Response: While we appreciate these comments, we reiterate that the 
only actions under Sec. Sec.  424.530(a)(15) and 424.535(a)(22) that 
could lead to a denial or revocation are those resulting in patient 
harm. We believe that some commenters assumed that the action itself, 
regardless of any impact on a patient, would be sufficient for CMS to 
invoke these provisions. This is incorrect. Patient harm must be a 
result. Since many determinations by state oversight boards and similar 
bodies do not involve patient harm, the physicians or other eligible 
professionals to which such determinations pertain will not be affected 
by Sec. Sec.  424.530(a)(15) and 424.535(a)(22) in any way.
    Concerning the first set of comments summarized here, we do not 
believe that Sec. Sec.  424.530(a)(15) and 424.535(a)(22) are overly 
vague or lack sufficient guidance. We outline in detail both the types 
of sanctions or actions that could invoke these provisions as well as 
the criteria that we will consider in our determinations. Although 
Sec. Sec.  424.530(a)(15) and 424.535(a)(22), like several of our other 
denial and revocation reasons, might appear to some to be more open-
ended and less clear-cut than, for example, a revocation based on the 
provider's exclusion from Medicare by the Office of Inspector General 
(OIG)(see Sec.  424.535(a)(2)), this is because of our need for 
flexibility in addressing various patient harm situations. We believe 
that Sec. Sec.  424.530(a)(15) and 424.535(a)(22) appropriately balance 
(1) the need for clarity concerning the actions that these provisions 
cover with (2) the importance of having sufficiently extensive criteria 
to ensure a fair and exhaustive review of the case. With respect to 
burden, the only physicians and other eligible professionals (out of a 
Medicare-enrolled or potentially enrolled universe of well over 2 
million) who could be impacted by these provisions are those very few 
who engage in the abusive behavior outlined therein. All other 
physicians and other eligible professionals will not be burdened.
    Regarding the second group of comments, we reiterate that the 
action must first have resulted in patient harm before CMS will even 
consider reviewing the case; without patient

[[Page 62928]]

harm, the matter is moot from the standpoint of Sec. Sec.  
424.530(a)(15) and 424.535(a)(22). We are also very cognizant of the 
relative severity of a Medicare revocation and the impact it can have 
on a physician's or other eligible professional's career, which is why 
we have historically exercised our authority under Sec.  424.535(a)'s 
revocation provisions only when the affected party's behavior is such 
that a revocation (after our thorough review of the case) is genuinely 
warranted. We intend to apply this principle to situations involving 
Sec.  424.535(a)(22). Moreover, and of paramount importance, we intend 
to invoke Sec.  424.535(a)(22) strictly in cases where the behavior in 
question (such as, but not limited to, sexual misconduct) and the 
consequent patient harm was significant in nature.
    Finally, we do not believe that Sec.  424.535(a)(22) will impair 
patient access to health care, specialized or otherwise. We have 
received few reports of access to care issues resulting from previous 
revocation action on our part under Sec.  424.535(a). Considering, as 
stated previously, that only a very small number of physicians and 
other eligible professionals would be affected by Sec.  424.535(a)(22), 
we do not foresee the latter provision creating barriers to care. 
Nonetheless, should such issues unexpectedly arise after Sec.  
424.535(a)(22)'s implementation, we will, as needed, consider 
mechanisms for resolving them.
    Comment: Several commenters stated that Sec.  424.535(a)(22) would 
discourage physicians and other eligible professionals from self-
reporting to medical boards, for they will be reluctant to disclose 
behavior (such as drug use and alcoholism) that could result in IRO or 
state action leading to a Medicare revocation. This, the commenters 
stated, makes the patient harm provision inconsistent with the 
nationwide effort to reduce the stigma associated with seeking 
treatment for substance abuse. The commenters added that Sec.  
424.535(a)(22) could also have a negative effect on medical boards' 
willingness to discipline individuals (or could otherwise affect their 
decisions) because doing so could invoke Sec.  424.535(a)(22). While 
remaining opposed to the provision, the commenters urged CMS to, at a 
minimum, narrow its scope to avoid targeting individuals engaged in 
mental/behavioral health and/or substance use disorder treatment and 
monitoring with their state physician health programs.
    Response: We appreciate and understand the commenters' concerns. We 
do not wish to discourage physicians and other eligible professionals 
from seeking whatever help they may need. Accordingly, we will remove 
the following criteria from Sec. Sec.  424.530(a)(15) and 
424.535(a)(22):
     Required participation in rehabilitation or mental/
behavioral health programs.
     Required abstinence from drugs or alcohol and random drug 
testing.
    We will also add a new paragraph to Sec. Sec.  424.530(a)(15) and 
424.535(a)(22) that specifically excludes these actions from the 
provisions' purviews. However, we note that the action or order must be 
restricted to required participation in a rehabilitation or mental/
behavioral health program or abstinence from drugs or alcohol and 
random drug testing. If the action involves either of these directives 
as well as an additional sanction that involves patient harm, the 
latter (but not the rehabilitation, abstinence, or testing portion of 
the directive) could invoke Sec.  424.530(a)(15) or Sec.  
424.535(a)(22).
    To illustrate how this change would apply, consider the following 
examples:

    Example 1-- In a case involving patient harm, a state oversight 
board requires Dr. X to enter a rehabilitation program. There are no 
other sanctions in the state's order. Since the state's action is 
restricted exclusively to rehabilitation, Sec.  424.530(a)(15) or 
Sec.  424.535(a)(22) would not apply.
    Example 2-- In a case not involving patient harm, a state 
oversight board issues a decision pertaining to Dr. X that: (1) 
Requires him to enter a rehabilitation program; and (2) imposes a 
fine on him. Sections 424.530(a)(15) and 424.535(a)(22) would not 
apply in any event because no patient harm was present.
    Example 3-- In a case involving patient harm, a state oversight 
board issues a decision pertaining to Dr. X that: (1) Requires him 
to enter a rehabilitation program; and (2) restricts his license for 
a 60-day period due to sexual misconduct. CMS would consider the 
board decision under Sec. Sec.  424.530(a)(15) and 424.535(a)(22), 
as applicable, because of the license restriction based on sexual 
misconduct.

    This change, in our view, will help reassure physicians and other 
eligible professionals that they can seek the assistance they require 
without concern that their rehabilitation and treatment efforts would 
be penalized under Sec. Sec.  424.530(a)(15) and 424.535(a)(22). It 
will balance this very important need with our belief that other 
actions within the state oversight board's directive could warrant 
consideration under Sec. Sec.  424.530(a)(15) and 424.535(a)(22).
    Comment: Numerous commenters stated that the patient harm 
provisions fail to focus on identifying and addressing demonstrably 
problematic providers and suppliers. For this reason alone, the 
commenters stated that: (1) The provisions should be withdrawn; and (2) 
CMS should instead adopt other means of identifying and disciplining 
such parties. If CMS decides to finalize Sec. Sec.  424.530(a)(15) and 
424.535(a)(22), the commenters urged CMS to take a much more targeted 
approach by, for instance, restricting the provisions to physicians and 
other eligible professionals who are identified as outliers (or 
otherwise higher-risk) through data analytics.
    Response: We believe that our previously mentioned restriction of 
Sec. Sec.  424.530(a)(15) and 424.535(a)(22) to egregious behavior are 
consistent with the commenters' recommendation to focus on outlier 
behavior. The overwhelming preponderance of physicians and other 
eligible professionals have not had a serious (nor, for that matter, 
any) state oversight board action. Those who have, we believe, could be 
considered outliers in terms of the volume and degree of professional 
misconduct.
    Comment: Several commenters requested that CMS furnish evidence 
showing a correlation between disciplinary actions taken (or not taken) 
by state oversight boards and fraud, abuse, and/or beneficiary harm in 
the Medicare program.
    Response: It has been our experience throughout the years that 
instances of problematic Medicare provider behavior detected at the 
state or federal level can pose, and have posed, threats to the 
Medicare program, the Trust Funds, and beneficiaries. Indeed, we have 
come across a number of such cases. In one situation, for example, a 
physician was placed on probation, fined, and suspended by the state 
board after multiple accusations by his patients for sexual assault. 
However, he was permitted to maintain his medical license, during which 
period he continued to sexually assault additional patients. It was not 
until multiple years after the initial fine and probation period that 
the state finally revoked his medical license, and it was only after 
this license action that CMS was able to revoke the physician's 
Medicare enrollment. However, with our new patient harm provisions, CMS 
could have taken immediate action based on the initial probation, fine, 
and suspension, thus perhaps avoiding the subsequent patient abuse that 
occurred.
    Comment: Several commenters stated that CMS did not articulate 
clear standards for how it will determine (based on its assessment of 
the proposed factors) whether there are sufficient grounds to invoke 
Sec. Sec.  424.530(a)(15) and 424.535(a)(22). The commenters added that 
the factor in each provision

[[Page 62929]]

concerning CMS' consideration of other relevant information gives CMS 
overly broad authority in making enrollment decisions.
    Response: We disagree that these provisions lack standards 
indicating how CMS will review cases thereunder. We clearly outline the 
criteria we will consider in our determinations. If the commenter is 
suggesting that each factor should contain definitive benchmarks, such 
as a minimum number of patients who were harmed by the conduct in 
question, we respectfully do not concur. As we have stated and several 
commenters have noted, every situation is different. We must have the 
discretion to fairly and fully consider the specific facts and 
circumstances involved. To establish firm thresholds could allow an 
individual who is repeatedly engaging in abusive behavior to avoid a 
denial or revocation because (using our previous example) he or she did 
not harm a certain number of patients. Such a result would be 
inconsistent with our obligation to protect the Medicare program and 
its beneficiaries.
    Nonetheless, we recognize the commenters' concerns regarding the 
factor involving our consideration of any other information we deem 
relevant. To provide greater clarity to affected physicians and other 
eligible professionals concerning the bases of our Sec. Sec.  
424.530(a)(15) and 424.535(a)(22) determinations, we will remove this 
factor from both provisions. However, we emphasize that this will not 
affect our continued inclusion of this same factor in several of our 
existing denial and revocation reasons. Nor are we precluding its use 
in possible future provisions. It is only due to the unique 
circumstances and potential fact patterns associated with our patient 
harm provisions that the criterion in question is being removed.
    Comment: One commenter stated that a physician or other eligible 
professional, as well as his co-workers and fellow providers, might 
prove reluctant to report his or her medical errors due to fear of a 
possible enrollment revocation. This commenter stated that this makes 
the entire health system less safe for Medicare beneficiaries.
    Response: We understand the commenter's concern. However, we 
believe that our restriction of Sec. Sec.  424.530(a)(15) and 
424.535(a)(22) to significant cases of patient harm will avoid the 
situation the commenter contemplates.
    Comment: Several commenters expressed concern that CMS did not 
formally define or clarify the meaning and scope of the term ``patient 
harm.'' The commenters stated that it would be inappropriate for CMS to 
deny or revoke enrollment without the provider understanding CMS' 
interpretation of the term. They urged CMS to be much more specific on 
what would qualify as patient harm and to explain how it would make 
patient harm determinations.
    Response: Concerning the commenters' second request, we previously 
indicated that in making determinations under the patient harm 
provisions, we will consider all of the specified factors as well as 
the totality of the circumstances. This will include a close and 
thorough analysis of the nature and degree of the patient harm. As for 
formally and officially defining the latter term in regulation, we 
believe the meaning of the term ``patient harm is self-evident, in that 
it involves some form of physical and/or psychological injury to the 
patient.
    Comment: Several commenters stated that patient harm and certain 
types of sanctions could occur through no fault of the provider and/or 
via an innocent error. Commenters cited instances where misleading or 
erroneous complaints were from irate or dissatisfied patients and their 
families or caregivers. To illustrate, an individual might: (1) 
Disagree with his physician's medically appropriate decision not to 
prescribe a certain medication; or (2) misunderstand the relative risks 
and benefits of a treatment as correctly communicated by the physician. 
The commenters stated that, in proposing its patient harm provisions, 
CMS overlooked the potential for such situations and the devastating 
consequences for innocent medical practitioners. One commenter stated 
that a better barometer of misconduct would be an intent to cause harm.
    Response: We recognize the potential for erroneous or unfounded 
complaints. We believe that many of these will be detected as such and 
appropriately dismissed at the state oversight board level, in which 
case Sec. Sec.  424.530(a)(15) and 424.535(a)(22) would not apply. As 
for restricting these provisions to instances of intentional patient 
harm, we disagree. Our overriding concern is with the harm itself, 
irrespective of whether it stemmed from the provider's willful 
misconduct, negligence, or other state of mind.
    Comment: Several commenters cited our statement in the proposed 
rule that modest sanctions would not automatically result in a 
revocation. They stated that the regulatory text does not include this 
language but only lists the factors that CMS would consider in its 
determinations. The commenters stated that an informal preamble 
statement does not furnish sufficient certainty to providers and 
creates the potential for arbitrary CMS decisions. The commenters also 
stated that this preamble language should be codified in the regulatory 
text. Additional commenters stated that CMS should define or more 
thoroughly identify what constitutes a modest sanction.
    Response: The language to which the commenters refer was simply 
background information designed to reassure stakeholders that not every 
case will result in a revocation. Such informal statements are 
typically not suitable for (and not included in) regulatory text and 
are more appropriately contained in the preamble. Furthermore, our 
discussions throughout this final rule should make clear that Sec.  
424.535(a)(22) will be applied: (1) With great care and circumspection; 
(2) in a non-arbitrary manner; (3) infrequently; and (4) only when the 
conduct and resulting patient harm were significant in nature.
    We respectfully decline to formally define or specify what 
constitutes a modest sanction versus, for instance, a non-modest 
sanction. The types of possible state oversight board orders and 
sanctions are many and varied. To identify them and then classify each 
one as either modest or not would, we believe, give an erroneous 
impression that certain groups of sanctions related to patient harm 
would always, would never, or only sometimes result in specific CMS 
decisions. All cases and actions are different, and, as already stated, 
we must preserve our flexibility in considering each of them on their 
own facts and merits.
    Comment: Several commenters stated that the list of sanctions that 
could trigger Sec. Sec.  424.530(a)(15) and 424.535(a)(22) (for 
example, license restrictions) are not necessarily indicative of 
patient harm.
    Response: We agree with these commenters, which is why we again 
reiterate that only those actions involving serious misconduct and 
patient harm could invoke Sec. Sec.  424.530(a)(15) and 424.535(a)(22).
    Comment: Several commenters stated that CMS does not have the 
statutory authority for Sec. Sec.  424.530(a)(15) and 424.535(a)(22). 
They noted that CMS relies in part on sections 1102 and 1871 of the Act 
as authority for these new provisions. (Sections 1102 and 1871 of the 
Act furnish general authority for our establishment of these 
requirements, which are designed for the efficient administration of 
the Medicare program.) The commenters stated that

[[Page 62930]]

Sec. Sec.  424.530(a)(15) and 424.535(a)(22) are not necessary to 
efficiently run the Medicare program; rather, by potentially 
interrupting care to Medicare beneficiaries, these provisions could 
lead to a more inefficient Medicare program. Second, the commenters 
noted that section 1866(j)(1)(A) of the Act requires the Secretary to 
establish an enrollment process for providers and suppliers. The 
commenters stated that this statute lists several components (for 
example, the establishment of temporary enrollment moratoria) that must 
be part of this process. None of these, however, include the denial and 
revocation of enrollment and certainly not on the grounds articulated 
in Sec. Sec.  424.530(a)(15) and 424.535(a)(22). The commenters further 
stated that section 1866(j)(2) of the Act, which describes required and 
optional elements of the provider enrollment screening process, does 
not address denials and revocations. Accordingly, the commenters 
asserted that CMS cannot rely upon section 1866(j)(1)(A) (or, for that 
matter, sections 1102 and 1871) as authority for Sec. Sec.  
424.530(a)(15) and 424.535(a)(22) and must therefore withdraw these two 
proposed regulatory provisions.
    Response: We disagree with the commenters. In previously 
establishing a significant number of our denial and revocation reasons 
under Sec. Sec.  424.530(a) and 424.535(a), we interpreted the term 
``efficient administration'' as giving CMS authority under sections 
1102 and 1871 of the Act to take steps to safeguard the integrity of 
the Medicare program and to protect beneficiaries, an interpretation 
that we believe also permits us to finalize Sec. Sec.  424.530(a)(15) 
and 424.535(a)(22). These regulations are needed to address the 
numerous enrollment scenarios involving problematic providers that can 
arise (and have arisen) over the course of our administration of the 
program.
    With respect to section 1866(j)(1)(A) of the Act, we have never 
viewed the provider enrollment process as being restricted to the steps 
involved in screening initial applicants. The process consists of much 
more than that, including, but not limited to, ensuring that an 
enrolled provider or supplier maintains compliance with all applicable 
Medicare policies. The same is true concerning section 1866(j)(2) of 
the Act. Provider enrollment screening continues after a provider or 
supplier is enrolled in the form of, for example, the revalidation 
process under Sec.  424.515 (which helps confirm whether an enrolled 
provider still meets all Medicare requirements) and monthly checks 
against the OIG's List of Excluded Individuals and Entities. It is not 
limited to the screening of initial applicants. Section 1866(j)(2)(D) 
of the Act, in other words, discusses both the screening of currently 
enrolled providers and suppliers and the screening of providers and 
suppliers as they periodically revalidate their enrollment. In summary, 
we respectfully do not believe that sections 1866(j)(1)(A) and 
1866(j)(2) of the Act become inapplicable once a provider is enrolled.
    We also disagree that sections 1102 and 1871 of the Act do not 
permit CMS to establish revocation authorities, especially regarding 
patient harm. Were we to accept this contention, enrolled providers and 
suppliers could engage in egregious behavior without fear of 
repercussions because CMS would have no authority to remove them from 
Medicare. We do not believe that Congress, in enacting these statutes, 
intended such a result.
    Comment: Several commenters stated that Sec.  424.535(a)(22) does 
not include any criteria or process by which CMS would determine when 
it would revoke enrollment, thus raising the potential for arbitrary 
decisions. For example, the commenters stated that: (1) Physicians with 
similar actions taken against them could be treated differently; and 
(2) state medical statutes and medical board review standards vary 
considerably. The commenters stated that treating all activities as 
being similar is inappropriate.
    Response: We disagree that Sec.  424.535(a)(22) lacks appropriate 
criteria. To the contrary, and as stated previously, both Sec. Sec.  
424.530(a)(15) and 424.535(a)(22) list specific factors that CMS must 
consider in its determinations. The factors account for our recognition 
that all cases, state oversight boards, and statutes are indeed 
different while furnishing enough clarity to help ensure that 
relatively similar cases are handled in as uniform a manner as 
possible.
    Comment: Numerous commenters stated that state oversight boards, 
not the federal government, are the appropriate entities for monitoring 
and disciplining physicians and, if warranted, restricting their 
authority to treat patients. The commenters stated that the proper 
punishment for physicians who have violated the law is to take action 
against his or her license; if the state upholds his or her right to 
practice, he or she should be allowed to remain enrolled in Medicare 
assuming all other program requirements are met. The commenters added 
that the patient harm provisions: (1) Represent an unprecedented 
overreach of the federal government's authority; (2) constitute an 
unwarranted intrusion into matters best left to states; (3) 
inappropriately substitute CMS' lack of clinical expertise for the 
expertise of the state oversight board's medical professionals; and (4) 
involve a mere after-the-fact desk review of the state oversight 
board's well-informed decisions. Several other commenters stated that 
our statement in the proposed rule that CMS (rather than state 
oversight boards) is ultimately responsible for the protection of 
Medicare beneficiaries is inaccurate; instead, the commenters stated, 
state oversight boards are responsible for ensuring the health, safety, 
and welfare of the state's residents (which include Medicare 
beneficiaries) through the enforcement of laws governing health care 
providers.
    Response: We certainly recognize and appreciate the very crucial 
role that state oversight boards perform in protecting the health of 
patients, enforcing medical laws, and overseeing physician and 
practitioner care. However, we do not believe these functions are 
exclusive to states. CMS indeed has oversight responsibility for the 
Medicare program, and this includes safeguarding the welfare of 
individuals who receive benefits under this program. State review of 
licensed physicians and other eligible professionals is a function 
entirely different from the federal government's administration of 
Medicare. Given this, we respectfully submit that CMS is not and should 
not be prohibited from taking action against a Medicare provider merely 
because the state oversight board may disagree with such action. That 
is, while we generally give great deference to state oversight boards 
and their judgments, there could be instances where CMS, in its 
oversight of Medicare, feels compelled to review a matter potentially 
impacting the Trust Funds and those beneficiaries whose health care is 
covered thereby. This overriding principle, rather than any desire to 
interfere with or usurp the decisions of state oversight boards, lies 
behind our patient harm provisions.
    Comment: A number of commenters expressed concern that our proposed 
patient harm provisions were discussed in a section of the proposed 
rule that also discussed OTP enrollment. The commenters stated that 
many provider organizations: (1) Were unaware of the provisions' 
presence; or (2) might believe that the provisions only applied to OTP 
physicians or other eligible professionals, rather than to all types of 
physicians and other eligible professionals or only to high-risk 
providers. Another commenter stated

[[Page 62931]]

that CMS should accordingly withdraw these provisions and re-propose 
them in a stand-alone rule to ensure an adequate opportunity for notice 
and comment. An additional commenter requested that CMS delay these 
provisions until it works with the provider community to help the 
latter understand the provisions' full implications.
    Response: Considering that Sec. Sec.  424.530(a)(15) and 
424.535(a)(22) are enrollment provisions, we maintain that grouping 
these provisions with those pertaining to OTP enrollment was the most 
sensible approach. We note that the titles of both the rule and the 
enrollment subsection clearly indicated that enrollment policies 
pertaining to patient harm were included therein. We also explicitly 
stated that the patient harm provisions applied to all types of 
physicians and other eligible professionals (not merely those 
associated with OTPs) and gave no indication that the provisions were 
limited to high-risk providers. Given the number of comments we 
received on Sec. Sec.  424.530(a)(15) and 424.535(a)(22), we believe 
that sufficient public notice was furnished regarding these provisions.
    Comment: One commenter stated that the list of possible actions 
against a physician that potentially fall under Sec. Sec.  
424.530(a)(15) and 424.535(a)(22) is extensive. The commenter 
questioned how these actions would be used or weighted in CMS' 
determination.
    Response: As previously mentioned, the particular action will be 
considered through CMS' analysis of the factors in Sec. Sec.  
424.530(a)(15) and 424.535(a)(22).
    Comment: Several commenters requested clarification as to whether: 
(1) CMS or the MAC would make Sec.  424.535(a)(22) revocation 
determinations; and (2) the affected physician or other eligible 
professional will be able to review the case. The commenters expressed 
concern that CMS would take action under the patient harm provisions 
without reviewing the underlying evidence or analysis regarding the 
prior action or having sufficient data to make a fair and thorough 
determination; such information, the commenters stated, would include, 
but not be limited to, the genesis of the complaint, the veracity of 
the allegations, and the rationale for (and deliberations involved in) 
the state's decision or the reasoning behind any settlement. To avoid 
this prospect, the commenters recommended that some form of due process 
be considered before enrollment is denied or revoked; this would help 
ensure that CMS has all the facts and circumstances available. For 
instance, they noted that state oversight boards permit the physician 
or practitioner to offer rebuttal evidence and to respond to the 
proposed adverse action before the board renders its decision. Stating 
that CMS did not articulate a clear or adequate appeals process that 
ensures fairness for the provider, the commenters asserted that CMS 
should adopt the process outlined in the previous sentence.
    Response: CMS, rather than an applicable CMS contractor, will 
typically make Sec. Sec.  424.530(a)(15) and 424.535(a)(22) 
determinations. Yet, we do not exclude the possibility that an 
applicable CMS contractor could make a denial or revocation 
determination under Sec. Sec.  424.530(a)(15) and 424.535(a)(22), 
respectively.
    Appeal rights under part 498 will be provided. However, as with all 
other revocations under Sec.  424.535, the affected physician or other 
eligible professional will be unable to review the case during our 
determination process. The reason for this longstanding policy is that 
we must be able to take prompt action, using our independent judgment, 
to halt potential threats to Medicare patients and the Trust Funds. We 
see no reason to exempt Sec.  424.535(a)(22) situations from this 
practice. Merely because the grounds for revocation under Sec.  
424.535(a)(22) are different from those in other revocation reasons 
does not require that the affected party be able to formally review, 
comment on, and contest its potential Sec.  424.535(a)(22) revocation 
before CMS is able to render a decision; indeed, instances of patient 
harm can represent a particularly serious danger to Medicare 
beneficiaries, thus requiring rapid measures on our part. We also 
reiterate that CMS is a federal agency and, as such, is not bound to 
utilize the same administrative processes and mechanisms that state 
oversight boards do.
    Insofar as the risk of an insufficient record, CMS in all 
revocation cases ensures that it has enough information on hand to make 
a fair and well-informed determination. Such will be so with Sec.  
424.535(a)(22), too.
    Comment: Several commenters stated that the patient harm provisions 
partially duplicate CMS' existing revocation authorities, such as, but 
not limited to: (1) Sec.  424.535(a)(21), which permits revocation if a 
physician or other eligible professional has a pattern or practice of 
abusive ordering, certifying, referring, or prescribing that threatens 
the health and safety of Medicare beneficiaries; and (2) CMS' ability 
to revoke enrollment if the individual's medical license is revoked. 
The commenters stated that CMS should rely on these authorities, which 
already protect against egregious behavior, rather than finalize the 
patient harm provisions. The commenters added that if CMS believes it 
needs additional revocation authority to address specific behaviors, it 
should articulate those behaviors and propose a revocation reason that 
is appropriately defined and specifically targeted.
    Response: We do not believe that Sec. Sec.  424.530(a)(15) and 
424.535(a)(22) duplicate our existing revocation authorities, for we 
currently have no provision that directly and specifically addresses 
and targets demonstrated cases of patient harm. Thus, we believe that 
Sec. Sec.  424.530(a)(15) and 424.535(a)(22) are necessary.
    Comment: While asserting that CMS should withdraw its patient harm 
provisions and instead work with industry stakeholders on solutions to 
its concerns, several commenters recommended that CMS at least consult 
state licensure boards, medical professional groups, and hospitals 
before finalizing its criteria. This would help ensure that the latter 
are applied in a fair and consistent fashion.
    Response: We respectfully decline to delay finalization of these 
provisions. We believe they are needed for the reasons described 
previously in this rule. Nonetheless, we always welcome feedback from 
provider organizations and would be pleased, after this rule is 
published, to hear any remaining concerns they may have.
    Comment: Several commenters sought clarification as to whether CMS 
will only consider those actions that have been fully adjudicated and 
complete, or also those still in progress. The commenters recommended 
the former approach.
    Response: CMS will be able to take action under Sec.  
424.530(a)(15) or Sec.  424.535(a)(22), as applicable, once a state 
oversight board reports a particular action or order pertaining to 
patient harm that CMS determines warrants denial or revocation action. 
However, if the action or order is later overturned, CMS will take 
reciprocal action, as appropriate, and rescind the denial or 
revocation.
    Comment: Concerning our proposed definition of ``state oversight 
board'' in Sec.  424.502, one commenter stated that regulatory boards 
exist for a variety of health professions and are not limited to 
medical boards. The commenter indicated that a more inclusive term than 
``state oversight board'' would be, for example, ``regulatory board,'' 
``state regulatory board,'' or ``state licensing board.''

[[Page 62932]]

    Response: We recognize that different types of regulatory boards 
exist for multiple health professions. While we appreciate the 
commenter's suggested edits, we believe that the term ``state oversight 
board'' is broad enough to cover the variety of administrative bodies 
to which the commenter refers.
    Comment: A commenter stated that a state-level action or IRO 
determination that occurred may not have any relation to a physician's 
or other eligible professional's participation in Medicare.
    Response: If we are correctly understanding the commenter's 
contention, it is indeed possible that the action or IRO determination 
in question may not have involved the physician's or other eligible 
professional's treatment of a Medicare patient. However, if the 
physician or other eligible professional is enrolling or enrolled in 
Medicare, we believe we have an obligation to consider the potential 
impact on Medicare beneficiaries of the patient harm that lay behind 
the state action or IRO determination.
    We also received a miscellaneous comment pertaining to the opt-out 
provisions covered in 42 CFR part 405, subpart D:
    Comment: A commenter requested that CMS revise and revoke the 
requirements in, respectively, Sec.  405.415(h) and (o) that state that 
private contracts between Medicare patients and physicians who have 
opted-out of Medicare must be re-signed every 2 years. The commenter 
stated that patients and physicians should have the flexibility to 
agree upon any mutually desired contract length. The commenter added 
that these contracts should be allowed to remain in effect as long as 
the physician remains opted-out of Medicare. These requested changes, 
the commenter stated, would reduce physician burden and eliminate 
confusion regarding the requirements in question.
    Response: We appreciate this comment but believe it is outside the 
scope of this rule.
d. Final Improper Prescribing and Patient Harm Provisions
    After reviewing the comments received, we are finalizing our 
proposed change to Sec.  424.535(a)(14) and our proposed definition of 
``state oversight board.'' For Sec. Sec.  424.530(a)(15) and 
424.535(a)(22), we are finalizing these provisions with the following 
exceptions:
     We are removing the following criteria from these 
provisions:
    ++ Required participation in rehabilitation or mental/behavioral 
health programs.
    ++ Required abstinence from drugs or alcohol and random drug 
testing.
     We are adding new paragraphs to these provisions that 
exclude from consideration those actions and orders restricted to: (1) 
Required participation in rehabilitation or mental/behavioral health 
programs; or (2) required abstinence from drugs or alcohol and random 
drug testing.
     We are also removing the criterion that reads: ``Any other 
information that CMS deems relevant to its determination.''
    In addition, the introductory amendatory language for the proposed 
regulatory text for Sec.  424.530(a)(15) stated, in part, that Sec.  
424.530(a)(12), (13), and (14) were being reserved. Similar 
introductory amendatory language for proposed Sec.  424.535(a)(22) 
stated that Sec.  424.535(a)(17) through (21) were being reserved. 
These statements are no longer applicable. The provisions in question 
are not being reserved. Therefore, we are removing these references. 
The only amendment to Sec.  424.530 is the addition of paragraph 
(a)(15); the lone amendment to Sec.  424.535 is the addition of 
paragraph (a)(22).

I. Deferring to State Scope of Practice Requirements

    When the Medicare program was signed into law in 1965, most skilled 
medical professional services in the United States were provided by 
physicians, with the assistance of nurses. Over the decades, the 
medical professional field has diversified and allowed for a wider 
range of certifications and specialties, including the establishment of 
mid-level practitioners such as nurse practitioners (NPs) and physician 
assistants (PAs). These practitioners are also known as advanced 
practice providers (APPs) or nonphysician practitioners (NPPs). 
Medicare policies and regulations have been updated over recent years 
to allow APPs or NPPs to provide services in Medicare-certified 
facilities within the extent of their scope of practice as defined by 
state law. In recognition of the qualifications of these practitioners, 
we seek to continue this effort.
1. Ambulatory Surgical Centers
a. Background
    Ambulatory surgical centers (ASCs), as defined at 42 CFR 416.2, are 
distinct entities that operate exclusively for the purpose of providing 
surgical services to patients not requiring hospitalization, in which 
the expected duration of services would not exceed 24 hours following 
admission. The surgical services performed at ASCs are scheduled, 
primarily elective, non-life-threatening procedures that can be safely 
performed in an outpatient setting. Currently, there are approximately 
5,800 Medicare certified ASCs in the United States.
    Section 1832(a)(2)(F)(i) of the Act specifies that ASCs must meet 
health, safety, and other requirements specified by the Secretary in 
order to participate in Medicare. The Secretary is responsible for 
ensuring that the ASC Conditions for Coverage (CfCs) protect the health 
and safety of all individuals treated by ASCs, whether they are 
Medicare beneficiaries or other patients. The ASC regulations were 
established in the ``Medicare Program; Ambulatory Surgical Services'' 
final rule published in the August 5, 1982 Federal Register (47 FR 
34082), and have since been amended several times.
    The regulations for Medicare and Medicaid participating ASCs are 
set forth at 42 CFR part 416. Section 416.42, ``Condition for coverage-
Surgical services'', states that surgical procedures must be performed 
in a safe manner by qualified physicians who have been granted clinical 
privileges by the governing body of the ASC in accordance with approved 
policies and procedures of the ASC.
    Currently, the ASC CfCs have two conditions that include patient 
assessment requirements for patients having surgery in an ASC, those 
are anesthetic risk and pre-surgery evaluation, and pre-discharge 
evaluation. In the November 18, 2008 final rule, ``Medicare Program; 
Changes to the Hospital Outpatient Prospective Payment System and CY 
2009 Payment Rates final rule (73 FR 68502), we revised some existing 
standards and created some new requirements. One of the new conditions 
added in 2008 was Sec.  416.52, ``Conditions for coverage--Patient 
admission, assessment and discharge''. This condition sets standards 
pertaining to patient pre-surgical assessment, post-surgical 
assessment, and discharge requirements that must be met before patients 
leave the ASC. Specifically, the discharge requirements at Sec.  
416.52(b)(1) require that a post-surgical assessment be completed by a 
physician, or other qualified practitioner, or a registered nurse with, 
at a minimum, post-operative care experience in accordance with 
applicable state health and safety laws, standards of practice, and ASC 
policy. The other discharge condition, at Sec.  416.42(a)(2), also 
finalized in the November 18, 2008 final rule, allows anesthetists, in 
addition to physicians, to evaluate each patient for proper anesthesia 
recovery. The requirement at

[[Page 62933]]

Sec.  416.42(a)(1) requires a physician to examine the patient 
immediately before surgery to evaluate the risk of anesthesia and the 
procedure to be performed.
    Through various inquiries from ASCs and communication with CMS by 
industry associations, we have received many requests to align the 
anesthetic risk and pre-surgery evaluation standard at Sec.  
416.42(a)(1) with the pre-discharge standard at Sec.  416.42(a)(2) by 
allowing an anesthetist, in addition to a physician, to examine the 
patient immediately before surgery to evaluate the risk of anesthesia 
and the risk of the procedure. For those ASCs that utilize non-
physician anesthetists, also known as certified registered nurse 
anesthetists (CRNAs), this revision would allow them to perform the 
anesthetic risk and evaluation on the patient they are anesthetizing 
for the procedure to be performed by the physician. CRNAs are advanced 
practice registered nurses who administer more than 43 million 
anesthetics to patients each year in the United States. CRNAs are 
Medicare Part B providers and since 1989, have billed Medicare directly 
for 100 percent of the PFS amount for services. CRNAs provide 
anesthesia for a wide variety of surgical cases and in some states are 
the sole anesthesia providers in most rural hospitals. A study 
published by Nursing Economic$ in May/June 2010, found that CRNAs 
acting as the sole anesthesia provider are the most cost-effective 
model for anesthesia delivery, and there is no measureable difference 
in the quality of care between CRNAs and other anesthesia providers or 
by anesthesia delivery model.\105\ We believe this alignment provides 
for continuity of care for the patient and allows the patient's 
anesthesia professional to have familiarity with the patient's health 
characteristics and medical history.
---------------------------------------------------------------------------

    \105\ Paul F. Hogan et. al, ``Cost Effectiveness Analysis of 
Anesthesia Providers.'' Nursing Economic$. 2010; 28:159-169.
---------------------------------------------------------------------------

b. Provisions
    We proposed to revise Sec.  416.42(a), Surgical services, to allow 
either a physician or an anesthetist, as defined at Sec.  410.69(b), to 
examine the patient immediately before surgery to evaluate the risk of 
anesthesia and the risk of the procedure to be performed. By amending 
the CfCs to allow an anesthetist or a physician to examine and evaluate 
the patient before surgery for anesthesia risk and the planned 
procedure risk, we will be allowing ASC patient evaluations to be more 
consistent by using the option for the same clinician to complete both 
pre- and post-procedure anesthesia evaluations.
    This change is a continuation of our efforts to reduce regulatory 
burden. It will increase supplier flexibility and reduce burden, while 
allowing qualified clinicians to focus on providing high-quality 
healthcare to their patients. We also requested comments and 
suggestions for other ASC requirements that could be revised to allow 
greater flexibility in the use of NPPs, and reduce burden while 
maintaining high quality health care.
    We received approximately 4,000 public comments on the proposed ASC 
requirements to allow CRNAs to perform pre-surgical patient evaluations 
and other potential revisions that could allow greater flexibility in 
the use of NPPs, and reduce burden while maintaining high quality 
health care. Commenters included healthcare industry associations, 
clinician associations, individual ASCs and clinicians, and the vast 
majority of comments were form letters. The following is a summary of 
the comments we received and our responses.
    Comment: The comments addressing the proposed regulatory change to 
allow either a physician or an anesthetist to examine the patient 
immediately before surgery to evaluate the risk of anesthesia and of 
the procedure to be performed were split between support and 
opposition. However, the majority of commenters supported the change to 
allow anesthetists, in addition to physicians, to evaluate patients 
before surgery for anesthesia risk. The commenters supporting the 
proposed option for an anesthetist noted the change would reduce 
burden, reduce healthcare costs, align the pre-surgical anesthetic 
evaluation with the post-surgical evaluation standard, and better 
enable the patient's anesthesia professional to have familiarity with 
the patient's health characteristics and medical history. The 
commenters noted that in many facilities, CRNAs may be the only 
anesthesia providers. In addition, the support comments were 
predominantly silent in addressing the risk evaluation of the planned 
surgical procedure. The commenters that opposed the addition of an 
anesthetist stated they believe it would jeopardize the safety of 
patients, that only physicians possess the medical background to assess 
the patient in an objective, evidence-based and patient-centric way, 
and that nurse anesthetist training is limited to anesthesia care 
delivery, not risk assessment, diagnosis, or medical decision making 
outside the scope of an anesthetic.
    Other commenters agreed with the proposed change to allow an 
anesthetist to complete the pre-surgical evaluation to align the pre 
and post-surgical evaluation standards and further suggested 
modifications to the proposed regulation text to clarify the roles of 
the anesthetist and the physician in the pre-surgical evaluation 
standard. They suggested a modification to the text that would clarify 
the anesthesia provider pre-surgical anesthesia evaluation 
responsibilities and the pre-surgical evaluation by the physician to 
determine the patient's capability to undergo the procedure safely.
    Response: Based on the comments we received, it seems commenters 
are addressing two specific, separate patient risk evaluations in the 
proposed Sec.  416.42(a)(1). The majority of commenters agreed with the 
proposed change to allow anesthetists the ability to conduct the pre-
surgical anesthesia risk evaluation. The commenters who opposed the 
change stated that the evaluation of the patient's ability to tolerate 
the overall procedure should remain with the physician, and we also 
agree. We believe it is beneficial and appropriate to clarify in 
regulation text the separate evaluations and who must be responsible 
for them. The commenters supporting the proposed change primarily 
address the anesthetists' ability to perform the anesthesia risk pre-
surgical assessment, aligning with the post-surgical anesthesia 
evaluation required by regulations that currently allow a physician or 
an anesthetist as defined at Sec.  410.69(b). Additional evidence 
regarding anesthesia safety was published in an August 2010 research 
study in Health Affairs that reported findings showing no differences 
in patient outcomes when anesthesia services are provided by CRNAs, 
physicians, or CRNAs supervised by physicians.\106\ Two additional 
research articles, studying anesthesia complications and safety, also 
found no differences in care between nurse anesthetists and physician 
anesthesiologists.107 108
---------------------------------------------------------------------------

    \106\ B. Dulisse and J. Cromwell, ``No Harm Found When Nurse 
Anesthetists Work Without Physician Supervision.'' Health Affairs. 
2010; 29: 1469-1475.
    \107\ Lewis SR, Nicholson A, Smith AF, Alderson P. Physician 
anesthetists versus non-physician providers of anesthesia for 
surgical patients. Cochrane Database of Systematic Reviews 2014, 
Issue 7. Art. No.: CD010357.
    \108\ Negusa B et al. Scope of practice laws and anesthesia 
complications: No measurable impact of certified registered nurse 
anesthetists expanded scope of practice on anesthesia-related 
complications. Medical Care June 2016, http://journals.laww.com/lww-medicalcare/Abstract/publishahead/ScopeofPracticeLawsandAnesthesia.98905.aspx.

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

[[Page 62934]]

    We believe the physician is the appropriate practitioner to perform 
the clinical assessment for the overall procedure, taking into account 
underlying patient comorbidities and all aspects of the surgical 
procedure to be performed to ensure a successful and optimal outcome of 
the planned procedure in an ASC setting. The physician or anesthetist, 
in tandem with the physician evaluating the procedure to be performed, 
would be evaluating the risk of anesthesia and the ability for the 
patient to tolerate the planned level of anesthesia.
    Based on comments we received, we are modifying the proposed change 
at Sec.  416.42(a)(1) to clarify that there are two components to any 
pre-procedure evaluation and require that, immediately before surgery, 
a physician must examine the patient to evaluate the risk of the 
procedure to be performed, and a physician or anesthetist must examine 
the patient to evaluate the risk of anesthesia. A physician may perform 
both parts of the pre-procedure evaluation. As noted in the proposed 
rule, we believe this change to the pre-surgical patient anesthetic 
risk evaluation provides alignment within the regulations, continuity 
of care for the patient, and better ensures the patient's anesthesia 
professional's familiarity with the patient's health characteristics 
and medical history. It will also reduce burden on ASCs by allowing 
additional members of the medical team to conduct pre-surgical 
anesthesia evaluations.
2. Hospice
a. Background
    Hospice care is a comprehensive, holistic approach to treatment 
that recognizes the impending death of a terminally ill individual, and 
warrants a change in the focus from curative care to palliative care 
for relief of pain and for symptom management. Medicare regulations 
define ``palliative care'' as patient and family centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice (42 CFR 418.3). The goal of hospice care is to help terminally 
ill individuals continue life with minimal disruption to normal 
activities while remaining primarily in the home environment. A hospice 
uses an interdisciplinary approach to deliver medical, nursing, social, 
psychological, emotional, and spiritual services through a 
collaboration of professionals and other caregivers, with the goal of 
making the beneficiary as physically and emotionally comfortable as 
possible. The hospice interdisciplinary group works with the patient, 
family, caregivers, and the patient's attending physician (if any) to 
develop a coordinated, comprehensive care plan; reduce unnecessary 
diagnostics or ineffective therapies; and maintain ongoing 
communication with individuals and their families and caregivers about 
changes in their condition. The care plan will shift over time to meet 
the changing needs of the patient, family, and caregiver(s) as the 
patient approaches the end of life.
    The regulations for Medicare and Medicaid participating hospices 
are set forth at 42 CFR part 418. Section 418.3 defines the term 
``attending physician'' as being a doctor of medicine or osteopathy, an 
NP, or a PA in accordance with the statutory definition of an attending 
physician at section 1861(dd)(3)(B) of the Act. Section 51006 of the 
Bipartisan Budget Act of 2018 revised the statute to add PAs to the 
statutory definition of the hospice attending physician for services 
furnished on or after January 1, 2019. As a result, PAs were added to 
the definition of a hospice attending physician as part of the 
``Medicare Program; FY 2019 Hospice Wage Index and Payment Rate Update 
and Hospice Quality Reporting Requirements'' final rule which was 
published in the August 6, 2018 Federal Register (83 FR 38622, 38634) 
(hereinafter referred to as the ``FY 2019 Hospice final rule''.)
    The role of the patient's attending physician, if the patient has 
one, is to provide a longitudinal perspective on the patient's course 
of illness, care preferences, psychosocial dynamics, and generally 
assist in assuring continuity of care as the patient moves from the 
traditional curative care model to hospice's palliative care model. The 
attending physician is not meant to be a person offered by, selected 
by, or appointed by the hospice when the patient elects to receive 
hospice care. Section 418.64(a) of the hospice regulations requires the 
hospice to provide physician services to meet the patient's hospice-
related needs and all other care needs to the extent that those needs 
are not met by the patient's attending physician. Thus, if a patient 
does not have an attending physician relationship prior to electing 
hospice care, or if the patient's attending physician chooses to not 
participate in the patient's care after the patient elects to receive 
hospice care, then the hospice is already well-suited to provide 
physician care to meet all of the patient's needs as part of the 
Medicare hospice benefit. If the patient has an attending physician 
relationship prior to electing hospice care and that attending 
physician chooses to continue to be involved in the patient's care 
during the period of time when hospice care is provided, the role of 
the attending physician is to consult with the hospice 
interdisciplinary group (also known as the interdisciplinary team) as 
described in Sec.  418.56, and to furnish care for conditions 
determined by the hospice interdisciplinary group to be unrelated to 
the terminal prognosis. The hospice interdisciplinary group must 
include the following members of the hospice's staff: A physician; a 
nurse; a social worker; and a counselor. The interdisciplinary group 
may also include other members based on the specific services that the 
patient receives, such as hospice aides and speech language 
pathologists. The hospice interdisciplinary group, as a whole, in 
consultation with the patient's attending physician (if any), the 
patient, and the patient's family and caregivers, are responsible for 
determining the course of the patient's hospice care and establishing 
the individualized plan of care for the patient that is used to guide 
the delivery of holistic hospice services and interventions, both 
medical and non-medical in nature.
b. Provisions
    In the role of a consultant to the hospice interdisciplinary group, 
the hospice patient's chosen attending physician may, at times, write 
orders for services and medications as they relate to treating 
conditions determined to be unrelated to the patient's terminal 
prognosis. The law allows for circumstances in which services needed by 
a hospice beneficiary would be completely unrelated to the terminal 
prognosis, but we believe that this situation would be the rare 
exception rather than the norm. Section 418.56(e) requires hospices to 
coordinate care with other providers who are also furnishing care to 
the hospice patient, including the patient's attending physician who is 
providing care for conditions determined by the hospice 
interdisciplinary group to be unrelated to the patient's terminal 
prognosis. As part of this coordination of care, it is possible that 
hospices may receive orders from the attending physician for drugs that 
are unrelated to the patient's terminal prognosis.

[[Page 62935]]

    The FY 2019 Hospice final rule amended the regulatory definition of 
``attending physician,'' as required by the statute, to include 
``physician assistant.'' Following publication of the FY 2019 Hospice 
final rule, stakeholders raised concerns regarding the requirements of 
Sec.  418.106(b). As currently written, hospices may not accept orders 
for drugs from attending physicians who are PAs because Sec.  
418.106(b) specifies that hospices may accept drug orders from 
physicians and NPs only. This regulatory requirement may impede proper 
care coordination between hospices and attending physicians who are 
PAs, and we believe that it should be revised.
    Therefore, we proposed to revise Sec.  418.106(b)(1) to permit a 
hospice to accept drug orders from a physician, NP, or PA. We proposed 
that the PA must be an individual acting within his or her state scope 
of practice requirements and hospice policy. We also proposed that the 
PA must be the patient's attending physician, and that he or she may 
not have an employment or contractual arrangement with the hospice. The 
role of physicians and NPs as hospice employees and contractors is 
clearly defined in the hospice CoPs; however, the CoPs do not address 
the role of PAs because the statute does not include PA services as 
being part of the Medicare hospice benefit. Therefore, we believe that 
it is necessary to limit the hospice CoPs to accepting only those 
orders from PAs that are generated outside of the hospice's operations.
    To more fully understand the current and future role of NPPs, 
including PAs, in hospice care and the hospice CoPs, we requested 
public comment on the following questions:
     What is the role of a NPP in delivering safe and effective 
hospice care to patients? What duties should they perform? What is 
their role within the hospice interdisciplinary group and how is it 
distinct from the role of the physician, nurse, social work, and 
counseling members of the group?
     Nursing services are a required core service within the 
Hospice benefit, as provided in section 1861(dd)(B)(i) of the Act, 
which resulted in the defined role for NPs in the Hospice COPs. Should 
other NPPs also be considered core services on par with NP services? If 
not, how should other NPP services be classified?
     In light of diverse existing state supervision 
requirements, how should NPP services be supervised? Should this 
responsibility be part of the role of the hospice medical director or 
other physicians employed by or under contract with the hospice? What 
constitutes adequate supervision, particularly when the NPP and 
supervising physician are located in different offices, such as hospice 
multiple locations?
     What requirements and timeframes currently exist at the 
state level for physician co-signatures of NPP orders? Are these 
existing requirements appropriate for the hospice clinical record? If 
not, what requirements are appropriate for the hospice clinical record?
     What are the essential personnel requirements for PAs and 
other NPPs?
    We received public comments on the proposed regulatory change to 
allow hospices to accept medication orders from PAs who are attending 
physicians as chosen by the patient that do not have an employment or 
contractual relationship with the hospice. We also received information 
in response to our solicitation for public comments regarding the 
current and future role of NPPs, including PAs, in hospice care and the 
hospice CoPs. The following is a summary of the comments we received 
and our responses.
    Comment: All comments regarding the proposed regulatory change to 
allow hospices to accept medication orders from PAs who are attending 
physicians as chosen by the patient that do not have an employment or 
contractual relationship with the hospice noted support for allowing 
hospice to accept drug orders from such PAs. Some commenters suggested 
that hospices should be allowed to accept orders from PAs employed by 
or under arrangement with the hospice.
    Response: We agree with the commenters that this proposed change is 
appropriate to assure care coordination between attending physicians 
who are PAs and hospices, and we are finalizing the proposal without 
change. We do not agree that PAs employed by or under arrangement with 
the hospice should be included in this rule, as such piecemeal 
inclusion without complimentary regulations to establish the scope of 
PA services in hospices may create patient safety and program 
vulnerabilities. It is clear from the comments that a notable portion 
of the physician assistant and hospice communities view the role of the 
physician assistant as an acceptable substitute for hospice physicians, 
which is not in accordance with current statutory provisions. We 
believe that this disconnect between public perception of the role of 
the PA and the requirements of the statute necessitates rulemaking to 
clearly set forth what is and is not permissible. We will consider this 
suggestion for future rulemaking.
    Comment: A few commenters disagreed with the idea that attending 
physicians who are physician assistants should be limited to 
prescribing only those medications or therapies that are not related to 
the terminal prognosis.
    Response: We did not propose, nor are we finalizing, any such 
limitations. Attending physicians, regardless of their qualifications, 
are consultants to the hospice interdisciplinary group. It is the 
hospice interdisciplinary group, comprised of, at minimum, a physician, 
nurse, social worker, and counselor in accordance with the requirements 
set forth in section 1861(dd)(2)(B)(i) of the Act, that is responsible 
for determining the content of the patient's hospice plan of care and 
issuing all necessary orders to implement that plan of care. Given 
that: (1) Each interdisciplinary group contains, at minimum, a 
physician member employed by or under arrangement with the hospice 
actively involved in the patient's care at all times, (2) hospice 
physician services must be available at all times, and (3) the 
physician member has the authority to write all orders necessary to 
implement the plan of care, the need for an attending physician outside 
of the hospice to write orders related to implementing the hospice plan 
of care should be rare.
    Comment: The majority of the commenters submitted information 
regarding the current and future role of NPPs, including PAs and 
advanced practice registered nurses (APRNs), in hospice care and the 
hospice CoPs.
    Response: We thank the commenters for sharing this information, and 
will take it into consideration when developing all future hospice CoPs 
related to the role of NPPs.
    Comment: One commenter posed the following question: There are a 
number of PAs in palliative care that are employed or under contract 
with the parent company that also operates the hospice. Would CMS 
consider these PAs to be an employee of the hospice if everyone 
operates under the same tax identification number?
    Response: Section 418.3, Definitions, of the hospice CoPs defines 
an employee as a person who: (1) Works for the hospice and for whom the 
hospice is required to issue a W-2 form on his or her behalf; (2) if 
the hospice is a subdivision of an agency or organization, an employee 
of the agency or organization who is assigned to the hospice; or (3) is 
a volunteer under the jurisdiction of the hospice. If a PA is assigned 
by the ``parent company'' to the hospice, then the PA is considered to 
be an ``employee'' of the hospice.

[[Page 62936]]

    Comment: Some commenters made suggestions related to hospice 
payment requirements, CMS manuals, and statutory requirements that are 
not within the scope of our proposal to revise the hospice CoPs or 
within our regulatory authority.
    Response: We have shared these out of scope comments with the 
appropriate CMS stakeholders.
    In accordance with public comments, we are finalizing the change at 
Sec.  418.106(b)(1) as proposed.

J. Advisory Opinions on the Application of the Physician Self-Referral 
Law

1. Statutory and Regulatory Background
    Section 4314 of the Balanced Budget Act of 1997 (Pub. L. 105-33, 
enacted August 5, 1997), added section 1877(g)(6) to the Act. Section 
1877(g)(6) of the Act requires the Secretary to issue written advisory 
opinions concerning whether a referral relating to designated health 
services (other than clinical laboratory services) is prohibited under 
section 1877 of the Act. On January 9, 1998, the Secretary issued a 
final rule with comment period in the Federal Register to implement and 
interpret section 1877(g)(6) of the Act (the 1998 advisory opinion 
rule). (See Medicare Program; Physicians' Referrals; Issuance of 
Advisory Opinions (63 FR 1646).) The regulations are codified in 
Sec. Sec.  411.370 through 411.389 (the physician self-referral 
advisory opinion regulations).
    Section 1877(g)(6)(A) of the Act states that each advisory opinion 
issued by the Secretary shall be binding as to the Secretary and the 
party or parties requesting the opinion. Section 1877(g)(6)(B) of the 
Act requires the Secretary, in issuing advisory opinions regarding the 
physician self-referral law, to apply the rules in paragraphs (b)(3) 
and (4) of section 1128D of the Act, to the extent practicable. This 
paragraph also requires the Secretary to take into account the 
regulations promulgated under paragraph (b)(5) of section 1128D of the 
Act.
    Section 1128D of the Act was added to the statute by section 205 of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
(Pub. L. 104-191, effective August 21, 1996). Among other things, 
section 1128D of the Act requires the Secretary, in consultation with 
the Attorney General, to issue written advisory opinions as to 
specified matters related to the anti-kickback statute in section 
1128B(b) of the Act, the safe harbor provisions in Sec.  1001.952, and 
other provisions of the Act under the authority of the Office of 
Inspector General (OIG). To implement and interpret section 1128D of 
the Act, OIG issued an interim final rule with comment period in the 
February 19, 1997 Federal Register entitled Medicare and State Health 
Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the 
OIG (62 FR 7350), revised and clarified its regulations in the July 16, 
1998 Federal Register (68 FR 38311), and updated its regulations in a 
final rule published in the July 17, 2008 Federal Register that solely 
revised certain procedural requirements for submitting payments for 
advisory opinion costs (73 FR 40982) (collectively, the OIG advisory 
opinion rule). The regulations are codified in part 1008 of this title 
of the Code of Federal Regulations (the OIG advisory opinion 
regulations).
    Section 1128D(b)(3) of the Act prohibits the Secretary from 
addressing in an advisory opinion whether: (1) Fair market value shall 
be or was paid or received for any goods, services, or property; or (2) 
an individual is a bona fide employee within the requirements of 
section 3121(d)(2) of the Internal Revenue Code of 1986. In the 1998 
advisory opinion rule, we incorporated these provisions into the 
physician self-referral law regulations (63 FR 1646). Section 
1128D(b)(4)(A) of the Act states that an advisory opinion related to 
OIG authorities is binding as to the Secretary and the party or parties 
requesting the opinion. This section is redundant of the provision in 
section 1877(g)(6)(A) of the Act, and therefore, not incorporated into 
the physician self-referral law advisory opinion regulations. Section 
1128D(b)(4)(B) of the Act provides that the failure of a party to seek 
an advisory opinion may not be introduced into evidence to prove that 
the party intended to violate the provisions of sections 1128, 1128A, 
or 1128B of the Act. We incorporated section 1128D(b)(4)(B) of the Act 
in the physician self-referral regulations at Sec.  411.388.
    As discussed previously, section 1877(g)(6)(B) of the Act requires 
the Secretary, to the extent practicable, to take into account the 
regulations issued under the authority of section 1128D(b)(5) of the 
Act (that is, the OIG advisory opinion regulations). Section 
1128D(b)(5)(A) of the Act requires that the OIG advisory opinion 
regulations must provide for: (1) The procedure to be followed by a 
party applying for an advisory opinion; (2) the procedure to be 
followed by the Secretary in responding to a request for an advisory 
opinion; (3) the interval in which the Secretary will respond; (4) the 
reasonable fee to be charged to the party requesting an advisory 
opinion; and (5) the manner in which advisory opinions will be made 
available to the public. We interpret the Congress' directive to take 
into account the OIG regulations to mean that we should use the OIG 
regulations as our model, but that we are not bound to follow them (63 
FR 1647). Nonetheless, in the 1998 advisory opinion rule, we largely 
adopted OIG's approach to issuing advisory opinions, stating that we 
intend for physician self-referral law advisory opinions to provide the 
public with meaningful advice regarding whether, based on specific 
facts, a physician's referral for a designated health service (other 
than a clinical laboratory service) is prohibited under section 1877 of 
the Act (63 FR 1648).
2. Revisions to the 1998 Advisory Opinion Process and Regulations
    In the June 25, 2018 Federal Register, we published a Request for 
Information Regarding the Physician Self-Referral Law (83 FR 29524) 
(June 2018 CMS RFI) that sought recommendations from the public on how 
to address any undue impact and burden of the physician self-referral 
statute and regulations. Although we did not specifically request 
comments on the physician self-referral advisory opinion regulations, 
we received a number of comments urging that CMS reconsider its 
approach to advisory opinions and transform the process such that the 
regulated industry may obtain expeditious guidance on whether a 
physician's referrals to an entity with which he or she has a financial 
relationship would be prohibited under section 1877 of the Act. These 
commenters stated their belief that the current advisory opinion 
process could be improved. Some commenters also stated that the process 
is too restrictive, noting that CMS has placed what the commenters see 
as unreasonable limits on the types of questions that qualify for an 
advisory opinion (for example, CMS will not issue an advisory opinion 
where the arrangement at issue is hypothetical and does not issue 
advisory opinions on general questions of interpretation), and that 
physician self-referral law advisory opinions apply only to the 
specific circumstances of the requestor. These commenters asserted that 
the OIG's advisory opinion process, upon which the physician self-
referral law advisory opinion process is modeled, is inappropriate as 
applied to a payment statute, noting that OIG opines on matters related 
to a felony criminal statute, whereas the physician self-referral law, 
by contrast, is a payment rule without a mens rea requirement.

[[Page 62937]]

Some commenters highlighted the complexity of the physician self-
referral regulations, the strict liability nature of the physician 
self-referral law, and the need for certainty before arrangements are 
initiated and claims submitted as reasons why an advisory opinion 
process related to a felony criminal statute is inappropriate for the 
physician self-referral law. Other commenters asserted that the process 
is arduous and inefficient. These commenters noted that the advisory 
opinion process can extend beyond the 90-day timeframe provided for at 
Sec.  411.380 and asserted that it lags behind the OIG process in terms 
of efficiency.
    In designing its advisory opinion process, OIG stated that it 
carefully balanced stakeholders' desire for an accessible process and 
meaningful and informed opinions with its need to closely scrutinize 
arrangements to insure that requesting parties are not inappropriately 
granted protection from sanctions. (63 FR 38312 through 38313). We 
appreciate that there are important differences between the physician 
self-referral law, a strict liability statute designed to prevent 
payment for services where referrals are affected by inherent financial 
conflicts of interest, and the anti-kickback statute, which is a 
criminal law designed to prosecute intentional acts of fraud and abuse.
    More than 20 years have passed since the 1998 advisory opinion 
regulations were issued. In those 20 years, we issued 31 advisory 
opinions,\109\ 15 of which addressed the 18-month moratorium on 
physician self-referrals to specialty hospitals in which they have an 
ownership or investment interest. In light of the comments received on 
the RFI, we undertook a fresh review of the 1998 advisory opinion 
process. We agree that it is important to have an accessible process 
that produces meaningful opinions on the applicability of section 1877 
of the Act, especially in light of the perceived complexity of the 
physician self-referral regulations, including the requirements of the 
various exceptions and the key terminology applicable to many of the 
exceptions. We recognize that our current advisory opinion process has 
not been widely utilized by stakeholders and has resulted in few 
opinions being issued to date. Accordingly, we reviewed our advisory 
opinion regulations in an effort to identify limitations and 
restrictions that may be unnecessarily serving as an obstacle to a more 
robust advisory opinion process.
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    \109\ These advisory opinions are available on CMS' website, at 
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/advisoryopinions.html. This number does not include advisory opinion 
requests that were withdrawn.
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    Failure to satisfy the requirements of an exception to the 
physician self-referral law carries significant consequences, 
regardless of a party's intent.\110\ The safe harbors under the anti-
kickback statute are voluntary, and the failure of an arrangement to 
fit squarely within a safe harbor does not automatically mean that the 
arrangement violates the anti-kickback statute. By contrast, the 
physician self-referral law prohibits a physician's referral if there 
is a financial relationship that does not satisfy the requirements of 
one of the enumerated exceptions. In other words, the physician self-
referral law is a strict liability law, and parties that act in good 
faith may nonetheless face significant financial exposure if they 
misunderstand or misapply the law's exceptions.
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    \110\ The CMS Voluntary Self-Referral Disclosure Protocol (SRDP) 
allows providers of services and suppliers to self-disclose actual 
or potential violations of the physician self-referral statute. 
Under the SRDP, CMS may reduce the amount due and owing for 
violations of section 1877 of the Act. Information about the SRDP 
can be found at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/CMS-Voluntary-Self-Referral-Disclosure-Protocol.pdf.
---------------------------------------------------------------------------

    Regulated parties' desire for certainty must be balanced with CMS' 
interest in maintaining the integrity of the advisory opinion process, 
and ensuring that it is not used to inappropriately shield improper 
financial arrangements. We believe that the risk of such misuse is 
acceptably low in this context because the advisory opinion authority 
at section 1877(g) of the Act is narrowly tailored. CMS can only issue 
favorable advisory opinions for arrangements that do not violate 
section 1877 of the Act, for example, because there is no referral for 
designated health services, there is no financial relationship, or the 
arrangement satisfies the requirements of an applicable exception. In 
contrast, OIG has issued favorable advisory opinions for arrangements 
that do not fit within a safe harbor where it has concluded, based on a 
totality of the facts and circumstances, that the arrangement poses a 
sufficiently low risk of fraud and abuse under the anti-kickback 
statute. CMS cannot similarly extend protection beyond the exceptions, 
so there is a structural limit on the scope of CMS' authority. 
Furthermore, a favorable advisory opinion from CMS does not immunize 
parties from liability under the anti-kickback statute.
    We proposed changes that would both clarify the process and remove 
limitations and restrictions that might be unnecessarily serving as 
obstacles to a more robust advisory opinion process.
a. General
    Comment: Commenters overwhelmingly supported the proposed 
modifications to the advisory opinion regulations, and many stated that 
the modifications, if finalized, would facilitate better understanding 
of how to comply with the law and help parties to nonabusive 
arrangements avoid the strict penalties that result from noncompliance. 
Some commenters stated that the proposed modifications to the advisory 
opinion process, if finalized, would assist in advancing innovation in 
care delivery by encouraging greater participation in value-based care 
and alternative payment arrangements. Several commenters agreed that 
the advisory opinion process for the physician self-referral law, a 
strict liability law, should not be identical to the advisory opinion 
process for the anti-kickback statute, a criminal law. Commenters 
expressed their hope that CMS would publish more advisory opinions in 
the future.
    Response: We appreciate the commenters' support for our efforts to 
reform the advisory opinion process. We agree that a well-functioning 
advisory opinion process could aid in advancing two of the Department's 
top priorities--reducing regulatory burden on providers and encouraging 
adoption of alternative payment models and coordinated care 
arrangements. A faster and more robust advisory opinion process 
facilitates the shift to value-based care arrangements by providing 
more guidance for parties trying to understand how the physician self-
referral law applies in an evolving and innovative marketplace. This 
will help to reduce provider burden by providing insight into what does 
and does not comply with the law, which encourages innovation.
    Comment: Several commenters who were generally supportive of the 
proposed modifications to the advisory opinion process also stated that 
changes to the 1998 advisory opinion rule should not further develop or 
create additional abusive self-referring arrangements.
    Response: This final rule does not change the number or scope of 
exceptions from the physician self-referral prohibition. This final 
rule merely updates the process for issuing advisory opinions on 
whether certain fact patterns would result in a prohibited referral. 
Under the advisory opinion process, requestors must provide, among 
other information, sufficient detail about the arrangement

[[Page 62938]]

and the named parties to the arrangement in its submission. The 
advisory opinion process involves communication with the requestor to 
ensure CMS has a clear understanding of the arrangement under review 
and the parties involved. We believe that the regulations governing the 
advisory opinion process contain sufficient guardrails to limit the 
risk of improper use of the advisory opinion process.
b. Matters Subject to Advisory Opinions (Sec.  411.370)
    Section 1877(g)(6) of the Act requires the Secretary to issue 
advisory opinions concerning ``whether a referral relating to 
designated health services (other than clinical laboratory services) is 
prohibited under this section.'' In accordance with section 
1877(g)(6)(B) of the Act, CMS adopted in regulation rules mirroring the 
requirements in paragraphs (b)(3) and (4) of section 1128D of the Act, 
which prohibit OIG from opining on whether an arrangement is fair 
market value and whether an individual is a bona fide employee within 
the requirements of section 3121(d)(2) of the Internal Revenue Code. In 
addition to these restrictions on matters that are not subject to 
advisory opinions, our current regulation at Sec.  411.370(b)(1) states 
that CMS does not consider, for purposes of an advisory opinion, 
requests that present a general question of interpretation, pose a 
hypothetical situation, or involve the activities of third parties. 
When explaining this regulation, we stated that we interpret section 
1877(g)(6) of the Act to allow for opinions on specific referrals 
involving physicians in specific situations (63 FR 1649). We also noted 
our reasons for avoiding opinions on generalized arrangements, stating 
that it would not be possible for an advisory opinion to reliably 
identify all the possible hypothetical factors that might lead to 
different results.
(i) Requests That Present a General Question of Interpretation or Pose 
a Hypothetical Situation
    Under our current regulations, we accept requests for advisory 
opinions that involve existing arrangements, as well as requests that 
involve arrangements into which the requestor plans to enter. While we 
did not propose an expansion of the scope of advisory opinion requests, 
we solicited comments on whether we should do so in the future. We 
proposed clarifications to Sec.  411.370(b) regarding matters that 
qualify for advisory opinions and the parties that may request them. 
Specifically, we proposed to clarify that the request for an advisory 
opinion must ``relate to'' (rather than ``involve'') an existing 
arrangement or one into which the requestor, in good faith, 
specifically plans to enter. Requestors continue to be obligated to 
disclose all facts relevant to the arrangement for which an advisory 
opinion is sought. We also proposed revisions to the regulation text 
for grammatical purposes.
    The following is a summary of the comments we received on the above 
proposals and our responses.
    Comment: Commenters generally supported the clarification that an 
advisory opinion request must ``relate to,'' rather than ``involve,'' 
an arrangement that is existing or into which the requestor plans to 
enter, although at least one commenter suggested that CMS not finalize 
this proposed clarification, based on the perception that it will not 
serve to decrease the volume of information that requestors will need 
to provide to CMS.
    Response: We are finalizing the proposal to consider questions that 
``relate to'' existing or planned arrangements. The modification is 
intended to provide further clarity on existing physician self-referral 
law advisory opinion policy. It is not intended to lessen the volume of 
information submitted, nor expand the scope of the advisory opinion 
process, but rather, to more precisely capture the appropriate scope of 
advisory opinion requests. As discussed further below, we will consider 
all complete requests that relate to either an existing or planned 
arrangement (that is, requests that describe a specific arrangement 
with sufficient detail).
    Comment: A number of commenters urged CMS to further expand the 
matters subject to advisory opinions to include requests that present a 
general question of interpretation or pose a hypothetical situation. 
These commenters suggested that this would provide needed clarification 
for providers, would help reduce confusion around compliance with the 
physician self-referral law, and would help reduce the administrative 
burden of compliance, especially for small and rural providers. Several 
of these commenters wanted the flexibility to request an advisory 
opinion before spending the significant time and resources required to 
draft and formalize proposed arrangements. Others cited concerns that 
if they wait to seek an advisory opinion until after an arrangement is 
in place, they risk being found to be out of compliance and could face 
penalties.
    Many commenters also acknowledged CMS' concern that expanding 
advisory opinions to cover hypothetical arrangements or general 
questions of interpretation could significantly increase the volume of 
advisory opinion requests. However, these commenters suggested that CMS 
could institute guardrails to ensure only legitimate and complete 
requests are entering into the process, such as imposing additional fee 
requirements, or using improved technology and intake processes for 
requests.
    One commenter stated that CMS should not reject an advisory opinion 
request on the grounds that it poses only a ``general question of 
interpretation,'' especially since the requestor has no opportunity to 
rebut CMS' determination. This commenter stated that the distinction 
between planned arrangements and general matters of interpretation is 
abstract and favors form over substance, and urged that the ``general 
question of interpretation'' restriction be deleted. This commenter 
also stated that the proposed rule's requirement for requestors to 
describe arrangements in a sufficient level of detail would provide a 
meaningful safeguard against misuse of the advisory opinion process.
    Response: We continue to believe that the Secretary's obligation 
under section 1877(g)(6) of the Act to issue advisory opinions 
concerning whether a referral relating to designated health services is 
prohibited under this section limits the subject of advisory opinions 
to questions about a specific referral made by a physician in a 
specific financial relationship under specific facts and circumstances. 
It remains our position that requests regarding hypothetical facts or 
general questions of interpretation are not appropriate for an advisory 
opinion. Further, although we proposed a number of changes to improve 
the advisory opinion process for stakeholders, we believe that 
expanding the process to include such questions could overwhelm the 
agency. As such, we are not expanding the scope of the advisory opinion 
process to include hypothetical arrangements or general questions of 
interpretation.
    However, based on comments received, we have reviewed the 
regulation's current terminology of a request ``present[ing] a general 
question of interpretation'' or ``pos[ing] a hypothetical situation,'' 
and acknowledge that these terms may lack sufficient clarity. Based on 
the comments received, there appears to be some confusion over how CMS 
distinguishes a planned arrangement--that is, a specific arrangement 
that does not yet exist but the requestor in good faith plans to 
enter--from a hypothetical

[[Page 62939]]

fact pattern or question of general interpretation. Therefore, we are 
removing this terminology at 11.370(b)(1).
    We accept and issue advisory opinions that relate to existing 
arrangements or arrangements into which the requestor intends to enter 
if it receives a favorable advisory opinion. To issue an advisory 
opinion, the requestor must provide, among other information, 
sufficient detail about the arrangement and the parties to the 
arrangement, including identifying information about one or both of the 
parties to the arrangement. Thus, the universe of acceptable advisory 
opinions would not include requests for guidance that interprets the 
physician self-referral law generally, such as whether generic 
noncompete provisions take into account the volume or value of a 
physician's referrals. Nor would the universe include a request to 
opine, in the abstract, whether a variety of compensation methodologies 
take into account the volume or value of referrals. Although we do not 
consider an arrangement to be a per se hypothetical matter simply 
because the parties have not yet entered into the arrangement, there 
are some matters that would be inappropriate for advisory opinions. 
These include requests for an advisory opinion regarding whether a 
physician's referral is prohibited under section 1877 of the Act where 
the underlying financial arrangement between the physician and the 
entity to which he or she refers designated health services is 
otherwise illegal or impermissible. For example, we would not accept a 
request for an advisory opinion regarding whether a referral is 
permissible if the claim for the designated health services could not 
be billed to the Medicare program for some reason unrelated to the 
physician self-referral law. We have made modifications to Sec.  
411.370(e) to reflect this view.
    We also appreciate the compliance burden on physicians and DHS 
entities subject to the physician self-referral law, as well as the 
significant consequences of noncompliance, and we acknowledge the 
desire for more timely guidance. Therefore, we are considering 
available means to provide general guidance and compliance advice 
outside of the advisory opinion process. Several commenters suggested 
that CMS issue more subregulatory guidance to provide greater clarity 
around the physician self-referral law and regulations. While 
subregulatory guidance must always be carefully constructed so as not 
to impose new obligations on regulated parties, CMS will explore 
opportunities to provide additional, appropriate guidance through 
subregulatory means. As we noted in the proposed rule, we respond to 
questions pertaining to the physician self-referral law through the CMS 
Physician Self-Referral Call Center email inbox, and frequently assists 
parties with identifying relevant guidance. The CMS Physician Self-
Referral Call Center resource is free to the public, and inquiries may 
be sent to [email protected]. For additional information, see 
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Call-Center.html. We also respond to frequently asked questions (FAQs) 
regarding the physician self-referral law from time to time. FAQs 
issued to date are available on our website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/FAQs.html.
    For these reasons, we are finalizing our proposed changes to Sec.  
411.370(b), with the modifications as described above. In response to 
commenters' desire for greater clarity around the types of requests 
that CMS will reject, we are also adding a new paragraph Sec.  
411.370(e)(1)(v) to clarify that CMS would decline to accept an 
advisory opinion request that involves a course of conduct that is not 
legally permissible for reasons other than section 1877 of the Act.
(ii) Acceptance of Requests
    Current Sec.  411.370(e) states that CMS does not accept an 
advisory opinion request or issue an advisory opinion if: (1) The 
request is not related to a named individual or entity; (2) CMS is 
aware that the same or substantially the same course of action is under 
investigation or is or has been the subject of a proceeding involving 
HHS or another governmental agency; or (3) CMS believes that it cannot 
make an informed opinion or could only make an informed opinion after 
extensive investigation, clinical study, testing, or collateral 
inquiry. We proposed changes to this regulation. First, we proposed to 
add to the reasons that CMS will not accept an advisory opinion request 
or issue an advisory opinion. Specifically, we proposed that CMS will 
not accept an advisory opinion request or not issue an advisory opinion 
with respect to a request that does not describe the arrangement at 
issue with a level of detail sufficient for CMS to issue an opinion, 
and the requestor does not timely respond to CMS requests for 
additional information. We believe that this is important to the 
agency's ability to focus its resources on complete requests.
    Second, we proposed to amend current Sec.  411.370(e)(2), which 
states that CMS will not issue an advisory opinion if it is aware that 
the same, or substantially the same, course of action is under 
investigation or is or has been the subject of a proceeding involving 
HHS or other government entities. Although CMS consults with other HHS 
components and governmental agencies, including OIG and DOJ, on pending 
advisory opinion requests, we believe the current regulation is too 
restrictive, and unnecessarily limits CMS' flexibility to issue timely 
guidance to requestors engaged in or considering legitimate business 
arrangements. Therefore, we proposed to modify Sec.  411.370(e)(2) to 
allow CMS more discretion to determine, in consultation with OIG and 
DOJ, whether acceptance of the advisory opinion request or issuance of 
the advisory opinion is appropriate. Specifically, we proposed at Sec.  
411.370(e)(2) that CMS may elect not to accept an advisory opinion 
request or issue an advisory opinion if, after consultation with OIG 
and DOJ, it determines that the course of action described in the 
request is substantially similar to conduct that is under investigation 
or the subject of a proceeding involving the Department or other law 
enforcement agencies, and that issuing an advisory opinion could 
interfere with the investigation or proceeding. We proposed to retain 
at renumbered Sec.  411.370(e)(1)(iii) the restriction on accepting 
requests if CMS is aware that the same course of action is under 
investigation or is, or has been the subject of a proceeding involving 
the Department or another governmental agency. We also proposed to 
clarify that CMS would consult with OIG and DOJ regarding 
investigations or proceedings involving the same course of conduct 
described in an advisory opinion request.
    We received public comments on these proposals. The following is a 
summary of the comments we received on the above proposals and our 
responses.
    Comment: Commenters were generally supportive of the requirement 
that requests must contain a level of detail sufficient to permit CMS 
to issue an informed opinion, and that it would be appropriate to 
reject a request if the requestor did not timely respond to CMS' 
request for additional information. Several commenters opined that this 
safeguard will protect against inappropriate use of the advisory 
opinion process.
    Response: We agree that this safeguard is necessary to protect the 
integrity of the advisory opinion process

[[Page 62940]]

and to ensure that CMS is focusing its resources on requests that 
provide sufficient detail to allow CMS to make an informed decision.
    Comment: Several commenters agreed with CMS' current policy of 
rejecting advisory opinion requests where the same course of action 
described in the request is the subject of an investigation or 
proceeding.
    Response: We are maintaining this current policy set forth at Sec.  
411.370(e)(1)(iii).
    Comment: Commenters supported the proposed modifications to Sec.  
411.370(e) that would give CMS more flexibility with respect to 
requests involving conduct that is substantially similar to conduct 
that is under investigation or is the subject of a law enforcement 
proceeding. Several commenters stated that the current restriction at 
Sec.  411.370(e)(2) unnecessarily limits CMS' ability to issue timely 
guidance to requestors engaged in or planning to enter into legitimate 
business arrangements. Several commenters urged CMS to reject such 
requests only where the issuance of an advisory opinion could have a 
direct effect on an investigation or proceeding. Several other 
commenters, however, suggested that CMS remove the restriction in its 
entirety, arguing that enforcement actions often involve lengthy 
investigations and litigation, and parties with substantially similar 
arrangements could be locked out of the advisory opinion process for 
long periods of time while these proceedings are ongoing. One commenter 
considered whether by maintaining the discretion to reject requests 
involving substantially similar conduct, CMS was unlikely to issue more 
advisory opinions than it currently issues.
    Response: We believe it is important for CMS to retain discretion 
to reject an advisory opinion request where we determine, after 
consultation with OIG and DOJ, that issuance of an opinion would 
interfere with a pending investigation or proceeding. However, we 
recognize that the exercise of this discretion could result in parties 
to legitimate arrangements being locked out of the advisory opinion 
process for lengthy periods of time, and having to make business 
decisions without the certainty that an advisory opinion can provide. 
While we will strive to be judicious in our exercise of discretion, we 
may not be in a position to respond to every request in a timeframe 
that suits the requestor. In those instances, it is up to regulated 
parties to decide whether to pursue a particular course of conduct in 
the absence of an advisory opinion.
    For the reasons stated above, we are finalizing our proposed 
changes to Sec.  411.370(e), and, as described above in section b.(i), 
adding a new paragraph (e)(1)(v) to clarify that CMS would decline to 
accept an advisory opinion that involves a course of conduct that is 
not legally permissible for reasons other than section 1877 of the Act.
c. Timeline for Issuing an Advisory Opinion (Sec.  411.380)
    Section 1877(g)(6) of the Act does not impose any deadlines by 
which the agency must respond to a physician self-referral law advisory 
opinion request, but it does require the Secretary to take into account 
OIG advisory opinion regulations under subsection (b)(5) of section 
1128D of the Act. Section 1128D(b)(5)(B)(i) of the Act provides that 
the Secretary shall be required to issue an advisory opinion no later 
than 60 days after the request is received. In the 1998 CMS advisory 
opinions rule, we adopted a 90-day timeframe for most requests. In 
addition, for requests that we determined, in our discretion, involve 
complex legal issues or highly complicated fact patterns, we reserved 
the right to issue an advisory opinion within a reasonable timeframe. 
We created this timeframe based upon our estimates of the volume and 
complexity of expected requests, and based upon our then-current 
staffing situation.
    We proposed to modify this time period and establish a 60-day 
timeframe for issuing advisory opinions. This period would begin on the 
date that CMS formally accepts a request for an advisory opinion. The 
60 days would be tolled during any time periods in which the request is 
being revised or additional information compiled and presented by the 
requestor. We are adopting a 60-working day timeframe, and clarifying 
that day refers to a ``working day,'' where ``working days'' is defined 
as days excluding Saturdays, Sundays, and legal holidays.\111\
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    \111\ ``Legal holidays'' include the days set aside by statute 
for observing New Year's Day, Martin Luther King Jr.'s Birthday, 
Washington's Birthday, Memorial Day, Independence Day, Labor Day, 
Columbus Day, Veterans' Day, Thanksgiving Day, and Christmas Day; 
and any day declared a holiday by the President or Congress.
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    We also considered whether CMS should provide requestors with the 
option to request expedited review. We believe that a more efficient 
and expeditious process could give stakeholders more certainty and 
encourage innovative care delivery arrangements. We solicited comment 
on the changes to the timeframe, whether CMS in the final rule should 
include a provision on expedited review and, if so, the parameters for 
expedited review.
    The following is a summary of the comments we received on these 
proposals and our responses.
    Comment: Commenters supported shortening the current 90-day 
timeframe to 60 days, although many commenters expressed skepticism 
that CMS would be able to meet such a deadline absent investment of 
additional resources or other process changes. One commenter requested 
more clarity as to when CMS ``formally accepts'' a request for an 
advisory opinion, thereby triggering the beginning of the 60-day 
timeframe.
    Response: We are finalizing a 60-working day timeframe for issuance 
of advisory opinions, which will begin on the date that CMS formally 
accepts a request for review. We will formally accept a request once 
the agency determines that (a) the request and any supplemental 
submissions describe the arrangement at issue with a level of detail 
sufficient for CMS to issue the opinion, and (b) the grounds for 
rejection of a request listed at Sec.  411.370(e) do not apply. We 
believe that the collection of user fees, a policy we proposed and are 
finalizing in this rule, will enable CMS to process advisory opinion 
requests in a timely fashion.
    Under our current regulation, we reserve the ability to extend this 
default time period for requests that present complex legal issues of 
first impression, or highly complicated fact patterns, and to suspend 
the time period in the circumstances listed at Sec.  411.380(c)(3). 
While we are maintaining this reservation of discretion, we appreciate 
commenters' views that requestors want some degree of assurance that 
their investment of time in the advisory opinion process will result in 
the timely issuance of an opinion.
    Current regulations provide for a 15-working day review period that 
begins on the date CMS receives a request for an advisory opinion. 
Under the new timeframe, CMS will maintain this 15-working day review 
period. During this time, we will review the submission to make a 
preliminary \112\ determination as to whether the submission describes 
the arrangement at issue with a level of detail sufficient for CMS to 
issue an opinion. For submissions clearly lacking in sufficient detail, 
we will notify the requestors of the deficiencies and request 
additional information. Once CMS makes a determination that the 
submission contains the necessary level

[[Page 62941]]

of detail, we will consult with DOJ and OIG to determine whether 
grounds exist to reject the request. If CMS determines that it can 
accept the request for review, we will notify requestors that their 
submission is formally accepted.
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    \112\ CMS may or may not later need to request additional 
information during the 60-working day review timeframe.
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    Comment: Commenters supported the establishment of an expedited 
pathway for advisory opinion requests, and several noted that an 
expedited option would be particularly helpful with respect to 
transactions with an impending deadline. However, many of these same 
commenters also noted that the expedited pathway would only be 
meaningful if CMS had the resources to adhere to it.
    Several commenters suggested that CMS establish a process for 
expedited review for relatively more straightforward requests that lend 
themselves to a ``yes'' or ``no'' answer, such as requests for CMS' 
opinion on whether an arrangement is ``indistinguishable in all 
material aspects'' from another arrangement upon which CMS has issued a 
favorable advisory opinion.
    Response: We agree with commenters that an expedited review process 
would be appropriate for requests that seek a determination as to 
whether an arrangement is ``indistinguishable in all material aspects'' 
from another arrangement that has been reviewed and found to comply 
with the physician self-referral law. Based on these comments, we are 
finalizing modifications to Sec.  411.380 to provide for expedited 
review for these types of requests only. Requestors would indicate in 
their advisory opinion requests that they are seeking expedited review. 
We will promptly make a determination on eligibility for expedited 
review, and communicate our decision to a requestor when notifying the 
requestor that CMS has formally accepted the request. The expedited 
review period of 30 working days would begin when CMS formally accepts 
the submission for review. We believe that the collection of user fees, 
a policy we proposed and are finalizing in this rule, will enable CMS 
to process advisory opinion requests in a timely fashion.
    Comment: Several commenters suggested that in instances where CMS 
does not issue an advisory opinion within the relevant timeframe, the 
requestor should be deemed to have received a favorable advisory 
opinion and should be protected from any sanctions until such time as 
CMS formally issues an opinion.
    Response: The physician self-referral law is a payment rule, and 
CMS is statutorily prohibited from making payment for DHS furnished 
pursuant to a prohibited referral where a financial arrangement exists 
and no exception applies. Therefore, we do not have the authority to 
``deem'' an individual or entity in compliance with the physician self-
referral law if such deeming would effectively override the statutory 
payment prohibition.
    Comment: One commenter requested that CMS clarify the criteria it 
uses to determine whether a request involves ``complex legal issues or 
fact patterns.''
    Response: We appreciate this comment and will consider providing 
guidance in the future as the agency gains more experience with the 
modified process.
    As a result of the comments, we are finalizing our proposal to 
issue advisory opinions within 60 working days of the submission being 
formally accepted. We are also finalizing a 30-working day expedited 
review pathway for requests that only seek a determination that an 
arrangement is indistinguishable in all material respects to an 
arrangement that is the subject of a favorable advisory opinion.
d. Certification Requirement (Sec.  411.373)
    In the 1998 CMS advisory opinions rule, we adopted a requirement 
identical to OIG's requirement that a requestor must certify to the 
truthfulness of its submissions, including its good faith intent to 
enter into proposed arrangements. CMS finalized regulations that 
require a requestor to make two certifications as part of its request 
for an advisory opinion. Under current Sec.  411.373(a), the requestor 
must certify that, to the best of the requestor's knowledge, all of the 
information provided as part of the request is true and correct and 
constitutes a complete description of the facts regarding which an 
advisory opinion is being sought. If the request relates to a proposed 
arrangement, current Sec.  411.373(b) states that the request must also 
include a certification that the requestor intends in good faith to 
enter into the arrangement described in the request. A requestor may 
make this certification contingent upon receiving a favorable advisory 
opinion from CMS or from both CMS and OIG. Under current Sec.  
411.372(b)(8), if the requestor is an individual, the individual must 
sign the certification; if the requestor is a corporation, the 
certification must be signed by the Chief Executive Officer, or a 
comparable officer; if the requestor is a partnership, the 
certification must be signed by a managing partner; and, if the 
requestor is a limited liability company, the certification must be 
signed by a managing member. We proposed to revise Sec.  411.372(b)(8) 
to clarify that the certification must be signed by an officer that is 
authorized to act on behalf of the requestor, but that the signing 
officer need not be the Chief Executive Officer. We also considered 
whether it would be appropriate to eliminate the certification 
requirement in our regulations, given that section 1001 of Title 18 of 
the United States Code prohibits material false statements in matters 
within the jurisdiction of a federal agency. We solicited comment on 
whether the existing certification requirement creates undue burden for 
requestors, and whether the requirement is necessary given section 
1001.
    The following is a summary of the comments we received on our 
proposals and our response.
    Comment: Commenters supported the modifications to Sec.  
411.372(b)(8) that would allow for any authorized officer of a 
corporation, in addition to the Chief Executive Officer of a 
corporation, to sign the certification statement. Most commenters 
thought the certification requirement was appropriate and not overly 
burdensome.
    Response: Given these comments, we are finalizing the proposed 
changes in Sec.  411.372(b)(8), and will maintain the certification 
requirement.
e. Fees for the Cost of Advisory Opinions (Sec.  411.375)
    In the 1998 CMS advisory opinions rule, we established a fee that 
is charged to requestors to cover the actual costs incurred by CMS in 
responding to a request for an advisory opinion. Under current Sec.  
411.375, there is an initial fee of $250, and parties are responsible 
for any additional costs incurred that exceed the initial $250 payment. 
A requestor may designate a triggering dollar amount, and CMS will 
notify the requestor if CMS estimates that the costs of processing the 
request have reached or are likely to exceed the designated triggering 
amount. This fee structure was modeled after the OIG regulations that 
were in effect at that time.
    Since CMS issued the 1998 CMS advisory opinions rule, OIG has 
updated its regulations to eliminate the initial fee, and instead 
charges requesting parties a consolidated final payment based on costs 
associated with preparing an opinion (73 FR 15936). In the proposed 
rule, we stated that we believe it is appropriate to adopt an hourly 
fee of $220 for the preparation of an advisory opinion. We said that we 
believe this amount reflects the costs incurred by the agency in 
processing an advisory opinion request. We also said that we were 
considering establishing an expedited pathway for requestors

[[Page 62942]]

that seek an advisory opinion within 30 days of the request, and 
charging $440 an hour to process the request, reflecting the extra 
resources necessary to produce an advisory opinion within the 
abbreviated timeframe. We requested comments on this approach. To 
ensure that obtaining an advisory opinion is affordable, and to prevent 
unfair surprises to requestors at the end of the process, we considered 
promulgating a cap on the amount of fees charged for an advisory 
opinion. We solicited comments on the amount of the cap. We also 
requested comments on whether CMS should eliminate the initial $250 
fee.
    The following is a summary of the comments we received on our 
proposals and our responses.
    Comment: Many commenters were supportive of a user fee structure to 
enable the agency to handle a greater volume of advisory opinion 
requests and issue opinions in a shorter timeframe. Several commenters 
thought that the $220 hourly fee was reasonable, and one commenter 
noted that the $220 rate would ensure that only legitimate requestors 
are using the advisory opinion process.
    Other commenters recommended alternatives to the proposed $220 
hourly fee. For instance, commenters recommended adopting an hourly fee 
of $175 to align with OIG's charges, or adopting a flat ``filing fee.'' 
One commenter said that physicians should not pay more than the costs 
CMS incurs in responding to a request for an opinion, and that if CMS 
is going to adopt an hourly rate of $220, the agency should justify 
that amount.
    One commenter stated that it would support user fees only to the 
extent those fees would enable the agency to issue advisory opinions on 
hypothetical facts, and cut the time the agency takes to issue advisory 
opinions. Another commenter stated that requestors should not be 
charged an hourly fee for work done by CMS after the expiration of the 
relevant time period.
    Response: We agree with commenters that moving to an hourly rate 
structure will enable CMS to more efficiently and timely process 
requests for advisory opinions. Furthermore, the proposed rate of $220 
is a reasonable rate given the experience and seniority of the staff 
and attorneys responding to advisory opinion requests. See, for 
example, USAO ATTORNEY'S FEES MATRIX--2015-2019, available at https://www.justice.gov/usao-dc/file/796471/download (reasonable hourly fee for 
an attorney with less than 2 years of experience practicing law exceeds 
$220 per hour for the 2018-2019 time period).
    Comment: Commenters largely supported the establishment of a higher 
hourly rate for expedited review.
    Response: Because we are finalizing an expedited review pathway 
only for certain types of requests that we expect to be more 
straightforward than other requests (that is, those that seek an 
opinion on whether an arrangement is ``indistinguishable in all 
material respects'' to another arrangement that is the subject of a 
favorable advisory opinion), we are not finalizing a $440 hourly rate 
at this time.
    Comment: Several commenters suggested that the agency provide 
potential requestors with a cost estimate prior to the requestor 
incurring any costs. Many commenters supported the adoption of a cap, 
and several commenters recommended that CMS make special accommodations 
for small and solo practitioners such that they can afford to request 
advisory opinions. For example, several commenters that supported the 
imposition of hourly fees urged CMS to consider waiving fees for small 
groups of up to 15 clinicians, to ensure that smaller practices have 
access to the advisory opinion process. However, no commenter offered 
any suggestions on what an appropriate cap might be.
    Response: We agree with commenters that in order for the advisory 
opinion process to be accessible, especially for rural providers and 
small and solo practitioners, the costs must be predictable and 
affordable. As we work on operationalizing these reforms to the 
advisory opinion process, we will consider whether it is feasible to 
provide requestors with a cost estimate for the review and issuance of 
an advisory opinion. We will also consider discounting, on a case-by-
case basis, the $220 hourly rate for requestors with demonstrated 
limited financial resources, such as certain rural providers or small 
or solo practitioners, or, alternatively, capping the total charges for 
an advisory opinion.
    Comment: Several commenters said they supported the elimination of 
the initial $250 fee, and that the elimination of the fee is 
appropriate if CMS were to finalize its hourly user fee structure.
    Response: We agree and will modify Sec.  411.375(a) to eliminate 
the initial $250 fee. Accordingly, we are also removing Sec.  
411.372(b)(9), which requires each advisory opinion request to include 
the initial $250 fee.
    Comment: Several commenters suggested that we allow requestors to 
establish a triggering dollar amount, similar to the process used under 
OIG advisory opinion regulations.
    Response: Our current regulations at Sec.  411.375(c)(2) allow for 
requestors to designate a triggering dollar amount as a means of 
controlling the cost associated with the advisory opinion process. We 
are maintaining this provision, which will be redesignated as Sec.  
411.375(b)(2).
    As a result of the comments, we are finalizing, with modification, 
our proposal on the timeline for issuance of an advisory opinion 
request, as well as certain modifications to clarify the process for 
formal acceptance of a submission.
f. Reliance on an Advisory Opinion (Sec.  411.387)
    As we considered improvements to the advisory opinion process, we 
also considered regulatory changes to clarify current CMS policies and 
practices, and make our advisory opinions more useful compliance tools 
for stakeholders. Specifically, we solicited comment on proposals, 
described in more detail below, to remove some of the regulatory 
provisions limiting the universe of individuals and entities that can 
rely on an advisory opinion, and to add language expressing what we 
believe are permissible uses of an advisory opinion.
    Section 1877(g)(6)(A) of the Act states that an advisory opinion 
shall be binding on the Secretary and on the party or parties 
requesting an opinion. Consistent with the policy adopted by OIG, CMS 
took the view that an advisory opinion may legally be relied upon only 
by the requestors. While section 1877 of the Act is silent on how third 
parties may use an advisory opinion, in regulation, CMS has precluded 
legal reliance on the opinion by non-requestor third parties. At the 
time, we stated that advisory opinions are capable of being misused by 
persons not a party to the transaction in question in order to 
inappropriately escape liability (63 FR 1648). While such a preclusion 
may be appropriate for purposes of an OIG advisory opinion on the 
application of a criminal statute, we stated in the proposed rule that 
we believed it may be unduly restrictive in the context of a strict 
liability payment rule that applies regardless of a party's intent.
    We recognize that in practice, parties to an arrangement that is 
the subject of a favorable advisory opinion will rely on the opinion, 
even if the parties did not join in the request. If, for instance, CMS 
determines that an arrangement does not constitute a financial 
relationship because it satisfies all requirements of an applicable

[[Page 62943]]

exceptions to the physician self-referral law, that determination would 
necessarily apply equally to any individuals and entities that are 
parties to the specific arrangement, for example, the referring 
physician and the entity to which he or she refers patients for 
designated health services. Thus, even if the physician party to the 
arrangement was not a requestor of the advisory opinion, the physician 
party is entitled to rely on that advisory opinion. We proposed changes 
to Sec.  411.387 to reflect this view. Specifically, we proposed at 
Sec.  411.387(a) that an advisory opinion would be binding on the 
Secretary and that a favorable advisory opinion would preclude the 
imposition of sanctions under section 1877(g) of the Act with respect 
to the party or parties requesting the opinion and any individuals or 
entities that are parties to the specific arrangement with respect to 
which the advisory opinion is issued.
    We proposed at Sec.  411.387(b) that the Secretary will not pursue 
sanctions under section 1877(g) of the Act against any individuals or 
entities that are parties to an arrangement that CMS determines is 
indistinguishable in all material aspects from an arrangement that was 
the subject of the advisory opinion. All facts relied on and 
influencing a legal conclusion in an issued favorable advisory opinion 
are material; deviation from that set of facts would result in a party 
not being able to claim the protection proposed in Sec.  411.387(b). A 
favorable advisory opinion with respect to one arrangement would not 
legally preclude CMS from pursuing violations against parties to a 
different arrangement. In practice, the Secretary will not use CMS 
enforcement resources for purposes of imposing sanctions under section 
1877(g) of the Act to investigate the actions of parties to an 
arrangement that CMS believes is materially indistinguishable from an 
arrangement that has received a favorable advisory opinion. As 
discussed above, such a determination would not preclude a finding by 
DOJ or OIG that the arrangement violates a law other than the physician 
self-referral law, including but not limited to the anti-kickback 
statute. If parties to an arrangement are uncertain as to whether CMS 
would view it as materially indistinguishable from an arrangement that 
has received a favorable advisory opinion, then those parties can 
submit an advisory opinion request. We solicited comment on this 
approach.
    Finally, we also proposed at Sec.  411.387(c) to recognize that 
individuals and entities may reasonably rely on an advisory opinion as 
non-binding guidance that illustrates the application of the physician 
self-referral law and regulations to specific facts and circumstances. 
We acknowledge that stakeholders already look to advisory opinions 
issued by CMS to inform their decision-making, and these changes will 
make clear that CMS acknowledges that such reliance is permissible and 
reasonable. We requested comments on all aspects of these proposals.
    The following is a summary of the comments we received on our 
proposals and our responses.
    Comment: Commenters were supportive of our proposals to remove the 
restrictions on the individuals and entities that can rely on an 
advisory opinion. These commenters stated that these modifications will 
help reduce confusion about compliance with the physician self-referral 
law, enhance utilization of the advisory opinion process, and maximize 
the ability of health care entities to innovate and form beneficial 
business arrangements.
    Response: We appreciate the support for these proposals, which we 
agree will remove unnecessary restrictions on how regulated individuals 
and entities can use advisory opinions to guide their decisions and aid 
in compliance activities.
    Comment: Several commenters encouraged CMS to continue publishing 
advisory opinions on its website, with identifiers and any privileged, 
confidential or proprietary information redacted. At least one 
commenter suggested that CMS publish an annual reporting summarizing 
the number of advisory opinions issued and statistics such as the 
number of advisory opinion requests submitted, the number withdrawn, 
and information on compliance with regulatory timelines.
    Response: We will continue to publish advisory opinions on our 
website as well as redact information that identifies the requestors 
and other specific parties. We encourage potential requestors to review 
the Department's regulations at 45 CFR part 5, which explain how to 
identify and protect confidential commercial information. We appreciate 
the suggestion regarding annual statistics on the number of advisory 
opinion requests received each year, and the disposition of those 
requests. We are not making any regulatory changes to address this 
comment, but we will consider publishing such statistics for the next 
calendar year.
    Comment: A few commenters pointed out that accountable care 
organization (ACO) arrangements can take on a variety of forms, so any 
single ACO arrangement may be substantially similar, but not identical 
to, another ACO arrangement that has been the subject of a favorable 
advisory opinion. These commenters urged CMS to consider how we might 
adopt a more flexible approach to enable parties to an ACO to rely on 
an advisory opinion issued to a substantially similar ACO.
    Response: Under the regulations we are adopting in this final rule, 
at Sec.  411.387(c), ACO participants could rely on an advisory opinion 
as non-binding guidance, even if their ACO arrangement is substantially 
similar to but not the same as the arrangement that is the subject of 
the advisory opinion. If the ACO's participants wanted more certainty 
as to whether CMS would view the factual differences as material, the 
ACO participants--subject to the physician self-referral law--could 
request their own advisory opinion through the expedited pathway. If we 
determined that the arrangement was materially distinct from others 
that have been the subject of favorable advisory opinions, the 
requestors would have the option of requesting a new advisory opinion 
through the normal process.
    Comment: Several commenters suggested that CMS should make clear in 
its regulations that reasonable reliance on an advisory opinion is 
sufficient to defeat a claim under the False Claims Act that a 
physician or entity knowingly submitted a false claim as a result of a 
violation of the physician self-referral law.
    Response: We are not authorized to and do not enforce the False 
Claims Act, and our authority to issue regulations governing the 
advisory opinion process does not give us the authority to issue 
regulations interpreting elements of the False Claims Act. We note that 
a favorable advisory opinion means that CMS has determined that 
specific referrals for designated health services referrals under the 
arrangement in question are not prohibited under section 1877 of the 
Act (as limited to the individuals or entities requesting the opinion 
and any individuals or entities that are parties to the specific 
arrangement with respect to which the favorable advisory opinion is 
issued so long as the specific arrangement as implemented does not 
deviate from the material facts upon which the advisory opinion is 
based).
    Comment: A few commenters requested that individuals who join 
arrangements that are the subject of issued advisory opinions have 
those advisory opinions apply to them retrospectively.
    Response: We appreciate this suggestion, however the applicability 
of an advisory opinion to an individual

[[Page 62944]]

joining the arrangement that is the subject of the issued advisory 
opinion would be a fact-specific determination.
    As a result of the comments, we are finalizing the proposed 
modifications to Sec.  411.387.
g. Rescission (Sec.  411.382)
    Under current Sec.  411.382, CMS may rescind or revoke an advisory 
opinion after it is issued if CMS determines that it is in the public 
interest to do so. To date, CMS has not rescinded an advisory opinion. 
At the time we finalized this regulation, which is modeled on OIG's 
rescission authority regulation, we sought comment on whether this 
approach reasonably balanced the government's need to ensure that 
advisory opinions are legally correct and the requestor's interest in 
finality (63 FR 1653). We again requested comment on this issue. 
Specifically, we solicited comments on whether CMS should retain a more 
limited right to rescind an advisory opinion; that is, CMS could 
rescind an advisory opinion only when there is a material regulatory 
change that impacts the conclusions reached, or when a party has 
received a negative advisory opinion and wishes to have the agency 
reconsider the request in light of new facts or law.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters generally supported limiting the grounds upon 
which CMS would rescind an advisory opinion. Specifically, most 
commenters agreed that rescission would be appropriate when there is a 
material regulatory change that affects the conclusions reached in an 
issued advisory opinion, or when a party that has received a negative 
advisory opinion wishes to have the agency reconsider the request in 
light of new facts or law.
    Response: We appreciate the feedback on the advisory opinion 
rescission policy, and agree that the proposed regulatory modification 
is warranted to provide regulated individuals and entities with greater 
clarity regarding when CMS believes a rescission may be appropriate. We 
are therefore modifying Sec.  411.382(a) to provide that CMS may 
rescind an advisory opinion if it determines that there is good cause 
to rescind the opinion. In addition, we are modifying Sec.  411.382(a) 
to provide that ``good cause'' exists when (i) there is a material 
change in the law that affects the conclusions reached in an opinion; 
or (ii) a party that has received a negative advisory opinion seeks 
reconsideration based on new facts or law.
    Comment: Many commenters encouraged CMS to provide adequate notice 
to affected parties and provide adequate time for parties to wind down 
existing arrangements. Several commenters suggested that CMS allow for 
a wind-down period. These commenters differed on the appropriate length 
of a wind-down period. Suggestions included 90 days, 120-180 days, and 
3-5 years. Several commenters also suggested that CMS provide for a 
reasonable period of public notice of no less than 30 days, given the 
expectation that non-requesting parties will rely on issued advisory 
opinions. Commenters also requested assurance that CMS would not apply 
an advisory opinion rescission or revocation in a retrospective manner.
    Response: Our current regulations at Sec.  411.382 already provide 
flexibility for CMS to allow for a reasonable ``wind down'' period to 
discontinue activities that are the subject of a rescinded advisory 
opinion. Because every arrangement is unique, and because the allowance 
of a wind down period amounts to an exercise of agency enforcement 
discretion, we do not believe it is appropriate for us to establish a 
minimum wind-down period in regulations. In the event that CMS does, in 
the future, rescind an advisory opinion, we will work with affected 
parties to determine a reasonable and appropriate wind down period.
    We appreciate commenters' suggestions regarding public notice of a 
potential rescission. We agree that providing public notice is 
appropriate given our expectation that non-requesting parties may be 
relying on an issued advisory opinion to guide their decisions and 
conduct. We are therefore finalizing an amendment to Sec.  411.382 that 
provides for advance notice to both the requestor and the public.
    As a result of the comments, we are finalizing changes to Sec.  
411.382 that will codify the limited instances that a rescission would 
be appropriate.
h. Other Modifications to Procedural Requirements
    We proposed minor modifications to Sec.  411.372 to improve 
readability and clarity. We also proposed to eliminate the reference to 
the provision of stock certificates as part of the advisory opinion 
request submission, as these are typically electronic and may not 
necessarily list the name of the owner. We requested comments on these 
and other updates to the procedure for submitting an advisory opinion 
request that will improve the efficiency of the review process.
    Comment: At least one commenter stated that our proposed 
modifications to the advisory opinion process did not address what they 
view as a disconnect between the OIG's enforcement of the anti-kickback 
statute and CMS' enforcement of the physician self-referral law. This 
commenter stated that the lack of a process to obtain joint agency 
advisory opinions on specific fact scenarios limits the ability of 
stakeholders to understand how the two agencies may interpret the two 
laws differently when reviewing the same factual situation. The 
commenter said it would be optimal if there were a joint process to 
obtain both agencies' input on hypothetical arrangements or questions 
of general applicability. They also said such a joint process would 
further the Administration's goal of reducing regulatory burden on 
providers.
    Response: We appreciate this comment and recognize that the 
physician self-referral advisory opinion process, standing alone, 
cannot give a regulated party certainty that its course of conduct is 
protected from scrutiny under the anti-kickback statute, even if that 
party has received a favorable advisory opinion from CMS regarding the 
arrangement in question. Currently, the timelines for issuing advisory 
opinions differ under the respective CMS and OIG regulations. 
Therefore, establishing a joint process is not feasible. However, we 
will consider how we could achieve greater alignment with the OIG 
process in the future.
    Comment: One commenter suggested that the agency explore whether it 
has legislative authority to issue opinions that offer protection for 
arrangements even if they may not squarely fit within an exception, but 
pose no significant risk of harm.
    Response: Due to the nature of the physician self-referral law, we 
do not have the legislative authority to protect referrals of 
designated health services that are furnished in violation of the law, 
even if it is the belief of the parties that the referrals are made 
pursuant to an arrangement that does not pose a significant risk of 
harm. Section 1877(g)(1) of the Act states that ``no payment may be 
made'' for prohibited referrals, and section 1877(g)(6) of the Act 
limits the scope of our advisory opinion authority to questions of 
whether or not a referral related to designated health services is 
prohibited. The commenter's request would require legislative change.

[[Page 62945]]

K. CY 2020 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This section of the final rule sets forth changes to the Quality 
Payment Program starting January 1, 2020, except as otherwise noted for 
specific provisions. The 2020 performance period of the Quality Payment 
Program will build upon the foundation that has been established in the 
first 3 years of the program, which provides a trajectory for 
clinicians moving to performance-based payments, and will gradually 
prepare clinicians for the 2022 MIPS performance period of the program 
and the 2024 MIPS payment year. Participation in both tracks of the 
Quality Payment Program--Advanced Alternative Payment Models (APMs) and 
Merit-based Incentive Payment System (MIPS)--has increased from 2017 to 
2018.\113\ The number of QPs--Qualifying APM Participations--nearly 
doubled from 2017 to 2018, from 99,076 to 183,306 clinicians. In MIPS, 
98 percent of eligible clinicians participated in 2018, up from 95 
percent in 2017. As the Quality Payment Program continues to mature, 
CMS recognizes additional long-term improvements will need to occur. We 
have taken stakeholder input into consideration to ensure that we 
continue to implement the Quality Payment Program as required while 
smoothing the transition where possible and offering targeted 
educational resources for program participants. For example, in an 
effort to get broad feedback on our MIPS Value Pathways (MVPs) 
participation framework we held a public webinar specifically focused 
on the topic, conducted 7 listening sessions with various stakeholder 
groups throughout the proposed rule comment period, and engaged with 
clinicians and others through several other public forums. We plan to 
continue engaging with clinicians and other stakeholders as we move 
forward developing the MVPs.
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Results at a Glance https://qpp-cm-prod-content.s3.amazonaws.com/uploads/586/2018%20QPP%20Participation%20Results%20Infographic.pdf.
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    While we continue efforts to strengthen the Quality Payment 
Program, we remain interested in clinician participation and engagement 
in the program, particularly as initial MVPs are developed for the 2021 
MIPS performance period. We have been given flexibility in establishing 
the cost performance category weight and performance threshold in the 
early years of the Quality Payment Program. The Bipartisan Budget Act 
of 2018 (BBA 2018) (Pub. L. 115-123, enacted February 9, 2018) extended 
the flexibility and transition years within the Quality Payment 
Program. Beginning with the 2024 MIPS payment year (2022 performance 
period), as required by law, the cost performance category under MIPS 
will be weighted at 30 percent and the performance threshold will be 
set at the mean or median of the final scores for all MIPS eligible 
clinicians with respect to a prior period specified by the Secretary. 
The provisions of this rule are intended to recognize our reduced 
flexibility beginning with the 2024 MIPS payment year and continue to 
put clinicians in a position to make the transition as required by 
statute.
b. Summary of Major Provisions
(1) MIPS Value Pathways
    We are committed to the transformation of MIPS, which will allow 
for: More streamlined and cohesive reporting; enhanced and timely 
feedback; and the creation of MVPs of integrated measures and 
activities that are meaningful to all clinicians from specialists to 
primary care clinicians and to patients. The new MVPs will remove 
barriers to APM participation and promote value by focusing on quality 
and cost measure and improvement activities built on foundational 
global or population quality measures calculated from claims-based 
quality data and promoting interoperability concepts.
    In the CY 2020 PFS proposed rule (84 FR 40735), we proposed to 
apply a new MVP framework beginning with the 2021 MIPS performance 
period/2023 MIPS payment year to simplify MIPS, improve value, reduce 
burden, help patients compare clinician performance, and better inform 
patient choice in selecting clinicians. As discussed in section 
III.K.3.a.(2) of this final rule, we are finalizing a modified proposal 
to define MVPs at Sec.  414.1305 as a subset of measures and activities 
established through rulemaking.
    Additionally, we will work with stakeholders to develop MVPs as a 
cohesive and meaningful participation experience for clinicians with an 
aligned set of measures and activities that are more relevant to a 
clinician's scope of practice, while further reducing reporting burden 
and easing the transition to APMs. We refer readers to the CY 2020 PFS 
proposed rule (84 FR 40732 through 40745) for more information on the 
MVP framework.
(2) Other Major MIPS Provisions
    In addition to the MVP framework, we are finalizing two significant 
proposals for the 2020 MIPS performance period:
     As discussed in section III.K.3.g.(3) of this final rule, 
we are finalizing the proposal to strengthen the Qualified Clinical 
Data Registry (QCDR) measure standards for MIPS to require measure 
testing, harmonization, and clinician feedback to improve the quality 
of QCDR measures available for clinician reporting. These policies 
relate to CY 2020 and CY 2021 for QCDRs.
     As discussed in section III.K.3.c.(2)(b)(iii) of this 
final rule, we are finalizing the proposed episode-based measures in 
the cost performance category to more accurately reflect the cost of 
care that specialists provide. Further, we are also finalizing the 
revised total per capita cost and the Medicare Spending Per Beneficiary 
(MSPB) measures.
    After consideration of public comments, we are not finalizing two 
significant proposals:
     As discussed in section III.K.3.c.(2)(a) of this final 
rule, we are not finalizing our proposal to weight the cost performance 
category at 20 percent for the 2022 MIPS payment year. Instead, we are 
continuing to weight the cost performance category at 15 percent in 
light of concerns noted regarding more detailed and actionable 
performance feedback. Hence, we are also continuing to weight the 
quality performance category, discussed in section III.K.3.c.(1)(b) of 
this final rule, at 45 percent. However, we will revisit increasing the 
weight of the cost performance category in next year's rulemaking to 
ensure clinicians are prepared for the significant increase in category 
weight by the 2024 MIPS payment year.
     As discussed in section III.K.3.e.(3) of this final rule, 
we are not finalizing our proposal to set the additional performance 
threshold at 80 points for the 2022 MIPS payment year and instead are 
finalizing the additional performance threshold at 85 points for the 
2022 MIPS payment year. We are also finalizing the additional 
performance threshold at 85 points for the 2023 MIPS payment year.
(3) Major APM Provisions
(a) Aligned Other Payer Medical Home Models
    We are finalizing the proposal to add the defined term, Aligned 
Other Payer Medical Home Model, to Sec.  414.1305. The definition of 
Aligned Other Payer Medical Home Model includes the same 
characteristics as the definitions of

[[Page 62946]]

Medical Home Model and Medicaid Medical Home Model, but it applies to 
other payer payment arrangements. We believe that structuring this 
definition in this manner is appropriate because we recognize that 
other payers could have payment arrangements that may be appropriately 
considered medical home models under the All-Payer Combination Option.
    Neither the current Medical Home Model financial risk and nominal 
amount standards nor the Medicaid Medical Home Model financial risk and 
nominal amount standards apply to other payer payment arrangements. 
Consistent with our decision to finalize our proposal to define the 
term Aligned Other Payer Medical Home Model, we are finalizing our 
proposal to amend Sec.  414.1420(d)(2), (d)(4), and (d)(8) to apply the 
same Medicaid Medical Home Model financial risk and nominal amount 
standards, including the 50 eligible clinician limit, to Aligned Other 
Payer Medical Home Models.
(b) Marginal Risk for Other Payer Advanced APMs
    We are finalizing our proposal to modify our definition of marginal 
risk when determining whether a payment arrangement is an Other Payer 
Advanced APM. We proposed that, in the event that the marginal risk 
rate varies depending on the amount by which actual expenditures exceed 
expected expenditures, we will compare the average marginal risk rate 
across all possible levels of actual expenditures to the marginal risk 
rate specified in the Other Payer Advance APM financial risk criterion, 
with exceptions for large losses and small losses, as described in 
Sec.  414.1420(d). When considering average marginal risk in the 
context of total risk, we believe that certain risk arrangements can 
create meaningful and significant risk-based incentives for performance 
and at the same time ensure that the payment arrangement has strong 
financial risk components.
(c) Estimated APM Incentive Payments and MIPS Payment Adjustments
    As we discuss in section VII.F.10.a. of this final rule, for the 
2022 payment year and based on estimated Advanced APM participation 
during the 2020 QP Performance Period, we estimate that between 210,000 
and 270,000 clinicians will become Qualifying APM Participants (QPs). 
Eligible clinicians who are QPs for the 2022 payment year are excluded 
from the MIPS reporting requirements and payment adjustment and will 
receive a lump sum APM Incentive Payment equal to 5 percent of their 
aggregate payment amounts for covered professional services for the 
year prior to the payment year. We estimate that the total lump sum APM 
Incentive Payments will be approximately $535-685 million for the 2022 
Quality Payment Program payment year.
    We estimate that there will be approximately 879,966 MIPS eligible 
clinicians for the 2020 MIPS performance period in section 
VII.F.10.b.(1)(b) of this final rule. The final number will depend on 
several factors, including the number of eligible clinicians excluded 
from MIPS based on their status as QPs or Partial QPs, the number that 
report as groups, and the number that elect to opt into MIPS in 
accordance with Sec.  414.1310(b)(1)(ii). In the 2022 MIPS payment 
year, MIPS payment adjustments, which only apply to payments for 
covered professional services furnished by a MIPS eligible clinician, 
will be applied based on a MIPS eligible clinician's performance on 
specified measures and activities within four integrated performance 
categories. We estimate that MIPS payment adjustments will be 
approximately equally distributed between negative MIPS payment 
adjustments ($433 million) and positive MIPS payment adjustments ($433 
million) to MIPS eligible clinicians, as required by the statute to 
ensure budget neutrality. Up to an additional $500 million is also 
available for the 2022 MIPS payment year for additional positive MIPS 
payment adjustments for exceptional performance for MIPS eligible 
clinicians whose final score meets or exceeds the additional 
performance threshold of 85 points that we are finalizing in section 
III.K.3.e.(3) of this final rule. However, the distribution will change 
based on the final population of MIPS eligible clinicians for the 2022 
MIPS payment year and the distribution of final scores under the 
program.
2. Definitions
    At Sec.  414.1305, we are finalizing definitions of the following 
terms:
     Aligned Other Payer Medical Home Model.
     Hospital-based MIPS eligible clinician.
     MIPS Value Pathway.
    We are also finalizing revisions to the following definition at 
Sec.  414.1305:
     Rural area.
    These terms and definitions are discussed in detail in relevant 
sections of this final rule.
3. MIPS Program Details
a. Transforming MIPS: MIPS Value Pathways
(1) Overview
    In the CY 2020 PFS proposed rule, we proposed an MVP definition 
that would prepare us to apply a new MVP framework beginning with the 
2021 MIPS performance period. This MVP framework would simplify MIPS, 
improve value, reduce burden, help patients compare clinician 
performance, and better inform patient choice in selecting clinicians. 
We refer readers to the CY 2020 PFS proposed rule (84 FR 40732 through 
40745) for more information on the MVP framework and the proposed MVP 
definition.
(2) Implementing MVPs
    In the CY 2020 PFS proposed rule (84 FR 40735), we described the 
MVP framework and proposed to define a MIPS Value Pathway at Sec.  
414.1305 as a subset of measures and activities specified by CMS. We 
noted that MVPs may include, but will not be limited to, administrative 
claims-based population health, care coordination, patient-reported 
(which may include patient reported outcomes, or patient experience and 
satisfaction measures), and/or specialty/condition specific measures. 
The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the MVP framework and 
proposed definition of an MVP because this could potentially reduce the 
complexity of the MIPS program and clinician burden. Many commenters 
agreed with the intent of the MVP framework to simplify MIPS, reduce 
burden, make the program more meaningful for clinicians and reduce 
barriers to movement into APMs.
    Response: We thank commenters for their support.
    Comment: Several commenters stated that the MVP framework was a 
positive first step and they would like to see further burden reduction 
beyond clinician measure selection burden, including the elimination of 
the siloed requirements and scoring approaches for each of the four 
performance categories. Several commenters suggested streamlined 
reporting or automatic credit for Promoting Interoperability and 
Improvement Activities performance categories. Several commenters 
recommended that participation in a specialty accreditation program 
earn credit as an improvement activity. Several commenters suggested 
the use of measures that satisfy the requirements of multiple 
performance

[[Page 62947]]

categories in MVPs. A few commenters provided an example of linking 
measures: One example was to allow a clinician to report the quality 
measure, Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%), and the 
improvement activity, Glycemic Screening Services (IA_PM_19) to receive 
credit for a quality measure and improvement activity.
    Response: We intend to develop MVPs in collaboration with 
stakeholders that align with guiding principles that include 
simplification and clinician burden reduction. We intend to work with 
stakeholders to develop MVPs that account for variation in specialty, 
size, and composition of clinician practices. We also intend that MVPs 
would allow for a more cohesive participation experience by connecting 
activities and measures from the 4 MIPS performance categories that are 
relevant to a patient population, a specialty or a medical condition, 
reducing the siloed nature of the current MIPS participation 
experience. We believe it is important to develop MVPs in unison with 
stakeholders to create low burden, meaningful MVPs that move clinicians 
along the value continuum and facilitate movement into APMs. Experience 
with MVPs that measure quality of care and patient experience of care, 
cost, continuous practice improvement, and effective management and 
transfers of health information will help to reduce barriers to APM 
participation. We would like to work with stakeholders to identify 
specialty accreditation programs, such as the American College of 
Surgeons' Commission on Cancer Accreditation program that demonstrate a 
commitment to quality improvement and alignment with MIPS quality 
measures. We intend to develop MVPs to connect measures across 
performance categories as indicated by the commenter's diabetes example 
above. We note that the MIPS statute requires the use of four 
performance categories now called Quality, Cost, Improvement 
Activities, and Promoting Interoperability in determining the MIPS 
composite performance score. While each performance category has its 
own requirements and associated list of measures or activities, it is 
possible that a single measure or activity may meet the respective 
criteria for inclusion in more than one performance category; however, 
we do not currently have any multicategory MIPS or QCDR measures 
available. We would be interested in working with stakeholders to pair 
the improvement activities and quality and cost measures, while 
leveraging foundational global or population health measures and 
Promoting Interoperability measures that would constitute an MVP. We 
are interested in the potential use of measures that could satisfy more 
than one of the four MIPS performance categories within our statutory 
constraints and welcome additional stakeholder engagement related to 
how to best structure and develop MVPs that entail low clinician 
burden. Feedback and suggestions will be considered as we undertake 
further rulemaking in future years.
    Comment: Many commenters indicated conditional support for the MVP 
framework, with concerns about the timeline and transition to MVPs in 
CY 2021. Many commenters requested a longer and more gradual timeline 
for MVP implementation. Several commenters suggested delaying MVP 
implementation by 1 year to CY 2022, while several others suggested a 
delay of a few years, with a few specifying a 2-year delay. Many 
commenters stated concerns that implementation in the 2021 MIPS 
performance period will not allow enough time to develop MVPs for all 
specialists, and several commenters indicated concerns about the time 
needed to educate clinicians on the use of MVPs. Many commenters 
supported MVPs as a voluntary reporting option in addition to the 
currently available options for MIPS participation. Several commenters 
recommended that MVPs be optional during a transition period. Several 
commenters supported the proposed MVP definition provided that MVPs are 
implemented as a voluntary gradual or multiyear pilot, allowing 
development and clinician MVP education time. A few commenters 
indicated that there is a need for stability in the Quality Payment 
Program and urged caution with implementation of the MVP framework.
    Response: We have not made any proposals regarding whether 
participation in MVPs will be mandatory or optional. We appreciate that 
we need to work diligently with stakeholders to develop and propose 
policies regarding many aspects of implementation of MVPs in the 2021 
MIPS performance period, including the extent of first year 
implementation or the feasibility of an initial pilot. Feedback and 
suggestions will be considered as we undertake further rulemaking in 
future years.
    Comment: A few commenters did not support implementing the MVP 
framework stating that the MVPs would create too much change and 
clinician confusion with a few commenters stating that MVPs would not 
serve the needs of their specialty (for example, dermatology, nurse 
practitioners, physician assistants, occupational therapy, audiology, 
speech language pathology), indicating insufficient numbers of quality 
measures for the specialty. A few commenters stated that certain 
clinician types, for example, nurse practitioners, have only a single 
Medicare specialty designation but practice in diverse specialty areas 
and that a limited number of potentially assigned MVPs may leave some 
clinicians out. A few commenters indicated that specialty clinicians 
would need either multiple MVPs or an MVP with a wide variety of 
measures and activities, because of the range of services provided by a 
specialty. For example, surgeons provide a wide range of procedures 
from neurosurgery to spine care. A few commenters indicated that 
clinicians new to MIPS reporting should have a delayed MVP timeline. A 
few commenters stated that the MVPs, as described, would not be able to 
meet the stated goals because MVPs may reduce the burden of measure 
selection, but will not reduce the overall burden of participating in 
MIPS, which the commenters indicated would require removing separate 
requirements for scoring and reporting for each of the performance 
categories. Many commenters did not support transitioning towards MVPs 
because this would reduce clinician choice in the selection of measures 
and activities; and may rely on measures and activities, including 
population health measures, viewed as not relevant to the clinician's 
clinical practice.
    Response: We believe achieving the goals of the MVP framework are 
worthwhile and understand the need to introduce change that is balanced 
against the burden required for clinicians to change workflows and 
participate in the program. A notable change for MIPS eligible 
clinicians with MVPs is that they would no longer select quality 
measures or improvement activities from a single inventory. Instead, 
measures and activities in an MVP would be connected around a clinician 
specialty or a clinical condition. We welcome ideas from stakeholders 
for developing MVPs that provide further burden reduction to 
clinicians. We acknowledge that a single MVP may not fit the needs of 
all clinician types and all clinicians in the specialty and would like 
to work with stakeholders to determine, to the extent possible, the 
number of MVPs needed for specialists and which measures and activities 
should be included. We would like to engage with clinicians in the 
field and their societies to develop applicable MVPs and foundational

[[Page 62948]]

population health administrative claims measures that are low burden 
and meaningful. We believe that holding all clinicians accountable for 
the same population health measures will align incentives, encourage 
coordination between clinicians and promote meaningful progress on 
measures. We seek ongoing engagement with stakeholders to identify 
population health measures that will drive collaborative, high-quality 
and timely care. We believe that ongoing engagement with stakeholders 
will lead to improved clinicians' experience with the Quality Payment 
Program and drive meaningful change in the delivery system. We will 
consider this feedback on how to best transition to MVPs and how to 
optimally include MVPs that meet the needs of all clinician 
specialties.
    Comment: Several commenters requested additional information about 
how equity would be maintained between clinicians reporting on MVPs and 
those using the currently available MIPS participation options, as well 
as between clinicians reporting on different MVPs, indicating a concern 
that one MIPS participation option or MVP should not be `easier' than 
others.
    Response: We agree that equity is critical to MVP implementation 
and requested feedback on approaches we should take to create equity 
across MVPs and across clinician types (84 FR 40742). We intend to work 
with stakeholders to determine approaches to maintain equity between 
MVP and the MIPS participation option, as well as clinicians reporting 
on different MVPs. This feedback will inform our process development as 
we further develop our MVP framework and unique MVPs and undertake 
future rulemaking.
    Comment: Many commenters expressed concerns related to the 
population health claims-based performance measures that would be 
selected for use in MVPs. Many commenters did not support the use of 
population health claims-based measures in MVPs because of reliability, 
validity, attribution, lack of risk adjustment, actionability concerns, 
and/or unintended consequences concerns. Several commenters supported 
foundational use of population health claims-based measures, with a few 
commenters supporting use of administrative measures that are 
consistent with Advanced APM measures stating that administrative 
measures can assess quality across time and the delivery system without 
clinician reporting and can be applied to various clinician types 
including specialties.
    Response: We intend to work in close partnership with stakeholders 
to identify measures and activities to include in MVPs. Our vision for 
MVPs is to connect the four performance categories while using a 
foundational layer of population health claims-based measures and 
interoperability on which to build quality, cost and improvement 
activity linkages. Please refer to the on line MVP graphic (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/587/MIPS%20Value%20Pathways%20Diagrams.zip) that provides an overview of 
our vision for the MIPS future state. Implementation of a foundational 
population health core measure set using administrative claims-based 
quality measures that can be broadly applied to communities or 
populations can result in MVP measure tracks that provide more 
uniformity in the program's measures, reduce clinician reporting 
burden, allow focus on important public health priorities, increase the 
value of MIPS performance data, and reduce barriers to APM 
participation. Additionally, we intend to examine these concerns 
regarding population health measure reliability, validity, attribution 
and risk adjustment and the technical challenges and address them to 
the extent feasible by working with the measure stewards and clinician 
experts. We believe that interoperability is also a foundational 
element that would apply to all clinicians, regardless of MVP, for whom 
the Promoting Interoperability performance category is required. We 
envision an initial uniform set of Promoting Interoperability measures 
in each MVP and will consider customizing MVP Promoting 
Interoperability measures in future years. We believe that eligible 
clinicians could benefit from more targeted approaches that assess the 
meaningful use of health IT in alignment with clinically relevant MVPs. 
The integration of population health measures and Promoting 
Interoperability measures into MVPs provides a degree of 
standardization across all clinician types and promotes an 
infrastructure on which to assess and improve value-based care. Measure 
feedback and suggestions will be considered as we undertake further 
rulemaking in future years.
    Comment: Many commenters indicated that a critical element of 
specifying the measures and activities within an MVP will be 
stakeholder engagement. Many commenters urged us to work in tandem with 
clinicians and specialty societies to develop MVPs. A few other 
commenters suggested that specialty societies should develop MVPs. A 
few commenters urged us to work with multi-stakeholder consensus-based 
organizations such as the Core Quality Measures Collaborative and to 
utilize existing specialty measure set development approaches to 
identify a list of measures for each MVP. A few commenters suggested 
that we allow stakeholders to comment on the detailed methodologies of 
a future MVP design and implementation plan as they become more fully 
developed.
    Response: We appreciate the commenters' recommendations on how the 
measures and activities should be specified in the MVPs and for 
articulating the critical importance of stakeholder engagement in MVP 
development. In recognition of our intention to specify MVPs with 
stakeholder input to the extent possible, we are modifying the proposed 
definition of MVP at Sec.  414.1305, by replacing the words, ``as 
specified by CMS'' with ``established through rulemaking''.
    After consideration of the comments, we are finalizing a 
modification of our proposal. Specifically, we are finalizing at Sec.  
414.1305 that MIPS Value Pathway means a subset of measures and 
activities established through rulemaking.
(3) Requests for Feedback on MVPs
    In the CY 2020 PFS proposed rule (84 FR 40739 through 40745), we 
requested public comments regarding several issues involving the MVPs. 
We received 2,100 comments related to implementation of MVPs. While we 
are not summarizing and responding to comments we received in this 
final rule, we thank the commenters for their responses and may take 
them into account as we develop future policies for the MVPs. We also 
are interested in engaging with stakeholders on additional ways to 
reduce burden in the MIPS program, in addition to what we have 
solicited comment on for MVPs. For example, in the context of MVPs, we 
are interested in solutions to reduce burden across all 4 MIPS 
categories such as use of standards such as Fast Healthcare 
Interoperability Resources (FHIR), number of measures across 
categories, reporting timeframes and data submission methods. We intend 
to continue a dialogue with stakeholders on these important MVP topics 
and may consider convening public forum listening sessions, webinars, 
and office hours or using additional opportunities such as the pre-
rulemaking process to further understand what is important to 
clinicians, patients, and stakeholders

[[Page 62949]]

and obtain further input as we develop MVPs.
b. Group Reporting
    For previous discussions of the policies for group reporting, we 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77070 through 77073) and the CY 2018 Quality Payment Program final rule 
(82 FR 53592 through 53593). In addition, for previous discussions of 
the policies for group reporting related to the Promoting 
Interoperability performance category, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 77214 through 77216) and the 
CY 2018 Quality Payment Program final rule (82 FR 53687).
    As discussed in the CY 2020 PFS proposed rule (84 FR 40745), it has 
come to our attention that the regulation text regarding group 
reporting at Sec.  414.1310(e)(3) through (5) contains duplicative 
language. Specifically, it is duplicative of the regulation text at 
Sec.  414.1310(e)(2)(ii) through (iv). To avoid redundancy and 
potential confusion, we proposed to remove Sec.  414.1310(e)(3) through 
(5). In addition, we have noticed that previously established policies 
for group reporting with regard to the Promoting Interoperability 
performance category (81 FR 77214 through 77216, 82 FR 53687) are not 
reflected in the regulation text for group reporting at Sec. Sec.  
414.1310(e)(2)(ii) and for virtual groups at Sec.  414.1315(d)(2). In 
the CY 2017 Quality Payment Program final rule (81 FR 77215), we stated 
that to report as a group for the Promoting Interoperability 
performance category, the group will need to aggregate data for all of 
the individual MIPS eligible clinicians within the group for whom they 
have data in CEHRT. In an effort to more clearly and concisely capture 
our existing policy for the Promoting Interoperability performance 
category, we proposed to revise Sec. Sec.  414.1310(e)(2)(ii) and 
414.1315(d)(2). Specifically, we proposed to revise Sec.  
414.1310(e)(2)(ii) to state that individual eligible clinicians that 
elect to participate in MIPS as a group must aggregate their 
performance data across the group's TIN, and for the Promoting 
Interoperability performance category, must aggregate the performance 
data of all of the MIPS eligible clinicians in the group's TIN for whom 
the group has data in CEHRT.
    Similarly, we proposed to revise Sec.  414.1315(d)(2) to state that 
solo practitioners and groups of 10 or fewer eligible clinicians that 
elect to participate in MIPS as a virtual group must aggregate their 
performance data across the virtual group's TINs, and for the Promoting 
Interoperability performance category, must aggregate the performance 
data of all of the MIPS eligible clinicians in the virtual group's TINs 
for whom the virtual group has data in CEHRT.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the clarification of the 
regulation text on group reporting and the need to aggregate the 
performance data across the group's TIN.
    Response: We appreciate the commenters' support.
    Comment: One commenter sought clarification regarding whether a 
virtual group needs to aggregate Promoting Interoperability performance 
data through reports or if the aggregation can be done manually prior 
to attestation. A few commenters sought clarification on whether there 
is a percentage of MIPS eligible clinicians that must have CEHRT for 
the group to attest due to their belief that the language as stated 
could be used to allow a group to only implement 2015 CEHRT for certain 
clinicians instead of across the entire TIN.
    Response: If all the clinicians in a group or virtual group share 
the same CEHRT, the reports from CEHRT will include all of their data. 
However, if they are using different CEHRT, they will have to run the 
reports for each iteration of CEHRT and manually perform the 
aggregation. We did not establish a threshold for the percentage of 
MIPS eligible clinicians that must be using CEHRT in order for the 
group to report for MIPS as a group. The group must submit data for all 
of the MIPS eligible clinicians in the group for whom the group has 
data in CEHRT.
    After consideration of the comments, we are finalizing these 
proposals, as proposed. Specifically, we are finalizing the proposals 
to: (1) Remove Sec.  414.1310(e)(3) through (5); (2) revise Sec.  
414.1310(e)(2)(ii) to state that individual eligible clinicians that 
elect to participate in MIPS as a group must aggregate their 
performance data across the group's TIN, and for the Promoting 
Interoperability performance category, must aggregate the performance 
data of all of the MIPS eligible clinicians in the group's TIN for whom 
the group has data in CEHRT; and (3) revise Sec.  414.1315(d)(2) to 
state that solo practitioners and groups of 10 or fewer eligible 
clinicians that elect to participate in MIPS as a virtual group must 
aggregate their performance data across the virtual group's TINs, and 
for the Promoting Interoperability performance category, must aggregate 
the performance data of all of the MIPS eligible clinicians in the 
virtual group's TINs for whom the virtual group has data in CEHRT.
c. MIPS Performance Category Measures and Activities
(1) Quality Performance Category
(a) Background
    We refer readers to Sec.  414.1330 through Sec.  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 2020 PFS proposed rule (84 FR 40745 through 40746), we:
     Proposed to weigh the quality performance category at 40 
percent for the 2022 MIPS payment year, 35 percent for the 2023 MIPS 
payment year, 30 percent for the 2024 MIPS payment year as described in 
Sec.  414.1330(b)(4), (5), and (6); the associated increases to the 
weight of the cost performance category are discussed in section 
III.K.3.c. (2) of this final rule;
     Solicited comment on adding narratives to the CAHPS for 
MIPS survey and on whether the survey should collect data at the 
individual eligible clinician level;
     Proposed to increase of the data completeness criteria to 
70 percent for the 2022 MIPS payment year as described in Sec.  
414.1340(b)(3);
     Proposed to require MIPS quality measure stewards to link 
their MIPS quality measures to existing and related cost measures and 
improvement activities, as applicable and feasible;
     Solicited comment as to whether we should consider 
realigning the MIPS quality measure update cycle with that of the eCQM 
annual update process;
     Proposed changes to the MIPS quality measure set as 
described in Appendix 1 of this proposed rule, including: Substantive 
changes to existing measures, addition of new measures, removal of 
existing measures, and updates to specialty sets;
     Solicited comment on whether we should increase the data 
completeness threshold for extremely topped out quality measures that 
are retained in the program due to limited availability of measures for 
a specific specialty and potential alternative solutions in addressing 
extremely topped out measures;
     Proposed to remove MIPS quality measures that do not meet 
case minimum and reporting volumes required for benchmarking after 
being in

[[Page 62950]]

the program for 2 consecutive CY performance periods;
     Proposed to remove quality measures from the program in 
instances where the measure steward or owner refuses to enter into a 
user agreement with CMS; and
     Requested information on a Potential Opioid Overuse 
Measure.
(b) Contribution to Final Score
    Under Sec.  414.1330(b)(2), we state that performance in the 
quality performance category will comprise 50 percent of a MIPS 
eligible clinician's final score for the 2020 MIPS payment year, and 
under Sec.  414.1330(b)(3), we state that performance in the quality 
performance category will comprise 45 percent of a MIPS eligible 
clinician's final score for MIPS payment year 2021. Section 
1848(q)(5)(E)(i)(I) of the Act, as amended by section 51003(a)(1)(C)(i) 
of the Bipartisan Budget Act of 2018, provides that 30 percent of the 
final score shall be based on performance for the quality performance 
category, but that for each of the 1st through 5th years for which MIPS 
applies to payments, the quality performance category performance 
percentage shall be increased so that the total percentage points of 
the increase equals the total number of percentage points that is based 
on the cost performance category performance is less than 30 percent 
for the respective year. As discussed in section III.K.3.c.(2) of this 
final rule, we proposed to weight the cost performance category at 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. Accordingly, we proposed to add Sec.  
414.1330(b)(4) to provide that performance in the quality performance 
category will comprise 40 percent of a MIPS eligible clinician's final 
score for the 2022 MIPS payment year. In addition, we proposed at Sec.  
414.1330(b)(5) to state that the quality performance category comprises 
35 percent of a MIPS eligible clinician's final score for the 2023 MIPS 
payment year. Lastly, we proposed to add Sec.  414.1330(b)(6) to state 
that the quality performance category comprises 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 will be modified over the next 
few years of the program will allow stakeholders to better plan and 
anticipate how eligible clinicians and group scores will be calculated 
in future years as we incrementally make changes to the final score 
weights.
    We received public comments on our proposals to incrementally 
reduce the weight of the quality performance category as we gradually 
increase the weight of the cost performance category. The following is 
a summary of the comments we received and our responses.
    Comment: A few commenters urged CMS to maintain the quality 
performance category weight at 45 percent for the 2020 MIPS performance 
period to allow for time to address underlying methodological and 
attribution issues related to the cost measures.
    Response: After consideration of the concerns we have heard on the 
cost measures within the cost performance category, as discussed in 
section III.K.3.c.(2) of this final rule, we have decided to retain the 
quality performance category weight at 45 percent for the 2020 
performance period. We will revisit changes to the quality and cost 
performance category weights through future rulemaking.
    Comment: A few commenters supported the proposal to decrease the 
weight of the quality category to 40 percent for the 2020 MIPS 
performance period and to 35 percent for the 2021 MIPS performance 
period.
    Response: We appreciate the commenters' support. However, after 
consideration of the concerns we have heard on the cost performance 
category, as discussed in section III.K.3.c.(2) of this final rule, 
particularly the concerns on feedback frequency, we have decided to 
finalize the quality performance category weight at 45 percent for the 
2020 performance period. We will revisit changes to the quality and 
cost performance category weights through future rulemaking.
    Comment: A few commenters opposed the proposal to increase the 
weight of the cost category to 20 percent during the 2020 performance 
year. One commenter opposed proposed changes to the quality performance 
category for the 2020-2022 MIPS performance periods because it sends 
the wrong message to clinicians and patients.
    Response: After consideration of the concerns we have heard on the 
cost measures within the cost performance category, as discussed in 
section III.K.3.c.(2) of this final rule particularly on the concerns 
of feedback frequency, we have decided to retain the quality 
performance category weight at 45 percent for the 2020 performance 
period. We do not believe that changes to the quality performance 
category weight will send the wrong message to clinicians and patients, 
as we believe there are benefits to both cost and quality measurement. 
We will revisit changes to the quality and cost performance category 
weights through future rulemaking.
    As a result of the comments, we are not finalizing our proposals. 
Therefore, the quality performance category will comprise 45 percent of 
a MIPS eligible clinician's final score for the 2022 MIPS payment year. 
We will revisit changes to the quality performance category's weights 
through future rulemaking and intend on providing additional education 
and outreach on how eligible clinicians can prepare to meet the 
incremental shifts in the quality and cost performance category 
weights.
(c) Quality Data Submission Criteria
(i) Submission Criteria for Groups Electing To Report the Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
    We did not propose any changes to the established submission 
criteria for the CAHPS for MIPS Survey. We refer readers to the CY 2019 
PFS final rule (83 FR 59756) for previously finalized policies 
regarding the CAHPS for MIPS survey. Although we did not make any 
proposals in regard to the CAHPS for MIPS survey in the CY 2020 PFS 
proposed rule, we solicited comments on numerous areas on how to expand 
the survey in future years (84 FR 40746 through 40747). While we are 
not summarizing and responding to comments we received in this final 
rule, we thank the commenters for their responses and may take them 
into account as we develop future policies for the CAHPS for MIPS 
survey.
(ii) Data Completeness Criteria
    We refer readers to the CY 2019 PFS final rule (83 FR 59756 through 
59758) where we discuss and codified at Sec.  414.1340 finalized data 
completeness criteria.
    As described in the CY 2018 Quality Payment Program final rule (82 
FR 53632 through 53634), we anticipated on proposing increases to the 
data completeness thresholds for data submitted on quality measures 
(QCDR measures, MIPS CQMs, eCQMs, and Medicare Part B Claims measures) 
in future years of the program. For MIPS payment years 2019 and 2020, 
the data completeness threshold was finalized and retained at 50 
percent. We provided an additional year for individual MIPS eligible 
clinicians and groups to gain experience with MIPS before increasing 
the data completeness threshold for MIPS payment year 2021, for which 
the

[[Page 62951]]

data completeness threshold was finalized at 60 percent.
    As discussed in the CY 2020 PFS proposed rule (84 FR 40747 through 
40748), we continue to believe it is important to incorporate higher 
data completeness thresholds over time to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on quality 
measures. We previously noted concerns raised about the unintended 
consequences of accelerating the data completeness thresholds too 
quickly, which may jeopardize a MIPS eligible clinicians' ability to 
participate and perform well under MIPS. We want to ensure that an 
appropriate yet achievable data completeness is applied to all eligible 
clinicians participating in MIPS. Based on our analysis of data 
completeness rates from data submission for the 2017 performance period 
of MIPS, as described in Table 42, we believe that it is feasible for 
eligible clinicians and groups to achieve a higher data completeness 
threshold.

 Table 42--CY 2017 Data Completeness Rates for MIPS Individual Eligible
                 Clinicians, Groups, and Small Practices
------------------------------------------------------------------------
      Average data
  completeness rate--          Average data            Average data
  individual eligible      completeness  rate--     completeness rate--
       clinician                  groups              small practices
------------------------------------------------------------------------
                76.14                    85.27                    74.76
------------------------------------------------------------------------

    With the support of the data in Table 42, and as described in the 
CY 2020 PFS proposed rule (84 FR 40748), we proposed to amend Sec.  
414.1340 to add paragraph (a)(3) to adopt a higher data completeness 
threshold for the 2020 MIPS performance period, such that MIPS eligible 
clinicians and groups submitting quality measure data on QCDR measures, 
MIPS CQMs, and eCQMS must submit data on at least a 70 percent of the 
MIPS eligible clinician or group's patients that meet the measure's 
denominator criteria, regardless of payer for the 2020 MIPS performance 
period. While we proposed the update to the data completeness threshold 
for QCDR measures, MIPS CQMs, and eCQMs, we inadvertently did not 
include the regulation text for Sec.  414.1340(a)(3) in the CY 2020 PFS 
proposed rule. Therefore, we have included regulation text for Sec.  
414.1340(a)(3) within this final rule to state that at least a 70 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer for the 2022 
MIPS payment year. As we observe increased use of electronic methods of 
reporting, such as EHRs and QCDRs, we believe it is important to 
continue to increase the data completeness threshold, and are 
interested in stakeholder feedback on an appropriate incremental 
approach, and on how this incremental increase should be implemented.
    In addition, in the CY 2020 PFS proposed rule (84 FR 40745), we 
proposed to increase the data completeness criteria for Medicare Part B 
Claims to 70 percent for the 2020 payment year as described in Sec.  
414.1340(b)(3). In Table 36 ``Summary of Data Completeness Requirements 
and Performance Period by Collection type for the 2020 MIPS Performance 
Period'' of the CY 2020 PFS proposed rule (84 FR 40748), the Medicare 
Part B Claims collection type is shown to have a performance period of 
January to December, and that the data completeness is at a 70 percent 
sample of individual MIPS eligible clinician's or group's Medicare Part 
B patients for the performance period. While we proposed the update to 
the data completeness threshold for Medicare Part B Claims, we 
inadvertently did not include the regulation text for Sec.  
414.1340(b)(3) in the CY 2020 PFS proposed rule. Therefore, we have 
included regulation text for Sec.  414.1340(b)(3) within this final 
rule to state that at least a 70 percent of the MIPS eligible clinician 
or group's patients that meet the measure's denominator criteria, 
regardless of payer for the 2022 MIPS payment year.
    In crafting our proposal, we also considered other thresholds, such 
as a higher threshold of 80 percent, but have concerns that requiring 
every clinician or group to adhere to an increased data completeness 
threshold that is increased by such a large amount may be considered 
burdensome to clinicians. We also requested comments on other 
considerations or possible thresholds we should consider, such as 
whether we should increase the data completeness threshold to 80 
percent to provide for more accurate assessments of quality.
    We received public comments on our proposal to increase the data 
completeness threshold for the quality performance category. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to increase the 
data completeness threshold, stating that the reporting of complete 
data is an important step in ensuring that performance is assessed 
accurately and that increasing data completeness will continue to 
convey the importance of quality reporting on all patients and 
potentially help establish benchmarks for new measures. A few 
commenters supported the increased threshold for data completeness to 
70 percent for several reasons, including the ability to improve the 
data that individual eligible clinicians and groups submit to 
registries. One commenter indicated that MIPS is currently structured 
so that practices who choose their measures often times choose those 
measures that are easy to collect and report as part of their existing 
clinical workflows. Some commenters expressed appreciation for basing 
our proposal on data from the field and some noted that many providers 
are reporting 100 percent of their data at this point. Commenters urged 
us to continue using a data driven approach to increasing thresholds in 
the future.
    Response: We appreciate the commenters' support and agree that an 
increase in the data completeness threshold will allow for a more 
accurate depiction in care and data provided to CMS, whether that is 
directly or through a third party intermediary. Our intention is to 
work to ensure that the quality measures used within the MIPS program 
are relevant and meaningful in a clinician's practice, and appreciate 
that stakeholders are at ease with incorporating these quality metrics 
into their existing clinical workflows. In addition, we intend to 
continue utilizing a data driven approach to increasing the data 
completeness thresholds in the future.
    Comment: A few commenters supported the proposal to increase the 
data completeness thresholds for four of the six MIPS data collection 
types from 60 percent to 70 percent of the clinician or group's 
patients that meet measure denominator criteria, and encouraged CMS to 
continue using a data-driven approach to increasing thresholds in the 
future.
    Response: We agree the reporting of complete data is essential in 
ensuring

[[Page 62952]]

that MIPS performance is assessed accurately. We plan to continue a 
data-driven approach to increasing the data completeness threshold in 
the future.
    Comment: Commenters noted to better enable eligible clinicians and 
groups to meet this higher threshold, CMS should ensure there is a 
sufficient number of applicable measures to choose from in the program. 
As CMS increases the data completeness threshold, the agency should 
also amend the timeline for MIPS CQMs and QCDR measures to be publicly 
posted.
    Response: As noted in section III.K.3.c.(1)(d) of this final rule, 
as we review the MIPS quality measure inventory for updates, we utilize 
multiple factors when determining whether a quality measure should be 
removed or added to the program. As a part of our decision making, we 
do consider the number applicable measures remaining for clinicians to 
consider. We will take into consideration the commenters' suggestion of 
posting measure specifications for both the MIPS quality and QCDR 
measures earlier than the existing timeframes.
    Comment: A few commenters opposed the proposed increase and 
requested clarifications. One commenter requested clarification as to 
whether the data used by CMS to support the policy represents all MIPS 
eligible clinicians across all reporting mechanisms, or represents a 
subset, such as claims. Another commenter stated their belief that the 
average rate of reporting is actually less than 70 percent because the 
statistic does not include data on patients not captured in registries 
or EHRs (which we understand to refer to data that does not include 
patients captured through claims data or are not electronically 
derived). One commenter noted that it was unclear from the data 
presented in the rule whether the average data completeness rate 
reflects Medicare only reporting or reporting across all payers.
    Response: The data used to support the increase in the data 
completeness threshold is reflective of all-payer data across all 
collection types, and is not just reflective of claims. The data 
completeness threshold under the legacy Physician Quality Reporting 
System (PQRS) program was at 80 percent, and historical data 
demonstrated that eligible clinicians had no issue with meeting that 
threshold. Since MIPS began as a new program in 2017, the data 
completeness threshold was lowered to allow for time for eligible 
clinicians and groups to become acclimated to the program. Since we 
will be entering year 4 of the program, we believe we have given 
eligible clinicians and groups sufficient time to become oriented to 
the program. In addition, as described above, we have come across 
instances where stakeholders, including third-party intermediaries have 
sought to use data selection criteria to misrepresent a clinician or 
group's performance for a performance period, commonly referred to as 
``cherry-picking,'' resulting in data that is not true, accurate, or 
complete. Therefore, we believe it is appropriate to finalize the 
increase to the data completeness threshold to 70 percent.
    Comment: One commenter expressed concern that there is no CMS 
guidance on how to select the percentage of patients they want to 
report on, and stated the lack of guidance leads to an inconsistent way 
of submitting data.
    Response: We disagree. The data submission and data completeness 
requirements at Sec. Sec.  414.1335 and 414.1340 and the guidance we 
provide in the 2019 MIPS Quality User Guide on the Quality Payment 
Program Resource Library (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/558/2019%20MIPS%20Quality%20User%20Guide.pdf) provides guidance 
as to how clinicians can submit in a consistent manner. We do not 
specify a methodology for how eligible clinicians can select the 
patients they want to report on because we believe some operational 
flexibility is appropriate provided the approach adopted is consistent 
with our regulations and guidance and does not allow ``cherry picking'' 
of data.
    Comment: Some commenters noted that some measures require a large 
amount of data collection, and suggested that reporting at this level 
will force practices--particularly small practices--to invest 
significant time and money in systems and infrastructures to collect 
and report data as electronic health records may not capture the 
necessary data elements or submit the required data.
    Response: We are aware that some quality measures require larger 
volumes of data over others such as those measures that are visit 
specific or require a follow-up within a specified timeframe. However, 
the data completeness threshold focuses on the percentage of eligible 
patients about whom the clinician must report data. With regards to the 
burden the data completeness threshold may cause for small practices, 
as indicated in the average data completeness table, we believe small 
practices are already exceeding the existing data completeness 
threshold and there will be no additional burden on the part of small 
practices.
    Comment: A few commenters expressed concern that it is 
unnecessarily complex and burdensome to increase the data completeness 
threshold when participants are already facing a switch to MIPS Value 
Pathways (MVPs).
    Response: While we understand that eligible clinicians will 
eventually transition to MVPs, it is important to note that this 
transition is not occurring for the 2020 performance period. Therefore, 
we believe it is important to continue to increase the data 
completeness threshold over time to ensure a more accurate assessment 
of a MIPS eligible clinician's performance on quality measures.
    After consideration of the comments, we are finalizing our proposal 
to amend Sec.  414.1340 to add paragraph (a)(3) to adopt a higher data 
completeness threshold for the 2020 MIPS performance period, such that 
MIPS eligible clinicians and groups submitting quality measure data on 
QCDR measures, MIPS CQMs, or eCQMs must submit data on at least a 70 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer for the 2022 
MIPS payment year. In addition, we are also finalizing our proposal to 
amend Sec.  414.1340 to add paragraph (b)(3) for Medicare Part B 
Claims, to state that, at least a 70 percent of the MIPS eligible 
clinician or group's patients that meet the measure's denominator 
criteria, regardless of payer for the 2022 MIPS payment year. Through 
future rulemaking, we intend on increasing the data completeness 
threshold to ensure a more accurate assessment of a MIPS eligible 
clinician's performance on quality measures. In addition, we are making 
a technical edit to Sec.  414.1340(a)(1) to revise ``the MIPS payment 
years 2019'' to ``MIPS payment year 2019'' to state at Sec.  
414.1340(a)(1), at least 50 percent of the MIPS eligible clinician or 
group's patients that meet the measure's denominator criteria, 
regardless of payer for the MIPS payment year 2019. Furthermore, we are 
making an additional technical edit to Sec.  414.1340(a)(2) to revise 
``the MIPS payment years 2020 and 2021'' to ``MIPS payment years 2020 
and 2021'' to state at Sec.  414.1340(a)(2), at least 60 percent of the 
MIPS eligible clinician or group's patients that meet the measure's 
denominator criteria, regardless of payer for MIPS payment years 2020 
and 2021.
    As discussed in the CY 2020 PFS proposed rule (84 FR 40748), we 
have received inquiries regarding perceived opportunities to 
selectively submit

[[Page 62953]]

MIPS data that are unrepresentative of a clinician or group's 
performance, suggesting that certain parties may have misunderstood the 
intent of our incremental approach to the data completeness thresholds, 
and may not fully appreciate their current regulatory obligations. As 
stated in Sec. Sec.  414.1390(b) and 414.1400(a)(5), all MIPS data 
submitted by or on behalf of a MIPS eligible clinician, group, or 
virtual group must be certified as true, accurate and complete. MIPS 
data that are inaccurate, incomplete, unusable, or otherwise 
compromised can result in improper payment. Using data selection 
criteria to misrepresent a clinician or group's performance for a 
performance period, commonly referred to as ``cherry-picking,'' results 
in data that are not true, accurate, or complete. Accordingly, we 
proposed to amend Sec.  414.1340 to add a new paragraph (d) to clarify 
that if quality data are submitted selectively such that the data are 
unrepresentative of a MIPS eligible clinician or group's performance, 
any such data would not be true, accurate, or complete for purposes of 
Sec.  414.1390(b) or Sec.  414.1400(a)(5). We received no comments on 
this proposal and are finalizing this text as proposed. We believe this 
clarification will emphasize to all parties that the data submitted on 
each measure is expected to be representative of the clinician's or 
group's performance and free of selection bias.
    We continue to urge all MIPS eligible clinicians to report on 
quality measures where they have performed the quality actions with 
respect to all applicable patients.
    We note that we did not propose any changes to Sec.  414.1340(c), 
which states that groups submitting quality measures data using the CMS 
Web Interface or a CMS-approved survey vendor to submit the CAHPS for 
MIPS survey must submit data on the sample of the Medicare Part B 
patients CMS provides, as applicable. We refer readers to the CY 2019 
PFS final rule (83 FR 59756 through 59758) for additional discussion of 
this requirement. Table 43 describes the data completeness requirements 
by collection type.
[GRAPHIC] [TIFF OMITTED] TR15NO19.087

(d) Selection of MIPS Quality Measures
(i) Call for Measures and Measure Selection Process
    In the CY 2019 PFS final rule (83 FR 59758 through 59761), we 
discuss the importance of classifying measures by meaningful measure 
areas, and updates to the definition of a high priority measure. We 
refer readers to the CY 2019 PFS final rule for additional details.
    Furthermore, in the CY 2018 Quality Payment Program final rule (82 
FR 53635 through 53637), we state that quality measure submissions 
submitted during the timeframe provided by us through the pre-
rulemaking process of each year will be considered for inclusion in the 
annual list of MIPS quality measures for the performance period 
beginning 2 years after the measure is submitted. This process is 
consistent with the pre-rulemaking process and the annual Call for 
Measures, which is further described through the CMS Pre-Rulemaking 
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking.html. The annual 
Call for Measures process allows for eligible clinician organizations 
and other relevant stakeholder organizations to identify and submit 
quality measures for consideration. Presumably, stakeholders would not 
submit measures for consideration unless they believe the measures are 
applicable to clinicians and can be reliably and validly measured. 
Through the annual convention of the consensus-based entity, 
stakeholders are given the opportunity provide input on whether or not 
they believe measures are applicable to clinicians, feasible, 
scientifically acceptable, reliable, and valid at the clinician level. 
We intend to continue to submit future MIPS quality measures to the 
consensus-based entity, as appropriate, and consider the 
recommendations provided as part of the comprehensive assessment of 
each measure considered for inclusion in MIPS. In addition, we must go 
through notice and comment rulemaking to consider stakeholder feedback 
prior to finalizing the annual list of quality measures. Furthermore, 
as required by statute, new measures must be submitted to an applicable 
specialty-appropriate, peer-reviewed journal. We refer readers to the 
CY 2018 Quality Payment Program final rule (82 FR 53636) for additional 
details on the peer-reviewed journal requirement.
    In the CY 2018 Quality Payment Program final rule (82 FR 53636), we 
requested stakeholders apply the following set of considerations when 
submitting quality measures for possible inclusion in MIPS:
     Measures that are not duplicative of an existing or 
proposed measure.

[[Page 62954]]

     Measures that are beyond the measure concept phase of 
development, with a strong preference for measures that have completed 
reliability, feasibility, and validity testing.
     Measures that are outcomes-based rather than process 
measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnoses and 
therapeutics.
     Measures that address the domain of care coordination.
     Measures that address of patient and caregiver experience.
     Measures that address efficiency, cost, and resource use.
     Measures that address significant variation in performance 
and are not considered topped out.
     Measures that are specified as a collection type other 
than Medicare Part B Claims. We encourage measure stewards to keep this 
in mind as they develop and submit measures for consideration.
    We also encourage stakeholders to consider electronically 
specifying their quality measures, as eCQMs, in order to encourage 
clinicians and groups to move towards the utilization of electronic 
reporting, as we believe electronic reporting will increase timeliness 
and efficiency of reporting by replacing manual data entry.
    In addition to the aforementioned considerations, when considering 
quality measures for possible inclusion in MIPS, we proposed that 
beginning with the 2020 Call for Measures process, MIPS quality measure 
stewards would be required to link their MIPS quality measures to 
existing and related cost measures and improvement activities, as 
applicable and feasible (84 FR 40749). MIPS quality measure stewards 
will be required to provide a rationale as to how they believe their 
measure correlates to other performance category measures and 
activities as a part of the Call for Measures process. We recognize 
there are instances where costs measures are not available for all 
clinician specialties or that improvement activities may not be 
associated with a given quality measure. However, we believe that when 
possible, it is important to establish a strong linkage between 
quality, cost, and improvement activities.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposal that measures 
stewards should link their quality measures with improvement activities 
and cost measures when possible. Commenters stated that it might be 
beneficial for CMS to require the same assessment by an Improvement 
Activities submitter as the agency would for a new MIPS measure.
    Response: We agree that this criteria could be applied to 
improvement activities as well, and will take it into consideration in 
future rulemaking.
    After consideration of the comments, we are finalizing that 
beginning with the 2020 Call for Measures process, MIPS quality measure 
stewards will be required to link their MIPS quality measures to 
existing and related cost measures and improvement activities, as 
applicable and feasible. MIPS quality measure stewards will be required 
to provide a rationale as to how they believe their measure correlates 
to other performance category measures and activities as a part of the 
Call for Measures process.
    Furthermore, previously finalized MIPS quality measures can be 
found in the 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). The new MIPS quality measures proposed for inclusion in 
MIPS for the 2020 performance period and future years are found in 
Table Group A of Appendix 1 of this proposed rule.
    In addition to the individual MIPS quality measures, we also 
develop and maintain specialty measure sets to assist MIPS eligible 
clinicians with choosing quality measures that are most relevant to 
their scope of practice. In the CY 2020 PFS proposed rule (84 FR 
40749), we erroneously indicated that changes were not made to the 
Pathology, Electro-Physiology Cardiac Specialist, and Interventional 
Radiology specialty set. We clarify that we requested comments on the 
Electro-Physiology Cardiac Specialist specialty set (84 FR 40954) and 
proposed changes to the Pathology specialty set (84 FR 41020 through 
41022). Our proposals for modifications to existing specialty sets and 
new specialty sets are discussed in Table Group B of Appendix 1 of this 
final 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 18, 2019,\114\ we announced that we would be accepting 
recommendations for potential new specialty measure sets or revisions 
to existing specialty measure sets for Year 4 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 those recommendations that we agree with were proposed 
in the CY 2020 PFS proposed rule.
---------------------------------------------------------------------------

    \114\ Listserv messaging was distributed through the Quality 
Payment Program listserv on January 18th, 2019, titled: ``CMS is 
Soliciting Stakeholder Recommendations for Potential Consideration 
of New Specialty Measure Sets for the Quality Performance Category 
and/or Revisions to the Existing Specialty Measure Sets for the 
Quality Performance Category for the 2020 Program Year of Merit-
based Incentive Payment System (MIPS).''
---------------------------------------------------------------------------

    In addition, MIPS quality measures with substantive changes can be 
found in Table Groups D and DD of Appendix 1 of this final rule. As 
discussed in Table DD of this final rule, we have determined based on 
extensive stakeholder feedback that the 2018 CMS Web Interface measure 
numerator guidance for the Preventive Care and Screening: Tobacco Use: 
Screening and Cessation Intervention measure is inconsistent with the 
intent of the CMS Web Interface version of this measure as modified in 
the CY 2018 Quality Payment Program final rule (82 FR 54164) and is 
unduly burdensome on clinicians. Moreover, due to the current guidance, 
we are unable to rely on historical data to benchmark the measure. 
Therefore, for the 2018 MIPS performance period and 2020 MIPS payment 
year, we are excluding the Web Interface version of this measure from 
MIPS eligible clinicians' quality scores in accordance with Sec.  
414.1380(b)(1)(i)(A)(2). Beginning with reporting for the 2019 MIPS 
performance period and 2021 MIPS payment adjustment, we proposed in 
Table DD of this final rule to update the CMS Web Interface measure 
numerator guidance. To the extent that this change constitutes a change 
to the MIPS scoring or payment methodology for the 2021 MIPS payment 
adjustment after the start of the 2019 MIPS 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

[[Page 62955]]

modify the measure in Table DD of this final rule because the current 
guidance is inconsistent with the intent of the CMS Web Interface 
version of this measure, as modified in the CY 2018 Quality Payment 
Program final rule, and unduly burdensome on clinicians. As discussed 
in Table DD of this final rule, we are finalizing this modification as 
proposed and expect that we will be able to benchmark and score the CMS 
Web Interface version of this measure for the 2019 MIPS performance 
period and 2021 MIPS payment adjustment. Furthermore, we refer readers 
to section III.E.1.b. of this final rule for a discussion on how the 
Preventive Care and Screening: Tobacco Use: Screening and Cessation 
Intervention quality measure will be scored for the Medicare Shared 
Savings Program.
    In addition, also as discussed in section III.E.1.b of this final 
rule, changes to the CMS Web Interface measures for MIPS that are 
proposed and finalized through rulemaking would also be applicable to 
ACO quality reporting under the Medicare Shared Savings Program. As 
discussed in Table Group A of Appendix 1 of this final rule, we 
proposed to add 1 new measure to the CMS Web Interface in MIPS. 
Furthermore, as discussed in Table Group C of Appendix 1 of this final 
rule, we proposed to remove 1 measure from the CMS Web Interface in 
MIPS. As discussed in Table Groups A and C of Appendix 1 of this final 
rule, we are not finalizing our proposed measure additions and removals 
for the CMS Web Interface in MIPS. Groups reporting CMS Web Interface 
measures for MIPS will be responsible for reporting the finalized 
measure set. We refer readers to the Appendix 1 of this final rule for 
additional details on the proposals related to changes in CMS Web 
Interface 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 as described above. We note that 
the current cycle of measure updates to MIPS quality measures is 
separate from the eCQM annual update process. An overarching timeline 
of milestones related to eCQMs available at https://ecqi.healthit.gov/ecqm-annual-timeline. We solicited stakeholder comment as to whether we 
should consider realigning the measure update cycle with that of the 
eCQM annual update process. While we are not summarizing and responding 
to comments we received in this final rule, we appreciate the responses 
and may take them into account as we develop future policies for the 
measure update process.
    In addition, we referred readers to the CY 2019 PFS final rule (83 
FR 59759) for additional details on reporting requirements of eCQM 
measures. Furthermore, as discussed in section III.D. of this final 
rule, we proposed to generally align the CY 2020 eCQM reporting 
requirements for the eligible professionals participating in the 
Medicaid Promoting Interoperability Program with the MIPS eCQM 
reporting requirements. We refer readers to section III.D. of this 
final rule for additional details and criteria on the Medicaid 
Promoting Interoperability Program proposals.
(ii) Global and Population-Based Measures
    Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary 
may use global measures, such as global outcome measures, and 
population-based measures for purposes of the quality performance 
category. We believe the purpose of global and population-based 
measures is to encourage systemic health care improvement for the 
populations being served by MIPS eligible clinicians. In addition, as 
described in the CY 2017 Quality Payment Program final rule (81 FR 
77130 through 77136), we believe that all MIPS eligible clinicians, 
including specialists and subspecialists, have a meaningful 
responsibility to their communities, which is why we chose to focus on 
population health and prevention measures for all MIPS eligible 
clinicians. It is important to note that an individual's health relates 
directly to population and community health, which is an important 
consideration for quality measurement in MIPS and in general. 
Furthermore, we have heard from stakeholders that we should drive 
quality measurement towards a set of population-based outcome measures 
to publicly report on quality of care.
    In addition, we believe including additional administrative claims 
based measures in the program will reduce the burden associated with 
quality reporting. Quality measures that are specified through the 
administrative claims collection type do not require separate data 
submission to CMS. Administrative claims measures are calculated based 
on data available from MIPS eligible clinicians' billings on Medicare 
Part B claims. For these reasons, as discussed in Table Group AA of 
Appendix 1 of this final rule, we proposed the inclusion of a 
population health based quality measure (the All-Cause Unplanned 
Admission for Patients with Multiple Chronic Conditions measure) 
beginning with the 2021 MIPS performance period. We proposed this 
measure with a delayed implementation until the 2021 performance period 
of MIPS, to allow for time to work through operational factors of 
implementing the measure. Factors include allowing for time for the 
All-Cause Unplanned Admission for Patients with Multiple Chronic 
Conditions measure to go through the Measures Under Consideration and 
Measures Application Partnership (MAP) process that is typically 
applied for all MIPS quality measures. We refer readers to section 
III.K.3.a. of this final rule for additional information on our 
interest to include other global and population-based measures in 
future years of MIPS, which we envision would include the modification 
of the submission requirements under the quality performance category.
    We received public comments on our proposal to include global and 
population-based measures. The following is a summary of the comments 
we received and our responses.
    Comment: A few commenters opposed the inclusion of population 
health quality measures in a clinician-focused program based on the 
belief that they could reduce the opportunity for improvements in 
patient outcomes, are unable to be tracked in real time, are outside of 
individual clinician's control, and require a large sample size to 
produce reliable data.
    Response: We disagree. We believe the purpose of global and 
population-based measures is to encourage systemic health care 
improvement for the populations being served by MIPS eligible 
clinicians. In addition, as described in the CY 2017 Quality Payment 
Program final rule (81 FR 77130 through 77136), we believe that all 
MIPS eligible clinicians, including specialists and subspecialists, 
have a meaningful responsibility to their communities, which is why we 
chose to focus on population health and prevention measures for all 
MIPS eligible clinicians. We disagree with commenters who believe that 
population health quality measures reduce the opportunity for 
improvements in patient outcomes and are unable to be tracked in real 
time. We believe population health measures increase opportunities to 
improve patient outcomes on a systemic health level for the populations 
being served by MIPS eligible clinicians, and that the ability to be 
tracked in real time is important, but even without real time tracking, 
we still see a benefit to including these measures in the

[[Page 62956]]

program. In addition, while administrative claims based measures may 
use a large sample size of data, the data collection is less burdensome 
than what is used for other collection types, since it is done without 
any submission required by the eligible clinician or group. It is 
important to note that population and community health may directly 
influence an individual's health, which is an important consideration 
for quality measurement in MIPS and in general. In addition, we believe 
that including additional administrative claims based measures in the 
program will reduce the burden associated with quality reporting. 
Quality measures that are specified through the administrative claims 
collection type do not require separate data submission to CMS. 
Administrative claims measures are calculated based on data available 
from MIPS eligible clinicians' billings on Medicare Part B claims. We 
intend on incrementally including population-based measures into MIPS, 
and will be looking to evaluate and address stakeholder concerns as a 
part of the process.
    Comment: A few commenters expressed concern about the use of these 
measures in this clinician-focused program due to their belief of 
inadequate risk adjustment and lack of consideration of social risk 
factors and complex patients.
    Response: We appreciate the feedback on the role risk adjustment, 
and complex patients in quality measurement. We continue to evaluate 
the potential impact of social risk factors on measure performance. One 
of our core objectives is to improve beneficiary outcomes. We want to 
ensure that complex patients, as well as those with social risk factors 
receive excellent care. While we believe the MIPS measures are valid 
and reliable, we will continue to investigate methods to ensure all 
clinicians are treated as fairly as possible within the program.
    Comment: One commenter opposed the inclusion of the All-Cause 
Unplanned Admission for Patients with MCCs beginning with the 2021 MIPS 
performance period with the rationale that because fraud and abuse laws 
impose restrictions on options for care coordination, it is 
inappropriate to have a quality measure that presumes effective care 
coordination.
    Response: We believe that the level of care coordination needed to 
perform well on this quality measure is possible within the existing 
fraud and abuse framework.
    Comment: Several commenters did not support the proposed adoption 
of the All-Cause Unplanned Admission for Patients with Multiple Chronic 
Conditions due to the belief that the measure lacks alignment and 
reliable attribution. Several commenters expressed concern that the 
measure does not provide actionable or meaningful feedback to 
clinicians, such as surgeons and specialists, while holding them 
accountable for admissions. One commenter recommended that the measure 
be reviewed by the MAP and NQF.
    Response: We appreciate the commenters' concerns regarding the 
measure's alignment and attribution, and the need for actionable 
feedback on the measures. We are not finalizing this measure for the 
2021 MIPS performance period/2023 MIPS payment year in this final rule, 
in order to work on addressing the commenters' feedback and to allow 
for the measure to be reviewed at the NQF's Measure Application 
Partnership meeting.
    After consideration of the comments, we are not finalizing the 
inclusion of the population health based All-Cause Unplanned Admission 
for Patients with Multiple Chronic Conditions measure, and will seek to 
propose it through future rulemaking once we are able to consider 
feedback from the MAP on this measure.
(iii) Topped Out Measures
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53637 through 53640), where we finalized the 4-year timeline to 
identify topped out measures, after which we may propose to remove the 
measures through future rulemaking. We also refer readers to the 2019 
MIPS Quality Benchmarks' file that is located on the Quality Payment 
Program resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which 
measure benchmarks are topped out for 2019 and would be subject to the 
scoring cap if they are also identified as topped out in the 2020 MIPS 
Quality Benchmarks' file. We note that the final determination of which 
measure benchmarks are subject to the topped out cap would not be 
available until the 2020 MIPS Quality Benchmarks' file is released in 
late 2019, but will eventually be posted on the Quality Payment Program 
Resource Library at https://qpp.cms.gov/about/resource-library.
    In the CY 2019 PFS final rule (83 FR 59761 through 59763), we 
finalized that once a measure has reached extremely topped out status 
(for example, a measure with an average mean performance within the 
98th to 100th percentile range), we may propose the measure for removal 
in the next rulemaking cycle, regardless of whether or not it is in the 
midst of the topped out measure lifecycle. However, we would also 
consider retaining the measure if there are compelling reasons as to 
why it should not be removed (for example, if the removal would impact 
the number of measures available to a specialist type or if the measure 
addressed an area of importance to the Agency). In the CY 2020 PFS 
proposed rule (84 FR 40750), we erroneously indicated that we were not 
removing extremely topped out measures from the Pathology specialty 
set. We clarify that we proposed to remove four extremely topped out 
measures from and add one measure to the Pathology set in Appendix 1 of 
the proposed rule (84 FR 41020 through 41022).
    Quality measures identified as extremely topped out are considered 
to have high, unvarying performance where no meaningful room for 
improvement can be identified, and are only identified as such through 
data received during the submission period. We have heard from 
stakeholders that some measures tend to appear topped out or extremely 
topped out due to clinicians' ability to select measures they expect to 
perform well on, and because of this, the data we receive is not 
actually representative of how clinicians perform across the country on 
these metrics. For this reason, we solicited comment on whether we 
should increase the data completeness threshold for quality measures 
that are identified as extremely topped out, but are retained in the 
program due to the limited availability of quality measures for a 
specific specialty. In addition, we solicited comment on potential 
alternative solutions in addressing extremely topped out measures. 
While we are not summarizing and responding to comments we received in 
this final rule, we appreciate the responses and may take them into 
account as we develop future policies for extremely topped out 
measures.
    We encourage stakeholders to continue their measure development 
efforts in creating new pathology specific quality measures that can 
demonstrate a meaningful performance gap, thereby offering 
opportunities for quality improvement. We also continue encourage 
pathologists to consider reporting on pathology specific QCDR measures 
through a CMS-approved QCDR available for the 2020 performance period. 
A list of CMS-approved QCDRs for the 2020 performance period will be 
made available on or prior to January 1, 2020, and will be posted on 
the Quality

[[Page 62957]]

Payment Program resource library at https://qpp.cms.gov/about/resource-library.
    In addition, in the CY 2019 PFS final rule (83 FR 59761 through 
59763), we also finalized our policy to exclude QCDR measures from the 
topped out measure timeline. When a QCDR measure reaches topped out 
status, as determined during the QCDR measure approval process, it may 
not be approved as a QCDR measure for the applicable performance 
period.
(iv) Removal of Quality Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77136 
through 77137), we discussed removal criteria for quality measures, 
including that a quality measure may be considered for removal if the 
Secretary determines that the measure is no longer meaningful, such as 
measures that are topped out. Furthermore, if a measure steward is no 
longer able to maintain the quality measure, it would also be 
considered for removal. In addition, in the CY 2019 PFS final rule (83 
FR 59763 through 59765), we communicated to stakeholders our desire to 
reduce the number of process measures within the MIPS quality measure 
set, we believe incrementally removing non-high priority process 
measures through notice and comment rulemaking is appropriate. We 
referred readers to the CY 2019 PFS final rule (83 FR 59763 through 
59765) for details on the previously established criteria to remove 
measures.
    In addition to previously established measure removal criteria, we 
have observed instances where MIPS quality measures have had low 
reporting rates year over year, and have made it difficult for some 
MIPS quality measures to achieve a benchmark. As a result, these 
measures have resulted in clinicians receiving no more than 3 points 
for each measure that is unable to meet benchmarking criteria. For 
these reasons, we proposed to remove MIPS quality measures that do not 
meet case minimum and reporting volumes required for benchmarking after 
being in the program for 2 consecutive CY performance periods (84 FR 
40751 through 40752). We believe that a time period of 2 consecutive CY 
performance periods is appropriate, as we anticipate that any newly 
finalized measure would need more than 1 CY performance period in order 
to observe measure reporting trends, and believe that 2 consecutive CY 
performance periods allows for sufficient time to monitor reporting 
volumes. We will factor in other considerations (such as, but not 
limited to: The robustness of the measure; whether it addresses a 
measurement gap; if the measure is a patient-reported outcome) prior to 
determining whether to remove the measure. Removing measures with this 
methodology ensures that the MIPS quality measures available in the 
program are truly meaningful and measureable areas, where quality 
improvement is sought and that measures that are low reported for 2 
consecutive CY performance periods are removed from the program. We 
believe low reported measures can point to that the measure concept 
does not provide meaningful measurement to most clinicians. If the 
measure has too few reporting clinicians and does not meet the case 
minimum and reporting volumes, but other considerations favor retaining 
the measure, we may consider keeping the MIPS quality measure, with the 
caveat that the measure steward should have a participation plan in 
place (prior to approval of the measure) to encourage reporting of the 
measure, such as education and communication or potentially measure 
specification changes. In addition, we refer readers to Table Group C 
of Appendix 1 of this final rule for a list of quality measures and 
rationales for removal. 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.
    We received public comments on our proposal to remove MIPS quality 
measures that do not meet case minimum and reporting volumes required 
for benchmarking after being in the program for 2 consecutive CY 
performance periods.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposal and expressed 
appreciation of CMS' move to a parsimonious measure set, with a caution 
for CMS to ensure each specialty will have enough measures to report in 
a meaningful manner.
    Response: We thank the commenters for their support.
    Comment: One commenter stated that eliminating a measure only after 
2 years in the program will deter measure stewards from investing in 
and developing new measures, maintaining existing measures, and putting 
forward MVP proposals. The commenter indicated the proposed policy 
would result in removing measures that developers have spent more than 
2 years to develop and test only to have it in the program for a small 
number of years and encouraged CMS to perform analysis and work with 
measure stewards to learn the time it takes for measures to achieve 
acceptable numbers of adoption.
    Response: While we understand the time it takes for measure 
stewards to develop and invest in quality measures, we also want to be 
mindful of the large volume of measures that accrue in our measure 
inventory year over year. There have been instances where quality 
measures have been in the MIPS or legacy PQRS program, where the 
reporting volumes are quite low, and that has been the basis to which 
we have established this policy. We believe that lowly-reported quality 
measures do not add value to a clinician's quality improvement 
strategy, and that having a large volume of measures can increase 
burden by providing too much choice. We are open to working with 
measure stewards to understand the time it takes for measures to 
achieve increased adoption, and would encourage those measure stewards 
to submit a participation plan for our consideration for measures that 
have not reached benchmarking thresholds within the 2-year timeframe.
    Comment: A few commenters suggested that CMS should assess each 
measure on a case-by-case basis rather than creating a blanket policy 
to remove them.
    Response: As noted above, as a part of our measure removal process, 
we intend to assess each measure on a case-by-case basis and will take 
into consideration multiple factors, including but not limited to: 
Whether the measure removal will impact the number of measures 
available to a given specialty; or whether the measure removal will 
result in no remaining outcome or high priority measures available to a 
specialty to meet the quality performance category reporting 
requirements.
    Comment: One commenter noted that data from the first 2 years of 
MIPS is not representative, as reporting requirements and performance 
thresholds for the program have changed over time.
    Response: We disagree. There has been evidence of quality measures 
that continue to be low-reported over several years, as we have tracked 
performance on many of these metrics from the

[[Page 62958]]

previous legacy program, PQRS. We do not believe low-reported quality 
measures provide value in a pay for performance quality program.
    Comment: A few commenters expressed concern about the proposal to 
remove MIPS quality measures that do not meet case minimum and 
reporting volumes required for benchmarking after being in the program 
for 2 consecutive CY performance periods. Commenters stated that low 
reporting rates are not always an indication of a low value measure. 
One commenter noted that some measures may only be reported by a small 
number of clinicians which represents a significant percentage of those 
caring for a specific patient population, and urged CMS to evaluate 
these important factors when assessing topped out status and making 
measure removal determinations. One commenter opposed this proposal and 
recommended that CMS allow appropriate time for measures to receive 
enough data to set benchmarks.
    Response: As discussed above, we believe that a time period of 2 
consecutive CY performance periods is appropriate, as we anticipate 
that any newly finalized measure would need more than 1 CY performance 
period in order to observe measure reporting trends, and believe that 2 
consecutive CY performance periods allows for sufficient time to 
monitor reporting volumes. We will factor in other considerations (such 
as, but not limited to: The robustness of the measure; whether it 
addresses a measurement gap; if the measure is a patient-reported 
outcome) prior to determining whether to remove the measure; the 
measure's relevance for sub-specialists. Removing measures with this 
methodology ensures that the MIPS quality measures available in the 
program are truly meaningful and measureable areas, where quality 
improvement is sought and that measures that are low reported for 2 
consecutive CY performance periods are removed from the program. We 
believe low reported measures can point to that the measure concept 
does not provide meaningful measurement to most clinicians. If the 
measure has too few reporting clinicians and does not meet the case 
minimum and reporting volumes, but other considerations favor retaining 
the measure, we may consider keeping the MIPS quality measure.
    Comment: Several commenters expressed concern about the number of 
measures proposed for removal, and recommended we maintain as broad an 
inventory of measures as possible. Several commenters urged CMS to 
reconsider the proposed removal of 55 quality measures or over 20 
percent of the quality category measures, particularly those proposed 
for removal due to topped out status or an ongoing lack of benchmark. 
Several commenters noted the removal of specific measures could impact 
the ability of specialists to participate fully and meaningfully in 
MIPS and could cause them to re-evaluate investment in developing new 
MIPS measures.
    Response: 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. as a part of our measure removal 
process, we intend to assess each measure on a case-by-case basis and 
will take into consideration multiple factors, including but not 
limited to: Whether the measure removal will impact the number of 
measures available to a given specialty or whether the measure removal 
will result in no remaining outcome or high priority measures available 
to a specialty to meet the quality performance category reporting 
requirements. While we intend on removing some quality measures from 
the program that no longer add value, as noted above, we are finalizing 
additional quality measures in the program (two patient-reported 
outcome measures, and one opioid-related measure, as well as the 
addition of seven new specialty sets, and continuously intend on 
evaluating the MIPS quality measure inventory on an annual basis.
    Based on these considerations, we have decided not to finalize the 
removal of certain measures (particularly some of those measures that 
are available to non-patient facing clinicians), and refer readers to 
Table Group C for detailed discussion on the measures we are no longer 
removing. We continuously encourage stakeholders to develop measures to 
not just address measurement gaps, but to also address and replace 
specialty specific topped out quality measures as we seek to eventually 
transition to MVPs.
    After consideration of the comments, we are finalizing our proposal 
to remove MIPS quality measures that do not meet case minimum and 
reporting volumes required for benchmarking after being in the program 
for 2 consecutive CY performance periods. We will factor in other 
considerations (such as, but not limited to: The robustness of the 
measure; whether it addresses a measurement gap; if the measure is a 
patient-reported outcome; consideration of the measure in developing 
MVPs) prior to determining whether to remove the measure.
    We have heard from stakeholders concerns on removing measures and 
the need for more notice before a measure is removed. Therefore, we are 
interested in what factors should be considered in delaying the removal 
of measures. For example, we have not heard concerns from stakeholders 
that selection bias may be impacting low reporting rates, we are 
interested if this is something we should consider, and how we could 
determine when low-reporting is due to selection bias versus instances 
where the measure is not a meaningful metric to the majority of 
clinicians who would have reported on the measure otherwise. We 
solicited comment on whether we should delay the removal of a specific 
quality measure by a year, for any of the MIPS quality measures 
identified for removal. We also requested feedback on which quality 
measure's removal should be delayed for a year, and why. While we are 
not summarizing and responding to comments we received in this final 
rule, we thank the commenters for their responses and may take them 
into account as we develop future policies for consideration to delay 
measure removals.
    Furthermore, when we finalize measures to be a part of the MIPS 
quality measure inventory for a given MIPS payment year, we generally 
intend that the measures will be available for reporting by or on 
behalf of all MIPS eligible clinicians since MIPS is a government 
quality reporting program. It has come to our attention that certain 
MIPS measure stewards have limited or prohibited the use of their 
measures by third party intermediaries such as QCDRs and qualified 
registries. To the extent that MIPS measure stewards limit the 
availability of previously finalized measures for MIPS quality 
reporting, including reporting by third party intermediaries on behalf 
of MIPS eligible clinicians, these limitations may lead to inadvertent 
increases in burden both for the MIPS eligible clinicians who rely on 
third party intermediaries and for third party intermediaries 
themselves. In addition, these limitations may adversely affect our 
ability to benchmark the measure or the robustness of the benchmark. 
For these reasons, we proposed to adopt an additional removal 
criterion, specifically, that we may consider a

[[Page 62959]]

MIPS quality measure for removal if we determine it is not available 
for MIPS quality reporting by or on behalf of all MIPS eligible 
clinicians. We solicited comments on this proposal.
    We received public comments on whether to adopt an additional 
removal criterion, specifically, that we may consider a MIPS quality 
measure for removal if we determine it is not available for MIPS 
quality reporting by or on behalf of all MIPS eligible clinicians. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters noted their support for our proposal to 
consider measures for removal if a measure steward does not make their 
measure available for reporting by or on behalf of all MIPS eligible 
clinicians it should be considered for removal.
    Response: We thank the commenters for their support.
    After consideration of the comments, we are finalizing the proposed 
measure removal criterion that we may consider a MIPS quality measure 
for removal if we determine it is not available for MIPS quality 
reporting by or on behalf of all MIPS eligible clinicians.
(v) Request for Information on Potential Opioid Overuse Measure
    To address concerns associated with long-term, high-dose opioids, 
we developed an electronic clinical quality measure (eCQM) titled: 
Potential Opioid Overuse. In the CY 2020 PFS proposed rule (84 FR 
40752), we solicited stakeholder feedback in several areas related to 
this measure. While we are not summarizing and responding to comments 
we received in this final rule, we thank the commenters for their 
responses and may take them into account as we consider further 
development of the Potential Opioid Overuse measure.
(2) Cost Performance Category
    For a description of the statutory basis and our existing policies 
for the cost performance category, we refer readers to the CY 2017 and 
CY 2018 Quality Payment Program final rules, and the CY 2019 PFS final 
rule (81 FR 77162 through 77177, 82 FR 53641 through 53648, and 83 FR 
59765 through 59776, respectively).
    In the CY 2020 PFS proposed rule (84 FR 40752 through 40762), we 
proposed to:
     Weight the cost performance category at 20 percent for 
MIPS payment year 2022, 25 percent for MIPS payment year 2023, and 30 
percent for MIPS payment year 2024 and all subsequent MIPS payment 
years;
     Change our approach to proposing attribution methodologies 
for cost measures by including the methodology in the measure 
specifications;
     Add 10 episode-based measures;
     Modify the total per capita cost and Medicare Spending Per 
Beneficiary (MSPB) measures; and
     Requested comments on the future inclusion of an 
additional episode-based measure.
    These proposals are discussed in more detail in the following 
sections of this final rule.
(a) Weight in the Final Score
    In the CY 2019 PFS final rule, we established at Sec.  
414.1350(d)(3) that the weight of the cost performance category is 15 
percent of the final score for the 2021 MIPS payment year (83 FR 59765 
through 59766). Section 51003(a)(1)(C) of the Bipartisan Budget Act of 
2018 (Pub. L. 115-123, February 9, 2018) (BBA of 2018) amended section 
1848(q)(5)(E)(i)(II)(bb) of the Act such that for each of the second, 
third, fourth, and fifth years for which the MIPS applies to payments, 
not less than 10 percent and not more than 30 percent of the MIPS final 
score shall be based on the cost performance category score. 
Additionally, section 1848(q)(5)(E)(i)(II)(bb) of the Act as amended 
states that it shall not be construed as preventing the Secretary from 
adopting a 30 percent weight if the Secretary determines, based on 
information posted under section 1848(r)(2)(I) of the Act, that 
sufficient cost measures are ready for adoption for use under the cost 
performance category for the relevant performance period. In the CY 
2019 PFS proposed rule, we solicited comments on how we should weight 
the cost performance category for the 2022 and 2023 MIPS payment years 
given the changes within the BBA of 2018 (83 FR 35901). We considered 
these comments when we developed our proposals for setting the weight 
of the cost performance category.
    In the CY 2020 PFS proposed rule (84 FR 40752), we proposed a 
steady increase in 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 stated that we believe 
this gradual and predictable increase would allow clinicians to 
adequately prepare for the 30 percent weight while gaining experience 
with the new cost measures. We recognized that cost measures are still 
being developed and that clinicians may not have the same level of 
familiarity or understanding of cost measures that they do of 
comparable quality measures. We also recognized that there may be 
greater understanding of the measures in the cost performance category 
as clinicians gain more experience with them.
    We proposed at Sec.  414.1350(d)(4) that the cost performance 
category would make up 20 percent of a MIPS eligible clinician's final 
score for the 2022 MIPS payment year (84 FR 40752). We stated that we 
plan to increase the weight of the cost performance category at 
standard increments of 5 percent each year until MIPS payment year 
2024. Therefore, we proposed at Sec.  414.1350(d)(5) to weight the cost 
performance category at 25 percent for the 2023 MIPS payment year and 
proposed at Sec.  414.1350(d)(6) to weight the cost performance 
category at 30 percent for the 2024 MIPS payment year and each 
subsequent MIPS payment year (84 FR 40752). This would allow us to meet 
the 30 percent cost performance category weight when required by the 
statute and give clinicians adequate time to gain experience with the 
cost measures while they represent a smaller portion of the final 
score. We stated that we also believe that a predictable increase in 
the weight of the cost performance category each year would allow 
clinicians to better prepare for each year going forward. We noted that 
we considered maintaining the weight of the cost performance category 
at 15 percent for the 2022 and 2023 MIPS payment years as we recognize 
that we are still introducing new measures for the cost performance 
category and clinicians are still gaining familiarity and experience 
with these new measures. However, recognizing that we are required by 
the statute to weight the cost performance category at 30 percent 
beginning with the 2024 MIPS payment year, we are concerned about 
having to increase the cost performance category's weight significantly 
for the 2024 MIPS payment year. We invited comments on whether we 
should consider an alternative weight for the 2022 and/or 2023 MIPS 
payment years.
    The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters supported our proposal to gradually 
increase the weight of the cost performance category to 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.
    Response: We thank the commenters for their support.

[[Page 62960]]

    Comment: Some commenters suggested maintaining the cost performance 
category weight at 15 percent until CMS is able to provide more 
detailed and actionable performance data to clinicians. Some examples 
of more detailed feedback include comparison information and data on 
the MIPS 2019 performance period cost measures or a format similar to 
the Quality and Resource Use Reports (QRURs) that were made available 
in connection with the Physician Quality Reporting System (PQRS) and 
Value Modifier (VM) programs. Some commenters suggested that CMS should 
wait to increase the weight of the cost performance category until 
clinicians gain more experience with and are more educated about the 
proposed and newly developed episode-based measures, and the modified 
total per capita cost and MSPB measures.
    Response: We agree with this concern and believe clinicians need 
more detailed and timely feedback on both new and existing cost 
measures in order to improve their performance in the cost performance 
category. We previously made the QRURs available to clinicians under 
the Physician Feedback Program, but the statute required those reports 
to end with 2017. In July of 2019, we provided detailed performance 
feedback reports to clinicians which included detailed information 
reflecting performance for the total per capita cost measure and MSPB 
clinician measure as specified for the 2018 MIPS performance period. We 
intend to provide similar feedback for all cost measures in July of 
2020, reflecting performance from the 2019 MIPS performance period and 
utilizing the measure specifications applicable for the 2019 MIPS 
performance period. We are committed to improving the feedback 
experience, including aiming to provide more granular and real-time 
data, for clinicians to better understand how they can improve their 
performance on these measures and in turn reduce the cost of care for 
Medicare beneficiaries. Once clinicians better understand and are more 
accustomed to reviewing the performance feedback reports on these 
episode-based and global cost measures, we would then expect to 
increase the cost performance category weight. Therefore, we believe it 
is best to maintain the 15 percent weight for the cost performance 
category for MIPS payment year 2022 in efforts to allow clinicians to 
become more familiar with the feedback process and allow us to continue 
to improve feedback reports.
    Comment: Many commenters opposed our proposal to gradually increase 
the weight of the cost performance category by 5 percent until MIPS 
payment year 2024 and utilize the flexibility established by the 
Bipartisan Budget Act of 2018 to weight the cost performance category 
between 10 and 30 percent. Some commenters expressed general concern 
about the quality of measures in the cost performance category 
including issues with appropriate attribution, reliability, and 
adjustment for social and complexity risk factors. Other commenters 
expressed concern about continued change and development in cost 
measures. A few commenters urged CMS to not increase the cost 
performance category weight in 2020 in light of the transition period 
to MVPs.
    Response: We understand that for many clinicians, cost measures are 
more difficult to understand than measures and activities in other 
performance categories. We believe that we can help to facilitate 
understanding by providing a more detailed level of feedback on 
performance on these measures. While we believe it is important to 
provide more detailed performance feedback to clinicians before 
increasing the weight of the cost performance category, we do not 
believe that the introduction of new and revised measures would require 
us to minimize the weight of the cost performance category. As in all 
performance categories of MIPS, there are continued opportunities to 
improve the measures and activities used to assess performance. We do 
believe that the cost measures that we are using in MIPS represent the 
best available measures and we take care to consider all of the 
important issues mentioned by the commenters, including attribution and 
risk adjustment, as part of the measure development process. 
Specifically regarding social and complexity risk factors, we continue 
to investigate ways to best accommodate the issue of social and patient 
complexity adjustment in measures. Currently, we use the CMS-HCC model 
to account for patient complexity, and we have also established a 
complex patient bonus as part of the MIPS final score, which accounts 
for elements of social complexity. We refer readers to our comment 
responses in section III.K.3.c.(2)(b)(iii) of this final rule for more 
detailed explanation of how we continue to address this issue.
    We also continue to revise measures to address concerns with 
attribution methodologies as discussed in section III.K.3.c.(2)(b)(v) 
of this final rule. In regards to reliability, we believe our current 
reliability threshold of 0.4 for measures in the cost performance 
category is both consistent with other CMS quality programs and ensures 
moderate reliability but does not substantially limit participation. We 
further discuss our policies related to reliability for cost measures 
in section III.K.3.c.(2)(b)(vi) of this final rule. Lastly, we 
anticipate that we may continue to use many of these proposed and newly 
developed episode-based measures within MVPs.
    Comment: A few commenters recommended maintaining the cost 
performance category weight at 15 percent until CMS develops more 
reliable and valid measures. One commenter stated that the cost 
methodology does not appropriately capture the cost of care for certain 
specialties particularly those that deliver costly procedures and treat 
highly complex patients.
    Response: We agree that it is important to have measures that are 
as reliable and valid as possible in the cost performance category. We 
have focused our efforts on developing episode-based measures, with 
significant clinical input to ensure that they reflect the services 
that can most be affected by the clinicians during the episode. We have 
also, as discussed in section III.K.3.c.(2)(b)(v) of this final rule, 
refined the existing total per capita cost and Medicare spending per 
beneficiary in a manner that we believe improves their validity. We 
will continue to evaluate cost measures that are included in MIPS on an 
ongoing basis and anticipate that measures could be added, modified, or 
removed through rulemaking as measure development continues. 
Additionally, we continue to work to develop new episode-based measures 
that could be considered for inclusion in the cost performance category 
in future years. We expect that future measures may apply to a greater 
range of specialties and clinical areas, including those that deliver 
costly procedures as suggested by commenters. However, once again, 
while we believe it is important to provide more detailed performance 
feedback to clinicians before increasing the weight of the cost 
performance category, we do not believe that the introduction of new 
and revised measures would require us to minimize the weight of the 
cost performance category. Section 1848(r)(2)(D)(i)(I) of the Act 
requires us to establish care episode groups and patient condition 
groups, which account for a target of an estimated one half of 
expenditures under parts A and B with such target increasing over time 
as appropriate. While we have developed some episode-based measures to 
target that goal as required, we shall continue our work to develop 
additional measures focusing on both additional specialty

[[Page 62961]]

types, as well as consider the important issue of treating highly 
complex patients. By continuing to gather detailed clinician and expert 
input on episode-based measures, such as through clinical subcommittees 
and technical expert panels convened by the measure development 
contractor, we hope to identify and mitigate potential unintended 
consequences each stage of the measure development process.
    After consideration of the public comments, we are not finalizing 
our proposal at Sec.  414.1350(d)(4) that the cost performance category 
would make up 20 percent of a MIPS eligible clinician's final score for 
the 2022 MIPS payment year. For the reasons discussed in our responses 
to comments above, we are instead continuing to weight the cost 
performance category at 15 percent for the 2022 MIPS payment year and 
are revising Sec.  414.1350(d)(3) to reflect that the cost performance 
category will be 15 percent of a MIPS eligible clinician's final score 
for MIPS payment years 2021 and 2022. We are also not finalizing our 
proposals at Sec.  414.1350(d)(5) to weight the cost performance 
category at 25 percent for the 2023 MIPS payment year and at Sec.  
414.1350(d)(6) to weight the cost performance category at 30 percent 
for the 2024 MIPS payment year and each subsequent MIPS payment year. 
We will consider the state of the performance feedback that we offer 
clinicians and expect to propose a weight for the cost performance 
category for the 2023 MIPS payment year in the CY 2021 PFS proposed 
rule.
    In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we 
will continue to evaluate whether sufficient cost measures are included 
under the cost performance category as we move towards the required 30 
percent weight in the final score. As described in section 
III.K.3.c.(2)(b)(iii) of this final rule, we proposed to add 10 
episode-based measures to the cost performance category beginning with 
the 2020 MIPS performance period (84 FR 40754 through 40759). We are 
continuing our efforts to develop more robust and clinician-focused 
cost measures. We will also be continuing to work on developing 
additional episode-based measures that we may consider proposing for 
the cost performance category in future years to address additional 
clinical conditions. Introducing more measures over time will allow 
more clinicians to be measured in this performance category, with an 
increasing focus on capturing costs for clinically associated services 
provided by clinicians for specific episodes of care. In section 
III.K.3.c.(2)(b)(v) of the proposed rule, we discussed modifications to 
both the total per capita cost and MSPB measures in an effort to ensure 
that our existing cost measures hold clinicians appropriately 
accountable (84 FR 40757 through 40759).
(b) Cost Criteria
(i) Background
    Under Sec.  414.1350(a), we specify cost measures for a performance 
period to assess the performance of MIPS eligible clinicians on the 
cost performance category. We will continue to evaluate cost measures 
that are included in MIPS on an ongoing basis and anticipate that 
measures could be added, modified, or removed through rulemaking as 
measure development continues. Any substantive changes to a measure 
would be proposed for adoption in future years through notice and 
comment rulemaking, following review by the Measure Applications 
Partnership (MAP). We would take all comments and feedback from both 
the public comment period and the MAP review process into consideration 
as part of the ongoing measure evaluation process. In the CY 2020 PFS 
proposed rule, we proposed to add 10 newly developed episode-based 
measures to the cost performance category for the CY 2020 performance 
period and future performance periods, and proposed modifications to 
both the total per capita cost and MSPB measures (84 FR 40754 through 
40759). Additionally, we summarized all new and existing measures that 
would be included in the cost performance category starting with the CY 
2020 performance period (84 FR 40761 through 40762). We stated that 
some modifications to measures used in the cost performance category 
might incorporate changes that would not substantively change the 
measure. Examples of such non-substantive changes may include updated 
diagnosis or procedure codes or risk adjustors. While we address such 
changes on a case-by-case basis, we stated that we generally believe 
these types of maintenance changes are distinct from substantive 
changes to measures that result in what are considered new or different 
measures. However, as described in section 3 of the Blueprint for the 
CMS Measures Management System Version 15 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf), if substantive changes to these measures that 
are owned and developed by CMS become necessary, we expect to follow 
the pre-rulemaking process for new measures, including resubmission to 
the Measures Under Consideration (MUC) list and consideration by the 
MAP. The MAP provides an additional opportunity for an 
interdisciplinary group of stakeholders to provide feedback on whether 
they believe the measures under consideration are applicable to 
clinicians and complement program-specific statutory and regulatory 
requirements. Through its Measure Selection Criteria, the MAP focuses 
on selecting high-quality measures that address the NQF's three aims of 
better care, healthy people/communities, and affordable care, as well 
as fill critical measure gaps and increase alignment among programs.
    In section III.K.3.c.(2)(b)(v)(A) of the CY 2020 PFS proposed rule, 
we summarized the timeline for measure development, including 
stakeholder engagement activities that are undertaken by the measure 
development contractor, which include a technical expert panel (TEP), 
clinical subcommittees, field testing, and education and outreach 
activities (84 FR 40756).
(ii) Attribution
    In this section of this final rule, we discuss our approach to the 
attribution methodology for cost measures along with revisions to our 
existing cost measures. In the CY 2017 Quality Payment Program final 
rule (81 FR 77168 through 77169), we adopted an attribution methodology 
for the total per capita cost measure under which beneficiaries are 
attributed using a method generally consistent with the method of 
assignment of beneficiaries used in the Shared Savings Program. We 
codified this policy under Sec.  414.1350(b)(2) in the CY 2019 PFS 
final rule (83 FR 59774). In the CY 2017 Quality Payment Program final 
rule (81 FR 77174 through 77176), we also adopted an attribution 
methodology for the MSPB measure under which an episode is attributed 
to the MIPS eligible clinician who submitted the plurality of claims 
(as measured by allowed charges) for Medicare Part B services rendered 
during an inpatient hospitalization that is an index admission for the 
MSPB measure during the applicable performance period. We codified this 
policy under Sec.  414.1350(b)(3) in the CY 2019 PFS final rule (83 FR 
59775).
    In the CY 2019 PFS final rule (83 FR 59775), we established at 
Sec.  414.1350(b)(6) that for acute inpatient medical condition 
episode-based measures, an episode is attributed to each MIPS eligible 
clinician who bills inpatient E/M claim lines during a

[[Page 62962]]

trigger inpatient hospitalization under a TIN that renders at least 30 
percent of the inpatient E/M claim lines in that hospitalization, and 
at Sec.  414.1350(b)(7) that for procedural episode-based measures, an 
episode is attributed to each MIPS eligible clinician who renders a 
trigger service as identified by HCPCS/CPT procedure codes.
    As discussed in section III.K.3.c.(2)(b)(v) of the CY 2020 PFS 
proposed rule, we have reevaluated the total per capita cost and MSPB 
measures (84 FR 40756 through 40759). In the process of evaluating 
these measures, the TEP identified areas for potential refinement 
within the attribution methodology, and the revised measures that we 
proposed included substantial changes to the attribution methodology. 
As we explained in section III.K.3.c.(2)(b)(v) of the proposed rule, we 
believe these new attribution methodologies better establish the 
relationship between the clinician and the patients. In general, for 
the cost performance category, we stated in the CY 2020 PFS proposed 
rule (84 FR 40753 through 40754) that we believe that attribution is a 
fundamental element of the measures, and we do not believe that a cost 
measure can be separated from its attribution methodology. Although in 
prior rulemaking, we have discussed the attribution methodologies for 
the cost measures in the preamble and included those methodologies in 
the regulation text, we stated that we intend to take a different 
approach going forward and address attribution as part of the measure 
logic and specifications. We stated that for this rulemaking and in 
future rulemaking, we will include the attribution methodology for each 
cost performance category measure in the measure specifications, which 
were available for review and public comment at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html during the 
public comment period for the proposed rule, and will be available in 
final form at https://qpp.cms.gov/about/resource-library after this 
final rule is published. We stated that we believe this approach is 
preferable because it would reduce complexity for MIPS eligible 
clinicians and other stakeholders by presenting the attribution 
methodology with the rest of the cost measure specifications, ensure 
non-substantive changes can be implemented without undertaking 
rulemaking, and align with the approach taken for measures in the 
quality performance category. Therefore, we proposed to revise Sec.  
414.1350(b)(2), (3), (6), and (7) to reflect that these previously 
finalized attribution methods apply for the 2017 through 2019 
performance periods (84 FR 40754). We also proposed to establish at 
Sec.  414.1350(b)(8) that beginning with the 2020 performance period, 
each cost measure would be attributed according to the measure 
specifications for the applicable performance period (84 FR 40754).
    In the CY 2017 Quality Payment Program final rule, we established a 
final policy to attribute cost measures at the TIN/NPI level, 
regardless of whether a clinician's performance for purposes of MIPS is 
assessed as an individual (the TIN/NPI level) or as part of a group 
(the TIN level) (81 FR 77175 through 77176). We codified this policy 
under Sec.  414.1350(b)(1) in the CY 2019 PFS final rule (83 FR 59774 
through 59775). Similar to the attribution methodology for cost 
measures, we stated in the CY 2020 PFS proposed rule (84 FR 40754) that 
we also believe that the level of attribution (TIN/NPI or TIN) is best 
addressed as part of the measure specifications, allowing for different 
considerations for group and individual attribution based on the 
underlying measure specification. We stated that for this rulemaking 
and in future rulemaking, we will include the level of attribution for 
each cost performance category measure in the measure specifications, 
which will be publicly available as described in the preceding 
paragraph. The measure specification documents will provide the 
methodology for assigning attribution to an individual clinician or a 
group, which will align with whether the participant is reporting data 
as an individual clinician or a group under the MIPS program. 
Therefore, we proposed to revise Sec.  414.1350(b)(1) to reflect that 
the current policy of attributing cost measures at the TIN/NPI level, 
regardless of whether a clinician's performance for purposes of MIPS is 
assessed as an individual or a group, applies for the 2017 through 2019 
performance periods (84 FR 40753). We stated that we intend for the new 
regulation text proposed at Sec.  414.1350(b)(8) also to include the 
level of attribution (individual clinician or group), so we did not 
propose additional regulation text. In section III.K.3.c.(2)(b)(vi)(B) 
of the proposed rule, we proposed to limit the assessment of certain 
cost measures to MIPS eligible clinicians who report as a group based 
on our assessment of the reliability of the measure at the group and 
individual level (84 FR 40760). Although this is not directly related 
to attribution, it does limit the assessment of certain measures for 
MIPS eligible clinicians who report as individuals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported our proposal to include the 
attribution methodology for each cost performance category measure in 
the measure specifications for this and all future proposed rules.
    Response: We thank the commenters for their support.
    Comment: One commenter stated that they are concerned with how 
proposed changes to attribution methodology will be made available to 
the public. The commenter suggested that this could increase complexity 
and make it difficult for the public to identify the changes.
    Response: We disagree with the commenter and believe this change 
would reduce complexity for MIPS eligible clinicians and other 
stakeholders by presenting the attribution methodology comprehensively 
along with the rest of the cost measure specifications.
    After consideration of the public comments, we are finalizing our 
proposal to revise Sec.  414.1350(b)(2), (3), (6), and (7) to reflect 
that the previously finalized attribution methods apply for the 2017 
through 2019 performance periods. We are also finalizing our proposal 
to establish at Sec.  414.1350(b)(8) that beginning with the 2020 
performance period, each cost measure will be attributed according to 
the measure specifications for the applicable performance period. 
Lastly, we are finalizing our proposal to revise Sec.  414.1350(b)(1) 
to reflect that the current policy of attributing cost measures at the 
TIN/NPI level, regardless of whether a clinician's performance for 
purposes of MIPS is assessed as an individual or a group, applies for 
the 2017 through 2019 performance periods.
(iii) Episode-Based Measures for the 2020 and Future Performance 
Periods
    In this section of the final rule, we discuss our proposal to add 
10 newly developed episode-based measures to the cost performance 
category beginning with the 2020 performance period. We developed 
episode-based measures to represent the cost to Medicare and 
beneficiaries for the items and services furnished during an episode of 
care (``episode''). Episode-based measures are developed to compare 
clinicians on the basis of the cost of the care clinically related to 
their initial treatment of a

[[Page 62963]]

patient and provided during the episode's timeframe. Specifically, we 
define cost based on the allowed amounts on Medicare claims, which 
includes both Medicare payments and beneficiary deductible and 
coinsurance amounts. We refer our readers to the CY 2019 PFS final rule 
for more detail on episode-based measures and how they are established 
(83 FR 59767).
    Prior to presenting our cost measures to the MAP for consideration, 
the measure development contractor has continued to seek extensive 
stakeholder feedback on the development of episode-based measures, 
building on the processes outlined in the CY 2018 PFS final rule (82 FR 
53644). For more information, we refer readers to the discussion in the 
CY 2020 PFS proposed rule (84 FR 40754 through 40755). Further detail 
can also be found in the Measure Development Process document at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-measure-development-process.pdf, which includes a discussion of the detailed 
clinical input obtained at each step, and details about the components 
of episode-based measures.
    We provided an initial opportunity for clinicians to review their 
performance under the new episode-based measures via national field 
testing conducted in fall of 2018. During field testing, we sought 
feedback from stakeholders on the draft measure specifications, 
feedback report format, and supplemental documentation through an 
online form, and we received 67 responses, including 25 comment 
letters. The measure development contractor shared the feedback on the 
draft measure specifications with the measure-specific workgroups, who 
considered it in providing input on further refinements after the end 
of field testing. A field testing feedback summary report, which 
details post-field testing refinements added based on the input from 
the measure-workgroups, is publicly available on the MACRA Feedback 
Page (https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html).
    Similar to previous years, we continued to engage clinicians and 
stakeholders, conducting extensive outreach activities. These 
activities included general informational email blasts, targeted email 
outreach to specialty societies, hosting office hours to gather input 
on additional opportunities for participation and outreach, and hosting 
the MACRA Cost Measures Field Testing Webinar to provide information 
about the measure development process and field test reports and a 
forum for stakeholder questions to ask questions.
    Following the successful field testing and review through the MAP 
process, we proposed to add the 10 episode-based measures listed in 
Table 44 as cost measures for the 2020 performance period and future 
performance periods (84 FR 40754).
    The detailed specifications for these 10 episode-based measures are 
available on the MACRA Feedback page (https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-
Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). These specifications 
documents consist of: (1) Methodology for constructing each measure; 
and (2) measure codes list file with medical codes and clinical logic. 
First, the methodology document provides an overview of the measure, 
including a description of the measure numerator and denominator, the 
patient cohort, and the care settings in which the measure is assessed. 
In addition, the document includes two one-page, high-level overviews 
of (1) methodology and (2) clinical logic and service codes, which were 
added in response to stakeholder feedback regarding provision of 
documentation with varying levels of detail to ensure the information 
is accessible to all stakeholders. The methodology document provides 
detailed descriptions of each logic step involved in constructing the 
episode groups and calculating the cost measure. Second, the measure 
codes list file contains the service codes and clinical logic used in 
the methodology, including the episode triggers, exclusions, episode 
sub-groups, assigned items and services, and risk adjustors. More 
information about the attribution methodology for each measure is 
available in section A.2 of the methodology documentation.
[GRAPHIC] [TIFF OMITTED] TR15NO19.088

    The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters supported our proposal to adopt the 10 
episode-based measures under the cost performance category for the 2020 
MIPS performance period and future performance periods.

[[Page 62964]]

    Response: We appreciate the support of the commenters.
    Comment: A few commenters expressed concern regarding the measure 
development process including the perceived lack of transparency in the 
process, the measure development timeline, and the reliance on 
administrative claims data for measure calculations. Some commenters 
expressed concern that the field-testing process for episode-based 
measures was inadequate and suggested a delay to allow clinicians more 
time to better understand the measures before they are used to 
determine cost performance category scores. One commenter recommended 
that CMS work with specialty societies throughout the maintenance 
process to ensure continuous input from the provider community. Another 
commenter appreciated that CMS provided feedback reports to clinicians 
who were attributed to episode-based measures during field testing. 
However, only a few clinicians could access the feedback reports to 
provide further input.
    Response: We aim to be open and transparent in every stage of the 
measure development process. The measure development process collects 
input at every step of development, including prioritizing episodes for 
measure development, for which our measure development contractor 
convened over 260 clinician experts across 10 Clinical Subcommittees. 
The measure development contractor subsequently convened 11 workgroups 
and over 130 clinician experts to obtain detailed clinical input on 
each aspect of the measures' specifications. For each meeting of these 
panels, the measure development contractor provided extensive analyses 
to inform the workgroup members' recommendations. This process, which 
began in April 2018 and concluded in January 2019, is discussed in 
detail in CY 2020 PFS proposed rule (84 FR 40754). The measure 
development process has also been refined based on stakeholder input 
received. For example, smaller, more focused measure-specific expert 
workgroups were added to develop the 10 new episode-based measures 
based on feedback the measure development contractor obtained from 
members of the first wave of clinical subcommittees. Additionally, as 
requested by stakeholders, the measure development contractor offered a 
listen-only observer dial-in line for stakeholders during the Wave 3 
measure-specific workgroup meetings convened in August 2019. We 
recognize stakeholders' requests for an extended development timeline 
to allow more opportunities for clinicians to provide input on the 
measures and will consider this feedback for future waves of measure 
development.
    We are committed to continuing to increase awareness about the 
measures both during field testing and through other education and 
outreach activities. During field testing, we provided extensive 
materials regarding the measures, including measure specifications, an 
FAQ document, a fact sheet, testing results, and mock reports for 
clinicians who did not receive a field test report. Additionally, we 
hosted webinars to provide information on the measures under field 
testing, one during the field testing period and another after field 
testing to provide an update on the measure refinements that resulted 
from field testing feedback. We have also posted additional 
documentation on the MACRA feedback page such as the measure 
justification forms, which provide more testing information for the 
measures. Given the extensive outreach we have conducted, as well as 
the education materials we have posted for these measures, we believe 
they are ready for implementation. We will continue to welcome feedback 
on how the field testing period and the development process can be 
further refined to increase awareness about the measures.
    Section 1848(r)(5) of the Act requires the Secretary, as the 
Secretary determines appropriate, to use certain claims data to conduct 
an analysis of resource use. We believe that an advantage of using 
claims data is that it creates no additional reporting burden for 
clinicians, which greatly increases the feasibility of calculating and 
reporting cost measures. We will continue to consider incorporating 
additional data sources in measure calculations and welcome feedback on 
potential alternatives.
    Comment: Some commenters expressed concern about a lack of 
alignment between cost and quality measures, stating as an example that 
the Screening/Surveillance Colonoscopy episode-based measure was 
finalized as the quality measure, Screening Colonoscopy Adenoma 
Detection Rate (Measure 343), was removed from the MIPS quality 
performance category. These commenters expressed concern that this 
would cause clinicians to focus on costs and not on quality. One 
commenter recommended that CMS complete an empiric validity test to 
demonstrate how each of these measures correlates to quality measures 
reported within MIPS.
    Response: As discussed in the CY 2020 PFS proposed rule (84 FR 
40732 through 40745), we are focused on moving the MIPS program forward 
with an aligned set of measures and activities known as an MVP. In the 
course of implementing the framework for MVPs, we will consider the 
relationship between cost and quality. We agree with the importance of 
cost and quality alignment, and view it as an essential component of 
episode-based measures. For instance, as part of episode group 
prioritization for development, the measure development contractor 
asked clinical subcommittee members to consider the measures' potential 
for alignment with established quality measures. This includes 
consideration of whether there is potential for overlap in covering the 
same patient cohort and the dimensions of care that the quality measure 
would be capturing in relation to a procedure or condition that the 
episode-based cost measure could focus on. We are also considering 
these comments on the quality measures retained and removed within the 
MIPS program in more detail in section III.K.3.c.(1)(d) of this final 
rule.
    Comment: Some commenters expressed concern that the episode-based 
measures proposed for inclusion in CY 2020 performance period and 
future years had not been endorsed by the NQF. One commenter 
recommended that all measures included in the MIPS program be endorsed 
by NQF.
    Response: We intend to submit the episode-based measures for NQF 
endorsement in a future endorsement cycle; however, NQF endorsement is 
not a requirement for implementing cost measures in MIPS. The MAP 
reviewed the episode-based measures and provided the recommendation of 
``conditional support for rulemaking'' with the condition that the 
measures be submitted for NQF endorsement. This review provided 
stakeholders with additional public comment opportunities, which the 
MAP considered along with submission materials regarding the 
reliability and validity of the measures. In addition, we provided 
testing results that examined the measures' scientific acceptability in 
the measure justification forms, which are available on the MACRA 
Feedback Page (https://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-
APMs/MACRA-Feedback.html). The measures have undergone a comprehensive 
stakeholder input process and extensive testing, and we believe they 
are ready for implementation.
    Comment: Some commenters suggested the inclusion of social risk 
factors such as sociodemographic status when risk adjusting the 
proposed

[[Page 62965]]

episode-based measures. Some of these commenters expressed concern that 
risk adjustment for the episode-based measures uses only variables 
included in the CMS-HCC risk adjustment model and other clinical 
characteristics, and they suggest that CMS explore alternative risk 
adjustment data to include. One commenter recommended that CMS not 
utilize claims data for risk adjustment.
    Response: Each measure's risk adjustment model employs a common 
starting point of the CMS-HCC model, but the measure-specific expert 
workgroups considered enhancements to the model through the addition of 
risk factors specifically adapted for each episode group. The measure 
development contractor provided empirical analyses stratifying patient 
(or episode) cohorts of interest to inform the workgroup members' 
considerations of how particular factors should be accounted for in 
each measure's risk adjustment model. Workgroup members also considered 
patient characteristics, factors outside of the influence of the 
attributed clinicians, or any other measure-specific factors that would 
help prevent unintended consequences.
    We are aware of the concern regarding risk adjustment for social 
risk factors and are continuing to consider options to account for 
social risk factors that would allow clinicians to view disparities 
that would potentially incentivize improvement in care for 
beneficiaries. We remain concerned about holding clinicians to 
different standards for the outcomes of their patients with social risk 
factors because we do not want to mask potential disparities. As part 
of the standard development and testing process, the measure 
development contractor conducted analyses to assess the impact of the 
following social risk factors: Income; education; population; 
employment; race; sex; and dual-eligibility status, which can be found 
in the measure justification forms for the episode-based measures 
available for download from the MACRA Feedback Page. Results of these 
analyses found very little to no effect on the predictive power of the 
risk adjustment models used when variables for social risk factors were 
included in the models, compared to using the current models. More 
information on these analyses is available in the measure justification 
forms posted on the MACRA Feedback Page (https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-
Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). We will continue to 
monitor the potential effect of social risk factors on episode-based 
measures implemented in MIPS on an ongoing basis.
    Regarding the use of claims data for risk adjustment, section 
1848(r)(5) of the Act requires the Secretary, as the Secretary 
determines appropriate, to use certain claims data to conduct an 
analysis of resource use. As we stated in a prior response, we believe 
that an advantage of using claims data is that it creates no additional 
reporting burden for clinicians, which greatly increases the 
feasibility of calculating and reporting cost measures. We will 
continue to consider incorporating additional data sources in risk 
adjustment and welcome feedback on potential alternatives.
    Comment: Some commenters expressed concerns regarding the perceived 
issue of double counting costs assigned to the revised total per capita 
cost and MSPB clinician measures and the episode-based measures. For 
example, commenters were concerned that costs may be double counted 
when clinicians are measured by more than one type of measure (that is, 
being measured by the MSPB clinician measure and an episode-based 
measure that have different frameworks, benchmarks, and comparison 
groups).
    Response: We understand the concern about double counting of costs 
to be a concern about the potential for a particularly costly service, 
episode, or patient to have an outsized effect on a clinician's cost 
measure performance as services can be included in more than one 
measure score calculation. We believe that the construction and 
calculation of the cost measures in fact guards against this 
possibility.
    Any given service and its associated cost is only included once per 
episode per attributed clinician for a given measure. Each measure then 
calculates the average observed to expected cost across episodes for an 
attributed clinician to generate a score for that particular measure. 
Each cost measure is calculated separately, and then averaged into a 
single score for the MIPS cost performance category. In the aggregation 
of a MIPS cost performance category score, the relative impact of a 
high or low cost service in each cost measure is averaged for a given 
clinician or clinician group, rather than simply counted twice. That 
is, calculation of the cost performance category score as an average of 
individual cost measure scores avoids compounding good or poor results, 
which would otherwise occur if the score was calculated as a simple 
addition of cost measure scores. This ensures that clinicians will not 
be double-penalized or rewarded for a high or low cost service.
    In addition, this approach allows each measure to capture clinician 
performance within the intent and scope of each individual measure. 
Episode-based measures only include costs related to the episode for a 
clinical condition or procedure and are focused on the clinician's 
specific role; in comparison, population-based measures include all 
services that are provided to a patient over a given timeframe to focus 
on a broader range of patient care. Specifically, the MSPB clinician 
measure assesses the cost performance of clinicians providing care at 
inpatient hospitals, while the total per capita cost measure focuses on 
primary care management outside the inpatient setting. By design, some 
costs for a patient may be included in more than one measure. For 
example, a patient with a primary care clinician who is providing 
overall care may be admitted to hospital to undergo a planned surgical 
procedure, which is performed by a surgeon. The TPCC measure assesses 
the primary care clinician's overall care for the patient, and the MSPB 
clinician measure evaluates the surgeon's inpatient care of the 
patient. By having the primary care clinician's responsibility ongoing 
before, during, and after the inpatient stay, the TPCC measure captures 
the nature of primary care. Similarly, by covering the surgeon who 
performs the procedure in the hospital, the MSPB clinician measure 
assesses the care before, during, and after the inpatient stay. Holding 
both the primary care clinician and surgeon responsible for the patient 
during the inpatient stay helps to align incentives across care 
settings through the patient care continuum, which encourages care 
coordination. To do otherwise may leave a gap in accountability, 
limiting the extent to which cost measures can operate together to 
encourage care coordination for improved patient outcomes.
    Comment: We received one comment stating that they were unable to 
review the measure specifications at the link provided.
    Response: We had posted the measure specifications at the link 
specified in the proposed rule for the duration of the public comment 
period, and we have reposted the specifications (updated to reflect the 
policies we are finalizing in this rule) on the MACRA Feedback page 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html). We expect to post the measure specifications in final 
form in

[[Page 62966]]

the Quality Payment Program resource library (https://qpp.cms.gov/about/resource-library) by the end of the year.
    Comment: A few commenters urged CMS to better educate clinicians to 
ensure that they understand how to interpret the measure specifications 
and feedback report data. One commenter urged CMS to ensure that cost 
measures are actionable by making episode-based cost measure field 
testing reports available after the testing period concludes. Some 
commenters urged CMS to provide real time feedback early in the year 
when new measures are used or calculate data for new measures using 
historical data for clinicians to better understand their performance 
and benchmark. A few commenters recommended that feedback reports 
provide more detailed information including demographic and clinical 
characteristics for attributed beneficiaries.
    Response: We will continue to work to increase familiarity with the 
measures through education and outreach activities. We produced various 
education and outreach materials during field testing, including 
measure specifications, an FAQ, fact sheet, testing results, and mock 
reports for clinicians who did not receive field test reports with 
performance feedback. In addition, we hosted a webinar, where we 
provided an overview of the field test reports and answered questions 
from stakeholders. Throughout the field testing period, we provided 
helpdesk support regarding field testing and the reports through the 
Quality Payment Program Service Center. Lastly, we convened office 
hours sessions with specialty societies to help coordinate targeted 
outreach and ensure that we reached clinicians who were most likely to 
be attributed the measures. We recognize the importance of education 
and outreach, and expect to continue these types of activities in 
future field testing periods.
    The field test reports from the fall 2018 field testing were 
available for review through for a period after the field testing 
period concluded and were removed once the portal was decommissioned. 
We are exploring alternative venues to facilitate access to the field 
test reports for future field testing. In this process, we will also 
consider ways the reports can be made available after the field testing 
period concludes.
    We appreciate the feedback regarding the availability of real time 
feedback early in the year. We note that the nature of claims-based 
measures presents additional considerations that affect the 
availability of real time feedback. We allow at least a 60-day run out 
to allow for adjustments to claims and ensure data completeness. This, 
along with episode length for the cost measures must be accounted for 
in considerations of providing real time feedback early in the 
beginning of the performance year. We will continue to explore ways to 
extend accessibility of materials such as the field test reports, to 
increase access to information about clinicians' expected performance. 
We will also continue to consider ways to offer actionable data and 
feedback on cost measures to clinicians in the future, including the 
format of reports and the information they contain.
    Comment: A few commenters supported the development and inclusion 
of episode-based measures but expressed concern that measures for their 
particular specialty or focus area, such as anesthesia, dermatology, 
chronic conditions and plastic surgery were not yet included. One 
commenter recommended that all measures to be fully vetted by 
clinicians to ensure their clinician relevance. A few commenters 
recommended that CMS accelerate and establish a process for the 
development of additional episode-based measures in order to ensure 
fair comparisons and reliability.
    Response: We continue to work to develop new episode-based measures 
that could be considered for inclusion in the cost performance category 
in future years. We expect that future measures may apply to a greater 
range of specialties and clinical areas, including areas suggested by 
commenters. In fact, episode-based measures focusing on chronic 
conditions and dermatology are currently being developed as part of 
Wave 3 of measure development. We expect these measures to undergo 
field testing next year. More information regarding Wave 3 measures is 
available on the MACRA Feedback Page (https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-
Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). We anticipate the 
development of additional waves of episode-based cost measures in the 
future that will expand the range of specialties and clinical areas 
included.
    Section 1848(r)(2)(D)(i)(I) of the Act requires us to establish 
care episode groups and patient condition groups, which account for a 
target of an estimated one half of expenditures under parts A and B 
with such target increasing over time as appropriate. The measure 
development process includes a data-driven expert input process that is 
critical to the development of robust, meaningful, and actionable 
episode-based measures, though it presents a trade-off between the 
number of measures we can develop and the level of clinician and expert 
input we can involve in this process. We aim to find the right balance 
to ensure the addition of meaningful episode-based measures, while 
still undergoing this comprehensive clinician-input driven process. 
While the development of more episode-based measures does increase the 
number of clinicians covered by the measures, it does not ensure fair 
comparisons and greater reliability. To ensure fair comparisons and 
greater reliability, we pair our extensive stakeholder input process 
with robust testing to ensure that the measures are clinically relevant 
and measure clinicians fairly and reliably. Information about measure 
testing is available in the National Summary Data Report and the 
measure justification forms, which are available on the MACRA feedback 
page (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html).
    Comment: A few commenters generally opposed the inclusion of 
episode-based measures. Some commenters recommended that CMS not 
include the proposed and newly developed episode-based measures until 
they can be further evaluated and better understand the implications on 
impacted clinicians. For example, CMS should consider whether episode-
based measures would create an unfair playing field amongst specialist 
and subspecialists. One commenter recommended that CMS adopt additional 
episode-based measures only in efforts to collect data to inform the 
development of MVPs.
    Response: We conducted extensive field testing activities in the 
Fall of 2018 to provide clinicians with an opportunity to gain 
experience with and evaluate their performance on the episode-based 
measures that were field tested. We have also performed testing on the 
measures, including reliability and validity testing. The details of 
the testing are available in the measure justification forms and 
National Summary Data Report posted on the MACRA Feedback Page (https:/
/www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html). The measures were also developed with extensive 
clinician and expert input to inform each aspect of the measure 
specifications. We believe that

[[Page 62967]]

the episode-based measures are ready for use in the program given the 
testing we have conducted and the extensive involvement of clinician 
experts in the development of the measures. We will also continue to 
develop new episode-based measures to cover a wider range of 
specialties that are not currently measured by the episode-based or 
population-based measures.
    We continue to work to develop new episode-based measures that 
could be considered for inclusion in the cost performance category in 
future years and appreciate the input about how to more closely link 
the development of episode-based measures and MVPs. We do note that 
while episode-based cost measures may be helpful for understanding the 
use of MVPs, these measures use Medicare claims data, so it is not 
necessary to adopt additional measures in order to collect data.
    As we develop additional cost measures, we aim to measure as many 
clinicians as possible in the cost performance category. We recognize 
that due to the current nature of measurement that some clinicians will 
be measured on more cost measures than others, while others will not be 
measured on cost at all. We believe that the principles of fairness 
espoused by the commenter can be supported by measuring clinicians 
using the best measures or activities in each performance category. 
However, we disagree that the episode-based measures would present an 
unfair playing field between specialists and subspecialists. Clinicians 
attributed under these measures are compared to peers who are similarly 
attributed. Clinicians who are not measured on the episode-based 
measures are potentially measured on the other cost performance 
category measures and similarly compared to their peers when assessing 
cost performance. We will continue to evaluate our scoring policies to 
ensure that scores reflect performance and not the practice specialty 
or type of a clinician or group.
    Comment: Some commenters expressed concern with certain 
specifications for the Hemodialysis Access Creation episode-based 
measure. These commenters expressed concern that the surgeon that 
performs the trigger procedure is not generally responsible for follow-
up management but would be held accountable under this measure. They 
also expressed concern that the measure did not differentiate between 
patients receiving the procedure for the first time or those who had 
the procedure previously. They also indicated that patients receiving 
this procedure were complex with multiple illnesses and that it would 
be difficult to differentiate services associated with hemodialysis 
from other services and to apply risk adjustment to this measure. One 
commenter suggested a change to the technical specifications of the 
measure to exclude patients who die within 90 days of the close of the 
episode. Another commenter recommended that the inclusion and exclusion 
criteria for this cost measure should include a clean, pre-trigger 
period of 12 months where the patient is not identified on a claim with 
a billing code for outpatient dialysis.
    Response: The measure was developed with expert clinical input from 
the workgroup to ensure that only costs of care within the reasonable 
influence of the attributed clinician for the defined patient 
population are included. Exclusions identify patient characteristics 
and factors in the patient's medical history that might adversely 
affect the patient's treatment during the episode, to an extent that is 
outside the influence of the managing clinician. As such, we do not 
believe that it is appropriate to retroactively exclude patients who 
die within 90 days after the close of the episode if they would 
otherwise fit in with a homogenous patient cohort captured by the 
measure. This is consistent with the measure framework for the episode-
based measures.
    The measure's risk adjustment model includes variables specific to 
the measure that recommended by the workgroup, in addition to those in 
the CMS-HCC model, that address issues of patient complexity and 
comorbidities. The model risk adjusts for the presence of previous 
procedures to account for patients undergoing multiple vascular access 
procedures, and adjusts for patients who undergo two-stage procedures.
    Lastly, including only pre-dialysis patients with an extended clean 
period, as suggested, excludes a very large portion of the patient 
population this measure aims to capture. We are concerned that this 
change may also incentivize clinicians to wait until a patient is on 
dialysis before placing a vascular access to avoid being attributed 
episodes. Delaying the placement of a suitable vascular access could 
negatively impact patient health outcomes and further increase the 
number of dialysis patients that begin treatment with a catheter. We 
are finalizing the Hemodialysis Access Creation measure as proposed.
    Comment: One commenter indicated that there are facilities such as 
academic medical centers and tertiary medical centers who may have 
disproportionately complex patients, which may result in higher costs 
within episodes. Hence, as result of cost measures including transfers 
and emergent cases, it would be inappropriate to compare the efficiency 
of these episodes among hospitals who do not have a similar complex 
patient population.
    Response: We recognize that complex patients may be costlier to 
treat, and the episode-based measures include robust statistical 
techniques to ensure that differences in the patient population are 
appropriately accounted for. Through risk adjustment, the measures are 
adjusted for factors outside of the clinician's control that can 
influence spending such as the care setting and patient characteristics 
to achieve a fair comparison of cost across clinicians. Risk adjustment 
aims to isolate the variation in clinicians' costs to Medicare to those 
costs that clinicians can reasonably influence. Accounting for these 
factors is one way to ensure the validity of cost measures and mitigate 
potential unintended consequences. Additionally, the creation of 
strictly defined episodes produces more homogeneous populations within 
each episode group that allows for more accurate comparisons of 
clinician performance.
    Comment: A commenter expressed concern that the measure exclusion 
list for the Inpatient COPD Exacerbation episode-based measure does not 
adequately capture patients who have undergone lung surgery/resection 
and should be excluded from this measure, and provided additional codes 
for CMS to consider adding to the list of codes used to capture 
patients who should be excluded due to history of lung resection.
    Response: Patients who have undergone lung surgery/resection are 
excluded in the Inpatient COPD Exacerbation measure; however, we agree 
that the additional lung resection codes suggested by the commenter 
would capture an additional group of lung resection patients. The 
addition of the suggested codes to the exclusions list is in keeping 
with the clinical input provided by the expert workgroup and would 
remove approximately 260 episodes, representing less than 0.1 percent 
of all episodes. As such, we are finalizing the Inpatient COPD 
Exacerbation measure with the exclusion list expanded to include the 
recommended lung resection codes, which are listed in the Inpatient 
COPD Exacerbation measure codes list file available for download on the 
MACRA Feedback Page (https://www.cms.gov/

[[Page 62968]]

Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-
Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html).
    Comment: One commenter expressed concern that the Non-Emergent CABG 
episode-based measure included the code 33406 (Replacement of the 
Aortic Valve Using Human Donor Valve on Heart-Lung Machine) as a 
trigger and not an exclusion. Additionally, the commenter also stated 
concerns that the stroke service assignment window of <15 days from 
trigger event was too long and believe <7 days would be more 
appropriate.
    Response: We agree that the suggested exclusion of code 33406 on 
trigger claims is clinically reasonable and in keeping with the 
intention of the Non-Emergent CABG measure expert workgroup not to 
assign procedures or conditions that represent small sub-populations 
with higher and unpredictable costs. CPT code 33406 indicates a unique 
type of aortic valve replacement in which the aortic valve is replaced 
by a human valve. This procedure is typically reserved for either 
patients with congenital heart disease or younger patients with 
infection of their native valve and occurs in a very different cohort 
of patients than the majority of Non-Emergent CABG measure episodes. 
These patient-level differences likely do influence downstream post-
operative recovery and costs. Other similar complicating operative 
factors are already excluded from the measure.
    To clarify, the Non-Emergent CABG episode-based measure does not 
include any stroke readmissions. The measure assigns inpatient 
rehabilitation facility (IRF) stays secondary to stroke post-CABG. Only 
stroke costs in the index hospitalization and subsequent rehabilitation 
are included in the proposed measure. Given that many post-CABG stays 
complicated by stroke are longer than 7 days, we do not intend to 
finalize any updates to the service assignment for the Non-Emergent 
CABG measure.
    We are finalizing the Non-Emergent CABG measure with the removal of 
CPT code 33406 from the list of episode triggers and addition of the 
code to the list of exclusions, found in the measure codes list on the 
MACRA Feedback page (https://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-
APMs/MACRA-Feedback.html).
    Comment: One commenter expressed concerns that CMS does not include 
the Acute Kidney Injury (AKI) Requiring New Inpatient Dialysis episode-
based measure for several reasons. The commenter indicated that the 
patient level variability in acuity/intensity of care required for the 
Acute Kidney Injury (AKI) Requiring New Inpatient Dialysis episode-
based measure, can make this measure a non-meaningful assessment of 
physician care, and has general concerns with the attribution 
methodology for this specific episode-based measure.
    Response: The Acute Kidney Injury (AKI) Requiring New Inpatient 
Dialysis measure was developed with expert clinical input to ensure 
that only costs of care within the reasonable influence of the 
attributed clinician, including nephrologists, for the defined patient 
population are included. In addition to risk adjustment variables in 
the CMS-HCC model that address issues of patient complexity and 
severity, the measure's risk adjustment model includes variables 
specific to the measure that were recommended by the workgroup to 
account for severity, such as variables for length of stays in the 
hospital or intensive care unit and recent admission to long term care 
facilities. Certain patient cohorts, such as those with diagnosis of 
end-stage renal disease (ESRD), post-discharge dialysis for ESRD, and 
kidney transplants are excluded from the patient population to ensure 
that the measure captures a homogenous population of patients. 
Additionally, the workgroup considered how to trigger and attribute 
episodes to ensure that they were clinically relevant and within a 
clinician's influence. An acute kidney injury episode is attributed to 
any clinician who bills a trigger procedure code for dialysis during 
the inpatient stay or to a nephrologist who bills an inpatient 
evaluation and management (E/M) service during the inpatient stay with 
hospital and critical care services accompanied by a diagnosis for 
acute kidney failure. This attribution methodology operationalizes the 
workgroup's recommendation for the measure development contractor to 
attribute Acute Kidney Injury (AKI) Requiring New Inpatient Dialysis 
episodes to the clinicians that are most likely to treat this patient 
cohort and to encourage care coordination for clinicians involved in 
the care continuum of patients included in this measure. We are 
finalizing the Acute Kidney Injury (AKI) Requiring New Inpatient 
Dialysis measure as proposed.
    Comment: A commenter expressed concerns with the current 
attribution methodology for episode-based measures. The commenter 
recommended that CMS include MIPS eligible clinicians who bill 
plurality of 97000 series codes during an episode. This modification 
would allow CMS to more accurately capture therapists within applicable 
episode-based measures.
    Response: The episode-based measures include all costs relevant to 
the episode, including services provided by therapists in the 97000 
series codes when appropriate for the treatment of the condition or 
procedure being measured. The episode-based measures are only 
attributed to those clinicians who either perform or assist with the 
procedure in question or are provide guiding care for the acute episode 
(for example, an orthopedist who performs a hip arthroplasty or a 
hospitalist that cares for a patient hospitalized for an acute 
exacerbation of chronic obstructive pulmonary disease). We will 
continue to consider how therapists that bill plurality of 97000 series 
codes can be included in existing and future episode-based cost 
measures.
    After consideration of the public comments, we are finalizing our 
proposal to include the 10 episode-based measures listed in Table 44 in 
the cost performance category beginning with the 2020 MIPS performance 
period with the modifications discussed in our responses to comments 
above.
(iv) Revisions to the Operational List of Care Episode and Patient 
Condition Groups and Codes
    Section 1848(r) of the Act specifies a series of steps and 
activities for the Secretary to undertake to involve the physician, 
practitioner, and other stakeholder communities in enhancing the 
infrastructure for cost measurement, including for purposes of MIPS and 
APMs. Section 1848(r)(2) of the Act requires the development of care 
episode and patient condition groups, and classification codes for such 
groups, and provides for care episode and patient condition groups to 
account for a target of an estimated one-half of expenditures under 
Parts A and B (with this target increasing over time as appropriate). 
Sections 1848(r)(2)(E) through (G) of the Act require the Secretary to 
post on the CMS website a draft list of care episode and patient 
condition groups and codes for solicitation of input from stakeholders, 
and subsequently, post an operational list of such groups and codes. 
Section 1848(r)(2)(H) of the Act requires that not later than November 
1 of each year (beginning with 2018), the Secretary shall, through 
rulemaking, revise the operational list as the Secretary determines may 
be appropriate, and that these revisions may be based on experience, 
new information developed

[[Page 62969]]

under section 1848(n)(9)(A) of the Act, and input from physician 
specialty societies and other stakeholders.
    In December 2016, we published the Episode-Based Measure 
Development for the Quality Payment Program (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Draft-list-of-episode-groups-and-trigger-codes-December-2016.zip) and requested input on a draft list of 
care episode and patient condition groups and codes as required by 
sections 1848(r)(2)(E) and (F) of the Act. We additionally requested 
feedback on our overall approach to cost measure development, including 
several pages of specific questions on the approach for clinicians and 
stakeholders to provide feedback. We used this feedback to modify our 
cost measure development and ensure that our approach is continually 
informed by stakeholder feedback. As required by section 1848(r)(2)(G) 
of the Act, in January 2018, we posted an operational list of 8 care 
episode groups and patient condition groups that we refined with 
extensive stakeholder input, along with the codes and logic used to 
define these episode groups. This operational list is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-Operational-List-of-Care-Episode-and-Patient-Condition-Codes.zip.
    Under section 1848(r)(5)(A)(iii) of the Act, to evaluate the 
resources used to treat patients with respect to care episode and 
patient condition groups, the Secretary shall, as the Secretary 
determines appropriate, conduct an analysis of resource use with 
respect to care episode and patient condition groups. In accordance 
with this section, we used the 8 care episode groups and patient 
condition groups included in the operational list as the basis for the 
8 episode-based measures that we developed in 2017 through early 2018 
and finalized for use in MIPS in the CY 2019 PFS final rule (83 FR 
59767-59773). We did not revise this operational list through 
rulemaking in 2018 as we did not receive stakeholder feedback 
requesting updates to how these episode groups are defined and there 
were no new developments requiring revisions. Under section 
1848(r)(2)(H) of the Act, we proposed to revise the operational list 
beginning with CY 2020 to include 10 new care episode and patient 
condition groups, based on input from clinician specialty societies and 
other stakeholders (84 FR 40756). The 10 care episode and patient 
condition groups were included in the draft list that we posted in 
December 2016 and refined based on extensive stakeholder input as 
described in section III.K.3.c.(2)(b)(v)(A) of this final rule. Our 
revisions to the operational list beginning with CY 2020 are available 
on our MACRA feedback page at https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-
MIPS-and-APMs/MACRA-Feedback.html. These care episode and patient 
condition groups serve as the basis for the 10 new episode-based 
measures that we proposed for the cost performance category in section 
III.K.3.c.(2)(b)(iii) of the proposed rule (84 FR 40754 through 40756) 
and are finalizing in Table 47 in section III.K.3.c.(2)(b)(viii) of 
this final rule.
    While we received many comments on measures that we proposed to 
include in the cost performance category as discussed in section 
III.K.3.c.(2)(b)(iii) of this rule, we did not receive any comments 
specifically on our proposal to revise the operational list. After 
reviewing and considering the comments on the merits of the proposed 
measures as discussed in those sections, we are finalizing our proposed 
revisions to the operational list beginning with CY 2020 to include the 
10 new care episode and patient condition groups.
(v) Revised Cost Measures Re-Evaluation Process for the Total Per 
Capita Cost and Medicare Spending Per Beneficiary Clinician Measures
    For the purpose of assessing performance of MIPS eligible 
clinicians in the cost performance category, we finalized both the 
total per capita cost and MSPB measures to be included in the MIPS 
program in CY 2017 Quality Payment Program final rule (81 FR 77166). We 
proposed to modify both of these measures based on stakeholder input 
from prior public comment periods and recommendations from the TEP (84 
FR 40756). We also proposed to modify the measure title from Medicare 
Spending Per Beneficiary (MSPB) to Medicare Spending Per Beneficiary 
clinician (MSPB clinician) to distinguish it from measures with similar 
names in use in other CMS programs and to improve clarity. We proposed 
to change the name from MSPB to MSPB clinician at Sec. Sec.  
414.1350(b)(3) and 414.1350(c)(2) (84 FR 40758). The measure 
development contractor convened the standing TEP and completed field 
testing to consider potential refinements to these measures, which we 
summarized in section III.K.3.c.(2)(b)(v)(A) of the proposed rule (84 
FR 40756 through 40757).
(A) Total Per Capita Cost Measure
    We finalized the total per capita cost measure for use in MIPS as 
an important measurement of clinician cost performance. Having been 
used in the Physician VM program, it had been tested and was reliable 
for Medicare populations and was familiar to the clinician community. 
When we finalized this measure for use in MIPS, we noted that as with 
all the cost measures, we will maintain this measure and update its 
specifications as appropriate (82 FR 53643). We continue to believe 
that the existing measure is appropriate to use in MIPS and continue to 
be committed to maintaining the cost measures with consideration of 
stakeholder input and testing. However, as a part of our routine 
measure maintenance, we re-evaluated the total per capita cost measure. 
The re-evaluation was informed by feedback received on this measure 
through prior public comment periods, as described in the CY 2017 (81 
FR 77017 through 77018) and CY 2018 (82 FR 53577 through 53578) Quality 
Payment Program final rules, as well as feedback that arose in the 
measure development contractor's discussions with the TEP during the 
process of re-evaluation. This feedback is summarized below:
     The total per capita cost measure's attribution 
methodology assigned costs to clinicians over which the clinician has 
no influence, such as costs occurring before the start of the 
clinician-patient relationship.
     The attribution methodology did not effectively identify 
primary care relationships between a patient and a clinician and could 
potentially attribute beneficiaries to a clinician not responsible for 
the beneficiaries' primary care.
     The measure did not account for the shared accountability 
of clinicians and that attributing costs to a single clinician or 
clinician group could cause fragmentation of care.
     The beneficiary risk factors were determined one year 
prior to the start of the performance period, which will preclude the 
risk adjustment methodology from reflecting the more expensive 
treatment resulting from comorbidities and/or complications that might 
arise during the performance period.
     The feedback summarized above informed the four 
modifications that we proposed for the total per capita cost measure.
    First, we proposed to change the attribution methodology to more 
accurately identify a beneficiary's primary care relationships (84 FR

[[Page 62970]]

40757). This is done by identifying a combination of services that 
occur within a short period and indicate the beginning of a 
relationship. More specifically, a primary care relationship is 
identified by a candidate event, defined as the occurrence of an E/M 
service such as an established patient assisted living visit or an 
outpatient visit (that is, the E/M primary care service), paired with 
one or more additional services indicative of general primary care (for 
example, routine chest X-ray, electrocardiogram, or a second E/M 
service provided at a later date). The candidate event initiates a 
year-long risk window from the E/M primary care service. The risk 
window is the period during which a clinician or clinician group could 
reasonably be held responsible for the beneficiary's treatment costs, 
and the initiation of the risk window at the onset of the candidate 
event ensures that costs are attributed only after the start of the 
clinician-patient relationship. Only the portion of the risk window 
that overlaps with the performance period, which is divided into 13, 4-
week blocks called beneficiary-months, is attributable to a clinician 
for a given performance period. For example, if the risk window were 
initiated during one MIPS performance period and ends in the following 
MIPS performance period, only the beneficiary-months that occur during 
the earlier MIPS performance period will be attributed to the 
clinician/clinician group to calculate the measure for that particular 
MIPS performance period. Dividing the performance period into 
beneficiary-months allows costs to be assigned to clinicians and 
clinician groups during the parts of the year they are primarily 
responsible for the patient's care management.
    With this methodology, it is possible for multiple candidate events 
to occur between a clinician and beneficiary over time, and an 
additional candidate event occurring during an existing risk window 
reaffirms and extends the period of the clinician's responsibility. For 
example, if 2 candidate events for the same clinician and the same 
beneficiary occur 6 months apart, a separate 12-month risk window 
initiates from the start of each of these candidate events, and the 
clinician may be attributed beneficiary-months spanning 18 months and 2 
different performance periods. As we described above, for risk windows 
that span multiple performance periods, only the beneficiary-months 
contained within a given performance period are used to calculate the 
measure for that performance period. Beneficiary-months that overlap 
between the 2 risk windows are collapsed to ensure that costs are only 
accounted for once. Furthermore, if different clinician groups 
initiated these 2 risk windows for the same beneficiary, the risk 
windows will occur concurrently and will be attributed to their 
respective TINs. Within an attributed TIN, only the clinician with the 
TIN/NPI combination performing the highest number of candidate events 
is attributed the beneficiary-months, since this TIN/NPI combination is 
deemed to have the most substantive relationship with the beneficiary. 
Finally, multiple TINs and TIN/NPIs billing under different TINs may be 
attributed beneficiary-months for the same beneficiary during the 
performance period. This attribution method allows multiple clinicians 
to be considered for the provision of ongoing primary care for a 
patient, which accounts for changes in primary care relationships (for 
example, for beneficiaries who move during the year) and reflects 
shared clinical responsibility for a patient's care.
    To illustrate how candidate events identify primary care 
relationships, we provided an example of a clinical scenario in which 
physicians in the primary care medical practice see a beneficiary as 
part of the beneficiary's routine health maintenance (84 FR 40757 
through 84 FR 40758). A beneficiary is feeling unwell and goes to a 
medical practice. At the practice, the beneficiary sees a family 
practice clinician who provides an E/M service (one that has been 
identified as related to primary care) for routine health maintenance. 
The clinician prescribes a course of medication as part of the care 
plan. The beneficiary returns to the same practice 2 months later when 
she notices new symptoms. At this visit, she sees a different family 
practice clinician who examines her, adjusts her care plan, and asks 
her to return in 3 months for a follow-up in case diagnostic testing or 
a change in medication is required. These two E/M services that occur 
within proximity (that is, the initial E/M service and the paired event 
2 months later--a second E/M service) constitute the candidate event 
and indicate that a primary care relationship has begun from the time 
of the first visit to the medical practice. The first E/M service 
(identified as related to primary care) opens a one-year period (or 
risk window) from the date of the service. This is illustrated 
graphically in section 2.0 of the measure specifications available on 
the MACRA Feedback page (https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-
MIPS-and-APMs/MACRA-Feedback.html). During the risk window, the 
attributed clinician/clinician group can be held responsible for the 
overall costs of care for that beneficiary. The TIN for the medical 
practice will be attributed the beneficiary and the TIN/NPI within this 
practice that provides the most primary care E/M services that initiate 
candidate events will be attributed the beneficiary. Under the current 
total per capita cost measure, the TIN and TIN/NPI will have been 
attributed this beneficiary from the beginning of the calendar year and 
held accountable for services the beneficiary might have received 
before her first visit to the medical practice.
    Second, we proposed to change the attribution methodology to more 
accurately identify clinicians who provide primary care services, by 
the addition of service category exclusions and specialty exclusions 
(84 FR 40758). Specifically, candidate events are excluded if they are 
performed by clinicians who: (1) Frequently perform non-primary care 
services (for example, global surgery, chemotherapy, anesthesia, 
radiation therapy); or (2) are in specialties unlikely to be 
responsible for providing primary care to a beneficiary (for example, 
podiatry, dermatology, optometry, ophthalmology). As a result of these 
exclusions, clinician specialties considered for attribution are only 
those primarily responsible for providing primary care, such as primary 
care specialties and internal medicine sub-specialties that frequently 
manage patients with chronic conditions that are in their area(s) of 
expertise. We did not propose to change the adjustment for specialty; 
as such, the measure will continue to adjust for specialty to account 
for variation in cost across clinician specialties and in clinician 
groups with diverse specialty compositions.
    Third, we proposed to change the risk adjustment methodology to 
determine a beneficiary's risk score for each beneficiary-month using 
diagnostic data from the year prior to that month rather than 
calculating one risk score for the entire performance period using 
diagnostic data from the previous year (84 FR 40758). This methodology 
will better account for any changes in the health status of the 
beneficiary for the duration of a primary care relationship and during 
the performance period. In addition, we proposed to add an 
institutional risk model to improve risk adjustment for clinicians 
treating institutionalized beneficiaries.

[[Page 62971]]

    Fourth, we proposed to change the measure to evaluate 
beneficiaries' costs on a monthly basis rather than an annual basis (84 
FR 40758). Specifically, the performance period during which costs are 
assessed is divided into 13 beneficiary-months, mentioned earlier, 
allowing for the measure and the risk adjustment model to reflect 
changes in patient health characteristics at any point throughout the 
performance period. In addition, this refinement will avoid measuring 
annualized costs for beneficiaries whose death date occurs during the 
performance period, which could potentially disincentivize care for 
older and sicker patients.
    Further detail about these changes to the measure, as well as a 
comparison to the total per capita cost measure as currently specified, 
is available in the measure specifications documents available on the 
MACRA Feedback page (https://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-
APMs/MACRA-Feedback.html).
    The revised total per capita cost measure underwent MAP review 
during the 2018-2019 cycle. In December 2018, the MAP Clinician 
Workgroup gave the preliminary recommendation of ``conditional support 
for rulemaking,'' with the condition of NQF endorsement. In January 
2019, the MAP Coordinating Committee reversed the Clinician Workgroup's 
preliminary recommendation and provided a final recommendation of ``do 
not support for rulemaking with potential for mitigation''. More detail 
on the mitigating factors is available in the MAP's final report at 
http://www.qualityforum.org/Publications/2019/03/MAP_Clinicians_2019_Considerations_for_Implementing_Measures_Final_Report.aspx.
    In the CY 2020 PFS proposed rule (84 FR 40758), we stated that we 
believe that the revised measure provides a more appropriate and valid 
attribution approach. We considered the option of proposing to remove 
the current version of the measure from the program and not proposing 
to replace it with a revised version. However, because we have 
developed and implemented only a handful of episode-based measures at 
this time, a substantial proportion of clinicians would be left with 
only the MSPB clinician measure for the cost performance category. 
Because fewer than half of all clinicians in MIPS meet the case minimum 
for the MSPB clinician measure, and no other measure addresses the 
costs of primary care, we stated that we believe it is appropriate to 
use the best version of the total per capita cost measure available to 
us. While we recognize and value the MAP's expressed concerns regarding 
the revised measure specifications, we stated that we believe that we 
have adequately addressed the mitigating factors through the 
information we have made publicly available (including testing results 
in the measure justification forms available at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html), as well as our 
discussions with stakeholders at the MAP and through further education 
and outreach activities. Thus, we proposed to include the total per 
capita cost measure with these revised specifications in the cost 
performance category beginning with the CY 2020 performance period (84 
FR 40757).
    The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters supported the proposed changes to the 
total per capita cost measure and the proposed changes in attribution, 
particularly the exclusion of certain clinicians from attribution based 
on the services provided.
    Response: We thank the commenters for their support.
    Comment: Many commenters opposed the inclusion of the revised total 
per capita cost measure, suggesting that broad measures of costs should 
not be included in a clinician program. Some commenters indicated that 
the proposed changes would not address their fundamental disagreement, 
particularly with attribution and reliability, by including the 
measure. Rather, some commenters believe that condition- or specialty-
specific measures more effectively gauge the costs that clinicians are 
able to influence. Other commenters recommended that only episode-based 
measures be included in the cost performance category. Some commenters 
indicated that the MAP had recommended against including the revised 
total per capita cost measure in the MIPS program because of multiple 
concerns related to attribution and actionability. Some commenters 
expressed concern about including a broad measure of costs of care 
without including a comparable quality measure.
    Response: We continue to believe that the total per capita cost 
measure provides an important measurement of clinician cost performance 
(82 FR 53644) and that the measure intent to capture broad, overall 
care plays a significant role in MIPS to complement the more granular 
information captured by episode-based measures. By including both 
episode- and population-based measures in the cost performance 
category, we are able to capture more aspects of care and ensure that 
there is continuity in clinician incentives throughout a patient's care 
trajectory. This measure has an important place in cost measurement 
given that the episode-based measures will only apply to a subset of 
clinicians at this time. We recognize the MAP's reservations about this 
measure; however, as discussed in the CY 2020 PFS proposed rule (84 FR 
40758), we believe that we have adequately addressed the mitigating 
factors outlined by the MAP. The MAP requested greater transparency 
around the attribution model and testing results, including examining 
validity and the impact of social risk factors, which we have addressed 
through the measure justification form we posted made publicly 
available, as well as our discussions with stakeholders at the MAP and 
through further education and outreach activities. The measure 
justification form is available on the MACRA Feedback Page (https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html). With regard to actionability, this measure has been 
refined to identify more effectively primary care relationships between 
clinicians and patients and attribute clinicians who are involved in 
the ongoing management of a patient's primary care. We believe the 
proposed revisions make it a more targeted measure focused on costs for 
primary care and it will provide actionable feedback about primary care 
clinicians' cost performance.
    Comment: Some commenters expressed concerns that the revised total 
per capita cost measure includes costs that are outside the reasonable 
control of a provider because the measure captures costs associated 
with care provided by others and costs they cannot influence, such as 
drug prices. Some commenters expressed concern that clinicians who 
manage care would be disadvantaged by this measure.
    Response: The revised total per capita cost measure continues to 
use payment standardized prices to account for differences in Medicare 
payments for the same service across Medicare suppliers for all 
services included in the measure, including for Part B drugs. The 
measure does not include Medicare Part D costs, as these costs are not 
yet payment-standardized. We are currently considering the feasibility 
of developing

[[Page 62972]]

a payment standardization for Part D costs to account for factors that 
are outside the control of clinicians. The measure development 
contractor would seek input from expert panels when considering the 
inclusion of Part D costs in cost measures, and any additions of Part D 
costs to measures implemented in MIPS would be addressed through future 
rulemaking. The total per capita cost measure focuses on primary care 
by design and includes all costs to provide a broad assessment of a 
clinician's management of the overall health of a patient, rather than 
a specific condition. In managing a patient's complete health, 
clinicians measured under the total per capita cost measure are 
incentivized to conduct patient follow-up, coordinate care amongst 
specialists, offer necessary referrals, and actively diagnose patients. 
Clinicians managing patients' care are the focus of this measure and 
are compared to their peers performing similar roles.
    Comment: Some commenters opposed the revised total per capita cost 
measure attribution methodology, specifically the process for 
establishing a primary care relationship between a patient and a 
clinician and how to define the end of a clinician responsibility for a 
patient. Some commenters indicated that this could be confusing for 
clinicians to understand. One commenter suggested that the revised 
attribution methodology could lead to multiple episodes occurring 
concurrently for the same clinician and patient. A few commenters 
expressed concern that the new attribution methodology did not have a 
method of establishing the end of a primary care relationship and could 
hold clinicians accountable for care after they were no longer managing 
care. Some commenters suggested that more than two services should be 
required to establish a primary care relationship. One commenter 
expressed concern that the attribution methodology did not account for 
patients who may reside in multiple localities throughout the year. One 
commenter expressed concern that that new attribution methodology does 
not properly reflect primary care relationships and identified cases in 
which a relationship would be identified through the methodology that 
were inappropriate, such as a clinician performing a pre-operative 
clearance. This commenter also identified situations in which a primary 
care relationship would not be established, such as when a clinician 
only sees a healthy patient once during the period. One commenter 
expressed concern that excluding specialists would reduce alignment 
between specialists and primary care clinicians.
    Response: The triggering methodology for the revised total per 
capita cost measure aims to effectively identifying a primary care 
relationship between a clinician and a patient by requiring two claims, 
a ``primary care'' E/M code (that is, an outpatient E/M code identified 
as being for primary care) and an additional ``primary care'' E/M code 
or primary care service. Requiring two claims within a defined, 
relatively short period and using multiple codes indicative of overall 
health care E/M ensures that clinicians are attributed based on 
evidence of a sustained relationship rather than a single patient 
visit. Requiring more than two claims would restrict the clinicians 
that can be measured and limit the beneficiary cohort to only those 
with more frequent physician services, who are usually sicker. On the 
other hand, we do not believe that a single E/M code is sufficient 
evidence to indicate that a clinician and patient have begun an ongoing 
relationship. We considered it prudent not to attribute patients to 
clinicians they have seen only for a single visit to avoid the risk of 
misattribution. In addition, the exclusion rules that we proposed to 
add ensure that the measure effectively captures clinicians who provide 
primary care. We exclude certain specialties that are unlikely to 
provide primary care from triggering events within a clinician group. 
We also examine clinician billing patterns to characterize a 
clinician's role as this may indicate that they are unlikely to be 
providing primary care; for example, we exclude clinicians who exceed a 
low threshold of beneficiaries in which they are providing anesthesia, 
global surgery, therapeutic radiation, and/or chemotherapy. These rules 
ensure that we properly attribute clinicians with established primary 
care relationships.
    The revised total per capita cost measures the overall cost of care 
delivered to a beneficiary with a focus on the primary care they 
receive. Primary care, by its nature, is ongoing and may span a long 
period so the revised total per capita cost measures clinicians for one 
year following an attribution event where evidence of a primary care 
relationship is identified. A longer attribution window allows the cost 
measure to capture the long-term benefits of ongoing primary care 
management that might not be fully realized within a short period. For 
example, preventive care services contribute cost to the measure when 
initially provided but should lower cost when measured over a 
sufficiently long time as they might avoid downstream costs that 
usually result from lack of preventive care. The clinician may continue 
to be attributed in a subsequent performance period if they bill new 
services that constitute a candidate event during an already open 
period of responsibility. In this construction, if multiple windows of 
attribution are opened, the attributed beneficiary months across the 
windows are consolidated into a continuous timeline of care. The 
clinician's responsibility for the attributed patients ultimately ends 
one year after the last attributable clinical event occurs. For 
patients with multiple residences during the year, the proposed 
revision to attribution would allow clinicians in both locations to be 
attributed concurrently, which would encourage coordination of care.
    Comment: Some commenters supported the change in attribution 
methodology that would exclude certain clinicians based on their 
provision of certain services, but expressed concern that physician 
assistants (PAs) and nurse practitioners (NPs) that work in 
collaboration with excluded specialties would still be attributed 
patient costs based on this methodology. Some commenters recommended an 
expansion of excluded specialties to include hematology, medical 
oncology, radiation oncology, hospitalists, specialties providing 
perioperative care and rheumatology. Some commenters recommended that 
group composition be considered in determining attribution at the TIN 
level, such as by assessing the number of individual clinicians who 
might be eligible or by excluding attribution to physician assistants 
or nurse practitioners in groups that primarily contained other 
clinicians who did not provide primary care.
    Response: We appreciate the support for the revised attribution 
methodology. We have assessed the frequency of TINs being attributed 
solely though physician assistants and nurse practitioners, and found 
that this occurs infrequently. We believe that it is appropriate to 
attribute clinicians and clinician groups that appear to provide 
primary care services in the claims data and expect that multi-
specialty TINs may include a wide range of specialties. Detailed 
information on testing results for specialties attributed within TINs 
can be found in the MACRA Cost Measures Post-Field Testing materials 
that are publicly available from the Quality Payment Program Webinar 
Library at https://qpp.cms.gov/about/webinars. Hospitalists, medical 
oncologists, and radiation specialties, as defined by the CMS provider 
specialty code, are

[[Page 62973]]

excluded from the revised total per capita cost measure, as they are 
not expected to provide primary care services. Other oncology 
specialties, including hematology oncology, medical oncology, 
gynecological oncology, and rheumatology are not excluded from the 
measure as they are likely to provide primary care services in the form 
of managing a chronic disease.
    Comment: Some commenters suggested that the revised total per 
capita cost measure should also include service-level exclusions.
    Response: The measure continues to capture all costs within a 
defined timeframe. Broad, population-based measures provide an 
important means of measuring healthcare spending as they capture a wide 
range of patients and, consequently, allow for more comparability 
between clinicians who are covered by the same measure. As a broad 
population-based, measure focused on primary care and clinicians that 
provide primary care services, the revised total per capita cost 
measure can produce meaningful results to pinpoint areas at the 
provider-level for improvements in cost efficiency while ensuring high-
quality primary care.
    By including all services, the measure is able to fully capture the 
broad range of services during a defined period and incentivize primary 
care clinicians to correctly diagnose and appropriately manage 
diseases, including specialty referrals.
    Comment: Many commenters expressed concern that they would be held 
accountable for the total per capita cost measure without having access 
to data to improve performance. Some commenters recommended that 
implementation of the measure be delayed at least a year to allow 
clinicians to review feedback. A few commenters asked that feedback on 
the measure be provided earlier and more frequently. One commenter 
indicated the difficulty for QCDRs in helping clinicians in working in 
this category without access to cost data on attributed patients. One 
commenter requested that CMS provide a report with the risk adjustment 
for all of their attributed patients under this measure.
    Response: We will consider these suggestions for future rulemaking. 
In July 2019, we did provide reports with detailed data on the total 
per capita cost measure as specified for the 2018 MIPS performance 
period. We will continue to provide this level of detailed data. We 
will also continue to consider ways to offer actionable data and 
feedback on cost measures to clinicians in the future, including the 
frequency and format of the performance data provided.
    Comment: Some commenters expressed concern that under the revised 
total per capita cost measure, beneficiary costs are counted multiple 
times as they may be attributed to multiple clinicians or clinician 
groups, even if they are not practicing as a team.
    Response: While beneficiary costs can be attributed to multiple 
clinicians or clinician groups, the measure calculation compares each 
clinician's observed episode costs to the predicted episode costs among 
their peers for patients with the same observable characteristics, 
rather than to a pre-defined standard. By comparing clinicians to their 
peers, who are all attributed in the same way, we can expect this 
comparison to be fair. This approach reflects the team-based nature of 
primary care, which has been emphasized in stakeholder feedback, and 
allows attribution to reflect changes in a beneficiary's primary care 
provider such as beneficiaries who move during the year. We believe 
that it is important to measure all clinicians who are responsible for 
playing a role in a patient's care, particularly as the scoring of the 
cost category is comparative to peers. Jointly responsible clinicians 
should each be recognized while collaborating to provide patient care.
    Comment: A few commenters expressed concern that clinicians in 
rural areas would be shown to have poor performance on the measure 
because of the nature of the area in which they practice. They 
suggested that smaller referral networks would reduce the opportunity 
for clinicians to help manage costs. A few commenters recommended that 
CMS winsorize, or limit extreme values in the measure score 
distribution, at the 95th percentile rather than the 99th percentile to 
address this issue. A few commenters recommended that rural clinicians 
only be compared to one another rather than to clinicians in urban or 
suburban settings.
    Response: The measure development contractor performed detailed 
testing on the revised total per capita cost measure to ensure that all 
clinicians are measured accurately and fairly, regardless of size, 
location, or the population they serve. This testing includes 
stratifying clinician measure scores by defining characteristics and 
investigating the clinician score distribution by percentile. 
Stratification is performed for each of the following characteristics: 
Urban/rural, census division, census region, risk score, and the number 
of beneficiary months attributed to the clinician. We analyze the 
distribution of measure scores for clinicians defined by these 
characteristics, as well as for the overall measure to ensure that 
there is a sufficiently large difference in measure scores among 
clinicians to determine a meaningful difference in performance. More 
information on testing for this measure, including how we determine 
meaningful differences in clinician performance, is available in the 
measure justification forms available on the MACRA Feedback Page 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html).
    Winsorizing, or limiting extreme values in the measure score 
distribution at the 95th percentile, as suggested, would narrow the 
distribution that determines the most costly clinicians, which would 
diminish clinicians' ability to distinguish themselves compared to 
their peers. This portion of the distribution represents an area where 
the least cost efficient care is realized so it is advantageous to 
consider it when calculating measure scores. The National Summary Data 
Report available on the MACRA feedback page shows similar score 
distributions for urban and rural clinicians, which indicates that they 
perform similarly under the revised total per capita cost measure. 
Given the similar performance distribution between rural and urban 
clinicians, limiting the measure at the 95th percentile would be 
unlikely to advantage rural clinicians relative to urban clinicians.
    Comment: A few commenters expressed concern about the risk 
adjustment used in the updated total per capita cost measure. A few 
commenters opposed the method of determining risk in 4-week blocks, 
believing that it added unnecessary complexity. One commenter expressed 
concern that HCC risk adjustment does not capture the risks associated 
with newly onset diseases such as cancer because the adjustment is 
based on a period prior to the measurement period.
    Response: The risk adjustment model for the revised total per 
capita cost measure accounts for beneficiary-level risk factors that 
can affect medical costs, regardless of the care provided. The 
performance period is a 1-year long period that is divided into 13, 4-
week blocks called beneficiary-months. Beneficiary-months that occur 
during a risk window and the measurement period are counted towards a 
clinician's or clinician group's measure scores. To ensure that the 
risk adjustment model

[[Page 62974]]

measures the influence of health status, as measured by diagnoses, on 
the treatment provided (costs incurred) rather than capturing the 
influence of treatment on a beneficiary's health status, the risk 
adjustment model uses risk factors from the year prior to each 
beneficiary-month. Dividing the performance period during which costs 
are assessed into 13 beneficiary-months allows the measure and the risk 
adjustment model to reflect changes in patient health characteristics 
that emerge throughout the performance period, including newly onset 
diseases. This refinement avoids measuring annualized costs for 
beneficiaries whose death date occurs during the performance period, 
which otherwise could potentially disincentivize care for more 
vulnerable patients.
    Comment: A few commenters expressed concern that the total per 
capita cost measure did not properly include risk adjustment for 
socioeconomic issues, which the commenters suggested were a common 
reason for higher costs.
    Response: Currently, risk adjustors for dual-eligibility and sex 
are included in the revised total per capita cost measure. As part of 
the standard development and re-evaluation processes, the measure 
development contractor conducted analyses to assess the impact of the 
following social risk factors: Income, education, employment, race, 
sex, and dual-eligibility status. Discussion of these results can be 
found in the measure justification form for the revised total per 
capita cost measure on the MACRA Feedback Page (https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-
Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). Our analyses 
indicate that the inclusion of social risk factors in the current risk 
adjustment model has a minor effect on measure scores. We will continue 
to monitor the effect of social risk factors on the revised measure on 
an ongoing basis.
    Comment: One commenter expressed concern that clinicians would not 
be able to track their performance from year to year due to the 
revisions in the specifications for the total per capita cost measure. 
This commenter recommended that the performance on the measure from 
previous years be recalculated.
    Response: As the revised total per capita measure continues to 
measure the overall cost of care delivered to a beneficiary with a 
focus on the primary care they receive from a clinician, we believe 
clinicians will be able to compare their performance from year to year 
and across iterations of the measure. Clinician performance amongst 
peers will continue to be measured under the same methodological 
conditions and assumptions so a clinician's relative performance would 
be comparable across iterations of the measure. At this time, we do not 
plan to recalculate performance on the revised measure for years prior 
to 2020.
    Comment: One commenter expressed concern that measuring costs on a 
monthly basis in the revised total per capita cost measure could result 
in clinicians with as few as 2 patients meeting the case minimum of 20.
    Response: To clarify, the revised total per capita cost measure has 
a case minimum of 20 beneficiaries. If an ongoing primary care 
relationship is established between a clinician and patient, the 
clinician will be attributed beneficiary-months for the patient and for 
a year. Clinicians will only be scored on the measure if they are 
attributed beneficiary-months across at least 20 patients.
    After consideration of the public comments, we are finalizing our 
proposal to include the total per capita cost measure with the revised 
specifications as proposed in the cost performance category beginning 
with the CY 2020 performance period.
(B) Medicare Spending Per Beneficiary Clinician Measure
    Similar to the total per capita cost measure, we finalized the MSPB 
clinician measure for use in MIPS as an important measurement of 
clinician cost performance. Having been used in the Physician VM 
program, it had been tested and was reliable for Medicare populations 
and was familiar to the clinician community. However, when we finalized 
this measure for use in MIPS, we noted that as with all the cost 
measures, we will maintain this measure and update its specifications 
as appropriate (82 FR 53643). We continue to believe that the existing 
measure is appropriate to use in MIPS and continue to be committed to 
maintaining this cost measure with consideration of stakeholder input 
and testing. Hence, we re-evaluated the MSPB clinician measure as part 
of our routine measure maintenance. The re-evaluation was informed by 
feedback received on this measure through prior public comment periods, 
as described in the CY 2017 Quality Payment Program final rule (81 FR 
77017 through 77018) and the CY 2018 Quality Payment Program final rule 
(82 FR 53577 through 53578), as well as feedback that arose in the 
measure development contractor's discussions with the standing TEP 
during the process of re-evaluation. This feedback is summarized below:
     The attribution methodology did not recognize the team-
based nature of inpatient care;
     The attribution based on the plurality of Part B service 
costs during index admission could potentially attribute episodes to 
specialties providing expensive services as opposed to those providing 
the overall care management for the patient; and
     The measure captured costs for services that are unlikely 
to be influenced by the clinician's care decisions.
    The feedback summarized above informed the two modifications that 
we proposed as part of the re-evaluation of this measure.
    First, we proposed to change the attribution methodology to 
distinguish between medical episodes (where the index admission has a 
medical MS-DRG) and surgical episodes (where the index admission has a 
surgical MS-DRG) (84 FR 40759). A medical episode is first attributed 
to the TIN billing at least 30 percent of the inpatient E/M services on 
Part B physician/supplier claims during the inpatient stay. The episode 
is then attributed to any clinician in the TIN who billed at least one 
inpatient E/M service that was used to determine the episode's 
attribution to the TIN. A surgical episode is attributed to the 
surgeon(s) who performed any related surgical procedure during the 
inpatient stay, as determined by clinical input, as well as to the TIN 
under which the surgeon(s) billed for the procedure. The list of 
related surgical procedures MS-DRGs may be found in the measure codes 
list for the revised measure on the MACRA Feedback page (https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html). This revised attribution methodology accounts for the 
team-based nature of care provided when managing medical conditions 
during an inpatient stay and allows for attribution to multiple 
clinicians to ensure that all clinicians involved in a beneficiary's 
care are appropriately attributed.
    Second, to account for the more limited influence clinicians' 
performance has on costs when compared with hospitals, we proposed to 
add service exclusions to the measure to remove costs that are unlikely 
to be influenced by the clinician's care decisions (84 FR 40759). 
Specifically, we proposed to exclude unrelated services specific to 
groups of MS-DRGs aggregated by major diagnostic

[[Page 62975]]

categories (MDCs). Some examples of unrelated services include 
orthopedic procedures for episodes triggered by MS-DRGs under Disorders 
of Gastrointestinal System (MDC 06 and MDC 07) or valvular procedures 
for episodes triggered by MS-DRGs under Disorders of the Pulmonary 
System (MDC 04).
    Further detail about these changes to the measure is included in 
the measure specifications documents, which are available at the MACRA 
Feedback page. This includes a comparison of the changes against the 
MSPB clinician measure as currently specified. A measure justification 
form containing testing results for this measure with the revisions is 
available on the MACRA Feedback page at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-
Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html. We proposed to 
include the revised MSPB clinician measure with these specifications in 
the cost performance category beginning with the CY 2020 performance 
period (84 FR 40758).
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposed attribution 
changes in the MSPB measure, in particular the separate attribution 
methods developed for medical and surgical episodes.
    Response: We thank the commenters for their support for the revised 
measure.
    Comment: Several commenters expressed general opposition to the 
inclusion of the revised MSPB measure in the MIPS program, noting that 
the measure was conditionally supported by the MAP pending review by 
the NQF but that there had been general concerns about the measure's 
risk adjustment and attribution. Some commenters suggested that only 
episode-based measures be included in the cost performance category, 
because they better identified the services that clinicians could 
influence.
    Response: After its review of the proposed revisions to MSPB 
clinician measure, the MAP finalized a recommendation of ``conditional 
support for rulemaking'' with the condition that the revised measure be 
submitted for NQF endorsement. We plan to submit the revised measure to 
a future endorsement cycle; however, NQF endorsement is not required 
for cost measures to be implemented in the program. Following the MAP, 
the measure development contractor conducted testing of scientific 
acceptability, including statistical calibration of the risk adjustment 
model and reliability testing to assess the measure's attribution 
methodology. The testing results were made available in the measure 
justification form available on the MACRA Feedback Page (https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html). We believe we have addressed the concerns raised by the 
MAP and that these revisions will ensure that the MSPB clinician 
measure continues to play an important role in the MIPS cost 
performance category.
    We also continue to believe that the revised MSPB clinician measure 
provides an important measurement of clinician cost performance (82 FR 
53644) complementing the episode-based measures. This measure evaluates 
the broad care related to an inpatient stay, which is a distinct 
measure focus from episode-based measures, which are intended to be 
more granular. By including both population- and episode-based measures 
in the cost performance category, a broader range of clinician care can 
be captured.
    Comment: Some commenters expressed concerns that the revised MSPB 
clinician measure includes costs that are outside of the control of a 
provider because the measure captures costs associated with care 
provided by others and costs they cannot influence, such as drug 
prices. One commenter expressed concern that the measure only 
considered Medicare fee-for-service (FFS) patients, particularly since 
the health status of patients on Medicare Advantage may differ from 
those using Medicare FFS.
    Response: As a population-based measure, the MSPB clinician measure 
is intended to reflect the cost to Medicare for a beneficiary's 
inpatient hospitalization. The measure does not include Medicare Part D 
costs and Part B drug costs that are included are payment standardized 
to remove factors outside the influence of clinicians. In addition, the 
revised measure excludes a list of services determined to be out of the 
influence of the clinician. The measure development contractor obtained 
input from the standing TEP and the MSPB Service Assignment Workgroup 
to identify and remove costs unlikely to be influenced by clinicians 
managing an acute inpatient stay. The MSPB Service Refinement Workgroup 
considered empirical analyses to identify service exclusions specific 
to Major Diagnostic Category (MDC) groupings, determined by the MS-DRG 
of the index admission. Based on these analyses, the MSPB Service 
Refinement Workgroup recommended exclusions for services that were 
unlikely to be under the influence of the clinician, and these 
exclusions were applied to revised MSPB clinician measure. Regarding 
the exclusive focus on FFS patients, the MSPB clinician measure is 
intended to focus on patients enrolled only in Medicare Parts A and B. 
While the covariates included in the risk adjustment model for the MSPB 
clinician measure are derived from the Medicare Advantage risk 
adjustment model, the risk scores (that is, normalized coefficients for 
each covariate) are not. MSPB clinician predicts regressions using MSPB 
episodes for FFS patients so that the expected spending related to 
certain conditions corresponds to the patient population being 
measured.
    Comment: A few commenters expressed concern about the attribution 
methodology for the revised MSPB measure. A few commenters expressed 
concern about using different attribution methods for medical and 
surgical episodes. One commenter opposed using different attribution 
methods because surgical care is often provided for a medical 
condition. One commenter expressed concern that certain specialties of 
clinician, such as pathology, could be attributed the costs of care 
inappropriately.
    Response: The changes to the attribution method of the revised MSPB 
clinician measure involves the use of separate attribution methods for 
medical and surgical episodes to identify the clinician(s) responsible 
for providing these different types of care and properly capture costs 
for more or less expensive episodes. The new methodology shifts 
attribution of episodes towards specialties that are more likely to be 
involved in managing the course of a patient's care, as we have heard 
concerns from stakeholders regarding the old methodology potentially 
attributing clinicians who do not provide the overall care management 
for a beneficiary. Additionally, the risk adjustment for the revised 
measure is ran within each MDC, and not between medical and surgical 
episodes. This allows for more accurate comparisons of predicted 
episode spending between clinicians treating patients with similar 
characteristics, rather than all attributed clinicians. Lastly, it is 
possible for specialties such as pathology to be attributed the revised 
MSPB clinician measure, as long as the pathologist is involved in the 
inpatient care of a patient and meets the attribution requirements.

[[Page 62976]]

    Comment: A few commenters expressed concern with how the MSPB 
clinician measure performance would be determined by the specialty of 
the clinician. They indicated that a specialty adjustment had been used 
on the measure as part of the VM program and expressed concern that the 
new measure would not include that adjustment. A few commenters 
expressed concern that specialties practicing in teams may not be 
attributed properly under the new measure.
    Response: To clarify, the MSPB measure currently in use in MIPS and 
the revised MSPB clinician measure do not include a specialty 
adjustment. However, the revised MSPB clinician has been refined to 
ensure effective attribution and compare similar clinicians. This is 
achieved by distinguishing between medical episodes and surgical 
episodes and risk adjusting for episodes within each MDC. These 
refinements allow for more accurate comparisons of predicted episode 
spending as clinicians are compared to other clinicians treating 
patients with similar characteristics, rather than being compared to 
all clinicians.
    Comment: One commenter expressed concern that under the revised 
MSPB clinician measure, costs for patients could be counted for more 
than one clinician or group and results of the measure could be 
misleading. One commenter suggested that only certain costs should be 
included in the MSPB measure, not all costs that occur during the 
episode.
    Response: The revised MSPB clinician measure assesses the cost to 
Medicare as a result of the services performed by an individual 
clinician during an MSPB clinician episode, which comprises the period 
immediately prior to, during, and following a patient's inpatient 
hospital stay. The measure was refined to exclude a defined list of 
services that are unlikely to be influenced by the clinician's care 
decisions and that are considered clinically unrelated to the 
management of care. The service exclusion rules are defined specific to 
the MDC of the index admission and were developed with expert clinical 
input from the MSPB Service Refinement Workgroup. Clinicians can choose 
how to participate in MIPS and have the option to report as a group or 
as individuals. Under the revised MSPB clinician measure, an episode 
can be attributed to multiple clinicians or clinician groups. The 
measure calculation risk adjusts each clinician's or clinician group's 
observed costs for patients with the same observable characteristics 
among their peers, rather than to a pre-defined standard. Given that 
the inpatient hospital setting is an important contributor to overall 
Medicare spending, gauging the efficacy of this spending requires 
measuring the cost performance of clinicians providing care at 
hospitals. The MSPB clinician measure provides valuable context for 
such progress in efficiency by measuring costs of care from a holistic 
perspective at the beneficiary level. Detailed information on how the 
MSPB clinician measure is calculated is provided in the measure 
methodology document available on the MACRA Feedback Page (https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html).
    Comment: A few commenters expressed concern about not receiving 
detailed feedback on the revised MSPB measure before it was proposed 
for use in the cost performance category. A few commenters recommended 
that the measure implementation be delayed by one year to allow more 
time for clinicians to review data.
    Response: In Fall 2018, we conducted extensive field testing for 
this measure. In addition to field test reports that provided detailed 
performance feedback to clinicians and clinician groups who met the 35 
episode case minimum, we provided public documentation such as measure 
methodology documents with detailed descriptions of the revisions to 
the measure, a fact sheet, and an FAQ. We also held public webinars to 
provide more information about the revised measure methodology. 
Subsequently, the measure underwent MAP review, which provided 
stakeholders more opportunities to provide feedback about the measure 
prior to its proposal for implementation. As such, we believe that the 
measure is ready for implementation at this time, and that it is not 
necessary to delay its implementation to a future year.
    Comment: A few commenters expressed concern that clinicians in 
rural areas would be shown to have poor performance on the measure 
because of the nature of the area in which they practice. They 
suggested that smaller referral networks would reduce the opportunity 
for clinicians to help manage costs. A few commenters recommended that 
CMS Winsorize, or limit extreme values in the MSPB clinician measure 
score distribution, at the 95th percentile rather than the 99th 
percentile to address this issue.
    Response: The measure development contractor performed detailed 
testing on the revised MSPB clinician measure to ensure that all 
providers are measured accurately and fairly, regardless of size, 
location, or the population they serve. This testing includes 
stratifying clinician measure scores by defining characteristics and 
investigating the clinician score distribution by percentile. 
Stratification is performed for each of the following characteristics: 
Urban/rural, census division, census region, risk score, and the number 
of episodes attributed to the clinician. We analyze the distribution of 
measure scores for clinicians defined by these characteristics, as well 
as for the overall measure to ensure that there is a sufficiently large 
difference in measure scores among clinicians to determine a meaningful 
difference in performance. Our testing results show similar score 
distributions for urban and rural clinicians, which indicates that they 
perform similarly under the revised MSPB clinician measure. More 
information on testing for this measure, including how we determine 
meaningful differences in clinician performance, is available in the 
measure justification form available on the MACRA Feedback Page 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html). The revised MPSB clinician measure methodology aims to 
limit the effects of certain values in the measure score distribution 
in two ways. First, the expected episode cost is winsorized at the 
lower bound by assigning the value of expected episode costs at the 
0.5th percentile of the distribution for episodes within the same MDC 
to all expected costs below the 0.5th percentile. Second, after 
winsorization, the measure excludes episodes with residual values below 
the 1st percentile and above the 99th percentile. Winsorizing expected 
episode cost at the 95th percentile would lower expected spending for 
the most complex patients and make it more difficult for clinicians to 
perform well. Lowering the threshold at which episodes with high 
residuals are excluded to the 95th percentile would narrow the 
distribution by removing more costly clinician episodes, which would 
diminish clinicians' ability to distinguish themselves compared to 
their peers. This portion of the distribution represents an area where 
the least cost-efficient care is realized so it is advantageous to 
consider it when calculating measure scores. After consideration of the 
public comments, we are finalizing our proposal to

[[Page 62977]]

include the MSPB clinician measure with the revised specifications as 
proposed in the cost performance category beginning with the CY 2020 
performance period.
(vi) Reliability
(A) Reliability for Episode-Based Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77170), we finalized a reliability threshold of 0.4 for 
measures in the cost performance category. In the CY 2019 PFS final 
rule, we established at Sec.  414.1350(c)(4) and (5) a case minimum of 
20 episodes for acute inpatient medical condition episode-based 
measures and 10 episodes for procedural episode-based measures (83 FR 
59773 through 59774). We examined the reliability of the 10 episode-
based measures listed in Table 45 at our established case minimums and 
found that all of these measures meet the reliability threshold of 0.4 
for the majority of groups at a case minimum of 10 episodes for 
procedural episode-based measures and 20 episodes for acute inpatient 
medical condition episode-based measures. All of the measures meet this 
standard at the individual clinician level as well, with the exception 
of the Lower Gastrointestinal Hemorrhage episode-based measure. In 
section III.K.3.c.(2)(b)(vi)(B) of the proposed rule, we discuss a 
proposal to limit our assessment of certain cost measures to groups 
(identified by a TIN) based on the results of our reliability analysis 
(84 FR 40760).
[GRAPHIC] [TIFF OMITTED] TR15NO19.089

(B) Limiting Assessment of Certain Measures to Groups
    We have assessed clinicians and groups on cost measures when they 
meet the case minimum for a measure. As part of our efforts to ensure 
reliable measurement, we have examined the reliability of cost measures 
at the group and individual level, as clinicians are able to 
participate in MIPS in either way. However, for clinicians who 
participate in MIPS as individuals, we have found the Lower 
Gastrointestinal Hemorrhage episode-based measure does not meet the 
reliability threshold of 0.4 that we established for measures in the 
cost performance category. While we considered not including the 
measure in MIPS for this reason, we do find that this measure meets the 
reliability threshold for those who participate in MIPS as part of a 
group. Therefore, we proposed to include the measure in the cost 
performance category only for MIPS eligible clinicians who report as a 
group or virtual group (84 FR 40760). We will continue to assess the 
reliability of cost measures for group and individual participation as 
the measures are introduced or are revised. If we identify measures 
that are similarly found to meet our reliability threshold at the group 
level but not at the individual level, we will again consider limiting 
the assessment of the measure to groups.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters generally agreed that the mean 
reliability for the Lower Gastrointestinal Hemorrhage episode-based 
measure at the TIN/NPI level is too low and should be used at the group 
level. One commenter indicated that the reliability is too low at the 
individual level and requested more details on the range of reliability 
values by practice size. The commenter also requested that CMS consider 
an exclusion for small practices for whom reliability is lower than the 
TIN mean of 0.51.
    Response: While we have not examined the relationship between 
practice size and the reliability of the cost measures, we have 
examined the relationship between case volume and the reliability of 
cost measures. The measure justification form for this measure, which 
is available on the MACRA Feedback Page (https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-
Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html), presents reliability 
at three different case sizes or volume thresholds. To some degree, the 
size of a practice may correlate with the case size for cost measures, 
as an individual clinician can only see so many patients.

[[Page 62978]]

We believe that establishing case minimums that are based on moderate 
reliability allows us to measure all clinicians and groups that meet 
those case minimums. As such, we do not believe that small practices 
who meet the moderate reliability threshold of 0.4 but are below 0.51 
should be excluded. We have established a small practice bonus within 
the quality performance category to accommodate the issues small 
practices may face. We will take the recommendation to provide 
additional reliability figures into consideration when providing future 
measure testing results and continue to monitor cost performance and 
reliability for small practices to ensure that the measures continue to 
accurately and fairly measure their performance.
    Comment: A few commenters expressed concerns that the 0.4 threshold 
is too low to ensure reliability and clinicians should not be held 
accountable for measures at this level of reliability. A few commenters 
recommended that CMS adopt a higher reliability such as 0.75 or 0.7. 
Additionally, a few commenters stated that the established case 
minimums should be set higher even though this may lead to fewer 
clinicians being attributed to the measure.
    Response: We appreciate the input on reliability thresholds. We 
finalized a reliability threshold of 0.4 for measures in the cost 
performance category in the CY 2017 Quality Payment Program final rule 
(81 FR 77169 through 77170) that is consistent with other CMS quality 
programs. We generally consider reliability levels between 0.4 and 0.7 
to indicate ``moderate'' reliability and levels above 0.7 to indicate 
``high'' reliability. In cases where we have considered high 
participation in the applicable program to be an important programmatic 
objective, we have selected the 0.4 moderate reliability standard. We 
believe this standard ensures moderate reliability but does not 
substantially limit participation.
    All measures proposed, with the exception of the Lower 
Gastrointestinal Hemorrhage measure that was proposed at the group 
level only, exceed the threshold at the clinician and clinician group 
level (84 FR 40759 through 40760). Detailed information about the 
development and reliability testing of the episode-based measures and 
revised cost measures is publicly available for download on the MACRA 
Feedback Page (https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html).
    After consideration of the comments, we are finalizing our proposal 
to include the Lower Gastrointestinal Hemorrhage episode-based measure 
in the cost performance category only for MIPS eligible clinicians who 
report as a group or a virtual group.
(C) Reliability for Revised Cost Measures
    In the CY 2017 Quality Payment Program final rule, we finalized a 
reliability threshold of 0.4 for measures in the cost performance 
category (81 FR 77169 through 77170). Additionally, we established a 
case minimum of 35 episodes for the MSPB clinician measure (81 FR 
77171) and a case minimum of 20 beneficiaries for the total per capita 
cost measure (81 FR 77170). We codified these case minimums at Sec.  
414.1350(c)(1) and (2) in the CY 2019 PFS final rule (83 FR 59774). We 
based these case minimums on our interest in ensuring that the majority 
of clinicians and groups that were measured met the threshold of 0.4 
reliability, which we believed best balanced our interest in ensuring 
moderate reliability without limiting participation. Given the 
significant changes to these measures that we proposed in section 
III.K.3.c.(2)(b)(v) of the proposed rule (84 FR 40757 through 40759), 
we again examined the reliability of the revised MSPB clinician and 
total per capita cost measures at these case minimums and found that 
the measures meet the reliability threshold of 0.4 for the majority of 
clinicians and groups at the existing case minimums, as shown in Table 
46.

  Table 46--Percent of TINs and TIN/NPIs That Meet 0.4 Reliability Threshold for the Revised MSPB Clinician and
                                         Total per Capita Cost Measures
----------------------------------------------------------------------------------------------------------------
                                  % TINs meeting 0.4                      % TIN/NPIs meeting
          Measure name                reliability      Mean reliability       reliability      Mean reliability
                                       threshold             TINs              threshold           TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Medicare Spending per                            100                0.77                 100                0.69
 Beneficiary Clinician..........
Total Per Capita Cost...........                 100                0.82                 100                0.89
----------------------------------------------------------------------------------------------------------------

    Based on this analysis, we did not propose any changes to the case 
minimums, which we previously finalized as 35 for the MSPB clinician 
measure, and 20 for the total per capita cost measure.
    Comment: A few commenters favored a case minimum of 35 for the 
revised total per capita cost and MSPB clinician measures to improve 
reliability and promote consistency within the cost performance 
category.
    Response: We do not believe it is necessary to increase the case 
minimum for the total per capita cost measure, as the majority of 
clinicians and clinician groups exceed the reliability threshold of 0.4 
at the existing case minimum of 20 beneficiaries. Keeping this case 
minimum would balance the goal of increased reliability with the goal 
of adopting cost measures that are applicable to a larger set of 
clinicians and clinician groups.
(vii) Request for Comments on Future Potential Episode-Based Measure 
for Mental Health
    We plan to continue to develop episode-based measures and propose 
to adopt them for the cost performance category in future rulemaking. 
As a part of these efforts, we seek to expand the range of procedures 
and conditions covered to ensure that more MIPS eligible clinicians 
have their cost performance assessed under clinically relevant episode-
based measures. In recognition of the importance of assessing mental 
health care, we developed an acute inpatient medical condition episode-
based measure for the treatment of inpatient psychoses and related 
conditions through the same process involving extensive expert 
clinician input as the measures in section III.K.3.c.(2)(b)(vii) of the 
proposed rule (84 FR 40760). The specifications for the Psychoses/
Related Conditions episode-based measure are available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-ebcm-measure-specs.zip. The Psychoses/Related Conditions episode-based 
measure represents an

[[Page 62979]]

opportunity to incentivize improvement in the field of mental health, a 
CMS priority area. We refer readers to the CY 2020 PFS proposed rule 
where we summarize the MAP's feedback and recommendations regarding the 
Psychoses/Related Conditions episode-based measure (84 FR 40760).
    In the CY 2020 PFS proposed rule, we solicited comments on the 
potential use of this new Psychoses/Related Conditions episode-based 
measure in the cost performance category in a future MIPS performance 
period (84 FR 40760). While we are not summarizing and responding to 
comments we received in this final rule, we thank the commenters for 
their responses, and we will consider them as we consider the potential 
inclusion of the Psychoses/Related Conditions episode-based measure in 
the future.
(viii) Summary of Previously Established and Finalized Measures for the 
Cost Performance Category for the 2020 and Future Performance Periods
    The previously established and finalized measures for the cost 
performance category for the 2020 and future performance periods are 
summarized in Table 47.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR15NO19.090


[[Page 62980]]


BILLING CODE 4120-01-C
(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), 
and the CY 2019 PFS final rule (83 FR 59776 through 59777).
    In this final rule, we are: (1) Modifying the definition of rural 
area; (2) updating Sec.  414.1380(b)(3)(ii)(A) and (C) removing the 
reference to the four listed accreditation organizations to be 
recognized as patient-centered medical homes and removing the reference 
to the specific accrediting organization for comparable specialty 
practices; (3) increasing the group reporting threshold to 50 percent; 
(4) establishing factors to consider for removal of improvement 
activities from the Inventory; (5) removing 15, modifying seven, and 
adding two new improvement activities for the 2020 performance period 
and future years; and (6) concluding and removing the CMS Study on 
Factors Associated with Reporting Quality Measures. These are discussed 
in more detail in this final rule.
(b) Small, Rural, or Health Professional Shortage Areas Practices
    For our previously established policies regarding small, rural, or 
Health Professional Shortage Areas Practices, we refer readers to the 
CY 2017 Quality Payment Program final rule (81 FR 77188), CY 2018 
Quality Payment Program final rule (82 FR 53581), and Sec.  414.1305. 
In the CY 2018 Quality Payment Program final rule (82 FR 53581 through 
53582), we changed the definition of rural area at Sec.  414.1305 to 
mean ZIP codes designated as rural, using the most recent Health 
Resources and Services Administration (HRSA) Area Health Resource File 
data set available.
    It has come to our attention that the rural area definition at 
Sec.  414.1305 includes the incorrect file name for the rural 
designation. While we used the correct file, we just referenced it 
incorrectly. Therefore, in the CY 2020 PFS proposed rule (84 FR 40762), 
we proposed to update the MIPS rural area definition by correcting the 
file name. In the CY 2017 Quality Payment Program final rule (81 FR 
77188), we incorrectly referenced the file we used for rural 
designation as ``the most recent Health Resources and Services 
Administration (HRSA) Area Health Resource File data set available'' 
instead of the correct file entitled ``Federal Office of Rural Health 
Policy (FORHP) eligible ZIP codes'' which may currently be found at 
https://www.hrsa.gov/rural-health/about-us/definition/datafiles.html. 
The HRSA Area Health Resources Files (AHRF) include data on Health Care 
Professions, Health Facilities, Population Characteristics, Economics, 
Health Professions Training, Hospital Utilization, Hospital 
Expenditures, and Environment at the county, state and national levels, 
from over 50 data sources \115\ but does not contain specific data on 
rurality developed by HRSA's FORHP. To be clear, we have been using the 
more appropriate FORHP eligible ZIP code file in all previous 3 years 
of MIPS; we simply inadvertently listed the incorrect file name in the 
definition. Furthermore, the definition of rural in MIPS is based on 
the rural definition developed by HRSA's FORHP which may be found at 
https://www.hrsa.gov/rural-health/about-us/definition/index.html. The 
FORHP defines all non-Metro counties as rural and uses an additional 
method of determining rurality called the Rural-Urban Commuting Area 
(RUCA) codes to designate rural Census Tracts within Metropolitan 
Counties. The FORHP eligible ZIP codes are available in a file located 
at https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/aboutus/definition/forhp-eligible-zips.xlsx. Therefore, we proposed to modify 
the definition of rural area at Sec.  414.1305 to mean a ZIP code 
designated as rural by the Federal Office of Rural Health Policy 
(FORHP), using the most recent FORHP Eligible ZIP Code file available.
---------------------------------------------------------------------------

    \115\ https://data.hrsa.gov/topics/health-workforce/ahrf.
---------------------------------------------------------------------------

    We invited public comment on our proposal as discussed in this 
final rule. We did not receive any comments on this proposal. 
Therefore, we are finalizing our proposal, as proposed, to modify the 
definition of rural area at Sec.  414.1305 to mean a ZIP code 
designated as rural by the Federal Office of Rural Health Policy 
(FORHP), using the most recent FORHP Eligible ZIP Code file available.
(c) Patient-Centered Medical Home and Comparable Specialty Practice 
Accreditation Organizations
    In the CY 2017 Quality Payment Program final rule (81 FR 77179 
through 77180), we finalized at Sec.  414.1380(b)(3)(ii) an expanded 
definition of what is acceptable for recognition as a certified-
patient-centered medical home or comparable specialty practice. 
Specifically, we finalized that one of the criteria, as stated at Sec.  
414.1380(b)(3)(ii)(A), is whether the practice has received 
accreditation from one of four accreditation organizations that are 
nationally recognized; paragraphs (b)(3)(ii)(A)(1) through (4) list the 
four organizations with nationally recognized patient-centered medical 
home accreditation programs: (1) The Accreditation Association for 
Ambulatory Health Care; (2) the National Committee for Quality 
Assurance (NCQA) Patient-Centered Medical Home; (3) The Joint 
Commission Designation; or (4) the Utilization Review Accreditation 
Commission (URAC) (81 FR 77180). In addition, we finalized another 
criteria at Sec.  414.1380(b)(3)(ii)(C), which states that the practice 
is a comparable specialty practice that has received the NCQA Patient-
Centered Specialty Recognition (81 FR 77180). Further, we finalized 
that the criteria for being a nationally recognized accredited patient-
centered medical home are that it must be national in scope and must 
have evidence of being used by a large number of medical organizations 
as the model for their patient-centered medical home (81 FR 77180).
    Since finalizing these criteria, it has come to our attention that 
we may have inadvertently been excluding other organizations. It was 
and is not our intention to limit patient-centered medical home or 
comparable specialty practice accreditation organizations to those 
listed. We realize that there may be additional accreditation 
organizations that have nationally recognized programs for accrediting 
patient-centered medical homes and comparable specialty practices that 
were not included. Therefore, in the CY 2020 PFS proposed rule (84 FR 
40763), we requested comments on our proposal to update Sec.  
414.1380(b)(3)(ii)(A) and (C) to remove specific entity names.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the proposed removal of 
specific entity names from Sec.  414.1380(b)(3)(ii)(A) and (C) because 
it broadened the criteria of a medical home and will be helpful to 
practices seeking to become accredited patient centered medical homes. 
One commenter stated that practices with these designations promote 
innovative delivery system reforms; meet stringent, robust criteria for 
clinical practice transformation; and are held to a high standard of 
care for the patients they serve.

[[Page 62981]]

    Response: We appreciate the support. We clarify that we are not 
broadening or changing our criteria for accreditation organizations. We 
continue to believe that the criteria established, for what we 
considered certified at Sec.  414.1380(b)(3)(iv) are appropriate and 
meet national guidelines. We are merely finalizing the removal of 
specific entity name examples at Sec.  414.1380(b)(3)(ii)(A) and (C).
    Comment: A few commenters did not support removing the names of the 
approved patient-centered medical home and comparable specialty 
practice programs that provide clinicians full credit for the MIPS 
improvement activities performance category. The commenters noted that 
the evidence-based formal patient-centered medical home criteria help 
to standardize effective practices and attributes in recognized 
practices, help payers standardize payments and compare performance 
without specifying which programs qualify. One commenter noted that 
without specifying which patient-centered medical home and comparable 
specialty practice programs qualify for certification, clinicians will 
lack assurance that participation in a given patient-centered medical 
home and comparable specialty practice program will earn the full 
improvement activities 15 points. The commenter recommended specifying 
and updating a public list of any additional qualified programs to 
address concern about excluding any programs that have the required 
national scope without creating uncertainty. One commenter noted that 
removing the named entities may encourage the development of patient-
centered medical home programs with below par standards and recommended 
that we review any programs that are not reviewed by the four named 
accreditation organizations to ensure they meet the same high standards 
for rigor.
    Response: We believe that removing specific patient-centered 
medical home accreditations organizations will level the playing field 
for any organization that meets the requirements. We refer readers to 
the Quality Payment Program website improvement activities landing page 
at https://qpp.cms.gov/mips/improvement-activities, where we have 
provided a few examples of accreditation organizations that are 
recognized or certified patient-centered medical home and comparable 
specialty practice programs. We disagree that removing the named 
entities may encourage the development of patient-centered medical home 
programs with below par standards as we are not broadening or changing 
our certification criteria for accreditation organizations. We are 
merely finalizing the removal of specific entity name examples at Sec.  
414.1380(b)(3)(ii)(A) and (C).
    Comment: One commenter requested clarification whether the proposal 
to regulatory text impacts NCQA recognition for patient-centered 
medical home and comparable specialty practice programs and 
subsequently credit for the improvement activities performance 
category.
    Response: We clarify that removing specific entity name examples of 
accreditation organizations from the regulations text does not speak to 
an organization's qualifications to provide accreditation for patient-
centered medical homes and comparable specialty practices. It was and 
is not our intention to limit patient-centered medical home or 
comparable specialty practice accreditation organizations to those 
listed in the regulations text. We realize that there may be additional 
accreditation organizations that have nationally recognized programs 
for accrediting patient-centered medical homes and comparable specialty 
practices that were not included. This change is an effort to make the 
regulations text more neutral. We refer readers to the Quality Payment 
Program website at https://qpp.cms.gov/mips/improvement-activities 
where we have provided a few examples of accreditation organizations 
that are recognized or certified patient-centered medical home and 
comparable specialty practice programs.
    After consideration of the comments, we are finalizing our 
proposal, as proposed, to update Sec.  414.1380(b)(3)(ii)(A) and (C) to 
remove specific entity name examples.
(d) Improvement Activities Data Submission
    We proposed changes to the improvement activities data submission 
for group reporting requirements, as discussed below.
(i) Submission Mechanisms
    For our previously established policies regarding improvement 
activities performance category submission mechanisms, we refer readers 
to the CY 2018 Quality Payment Program final rule (82 FR 53650 through 
53656), the CY 2019 PFS final rule (83 FR 59777), and Sec.  
414.1360(a)(1). We did not propose any changes to these policies.
(ii) Submission Criteria
    For our previously established policies regarding improvement 
activities performance category submission criteria, we refer readers 
to the CY 2017 Quality Payment Program final rule (81 FR 77185), the CY 
2018 Quality Payment Program final rule (82 FR 53651 through 53652), 
the CY 2019 PFS final rule (83 FR 59777 through 59778), and Sec.  
414.1380. We did not propose any changes to these policies.
(iii) Group Reporting
    In the CY 2020 PFS proposed rule (84 FR 40763 through 40764), we 
made two proposals with respect to group reporting to: (a) Increase the 
group reporting threshold from at least one clinician to at least 50 
percent of the group beginning with the 2020 performance year, and (b) 
at least 50 percent of a group's National Provider Identifiers (NPIs) 
must perform the same activity for the same continuous 90 days in the 
performance period beginning with the 2020 performance year. These are 
discussed in more detail below.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77181), in response to a public comment, we stated that if at least 
one clinician within the group is performing the activity for a 
continuous 90 days in the performance period, the group may report on 
that activity. In addition, we specified that all MIPS eligible 
clinicians reporting as a group would receive the same score for the 
improvement activities performance category if at least one clinician 
within the group is performing the activity for a continuous 90 days in 
the performance period (81 FR 77181).
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30053), 
we requested comment for future consideration on issues related to 
whether we should establish a minimum threshold (for example, 50 
percent) of the clinicians (NPIs) that must complete an improvement 
activity for the entire group (Taxpayer Identification Number (TIN)) to 
receive credit in the improvement activities performance category in 
future years. Some commenters expressed concerns that setting a minimum 
threshold would add complexity or burden for clinicians. Other 
commenters supported the establishment of a minimum participation 
threshold in future years, noting that a minimum threshold will ensure 
scoring is reflective of care delivered by the group as a whole rather 
than one or a few high-performing clinicians.
    We believe that by Year 4 (2020 performance year) of the Quality 
Payment Program, clinicians should be familiar with the improvement 
activities performance category. We believe that increasing the minimum 
threshold for a

[[Page 62982]]

group to receive credit for the improvement activities performance 
category will not present additional complexity and burden for a group. 
With over 100 improvement activities available for eligible clinicians 
to choose from in the improvement activities Inventory, which may be 
found at the Quality Payment Program website https://qpp.cms.gov/, that 
provide a range of options for clinicians seeking to improve clinical 
practice that are not specific to practice size, specialty, or practice 
setting. We believe that a group should be able to find applicable and 
meaningful improvement activities to complete that would apply to at 
least 50 percent of individual MIPS eligible clinicians in a group.
    Therefore, in the CY 2020 PFS proposed rule (84 FR 40763), we 
proposed to increase the minimum number of clinicians in a group or 
virtual group who are required to perform an improvement activity to 50 
percent for the improvement activities performance category beginning 
with the 2020 performance year and future years. We note that once 
finalized the changes to the group threshold will have no impact on the 
previously finalized policy that eligible clinicians participating in 
an APM will receive full points for the improvement activities 
performance category as discussed in the CY 2017 Quality Payment 
Program final rule (81 FR 77258 through 77260). This is an increase to 
the previously established requirement finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77181) that only one clinician within 
a TIN needs to attest to the completion of an improvement activity to 
get credit towards the MIPS final score. We believe a 50 percent 
threshold is achievable and appropriate because, if a group or virtual 
group has implemented an improvement activity, the activity should be 
recognized and adopted throughout much of the practice to improve 
clinical practice, care delivery, and outcomes. This aligns with our 
definition of an improvement activity at Sec.  414.1305. In crafting 
our proposal, we also considered other thresholds, such as a lower 
threshold of 25 percent. However, we believe that improvement 
activities should be adopted throughout much of the practice to achieve 
improved outcomes. We do not believe that 25 percent group 
participation will reflect improved outcomes. We also considered a 
higher threshold of 100 percent, but have concerns that requiring every 
clinician within a group to perform improvement activities may be 
premature at this time because increasing the threshold by such a large 
amount may be considered burdensome to clinicians. However, we believe 
that 50 percent provides an appropriate balance between requiring at 
least half of the NPIs reporting as part of a group to participate in 
the improvement activities performance category and acknowledging the 
challenges to requiring every NPI in a group to perform the improvement 
activity for a group to receive credit. We also believe our proposal 
aligns with the 50 percent threshold for the number of practice sites 
that must be recognized for a TIN to receive full credit as a patient-
centered medical home (82 FR 53655) and is both achievable and 
appropriate at this time.
    Furthermore, we believe that requiring at least 50 percent of a 
group or TIN to perform an improvement activity for the same continuous 
90-day performance period will facilitate improvement in clinical 
practice within a TIN. As discussed in the CY 2017 Quality Payment 
Program final rule (81 FR 77186), we considered setting the threshold 
for the minimum time required for performing an activity to longer 
periods up to a full calendar year. However, after researching several 
organizations we stated that we believed a minimum of 90 days is a 
reasonable amount of time (81 FR 77186). In addition, in response to 
comments we stated that we believed that each activity can be performed 
for a full 90 consecutive days by some, if not all, MIPS eligible 
clinicians, and that there are a sufficient number of improvement 
activities included that any eligible clinician may select and perform 
for a continuous 90 days that will allow them to successfully report 
under this performance category (81 FR 77186).
    Therefore, we requested comments on our proposal to revise Sec.  
414.1360(a)(2) to state that beginning with the 2020 performance year, 
each improvement activity for which groups and virtual groups submit a 
yes response in accordance with paragraph (a)(1) of this section must 
be performed by at least 50 percent of the NPIs billing under the 
group's TIN or virtual group's TINs, as applicable; and these NPIs must 
perform the same activity for the same continuous 90 days in the 
performance period. To be clear, other submission requirements will 
remain the same. In other words, each TIN will need to submit an 
attestation for each improvement activity selected that at least 50 
percent of its NPIs performed the same activity for the same continuous 
90 days in the performance period. For example, TIN 1234 attests that 
at least 50 percent of its NPIs performed the improvement activity 
entitled: ``Participation in a QCDR that promotes use of patient 
engagement tools'' (IA_BE_7) for the same continuous 90-day period. 
Because IA_BE_7 is medium-weighted, the example TIN will receive 10 
points toward the total possible improvement activities score. TIN 1234 
also attests that at least 50 percent of its NPIs performed the 
improvement activity entitled: ``Implementation of formal quality 
improvement methods, practice changes, or other practice improvement 
processes'' (IA_PSPA_19) for the same continuous 90-day period. Because 
IA_PSPA_19 is medium-weighted, the example TIN will receive another 10 
points toward the total possible improvement activities score. We refer 
readers to the CY 2019 Quality Payment Program final rule (83 FR 59753 
through 59754) where we discuss the data submission deadline which was 
finalized at Sec.  414.1325(e)(1) as follows: For the direct, login and 
upload, login and attest, and CMS Web Interface submission types, March 
31 following the close of the applicable performance period or a later 
date as specified by CMS.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the proposal to have at least 
50 percent of clinicians reporting as a group perform the same activity 
for the same continuous 90 days in the performance period as they noted 
that it would promote increased participation in the improvement 
activities performance category by clinicians in groups. They stated 
that it would ensure scoring is reflective of care delivered by the 
group as a whole rather than one or a few high-performing clinicians.
    Response: We thank the commenters for their support.
    Comment: Several commenters recommended alternative thresholds 
ranging from 5 to 25 percent, noting concerns that it may be 
impractical for groups to meet the proposed 50 percent threshold which 
could then disincentivize performance in the improvement activities 
performance category. A few commenters requested a more gradual 
increase to enable groups to amend current efforts to meet the policy 
requirement. Commenters recommended the development of a pilot program 
including options to test a gradual increase at a few sites and to test 
more feasible thresholds. A more reasonable number of eligible 
clinicians within groups who would be required to participate in an 
improvement activity because some improvement activities

[[Page 62983]]

lend themselves to widespread participation such as being part of a 
group that provides 24/7 access to care or participation in a Patient 
Safety Organization. One commenter recommended an alternative threshold 
that sets a percentage or minimum number of clinicians (such as 30) 
that does not limit options for large groups. One commenter recommended 
a percentage between 10 percent and 25 percent because 50 percent is 
too drastic of an increase and the ambiguity and uncertainty on how to 
quantify clinician participation at the 50 percent level. One commenter 
recommended a number between one clinician and 50 percent of clinicians 
is appropriate believing the correct number needs further study. One 
commenter stated this is a significant policy change and recommended a 
more gradual approach to a threshold of 25 percent. One commenter 
recommended a modification to 20 percent of total NPIs within a TIN 
believing it is a good sample size and would reduce burden. Another 
commenter recommended an alternative threshold of 1 percent or 5 
clinicians, whichever is greater. One commenter recommended a cap on 
the number of providers required to attest, such as no more than 25 
eligible clinicians from any one TIN. Another commenter recommended 
lowering the percentage or to provide for reporting to be `by 
department' because there may be advantages for reporting at the 
department level. One commenter recommended delaying implementation of 
the 50 percent threshold until CY 2021 to give large groups adequate 
time to implement needed changes. One commenter requested clarification 
whether the proposal intends that the 50 percent threshold applies to 
50 percent of the total NPIs under the TIN. Other commenters 
recommended an increase to 5 or 10 percent because raising the bar to 
50 percent of clinicians in a group would significantly increase 
burden; making it impossible in some cases for groups to attest to the 
required number of improvement activities to receive partial or full 
credit for the performance category; and that there are few clinician 
leaders in a group who are actively engaged in a particular improvement 
activity. One commenter noted a 10 percent threshold is a reasonable 
compromise.
    Response: We do not believe that setting thresholds at 5 percent, 
10 percent, or 25 percent is appropriate as it does not provide a 
comprehensive representation of the entire group. We believe that 
requiring at least 50 percent of the group to perform the same activity 
provides an appropriate balance between requiring at least half of the 
NPIs reporting as part of a group to participate in the improvement 
activities performance category and acknowledging the challenges to 
requiring every NPI in a group to perform the improvement activity for 
a group to receive credit. The common goal of group reporting should be 
group practice transformation and improved patient outcomes. If each 
clinician is reporting on a different improvement activity, we do not 
believe that would meet the common goal of group reporting. Moreover, 
while we understand that one clinician completing an activity may have 
benefits, we do not believe that only one clinician completing an 
activity would create a widespread benefit for an entire group. While 
in some small groups, one participant may have a greater impact, for 
larger groups, one participant is a very low bar. We believe a 50 
percent threshold is appropriate because it will encourage increased 
clinician participation, provide for more meaningful clinical practice 
transformation, and will require a level of clinician participation 
more appropriate for the group to receive credit. We believe increasing 
the threshold to at least 50 percent of the clinicians in the group 
moves the improvement activities performance category towards greater 
impact and value aligning with the MVP framework. In addition, using a 
50 percent threshold for the group is less than what clinicians must do 
in other performance categories. In the quality performance category, 
we have established that 100 percent of the group, to the extent the 
group has patients that are applicable to the measure, must comply with 
our requirements (81 FR 77072). Additionally, for the cost performance 
category, we have established a 100 percent threshold to calculate 
those measures (81 FR 77072).
    We believe a 50 percent threshold will increase clinician 
participation, provide for more meaningful clinical practice 
transformation, and require a level of clinician participation more 
appropriate for the MVP goal of greater value and impact. In addition, 
we believe a 50 percent threshold is achievable and appropriate 
because, if a group or virtual group has implemented an improvement 
activity, the activity should be recognized and adopted throughout much 
of the practice to improve clinical practice, care delivery, and 
outcomes. Furthermore, we believe that 50 percent provides an 
appropriate balance between requiring at least half of the NPIs 
reporting as part of a group to participate in the improvement 
activities performance category while acknowledging the challenges to 
requiring every NPI in a group to perform the improvement activity for 
a group to receive credit. This aligns with the 50 percent threshold 
for the number of practice sites that must be recognized for a TIN to 
receive full credit as a patient-centered medical home (82 FR 53655) 
and is both achievable and appropriate at this time. We do not believe 
that increasing the group threshold to 50 percent for improvement 
activities should hinder participation in other facility initiatives. 
We anticipate that in future rulemaking, we will continue to increase 
this threshold. Our future goal would be to have 100 percent of a group 
performing the same activity during any 90-day period within the same 
performance year.
    We are unclear on why one commenter stated that there is 
``ambiguity and uncertainty on how to quantify clinician participation 
at the 50 percent level''. If the commenter is requesting clarification 
on how to count clinicians towards the 50 percent when there is an 
uneven number of clinicians in the group. In that instance, the group 
would need to go up to the next whole number to account for 50 percent 
of the clinicians in the group. For example, if the group consists of 
13 members then at least 7 clinicians would need to report the same 
improvement activity for any continuous 90 days in the performance year 
for the activity to count towards the improvement activity performance 
category score. The Inventory provides a detailed description of what 
is required to complete a particular activity. In addition, we have 
provided several resources such as a Quick Start Guide and Fact Sheet 
on the Quality Payment Program website at https://qpp.cms.gov/about/resource-library. If clinicians have further questions they may contact 
the Quality Payment Program service center at [email protected] or at 1-
866-288-8292. We also believe that we are providing a gradual approach 
to increasing the group requirements for the improvement activities 
performance category, as for the first 3 years of MIPS we only required 
one clinician from a group to perform and report on an improvement 
activity. As we are preparing to enter Year 4 (CY 2020) of the program 
we believe we should increase the group reporting threshold for 
improvement activities to better align with the other performance 
categories.
    We do not believe a pilot is necessary to attain information on 
whether a

[[Page 62984]]

group is capable of completing improvement activities from the 
Inventory as they are broad and are not specific to practice size, 
specialty, or practice setting. We understand that there are some 
improvement activities that might lend themselves to widespread 
participation. We also believe that groups are able to discern which 
activities would best meet the needs of their group.
    Comment: Many commenters did not support the requirement for 50 
percent of clinicians in the group to report on the same activity, 
rather than any activity, within the same 90-day window for group or 
virtual group improvement activity reporting, noting that it would be 
impractical. A few commenters recommended that we modify our proposal 
to a lower threshold which represents the percentage of clinicians in 
the group who satisfy any activity rather than the same activity over 
the same 90-day period. One commenter noted it would be impractical to 
expect all clinicians in a larger group to perform the same activity 
over the same 90-day period and recommended no change to the current 
policy. However, the commenter continued that if the policy is changed, 
then it should be modified to provide that a certain percentage of 
clinicians in the group (ideally less than 50 percent) can complete any 
single activity, rather than the same activity, over the performance 
year, rather than over the same 90-day period, if the same 90-day 
period would not apply to all those attesting to the activity. Another 
commenter recommended modifying the proposal to a certain percentage of 
clinicians in the group, for example, less than 50 percent, which must 
complete any single activity, rather than the same activity, over the 
performance year, rather than over the same 90-day period. One 
commenter recommended that clinicians within multi-specialty groups and 
virtual groups should elect the improvement activities that are most 
relevant to them and complete them in a 90-day window of the calendar 
year that best works with their patient, surgical, call and delivery 
schedule. One commenter expressed concerns about the ``erosion of 
flexibility'' in the improvement activities performance category. One 
commenter recommended modifying the proposal to require groups to 
complete at least 45 consecutive days during each of 2 consecutive 
performance periods believing this approach would lower burden on 
clinicians and encourage participation. A few commenters expressed 
concerns that a 50 percent threshold may be problematic for groups with 
a high percentage of clinician volunteers participating in Emergency 
Response and Preparedness activities such as ``Participation in a 60-
day or greater effort to support domestic or international humanitarian 
needs'' (IA_ERP_2) that require staggered leaves to continue to provide 
care to their local patients.
    Response: We appreciate feedback that requiring 50 percent of a 
group to perform the same activity for the same 90-days may present 
challenges for large or multi-specialty groups. We believe that 
requiring at least 50 percent of the group to perform the same activity 
provides an appropriate balance between requiring at least half of the 
NPIs reporting as part of a group to participate in the improvement 
activities performance category and acknowledging the challenges to 
requiring every NPI in a group to perform the improvement activity for 
a group to receive credit. However, we do not want to inhibit the 
clinician's ability to be engaged and fully participate in the selected 
improvement activity due to scheduling conflicts as noted by 
commenters. Thus after consideration, we are modifying the proposed 
policy to balance substantive practice transformation and improved 
patient outcomes with more flexibility for groups to determine how to 
implement and perform improvement activities in a way that minimizes 
disruption to clinical practice, and maintains focus on patient care. 
Therefore, we are finalizing a modified version of our proposal, such 
that at least 50 percent of a group's National Provider Identifiers 
(NPIs) must perform the same activity for any continuous 90 days in the 
performance period beginning with the 2020 performance year. Instead of 
requiring clinicians to perform the same activity for the same 
continuous 90 days, this will allow clinicians flexibility to choose 
the most appropriate 90-day period while still increasing the number of 
clinicians required to report. Under the modified policy, a group could 
choose to perform an activity for the entire performance year to 
capture the participation of at least 50 percent of the group's 
clinicians. That is, while 50 percent of NPIs in a group must perform 
the same improvement activity for a continuous 90-day period, they do 
not need to perform the activity during the same period. For example, 
some NPIs could perform ``Practice Improvements for Bilateral Exchange 
of Patient Information'' (IA_CC_13) during January while others could 
perform the same activity in June. In that instance, the group 
attestation would need to reflect the year-long participation. If the 
clinicians' leave times are staggered, we recommend the clinicians 
choose different continuous 90-day time periods during the performance 
year to perform the same improvement activity. In this instance, the 
group would select activities that may span over the entire performance 
year to cover all clinicians. We are also revising Sec.  414.1360(a)(2) 
to reflect this modification.
    Comment: Many commenters noted their belief that the proposal could 
force clinicians to participate in an improvement activity that has no 
relevance in the field in which they are providing care and recommended 
that eligible clinicians have the freedom to choose the improvement 
activities they deem most meaningful. Another commenter recommended 
setting a percent threshold across the group that allows for 
variability in activity selection to enable clinicians to choose what 
is most clinically relevant to them. Other commenters expressed concern 
that the increased threshold disincentivizes specialties from picking 
improvement activities which are clinically relevant to them such as 
when cardiologists in a multispecialty group may not make up 50 percent 
of the NPIs under the same TIN.
    Response: The improvement activities Inventory has been developed 
to be applicable to broad groups of clinicians. Most improvement 
activities may be applied to general practice or specialty settings, 
and therefore, are accessible to groups with large portions of 
specialty clinicians, or multi-specialty practices. For the CY 2020 
MIPS performance period, the improvement activities Inventory will have 
20 specialty-specific improvement activities and 85 improvement 
activities that are broadly applicable to both specialists and general 
practitioners. We believe that at least 50 percent of a group's 
eligible clinicians should be able to find applicable improvement 
activities as we have included broad improvement activities that are 
not specific to practice size, specialty, or practice setting. For 
example, the Inventory contains improvement activities that may be 
applied broadly such as: ``Completion of an Accredited Safety or 
Quality Improvement Program'' (IA_PSA_28) and ``Provide 24/7 Access to 
MIPS Eligible Clinicians or Groups Who Have Real-Time Access to 
Patient's Medical Record'' (IA_EPA_1). Regarding the multispecialty 
group, we believe that specialists should be participating in general 
improvement activities, as well as activities that are more specialty 
focused. We are not barring eligible

[[Page 62985]]

clinicians from performing additional improvement activities they deem 
relevant to their specialty; rather, we encourage this to promote 
practice improvement.
    Comment: Many commenters did not support the proposal to increase 
the threshold to 50 percent of the clinicians in the group to perform 
the same improvement activity for the same 90-day period because of the 
interests and burden for multi-specialty groups. Several commenters 
stated that finding two to four activities that 50 percent of 
specialists are involved in during the same 90-day period will be 
difficult, burdensome, onerous to achieve, impractical, and will result 
in clinicians reporting on a significantly higher number of improvement 
activities than are required in the improvement activities performance 
category, and may result in less engagement in improvement activities. 
A few commenters stated there would be a large administrative burden 
for multi-specialty groups that are not hospital-based and academic 
medical groups that consist of multiple specialty and sub-specialties. 
One commenter noted that the proposal may not be achievable for multi-
specialty groups because of scheduling conflicts.
    One commenter did not support the proposal because large groups 
often implement different improvement activities for different types of 
specialties and the 50 percent threshold would limit the selection of 
improvement activities to those that could be applied to a broader 
number of clinicians. The commenter provided an example of a group that 
develops a program to integrate primary care and mental health services 
to address ``Integration facilitation and promotion of the colocation 
of mental health and substance use disorder services in primary and/or 
non-primary clinical care settings'' (IA_BMH_6) that may involve 
primary care clinicians and mental health clinicians; however, if 
primary care and mental health only make up 40 percent of a group, the 
improvement activity would not ``count'' under the proposal.
    One commenter noted the proposal would discourage participation by 
some clinicians, particularly those in large, multi-specialty groups 
because clinicians participate in numerous improvement activities which 
can be expensive and the investment should be recognized by providing 
credit under the MIPS program. The commenter noted that the investment 
should be recognized by providing credit under the MIPS program. One 
commenter noted that other members of the group may not have the time 
or resources necessary to participate in that activity and that raising 
the threshold to 50 percent would disincentivize those clinician 
leaders from participating in the activity, since they would know that 
there would be no way their group would receive credit.
    Another commenter expressed concern about fixing any threshold 
amount because of varying group composition, size, culture and learning 
environments; that the improvement activity itself may not be suitable 
to attaining a fixed threshold; and that applying a fixed threshold 
will likely increase clinician burden due to the documentation 
requirement necessary to demonstrate meeting that threshold and 
recommended if a threshold must be set that consideration be given to 
something lower than 50 percent, and provided 10 percent as an example.
    Response: We appreciate that requiring 50 percent of a group to 
perform the same activity for the same 90-days may present challenges 
for large or multi-specialty groups including groups that are not 
hospital-based and academic groups with multiple specialties and sub-
specialties. We refer readers to our modified policy as discussed 
above, which allows a group more flexibility to complete the activity, 
such that a group has the entire performance year to ensure that 50 
percent of clinicians in the group perform the improvement activity for 
any continuous 90-days in the performance year. We acknowledge that 
this policy may cause a minor decrease in flexibility in the 
improvement activities performance category in regards to the selection 
of the activity. However, clinicians are able to choose the improvement 
activity that is most meaningful to their group. Although, we do 
acknowledge that increasing the group threshold requirement may result 
in some improvement activities no longer applying for certain 
practices, the program currently has over 100 improvement activities 
available and clinicians have flexibility to select ones that are 
appropriate. In addition, we do not believe that the modified policy 
will limit the selection of improvement activities to those that could 
be applied to a broader number of clinicians, as the Inventory was 
created to be broadly applicable and includes activities that are not 
specific to practice size, specialty, or practice setting. We encourage 
practices to perform improvement activities that are relevant to their 
practice and will demonstrate practice improvements that will be 
beneficial to their patients. Regarding the comment about a group where 
only 40 percent of the clinicians where able to participate in the 
activity; the group would not meet the 50 percent threshold. However, 
we encourage groups to continue to engage in improvement initiatives 
that are relevant to their practice. As noted by one commenter, we have 
a broad Inventory because not every improvement activity will be 
applicable to every clinician or practice. We appreciate that 
clinicians take steps to improve their practice and encourage uptake of 
a range of clinical practice improvements, not all of which will be 
eligible for credit in the improvement activities performance category, 
but still result in improved quality of care and improved patient 
outcomes.
    Comment: Many commenters did not support the proposal to increase 
the threshold to 50 percent and noted that it discourages full 
participation in the improvement activities performance category as the 
proposal may increase administrative burden, be impractical, and adds 
another layer of complexity by altering the policy that clinicians have 
worked to adhere to. A few commenters did not support the threshold 
because of the administrative burden of initiating and coordinating 
widespread adoption of improvement activities and one noted the 
complexity of tracking adherence in non-employed situations such as 
with virtual groups and accountable care organizations. Other 
commenters expressed concerns with the documentation requirements for 
groups to meet the proposed 50 percent threshold. Another commenter 
believed that applying a fixed threshold will likely increase clinician 
burden due to the documentation requirement necessary to demonstrate 
meeting that threshold and recommended if a threshold must be set that 
consideration be given to something lower than 50 percent, and provided 
10 percent as an example. One commenter noted that a percentage 
requirement will increase the documentation burden by requiring roll 
call at meetings and tracking participant's involvement. Another 
commenter noted that the data collection burden on the group and 
attestation collection process for the qualified registry or QCDR may 
be significant. One commenter expressed concern with the increase in 
the amount of data needed to support that an improvement activity was 
performed in case of an audit and that duplicative efforts may be 
needed to provide sufficient evidence in support of larger numbers of 
clinicians. Other commenters expressed concern that tracking the 
performance of clinicians

[[Page 62986]]

who are part of a TIN structure with a very large number of clinicians, 
which they stated is typical for academic medical centers, is a 
monumental task and undermines the purpose of group reporting. One 
commenter expressed concern that the proposed increase is significant 
for all groups, regardless of size, and that it increases the burden of 
documentation and will lead to reduced revenues and additional costs 
for the eligible clinician or group. One commenter believed the 
proposal would place further burden upon the dwindling number of 
independent groups across the country. Another commenter recommended 
that the proposal should be one of two options, that clinicians could 
select either: (1) 50 percent of the group performs the same activity; 
or (2) 75 percent of clinicians in a group could perform multiple 
activities, each for 90 days.
    Response: We do not believe that there will be a significant 
increase in difficulty in relation to tracking of clinician's 
participation in a particular improvement activity. We appreciate that 
there is an increase in administrative tracking of each clinician in a 
group who performed the improvement activity and the maintenance of 
maintaining that documentation for audit purposes, but also note that 
the attestation requirement is the same. We are balancing the increased 
effort to track clinician performance in a group to meet the 50 percent 
threshold with the interest in improving quality care and transforming 
clinical practice; we believe that a 50 percent threshold is an 
appropriate increase to improve quality care throughout a clinical 
practice at this time. We also believe that improvement activities are 
investments in clinical practice and should not be viewed as costs or 
reduced revenues.
    We note that we have not changed our requirements for data 
submission. It remains as an attestation. We believe more clinicians 
participating in improvement activities and tracking 50 percent of a 
group's participation will not significantly increase the effort 
clinicians will expend to submit attestations to the designated 
reporting authority. The minor difference from the previous requirement 
is that the designated reporting authority will be attesting for 50 
percent of the group rather than for a single clinician. We do not want 
to inhibit the clinician's ability to be engaged and fully participate 
in the selected improvement activity. We believe that our modifications 
to the proposed policy as discussed previously will enable groups to 
determine how to implement and perform improvement activities in a way 
that minimizes any clinical disruption, and maintains focus on patient 
care.
    As discussed in the CY 2020 PFS proposed rule (84 FR 40902), we 
believe that given groups' familiarity with the improvement activities 
in the improvement activities Inventory, we believe that a group would 
find applicable and meaningful activities to complete that are not 
specific to practice size, specialty, or practice setting and would 
apply to at least 50 percent of individual MIPS eligible clinicians in 
the group. Therefore, an increase in the minimum threshold for a group 
to receive credit for the improvement activities performance category 
should not present additional complexity or burden. We also 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 final rule 
because previously finalized improvement activities continue to apply 
for the current and future years unless otherwise modified per rule-
making (82 FR 54175). Further, as discussed in the 2020 PFS proposed 
rule (84 FR 40870), we stated that because eligible clinicians attest 
to improvement activities at the group level, there is no impact on 
reporting burden as a result of this proposal. Most of the improvement 
activities in the Inventory remain unchanged for the 2020 MIPS 
performance period. Of the activities that are being removed or 
modified many were duplicative which means many clinicians or groups 
would be able to continue the activity, but it would be reported under 
a different activity in the improvement activities Inventory. We 
appreciate the 50 percent group threshold option as one of the 
commenters' suggestions. We do not believe the other suggestion of 
requiring 75 percent of the group to perform different activities is 
appropriate. First, a 75 percent group threshold is a steep increase 
from the current group reporting threshold of one participant. Second, 
we believe the group should be performing the same activity in order to 
facilitate improvement. We anticipate that in future rulemaking, we 
will continue to increase this threshold. Our future goal would be to 
have 100 percent of a group performing the same activity during any 90-
day period within the same performance year.
    Comment: One commenter expressed concern for the unintended 
consequence of driving organizations toward continually attesting to 
``very basic foundational improvement activities'' rather than 
attempting to perform more focused, difficult, and risk-attendant 
levels of improvement.
    Response: We do not agree that increasing the group threshold 
reporting threshold to 50 percent will cause groups to choose basic 
improvement activities. The improvement activities Inventory was 
created to be broadly applicable and includes activities that are not 
specific to practice size, specialty, or practice setting. We believe 
increasing the threshold to at least 50 percent of the clinicians in 
the group moves the improvement activities performance category towards 
greater impact and value aligning with the MVP framework. We believe a 
50 percent threshold will increase clinician participation, provide for 
more meaningful clinical practice transformation, and require a level 
of clinician participation more appropriate for the MVP goal of greater 
value and impact. We believe the modified final policy will encourage 
increased clinician participation, provide for more meaningful clinical 
practice transformation, and will require a level of clinician 
participation more appropriate for the group to receive credit. We do 
not believe that it benefits a large group or the patient if only one 
clinician is undertaking quality improvement efforts because there is 
not necessarily widespread implementation of the quality initiative.
    Comment: One commenter noted the proposed threshold may isolate 
individual groups from working across medical departments within 
healthcare settings and noted its impact on preventing clinicians from 
full participation in facility initiatives.
    Response: We disagree that our policy would isolate individual 
groups from working across medical departments within healthcare 
settings. The 50 percent group threshold policy is intended for MIPS 
eligible clinicians who want credit as a group and is not a limitation 
on clinicians who may be in a particular TIN from participating in any 
other improvement-related activities outside of MIPS, including those 
they may be implemented at a facility. Our policy does not restrict 
clinicians to only participating in activities that improve clinical 
practice through MIPS. Clinicians may also perform other improvement 
activities within MIPS should they so desire (but would not receive 
credit for performing the improvement activity for the group).
    Comment: One commenter noted the proposed increase to 50 percent 
would be particularly burdensome for small practices and recommended 
that requiring only one clinician to perform an improvement activity 
for the group to

[[Page 62987]]

receive credit should be sufficient for small practices. Another 
commenter stated the increase is too steep and will jeopardize the 
ability of clinicians in rural areas to meet the requirements because 
they will be unable to locate improvement activities for which half 
their clinicians in their practice can participate in.
    Response: We disagree. We believe that this proposal would be 
easier for a small group to accomplish than a larger group since there 
will be less clinicians required to complete the activity. We also 
refer readers to our modification to the proposal discussed above. 
Instead of requiring clinicians to perform the same activity for the 
same continuous 90 days, the modified policy will allow clinicians 
flexibility to choose the most appropriate 90-day period while still 
increasing the number of clinicians required to report. We believe the 
modified final policy will encourage increased clinician participation, 
provide for more meaningful clinical practice transformation, and will 
require a level of clinician participation more appropriate for the 
group to receive credit. We do not believe that it benefits a group or 
the patient if only one clinician is undertaking quality improvement 
efforts because there is not necessarily widespread implementation of 
the quality initiative.
    We note that we finalized special scoring for small practices for 
the improvement activities performance category in the CY 2017 Quality 
Payment Program final rule (81 FR 77185) at Sec.  414.1360 that for 
MIPS eligible clinicians and groups that are small practices, practices 
located in rural areas or geographic HPSAs, or non-patient facing MIPS 
eligible clinicians or groups, to achieve the highest score, one high-
weighted or two medium-weighted improvement activities are required. 
For these MIPS eligible clinicians and groups, to achieve one-half of 
the highest score, one medium-weighted improvement activity is 
required. We finalized that small practices, especially those in rural 
locations and in health professional shortage areas, are required to 
report only the maximum of two (2) activities in the improvement 
activities performance category instead of the four (4) required for 
larger practices. Finally, as discussed in the CY 2017 Quality Payment 
Program final rule (81 FR 77012) the Small, Underserved, and Rural 
Support initiative is available to provide free, customized technical 
assistance to clinicians in small practices. More information regarding 
the Small, Underserved, and Rural Support initiative may be found on 
the Quality Payment Program website at https://qpp.cms.gov/about/small-underserved-rural-practices.
    Comment: One commenter expressed concern that imposing a 50 percent 
threshold would prevent a group from reporting any of the improvement 
activities at the group level if reporting through a QCDR. The 
commenter provided an example of a multi-specialty group comprised of 
optometrists, retinal specialists, and ophthalmologists which only have 
four out of ten clinicians reporting through a QCDR due to their scope 
of clinical practice and availability of relevant QCDR measures.
    Response: An eligible clinician should perform improvement 
activities that are relevant and improve clinical practice whether 
reporting and submitting as a group or individual aside from the chosen 
reporting method. The Improvement Activities Inventory includes a broad 
number of improvement activities that are not only relevant to groups 
but also to individuals. If an improvement activity is more appropriate 
for an individual clinician, a group should not be considering it. We 
include improvement activities that are not only relevant to groups but 
also to individuals. We believe that improvement activities that are 
relevant to groups, the 50 percent threshold is most appropriate. We 
clarify that if clinician groups reporting to a QCDR that do not meet 
the 50 percent threshold could: (1) Work with the QCDR to have their 
data submitted for the entire group, not just a subset needed to meet 
the 50 percent threshold; (2) directly attest to the improvement 
activity as a group; or (3) submit improvement activities as 
individuals. No matter which submission method the group decides to 
utilize the clinicians would still be required to utilize the 
improvement activities Inventory to choose and complete their 
activities as QCDRs do not own improvement activities.
    Comment: One commenter recommended using a threshold of 50 percent 
of clinicians in a group who could complete a relevant improvement 
activity, rather than 50 percent of all clinicians who should complete 
the activity in the group.
    Response: We believe, at a minimum, 50 percent of all clinicians in 
the group should complete the same activity to facilitate practice 
improvement. We believe it is impractical to determine who ``could'' 
complete a particular activity and would add more complexity and burden 
for a practice to assess and track which clinicians have the ability to 
complete a specific improvement activity.
    Comment: One commenter expressed concern that this proposal does 
not align with the APM track of the Quality Payment Program because 
APMs are not held to a similar threshold that takes into consideration 
how many clinicians within the APM completed the activity.
    Response: The improvement activities performance category scoring 
methodology under the APM scoring standard is designed to reflect the 
unique statutory and regulatory reporting and scoring requirements and 
methodologies specific to APM entities (81 FR 77266). While we 
generally prefer to align scoring standards within MIPS, perfect 
alignment between the two scoring standards is not always achievable.
    Comment: One commenter did not support the proposed policy change 
and noted their concern that the policy does not contemplate common 
management structures of specialty groups and departments. The 
commenter stated that specialty groups often facilitate quality 
initiatives, data and training through a select few clinical quality 
leaders or, for larger groups, quality committees. They noted that 
management structures of groups are often structured with one or a 
handful of quality champions who must then communicate with and train 
members of the group on initiatives, goals and best practices in 
quality improvement. The commenter also noted that we should take these 
management structures into account when increasing the group threshold. 
Another commenter expressed concern that implementing a percentage 
requirement underestimates the role and impact of a lead quality 
improvement clinician in a group. One commenter recommended 
clarification for improvement activities which are completed by an 
organization rather than by an individual clinician because 
organization-level participation should be taken into account where 
appropriate. This commenter provided an example of an organization that 
implements an antimicrobial stewardship program (ASP) which will have 
an impact on all clinicians in the organization, but that most 
clinicians will not directly participate in a tangible manner; the 
commenter believed that all clinicians in the organization are de facto 
participants in the ASP. A few commenters recommended a differentiation 
between improvement activities best suited for individual clinician 
improvement from those that may be applicable to a group quality 
champion, champions or committee and

[[Page 62988]]

that includes documentation requirements.
    Response: When crafting a national policy we do consider impacts on 
clinicians and groups in various management structures and settings. We 
provide flexibility and choice for selecting improvement activities 
that are appropriate for the group that are not dependent on management 
structures. We do not believe that setting a group threshold 
underestimates the role and impact of the lead quality improvement 
clinician. Rather, we believe that it provides a minimum standard of 
group participation and encourages quality improvement actions by more 
than just one singular clinician. We encourage 100 percent of the 
clinicians in a group to participate in the quality improvement action 
and to complete as many improvement activities beyond the minimum 50 
percent required by the MIPS program.
    We have not provided individual versus group differentiation in the 
Inventory in the past as we have kept the Inventory broad, thereby 
allowing clinicians to choose what activities are most relevant to 
their practice. We will take this comment into consideration as we 
craft future policies. We provide several resources that may be 
utilized for assistance with selection of an improvement activity. 
First, the improvement activities Inventory provides a detailed 
description of each activity. In addition, we provide resources on the 
Quality Payment Program website which is available at https://qpp.cms.gov/. Finally, the Small, Underserved, and Rural Support 
initiative is available to provide free, customized technical 
assistance to clinicians in small practices. As discussed in the CY 
2017 Quality Payment Program final rule (81 FR 77012), the Small, 
Underserved, and Rural Support initiative is available to provide free, 
customized technical assistance to clinicians in small practices. More 
information regarding the Small, Underserved, and Rural Support 
initiative may be found on the Quality Payment Program website at 
https://qpp.cms.gov/about/small-underserved-rural-practices. In 
addition, if clinicians have further questions they may contact the 
Quality Payment Program service center at [email protected] or at 1-866-
288-8292.
    Comment: Several commenters did not support the proposed increase 
and noted that it does not reflects the realities of clinical practice. 
These commenters stated that a specific improvement activity might be 
applicable to only one or two clinicians, but still have the capacity 
to vastly improve and impact a large portion of the group's patients. A 
few commenters requested clarification on how credit would be applied 
to groups in a scenario when a small subset of a group's clinicians 
cover extended hours for all of the clinic's patients, but patient 
access improves for the entire population served. One commenter 
referenced an example in which a group hires an additional fulltime 
clinician to extend office hours; the group as a whole invested in a 
new clinician to increase its availability to its patients and should 
be recognized as such. Another commenter provided an example in which a 
clinic extended its hours for all of the clinic's patients, regardless 
of the percentage of clinicians who work the extended hours, and 
questioned how a group with 20 clinicians would receive improvement 
activities credit.
    Response: We do understand the realities of clinical practice and 
believe that improvement activities are broadly applicable. While we 
understand that one clinician completing an activity may have benefits, 
we do not believe that only one clinician completing an activity would 
necessarily create a widespread benefit for an entire group. While in 
some small groups, one participant may have a greater impact, for 
larger groups, one participant is a very low bar. We do not agree the 
commenter's example of hiring an additional full time clinician to 
extend office hours demonstrates group level improvement. For example, 
to demonstrate meaningful practice improvement for an improvement 
activity like ``Provide 24/7 access to eligible clinicians or groups 
who have real-time access to patient's medical record'' (IA_EPA_1), 
under our modified policy discussed above, the group could utilize 5 
out of the 20 clinicians for one continuous 90-day performance period 
and another 5 clinicians for an additional continuous 90-day 
performance period. In this example, the group could achieve the 90-day 
threshold while providing increased access to their patients. We 
encourage individual clinicians to perform improvement activities that 
impact the entire group.
    After consideration of the comments, we are finalizing our proposal 
with modification, such that instead of requiring that a group must 
perform the same activity for the same continuous 90 days in the 
performance period as proposed, we are requiring that a group must 
perform the same activity during any continuous 90-day period within 
the same performance year. Therefore, we are revising Sec.  
414.1360(a)(2) to state that beginning with the 2020 performance year, 
each improvement activity for which groups and virtual groups submit a 
yes response in accordance with paragraph (a)(1) of this section must 
be performed by at least 50 percent of the NPIs billing under the 
group's TIN or virtual group's TINs, as applicable; and the NPIs must 
perform the same activity during any continuous 90-day period within 
the same performance year.
(e) Improvement Activities Inventory
    In the CY 2020 PFS proposed rule (84 FR 40764 through 40765), in 
this final rule we are finalizing changes to the improvement activities 
Inventory: (1) Establishing removal factors to consider when proposing 
to remove improvement activities from the Inventory; (2) removing 15 
improvement activities for the 2020 performance period and future years 
contingent on our proposed removal factors being finalized; (3) 
modifying seven existing improvement activities for the 2020 
performance period and future years; and (4) adding two new improvement 
activities for the 2020 performance period and future years. These are 
discussed in more detail in this final rule.
(i) Factors for Consideration in Removing Improvement Activities
    In the CY 2017 Quality Payment Program final rule (82 FR 53660 
through 53661), we discussed that in future years, we anticipated 
developing a process and establishing factors for identifying 
improvement activities for removal from the improvement activities 
Inventory through the Annual Call for Activities process. In the CY 
2018 Quality Payment Program proposed rule (82 FR 30056), we invited 
public comments on what criteria should be used to identify improvement 
activities for removal from the Inventory. A few commenters did not 
support the idea of establishing removal factors for improvement 
activities, believing that many groups have made financial investments 
to perform these improvement activities and that no activities should 
be removed. Some commenters suggested that we should remove improvement 
activities that: Have become obsolete, are topped out, do not show 
demonstrated improvements over time, or are not attested to for three 
consecutive years. The commenters recommended that their removal should 
be conducted using an approach similar to what is used for the removal 
of quality measures. In our responses, we stated

[[Page 62989]]

that we appreciate the commenters input. In addition, we understand 
that many groups may have made financial investments to perform these 
improvement activities, but believe that over time, certain improvement 
activities should be considered for removal to ensure the list is 
robust and relevant. We will fully examine each activity prior to 
removal. In addition, we stated that commenters would have an 
opportunity to provide their input during notice-and-comment 
rulemaking. We agreed with commenters that we should remove improvement 
activities as needed and should consider the removal criteria already 
established for quality measures. We continue to believe that having 
factors to consider in removing improvement activities would provide 
transparency and alignment with the removal of quality measures. 
Therefore, we proposed to adopt the following factors for our 
consideration when proposing the removal of an improvement activity:
     Factor 1: Activity is duplicative of another activity;
     Factor 2: There is an alternative activity with a stronger 
relationship to quality care or improvements in clinical practice;
     Factor 3: Activity does not align with current clinical 
guidelines or practice;
     Factor 4: Activity does not align with at least one 
meaningful measures area;
     Factor 5: Activity does not align with the quality, cost, 
or Promoting Interoperability performance categories;
     Factor 6: There have been no attestations of the activity 
for 3 consecutive years; or
     Factor 7: Activity is obsolete.
    These factors directly reflect those already finalized for quality 
measures found in the CY 2019 PFS final rule (83 FR 59765). The removal 
of improvement activities from the Inventory, including discussion of 
the removal factor(s) considered, will occur through notice-and-comment 
rulemaking. We note that these removal factors are considerations taken 
into account when deciding whether or not to remove improvement 
activities; but they are not firm requirements.
    Therefore, we invited public comments on our proposal to implement 
factors to consider in removing improvement activities from the 
Inventory. In conjunction with this proposal, we proposed a number of 
improvement activity removals as discussed in the next section and in 
Appendix 2 of this final rule. Those removals are contingent upon 
finalization of these removal factors.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the establishment of seven 
factors for consideration on whether to remove particular improvement 
activities from improvement activities Inventory because they believed 
that the criteria are well aligned with the agency's Meaningful 
Measures framework and would help promote the inclusion of activities 
that have a meaningful link to better quality of care. One commenter 
supported the effort to align criteria for improvement activity removal 
with quality measure removal criteria. One commenter supported the 
seven factors and particularly the removal of improvement activities 
that may be duplicative.
    Response: We agree and appreciate the commenter's support.
    Comment: One commenter supported the proposed removal factor 3. 
Another commenter stated that they appreciate our efforts to align 
criteria for improvement activity removal with quality measure removal 
criteria. The commenter requested clarification of our interpretation 
of the final criteria and the use of the word ``obsolete.''
    Response: We consider an activity ``obsolete'' when it is no longer 
available, and therefore, cannot be completed by eligible clinicians as 
an improvement activity. For example, in Appendix 2 of this final rule 
we are finalizing the removal of ``TCPI Participation'' (IA_CC_4) under 
removal factor 7. This improvement activity is obsolete because the 
Transforming Clinical Practice Initiative (TCPI) ended on September 28, 
2019 and clinicians are no longer able to attest to this improvement 
activity.
    Comment: A few commenters expressed concerns that we are removing 
improvement activities from the MIPS program too rapidly and limiting 
clinician choice. A few commenters expressed concerns that many groups 
have made financial investments to perform a particular improvement 
activity and that removal of improvement activities could jeopardize 
the group's return on that investment while requiring new program 
costs. One commenter recommended that we be judicious in the removal of 
improvement activities. One commenter recommended that no activities 
should be removed from the list unless they are obsolete, such as 
activities that require participating in a program that no longer 
exists. One commenter noted that the trend toward measure consolidation 
and activity removal seen now in both the improvement activities and 
the quality performance category will prove limiting to clinicians. 
This commenter noted that we should ensure that clinicians can continue 
to tailor improvements to their practice and not unintentionally limit 
practices by over-pruning the improvement activities and measures of 
the MIPS program because improvement cannot and should not become a 
one-size-fits-all process. One commenter did not support removing 
improvement activities from the improvement activities Inventory 
stating it is contrary to the intent of the improvement activities 
performance category and recommended a judicious approach to the 
removal process and that the improvement activities performance 
category should support the performance of any improvement activity 
that improves patient care. This commenter noted that a policy that 
removes activities from the improvement activities Inventory would 
stymie this goal, suggesting that groups should only implement 
temporary rather than long-term changes and that removing activities 
could harm groups and patients, particularly those in small and rural 
practices, which often have limited financial and personnel resources.
    Response: We do not believe we are removing improvement activities 
too rapidly. We have been judicious in our proposals to remove 
activities in line with the removal criteria we have proposed. We agree 
that practice improvement should not be a one-size-fits-all process. We 
intend to keep the improvement activities Inventory as broad as 
appropriate to allow clinicians to apply the improvement activities in 
a clinically relevant and meaningful manner. We believe to ensure that 
the improvement activities Inventory stays relevant and robust, it is 
essential to establish removal criteria. We continue to believe that 
having factors to consider in removing improvement activities would 
provide transparency and alignment with the removal of quality 
measures. We are not suggesting that groups should only implement 
temporary improvements, to the contrary, we encourage long term 
improvements in clinical practices. We do not believe that removing 
activities could harm groups and patients, particularly those in small 
and rural practices. We encourage clinicians across all practice sizes, 
including small and rural practices, to continue to perform quality 
initiatives that facilitate the delivery of high quality care, help 
transform clinical practice and are in the best interest of patient 
care the best

[[Page 62990]]

interest of patient care. We understand that many groups may have made 
financial investments to perform these improvement activities, but 
believe that over time, certain improvement activities should be 
considered for removal to ensure the list is robust and relevant. We 
will fully examine each activity prior to removal. In addition, 
commenters would have an opportunity to provide their input during 
notice-and-comment rulemaking.
    Comment: A few commenters did not support factor 5 that provides 
for the removal of an activity that does not align with the quality, 
cost, or Promoting Interoperability performance categories, because the 
improvement activities performance category should allow for 
innovation. A few commenters stated that factor 5 could increase the 
burden on clinicians by limiting improvement activities related to 
their scope of practice. One commenter noted that the purpose of the 
improvement activities performance category is to provide credit to 
clinicians for work towards improving care and that factor 5 would 
constrain the development and inclusion of potentially innovative 
activities because they do not align with the other three performance 
categories. One commenter recommended delaying factor 5 until the MVPs 
have been finalized, implemented, and assessed.
    Response: The improvement activities performance category supports 
innovation, as well as activities that go beyond the standard of care. 
We do not believe that aligning the performance categories will limit 
activities related to a clinician's scope of practice as the activities 
within the Inventory were created to be broad and are not specific to 
practice size, specialty, or practice setting. In addition, we do not 
believe we should delay implementing factor 5 as we believe it is 
important for improvement activities to align with the other 
performance categories in order to provide a more cohesive program and 
must make an effort to move in that direction. As discussed in the CY 
2020 PFS proposed rule (84 FR 40732 through 40733), we provided an 
overview of the MVP framework for future proposals beginning with the 
2021 MIPS performance period/2023 MIPS payment year to simplify MIPS, 
improve value, reduce burden, help patients compare clinician 
performance, and better inform patient choice in selecting clinicians. 
We agree that the MIPS program encourages clinicians to pursue measures 
and activities that improve care. We also believe that it is imperative 
that we streamline the program through the creation of the MVPs. To 
have one cohesive program, we intend to align all of the performance 
categories to create the MVPs. Therefore, we believe that removal 
factor 5 should be a consideration when removing improvement activities 
from the MIPS program to lay the groundwork for MVPs. We refer readers 
to section III.k.3.a. of this final rule for further discussions on the 
MVP framework.
    Comment: A few commenters expressed concerns with factor 1. One 
commenter recommended that we be judicious in the removal of 
improvement activities, particularly if utilizing the proposed 
``duplicative'' criteria. One commenter noted that some improvement 
activities may appear, similar on the surface, but may be implemented 
differently in various clinical settings and encouraged us to consider 
specific ways in which seemingly ``duplicative'' activities are 
actually utilized in the various clinical settings. One commenter 
cautioned removing too many ``duplicative'' improvement activities from 
the list without ensuring that the corresponding remaining activity 
does not require clinicians to perform more work than in the 
``duplicative'' one.
    Response: We appreciate the commenters' support. We want to assure 
stakeholders that we have and will continue to fully examine each 
activity prior to proposing to remove the improvement activity. As 
discussed above, the removal of an improvement activity from the 
Inventory, including discussion of the removal factor(s) considered, 
will occur through notice-and-comment rulemaking. Therefore, commenters 
will have an opportunity to provide their input during the notice-and-
comment rulemaking process.
    After consideration of the comments, we are finalizing our 
proposal, as proposed, to adopt the seven factors discussed above, for 
our consideration when proposing the removal of an improvement 
activity.
(ii) New Improvement Activities and Modifications to and Removal of 
Existing Improvement Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would add new improvement activities or modifications 
to existing improvement activities to the improvement activities 
Inventory through notice-and-comment rulemaking. We refer readers to 
Table H in the Appendix of the CY 2017 Quality Payment Program final 
rule (81 FR 77177 through 77199), Tables F and G in the Appendix of the 
CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229), 
and Tables X and G in the Appendix 2 of the CY 2019 PFS final rule (83 
FR 60286 through 60303) 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 final rule, we are: (1) 
Removing 15 improvement activities from the Inventory beginning with 
the 2020 performance period, (2) modifying seven existing improvement 
activities for 2020 performance period and future years, and (3) adding 
two new improvement activities for 2020 performance period and future 
years. We refer readers to Appendix 2 of this final rule for further 
details. Our improvement activities removals are made in conjunction 
with our adoption of removal factors.
(f) CMS Study on Factors Associated With Reporting Quality Measures
    In this final rule, we are finalizing our proposal to end this 
study and concurrently, remove the incentive under the improvement 
activity performance category that this study provided for study 
participants.
(i) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77195), we 
created the Study on Improvement Activities and Measurement. In our 
quest to create a culture of improvement using evidence-based medicine 
on a consistent basis, we believe fully understanding the strengths and 
limitations of the current processes of collecting and submitting 
quality measurement data is crucial to better understand and improve 
these current processes. We proposed to conduct a study on clinical 
improvement activities and measurement to examine clinical quality 
workflows and data capture using a simpler approach to quality measures 
(81 FR 77195). In the CY 2018 Quality Payment Program final rule (82 FR 
53662) and CY 2019 PFS final rule (83 FR 59783), we finalized updates 
to the study.
    Starting in CY 2017, this annual study was slated for a minimum 
period of 3 years, as stated in CY 2019 PFS final rule (83 FR 59776). 
Study participants were recruited every study year. The study 
population started in CY 2017 with a minimum of 42 individuals (81 FR 
77195), grew to a minimum of 102 individuals for CY 2018 (82 FR 53662) 
and 200 individuals for CY 2019 (83 FR 59783). Each years' study 
population is comprised of the following categories: Urban versus non-
urban, groups and individual clinicians; clinicians

[[Page 62991]]

reporting quality measures in groups or reporting individually, 
different practice sizes; and different specialty groups (81 FR 77195). 
These changes to the study sample size over the years provided data for 
the study's analysis. The goals of the study are to see whether there 
will be improved outcomes, reduced burden in reporting, and 
enhancements in clinical care by selected MIPS eligible clinicians 
desiring: A more data driven approach to quality measurement, measure 
selection unconstrained by a CEHRT program or system, improving data 
quality submitted to CMS, enabling CMS get data more frequently and 
provide feedback more often (81 FR 77195). To encourage participation 
by clinicians and counterbalance clinician burden for anticipation of 
study, participating clinicians were incentivized with full improvement 
activity credit as finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77195 through 77197).
(ii) Study End and Removal
    We believe by the end of 2020 we will have reached the minimum 
sample size and have accrued the minimum data needed for the analysis 
to achieve the study goals. Therefore, in the CY 2020 PFS proposed rule 
(84 FR 40765), we proposed to conclude this study at the end of the CY 
2019 performance period. In conjunction with our proposal to end the 
study, we also proposed to remove the study and the incentive provided 
towards the improvement activity performance category beginning with 
the 2020 performance period because it would be obsolete (removal 
factor 7). As a result, the full improvement activity credit given to 
participants as finalized in the CY 2017 Quality Payment Program final 
rule (81 FR 77195 through 77197), would no longer be available starting 
with the 2020 performance period.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters encouraged us to continue to seek ways to 
incentivize clinician organizations and vendors to participate in 
measure or program development to ensure true quality measurement and 
improvement. One commenter supported that this study has reached its 
statutory requirements; recommended that the results and the data be 
made publicly available once analysis is complete in Spring 2020; and 
encouraged us to conduct similar studies in future years as the program 
evolves. One commenter recommended that we should be continuously 
evaluating measures and improvement activities especially as the MIPS 
program progresses and requirements become more stringent.
    Response: We refer readers to subsection ``(iii) Future Steps'' 
below where we discuss our plans to make the study results and 
recommendations available to the public. We also plan to continue to 
pursue ways to improve outcomes, reduce burden in the collection and 
reporting of clinician quality measures, and enhance clinical care. We 
continue to utilize the Blueprint for the CMS Measures Management 
System and stakeholder input to continuously maintain and improve our 
measures to meet the requirements and standards of MIPS.
    After consideration of the comments, we are finalizing our 
proposal, as proposed, to conclude this study at the end of the CY 2019 
performance period and to remove the study and the incentive provided 
towards the improvement activity performance category beginning with 
the 2020 performance period under removal factor 7.
(iii) Future Steps
    After completing this data collection phase, we next plan to 
analyze the data gathered (which include lessons learned) and to make 
recommendations to improve outcomes, reduce burden, and enhance 
clinical care. We plan to finish the final data analysis by spring 
2020. This analysis would contain all the study years. It would show 
the trends and associations of all the factors we examined. It would 
also show the lessons learned by study participants over the 3 years of 
the study. At the conclusion of this study and after analysis of the 
results, we plan to shift our focus to implementation of 
recommendations. We intend for this to include feedback to clinicians 
and stakeholders and educational and outreach work. We plan to 
undertake education and outreach to the public. We would also include 
the results in other Quality Payment Program educational materials such 
as webinars.
(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. In prior rulemaking, we referred to this 
performance category as the Advancing Care Information performance 
category, and it was reported by MIPS eligible clinicians as part of 
the overall MIPS program. In 2018, we renamed the Advancing Care 
Information performance category as the Promoting Interoperability 
performance category (83 FR 35912). 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.
    For the Promoting Interoperability performance category, our 
proposals included (84 FR 40766 through 84 FR 40784): (1) For the 2023 
MIPS payment year, establishing a performance period of a minimum of a 
continuous 90-day period within CY 2021, up to and including the full 
calendar year; (2) making the Query of Prescription Drug Monitoring 
Program (PDMP) measure optional in CY 2020, and in the event we 
finalize this proposal, making the e-Prescribing measure worth up to 10 
points in CY 2020; (3) removing the numerator and denominator for the 
Query of PDMP measure and instead requiring a ``yes/no'' response 
beginning in CY 2019; (4) removing the Verify Opioid Treatment 
Agreement measure beginning in CY 2020; (5) redistributing the points 
for the Support Electronic Referral Loops by Sending Health Information 
measure to the Provide Patients Access to Their Health Information 
measure if an exclusion is claimed, beginning in CY 2019; (6) revising 
the description of the Support Electronic Referral Loops by Receiving 
and Incorporating Health Information measure exclusion to more clearly 
and precisely capture our intended policy, beginning in CY 2019; (7) 
continuing the existing policy of reweighting the Promoting 
Interoperability performance category for certain types of nonphysician 
practitioner (NPP) MIPS eligible clinicians for the performance period 
in 2020; and (8) proposals related to hospital-based MIPS eligible 
clinicians and non-patient facing MIPS eligible clinicians in groups.
(b) Goals of Changes to the Promoting Interoperability Performance 
Category
    As we look toward the future of the Promoting Interoperability 
performance category, the general goals of the policies that we are 
adopting in this final rule center on: (1) A priority of stability 
within the performance category after the recent changes made in the CY 
2019 PFS final rule (83 FR 59785 through 59820) while continuing to 
further interoperability through the use of CEHRT; (2) reducing 
administrative burden; (3) continued use of 2015 Edition CEHRT; (4) 
improving patient access to their health

[[Page 62992]]

information so they can make fully informed health care decisions; and 
(5) continued alignment with the Medicare Promoting Interoperability 
Program for eligible hospitals and CAHs, where appropriate.
(c) Promoting Interoperability Performance Category Performance Period
    As finalized in the CY 2019 PFS final rule at Sec.  414.1320(e)(1) 
(83 FR 59745 through 59747), for purposes of the 2022 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 
2022 MIPS payment year, the performance period for the Promoting 
Interoperability performance category is a minimum of a continuous 90-
day period within CY 2020, up to and including the full CY 2020 
(January 1, 2020 through December 31, 2020).
    For the 2023 MIPS payment year, we proposed to add Sec.  
414.1320(f)(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 (CY 2021) (84 FR 40766). This proposal aligned with the 
proposed EHR reporting period in CY 2021 for the Medicare Promoting 
Interoperability Program for eligible hospitals and CAHs (84 FR 19554 
through 19555). We stated that we believe this would be an appropriate 
performance period because of the maturation needed within the 
performance category, including the changes to measures and other 
changes being proposed in this rule. In addition, it would offer 
stability and continuity for the Promoting Interoperability performance 
category after the performance category overhaul that was finalized in 
the CY 2019 PFS final rule (83 FR 59785 through 59820).
    We requested public comments on this proposal, and the following is 
a summary of the comments we received and our responses.
    Comment: Many commenters supported the minimum of a continuous 90-
day performance period that occurs 2 years prior to the applicable MIPS 
payment year. Commenters stated that the proposed performance period 
would allow MIPS eligible clinicians to adequately plan for any system 
updates and that it reduces administrative and regulatory burden. 
Several commenters also expressed their appreciation toward CMS for its 
efforts, including the proposed 90-day performance period, to help 
stabilize the Promoting Interoperability performance category.
    Response: We agree that keeping the performance period to a minimum 
of 90 consecutive days affords MIPS eligible clinicians the flexibility 
they may need to develop and update their evolving EHRs.
    Comment: Some commenters suggested that CMS should make the minimum 
90-day performance period permanent, as opposed to what CMS has done 
over the past several years, which is to propose the minimum 90-day 
performance period each year.
    Response: We thank the commenter for the suggestion, and we may 
take this into consideration for future rulemaking. We are still in the 
initial years of implementing the Promoting Interoperability 
performance category after our overhaul and we believe it is important 
to maintain flexibility as we gain experience so that we can evaluate 
and determine whether adjustments are needed.
    Comment: One commenter asked if the proposed performance period 
would require reporting on all patients during the 90-day period, or if 
this is an option being added within the full calendar year.
    Response: For the 2023 MIPS payment year, a MIPS eligible clinician 
would have to select and report data for patients from any continuous 
90-day period, at a minimum, within CY 2021. The MIPS eligible 
clinician may choose to report data from a period longer than 90 
consecutive days, up to and including the full CY 2021.
    After consideration of the public comments we received, for the 
2023 MIPS payment year, we are finalizing the proposal to add Sec.  
414.1320(f)(1) and 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 (CY 2021).
(d) Promoting Interoperability Performance Category Measures for MIPS 
Eligible Clinicians
(i) Changes to Measures for the e-Prescribing Objective
(A) Background
    Beginning with the performance period in CY 2019, we adopted two 
new measures for the e-Prescribing objective that are based on 
electronic prescriptions for controlled substances: (1) Query of 
Prescription Drug Monitoring Program (PDMP) (83 FR 59800 through 
59803); and (2) Verify Opioid Treatment Agreement (83 FR 59803 through 
59806). During the comment period for the CY 2019 PFS proposed rule (83 
FR 35921 through 35925), we received extensive comments from 
stakeholders regarding the Query of PDMP measure and the Verify Opioid 
Treatment Agreement measure. While this feedback was the main catalyst 
for our proposals, we noted in the CY 2020 PFS proposed rule (84 FR 
40766 through 40769) that there have also been significant legislative 
changes that have the potential to positively impact the Promoting 
Interoperability performance category, specifically the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for 
Patients and Communities Act (SUPPORT Act) (Pub. L. 115-271, enacted 
October 24, 2018). While this legislation was not the main reason for 
our proposals, we stated that we believe it may significantly affect 
the maturation, requirements, and use of PDMPs and state networks upon 
which the Query of PDMP measure is dependent.
(B) Query of Prescription Drug Monitoring Program (PDMP) Measure
    As discussed in the CY 2020 PFS proposed rule (84 FR 40766 through 
40769), we proposed to make the Query of PDMP measure optional and 
eligible for 5 bonus points for the e-Prescribing objective in CY 2020. 
Making the measure optional in CY 2020 would allow time for further 
integration of PDMPs and EHRs to minimize the burden on MIPS eligible 
clinicians reporting this measure while still giving clinicians an 
opportunity to report on and earn points for the measure. We proposed 
that, in the event we finalize this proposal for the Query of PDMP 
measure, the e-Prescribing measure would be worth up to 10 points in CY 
2020.
    In addition, beginning with the CY 2019 performance period, we 
proposed to remove the numerator and denominator established for the 
Query of PDMP measure in the CY 2019 PFS final rule (83 FR 59800 
through 59803), and instead require a ``yes/no'' attestation response. 
A ``yes'' response would indicate that for at least one Schedule II 
opioid electronically prescribed using CEHRT during the performance 
period, the MIPS eligible clinician then used data from CEHRT to 
conduct a query of a PDMP for prescription drug history, except where 
prohibited and in accordance with applicable law.

[[Page 62993]]

    We invited public comments on these proposals, and the following is 
a summary of the comments we received and our responses.
    Comment: A majority of commenters supported the proposed changes to 
the Query of PDMP measure and agreed with the measure remaining 
optional in CY 2020. One commenter further recommended that in the 
future, regardless of whether the measure is optional or required, HHS' 
Office of the National Coordinator for Health Information Technology 
(ONC) should consider adopting new certification criteria requiring 
EHRs to integrate with PDMPs. Commenters also agreed with changing the 
measure to a ``yes/no'' attestation response rather than reporting a 
numerator and denominator. Commenters indicated that these changes 
would reduce unnecessary burden, as developing custom reports can often 
be time-consuming and inaccurate.
    Response: We believe this proposal would help reduce overall 
clinician burden by eliminating the need for clinicians to manually 
track the number of times that they query a PDMP outside of CEHRT 
functionality. We recognize there is currently limited standardization 
of interfaces between CEHRT technology and PDMPs, and we will continue 
to collaborate with ONC to explore how the ONC certification program 
could support PDMP-EHR integration in the future. We note that PDMP-EHR 
integration may refer to varying approaches for the access and viewing 
of PDMP data from an EHR and is used to refer, as well to the 
incorporation of the PDMP data into the EHR record. For more 
information on relevant standards we refer readers to the ONC 
Interoperability Standards Advisory (see https://www.healthit.gov/isa/allows-a-prescriber-request-a-patients-medication-history-a-state-prescription-drug-monitoring and https://www.healthit.gov/isa/allows-exchange-state-prescription-drug-monitoring-program-pdmp-data).
    Comment: One commenter stated that in the CY 2020 PFS proposed rule 
(84 FR 40771 through 40775) Table 41: Objectives and Measures for the 
Promoting Interoperability Performance Category in 2020, there is no 
exclusion information for the Query of PDMP measure and sought 
clarification on whether the Query of PDMP measure offers any 
exclusions. More specifically, given that some clinicians do not 
prescribe Schedule II controlled substances, how should they respond if 
the measure would require a ``yes/no'' response?
    Response: As stated in the CY 2019 PFS proposed rule period (83 FR 
59800 through 59803), we did not provide exclusions for the Query of 
PDMP measure as it was optional and eligible for bonus points. We still 
do not believe that exclusions would be necessary for the Query of PDMP 
measure if it is to remain optional and eligible for bonus points in CY 
2020. Eligible clinicians who choose not to report on the optional 
measure may still earn a score for the Promoting Interoperability 
performance category.
    Comment: One commenter stated that they believe the Query of PDMP 
measure should not be optional given that they have been able to 
successfully standardize queries into their patient-centered clinical 
programs. While they agree that challenges and variations between 
states are real, their opinion is that it is not insurmountable and 
that maintaining strong PDMP incentives would help drive much needed 
improvements.
    Response: We appreciate the commenter's effort to operationalize 
this measure into their workflow; however, the majority of stakeholder 
feedback that implementing and calculating this measure can impose 
significant burden on clinicians and should not be a required measure. 
In addition, we received substantial feedback from commenters, health 
IT vendors, and specialty societies that the flexibility within the 
numerator and denominator calculations finalized in the CY 2019 PFS 
final rule (83 FR 59800 through 59803) presents unintended challenges, 
such as the significant burden associated with IT system design and 
development needed to accommodate the measure and any future changes to 
it.
    Comment: One commenter questioned whether the query of the PDMP 
must be performed by the same eligible clinician or health care 
professional who prescribes the Schedule II opioid.
    Response: We do not require the query of the PDMP be performed by 
the same eligible clinician who prescribes the Schedule II opioid. We 
believe that MIPS eligible clinicians should determine what is most 
appropriate, in accordance with applicable law, for the medical staff 
involved in performing the queries based on their own standard 
operating procedures, guidelines, and preferences.
    Comment: One commenter shared concerns that a ``yes/no'' optional 
measure may diminish overall reporting, thus undermining an essential 
component in addressing the current opioid epidemic.
    Response: We understand such concerns and appreciate the feedback. 
However, specifically regarding the Query of PDMP measure, we believe 
it is premature for this activity to be assessed with a numerator/
denominator as part of a performance-based measure. At the present 
time, with limited use of consistent standards-based approaches to 
supporting the integration between CEHRT and state PDMPs, this 
contributes to MIPS eligible clinicians having to manually track each 
individual query. Considering the added burden that doing so creates, 
we believe a ``yes/no'' response is more appropriate.
    Comment: Some commenters expressed concerns with the PDMP measure 
due to varying privacy or security protocols in place, as well as other 
related aspects lacking uniformity in the implementation of independent 
PDMPs across state lines. Given that there are limited formalized, 
standard criteria for PDMP functionality, commenters stated that the 
measure is still not ready for mandatory inclusion in the Promoting 
Interoperability performance category. Another commenter recommended 
that the PDMP measure be considered optional for reporting in CY 2021 
as well.
    Response: We understand that PDMP systems are composed of various 
processes and components that vary significantly across state lines, 
and that in any given state the PDMP system may include a variety of 
state-developed and vendor-based solutions along with the core PDMP 
database. State laws and policies also differ on data storage, use, 
access roles, disclosures, and key definitions. The degree of PDMP and 
health IT access integration (how the provider can access the PMDP) may 
vary significantly across states, as well as within states by product 
or health system. Today, it is our understanding that most PDMP systems 
allow a provider ``view only'' access to PDMP data rather than allowing 
for the seamless integration of discrete data from the PDMP system into 
a patient's record.
    The SUPPORT Act includes new requirements and federal funding for 
PDMP enhancement, integration, and interoperability, and establishes 
mandatory use of PDMPs by certain Medicaid providers. We are 
continuously working with various stakeholders and ONC to evaluate the 
implementation of the SUPPORT Act, as well as its related progress 
around furthering PDMP-EHR integration.
    We proposed to change the measure to optional in CY 2020 to account 
for readiness concerns such as those raised

[[Page 62994]]

by stakeholders. We are dedicated to alleviating the concerns as we 
work to further develop the measure. We have not made a proposal with 
regard to the measure's status for CY 2021.
    After consideration of the public comments we received, we are 
finalizing the proposal to make the Query of PDMP measure optional and 
eligible for 5 bonus points for the Electronic Prescribing objective in 
CY 2020. Given that we are finalizing this proposal for the Query of 
PDMP measure, we are also finalizing the proposal that the e-
Prescribing measure will be worth up to 10 points in CY 2020. Lastly, 
we are finalizing the proposal to remove the numerator and denominator 
previously established for the Query of PDMP measure in the CY 2019 PFS 
final rule (83 FR 59800 through 59803) and instead require a ``yes/no'' 
response beginning with the 2019 performance period.
    We will continue to work to improve EHR integration with PDMPs as 
we believe that making the Query of PDMP measure optional for the long-
term would be inconsistent with the recommendations of the President's 
Opioid Commission (https://www.whitehouse.gov/wp-content/uploads/2019/05/Opioid-Commission-Report-One-Year-Later-20190507.pdf). We may 
propose modifications to this measure in future rulemaking.
(B) Verify Opioid Treatment Agreement Measure
    In the CY 2019 PFS final rule (83 FR 59803 through 59806), we 
finalized the Verify Opioid Treatment Agreement measure as optional in 
both CYs 2019 and 2020. Since we proposed this measure, we have heard 
from stakeholders that this measure has presented significant 
implementation challenges and an increase in burden, and does not 
further interoperability. Stakeholders have indicated that the measure 
is vague, burdensome to measure, and does not necessarily offer high 
clinical value to health care providers or support the clinical goal of 
supporting OUD treatment. For the reasons discussed in the proposed 
rule (84 FR 40769), we proposed to remove the Verify Opioid Treatment 
Agreement measure from the Promoting Interoperability performance 
category beginning with the performance period in CY 2020.
    We invited public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: The majority of commenters were in general agreement with 
removing the Verify Opioid Treatment Agreement measure. Several 
commenters stated that if the measure were to remain, it would result 
in increased provider burden and decreased interoperability. One 
commenter supported removing the measure at least until treatment 
agreement standards themselves are addressed, clarified, and adequately 
piloted by CMS or ONC. Other commenters further stated their belief 
that this measure lacks standards defining specific data points and 
structure to be included in a treatment agreement. One commenter who 
supported the measure's removal indicated that the decision over 
whether to use opioid treatment agreements (as part of the physician-
patient treatment relationship) should be left solely to the clinical 
judgment of individual attending physicians.
    Response: While we agree that while addressing OUD prevention and 
treatment is essential, we believe that the Verify Opioid Treatment 
Agreement measure presents significant implementation challenges, leads 
to increases in burden, and does not promote interoperability. We 
appreciate the commenter's suggestion of conducting a pilot of 
treatment agreement standards and we may consider this in the future. 
We appreciate the suggestions on how to enhance and improve such a 
measure as we continue to combat the opioid crisis. We do acknowledge 
that there is not consensus regarding whether opioid treatment 
agreements should be required and whether they should be considered a 
potential component of the physician-patient treatment relationship.
    Comment: A few commenters requested that the measure remain 
optional for CY 2020 instead of being removed. They suggested this 
would provide the measure extra time for new, clarifying guidance to be 
formulated in regards to the measure's future expectations. An 
additional commenter similarly requested confirmation on whether the 
measure's scoring component would remain a numerator/denominator 
calculation or if it would be changed to a ``yes/no'' attestation 
response.
    Response: We appreciate the concerns and suggestions addressed by 
the commenters who believe the Verify Opioid Treatment Agreement 
measure should remain optional in CY 2020. However, we disagree that 
the Verify Opioid Treatment Agreement measure should remain an optional 
measure with bonus points through CY 2020 given the strong provider 
community feedback, including reasons noted in this section such as the 
lack of standards or concrete program-wide definitions. While a 
commenter requested changing the measure to a yes/no attestation for CY 
2019, we have decided that the measure will remain an optional, 
numerator/denominator-based measure in CY 2019 only.
    Comment: Some commenters agreed that an opioid-specific measure is 
important in addressing the current epidemic, but stated that the 
Verify Opioid Treatment Agreement measure should be removed while 
simultaneously encouraging innovation through a future collaborative 
measure development process. The commenters indicated that this measure 
is burdensome and vague, presenting significant implementation 
challenges as it is easily subject to misinterpretation until clear 
certification requirements are formally established.
    Response: We agree with the commenters who stated that the measure 
is vague which causes implementation challenges. Additionally, the lack 
of certification criteria and standards may result different 
interpretations by vendors which may limit interoperability. We 
appreciate the support in the removal of this measure.
    After consideration of the public comments we received, we are 
finalizing the proposal to remove the Verify Opioid Treatment Agreement 
measure from the Promoting Interoperability performance category 
beginning with the performance period in CY 2020.
(ii) Health Information Exchange Objective
(A) Modification of the Support Electronic Referral Loops by Sending 
Health Information Measure
    In the CY 2019 PFS final rule (83 FR 59807 through 59808), we 
renamed the Send a Summary of Care measure to the Support Electronic 
Referral Loops by Sending Health Information measure. Although an 
exclusion is available for this measure (83 FR 59808), we acknowledged 
that we did not address in the CY 2019 PFS proposed rule how the points 
for the measure would be redistributed in the event that an exclusion 
is claimed, and stated that we intended to propose a redistribution 
policy in this year's rulemaking (83 FR 59795). Accordingly, in the CY 
2020 PFS proposed rule, we proposed to redistribute the 20 points 
associated with the Support Electronic Referral Loops by Sending Health 
Information measure to the Provide Patients

[[Page 62995]]

Electronic Access to Their Health Information measure if an exclusion 
is claimed (84 FR 40770). We further stated in the proposed rule that 
if exclusions are claimed for both the Support Electronic Referral 
Loops by Receiving and Incorporating Health Information measure and the 
Support Electronic Referral Loops by Sending Health Information 
measure, the combined 40 points associated with both measures would be 
redistributed to the Provide Patients Electronic Access to Their Health 
Information measure. Lastly, we proposed that this redistribution 
policy would be applicable starting with the 2019 performance period/
2021 MIPS payment year.
    We received public comments on our proposals and the following is a 
summary of the comments we received and our responses.
    Comment: A majority of commenters fully supported our proposals for 
point redistribution when an exclusion is claimed for one or both of 
these measures.
    Response: We appreciate the overwhelming support and agree that our 
proposed approach to point redistribution is appropriate.
    Comment: One commenter did not fully agree with redistributing all 
40 points from both measures to the Provide Patients Electronic Access 
to Their Health Information measure. The commenter stated that this 
would place too much weight on a measure that has been required for 
years.
    Response: We believe that many MIPS eligible clinicians may be 
eligible to claim exclusions for both the Support Electronic Referral 
Loops by Receiving and Incorporating Health Information measure and the 
Support Electronic Referral Loops by Sending Health Information 
measure. With this, we have chosen to redistribute the points to the 
Provide Patients Electronic Access to their Health Information measure. 
We believe that the emphasis placed on the Provide Patients Electronic 
Access to their Health Information measure through the redistribution 
of points reflects our emphasis on patient engagement in their health 
care and patient's electronic access of their health information 
through the use of APIs.
    Comment: One commenter did not support this proposal stating that 
this redistribution pattern could provide an unfair advantage to 
smaller organizations that claim the exclusion, leading to overall 
skewed scoring.
    Response: We disagree, and believe redistributing the points to the 
Provide Patients Electronic Access to their Health Information measure 
emphasizes improved electronic access to patient health information and 
allows for health IT solutions that encourage adoption and innovation 
in the use of CEHRT.
    After consideration of the public comments we received, we are 
finalizing the proposal to redistribute the 20 points associated with 
the Support Electronic Referral Loops by Sending Health Information 
measure to the Provide Patients Electronic Access to Their Health 
Information measure if an exclusion is claimed. Furthermore, if 
exclusions are claimed for both the Support Electronic Referral Loops 
by Receiving and Incorporating Health Information measure and the 
Support Electronic Referral Loops by Sending Health Information 
measure, the combined 40 points associated with both measures will be 
redistributed to the Provide Patients Electronic Access to Their Health 
Information measure. Lastly, we are finalizing the proposal that this 
redistribution policy is applicable starting with the 2019 performance 
period/2021 MIPS payment year.
(B) Modification of the Support Electronic Referral Loops by Receiving 
and Incorporating Health Information Measure
    In the CY 2019 PFS final rule (83 FR 59808 through 59812), we 
replaced the Request/Accept Summary of Care measure and the Clinical 
Information Reconciliation measure with a new measure called the 
Support Electronic Referral Loops by Receiving and Incorporating Health 
Information measure. Additionally, we established the following 
exclusion for the new measure at that time: Any MIPS eligible clinician 
who receives fewer than 100 transitions of care or referrals or has 
fewer than 100 encounters with patients never before encountered during 
the performance period would be excluded from this measure (83 FR 
59812). In the CY 2020 PFS proposed rule (84 FR 40770), we proposed to 
revise the description of this exclusion to more clearly and precisely 
capture our intended policy, to reads as follows: Any MIPS eligible 
clinician who receives transitions of care or referrals or has patient 
encounters in which the MIPS eligible clinician has never before 
encountered the patient fewer than 100 times during the performance 
period. We proposed that the revised description of the exclusion would 
be applicable beginning with the 2019 performance period/2021 MIPS 
payment year.
    We received public comments on our proposal and the following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal to revise the 
description of the exclusion, stating that the original verbiage was 
difficult to interpret.
    Response: We agree with the commenters that revising the 
description of this exclusion would help to reduce any potential 
confusion or misinterpretation.
    Comment: Many commenters did not support the proposal to revise the 
description of the exclusion, stating that it would be more difficult 
to meet the exclusion criteria than under the previously established 
language.
    Response: We appreciate the commenters' feedback and respectfully 
disagree. As we noted in the PFS proposed rule (84 FR 40770), the 
description of the exclusion that we included in the CY 2019 PFS final 
rule (83 FR 59812) could be construed in a way that would make the 
exclusion more difficult for a MIPS eligible clinician to meet. 
Specifically, it could be read to create two different sets of 
exclusion criteria, which was not our intention. Our proposal simply 
reflects our intention to retain the same exclusion from the Request/
Accept Summary of Care measure.
    Comment: Several commenters did not support the proposal to revise 
the description of the exclusion, stating that eligible clinicians who 
do not receive a summary of care are unable to report on the measure, 
thereby receiving a denominator of zero, by no fault of their own.
    Response: We appreciate the comments and concerns submitted by the 
commenters. If a clinician does not receive any summaries of care, the 
clinician may be eligible to claim the exclusion. If the exclusion is 
not applicable, the clinician must submit a numerator of at least one 
to fulfill the measure.
    After consideration of the public comments we received, we are 
finalizing the proposal to revise the description of the exclusion for 
the Support Electronic Referral Loops by Receiving and Incorporating 
Health Information measure, as follows: Any MIPS eligible clinician who 
receives transitions of care or referrals or has patient encounters in 
which the MIPS eligible clinician has never before encountered the 
patient fewer than 100 times during the performance period. We are also 
finalizing the proposal that the revised description of the exclusion 
will be applicable starting with the 2019 performance period/2021 MIPS 
payment year.

[[Page 62996]]

(iii) Public Health and Clinical Data Exchange--Syndromic Surveillance 
Reporting
    In the CY 2018 Quality Payment Program final rule (82 FR 53674), we 
established the measure description for the Syndromic Surveillance 
Reporting measure as follows: ``The MIPS eligible clinician is in 
active engagement with a public health agency to submit syndromic 
surveillance data from an urgent care setting.'' However, in the CY 
2019 PFS final rule (83 FR 59798), we inadvertently stated that the 
measure description was as follows: ``The MIPS eligible clinician is in 
active engagement with a public health agency to submit syndromic 
surveillance data from a non-urgent care setting'' (emphasis added). We 
did not intend to replace ``urgent care'' with ``non-urgent care'' in 
the measure description, and we regret any confusion our typographical 
error may have caused. To alleviate any future confusion surrounding 
the description, we are restating the measure description for the 
Syndromic Surveillance Reporting measure here and in the table below as 
follows: ``The MIPS eligible clinician is in active engagement with a 
public health agency to submit syndromic surveillance data from an 
urgent care setting''.
    For ease of reference, Table 48 lists the objectives and measures 
for the Promoting Interoperability performance category for the 2020 
performance period as revised to reflect the final policies established 
in this final rule. For more information on the 2015 Edition 
certification criteria required to meet the objectives and measures, we 
refer readers to Table 43 in the CY 2019 PFS final rule (83 FR 59817).
BILLING CODE 4120-01-P

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Vol. 84

Friday,

No. 221

November 15, 2019

Part II--Continued

Book 2 of 2 Books

Pages 62997-63564





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 403, 409, 410, et al.



Medicare Program; CY 2020 Revisions to 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; 
Establishment of an Ambulance Data Collection System; Updates to the 
Quality Payment Program; Medicare Enrollment of Opioid Treatment 
Programs and Enhancements to Provider Enrollment Regulations Concerning 
Improper Prescribing and Patient Harm; and Amendments to Physician 
Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding 
and Payment for Evaluation and Management, Observation and Provision of 
Self-Administered Esketamine; Final and Interim Final Rules

  Federal Register / Vol. 84 , No. 221 / Friday, November 15, 2019 / 
Rules and Regulations  

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BILLING CODE 4120-01-C
(e) Scoring Methodology
(i) Changes to the Scoring Methodology for the 2020 Performance Period
    In the CY 2019 PFS final rule (83 FR 59785 through 59796), we 
finalized a new performance-based scoring methodology for the Promoting 
Interoperability performance category beginning with the performance 
period in 2019. As previously discussed in section III.K.3.c.(4)(d)(i) 
of this final rule, we are finalizing our proposals for CY 2020 to: (1) 
Make the Query of PDMP measure optional and eligible for five bonus 
points in CY 2020; (2) make the e-Prescribing measure worth up to 10 
points in CY 2020, and (3) remove the Verify Opioid Treatment Agreement 
measure beginning in CY 2020. Table 49 reflects the proposals that we 
are finalizing, although the maximum points available do not include 
points that would be redistributed in the event that an exclusion is 
claimed.

[[Page 63003]]

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(f) Additional Considerations
(i) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    In prior 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, 
2018, and 2019 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. We stated our intention to use data from the 
first performance period (2017) to further evaluate the participation 
of these MIPS eligible clinicians in the 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. While 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 example, 
when a group of MIPS eligible clinicians chooses to report for MIPS as 
a group, the data submitted are representative of that entire group, as 
opposed to each individual MIPS eligible clinician in the group 
submitting data that exclusively reflect his/her own performance. 
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. Additionally, we are challenged because many of 
the measures that were available for submission for the 2017 
performance period are now unavailable, due to our discontinuation of 
the Promoting Interoperability transition measure set, and the overhaul 
of the performance category that further reduced the number of 
available measures. For these reasons, we were unable to determine, at 
the time we were developing the CY 2020 PFS proposed rule, whether the 
measures currently specified for the Promoting Interoperability 
performance category for the 2020 performance period are applicable and 
available for NPs, PAs, CRNAs, and CNSs. However, as more data become 
available, we plan to reevaluate the measures and consider how we could 
ensure that there are sufficient measures applicable and available for 
these types of MIPS eligible clinicians.
    Therefore, we proposed to continue the existing policy of 
reweighting the Promoting Interoperability performance category for 
NPs, PAs, CRNAs, and CNSs for the performance period in 2020, and to 
revise Sec.  414.1380(c)(2)(i)(A)(5) to reflect this proposal.
    We received public comments on our proposals and the following is a 
summary of the comments we received and our responses.
    Comment: The majority of commenters supported our proposal to 
continue to reweight the Promoting Interoperability performance 
category for NPs, PAs, CRNAs, and CNSs for the performance period in 
2020.
    Response: We agree that reweighting the Promoting Interoperability 
performance category for NPs, PAs, CRNAs, and CNSs for CY 2020 is 
appropriate. We hope that in the future more of these clinician types 
will be utilizing CEHRT and will be able to submit data for this 
performance category.
    After consideration of the comments, we are finalizing our proposal 
to

[[Page 63004]]

continue the existing policy of reweighting the Promoting 
Interoperability performance category for NPs, PAs, CRNAs, and CNSs for 
the performance period in 2020, and to revise Sec.  
414.1380(c)(2)(i)(A)(5) to reflect this policy.
(ii) Physical Therapists, Occupational Therapists, Qualified Speech-
Language Pathologist, Qualified Audiologists, Clinical Psychologists, 
and Registered Dieticians or Nutrition Professionals
    In the CY 2019 PFS final rule (83 FR 59819 through 59820), we 
adopted a policy at Sec.  414.1380(c)(2)(i)(A)(4) to apply the same 
automatic reweighting policy we adopted for NPs, PAs, CNSs, and CRNAs 
for the performance periods in 2017 through 2019 to these new types of 
MIPS eligible clinicians (physical therapists, occupational therapists, 
qualified speech-language pathologist, qualified audiologists, clinical 
psychologists, and registered dieticians or nutrition professionals) 
for the performance period in 2019. Because many of these clinician 
types were or are not eligible to participate in the Medicare or 
Medicaid Promoting Interoperability Programs, 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 III.K.3.c.(4)(f)(i) of the CY 
2020 PFS proposed rule (84 FR 40776), for the performance period in 
2020, we proposed to continue the existing policy of reweighting the 
Promoting Interoperability performance category for physical 
therapists, occupational therapists, qualified speech-language 
pathologist, qualified audiologists, clinical psychologists, and 
registered dieticians or nutrition professionals, and to revise Sec.  
414.1380(c)(2)(i)(A)(4) to reflect this proposal. We invited comments 
on this proposal.
    We received public comments on our proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters supported CMS' reweighting of the 
Promoting Interoperability performance category for physical 
therapists, occupational therapists, qualified speech-language 
pathologists, qualified audiologists, clinical psychologists, and 
registered dieticians or nutrition professionals.
    Response: We appreciate the support for our proposal.
    Comment: Several commenters expressed their concerns about there 
not being appropriate measures in place to accommodate the practices of 
NPPs.
    Response: Currently, the data from physical therapists, 
occupational therapists, qualified speech-language pathologists, 
qualified audiologists, clinical psychologists, and registered 
dieticians or nutrition professionals is too limited to support the 
addition of measures that are tailored to the specific practices of 
NPPs. However, we encourage stakeholders to submit their ideas and 
suggestions to us during our annual call for measures.
    Comment: One commenter suggested adding chiropractic clinicians to 
the automatic reweighting of the Promoting Interoperability performance 
category that is currently available for physical therapists, 
occupational therapists, and qualified speech-language pathologists, 
until additional meaningful measures are available.
    Response: We thank the commenter for the suggestion. However, 
chiropractors were eligible professionals under section 1848(o)(5)(C) 
of the Act, and thus were eligible to participate in the Medicare EHR 
Incentive Program, unlike the types of NPPs mentioned by the commenter. 
The same rationale for reweighting the Promoting Interoperability 
performance category does not apply to chiropractors.
    After consideration of the comments, we are finalizing the proposal 
to continue the existing policy of reweighting the Promoting 
Interoperability performance category for physical therapists, 
occupational therapists, qualified speech-language pathologist, 
qualified audiologists, clinical psychologists, and registered 
dieticians or nutrition professionals, and to revise Sec.  
414.1380(c)(2)(i)(A)(4) to reflect this policy.
(iii) Hospital-Based MIPS Eligible Clinicians in Groups
    We define a hospital-based MIPS eligible clinician under Sec.  
414.1305 as a MIPS eligible clinician who furnishes 75 percent or more 
of his or her covered professional services in sites of services 
identified by the Place of Service (POS) codes used in the HIPAA 
standard transaction as an inpatient hospital (POS 21), on campus 
outpatient hospital (POS 22), off campus outpatient hospital (POS 19), 
or emergency room (POS 23) setting, based on claims for the MIPS 
determination period (81 FR 77238 through 77240, 82 FR 53686 through 
53687, 83 FR 59727 through 59730). We established under Sec.  
414.1380(c)(2)(i)(C)(6) that a MIPS eligible clinician who is a 
hospital-based MIPS eligible clinician as defined in Sec.  414.1305 
will be assigned a zero percent weight for the Promoting 
Interoperability performance category, and the points associated with 
the Promoting Interoperability performance category will be 
redistributed to another performance category or categories (81 FR 
77238 through 77240, 82 FR 53684, 83 FR 59871). However, if a hospital-
based MIPS eligible clinician chooses to report on the Promoting 
Interoperability performance category measures, 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 regardless of 
their Promoting Interoperability performance category score. We stated 
that this policy includes MIPS eligible clinicians choosing to report 
as part of a group or part of a virtual group (82 FR 53687).
    Under Sec.  414.1310(e)(2)(ii), individual eligible clinicians that 
elect to participate in MIPS as a group must aggregate their 
performance data across the group's TIN (81 FR 77058). For groups 
reporting on the Promoting Interoperability performance category, we 
stated that group data should be aggregated for all MIPS eligible 
clinicians within the group (81 FR 77214 through 77216, 82 FR 53687). 
We stated that this includes those MIPS eligible clinicians who may 
qualify for a zero percent weighting of the Promoting Interoperability 
performance category due to circumstances such as a significant 
hardship or other type of exception, hospital-based or ASC-based 
status, or certain types of NPPs (82 FR 53687). We established at Sec.  
414.1380(c)(2)(iii) that for MIPS eligible clinicians submitting data 
as a group or virtual group, in order for the Promoting 
Interoperability performance category to be reweighted, all of the MIPS 
eligible clinicians in the group or virtual group must qualify for 
reweighting (82 FR 53687, 83 FR 59871). We have heard from several 
stakeholders that our policy for groups that include hospital-based 
MIPS eligible clinicians sets a threshold that is too restrictive for a 
variety of reasons. Some stated that due to high turnover rates for 
hospital medicine groups, many such groups rely on locum tenens 
clinicians who may practice in multiple settings. They stated that if a 
hospital medicine group includes only one MIPS eligible clinician who 
does not meet the definition of a hospital-based MIPS eligible 
clinician, it could prevent the group from qualifying for reweighting 
because not all of the MIPS eligible clinicians in the group would be 
considered hospital-based. A few acknowledged that while hardship

[[Page 63005]]

exceptions are available for MIPS eligible clinicians who lack control 
over CEHRT because they use the hospital's CEHRT, it is an 
administrative burden to have to submit a hardship exception 
application, especially if the clinician has a locum tenens 
relationship.
    In the CY 2020 PFS proposed rule (84 FR 40776 through 40777), we 
stated our belief that hospital medicine groups may face unique 
circumstances due to the nature of their practice area and the staffing 
practices described by stakeholders. Thus, we proposed to revise the 
definition of a hospital-based MIPS eligible clinician under Sec.  
414.1305 to include groups and virtual groups. We proposed that, 
beginning with the 2022 MIPS payment year, a hospital-based MIPS 
eligible clinician under Sec.  414.1305 means an individual MIPS 
eligible clinician who furnishes 75 percent or more of his or her 
covered professional services in sites of service identified by the POS 
codes used in the HIPAA standard transaction as an inpatient hospital, 
on-campus outpatient hospital, off campus outpatient hospital, or 
emergency room setting based on claims for the MIPS determination 
period, and a group or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or virtual group's TINs, as 
applicable, meet the definition of a hospital-based individual MIPS 
eligible clinician during the MIPS determination period.
    We stated that we believe that a threshold of more than 75 percent 
is appropriate because it is consistent with the thresholds for groups 
in the definitions of facility-based MIPS eligible clinician and non-
patient facing MIPS eligible clinician under Sec.  414.1305. We 
proposed to revise Sec.  414.1380(c)(2)(iii) to specify that for the 
Promoting Interoperability performance category to be reweighted for a 
MIPS eligible clinician who elects to participate in MIPS as part of a 
group or virtual group, all of the MIPS eligible clinicians in the 
group or virtual group must qualify for reweighting, or the group or 
virtual group must meet the proposed revised definition of a hospital-
based MIPS eligible clinician (or the definition of a non-patient 
facing MIPS eligible clinician in Sec.  414.1305, as proposed in 
section III.K.3.c.(4)(f)(iv) of the proposed rule (84 FR 40777).
    The following is a summary of the public comments we received and 
our responses.
    Comment: Commenters appreciated our proposal to lower the 
percentage of MIPS eligible clinicians that need to be considered 
hospital-based for a group or virtual group to be considered hospital-
based. Commenters stated that a threshold of 100 percent was very 
difficult to achieve and a threshold of more than 75 percent is much 
more achievable. Some commenters stated that a threshold of more than 
75 percent is reasonable and aligns with the threshold that CMS uses in 
the facility-based measurement approach in the MIPS cost and quality 
performance categories. Others believed that the proposed change will 
increase flexibility for clinicians practicing in a hospital setting. 
Another commenter stated that the revised definition better reflects 
the realities of practice. One commenter appreciated the recognition 
that the previous definition of a hospital-based groups was confusing 
and difficult for clinicians to meet and thanked CMS for our 
responsiveness to stakeholder concerns. Several commenters stated that 
the ``all or nothing rule'' (requiring 100 percent of the MIPS eligible 
clinicians in the group or virtual group to qualify for reweighting) 
was unfair and penalizes hospital-based clinicians who work in multi-
specialty groups.
    Response: We appreciate the support for our proposal and agree that 
a threshold of more than 75 percent would account for the unique 
circumstances faced by hospital-based groups such as locum tenens 
arrangements and high turnover rates.
    Comment: One commenter urged CMS to consider reweighting a group if 
more than 75 percent of the group qualifies for reweighting for any 
reason.
    Response: We appreciate this suggestion, but we believe that 
hospital medicine groups may face unique circumstances due to the 
nature of their practice area that clinicians who practice in non-
hospital settings would not experience, and thus we decline to adopt 
the commenter's suggestion.
    After consideration of the public comments, we are finalizing the 
proposal to revise the definition of a hospital-based MIPS eligible 
clinician under Sec.  414.1305 to include groups and virtual groups. We 
are finalizing the proposal that, beginning with the 2022 MIPS payment 
year, a hospital-based MIPS eligible clinician under Sec.  414.1305 
means an individual MIPS eligible clinician who furnishes 75 percent or 
more of his or her covered professional services in sites of service 
identified by the POS codes used in the HIPAA standard transaction as 
an inpatient hospital, on-campus outpatient hospital, off campus 
outpatient hospital, or emergency room setting based on claims for the 
MIPS determination period, and a group or virtual group provided that 
more than 75 percent of the NPIs billing under the group's TIN or 
virtual group's TINs, as applicable, meet the definition of a hospital-
based individual MIPS eligible clinician during the MIPS determination 
period. We are also finalizing the proposal to revise Sec.  
414.1380(c)(2)(iii) to specify that for the Promoting Interoperability 
performance category to be reweighted for a MIPS eligible clinician who 
elects to participate in MIPS as part of a group or virtual group, all 
of the MIPS eligible clinicians in the group or virtual group must 
qualify for reweighting, or the group or virtual group must meet the 
definition of a hospital-based MIPS eligible clinician or a non-patient 
facing MIPS eligible clinician as defined in Sec.  414.1305.
(iv) Non-Patient Facing MIPS Eligible Clinicians in Groups
    We define a non-patient facing MIPS eligible clinician under Sec.  
414.1305 as an individual MIPS eligible clinician who bills 100 or 
fewer patient facing encounters (including Medicare telehealth services 
defined in section 1834(m) of the Act), as described in paragraph (3) 
of this definition, during the MIPS determination period, and a group 
or virtual group provided that more than 75 percent of the NPIs billing 
under the group's TIN or virtual group's TINs, as applicable, meet the 
definition of a non-patient facing individual MIPS eligible clinician. 
We established under Sec.  414.1380(c)(2)(i)(C)(5) that a MIPS eligible 
clinician who is a non-patient facing MIPS eligible clinician as 
defined in Sec.  414.1305 will be assigned a zero percent weight for 
the Promoting Interoperability performance category, and the points 
associated with the Promoting Interoperability performance category 
will be redistributed to another performance category or categories (81 
FR 77240 through 77243, 82 FR 53680-53682, 83 FR 59871). However, if a 
non-patient facing MIPS eligible clinician chooses to report on the 
Promoting Interoperability performance category measures, 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 
regardless of their Promoting Interoperability performance category 
score. We stated that this policy includes MIPS eligible clinicians 
choosing to report as part of a group or part of a virtual group (82 FR 
53687).
    As noted in the CY 2020 PFS proposed rule (84 FR 40777), in 
connection with our discussion of hospital-based MIPS eligible 
clinicians in groups, under Sec.  414.1380(c)(2)(iii), for

[[Page 63006]]

MIPS eligible clinicians submitting data as a group or virtual group, 
in order for the Promoting Interoperability performance category to be 
reweighted, all of the MIPS eligible clinicians in the group or virtual 
group must qualify for reweighting. We proposed (84 FR 40777) to revise 
Sec.  414.1380(c)(2)(iii) to account for groups and virtual groups that 
meet the revised definition of a hospital-based MIPS eligible clinician 
under Sec.  414.1305, which would only require the group or virtual 
group to meet a threshold of more than 75 percent instead of a 
threshold of all of the MIPS eligible clinicians in the group or 
virtual group. In an effort to more clearly and concisely capture our 
existing policy for non-patient facing MIPS eligible clinicians, we 
proposed to revise Sec.  414.1380(c)(2)(iii) to also account for a 
group or virtual group that meets the definition of a non-patient 
facing MIPS eligible clinician under Sec.  414.1305, such that the 
group or virtual group only has to meet a threshold of more than 75 
percent.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported a definition of a non-patient facing 
group as one in which more than 75 percent of the group's members 
qualify as non-patient facing and eligible for Promoting 
Interoperability performance category reweighting. One commenter noted 
that the clarification is helpful for physician groups that have a 
small number of patient facing clinicians embedded in a much larger 
group of non-patient facing clinicians.
    Response: We believe that our proposed revision to the regulation 
text would help to alleviate confusion surrounding our policy for 
groups and virtual groups that include non-patient facing MIPS eligible 
clinicians.
    Comment: One commenter suggested that CMS should make it easier for 
groups to evaluate whether they may qualify as hospital-based or non-
patient facing by enhancing the Quality Payment Program Participation 
Status Tool on the Quality Payment Program website to show eligibility 
and special statuses for TINs, in addition to NPIs.
    Response: We appreciate this suggestion and have added the ability 
to check eligibility for all clinicians associated with a practice as a 
feature of our Quality Payment Program Participation Status Tool.
    After consideration of the public comments that we received, we are 
finalizing our proposal to revise Sec.  414.1380(c)(2)(iii) to also 
account for a group or virtual group that meets the definition of a 
non-patient facing MIPS eligible clinician under Sec.  414.1305, such 
that the group or virtual group only has to meet a threshold of more 
than 75 percent of the NPIs billing under the group's TIN or virtual 
group's TINs, as applicable, meet the definition of a non-patient 
facing individual MIPS eligible clinician.
(g) Future Direction of the Promoting Interoperability Performance 
Category
    In the CY 2020 PFS proposed rule (84 FR 40777 through 40784), we 
included Requests for Information regarding several issues involving 
the Promoting Interoperability performance category. While we are not 
summarizing and responding to comments we received in this final rule, 
we thank the commenters for their responses and we may take them into 
account as we develop future policies for the Promoting 
Interoperability performance category.
(5) APM Scoring Standard for MIPS Eligible Clinicians Participating in 
MIPS APMs
(a) Overview
    As codified at Sec.  414.1370(a), 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.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77246), the APM scoring standard is designed to reduce reporting 
burden for these clinicians by reducing the need for duplicative data 
submission to MIPS and their respective APMs, and to avoid potentially 
conflicting incentives between those APMs and MIPS.
    We established at Sec.  414.1370(c) that the MIPS performance 
period under Sec.  414.1320 applies for the APM scoring standard. We 
finalized under Sec.  414.1370(f) that the MIPS final score calculated 
for the APM Entity is applied to each MIPS eligible clinician in the 
APM Entity, and the MIPS payment adjustment is applied at the TIN/NPI 
level for each MIPS eligible clinician in the APM Entity group. Under 
Sec.  414.1370(f)(2), if the APM Entity group is excluded from MIPS, 
all eligible clinicians within that APM Entity group are also excluded 
from MIPS.
    As finalized at Sec.  414.1370(h)(1) through (4), the performance 
category weights used to calculate the MIPS final score for an APM 
Entity group for the APM scoring standard performance period are: 
Quality at 50 percent; cost at 0 percent; improvement activities at 20 
percent; and Promoting Interoperability at 30 percent.
(b) MIPS APM Criteria
    We established at Sec.  414.1370(b) that for an APM to be 
considered a MIPS APM, it must satisfy the following criteria: (1) APM 
Entities must participate in the APM under an agreement with CMS or by 
law or regulation; (2) the APM must require that APM Entities include 
at least one MIPS eligible clinician on a Participation List; (3) the 
APM must base payment on quality measures and cost/utilization; and (4) 
the APM must be neither a new APM for which the first performance 
period begins after the first day of the MIPS performance year nor an 
APM in the final year of operation for which the APM scoring standard 
is impracticable. In the CY 2019 PFS final rule (59820 through 59821), 
we clarified that we consider whether each distinct track of an APM 
meets the criteria to be a MIPS APM and that it is possible for an APM 
to have tracks that are MIPS APMs and tracks that are not MIPS APMs. We 
also clarified that we consider the first performance year for an APM 
to begin as of the first date for which eligible clinicians and APM 
entities participating in the model must report on quality measures 
under the terms of the APM.
    Based on the MIPS APM criteria, we expect that the following 10 
APMs will satisfy the requirements to be MIPS APMs for the 2020 MIPS 
performance period:
     Comprehensive ESRD Care Model (all Tracks).
     Comprehensive Primary Care Plus Model (all Tracks).
     Next Generation ACO Model.
     Oncology Care Model (all Tracks).
     Medicare Shared Savings Program (all Tracks).
     Medicare ACO Track 1+ Model.
     Bundled Payments for Care Improvement Advanced.
     Maryland Total Cost of Care Model (Maryland Primary Care 
Program).
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
     Independence At Home Model.
    Final CMS determinations of MIPS APMs for the 2020 MIPS performance 
period will be announced via the Quality Payment Program website at 
https://qpp.cms.gov/. Further, we make these determinations based on 
the established MIPS APM criteria as specified in Sec.  414.1370(b).
(c) Calculating MIPS APM Performance Category Scores
(i) Quality Performance Category
    As noted, the APM scoring standard is designed to reduce reporting 
burden

[[Page 63007]]

for MIPS eligible clinicians participating in MIPS APMs by reducing the 
need for duplicative data submission to MIPS and their respective APMs, 
and to avoid potentially conflicting incentives between those APMs and 
MIPS. As discussed in the CY 2017 Quality Payment Program final rule 
(81 FR 77246), due to operational constraints, we did not require MIPS 
eligible clinicians participating in MIPS APMs other than the Shared 
Savings Program and the Next Generation ACO Model to submit data on 
quality measures for purposes of MIPS for the 2017 MIPS performance 
period. As discussed in the CY 2018 Quality Payment Program final rule 
(82 FR 53695), we designed a means of overcoming these operational 
constraints and required MIPS eligible clinicians participating in such 
MIPS APMs to submit data on APM quality measures for purposes of MIPS 
beginning with the 2018 MIPS performance period. We also finalized a 
policy to reweight the quality performance category to zero percent in 
cases where an APM has no measures available to score for the quality 
performance category for a MIPS performance period, such as where none 
of the APM's measures would be available for calculating a quality 
performance category score by the close of the MIPS submission period 
because measures were removed from the APM measure set due to changes 
in clinical practice guidelines. Although we anticipated different 
scenarios where quality would need to be reweighted, we did not 
anticipate at that time that the quality performance category would 
need to be reweighted regularly.
    After several years of implementation of the APM scoring standard, 
we have found that for participants in certain MIPS APMs (as defined in 
Sec.  414.1305), it often is not operationally possible to collect and 
score performance data on APM quality measures for purposes of MIPS 
because these APMs run on episodic or yearly timelines that do not 
always align with the MIPS performance periods and deadlines for data 
submission, scoring, and performance feedback. In addition, although we 
anticipated different scenarios where quality would need to be 
reweighted, we do not believe the quality performance category should 
be reweighted regularly.
    To achieve the aims of the APM scoring standard, we believe it is 
necessary to consider new approaches to quality performance category 
scoring.
(A) Allowing MIPS Eligible Clinicians Participating in MIPS APMs To 
Report on MIPS Quality Measures
    We proposed to allow MIPS eligible clinicians participating in MIPS 
APMs to report on MIPS quality measures in a manner similar to our 
established policy for the Promoting Interoperability performance 
category under the APM scoring standard for purposes of the MIPS 
quality performance category beginning with the 2020 MIPS performance 
period.
    Similar to our approach for the Promoting Interoperability 
performance category, we would allow MIPS eligible clinicians in MIPS 
APMs to receive a score for the quality performance category either 
through individual or TIN-level reporting based on the generally 
applicable MIPS reporting and scoring rules for the quality performance 
category. Under such an approach, we would attribute one quality score 
to each MIPS eligible clinician in an APM Entity by looking at both 
individual and TIN-level data submitted for the eligible clinician and 
using the highest reported score, excepting scores reported by a 
virtual group. Thus, we would use the highest individual or TIN-level 
score attributable to each MIPS eligible clinician in an APM Entity in 
order to determine the APM Entity score based on the average of the 
highest scores for each MIPS eligible clinician in the APM Entity.
    As with Promoting Interoperability performance category scoring, 
each MIPS eligible clinician in the APM Entity group would receive one 
score, weighted equally with that of the other MIPS eligible clinicians 
in the APM Entity group, and we would calculate one quality performance 
category score for the entire APM Entity group. If a MIPS eligible 
clinician has no quality performance category score--if the 
individual's TIN did not report and the individual did not report--that 
MIPS eligible clinician would contribute a score of zero to the 
aggregate APM Entity group score.
    We would use scores reported by an individual MIPS eligible 
clinician or a TIN reporting as a group; we would not accept virtual 
group level reporting because a virtual group level score is too far 
removed from the eligible clinician's performance on quality measures 
for purposes of the APM scoring standard.
    We requested comment on our proposal.
    We received several public comments on our proposal to use the 
highest TIN or individual score attributable to each MIPS eligible 
clinician, excepting virtual group level reporting, for purposes of the 
MIPS quality performance category beginning with the 2020 MIPS 
performance period. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters supported our proposal to allow for MIPS 
quality measure reporting to be used in calculating a MIPS APM Entity 
score.
    Response: We appreciate the commenters' support. We agree that this 
new approach will provide the best opportunity to score many MIPS 
eligible clinicians on quality performance.
    Comment: Some commenters supported our proposal to allow scoring at 
the individual or group level to be rolled up to the APM Entity level, 
thereby allowing individuals in multi-specialty APMs to focus and be 
scored on measures most applicable to their practices.
    Response: We thank commenters for their support. We agree that this 
approach would provide value by allowing individuals to be scored based 
on measures that are the most clinically relevant.
    Comment: Some commenters expressed concerns about the additional 
reporting burden required to report on quality to both MIPS and their 
respective APMs. Some suggested that CMS make MIPS reporting optional 
for each APM Entity and create a quality category score only in 
situations where the APM Entity has elected to report.
    Response: We acknowledge this proposed change in policy may 
introduce additional burden for some MIPS APM participants. We 
anticipate, however, this effect being limited to instances where 
participants' TINs do not already report separately to MIPS. We believe 
any potential burden will be further mitigated by our proposal to allow 
APM Entity-level quality reporting for MIPS, as discussed in section 
III.J.3.c.(5)(i)(C) of this final rule.
    We remind commenters that we are required by section 
1848(q)(5)(E)(i)(I) of the Act, to calculate a MIPS quality performance 
category score for MIPS eligible clinicians. As such, we cannot make 
MIPS reporting a wholly voluntary activity through regulatory action. 
Further, under a scenario in which no MIPS quality reporting was 
performed under any of the means available, section 1848(q)(5)(B)(i) of 
the Act requires the assignment of the lowest possible quality score.
    After consideration of the comments, we are finalizing the proposal 
as proposed to require MIPS quality reporting by MIPS eligible 
clinicians in

[[Page 63008]]

MIPS APMs at either the APM Entity, TIN, or individual level.
(B) APM Quality Reporting Credit
    We proposed to apply a minimum score of 50 percent, or an ``APM 
Quality Reporting Credit,'' under the MIPS quality performance category 
for certain APM entities participating in MIPS APMs where the APM 
quality data cannot be used for MIPS purposes as outlined below. 
Several provisions of the statute address the possibility of 
considerable overlap between the requirements of MIPS and those of an 
APM. Most notably, section 1848(q)(1)(C)(ii) of the Act excludes QPs 
and partial QPs who do not elect to participate in MIPS from the 
definition of a MIPS eligible clinician. In addition, under section 
1848(q)(5)(C)(ii) of the Act, a MIPS eligible clinician's participation 
in an APM (as defined in section 1833(z)(3)(C) of the Act) earns such 
MIPS eligible clinician a minimum score of one-half of the highest 
potential score for the improvement activities performance category.
    In particular, we believe that section 1848(q)(5)(C)(ii) of the Act 
reflects an understanding that APM participation requires significant 
investment in improving clinical practice, which may be duplicative 
with the requirements under the improvement activities performance 
category. We believe that MIPS APMs require an equal or greater 
investment in quality, which, due to operational constraints, cannot 
always be reflected in a MIPS quality performance category score. 
Accordingly, we proposed to apply a similar approach to quality 
performance category scoring under the APM scoring standard. We 
proposed that APM Entity groups participating in certain MIPS APMs 
receive a minimum score of one-half of the highest potential score for 
the quality performance category, beginning with the 2020 MIPS 
performance period. To clarify, our proposal was intended to apply 
specifically to those MIPS APMs that do not utilize MIPS measures and 
data collection types.
    To the extent possible, we would calculate the final score by 
adding to the credit any additional MIPS quality score received on 
behalf of the individual NPI or the TIN. For the purposes of final 
scoring this credit would be added to any MIPS quality measure scores 
we receive. All quality category scores would be capped at 100 percent. 
For example, if the additional MIPS quality score were 40 percent, that 
would be added to the 50 percent credit for a total of 90 percent; if 
the quality score were 70 percent, that would be added to the 50 
percent credit and because the result is 120 percent, the cap would be 
applied for a final score of 100 percent.
    We received public comments on our proposal to calculate the 
quality performance category score for APM Entity groups participating 
in MIPS APMs where APM quality data cannot be used for MIPS purposes, 
to add to the applicable APM Entity level quality performance score a 
50 percent quality reporting credit, for a total score of up to 100 
percent. The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported our policy to provide a 50 
percent quality reporting credit for those APM Entity groups that are 
participating in MIPS APMs that are already required to report quality 
measures for purposes of their APM, but for which the reported quality 
data cannot be used for MIPS purposes, to mitigate the duplicative 
reporting now required for MIPS quality scoring.
    Response: We thank commenters for their support of our proposal.
    Comment: A few commenters supported the use of an APM quality 
reporting credit, but urged CMS to make the credit 100 percent of the 
quality performance category.
    Response: We appreciate the support for our proposed policy, but we 
do not believe that providing a quality reporting credit of 100 percent 
for the quality performance category would satisfy the statutory 
requirements at section 1848(q)(5)(E)(i)(I) of the Act that we measure 
``performance'' on quality measures under the quality performance 
category. Furthermore, we do not believe that simply participating in a 
MIPS APM is a sufficient demonstration of performance on quality 
measures to warrant a score of 100 percent; rather, we interpret the 
statutory requirement at section 1848(q)(5)(D) of the Act to mean that 
we are to assess performance on quality measures not only for the sake 
of generating a score, but for the purpose of measuring year over year 
improvement, and rewarding those efforts as well. Therefore, we 
proposed to use a 50 percent quality reporting credit in combination 
with an achievement score in calculating an APM Entity's quality 
performance category score for APM Entity groups participating in MIPS 
APMs where quality data cannot be used for MIPS purposes.
    Comment: Some commenters recommended that CMS increase the quality 
reporting credit to the minimum number of points required to ensure APM 
Entities receive a neutral payment adjustment under the APM scoring 
standard.
    Response: We considered several different approaches for setting 
the APM Quality Reporting Credit, including an approach where the 
credit would be equal to the minimum number of points needed in the 
quality performance category which, when added to the automatic credit 
applied for the improvement activities performance category, would 
guarantee MIPS APM participants a MIPS score equal to or greater than 
the performance threshold for a given Quality Payment Program 
performance year. Upon further consideration, we found that such an 
approach would give MIPS APM participants a competitive advantage 
within MIPS as the performance threshold increased, but would function 
more as a safety net against a downward MIPS adjustment than as a 
reward for quality measure reporting that they had already done.
    We believe that the APM Quality Reporting Credit of one-half of the 
performance category score better reflects the intent of rewarding a 
specific performance activity, reporting, than an approach where the 
primary purpose is to guarantee a specific outcome within the MIPS 
program.
    Comment: Some commenters disagreed with our proposal to assign an 
APM Quality Reporting Credit for certain MIPS APM participants, as it 
would have the effect of raising the performance threshold and making 
it more difficult for other MIPS eligible clinicians to receive a top 
score.
    Response: While we do anticipate that this APM Quality Reporting 
Credit may have an effect on APM Entities' quality performance category 
scores, our data suggest that the totality of our APM scoring standard 
policies should produce APM Entity quality performance category scores 
that are roughly equal to, or perhaps slightly lower than they would 
have been under the APM scoring standard rules if we had been able to 
implement them as finalized. We believe that the proposed approach 
would reward MIPS APM participants for the quality reporting they 
undertake within their APMs, which we had intended to but cannot use 
for purposes of MIPS, without unduly advantaging them relative to the 
MIPS performance threshold. With this in mind, we do not anticipate any 
negative impacts on other MIPS eligible clinicians as a result of this 
policy.
    We are finalizing the policy to assign an APM Quality Reporting 
Credit of one-half of the quality performance category score under the 
APM scoring standard for APM Entity groups participating in MIPS APMs 
where

[[Page 63009]]

quality data cannot be used for MIPS purposes.
(aa) Exceptions From APM Quality Reporting Credit
    Under this policy, we would not apply the APM Quality Reporting 
Credit to the APM Entity group's quality performance score for those 
APM Entities reporting only through a MIPS quality reporting data 
submission types according to the requirements of their APM, such as 
the Medicare Shared Savings Program, which requires participating ACOs 
to report through the CMS Web Interface and the CAHPS for ACOs survey 
measures. In these cases, no burden of duplicative reporting would 
exist, and there would not be any additional unscored quality measures 
for which to give credit.
    In the case where an APM Entity group is in an APM that requires 
reporting through a MIPS quality reporting data submission type under 
the terms of participation in the APM, should the APM Entity group fail 
to report on required quality measures, the individual eligible 
clinicians and TINs that make up that APM Entity group would still have 
the opportunity to report quality measures to MIPS for purposes of 
calculating a MIPS quality performance category score as finalized for 
all MIPS APMs in accordance with Sec.  414.1370(g)(1)(ii). However, as 
in these cases no burden of duplicative reporting would exist, they 
would not receive the APM Quality Reporting credit.
    We did not receive any comments on this proposal, and we are 
finalizing as proposed.
(C) Additional Reporting Option for APM Entities
    We recognize that some APM Entities may have a particular interest 
in ensuring that MIPS eligible clinicians in the APM Entity group 
perform well in MIPS, or in reducing the overall burden of joining the 
APM Entity. Likewise, we recognize that some MIPS APMs, such as the CMS 
Web Interface reporters, already require reporting on MIPS quality 
measures as part of participation in the APM. Therefore, we proposed 
that, in instances where an APM Entity has reported quality measures to 
MIPS through a MIPS submission type and using MIPS data collection type 
on behalf of the APM Entity group, we would use that quality data to 
calculate an APM Entity group level score for the quality performance 
category. We believe this approach best ensures that all participants 
in an APM Entity group receive the same final MIPS score while reducing 
reporting burden to the greatest extent possible. We received no public 
comments on our proposal that in instances where an APM Entity reports 
quality measures to MIPS through a MIPS submission type and using MIPS 
data collection type on behalf of the APM Entity group, we will use 
that quality data to calculate an APM Entity group level score for the 
quality performance category. We are finalizing the policy as proposed.
(D) Bonus Points and Caps for the Quality Performance Category
    In the 2018 Quality Payment Program final rule (82 FR 53568, 
53700), we finalized our policies to include bonus points in the 
performance category score calculation when scoring quality at the APM 
Entity group level. Because these adjustments would, under the policies 
we are finalizing in section III.J.3.d.(1)(b) of this final rule, 
already be factored in when calculating an individual or TIN-level 
quality performance category score before the quality scores are 
rolled-up and averaged to create the APM Entity group level score, we 
proposed not to continue to calculate these adjustments at the APM 
Entity group level in the case where an APM Entity group's quality 
performance score is reported by its composite individuals or TINs. 
However, in the case of an APM Entity group that chooses to or is 
required by its APM to report on MIPS quality measures at the APM 
Entity group level, we proposed to continue to apply any bonuses or 
adjustments that are available to MIPS groups for the measures reported 
by the APM Entity and to calculate the applicability of these 
adjustments at the APM Entity group level.
    The following is a summary of the comments we received and our 
responses.
    Comment: A commenter supported this policy, as it eliminates 
possible duplicative awards of bonus points.
    Response: We appreciate the commenter's support.
    We are finalizing this policy as proposed.
(E) Special Circumstances
    In prior rulemaking, with regard to the quality performance 
category, we did not include MIPS eligible clinicians who are subject 
to the APM scoring standard in the automatic extreme and uncontrollable 
circumstances policy or the application-based extreme and 
uncontrollable circumstances policy that we established for other MIPS 
eligible clinicians (82 FR 53780-53783, 53895-53900; 83 FR 59874-
59875). However, in the CY 2020 PFS proposed rule (84 FR 40786), we 
proposed to allow MIPS eligible clinicians participating in MIPS APMs 
to report on MIPS quality measures and be scored for the MIPS quality 
performance category based on the generally applicable MIPS reporting 
and scoring rules for the quality performance category. We also had 
proposed that the same extreme and uncontrollable circumstances 
policies that apply to other MIPS eligible clinicians with regard to 
the quality performance category also should apply to MIPS eligible 
clinicians participating in MIPS APMs who would report on MIPS quality 
measures as proposed. Therefore, beginning with the 2020 MIPS 
performance period/2022 MIPS payment year and only with regard to the 
quality performance category, we proposed to apply the application-
based extreme and uncontrollable circumstances policy (82 FR 53780-
53783) and the automatic extreme and uncontrollable circumstances 
policy (83 FR 59874-59875) that we previously established for other 
MIPS eligible clinicians and codified at Sec.  414.1380(c)(2)(i)(A)(6) 
and (8), respectively, to MIPS eligible clinicians participating in 
MIPS APMs who are subject to the APM scoring standard and would report 
on MIPS quality measures as proposed in section III.J.3.c.(5)(c)(i) of 
the CY 2020 PFS proposed rule. We also proposed to limit the 
application of these policies to the quality performance category 
because the policy we then proposed and now are finalizing pertains to 
reporting on MIPS quality measures.
    Under the previously established policies, MIPS eligible clinicians 
who are subject to extreme and uncontrollable circumstances may receive 
a zero percent weighting for the quality performance category in the 
final score (82 FR 53780-53783, 83 FR 59874-59875). Similar to the 
policy for MIPS eligible clinicians who qualify for a zero percent 
weighting of the Promoting Interoperability performance category (82 FR 
53701 through 53702), we proposed that if a MIPS eligible clinician who 
qualifies for a zero percent weighting of the quality performance 
category in the final score is part of a TIN reporting at the TIN level 
that includes one or more MIPS eligible clinicians who do not qualify 
for a zero percent weighting, we would not apply the zero percent 
weighting to the qualifying MIPS eligible clinician. The TIN would 
still report on behalf of the entire group, although the TIN would not 
need to report data for the qualifying MIPS eligible clinician. All 
MIPS eligible clinicians in the TIN who

[[Page 63010]]

are participants in the MIPS APM would count towards the TIN's weight 
when calculating the aggregated APM Entity score for the quality 
performance category.
    However, in this circumstance, if the MIPS eligible clinician is a 
solo practitioner and qualified for a zero percent weighting, or if the 
MIPS eligible clinician's TIN did not report at the group level and the 
MIPS eligible clinician is individually eligible for a zero percent 
weighting, or if all MIPS eligible clinicians in a TIN qualified for 
the zero percent weighting, neither the TIN nor the individual would be 
required to report on the quality performance category and would be 
assigned a weight of zero when calculating the APM Entity's quality 
performance category score.
    If quality performance data were reported by or on behalf of one or 
more TIN/NPIs in an APM Entity group, a quality performance category 
score would be calculated for, and would be applied to, all MIPS 
eligible clinicians in the APM Entity group. If all MIPS eligible 
clinicians in all TINs of an APM Entity group qualify for a zero 
percent weighting of the quality performance category, the quality 
performance category would be weighted at zero percent of the MIPS 
final score.
    We solicited comments from the public in this discussion of how 
best to address the technical infeasibility of scoring quality for many 
of our MIPS APMs, and whether the above described policy or some other 
approach may be an appropriate path forward for the APM entity group 
scoring standard in CY 2020.
    Comment: Several commenters supported the greater uniformity within 
MIPS through this policy.
    Response: We appreciate the commenters' support.
    After consideration of public comments, we are finalizing the 
policy as proposed.
(F) Request for Comment on APM Scoring Beyond 2020
    We also solicited comments on potential policies to potentially be 
included in future years' rulemaking to further address the changing 
statutory incentives for APM participation in coming years. We want the 
design of the APM scoring standard to continue to encourage appropriate 
shifts of MIPS eligible clinicians into MIPS APMs and Advanced APMs 
while ensuring fair treatment for all MIPS eligible clinicians.
    We noted in the CY 2020 PFS proposed rule (84 FR 40787) and 
reiterate now that the QP threshold will be increasing in future years, 
potentially resulting in larger proportions of Advanced APM 
participants being subject to MIPS under the APM scoring standard. At 
the same time the MIPS performance threshold will be increasing 
annually, gradually reducing the impact of the APM scoring standard on 
participants' ability to achieve a neutral or positive payment 
adjustment under MIPS.
    We received public comments with general support for finding new 
ways to continue to reward APM participation without giving APM 
participants an undue advantage within MIPS, without specific support 
for or opposition to any potential approach discussed below. We 
continue to seek input form the stakeholder community as we continue to 
consider these and other policies that may be included in future 
rulemaking.
(aa) Sunsetting the APM Quality Reporting Credit for APM Entities
    One approach we indicated we may consider beginning in the 2021 
performance year would be to apply the APM Quality Reporting Credit 
described above, if finalized, to specific APM Entities for a maximum 
number of MIPS performance years; this may be set for all APMs or tied 
to the end of each APM's initial agreement period.
    We discussed our belief that this approach would create an 
incentive for new APM Entity groups to continue to form and join new 
MIPS APMs while maintaining the incentive for APM Entity groups and 
MIPS eligible clinicians to continue to strive to achieve QP status.
(bb) Sunsetting the APM Quality Reporting Credit for Non-Advanced APMs
    Similar to the first approach, we may consider an approach whereby 
we would implement the above approach to quality scoring and then phase 
out the APM Quality Reporting Credit for MIPS APMs that are not also 
Advanced APM.
    We would have the option to implement this change by removing the 
APM Reporting Credit for non-Advanced MIPS APMs entirely at the end of 
a set number of years for all non-Advanced APMs (for example, 2 years).
    Alternately, we could tie this sunsetting of the APM Quality 
Reporting Credit for a non-Advanced APM to the initial agreement period 
of each APM, creating a well-timed incentive for movement into APM 
tracks that are Advanced APMs after the initial agreement period after 
the start of the APM. This approach also would complement the shift we 
are seeing within APMs, such as the Shared Savings Program, to require 
APM participants to move into two-sided risk tracks and Advanced APMs 
within 2 to 5 years of joining the model or program.
(cc) Sunsetting the APM Quality Reporting Credit for APM Entities in 
One-Sided Risk Tracks
    One possible way of acknowledging the uncertainty involved with 
joining an APM without extending the APM Reporting Credit to all APM 
participants would be to retain the APM Quality Reporting Credit for 
all two-sided risk APM tracks but to remove this credit for 
participants in all one-sided risk tracks except for those APM Entities 
in the first 2 years--or first agreement period--of a MIPS APM.
    We believe this approach would help ease the transition from MIPS 
to APM participation and ultimately into Advanced APM participation. 
However, this approach would continue to provide the APM Quality 
Reporting Credit for participants in two-sided risk APMs who have not 
reached the QP threshold. In this way, we could create an incentive for 
APM participants to move towards Advanced APMs, even in situations 
where it is unlikely the participant would be able to reach the QP 
threshold.
(dd) Retain Different APM Quality Reporting Credits for Advanced APMs 
and MIPS APMs
    Another available option would be to apply an APM Reporting Credit, 
as described above to all MIPS APM participants but base the available 
credit on the level of risk taken on in the MIPS APM. For example, the 
maximum 50 percent credit may continue to be available to APM Entities 
in MIPS APMs that are Advanced APMs while the value of the credit may 
be limited to 25 percent for participants in MIPS APMs that are one-
sided risk tracks, or otherwise not Advanced APMs. We solicited 
comments on how we might best divide these tracks and address the 
advent of two-sided risk MIPS APMs that do not meet the nominal amount 
and financial risk standards in order to be considered an Advanced APM, 
and what an appropriate reporting credit would be for these tracks.
(ee) Other Options
    We solicited comments and suggestions on other ways in which we 
could modify the APM scoring standard to continue to encourage MIPS 
eligible clinicians to join APMs, with an emphasis on encouraging 
movement toward participation in two-sided risk APMs that may qualify 
as Advanced APMs.

[[Page 63011]]

(d) Excluding Virtual Groups From APM Entity Group Scoring
    Due to concerns that virtual groups could be used to calculate APM 
Entity group scores, we have excluded virtual group MIPS scores when 
calculating APM Entity group scores. Previously, we have effectuated 
this exclusion through the use and application of terms defined in 
Sec.  414.1305, specifically, ``APM Entity,'' ``APM Entity group,'' 
``group,'' and ``virtual group.'' To improve clarity around the 
exclusion of virtual group scores in calculating APM Entity group 
scores, we proposed to effectuate this exclusion more explicitly, by 
amending Sec.  414.1370(e)(2) to state that the score calculated for an 
APM Entity group, and subsequently the APM Entity, for purposes of the 
APM scoring standard does not include MIPS scores for virtual groups.
    We did not receive any comments on this proposal. We are finalizing 
this policy as proposed.
(e) MIPS APM Performance Feedback
    As we discussed in the CY 2017 and 2018 Quality Payment Program 
final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively), 
MIPS eligible clinicians who are scored under the APM scoring standard 
will receive performance feedback under section 1848(q)(12) of the Act.
    Regarding access to performance feedback, while split-TIN APM 
Entities and their participants can only access their performance 
feedback at the APM Entity group or individual MIPS eligible clinician 
level, MIPS eligible clinicians participating in the Shared Savings 
Program, which is a full-TIN APM, were able to access their performance 
feedback at the ACO participant TIN level for the 2017 performance 
period. However, due to confusion caused by the policy in cases, where 
not all eligible clinicians in a Shared Savings Program participant TIN 
received the APM Entity score, for example eligible clinicians that 
terminate before the first snapshot, we intend to better align 
treatment of Shared Savings Program ACOs and their participant TINs 
with other APM Entities and, where appropriate, with other MIPS groups. 
We will continue to allow ACO participant TIN level access to the APM 
Entity group level final score and performance feedback, as well as 
provide the APM Entity group level final score and performance feedback 
to individual MIPS eligible clinicians who bill through the TINs 
identified on the ACO's ACO participant list. However, we will also 
provide TIN level performance feedback to ACO participant TINs that 
will include the information that is available to all TINs 
participating in MIPS, including the applicable final scores for MIPS 
eligible clinicians billing under the TIN, regardless of their MIPS APM 
participation status.
(f) Regulation Text
    Due to a clerical error, the regulation text corresponding with the 
proposals discussed in section III.J.3.c.(5) of this final rule was 
omitted from the publication of the proposed rule. The proposals were 
discussed at length in the preamble where we solicited public comment. 
This preamble text included a detailed explanation of the proposed 
changes to the regulation text. The preamble text also cross-referenced 
the missing regulation text, such as page 84 FR 40786, such that the 
intent to codify the proposals would have been apparent to readers. We 
received several detailed public comments on our proposals. These 
comments indicate that readers accurately understood the proposed 
policy and our intent to codify it, and as discussed in section 
III.J.3.c.(5) of this final rule, were generally supportive of the 
proposal. As such, we are finalizing the proposed policies, as 
explained above, including amending Sec.  414.1370(g)(1) accordingly.
d. MIPS Final Score Methodology
(1) Performance Category Scores
(a) Background
    For the 2022 MIPS payment year, we intend to continue to build on 
the scoring methodology we finalized for prior years, which allows for 
accountability and alignment across the performance categories and 
minimizes burden on MIPS eligible clinicians. The rationale for our 
scoring methodology continues to be grounded in the understanding that 
the MIPS scoring system has many components and various moving parts. 
As we transform MIPS through the MVP framework as discussed in section 
III.K.3.a. of this final rule, we may propose modifications to our 
scoring methodology in future rulemaking as we continue to develop a 
methodology that emphasizes simplicity and that is understandable for 
MIPS eligible clinicians.
    In the CY 2020 PFS proposed rule (84 FR 40788 through 40792), we 
proposed policies to help eligible clinicians as they participate in 
the 2020 performance period/2022 MIPS payment year, and as we move 
beyond the transition years of the program.
(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.
    As we move towards the transformation of the program through the 
MVP Framework discussed in section III.K.3.a. of this final rule, we 
anticipate we will revisit and remove many of our scoring policies such 
as the 3-point floor, bonus points, and assigning points for measures 
that cannot be scored against a benchmark through future rulemaking. As 
we proposed to transform the MIPS program through the MVP framework, 
our goal was to incorporate ways to address these issues without 
developing special scoring policies. We refer readers to the 2020 PFS 
proposed rule (84 FR 40741 through 40742) for further discussion on 
scoring of MVPs.
    In section III.K.3.d.(1) of this final rule, we discuss the limited 
proposals for our scoring policies as we anticipate future changes as 
we work to transform MIPS through the MVP framework. In the CY 2020 PFS 
proposed rule (84 FR 40788 through 40792), we proposed to: (1) Maintain 
the 3-point floor for measures that can be scored for performance; (2) 
develop benchmarks based on flat percentages in specific cases where we 
determine the measure's otherwise applicable benchmark could 
potentially incentivize inappropriate treatment; (3) continue the 
scoring policies for measures that do not meet the case-minimum 
requirement, do not have a benchmark, or do not meet the data-
completeness criteria; (4) maintain the cap on measure bonus points for 
high-priority measures and end-to-end reporting; and (5) continue the 
improvement scoring policy. In addition, we requested comment on future 
approaches to scoring the CAHPS for MIPS survey measure if new 
questions are added to the survey.
(i) Assigning Quality Measure Achievement Points
    We refer readers to Sec.  414.1380(b)(1) for more on our policies 
for scoring performance on quality measures.

[[Page 63012]]

(A) Scoring Measures Based on Achievement
    We 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). 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 the 3-point floor was for the transition year 
and that we would revisit the 3-point floor in future years.
    For the 2022 MIPS payment year, we proposed to again apply a 3-
point floor for each measure that can be reliably scored against a 
benchmark based on the baseline period. As we move towards the MVP 
framework discussed in section III.K.3.a. of this final rule, we 
anticipate we will revisit and possibly remove the 3-point floor 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 proposed to amend Sec.  414.1380(b)(1)(i) 
to remove the years 2019, 2020, and 2021 and adding in its place the 
years 2019 through 2022 to provide that for the 2019 through 2022 MIPS 
payment years, MIPS eligible clinicians receive between 3 and 10 
measure achievement points (including partial points) for each measure 
required under Sec.  414.1335 on which data is submitted in accordance 
with Sec.  414.1325 that has a benchmark at paragraph (b)(1)(ii) of 
this section, meets the case minimum requirement at paragraph 
(b)(1)(iii) of this section, and meets the data completeness 
requirement at Sec.  414.1340. The number of measure achievement points 
received for each 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.
    We received public comments on our proposal to again apply a 3-
point floor for each measure that can be reliably scored against a 
benchmark based on the baseline period. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters supported CMS' proposal to maintain the 
3-point floor for each measure that can be reliably scored against a 
benchmark based on the baseline period for the 2022 MIPS payment year 
because they believe the consistency makes it easier for clinicians to 
understand MIPS scoring complexities, improves workflow processes, 
offers a reasonable backstop for unpredictable performance, encourages 
program participation, and is critical for small and rural practices 
that have less resources and require more time to advance quality 
initiatives.
    Response: We thank commenters for their support. As stated in the 
2020 PFS proposed rule (84 FR 40788), as we move towards implementation 
of the MVP framework, we anticipate we will revisit the 3-point floor 
in future years since this scoring policy was intended to be temporary.
    After consideration of the comments, we are finalizing our proposal 
for the MIPS 2022 payment year to again apply a 3-point floor for each 
measure that can be reliably scored against a benchmark based on the 
baseline period. We will amend Sec.  414.1380(b)(1)(i) as proposed.
(B) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, 
and Benchmark Requirements
    We refer readers to Sec.  414.1380(b)(1)(i)(A) and (B) for more on 
our scoring policies for a measure that is submitted but is unable to 
be scored because it does not meet the required case minimum, does not 
have a benchmark, or does not meet the data completeness requirement. A 
summary of the policies for the CY 2020 MIPS performance period is 
provided in Table 50.

[[Page 63013]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.097

    For the 2022 MIPS payment year, we proposed to again apply the 
special scoring policies for measures that meet the data completeness 
requirement but do not have a benchmark or meet the case minimum 
requirement. Accordingly, we proposed to amend Sec.  
414.1380(b)(1)(i)(A)(1) to remove the years 2019, 2020, and 2021 and 
add in its place the years 2019 through 2022 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 2022 MIPS payment years, MIPS eligible clinicians receive 
3 measure achievement points for each submitted measure that meets the 
data completeness requirement, but does not have a benchmark or meet 
the case minimum requirement.
    We received public comments on our proposal to again apply the 
special scoring policies for measures that meet the data completeness 
requirement, but do not have a benchmark or meet the case minimum 
requirement. The following is a summary of the comments we received and 
our responses.
    Comment: One commenter supported our proposal to retain the 3-point 
floor for small practices who submit data, but do not meet the data 
completeness threshold.
    Response: We appreciate the commenter's support. However, we stress 
that these policies are not meant to be permanent, and as clinicians 
continue to gain experience with the program, we will revisit the 
appropriateness of these policies in future rulemaking.
    Comment: A few commenters recommended incentivizing clinicians to 
report on new measures and measures without benchmarks by eliminating 
the scoring cap for measures with no benchmarks and providing clear and 
prospective benchmarks for new measures so that benchmarking data can 
be gathered and used since providers have little control over CMS-
established benchmarks. A few commenters noted that low reporting rates 
are not an indication of low value or non-meaningful measures and as 
scoring is designed now, clinicians must choose between submitting data 
on a less relevant measure, with the potential to earn 10 points, or 
receiving the capped 3 points for submitting a relevant measure with no 
benchmark. A few commenters recommended that CMS include a bonus for 
submitting on new measures to incentivize the use and increase data 
collection.
    Response: We recognize stakeholders' concerns regarding the 
assignment of 3 points to measures without a benchmark. We will take 
them into consideration in the future. As stated in the CY 2018 PFS 
final rule (82 FR 53729), we selected the 3-point cap because we did 
not want to provide more credit for reporting a measure that cannot be 
reliably scored against a benchmark than for measures for which we can 
measure performance against a benchmark. We remind commenters that we 
only apply the 3-point cap if we cannot create a benchmark for a 
measure. For many new measures, we do anticipate that a benchmark will 
be able to be created which will allow for up to 10 points. As we 
stated in the proposed rule (84 FR 40788), we envision that the 
progression of the MIPS program under the MVP framework will allow us 
to remove

[[Page 63014]]

some of the scoring complexity associated with the MIPS program. We 
anticipate that removing caps and bonuses could be part of this 
framework. As the program implementation continues, we want to ensure 
that our policies align with our goal of improving quality and 
decreasing burden. As such, we do not believe that eliminating or 
altering the finalized cap on the points available under the quality 
performance category for the 2022 MIPS payment year would support that 
goal.
    After consideration of the comments, we are finalizing our proposal 
for the MIPS 2022 payment year to again apply the special scoring 
policies for measures that meet the data completeness requirement but 
do not have a benchmark or meet the case minimum requirement. We will 
amend Sec.  414.1380(b)(1)(i)(A)(1) as proposed.
(C) Modifying Benchmarks To Avoid the Potential for Inappropriate 
Treatment
    We established at Sec.  414.1380(b)(1)(ii) 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. We also established at Sec.  
414.1380(b)(1)(i) that the number of measure achievement points 
received for each such measure is determined based on the applicable 
benchmark decile category and the percentile distribution.
    We believe all the measures in the MIPS program are of high 
standard as they have undergone extensive review prior to their 
inclusion in the program. MIPS measures go through the rulemaking 
process, and QCDR measures have an approval process before they are 
included in MIPS. We also believe our benchmarking generally provides 
an objective way to compare performance differences across different 
types of quality measures. However, we have heard concerns from 
stakeholders that for a few measures, the benchmark methodology may 
incentivize the inappropriate treatment of certain patients, in order 
for a clinician to achieve a score in the highest decile. Our scoring 
system already provides some protection from inappropriate treatment 
because all clinicians in the top 10 percent of the distribution 
receive the same 10-point score, thus a clinician with performance in 
the 90th percentile has no incentive to go higher. However, for certain 
measures with benchmarks set at very high or maximum performance in the 
top decile, we are concerned that these levels may not be 
representative and may not provide the most appropriate incentives for 
clinicians. Specifically, there are some measures that may have the 
potential to encourage clinicians to alter the clinical interaction 
with patients inappropriately, regardless of the individual patient's 
circumstances, in order to achieve that top decile performance level, 
for example, intermediate outcome measures that may encourage 
clinicians to over treat patients in order to achieve the highest 
performance level. Patient safety is our primary concern; therefore, we 
proposed to establish benchmarks based on flat percentages in specific 
cases where we determine the measure's otherwise applicable benchmark 
can potentially incentivize treatment that can be inappropriate for a 
particular patient type (84 FR 40789 through 40790). Rather than 
develop benchmarks based on the distribution of scores we will base 
them on flat percentages such that any performance rate at or above 90 
percent will be in the top decile and any performance rate above 80 
percent will be in the second highest decile, and this will continue 
for the remaining deciles. We believe the measures that will fall under 
this methodology are high-priority or outcome measures for clinicians 
to focus on. However, we want to ensure that benchmarks are set to 
incentivize the most appropriate behavior, and ensure that our method 
for scoring against a benchmark accurately reflects performance and 
does not result in clinicians receiving low scores, despite adherence 
to the most appropriate treatment.
    For the measures identified, we proposed to use a flat percentage, 
similar to how the Shared Savings Program uses flat percentages to set 
benchmarks for measures with high performance. We selected this 
methodology for the following reasons: First, it is a straight-forward 
and simple methodology that currently exists for some MIPS measures 
that are collected through the CMS Web Interface. Second, because we 
are applying this methodology to measures with very high performance, 
we believe this approach is consistent with the Shared Saving Program 
approach established at Sec.  425.502(b)(2)(ii) of using flat 
percentages to set benchmarks when many reporters demonstrate high 
achievement on a measure. The Shared Savings Program uses this method 
to avoid penalizing high ACO performance; however, in this case, we 
will be applying the flat percentages to ensure that the benchmark does 
not result in inappropriate and potentially harmful patient treatment. 
We believe this adjustment will provide additional protection to 
patients and reduce the potential incentive for inappropriate treatment 
of patients.
    We proposed that to determine whether a measure benchmark may not 
provide the most appropriate incentives for treatment, thus creating 
the potential for inappropriate treatment based on the patient's 
circumstances, CMS medical officers will assess if there are patients 
for whom it would be inappropriate to achieve the outcome targeted by 
the measure benchmark. This assessment will include reviews of factors 
such as whether the measure specifications allow for clinical judgment 
to adjust for inappropriate outcomes, if the benchmarks for any of the 
impacted measure's collection types could put these patients at risk by 
setting a potentially harmful standard for top decile performance, or 
whether the measure is topped out. The intent of the assessment is to 
have CMS medical officers determine whether certain measure benchmarks 
may have unintended consequences that put patients at risk and the 
measure benchmark should therefore move to a flat percentage. The 
assessment will take into account all available information, including 
from the medical literature, published practice guidelines, and 
feedback from clinicians, groups, specialty societies, and the measure 
steward. Before applying the flat percentage benchmarking methodology 
to any recommended measure, we will propose the modified benchmark for 
the applicable MIPS payment year through rulemaking. This policy will 
be effective beginning with the CY 2020 MIPS performance period (and 
thus the 2022 MIPS payment adjustment year). We also solicited comment 
on future actions we should take to help us in determining which 
measures to apply the flat percentage benchmarking to; for example, 
convening a technical expert panel.
    We have identified two measures for which we believe we need to 
apply benchmarks based on flat percentages to avoid potential 
inappropriate treatment--MIPS #1 (NQF 0059): Diabetes: Hemoglobin A1c 
(HbA1c) Poor Control >9%) and MIPS #236 (NQF 0018): Controlling High 
Blood Pressure. Although there are protections built into both of these 
measures, such as the use of less stringent requirements than current 
clinical guidelines, they lack comprehensive denominator exclusions and 
risk-adjustment or risk-stratification, which can lead to the possible 
over treatment of patients in order to meet numerator compliance.

[[Page 63015]]

Overtreatment could lead to instances where the patient's blood sugar 
or blood pressure is lowered to a level that meets the measure standard 
but is too low for their optimum health given other coexisting medical 
conditions.
    Because the factors for determining if a measure benchmark has the 
potential to cause inappropriate treatment may include both measure and 
benchmark considerations, we are concerned that all the benchmarks 
associated with the different collection types of a measure could be 
affected. Therefore, we proposed to use the flat percentage benchmarks 
as an alternative to our standard method of calculating benchmarks by a 
percentile distribution of measure performance rates under for all 
collection types where the top decile for any measure benchmark is 
higher than 90 percent under the performance-based benchmarking 
methodology at Sec.  414.1380(b)(1)(ii) (84 FR 40790). We are limiting 
the application of the flat percentage methodology to all collection 
types where the top decile for any measure benchmark is higher than 90 
percent so that our flat percentage methodology will actually reduce or 
remove the incentive for inappropriate care. If the top decile was 
originally below 90 percent, using the flat percentages would actually 
raise the level up to 90 percent, and therefore, provide a stronger 
incentive to provide inappropriate care in order to get the top score. 
We also solicited comment on whether we should use a criteria different 
than applying it to collection types where the top decile would be 
higher than 90 percent if the benchmark was based on a distribution. 
For the two measures we proposed to modify, we will not know which 
benchmarks and their associated collection types are impacted until we 
run our analysis; however, based on the benchmarks for the 2019 MIPS 
performance period, we anticipate using the modified benchmarks for the 
Medicare Part B claims and the MIPS CQM collection types.
    We considered whether we should rerun the benchmarks excluding 
those in the top decile but are concerned that the approach will add 
complexity to the program overall. We solicited comment on whether we 
should consider different methodologies for the modified benchmarks 
such as excluding the top decile or increasing the required data 
completeness for the measure to a very high level (for example, 95 to 
100 percent) and use performance period benchmarks rather than 
historical benchmarks.
    We proposed to add paragraph Sec.  414.1380(b)(1)(ii)(C) to state 
that beginning with the 2022 MIPS payment year, for each measure that 
has a benchmark that CMS determines has the potential to result in 
inappropriate treatment, we will set benchmarks using a flat percentage 
for all collection types where the top decile is higher than 90 percent 
under the methodology at Sec.  414.1380(b)(1)(ii). We also proposed to 
revise the text at Sec.  414.1380(b)(1)(ii) to provide exceptions and 
to clarify the requirement that benchmarks will be based on performance 
by collection type, from all available sources, including MIPS eligible 
clinicians and APMs, to the extent feasible, during the applicable 
baseline or performance period.
    We received public comments on our proposals to set benchmarks 
using a flat percentage for all collection types where the top decile 
is higher than 90 percent under the methodology if there are patients 
for whom it would be inappropriate to achieve the outcome targeted by 
the measure, and our proposal to apply the flat percentages to the 
following two measures: MIPS #1 (NQF 0059): Diabetes: Hemoglobin A1c 
(HbA1c) Poor Control (>9) and MIPS #236 (NQF #0018), Controlling High 
Blood Pressure. The following is a summary of the comments we received 
and our responses.
    Comment: Several commenters supported our proposal to set 
benchmarks using a flat percentage for all collection types where the 
top decile is higher than 90 percent under the methodology if there are 
patients for whom it would be inappropriate to achieve the outcome 
targeted by the measure. One commenter supported our proposal to apply 
the flat percentages to the following measure: MIPS #236 (NQF #0018), 
Controlling High Blood Pressure, to avoid inappropriate treatment. This 
commenter expressed concern that a one-size-fits-all blood pressure 
goal of < 140/90 mm Hg may erroneously suggest to patients and their 
clinicians that their treatment is adequate if they reach this goal. 
Another commenter supported our proposal to propose any specific 
measures to which they would apply this methodology through formal 
rulemaking to allow for stakeholder input.
    Response: We appreciate the commenters' support. We believe 
identifying these measures through rulemaking provides a transparent 
process for the public to provide feedback.
    Comment: One commenter suggested that CMS apply flat percentage 
benchmarks to otherwise ``topped out'' patient safety measures that 
should remain in the program due to their importance to patient safety.
    Response: We intend to apply this policy to all measures with 
potential for inappropriate treatment based on the patient's 
circumstances. We believe it is important that we take a performance 
based approach to scoring, such that our benchmarks are based on a 
distribution of scores. We do not believe it would be appropriate to 
apply this standard broadly to a measure without this analysis. We 
recommend that stakeholders contact us through our service center if 
they have identified a measure that they believe would meet the 
requirements to apply flat percentage benchmarks so that we may 
consider it for future rulemaking. We may consider in future years 
revisiting flat percentage benchmarks as we transform MIPS through the 
implementation of the MVP framework discussed in section III.K.3.a. of 
this final rule. We also note that the measures that we selected to 
apply the flat percentage benchmarks to are not topped out for any of 
the collection types.
    Comment: Several commenters recommended different methodologies 
that CMS could consider for the modified benchmarks. Several commenters 
encouraged CMS to use an approach where certain thresholds are 
determined based on expert opinion but interim values are informed by 
actual performance. Recognizing that this would be a more complex 
approach, these commenters believed that the thresholds should always 
be determined in part by data driven aspects such as peer performance 
and clinical evidence, in addition to manually fixed thresholds to 
ensure clinical relevance and fairness of measure benchmarks.
    A few commenters encouraged CMS to use other methods of setting 
benchmarks, such as adding exclusions or risk stratifications to all 
measures, or reducing all benchmarks for all measures, including all 
collection types, by a certain percentage, an equivalent number of 
points. One commenter suggested that CMS consider developing benchmarks 
based on actual performance, with a cap based on rates for the highest 
performers and partial credit for achieving progress toward the target.
    Response: We agree with commenters that using a data driven 
approach to benchmarks is preferred. While we received some information 
about the different methods, we do not believe we have sufficient 
information to conduct the analysis suggested for the measures we 
proposed to operationalize the alternatives for the 2020 MIPS

[[Page 63016]]

performance period. However, we are interested in working with 
stakeholders to better understand these alternative methods and would 
consider revising this policy through future rulemaking. Additionally, 
we plan to continue working with measure stewards to ensure the 
measures include appropriate exclusions or risk stratifications.
    Comment: Several commenters did not support our proposal to set 
benchmarks using a flat percentage for all collection types where the 
top decile is higher than 90 percent under the methodology if there are 
patients for whom it would be inappropriate to achieve the outcome 
targeted by the measure. While commenters recognized the need for a 
specialized approach, they expressed concerns regarding the 
consequences of this approach. Specifically, one commenter expressed 
concern that the measures proposed for the application of the flat 
percentages are claims based measures and MIPS CQMs, and that the 
application of the flat benchmark may unfairly lower the bar for 
clinicians utilizing the claims-based and MIPS CQM versions of the 
measures, without providing the same adjustment to all collection 
types. Another commenter expressed concern that the approach would lead 
to inconsistent evaluation of clinicians, as clinicians would be 
compared to their peers on some measures, but compared on flat 
thresholds on other measures that are unrelated to peer performance.
    Response: We recognize that not applying the same benchmarking 
methodology to all collection types may create some inconsistent 
evaluation between collection types for a single measure. On the other 
hand, we know there are differences in performance by data collection 
type, and we are concerned that if we apply this method to all 
collection types without regard to the collection type distribution, 
then we would harm those with top performance for certain collection 
types. Given this tension, we believe it is better to limit the 
benchmark proposal to those collection types where the top decile is 90 
percent or higher. We also intend to apply this policy in very limited 
circumstances where there is a concern with incentives for 
inappropriate treatment. At this time, we are proceeding cautiously 
with this approach by limiting application of this policy to two 
measures and two collections types. We may revisit this policy through 
future rulemaking.
    Comment: A few commenters did not support our proposal to apply the 
flat percentages to the following measures: MIPS #1 (NQF 0059): 
Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9) and MIPS #236 (NQF 
#0018), Controlling High Blood Pressure. These commenters expressed 
concern that the approach would not address the issue of potential 
inappropriate care, inappropriate treatment is rare for these measures, 
and our approach could potentially discourage appropriate care. A few 
commenters suggested that addressing exclusions for these measures 
might solve the issue of potential inappropriate care. However, another 
commenter cautioned against an approach based on exclusions. This 
commenter expressed concern that exclusions would not address every 
possible circumstance for each measure, and that expanding exclusions 
may have the inverse consequence of having systems focus on 
documentation improvements instead of clinical quality improvements.
    Response: For these two measures, we have heard concern from 
stakeholders that clinicians may feel pressure to meet the measures 
standards at a high level, which could result in inappropriate 
treatments in patients for whom the specified level of control of blood 
pressure or blood sugar may be different from the precise measure 
specifications. As long as the percent of these patients (those who may 
be at risk because they fall in this category) is less than 10 percent 
of the practice's eligible cases, our flat benchmark approach can 
completely remove any potential incentive to over-treat. While this 
approach would allow the same score (10 points) for any clinician who 
chose to lower their performance down to 90 percent from a higher 
level, we believe that the clinicians for whom this would be possible 
are already high performing clinicians who would not knowingly 
undertreat their patients. Regarding commenters' concerns around 
exclusions, the measure steward for these two measures has advised CMS 
of additional denominator exclusions for the 2022 MIPS payment year and 
future years. We refer readers to Appendix 1, Table Group D (Previously 
Finalized Quality Measures with Substantive Changes Finalized for the 
2022 MIPS Payment Year and Future Years) for additional details 
regarding these changes to the measures. We plan to continue working 
with measure stewards to ensure the measures include appropriate 
exclusions or risk stratifications. Additionally, we will work with 
stakeholders to better understand alternative methods and we may 
revisit this policy through future rulemaking.
    Comment: One commenter recommended that when CMS determines a 
collection type for a measure where the top decile is higher than 90 
percent under the methodology if there are patients for whom it would 
be inappropriate to achieve the outcome targeted by the measure, then 
CMS should either remove the measure from that specific collection type 
or modify the measure so that inappropriate actions do not count 
positively, or remove and replace the measure.
    Response: As noted in the CY 2020 Quality Payment Program proposed 
rule (84 FR 40751) and referred to in section III.K.3.c.(1)(d)(iv) of 
this final rule, we have established a robust set of removal criteria 
for quality measures. We will continue to work with quality measure 
stewards on future modifications of the measures and may consider 
removing or replacing any measures through notice and comment 
rulemaking as appropriate. At this time, we believe that the flat 
percentage benchmarks will allow the measure to stay in the program 
without incentivizing inappropriate care. We did not propose that we 
would substantively change the measures from their original state, as 
would be done if we were to no longer count patients that meet the 
requirements of the numerator when performance is high, as suggested by 
the commenter. However, we may consider this approach and consider 
removal of collection types through future rulemaking. We encourage 
stakeholders to develop meaningful measures that promote the quality 
outcomes and interactions for patients, additional viable quality 
measures, and robust performance data.
    After consideration of public comments, we are finalizing a policy 
to use the flat percentage benchmarks as an alternative to our standard 
method of calculating benchmarks by a percentile distribution of 
measure performance rates for all collection types where the top decile 
for any measure benchmark is higher than 90 percent and when CMS 
medical officers assess that there are patients for whom it would be 
inappropriate to achieve the outcome targeted by the measure benchmark. 
We will revise the text at Sec.  414.1380(b)(1)(ii) as proposed and add 
paragraph Sec.  414.1380(b)(1)(ii)(C) to state that beginning with the 
2022 MIPS payment year, for each measure that has a benchmark that CMS 
determines has the potential to result in inappropriate treatment, we 
will set benchmarks using a flat percentage for all collection types 
where the top decile is higher than 90 percent under the methodology at 
Sec.  414.1380(b)(1)(ii). We are also finalizing our proposal to apply 
the flat percentages to the following two

[[Page 63017]]

measures: MIPS #1 (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor 
Control (>9%) and MIPS #236 (NQF #0018): Controlling High Blood 
Pressure.
(ii) Request for Feedback on Additional Policies for Scoring the CAHPS 
for MIPS Survey Measure
    We refer readers to Sec.  414.1380(b)(1)(vii)(B) for more on our 
policy on reducing the total available measure achievement points for 
the quality performance category by 10 points for groups that submit 5 
or fewer quality measures and register for the CAHPS for MIPS survey, 
but do not meet the minimum beneficiary sampling requirements.
    In the CY 2020 PFS proposed rule (84 FR 40791), we did not propose 
any changes to the scoring of the CAHPS for MIPS survey measure. 
However, to the extent consistent with our authority to collect such 
information under section 1848(q) of the Act, we considered expanding 
the information collected in the CAHPS for MIPS survey measure, 
described in section III.K.3.c.(1) of this final rule, and solicited 
comment on scoring. One consideration is adding narrative questions to 
the CAHPS for MIPS survey measure, which would invite patients to 
respond to a series of questions in free text, such as responding to 
open ended questions and describing their experience with care in their 
own words. We believe narratives from patients about their health care 
experiences would be helpful to other patients when selecting a 
clinician and can provide a valuable complement to standardized survey 
scores, both to help clinicians understand what they can do to improve 
care and to engage and inform patients about differences among their 
experiences of care. On the other hand, there may be concerns about the 
accuracy and usefulness of narrative information reported by patients. 
For more information on the rationale for adding narrative questions, 
we refer readers to the CY 2020 PFS proposed rule (84 FR 40746 through 
40747). In addition, we are interested in learning from organizations 
with experience scoring narrative information, including methodologies. 
We will work with stakeholders on user testing before proposing any 
such methodology in future rulemaking. We also considered adding an 
additional CAHPS for MIPS survey question allowing patients to provide 
a score for their overall experience and satisfaction rating with a 
recent health care encounter, to capture the patient ``voice'' and 
provide patients with information useful to making a decision on 
clinicians, as detailed in the CY 2020 PFS proposed rule (84 FR 40744). 
We received feedback regarding how to score this measure and on new 
questions that could potentially be added to the calculation for a 
score for the CAHPS for MIPS survey measure. We will consider the 
feedback received for future notice and comment rulemaking.
(iii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality 
Performance Category Criteria
    In the CY 2019 PFS final rule (83 FR 35950), we finalized our 
proposal to modify our validation process to provide that it only 
applies to MIPS CQMs and the claims collection type, regardless of the 
submitter type chosen.
    In the CY 2020 PFS proposed rule (84 FR 40791), we did not propose 
any changes to this policy. However, we refer readers to section 
III.K.3.d.(2)(b)(ii)(A) of this final rule for discussion on the rare 
circumstances when we are unable to calculate a quality performance 
category score for a MIPS eligible clinician because they do not have 
applicable or available quality measures. If we are unable to score the 
quality performance category for a MIPS eligible clinician, then we 
will reweigh the clinician's quality performance category score 
according to the reweighting policies described in sections 
III.K.3.d.(2)(b)(iii) of this final rule.
(iv) Incentives To Report High-Priority Measures
    We refer readers to Sec.  414.1380(b)(1)(v)(A) for more on the cap 
on high-priority measure bonus points for the first 3 years of MIPS at 
10 percent of the denominator (total possible measure achievement 
points the MIPS eligible clinician could receive in the quality 
performance category) of the quality performance category.
    In the CY 2019 PFS final rule (83 FR 59851), we finalized technical 
updates to Sec.  414.1380(b)(1) to more clearly and concisely capture 
previously established policies in the section. During this effort we 
inadvertently added that a high priority measure must have a benchmark. 
This was not intended to be a policy change. We are clarifying that in 
order for a measure to qualify for high priority bonus points it must 
meet case minimum and data completeness and not have a zero percent 
performance. The measure does not need to have a benchmark. 
Accordingly, we proposed to revise Sec.  414.1380(b)(1)(v)(A)(1)(i) to 
provide that each high priority measure must meet the case minimum 
requirement at paragraph (b)(1)(iii) of this section, meet the data 
completeness requirement at Sec.  414.1340, and have a performance rate 
that is greater than zero (84 FR 40791).
    We also removed high priority bonus points for CMS Web interface 
reporters in the CY 2019 PFS final rule (83 FR 59850 through 59851). We 
refer readers to the CY 2019 PFS final rule for further discussion on 
this policy.
    In the CY 2020 PFS proposed rule (84 FR 40791), we proposed to 
maintain the cap on measure points for reporting high priority measures 
for the 2022 MIPS payment year. Accordingly, we proposed to revise 
Sec.  414.1380(b)(1)(v)(A)(1)(ii) to remove the years 2019, 2020, and 
2021 and adding in its place the years 2019 through 2022 to provide 
that for the 2019 through 2022 MIPS payment years, the total measure 
bonus points for high priority measures cannot exceed 10 percent of the 
total available measure achievement points.
    We received public comments on our proposal to clarify that a 
measure does not need to have a benchmark in order to qualify for high 
priority bonus points and our proposal to maintain the cap on measure 
points for reporting high priority measures for the 2022 MIPS payment 
year. The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the high priority bonus and 
CMS' proposal to maintain the cap on measure points for reporting high 
priority measures for the 2022 MIPS payment year. One commenter cited 
an example cap at 10 percent of the total available measure achievement 
points through 2022 and expressed its belief that these points are 
helpful to the reporting of outcome and high priority measures and also 
that the consistency of scoring policy assists with provider 
understanding and approval of the program. A few commenters recommended 
that CMS continue to incentivize reporting by awarding MIPS bonus 
points or cross-category credit.
    One commenter recommended further incentivizing bonus points for 
high priority measures because in some cases MIPS CQMs score higher 
than QCDR measures without the bonus points.
    Response: We appreciate the recommendations. We agree that 
continuing the scoring policy provides consistency and will take the 
recommendations into consideration in the future rulemaking as we move 
toward the implementation of the MVP framework. We believe that our 
current policy of capping the high-priority measure bonus at 10 percent 
of the denominator prevents incentivizing the reporting of additional 
measures over a

[[Page 63018]]

focus on performance in relevant clinical areas, and mask poor 
performance with higher bonus points.
    After consideration of the comments, we are finalizing our proposal 
to clarify that a measure does not need to have a benchmark in order to 
qualify for high priority bonus points and our proposal to maintain the 
cap on measure points for reporting high priority measures for the 2022 
MIPS payment year. We will revise Sec.  414.1380(b)(1)(v)(A)(1)(i) and 
(b)(1)(v)(A)(1)(ii) as proposed.
(v) Incentives To Use CEHRT To Support Quality Performance Category 
Submissions
    We refer readers to Sec.  414.1380(b)(1)(v)(B) for more on our 
policy assigning one bonus point for each quality measure submitted 
with end-to-end electronic reporting, under certain criteria.
    In the CY 2020 PFS proposed rule (84 FR 40791), we proposed to 
continue to assign and maintain the cap on measure bonus points for 
end-to-end electronic reporting for the 2022 MIPS payment year. We 
believe with the framework for transforming MIPS through the MVPs 
discussed in the 2020 PFS proposed rule (84 FR 40739), we can find ways 
in future years to incorporate eCQM measures without needing to 
incentivize end-to-end reporting with bonus points. As a result, we 
will wait until there is further policy development under the framework 
before proposing to remove our policy of assigning bonus points for 
end-to-end electronic reporting. Accordingly, we proposed to revise 
Sec.  414.1380(b)(1)(v)(B)(1)(i) to remove the years 2019, 2020, and 
2021 and add in its place the years 2019 through 2022 to provide that 
for the 2019 through 2022 MIPS payment years, the total measure bonus 
points for measures submitted with end-to-end electronic reporting 
cannot exceed 10 percent of the total available measure achievement 
points.
    We received public comments on our proposal to continue to assign 
and maintain the cap on measure bonus points for end-to-end electronic 
reporting for the 2022 MIPS payment year. The following is a summary of 
the comments we received and our responses.
    Comment: A few commenters supported the proposal to continue the 
end-to-end electronic reporting bonus points for providers utilizing 
electronic tools for MIPS reporting.
    Response: We appreciate the commenters' support.
    Comment: A few commenters opposed the proposal to maintain the 10 
percent cap on end-to-end electronic reporting points. Some commenters 
suggested that the MIPS scoring methodology should award credit across 
multiple MIPS performance categories and that continuing the cap on the 
bonus in the quality performance category would be counter to 
incentives to build capacity for digital data. A few commenters 
suggested that bonus points should be awarded in the PI performance 
category in addition to bonus points in the quality performance 
category.
    Response: We appreciate commenters' concerns and will take their 
recommendations into consideration for the future. As we stated in the 
proposed rule (84 FR 40791), we envision that the progression of the 
MIPS program under the MVP framework will allow us to remove some of 
the scoring complexity associated with the MIPS program. We anticipate 
that removing bonuses would be part of this framework. As such, we do 
not believe that eliminating or altering the cap on the bonus points 
available under the quality performance category for the 2022 MIPS 
payment year would support that goal. We also understand the interest 
in being as flexible as possible in awarding clinicians for supporting 
the goals of the program such as reporting through end-to-end CEHRT. We 
will continue to consider the best ways to support this goal in future 
rulemaking.
    After consideration of the comments, we are finalizing our proposal 
to continue to assign and maintain the cap on measure bonus points for 
end-to-end electronic reporting for the 2022 MIPS payment year. We will 
revise Sec.  414.1380(b)(1)(v)(B)(1)(i) as proposed.
(vi) 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 and 2021 MIPS payment year, we will 
assume a quality performance category achievement percent score of 30 
percent if a MIPS eligible clinician earned a quality performance 
category score less than or equal to 30 percent in the previous year.
    In the CY 2020 PFS proposed rule (84 FR 40791 through 40792), we 
proposed to continue our previously established policy for the 2022 
MIPS payment year and to revise Sec.  414.1380(b)(1)(vi)(C)(4) to 
remove the phrase ``2020 and 2021 MIPS payment year'' and adding in its 
place the phrase ``2019 through 2022 MIPS payment years'' to provide 
that for the 2020 through 2022 MIPS payment years, we will assume a 
quality performance category achievement percent score of 30 percent if 
a MIPS eligible clinician earned a quality performance category score 
less than or equal to 30 percent in the previous year. However, we 
misstated the replacement phrase, and clarify here that we will revise 
Sec.  414.1380(b)(1)(vi)(C)(4) to remove the phrase ``2020 and 2021 
MIPS payment year'' and add in its place the phrase ``2020 through 2022 
MIPS payment years''. Specifically, for the 2022 MIPS payment year, we 
will compare the MIPS eligible clinician's quality performance category 
achievement percent score for the 2020 MIPS performance period to an 
assumed quality performance category achievement percent score of 30 
percent if the MIPS eligible clinician earned a quality performance 
category score less than or equal to 30 percent for the 2019 MIPS 
performance period.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported CMS' proposal to assume the 
quality performance category achievement score equals 30 percent if 
MIPS eligible clinicians earned a quality performance category score 
less than or equal to 30 percent in the previous year.
    Response: We thank the commenter for their support.
    After consideration of the comments, we are finalizing our proposal 
to continue assume a quality performance category achievement percent 
score of 30 percent if a MIPS eligible clinician earned a quality 
performance category score less than or equal to 30 percent in the 
previous year. Consistent with our proposal, we will revise Sec.  
414.1380(b)(1)(vi)(C)(4) to remove the phrase ``2020 and 2021 MIPS 
payment year'' and add in its place the phrase ``2020 through 2022 MIPS 
payment years''.
(c) Facility-Based Measurement Scoring Option for the Quality and Cost 
Performance Categories for the 2022 MIPS Payment Year
(i) Background
    For our previously established policies regarding the facility-
based measurement scoring option, we refer readers to both the CY 2018 
Quality Payment Program final rule (82 FR 53752 through 53767) and the 
CY 2019 PFS final rule (83 FR 59856 through 59867). In the CY 2019 PFS 
proposed rule (83 FR 35962 through 35963), we requested comments on a 
number of issues and topics related to whether we should expand the 
facility-based scoring option to other facilities and programs in 
future years, particularly the use of end-stage renal disease (ESRD) 
and post-

[[Page 63019]]

acute care (PAC) settings as the basis for facility-based measurement 
and scoring. We appreciate the many comments we received in response to 
this request. We did not propose an expansion to other facility types 
as part of this rule but may consider addressing this issue in future 
rulemaking.
(ii) Facility-Based Measurement Eligibility
    In the CY 2019 PFS final rule (83 FR 59856 through 59860), we 
established the policies that determine eligibility for scoring for 
facility-based measurement as an individual and as a group. In the CY 
2019 PFS final rule, we established at Sec.  414.1380(e)(2)(i)(C) that 
a MIPS eligible clinician is facility-based if the clinician can be 
attributed, under the methodology specified in Sec.  414.1380(e)(5), to 
a facility with a value-based purchasing score for the applicable 
period. While we did not propose any changes to the eligibility of 
facility-based measurement for individuals or groups, we proposed to 
amend Sec.  414.1380(e)(2)(i)(C) to improve clarity (84 FR 40792). 
Specifically, we proposed to amend Sec.  414.1380(e)(2)(i)(C) to state 
that a MIPS eligible clinician is facility-based if the clinician can 
be assigned, under the methodology specified in Sec.  414.1380(e)(5), 
to a facility with a value-based purchasing score for the applicable 
period. We hope to avoid any ambiguity as we have used the term 
``attribute'' and ``attribution'' in two ways. We have used the term to 
refer to the use of the facility's performance in place of the 
clinician's own performance (83 FR 59857). We have also used the term 
at Sec.  414.1380(e)(2)(i)(C) to reference our method of connecting 
clinicians to a facility and indicate that the facility score will be 
the clinician's score. We believe these are related but distinct 
concepts; therefore, we proposed to revise Sec.  414.1380(e)(2)(i)(C) 
to use the term ``assign'' instead of ``attribute.'' We believe this 
change in language more clearly describes how a clinician receives a 
score under facility-based measurement while avoiding making any 
changes to our methods in determining eligibility for facility-based 
measurement or their score. This does not constitute a change in 
policy.
    We received public comments on our proposal to amend Sec.  
414.1380(e)(2)(i)(C) to state that a MIPS eligible clinician is 
facility-based if the clinician can be assigned, under the methodology 
specified in Sec.  414.1380(e)(5), to a facility with a value-based 
purchasing score for the applicable period. The following is a summary 
of the comments we received and our responses.
    Comment: A few commenters supported our technical proposal which 
clarifies that a MIPS eligible clinician is facility-based if the 
clinician can be assigned to a facility, as opposed to saying 
attributed.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing our 
proposal to amend Sec.  414.1380(e)(2)(i)(C) to state that a MIPS 
eligible clinician is facility-based if the clinician can be assigned, 
under the methodology specified in Sec.  414.1380(e)(5), to a facility 
with a value-based purchasing score for the applicable period.
(iii) Facility-Based Measures for CY 2020 MIPS Performance Period/2022 
MIPS Payment Year
    For informational purposes, we are providing in Table 51 a list of 
the measures included in the FY 2021 Hospital VBP Program measure set 
that will be used in determining the quality and cost performance 
category scores for the CY 2020 MIPS performance period/2022 MIPS 
payment year. The FY 2021 Hospital VBP Program has adopted 12 measures 
covering 4 domains (83 FR 20412 through 20413). The performance period 
for measures in the Hospital VBP Program varies depending on the 
measure, and some measures include multi-year performance periods. 
These measures are determined through separate rulemaking; the 
applicable rulemaking is usually the Hospital Inpatient Prospective 
Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care 
Hospital (LTCH) Prospective Payment System (PPS) rule. We are using 
these measures, benchmarks, and performance periods for the purposes of 
facility-based measurement in accordance with Sec.  414.1380(e)(1). The 
measures for FY 2021 Hospital VBP Program were summarized in the FY 
2019 IPPS/LTCH PPS proposed rule (83 FR 41454 through 41455).

[[Page 63020]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.098

(d) Scoring the Improvement Activities Performance Category
    For our previously established policies regarding scoring the 
improvement activities performance category, we refer readers to Sec.  
414.1380(b)(3), the CY 2018 Quality Payment Program final rule (82 FR 
53767 through 53769), and the CY 2019 PFS final rule (83 FR 59867 
through 59868). We also refer readers to Sec.  414.1355 and the CY 2017 
Quality Payment Program final rule (81 FR 77177 through 77199), the CY 
2018 Quality Payment Program final rule (82 FR 53648 through 53662), 
and the CY 2019 PFS final rule (83 FR 59776 through 59785) for our 
previously established policies regarding the improvement activities 
performance category generally and section III.K.3.c.(3) of this final 
rule, where we discuss our final policies for the improvement 
activities performance category.
(e) Scoring the Promoting Interoperability Performance Category
    We refer readers to section III.K.3.c.(4) of this final rule, where 
we discuss our final policies for the Promoting Interoperability 
performance category.
    For our previously established policies regarding scoring the 
Promoting Interoperability` performance category, we refer readers to 
Sec.  414.1380(b)(4), the CY 2017 Quality Payment Program final rule 
(81 FR 77216-77227), the CY 2018 Quality Payment Program final rule (82 
FR 53663 through 53670), and the CY 2019 PFS final rule (83 FR 59785 
through 59796). We also refer readers to Sec.  414.1375 and the CY 2017 
Quality Payment Program final rule (81 FR 77199 through 77245), the CY 
2018 Quality Payment Program final rule (82 FR 53663 through 53688), 
and the CY 2019 PFS final rule (83 FR 59785 through 59820) for our 
previously established policies regarding the Promoting 
Interoperability (formerly the advancing care information) performance 
category generally.
(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 Quality 
Payment Program final rule (81 FR 77319 through 77329), CY 2018 Quality 
Payment Program final rule (82 FR

[[Page 63021]]

53769 through 53785), and CY 2019 PFS final rule (83 FR 59868 through 
59878). In the CY 2020 PFS proposed rule (84 FR 40793 through 40800), 
we proposed to continue the complex patient bonus for the 2022 MIPS 
payment year and proposed performance category reweighting policies for 
the 2022, 2023, and 2024 MIPS payment years. These proposals are 
discussed in more detail in this section of the final rule.
(a) Complex Patient Bonus for the 2022 MIPS Payment Year
    In the CY 2019 PFS final rule (83 FR 59869 through 59870), under 
the authority in section 1848(q)(1)(G) of the Act, we finalized at 
Sec.  414.1380(c)(3) to maintain the complex patient bonus, which we 
previously finalized in the CY 2018 Quality Payment Program final rule 
(82 FR 53771 through 53776), of up to five points to be added to the 
final score for the 2021 MIPS payment year. The complex patient bonus 
was developed as a short-term solution to address the impact patient 
complexity may have on MIPS scoring that we would revisit on an annual 
basis while we continue to work with stakeholders on methods to account 
for patient risk factors. Our overall goal for the complex patient 
bonus was twofold: (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. For a detailed description of the 
complex patient bonus finalized for prior MIPS payment years, please 
refer to the CY 2018 Quality Payment Program final rule (82 FR 53771 
through 53776) and CY 2019 PFS final rule (83 FR 59869 through 59870).
    For the 2020 MIPS performance period/2022 MIPS payment year, we 
proposed (84 FR 40793) to continue the complex patient bonus as 
finalized for the 2019 MIPS performance period/2021 MIPS payment year 
and to revise Sec.  414.1380(c)(3) to reflect this policy. In the CY 
2020 PFS proposed rule (84 FR 40794), we noted that although we 
intended to maintain the complex patient bonus as a short-term 
solution, we did not believe we had sufficient information available to 
develop a long-term solution to account for patient risk factors in 
MIPS such that we would be able to include a different approach in the 
proposed rule. Section 1848(q)(1)(G) of the Act requires us to consider 
risk factors in our scoring methodology for MIPS. Specifically, it 
provides that the Secretary, on an ongoing basis, shall, as the 
Secretary determines appropriate and based on individuals' health 
status and other risk factors, assess appropriate adjustments to 
quality measures, cost measures, and other measures used under MIPS and 
assess and implement appropriate adjustments to payment adjustments, 
final scores, scores for performance categories, or scores for measures 
or activities under MIPS. In doing so, the Secretary is required to 
take into account the relevant studies conducted by the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) under section 
2(d) of the Improving Medicare Post-Acute Care Transformation Act of 
2014 (IMPACT Act) (Pub. L. 113-185, enacted October 6, 2014) and, as 
appropriate, other information, including information collected before 
completion of such studies and recommendations. ASPE completed its 
first report \116\ 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. In the CY 2020 PFS proposed 
rule (84 FR 40794), we noted the second ASPE report is expected in 
October 2019. At the time of publication of this final rule, the report 
has not been released. When the report becomes available, we intend to 
consider its recommendations for future rulemaking. At the time of 
publication of the CY 2020 PFS proposed rule, we did not believe 
additional data sources were available that would be feasible to use as 
the basis for a different approach to account for patient risk factors 
in MIPS. We plan to continue working with ASPE, the public, and other 
key stakeholders on this important issue to identify policy solutions 
that achieve the goals of attaining health equity for all beneficiaries 
and minimizing unintended consequences.
---------------------------------------------------------------------------

    \116\ U.S. Department of Health and Human Services, Office of 
the Assistant Secretary for Planning and Evaluation, Report to 
Congress: Social Risk Factors and Performance Under Medicare's 
Value-Based Purchasing Programs (2016). Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
---------------------------------------------------------------------------

    In the CY 2020 PFS proposed rule (84 FR 40794), we considered 
whether the data still support the complex patient bonus at the final 
score level. We replicated analyses similar to the ones presented in 
Table 27 of the CY 2018 Quality Payment Program final rule (82 FR 
53776). These analyses used the data submitted for the Quality Payment 
Program for the 2017 MIPS performance period and assessed eligibility 
and final scores based on the proposals we made for the 2020 MIPS 
performance period/2022 MIPS payment year using the methodology 
described in the Regulatory Impact Analysis in section VI. of the CY 
2020 PFS proposed rule (84 FR 40898 through 40900).
    Overall, the analysis of preliminary data referenced in the CY 2020 
PFS proposed rule (84 FR 40793 through 40795) shows a consistent 
relationship between the dual eligible ratio quartiles and the average 
MIPS final scores only for individuals, where the average MIPS final 
score decreases as the quartile increases. We saw slight differences in 
the average HCC risk score and dual eligible ratio quartiles for 
groups, but virtually no difference for average HCC risk score for 
individuals. However, we had only 1 year of data and we noted more 
recent data may bring different results. In addition, at the time of 
publication of the proposed rule, we were awaiting a second report from 
ASPE in October 2019 that we expected would provide more direction for 
our approach to accounting for risk factors in MIPS. We were concerned 
that without the information from ASPE and without observing a clear 
trend that would require a change in our methodology, making any 
changes beyond our proposal to continue this policy would be premature.
    We received public comments on our proposal to continue the complex 
patient bonus for one additional year. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters supported our proposal to continue the 
complex patient bonus for the 2022 MIPS payment year. One commenter 
urged CMS to exercise caution in updating the complex patient bonus 
based on MIPS final scores from the 2017 MIPS performance period 
because these scores did not include cost measures and do not fully 
capture scoring variation based on clinical or social risk factors. The 
commenter also indicated that additional policy changes could impact 
MIPS final scores.
    Response: We agree that scoring changes over the different MIPS 
payment years could impact MIPS final scores. We clarify that our 
analysis in the CY 2020 PFS proposed rule (84 FR 40793 through 40795) 
used data submitted for the 2017 performance period but estimated 
eligibility and final scores for the 2020 performance period by 
proxying a score using the methods described in the CY 2020 PFS 
proposed

[[Page 63022]]

rule (84 FR 40894 through 40901) to supplement the gap in data needed 
to estimate scores for the 2020 performance period. The additional data 
sources included the following cost measures: Total per capita cost 
measure performance based on the proposed revised measure using claims 
data from October 2016 through September 2017; and the proposed revised 
MSPB clinician measure and the 10 proposed episode-based measures based 
on claims data from January through December of 2017 (84 FR 40898). 
Therefore, the estimates did include the cost measures that would apply 
for the 2020 performance period. The methodology in the Regulatory 
Impact Analysis of the CY 2020 PFS proposed rule (84 FR 40894 through 
40901) also included the complex patient bonus from the 2018 
performance period (84 FR 40899); however, we did not include that 
bonus in the final score used for this analysis because we wanted to 
assess the difference in final scores prior to the application of the 
complex patient bonus. This is consistent with our original analysis 
when we proposed the complex patient bonus in the CY 2018 Quality 
Payment Program proposed rule (82 FR 30136).
    We have updated this analysis with the most recent data in Table 
52. Specifically, as described in section VII.F.10 of this final rule, 
we used data submitted for the 2018 MIPS performance period as an input 
to estimate the 2020 MIPS performance period final scores.
[GRAPHIC] [TIFF OMITTED] TR15NO19.099

    The updated analysis reinforces findings from the analysis in the 
CY 2020 PFS proposed rule (84 FR 40795), again failing to find a 
consistent linear relationship between HCC quartiles and MIPS final 
scores, or dual eligible ratio quartiles and MIPS final scores. In the 
earlier analysis a consistent linear relationship was still found for 
MIPS final scores for individual reporters and dual eligible ratio 
quartiles. In the updated analysis, we did not observe a consistent 
linear relationship for any reporting type or complexity measure. For 
example, for groups, we estimate mean MIPS final scores to be higher 
for groups in the second quartile of dual eligible ratio or HCC 
quartile, than for groups in the first, lowest quartile. For 
individuals, mean MIPS final scores are estimated to be slightly higher 
for those with the highest average HCC, than for those with the lowest 
average HCC. It appears that other, unmeasured factors in addition to 
HCC and dual eligible ratio may be impacting MIPS scores in the 2018 
data. We do see differences from the top and bottom quartile in three 
of the four comparisons (individual-dual eligible quartiles, and in 
both group reporting comparisons), so we are intending to finalize as 
proposed. However, given the inconsistent findings, we intend to 
revisit the size and structure of the complex patient bonus through 
future rulemaking.
    Comment: A few commenters pointed out perceived limitations in the 
use of the HCC risk score in calculating the complex patient bonus; 
specifically, they believed it does not fully capture factors that 
increase risk or complexity for many specialties. One commenter 
suggested that CMS identify new data sets and strategies to better 
represent clinical and social complexity. One commenter suggested that 
CMS use geographic location as a proxy for social risk because 
geographic location is often associated with available resources and 
access to medical care.
    Response: We thank the commenters for their suggestions and will 
take them into consideration as we consider options for updating the 
complex patient bonus in future years. We hope to be able to reference 
the ASPE report findings in future rulemaking. The complex patient 
bonus was intended to be a temporary solution while more permanent 
solutions were identified. We understand that both HCC risk scores and 
dual eligibility have some limitations as proxies for social risk 
factors. However, we are not aware of data sources for indicators such 
as income and education that are readily available for all Medicare 
beneficiaries that would be more complete indices of a patient's 
complexity. Therefore, we have decided to pair the HCC risk score

[[Page 63023]]

with the proportion of dual eligible patients to create a more complete 
complex patient indicator than can be captured using HCC risk scores 
alone. We will evaluate additional options in future years based on any 
updated data or additional information to better account for social 
risk factors while minimizing unintended consequences and consider 
these as we move forward.
    After consideration of public comments, we are finalizing our 
proposal for the 2020 MIPS performance period/2022 MIPS payment year, 
to continue the complex patient bonus as finalized for the 2019 MIPS 
performance period/2021 MIPS payment year, as well as our proposed 
revisions to Sec.  414.1380(c)(3).
(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 
and CY 2018 Quality Payment Program final rules (81 FR 77320 through 
77329 and 82 FR 53779 through 53785, respectively), as well as the CY 
2019 PFS final rule (83 FR 59870 through 59878). As finalized in 
section III.K.3.c.(2)(a) of this final rule, the cost performance 
category will make up 15 percent of a MIPS eligible clinician's final 
score for the 2022 MIPS payment year. As finalized in section 
III.K.3.c.(1)(b) of this final rule, the quality performance category 
will thus make up 45 percent of a MIPS eligible clinician's final score 
the 2022 MIPS payment year. As described in sections III.K.3.c.(2)(a) 
and III.K.3.c.(1)(b) of this final rule, we are not finalizing weights 
for the cost and quality performance categories for the 2023 and 2024 
MIPS payment years. Table 53 summarizes the finalized weights for each 
performance category.

Table 53--Weights by MIPS Performance Category for the 2022 MIPS Payment
                                  Year
------------------------------------------------------------------------
                                                             2022 MIPS
                  Performance category                     payment year
                                                             (percent)
------------------------------------------------------------------------
Quality.................................................              45
Cost....................................................              15
Improvement Activities..................................              15
Promoting Interoperability..............................              25
------------------------------------------------------------------------

(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 for 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 2019 PFS 
final rule (83 FR 59871 through 59876).
(A) Reweighting Performance Categories Due to Data That Are Inaccurate, 
Unusable, or Otherwise Compromised
    In the proposed rule (84 FR 40796 through 40797), we discussed our 
belief that measures and activities may not be available to a MIPS 
eligible clinician for the quality, cost, and improvement activities 
performance categories under section 1848(q)(5)(F) of the Act when data 
related to the measures and activities are inaccurate, unusable or 
otherwise compromised due to circumstances that are outside of the 
control of the MIPS eligible clinician or its agents. In addition, we 
discussed our belief that data that are inaccurate, unusable or 
otherwise compromised due to circumstances that are outside of the 
control of the MIPS eligible clinician or its agents could constitute a 
significant hardship for purposes of the Promoting Interoperability 
performance category under section 1848(o)(2)(D) of the Act. We 
proposed a new policy to allow reweighing for any performance category 
if, based on information we learn prior to the beginning of a MIPS 
payment year, we determine data for that performance category are 
inaccurate, unusable or otherwise compromised due to circumstances 
outside of the control of the MIPS eligible clinician or its agents. 
For more information on our reasons for this proposal, please refer to 
the proposed rule (84 FR 40796 through 40797).
    For purposes of this reweighting policy, we proposed that 
reweighting would take into account both what control the clinician had 
directly over the circumstances and what control the clinician had 
indirectly through its agents. We intended the term agent to include 
any individual or entity, including a third party intermediary as 
described in Sec.  414.1400, acting on behalf of or under the 
instruction of the MIPS eligible clinician. We solicited comments on 
this approach and possible alternatives for balancing efforts to allow 
reweighting in circumstances in which clinicians are not culpable for 
compromised data while maintaining financial incentives for clinicians, 
third party intermediaries and other parties to prevent and correct 
compromised data.
    We proposed that our determination of whether reweighting will be 
applied under this policy could take into account any information known 
to the agency and we would consider the information we obtain on a 
case-by-case basis for reweighting. We anticipated considering 
information provided to us through routine communication channels for 
the Quality Payment Program by any submitter type as defined under 
Sec.  414.1305, as well as other relevant information sources of which 
we are aware. We requested that third party intermediaries, to the 
extent feasible, inform MIPS eligible clinicians if the third party 
intermediary believes their data may have been compromised. To the 
extent third party intermediaries believe that MIPS data may be 
compromised, we encouraged them to provide us with a list of or other 
identifying information for all MIPS eligible clinicians who may have 
been affected by such issues, so that we may evaluate the circumstances 
in a timely

[[Page 63024]]

manner. We also encouraged MIPS eligible clinicians to contact us and 
self-identify if they believe they have compromised data; they should 
not rely solely on a third party intermediary to do so. We recognized 
that there may be scenarios when a MIPS eligible clinician or one or 
more of its agents becomes aware of potential data issues prior to 
submission of data. We solicited comment on whether and how our 
proposed reweighting policy should apply to these circumstances. We 
noted that compromised data are not true, accurate or complete for 
purposes of Sec.  414.1390(b) or Sec.  414.1400(a)(5) and knowing 
submission of compromised data may result in remedial action against 
the submitter. We noted that a MIPS eligible clinician should not 
submit data and should not allow the submission of his or her data if 
the MIPS eligible clinician knows that the data are inaccurate, 
unusable, or otherwise compromised.
    We proposed to determine whether the requirements for reweighting 
are met by assessing if: (1) The MIPS eligible clinician's data are 
inaccurate, unusable, or otherwise compromised; and (2) the data are 
compromised due to circumstances outside of the control of the MIPS 
eligible clinician or agent. We would make the determination of whether 
the clinician's data are inaccurate, unusable or otherwise compromised 
based on documentation of the issue and its demonstrated effect on data 
of the particular MIPS eligible clinician. As noted above, we proposed 
to limit this policy to cases where data are compromised outside the 
control of the clinician or its agent because we do not want to create 
incentives for clinicians or third party intermediaries to knowingly 
submit compromised data and want to encourage clinicians and their 
agents to take reasonable efforts to correct data that they believe 
maybe not compromised. Factors relevant to whether the circumstances 
were outside the control of the clinician and its agents include: 
whether the affected MIPS eligible clinician or its agents knew or had 
reason to know of the issue; whether the affected MIPS eligible 
clinician or its agents attempted to correct the issue; and whether the 
issue caused the data submitted to be inaccurate or unusable for MIPS 
purposes. We solicited feedback on these factors and whether there are 
additional factors we should consider to determine if there should be 
reweighing based on compromised data. If we determine that a MIPS 
eligible clinician's data were compromised and the conditions for 
reweighting are met, we proposed to notify the clinician of this 
determination through the performance feedback that we provide under 
section 1848(q)(12) of the Act if feasible, or through routine 
communication channels for the Quality Payment Program. We emphasized 
that the proposed reweighting policy is solely intended to mitigate the 
potential adverse financial impact of compromised data on the MIPS 
eligible clinician; a determination under this policy that data are 
compromised due to circumstances outside of the control of the MIPS 
eligible clinician and its agent, and therefore, that reweighting will 
occur for that clinician does not indicate and should not be 
interpreted to suggest that a third party intermediary or other 
individual or entity could not be held liable for the compromised data.
    We proposed to apply reweighting only in cases when we learn of the 
compromised data before the beginning of the associated MIPS payment 
year because we want to encourage MIPS eligible clinicians and their 
agents to inform us of these concerns in a timely basis so we can 
update our data sets timely, while minimizing the impacts to other 
stakeholders who utilize MIPS data. For example, the Physician Compare 
website utilizes MIPS data to provide information to patients, 
consumers and other stakeholders when selecting a clinician or group. 
We noted our concern that without the appropriate incentive to notify 
us in a timely manner, clinicians and their agents may delay 
disclosures that data may be compromised and with these delays the MIPS 
data could be in an increased state of flux which will reduce the 
usefulness of the data to stakeholders. We were interested in feedback 
on whether there are other factors we should consider when adopting a 
timeline for reweighting due to compromised data and whether the period 
should be broader. We solicited comment on whether we should restrict 
our reweighting due to compromised data to instances when we learn the 
relevant information prior to the beginning of the MIPS payment year 
and whether there are other incentives for MIPS eligible clinicians to 
alert us to concerns about compromised data. We emphasized that if we 
determine a MIPS eligible clinician has submitted compromised data for 
a performance category during the associated payment year or at a later 
point, the MIPS eligible clinician would not qualify for reweighting 
under this proposal. Instead, for the performance categories with 
compromised data, the clinician's performance category score would be 
zero and the scoring weight for the category would not be 
redistributed.
    In summary, under the authority in sections 1848(q)(5)(F) and 
1848(o)(2)(D) of the Act, we proposed at Sec.  414.1380(c)(2)(i)(A)(9), 
and (c)(2)(i)(C)(10), beginning with the 2018 MIPS performance period 
and 2020 MIPS payment year, to reweight the performance categories for 
a MIPS eligible clinician who we determine has data for a performance 
category that are inaccurate, unusable or otherwise compromised due to 
circumstances outside of the control of the clinician or its agents if 
we learn the relevant information prior to the beginning of the 
associated MIPS payment year. In addition, we proposed to amend Sec.  
414.1380(c)(2)(i)(C) to ensure that the reweighting proposed at Sec.  
414.1380(c)(2)(i)(C)(10), would not be voided by the submission of data 
for the Promoting Interoperability performance category as is the case 
with other significant hardship exceptions. We solicited comment on 
this proposal and alternatives to potentially mitigate the impact on 
MIPS eligible clinicians who through no fault of their own have data in 
a performance category that are inaccurate, unusable or are otherwise 
compromised.
    We received public comments on our proposal and alternatives to 
potentially mitigate the impact on MIPS eligible clinicians who through 
no fault of their own have data in a performance category that are 
inaccurate, unusable or are otherwise compromised. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported our proposal to reweight MIPS 
eligible clinicians impacted by data that are inaccurate, unusable, or 
otherwise compromised. Commenters indicated that in instances when data 
are inaccurate, unusable, or otherwise compromised outside of the 
control of the MIPS eligible clinician, relief for the clinician is 
appropriate.
    Response: We appreciate the commenters' support of our proposal.
    Comment: One commenter supported our policy to apply reweighting 
beginning with the 2018 MIPS performance period and the 2020 MIPS 
payment year so that MIPS eligible clinicians impacted by circumstances 
during that year can be provided with relief.
    Response: We appreciate the commenter's support. We believe it is 
important to apply this policy beginning with the 2018 performance 
period/2020 MIPS payment year in case any circumstances have occurred 
that impact this payment year that have been

[[Page 63025]]

recently discovered. MIPS eligible clinicians and third party 
intermediaries can alert CMS through the help desk at [email protected] 
regarding any data that they believe may be inaccurate, unusable or 
otherwise compromised.
    Comment: One commenter supported our proposal that submission of 
data for the Promoting Interoperability performance category would not 
nullify reweighting under the proposed policy.
    Response: We appreciate the commenter's support.
    Comment: One commenter supported the proposal because the commenter 
believed it would promote competition among EHR vendors by removing a 
significant obstacle to switching vendors during performance periods.
    Response: We thank the commenter for their support. However, we 
note that our goal for this proposal was to mitigate for MIPS eligible 
clinicians the potential adverse scoring impact of data that are 
inaccurate, unusable, or otherwise compromised, and we did not intend 
for the proposal to impact competition among vendors.
    Comment: A few commenters provided suggestions for the types of 
circumstances where they believe actions by their third party 
intermediary could lead to data being inaccurate, unusable, or 
otherwise compromised outside of the control of the clinician or its 
agents. These include instances when the third party intermediary goes 
out of business, makes a data submission error, or experiences a loss 
of data (examples may include storage malfunction; or the vendor not 
capturing data appropriately, resulting in incorrect measure data).
    Response: We believe that, depending on the specific circumstances 
and timing, these circumstances could be covered under this policy. We 
encourage MIPS eligible clinicians and their agents experiencing these 
types of circumstances to communicate with us as early as possible to 
provide details about the circumstances surrounding these events. We 
also note that, depending on the specific circumstances, we may 
determine that the conduct of the third party intermediary warrants 
taking remedial action or terminating the third party intermediary in 
accordance with Sec.  414.1400(f).
    Comment: One commenter expressed the belief that we should include 
circumstances under this policy where a third party intermediary 
experiences a cyberattack causing any of the following: loss of data, 
loss of access to data, inability to analyze data, inability to package 
data, inability to transmit data to CMS, or any other significant 
obstacle to data collection or submission. The commenter also suggested 
this policy should include circumstances when a third party 
intermediary experiences an extreme and uncontrollable event, such as a 
natural disaster.
    Response: We believe that our policy could apply in cases when a 
MIPS eligible clinician or their agent is impacted by a cyberattack 
that causes the eligible clinician's data to be inaccurate, unusable, 
or otherwise unusable. We clarify that this could apply even in cases 
where data are not able to be submitted as a result of the attack. We 
note that eligibility for reweighting would depend on the specific 
circumstances and timing, including the safeguards that were in place 
to prevent such attacks. We further emphasize that there is an 
expectation that third party intermediary take reasonable steps to 
prevent these attacks from occurring, and that, depending on the 
circumstances, CMS may determine that the conduct of the third party 
intermediary warrants taking remedial action or terminating the third 
party intermediary in accordance with Sec.  414.1400(f). Finally, we 
agree with the commenter that our policy could apply in cases when a 
third intermediary experiences a natural disaster that causes the MIPS 
eligible clinician's data to be inaccurate, unusable, or otherwise 
unusable.
    Comment: One commenter urged us to consider applying the proposed 
policy to scenarios where hospital-based clinicians are impacted by 
changes in hospital contracts that occur midway through the year. One 
example provided was when a hospital contract with a group ends, and 
the group may only have incomplete data from that hospital and may not 
be able to fully or accurately report. Another example provided was 
where a group begins a new contract with a hospital late in the year 
and may not be able to receive enough data from the new or prior 
hospital to fully and accurately report for MIPS.
    Response: We believe that our policy could apply in cases where a 
clinician's data are rendered inaccurate, unusable, or otherwise 
compromised due to changes in hospital contracts that are outside the 
control of the clinician or its agents; however, in the examples 
provided it is not clear that the data issues associated with the 
contract changes would meet these criteria. In cases where MIPS 
eligible clinicians undergo transitions in hospital contracts, we 
encourage MIPS eligible clinicians to work with their contracting 
hospital to obtain data, including in cases where the MIPS eligible 
clinician may terminate a contract or may initiate a new contract.
    Comment: One commenter suggested that we ensure that the 
requirements for MIPS eligible clinicians to alert us of relevant 
information are not unduly burdensome. For instance, the commenter 
proposed that each MIPS eligible clinician associated with a single 
third party intermediary that has compromised its users' data should 
not be required to submit evidence to CMS that their data were 
impacted.
    Response: We intend for our reweighting determinations to take into 
account information that we learn of from a variety of channels, 
including through various communication channels and through third 
party intermediaries. To the extent possible, when we learn of data 
that have been compromised and receive sufficient information to 
determine the conditions for reweighting have been met for a MIPS 
eligible clinician, we intend to provide reweighting without requiring 
any action on the part of the MIPS eligible clinician. However, there 
may be some circumstances under which we will be unable to reach a 
conclusion regarding reweighting unless the MIPS eligible clinician 
provides us with information. For example, if we become aware that a 
third party intermediary has a data integrity issue that has resulted 
in compromised data for some but not all of its customers, MIPS 
eligible clinicians could help us reach a determination regarding 
potential reweighting by providing us with information, such as their 
clinician identifiers (for example, TIN/NPI or other identifiers) and 
submission type, through the Quality Payment Program help desk.
    Comment: A few commenters urged us to notify MIPS eligible 
clinicians as early as possible if the agency receives reports 
suggesting they may have compromised data and provide them with 
information to understand how they can correct the problem going 
forward. Commenters also suggested that we work with impacted MIPS 
eligible clinicians to identify alternative reporting options, if 
feasible.
    Response: When we learn of circumstances that suggest MIPS data are 
inaccurate, unusable or otherwise compromised, we will aim to provide 
information to the MIPS eligible clinicians whose data may have been 
compromised on an ongoing and timely basis. In cases where the data 
concern is associated with a third party intermediary and the issue is 
identified prior to the data submission deadline,

[[Page 63026]]

we agree that it would be ideal for MIPS eligible clinicians to 
identify alternate arrangements if any that may allow them to submit 
uncompromised data. For example, in scenarios where the underlying 
source data are uncompromised a MIPS eligible clinician may be able to 
identify a new third party intermediary that may be able to utilize 
their source data.
    Comment: One commenter indicated that we should not apply 
reweighting in cases when a MIPS eligible clinician knowingly submitted 
data that are inaccurate, unusable, or otherwise compromised.
    Response: A MIPS eligible clinician who has submitted compromised 
data would receive a score of zero for the performance category. 
Eligible clinicians who unknowingly submitted compromised data, or were 
not able to submit data due to their data being compromised may be able 
to receive reweighting if the circumstances were outside their control. 
However, an eligible clinician who knowingly submits compromised data 
would not be eligible for reweighing because the submission of 
compromised data was within the clinician's control. In addition, we 
note that compromised data are not true, accurate, or complete for 
purposes of Sec.  414.1390(b) or Sec.  414.1400(a)(5), and knowing 
submission of compromised data may result in remedial action against 
the submitter.
    Comment: One commenter requested clarification as to how we would 
determine what constitutes compromised data and whether the 
circumstances were outside the control of the MIPS eligible clinician.
    Response: We appreciate the request for clarification. We intend to 
make this determination on a case-by-case basis based on information 
known to the agency.
    Comment: One commenter suggested that we stipulate that we will not 
hold third party intermediaries who inform CMS of relevant 
circumstances liable under current fraud, waste, and abuse laws and 
regulations or current laws and regulations governing the certification 
of their products. The commenter pointed to policies elsewhere in HHS 
under which parties can limit their liability by self-disclosing prior 
misconduct as a potential guide for policy in MIPS. The commenter 
suggested a framework under which a health IT developer or third-party 
intermediary would not face liability in connection with compromised 
data if it discloses the issue to CMS and eligible clinicians in good 
faith.
    Response: We intended for this policy to provide flexibility for 
MIPS eligible clinicians whose data are inaccurate, unusable, or 
otherwise compromised due to circumstances outside the control of 
clinicians and their agents. We did not develop this policy to hold 
harmless third party intermediaries or other agents for any role they 
play in data inaccuracies. CMS does not have authority to waive 
liability as it relates to fraud, waste, and abuse laws or to alter the 
certification requirements of health information technology. 
Furthermore, we plan to share information as appropriate with law 
enforcement and with ONC to the extent we learn of concerns involving 
CEHRT, as defined at Sec.  414.1305. We also note that third party 
intermediaries that submit data that are inaccurate, unusable or 
otherwise compromised may be subject to remedial action or termination 
in accordance with Sec.  414.1400(f).
    Comment: One commenter suggested that CMS apply this policy when 
MIPS eligible clinicians or third party intermediaries become aware of 
relevant information prior to the end of the MIPS data submission 
period, because doing so would encourage MIPS eligible clinicians, 
health IT vendors, and third party intermediaries to inform CMS of 
relevant information in a timely manner. One commenter suggested that 
CMS consider the timing of the discovery of the compromised data when 
making a determination of whether to apply reweighting.
    Response: We agree that MIPS eligible clinicians and third party 
intermediaries should alert CMS of relevant information in a timely 
manner. If a MIPS eligible clinician with compromised data requests 
reweighting under this policy, we would consider both the timing of 
when the clinician learned the data were compromised and the state of 
the data to determine whether reweighting is appropriate. We believe 
there may be some circumstances where a MIPS eligible clinician learns 
that their data is inaccurate, unusable, or otherwise compromised 
before the end of the data submission period and the source data is 
unaffected. In these instances, we believe the MIPS eligible clinician 
should explore alternatives and if possible submit data that are 
uncompromised.
    Comment: One commenter supported our proposal to limit the policy 
to information we learn of prior to the beginning of the applicable 
MIPS payment year.
    Response: We thank the commenter for their support of our proposal.
    Comment: One commenter requested that we ensure the terms ``any 
individual or entity'' within the definition of ``agent'' for purposes 
of this policy include practice staff, billing vendors, practice 
vendors, consultants, chart abstractors, and the like because these 
entities are often the root cause of data errors or incomplete 
reporting.
    Response: We proposed that the term agent include any individual or 
entity, including a third party intermediary as described in Sec.  
414.1400, acting on behalf of or under the instruction of the MIPS 
eligible clinician (84 FR 40796). In reviewing individual circumstances 
to determine if reweighting is warranted, we will consider the specific 
circumstances that led to data being inaccurate, unusable, or otherwise 
compromised and will consider whether individuals or entities involved 
in the data errors were working in a capacity within the control of the 
clinician and whether quality control processes should have been in 
place to prevent errors.
    Comment: One commenter requested that we extend the policy into the 
payment year for instances when the MIPS eligible clinician learns 
about the data issue after receiving payment adjustments.
    Response: We continue to believe it is appropriate to apply 
reweighting only in cases when we learn of the compromised data before 
the beginning of the associated MIPS payment year because we want to 
encourage MIPS eligible clinicians and their agents to inform us of 
these concerns in a timely manner so we can update our data sets 
timely, while minimizing the impacts to other stakeholders who utilize 
MIPS data.
    After consideration of the comments we received, we are finalizing 
our proposal at Sec.  414.1380(c)(2)(i)(A)(9) and (c)(2)(i)(C)(10) to, 
beginning with the 2018 MIPS performance period and 2020 MIPS payment 
year, reweight the performance categories for a MIPS eligible clinician 
we determine has data for a performance category that are inaccurate, 
unusable or otherwise compromised due to circumstances outside of the 
control of the clinician or its agents if we learn the relevant 
information prior to the beginning of the associated MIPS payment year. 
In addition, we are finalizing our proposed amendment to Sec.  
414.1380(c)(2)(i)(C) to ensure that the reweighting at Sec.  
414.1380(c)(2)(i)(C)(10) will not be voided by the submission of data 
for the Promoting Interoperability performance category.
    We note that we previously finalized at Sec.  414.1380(c) that if a 
MIPS eligible

[[Page 63027]]

clinician is scored on fewer than two performance categories, he or she 
will receive a final score equal to the performance threshold (81 FR 
77326 through 77328 and 82 FR 53778 through 53779). Therefore, if a 
MIPS eligible clinician is scored on fewer than two performance 
categories as a result of reweighting due to compromised data, he or 
she would receive a final score equal to the performance threshold.
(iii) Redistributing Performance Category Weights
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77325 through 77329 and 82 FR 53783 through 53785, 53895 through 
53900), in the CY 2019 PFS final rule (83 FR 59876 through 59878), and 
at Sec.  414.1380(c)(2)(ii), we established policies for redistributing 
the weights of performance categories for the 2019, 2020, and 2021 MIPS 
payment years 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.
    In the CY 2020 PFS proposed rule (84 FR 40798), we discussed our 
belief that it would not be appropriate to redistribute weight from the 
other performance categories to the cost performance category for the 
2022 MIPS payment year, except in scenarios in which the only other 
scored performance category is the improvement activities performance 
category. We noted that we had proposed substantial changes to the MSPB 
and total per capital cost measures, as well as adding 10 new episode-
based measures (84 FR 40753 through 40762). We stated that we believed 
it is appropriate to provide MIPS eligible clinicians additional time 
to adjust to these changes prior to redistributing weight to the cost 
performance category. Under the proposals we made in the proposed rule, 
as described in more detail below, we would begin to redistribute more 
weight to the cost performance category beginning with the 2023 MIPS 
payment year, because MIPS eligible clinicians will have had more 
experience being scored on cost measures at that point, and will have 
had time to adjust to the changes to existing measures and new episode-
based measures that we proposed.
    Beginning with the 2022 MIPS payment year, we proposed to not 
redistribute performance category weights to the improvement activities 
performance category in any scenario (84 FR 40798). 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 stated that we believe 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. Therefore, we stated that we believe it is no longer 
appropriate to increase the weight of the improvement activities 
performance category above 15 percent under our redistribution 
policies. We noted that in situations where the weights of both the 
quality and Promoting Interoperability performance categories are 
redistributed, cost would be weighted at 85 percent and improvement 
activities would be weighted at 15 percent. We stated that we believe 
this would help 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).
    For the 2022 MIPS payment year, we proposed at Sec.  
414.1380(c)(2)(ii)(D) similar redistribution policies to our policies 
finalized for the 2021 MIPS payment year (83 FR 59876 through 59878), 
with minor modifications, as shown in Table 54 (84 FR 40798). First, we 
adjusted our redistribution policies to account for a cost performance 
category weight of 20 percent for the 2022 MIPS payment year. We also 
proposed, in scenarios when the cost performance category weight is 
redistributed while the Promoting Interoperability performance category 
weight is not, to redistribute a portion of the cost performance 
category weight to the Promoting Interoperability performance category, 
as well as to the quality performance category. We stated that we 
believe this is appropriate given our current focus on working with the 
Office of the National Coordinator for Health IT (ONC) on 
implementation of the interoperability provisions of the 21st Century 
Cures Act (the Cures Act) (Pub. L. 115-233, enacted December 13, 2016) 
to ensure seamless but secure exchange of health information for 
clinicians and patients. While we have previously redistributed all of 
the cost performance category weight to the quality performance 
category (83 FR 59876 through 59878), we proposed to redistribute 15 
percent to the quality performance category and 5 percent to the 
Promoting Interoperability performance category for the 2022 MIPS 
payment year (see Table 54). This proposed change would emphasize the 
importance of interoperability without overwhelming the contribution of 
the quality performance category to the final score. We also proposed 
to weight the improvement activities performance category at 15 percent 
and to weight the Promoting Interoperability performance category at 85 
percent for the 2022 MIPS payment year when the quality and cost 
performance categories are each weighted at zero percent, to align with 
our focus on interoperability and pursuant to our proposal of not 
redistributing weight to the improvement activities performance 
category (84 FR 40798).

[[Page 63028]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.100

    We received public comments on our proposed redistribution policies 
for the 2022 MIPS payment year. The following is a summary of the 
comments we received and our responses.
    Comment: A few commenters supported our proposal to generally not 
redistribute weight to the cost performance category for the 2022 MIPS 
payment year.
    Response: We appreciate the commenters' support. We are finalizing 
this policy with a minor modification, which is discussed in more 
detail below, to decrease the amount of weight redistributed to the 
cost performance category when the cost and improvement activities 
performance categories are the only performance categories scored.
    Comment: Several commenters expressed concern with our proposal to 
no longer redistribute weight to the improvement activities performance 
category and in particular expressed concern when only cost and 
improvement activities performance categories are scored because cost 
would be 85 percent of the final score. Commenters also stated that it 
will not necessarily be a rare occurrence for a MIPS eligible clinician 
to be scored on only cost and improvement activities, and expressed 
concerns with the attribution methodologies used in cost measures. A 
few commenters expressed concerns about redistributing to the cost 
category due to issues with cost measures, such as attribution, 
reliability, and actionability. Commenters further noted that cost 
measures are fairly new and even those with which they have had 
experience (TPCC and MSPB) were having major updates to their 
specifications. One commenter did not agree with our assertion that 
this policy would reduce incentives to not report measures for the 
quality performance category, but did not provide further details. One 
commenter stated that the Quality Payment Program should focus on 
performance categories that support quality improvement, such as the 
improvement activities performance category, rather than on the cost 
performance category, because quality improvement is so important for 
patient care.
    Response: We agree with commenters that the improvement activities 
performance category reflects important aspects of quality improvement 
and performance. However, we do have concerns with redistributing a 
substantial portion of the performance category weights to the 
improvement activities performance category due to a lack of 
variability in performance for this category, and we continue to 
believe that we should not redistribute weight to the improvement 
activities performance category. However, we agree with commenters that 
a weight of 85 percent for the cost performance category is not 
appropriate for the 2022 MIPS payment year. As noted in section 
III.K.3.c.(2)(b) of this final rule, opportunities to improve 
performance in the cost performance category are somewhat dependent on 
the performance feedback on cost measures we are able to provide. As we 
have provided detailed feedback on the cost measures for the first time 
during the 2019 performance period and expect to provide detailed 
feedback on new and revised cost measures for the first time during the 
2020 performance period, we believe that we should not weight the cost 
performance category so heavily for the 2022 MIPS payment year. We 
believe that weighting the cost and improvement activities performance 
categories each at 50 percent would appropriately balance our concerns 
with redistributing weight to the improvement activities performance 
category and the concerns raised by commenters with a weight of 85 
percent for the cost performance category.
    Comment: One commenter stated that our current reweighting policies 
put undue emphasis on the quality performance category, and suggested 
that CMS redistribute weight evenly to the quality and improvement 
activities performance categories, especially for non-patient facing 
clinicians who may lack applicable measures and are spending valuable 
time performing quality improvement activities for the improvement 
activities performance category.
    Response: Under our existing policies, we have generally 
redistributed weight to the quality performance category. The quality 
performance category is a critical component of value-based care, and 
therefore, we believe performance

[[Page 63029]]

on quality measures is important. In addition, there is variation in 
performance for the quality performance category, but for the 
improvement activities we are only assessing whether the MIPS eligible 
clinician completed activities. Finally, we believe that redistributing 
weight to the quality performance category would encourage MIPS 
eligible clinicians to report on quality measures as a zero score for 
this performance category would have more significant impact. However, 
over time, we want to redistribute more weight to the cost and 
Promoting Interoperability performance categories, and less to the 
quality performance category, to have better alignment between the cost 
and quality performance categories and due to our focus on 
interoperability. In general, we want to avoid redistributing weight to 
the improvement activities performance category because we believe 
other performance categories can better identify variation in 
performance.
    Comment: One commenter stated that it is appropriate to delay the 
redistribution of more weight to the Promoting Interoperability 
performance category while ONC and other stakeholders work to make 
functional interoperability a reality.
    Response: We thank the commenter for sharing their concern, but we 
continue to believe it is appropriate to increase the amount of weight 
redistributed to the Promoting Interoperability performance category in 
order to align with our focus on interoperability.
    After consideration of the comments we received, we are finalizing 
our redistribution policies for the 2022 MIPS payment year at Sec.  
414.1380(c)(2)(ii)(D) as proposed with a few modifications. In sections 
III.K.3.c.(1)(b) and III.K.3.c.(2)(a) of this final rule, we are 
finalizing different generally applicable weights for the quality and 
cost performance categories, respectively, than what we proposed. For 
the 2022 MIPS payment year, we are finalizing a quality performance 
category weight of 45 percent (instead of 40 percent as proposed) and a 
cost performance category weight of 15 percent (instead of 20 percent 
as proposed). Accordingly, we are modifying the numerical amounts of 
weight that we will redistribute to account for these different weights 
for quality and cost, as shown in Table 55. In addition, in the 
scenario when only the improvement activities and cost performance 
categories are scored, we will provide a weight of 50 percent for each 
performance category, as shown in Table 55.
[GRAPHIC] [TIFF OMITTED] TR15NO19.101

    In the CY 2020 PFS proposed rule, we proposed weights for the cost 
performance category of 25 and 30 percent for the 2023 and 2024 MIPS 
payment years, respectively (84 FR 40752 through 84 FR 40753). Because 
MIPS eligible clinicians will have had more experience being scored on 
cost measures, we stated that we believe it would be appropriate to 
begin redistributing even more of the performance category weights to 
the cost performance category beginning with the 2023 MIPS payment 
year. While we proposed to redistribute weight to the cost performance 
category for the 2022 MIPS payment year in scenarios in which only the 
cost and improvement activities performance categories are scored, we 
stated that we believe that we should redistribute weight to the cost 
performance category in other scenarios beginning with the 2023 MIPS 
payment year. We stated that in general, we would redistribute 
performance category weights so that the quality and cost performance 
categories are almost equal. For simplicity, we would redistribute the 
weight in 5-point increments. If the redistributed weight cannot be 
equally divided between quality and cost in 5-point increments, we 
would redistribute slightly more weight to quality than cost. We stated 
that we believe that redistributing weight equally to quality and cost 
is consistent with our goal of greater alignment between the quality 
and cost performance categories (84 FR 40797 through 40798). We stated 
that we would also continue to redistribute weight to the Promoting 
Interoperability

[[Page 63030]]

performance category, but we would ensure that if the quality and cost 
performance categories are scored, they would have a higher weight than 
the Promoting Interoperability performance category. For example, 
beginning with the 2024 MIPS payment year, if the improvement 
activities performance category is the only performance category to be 
reweighted to zero percent, quality and cost would be 40 and 35 
percent, respectively, and we would not increase the weight of the 
Promoting Interoperability performance category (weighted at 25 
percent) so that it would not exceed the weight of the quality or cost 
performance categories. Our proposed redistribution polices for the 
2023 and 2024 MIPS payment years, which we proposed to codify at Sec.  
414.1380(c)(2)(ii)(E) and (F), are presented in Tables 56 and 57.
[GRAPHIC] [TIFF OMITTED] TR15NO19.102

[GRAPHIC] [TIFF OMITTED] TR15NO19.103


[[Page 63031]]


    We received public comments on our proposed redistribution policies 
for the 2023 and 2024 MIPS payment years. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters did not support our proposal to begin 
to redistribute weight to the cost performance category in any 
scenario. Commenters indicated that, as CMS adds more measures to the 
cost performance category, more measures will be in their first or 
second year of use. Furthermore, one commenter expressed concern that 
cost measures exclude Part D costs. Another commenter believed other 
performance categories have a stronger focus on care quality because 
they measure aspects of care improvement rather than resource use. 
Another commenter believed that MIPS eligible clinicians who receive 
reweighting for the promoting interoperability performance category are 
often in small and/or rural practices with limited resources, and 
increasing the weight of the cost performance category would place them 
at a greater disadvantage.
    Response: As described in sections III.K.3.c.(1)(b) and 
III.K.3.c.(2)(a) of this final rule, we are not finalizing weights for 
the cost and quality performance categories for the 2023 and 2024 MIPS 
payment years. Instead, we have decided to maintain the weight of the 
cost performance category at 15 percent for the 2022 MIPS payment year 
and address its weight for the 2023 and 2024 MIPS payment years in 
future rulemaking. As a result, we have decided not to finalize 
redistribution policies for the 2023 and 2024 MIPS payment years 
because we have not established the generally applicable weights for 
these years. However, we will take these comments into consideration in 
future rulemaking.
    After consideration of public comments, we are no longer finalizing 
performance category weights for the 2023 and 2024 MIPS payment years. 
Therefore, we are no longer finalizing weights for the cost and quality 
performance categories for the 2023 and 2024 MIPS payment years.
e. MIPS Payment Adjustments
(1) Background
    For our previously established policies regarding the final score 
used in MIPS payment adjustment calculations, we refer readers to the 
CY 2019 PFS final rule (83 FR 59878 through 59894), CY 2018 Quality 
Payment Program final rule (82 FR 53785 through 53799) and CY 2017 
Quality Payment Program final rule (81 FR 77329 through 77343).
    In the CY 2020 PFS proposed rule (84 FR 40800 through 40804), we 
proposed to: (1) Set the performance threshold for the 2022 and 2023 
MIPS payment years and (2) set the additional performance threshold for 
exceptional performance for the 2022 and 2023 MIPS payment years.
(2) Establishing the Performance Threshold
    Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, 
the Secretary shall compute a performance threshold with respect to 
which the final scores of MIPS eligible clinicians are compared for 
purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act for a year. The performance threshold 
for a year must be either the mean or median (as selected by the 
Secretary, and which may be reassessed every 3 years) of the final 
scores for all MIPS eligible clinicians for a prior period specified by 
the Secretary.
    Section 1848(q)(6)(D)(iii) of the Act 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. The performance thresholds for the first 3 years of 
MIPS are presented in Table 58.

 Table 58--Performance Thresholds for the 2019 MIPS Payment Year, 2020 MIPS Payment Year, and 2021 MIPS Payment
                                                      Year
----------------------------------------------------------------------------------------------------------------
                                                                  2019 MIPS        2020 MIPS        2021 MIPS
                                                                 payment year     payment year     payment year
                                                                   (points)         (points)         (points)
----------------------------------------------------------------------------------------------------------------
Performance Threshold........................................               3               15               30
----------------------------------------------------------------------------------------------------------------

    To determine a performance threshold to propose for the fourth year 
of MIPS (2020 MIPS performance period/2022 MIPS payment year) and the 
fifth year of MIPS (2021 MIPS performance period/2023 MIPS payment 
year), in the CY 2020 PFS proposed rule (84 FR 40801), we again relied 
upon the special rule in section 1848(q)(6)(D)(iii) of the Act, as 
amended by 51003(a)(1)(D) of the Bipartisan Budget Act of 2018.
    As required by section 1848(q)(6)(D)(iii) of the Act, we considered 
data available from a prior period with respect to performance on 
measures and activities that may be used under the MIPS performance 
categories. In accordance with clause (iv) of section 1848(q)(6)(D) of 
the Act, we also considered which data could be used to estimate the 
performance threshold for the 2024 MIPS payment year to ensure a 
gradual and incremental transition from the performance threshold we 
would establish for the 2022 MIPS payment year. In accordance with 
section

[[Page 63032]]

1848(q)(6)(D)(i) of the Act, the performance threshold for the 2024 
MIPS payment year will be either the mean or median of the final scores 
for all MIPS eligible clinicians for a prior period specified by the 
Secretary.
    As noted in the CY 2020 PFS proposed rule (84 FR 40801), to 
estimate the performance threshold for the 2024 MIPS payment year, we 
considered the actual MIPS final scores for MIPS eligible clinicians 
for the 2019 MIPS payment year and the estimated MIPS final scores for 
the 2020 MIPS payment year and 2021 MIPS payment year. We analyzed the 
actual final scores for the first year of MIPS (the 2019 MIPS payment 
year) and found the mean final score was 74.01 points and the median 
final score was 88.97 points, as described in the CY 2019 PFS final 
rule (83 FR 59881). In the Regulatory Impact Analysis of the CY 2019 
PFS final rule, we used data submitted for the first year of MIPS (2017 
MIPS performance period/2019 MIPS payment year) and applied the scoring 
and eligibility policies for the third year of MIPS (2019 MIPS 
performance period/2021 MIPS payment year) to estimate the potential 
final scores for the 2021 MIPS payment year. The estimated mean final 
score for the 2021 MIPS payment year was 69.53 points and the median 
final score was 78.72 points (83 FR 60048). We also estimated mean and 
median final scores for the 2020 MIPS payment year of 80.3 points and 
90.91 points, respectively, based on information in the Regulatory 
Impact Analysis in the CY 2018 Quality Payment Program final rule (82 
FR 53926 through 53950). Specifically, we used 2015 and 2016 PQRS data, 
2014 and 2015 CAHPS for PQRS data, 2014 and 2015 VM data, 2015 and 2016 
Medicare and Medicaid EHR Incentive Program data, the data prepared to 
support the 2017 performance period initial determination of clinician 
and special status eligibility, the initial QP determination file for 
the 2019 MIPS payment year, the 2017 MIPS measure benchmarks, and other 
available data to model the final scores for clinicians estimated to be 
MIPS eligible in the 2020 MIPS payment year (82 FR 53930). In the CY 
2020 PFS proposed rule, we considered using the actual final scores for 
the 2020 MIPS payment year; however, the data used to calculate the 
final scores was submitted through the first quarter of 2019, and final 
scores for MIPS eligible clinicians were not available in time for us 
to use in our analyses for purposes of the proposed rule; we stated our 
intention to include those results in the final rule if available (84 
FR 40801). We believed the data points based on actual data from the 
2017 MIPS performance period/2019 MIPS payment year were appropriate to 
use in our analysis in projecting the estimated performance threshold 
for the 2024 MIPS payment year. However, we also noted that after we 
analyze the actual final scores for the 2020 MIPS payment year, if we 
see the mean or median final scores significantly increasing or 
decreasing, we will consider modifying our estimation of the 
performance threshold for the 2024 MIPS payment year accordingly. Table 
51 of the CY 2020 PFS proposed rule summarized the different estimated 
performance thresholds for the 2024 MIPS payment year (84 FR 40802).
    In the CY 2020 PFS proposed rule, we chose the mean final score of 
74.01 points for the 2019 MIPS payment year as our estimate of the 
performance threshold for the 2024 MIPS payment year because it 
represents a mean based on actual data; is more representative of 
clinician performance because all final scores are considered in the 
calculation; is more achievable for clinicians, particularly for those 
that are new to MIPS; and is a value that falls generally in the middle 
of potential values for the performance threshold referenced in Table 
51 in the CY 2020 PFS proposed rule (84 FR 40802). In the CY 2019 PFS 
proposed rule (83 FR 35972), we had requested comment on our approach 
to estimating the performance threshold for the 2024 MIPS payment year, 
which was based on the estimated mean final score for the 2019 MIPS 
payment year, and whether we should use the median instead of the mean. 
A summary of comments was included in CY 2020 PFS proposed rule (84 FR 
40802).
    We noted that estimating the performance threshold for the 2024 
MIPS payment year based on the mean final score for the 2019 MIPS 
payment year is only an estimation that we are providing in accordance 
with section 1848(q)(6)(D)(iv) of the Act. We proposed to use data from 
the 2019 MIPS payment year because it was the only MIPS final score 
data available and usable in time for the publication of the CY 2020 
PFS proposed rule (84 FR 40802).
    We anticipated that the mean and median data points for the 2020 
MIPS payment year would be available for consideration prior to 
publication of the final rule and solicited comment on whether and how 
we should use this information to update our estimates.
    Since the publication of the CY 2020 PFS proposed rule, we now have 
the actual final score data for the 2020 MIPS payment year with which 
to estimate the mean and median. We note these values are estimates and 
that the mean and median may change as we finish the targeted review 
process for the 2020 MIPS payment year. In addition, we anticipate that 
the scores of some MIPS eligible clinicians may change as a result of 
the policy that we are finalizing in section III.K.3.d.(2)(b)(ii)(A) of 
this final rule to reweight the performance categories for a MIPS 
eligible clinician due to compromised data. We estimate the mean of the 
actual final scores for the 2020 MIPS payment year at 86.91 points and 
the median at 99.63 points although, again, the values may change after 
the completion of targeted reviews and due to the reweighting policy 
for data that are inaccurate, unusable, or otherwise compromised. We 
noted in the CY 2020 PFS proposed rule (84 FR 40802) some policies 
which could increase final scores. For example, beginning with the 2020 
MIPS payment year, we increased the low-volume threshold compared to 
the 2019 MIPS payment year. We also added incentives for improvement 
scoring for the quality performance category and bonuses for complex 
patients and small practices.
    We refer readers to Table 59 for potential values for estimating 
the performance threshold for the 2024 MIPS payment year based on the 
mean or median final score from prior periods. We have updated this 
table from the CY 2020 PFS proposed rule (84 FR 40802) to include the 
actual final score data for the 2020 MIPS payment year. We have also 
updated this table to include an estimate of the mean and median for 
the 2022 MIPS payment year from our Regulatory Impact Analysis in 
section VII.F.10. of this final rule as this estimate incorporates the 
newly available data for the 2020 MIPS payment year.

[[Page 63033]]



 Table 59--Potential Values for Estimated Performance Threshold for the 2024 MIPS Payment Year Based on the Mean
 or Median Final Score for the 2019 MIPS Payment Year, 2020 MIPS Payment Year, 2021 MIPS Payment Year, and 2022
                                                MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                     2019 MIPS       2020 MIPS       2021 MIPS       2022 MIPS
                                                  payment year *   payment year    payment year    payment year
                                                     (points)       ** (points)    *** (points)    *** (points)
----------------------------------------------------------------------------------------------------------------
Mean Final Score................................           74.01           86.91           69.53           76.67
Median Final Score..............................           88.97           99.63           78.72           83.57
----------------------------------------------------------------------------------------------------------------
* Mean and median final scores based on actual final scores for the 2019 MIPS payment year as published in CY
  2019 PFS final rule RIA (83 FR 60048).
** Mean and median final scores based on actual final scores for the 2020 MIPS payment year. Mean and median may
  change after the completion of targeted reviews and due to the reweighting policy for data that are
  inaccurate, unusable, or otherwise compromised.
*** Mean and median final scores based on estimated final scores for the 2021 MIPS payment year as published in
  CY 2019 PFS final rule RIA (83 FR 60048) and the 2022 MIPS payment year as estimated in section VII. of this
  final rule.

    We noted in the CY 2020 PFS proposed rule (84 FR 40801 through 
40802) that we would analyze the actual final scores for the 2020 MIPS 
payment year, and because the data is now available and usable, we have 
updated our analyses. As illustrated in Table 59, we found the mean and 
median final scores for the 2020 MIPS payment year are higher than the 
values for the 2019 MIPS payment year and higher than our original 
estimate from the CY 2020 PFS proposed rule which had an estimated mean 
of 80.30 and median of 90.91 (84 FR 40802); however, we also estimated 
the final scores for the 2021 MIPS payment year will be lower than the 
values for both the 2019 and 2020 MIPS payment years.
    In the CY 2020 PFS proposed rule (84 FR 40802), we noted that using 
final scores from the early years of MIPS has numerous limitations and 
may not be similar to the distribution of final scores for the 2024 
MIPS payment year. Recognizing the limitations of data for the 2019 
MIPS payment year and the 2020 MIPS payment year, we requested comments 
in the CY 2020 PFS proposed rule on whether we should update or modify 
our estimates (84 FR 40802).
    We proposed a performance threshold of 45 points for the 2022 MIPS 
payment year and a performance threshold of 60 points for the 2023 MIPS 
payment year to be codified at Sec.  414.1405(b)(7) and (8), 
respectively. A performance threshold of 45 points for the 2022 MIPS 
payment year and 60 points for the 2023 MIPS payment year would be an 
increase that is consistent with the increase in the performance 
threshold from the 2020 MIPS payment year (15 points) to the 2021 MIPS 
payment year (30 points), and we believe it would allow for a 
consistent increase over time that provides a gradual and incremental 
transition to the performance threshold we will establish for the 2024 
MIPS payment year, which we estimated in the CY 2020 PFS proposed rule 
(84 FR 40802) to be 74.01 points.
    In the CY 2020 PFS proposed rule (84 FR 40802), we provided the 
example that if in future rulemaking we were to set the performance 
threshold for the 2024 MIPS payment year at 75 points (which is close 
to the mean final score for the 2019 MIPS payment year), this would 
represent an increase in the performance threshold of approximately 45 
points from the 2021 MIPS payment year (that is, the difference from 
the Year 3 performance threshold of 30 points to a Year 6 performance 
threshold of 75 points). We stated that we believe an increase of 
approximately 15 points each year, from Year 3 through Year 6 of the 
MIPS program, would provide for a gradual and incremental transition 
toward a performance threshold that must be set at the mean or median 
final score for a prior period in Year 6 of the MIPS program (84 FR 
40802).
    We stated that we also believe this increase of 15 points per year 
could incentivize higher performance by MIPS eligible clinicians and 
that a performance threshold of 45 points for the 2022 MIPS payment 
year, and a performance threshold of 60 points for the 2023 MIPS 
payment year, represent a meaningful increase compared to 30 points for 
the 2021 MIPS payment year, while maintaining flexibility for MIPS 
eligible clinicians in the pathways available to achieve this 
performance threshold (84 FR 40802). In the CY 2020 PFS proposed rule 
(84 FR 40807 through 40809), we provided examples of the ways 
clinicians can meet or exceed the proposed performance threshold for 
the 2022 MIPS payment year.
    We recognized that some MIPS eligible clinicians may not exceed the 
proposed performance thresholds either due to poor performance or by 
failing to report on an applicable measure or activity that is required 
(84 FR 40803). We also recognized the unique challenges for small 
practices and rural clinicians that could prevent them from meeting or 
exceeding the proposed performance thresholds and sought feedback in 
the proposed rule on the participation of small and rural practices in 
MVPs (84 FR 40740).
    We invited public comment on our proposals to set the performance 
threshold for the 2022 MIPS payment year at 45 points and to set the 
performance threshold for the 2023 MIPS payment year at 60 points. We 
also solicited comment on whether we should adopt a different 
performance threshold in this final rule if we determine that the 
actual mean or median final scores for the 2020 MIPS payment year are 
higher or lower than our estimated performance threshold for the 2024 
MIPS payment year of 74.01 points. We anticipated the data will change 
over time and that the distribution of final scores will differ from 
one year to the next. We also solicited comment on whether the increase 
should be more gradual for the 2022 MIPS payment year, which would mean 
a lower performance threshold (for example, 35 instead of 45 points), 
or whether the increase should be steeper (for example, 50 points). We 
also solicited comment on alternative numerical values for the 
performance threshold for the 2022 MIPS payment year. For the 2023 MIPS 
payment year, we alternatively considered whether the performance 
threshold should be set at a lower or higher number, for example, 55 
points or 65 points, and also solicited comment on alternative 
numerical values for the performance threshold for the 2023 MIPS 
payment year.
    We received public comments on our proposals to set the performance 
threshold at 45 points for the 2022 MIPS payment year and at 60 points 
for the 2023 MIPS payment year. We also received public comments on 
whether the performance threshold for the 2022

[[Page 63034]]

MIPS payment year and the 2023 MIPS payment year should be higher or 
lower; whether we should adopt alternative numerical values for the 
performance threshold for the 2022 MIPS payment year and the 2023 MIPS 
payment year; and whether we should adopt a different performance 
threshold in this final rule if we determine that the actual mean or 
median final scores for the 2020 MIPS payment year are higher or lower 
than the 74.01 points estimated for the 2024 MIPS payment year.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported the proposed performance 
thresholds. Several commenters believed that the higher performance 
thresholds are a reasonable and gradual increase; would encourage 
participation; motivate clinicians to improve health care quality; hold 
clinicians accountable for quality and cost; ensure the incentives are 
conveyed to those clinicians who are attaining the thresholds needed to 
continually provide high quality health care for all patients; and 
would benefit clinicians in the transition to value-based payment. One 
commenter indicated that the proposal should give more genuinely high-
quality clinicians meaningful bonuses, which in the past have been 
small due to MIPS policies and budget neutrality requirements.
    Response: We agree that MIPS should incentivize clinicians to 
perform at a high level and support their transition to value-based 
care and believe that raising the performance threshold helps 
accomplish that goal. In addition, as discussed in section 
III.K.3.e.(3) of this final rule, we are raising the additional 
performance threshold to recognize and incentivize clinicians that 
provide high value care.
    Comment: A few commenters did not support the proposed performance 
threshold of 45 points for the 2022 MIPS payment year believing that 
current policies and clinician participation levels make it impossible 
for high performing clinicians to achieve the advertised positive 
adjustment and receive a meaningful incentive for participation in 
MIPS. One commenter also expressed concerns that MIPS reporting 
requires investments in technology, staffing, as well as adjustments to 
workflows to meet quality measure requirements throughout the year and 
that practices committed to quality care and performing at exceptional 
levels receive adjustments of less than two percent for reaching the 
highest levels of MIPS scoring. Another commenter stated that the 
proposed performance thresholds and the low-volume threshold lead to an 
unsustainable distribution of scores.
    Response: We recognize that, due to statutory requirements of 
budget neutrality and the application of a scaling factor, high 
performers may receive payment adjustments that are different than the 
applicable percent for the year provided in the statute (for example, 9 
percent for the 2022 MIPS payment year). While a higher performance 
threshold may enlarge the estimated decrease in aggregate allowed 
charges resulting from the application of negative MIPS payment 
adjustment factors, and therefore, may increase the scaling factor, we 
believe the proposed performance thresholds of 45 points for the 2022 
MIPS payment year and 60 points for the 2023 MIPS payment year would 
encourage movement toward value-based care with a focus on the delivery 
of high quality care for Medicare beneficiaries and provide a gradual 
and incremental transition to the estimated performance threshold for 
the 2024 MIPS payment year, as required by the statute. We also believe 
that the additional performance threshold for exceptional performance 
discussed later in section III.K.3.e.(3) of this final rule provides an 
additional financial incentive for high performers and will continue to 
incentivize their exceptional performance.
    Comment: A few commenters did not support adopting a different 
performance threshold than the proposed performance thresholds of 45 
points and 60 points, for the 2022 and 2023 MIPS payment years, 
respectively, if the actual mean or median final scores for the 2020 
MIPS payment year are higher than the estimated performance threshold 
of 74.01 points for the 2024 MIPS payment year. One commenter 
recommended that the performance threshold should not increase even if 
the actual scores for the 2018 MIPS performance period are higher than 
expected. One commenter recommended lowering the performance threshold, 
or, alternatively, not increasing it and cited concern for small 
practices.
    Response: We thank the commenters for their suggestions. Since the 
publication of the CY 2020 PFS proposed rule, the actual final score 
data for the 2020 MIPS payment year have become available and usable. 
For the 2020 MIPS payment year, the calculated mean and median of the 
actual final scores are 86.91 points and 99.63 points, respectively 
(although the mean and median may change after the completion of 
targeted reviews and due to the reweighting policy for data that are 
inaccurate, unusable, or otherwise compromised). Those mean and median 
final scores are higher than our estimates of 80.30 for the mean and 
90.91 for the median that we included in Table 51 of the CY 2020 PFS 
proposed rule (84 FR 40802). We noted in the CY 2020 PFS proposed rule 
(84 FR 40801) that after we analyze the actual final scores for the 
2020 MIPS payment year, if the mean or median final scores are 
significantly higher or lower, we will consider modifying our 
estimation of the performance threshold for the 2024 MIPS payment year. 
In considering whether to modify our estimate of the performance 
threshold for the 2024 MIPS payment year, we took into account how the 
actual mean and median final scores for the 2019 and 2020 MIPS payment 
years align with the projected mean and median final scores for 2021 
and 2022 MIPS payment years and considered the differences in the 
eligibility and scoring policies for the different MIPS payment years.
    We note that our original estimates for the 2020 MIPS payment year 
were lower than the actual values for the 2020 MIPS payment year. The 
difference in actual versus estimated values for the 2020 MIPS payment 
year may be partially due to the data sources available for estimates 
at that time. The estimates for the 2020 MIPS payment year were created 
using data from legacy programs, such as the Physician Quality 
Reporting System (PQRS) and the Value Modifier and the models applied 
participation assumptions (82 FR 53926 through 53948). In contrast, the 
estimated final scores for the 2021 and 2022 MIPS payment years 
incorporate data that were submitted for MIPS. These estimates also 
have limitations and assumptions; however, we believe that using MIPS 
submission data provides a better approximation of potential MIPS 
participation and performance. Specifically, for the 2021 MIPS payment 
year, we estimated final scores using primarily data submitted for MIPS 
for the 2017 MIPS performance period, including data submitted for the 
quality, improvement activities, and Promoting Interoperability (which 
was called advancing care information for the 2017 MIPS performance 
period) performance categories. For the 2022 MIPS payment year, we 
updated the analysis to include information submitted for the 2018 MIPS 
performance period. In addition to using MIPS submission data, we 
integrated additional data sources: CAHPS for MIPS and CAHPS for ACOs, 
the total per capita cost measure, Medicare

[[Page 63035]]

Spending Per Beneficiary (MSPB) clinician measure, the episode-based 
measures and other data sets. For a complete description of the data 
sources and our methodology to estimate the 2021 MIPS payment year 
final scores, please refer to the Regulatory Impact Analysis in the CY 
2019 PFS final rule (83 FR 60046 through 83 FR 60059). For a complete 
description of the data sources and methodology for the projected 2022 
MIPS payment year final scores, please refer to the Regulatory Impact 
Analysis in section VII. of this final rule.
    When we compare the actual mean and median scores from the 2019 and 
2020 MIPS payment years to the projected mean and median scores for the 
2021 and 2022 MIPS payment years (see Table 59), we see that the 2020 
MIPS payment year mean final score of 86.91 is higher than the 
projected mean final scores for the 2021 and 2022 MIPS payment years 
(69.53 and 76.67, respectively). In contrast, the mean result for the 
2019 MIPS payment year (74.01) falls between the projected means for 
the 2021 and 2022 MIPS payment years (69.53 and 76.67, respectively). 
The median actual values for both the 2019 and 2020 MIPS payment years 
are higher than the projected median values for the 2021 and 2022 MIPS 
payment years.
    In addition to comparing the actual and estimated mean and median 
final scores across different payment years, we also considered the 
policy differences across the different MIPS payment years. We stated 
in the CY 2020 PFS proposed rule (84 FR 40802) that we understood using 
final scores from the early years of MIPS had numerous limitations. We 
also noted that the distribution of final scores for the 2024 MIPS year 
may be different from the early years due to eligibility and scoring 
policy changes. For example, beginning with the 2020 MIPS payment year, 
we increased the low-volume threshold compared to the 2019 MIPS payment 
year. We also added incentives for improvement scoring for the quality 
performance category and bonuses for complex patients and small 
practices, which could increase scores. Starting with the 2021 MIPS 
payment year, we modified our eligibility to include new clinician 
types and an opt-in policy, revised the small practice bonus, 
significantly revised the Promoting Interoperability performance 
category scoring methodology, and added a topped-out cap for certain 
topped out quality measures. In addition, the performance category 
weights changed each payment year which limits the comparability of the 
actual mean or median final scores from either the 2019 or 2020 MIPS 
payment year to future payment year performance.
    Given these concerns, and based on feedback from commenters, we 
have decided to take a conservative approach for estimating the 2024 
MIPS payment year performance threshold. We believe the policy changes 
across MIPS payment years, in conjunction with the projected decrease 
in mean and median final scores from the 2020 MIPS payment year, 
justifies using the mean from the 2019 MIPS payment year (74.01 points) 
as the estimated performance threshold for the 2024 MIPS payment year. 
Despite differences in policies for the 2019 MIPS payment year compared 
to later MIPS payment years, this value is the lowest of all the actual 
mean final scores and falls between the projected mean final scores for 
the 2021 and 2022 MIPS payment year. If we increase our estimated 
performance threshold for the 2024 MIPS payment year based on the 
actual scores for the 2020 MIPS payment year (and accordingly increase 
the performance threshold for 2022 and 2023 MIPS payment years), then 
we may be forcing a transition that may not be gradual and incremental. 
As discussed further in our responses to comments, we are finalizing 
the performance thresholds for the 2022 and 2023 MIPS payment years as 
proposed, but 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.
    Comment: A few commenters expressed concerns with the use of data 
from the 2017 MIPS performance period and 2019 MIPS payment year to set 
the performance threshold at 45 points stating that data from the 2017 
MIPS performance period is not an accurate representation of current 
actual performance because of policy changes to the MIPS program; is 
based on one year of data that is not indicative of performance in the 
future; and that the threshold is too high for small practices. 
Commenters recommended that CMS instead focus on ensuring stability and 
participation in MIPS.
    Response: We appreciate the need to ensure relevant data are used 
to develop performance thresholds. As discussed in the previous 
response, we also agree that there are limitations with using final 
scores from the early years of MIPS (including the 2017 MIPS 
performance period which is associated with the 2019 MIPS payment 
year). We have considered all available data and found that the mean of 
74.01 points for the 2019 MIPS payment year is the lowest of the two 
actual mean scores available and is close to our projections for mean 
final scores for the 2021 and 2022 MIPS payment years illustrated in 
Table 59. Therefore, we believe that 74.01 points is an appropriate 
estimate for a performance threshold for the 2024 MIPS payment year. We 
also believe the proposed performance thresholds of 45 points and 60 
points for the 2022 and 2023 MIPS payment years, respectively, are 
appropriate because they would represent a gradual and incremental 
transition to the estimated performance threshold for the 2024 MIPS 
payment year, as required by the statute. We may revisit the 
performance threshold for the 2023 MIPS payment year in future 
rulemaking if we determine there is additional data to suggest our 
estimate should be modified.
    We acknowledge the concerns regarding the potential burden on small 
practices. There are special policies available for small practices 
such as the small practice bonus and special scoring for the 
improvement activities performance category, and the availability of 
customized technical assistance through the Small, Underserved, and 
Rural Support Initiative to assist clinicians in small practices. 
Finally, we note that we expect a majority of clinicians in all 
practice sizes will receive a positive payment adjustment if they 
participate in MIPS. As shown in Table 123 within the Quality Payment 
Program section of the Regulatory Impact Analysis in section VII. of 
this final rule, 92.5 percent of clinicians who participate in MIPS 
receive a neutral or positive payment adjustment.
    Comment: A few commenters suggested that the performance threshold 
remain at 30 points to allow clinicians to adjust to changes with 
program requirements. Some commenters recommended that CMS rework 
incentives for participation instead of increasing the performance 
threshold and the possibility of a negative payment adjustment. Several 
commenters recommended a smaller increase in the performance threshold 
for the 2022 MIPS payment year. One commenter suggested an increase 
from 30 points to 35 points because this increase would be consistent 
with the size of the proposed increase in the additional performance 
threshold for exceptional performance. One commenter stated a lower 
performance threshold of score of 35 points would reduce the magnitude 
of payment adjustments and the consequences of penalties or bonuses. 
One commenter

[[Page 63036]]

recommended that the performance threshold for the 2022 MIPS payment 
year should increase to 40 points and that the increase for the 2023 
MIPS payment year should be delayed, but did not provide reasons for 
that recommendation.
    Response: We thank the commenters for their suggestions. However, 
we do not believe that keeping the performance threshold at 30 points 
or increasing the performance threshold by 5 or 10 points would as 
effectively incentivize the delivery of high quality care for the 2022 
MIPS payment year. We also do not believe it would provide as much of a 
gradual and incremental transition to the estimated performance 
threshold for the 2024 MIPS payment year, which we have estimated in 
the proposed rule at 74.01 points and still believe is an appropriate 
estimate after consideration of available data referenced in Table 59. 
We note that 74.01 points is the lowest of the two actual mean scores 
available and is close to our projections for mean final scores for the 
2021 and 2022 MIPS payment years. We believe our proposal is an 
appropriate increase of 15 points from the performance threshold of 30 
points for the 2021 MIPS payment year that would encourage an increased 
focus on the delivery of high-quality care to be successful in MIPS and 
receive a neutral or positive payment adjustment. In addition, we note 
that the gap from 30 points to approximately 75 points is much larger 
than any potential increase to the additional performance threshold. We 
also believe that delaying an increase for the 2023 MIPS payment year 
does not support our efforts to help eligible clinicians plan for 
future performance requirements under MIPS. We also believe that it is 
beneficial for planning purposes that we finalize the performance 
threshold for the 2023 MIPS payment year; however, we may revisit the 
performance threshold for the 2023 MIPS payment year in future 
rulemaking if we receive additional data that would cause us to 
reconsider our estimate of the performance threshold for the 2024 MIPS 
payment year.
    Comment: One commenter stated the performance threshold should 
increase to 50 points for the 2022 MIPS payment year based on the 
increased mean score for the 2020 MIPS payment year which was mentioned 
in a webinar.
    Response: We believe that an increase of 15 points from the 
performance threshold of 30 points for the 2021 MIPS payment year is an 
appropriate increase to incentivize high clinician performance. As 
discussed earlier, we believe a conservative approach is warranted for 
estimating the performance threshold for the 2024 MIPS payment year. 
Even though the actual mean score for the 2020 MIPS payment year is 
higher than we estimated, we do not believe that a higher actual mean 
score for the 2020 MIPS payment year warrants an increase to our 
proposed performance threshold for the 2022 MIPS payment year because 
we project the mean final scores for the 2021 MIPS payment year and the 
2022 MIPS payment year to be lower than the mean final score for the 
2020 MIPS payment. We also believe an increase to 50 points is too 
steep and that a performance threshold at 45 points for the 2022 MIPS 
payment year allows for a gradual and incremental transition to our 
estimated performance threshold for the 2024 MIPS payment year of 74.01 
points.
    Comment: Several commenters did not support our proposal of 45 
points for the performance threshold for the 2022 MIPS payment year and 
stated that small and rural practices would be at a disadvantage to 
participate in MIPS compared to the larger groups. Some commenters 
recommended more bonus opportunities and developing a separate 
performance threshold for small and rural practices. One commenter 
stated that the increase in the performance threshold might lead to 
practice consolidation for small practices.
    Response: We acknowledge the concerns of commenters regarding the 
potential impact on small practices. As discussed in a prior response, 
we have established special policies available for small practices to 
support their efforts to be successful in MIPS.
    We also believe that different performance criteria for certain 
types of clinicians or practices may create more confusion and burden 
than a cohesive set of criteria; moreover, we are statutorily required 
to establish a single performance threshold for all MIPS eligible 
clinicians. We do not have data that would support the theory that 
increasing the performance threshold leads to the consolidation of 
small practices.
    Comment: A few commenters did not support the increase in the 
performance threshold for the 2022 and 2023 MIPS payment years and 
stated it would have a negative impact on specialists. Some commenters 
noted this increase would make it difficult for pathologists, 
audiologists, physical therapists, ambulatory surgical center (ASC)-
based and hospital-based MIPS eligible clinicians to meet the threshold 
due to a lack of quality measures for these practices. One commenter 
stated audiologists should be exempt from negative payment adjustments. 
One commenter expressed concern that quality measurement reporting 
requirements could result in lower scores for some specialties. One 
commenter recommended an analysis of the distribution of overall scores 
by specialty and sub-specialty is needed to help address disadvantages 
and possible upcoming negative adjustments.
    Response: We appreciate the unique challenges faced by MIPS 
eligible clinicians that are in specialty practices, including 
pathologists, audiologists, physical therapists, and ASC-based and 
hospital-based MIPS clinicians. We believe that there are multiple 
pathways for clinicians, including specialty practices, to meet or 
exceed the performance threshold and be successful in MIPS and refer to 
the examples discussed at section III.K.3.e.(4) of this final rule. We 
also note that there are policies that adjust the quality performance 
category scores to account for the number of available quality 
measures, such as data validation process discussed in the CY 2017 
Quality Payment Program final rule (81 FR 77290 through 77291) and the 
CY 2019 PFS final rule (83 FR 35950), and to assess if clinicians have 
fewer than 6 measures available and applicable for the quality 
performance category.
    Comment: Several commenters expressed concerns with increasing the 
proposed thresholds while proposing significant changes to the cost and 
Promoting Interoperability performance categories believing that 
clinicians would not have enough time to adjust to the changes and this 
could result in lower scores.
    Response: We acknowledge the concerns submitted by the commenters. 
We recognize that some requirements and scoring policies in the MIPS 
program have changed from year to year, including from the 2021 MIPS 
payment year to the 2022 MIPS payment year, but we believe the proposed 
performance threshold of 45 points for the 2022 MIPS payment year and 
60 points for the 2023 MIPS payment year are appropriate increases that 
encourage increased participation and engagement in the MIPS program 
and that incentivize clinicians to transition to value-based care. We 
also note that we have modified the weight of the cost performance 
category in response to comments; specifically, we maintain the weight 
of the cost performance category at 15 percent for 2022 MIPS payment 
year to allow clinicians to become more familiar with the performance 
feedback process and allow us to continue to improve feedback reports. 
We do not

[[Page 63037]]

believe the policy changes to the Promoting Interoperability 
performance category referenced in section III.K.3.c.(4) of this final 
rule would require additional time for clinicians to adjust in order to 
avoid a negative payment adjustment. We also believe there are multiple 
pathways to meeting or exceeding a performance threshold of 45 points 
and refer readers to examples discussed at section III.K.3.e.(4) of 
this final rule.
    After consideration of public comments, we are finalizing our 
proposal to set the performance threshold at 45 points for the 2022 
MIPS payment year and at 60 points for the 2023 MIPS payment year. We 
are codifying the performance threshold for the 2022 MIPS payment year 
at Sec.  414.1405(b)(7) and codifying the performance threshold for the 
2023 MIPS payment year at Sec.  414.1405(b)(8).
(3) Additional Performance Threshold for Exceptional Performance
    Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to 
compute, for each year of the MIPS, an additional performance threshold 
for purposes of determining the additional MIPS payment adjustment 
factors for exceptional performance under section 1848(q)(6)(C) of the 
Act. For each such year, the Secretary shall apply either of the 
following methods for computing the additional performance threshold: 
(1) The threshold shall be the score that is equal to the 25th 
percentile of the range of possible final scores above the performance 
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) 
the threshold shall be the score that is equal to the 25th percentile 
of the actual final scores for MIPS eligible clinicians with final 
scores at or above the performance threshold for the prior period 
described in section 1848(q)(6)(D)(i) of the Act. Under section 
1848(q)(6)(C) of the Act, a MIPS eligible clinician with a final score 
at or above the additional performance threshold will receive an 
additional MIPS payment adjustment factor and may share in the $500 
million of funding available for the year under section 
1848(q)(6)(F)(iv) of the Act.
    As we discussed in the CY 2020 PFS proposed rule (84 FR 40800 
through 40803), we relied on the special rule under section 
1848(q)(6)(D)(iii) of the Act to propose a performance threshold of 45 
points for the 2022 MIPS payment year and to propose a performance 
threshold of 60 points for the 2023 MIPS payment year. The special rule 
under section 1848(q)(6)(D)(iii) of the Act also applies for purposes 
of establishing an additional performance threshold for a year, for the 
initial 5 years of MIPS. For the 2022 MIPS payment year and the 2023 
MIPS payment year, we proposed again to rely on the discretion afforded 
by the special rule and to decouple the additional performance 
threshold from the performance threshold.
    For illustrative purposes, we considered what the numerical values 
would be for the additional performance threshold under one of the 
methods described in section 1848(q)(6)(D)(ii) of the Act: The 25th 
percentile of the range of possible final scores above the performance 
threshold. With a proposed performance threshold of 45 points, the 
range of total possible points above the performance threshold is 45.01 
to 100 points and the 25th percentile of that range is 58.75, which is 
just more than one-half of the possible 100 points in the MIPS final 
score. We stated that we do not believe it would be appropriate to 
lower the additional performance threshold to 58.75 points because it 
is below the mean and median final scores for each of the prior 
performance periods that are referenced in Table 51 of the CY 2020 PFS 
proposed rule (84 FR 40802). Similarly, with a proposed performance 
threshold for the 2023 MIPS payment year of 60 points, the range of 
possible points above the performance threshold is 60.01 to 100 points 
and the 25th percentile of that range is 69.99 points. We stated that 
we do not believe it would be appropriate to lower the additional 
performance threshold to 69.99 points because it is below or close to 
the mean and median final scores for each of the prior performance 
periods that are referenced in Table 51 of the CY 2020 PFS proposed 
rule (84 FR 40802).
    We relied on the special rule under section 1848(q)(6)(D)(iii) of 
the Act and proposed at Sec.  414.1405(d)(6) to set the additional 
performance threshold for the 2022 MIPS payment year at 80 points and 
proposed at Sec.  414.1405(d)(7) to set the additional performance 
threshold for the 2023 MIPS payment year at 85 points. These values are 
higher than the 25th percentile of the range of the possible final 
scores above the proposed performance threshold for the 2022 and 2023 
MIPS payment years.
    We originally proposed 80 points for the additional performance 
threshold for the 2021 MIPS payment year in the CY 2019 PFS proposed 
rule (83 FR 35973) although we finalized 75 points in the CY 2019 PFS 
final rule (83 FR 59886). In the CY 2019 PFS final rule, we noted the 
impact that policy changes for the 2021 MIPS payment year could have on 
final scores as clinicians are becoming familiar with these changes and 
noted our belief that 75 points was appropriate for Year 3 of MIPS (83 
FR 59883 through 59886). We also signaled our intent to increase the 
additional performance threshold in future rulemaking (83 FR 59886).
    We stated that we believe that 80 points and 85 points are minimal 
and incremental increases over the additional performance threshold of 
75 points for the 2021 MIPS payment year (84 FR 40803). We stated that 
we also believe it is appropriate to raise the bar on what is rewarded 
as exceptional performance for the 2022 and 2023 MIPS payment years and 
that increasing the additional performance threshold each year will 
encourage clinicians to increase their focus on value-based care and 
enhance the delivery of high quality care for Medicare beneficiaries 
(84 FR 40803).
    An additional performance threshold of 80 points and 85 points 
would each require a MIPS eligible clinician to participate and perform 
well in multiple performance categories. Generally, under the 
performance category weights for the 2022 MIPS payment year proposed in 
the CY 2020 PFS proposed rule (84 FR 40795), a MIPS eligible clinician 
who is scored on all four performance categories could receive a 
maximum of 40 points towards the final score for the quality 
performance category or a maximum score of 65 points for participating 
in the quality performance category and Promoting Interoperability 
performance category, which are both below the proposed 80-point and 
85-point additional performance thresholds. In addition, 80 points and 
85 points are at a high enough level that MIPS eligible clinicians must 
submit data for the quality performance category to achieve this 
target. We stated that we believe setting the additional performance 
threshold at 80 points and 85 points could increase the incentive for 
exceptional performance while keeping the focus on quality performance 
(84 FR 40802).
    We noted that under section 1848(q)(6)(F)(iv) of the Act, funding 
is available for additional MIPS payment adjustment factors under 
section 1848(q)(6)(C) of the Act only through the 2024 MIPS payment 
year, which is the sixth year of the MIPS program (84 FR 40804). We 
stated that we believe it is appropriate to further incentivize 
clinicians whose performance meets or exceeds the additional 
performance threshold for the fourth and fifth years of the MIPS 
program (84 FR 40804). We recognized that setting a higher additional 
performance threshold may result in fewer clinicians receiving 
additional MIPS payment adjustments

[[Page 63038]]

(84 FR 40804). We also noted that a higher additional performance 
threshold could increase the maximum additional MIPS payment adjustment 
that a MIPS eligible clinician potentially receives if the funds 
available (up to $500 million for each year) are distributed over fewer 
clinicians that have final scores at or above the higher additional 
performance threshold (84 FR 40804).
    We invited public comment on our proposals to set the additional 
performance threshold at 80 points for the 2022 MIPS payment year and 
at 85 points for the 2023 MIPS payment year. Alternatively, for the 
2022 MIPS payment year, we considered whether the additional 
performance threshold should remain at 75 points or be set at a higher 
number, for example, 85 points, and also solicited comment on 
alternative numerical values for the additional performance threshold 
for the 2022 MIPS payment year. We referred readers to the RIA in the 
CY 2020 PFS proposed rule (84 FR 40911) for the estimated maximum 
payment adjustments when the additional performance threshold is set at 
80 points and at 85 points, respectively, for the 2022 MIPS payment 
year.
    Alternatively, for the 2023 MIPS payment year, we also considered 
whether the additional performance threshold should remain at 80 points 
as proposed for the 2022 MIPS payment year or whether a different 
numerical value should be adopted for the 2023 MIPS payment year, and 
also solicited comment on alternative numerical values for the 
additional performance threshold for the 2023 MIPS payment year. 
Additionally, in the event that we adopt different numerical values for 
the performance threshold in the final rule than proposed in the CY 
2020 PFS proposed rule (84 FR 40800 through 40803), we solicited 
comment on whether we should adopt different numerical values for the 
additional performance threshold and how we should set those values. We 
also solicited comment on how the distribution of the additional MIPS 
payment adjustments across MIPS eligible clinicians may impact 
exceptional performance by clinicians participating in MIPS. For 
example, the distribution of the additional MIPS payment adjustments 
could result in a higher additional MIPS payment adjustment available 
to fewer clinicians or could result in a lower additional MIPS payment 
adjustment available to a larger number of clinicians. We also reminded 
readers that we anticipate the data will change over time and that the 
distribution of final scores will differ from one year to the next.
    We received public comments on our proposals to set the additional 
performance threshold at 80 points for the 2022 MIPS payment year and 
at 85 points for the 2023 MIPS payment year. We also received public 
comments on alternative numerical values for the additional performance 
threshold for the 2022 MIPS payment year
    We also received public comments on alternative numerical values 
for the additional performance threshold for the 2023 MIPS payment 
year, whether we should adopt different numerical values for the 
additional performance threshold and how we should set those values, 
and how the distribution of the additional MIPS payment adjustments 
across MIPS eligible clinicians may impact exceptional performance by 
clinicians participating in MIPS.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter did not support the proposed additional 
performance threshold for the 2022 MIPS payment year and stated the 
additional performance threshold should be 85 points based on the 
increased mean score for 2020 MIPS payment year. Another commenter 
expressed concerns that clinicians who have invested in their practices 
to meet quality measure requirements and are performing at exceptional 
levels receive low payment adjustments of less than 2 percent for 
reaching the highest levels of MIPS scoring.
    Response: We appreciate the investments made by clinicians to make 
improvements in their clinical practice and their efforts to transition 
to value-based care in the Medicare program. We note that a higher 
additional performance threshold could increase the maximum additional 
payment adjustment that a MIPS eligible clinician could potentially 
receive if the funds available (up to $500 million for the year) are 
distributed over fewer clinicians that score at or above the higher 
additional performance threshold. We appreciate the commenter's 
suggestion of 85 points for the additional performance threshold for 
the 2022 MIPS payment year.
    We believe it is important to incentivize exceptional performance 
in MIPS and will increase the additional performance threshold from our 
proposal for the 2022 MIPS payment year of 80 points to 85 points. This 
adjustment would raise the bar on exceptional performance and provide 
an appropriate financial incentive for high performers.
    As discussed in section VII.F.10 of the Regulatory Impact Analysis 
in this final rule, we estimate that the number of MIPS eligible 
clinicians receiving an additional payment adjustment with the 
additional performance threshold at 80 points and 85 points is 533,069 
and 390,354 MIPS eligible clinicians, respectively. We found that 
increasing the additional performance threshold to 85 points rather 
than 80 points leads to a decrease in the number of MIPS eligible 
clinicians that would receive an additional payment adjustment by 
142,715 clinicians. The estimated 390,354 MIPS eligible clinicians 
expected to receive the additional payment adjustment when the 
additional performance threshold is set at 85 points is about 44 
percent of the MIPS eligible population compared to 61 percent of the 
MIPS eligible population when the additional performance threshold is 
set at 80 points. We also estimate that the maximum payment adjustment 
(for a MIPS eligible clinician with a final score of 100 points) would 
increase from 4.5 to 6.2 percent. However, this projection is only an 
estimate and may change based on the distribution of actual final 
scores for clinicians with final scores at or higher than the 
additional performance threshold and the associated Medicare payments. 
Given this analysis, we believe that increasing the additional 
performance threshold to 85 points for the 2022 MIPS payment year would 
provide an appropriate incentive for exceptional clinician performance.
    We also note that the funding for the additional payment adjustment 
ends with the 2024 MIPS payment year and believe the additional 
performance threshold should be set at a number that encourages the 
transition to value-based care.
    For the reasons discussed above, we believe 85 points is 
appropriate for the additional performance threshold for the 2022 MIPS 
payment year; therefore, we will finalize 85 points for the additional 
performance threshold for exceptional performance for both the 2022 and 
2023 MIPS payment years.
    Comment: A few commenters supported the proposed additional 
performance threshold for exceptional performance because they would 
reasonably raise the bar on what is rewarded as exceptional 
performance; ensure that clinicians continue to be held accountable for 
quality and cost; incentivize individuals and groups to continuously 
improve performance; and motivate health care providers to continually 
provide high quality health care for all patients. A few commenters 
supported our proposals believing that high-quality clinicians should 
receive

[[Page 63039]]

larger bonuses for meeting the additional performance threshold.
    Response: We agree with commenters that increasing the additional 
performance threshold incentivizes individuals and groups to 
continuously improve performance and motivates health care providers to 
continually provide high quality health care for all patients. However, 
we also note that we received comments expressing concern that the MIPS 
payment adjustments would not provide for appropriate financial 
incentives for exceptional performers in MIPS.
    We have considered the totality of the comments and more recent 
data discussed in the Regulatory Impact Analysis at section VII. of 
this final rule estimating the number of eligible clinicians receiving 
an additional payment adjustment and the potential increase in the 
additional payment adjustment with the additional performance threshold 
set at 80 points and 85 points and we believe it is appropriate to 
finalize a higher additional performance threshold for the 2022 MIPS 
payment year that further incentivizes continued care improvement by 
high performing clinicians that have invested in quality care and are 
exceptional performers in MIPS. Given this, we believe that an increase 
of 10 points from the additional performance threshold of 75 points for 
the 2021 MIPS payment year is a reasonable increase for the 2022 MIPS 
payment year and would provide an appropriate financial incentive for 
clinicians to deliver exceptional performance in MIPS.
    Comment: Several commenters did not support the proposal to set the 
additional performance threshold at 80 points for the 2022 MIPS payment 
year. A few commenters stated it should remain at 75 points for the 
2022 MIPS payment year and to 80 points for the 2023 MIPS payment year 
believing that clinicians should have more time to implement quality 
improvement projects. A few commenters stated the additional 
performance threshold should not exceed the 75-point threshold until 
more insight is gained by practice size. One commenter indicated that 
the proposed additional performance thresholds are too high and would 
have a negative impact on small practices. A few commenters did not 
support the proposals for the additional performance threshold and 
noted changes to the improvement activities and Promoting 
Interoperability performance categories would impede the ability to 
achieve high scores. One commenter recommended the additional 
performance threshold remain at 75 points for the 2022 MIPS payment 
year should the proposal to increase the percentage of clinicians who 
must perform an improvement activity for the group to receive credit 
for the improvement activities performance category be finalized.
    Response: We believe that an increase for the additional 
performance threshold is appropriate for the 2022 MIPS payment year and 
the 2023 MIPS payment year to encourage high performance across all 
clinician practices and to support their transition to value-based 
care. We believe that keeping the additional performance threshold at 
75 points for the 2022 MIPS payment year and increasing it to 80 points 
for the 2023 MIPS payment year does not appropriately raise the bar on 
exceptional performance. We also note that clinicians could still meet 
or exceed the performance threshold and receive a neutral or positive 
payment adjustment to be successful in the MIPS program. We recognize 
the unique challenges for eligible clinicians in small practices 
participating in MIPS and believe that special policies provide some 
relief for small practices seeking to perform well as referenced in 
earlier in this section of the final rule. We also believe that 
increasing the additional performance threshold aligns with policy 
changes for the 2022 MIPS payment year for the Promoting 
Interoperability performance category discussed at section 
III.K.3.c.(4) of this final rule and the changes to the group 
submission requirement for the improvement activities performance 
category discussed at section III.K.3.c.(3)(d) of this final rule that 
appropriately raise the bar on clinician performance for 2022 MIPS 
payment year and further support the transition toward value-based 
care.
    Comment: A few commenters did not support the increase in the 
additional performance threshold for the 2022 and 2023 MIPS payment 
years believing it would have a negative impact on specialists. A few 
commenters stated achieving a score above 80 points would be difficult 
for some specialties and sub-specialties with a low number of quality 
measures, such as pathology. One commenter stated it is increasingly 
difficult for some specialties to meet some of the metrics, such as the 
Promoting Interoperability measures, and that exceptional performance 
should not imply a competition across specialties but be based on truly 
meaningful measures. One commenter stated an increase would make it 
difficult for hospital-based MIPS clinicians to meet the threshold due 
to a lack of quality measures. One commenter recommended an analysis of 
the distribution of overall scores by specialty and sub-specialty to 
address disadvantages and possible negative adjustments.
    Response: We acknowledge that the number of quality measures 
available to clinicians can vary by specialty and practice, including 
pathology and for hospital-based clinicians. We believe our quality 
performance category scoring validation policy accounts for certain 
instances where clinicians have fewer than 6 measures available. We 
also believe these adjustments allow us to develop a fair comparison 
across different MIPS eligible clinicians and would not preclude 
clinicians in specialty practices from reaching the additional 
performance threshold. We agree that performance measurement should be 
based on meaningful measures and that our policies account for when 
measures are not available or applicable. We are also looking at ways 
to implement MVPs in a way to make the program more meaningful for 
clinicians.
    Comment: Some commenters stated the additional performance 
threshold should increase based on performance results from the 
previous year rather than an arbitrary change.
    Response: We disagree with the characterization that the additional 
performance threshold is set arbitrarily. In the proposed rule (84 FR 
40803), for illustrative purposes, we considered what the numerical 
values would be for the additional performance threshold under one of 
the methods described in section 1848(q)(6)(D)(ii) of the Act: the 25th 
percentile of the range of possible final scores above the performance 
threshold. With a proposed performance threshold of 45 points, the 
range of total possible points above the performance threshold is 45.01 
to 100 points and the 25th percentile of that range is 58.75, which is 
just more than one-half of the possible 100 points in the MIPS final 
score. Similarly, with a proposed performance threshold for the 2023 
MIPS payment year of 60 points, the range of possible points above the 
performance threshold is 60.01 to 100 points and the 25th percentile of 
that range is 69.99 points. We still do not believe it would be 
appropriate to lower the additional performance threshold to 69.99 
points or 58.75 points because these numbers are below or close to the 
mean and median final scores for each of the prior performance periods 
that are referenced in Table 59.
    After consideration of public comments, we are not finalizing our 
proposal to set the additional performance threshold at 80 points for 
the 2022 MIPS payment year, and

[[Page 63040]]

instead, are finalizing the additional performance threshold at 85 
points for the 2022 MIPS payment year. We are finalizing the additional 
performance threshold at 85 points for the 2023 MIPS payment year as 
proposed. We are codifying the additional performance threshold for the 
2022 MIPS payment year and for the 2023 MIPS payment year at Sec.  
414.1405(d)(6).
(4) Example of Adjustment Factors
    In the CY 2020 PFS proposed rule (84 FR 40804 through 40809),we 
provided a figure and several tables as illustrative examples of how 
various final scores would be converted to a MIPS payment adjustment 
factor, and potentially an additional MIPS payment adjustment factor, 
using the statutory formula and based on our proposed policies for the 
2022 MIPS payment year. We are updating the figure and tables based on 
our finalized policies in this final rule.
    Figure 1 provides an example of how various final scores will be 
converted to a MIPS payment adjustment factor, and potentially an 
additional MIPS payment adjustment factor, using the statutory formula 
and based on the policies for the 2022 MIPS payment year in this final 
rule. In Figure 1, the performance threshold is 45 points. The 
applicable percentage is 9 percent for the 2022 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 
2022 MIPS payment year) and results in the lowest payment adjustment, 
and 100 being the highest possible score which receives the highest 
positive applicable percentage and results 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 11.25 points based on 
the performance threshold of 45 points for the 2022 MIPS payment year). 
All MIPS eligible clinicians with a final score in this range will 
receive the lowest negative applicable percentage (negative 9 percent 
for the 2022 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 will be less than or equal to 9 percent. If the scaling factor is 
above 1.0, but less than or equal to 3.0, then the MIPS payment 
adjustment factor for a final score of 100 will be higher than 9 
percent.
    Only those MIPS eligible clinicians with a final score equal to 45 
points (which is the performance threshold in this example) will 
receive a neutral MIPS payment adjustment. Because the performance 
threshold is 45 points, we anticipate that more clinicians will receive 
a positive adjustment than a negative adjustment and that the scaling 
factor will be less than 1 and the MIPS payment adjustment factor for 
each MIPS eligible clinician with a final score of 100 points will be 
less than 9 percent.
    Figure 1 illustrates an example of the slope of the line for the 
linear adjustments for the 2022 MIPS payment year, but it can change 
considerably as new information becomes available. In this example, the 
scaling factor for the MIPS payment adjustment factor is 0.1401. In 
this example, MIPS eligible clinicians with a final score equal to 100 
will have a MIPS payment adjustment factor of 1.261 percent (9 percent 
x 0.1401). (Note that this is prior to adding the additional payment 
adjustment for exceptional performance, which is explained below.)
    The additional performance threshold for the 2022 MIPS payment year 
is 85 points. An additional MIPS payment adjustment factor of 0.5 
percent starts at the additional performance threshold and increases on 
a linear sliding scale up to 10 percent. This linear sliding scale line 
is also multiplied by a scaling factor that is greater than zero and 
less than or equal to 1.0. The scaling factor will be determined so 
that the estimated aggregate increase in payments associated with the 
application of the additional MIPS payment adjustment factors is equal 
to $500 million. In Figure 1, the example scaling factor for the 
additional MIPS payment adjustment factor is 0.499. Therefore, MIPS 
eligible clinicians with a final score of 100 will have an additional 
MIPS payment adjustment factor of 4.99 percent (10 percent x 0.499). 
The total adjustment for a MIPS eligible clinician with a final score 
equal to 100 would be 1 + 0.0126 + 0.0499 = 1.0625, for a total 
positive MIPS payment adjustment of 6.25 percent.
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[[Page 63041]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.104

    The final MIPS payment adjustments will be determined by the 
distribution of final scores across MIPS eligible clinicians and the 
performance threshold. More MIPS eligible clinicians above the 
performance threshold means the scaling factors will decrease because 
more MIPS eligible clinicians receive a positive MIPS payment 
adjustment factor. More MIPS eligible clinicians below the performance 
threshold means the scaling factors will increase because more MIPS 
eligible clinicians will receive a negative MIPS payment adjustment 
factor and relatively fewer MIPS eligible clinicians will receive a 
positive MIPS payment adjustment factor.
    Table 60 illustrates the changes in payment adjustments based on 
the final policies for the 2020 and 2021 MIPS payment years, and the 
policies for the 2022 and 2023 MIPS payment years discussed in this 
final rule, as well as the statutorily-required increase in the 
applicable percent as required by section 1848(q)(6)(B) of the Act.

[[Page 63042]]

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[[Page 63043]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.106

    We have provided updated examples below with the policies finalized 
for the 2022 MIPS payment year to demonstrate scenarios in which MIPS 
eligible clinicians can achieve a final score above the proposed 
performance threshold of 45 points based on our final policies.
Example 1: MIPS Eligible Clinician in Small Practice Submits 5 Quality 
Measures and 1 Improvement Activity
    In the example illustrated in Table 61, a MIPS eligible clinician 
in a small practice reporting individually exceeds the performance 
threshold by performing at the median level for 5 quality measures via 
Part B claims collection type and one medium-weight improvement 
activity. The practice does not submit data for the Promoting 
Interoperability performance category, but does submit a significant 
hardship exception application which is approved; therefore, the weight 
for the Promoting Interoperability performance

[[Page 63044]]

category is redistributed to the quality performance category under the 
proposed reweighting policies finalized in section 
III.K.3.d.(2)(b)(iii) of this proposed rule. We also assumed the small 
practice has a cost performance category percent score of 50 percent. 
Finally, we assumed a complex patient bonus of 3 points which 
represents the average HCC risk score for the beneficiaries seen by the 
MIPS eligible clinician, as well as the proportion of Medicare 
beneficiaries that are dual eligible. There are special scoring rules 
for the improvement activities performance category which affect MIPS 
eligible clinicians in a small practice.
     Six measure achievement points for each of the 5 quality 
measures submitted at the median level of performance. We refer readers 
to Sec.  414.1380(b)(1)(i) for further discussion of the quality 
performance category scoring policy. Because the measures are submitted 
via Part B claims, they do not qualify for the end-to-end electronic 
reporting bonus, nor do the measures submitted qualify for the high-
priority bonus. The small practice bonus of 6 measure bonus points 
apply because at least 1 measure was submitted. Because the MIPS 
eligible clinician does not meet full participation requirements, the 
MIPS eligible clinician does not qualify for improvement scoring. We 
refer readers to Sec.  414.1380(b)(1)(vi) for the full participation 
requirements for improvement scoring. Therefore, the quality 
performance category is (30 measure achievement points + 6 measure 
bonus points)/60 total available measure points + zero improvement 
percent score which is 60 percent.
     The Promoting Interoperability performance category weight 
is redistributed to the quality performance category so that the 
quality performance category score is worth 70 percent of the final 
score. We refer readers to section III.K.3.d.(2)(b)(iii) of this final 
rule for a discussion of this policy.
     MIPS eligible clinicians in small practices qualify for 
special scoring for improvement activities so a medium weighted 
activity is worth 20 points out of a total 40 possible points for the 
improvement activities performance category. We refer readers to Sec.  
414.1380(b)(3) for further detail on scoring policies for small 
practices for the improvement activities performance category.
     This MIPS eligible clinician exceeds the performance 
threshold of 45 points (but does not exceed the additional performance 
threshold). This score is summarized in Table 61.
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Example 2: Group Submission Not in a Small Practice
    In the example illustrated in Table 62, a MIPS eligible clinician 
in a medium size practice participating in MIPS as a group receives 
performance category scores of 80 percent for the quality performance 
category, 60 percent for the cost performance category, 90 percent for 
the Promoting Interoperability performance category, and 100 percent 
for improvement activities performance category. There are many paths 
for a practice to receive an 80 percent score in the quality 
performance category, so for simplicity we are assuming the score has 
been calculated at this amount. Again, for simplicity, we assume a 
complex patient bonus of 3 points. The final score is calculated to be 
85.5 points, and both the performance threshold of 45 points and the 
additional performance threshold of 85 points are exceeded. In this 
example, the group practice exceeds the additional performance 
threshold and will receive the additional MIPS payment adjustment.

[[Page 63045]]

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Example 3: Non-Patient Facing MIPS Eligible Clinician
    In the example illustrated in Table 63, an individual MIPS eligible 
clinician that is non-patient facing and not in a small practice 
receives performance category scores of 50 percent for the quality 
performance category, 50 percent for the cost performance category, and 
50 percent for 1 medium-weighted improvement activity. Again, there are 
many paths for a practice to receive a 50 percent score in the quality 
performance category, so for simplicity we are assuming the score has 
been calculated. Because the MIPS eligible clinician is non-patient 
facing, they qualify for special scoring for improvement activities and 
receive 20 points (out of 40 possible points) for the medium weighted 
activity. Also, this individual did not submit Promoting 
Interoperability measures and qualifies for the automatic 
redistribution of the Promoting Interoperability performance category 
weight to the quality performance category. Again, for simplicity, we 
assume a complex patient bonus of 3 points.
    In this example, the final score is 53 points and the performance 
threshold of 45 points is exceeded while the additional performance 
threshold of 85 points is not.
[GRAPHIC] [TIFF OMITTED] TR15NO19.109

BILLING CODE 4120-01-C
    We note that these examples are not intended to be exhaustive of 
the types of participants in MIPS nor the opportunities for reaching 
and exceeding the performance threshold.
f. Targeted Review and Data Validation and Auditing
    For previous discussions of our policies for targeted review, we 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77353 through 77358).
    In the CY 2020 PFS proposed rule (84 FR 40809 through 40810), we 
proposed to: (1) Identify who is eligible to request a targeted review; 
(2) revise the timeline for submitting a targeted review request; (3) 
add criteria for denial of a targeted review request; (4) update 
requirements for requesting additional information; (5) state who will 
be notified of targeted review decisions and require retention of 
documentation submitted; and (6) codify the policy on scoring 
recalculations. These proposals are discussed in more detail in this 
section of the final rule.
(1) Targeted Review
(a) Who Is Eligible To Request Targeted Review
    In the CY 2017 Quality Payment Program final rule, we established 
at Sec.  414.1385(a) that MIPS eligible clinicians and groups may 
submit a targeted review request and that these submissions could be 
with or without the assistance of a third party intermediary (81 FR 
77353). As we stated in the CY 2020 PFS proposed rule (84 FR 40809), in 
our efforts to minimize burden on MIPS eligible

[[Page 63046]]

clinicians and groups, we believe it is important to allow designated 
support staff and third party intermediaries to submit targeted review 
requests on their behalf. To expressly acknowledge the role of 
designated support staff and third party intermediaries in the targeted 
review process, we proposed to revise Sec.  414.1385(a)(1) to state 
that a MIPS eligible clinician or group (including their designated 
support staff), or a third party intermediary as defined at Sec.  
414.1305, may submit a request for a targeted review. MIPS eligible 
clinicians and groups (including their designated support staff) can 
request a targeted review by logging into the Quality Payment Program 
website at qpp.cms.gov, and after reviewing their performance feedback 
for the relevant performance period and MIPS payment year, they can 
submit a request for targeted review. An authorized third party 
intermediary as defined at Sec.  414.1305, such as a qualified 
registry, health IT vendor, or QCDR, that does not have access to their 
clients' performance feedback still would be able to request a targeted 
review on behalf of their clients. Third party intermediaries do not 
have access to the performance feedback of MIPS eligible clinicians and 
groups; therefore, we will share an URL link to the Targeted Review 
Request Form with these designated entities. In the CY 2017 Quality 
Payment Program final rule, we established at Sec.  414.1385(a)(2) that 
we will respond to each request for targeted review timely submitted 
and determine whether a targeted review is warranted (81 FR 77353). We 
proposed to redesignate this provision as Sec.  414.1385(a)(4).
    The following is a summary of the comments we received on the 
proposals regarding who is eligible to request targeted review and our 
responses.
    Comment: Several commenters supported the proposal for a MIPS 
eligible clinician, group (including their designated support staff), 
or a third-party intermediary to have the ability to submit a request 
for a targeted review because of the belief that the policy takes into 
account resources of small and mid-sized groups and reduces 
administrative burden on physician practices. Commenters also supported 
the proposal because they believed third party intermediaries may 
potentially have more of a working knowledge of measure scoring and 
streamlining review requests, which may expedite review and approval of 
a targeted review request.
    Response: We agree that the proposal allowing for a MIPS eligible 
clinician, group (including their designated support staff), or a 
third-party intermediary to submit a request for a targeted review 
takes into account the resources of small and mid-sized groups. We 
recognize the benefit of allowing those working with clinicians, such 
as support staff and third party intermediaries, to submit a targeted 
review request therefore reducing burden for MIPS eligible clinicians 
and groups and improving the efficiency of the targeted review process.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to revise Sec.  414.1385(a)(1) to 
state that a MIPS eligible clinician or group (including their 
designated support staff), or a third party intermediary as defined at 
Sec.  414.1305, may submit a request for a targeted review. We received 
no comments on our proposal to redesignate as Sec.  414.1385(a)(4) the 
provision previously designated as Sec.  414.1385(a)(2), which states 
that we will respond to each request for targeted review timely 
submitted and determine whether a targeted review is warranted and are 
finalizing the redesignation as proposed.
(b) Timeline for Targeted Review Requests
    In the CY 2017 Quality Payment Program final rule (81 FR 77358), we 
finalized at Sec.  414.1385(a)(1) that MIPS eligible clinicians and 
groups have a 60-day period to submit a request for targeted review, 
which begins on the day we make available the MIPS payment adjustment 
factor, and if applicable the additional MIPS payment adjustment factor 
(collectively referred to as the MIPS payment adjustment factors), for 
the MIPS payment year and ends on September 30 of the year prior to the 
MIPS payment year or a later date specified by CMS. During the first 
year of targeted review for MIPS, we allowed MIPS eligible clinicians 
and groups 90 days, with an additional 14-day extension, to submit a 
targeted review request. In response to user feedback, in December 
2018, we made available revised performance feedback to MIPS eligible 
clinicians and groups who had filed a targeted review request. As we 
stated in the CY 2020 PFS proposed rule (84 FR 40809), we believe it is 
important to ensure MIPS eligible clinicians and groups have an 
opportunity to review their revised performance feedback prior to the 
application of the MIPS payment adjustment factors. We stated that we 
anticipate that by limiting the targeted review period to 60 days, we 
would be able to make available the revised performance feedback during 
October of the year prior to the MIPS payment year, which would be 
approximately 2 months earlier than what we were able to do for the 
first year of targeted review. Therefore, we proposed to revise Sec.  
414.1385(a)(2) to state 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, and to state that 
the targeted review request submission period may be extended as 
specified by CMS. We proposed this change would apply beginning with 
the 2019 performance period.
    The following is a summary of the comments we received on the 
proposals regarding the timeline for targeted review requests and our 
responses.
    Comment: A few commenters supported the proposal to change the 
timeline for submitting a targeted review request to 60 days because of 
their belief that it is a reasonable amount of time, may allow for a 
consistent period of time to submit questions, and may give CMS 
flexibility if feedback reports are delayed.
    Response: We agree that the proposal to limit the period for 
submitting a targeted review request to 60 days is reasonable and 
adequate.
    Comment: A few commenters expressed concern with the proposal to 
change the timeline for submitting a targeted review request to 60 days 
because they indicated it may limit an eligible clinician's time to 
review their performance feedback report, particularly eligible 
clinicians who may have been assessed inaccurately. One commenter 
expressed concern and recommended increased transparency related to the 
timeline for targeted review requests for eligible clinicians, groups 
(and their support staff), and third-party intermediaries. One 
commenter expressed concern over the proposal and recommended adding a 
targeted review category specific to vendor issues that would apply to 
eligible clinicians who experienced a data submission issue caused by a 
third-party intermediary. One commenter expressed concern and 
recommended adding an exception to the targeted review timeline for 
eligible clinicians and groups who have received an automatic extreme 
and uncontrollable circumstances exception.
    Response: We believe that a 60-day submission period for targeted 
review requests is sufficient, as we have seen that eligible clinicians 
or groups who have identified errors typically submit targeted review 
requests at the start of the targeted review request submission

[[Page 63047]]

period, with a significant decrease in targeted review requests towards 
the end of the period. The release of the MIPS payment adjustment 
factors and performance feedback reports at the start of the targeted 
review request submission period would allow ample time for eligible 
clinicians, groups (and their support staff), and third-party 
intermediaries to properly submit an informed targeted review request. 
We believe that our proposal to limit the targeted review request 
submission period to 60 days would provide transparency related to the 
timeline for targeted review requests. We appreciate the recommendation 
of adding a targeted review category specific to third party 
intermediary issues. However, we continue to believe that MIPS eligible 
clinicians and groups are ultimately responsible for the data that is 
submitted by their third party intermediary and should hold their third 
party intermediary accountable for accurate reporting. In addition, in 
section III.K.3.d.(2)(b)(ii)(A) of this final rule, we are establishing 
a policy to reweight the performance categories for a MIPS eligible 
clinician who we determine has data that are inaccurate, unusable or 
otherwise compromised due to circumstances outside of the control of 
the clinician or its agents, which could address some of the 
commenter's concerns about vendor issues. We appreciate the feedback 
concerning extreme and uncontrollable circumstances. We will continue 
to reweight the performance categories for MIPS eligible clinicians who 
qualify for the automatic extreme and uncontrollable circumstances 
policy, without the submission of a targeted review request, and we do 
not believe an exception to the targeted review timeline is warranted.
    Comment: One commenter recommended aligning the MIPS and APM 
timelines in order for MIPS targeted reviews to be completed prior to 
the release of the APM results because they believe it may allow for 
corrections to reflect the final ACO Quality Scores and Shared Savings 
rates.
    Response: We currently send unofficial reports to eligible 
clinicians that do reflect a change in ACOs, as a result of a targeted 
review or other changes. Due to ACO scoring update parameters, 
unfortunately, the APM and MIPS programmatic timing of report releases 
and the end of targeted review cannot be aligned.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to revise Sec.  414.1385(a)(2) to 
state 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 we make available the MIPS payment adjustment 
factors for the MIPS payment year, and to state that the targeted 
review request submission period may be extended as specified by CMS. 
We are finalizing our proposal, as proposed, that this change will 
apply beginning with the 2019 performance period.
(c) Denial of Targeted Review Requests
    Each targeted review request is carefully reviewed based upon the 
information provided at the time the request is submitted. During the 
first year of targeted review, CMS received many targeted review 
requests that were duplicative. We continue to seek opportunities to 
limit burden and improve the efficiency of our processes. Therefore, we 
proposed (84 FR 40810) to revise Sec.  414.1385(a)(3) to state that a 
request for a targeted review may be denied if: The request is 
duplicative of another request for targeted review; the request is not 
submitted during the targeted review request submission period; or the 
request is outside of the scope of targeted review, which is limited to 
the calculation of the MIPS payment adjustment factors applicable to 
the MIPS eligible clinician or group for a year. We stated that 
notification would be provided to the individual or entity that 
submitted the targeted review request as follows:
     If the targeted review request is denied; in this case, 
there will be no change to the MIPS final score or associated MIPS 
payment adjustment factors for the MIPS eligible clinician or group.
     If the targeted review request is approved; in this case, 
the MIPS final score and associated MIPS payment adjustment factors may 
be revised, if applicable, for the MIPS eligible clinician or group.
    The following is a summary of the comments we received on the 
proposals regarding the denial of targeted review requests and our 
responses.
    Comment: One commenter suggested that CMS should not deny both 
requests for targeted review if duplicate requests are received because 
they indicated it may be punitive to eligible clinicians who are 
attempting to fix issues in their performance feedback, MIPS final 
scores, and/or payment adjustment determination.
    Response: We agree and will only deny the duplicate request for a 
targeted review, not the initial request. If there is a change to an 
eligible clinician or groups performance feedback, MIPS final scores, 
and/or payment adjustment determination, that targeted review would not 
be considered a duplicate but viewed as additional information around 
that initial targeted review request.
    Comment: One commenter expressed concern with the proposal to add 
criteria for denial of a targeted review request and recommended 
instituting a process for reviewing targeted review requests that have 
been denied because of their belief that such a review process may 
promote integrity within MIPS.
    Response: We believe that establishing the reasons for which a 
targeted review request may be denied creates transparency with the 
targeted review process and MIPS, and improves the efficiency of our 
processes. However, we believe that further review of requests that 
have been denied may be counterproductive to the efficiency of our 
processes. We note that section 1848(q)(13)(A) of the Act describes the 
review process as ``targeted'' and ``informal,'' and on that basis, we 
do not believe that further review of requests that have been denied is 
warranted (81 FR 77353).
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to revise Sec.  414.1385(a)(3) to 
state that a request for a targeted review may be denied if: The 
request is duplicative of another request for targeted review; the 
request is not submitted during the targeted review request submission 
period; or the request is outside of the scope of targeted review, 
which is limited to the calculation of the MIPS payment adjustment 
factors applicable to the MIPS eligible clinician or group for a year.
(d) Request for Additional Information
    In the CY 2017 Quality Payment Program final rule (81 FR 77358), we 
finalized at Sec.  414.1385(a)(3) that the MIPS eligible clinician or 
group may include additional information in support of their request 
for targeted review at the time the request is submitted, and if CMS 
requests additional information from the MIPS eligible clinician or 
group, it must be provided and received by CMS within 30 days of the 
request, and that non-responsiveness to the request for additional 
information may result in the closure of the targeted review request, 
although the MIPS eligible clinician or group may submit another 
request for targeted review before the deadline. Supporting 
documentation is a critical component of evaluating and processing a 
targeted review request. We may need to request supporting 
documentation, as

[[Page 63048]]

each targeted review request is reviewed individually and by category. 
Therefore, we proposed (84 FR 40810) to add Sec.  414.1385(a)(5) to 
state that a request for a targeted review may include additional 
information in support of the request at the time it is submitted. If 
CMS requests additional information from the MIPS eligible clinician or 
group that is the subject of a request for a targeted review, it must 
be provided and received by CMS within 30 days of CMS' request. Non-
responsiveness to CMS' request for additional information may result in 
a final decision based on the information available, although another 
request for a targeted review may be submitted before the end of the 
targeted review request submission period. Documentation can include, 
but is not limited to:
     Supporting extracts from the MIPS eligible clinician or 
group's EHR.
     Copies of performance data provided to a third party 
intermediary by the MIPS eligible clinician or group.
     Copies of performance data submitted to CMS.
     Quality Payment Program Service Center ticket numbers.
     Signed contracts or agreements between a MIPS eligible 
clinician/group and a third party intermediary.
    The following is a summary of the comments we received on the 
proposals regarding requests for additional information and our 
responses.
    Comment: Commenters expressed concern regarding the proposal to 
update requirements for requesting additional information as part of 
targeted review, specifically recommending a one-time extension of the 
30-day timeframe for eligible clinicians and groups to submit 
additional information. A commenter shared their belief that quality 
data held by a third party intermediary may not be accessible within 
the 30-day timeframe.
    Response: We agree that in certain circumstances, an extension to 
the 30-day timeframe may be warranted. We will consider granting an 
extension on a case-by-case basis, but the request for an extension 
should be submitted before the end of the 30-day period.
    After consideration of the public comments received, we are 
finalizing our proposal, with modification, to add Sec.  414.1385(a)(5) 
to state that a request for a targeted review may include additional 
information in support of the request at the time it is submitted. If 
we request additional information from the MIPS eligible clinician or 
group that is the subject of a request for a targeted review, it must 
be provided and received by CMS within 30 days of CMS' request. Non-
responsiveness to our 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. The 
modification to the regulation text is intended to clarify that if 
another request for targeted review is submitted, it cannot be 
duplicative of a prior request.
(e) Notification of Targeted Review Decisions
    In the CY 2017 Quality Payment Program final rule (81 FR 77358), we 
finalized at Sec.  414.1385(a)(4) that decisions based on the targeted 
review are final, and there is no further review or appeal. We proposed 
(84 FR 40810) to renumber this paragraph as Sec.  414.1385(a)(7) and to 
add text to Sec.  414.1385(a)(7) to state that CMS will notify the 
individual or entity that submitted the request for a targeted review 
of the final decision. To align with policies finalized at Sec.  
414.1400(g) regarding the auditing of entities submitting MIPS data, we 
also proposed to add Sec.  414.1385(a)(8) to state that documentation 
submitted for a targeted review must be retained by the submitter for 6 
years from the end of the MIPS performance period.
    The following is a summary of the comments we received on the 
proposals regarding the notification of targeted review decisions and 
our responses.
    Comment: One commenter did not support our existing policy that 
targeted review decisions are final and no appeal or further review may 
be requested. They recommended that the targeted review process should 
expand beyond a one-level process, allow for live technical assistance, 
and include detailed feedback on the results, particularly on why 
eligible clinicians or groups may have a particular score. They noted 
that these changes to the process may help identify areas for 
improvement and may decrease errors over time.
    Response: As mentioned in a prior response, we believe that further 
review of targeted review decisions may be counterproductive to the 
efficiency of our processes. We again note that section 1848(q)(13)(A) 
of the Act describes the review process as ``targeted'' and 
``informal,'' and on that basis, we do not believe that a second level 
of review process is warranted. At this time, we cannot operationalize 
live technical assistance on performance feedback or scores due to time 
required for researching individual data, program limitations and the 
volume of targeted review requests received. We currently hold webinars 
for stakeholder engagement and that may highlight areas of improvement 
and possibly decrease errors over time.
    Comment: One commenter supported the proposal to require retention 
of documentation submitted for targeted review for 6 years because they 
believed that it may ensure accuracy of targeted reviews.
    Response: We agree that the proposal to require retention of 
documentation submitted for targeted review for 6 years is beneficial 
and maintains integrity within the targeted review process.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to add Sec.  414.1385(a)(8) to 
state that documentation submitted for a targeted review must be 
retained by the submitter for 6 years from the end of the MIPS 
performance period. We did not receive comments on our proposal to 
renumber as Sec.  414.1385(a)(7), the provision at Sec.  
414.1385(a)(4), which states that decisions based on the targeted 
review are final, and there is no further review or appeal and we are 
finalizing this renumbering as proposed.
(f) Scoring Recalculations
    In the CY 2017 Quality Payment Program final rule (81 FR 77353), we 
stated that if a request for targeted review is approved, the outcome 
of such review may vary. We stated, for example, we may determine that 
the clinician should have been excluded from MIPS, re-distribute the 
weights of certain performance categories within the final score (for 
example, if a performance category should have been weighted at zero), 
or recalculate a performance category score in accordance with the 
scoring methodology for the affected category, if technically feasible 
(81 FR 77353). Therefore, we proposed (84 FR 40810) to add Sec.  
414.1385(a)(6) to state that if a request for a targeted review is 
approved, CMS may recalculate, to the extent feasible and applicable, 
the scores of a MIPS eligible clinician or group with regard to the 
measures, activities, performance categories, and final score, as well 
as the MIPS payment adjustment factors.
    The following is a summary of the comments we received on the 
proposals regarding scoring recalculations and our responses.
    Comment: A commenter recommended that once a targeted review is 
approved and if the score of an eligible clinician or group with regard 
to measures, activities, performance categories, and final score, as 
well as payment adjustment is

[[Page 63049]]

changed, a written alert should be issued to the eligible clinician or 
group that provides additional details explaining the change.
    Response: After we notify the submitter of a targeted review 
request of our final decision, the MIPS eligible clinician or group 
that is the subject of the request should review their performance 
feedback regarding updated performance category or final score results. 
We will consider an automated notification of performance feedback 
changes with basic explanation in future years.
    We are finalizing our proposal, as proposed, to add Sec.  
414.1385(a)(6) to state that if a request for a targeted review is 
approved, we may recalculate, to the extent feasible and applicable, 
the scores of a MIPS eligible clinician or group with regard to the 
measures, activities, performance categories, and final score, as well 
as the MIPS payment adjustment factors.
(2) Data Validation and Auditing
    For previous discussions of our policies for data validation and 
auditing at Sec.  414.1390, we refer readers to the CY 2017 Quality 
Payment Program final rule (81 FR 77358 through 77362). Among other 
requirements, Sec.  414.1390(b) establishes that all MIPS eligible 
clinicians and groups that submit data and information to CMS for 
purposes of MIPS must certify to the best of their knowledge that the 
data submitted is true, accurate and complete. MIPS data that are 
inaccurate, incomplete, unusable or otherwise compromised can result in 
improper payment. Despite these existing obligations, we have received 
inquiries regarding perceived opportunities to selectively submit data 
that are unrepresentative of the MIPS performance of the clinician or 
group. Using data selection criteria to misrepresent a clinician or 
group's performance for an applicable performance period, commonly 
referred to as ``cherry-picking,'' results in data submissions that are 
not true, accurate or complete. A clinician or group cannot certify 
that data submitted to CMS are true, accurate and complete to the best 
of its knowledge if they know the data submitted is not representative 
of the clinician's or group's overall performance for a performance 
period. Accordingly, a clinician or group that submits a certification 
under Sec.  414.1390(b) in connection with the submission of data they 
know is cherry-picked has submitted a false certification in violation 
of existing regulatory requirements. If we believe cherry-picking of 
data may be occurring, we may subject the MIPS eligible clinician or 
group to auditing in accordance with Sec.  414.1390(a) and in the case 
of improper payment a reopening and revision of the MIPS payment 
adjustment in accordance with Sec.  414.1390(c).
    The following is a summary of the comments we received on data 
validation and auditing and our responses.
    Comment: One commenter recommended that CMS publish aggregate 
findings of previous audits with regard to suspected instances of 
cherry-picked data.
    Response: We appreciate the feedback and will consider publishing 
the aggregate findings of previous audits surrounding cherry-picked 
data in connection with future educational efforts.
    Comment: A commenter requested clarification that if a clinician 
who submits data on a single patient in order to receive the minimum 
point threshold for a quality measure, CMS would not conclude the 
clinician was cherry-picking data.
    Response: We are clarifying that existing policy takes into 
consideration that MIPS eligible clinicians may submit data in 
accordance with CMS data submission requirements on a single measure. 
We believe that even in the context of submitting data on a single 
patient in order to receive the minimum point threshold, the patient 
selected should be representative. In other instances where cherry-
picking is suspected, we will determine whether a clinician is using 
selection criteria inappropriately to create an unrepresentative 
submission for MIPS performance on a case-by-case basis. For additional 
policies on MIPS final score methodologies, we refer readers to section 
III.K.3.d of this final rule.
    Comment: A few commenters supported the statement that if CMS 
believes the cherry-picking of data may be occurring, a MIPS eligible 
clinicians or group may be audited and in the case of improper payment, 
MIPS payment adjustment may be reopened and revised.
    Response: We appreciate the commenters support and agree that if 
the cherry-picking of data is suspected that a MIPS eligible clinician 
or group may be audited and in the case of improper payment, a MIPS 
payment adjustment may be reopened and revised.
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), 
and the CY 2019 PFS final rule (83 FR 59894 through 59910) for our 
previously established policies regarding third party intermediaries.
    In the CY 2020 PFS proposed rule (84 FR 40811 through 40821), we 
proposed to make several changes. We proposed to establish new 
requirements for MIPS performance categories that must be supported by 
QCDRs, qualified registries, and Health IT vendors. We proposed to 
modify the criteria for approval as a third party intermediary, and 
establish new requirements to promote continuity of service to 
clinicians and groups that use third party intermediaries for their 
MIPS submissions. With respect to QCDRs, we also proposed requirements 
to: Engage in activities that will foster improvement in the quality of 
care; and enhance performance feedback requirements. These QCDR 
proposals would also affect the self-nomination process. We also 
proposed to update considerations for QCDR measures. With respect to 
qualified registries, we also proposed to require enhanced performance 
feedback requirements. Finally, we clarified the remedial action and 
termination provisions applicable to all third party intermediaries.
    Because we believe that third party intermediaries, such as QCDRs, 
represent a useful path to fulfilling MIPS requirements while reducing 
the reporting burden for clinicians, we believe the policies discussed 
in this section justify the Collection of Information and Regulatory 
Impact Analysis burden estimates discussed in sections VI. and VII. of 
this final rule, respectively, for additional information on the costs 
and benefits.
(1) 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 at Sec.  414.1400(a)(2) (83 FR 
60088) for our current policy regarding the types of MIPS data third-
party intermediaries may submit. In summary, the current policy is that 
QCDRs, qualified registries, and health IT vendors may submit data for 
any of the following MIPS performance categories: Quality (except for 
data on the CAHPS for MIPS survey); improvement activities; and 
Promoting Interoperability. Through education and outreach, we have 
become aware of stakeholders' desires to have a more cohesive 
participation experience across

[[Page 63050]]

all performance categories under MIPS. Specifically, we have heard of 
instances where clinicians would like to use their QCDR or qualified 
registry for reporting the improvement activities and promoting 
interoperability performance categories, but their particular third 
party intermediary does not support all categories, only quality. Based 
on this feedback and additional data regarding QCDRs and qualified 
registries respectively, which are discussed further below, we believe 
it is reasonable to strengthen our policies at Sec.  414.1400(a)(2), 
and require QCDRs and qualified registries to support three performance 
categories: Quality; improvement activities; and Promoting 
Interoperability. Accordingly, we proposed to amend Sec.  
414.1400(a)(2) to state that beginning with the 2023 MIPS payment year 
(2021 performance period) and for all future years, for the MIPS 
performance categories identified in the regulation, QCDRs and 
qualified registries must be able to submit data for each category, and 
Health IT vendors must be able to submit data for at least one category 
(84 FR 40811). We solicited feedback on the benefits and burdens of 
this proposal, including whether the requirement to support all three 
identified categories of MIPS performance data should extend to health 
IT vendors.
    As discussed in the CY 2020 PFS proposed rule, however, we 
recognized the need to create an exception such that third party 
intermediaries would not be required to submit data for the Promoting 
Interoperability performance category if it only represents MIPS 
eligible clinicians, groups and virtual groups that are eligible for 
reweighting under the Promoting Interoperability performance category. 
For example, as discussed in the CY 2019 PFS final rule (83 FR 59819 
through 59820), physical therapists generally are eligible for 
reweighting of the Promoting Interoperability performance category to 
zero percent of the final score; therefore, under this exception, a 
QCDR or qualified registry that represents only physical therapists 
that reweighted the Promoting Interoperability performance category to 
zero percent of the final score, would not be required to support the 
Promoting Interoperability performance category. Therefore, we proposed 
to revise Sec.  414.1400(a)(2)(iii) to state that for the Promoting 
Interoperability performance category, the requirement applies if the 
eligible clinician, group, or virtual group is using CEHRT; however, a 
third party could 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)-(7) or Sec.  414.1380(c)(2)(i)(C)(9) (84 FR 
40811). We refer readers to section III.K.3.c.(4) of this final rule 
for additional information on the clinician types that are eligible for 
reweighting the Promoting Interoperability performance category. We 
noted that we anticipate using the self-nomination vetting process to 
assess whether the QCDR or qualified registry is subject to our 
requirement to support reporting the Promoting Interoperability 
performance category. We solicited comments on this proposal, including 
the scope of the exception from the Promoting Interoperability 
reporting requirement for certain types of QCDRs and qualified 
registries. Specifically, we solicited comment on whether we should 
more narrowly tailor, or conversely broaden, the proposed exceptions 
for when QCDRS and qualified registries must support the Promoting 
Interoperability performance category.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters expressed their agreement with the 
proposal to require QCDRs and qualified registries to support the 
reporting of data for the quality, Promoting Interoperability, and the 
improvement activities performance categories, as well as the exemption 
for third party intermediaries who only serve specialties that are 
exempt from the Promoting Interoperability performance category.
    Response: We thank commenters for their support. We direct readers 
to the QCDR and qualified registry sections below III.K.3.g.(3) and 
III.K.3.g.(4) for detailed comment and responses regarding these 
proposals.
    Comment: Several commenters expressed their belief that the scope 
of proposals in the proposed rule negatively impacts QCDRs and 
Qualified Registries in general to the point where some third-party 
intermediaries may end their participation in MIPS. They believe the 
proposals shift costs and burden of administering the MIPS program onto 
physicians via their specialty societies that create measures and have 
QCDRs and require QCDRs to perform services that were not part of the 
original quality program.
    Response: The intent of our proposals is to ensure that the QCDRs 
and qualified registries that are approved in the program are of the 
highest quality, and can be used as reliable resources to support 
quality reporting on behalf of eligible clinicians and groups. We 
understand that an increase in requirements may cause increased burden 
to QCDRs and qualified registries, but believe that high-performing 
third party intermediaries are capable of meeting these requirements. 
Through the legacy PQRS program and the first few years of MIPS, we 
have witnessed instances of third party intermediaries, specifically 
QCDRs and qualified registries leaving the program mid-performance 
period, creating additional burden to the clinicians who were depending 
on them for reporting purposes. There have also been instances where 
QCDRs and qualified registries were unable to support measures, after 
indicating they could, or having errors related to data submissions. We 
believe these type of issues also contribute to clinician burden and 
are addressed through our additional policies as described in this 
section of the final rule. We refer readers to the Collection of 
Information and Regulatory Impact Analysis burden estimates discussed 
in sections VI. and VII. of this final rule, respectively, for 
additional information on the costs and benefits related to our 
finalized policies.
    Comment: Many commenters opposed the proposal to require QCDRs to 
support the reporting of data for the quality, Promoting 
Interoperability, and improvement activities performance categories, 
specifically citing the requirements to audit and validate Promoting 
Interoperability data and improvement activities. Several of the 
commenters stated their opinion that this would represent a significant 
additional burden, in part due to what they believe to be large 
increase in the data that would need to be collected without adding any 
distinct benefit to MIPS eligible clinicians and groups who already 
have other methods available for reporting MIPS data, and that some 
QCDRs may incur additional costs from EHR vendors who may charge fees 
for providing additional necessary reports. One commenter also cited 
their belief that the QCDRs/registries currently supporting the 
Promoting Interoperability performance category use a health 
information exchange (https://www.healthit.gov/topic/health-it-and-health-information-exchange-basics/what-hie) and that vendors operating 
in areas that do not have a health information exchange would not be 
able to report on these measures. A few commenters cited their opinion 
that if the proposal is finalized, the resulting burden may result in 
many QCDRs electing to reevaluate their decisions to

[[Page 63051]]

seek approval to submit MIPS data. A few commenters also stated their 
opinion that if the proposal is finalized, they would need CMS to 
provide additional guidance and descriptions of what data would be 
necessary to validate that an individual MIPS eligible clinician or 
group could appropriately attest to a specific improvement activity.
    Response: We thank the commenters for their suggestions. However, 
in this case, a majority of existing qualified registries and QCDRs 
already support all three performance categories which require data 
submission. We do acknowledge that a small minority of qualified 
registries and QCDRs may not be able to comply with this requirement, 
and as a result may elect not to continue in the Quality Payment 
Program. While we do not yet have data to share for how clinicians 
participated in 2019 (year 3), we do want to indicate that we have 
observed from 2017 (year 1) to 2018 (year 2) approximately 24 percent 
increasing to 36 percent of clinicians have used their QCDR/qualified 
registry for submitting for all 3 performance categories. We believe 
when this policy becomes finalized, more MIPS eligible clinicians may 
want to use this method as a burden reduction on data submission. We 
also believe the added benefit this policy provides to clinicians who 
want to use a qualified registry or QCDR to support data submission for 
the three performance categories outweighs the small number of 
qualified registries and QCDRs that are not able to comply, and that is 
why we are taking this step to finalize this policy.
    As described in the CY 2017 Quality Payment Program final rule (81 
FR 77366 and 81 FR 77384), QCDRs and qualified registries must audit a 
subset of data prior to submission for all performance categories that 
the QCDR or qualified registry is submitting data on, that is, quality, 
improvement activities, and promoting interoperability (previously 
known as advancing care information). We understand that this policy 
will require the minority of existing QCDRs and qualified registries 
who do not support all three performance categories to take on 
additional efforts and resources to support the remaining performance 
categories in order to retain their approval. Although some EHR vendors 
may charge for reports, we believe that the costs will be minimal 
because CEHRT includes the capability to calculate the Promoting 
Interoperability measures and the reports that must be generated. In 
addition, the use of health information exchanges (https://www.healthit.gov/topic/health-it-and-health-information-exchange-basics/what-hie) is an option for transmitting data; their use is not a 
requirement.
    However, we believe that this policy allows for QCDRs and qualified 
registries to become one-stop-shops for reporting, and will thereby 
reduce reporting burden for eligible clinicians and groups. Under our 
current data validation processes, as described in the CY 2017 Quality 
Payment Program final rule (81 FR 77368 through 77369) and (81 FR 77384 
through 77385), QCDRs and qualified registries are required to provide 
information on their sampling methodology. For example, it is 
encouraged that 3 percent of TIN/NPIs submitted be sampled with a 
minimum sample of 10 TIN/NPIs or a maximum sample of 50 TIN/NPIs. For 
each TIN/NPI sampled, it is encouraged that 25 percent of the TIN/NPI's 
patients (with a minimum sample of 5 patients (with a maximum sample of 
50 patients). We would expect that this review of patient medical 
records would be done to validate that the pertinent quality actions 
were done for measures and activities done by the clinician and group. 
In addition, validation guidance clarifications can be found within the 
improvement activities validation document at the MIPS Data Validation 
Document link.
    Comment: A few commenters asserted that CMS should remunerate QCDRs 
for the associated cost of performing pre-submission audits of the 3 
performance categories.
    Response: We disagree that we should have to remunerate QCDRs for 
the cost associated with validating QCDR data prior to submission for 
the three performance categories, as we believe validation is a part of 
the duties of a QCDR.
    Comment: A few commenters stated that if the proposal is finalized, 
it should not be finalized for the 2020 self-nomination process as it 
does not give QCDRs or clinicians enough time to incorporate it into 
their processes and workflows.
    Response: We clarify that this policy will not be required by QCDRs 
or qualified registries for the 2020 self-nomination process. As stated 
in the CY 2020 PFS proposed rule (84 FR 40811), we proposed that 
beginning with the 2021 performance period and for future years, to 
require QCDRs to support three performance categories: Quality, 
improvement activities; and Promoting Interoperability. This policy 
would take effect beginning with the 2023 MIPS payment year or the 2021 
performance period. Specifically, the 2021 self-nomination period which 
begins on July 1, 2020 and ends on September 1, 2020, which gives QCDRs 
sufficient time to incorporate this reporting into their workflows. As 
mentioned above, based on our review, a majority of QCDRs and qualified 
registries already support all three performance categories, and 
therefore, they should already have it incorporated into their 
processes and workflows. To clarify, this policy requires that QCDRs 
and qualified registries support all three performance categories, but 
does not require that an eligible clinician or group to report all 
three performance categories through a QCDR or qualified registry. We 
note in this final rule that the 2021 performance period corresponds to 
the 2023 MIPS payment years and are updating our policies to reflect 
this terminology for consistency.
    Comment: One commenter stated that the proposals to require QCDRs 
and qualified registries to support the reporting of the quality, 
Promoting Interoperability, and improvement activities performance 
categories does not appropriately account for use cases in which a 
health IT vendor acts as both an EHR and a QCDR/qualified registry. The 
commenter asked CMS to exempt organizations that are EHRs that also 
have met the requirements to be considered a QCDRs/Qualified Registries 
from the requirement for QCDRs/Qualified Registries to support all 
three performance categories if the vendor offers the ability to 
support the reporting of the remaining performance categories through 
their EHR. The commenter further believed that a health IT vendor who 
supports all performance categories, regardless of whether it is 
accomplished via EHR or qualified registry/QCDR, will suffice in terms 
of supporting clinicians who participate in MIPS. One commenter 
expressed the belief that health IT vendors should be held to the same 
standards as QCDRs and qualified registries, particularly considering 
that EHRs contain much of the data needed to report on any of the three 
categories, and as such, CEHRT should be able to support and report on 
all three performance categories.
    Response: We believe that a qualified registry or QCDR should 
support all three performance categories, regardless of the other types 
of services they may provide. Health IT vendors and other organizations 
who act as an EHR in addition to being a QCDR or qualified registry 
would not be exempt from this requirement. The intent of requiring 
QCDRs and qualified registries to support all three performance 
categories is to reduce reporting burden on behalf of the clinician who 
may have previously been forced to use multiple submission types to 
report to CMS for

[[Page 63052]]

purposes of MIPS. In addition, we appreciate the commenter's feedback 
that health IT vendors should be held to the same standards as QCDRs 
and qualified registries, and may consider this feedback in future 
rulemaking. We also believe it is important for all approved QCDRs and 
qualified registries to be able to submit MIPS data in all MIPS 
performance categories as needed by their MIPS eligible clinicians, 
groups, and virtual groups. Our policy goal is to reduce burden on 
clinicians and groups by ensuring they can use a single third party 
intermediary to submit all data on quality, improvement activities, and 
promoting interoperability. Creating an exception if multiple 
intermediaries are owned by the same organization would be inconsistent 
with this goal. For example, some organizations could require an 
eligible clinician or group to pay two separate fees, one to use its 
QCDR or qualified registry, and another to use its EHR. We would like 
to streamline services in order to give eligible clinicians and groups 
a less burdensome reporting experience. We note that we will be 
monitoring changes in this space.
    Comment: A few commenters stated that the proposed exemption for 
qualified registries and QCDRs whose participants receive an exemption 
under the special status categories for the Promoting Interoperability 
performance category is unclear. Specifically, a commenter stated that 
CMS does not provide an indication as to the percentage of participants 
that would have to be exempt for the qualified registry or QCDR to not 
have to accept and submit Promoting Interoperability data, while 
another commenter sought clarity as to which specific specialties would 
be subject to the exemption.
    Response: QCDRs and qualified registries are expected to support 
data submission in the MIPS performance category for Promoting 
Interoperability for each of its MIPS eligible clinicians, groups or 
virtual groups to which this performance category applies. However, a 
third party could be excepted from this requirement if all of the third 
party intermediary's 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)(7) or Sec.  
414.1380(c)(2)(i)(C)(9) (84 FR 40811). Accordingly, a third party 
intermediary may not be required to submit data for the Promoting 
Interoperability performance category if it only represents MIPS 
eligible clinicians, groups, and virtual groups that are eligible for 
reweighting under the Promoting Interoperability performance category. 
For example, as discussed in the CY 2019 PFS final rule (83 FR 59819 
through 59820), physical therapists generally are eligible for 
reweighting of the Promoting Interoperability performance category to 
zero percent of the final score; therefore, under this exception, a 
QCDR or qualified registry that represents only physical therapists 
that reweighted the Promoting Interoperability performance category to 
zero percent of the final score, would not be required to support the 
Promoting Interoperability performance category. Similarly, a QCDR or 
qualified registry may not be required to support the Promoting 
Interoperability performance category if it supported only following 
clinician types: Occupational therapists; qualified speech-language 
pathologists; qualified audiologists; clinical psychologists; and 
registered dieticians or nutrition professionals, as described in Sec.  
414.1380(c)(2)(i)(A)(4). In contrast, a QCDR or qualified registry 
cannot be excepted from this requirement and must be able to submit 
data for the Promoting Interoperability performance category so long as 
it supports any clinician, group or virtual group that uses CEHRT and 
is not identified as eligible for reweighting of the Promoting 
Interoperability performance category. We refer readers to section 
III.K.3.c.(4) of this final rule for additional details on the 
Promoting Interoperability performance category.
    After consideration of the comments, we are finalizing our 
proposals with technical modifications for clarity and consistency with 
the existing provisions of Sec.  414.1400. Specifically, we are 
finalizing changes to Sec.  414.1400(a)(2) to state that beginning with 
the 2023 MIPS payment year, QCDRs and qualified registries must be able 
to submit data for all of the MIPS performance categories identified in 
the regulation, and Health IT vendors must be able to submit data for 
at least one such category. We are also finalizing our proposal to 
amend Sec.  414.1400(a)(2)(iii), as proposed, to state that for the 
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).
(2) Approval Criteria for Third Party Intermediaries
    We refer readers to Sec.  414.1400(a)(4) and the CY 2019 PFS final 
rule (83 FR 59894 through 59895, 60088) for previously finalized 
policies related to the approval criteria for third party 
intermediaries.
    Based on experience with third party intermediaries thus far, in 
the CY 2020 PFS proposed rule (84 FR 40811), we proposed to adopt two 
additional criteria for approval at Sec.  414.1400(a)(4) to ensure 
continuity of services to MIPS eligible clinicians, groups, and virtual 
groups that utilize the services of third party intermediaries. 
Specifically, we have experienced instances where a third party 
intermediary withdraws mid-performance period, which impacts the 
clinician or group's ability to participate in the MIPS program, 
through no fault of their own. We proposed two changes to help prevent 
these disruptions (84 FR 40811 through 40812). First, we proposed at 
Sec.  414.1400(a)(4) to add a new paragraph (v) to establish that a 
condition of approval for a third party intermediary is for the entity 
to agree to provide services for the entire performance period and 
applicable data submission period (84 FR 40812). In addition, we 
proposed at Sec.  414.1400(a)(4) to add a new paragraph (vi) to 
establish that a condition of approval is for a third party 
intermediary to agree that 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 data 
submission mechanism or third party intermediary according to a CMS 
approved transition plan (84 FR 40812). We believe it is important to 
condition the approval of a third party intermediary on the entity 
agreeing to follow this process so that in the case a third-party 
intermediary fails to meet its obligation under the proposed Sec.  
414.1400(a)(4)(v) to provide services for the entire performance period 
and corresponding data submission period, the third party intermediary 
and the clinicians, groups, and virtual groups it serves have common 
expectations of the support the third party intermediary will provide 
to its users in connection with its withdrawal (84 FR 40812). We 
believe these proposed conditions of approval will help ensure that 
entities seeking to become approved as third party intermediaries are 
aware of the expectations to provide continuous service for the 
duration of the entire performance period and corresponding data 
submission period, will help reduce the extent to which the clinicians, 
groups, and virtual groups are inadvertently impacted by a third

[[Page 63053]]

party intermediary withdrawing from the program, and will help 
clinicians, groups, and virtual groups avoid additional reporting 
burden that may result from withdrawals mid-performance period (84 FR 
40812). We note that we proposed, if CMS determines that a third party 
intermediary has ceased to meet either of these proposed criteria for 
approval, CMS may take remedial action or terminate the third party 
intermediary in accordance with Sec.  414.1400(f) (84 FR 40812). We 
also refer readers to sections III.K.3.g.(3) and III.K.3.g.(4) of this 
final rule where we discuss these topics for QCDRs and qualified 
registries specifically.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported the proposal to require third 
party intermediaries to attest that they will provide services for the 
entire performance period and to agree to provide a transition plan to 
an alternative data submission mechanism or third-party intermediary 
prior to discontinuing services.
    Response: We thank the commenters for their support.
    Comment: One commenter stated that the requirement to provide 
transition plans for participants in the case of service 
discontinuation should not be approved as it would be extremely 
burdensome for a third party intermediary to have to do individual 
transition plans given that the decision in this circumstance lies with 
the clinicians and their practices to make such a transition. In place 
of the requirement, the commenter recommended that a ``CMS-approved 
transition advisory plan'' be developed due to its belief that 
additional requirements are unnecessary, without proven benefit, and 
would not lead to any earlier identification of quality issues. The 
same commenter encouraged CMS to remain sensitive to and flexible in 
dealing with any extenuating circumstances outside the registry's 
direct control that could lead to or cause an interruption in MIPS 
reporting services.
    Response: We thank the commenter for their suggestions. We clarify 
that in instances where a clinician or group is leaving a third party 
intermediary on its own volition, a transition plan, while encouraged, 
is not required from a QCDR or a qualified registry. Our proposal 
addresses the opposite scenario--if QCDRs and qualified registries 
discontinue services to their MIPS eligible clinician, group or virtual 
group during a performance period. We believe it is important for a 
third party intermediary to agree that prior to discontinuing services, 
the third party intermediary must support the transition of such MIPS 
eligible clinician, group, or virtual group to an alternate submitter 
type (and as needed alternate collection type) or third party 
intermediary according to a CMS approved a transition plan. We have 
experienced scenarios where QCDRs and qualified registries have 
withdrawn from participation in the middle of the performance period, 
which causes inadvertent burden on eligible clinicians and groups who 
have to then scramble to find alternative methods of submitting their 
data to us in order to satisfy the reporting requirements for a given 
performance year. Eligible clinicians and groups that use qualified 
registries or QCDRs, utilize them as a way to mitigate reporting 
burden. We disagree that requiring a transition plan is unnecessary and 
without benefit; QCDRs and qualified registries should explain their 
mitigation strategy in informing their clients on alternative methods 
of reporting. We appreciate the commenter's recommendation that we 
develop a ``CMS-approved transition advisory plan'', but disagree that 
it is appropriate. The strategy utilized in transitioning clients off a 
QCDR or qualified registry's platform should be left to the QCDR or 
qualified registry to determine, based on their size, volume of 
clinicians and groups, the timing to which they will completely 
discontinue service as a QCDR or registry, and other factors that may 
be unique to a given QCDR/qualified registries specific business 
relationship with a clinician. We believe it is important for each 
transition plan to take into consideration the above mentioned factors, 
which is why we believe it is appropriate to provide flexibility to the 
third party intermediaries to craft a transition plan for our review 
and approval. While we understand that sometimes issues arise outside 
of the registry's direct control, impacting a registry's ability to 
provide services, we believe that a transition plan should be required 
regardless of the reason that the third party intermediary is 
discontinuing services.
    After consideration of the comments, we are finalizing at Sec.  
414.1400(a)(4), as proposed, to add a new paragraph (v) to establish 
that a condition of approval for a third party intermediary is for the 
entity to agree to provide services for the entire performance period 
and applicable data submission period. Also, we are finalizing at Sec.  
414.1400(a)(4) to add paragraph (vi) with modification. Instead of 
requiring the third party intermediary to support the transition of 
such MIPS eligible clinician, group, or virtual group to an alternate 
data submission mechanism or third party intermediary, we are 
finalizing that the third party intermediary must support the 
transition of such MIPS eligible clinician, group, or virtual group to 
an alternate submitter type, or for any measures on which data has been 
collected, alternate collection type or third party intermediary 
according to a CMS approved a transition plan. This modification to the 
specific submission terms in this policy is to be consistent with the 
terminology used in Sec. Sec.  414.1325 and 414.1335 (83 FR 59749 
through 59754). As such, we are finalizing at Sec.  414.1400(a)(4) to 
add a new paragraph (vi) to establish that a condition of approval is 
for the third party intermediary to agree that 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 transition plan.
    Third party intermediaries are not required to support the 
transition of MIPS eligible clinicians, groups, or virtual groups to an 
alternate collection type for measures on which no data has been 
collected. We note that for QCDR measures, supporting the transition to 
an alternate collection type may not be feasible in every case. If we 
determine that a third party intermediary has ceased to meet either of 
these criteria for approval, we may take remedial action or terminate 
the third party intermediary in accordance with Sec.  414.1400(f).
(3) Qualified Clinical Data Registries (QCDRs)
    In the CY 2020 PFS proposed rule (84 FR 40812 through 40814), we 
proposed: (a) QCDR approval criteria; and (b) various policies related 
to QCDR measures. These proposed policies would also affect the QCDR 
self-nomination process.
(a) QCDR Approval Criteria
    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, which requires the Secretary to establish requirements for an 
entity to be

[[Page 63054]]

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), and Sec.  414.1400(a)(4) through (b) for 
previously finalized policies about third party intermediaries and QCDR 
approval criteria. In the CY 2020 PFS proposed rule (84 FR 40812 
through 40814), we proposed to add to those policies to require QCDRs 
to: (a) Support all three performance categories where data submission 
is required; (b) engage in activities that will foster improvement in 
the quality of care; and (c) enhance performance feedback requirements.
(i) Requirement for QCDRs To Support All Three Performance Categories 
Where Data Submission Is Required
    In the CY 2020 PFS proposed rule (84 FR 40811), we proposed to 
require QCDRs and qualified registries to support three performance 
categories: Quality, improvement activities, and Promoting 
Interoperability. In this section, we discuss QCDRs specifically. As 
previously stated in the CY 2017 Quality Payment Program final rule (81 
FR 77363 through 77364), section 1848(q)(1)(E) of the Act encourages 
the use of QCDRs in carrying out MIPS. Although section 
1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to 
encourage MIPS eligible clinicians to use QCDRs to report on applicable 
measures for the quality performance category, and section 
1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the 
provision of performance feedback through QCDRs, the statute does not 
specifically address use of QCDRs for the other MIPS performance 
categories (81 FR 77363). Although we previously could have limited the 
use of QCDRs to assessing only the quality performance category under 
MIPS and providing performance feedback, we believed (and still 
believe) it would be less burdensome for MIPS eligible clinicians if we 
expand QCDRs' capabilities (81 FR 77363). By allowing QCDRs to report 
on quality measures, improvement activities, and Promoting 
Interoperability measures, we alleviate the need for individual MIPS 
eligible clinicians and groups to use a separate mechanism to report 
data for these performance categories (81 FR 77363). It is important to 
note that QCDRs do not need to submit data for the cost performance 
category since these measures are administrative claims-based measures 
(81 FR 77363).
    As noted above, based on previously finalized policies in the CY 
2017 Quality Payment Program final rule (81 FR 77363 through 77364) and 
as further revised in the CY 2019 PFS final rule at Sec.  
414.1400(a)(2) (83 FR 60088), the current policy is that QCDRs, 
qualified registries, and health IT vendors may submit data for any of 
the following MIPS performance categories: Quality (except for data on 
the CAHPS for MIPS survey); improvement activities; and Promoting 
Interoperability.
    Through education and outreach, we have become aware of 
stakeholders' desires to have a more cohesive participation experience 
across all performance categories under MIPS. Specifically, we have 
heard of instances where clinicians would like to use their QCDR for 
reporting the improvement activities and promoting interoperability 
performance categories, but their particular QCDR does not support all 
categories, only quality. This results in the clinician needing to 
enter into a business relationship with another third party to complete 
their MIPS reporting or leverage a different submitter type or 
submission type, which can create additional burden to the clinician. 
We believe that requiring QCDRs to be able to support these performance 
categories will be a step towards addressing stakeholders concerns on 
having a more cohesive participation experience across all performance 
categories under MIPS. In addition, we believe this proposal will help 
to reduce the reporting burden MIPS eligible clinicians and groups face 
when having to utilize multiple submission mechanisms to meet the 
reporting requirements of the various performance categories. 
Furthermore, as we move to a more cohesive participation experience 
under the MIPS Value Pathways (MVP), as discussed in the CY 2020 PFS 
proposed rule (84 FR 40732 through 40745), we believe this proposal 
will assist clinicians in that transition. We also refer readers to 
section III.K.3.a. of this final rule where the MIPS MVP is discussed.
    Based on our review of existing 2019 QCDRs through the 2019 QCDR 
Qualified Posting, approximately 92 QCDRs, or about 72 percent of the 
QCDRs currently participating in the program, are supporting all three 
performance categories. When the CY 2020 PFS proposed rule was 
published the 2019 QCDR Qualified Posting was available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/347/2019%20QCDR%20Qualified%20Posting_Final_v3.xlsx (84 FR 40813). Since 
the publication of that proposed rule, the link has since been updated 
and is now available in the Quality Payment Program Resource Library at 
https://qpp.cms.gov/about/resource-library by searching for the ``2019 
QCDR Qualified Posting.'' In addition, in our review of prior data 
through previous qualified postings for the 2017 and 2018 performance 
periods, we have observed that a majority of the QCDRs participating in 
the program supported the three performance categories that require 
data submission. In 2017, 73 percent (approximately 83 QCDRs) and in 
2018, 73 percent (approximately 110 QCDRs) have supported all three 
performance categories. While we do not yet have data to share for how 
clinicians participated in 2019 (year 3), we do want to indicate that 
we have observed from 2017 (year 1) to 2018 (year 2) approximately 24 
percent increasing to 36 percent of clinicians have used their QCDR/
qualified registry for submitting for all 3 performance categories. We 
believe when this policy becomes finalized, more MIPS eligible 
clinicians may want to use this method as a burden reduction on data 
submission. Based on this data, we believe it is reasonable to want to 
continue to strengthen our policies at Sec.  414.1400(a)(2) by 
requiring that QCDRs have the capacity to support the reporting 
requirements of the quality, improvement activities, and promoting 
interoperability performance categories.
    Therefore, beginning with the 2021 performance period and for 
future years, we proposed to require QCDRs to support three performance 
categories: Quality, improvement activities, and Promoting 
Interoperability (84 FR 40813). We note that the 2021 performance 
period corresponds to the 2023 MIPS payment years and are updating our 
policies here in this final rule to reflect this terminology for 
consistency. Additionally, for reasons, as discussed above, we proposed 
to amend Sec.  414.1400(a)(2) to state, beginning with the 2023 MIPS 
payment year (2021 performance period) and for all future years, for 
the following MIPS performance categories, QCDRs must be able to submit 
data for all categories, and Health IT vendors must be able to submit 
data for at least one category: Quality (except for data on the CAHPS 
for MIPS survey); improvement activities; and Promoting 
Interoperability with an exception. As discussed in the CY 2020 PFS 
proposed rule (84 FR 40811), we proposed that based on the amendment to 
Sec.  414.1400(a)(2)(iii), for the Promoting Interoperability 
performance category, the requirement applies if the eligible 
clinician, group, or virtual group is using CEHRT; however, a third 
party

[[Page 63055]]

could 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), (c)(2)(i)(A)(5), 
(c)(2)(i)(C)(1) through (c)(2)(i)(C)(7), or (c)(2)(i)(C)(9) (84 FR 
40813). As part of this proposal, we would require QCDRs to attest to 
the ability to submit data for these performance categories, as 
applicable, at time of self-nomination.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed with the proposal to require 
QCDRs to support the reporting of data for the quality, Promoting 
Interoperability, and the improvement activities performance 
categories, as well as the exemption for QCDRs who serve specialties 
that are exempt from the Promoting Interoperability performance 
category. Some commenters noted their QCDRs are already submitting data 
on all three performance categories, while other QCDRs report measures 
in the Quality Category and attest to improvement activities.
    Response: We thank commenters for their support.
    Comment: One commenter noted that the proposal should not be 
considered until after the 21st Century Cures Act: Interoperability, 
Information Blocking, and the ONC Health IT Certification Program Rule 
(21st Century Cure Act) final rule is published and the updated 
standards are implemented.
    Response: We understand the interest in coordinating with the 
updates to standards that may be included in the 21st Century Cures Act 
final rule, however we do not believe that the proposals under the 21st 
Century Cures Act will have a significant impact on the ability of 
QCDRs to report measures for the Promoting Interoperability category. 
We note this requirement was proposed with a delayed implementation, 
beginning with the 2023 MIPS payment year (2021 performance period), 
which should accommodate timing for any updates to standards. When the 
21st Century Cures Act final rule is published we will determine if 
additional modifications are necessary and may address in future rule 
making.
    Comment: One commenter requested CMS provide additional 
clarification regarding the number of measures from each performance 
category that will be required for approval.
    Response: As described in the CY 2017 Quality Payment Program final 
rule (81 FR 77368), QCDRs and qualified registries are required to 
support the minimum number of measures to meet the reporting 
requirements of the Quality performance category. Through the 
finalization of the policy to require QCDRs and qualified registries to 
support all three performance categories in this final rule, we 
encourage third parties to support the minimum number of measures and 
activities to support the Promoting Interoperability performance 
category as discussed in Sec.  414.1375 (83 FR 59798 through 59817) and 
Improvement Activities performance category as discussed in the CY 2017 
Quality Payment Program final rule (81 FR 77185, in order to offer a 
complete reporting experience to eligible clinicians and groups.
    Comment: One commenter questioned whether the QCDR will be required 
to audit data submitted for all performance categories. One commenter 
stated their belief that if the proposal is finalized, CMS should 
define more clearly how improvement activities should be documented to 
help standardize auditing by third party intermediaries and alleviate 
any additional burden associated with the requirement.
    Response: Under our current data validation processes, as described 
in the CY 2017 Quality Payment Program final rule (81 FR 77368 through 
77369) and (81 FR 77384 through 77385), QCDRs and qualified registries 
are required to provide information on their sampling methodology. For 
example, it is encouraged that 3 percent of TIN/NPIs submitted be 
sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 
TIN/NPIs. For each TIN/NPI sampled, it is encouraged that 25 percent of 
the TIN/NPI's patients (with a minimum sample of 5 patients (with a 
maximum sample of 50 patients). We would expect that this review of 
patient medical records would be done to validate that the pertinent 
quality actions were done for measures and activities done by the 
clinician and group. In addition, validation guidance clarifications 
can be found within the improvement activities validation document at 
the MIPS Data Validation Document link. With regards to auditing 
whether improvement activities have been completed by a clinician or 
group, it is important for a third party intermediary to validate that 
an action has been done through review of medical records or other 
forms of documentation that will indicate that the quality action and/
or improvement activity has been completed.
    After consideration of the comments, we are finalizing our 
proposals with technical modifications for clarity and consistency with 
the existing provisions of Sec.  414.1400. As discussed in section 
III.K.3.g.(1) of this final rule, we are amending Sec.  414.1400(a)(2) 
to state that beginning with the 2023 MIPS payment year, QCDRs and 
qualified registries must be able to submit data for all of the MIPS 
performance categories identified in the regulation, and Health IT 
vendors must be able to submit data for at least one such category. We 
are also finalizing our proposal to amend Sec.  414.1400(a)(2)(iii), as 
proposed, to state that for the 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). 
We refer readers to section III.I.3.d.(2) of this final rule where 
reweighting policies are discussed. We are also finalizing that QCDRs 
are required to attest to the ability to submit data for these 
performance categories, as applicable, at time of self-nomination.
(ii) Requirement for QCDRs To Engage in Activities That Will Foster 
Improvement in the Quality of Care
    We generally refer readers to section 1848(m)(3)(E)(i) and (v) of 
the Act, which requires the Secretary to establish requirements for an 
entity to be considered a qualified clinical data registry and a 
process to determine whether or not an entity meets such requirements. 
Section 1848(m)(3)(E)(ii)(IV) of the Act provides that in establishing 
such requirements, the Secretary must consider whether an entity, among 
other things, supports quality improvement initiatives for 
participants.
    As detailed at Sec.  414.1305(1) a QCDR means: For the 2019, 2020 
and 2021 MIPS payment year, a CMS-approved entity that has self-
nominated and successfully completed a qualification process to 
determine whether the entity may collect medical or clinical data for 
the purpose of patient and disease tracking to foster improvement in 
the quality of care provided to patients.
    Although ``improvement in the quality of care'' is broadly included 
under paragraph (2) of the definition of a QCDR at Sec.  414.1305 in 
the 2019 PFS final rule (83 FR 59897), we want to further clarify how a 
QCDR can be successful in fostering improvement in the quality of care 
provided to patients by clinicians and groups. We understand putting 
parameters around exactly what improvement in the quality of care may 
be can be difficult due to the varying nature of QCDRs

[[Page 63056]]

organizational structures. For example, we have QCDRs that are founded 
by both large and small specialty societies, and healthcare systems 
where the volumes of services, available resources, and volume of 
members may vary. However, we believe QCDRs should enhance education 
and outreach to clinicians and groups to improve patient care.
    The definition of qualified clinical data registry (QCDR) at Sec.  
414.1305(2) currently states that beginning with the 2022 MIPS payment 
year, an entity that demonstrates clinical expertise in medicine and 
quality measurement development experience and collects medical or 
clinical data on behalf of a MIPS eligible clinician for the purpose of 
patient and disease tracking to foster improvement in the quality of 
care provided to patients. In the CY 2020 PFS proposed rule (84 FR 
40813), we proposed policies with regards to ``foster improvement in 
the quality of care''.
    Therefore, we proposed to add Sec.  414.1400(b)(2)(iii) that 
beginning with the 2023 MIPS payment year, the QCDRs must foster 
services to clinicians and groups to improve the quality of care 
provided to patients by providing educational services in quality 
improvement and leading quality improvement initiatives (84 FR 40813). 
Quality improvement services may be broad, and do not necessarily have 
to be specific towards an individual clinical process. An example of a 
broad quality improvement service would be for the QCDR to provide 
reports and educating clinicians on areas of improvement for patient 
populations by clinical condition for specific clinical care criteria. 
Furthermore, an example of an individual clinical process specific 
quality improvement service would be if the QCDR supports a metric that 
measures blood pressure management, the QCDR could use that data to 
identify best practices used by high performers and broadly educate 
other clinicians and groups on how they can improve the quality of care 
they provide. We believe educational services in quality improvement 
for eligible clinicians and groups would encourage meaningful and 
actionable feedback for clinicians to make improvements in patient 
care. To be clear, these QCDR quality improvement services would be 
separate and apart from any activities that are reported on under the 
improvement activities performance category. We believe improvement 
activities can be distinguished from quality improvement services, 
because they are actions taken by MIPS eligible clinicians under the 
improvement activities performance category. Improvement activities 
means an activity that relevant MIPS eligible clinician, organizations 
and other relevant stakeholders identify as improving clinical practice 
or care delivery and that the Secretary determines, when effectively 
executed, is likely to result in improved outcomes (Sec.  414.1305). 
Quality improvement services, on the other hand, would be actions taken 
by the QCDR. While these QCDR quality improvement services could 
potentially overlap with an improvement activity, requirements for the 
improvement activities performance category would still apply to MIPS 
eligible clinicians and groups.
    We proposed to require QCDRs to describe the quality improvement 
services they intend to support in their self-nomination for CMS review 
and approval. We intend on including the QCDR's approved quality 
improvement services in the qualified posting for each approved QCDR 
(84 FR 40813).
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed with the proposal to require 
QCDRs to engage in activities that improve quality of care and further 
cited their appreciation for the flexibility provided by CMS to meet 
the requirement. A few commenters suggested that CMS should provide a 
minimum threshold such as sharing links to the quality improvement 
education website or a QCDR platform with trending performance graphs. 
One commenter expressed its concern the terminology being used due to 
its opinion that improvement activities conducted by the MIPS eligible 
clinician and improvement services provided by the QCDR can be 
confusing.
    Response: We thank commenters for their support, and while we agree 
this proposal is important to engage QCDRs in activities that will 
foster improvement in the quality of care; after reviewing public 
comments received, we are not finalizing this proposal. However, since 
this policy is important to the quality of care, as well as, CMS, we 
want to prepare QCDRs for this policy to be considered for future 
rulemaking and would encourage QCDRs to start planning for this 
possibility. While we did not state a minimum threshold of the type of 
service that needs to be provided as part of our proposal, as described 
in the CY 2020 PFS proposed rule (84 FR 40813), we provided examples of 
services, such as enhanced education and outreach, or providing reports 
and educating clinicians on areas of improvement for patient 
populations by clinical condition for specific clinical care criteria. 
We appreciate the commenters' suggestions for providing a minimum 
threshold, and may consider this feedback for future rulemaking. As 
part of future rulemaking we may also consider requirements that would 
require that the QCDRs describe the activities they are proposing to 
support as a part of their self-nomination application, as well as the 
ability of the QCDR to provide this service to all the clinicians and 
groups it supports for a given performance period. We appreciate the 
concern with potential confusion between quality improvement services 
and improvement activities, in any future rulemaking we would be sure 
to clearly communicate that they are different as a part of our 
subregulatory guidance to educate stakeholders.
    Comment: Several commenters disagreed with the proposal to require 
QCDRs to engage in activities that improve quality of care citing 
concerns that the policy is vague, unclear, and could be used in an 
arbitrary fashion to possibly compare or rank QCDRs. A few commenters 
stated that additional details are necessary regarding what activities 
would meet this requirement, with a few commenters expressing that in 
place of finalizing this proposal, CMS should search for additional 
alternatives or publish a separate request for information followed by 
rulemaking that describes this proposal in more detail so that the 
public can provide a more thoughtful response.
    Response: We thank the commenters' for their suggestions and agree 
that clarity is an important part of rulemaking. We agree with 
commenters that there needs to be more specificity in this proposal, 
and therefore, are not finalizing this requirement for this rule. 
Additionally, even though we are not finalizing this proposal, we 
continue to believe this policy is important, especially in the regard 
that QCDR applicants can innovate ideas for quality improvement 
services as they self-nominate, based on their capabilities and the 
needs of their clinicians and groups.
    We did not intend on the policy to be vague, unclear, or arbitrary 
but intended to provide flexibility to the QCDR as to the type of 
improvement service they may offer; the services offered would not be 
used to rank the QCDRs in any way but to serve as a helpful resource 
for clinicians and groups. To that end, we did not want to standardize 
the type of quality improvement services a QCDR should offer, and so we 
intentionally crafted a policy that was not overly

[[Page 63057]]

specific. With the understanding that QCDRs differ in size, we wanted 
to leave the type of service available up to the QCDR to determine what 
is feasible and appropriate for the clinicians and groups they support. 
An example of a broad quality improvement service would be for the QCDR 
to provide reports and educating clinicians on areas of improvement for 
patient populations by clinical condition for specific clinical care 
criteria. Furthermore, an example of an individual clinical process 
specific quality improvement service would be if the QCDR supports a 
metric that measures blood pressure management, the QCDR could use that 
data to identify best practices used by high performers and broadly 
educate other clinicians and groups on how they can improve the quality 
of care they provide. Our intention was not to compare QCDRs to one 
another, but to expand the quality improvement initiatives a QCDR could 
support and offer. This policy was meant to require QCDRs to describe 
the activities they would plan to support as a part of their self-
nomination application. We will take these comments into consideration 
for future rulemaking.
    Comment: One commenter stated their belief that if this proposal is 
finalized, implementation should be delayed to give QCDRs the time to 
develop the necessary processes and identify the resources required to 
develop these types of services. Several commenters stated that this 
would require budgeting, planning and coordinating across staff or 
departmental areas that may not already be in place. Others stated that 
it would be too difficult or infeasible for QCDRs to change their 
business models to adopt.
    Response: As discussed in the CY 2020 PFS proposed rule (84 FR 
40813), this policy was proposed with a delayed implementation 
beginning with the 2023 MIPS payment year (for the 2021 performance 
period). We understand that there may be time needed to prepare for 
this requirement, including time to budget, plan, coordinate from a 
staffing perspective, and possibly prepare for from a business 
perspective. Taking these public comments into account we are not 
finalizing this proposal in this rule. We will take these comments into 
consideration for future rulemaking.
    Comment: Several commenters stated this policy may be unnecessary 
considering the reports and activities QCDRs already conduct aimed at 
improving quality.
    Response: As stated above, we are not finalizing this policy at 
this time. However, we do want to clarify that while some of the 
activities currently being done by QCDRs could fulfill the proposal for 
fostering quality improvement, not all QCDRs are consistently providing 
these reports to their participating clinicians. We intended to provide 
flexibility to the QCDR as to the type of improvement service they may 
offer. We will consider this feedback as we develop a potential 
proposal for future rulemaking.
    Comment: Several commenters stated that this policy would expand 
responsibilities of QCDRs beyond their initially intended functions. 
Other commenters stated that this would create undue burden especially 
for small QCDRs.
    Response: As stated above, we are not finalizing this policy at 
this time. However, we believe that there are many existing QCDRs that 
already provide quality improvement services, even outside of the 
Quality Payment Program. Our vision for QCDRs requires the need for 
evolvement by the QCDRs to potentially providing additional services 
that what was initially required under the legacy PQRS program or under 
the first few years of MIPS. We do not believe that such a policy would 
create undue burden on smaller QCDRs. We will take this feedback into 
consideration when developing a potential proposal for future 
rulemaking.
    After consideration of the comments, we are not finalizing our 
proposals. Specifically, we are not finalizing at Sec.  
414.1400(b)(2)(iii) that beginning with the 2023 MIPS payment year, the 
QCDRs must foster services to clinicians and groups to improve the 
quality of care provided to patients by providing educational services 
in quality improvement and leading quality improvement initiatives. We 
are also not finalizing the proposed requirement that QCDRs describe 
the quality improvement services they intend to support in their self-
nomination for CMS review and approval. While we are not including the 
QCDR's approved quality improvement services in the qualified posting 
for each approved QCDR, we will consider proposing this requirement in 
subsequent future rulemaking, and would encourage QCDRs to prepare as 
such.
(iii) Enhanced Performance Feedback Requirement
    Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to 
encourage the provision of performance feedback through QCDRs. In 
addition, in establishing the requirements, the Secretary must 
consider, among other things, whether an entity provides timely 
performance reports to participants at the individual participant level 
(section 1848(m)(3)(E)(ii)(III) of the Act). Currently, CMS requires 
QCDRs to provide timely performance feedback at least 4 times a year on 
all of the MIPS performance categories that the QCDR reports to CMS (82 
FR 53812). Based on our experiences thus far under the Quality Payment 
Program, we agree that providing feedback at least 4 times a year is 
appropriate. However, in the future CMS would like to see, and 
therefore, encourages QCDRs, to provide timely feedback on a more 
frequent basis more than 4 times a year. Receipt of more frequent 
feedback will help clinicians and groups make more timely changes to 
their practice to ensure the highest quality of care is being provided 
to patients. We see value in providing more timely feedback to meet the 
objectives \117\ of the Quality Payment Program in improving the care 
received by Medicare beneficiaries, lowering the costs to the Medicare 
program through improvement of care and health, and advance the use of 
healthcare information between allied providers and patients. We also 
believe there is value in this performance feedback, and therefore, 
encourage QCDRs to work with their clinicians to get the data in 
earlier in the reporting period so the QCDR can give meaningful, timely 
feedback.
---------------------------------------------------------------------------

    \117\ Quality Payment Program Overview. https://qpp.cms.gov/about/qpp-overview.
---------------------------------------------------------------------------

    In the QCDR performance feedback currently being provided to 
clinicians and groups, we have heard from stakeholders that that not 
all QCDRs provide feedback the same way. We have heard through 
stakeholder comments that some QCDR feedback contains information 
needed to improve quality, whereas other QCDR feedback does not supply 
such information due to the data collection timeline. Additionally, we 
believe that clinicians would benefit from feedback on how they compare 
to other clinicians who have submitted data on a given measure (MIPS 
quality measure or QCDR measure) within the QCDR they are reporting 
through, so they can identify areas of measurement in which improvement 
is needed, and furthermore, they can see how they compare to their 
peers based within a QCDR, since the feedback provided by the QCDR 
would be limited to those who reported on a given measure using that 
specific QCDR.

[[Page 63058]]

    Therefore, we proposed a change so that QCDRs structure feedback in 
a similar manner (84 FR 40814). We proposed a new paragraph at Sec.  
414.1400(b)(2)(iv), beginning with the 2023 MIPS payment year, to 
require that QCDRs provide performance feedback to their clinicians and 
groups at least 4 times a year, and provide specific feedback to their 
clinicians and groups on how they compare to other clinicians who have 
submitted data on a given measure within the QCDR (84 FR 40814). (Note: 
Since we are not finalizing Sec.  414.1400(b)(2)(iii) (see section 
III.K.3.g.(3)(a)(ii) of this final rule), the previously proposed Sec.  
414.1400(b)(2)(iv) will now become Sec.  414.1400(b)(2)(iii).) 
Exceptions to this requirement may occur if the QCDR does not receive 
the data from their clinician until the end of the performance period. 
We also solicited comment on other exceptions that may be necessary 
under this requirement.
    We also understand that QCDRs can only provide feedback on data 
they have collected on their clinicians and groups, and realize the 
comparison would be limited to that data and not reflect the larger 
sample of those that have submitted on the measure for MIPS, which the 
QCDR does not have access to. We believe QCDR internal comparisons can 
still help MIPS eligible clinicians identify areas where further 
improvement is needed. The ability for MIPS eligible clinicians to be 
able to know in real time how they are performing against their peers, 
within a QCDR, provides immediate actionable feedback. We believe this 
provides value gained for clinicians as the majority of QCDRs are 
specialty specific or regional based, therefore the clinician can gain 
peer comparisons that are specific to their peer cohort, which can be 
specialty specific or locality based. Furthermore, we also proposed to 
strengthen the QCDR self-nomination process at Sec.  414.1400(b)(1) to 
add that beginning with the 2023 MIPS payment year, QCDRs are required 
to attest during the self-nomination process that they can provide 
performance feedback at least 4 times a year (as specified at Sec.  
414.1400(b)(2)(iii)) (84 FR 40814). We received public comments on 
these proposals. The following is a summary of the comments we received 
and our responses.
    Comment: Several commenters agreed with the proposal for QCDRs to 
provide enhanced performance feedback at least 4 times a year including 
comparisons to other clinicians who reported the same measure, at 
minimum. Commenters expressed their belief that the feedback and 
comparison is very beneficial to their participants and helps them 
identify potential areas for performance improvement as compared to 
their peers.
    Response: We thank commenters for their support.
    Comment: A few of the commenters stated their opinion that CMS 
should finalize exceptions for occasions when the QCDR does not receive 
data from the clinician until the end of the performance period.
    Response: As proposed in the CY 2020 PFS proposed rule (84 FR 
40814), we also stated that exceptions to this requirement may occur if 
the QCDR does not receive the data from their clinician until the end 
of the performance period. We would depend on the QCDRs to let us know 
as soon as possible when there are issues that arise that would cause a 
delay in providing performance feedback.
    Comment: Another commenter stated its opinion that while it agrees 
with the intent of providing enhanced feedback at least 4 times per 
year, without requiring data be submitted regularly and consistently 
across all collection types, improvement in individual patient and 
population health outcomes may not be experienced as originally 
intended in the MACRA legislation.
    Response: We appreciate the feedback on requiring data to be 
submitted regularly and consistently across all collection types, but 
believe that improvements in individual patients and population health 
outcomes can still be experienced in smaller cohorts on a QCDR by QCDR 
basis.
    After consideration of the comments, we are finalizing our proposal 
with technical modifications to update the numbering, Sec.  
414.1400(b)(2)(iv) will now become Sec.  414.1400(b)(2)(iii) because we 
did not finalize the requirement for QCDRs to engage in activities that 
would foster improvement in the quality of care proposal at Sec.  
414.1400(b)(2)(iii) per section III.K.3.g.(3)(a)(ii) of this final 
rule. Specifically, we are finalizing at Sec.  414.1400(b)(2)(iii), 
beginning with the 2023 MIPS payment year, to require that QCDRs 
provide performance feedback to their clinicians and groups at least 4 
times a year, and provide specific feedback to their clinicians and 
groups on how they compare to other clinicians who have submitted data 
on a given measure within the QCDR. Exceptions to this requirement may 
occur if the QCDR does not receive the data from their clinician until 
the end of the performance period. In addition, we are also finalizing 
our proposal as proposed, to strengthen the QCDR self-nomination 
process at Sec.  414.1400(b)(1) to add that beginning with the 2023 
MIPS payment year, QCDRs are required to attest during the self-
nomination process that they can provide performance feedback at least 
4 times a year (as specified at Sec.  414.1400(b)(2)(iii)) (84 FR 
40814).
    In addition, the current performance period begins January 1 and 
ends on December 31st, and the corresponding data submission deadline 
is typically March 31st as described at Sec.  414.1325(e)(1). As 
discussed above, we have heard from QCDR stakeholders that in some 
instances clinicians wait until the end of the performance period to 
submit data to the third party intermediary, who are then unable to 
provide meaningful feedback to their clinicians 4 times a year. 
Therefore, in the CY 2020 PFS proposed rule (84 FR 40814), we sought 
comment for future notice-and-comment rulemaking on whether we should 
require MIPS eligible clinicians, groups, and virtual groups who 
utilize a QCDR to submit data throughout the performance period, and 
prior to the close of the performance period (that is, December 31st). 
We also sought comment for future notice-and-comment rulemaking, on 
whether clinicians and groups can start submitting their data starting 
April 1 to ensure that the QCDR is providing feedback and the clinician 
or group during the performance period (84 FR 40814). This would allow 
QCDRs some time to provide enhanced and actionable feedback to MIPS 
eligible clinicians prior to the data submission deadline.
    While we are not summarizing and responding to these comments we 
received in this final rule, we thank the commenters for their 
responses and will take them into consideration as we develop future 
policies for QCDRs.
(b) QCDR Measures
    We refer readers to Sec.  414.1400(b)(1), the CY 2018 Quality 
Payment Program final rule (82 FR 53814) and the CY 2019 PFS final rule 
(83 FR 59898 through 59900) for our previously established policies for 
the QCDR measure self-nomination process. In the CY 2020 PFS proposed 
rule (84 FR 40814 through 40819), we proposed policies related to: (a) 
Considerations for QCDR measure approval; (b) requirements for QCDR 
measure approval; (c) considerations for QCDR measure rejections; (d) 
the approval process; and (e) QCDR measures that have failed to reach 
benchmarking thresholds. These are discussed in detail below.

[[Page 63059]]

(c) QCDR Measure Requirements
    In this final rule, we are clarifying that the newly finalized QCDR 
measure considerations and requirements for approval apply to all QCDR 
measures, regardless of whether they have been approved for previous 
performance periods or are new QCDR measures for the 2021 performance 
period and future years. We will not be grandfathering in previously 
approved QCDR measures.
(i) 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 
will help to ensure that the measures made available in MIPS are 
meaningful to a clinician's scope of practice. In the CY 2020 PFS 
proposed rule (84 FR 40814), we proposed to codify established QCDR 
measure considerations and proposed, beginning with the CY 2021 
performance period, a number of QCDR measure specific requirements, 
that would generally align with MIPS measure policies, which can be 
found in the CY 2018 Quality Payment Program final rule (82 FR 53636), 
and as described in the CY 2020 PFS proposed rule (84 FR 40745 through 
40752), as well as section III.K.3.c.(1) of this final rule.
(A) QCDR Measure Considerations
(aa) Previously Finalized QCDR Measure Considerations
    We generally refer readers to the Sec.  414.1400(b)(3), CY 2017 
Quality Payment Program final rule (81 FR 77374 through 77375) and the 
CY 2019 PFS final rule (83 FR 59900 through 59902) for previously 
finalized standards and criteria used for selecting and approving QCDR 
measures. QCDR measures are reviewed for inclusion on an annual basis 
during the QCDR measure review process that occurs once the self-
nomination period closes (82 FR 53810). All previously approved QCDR 
measures and new QCDR measures are currently reviewed on an annual 
basis to determine whether they are appropriate for the program (82 FR 
53811). The QCDR measure review process occurs after the self-
nomination period closes on September 1st. QCDR measures are not 
finalized or removed through notice and comment rulemaking; instead, 
they are currently approved or not approved through a subregulatory 
processes (82 FR 53639).
    In the CY 2019 PFS final rule (83 FR 59902), we finalized our 
proposal to apply the following criteria beginning with the 2021 MIPS 
payment year when considering QCDR measures for possible inclusion in 
MIPS:
     Measures that are beyond the measure concept phase of 
development.
     Preference given to measures that are outcome-based rather 
than clinical process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain for care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost and resource use.
     Measures that address significant variation in 
performance.
    In the CY 2020 PFS proposed rule (84 FR 40815), we proposed to 
codify a number of those previously finalized QCDR measure 
considerations that we had finalized in the CY 2019 PFS final rule (83 
FR 59902). We also proposed to amend Sec.  414.1400 by adding Sec.  
414.1400(b)(3)(iv) to include the following previously finalized QCDR 
measure considerations for approval (84 FR 40815):
     Preference for measures that are outcome-based rather than 
clinical process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain of care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost, and resource use.
    More information on QCDR measure approval criteria can be found in 
the QCDR/qualified registry Self-Nomination Tool-Kit in the Quality 
Payment Program Resource Library.
    We refer readers to the CY 2020 PFS proposed rule (84 FR 40815) and 
section III.K.3.g.(3)(c)(i)(B) of this final rule where we discuss 
changes to the following previously finalized considerations into 
requirements:
     Measures that are beyond the measure concept phase of 
development.
     Measures that address significant variation in 
performance.
    We did not receive public comments on this proposal.
    Therefore, we are finalizing our proposal as proposed by adding 
Sec.  414.1400(b)(3)(iv) to include the following QCDR measure 
considerations for approval:
     Preference for measures that are outcome-based rather than 
clinical process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain of care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost, and resource use.
    We refer readers to section III.K.3.g.(3)(c)(i)(B)(aa) of this 
final rule, for a discussion regarding the following previously 
finalized considerations into requirements (84 FR 40815):
     Measures that are beyond the measure concept phase of 
development.
     Measures that address significant variation in 
performance.
(bb) New QCDR Measure Considerations for Approval
(AA) QCDR Measure Availability
    In the CY 2018 Quality Payment Program final rule (82 FR 53813 
through 53814), we finalized a policy beginning with the 2018 
performance period, that allowed QCDRs to seek permission from another 
QCDR to use an existing and approved QCDR measure. If a QCDR would like 
to report on an existing QCDR measure that is owned by another QCDR, 
they must have permission from the QCDR that owns the measure that they 
can use the measure for the performance period. Permission must be 
granted at the time of self-nomination, so that the QCDR that is using 
the QCDR measure can include written proof of permission for CMS review 
and approval. We also finalized in the CY 2018 Quality Payment Program 
final rule (82 FR 53814) that once QCDR measures are approved, we will 
assign QCDR measure IDs, and the same measure IDs must be used by the 
other QCDRs that have permission to also report on the measure.
    We generally encourage QCDR measure owners to permit other QCDRs to 
report their measures on behalf of MIPS eligible clinicians for 
purposes of MIPS. To the extent that QCDR measure owners limit the 
availability of their measures, such limitations may adversely affect a 
QCDR's ability to benchmark the measure, the robustness of the 
benchmark, or the comparability of MIPS eligible clinicians' 
performance results on the measure. For these reasons, we proposed to 
amend Sec.  414.1400 to add paragraph (b)(3)(iv)(H) to state that CMS 
may consider the extent to which a QCDR measure is available to MIPS 
eligible clinicians reporting through QCDRs other than the QCDR measure 
owner for purposes of MIPS (84 FR 40815). If CMS determines

[[Page 63060]]

that a QCDR measure is not available to MIPS eligible clinicians, 
groups, and virtual groups reporting through other QCDRs, CMS may not 
approve the measure.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses. We also 
acknowledge that we received several comments that were out of scope 
for this final rule, and therefore, are not addressing in this rule, 
but thank commenters for this feedback.
    Comment: A few commenters supported the proposal to consider QCDR 
measure availability as part of the QCDR measure approval process due 
to their beliefs that it would encourage harmonization and 
collaboration among QCDRs while reducing duplication resulting from the 
unwillingness of some QCDRs to share measures.
    Response: We thank commenters for their support.
    Comment: Several commenters stated that CMS should provide an 
opportunity for QCDR measure owners to respond to allegations of 
unavailability before this is allowed to be a consideration in the 
measure approval process.
    Response: We agree that QCDR measure owners should be given a 
chance to respond to instances where there is alleged blocking of the 
use of a QCDR measure. Therefore, we request that QCDRs keep 
documentation as to why a QCDR measure licensing agreement could not be 
reached, and on a case by case basis we will review the information on 
why the QCDR measure was not made available to another QCDR. We would 
expect that QCDR measure owners would be able to provide evidence to 
support their claim, should it be requested, as to why a given QCDR 
should not be allowed to use their QCDR measure.
    Comment: Many commenters disagreed with the proposal to consider 
the extent to which a QCDR measure is available to other QCDRs as part 
of the measure approval process citing concerns regarding inappropriate 
or inconsistent implementation, incorrect understanding of measure 
specifications, and lack of standardized data methods resulting in 
inaccurate benchmarking by the borrowing QCDR. Another commenter stated 
they would consider the sharing of measures if the other QCDR adhered 
to certain standards and terms set out by the QCDR measure owner.
    Response: We thank the commenters for raising these concerns. To 
respond, we first clarify that the intent of this proposal was to 
ensure that all QCDR measures that are considered for a given 
performance period, are readily available for other QCDRs to license. 
In practice, this would mean that should the borrowing QCDR meet the 
terms of a QCDR measure owner's license agreement, the borrowing QCDR 
should be able to report on the measure. We do not dictate what is to 
be included in a QCDR measure licensing agreement, or if fees and to 
what amount are tied to QCDR measure licensure, and ultimately defer to 
the QCDR measure owner, borrower, and their respective legal teams to 
come to an agreement. We would expect that if QCDRs decide to require a 
QCDR measure licensure agreement for its QCDR measures, it would 
include the QCDR measure owner's terms of use. The terms may include 
implementation criteria to ensure that the measure is programmed and 
collected in a way that is consistent with what the QCDR measure owner 
intends, thereby avoiding concerns with inappropriate or inconsistent 
implementation. In the CY 2019 PFS final rule (83 FR 59895 through 
59897), we finalized changes to the definition of a QCDR at Sec.  
414.1305 that beginning with the 2022 MIPS payment year, that a QCDR is 
an entity with clinical expertise in medicine and in quality 
measurement development that collects medical or clinical data on 
behalf of a MIPS eligible clinician for the purpose of patient and 
disease tracking to foster improvement in the quality of care provided 
to patients. We believe that QCDRs that are approved based on the 
revised QCDR definition for the 2022 MIPS payment year and future 
years, will be able to understand measure specifications since they are 
required to have measure development expertise and thereby understand 
measure specifications in order to be approved as a QCDR. Furthermore, 
as a part of the QCDR measure license user agreement, QCDR measure 
owners could include the data standardization methods they wish to be 
used to ensure consistent data collection, to ensure that borrowing 
QCDRs are utilizing the same standards consistently. We believe 
approved QCDRs should be able to comprehend and adhere to a preferred 
standardized data methodology, should the QCDR measure owner have one. 
In addition, QCDRs that are approved for the 2020 performance period 
and future years, should be able to utilize standardized data 
methodologies based on their measure experience. For QCDR measure 
owners that implement QCDR measure licensing agreements which include 
terms of use, they may come to find instances where a borrowing QCDR 
does not meet their terms prior to granting permission to borrowing the 
measure. We would expect QCDR measure owners to be able to provide 
evidence to justify instances where their measure was made available 
but ultimately could not be borrowed by another QCDR, for CMS' 
consideration on a case-by-case basis. Our intention with this policy 
is to move away from having duplicative measures in the program, simply 
because QCDRs are unwilling to license their QCDR measures to one 
another. Continuously retaining duplicative QCDR measures in the 
program because QCDRs are unwilling to license measures to one another 
is counterintuitive to the Meaningful Measure Initiative, and leads to 
measure bloat. In instances where CMS finds that QCDRs are blocking the 
use of their QCDR measure from other QCDRs without any evidence that 
proves the borrowing QCDR is unable to meet the QCDR measure owner's 
terms, we will likely approve another similar QCDR measure over this 
one. All factors will be considered prior to CMS determining which QCDR 
measure will continue on in the program.
    Comment: Some commenters were concerned with the dilution of 
important feedback that is needed to drive key improvements in care.
    Response: We disagree that allowing other QCDRs to borrow a QCDR's 
measure will lead to the dilution of important feedback that is needed 
to drive key improvements in care. Having a larger cohort of MIPS 
eligible clinicians reporting on a given QCDR measure will provide for 
more meaningful data that will give MIPS eligible clinicians and groups 
a better idea of how they compare to their peers. Therefore, the data 
will provide a more accurate picture of where there are areas of 
improvement in order to drive quality in the care provided.
    Comment: Several commenters expressed other concerns with the 
proposal including their beliefs that: The term ``available'' is not 
well defined and that CMS should elaborate on what criteria it would 
use to determine whether a measure is truly unavailable for reporting 
through other QCDRs. One commenter requested that CMS provide scenarios 
of what the proposal was trying to address.
    Response: We thank the commenters for raising these concerns. To 
clarify, a QCDR measure is available when the QCDR measure owner is 
willing to allow other QCDRs to borrow their QCDR measure with the 
appropriate permissions and/or licensing. We leave measure license user 
agreements, expectations, and terms between the measure owner and 
borrower. We are

[[Page 63061]]

trying to address scenarios in which a QCDR measure is approved, but 
the QCDR measure owner does not allow any outside QCDRs to use their 
QCDR measure. We wish to place higher priority on measures that can be 
used by all clinicians participating in the program.
    Comment: Some commenters stated that withholding measure approval 
based on lack of availability would potentially deprive clinicians of 
an otherwise valid and useful measure to report on.
    Response: We understand the commenters concern, but want to ensure 
that duplicative measures are not approved because QCDRs are unwilling 
to license QCDR measures to one another. If a QCDR measure is not 
approved, it does not mean it cannot be collected on by the QCDR for 
purposes of quality improvement, rather the measure would not be 
available for MIPS eligible clinicians to use for participating under 
MIPS and any data collected on that measure would not be applicable for 
MIPS.
    After consideration of the comments, we are finalizing our proposal 
as proposed to amend Sec.  414.1400 to add paragraph (b)(3)(iv)(H) to 
state that CMS may consider the extent to which a QCDR measure is 
available to MIPS eligible clinicians reporting through QCDRs other 
than the QCDR measure owner for purposes of MIPS. If CMS determines 
that a QCDR measure is not available to MIPS eligible clinicians, 
groups, and virtual groups reporting through other QCDRs, we may not 
approve the measure.
(BB) QCDR Measure Addresses a Measurement Gap
    As a part of the QCDR measure development process, QCDRs should 
conduct an environmental scan of existing QCDR measures; MIPS quality 
measures; quality measures retired from the legacy program, PQRS; and 
review the most recent CMS Quality Measure Development Plan Annual 
Report, which is currently available for 2019 at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/2019-Quality-MDP-Annual-Report-and-Appendices.zip and the Blueprint for the CMS Measures 
Management System: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf for guidance 
in areas where CMS has identified gaps in quality measurement to reduce 
the possibility of duplicative measure development. In the CY 2020 PFS 
proposed rule (84 FR 40815), we proposed to amend Sec.  414.1400 to add 
Sec.  414.1400(b)(3)(iv)(I) to state that we would give greater 
consideration to measures for which QCDRs: (a) Conducted an 
environmental scan of existing QCDR measures; MIPS quality measures; 
quality measures retired from the legacy Physician Quality Reporting 
System (PQRS) program; and (b) utilized the CMS Quality Measure 
Development Plan Annual Report and the Blueprint for the CMS Measures 
Management System to identify measurement gaps prior to measure 
development (84 FR 40815).
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter requested clarification on whether a 
performance gap needs to be demonstrated by data collection via a 
registry over a specified period of time (for example, 2 years), or if 
a health care survey would sufficiently demonstrate evidence of a 
performance gap. The commenter also questioned what constitutes 
``significant variation'' to ensure proposed measures meet CMS' 
expectations.
    Response: In the proposed rule, we proposed that we would give 
greater consideration to measures for which QCDRs: (a) Conducted an 
environmental scan of existing QCDR measures; MIPS quality measures; 
quality measures retired from the legacy Physician Quality Reporting 
System (PQRS) program; and (b) utilized the CMS Quality Measure 
Development Plan Annual Report and the Blueprint for the CMS Measures 
Management System to identify measurement gaps prior to measure 
development (84 FR 40815). The Blueprint for the CMS Measures 
Management System https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf defines a 
performance gap as when there is known variation in performance. A 
measure that is considered to have a performance gap would not be 
considered topped out, as described in the CY 2017 Quality Payment 
Program final rule (81 FR 77282 through 77283). The performance gap may 
be identified by data submitted to the registry on the given measure, 
or through current clinical study citations (within the past 5 years), 
a health care survey would not provide sufficient evidence of a 
performance gap.
    After consideration of the comments, we are finalizing our proposal 
as proposed, to amend Sec.  414.1400 to add Sec.  414.1400(b)(3)(iv)(I) 
to state that we would give greater consideration to measures for which 
QCDRs: (a) Conducted an environmental scan of existing QCDR measures; 
MIPS quality measures; quality measures retired from the legacy 
Physician Quality Reporting System (PQRS) program; and (b) utilized the 
CMS Quality Measure Development Plan Annual Report and the Blueprint 
for the CMS Measures Management System to identify measurement gaps 
prior to measure development.
(CC) QCDRs Measures Meeting Benchmarking Thresholds
    Over the first 2 years of MIPS, we have observed instances where 
QCDR measures have been approved for continued use in the program, but 
have had low reporting volumes, below the case minimum and reporting 
volume thresholds required for a measure to be benchmarked within the 
program. As described in the CY 2017 Quality Payment Program final rule 
(81 FR 77277 through 77282), for benchmarks to be developed, a measure 
must have a minimum of 20 individual clinicians or groups who reported 
the measure to meet the data completeness requirement and the minimum 
case size criteria. QCDRs should be aware of which measures are 
considered low-reported, since measures that do not meet benchmarking 
thresholds result in a 3-point floor, as described in the CY 2017 
Quality Payment Program final rule (81 FR 77282). QCDR measures are 
reviewed and approved on an annual basis, and as a part of the review 
process, we review: The benchmarking file from the previous year (for 
example, the 2019 Quality Benchmark file, found on the Quality Payment 
Program Resource Library, which is available at https://qpp.cms.gov/about/resource-library); production submission data submitted from the 
previous year's data submission period; and data provided to us by the 
QCDRs themselves. Note to readers when the CY 2020 PFS proposed rule 
was published the 2019 Quality Benchmark file could be found at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/342/2019%20MIPS%20Quality%20Benchmarks.zip however after publishing that 
rule, the link has since been updated and can now be found at the link 
above (https://qpp.cms.gov/about/resource-library) by searching for 
``2019 Quality Benchmark file.''
    In the CY 2020 PFS proposed rule (84 FR 40816), as discussed in our 
QCDR measure rejection considerations, we proposed that a QCDR measure 
that does not meet case minimum and reporting volumes required for 
benchmarking after being in the program for 2 consecutive CY 
performance may not continue to be

[[Page 63062]]

approved in the future if our proposal is finalized as proposed. We 
noted that this factor is parallel to what was proposed for MIPS 
quality measures in section III.K.3.c.(1) of the proposed rule (84 FR 
40816), which is being finalized in section III.K.3.c.(1) of this final 
rule, and is important when considering the volume of QCDR measures 
that are currently in the program that have had low reporting rates 
year-over-year. We proposed to amend Sec.  414.1400 to add paragraph 
(b)(3)(iv)(J) to state that, beginning with the 2020 performance 
period, we place greater preference on QCDR measures that meet case 
minimum and reporting volumes required for benchmarking after being in 
the program for 2 consecutive CY performance periods (84 FR 40816). 
Those that do not, may not continue to be approved. We refer readers to 
section III.K.3.g.(3)(c)(ii) in the proposed rule (84 FR 40816) and 
section III.K.3.g.(3)(c)(ii) of this final rule, for a discussion on 
how QCDRs may create participation plans for existing approved QCDR 
measures that have failed to reach benchmarking thresholds, in order to 
be reconsidered for future use. We also refer readers to Sec.  414.1330 
for additional information.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters disagreed with the proposal to 
potentially reject QCDR measures that do not meet case minimum and 
reporting volumes required for benchmarking after being in the program 
for 2 consecutive CY performance periods due to their beliefs that the 
policy of awarding fewer points for reporting non-benchmarked measures 
is enough to discourage use of these measures without further 
negatively impacting clinicians who have few other measures to report.
    Response: While the quality scoring policy referenced by the 
commenters that provides a 3-point floor for measures that are 
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 could have an impact on reduced reporting 
volumes, we believe this 2-year lifecycle and participation plan will 
more directly address the issue of low reported measures. We refer 
readers to section III.K.3.d.(1) and Sec.  414.1380(b)(1)(i)(A) and (B) 
which provides details on the MIPS performance category scores.
    Comment: A few commenters disagreed with the proposal due to their 
beliefs that it would reduce the number of available measures to a 
point that it would be a hardship for certain specialties to 
participate in MIPS; and eliminating a measure after 2 years in the 
program would deter QCDRs from investing in and developing new 
measures, maintaining existing measures, and putting forward MVP 
proposals. A few commenters expressed their opinion that prior to 
rejecting a QCDR measure that is not meeting thresholds, CMS should 
work with QCDR measure stewards to understand why a measure is not 
meeting thresholds and the importance of these measures to clinicians 
in specialized fields or clinicians treating less common diseases or 
conditions.
    Response: While we appreciate the commenters concerns, we believe 
that maintaining low-reported measures in the program over multiple 
years, is counterintuitive to the Meaningful Measurement Initiative and 
indicative of metrics that are not of interest to the majority of 
clinicians within a given specialty. We believe that removing low-
reported measures should not deter QCDRs in investing and developing 
new measures, maintaining existing measures, or putting forward MVP 
proposals. We believe that tracking measure reporting volumes over the 
years will allow QCDRs to determine whether the metric is meaningful to 
their eligible clinicians and group and allow for them to make 
revisions to existing measures or develop new measures accordingly. In 
addition, we are aware of instances in which measures may be low-
reported due to being highly sub-specialized. Because of that, we 
proposed a potential mitigation strategy for QCDR measures with low-
reporting volumes that do not meet benchmarking thresholds. As 
described in the CY 2020 PFS proposed rule (84 FR 40819), in instances 
where a QCDR believes a low-reported QCDR measure that did not meet 
benchmarking thresholds is still important and relevant to a 
specialist's practice, the QCDR may develop and submit a QCDR measure 
participation plan for our consideration. The QCDR measure 
participation plan must include the QCDR's detailed plans and changes 
to encourage eligible clinicians and groups to submit data on the low-
reported QCDR measure for purposes of the MIPS program. As examples, a 
QCDR measure participation plan could include one or more of the 
following: Development of an education and communication plan; update 
the QCDR measure's specification with changes to encourage broader 
participation, which would require review and approval by us; or 
require reporting on the QCDR measure as a condition of reporting 
through the QCDR. Prior to measures being eliminated from the program 
for a given specialty, we do conduct a review of remaining MIPS quality 
measures and QCDR measures to determine if there is a sufficient number 
of measures left. Once a participation plan is implemented, we plan to 
monitor the QCDR measure to determine if there is an increase in 
reporting volumes. We understand that the measure development process 
is time-consuming and costly, however. If a QCDR measure is removed 
because of low-reporting volumes, but a QCDR continues to collect data 
on the measure outside of the MIPS program, the measure could be 
reconsidered for the program in the future. As we develop MVPs, we will 
consider how each policy interacts and make any appropriate adjustments 
in future rulemaking.
    Comment: A few commenters opposed the proposal due to their beliefs 
that: The 2-year period is not long enough for some measures to achieve 
acceptable numbers of adoption or for EHR vendors to complete data 
integration to support QCDR measures and that failure to achieve 
benchmark status does not necessarily indicate that a measure is not 
meaningful. In regards to the time necessary for EHR vendors to support 
QCDR measures, one commenter noted this process can take up to 18 
months from the time a vendor learns of a new or revised set of QCDR 
measures until the development life cycle is complete.
    Response: The 2-year timeframe was decided upon after review and 
consideration of benchmarking trends as indicated in the quality 
measure benchmark files, for the appropriate amount of time a measure 
typically needs to reach benchmarking thresholds. While we appreciate 
the commenters concerns, to clarify, EHR vendors would only be able to 
report on QCDR measures if they self-nominate to be a QCDR, and meet 
the QCDR definition, as described at Sec.  414.1400(b)(2)(ii) in the CY 
2019 PFS final rule (83 FR 59895 through 59896). Since QCDRs will be 
required to test their measures prior to self-nominating them, as 
reflected at Sec.  414.1400(b)(3)(v)(C), it is assumed that the QCDR 
would have considered the time it takes for data integration from an 
EHR prior to testing the measure to ensure that measure is feasible. If 
a QCDR cannot timely complete the data integration process for a QCDR 
measure, it should delay self-nominating that QCDR measure until it is

[[Page 63063]]

implementable. We note that QCDR measures should not be submitted for 
consideration until they are fully developed and tested, including the 
ability to be supported by EHR vendors. In addition, we believe this 
issue is mitigated, as described in the CY 2020 PFS proposed rule (84 
FR 40817) and in this final rule, by our requirement to add paragraph 
(b)(3)(v)(D) that 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. The data 
collected must demonstrate whether the QCDR measure is valid and 
reflects an important clinical concept(s) that clinicians wish to be 
measured on. By collecting data on the QCDR measure prior to self-
nomination, QCDRs would be able to demonstrate whether the measure is 
implementable and data collection on the metric is possible.
    As described in the CY 2020 PFS proposed rule (84 FR 40819), in 
instances where a QCDR believes a low-reported QCDR measure, that did 
not meet benchmarking thresholds within the 2-year timeframe, is still 
important and relevant to a specialist's practice, the QCDR may develop 
and submit a QCDR measure participation plan for our consideration. As 
discussed in section III.K.3.g.(3)(c)(iii) of this final rule, the QCDR 
measure participation plan must include the QCDR's detailed plans and 
changes to encourage eligible clinicians and groups to submit data on 
the low-reported QCDR measure for purposes of the MIPS program.
    Comment: A few commenters stated their opinion that CMS should 
delay implementation of the proposal due to their belief that it would 
be inappropriate to finalize a requirement after the deadline for 2020 
QCDR self-nominations has passed, as well as not allowing QCDRs enough 
time to reevaluate their measure submission strategies.
    Response: We disagree with the commenters suggestion that we delay 
this policy based on the passed deadline for 2020 QCDR self-
nominations. We believe that enacting this policy for the 2020 
performance period allows us to ensure that the QCDR measures available 
for the performance period are meaningful and believe that the 
participation plan policy, as discussed in section 
III.K.3.g.(3)(c)(iii) of this final rule provides additional 
flexibility for low-reported QCDR measures that are currently under 
review for the 2020 performance period. If the QCDR measure is 
identified as an existing measure that is continuously low-reported, 
the QCDR has a chance to develop and submit a participation plan as a 
part of the QCDR measure reconsideration process.
    Comment: One commenter requested additional clarity on the proposal 
to reject QCDR measures that do not meet case minimum and reporting 
volumes required for benchmarking after being in the program for two 
consecutive CY performance periods. The commenter requested 
clarification as to whether a measure would be rejected if it failed to 
meet benchmarking thresholds via one collection type but met thresholds 
via another.
    Response: To clarify, QCDR measures are available through only a 
single collection type, a QCDR, and therefore, for purposes of the MIPS 
program a QCDR would only be submitting data on a QCDR measure only 
through a QCDR for purposes of MIPS reporting. However, if a QCDR has 
additional information or performance rate related information to 
share, utilizing data collected outside of the MIPS program, they may 
do so in the development of a participation plan as discussed above.
    After consideration of the comments, we are finalizing Sec.  
414.1400 to add paragraph (b)(3)(iv)(J), as proposed, to state that, 
beginning with the 2020 performance period, we place greater preference 
on QCDR measures that meet case minimum and reporting volumes required 
for benchmarking after being in the program for 2 consecutive CY 
performance periods. Those that do not meet this requirement, may not 
continue to be approved. We refer readers to section 
III.K.3.g.(3)(c)(ii) in the final rule, for discussion on how QCDRs may 
create participation plans for existing approved QCDR measures that 
have failed to reach benchmarking thresholds, in order to be 
reconsidered for future use.
(B) QCDR Measure Requirements
(aa) Previously Finalized Requirements Considerations Codified as 
Requirements
    In the CY 2020 PFS proposed rule (84 FR 40815), we proposed to 
change two previously finalized measure considerations into 
requirements and codify those requirements. In the CY 2019 PFS final 
rule, we previously finalized that we would apply certain criteria 
beginning with the 2021 MIPS payment year when considering QCDR 
measures for possible inclusion in MIPS (83 FR 59902). We refer readers 
to section III.K.3.g.(3)(c)(i)(A) of this final rule where we discuss 
our proposal to codify the majority as measure considerations (84 FR 
40816). However, for two of those previously finalized considerations, 
in the CY 2020 PFS proposed rule, we proposed them as requirements (84 
FR 40816):
     Measures that are beyond the measure concept phase of 
development.
     Measures that address significant variation in 
performance.

We believe the previously finalized consideration that measures are 
beyond the measure concept phase of development should be a requirement 
because measures that do not surpass the measure concept phase will not 
be able to complete another QCDR measure requirement, measure testing. 
In addition, we believe the previously finalized consideration that 
measures address significant variation in performance should be a 
requirement because QCDR measures that do not demonstrate performance 
variation will likely be identified as topped out and will not be 
approved.
    Therefore, beginning with the 2020 performance period, we proposed 
to change both of those considerations into requirements and proposed 
to amend Sec.  414.1400 by adding Sec.  414.1400(b)(3)(v) to include 
the following (84 FR 40816):
     Measures that are beyond the measure concept phase of 
development.
     Measures that address significant variation in 
performance.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters agreed with the proposed requirements for 
a QCDR measure to be beyond the concept phase of development and 
address a significant variation in performance during the approval 
process.
    Response: We thank the commenters for their support.
    After consideration of the comments, we are finalizing our proposal 
as proposed, beginning with the 2020 performance period, to change both 
of the below listed considerations into requirements and add Sec.  
414.1400(b)(3)(v) to include the following for QCDR measure 
requirements for approval:
     Measures that are beyond the measure concept phase of 
development.
     Measures that address significant variation in 
performance.
(bb) Linking QCDR Measures to Cost Measures, Improvement Activities, 
and MIPS Value Pathways (MVP)
    To prepare QCDR measures for self-nomination, we believe there 
should be consideration of how these QCDR measures relate to similar 
topics covered through the other performance categories. We believe (as 
noted in the

[[Page 63064]]

CY 2020 PFS proposed rule (84 FR 40816)) that to transform the MIPS 
program to one of value, MIPS measures and QCDR measures, should have 
an associated cost measure, improvement activity, and eventually a 
corresponding MVP. This would strengthen the QCDR measure's relevance 
in the program. We believe that evaluating the strength of these 
linkages may decrease the frequency of receiving extraneous QCDR 
measures that are not relevant or meaningful within the framework of 
the MIPS program.
    Therefore, in the CY 2020 PFS proposed rule, beginning with the 
2021 performance period and future years, we proposed that QCDRs must 
identify a linkage between their QCDR measures to the following, at the 
time of self-nomination: (a) Cost measure (as found in the CY 2020 PFS 
proposed rule (84 FR 40752 through 40762); (b) Improvement Activity (as 
found in Appendix 2: Improvement Activities Tables of the CY 2020 PFS 
proposed rule (84 FR 41275 through 41283)); or (c) CMS developed MVPs 
(as described in Table 34 of the CY 2020 PFS proposed rule (84 FR 40737 
through 40738). Under the pathway framework for example, a surgery 
specific QCDR should be able to correlate their surgery-related QCDR 
measure to an MVP, such as the Major Surgery pathway.
    We understand that not all measures may have a direct link. In 
cases where a QCDR measure does not have a clear link to a cost 
measure, improvement activity, or an MVP, we would consider exceptions 
if the potential QCDR measure otherwise meets the QCDR measure 
requirements defined above.
    However, we believe that when possible, it is important to 
establish a strong linkage between quality, cost, and improvement 
activities. Therefore, we also proposed to amend Sec.  414.1400 to add 
paragraph (b)(3)(iv)(G) to require, beginning with the 2021 performance 
period, that QCDRs link their QCDR measures to the following at the 
time of self-nomination: (a) Cost measure; (b) improvement activity; 
and (c) an MVP (84 FR 40816). If the potential QCDR measure otherwise 
meets the QCDR measure requirements but does not have a clear link to a 
cost measure, improvement activity, or an MVP, we would consider 
exceptions for measures that otherwise meet the QCDR measure 
requirements and considerations as discussed above.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed with the proposal to require 
that QCDR measures be linked to cost measures, improvement activities, 
and MVPs. Several commenters supported an exception in cases where a 
QCDR measure lacks a clear link to either a cost measure, improvement 
activity, or MVP.
    Response: We thank commenters for their support.
    Comment: One commenter cited its belief that the proposal is not 
consistent with the regulatory language in that, the proposal states 
the linkage must be made to at least one of the categories while the 
regulatory language states the linkage must be made to all three. 
Another commenter stated that it is unclear whether the QCDR measure 
should be linked to at least one or all three of the performance 
categories. A few commenters sought clarification on the proposal to 
require QCDR measures be linked to cost measures, Improvement 
Activities, and MVPs, specifically whether QCDRs must link their 
measures to a cost measure, improvement activity, or a CMS-developed 
MVP, or all three; and how QCDRs will be required to identify linkages.
    Response: In the CY 2020 PFS proposed rule (84 FR 40816), we stated 
that ``we believe that to transform the MIPS program to one of value, 
MIPS measures and QCDR measures, should have an associated cost 
measure, improvement activity, and eventually a corresponding MVP.'' In 
addition, we also stated, ``therefore, we also propose to amend Sec.  
414.1400 to add paragraph (b)(3)(iv)(G) to require, beginning with the 
2021 performance period, that QCDRs link their QCDR measures as 
feasible to the following at the time of self-nomination: (a) Cost 
measure; (b) improvement activity; and (c) an MVP'' (84 FR 40816). 
However, we also proposed (84 FR 40816) that beginning with the 2021 
performance period and future years, QCDRs must identify a linkage 
between their QCDR measures to the following, at the time of self-
nomination: (a) Cost measure (as found in the CY 2020 PFS proposed rule 
(84 FR 40752 through 40762); (b) Improvement Activity (as found in 
Appendix 2: Improvement Activities Tables of the CY 2020 PFS proposed 
rule (84 FR 41275 through 41283)); or (c) CMS developed MVPs. We 
apologize for the confusion. We intended for the proposal to 
consistently use the term ``or,'' meaning that QCDRs would be required 
to link their measure to at least one performance category as feasible. 
Therefore, we are clarifying our requirement here in this final rule 
that QCDRs would not be required to link to all three performance 
categories at this time; but should try to link their measure to the 
performance categories as feasible.
    Comment: A few commenters expressed concerns with the proposal to 
require QCDR measures to be linked with cost measures, improvement 
activities, and MIPS Value Pathways, noting that some specialties are 
not currently included in the cost category and/or MIPS Value Pathways 
and therefore, urged CMS to account for these types of clinicians by 
building flexibility into QCDR measure requirements. Other commenters 
noted linking to cost measures, improvement activities, and MIPS Value 
Pathways should be optional and not required.
    Response: We appreciate the concerns raised by these commenters. We 
refer readers to our clarification above--QCDRs would be required to 
link their measure to at least one, not all three, performance category 
as feasible. In cases where a QCDR measure does not have a clear link 
to a cost measure, improvement activity, or MVP, we proposed that we 
would consider exceptions if the potential QCDR measure otherwise met 
the QCDR measure requirements and considerations such as addressing a 
measurement gap. As stated in our proposal in the CY 2020 PFS proposed 
rule (84 FR 40926), in cases where a QCDR measure does not have a clear 
link to a cost measure, improvement activity, or MVP, we would consider 
exceptions if the potential QCDR measure otherwise met the QCDR measure 
requirements and considerations. If a QCDR measure cannot be linked to 
a cost measure because the specialty isn't reflected in the cost 
measures, then the QCDR would indicate there are no cost measures to 
link in their QCDR measure submission for us to note as a part of our 
review.
    Comment: Several commenters stated that the method for linking QCDR 
measures is unclear as is the information required to explain the link. 
One commenter requested CMS provide additional education and guidance 
to QCDRs to assist them in adequately meeting the new requirement.
    Response: As QCDRs consider which QCDR measures they want to submit 
for consideration, they should work to identify relationships that can 
link their QCDR measure to measures and activities in other performance 
categories. For example, a link can be established if the associated 
measures and activities address the same clinical condition or disease. 
We will require the QCDR to provide a narrative with their QCDR measure 
specification that

[[Page 63065]]

identifies the other measures and activities that relate, and explain 
why they believe there is a link. We agree that additional education 
and guidance would be beneficial. We plan to provide education to QCDRs 
to ensure that they adequately understand this requirement.
    Comment: Several commenters disagreed with the proposal to require 
QCDR measures be linked to cost measures, improvement activities, and 
MIPS Value Pathways, citing their beliefs that: CMS should not 
implement any changes related to MIPS Value Pathways until the Agency 
has received and considered all comments related to the proposal and 
conducted outreach and meetings prior to the publication of next year's 
proposed rule (or alternatively a separate request for information 
(RFI) soliciting feedback). These commenters also expressed concern 
that continued development of new episode-based cost measures and MVPs 
may mean applicable measures and MVPs are not available at the time of 
self-nomination. One commenter noted that the effective date of this 
proposal is too soon and should be deferred until the MVP framework is 
established and measure developers have the necessary time to adapt to 
the new requirements and establish new measures to align with this new 
focus.
    Response: This policy was proposed with a delayed implementation, 
to take into effect for the 2021 performance period, in order for QCDRs 
to get acclimated with developing linkages between QCDR measures and 
measures and activities found within other performance categories, as a 
way to prepare for MVPs. In the time between the proposed and final 
rule, we have conducted stakeholder outreach through listening sessions 
and public facing webinars, while also reviewing comments received as 
it related to MVPs. We believe the 2021 performance period is an 
appropriate timeframe because it coincides with the timing, since the 
MVP framework is being finalized in this final rule, in which the first 
set of MVPs will be developed for 2021. Furthermore, we note that this 
policy establishes linkages as feasible, therefore while it's 
preferable, it is not mandatory to link a QCDR measure to a future MVP. 
If an MVP is not available at the time of self-nomination, a QCDR 
should try to link their QCDR measure to a relevant cost measure and 
improvement activity as feasible.
    After consideration of the comments, we are finalizing our proposal 
with clarification that QCDRs are required to link their measure to at 
least one performance category as feasible. Therefore, we are amending 
Sec.  414.1400 to reflect this clarification and add paragraph 
(b)(3)(iv)(G) to require, beginning with the 2021 performance period, 
that QCDRs link their QCDR measures as feasible to at least one of the 
following at the time of self-nomination: (a) Cost measure; (b) 
improvement activity; or (c) an MVP. In cases where a QCDR measure does 
not have a clear link to a cost measure, improvement activity, or an 
MVP, we would consider exceptions if the potential QCDR measure 
otherwise meets the QCDR measure requirements and considerations as 
discussed above.
(cc) Completion of QCDR Measure Testing
    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 criteria in order 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 moved forward with a 
proposal in the CY 2020 PFS proposed rule (84 FR 40816).
    Beginning with the 2021 performance period and future years, we 
proposed, that for a QCDR measure to be considered for use in the 
program, all QCDR measures submitted at the time of self-nomination 
must be fully developed with completed testing results at the clinician 
level, as defined by 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), and as 
used in the testing of MIPS quality measures prior to the submission of 
those measures to the Call for Measures (84 FR 40816 through 40817). We 
believe that full development and testing with completed testing 
results at the clinician level helps to demonstrate whether the QCDR 
measure is ready for implementation at the time of self-nomination. We 
intend to include only measures that are valid, reliable, and feasible 
for use by clinicians and will be consistent with the criteria that is 
expected of MIPS quality measures. As a result, we also proposed to 
amend Sec.  414.1400 to add paragraph (b)(3)(v)(C) to reflect this 
proposal (84 FR 40817). At Sec.  414.1400(b)(3)(v)(C), we proposed 
beginning with the 2021 performance period, all QCDR measures must be 
fully developed and tested, with complete testing results at the 
clinician level, prior to submitting the QCDR measure at the time of 
self-nomination (84 FR 40817).
    We noted that the testing process for quality measures is dependent 
on the measure type (for example, a measure that is specified as an 
eCQM measure has additional steps it must undergo when compared to 
other measure types). The National Quality Forum (NQF) has developed 
guides for measure testing criteria and standards which further 
illustrate these differences based on measure type. Additionally, the 
costs associated with testing vary based on the complexity of the 
measure and the developing organization. The Journal of the American 
Medical Association states that the costs associated with quality 
measures are generally unknown or unreported.\118\ While we understand 
the proposed policy will result in additional costs for QCDRs to 
develop measures, given the uncertainty regarding the number and types 
of measures that will be proposed in future performance periods coupled 
with the lack of available cost data on measure development and 
testing, we are unable to determine the financial impact of this 
proposal on QCDRs beyond the likelihood of it being more than trivial. 
Likewise, we understand that some QCDRs already perform measure testing 
prior to submission for approval while others do not. This variability 
makes it difficult to estimate the incremental impact of this 
regulation. Please refer to section VII., the Regulatory Impact 
Analysis, of this final rule for additional details.
---------------------------------------------------------------------------

    \118\ Schuster, Onorato, and Meltzer. ``Measuring the Cost of 
Quality Measurement: A Missing Link in Quality Strategy'', Journal 
of the American Medical Association. 2017; 318(13):1219-1220. 
https://jamanetwork.com/journals/jama/fullarticle/2653111?resultClick=1.
---------------------------------------------------------------------------

    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters agreed with the proposal to require 
measure testing prior to a QCDR measure being submitted for approval.
    Response: We thank commenters for their support.
    Comment: A few commenters requested clarification on the level of 
testing for which CMS is asking and whether it is full NQF-level 
specification and endorsement or a feasibility and validity test within 
the QCDR due to their opinion that NQF-level specification testing is 
both burdensome and expensive.

[[Page 63066]]

    Response: As stated in the CY 2020 PFS proposed rule (84 FR 40816 
through 40817), we proposed that all QCDR measures submitted at the 
time of self-nomination must be fully developed with completed testing 
results at the clinician level, as defined by 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), and as used in the testing of MIPS quality 
measures prior to the submission of those measures to the Call for 
Measures. As a reminder, we do not currently require QCDR measures to 
be NQF endorsed in order to be approved for use in the program. We 
believe in utilizing the existing NQF testing standard without 
variation, to avoid inconsistencies that may result from substandard 
results. We understand that measure testing requires an additional 
level of effort, cost, and time, but believe that measure testing 
ensures that measures are reliable, valid, and feasible. By completing 
this testing, QCDRs will avoid instances of discovering mid-year that 
their measure is not feasible or collectible, and will avoid adding to 
clinician reporting burden.
    Comment: A commenter cited their opinion that should the proposal 
be finalized, CMS should provide leniency on following the CMS 
Blueprint for the CMS Measures Management System due to its belief that 
it was developed for use by measure contractors who presumably have 
dedicated resources, both in staffing and funding, to do the sole work 
of measure development, testing and maintenance; and that the measure 
development timeline and requirements as laid out in the Blueprint are 
aggressive, particularly for organizations dependent on limited funds 
and expert volunteers to complete the work.
    Response: We disagree on providing leniency on testing 
requirements, as we expect to uphold the testing requirements that are 
utilized for MIPS quality measures through the CMS Blueprint for 
Measures Management System, and that the standard is upheld 
consistently for all QCDR measures and MIPS quality measures within the 
program. We believe QCDRs should research testing requirements for 
planning purposes from a timing and budget perspective. We will not 
consider measures that have incomplete testing results or those that do 
not meet the testing standards. Further the process outlined in the CMS 
Blueprint for the CMS Measures Management System is very thorough and 
following the Blueprint will substantially increase the scientific 
acceptability of the measure, and likelihood of the measure receiving 
endorsement. We note that while the Blueprint is required for CMS 
measure development contractors, it is a resource that can be used by 
any measure developer. We do recognize that resource availability in 
measure testing may vary, however, we reiterate the importance of 
following the Blueprint to produce a sound measure. Additionally, CMS 
provides support through webinars, resources, etc. through the Measure 
Management System: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Content-Page.html For Measure 
Management System webinar sign-up we direct readers to email 
[email protected].
    Comment: Many commenters disagreed with the proposal to require 
QCDR measures to have completed testing prior to nomination due to 
their beliefs that: It would delay the creation and submission of new 
measures by a number of months or even years; the process would be cost 
prohibitive for many QCDRs, especially those administered by non-profit 
medical societies; may result in some QCDRs electing to cease measure 
development or no longer participating in the MIPS program; could lead 
to increased licensing fees or participation fees for clinicians; and 
it removes the ability for clinicians to report on measures that are 
not in the CMS measure inventory.
    Response: While we understand the increased time and cost burdens 
associated with measure testing, we believe the benefits of completed 
measure testing far outweigh the burdens of it. We want all measures 
available in the MIPS program to be reliable, feasible, valid, and 
implementable within the program. We want to avoid scenarios that would 
arise by allowing measures that do not meet these standards which then 
may lead to issues with the measure mid-performance period. We do not 
believe it is appropriate to have untested measures within the MIPS 
program since clinician's performance on measures have impacts on their 
payments. Furthermore, as we have signaled through previous rulemaking 
cycles (83 FR 59901 through 59902), we have intended to raise the bar 
for QCDR measures that are available for reporting within the MIPS 
program. We disagree that measure testing removes the ability for 
clinicians to report on measures that are not within the CMS inventory. 
To clarify, QCDRs can collect data on measures for purposes of quality 
improvement outside of the program, without reporting the data to CMS 
for purposes of MIPS.
    Comment: Some commenters stated that this policy is contrary to 
Congress' initial intent for QCDRs to serve as testbeds for more robust 
and creative measures.
    Response: We disagree with the commenter that this policy is 
contrary to Congress' intent for QCDRs as there is no reference in 
section 1848(q) of the Act to QCDRs serving as ``testbeds'' for more 
robust and creative measures.
    Comment: A few commenters suggested testing measures during a trial 
period during which performance would not be counted against 
clinicians, and they may be offered some small incentive to report on 
the measures so that the developer can continue to refine them; or 
using interim testing results which could be collected while the 
measure is in use. One commenter expressed its belief that the proposal 
is unreasonable for smaller specialties or specialties where clinicians 
are more likely in small/solo practices due to the difficulty in 
operationalizing new measures and providing test data; and that the 
limited ability to use the Bonnie eCQM test deck also contributes to 
requiring large facilities with significant resources. This commenter 
also stated their belief that testing methodologies employed by 
academic medical centers could lack applicability and could cause 
measures commonly used by small/solo practitioners to fail external 
validity testing.
    Response: We thank the commenters for their suggestions. We believe 
there is value and importance in ensuring the scientific rigor of 
measures through measure testing; and therefore, we will not accept 
trial testing in place of fully completed testing data at the clinician 
level. We understand there may be limitations with small specialties 
and the lack of resources to test measures, but believe it is important 
to only include measures that are valid, reliable, and feasible in the 
program. We want to ensure that the testing methodology used by all, 
including academic medical centers, in a consistent manner to ensure 
that results meet testing standards. In response to commenters on the 
limited ability to use the Bonnie eCQM test deck, we clarify that 
testing verifies the behavior of the eCQM logic. Bonnie tests the 
measure logic against the constructed patient test deck and evaluates 
whether the logic aligns with the intent of the measure. This is an 
element of the testing and is not full validity, reliability and 
feasibility testing. Bonnie is open source and free to use, so it is an 
available option for testing measure logic. We refer readers

[[Page 63067]]

to https://bonnie.healthit.gov/ for additional information on Bonnie.
    Comment: A few commenters expressed their opinion that since QCDRs 
may have access to real-world EHR data, it should be recognized by CMS 
as a means to achieve the goals of measure testing without having to 
test measures according to the methods outlined by NQF and the CMS 
measures blueprint. Finally, one commenter suggested that in place of 
this proposal, the proposal to require collection of 12 months of data 
prior to nominating a new QCDR measure could be used in its place.
    Response: We disagree that having real-world access to EHR data is 
comparable to that of measure testing data or that requiring collection 
of 12 months of data on a QCDR measure could replace measure testing. 
Regardless of the QCDR measure's data source, all QCDR measures should 
be fully tested to ensure the measure is valid, reliable, and 
implementable at the clinician level. We clarify that the requirement 
to collect data on a QCDR measure prior to self-nominating is separate 
and apart from the requirement to fully test the measure. Data 
collection is meaningful because it demonstrates whether a measure is 
implementable and if there is interest by the clinician community on 
reporting on that metric.
    Comment: One commenter stated that if the proposal if finalized, 
CMS should provide additional flexibility to their proposed timeframes 
for measures dealing with less common medical problems as it is often 
not feasible to measure rare surgical outcome events during the course 
of 1 year in a way that is statistically appropriate or reliable.
    Response: We clarify that all QCDR measures, regardless of whether 
they have been approved for previous performance periods or are new 
QCDR measures will be expected to meet these new QCDR measures 
requirements and considerations to be approved for the 2021 performance 
period and future years. We will not be grandfathering in previously 
approved QCDR measures. To further clarify, we have not proposed 
timeframes for measure testing. As described in the CY 2020 PFS 
proposed rule (84 FR 40817), the testing process for quality measures 
is dependent on the measure type, for example, a measure that is 
specified as an eCQM measure has additional steps that it undergoes 
when compared to other measure types. We defer to QCDR measure owners 
as the experts in their specialty. We refer QDCRs to the Blueprint for 
the CMS Measures Management System (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf) for measure testing criteria and standards to determine 
timeframes that are appropriate for individual QCDR measure testing to 
ensure consistent and reliable standards are used. If a QCDR believes 
that they need more than 1 year is needed to ensure a measure is 
statistically appropriate, reliable, and to complete measure testing at 
the clinician level, then they should delay self-nominating the QCDR 
measure until testing is completed. Furthermore, we refer readers to 
the CY 2020 PFS proposed rule (84 FR 40818), where we proposed, and are 
finalizing in section III.K.3.g.(3)(c)(i) of this final rule, to reject 
QCDR measures that focus in on rare events or ``never events'' in the 
measurement period, and provided fires in the operating room as an 
example of a rare event.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, we are finalizing Sec.  
414.1400(b)(3)(v)(C), to state that beginning with the 2021 performance 
period, all QCDR measures must be fully developed and tested, with 
complete testing results at the clinician level, prior to submitting 
the QCDR measure at the time of self-nomination. We are also finalizing 
our proposal that all QCDR measures submitted at the time of self-
nomination must be fully developed with completed testing results at 
the clinician level, as defined by 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), and as used in the testing of MIPS quality measures 
prior to the submission of those measures to the Call for Measures.
(dd) Collection of Data on QCDR Measures
    We have observed several instances in which QCDRs have attempted to 
use the MIPS Program to ``test'' out measure concepts without concrete 
evidence that there is a measurement performance gap. We want to 
discourage that and ensure QCDR measures used for the MIPS Program are 
valid and reliable. In addition, through reviews of QCDR measure 
submissions, where reporting data was provided by the QCDR or through 
submission data from the 2017 performance period, we have identified 
some current QCDR measures in the program that have continuously low 
reporting rates, which affects the ability to meet benchmarking 
criteria. The data submitted is insufficient in meeting the case 
minimum and volume thresholds required for benchmarking.
    Therefore, in the CY 2020 PFS proposed rule, we proposed to require 
QCDRs to collect data on the potential QCDR measure (84 FR 40817). For 
a QCDR measure to be considered for use in the program, beginning with 
the 2021 performance period and future years, we proposed to amend 
Sec.  414.1400 to add paragraph (b)(3)(v)(D) that 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 (84 FR 40817). The data collected must demonstrate 
whether the QCDR measure is valid and reflects an important clinical 
concept(s) that clinicians wish to be measured on. By collecting data 
on the QCDR measure prior to self-nomination, QCDRs would be able to 
demonstrate whether the measure is implementable and data collection on 
the metric is possible. In addition, the data collected on the QCDR 
measure prior to self-nomination, could be used to demonstrate that 
there is a performance gap and need for measurement. We suggest QCDRs 
to collect data on as many months as possible, but encourage QCDRs to 
collect data for 12 months prior to submitting the QCDR measure for our 
consideration at the time of self-nomination, since quality reporting 
requires 12 months of data, as described in Sec.  414.1335, as this 
will also likely increase the chance that the measure will be able to 
be benchmarked.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter agreed with the proposal to require 
collection of data prior to submitting a QCDR measure for approval.
    Response: We thank the commenter for their support.
    Comment: One commenter advised CMS to delay implementation of this 
requirement for an additional year due to their belief that in order to 
meet this standard in 2021, QCDRs would need to begin immediately in 
2020 to work on collection of this data, which may not be feasible 
given that budgets and timelines have already been planned for the 
year.
    Response: We thank the commenter for their suggestion but disagree 
that there needs to be a delay in the implementation of this policy. We 
believe that implementing this requirement beginning with the 2021 
performance period would allow for sufficient time needed for planning 
and

[[Page 63068]]

budgeting. We believe that this requirement to collect data on the 
measure prior to submitting it to CMS coincides with the need for data 
collection as a part of the measure testing process, and therefore, 
would believe that if a QCDR measure has completed testing as outlined 
in the CMS Blueprint https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf, the QCDR 
would also be able to collect data on the measure to meet this 
requirement.
    Comment: Several commenters disagreed with the proposal to require 
collection of data on QCDR measures prior to nomination due to their 
beliefs that it would unnecessarily delay the creation and submission 
of new measures, further challenging participation of specialists who 
have very few measures to report; would create additional burden and 
may cause some QCDRs to end participation in MIPS; and would require 
financial resources most specialty societies do not have. One commenter 
expressed its opinion that collection of data should not be a 
determinant of clinical importance as public comments may reveal 
importance and given that similar measures may be approved, clinicians 
may elect to report to one even when both are clinically important.
    Response: We thank the commenters for raising these concerns. We 
believe that the benefits of this policy outweigh the burdens. While we 
understand that data collection may not be a determinant of clinical 
importance of a measure, data collection is important because it 
demonstrates whether a measure is implementable and if there is 
interest by the clinician community on reporting on that metric. We 
expect there to be a need for some data collection for testing 
purposes, as described in section III.K.3.g.(3)(c)(i)(B) of this final 
rule, and therefore, would believe that if a QCDR measure has completed 
testing as outlined in the CMS Blueprint, the QCDR measure would also 
be able to meet this requirement.
    Comment: One commenter suggested that in place of the proposal, 
QCDR measures could be approved under a testing/provisional status 
during which CMS would allow credit, such as a base 3-5 points or fully 
meeting improvement activity requirements.
    Response: We disagree with the commenter's suggestion of giving 
QCDR measures provisional approval prior to meeting this requirement. 
We want all measures available in the MIPS program to be reliable, 
feasible, and valid, and implementable within the program. We do not 
believe QCDRs should be using the MIPS program as a test-bed for 
measure development, particularly since this is a pay-for-performance 
program and clinician's performance on measures have impacts on their 
payments.
    Comment: One commenter stated that CMS should not penalize a QCDR 
for providing data for a period of less than 12 months for QCDR 
measures as collecting data for a 12-month period may be difficult 
given that the timelines of the MIPS submission cycle during the months 
of January-March, the requirement for QCDRs to be operational on 
January 1, and the self-nomination deadlines September 1; around which 
the QCDR's measure development and update processes have been 
established.
    Response: To clarify, as described in the CY 2020 PFS proposed rule 
(84 FR 40817), we suggest QCDRs to collect data on as many months as 
possible, but encourage QCDRs to collect data for 12 months prior to 
submitting the QCDR measure for our consideration at the time of self-
nomination. While we encourage 12 months of data, we do understand 
there may be instances where less than 12 months of data may be 
available, depending on the data available as a result of measure 
testing or the availability of the QCDR measure during past performance 
periods in MIPS.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, we are requiring QCDRs to collect 
data on potential QCDR measures. Beginning with the 2021 performance 
period and future years, for a QCDR measure to be considered for use in 
the program, we are adding Sec.  414.1400 (b)(3)(v)(D) to state that 
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. The data collected 
must demonstrate whether the QCDR measure is valid and reflects an 
important clinical concept(s) that clinicians wish to be measured on.
(ee) Duplicative QCDR Measures
    As first discussed by commenters in the CY 2018 Quality Payment 
Program final rule (82 FR 53814), the topic of ``shared'' measures was 
discussed and how would CMS intend to harmonize. In the CY 2019 PFS 
proposed rule (83 FR 35983), and further discussed in CY 2019 PFS final 
rule (83 FR 59901), we shared that we believe duplicative measures are 
counterintuitive to the Meaningful Measures initiative that promotes 
more focused quality measure development towards outcomes that are 
meaningful to patients, families and their providers. Therefore, it is 
our intent to move toward measure harmonization, which supports our 
efforts to increase measure alignment and eliminate redundancy both 
within the MIPS measure set and across our programs (83 FR 59901). 
Taking the previous feedback into consideration, we moved forward with 
a proposal in the CY 2020 PFS proposed rule (84 FR 40817).
    In the CY 2020 PFS proposed rule (84 FR 40817), we proposed, 
beginning with the 2020 performance period, that after the self-
nomination period closes each year, we will review newly self-nominated 
and previously approved QCDR measures based on considerations as 
described in the CY 2019 PFS final rule (83 FR 59900 through 59902). In 
instances in which multiple, similar QCDR measures exist that warrant 
approval, we may provisionally approve the individual QCDR measures for 
1 year with the condition that QCDRs address certain areas of 
duplication with other approved QCDR measures in order to be considered 
for the program in subsequent years. The QCDR could do so by 
harmonizing its measure with, or significantly differentiating its 
measure from, other similar QCDR measures. QCDR measure harmonization 
may require two or more QCDRs to work collaboratively to develop one 
cohesive QCDR measure that is representative of their similar yet, 
individual measures. In other words, we would not approve duplicative 
QCDR measures (which will be identified as a part of our scan of 
previously approved measures, and new QCDR measure submissions) if 
QCDRs choose not to address the areas of duplication with other 
approved QCDR measures identified by us during the previous year's QCDR 
measure review period. We believe this policy would help to reduce the 
number of duplicative QCDR measures that are submitted as a part of the 
self-nomination process. Adding a structured timeframe provides 
transparency to QCDRs who will know what next steps to expect if they 
do not address the identified areas of duplication as requested. 
Therefore, we proposed to amend Sec.  414.1400 to add paragraph 
(b)(3)(v)(E) to state beginning with the 2022 MIPS payment year (2020 
performance period), CMS may provisionally approve the individual QCDR 
measures for 1 year with the condition that QCDRs address certain areas 
of duplication with other

[[Page 63069]]

approved QCDR measures in order to be considered for the program in 
subsequent years (84 FR 40818). If the QCDR measures are not 
harmonized, CMS may reject the duplicative QCDR measure(s) as discussed 
in the CY 2020 PFS proposed rule (84 FR 40818).
    We received public comments on these proposals. We acknowledge that 
we received several comments that were out of scope for this final 
rule, which we are not addressing in this rule, but thank commenters 
for the feedback. The following is a summary of the in-scope comments 
we received and our responses.
    Comment: One commenter expressed its opinion that allowing 
duplicative measure concepts to go forward in the MIPS program fosters 
confusion among clinicians and competition among QCDRs, rather than 
collaboration; and that organizations will not be able to continue to 
invest in advancing meaningful quality measures if their measure 
concepts are able to be appropriated with superficial changes and then 
supported by CMS.
    Response: We agree with the commenter's concerns on duplicative 
measures creating confusion for clinicians. However, we note that we 
have continuously encouraged QCDRs to collaborate to develop cohesive, 
robust QCDR measures through the use of QCDR measure informal group 
discussions, reminders on monthly support calls and at QCDR measure 
preview calls. We have come across instances where QCDRs have refused 
to collaborate with one another, exacerbating the issue of competition 
rather than mitigating it.
    To clarify, as a part of the QCDR measure review process, we review 
all new QCDR measures submitted at the time of self-nomination and 
compare the new measures to previously approved QCDR measures. In 
instances where there are no significant differences, for example, in 
patient population or quality action, and the specification of the new 
measure is duplicate of an existing measure, we would reject the new 
measure and recommend the QCDR to seek permission to use the existing 
approved QCDR measure. In instances where there is overlap, and both 
measures cover a similar clinical concept, but with differing quality 
actions or patient populations, we will request measure harmonization. 
In instances where QCDRs cannot or refuse to collaborate to harmonize 
their measures, we will select and approve the most robust QCDR measure 
and reject any duplicative ones.
    Comment: Some commenters requested additional clarification and 
guidance should the proposal be finalized. Some commenters stated that 
CMS should provide clear guidance when and how measures should be 
harmonized in order to ensure that contractor decisions are as uniform 
as possible Other commenters requested timelines for making changes or 
harmonizing measures, what safeguards will be implemented to ensure 
harmonization will only occur when clinically appropriate; and 
accountability of QCDRs that do not have appropriate experience or 
expertise in the field of medicine covered by the measure.
    Response: We agree that clear guidance should be communicated to 
QCDRs who have been identified to collaborate on harmonization efforts. 
After the close of the self-nomination period, we will review QCDR 
self-nomination applications. As a part of this measure review process, 
we will identify similar QCDR measures for harmonization and then 
notify the relevant QCDRs through the Self-Nomination Portal that their 
QCDR measures have been identified for measure harmonization. In this 
communication, we will include our reasons as to why we believe 
harmonization is appropriate, including where we believe duplication 
exists, points of contact from the other identified QCDRs, and 
information regarding provisional approval for the given year. As 
proposed in the CY 2020 PFS proposed rule (84 FR 40818), we specified 
that we may provisionally approve the individual QCDR measures for 1 
year with the condition that QCDRs address certain areas of duplication 
with other approved QCDR measures within that year, prior to the next 
self-nomination period. With regards to ensuring that harmonization 
will only occur when clinically appropriate, we do review clinical 
appropriateness when requesting harmonization; however, we rely on the 
QCDRs to indicate, as a part of their QCDR measure reconsideration, 
when and why they believe harmonization is not appropriate. The 
additional information provided may be used to reconsider whether the 
QCDR measure should be harmonized or not.
    Comment: Several commenters cited their belief that CMS should 
grant 2 years of provisional approval instead of 1.
    Response: We disagree that a 2-year provisional approval cycle 
should be granted in these scenarios, as we believe it is important not 
to prolong measure harmonization. We understand that measure 
harmonization takes time for there to be agreement amongst the QCDRs 
and their technical expert panels. However, we believe it is 
counterintuitive to the Meaningful Measure Initiative to prolong 
retaining duplicative measures in the program.
    Comment: A few commenters stated their concerns over the process 
CMS will utilize to determine which QCDR measures are duplicative. Some 
commenters stated that CMS clarify the criteria for determinations that 
QCDR measures are duplicative. A few commenters encouraged CMS to: 
Consider the level of rigor in evidence or testing process between 
QCDRs; make determinations based on a comparison of the technical 
specifications; consider that an existing measure with baseline 
performance should not be rejected in favor of a new measure without 
prior data collection or baseline performance; consider a QCDR's 
relevant expertise or experience in the specialty or treatment area 
covered by a particular measure should be given. One commenter stated 
that if CMS identifies a measure that needs to be harmonized, CMS 
should provide the clinical rationale for harmonization. Another 
commenter stated that CMS and their contractors should consult with 
clinicians and measurement staff in the specialty societies regarding 
clinical aspects of measurement.
    Response: We thank the commenters for raising these concerns. As a 
part of the review process, QCDR measure specifications are 
comparatively reviewed for similarities and differences when they 
address the same clinical topic. QCDR measures are considered 
duplicative if there are no differences between the measure 
specifications from a comparative perspective. To clarify, in instances 
where a new QCDR measure is duplicative of an existing QCDR measure, we 
would reject the new duplicative QCDR measure and tell the QCDR to 
request permission to use the existing QCDR measure. We would request 
measure harmonization in instances where QCDR measures are identified 
as similar. QCDR measures are reviewed to identify similarities and 
differences in areas that include (but are not limited to): Clinical 
concept being measured, quality action (for example, screening versus 
screening and follow-up), patient population, clinical setting (place 
of service), and the clinician type eligible to report on the measure. 
We thank the commenters for their suggestions of what CMS should 
consider, but note that for the 2020 performance period and in previous 
years, we have not previously required measure testing, and it would, 
therefore,

[[Page 63070]]

be difficult to evaluate all QCDR measures with this criteria, if it is 
not consistently required. With regards to the suggestion that an 
existing measure with baseline performance should not be rejected in 
favor of a new measure without prior data collection or baseline 
performance, we believe that the data collection requirement for QCDR 
measures, beginning with the 2021 performance period will mitigate this 
concern. However, this would not be the only reason we would select an 
existing measure over a new QCDR measure. While some consideration 
would be given to an existing measure, there have been instances where 
a similar measure with a more vigorous (or robust) quality action had 
been submitted for consideration. In instances where we are able to 
identify strong qualities in both similar measures, we ask for measure 
harmonization. In instances, where one measure completely overlaps 
another's clinical concept but includes a more robust quality action, 
our preference would be to select the more robust QCDR measure 
(regardless of a given QCDR measure's history within the program). We 
expect QCDRs to be nimble and innovative and work collaboratively and 
independently to develop inventive measures that go beyond standard-of-
care, process measures. A QCDR's relevant expertise in the specialty is 
given some consideration, but would not be the deciding factor as 
several QCDRs may have overlapping expertise. In instances in which a 
QCDR has simply duplicated another existing approved QCDR measure 
without modification, we would not approve the newly duplicated QCDR 
measure. Furthermore, we appreciate the commenter's suggestion that we 
consult with clinicians and measurement staff in the specialty 
societies regarding clinical aspects of measurement. We want to note 
that QCDR measures are reviewed by staff and contractors who have 
various clinical backgrounds and experience with quality measures, 
including input from physicians on CMS staff and on our contracting 
team. There may be instances where the QCDR is affiliated with a 
specialty society, but this is not always the case. We would expect 
that QCDRs would develop QCDR measures reflective of their area of 
clinical experience and strength, and continuously engage in 
discussions with the QCDRs regarding the clinical aspects of their QCDR 
measures through QCDR measure preview calls and QCDR measure 
reconsideration calls. It is at these meetings where QCDRs are given 
the opportunity to present and rationalize the need for quality metrics 
around the topic at hand. We disagree that specialty societies should 
be involved in evaluating QCDR measures for which they are not the 
owners of, while we understand they may be experts in their respected 
field, we believe conflicts of interest may arise when the specialty 
society themselves have their own QCDR and are then allowed to evaluate 
QCDR measures from another QCDR of the same specialty.
    Comment: A few commenters stated that CMS should not encourage 
harmonization in cases where one QCDR is effectively trying to use 
another QCDR's measure without license or compensation.
    Response: In instances in which a QCDR has simply duplicated 
another existing approved QCDR measure without modification, we would 
not request harmonization or approve the newly duplicated QCDR measure. 
The QCDR will be requested to seek permission from the QCDR who owns 
the previously approved QCDR measure. Ultimately, any concerns with 
infringement of intellectual property of QCDR measures between QCDRs 
will be left between the QCDRs to mitigate and resolve.
    Comment: A few commenters disagreed with CMS' encouragement of 
harmonization due to their belief that the process of achieving 
harmonization is difficult ``when one QCDR may own the changes and 
carry them out while another QCDR may act as the measure steward.'' One 
commenter asserted that harmonization places undue burden to reporting 
clinicians and eliminates the flexibility that had been originally 
built into QCDR measure reporting.
    Response: We thank the commenter for raising these concerns. In our 
view, QCDR measures that are not harmonized place undue burden on 
reporting clinicians and eliminates flexibility. The brunt of the 
responsibility falls to QCDRs to resolve duplication and harmonization 
efforts to submit a consolidated QCDR measure. We believe measure 
harmonization is consistent with the Meaningful Measure Initiative. The 
purpose of measure harmonization is to reduce and consolidate the 
number of duplicative or similar measures within the program, which 
would result in a larger cohort of clinicians reporting on a 
consolidated measure. We believe this would improve the likelihood that 
newly harmonized measures will be able to reach benchmarking 
thresholds. We expect that if QCDRs are unable to determine roles and 
responsibilities as it pertains to measure harmonization efforts, they 
would inform CMS; we would use such information to help determine 
whether the most robust measure should instead just be selected.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, beginning with the 2020 
performance period, we are finalizing that after the self-nomination 
period closes each year, we will review newly self-nominated and 
previously approved QCDR measures based on considerations as described 
in the CY 2019 PFS final rule (83 FR 59900 through 59902). We are also 
finalizing our proposal to amend Sec.  414.1400 to add paragraph 
(b)(3)(v)(E) to state that 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 in order to be considered for the program 
in subsequent years. If the QCDR measures are not harmonized, CMS may 
reject the duplicative QCDR measure(s) as discussed in section 
III.K.3.g.(3)(c)(i)(C) of this final rule.
(C) QCDR Measure Rejections
    In the CY 2020 PFS proposed rule (84 FR 40818), we proposed QCDR 
measure rejection criteria that generally align with finalized removal 
criteria for MIPS quality measures in the CY 2019 PFS final rule (83 FR 
59763 through 59765). Utilizing these considerations would help to 
ensure that QCDR measures available in the program are truly meaningful 
and measurable areas where quality improvement is sought. As part of 
the proposal (84 FR 40818), all previously approved QCDR measures and 
new QCDR measures would be reviewed on an annual basis (as a part of 
the QCDR measure review process that occurs after the self-nomination 
period closes on September 1st) to determine whether they are 
appropriate for the program.
    We proposed to amend Sec.  414.1400 to add paragraph (b)(3)(vii) to 
state that beginning with the 2020 performance period, QCDR measure 
rejection criteria, include, but are not limited to, the following 
factors (84 FR 40818):
     QCDR measures that are duplicative or identical to other 
QCDR measures or MIPS quality measures that are currently in the 
program.
     QCDR measures that are duplicative or identical to MIPS 
quality measures that have been removed from MIPS through rulemaking.
     QCDR measures that are duplicative or identical to quality 
measures used under the legacy Physician Quality

[[Page 63071]]

Reporting System (PQRS) program, which have been retired.
     QCDR measures that meet the ``topped out'' definition as 
described at Sec.  414.1305 and in the CY 2017 Quality Payment Program 
final rule (81 FR 77282 through 77283). If a QCDR measure is topped out 
and rejected, it may be reconsidered for the program in future years if 
the QCDR can provide evidence through additional data and/or recent 
literature that a performance gap exists and show that the measure is 
no longer topped out during the next QCDR measure self-nomination 
process.
     QCDR measures that are process-based, with considerations 
to whether the removal of the process measure impacts the number of 
measures available for a specific specialty.
     Whether the QCDR measure has potential unintended 
consequences to a patient's care. For example, the measure disqualifies 
a patient from receiving oxygen therapy or other comfort measures.
     Considerations and evaluation of the measure's performance 
data, to determine whether performance variance exists.
     Whether the previously identified areas of duplication 
have been addressed as requested. (We refer readers to our proposal 
discussed in section III.K.3.g.(3)(c)(i)(B) of the CY 2020 PFS proposed 
rule (84 FR 40816).)
     QCDR measures that split a single clinical practice or 
action into several QCDR measures. For example, splitting a measure 
into multiple measures based on a particular body extremity: 
Improvement in toe pain--the 5th toe, and a separate measure for the 
2nd toe.
     QCDR measures that are ``check-box'' with no actionable 
quality action. For example, a QCDR measure that measures that a survey 
has been distributed to patients.
     QCDR measures that do not meet the case minimum and 
reporting volumes required for benchmarking after being in the program 
for 2 consecutive years (we also refer readers to our proposal in 
section III.K.3.g.(3)(c)(ii) of the proposed rule (84 FR 40818).
     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 action, where CMS preference is to 
include the new QCDR measure rather than requesting QCDR measure 
harmonization.
     QCDR measures with clinician attribution issues, where the 
quality action is not under the direct control of the reporting 
clinician. (That is, the quality aspect being measured cannot be 
attributed to the clinician or is not under the direct control of the 
reporting clinician).
     QCDR measures that focus on rare events or ``never 
events'' in the measurement period. An example of a ``never event'' 
would be a fire in the operating room.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters agreed with the proposed QCDR measure 
rejection criteria, specifically noting that the criteria make QCDRs a 
more comprehensive solution for providers and allow them to better 
leverage the data they are collecting.
    Response: We thank commenters for their support.
    Comment: A few commenters urged CMS to consider the limited number 
of measures available to non-patient facing clinicians when evaluating 
process-based measures.
    Response: As a part of our QCDR measure considerations, we will 
take into consideration the availability of measures for a given 
specialty, particularly those for non-patient facing clinicians. While 
our general preference is to have more outcome measures in the program, 
we do understand a need for process measures, particularly for non-
patient facing clinicians. Non-patient facing clinicians are limited in 
the availability of outcome measures that are available and measurable 
within their practice. Therefore, in instances where the outcome 
related metrics are limited or topping out, we encourage non-patient 
facing specialties to develop measures that address a high priority 
area (such as patient experience or care coordination) when it is not 
feasible to develop outcome measures.
    Comment: One commenter disagreed with what they believe is the 
routine removal of QCDR process measures without regard to their 
relationship to outcome, impact on safety, demonstrated gap in 
practice, or the duration of time before an outcome measure exists or 
before outcome data are available. The commenter further noted that 
process measures should not be rejected if QCDR data proves that they 
improve outcomes and they are not topped out, as process measures 
require considerable work, are not ``check box'' measures, are 
difficult to perform, and target a demonstrated gap in practice.
    Response: While our general preference is to have more outcome 
measures in the program, we do understand a need for process measures, 
particularly for non-patient facing clinicians. We would encourage 
specialties to develop measures that address a high priority area when 
it is not feasible to develop outcome measures. In addition, we will 
take into consideration performance gap information that is provided by 
a QCDR that demonstrates a process measure is not topped out. As a part 
of the QCDR measure review process, we do take into consideration any 
concerns with safety, any gap information a QCDR can provide to 
demonstrate one exists. We note that while we generally prefer outcome 
measures, and would like to move away from process measures in the 
program, we understand the time it takes to develop outcome measures. 
We consider ``check box'' measures, as measures that we have observed 
to be low-bar process measures that require a limited quality action 
that top out fairly quickly within the MIPS program and in our legacy 
PQRS program. If QCDRs are able to demonstrate a gap in practice for 
their process measure that information will be considered as a part of 
the QCDR measure approval process. In instances where QCDRs may 
disagree with their QCDR measure rejection, they may request a 
reconsideration call to discuss their position with CMS.
    Comment: One commenter disagreed with the following rejection 
criteria: ``QCDR measures with clinician attribution issues, where the 
quality action is not under the direct control of the reporting 
clinician. (That is, the quality aspect being measured cannot be 
attributed to the clinician or is not under the direct control of the 
reporting clinician)''. The commenter believed that it is often the 
case that a quality action is not in a clinician's direct control, but 
that does mean the clinician should not take responsibility for 
ensuring high quality of care; another words in instances when the 
measure is not directly attributable to the clinician, the clinician 
should not be held responsible for the quality of care. The commenter 
further cited their belief that this criterion is contrary to CMS' 
overarching goal of promoting and rewarding coordinated care.
    Response: We understand the importance of care coordination, but we 
also believe it is important that clinicians and groups are not 
inadvertently penalized for actions that are outside of their control. 
We understand that clinicians may not always have direct control of the 
quality action taking place, and that there are instances where care 
utilizes a team-based approach. We have discussed our concerns 
regarding attribution and holding an individual clinician responsible 
for the results of a team-based approach with QCDRs during

[[Page 63072]]

some of their QCDR measure reconsideration calls, and they have 
clarified that in some specialties, this is the approach they choose to 
use to provide high quality care. Many patient outcomes are multi-
factorial and can be influenced by the actions of multiple clinicians, 
even if none of them control it directly. After the QCDR measure self-
nomination period, as part of our measure review process, we review 
clinician attribution criteria. As part of the QDCR measure nomination, 
for measures that do not have a clear clinician attribution, we 
encourage QCDRs to submit a short explanation. We continue to be open 
to having discussions with QCDRs as they develop QCDR measures to 
understand the way in which they have attributed a measure. We do note 
that we will expect that QCDRs will provide evidence that shows that 
their attribution methodologies are valid, and will note that we will 
ultimately decide the QCDR measures approval status on a case-by-case 
basis.
    Comment: One commenter expressed concern that the term ``robust'' 
is not clearly defined as part of the rejection criteria: ``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 action, where CMS preference is to include the new 
QCDR measure rather than requesting QCDR measure harmonization''.
    Response: A robust measure refers to measures with the most 
vigorous quality action or guidance or as a descriptor to describe 
strong, vigorous, or thoroughly vetted components of a measure. We also 
refer readers to the CMS Blueprint where we have similarly defined 
``robust'': https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
    Comment: A few commenters disagreed with the policy for rejecting 
topped-out QCDR measures due to their beliefs that CMS is limiting the 
number of specialty-specific measures available in the MIPS program by 
not providing QCDRs a grace period to phase out measures; and that CMS 
should allow QCDR measure developers to re-tool measures removed from 
the program into specialty or procedure-specific measures. One 
commenter expressed its belief that allowing QCDR measures to be phased 
out over more than a 1-year period will give measure owners time to 
appropriately phase out the measure, and determine what subsequent 
action to take, such as retiring the measure, modifying the measure to 
make it more robust, or creating a complementary measure. Another 
commenter requested that CMS publicly report measure data stratified by 
specialty, as well as practice size and type, prior to removing a 
measure due to it being topped out.
    Response: We thank the commenter for their input but note that we 
do not see the need for a grace period to phase out QCDR measures. It 
is not consistent with the Meaningful Measures Initiative to retain 
topped out QCDR measures in the program when there are other relevant 
measures available for a given specialty. As a part of the review 
process, consideration is given to the number of measures remaining for 
a given specialty, whether there are additional specialty related 
measures in other QCDRs, and considerations to the MIPS quality 
measures inventory prior to rejecting a QCDR measure. In addition, 
QCDRs are expected to be nimble and innovative to work collaboratively 
and independently to develop inventive measures, which go beyond 
standard-of-care, process measures, that are often considered low-bar. 
We anticipate that QCDRs monitor the progress of their QCDR measures 
throughout the performance period, as well as year-over-year, and 
through their innovation, will work to submit new QCDR measures in 
future self-nomination periods. As a part of our QCDR measure removal 
process, we do give consideration to the availability of other 
specialty-specific measures, particularly outcome or high priority 
measures, available in the MIPS program prior to flagging any given 
measure for removal. In addition, performance data provided in the QCDR 
measure self-nomination demonstrating that a performance gap still 
exists will be taken into consideration prior to a final decision.
    Comment: One commenter stated its opinion that a topped out measure 
should not be retired without having an alternative measure in place.
    Response: As a part of the measure removal process, we typically 
evaluate the availability of measures to a given specialty as a part of 
the removal process. QCDRs are expected to be innovative in their 
development, and we believe since they can support QCDR and MIPS 
quality measures, there should be a sufficient number of measures left 
for a given specialty.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, we are finalizing that all 
previously approved QCDR measures and new QCDR measures would be 
reviewed on an annual basis (as a part of the QCDR measure review 
process that occurs after the self-nomination period closes on 
September 1st) to determine whether they are appropriate for the 
program. We are also amending Sec.  414.1400 to add paragraph 
(b)(3)(vii) to state that beginning with the 2020 performance period, 
we will reject QCDR measures with consideration of, but not limited to, 
the following factors:
     QCDR measures that are duplicative or identical to other 
QCDR measures or MIPS quality measures that are currently in the 
program.
     QCDR measures that are duplicative or identical to MIPS 
quality measures that have been removed from MIPS through rulemaking.
     QCDR measures that are duplicative or identical to quality 
measures used under the legacy Physician Quality Reporting System 
(PQRS) program, which have been retired.
     QCDR measures that meet the ``topped out'' definition as 
described at Sec.  414.1305 and in the CY 2017 Quality Payment Program 
final rule (81 FR 77282 through 77283). If a QCDR measure is topped out 
and rejected, it may be reconsidered for the program in future years if 
the QCDR can provide evidence through additional data and/or recent 
literature that a performance gap exists and show that the measure is 
no longer topped out during the next QCDR measure self-nomination 
process.
     QCDR measures that are process-based, with considerations 
to whether the removal of the process measure impacts the number of 
measures available for a specific specialty.
     Whether the QCDR measure has potential unintended 
consequences to a patient's care. For example, the measure disqualifies 
a patient from receiving oxygen therapy or other comfort measures.
     Considerations and evaluation of the measure's performance 
data, to determine whether performance variance exists.
     Whether the previously identified areas of duplication 
have been addressed as requested. (We refer readers to our proposal 
discussed in section III.K.3.g.(3)(c)(i)(B) of this final rule.)
     QCDR measures that split a single clinical practice or 
action into several QCDR measures. For example, splitting a measure 
into multiple measures based on a particular body extremity: 
Improvement in toe pain- the 5th toe, and a separate measure for the 
2nd toe.
     QCDR measures that are ``check-box'' with no actionable 
quality action. For example, a QCDR measure that measures that a survey 
has been distributed to patients.
     QCDR measures that do not meet the case minimum and 
reporting

[[Page 63073]]

volumes required for benchmarking after being in the program for 2 
consecutive years (we also refer readers to our proposal in section 
III.K.3.g.(3)(c)(ii) of this final rule).
     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 action, where CMS preference is to 
include the new QCDR measure rather than requesting QCDR measure 
harmonization.
     QCDR measures with clinician attribution issues, where the 
quality action is not under the direct control of the reporting 
clinician. (That is, the quality aspect being measured cannot be 
attributed to the clinician or is not under the direct control of the 
reporting clinician).
     QCDR measures that focus on rare events or ``never 
events'' in the measurement period. An example of a ``never event'' 
would be a fire in the operating room.
(ii) QCDR Measure Review Process
(A) Current QCDR Measure Approval Process
    We refer readers to 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), and the CY 2019 PFS final rule (83 FR 
59900 through 59906), and Sec.  414.1400(b)(3) for our previously 
established policies for the QCDR measure self-nomination process. QCDR 
measures are reviewed for inclusion on an annual basis during the QCDR 
measure review process that occurs once the self-nomination period 
closes (82 FR 53810). All previously approved QCDR measures and new 
QCDR measures are currently reviewed on an annual basis to determine 
whether they are appropriate for the program (82 FR 53811). The QCDR 
measure review process occurs after the self-nomination period closes 
on September 1st. QCDR measures are not finalized or removed through 
notice and comment rulemaking; instead, they are currently approved or 
not approved through a subregulatory processes (82 FR 53639). While we 
would continue to review measures on an annual basis, in the CY 2020 
PFS proposed rule, we proposed the addition of a multi-year approval 
process (84 FR 40818).
(B) Multi-Year QCDR Measure Approval
    Previously in the CY 2018 Quality Payment Program final rule (82 FR 
53808), we discussed our concerns with multi-year approval for QCDR 
measures and sought comment from stakeholders as to how to mitigate our 
concerns. Based on the evolution of public comments in the CY 2019 PFS 
final rule (83 FR 59898 through 59901) and ongoing engagement with 
QCDRs, we are made a proposal in the CY 2020 PFS proposed rule (84 FR 
40818).
    Currently, our QCDR measure approvals are on a year-to-year basis 
(82 FR 53811), from September to December once self-nomination occurs. 
In addition to that process, to help reduce yearly self-nomination 
burden and address stakeholder feedback (83 FR 59898 through 59901), in 
the CY 2020 PFS proposed rule (84 FR 40818), we proposed to amend Sec.  
414.1400 to add paragraph (b)(3)(vi) to implement, beginning with the 
2021 performance period, 2-year QCDR measure approvals (at our 
discretion) for QCDR measures that attain approval status by meeting 
the QCDR measure considerations and requirements described above.
    However, as proposed, upon annual review, we may revoke the second 
year's approval if a QCDR measure approved for 2 years is (84 FR 40818 
through 40819):
     Topped out (we refer readers to Sec.  414.1305, in the CY 
2017 Quality Payment Program final rule (81 FR 77282 through 77283));
     Duplicative of a more robust measure (this proposal aligns 
with our proposal at section III.K.3.g.(3)(c) in the proposed rule (84 
FR 40814 through 40819);
     Reflects an outdated clinical guideline;
     Requires measure harmonization (this proposal aligns with 
our proposal at section III.K.3.g.(3)(c)(i)(B) in the proposed rule (84 
FR 40816)); or
     The QCDR self-nominating the QCDR measure is no longer in 
good standing, as described in the CY 2018 Quality Payment Program 
final rule (82 FR 53808).
    We believe that this policy should be an incentive for QCDRs who 
have remained in good standing in the program. Additionally, for QCDRs 
not in good standing, we want to make clear that we would not remove a 
measure mid-year; rather, the measure's 2-year approval would be 
revoked during annual review after 1 year and the QCDR's measures would 
no longer qualify for multi-year approval in the future. For example, 
if QCDR ABC is placed on probation in July, all of the QCDR's measures 
still would be available for reporting for that performance period 
(until December 31st); however, if any of QCDR ABC's QCDR measures were 
previously approved for 2 years, the approval would be revoked for the 
second year.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed with the proposal to approve 
QCDR measures for multiple years due to their beliefs that approving 
measures for multiple years and posting updated specifications by 
November 1 would: Allow individuals and groups a better opportunity to 
meet the proposed 70 percent data completeness threshold; allow 
sufficient time for measure implementation, data collection for the 
next year's self-nomination, and improvement opportunities for 
practices; provide stability to MIPS; reduce burden; and allow for 
additional resources to be utilized for development of new measures.
    Response: We thank commenters for their support.
    Comment: A few commenters stated that QCDR measures should be 
approved for 2 years without being subject to CMS discretion as long as 
the measure satisfies QCDR measure requirements.
    Response: We believe a 2-year approval should be left to our 
discretion, because many considerations must be given: QCDR's ability 
to comply with program requirements, considerations to other QCDR 
measures with more robust quality actions, future changes to program 
requirements, and in consideration of future transitions to MVPs.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, we are amending Sec.  414.1400 to 
add paragraph (b)(3)(vi) to implement, beginning with the 2021 
performance period, 2-year QCDR measure approvals (at our discretion) 
for QCDR measures that attain approval status by meeting the QCDR 
measure considerations and requirements described above. However, upon 
annual review, we may revoke the second year's approval if a QCDR 
measure approved for 2 years is:
     Topped out (we refer readers to Sec.  414.1305, in the CY 
2017 Quality Payment Program final rule (81 FR 77282 through 77283));
     Duplicative of a more robust measure (this proposal aligns 
with our proposal at section III.K.3.g.(3)(c) in this final rule);
     Reflects an outdated clinical guideline;
     Requires measure harmonization (this proposal aligns with 
our proposal at section III.K.3.g.(3)(c)(i)(B) in this final rule); or
     The QCDR self-nominating the QCDR measure is no longer in 
good

[[Page 63074]]

standing, as described in the CY 2018 Quality Payment Program final 
rule (82 FR 53808).
(iii) Participation Plan for Existing QCDR Measures That Have Failed To 
Reach Benchmarking Thresholds
    We refer readers to the CY 2020 PFS proposed rule for discussion of 
the consideration of QCDR measures that fail to meet benchmarking 
thresholds after being in the program for 2 consecutive CY performance 
may not continue to be approved in the future (84 FR 40814 through 
40818).
    However, we understand that there are instances where measures that 
are low-reported may still be considered important to a respective 
specialty. Therefore, in the CY 2020 PFS proposed rule (84 FR 40819), 
beginning with the 2020 performance period, we proposed to amend Sec.  
414.1400 to add paragraph (b)(3)(iv)(J)(1) to state that in instances 
where a QCDR believes the low-reported QCDR measure that did not meet 
benchmarking thresholds is still important and relevant to a 
specialist's practice, that the QCDR may develop and submit a QCDR 
measure participation plan for our consideration (84 FR 40819). This 
QCDR measure participation plan must include the QCDR's detailed plans 
and changes to encourage eligible clinicians and groups to submit data 
on the low-reported QCDR measure for purposes of the MIPS program. As 
examples, a QCDR measure participation plan could include one or more 
of the following:
     Development of an education and communication plan.
     Update the QCDR measure's specification with changes to 
encourage broader participation, which would require review and 
approval by us.
     Require reporting on the QCDR measure as a condition of 
reporting through the QCDR.
    To be clear, implementation of a participation plan would not 
guarantee that a QCDR measure would be approved for a future 
performance period, as we consider many factors in whether to approve 
QCDR measures. At the following annual review of QCDR measures, we 
would analyze the measure's data submissions to determine whether the 
QCDR measure participation plan was effective (meaning, reporting 
volume increased, thereby increasing the likelihood of the QCDR measure 
being benchmarked). If the data does not show an increase in reporting 
volume, we may not approve the QCDR measure for the subsequent year.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters agreed with the proposal to allow QCDRs 
to submit measure participation plans for QCDR measures that have 
failed to meet benchmarking thresholds and urge CMS to leave open a 
mechanism for the retention of measures that are important to small 
segments of reporting clinicians, even if those measures fail to reach 
a benchmark, as this is very critical to ensuring that important 
measures are not removed from the program due to scoring methodologies 
and preferences, and to encourage reporting on high value measures.
    Response: We thank the commenters for their support.
    Comment: One commenter requested that CMS specify in the final rule 
when notice of low reporting volume will be given so that QCDRs may 
have ample time to develop and implement the participation plan.
    Response: QCDRs should be monitoring the reporting of their QCDR 
measures throughout the year and should be able to identify when their 
measures are low-reported. In addition, existing QCDR measures who have 
reached benchmarking thresholds would be included in the Quality 
benchmarking file that is posted annually in the Quality Payment 
Program Resource Library.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, beginning with the 2020 
performance period, we are amending Sec.  414.1400 to add paragraph 
(b)(3)(iv)(J)(1) to state in instances where a QCDR believes the low-
reported QCDR measure that did not meet benchmarking thresholds is 
still important and relevant to a specialist's practice, that the QCDR 
may develop and submit a QCDR measure participation plan for our 
consideration. This QCDR measure participation plan must include the 
QCDR's detailed plans and changes to encourage eligible clinicians and 
groups to submit data on the low-reported QCDR measure for purposes of 
the MIPS program.
(4) 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) and the 
CY 2019 PFS final rule proposed rule (83 FR 59906) for our previously 
finalized policies regarding qualified registries. In the CY 2020 PFS 
proposed rule (84 FR 40819), we proposed to update qualified registry 
required services. These proposed policies would also affect the 
qualified registry self-nomination process.
(a) Qualified Registry Required Services
(i) Requirement for Qualified Registries To Support All Three 
Performance Categories Where Data Submission Is Required
    We refer readers to section 1848(k)(4) of the Act for statutory 
authority. We also refer readers to section III.K.3.g.(1) in this final 
rule, where we discuss our proposal to require QCDRs and qualified 
registries to support three performance categories: Quality, 
improvement activities, and Promoting Interoperability (84 FR 40811). 
In addition, we refer readers to section III.K.3.g.(3)(a)(i) of this 
final rule where we discuss a parallel requirement for QCDRs (84 FR 
40812 through 40813). In this section, we discuss qualified registries 
specifically. Based on previously finalized policies the CY 2017 
Quality Payment Program final rule (81 FR 77363 through 77364) and as 
further revised in the CY 2019 PFS final rule at (83 FR 60088) and 
Sec.  414.1400(a)(2), the current policy is that QCDRs, qualified 
registries, and health IT vendors may submit data for any of the 
following MIPS performance categories: Quality (except for data on the 
CAHPS for MIPS survey); improvement activities; and Promoting 
Interoperability.
    We want to continue to strengthen our policies at Sec.  
414.1400(a)(2). Based on our review of existing 2019 qualified 
registries, approximately 95 qualified registries, or about 70 percent 
of the qualified registries currently participating in the program are 
supporting all three performance categories. While we do not yet have 
data to share for how clinicians participated in 2019 (year 3), we do 
want to indicate that we have observed from 2017 (year 1) to 2018 (year 
2) approximately 24 percent increasing to 36 percent of clinicians have 
used their QCDR/qualified registry for submitting for all 3 performance 
categories. We believe when this policy becomes finalized, more MIPS 
eligible clinicians may want to use this method as a burden reduction 
on data submission. When the CY 2020 PFS proposed rule was published 
the 2019 Qualified Registries Qualified Posting was available at 
https://qpp-cm-prod-content.s3.amazonaws.com/uploads/348/2019%20Qualified%20Registry%20Posting_Final_v1.0.xlsx (84 FR 40819). 
Since the publication of that proposed rule, the link has since been 
updated and is now available on the Quality Payment Program resource 
library at https://qpp.cms.gov/about/resource-library by searching 
``2019 Qualified Registries Qualified Posting.''

[[Page 63075]]

We believe it is reasonable that all qualified registries have the 
capacity to support the improvement activities and promoting 
interoperability performance categories.
    We believe that requiring qualified registries to be able to 
support these performance categories will be a step towards addressing 
stakeholders concerns on having a more cohesive participation 
experience across all performance categories under MIPS. In addition, 
we believe this proposal will help to reduce the reporting burden MIPS 
eligible clinicians and groups face when having to utilize multiple 
submission mechanisms to meet the reporting requirements of the various 
performance categories. Furthermore, as we move to a more cohesive 
participation experience under the MVPs, as discussed in the CY 2020 
PFS proposed rule (84 FR 40732 through 40745), we believe this proposal 
will assist clinicians in that transition. We also refer readers to 
section III.K.3.a. of this final rule where the MIPS MVP is discussed.
    Therefore, as discussed in the CY 2020 PFS proposed rule (84 FR 
40819), beginning with the 2023 MIPS payment year (2021 performance 
period) and for future years, we proposed at Sec.  414.1400(a)(2) to 
require qualified registries to support all three performance 
categories: Quality (except for data on the CAHPS for MIPS survey); 
improvement activities; and Promoting Interoperability with an 
exception. As discussed in the CY 2020 PFS proposed rule (84 FR 40819), 
we proposed that based on the amendment to Sec.  414.1400(a)(2)(iii), 
to state that for the Promoting Interoperability performance category, 
the requirement applies if the eligible clinician, group, or virtual 
group is using CEHRT; however, a third party could 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), (c)(2)(i)(A)(5), (c)(2)(i)(C)(1) through 
(c)(2)(i)(C)(7), or (c)(2)(i)(C)(9). As part of this proposal, we will 
(84 FR 40819 through 40821) require qualified registries to attest to 
the ability to submit data for these performance categories, as 
applicable, at time of self-nomination. We also proposed this same 
requirement for QCDRs in section III.K.3.g.(3) of the CY 2020 PFS 
proposed rule (84 FR 40813) and refer readers to section III.K.3.g.(3) 
of this final rule for a discussion.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters agreed with the proposal to require 
qualified registries to support the reporting of data for the quality, 
Promoting Interoperability, and improvement activities performance 
categories, as well as the exemption for qualified registries who serve 
specialties that are exempt from the Promoting Interoperability 
performance category.
    Response: We thank the commenters for their support.
    Comment: A few commenters noted that the proposal should not be 
considered until after the final 21st Century Cures rules are published 
and the updated standards are implemented.
    Response: We understand the interest in coordinating with the 
updates to standards that may be included in the 21st Century Cures Act 
final rule, however we do not believe that the proposals under the 21st 
Century Cures Act will have a significant impact on the ability of 
qualified registries to report measures for the Promoting 
Interoperability category. We note this requirement was proposed with a 
delayed implementation, beginning with the 2023 MIPS payment year (2021 
performance period), which should accommodate timing for any updates to 
standards. When the 21st Century Cures Act final rule is published we 
will determine if additional modifications are necessary and may 
address in future rule making.
    Comment: One commenter cited its opinion that if the proposal is 
finalized, the resulting burden may result in many qualified registries 
electing to reevaluate their decisions to seek approval to submit MIPS 
data.
    Response: While we understand that this requirement may add burden 
to qualified registries, we want to note a majority of existing 
qualified registries already support all three performance categories. 
In addition, we believe it is important that qualified registries act 
as one-stop-shops for reporting to reduce the reporting burden on 
eligible clinicians and groups.
    Comment: Multiple commenters also stated their opinion that if the 
proposal to require qualified registries to support the three 
performance categories is finalized, they would need CMS to provide 
additional guidance and descriptions of what data would be necessary to 
validate that an individual MIPS eligible clinician or group could 
appropriately attest to a specific activity.
    Response: Under our current data validation processes, as described 
in the CY 2017 Quality Payment Program final rule (81 FR 77368 through 
77369) and (81 FR 77384 through 77385), QCDRs and qualified registries 
are required to provide information on their sampling methodology. For 
example, it is encouraged that 3 percent of TIN/NPIs submitted be 
sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 
TIN/NPIs. For each TIN/NPI sampled, it is encouraged that 25 percent of 
the TIN/NPI's patients (with a minimum sample of 5 patients (with a 
maximum sample of 50 patients). We would expect that this review of 
patient medical records would be done to validate that the pertinent 
quality actions were done for measures and activities done by the 
clinician and group. In addition, validation guidance clarifications 
can be found within the improvement activities validation document at 
the MIPS Data Validation Document link. Third party intermediaries 
should utilize existing validation procedures to audit data submitted. 
With regards to auditing whether improvement activities have been 
completed by a clinician or group, a third party vendor can validate 
that an action has been done through review of medical records or other 
forms of documentation that will indicate that the quality action and/
or improvement activity has been completed.
    Comment: One commenter requested that CMS provide a mechanism for 
exempting MIPS qualified registries approved for the 2019 MIPS 
performance period if they submit a rationale for not supporting all 
three performance categories.
    Response: We clarify that this requirement to support all three 
performance categories will take into effect starting with the 2021 
performance period. Qualified registries will be required to support 
the quality and improvement activity performance categories. A third 
party intermediary may not be required to submit data for the Promoting 
Interoperability performance category if it only represents MIPS 
eligible clinicians, groups, and virtual groups that are eligible for 
reweighting under the Promoting Interoperability performance category. 
For example, as discussed in the CY 2019 PFS final rule (83 FR 59819 
through 59820), physical therapists generally are eligible for 
reweighting of the Promoting Interoperability performance category to 
zero percent of the final score; therefore, under this exception, a 
QCDR or qualified registry that represents only physical therapists 
that reweighted the Promoting Interoperability performance category to 
zero percent of the final score, would not be required to support the 
Promoting Interoperability performance category. In addition, QCDRs or

[[Page 63076]]

qualified registries that supported one of the following clinician 
types (and no others): Occupational therapists; qualified speech-
language pathologists; qualified audiologists; clinical psychologists; 
and registered dieticians or nutrition professionals, as described in 
Sec.  414.1380(c)(2)(i)(A)(4) would be excepted from supporting the 
Promoting Interoperability performance category. In contrast, a QCDR or 
qualified registry cannot be excepted from this requirement and must be 
able to submit data for the Promoting Interoperability performance 
category so long as it supports any clinician, group or virtual group 
that uses CEHRT and is not identified as eligible for reweighting of 
the Promoting Interoperability performance category.
    After consideration of the comments, we are finalizing our 
proposals with technical modifications for clarity and consistency with 
the existing provisions of Sec.  414.1400. As discussed in section 
III.K.3.g.(1), above in this final rule, we are amending Sec.  
414.1400(a)(2) to state that beginning with the 2023 MIPS payment year, 
QCDRs and qualified registries must be able to submit data for all of 
the MIPS performance categories identified in the regulation, and 
Health IT vendors must be able to submit data for at least one such 
category. We are also finalizing our proposal to amend Sec.  
414.1400(a)(2)(iii), as proposed, to state that for the 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)). We will require qualified 
registries to attest to the ability to submit data for these 
performance categories, as applicable, at time of self-nomination (84 
FR 40819 through 40821).
(ii) Enhanced Performance Feedback Requirement
    Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to 
encourage the provision of performance feedback through qualified 
registries. In addition, in establishing the requirements, the 
Secretary must consider, among other things, whether an entity 
``provides timely performance reports to participants at the individual 
participant level''. Currently, CMS requires qualified registries to 
provide feedback on all of the MIPS performance categories at least 4 
times per year (81 FR 77367 through 77386). While based on our 
experiences thus far during the initial years of the Quality Payment 
Program, we agree that providing feedback at least 4 times a year is 
appropriate. However, in the future CMS would like to see, and 
therefore, encourages qualified registries, to provide timely feedback 
on a more frequent basis more than 4 times a year. Receipt of more 
frequent feedback will help clinicians and groups make more timely 
changes to their practice to ensure the highest quality of care is 
being provided to patients. We see value in providing more timely 
feedback to meet the objectives \119\ of the Quality Payment Program in 
improving the care received by Medicare beneficiaries, lowering the 
costs to the Medicare program through improvement of care and health, 
and advance the use of healthcare information between allied providers 
and patients. We also believe there is value in this performance 
feedback, and therefore, encourage qualified registries to work with 
their clinicians to get the data in earlier in the reporting period so 
the qualified registry give that meaningful timely feedback.
---------------------------------------------------------------------------

    \119\ Quality Payment Program Overview. https://qpp.cms.gov/about/qpp-overview.
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    Surrounding the qualified registry performance feedback provided to 
clinicians and groups, we have heard from stakeholders that not all 
qualified registries provide feedback the same way. We have heard 
through stakeholder comments some qualified registries feedback 
contains information needed to improve quality, whereas other qualified 
registries feedback does not supply such information due to the data 
collection timeline. Additionally, we believe that clinicians would 
benefit from feedback on how they compare to other clinicians who have 
submitted data on a given MIPS quality measure within the qualified 
registry they are reporting through, so they can identify areas of 
measurement in which improvement is needed, and furthermore they can 
see how they compare to their peers based within a qualified registry, 
since the feedback provided by the qualified registry would be limited 
to those who reported on a given measure using that specific qualified 
registry.
    As a result, we proposed to add a new paragraph at Sec.  
414.1400(c)(2) to require (i) and (ii) (84 FR 40820). We simply 
proposed to revise the current Sec.  414.1400(c)(2) to reclassify at 
paragraph (c)(2)(i) that beginning with the 2022 MIPS payment year, the 
qualified registry must have at least 25 participants by January 1 of 
the year prior to the applicable performance period (84 FR 40820). 
Additionally, we proposed to add a new paragraph, Sec.  
414.1400(c)(2)(ii), beginning with the 2023 MIPS payment year, to 
require that qualified registries provide the following as a part of 
the performance feedback given at least 4 times a year, and provide 
specific feedback to their clinicians and groups on how they compare to 
other clinicians who have submitted data on a given measure within the 
qualified registry (84 FR 40820). We understand that there would be 
instances in which the qualified registry cannot meet this requirement; 
and therefore, we also proposed an exception to this requirement: If 
the qualified registry does not receive the data from their clinician 
until the end of the performance period, this will preclude the 
qualified registry from providing feedback 4 times a year, and the 
qualified registry could be excepted from this requirement (84 FR 
40820). We also solicited comment on other exceptions that may be 
necessary under this requirement.
    We also understand that qualified registries can only provide 
feedback on data they have collected on their clinicians and groups, 
and realize the comparison would be limited to that data and not 
reflect the larger sample of those that have submitted on the measure 
for MIPS, which the qualified registry does not have access to. We 
believe qualified registry internal comparisons can still help MIPS 
eligible clinicians identify areas where further improvement is needed. 
The ability for MIPS eligible clinicians to be able to know in real 
time how they are performing against their peers, within a qualified 
registry, provides immediate actionable feedback.
    Furthermore, in the CY 2020 PFS proposed rule (84 FR 40820), we 
also proposed to strengthen the qualified registry self-nomination 
process at Sec.  414.1400(c)(1) to add that beginning with the 2023 
MIPS payment year, qualified registries are required to attest during 
the self-nomination process that they can provide performance feedback 
at least 4 times a year (as specified at Sec.  414.1400(c)(2)(ii)). We 
refer readers to section III.K.3.g.(3)(1) of this final rule where we 
discuss a parallel requirement for QCDRs (84 FR 40814); we intend to 
have the same requirements for both QCDRs and qualifies registries.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed with the proposal for qualified 
registries to provide enhanced performance feedback at least 4 times a 
year including comparisons to other

[[Page 63077]]

clinicians who reported the same measure, at minimum. A few commenters 
agreed with the proposal that beginning in 2021, feedback from 
qualified registries must be provided at least 4 times a year and must 
include information on how participants compare to other clinicians 
within the qualified registry who have submitted data on a given 
measure. Commenters noted that this feedback and comparison is very 
beneficial to their participants and helps them identify potential 
areas for performance improvement as compared to their peers.
    Response: We thank the commenters for their support.
    Comment: Other commenters expressed concern that this would not 
provide participants with feedback on their performance from a 
programmatic perspective as a single registry does not represent a 
participant's entire peer cohort and providing registry-specific 
comparative performance feedback to compare their performance with that 
of their peers or predict their potential MIPS performance. Instead, 
the commenters stated their belief that it would be more appropriate to 
compare a MIPS eligible clinician or group's performance against the 
published benchmark.
    Response: We thank the commenter for raising this concern. To 
clarify, the intent of providing eligible clinicians and groups with 
this performance feedback is to give them feedback on how they compare 
to other clinicians (their peers) who have submitted data on a given 
MIPS quality measure within the qualified registry they are reporting 
through. Additionally, the intent of this feedback is so clinicians can 
identify areas of quality measurement in which improvement is needed, 
and furthermore, they can see how they compare to their peers based 
within a qualified registry. While we understand that it is not 
feasible for a single registry to represent the cohort of all 
clinicians who have reported on a given measure, it at least gives the 
clinicians within the single registry an idea of how well they 
performed with other fellow clinicians within the registry. We believe 
that it is important to provide meaningful data back to clinicians to 
understand and identify areas for improvement. We are only able to 
compare a MIPS eligible clinician or group's performance against a 
published benchmark when the qualified registry measure has reached the 
appropriate benchmarking and reporting thresholds, after the submission 
period for a given performance period closes. However, we believe it is 
important that clinicians and groups receive performance feedback in a 
timely fashion, by their qualified registry, in order to make real-time 
process improvements to their practice to improve the quality of care.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, we are amending Sec.  
414.1400(c)(2) to add (i) and (ii). We are amending the current Sec.  
414.1400(c)(2) to reclassify at paragraph (c)(2)(i) that beginning with 
the 2022 MIPS payment year, the qualified registry must have at least 
25 participants by January 1 of the year prior to the applicable 
performance period. Additionally, we are also finalizing a new 
paragraph at Sec.  414.1400(c)(2)(ii) to require that, beginning with 
the 2023 MIPS payment year, qualified registries provide the following 
as a part of the performance feedback given at least 4 times a year, 
provide specific feedback to their clinicians and groups on how they 
compare to other clinicians who have submitted data on a given measure 
within the qualified registry. We are also finalizing an exception to 
this requirement: If the qualified registry does not receive the data 
from their clinician until the end of the performance period, this will 
preclude the qualified registry from providing feedback 4 times a year, 
and the qualified registry could be excepted from this requirement. We 
are also finalizing, as proposed, at Sec.  414.1400(c)(1) to add that 
beginning with the 2023 MIPS payment year, qualified registries are 
required to attest during the self-nomination process that they can 
provide performance feedback at least 4 times a year (as specified at 
Sec.  414.1400(c)(2)(ii)).
    In the CY 2020 PFS proposed rule (84 FR 40814), we sought comment 
for future notice-and-comment rulemaking on whether we should require 
MIPS eligible clinicians, groups, and virtual groups who utilize a 
qualified registry to submit data throughout the performance period, 
and prior to the close of the performance period (that is, December 
31st). The current performance period begins January 1 and ends on 
December 31st, and the corresponding data submission deadline is 
typically March 31st as described at Sec.  414.1325(e)(1). We also 
sought comment for future notice-and-comment rulemaking, on whether 
clinicians and groups can start submitting their data starting April 1 
to ensure that the qualified registry is providing feedback and the 
clinician or group during the performance period. This would allow 
qualified registries some time to provide enhanced and actionable 
feedback to MIPS eligible clinicians prior to the data submission 
deadline.
    While we are not summarizing and responding to comments we received 
on this topic in this final rule, we thank the commenters for their 
responses and will take them into consideration as we develop future 
policies for qualified registries.
(5) 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) and the CY 2019 PFS final rule (83 FR 
59908 through 59910) for previously finalized policies for remedial 
action and termination of third party intermediaries.
    As explained in the CY 2020 PFS proposed rule (84 FR 40820), based 
on experience with third party intermediaries thus far, we have 
concerns that certain third party intermediaries may not fully 
appreciate their existing compliance obligations or the implications of 
non-compliance. Among other provisions, Sec.  414.1400(a)(5) 
specifically obligates each third party intermediary to certify that 
all data it submits to CMS on behalf of a MIPS eligible clinician, 
group or virtual group is true, accurate and complete to the best of 
its knowledge. Section 414.1400(f)(1) states that, after providing 
written notice, CMS may take remedial action or terminate a third party 
intermediary if CMS determines that the third party intermediary has 
ceased to meet one or more of the applicable criteria for approval or 
has submitted data that is inaccurate, unusable or otherwise 
compromised. Moreover, Sec.  414.1400(f)(3) identifies specific 
circumstances under which CMS may determine that data submitted by a 
third party intermediary meets the standard for inaccurate, unusable or 
otherwise compromised data.
    Third parties intermediaries have an affirmative obligation to 
certify that the data they submit on behalf of a MIPS eligible 
clinician, group or virtual group are true, accurate and complete to 
the best of its knowledge. MIPS data that are inaccurate, incomplete, 
unusable or otherwise compromised can result in improper payment. Using 
data selection criteria to misrepresent a clinician or group's 
performance for an applicable performance period, commonly referred to 
as ``cherry-picking,'' results in data submissions that are not true, 
accurate or complete. A third party intermediary cannot certify that 
data submitted to CMS by the third party intermediary are true, 
accurate and complete to the best of its knowledge if the third party 
intermediary knows the data submitted

[[Page 63078]]

are not representative of the clinician's or group's performance. 
Accordingly, a third party intermediary that submits a certification 
under Sec.  414.1400(a)(5) in connection with the submission of data it 
knows are cherry-picked has submitted a false certification in 
violation of existing regulatory requirements. If CMS believes cherry-
picking of data may be occurring, we may subject the third party 
intermediary and its clients to auditing in accordance with Sec.  
414.1400(g).
    In the CY 2020 PFS proposed rule (84 FR 40821), we explained that 
despite these existing obligations, we have received inquiries from 
third party intermediaries regarding perceived opportunities to 
selectively submit data that are unrepresentative of the MIPS 
performance of the clinician or group for which the third party 
intermediary is submitting data. These inquires suggest that certain 
third party intermediaries may not fully appreciate their current 
regulatory obligations or their implications.
    The current regulations at Sec.  414.1400(f) clearly establish that 
CMS enforcement authority includes the authority to pursue remedial 
actions or termination based on its determination that a third party 
intermediary was non-compliant with any applicable criteria for 
approval in Sec.  414.1400(a) through (e) or if the third party 
intermediary submitted data that are inaccurate, unusable or otherwise 
compromised. Compliance with Sec.  414.1400(a)(5) is a criteria for 
approval. Using data selection criteria to misrepresent a clinician or 
group's performance for an applicable performance period results in 
data that are inaccurate, unusable and otherwise compromised. 
Accordingly, if CMS determined that third party intermediary knowingly 
submitted data that are not representative of the clinician's or 
group's performance and certified that the submitted data were true, 
accurate and complete, CMS would have multiple grounds to impose 
remedial action or termination under existing regulations.
    As described in the CY 2020 PFS proposed rule (84 FR 40821), we 
proposed two changes to more expressly emphasize CMS enforcement 
authority. First, we proposed to clarify that remedial action and 
termination provisions at Sec.  414.1400(f)(1) are triggered if we 
determine that a third party intermediary submits a false certification 
under paragraph (a)(5). Second, we proposed to clarify that CMS 
authority to bring remedial actions or terminate a third party 
intermediary for submitting data that is inaccurate, unusable or 
otherwise compromise extends beyond the specific examples set forth in 
Sec.  414.1400(f)(3). We explained that with these revisions and a 
grammatical correction proposed at Sec.  414.1400(f)(1), we would 
affirm existing CMS authority to purse remedial actions or termination 
if we determine that a third party intermediary has ceased to meet one 
or more of the applicable criteria for approval, submits a false 
certification under paragraph (a)(5), or has submitted data that are 
inaccurate, incomplete, unusable, or otherwise compromised (84 FR 
40821). We noted that we anticipate that these revisions will emphasize 
to third party intermediaries the sanctions they may face from CMS if 
they submit improper data to CMS. In addition, we noted that third 
party intermediaries may face liability under the federal False Claims 
Act if they submit or cause to submission of false MIPS data.
    We proposed revisions to Sec.  414.1400(f)(3) to clarify the intent 
of this provision (84 FR 40821). We also refer readers to CY 2019 PFS 
final rule (83 FR 59908 through 59910) for the discussion of the 
evolution of policies regarding remedial actions and termination of a 
third party intermediary. The agency's enforcement authority as 
codified in Sec.  414.1400(f) broadly extends to include instances of 
willful misconduct by the third party intermediary and well as other 
instances in which a third party intermediary inadvertently submits 
data with deficiencies and errors that render the data ``inaccurate, 
unusable or otherwise compromised.'' To facilitate a more fulsome 
understanding on when inadvertent conduct could trigger an enforcement 
action against a third party intermediary, the current regulatory text 
in Sec.  414.1400(f)(3) provides that the threshold for ``inaccurate, 
unusable or otherwise compromised'' may be met if the submitted data 
includes TIN/NPI mismatches, formatting issues, calculation errors, or 
data audit discrepancies that affect more 3 percent of the total number 
of MIPS eligible clinicians or groups for which data was submitted by 
the third party intermediary. Through the CY 2020 PFS proposed rule (84 
FR 40821), we proposed to add the phrase ``including but not limited 
to'' to the text of Sec.  414.1400(f)(3) to emphasize that this 
provision is illustrative of circumstances that may result in 
enforcement action and should not be misinterpreted to limit the 
agency's ability to impose remedial actions or terminate a third party 
intermediary that knowingly submits inaccurate data.
    Lastly, we proposed grammatical corrections related to the use of 
the plural term ``data'' (84 FR 40821).
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters expressed support for CMS conducting 
audits if we believe data have been ``cherry-picked'' or are otherwise 
not accurate.
    Response: We thank commenters for their support.
    Comment: Another commenter further encouraged CMS to publish 
aggregate information from their 2018 auditing of MIPS eligible 
clinicians and groups with regard to suspected instances of cherry-
picked data in regard to third party intermediaries.
    Response: We thank the commenter for their suggestion, and would 
encourage them to clarify what type of aggregated data they are looking 
for as these types of audit results are not typically published.
    Comment: A few commenters stated that although CMS has provided 
some indication of what may constitute an inaccuracy, greater clarity 
and transparency is critical so that registries can implement 
appropriate checks and identify additional data inaccuracies or errors 
beyond those that are detected through each registry's CMS approved 
data validation plan. The commenters further urged CMS to: Clearly 
define a registry's responsibility to address data inaccuracies that 
can be attributed to data that the registry has access to, controls and 
manages; consider developing a report that describes and differentiates 
errors, as well as other ``issues'' that should be brought to the 
registry's attention; clearly define what is considered when 
calculating an error rate; and provide additional detail regarding CMS' 
description of criteria that may disqualify a third-party intermediary. 
One commenter specifically stated its belief that when individuals or 
practices withhold Medicare billing data, this unavailable data should 
not be counted against the registry as an inaccuracy since the registry 
has no readily available solution to address this issue without access 
to current CMS' claims data. One commenter encouraged CMS to release 
additional instructions for individual clinicians and groups to 
understand their responsibilities in submitting accurate and complete 
data and not hold third-parties accountable for data issues outside 
their control.
    Response: We thank the commenters for their suggestions. As 
described in the CY 2017 Quality Payment Program

[[Page 63079]]

final rule (81 FR 77366 through 77374), and through our resources in 
the Quality Payment Program Resource Library, such as our 2020 Self-
Nomination Tool Kit for QCDR and qualified registries: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/580/2020%20Self-Nomination%20Toolkit%20for%20QCDRs%20%26%20Qualified%20Registries.zip 
we provide further descriptions of the expectations of data validation 
plans and examples of what would constitute data inaccuracies, 
including the guidance that the QCDR should make CMS aware of any 
errors that may impact a clinician's ability to report or how the 
clinician may score on a measure or overall. We refer commenters to the 
MIPS Data Validation Execution Report (DVER) template and the self-
nomination factsheet for further details on expectations of data 
validation and discussion of remedial action and termination due to 
these error rates, both documents can be found on the Quality Payment 
Program Resource Library https://qpp.cms.gov/about/resource-library. In 
addition, on a monthly basis through our mandatory support calls (81 FR 
77368), we have typically reminded our approved QCDRs and qualified 
registries of our expectations for the data validation execution report 
and the methodology for calculating error rates and we anticipate using 
these calls and other guidance for additional education of third party 
intermediaries in the future. We will look to provide additional 
education to clinicians and groups in understanding their 
responsibility to help ensure the data submitted on their behalf by 
third party intermediaries are true, accurate, and complete data. 
However, we believe third parties intermediaries are also accountable 
for the accuracy of what they submit to CMS. If a third party 
intermediary finds inaccuracies or data integrity issues, it should 
ensure that it does not knowingly submit data that are 
misrepresentative, and are not true, accurate, or complete. We will 
take the commenters suggestions into future consideration.
    Comment: A few commenters requested clarification on whether 
specific scenarios involved data inaccuracies that would trigger 
remedial action. One commenter sought clarification on whether a data 
submission is inaccurate if the submission misstates whether a 
clinician is a non-MIPS eligible clinician, a Qualified APM Participant 
or other APM participant; and if that misstatement would trigger a 
remedial action under Sec.  414.1400(f). Another commenter sought 
clarification as to whether a qualified registry would be subject to 
remedial action if the data submitted did not meet appropriate data 
completeness thresholds.
    Response: We believe it is the responsibility of the third party 
intermediary to validate data prior to submission to CMS and to ensure 
that the data is true, accurate, and complete to the best of its 
knowledge. This certification is applicable to information regarding a 
clinician's eligibility status. We expect that data submitted by third 
party intermediaries are true, accurate and complete to the best of the 
submitter's knowledge. If a third party intermediary knows data are not 
true, accurate or complete, the third party intermediary should not 
submit those data. Whether CMS will bring remedial action or terminate 
a third party intermediary under Sec.  414.1400(f) for submitting a 
false certification or for submitting data that are inaccurate, 
unusable or otherwise compromised depends on the particular facts and 
circumstances. If a third party intermediary submits data that misstate 
whether a clinician is non-eligible, a Qualified APM Participant, or 
other APM participant then the third party intermediary has submitted 
data that are inaccurate. We believe that third party intermediaries 
should be able to track the eligibility status of the clinicians and 
groups they support MIPS reporting for, particularly as it pertains to 
MIPS eligible, voluntary participation, and opt-ins. That is to also to 
account for those clinicians and groups who have chosen to opt-in 
participating in the program. If we determine a third party 
intermediary is misrepresenting the status of its clinicians, we would 
anticipate seeking a corrective action plan from the third party 
intermediary to address these deficiencies. If its submission meets 
applicable program requirements, such as a submission of data on a 
single patient to meet a minimum threshold, a third party intermediary 
may be able to accurately certify that the data it is submitting are 
true, accurate and complete even if the data does not meet the data 
completeness threshold for an individual eligible clinician. Data 
submissions that do not meet appropriate data completeness thresholds 
(as described in section III.K.3.c of this final rule) will not receive 
an error message from the system, and will be scored according to the 
scoring regulations at Sec.  414.1380. If the data submitted does not 
satisfy the data completeness thresholds, the submission is unlikely to 
receive full credit, and will be scored accordingly; however, this 
alone would not render the third party intermediary's submission 
incomplete for purposes Sec.  414.1400. Through our resources in the 
Quality Payment Program Resource Library, known as our 2020 Self-
Nomination Tool Kit (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/580/2020%20Self-Nomination%20Toolkit%20for%20QCDRs%20%26%20Qualified%20Registries.zip), 
we provide further descriptions of the expectations of data validation 
plans and examples of what would constitute data inaccuracies. Failure 
to comply with program regulations could result in remedial action. 
From the data error perspective, we remind third party intermediaries 
that they are expected to certify that their data submissions are true, 
accurate, and complete to the best of their knowledge.
    Comment: One commenter expressed their belief that the provision in 
Sec.  414.1400(f)(3)(ii) which gives weight to data errors that affect 
3 percent of the MIPS eligible clinicians and groups whose data was 
submitted by the third party intermediary may unfairly penalize third 
party intermediaries with a small number of participants. The commenter 
provided the example that a quality registry reporting for only 25 
clinicians triggering the 3 percent threshold if its submission 
included a data error on a single patient of a single clinician. The 
commenter recommended revising the provision such that the threshold 
was measured based on the percentage of patients reported by third 
party intermediary rather than the percentage of clinicians.
    Response: We believe it is important to hold third party 
intermediaries responsible for data errors regardless of the volume of 
clinicians and groups they support. Third party intermediaries with 
smaller volumes of reporting clinicians and groups should be able to 
ensure the accuracy of the data they submit and have fewer errors when 
compared to larger third party intermediaries. To facilitate a more 
fulsome understanding on when inadvertent conduct could trigger an 
enforcement action against a third party intermediary, the current 
regulatory text in Sec.  414.1400(f)(3) provides that the threshold for 
``inaccurate, unusable or otherwise compromised'' may be met if the 
submitted data includes TIN/NPI mismatches, formatting issues, 
calculation errors, or data audit discrepancies that affect more 3 
percent of the total number of MIPS eligible

[[Page 63080]]

clinicians or groups for which data was submitted by the third party 
intermediary. Through the CY 2020 PFS proposed rule (84 FR 40821), we 
proposed to add the phrase ``including but not limited to'' to the text 
of Sec.  414.1400(f)(3) to emphasize that this provision is 
illustrative of circumstances that may result in enforcement action and 
should not be misinterpreted to limit the agency's ability to impose 
remedial actions or terminate a third party intermediary that knowingly 
submits inaccurate data. We disagree with the commenter's suggestion to 
revise the policy to state that the threshold should be measures based 
on the percentage of patients reported by the third party 
intermediaries rather than the percentage of clinicians because this 
auditing at the patient level does not allow us to determine the 
overall impact of the data error to the cohort of clinicians who 
utilized the third party to report. Utilizing the percentage of 
patients as the data error threshold may lead to inaccurate 
representations of the overall impact of a data error found through 
third party reporting.
    Comment: Some commenters urged CMS to be mindful that from their 
perspective third party intermediaries, especially specialty society 
clinical data registries, do not have the capacity to tell whether a 
group has specifically submitted false or incomplete data. These 
commenters believed it is the responsibility of the MIPS eligible 
clinician or group to demonstrate to CMS that their data are accurate 
and complete using documentation as described by CMS in this rule. 
Moreover, if ``cherry-picking'' is found by CMS, these commenters 
believed the audit should be sent to the MIPS eligible clinician or 
group, and not the third party intermediary.
    Response: We believe it is the responsibility of the third party 
intermediary to validate data prior to submission to CMS and to ensure 
that the data it submits are true, accurate, and complete to the best 
of its knowledge. It should be a joint responsibility of the eligible 
clinician and the third party intermediary to ensure that data 
submitted to CMS is true and reflective of their scope of practice, 
while avoiding selection bias.
    After consideration of the comments, we are finalizing our 
proposals as proposed. Specifically, we are finalizing that remedial 
action and termination provisions at Sec.  414.1400(f)(1) are triggered 
if we determine that a third party intermediary submits a false 
certification under paragraph (a)(5). Additionally, we are finalizing 
that CMS authority to bring remedial actions or terminate a third party 
intermediary for submitting data that are inaccurate, unusable or 
otherwise compromised extends beyond the specific examples set forth in 
Sec.  414.1400(f)(3). We added the phrase ``including but not limited 
to'' to the text of Sec.  414.1400(f)(3) to emphasize that this 
provision is illustrative of circumstances that may result in 
enforcement action and should not be misinterpreted to limit the 
agency's ability to impose remedial actions or terminate a third party 
intermediary that knowingly submits inaccurate data. In addition, we 
note that third party intermediaries may face liability under the 
federal False Claims Act if they submit or cause to submission of false 
MIPS data.
    Lastly, we are finalizing the corrections related to the use of the 
plural term of ``data.''
h. Public Reporting on Physician Compare
(1) Background
    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), and the Physician Compare Initiative website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
    We proposed to publicly report on Physician Compare: (1) Aggregate 
MIPS data, including the minimum and maximum MIPS performance category 
and final scores earned by MIPS eligible clinicians, beginning with 
Year 2 (CY 2018 data, available starting in late CY 2019), as 
technically feasible; and (2) an indicator on the profile page or in 
the downloadable database that displays if a MIPS eligible clinicians 
is scored using facility-based measurement, as specified under Sec.  
414.1380(e)(6)(vi), as technically feasible (see 84 FR 40821 through 
40824). A summary of the comments received and our finalized policies 
are discussed in more detail in this final rule.
(2) Regulation Text Changes
    Section 1848(q)(9)(A) and (D) of the Act requires that we publicly 
report on Physician Compare in an easily understandable format:
     The final score for each MIPS eligible clinician;
     Performance of each MIPS eligible clinician for each 
performance category;
     Periodic aggregate information on the MIPS, including the 
range of final scores for all MIPS eligible clinicians and the range of 
performance of all the MIPS eligible clinicians for each performance 
category; and
     The names of eligible clinicians in advanced APMs and, to 
the extent feasible, the names of such advanced APMs and the 
performance of such APMs.
    Section 1848(q)(9)(B) of the Act requires that the information made 
available under section 1848(q)(9) of the Act must indicate, where 
appropriate, that publicized information may not be representative of 
the eligible clinician's entire patient population, the variety of 
services furnished by the eligible clinician, or the health conditions 
of individuals treated.
    To more completely and accurately reference the data available for 
public reporting on Physician Compare, we proposed to amend Sec.  
414.1395 by adding paragraph (a)(1) stating that CMS posts on Physician 
Compare, in an easily understandable format: (i) Information regarding 
the performance of MIPS eligible clinicians, including, but not limited 
to, final scores and performance category scores for each MIPS eligible 
clinician; and (ii) the names of eligible clinicians in Advanced APMs 
and, to the extent feasible, the names and performance of such Advanced 
APMs. As discussed in section III.K.3.h.(3) of this final rule, we also 
proposed to amend Sec.  414.1395 by adding paragraph (a)(2) stating 
that CMS periodically posts on Physician Compare aggregate information 
on the MIPS, including the range of final scores for all MIPS eligible 
clinicians and the range of the performance of all MIPS eligible 
clinicians with respect to each performance category. Finally, we 
proposed to amend Sec.  414.1395 by adding paragraph (a)(3) stating 
that the information made available under Sec.  414.1395 will indicate, 
where appropriate, that publicized information may not be 
representative of an eligible clinician's entire patient population, 
the variety of services furnished by the eligible clinician, or the 
health conditions of individuals treated.
    We did not receive public comments on the proposed regulation text 
changes. As such, we are finalizing our policy as proposed to amend 
Sec.  414.1395 by adding paragraph (a)(1) stating that CMS posts on 
Physician Compare, in an easily understandable format: (1) Information 
regarding the performance of MIPS eligible clinicians, including, but 
not limited to, final scores and

[[Page 63081]]

performance category scores for each MIPS eligible clinician; and (2) 
the names of eligible clinicians in Advanced APMs and, to the extent 
feasible, the names and performance of such Advanced APMs. In addition, 
we are finalizing our policy as proposed to amend Sec.  414.1395 by 
adding paragraph (a)(3) stating that the information made available 
under Sec.  414.1395 will indicate, where appropriate, that publicized 
information may not be representative of an eligible clinician's entire 
patient population, the variety of services furnished by the eligible 
clinician, or the health conditions of individuals treated.
(3) Final Score, Performance Categories, and Aggregate Information
    Section 1848(q)(9)(D) of the Act requires the Secretary to 
periodically post on Physician Compare aggregate information on the 
MIPS, including the range of composite scores for all MIPS eligible 
clinicians and the range of the performance of all MIPS eligible 
clinicians with respect to each performance category. We refer readers 
to the CY 2018 Quality Payment Program final rule (82 FR 53823), where 
we previously finalized policies to publicly report on Physician 
Compare, either on profile pages or in the downloadable database, the 
final score for each MIPS eligible clinician and the performance of 
each MIPS eligible clinician for each performance category, and to 
periodically post aggregate information on the MIPS, including the 
range of final scores for all MIPS eligible clinicians and the range of 
performance of all the MIPS eligible clinicians for each performance 
category, as technically feasible, for all future years.
    Although we previously finalized a policy to periodically post 
aggregate information on the MIPS, as technically feasible, for all 
future years, we have not proposed or finalized in rulemaking a 
specific timeframe for doing so. As part of our phased approach to 
public reporting, we wanted to first gain experience with the MIPS data 
prior to publicly reporting it in aggregate, since we had not publicly 
reported on Physician Compare aggregate data under legacy programs. For 
example, we publicly reported the Physician Quality Reporting System 
(PQRS) performance information only at an individual clinician and 
group practice level. Now that we have experience with the MIPS data, 
including the Year 1 performance information which was not available 
for analysis at the time of prior rulemaking, we can now propose a 
specific timeframe for publicly reporting aggregate MIPS data on 
Physician Compare.
    Therefore, in accordance with section 1848(q)(9)(D) of the Act, we 
proposed to publicly report on Physician Compare aggregate MIPS data, 
including the minimum and maximum MIPS performance category and final 
scores earned by MIPS eligible clinicians, beginning with Year 2 (CY 
2018 data, available starting in late CY 2019), as technically 
feasible, and to codify this policy at Sec.  414.1395(a) (84 FR 40822). 
We clarify that the aggregate data publicly reported would be inclusive 
of all MIPS eligible clinicians. We also note that some aggregate MIPS 
data is already publicly available in other places, such as via the 
Quality Payment Program Experience Report. We note that the 2017 
Quality Payment Program Experience Report is available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/491/2017%20QPP%20Experience%20Report.pdf. As noted in the CY 2018 Quality 
Payment Program final rule (82 FR 53823), we will use statistical 
testing and user testing, as well as consultation with the Physician 
Compare Technical Expert Panel, to determine how and where these data 
are best reported on Physician Compare (for example in the Physician 
Compare Downloadable Database or on the Physician Compare Initiative 
page). In addition to minimum and maximum MIPS performance category and 
final scores, we also solicited comment on any other aggregate 
information that stakeholders will find useful for future public 
reporting on Physician Compare.
    We received public comments on other aggregate information that 
stakeholders will find useful for future public reporting on Physician 
Compare. The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported publicly reporting aggregate 
MIPS data, including the minimum and maximum MIPS performance category 
and final scores earned by MIPS eligible clinicians, beginning with 
Year 2 (2018 data available starting in late 2019). A few commenters 
supported the goals of public reporting information on Physician 
Compare yet remained concerned that Medicare patients and their 
caregivers may not be able to accurately understand and interpret 
aggregated information, such as the minimum and maximum MIPS 
performance category and final scores earned by MIPS eligible 
clinicians. Two commenters supported publicly reporting information on 
Physician Compare, but expressed concern about the accuracy of the data 
while another commenter that supported public reporting also noted that 
publishing aggregate information may not be meaningful for certain 
clinician types. One commenter recommended delaying publicly reporting 
aggregate information until concerns around accuracy of the data can be 
resolved.
    Response: We appreciate commenters support and the concerns raised. 
We note that section 1848(q)(9)(D) of the Act requires the Secretary to 
periodically post on Physician Compare aggregate information on the 
MIPS, including the range of composite scores for all MIPS eligible 
clinicians and the range of the performance of all MIPS eligible 
clinicians with respect to each performance category. In addition, we 
will use statistical testing and user testing, as well as consultation 
with the Physician Compare Technical Expert Panel, to determine how and 
where these data are best reported on Physician Compare to ensure these 
data are understood and interpreted accurately. We believe we should 
employ the same phased approach to ensure the data made public 
accurately represents clinical performance and is understood by website 
users. We will actively work to ensure that the language on the website 
and the additional education and outreach conducted for patients and 
caregivers continues to make this information clear. In addition, we 
will work to ensure all data publicly reported on Physician Compare is 
accurate. As such, all data available for public reporting are 
available for review and correction during the targeted review process, 
as specified at Sec.  414.1385. Data under review will not be publicly 
reported until the review is complete. We clarify that aggregate data 
will reflect MIPS eligible clinicians and groups collectively and will 
not be specialty-specific.
    After consideration of the comments, we are finalizing our proposal 
to publicly report on Physician Compare aggregate MIPS data, including 
the minimum and maximum MIPS performance category and final scores 
earned by MIPS eligible clinicians, beginning with Year 2 (CY 2018 
data, available starting in late CY 2019), as technically feasible. We 
are also finalizing our proposal to amend Sec.  414.1395 by adding 
paragraph (a)(2) stating that we periodically post on Physician Compare 
aggregate information on the MIPS, including the range of final scores 
for all MIPS eligible clinicians and the range of the performance of 
all MIPS eligible

[[Page 63082]]

clinicians with respect to each performance category.
(4) Quality
    For previous discussions on publicly reporting quality performance 
category information on the Physician Compare website, we refer readers 
to the CY 2018 Quality Payment Program final rule (82 FR 53824) and the 
CY 2019 Quality Payment Program final rule (83 FR 59912).
    Although we did not make any proposals regarding publicly reporting 
quality performance category information, we solicited additional 
comments on adding patient narratives to the Physician Compare website 
in future rulemaking, to the extent consistent with our authority to 
collect such information under section 1848(q) of the Act and our 
authority to include an assessment of patient experience and patient, 
caregiver, and family engagement under section 10331(a)(2)(E) of the 
Affordable Care Act.
    Physician Compare website user testing has repeatedly shown that 
Medicare patients and caregivers greatly desire narrative reviews, 
quotes and testimonials by their peers, and a single overall ``value 
indicator,'' reflective for each MIPS eligible clinician and group, and 
will expect to find such information on the Physician Compare website 
already, based on their experiences with other consumer-oriented 
websites. We currently do not display any narrative patient 
satisfaction information on Physician Compare or any single overall 
value indicator for MIPS eligible clinicians and groups (except MIPS 
performance category and final scores); currently all performance 
information on Physician Compare is publicly reported at the individual 
measure level. Therefore, we solicited comment on the value of and 
considerations for publicly reporting such information to assist 
patients and caregivers with making healthcare decisions, building upon 
the feedback received in response to the CY 2018 Quality Payment 
Program proposed rule (82 FR 30166 through 30167), in which we 
specifically sought comment on publicly reporting responses to five 
open-ended questions that are part of the Agency for Healthcare 
Research and Quality (AHRQ)'s CAHPS Patient Narrative Elicitation 
Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html). While we are not summarizing and responding to 
comments we received in this final rule, we appreciate the responses 
from the commenters and may take them into account as we develop future 
policies for public reporting on Physician Compare.
    We refer readers to section III.K.3.c.(1)(c)(i) of this final rule 
for an additional solicitation for comments to add narrative reviews 
into the CAHPS for MIPS group survey in future rulemaking.
    To be publicly reported on Physician Compare, patient narrative 
data will have to meet our public reporting standards, described at 
Sec.  414.1395(b), and reviewed in consultation with the Physician 
Compare Technical Expert Panel, to determine how and where these data 
would be best reported on Physician Compare. We solicited comment on 
the value of collecting and publicly reporting information from 
narrative questions and other patient-reported outcome measures 
(PROMs), as well as publishing a single ``value indicator'' reflective 
of cost, quality and patient experience and satisfaction with care for 
each MIPS eligible clinician and group, on the Physician Compare 
website and will consider feedback from the patient, caregiver, and 
clinician communities before proposing any policies in future 
rulemaking. We also noted that if we propose to publicly report patient 
narratives in future rulemaking, we will address all related patient 
privacy safeguards consistent with section 10331(c) of the Affordable 
Care Act, which requires that information on physician performance and 
patient experience is not disclosed in a manner that violates the 
Freedom of Information Act (5 U.S.C. 552) or the Privacy Act of 1974 (5 
U.S.C. 552a) with regard to the privacy individually identifiable 
health information, and other applicable law. While we are not 
summarizing and responding to comments we received in this final rule, 
we appreciate the responses from the commenters and may take them into 
account as we develop future policies for public reporting on Physician 
Compare.
(5) Promoting Interoperability
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53827) and the CY 2019 Quality Payment Program final rule (83 FR 
59913) for previously finalized policies related to the Promoting 
Interoperability performance category and Physician Compare.
    Although we did not make any proposals regarding publicly reporting 
Promoting Interoperability category information, we refer readers to 
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 in the Federally Facilitated Exchanges and Health Care 
Providers'' proposed rule (referred to as the Interoperability and 
Patient Access proposed rule) published in the March 4, 2019 Federal 
Register (84 FR 7646 through 7647), where we proposed to include an 
indicator on Physician Compare for the eligible clinicians and groups 
that submit a ``no'' response to any of the three prevention of 
information blocking attestation statements in Sec.  
414.1375(b)(3)(ii)(A) through (C). To report successfully on the 
Promoting Interoperability performance category, in addition to 
satisfying other requirements, a MIPS eligible clinician must submit an 
attestation response of ``yes'' for each of these statements. These 
statements contain specific representations about a clinician's 
implementation and use of CEHRT and are intended to verify that a MIPS 
eligible clinician has not knowingly and willfully taken action (such 
as to disable functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology. In the event that these 
statements are left blank, that is, a ``yes'' or a ``no'' response is 
not submitted, the attestations would be considered incomplete, and we 
would not include an indicator on Physician Compare. We also proposed 
to post this indicator on Physician Compare, either on the profile 
pages or the downloadable database, as feasible and appropriate, 
starting with the 2019 performance period data available for public 
reporting starting in late 2020. We refer readers to the CY 2017 
Quality Payment Program final rule for additional information on these 
attestation statements (81 FR 77028 through 77035).
(6) Facility-Based Clinician Indicator
    As discussed in the CY 2018 Quality Payment Program final rule (82 
FR 53823), we finalized a policy to publicly report the MIPS 
performance category and final scores earned by each MIPS eligible 
clinician on Physician Compare, either on profile pages or in the 
downloadable database. We also finalized that we will make all measures 
under the MIPS quality performance category available for public 
reporting on Physician Compare, either on profile pages or in the 
downloadable database, as technically feasible (82 FR 53824). We will 
use statistical testing and user testing to determine how and where 
measures are reported on Physician Compare. We established at

[[Page 63083]]

Sec.  414.1380(e) a facility-based measurement scoring option under the 
MIPS quality and cost performance categories for clinicians that meet 
certain criteria beginning with the 2019 MIPS performance period/2021 
MIPS payment year. Section 414.1380(e)(1)(ii) provides that the scoring 
methodology applicable for MIPS eligible clinicians scored with 
facility-based measurement is the Total Performance Score methodology 
adopted for the Hospital VBP Program, for the fiscal year for which 
payment begins during the applicable MIPS performance period.
    With this in mind, we have considered how to best display facility-
based MIPS eligible clinician quality and cost information on Physician 
Compare, appreciating our obligation to publicly report certain MIPS 
data for MIPS eligible clinicians and groups. As those clinicians and 
groups scored under the facility-based option are MIPS eligible, we 
will publicly report their performance category and MIPS final scores 
on Physician Compare and considered two options for publicly reporting 
their facility-based measure-level performance information on Physician 
Compare: (a) Displaying hospital-based measure-level performance 
information on Physician Compare profile pages, including scores for 
specific measures and the hospital overall rating; or (b) including an 
indicator showing that the clinician or group was scored using the 
facility-based scoring option with a link from the clinician's 
Physician Compare profile page to the relevant hospital's measure-level 
performance information on Hospital Compare. We believe that a link 
from the clinician's Physician Compare profile page to the relevant 
hospital's performance information on Hospital Compare is preferable 
for several reasons including: Concerns about duplication with Hospital 
Compare, interpretability by Physician Compare website users expecting 
to find clinician-level, rather than hospital-level, information and 
operational feasibility. Additionally, we believe this approach is 
consistent with our consumer testing findings that Medicare patients 
and caregivers find value in information on the relationships 
clinicians and groups may have with facilities where they perform 
services. We note that the facility-based scoring indicator would be 
separate from the hospital affiliation information for admitting 
privileges currently posted on Physician Compare profile pages.
    For these reasons, we proposed to make available for public 
reporting an indicator on the Physician Compare profile page or 
downloadable database that displays if a MIPS eligible clinician is 
scored using facility-based measurement, as specified under Sec.  
414.1380(e)(6)(vi), as technically feasible (84 FR 40824). We also 
proposed to provide a link to facility-based measure-level information, 
as specified under Sec.  414.1380(e)(1)(i), for such MIPS eligible 
clinicians on Hospital Compare, as technically feasible. In addition, 
we proposed to post this indicator on Physician Compare with the 
linkage to Hospital Compare beginning with CY 2019 performance period 
data available for public reporting starting in late CY 2020 and for 
all future years, as technically feasible. We requested comment on this 
proposal.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported making available for public 
reporting an indicator on the Physician Compare profile page or 
downloadable database that displays if a MIPS eligible clinician is 
scored using facility-based measurement and provide a link to facility-
based measure-level information for such MIPS eligible clinicians on 
Hospital Compare, as technically feasible. One commenter supported the 
goals of public reporting information on Physician Compare yet remained 
concerned that Medicare patients and their caregivers may not be able 
to accurately understand and interpret the facility-based indicator. A 
few commenters supported publicly reporting the facility-based 
indicator and recommended providing context and/or CMS providing 
explanatory text mentioning that facility-level measures assess care 
provided at a facility level, rather than a clinician or group level.
    Response: We note that findings from our consumer testing indicate 
that Medicare patients and caregivers find value in information on the 
relationships clinicians and groups may have with facilities where they 
perform services. In addition, we note that with the exception of data 
that must be mandatorily reported on Physician Compare, data included 
on Physician Compare must meet our public reporting standards, as 
described at Sec.  414.1395(b). This means data included on Physician 
Compare public facing profile pages must resonate with website users as 
determined by CMS. We will use statistical testing and user testing, as 
well as consultation with the Physician Compare Technical Expert Panel, 
to determine how and where these data are best reported on Physician 
Compare, including either on profile pages or the downloadable database 
and to provide the appropriate context and explanatory text for 
Medicare patients and caregivers.
    After consideration of the comments, we are finalizing our proposal 
to make available for public reporting an indicator on the Physician 
Compare profile page or downloadable database that displays if a MIPS 
eligible clinician is scored using facility-based measurement, as 
specified under Sec.  414.1380(e)(6)(vi), as technically feasible. We 
are also finalizing our proposal to provide a link to facility-based 
measure-level information, as specified under Sec.  414.1380(e)(1)(i), 
for such MIPS eligible clinicians on Hospital Compare, as technically 
feasible. In addition, we are finalizing our proposal to post this 
indicator on Physician Compare with the linkage to Hospital Compare 
beginning with CY 2019 performance period data available for public 
reporting starting in late CY 2020 and for all future years, as 
technically feasible.
4. Overview of the APM Incentive
a. Overview
    Section 1833(z) of the Act requires that an incentive payment be 
made in years 2019 through 2024 (or, in years after 2025, a different 
PFS update) to Qualifying APM Participants (QPs) for achieving 
threshold levels of participation in Advanced APMs. In the CY 2017 
Quality Payment Program final rule (81 FR 77399 through 77491), we 
finalized the following policies:
     Beginning in payment year 2019, if an eligible clinician 
participated sufficiently in an Advanced APM during the QP Performance 
Period, that eligible clinician may become a QP for the year. Eligible 
clinicians who are QPs are excluded from the MIPS reporting 
requirements for the performance year and payment adjustment for the 
payment year.
     For payment years from 2019 through 2024, QPs receive a 
lump sum incentive payment equal to 5 percent of their prior year's 
estimated aggregate payments for Part B covered professional services. 
Beginning in payment year 2026, QPs receive a differentially higher 
update under the PFS for the year than non-QPs.
     For payment years 2019 and 2020, eligible clinicians may 
become QPs only through participation in Medicare Advanced APMs.
     For payment years 2021 and later, eligible clinicians may 
become QPs through a combination of participation in Medicare Advanced 
APMs and Other Payer Advanced APMs (which we refer

[[Page 63084]]

to as the All-Payer Combination Option).
    In the CY 2018 Quality Payment Program final rule (82 FR 53832 
through 53895), we finalized clarifications, modifications, and 
additional details pertaining to Advanced APMs, QP and Partial QP 
determinations, Other Payer Advanced APMs, Determination of Other Payer 
Advanced APMs, Calculation of All-Payer Combination Option Threshold 
Scores and QP Determinations, and Physician-Focused Payment Models 
(PFPMs).
    In the CY 2019 PFS final rule (83 FR 59915 through 59940), we 
finalized clarifications, modifications, and additional details 
pertaining to use of Certified Electronic Health Record Technology 
(CEHRT), MIPS-comparable quality measures, bearing financial risk for 
monetary losses, the QP Performance Period, Partial QP election to 
report to MIPS, Other Payer Advanced APM criteria, determination of 
Other Payer Advanced APMs, calculation of All-Payer Combination Option 
Threshold Scores and QP determinations under the All-Payer Combination 
Option.
    In this final rule, we discuss policies pertaining to Advanced APMs 
and the All-Payer Combination Option.
b. Terms and Definitions
    As we continue to develop the Quality Payment Program, we have 
identified the need to propose new definitions to go along with the 
previously defined terms. A list of the previously defined terms is 
available in the CY 2017 Quality Payment Program final rule (81 FR 
77537 through 77540), the CY 2018 Quality Payment Program final rule 
(82 FR 53951 through 53952), and in the CY 2019 PFS final rule (83 FR 
60075 through 60076), and reflected in our regulation at Sec.  
414.1305.
    In the CY 2017 Quality Payment Program final rule, we defined the 
term ``Medical Home Model'' and ``Medicaid Medical Home Model.'' Since 
defining these terms in the CY 2017 Quality Payment Program final rule, 
we solicited comment on whether or not to establish a similar 
definition to describe payment arrangements similar to Medical Home 
Models and Medicaid Medical Home Models that are operated by other 
payers (82 FR 30180).
    As discussed in the CY 2020 PFS proposed rule (84 FR 40731), we 
proposed to add the defined term ``Aligned Other Payer Medical Home 
Model'' to Sec.  414.1305, to mean a payment arrangement (not including 
a Medicaid payment arrangement) operated by an other payer that 
formally partners with CMS in a CMS Multi-Payer Model that is a Medical 
Home Model through a written expression of alignment and cooperation, 
such as a memorandum of understanding (MOU), and is determined by CMS 
to have the following characteristics:
     The other payer payment arrangement has a primary care 
focus with participants that primarily include primary care practices 
or multispecialty practices that include primary care physicians and 
practitioners and offer primary care services. For the purposes of this 
provision, primary care focus means the inclusion of specific design 
elements related to eligible clinicians practicing under one or more of 
the following Physician Specialty Codes: 01 General Practice; 08 Family 
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 
Clinical Nurse Specialist; and 97 Physician Assistant;
     Empanelment of each patient to a primary clinician; and
     At least four of the following: Planned coordination of 
chronic and preventive care; Patient access and continuity of care; 
Risk-stratified care management; Coordination of care across the 
medical neighborhood; Patient and caregiver engagement; Shared 
decision-making; and/or Payment arrangements in addition to, or 
substituting for, fee-for-service payments (for example, shared savings 
or population-based payments).
    We are finalizing this proposal. For additional discussion related 
to this definition of Aligned Other Payer Medical Home Model, please 
see section III.K.4.e of this final rule.
c. Advanced APMs
(1) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77408), we 
finalized the criteria that define an Advanced APM based on the 
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An 
Advanced APM is an APM that:
     Requires its participants to use certified EHR technology 
(CEHRT) (81 FR 77409 through 77414);
     Provides for payment for covered professional services 
based on quality measures comparable to measures under the quality 
performance category under MIPS (81 FR 77414 through 77418); and
     Either requires its participating APM Entities to bear 
financial risk for monetary losses that are in excess of a nominal 
amount, or is a Medical Home Model expanded under section 1115A(c) of 
the Act (81 FR 77418 through 77431). We refer to this criterion as the 
financial risk criterion.
    In the CY 2018 Quality Payment Program final rule (82 FR 53832 
through 53895), we finalized clarifications, modifications, and 
additional details pertaining to the Advanced APM criteria, Qualifying 
APM Participant (QP) and Partial QP determinations, the Other Payer 
Advanced APM criteria, Determination of Other Payer Advanced APMs, 
Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations, and we discussed Physician-Focused Payment Models 
(PFPMs).
    In the CY 2019 PFS final rule (83 FR 59915 through 59938), we 
finalized the following:
    Use of CEHRT:
     We revised Sec.  414.1415(a)(i) to specify that an 
Advanced APM must require at least 75 percent of eligible clinicians in 
each APM Entity, or, for APMs in which hospitals are the APM Entities, 
each hospital, use CEHRT as defined at Sec.  414.1305 to document and 
communicate clinical care with patients and other health care 
professionals.
    MIPS-Comparable Quality Measures:
     We revised Sec.  414.1415(b)(2) to clarify, effective 
January 1, 2020, that at least one of the quality measures upon which 
an Advanced APM bases payment must either be finalized on the MIPS 
final list of measures, as described in Sec.  414.1330; endorsed by a 
consensus-based entity; or determined by CMS to be evidenced-based, 
reliable, and valid.
     We revised the requirement at Sec.  414.1415(b)(3) that 
the quality measures upon which an Advanced APM bases payment must 
include at least one outcome measure (unless there are no available or 
applicable outcome measures included in the MIPS final quality measures 
list for the Advanced APM's first QP Performance Period) to provide, 
effective January 1, 2020, that at least one such outcome measure must 
either be finalized on the MIPS final list of measures as described in 
Sec.  414.1330; endorsed by a consensus-based entity; or determined by 
CMS to be evidence-based, reliable, and valid.
    Bearing Financial Risk for Monetary Losses:
     We revised Sec.  414.1415(c)(3)(i)(A) to maintain the 
generally applicable revenue-based nominal amount standard at 8 percent 
of the average estimated total Medicare Parts A and B revenue of all 
providers and suppliers in participating APM Entities for QP 
Performance Periods 2021 through 2024.
    In this section of the final rule, we address policies regarding 
several aspects of the Advanced APM criterion on bearing financial risk 
for monetary losses--specifically our proposal to amend the definition 
of expected

[[Page 63085]]

expenditures, and our request for comment on whether certain items and 
services should be excluded from the capitation rate for our definition 
of full capitation arrangements.
(2) Bearing Financial Risk for Monetary Losses
(a) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77418), we 
divided the discussion of this criterion into two main topics: (1) What 
it means for an APM Entity to bear financial risk for monetary losses 
under an APM (which we refer to as either the generally applicable 
financial risk standard or Medical Home Model financial risk standard); 
and (2) what levels of risk we would consider to be in excess of a 
nominal amount (which we refer to as either the generally applicable 
nominal amount standard or the Medical Home Model nominal amount 
standard).
(b) Expected Expenditures
    In the CY 2017 Quality Payment Program final rule (81 FR 77550), we 
established a definition of expected expenditures at Sec.  
414.1415(c)(5) to mean the beneficiary expenditures for which an APM 
Entity is responsible under an APM. For episode payment models, 
``expected expenditures'' means the episode target price. We 
established this definition of expected expenditures for the purposes 
of applying the Advanced APM financial risk criterion to determine 
whether an APM meets the generally applicable nominal amount standard.
    In the CY 2017 Quality Payment Program proposed rule (81 FR 28305 
through 28309), we proposed to measure three dimensions of risk under 
our generally applicable nominal amount standards: (1) Marginal risk, 
which refers to the percentage of the amount by which actual 
expenditures exceed expected expenditures for which an APM Entity would 
be liable under the APM; (2) minimum loss rate (MLR), which is a 
percentage by which actual expenditures may exceed expected 
expenditures without triggering financial risk; and (3) total potential 
risk, which refers to the maximum potential payment for which an APM 
Entity could be liable under the APM.
    However, based on commenters' concerns regarding technical 
complexity, we did not finalize the marginal risk and MLR components of 
the generally applicable nominal amount standard under the Advanced APM 
criteria (81 FR 77427), but did finalize those additional elements of 
risk under the Other Payer Advanced APM criteria. We stated in the CY 
2017 Quality Payment Program final rule (81 FR 77426) that it is not 
necessary to include the marginal risk and MLR components in the 
generally applicable nominal amount standard for Advanced APMs because 
we are committed to creating Advanced APMs with strong financial risk 
designs that incorporate risk adjustment, benchmark methodologies, 
sufficient stop-loss amounts, and sufficient marginal risk; and that 
all APMs involving financial risk that we operate now or in the future 
would meet or exceed the proposed marginal risk and MLR requirements. 
In the CY 2017 Quality Payment Program proposed rule (81 FR 28306), we 
explained that, to determine whether an APM satisfies the marginal risk 
component of the generally applicable nominal amount standard, we would 
examine the payment required under the APM as a percentage of the 
amount by which actual expenditures exceeded expected expenditures. We 
proposed that we would require this percentage to exceed a required 
marginal risk percentage of 30 percent regardless of the amount by 
which actual expenditures exceeded expected expenditures. We believed 
that any marginal risk below 30 percent could create scenarios in which 
the total risk could be very high, but the average or likely risk for 
an APM Entity would actually be very low (81 FR 28306).
    Our rationale for proposing the marginal risk requirement was that 
the inclusion of the marginal risk requirement would contribute to 
maintaining a more than nominal level of average or likely risk under 
an Advanced APM. We did not finalize the marginal risk requirement 
under the Advanced APM criteria because, as noted above, we believed 
that all Advanced APMs that we operate now or would potentially operate 
in the future would meet or exceed the previously proposed marginal 
risk and MLR requirements, and we believed the total risk portion of 
the nominal amount standard alone was sufficient to ensure that the 
level of average or likely risk under an Advanced APM would actually be 
more than nominal for participants.
    However, based on our experience to date, we became concerned that 
the total risk portion of the benchmark-based nominal amount standard 
as currently constructed may not always be sufficient to ensure that 
the level of average or likely risk under an Advanced APM is actually 
more than nominal for participants. This is because the benchmark-based 
nominal amount standard at Sec.  414.1415(c)(3)(i)(B) is dependent upon 
the definition of expected expenditures codified at Sec.  
414.1415(c)(5), where expected expenditures are defined as the 
beneficiary expenditures for which an APM Entity is responsible under 
an APM, and for episode payment models, the episode target price.
    In our experience implementing the Quality Payment Program and 
considering the diversity of model designs, we came to believe there is 
a need to amend the definition of expected expenditures to further 
ensure there are more-than-nominal levels of average or likely risk 
under an Advanced APM that would meet the generally applicable 
benchmark-based nominal amount standard. For instance, an APM could 
have a sufficient total risk to meet the benchmark-based nominal amount 
standard and a sharing rate that results in adequate marginal risk if 
actual expenditures exceed expected expenditures. However, in that same 
APM, the level of expected expenditures reflected in the APM's 
benchmark or episode target price could be set in a manner that would 
substantially reduce the amount of loss the APM Entity would reasonably 
expect to incur.
    For an APM to meet the generally applicable benchmark-based nominal 
amount standard, we believe there should be not only the potential for 
financial losses based on expenditures in excess of the benchmark as 
provided in Sec.  415.1415(c)(3)(i)(B) of our regulations, but also a 
meaningful possibility that an APM Entity might exceed the benchmark. 
If the benchmark is set in such a way that it is extremely unlikely 
that participants would exceed it, then there is little potential for 
participants to incur financial losses, and the amount of risk is 
essentially illusory.
    Therefore, in the CY 2020 PFS proposed rule (84 FR 40731 through 
40732), we proposed to amend the definition of expected expenditures at 
Sec.  414.1415(c)(5). Specifically, we proposed to define expected 
expenditures for purposes of this section as the beneficiary 
expenditures for which an APM Entity is responsible under an APM. For 
episode payment models, expected expenditures means the episode target 
price. For purposes of assessing financial risk for Advanced APM 
determinations, the expected expenditures under the terms of the APM 
should not exceed the expected Medicare Parts A and B expenditures for 
a participant in the absence of the APM. If expected expenditures under 
the APM exceed the Medicare Parts A and B

[[Page 63086]]

expenditures that an APM Entity would be expected to incur in the 
absence of the APM, such excess expenditures are not considered when 
CMS assesses financial risk under the APM for Advanced APM 
determinations.
    In general, expected expenditures are expressed as a dollar amount, 
and may be derived for a particular APM from national, regional, APM 
Entity-specific, and/or practice-specific historical expenditures 
during a baseline period, or other comparable expenditures. However, in 
making our proposal, we recognized that expected expenditures under an 
APM often are risk-adjusted and trended forward, and may be adjusted to 
account for expenditure changes that are expected to occur as a result 
of APM participation. For the purpose of the definition of expected 
expenditures that we proposed, we would not consider risk adjustments 
to be excess expenditures when comparing expected expenditures under 
the APM to the costs that an APM Entity would be expected to incur in 
the absence of the APM.
    We proposed the amendment to the definition of expected 
expenditures to allow us to ensure that there are more-than-nominal 
amounts of average or likely risk under an APM that meets the generally 
applicable benchmark-based nominal amount standard. We also believed 
that the proposed amended definition of expected expenditures, 
particularly the proposal to not consider excess expenditures when 
determining whether an APM meets the benchmark-based nominal amount 
standard, would provide a more appropriate basis for us to assess 
whether an APM Entity would bear more than a nominal amount of 
financial risk for participants under the generally applicable 
benchmark-based nominal amount standard.
    We also proposed a similar amendment to the definition of expected 
expenditures for the Other Payer Advanced APM generally applicable 
nominal amount standard in section III.I.4.d.(2)(b)(i) of this final 
rule.
    We sought comment on this proposal. The following is a summary of 
the comments we received and our responses.
    Comment: A few commenters opposed the proposed amended definition 
of expected expenditures. These commenters were concerned that 
application of the proposed definition of expected expenditures could 
potentially cause some current Advanced APMs to no longer meet the 
generally applicable nominal amount standard beginning in CY 2020, and 
thus to no longer be Advanced APMs.
    Response: It is possible that application of the amended definition 
could lead to a current Advanced APM no longer meeting the expected 
expenditure nominal amount standard at Sec.  414.1415(c)(3)(i)(B), and 
potentially no longer being an Advanced APM if it does not meet the 
standard at Sec.  414.1415(c)(3)(i)(A). However, all Advanced APMs for 
CY 2019 that satisfy the current generally applicable nominal amount 
standard by meeting the expected expenditure nominal amount standard at 
Sec.  414.1415(c)(3)(i)(B) would continue to do so under the proposed 
amended definition of expected expenditures.
    Comment: A few commenters supported the exclusion of risk 
adjustment when considering what constitutes excess expenditures.
    Response: We thank the commenters for their support of our proposal 
and will not consider risk adjustments to be excess expenditures when 
comparing expected expenditures under the APM to the costs that an APM 
Entity would be expected to incur in the absence of the APM.
    After considering the public comments received, we are finalizing 
our proposal to amend the definition of expected expenditures at Sec.  
414.1415(c)(5) without modification.
(c) Excluded Items and Services Under Full Capitation Arrangements
    In the CY 2017 Quality Payment Program final rule (81 FR 74431), we 
finalized a capitation standard at Sec.  414.1415(c)(6), which provides 
that a full capitation arrangement meets the Advanced APM financial 
risk criterion. We defined a capitation arrangement as a payment 
arrangement in which a per capita or otherwise predetermined payment is 
made under the APM for all items and services for which payment is made 
through the APM furnished to a population of beneficiaries, and no 
settlement is performed to reconcile or share losses incurred or 
savings earned by the APM Entity. We clarified that arrangements 
between CMS and Medicare Advantage Organizations under the Medicare 
Advantage program are not considered capitation arrangements for 
purposes of this definition.
    In the CY 2019 PFS final rule (83 FR 59939), we made technical 
corrections to the Advanced APM financial risk capitation standard at 
Sec.  414.1415(c)(6). These corrections clarified that our financial 
risk capitation standard applies only to full capitation arrangements 
where a per capita or otherwise predetermined payment is made under the 
APM for all items and services furnished to a population of 
beneficiaries during a fixed period of time, and no settlement or 
reconciliation is performed.
    As we began to collect information on other payer payment 
arrangements for purposes of making Other Payer Advanced APM 
determinations, we noticed that some payment arrangements that are 
submitted as capitation arrangements consistent with Sec.  
414.1420(d)(7) include a list of services that have been excluded from 
the capitation rate, such as hospice care, organ transplants, and out-
of-network emergency services. In reviewing these exclusion lists, we 
came to believe that it may be appropriate for CMS to allow certain 
capitation arrangements to be considered ``full'' capitation 
arrangements even if they categorically exclude certain items or 
services from payment through the capitation rate.
    As such, in the CY 2020 PFS proposed rule (84 FR 40827), we 
solicited comments on what categories of items and services might be 
excluded from a capitation arrangement that would still be considered a 
full capitation arrangement. Specifically, we solicited comment on 
whether there are common industry practices to exclude certain 
categories of items and services from capitated payment rates and, if 
so, whether there are common principles or reasons for excluding those 
categories of services. We also sought comment on what percentage of 
the total cost of care such exclusions typically account for under what 
is intended to be a ``full'' global capitation arrangement. We also 
solicited comment on how non-Medicare payers define or prescribe 
certain categories of services that are excluded from global capitation 
payment arrangements.
    We received a few comments on this topic as summarized below.
    Comment: All commenters were supportive of excluding certain items 
and services from the definition of full capitation arrangements for 
the purposes of the advanced APM financial risk criterion. They 
asserted that the exclusion of certain services from the definition of 
full capitation arrangements for purposes of the Advanced APM financial 
risk criterion would provide the ability to tailor different APMs to 
meet the needs of different payers and provider types. The commenters 
also identified specific items and services such as hospice care, 
emergency care, or specific high cost pharmaceuticals.
    Response: We will take these comments into consideration as we 
consider possible proposals in future rulemaking.

[[Page 63087]]

(3) Summary
    In this section, we are finalizing the following policy:
     Expected Expenditures: We are finalizing as proposed an 
amendment to the definition of expected expenditures at Sec.  
414.1415(c)(5) to state that for the purposes of this section, for 
purposes of assessing financial risk for Advanced APM determinations, 
the expected expenditures under the terms of the APM should not exceed 
the expected Medicare Parts A and B expenditures for a participant in 
the absence of the APM. If expected expenditures under the APM exceed 
the Medicare Parts A and B expenditures that an APM Entity would be 
expected to incur in the absence of the APM, such excess expenditures 
are not considered when CMS assesses financial risk under the APM for 
Advanced APM determinations.
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.
(2) Group Determination
(a) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77439 
through 77440), we finalized that QP determinations would generally be 
made at the APM Entity level, but for two exceptions in which we make 
the QP determination at the individual level: (1) Individuals 
participating in multiple Advanced APM Entities, none of which meet the 
QP threshold as a group; and (2) eligible clinicians on an Affiliated 
Practitioner List when that list is used for the QP determination 
because there are no eligible clinicians on a Participation List for 
the APM Entity (81 FR 77439 through 77443). As a result, the QP 
determination for the APM Entity generally applies to all the 
individual eligible clinicians who are identified as part of the APM 
Entity participating in an Advanced APM. 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 to their NPIs, for the relevant payment year. The QP 
determination calculations are aggregated using data for all eligible 
clinicians participating in the APM Entity on a determination date 
during the QP Performance Period.
(b) Application of Partial QP Status
    In the CY 2017 Quality Payment Program final rule (81 FR 77440), we 
stated that we would apply QP status at the NPI level instead of at the 
TIN/NPI level. We noted that an individual clinician identified by an 
NPI may have reassigned billing rights to multiple TINs, resulting in 
multiple TIN/NPI combinations being associated with one individual 
clinician (NPI). We also stated that if QP status was only applied to 
one of an individual clinician's multiple TIN/NPI combinations, an 
eligible clinician who is a QP for only one TIN/NPI combination might 
still have to report under MIPS for another TIN/NPI combination. Under 
that approach, the APM Incentive Payment would be based on only a 
fraction of the clinician's covered professional services instead of, 
as we believe is the most logical reading of the statute, all those 
services furnished by the individual clinician, as represented by an 
NPI. Therefore, we expressed our concern with applying QP status only 
to a specific TIN/NPI combination as it would not effectuate the goals 
of the APM incentive path of the Quality Payment Program to reward 
individual clinicians for their commitment to Advanced APM 
participation.
    For Partial QPs, we currently apply Partial QP status at the NPI 
level across all TIN/NPI combinations as we have for QP status. 
However, in the CY 2020 PFS proposed rule (84 FR 40827 through 40828), 
we explained that for eligible clinicians who are Partial QPs, based on 
our experience implementing the Quality Payment Program and feedback 
from stakeholders, we believe it would be more appropriate to apply any 
exclusion from MIPS reporting requirements and payment adjustments only 
to TIN/NPI combinations affiliated with that TIN. Under our current 
policy, Partial QPs are excluded from the MIPS reporting requirements 
and payment adjustment based on an election made at the APM Entity or 
individual eligible clinician level, and this exclusion is currently 
applied at the NPI level across all of their TIN/NPI combinations. 
Partial QPs do not receive an APM Incentive Payment; rather, the APM 
Entity in which the Partial QPs participated is permitted to choose 
whether to be subject to the MIPS reporting requirements and payment 
adjustments. As such, while an eligible clinician who is a Partial QP 
might wish to be excluded from MIPS reporting requirements and payment 
adjustments with respect to the TIN/NPI combination that relates to the 
APM Entity in the Advanced APM through which they achieved Partial QP 
status, that same eligible clinician might wish to report to MIPS and 
receive a MIPS payment adjustment with respect to other TIN/NPI 
combinations (for example, because they anticipate receiving an upward 
MIPS payment adjustment).
    Therefore, we proposed that beginning with the 2020 QP Performance 
Period, Partial QP status would apply only to the TIN/NPI 
combination(s) through which an individual eligible clinician attains 
Partial QP status, and to amend our regulation by adding Sec.  
414.1425(d)(5) to reflect this change. This means that any MIPS 
election for a Partial QP would only apply to the TIN/NPI combination 
through which Partial QP status is attained, so that an eligible 
clinician who is a Partial QP for only one TIN/NPI combination may 
still be a MIPS eligible clinician, and subject to the MIPS reporting 
requirements and payment adjustment, for other TIN/NPI combinations.
    We received public comments on our proposal. We thank the 
commenters for the public comments on this proposal. After including 
our proposal in the CY 2020 PFS proposed rule (84 FR 40827 through 
40828), we further investigated the system requirements to implement 
the proposed policy. Our current data systems apply Partial QP 
assignment to NPIs, rather than to TIN/NPI combinations, and we 
determined that we would not be able to modify our system to implement 
the proposed policy, if finalized, for the 2020 QP Performance Period. 
After taking into account our operational limitations, we are not 
finalizing the proposed policy. We will review and consider the public 
comments received, continue to seek stakeholder feedback and, if 
appropriate, proposed policies pertaining to Partial QPs in future 
rulemaking.
(3) QP Performance Period
(a) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77446 
through 77447), we finalized for the timing of QP determinations that a 
QP Performance Period runs from January 1 through August 31 of the 
calendar year that is 2 years prior to the payment year. We finalized 
that during the QP Performance Period, we will make QP determinations 
at three separate snapshot dates (March 31, June 30, and August 31), 
each of which will be a final determination for the eligible clinicians

[[Page 63088]]

who are determined to be QPs. The QP Performance Period and the three 
separate QP determinations apply similarly for both the group of 
eligible clinicians on a Participation List and the individual eligible 
clinicians on an Affiliated Practitioner List.
(b) APM Entity Termination
    In the CY 2017 Quality Payment Program final rule, we finalized at 
Sec. Sec.  414.1425(c)(5) and 414.1425(d)(3) that an eligible clinician 
is not a QP or Partial QP for a year if the APM Entity group 
voluntarily or involuntarily terminates from an Advanced APM before the 
end of the QP Performance Period (81 FR 77446 through 77447). We also 
finalized at Sec. Sec.  414.1425(c)(6) and 414.1425(d)(4) that an 
eligible clinician is not a QP or Partial QP for a year if one or more 
of the APM Entities in which the eligible clinician participates 
voluntarily or involuntarily terminates from the Advanced APM before 
the end of the QP Performance Period, and the eligible clinician does 
not achieve a Threshold Score that meets or exceeds the QP or Partial 
QP payment amount threshold or QP or Partial QP patient count threshold 
based on participation in the remaining non-terminating APM Entities 
(81 FR 77446 through 77447). We finalized these policies in part to 
ensure that APM Entities and eligible clinicians who achieve QP or 
Partial QP status during a QP Performance Period actually assume a more 
than a nominal amount of financial risk, as is necessary for Advanced 
APMs, for at least the full QP performance period from January 1 
through August 31, if not the entire performance year under the 
Advanced APM.
    Currently, under the terms of some Advanced APMs, APM Entities can 
terminate their participation in the Advanced APM while bearing no 
financial risk after the end of the QP Performance Period for the year 
(August 31). Under our current regulation, an APM Entity's termination 
after that date would not affect the QP or Partial QP status of all 
eligible clinicians in the APM Entity. In the CY 2020 PFS proposed rule 
(84 FR 40828), we acknowledged that it may be appropriate for an 
Advanced APM to allow participating APM Entities to terminate without 
bearing financial risk for that performance period under the terms of 
the Advanced APM itself, including allowing such terminations to occur 
after the end of the QP Performance Period (August 31). However, we 
noted that allowing those eligible clinicians to retain their QP or 
Partial QP status without having borne financial risk under the 
Advanced APM through which they attained QP or Partial QP status is not 
aligned with the structure and principles of the Quality Payment 
Program, which is designed to reward those APM Entities and eligible 
clinicians for meaningfully assuming more than a nominal amount of 
financial risk, as required by the Advanced APM criteria. A critical 
aspect of Advanced APMs is that participants must bear more than a 
nominal amount of financial risk under the model. If an APM Entity 
terminates participation in the Advanced APM without financial 
accountability, the APM Entity has not yet borne more than a nominal 
amount of financial risk. As such, we do not believe it is appropriate 
for eligible clinicians in an APM Entity that terminates after QP 
determinations are made, but before bearing more than a nominal amount 
of financial risk, to retain any status as QPs or Partial QPs.
    Therefore, regarding QP status, in the CY 2020 PFS proposed rule 
(84 FR 40827 through 40828), we proposed to revise our regulation at 
Sec.  414.1425(c)(5) and to add Sec.  414.1425(c)(5)(i) and (ii) to 
state, beginning with the 2020 QP Performance Period, that an eligible 
clinician is not a QP for a year if: (1) The APM Entity voluntarily or 
involuntarily terminates from an Advanced APM before the end of the QP 
Performance Period; (2) or the APM Entity voluntarily or involuntarily 
terminates from an Advanced APM at a date on which the APM Entity would 
not bear financial risk under the terms of the Advanced APM for the 
year in which the QP Performance Period occurs. In addition, we 
proposed to revise our regulation at Sec.  414.1425(c)(6) and add 
Sec. Sec.  414.1425(c)(6)(i) and (ii) to state, beginning with the 2020 
QP Performance Period, that an eligible clinician is not a QP for a 
year if: (1) One or more of the APM Entities in which the eligible 
clinician participates voluntarily or involuntarily terminates from the 
Advanced APM before the end of the QP Performance Period, and the 
eligible clinician does not achieve a Threshold Score that meets or 
exceeds the QP payment amount threshold or QP patient count threshold 
based on participation in the remaining non-terminating APM Entities; 
or (2) one or more of the APM Entities in which the eligible clinician 
participates voluntarily or involuntarily terminates from the Advanced 
APM at a date on which the APM Entity would not bear financial risk 
under the terms of the Advanced APM for the year in which the QP 
Performance Period occurs, and the eligible clinician does not achieve 
a Threshold Score that meets or exceeds the QP payment amount threshold 
or QP patient count threshold based on participation in the remaining 
non-terminating APM Entities.
    Regarding Partial QP status, in the CY 2020 PFS proposed rule (84 
FR 40828), we also proposed to revise Sec.  414.1425(d)(3) and add 
Sec. Sec.  414.1425(d)(3)(i) and (ii), to state, beginning with the 
2020 QP Performance Period, that an eligible clinician is not a Partial 
QP for a year if: (1) The APM Entity voluntarily or involuntarily 
terminates from an Advanced APM before the end of the QP Performance 
Period; or (2) the APM Entity voluntarily or involuntarily terminates 
from an Advanced APM at a date on which the APM Entity would not bear 
financial risk under the terms of the Advanced APM for the year in 
which the QP Performance Period occurs. We also proposed to revise 
Sec.  414.1425(d)(4) and add Sec. Sec.  414.1425(d)(4)(i) and (ii), to 
state, beginning with the 2020 QP Performance Period, that an eligible 
clinician is not a Partial QP for a year if: (1) One or more of the APM 
Entities in which the eligible clinician participates voluntarily or 
involuntarily terminates from the Advanced APM before the end of the QP 
Performance Period, and the eligible clinician does not achieve a 
Threshold Score that meets or exceeds the Partial QP payment amount 
threshold or Partial QP patient count threshold based on participation 
in the remaining non-terminating APM Entities; or (2) one or more of 
the APM Entities in which the eligible clinician participates 
voluntarily or involuntarily terminates from the Advanced APM at a date 
on which the APM Entity would not bear financial risk under the terms 
of the Advanced APM for the year in which the QP Performance Period 
occurs, and the eligible clinician does not achieve a Threshold Score 
that meets or exceeds the Partial QP payment amount threshold or 
Partial QP patient count threshold based on participation in the 
remaining non-terminating APM Entities. We believe these amendments and 
additions account for the scenarios in which an APM Entity could 
terminate from an Advanced APM at a date on which the APM Entity would 
not incur any financial accountability under the terms of the Advanced 
APM.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters opposed our proposal. A few of these 
commenters agreed that QPs in APM Entities that terminated their

[[Page 63089]]

participation in an Advanced APM without bearing financial risk should 
not receive the APM Incentive Payment. These commenters expressed 
concern that there would be a very short window of time between the 
termination from the Advanced APM and the reporting deadlines required 
for reporting to MIPS such that there would not be enough time to 
prepare for MIPS reporting for that year.
    Response: We have consistently maintained that participants in 
Advanced APMs may be considered MIPS eligible clinicians and that they 
may need to report to MIPS, depending on whether they attain QP or 
Partial QP status. Eligible clinicians who participate with one or more 
APM Entities in Advanced APMs are MIPS eligible clinicians unless they 
are excluded from MIPS based on QP or Partial QP status, or some other 
ground. As such, they are potentially subject to the MIPS reporting 
requirements and payment adjustment throughout the performance year. We 
encourage individual eligible clinicians who are Advanced APM 
participants to check their QP or Partial QP status throughout the year 
online, and to communicate with their APM Entities in case there are 
any changes at the APM Entity Level that may affect whether they will 
need to report to MIPS.
    Comment: One commenter suggested that for involuntary terminations, 
of an APM Entity's participation in an Advanced APM, affected eligible 
clinicians should retain their QP or Partial QP status based on their 
significant investment and participation in the Advanced APM.
    Response: We acknowledge that participation in Advanced APMs is a 
significant investment. However, we also recognize that opportunities 
exist to take advantage of the program. Whether termination is 
voluntary or involuntary, we have a duty to ensure that the benefits of 
QP or Partial QP status, including the APM Incentive Payment and any 
exemption from the MIPS reporting requirements and payment adjustment 
is based on fully meeting the elements of Advanced APM participation, 
including the requirement that an APM Entity in an Advanced APM is 
actually required to bear a more than nominal amount of financial risk 
during the relevant QP Performance Period.
    We are finalizing our proposed policies without modification that 
an eligible clinician is not a QP or a Partial QP for the year through 
an APM Entity that voluntarily or involuntarily terminates from an 
Advanced APM at a date on which the APM Entity will not bear financial 
risk under the terms of the Advanced APM for the year in which the QP 
Performance Period occurs.
(4) Summary
    In this section, we are taking the following actions on our 
proposed policies:
     Application of Partial QP Status: We are not finalizing 
our proposal that, beginning with the 2020 QP Performance Period, 
Partial QP status will apply only to the TIN/NPI combination(s) through 
which an individual eligible clinician attains Partial QP status.
     APM Entity Termination: We are finalizing without 
modification the proposal to revise our regulations at Sec. Sec.  
414.1425(c)(5) and (6) and (d)(3) and (4) to state that an eligible 
clinician is not a QP or a Partial QP for the year when an APM Entity 
terminates voluntarily or involuntarily from an Advanced APM at a date 
on which the APM Entity will not bear financial risk under the terms of 
the Advanced APM for the year in which the QP Performance Period 
occurs.
e. All-Payer Combination Option
(1) Overview
    Section 1833(z)(2)(B)(ii) of the Act requires that beginning in 
payment year 2021, in addition to the Medicare Option, eligible 
clinicians may become QPs through the Combination All-Payer and 
Medicare Payment Threshold Option, which we refer to as the All-Payer 
Combination Option. In the CY 2017 Quality Payment Program final rule 
(81 FR 77459), we finalized our overall approach to the All-Payer 
Combination Option. The Medicare Option focuses on participation in 
Advanced APMs, and we make QP determinations under this option based on 
Medicare Part B covered professional services attributable to services 
furnished through an APM Entity. The All-Payer Combination Option does 
not replace or supersede the Medicare Option; instead, it will allow 
eligible clinicians to become QPs by meeting the QP thresholds through 
a pair of calculations that assess a combination of both Medicare Part 
B covered professional services furnished through Advanced APMs and 
services furnished through payment arrangements offered by payers other 
than Medicare that CMS has determined meet the criteria to be Other 
Payer Advanced APMs. We finalized that beginning in payment year 2021, 
we will conduct QP determinations sequentially so that the Medicare 
Option is applied before the All-Payer Combination Option (81 FR 
77438). The All-Payer Combination Option encourages eligible clinicians 
to participate in payment arrangements that satisfy the Other Payer 
Advanced APM criteria with payers other than Medicare. It also 
encourages sustained participation in Advanced APMs across multiple 
payers.
    We finalized that the QP determinations under the All-Payer 
Combination Option are based on payment amounts or patient counts as 
illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017 
Quality Payment Program final rule (81 FR 77460 through 77461), 
presented in this final rule as Tables 64A and 64B and Figures 2 and 3. 
We also finalized that, in making QP determinations with respect to an 
eligible clinician, we will use the Threshold Score (that is, based on 
payment amount or patient count) that is most advantageous to the 
eligible clinician toward achieving QP status, or if QP status is not 
achieved, Partial QP status, for the year (81 FR 77475).

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    Unlike the Medicare Option where we have access to all of the 
information necessary to determine whether an APM meets the criteria to 
be an Advanced APM, we cannot determine whether payment arrangements 
offered by other payers meet the criteria to be an Other Payer Advanced 
APM without receiving information about the payment arrangements from 
an external source. Similarly, we do not have the necessary payment 
amount and patient count information to determine under the All-Payer 
Combination Option whether an eligible clinician meets the payment 
amount or patient count threshold to be a QP without receiving certain 
information from an external source.
    In the CY 2018 Quality Payment Program final rule (82 FR 53844 
through 53890), we established additional policies to implement the 
All-Payer Combination Option and finalized certain modifications to our 
previously finalized policies. A detailed summary of those policies can 
be found at 82 FR 53874 through 53876 and 53890 through 53891.
    In the CY 2019 PFS final rule (83 FR 59926 through 59938), we 
finalized the following:
Other Payer Advanced APM Criteria
     We changed the CEHRT use criterion so that in order to 
qualify as an Other Payer Advanced APM as of January 1, 2020, the other 
payer arrangement must require at least 75 percent of participating 
eligible clinicians in each participating APM Entity group, or each 
hospital if hospitals are the APM Entities, use CEHRT to document and 
communicate clinical care.
     We allowed payers and eligible clinicians to submit 
evidence as part of their request for an Other Payer Advanced APM 
determination that CEHRT is used by the requisite percentage of 
eligible clinicians participating in the payment arrangement (50 
percent for 2019, and 75 percent for 2020 and beyond) to document and 
communicate clinical care; and specified that we will use such evidence 
to demonstrate the level of CEHRT use, whether or not CEHRT use is 
explicitly required under the terms of the payment arrangement.
     We amended Sec.  414.1420(c)(2), effective January 1, 
2020, to provide that at least one of the quality measures used in the 
payment arrangement in paragraph (c)(1) of this regulation must be:
    ++ Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    ++ Endorsed by a consensus-based entity; or
    ++ Determined by CMS to be evidenced-based, reliable, and valid.
     We revised Sec.  414.1420(c)(3) to require that, effective 
January 1, 2020, unless there is no applicable outcome measure on the 
MIPS quality measure list, that to be an Other Payer Advanced APM, an 
other payer arrangement must use an outcome measure, that must be:
    ++ Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    ++ Endorsed by a consensus-based entity; or
    ++ Determined by CMS to be evidenced-based, reliable, and valid.
     We also revised our regulation at Sec.  414.1420(c)(3)(i) 
to provide that, for payment arrangements determined to be Other Payer 
Advanced APMs for the 2019 performance year that did not include an 
outcome measure that is evidence-based, reliable, and valid, and that 
are resubmitted for an Other Payer Advanced APM determination for the 
2020 performance year (whether for a single year, or for a multi-year 
determination as finalized in CY 2019 PFS final rule (83 FR 55931 
through 55932), we would continue to apply the previous requirements 
for purposes of those determinations. This revision also applies to 
payment arrangements in existence prior to the 2020 performance year 
that are submitted for determination to be Other Payer Advanced APMs 
for the 2020 performance year and later.
     We revised Sec.  414.1420(d)(3)(i) to maintain the 
generally applicable revenue-based nominal amount standard at 8 percent 
of the total combined revenues from the payer of providers and 
suppliers in participating APM Entities for QP Performance Periods 2021 
through 2024.
Determination of Other Payer Advanced APMs
     We finalized details regarding the Payer Initiated Process 
for Remaining Other Payers. To the extent possible, we aligned the 
Payer Initiated Process for Remaining Other Payers with the previously 
finalized Payer Initiated Process for Medicaid, Medicare Health Plans, 
and CMS Multi-Payer Models.
     We eliminated the Payer Initiated Process that is 
specifically for CMS Multi-Payer Models. These payers will be able to 
submit their arrangements through the Payer Initiated Process for 
Remaining Other Payers as finalized in the CY 2019 PFS final rule (82 
FR 59933 through 59935), or through the Medicaid or Medicare Health 
Plan

[[Page 63092]]

payment arrangement submission processes, and no longer need a special 
pathway.
Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
     We added a third alternative to allow requests for QP 
determinations at the TIN level in instances where all clinicians who 
reassigned billing rights under the TIN participate in a single APM 
Entity. We modified our regulation at Sec.  414.1440(d) by adding a 
third alternative to allow QP determinations at the TIN level in 
instances where all clinicians who have reassigned billing under the 
TIN participate in a single APM Entity, as well as to assess QP status 
at the most advantageous level for each eligible clinician.
     We clarified that, in making QP determinations using the 
All-Payer Combination Option, eligible clinicians may meet the minimum 
Medicare threshold using one method, and the All-Payer threshold using 
the same or a different method. We codified this clarification by 
amending Sec.  414.1440(d)(1).
     We extended the weighting methodology that is used to 
ensure that an eligible clinician does not receive a lower score on the 
Medicare portion of their all-payer calculation under the All-Payer 
Combination Option than the Medicare Threshold Score they received at 
the APM Entity level in order to apply a similar policy to the proposed 
TIN level Medicare Threshold Scores.
    In this section of the final rule, we are finalizing our proposed 
definition of the term Aligned Other Payer Medical Home Model. We are 
also finalizing our proposals regarding bearing financial risk for 
monetary losses, specifically the Medicaid Medical Home Model financial 
risk standard and our proposed amendment to the definition of expected 
expenditures. We also discuss our request for comment on whether 
certain items and services could be excluded from the capitation rate 
consistent with our definition of full capitation arrangements.
(2) Aligned Other Payer Medical Home Models
(a) Definition
    As we explained when finalizing the definitions of Medical Home 
Model and Medicaid Medical Home Model in the CY 2017 Quality Payment 
Program final rule, MACRA does not define ``medical homes,'' but 
sections 1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB), 
1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act 
make medical homes an instrumental piece of the law (81 FR 77403). The 
terms Medical Home Model and Medicaid Medical Home Model are limited to 
Medicare and Medicaid payment arrangements, respectively, and do not 
include other payer payment arrangements.
    As we discuss in section III.I.4.b. of this final rule, in the CY 
2020 PFS proposed rule (84 FR 40832), we proposed to amend Sec.  
414.1305 to add the defined term ``Aligned Other Payer Medical Home 
Model'', which would mean an aligned other payer payment arrangement 
(not including a Medicaid payment arrangement) operated by an other 
payer formally partnering in a CMS Multi-Payer Model that is a Medical 
Home Model through a written expression of alignment and cooperation 
with CMS, such as a memorandum of understanding (MOU), and is 
determined by CMS to have the following characteristics:
     The other payer payment arrangement has a primary care 
focus with participants that primarily include primary care practices 
or multispecialty practices that include primary care physicians and 
practitioners and offer primary care services. For the purposes of this 
provision, primary care focus means the inclusion of specific design 
elements related to eligible clinicians practicing under one or more of 
the following Physician Specialty Codes: 01 General Practice; 08 Family 
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 
Clinical Nurse Specialist; and 97 Physician Assistant;
     Empanelment of each patient to a primary clinician; and
     At least four of the following: Planned coordination of 
chronic and preventive care; Patient access and continuity of care; 
risk-stratified care management; coordination of care across the 
medical neighborhood; patient and caregiver engagement; shared 
decision-making; and/or payment arrangements in addition to, or 
substituting for, fee-for-service payments (for example, shared savings 
or population-based payments).
    The proposed definition of Aligned Other Payer Medical Home Model 
includes the same characteristics as the definitions of Medical Home 
Model and Medicaid Medical Home Model, but it applies to other payer 
payment arrangements. In the CY 2020 PFS proposed rule (84 FR 40832), 
we explained that we believe that structuring this definition in this 
manner is appropriate because we recognize that there may be medical 
homes that are operated by other payers that may be appropriately 
considered medical home models under the All-Payer Combination Option.
    We proposed to exclude Medicaid payment arrangements from this 
definition of Aligned Other Payer Medical Home Model because we have 
previously defined the term Medicaid Medical Home Model at Sec.  
414.1305 and we believe it is important to distinguish Medicaid payment 
arrangements from other payment arrangements, given the requirements in 
sections 1833(z)(2)(B)(ii)(I)(bb) and 1833(z)(3)(B)(ii)(I)(bb) of the 
Act requiring us to consider whether there is a medical home or 
alternative payment model under the Title XIX state plan in each state 
when making QP determinations using the All-Payer Combination Option.
    For purposes of the Aligned Other Payer Medical Home Model 
definition, for an arrangement to be aligned, we explained that we mean 
through a written expression of alignment and cooperation with CMS, 
such as an MOU. CMS Multi-Payer Models require alignment across the 
different payers, and a written expression reflects the fact that each 
arrangement has been reviewed by CMS and CMS has determined that the 
other payer payment arrangement is aligned with a CMS Multi-Payer Model 
that is a Medical Home Model. We proposed to limit this Aligned Other 
Payer Medical Home Model definition to other payer payment arrangements 
that are aligned with CMS Multi-Payer Models that are Medical Home 
Models because we can be assured that the structure of these 
arrangements is similar to the Medical Home Models and Medicaid Medical 
Home Models for which we have already made a similar determination. 
Based on our experience to date, we anticipate that participants in 
these arrangements may generally be more limited in their ability to 
bear financial risk than other entities because they may be smaller and 
predominantly include primary care practitioners, whose revenues are a 
smaller fraction of the patients' total cost of care than those of 
other eligible clinicians. At the same time, we do not believe that 
participants in all medical homes, regardless of payer, face the same 
limitations on their ability to bear financial risk. We explained that 
we believe that some participants may have different organizational or 
financial circumstances that allow them to bear greater such risk. We 
believe that applying the proposed Aligned Other Payer Medical Home 
Model definition to all other payer payment arrangements

[[Page 63093]]

would create potential new opportunities for gaming in commercial 
settings where we do not have control over the design of such models. 
However, we believe that payment arrangements that have been aligned 
and are similar to a Medicaid Home Model, where we have already put in 
place policies to control against gaming, would be similarly 
constrained.
    In addition, we have acquired additional understanding of some 
other payer payment arrangements after one year of experience with the 
Payer Initiated Process, which included some arrangements that are 
aligned with CMS Multi-Payer Models that are Medical Home Models.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported our proposed definition of 
the term Aligned Other Payer Medical Home Model.
    Response: We appreciate the support for adding the defined term 
Aligned Other Payer Medical Home Model.
    Comment: Some commenters expressed concern that the proposed 
definition of Aligned Other Payer Medical Home Models would include 
only those other payer payment arrangements that meet the definition as 
proposed, requiring alignment with CMS Multi-Payer Models, and not 
including other payer payment arrangements that are not aligned with a 
CMS Multi-Payer Model. These commenters recommend that the definition 
be broadened to include any other payer payment arrangement that would 
not be formally partnering with a CMS Multi-Payer Model, but would 
otherwise meet the proposed definition. These commenters stated that 
CMS is being too prescriptive, and limiting the definition would 
unnecessarily limit opportunities for participation by eligible 
clinicians in other payer payment arrangements that would have all of 
the characteristics of medical home models. Some of these same 
commenters stated that, while they understood CMS' concern with 
potential gaming related to payment arrangements that have lower 
nominal risk thresholds, they believe CMS is already collecting 
sufficient information to allow for monitoring of other payer payment 
arrangements such that limiting the definition to only include other 
payer arrangements that are aligned with CMS Multi-Payer Models is not 
necessary. One commenter stated that CMS has generally attempted to 
align Advanced APM and Other Advanced APM policies, and asserted that 
approach should carry over to inclusion of all commercial payment 
arrangements that meet the Medical Home Model definition.
    Response: We continue to be concerned about the potential for 
gaming associated with payment arrangements where we do not have any 
control over the design. We necessarily rely on a limited set of self-
reported information, and as a result, we have a limited capability to 
monitor for, or respond effectively to, potential gaming. We also 
believe our cautious approach is appropriate given that the All-Payer 
Combination Option has only been available since the 2019 QP 
Performance Period and we are still gathering additional information 
and experience. We acknowledge that limiting the definition of Aligned 
Other Payer Medical Home Model to only include other payer payment 
arrangements that meet the proposed definition, including alignment 
with a CMS Multi-Payer Model, may result in some other payer payment 
arrangements not being considered an Aligned Other Payer Medical Home 
Model even though they may be structurally similar to Medical Home 
Models and Medicaid Medical Home Models. However, as we discussed in 
the CY 2020 PFS proposed rule (84 FR 40833), we continue to believe 
that finalizing the definition as proposed is the best approach for 
expanding innovation while ensuring program integrity.
    After considering public comments, we are finalizing without 
modification our proposal to amend Sec.  414.1305 to define the term 
``Aligned Other Payer Medical Home Model''.
(b) Other Payer Advanced APM Criteria for Aligned Other Payer Medical 
Home Models
    As defined in Sec.  414.1305, an Other Payer Advanced APM is an 
other payer arrangement that meets the Other Payer Advanced APM 
criteria set forth in Sec.  414.1420. Accordingly, in the CY 2020 PFS 
proposed rule (84 FR 40833), we proposed that the CEHRT criterion 
codified in Sec.  414.1420(b) and the use of quality measures criterion 
codified in Sec.  414.1420(c) will apply to any Aligned Other Payer 
Medical Home Model for which we will make an Other Payer Advanced APM 
determination. Further, we proposed to revise Sec.  414.1420(d)(8) to 
require Aligned Other Payer Medical Home Models to comply with the 50 
eligible clinician limit to align with the requirements that apply to 
Medical Home Models and Medicaid Medical Home Models.
    Regarding the applicable financial risk and nominal amount 
standards, consistent with the financial risk and nominal amount 
standards applicable to Medical Home Models and Medicaid Medical Home 
Models, we proposed that the Aligned Other Payer Medical Home Model 
financial risk and nominal amount standards will be the same as the 
Medicaid Medical Home Model financial risk and nominal amount 
standards. We proposed corresponding amendments to Sec.  414.1420(d)(2) 
and (4) so that those sections would reflect the Medicaid Medical Home 
Model and Aligned Other Payer Medical Home Model financial risk 
standard, and Medicaid Medical Home Model and Aligned Other Payer 
Medical Home Model nominal amount standard, respectively. We proposed 
this policy consistent with our principle of aligning the Advanced APM 
criteria and Other Payer Advanced APM criteria to the extent feasible 
and appropriate, as well as our continued belief that organization size 
is a proxy for potential risk-bearing capacity.
    We did not receive any public comments on our proposal that the 
CEHRT criterion in Sec.  414.1420(b) and the use of quality measures 
criterion in Sec.  414.1420(c) will apply to any Aligned Other Payer 
Medical Home Model for which we will make an Other Payer Advanced APM 
determination. We discuss public comments regarding our proposal to 
apply the 50 eligible clinician limit to Aligned Other Payer Medical 
Home Models in section III.K.4.e.(3)(b) of this final rule.
    We are finalizing without modification our proposal that the CEHRT 
criterion codified in Sec.  414.1420(b) and the use of quality measures 
criterion codified in Sec.  414.1420(c) will apply to any Aligned Other 
Payer Medical Home Model for which we will make an Other Payer Advanced 
APM determination.
(c) Determination of Aligned Other Payer Medical Home Model and Other 
Payer Advanced APM Status
    In the CY 2020 PFS proposed rule (84 FR 40833), we proposed that 
payers may submit other payer arrangements for CMS determination as 
Aligned Other Payer Medical Home Models and Other Payer Advanced APMs, 
as applicable, through the Payer Initiated Process, to be effective 
January 1, 2020, for applications for the 2021 QP Performance Period. 
In the CY 2019 PFS final rule, we finalized a process for Remaining 
Other Payers to submit other payer arrangements for CMS determination 
of Other Payer Advanced APM status (83 FR 59934 through 59935). Other 
payers will be required to submit their other payer arrangements

[[Page 63094]]

for CMS determination as Aligned Other Payer Medical Home Models and 
Other Payer Advanced APMs, as applicable, using this Remaining Other 
Payer process.
    We also proposed that APM Entities and eligible clinicians can 
submit other payer arrangements for CMS to determine whether they are 
Aligned Other Payer Medical Home Models and Other Payer Advanced APMs, 
as applicable, through the Eligible Clinician Initiated Process.
    We received no public comments on these proposals. We are 
finalizing our proposal without modification that payers may submit 
other payer arrangements for CMS determination as Aligned Other Payer 
Medical Home Models and Other Payer Advanced APMs, as applicable, 
through the Payer Initiated Process. This policy will be effective 
January 1, 2020, beginning with applications submitted for the 2021 QP 
Performance Period. Other payers will submit their other payer 
arrangements for CMS determination as Aligned Other Payer Medical Home 
Models and Other Payer Advanced APMs, as applicable, using this 
Remaining Other Payer process. We are also finalizing our proposal 
without modification that APM Entities and eligible clinicians can 
submit other payer arrangements for CMS to determine whether they are 
Aligned Other Payer Medical Home Models and Other Payer Advanced APMs, 
as applicable, through the Eligible Clinician Initiated Process.
(3) Bearing Financial Risk for Monetary Losses
(a) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77466), we 
divided the discussion of this criterion into two main topics: (1) What 
it means for an APM Entity to bear financial risk if actual aggregate 
expenditures exceed expected aggregate expenditures under a payment 
arrangement (which we refer to as either the generally applicable 
financial risk standard or Medicaid Medical Home Model financial risk 
standard); and (2) what levels of risk we would consider to be in 
excess of a nominal amount (which we refer to as either the generally 
applicable nominal amount standard or the Medicaid Medical Home Model 
nominal amount standard).
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for a Medicaid Medical Home Model to be an Other Payer Advanced 
APM, if the APM Entity's actual aggregate expenditures exceed expected 
aggregate expenditures, the Medicaid Medical Home Model must:
     Withhold payment for services in the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians;
     Require direct payment by the APM Entity to the Medicaid 
program; or
     Require the APM Entity to lose the right to all or part of 
an otherwise guaranteed payment or payments.
    We based this standard on our belief that Medicaid Medical Home 
Models are unique types of Medicaid APMs because they are identified 
and treated differently under the statute. We believe it is appropriate 
to establish a unique standard for bearing financial risk that reflects 
these statutory differences and remains consistent with the statutory 
scheme, which is to provide incentives for participation by eligible 
clinicians in Advanced APMs (81 FR 77467 through 77468).
    In addition, to be an Other Payer Advanced APM, a Medicaid Medical 
Home Model must require that the total annual amount that an APM Entity 
potentially owes or foregoes under the Medicaid Medical Home Model must 
be at least:
     For QP Performance Period 2019, 3 percent of the APM 
Entity's total revenue under the payer.
     For QP Performance Period 2020, 4 percent of the APM 
Entity's total revenue under the payer.
     For QP Performance Period 2021 and later, 5 percent of the 
APM Entity's total revenue under the payer.
(b) Aligned Other Payer Medical Home Model Financial Risk and Nominal 
Amount Standards
    Neither the current Medical Home Model financial risk and nominal 
amount standards nor the Medicaid Medical Home Model financial risk and 
nominal amount standards apply to similar arrangements with other 
payers for purposes of Other Payer Advanced APM determinations. 
Consistent with the proposal we are finalizing in this rule to define 
the term, Aligned Other Payer Medical Home Model. In the CY 2020 PFS 
proposed rule (84 FR 40834), we proposed to amend Sec.  414.1420(d)(2) 
and (d)(4) of our regulations to conform the financial risk and nominal 
amount standards for Aligned Other Payer Medical Home Models with the 
existing Medicaid Medical Home Model financial risk and nominal amount 
standards. Recognizing the similar characteristics of these ``medical 
home'' other payer payment arrangements, we believe that the same 
financial risk and nominal amount standards should be applied to 
Aligned Other Payer Medical Home Models as to Medicaid Medical Home 
Models.
    Further, we proposed a corresponding amendment to Sec.  
414.1420(d)(2)(ii) to state that, based on the APM Entity's failure to 
meet or exceed one or more specified performance standards, an Aligned 
Other Payer Medical Home Model must require the direct payment by the 
APM Entity to the payer. This amendment would further conform the 
requirements for Aligned Other Payer Medical Home Models with the 
current requirements for Medicaid Medical Home Models.
    We explained that we believe that if we applied the Medicaid 
Medical Home Model financial risk and nominal amount standards to all 
other payer arrangements that would meet the Aligned Other Payer 
Medical Home Model definition, but for the arrangements' not being 
aligned with a CMS Multi-Payer Model that is a Medical Home Model, we 
might create gaming opportunities whereby other payers might develop 
arrangements that appear to be medical homes solely to take advantage 
of the unique nominal amount standard. This would be of particular 
concern because we have less insight into the nature of arrangements 
not aligned with CMS Multi-Payer Models.
    In addition, as the 50 eligible clinician limit as codified in 
Sec. Sec.  414.1415(c)(7) and 414.1420(d)(8) currently applies to 
Medical Home Models and Medicaid Medical Home Models, respectively, we 
correspondingly proposed that the 50 eligible clinician limit apply to 
Aligned Other Payer Medical Home Models by amending Sec.  
414.1420(d)(8).
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported our proposed amendment to our 
regulations to conform the financial risk and nominal amount standards 
for Aligned Other Payer Medical Home Models with those for Medicaid 
Medical Home Models.
    Response: We appreciate the commenters' support for our proposal.
    Comment: A few commenters supported our proposal to make 
corresponding revisions to Sec.  414.1420(d)(2)(ii) to add that an 
Aligned Other Payer Medical Home Model must require the direct payment 
by the APM Entity to the payer, aligning with the current requirement 
for Medicaid Medical Home Models.

[[Page 63095]]

    Response: We appreciate the commenters' support for our proposal.
    Comment: Two commenters opposed our proposal to require Aligned 
Other Payer Medical Home Models to comply with the 50 eligible 
clinician limit to align with the requirements that apply to Medical 
Home Models and Medicaid Medical Home Models. These commenters stated 
that the application of the 50 eligible clinician limit to Aligned 
Other Payer Medical Home Models is an arbitrary cap that would 
unnecessarily limit the adoption of such payment arrangements by 
excluding certain entities and clinicians who would benefit from 
participating in an Aligned Other Payer Medical Home Model. 
Specifically, the commenters expressed concern that certain large 
specialty groups would be unable to participate in Aligned Other Payer 
Medical Home Models if the 50 eligible clinician limit were finalized.
    Response: As a general principle, we align policies pertaining to 
the Advanced APM criteria and the Other Payer Advanced APM criteria to 
the extent feasible and appropriate. We continue to believe that 
alignment of the requirements that apply to Medical Home Models, 
Medicaid Medical Home Models, and Aligned Other Payer Medical Home 
Models, including the 50 eligible clinician limit, is appropriate.
    After considering public comments, we are finalizing our proposal, 
without modification, to amend Sec.  414.1420(d)(2) and (4) to conform 
the financial risk and nominal amount standards for Aligned Other Payer 
Medical Home Models with the existing Medicaid Medical Home Model 
financial risk and nominal amount standards for Medicaid Medical Home 
Models as proposed. We are also finalizing without modification our 
proposal that the 50 eligible clinician limit apply to Aligned Other 
Payer Medical Home Models by amending Sec.  414.1420(d)(8).
(b) Generally Applicable Other Payer Advanced APM Nominal Amount 
Standard
(i) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77471), we 
finalized at Sec.  414.1420(d)(3)(ii) that except for risk arrangements 
described under the Medicaid Medical Home Model Standard, for a payment 
arrangement to meet the nominal amount standard, the specific level of 
marginal risk must be at least 30 percent of losses in excess of the 
expected expenditures and total potential risk must be at least 4 
percent of the expected expenditures. Furthermore, we finalized that a 
payment arrangement must require APM Entities to bear financial risk 
for at least 3 percent of the expected expenditures for which an APM 
Entity is responsible under the payment arrangement. Section 
414.1420(d)(6) provides that, for purposes of this section, expected 
expenditures is defined as the Other Payer Advanced APM benchmark or, 
for episode payment models, as the episode target price.
(ii) Marginal Risk
    As we stated in the 2017 Quality Payment Program final rule (81 FR 
77470), to determine that a payment arrangement satisfies the marginal 
risk portion of the nominal amount standard, we would examine the 
payment required under the payment arrangement as a percentage of the 
amount by which actual expenditures exceeded expected expenditures. 
Specifically, for marginal risk we finalized that for a payment 
arrangement to meet the nominal amount standard, the specific level of 
marginal risk must be at least 30 percent of losses in excess of the 
expected expenditures. We also stated that the rate of marginal risk 
could vary with the amount of losses.
    To date, we have applied the marginal risk requirement as requiring 
that a payment arrangement must exceed the marginal risk rate of 30 
percent at all levels of total losses even as the marginal risk rate 
varies depending on the amount by which actual expenditures exceed 
expected expenditures, consistent with Sec.  414.1420(d)(5)(i). For 
example, certain other payer arrangements where the marginal risk met 
or exceeded 30 percent at lower levels of losses in excess of expected 
expenditures, but fell below 30 percent at higher levels of losses, 
would not meet the marginal risk requirement of the generally 
applicable nominal amount standard.
    In general, this approach has worked well and served its intended 
purpose of ensuring only other payer arrangements with strong financial 
risk components are determined to be Other Payer Advanced APMs. At the 
same time, this policy has necessitated that we determine that certain 
other payer arrangements are not Other Payer Advanced APMs even though 
they include strong financial risk components and well exceed the 30 
percent marginal risk requirement at the most common levels of losses 
in excess of expected expenditures, and employ marginal risk rates 
below 30 percent only at much higher levels of losses. We do not 
believe these other payer arrangements include marginal risk rates 
below 30 percent to avoid subjecting participants to more than nominal 
amounts of risk. Rather, we believe that these other payer arrangements 
employ the lower marginal risk rates at higher levels of losses in 
order to protect participants from potentially catastrophic losses and 
undue financial burden that might arise because of market factors 
likely outside their control.
    Therefore, in the CY 2020 PFS proposed rule (84 FR 40834), we 
proposed to amend Sec.  414.1420(d)(5)(i) to provide that in event that 
the marginal risk rate varies depending on the amount by which actual 
expenditures exceed expected expenditures, we would use the average 
marginal risk rate across all possible levels of actual expenditures 
for comparison to the marginal risk rate specified in paragraph 
(d)(3)(ii) of this section, with exceptions for large losses and small 
losses as described in paragraphs (d)(5)(ii) and (d)(5)(iii) of this 
section.
    We proposed that we would calculate the average marginal risk rate 
in two steps. An example of such a calculation is presented in Table 
65. This example uses a model that relies on a Total Cost of Care 
(TCOC) benchmark. This methodology for the calculating average marginal 
risk rate can also be applied to other types of other payer payment 
arrangements. In this example, we first take the sum of the marginal 
risk for each percent above the Total Cost of Care (TCOC) benchmark to 
determine the participant losses. For example, at 3 percent add 50 
percent (amount for 1 percent above benchmark) plus 50 percent (amount 
for 2 percent above benchmark) plus 50 percent (amount for 3 percent 
above benchmark), which equals 1.50 percent. Second, we divide the 
participant losses by the percentage above the benchmark (in our 
example, 1.50 percent divided by 3) to get average marginal risk. The 
average marginal risk rate remains above 30 percent at all levels of 
potential losses up to the point where the participant would be 
responsible for losses equal to the total potential risk requirement of 
3 percent. We note that this example presents the calculation only up 
to the point where the total potential risk requirement is met.

[[Page 63096]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.114

    As we discussed in the CY 2020 PFS proposed rule (84 FR 40835), 
with this proposed amendment, significant and meaningful financial risk 
would continue to be required for Other Payer Advanced APMs because the 
average marginal risk rate would need to be at least 30 percent. At the 
same time, the proposed amendment would allow us to recognize that 
significant and meaningful risk can be present even where there is wide 
variation in the application of marginal risk rates, allowing for 
continued innovation in the marketplace. This proposed policy is 
intended to ensure that all Other Payer Advanced APMs include marginal 
risk of at least 30 percent up to the point that the participant owes 3 
percent of losses, which is the intended effect of the current marginal 
risk standard, while providing flexibility to avoid excluding certain 
payment arrangements that have strong financial risk designs. When 
considering average marginal risk in the context of total risk, as we 
propose to do for Other Payer Advanced APM determinations, certain risk 
arrangements can create meaningful and significant risk-based 
incentives for performance and at the same time ensure that the payment 
arrangement has strong financial risk components.
    We note that in making this change we would not lower the standard 
for the applicable marginal risk rate, but rather allow for new 
flexibility as to how it can be met. In the CY 2020 PFS proposed rule, 
we clarified that the amendment as proposed would not change the 
allowance for large losses provision as described in paragraph 
(d)(5)(ii) of Sec.  414.1420, so that when calculating the average 
marginal risk rate, we may disregard the marginal risk rates that apply 
in cases when actual expenditures exceed expected expenditures by an 
amount sufficient to require the APM Entity to make financial risk 
payments under the payment arrangement greater than or equal to the 
total risk requirements. We also clarified that the proposal would not 
change the exception for small losses described in paragraph 
(d)(5)(iii).
    We received comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: Several commenters supported our proposal, and no 
commenters opposed our proposal. Two of these commenters stated that 
the proposal would provide greater flexibility in the design of other 
payer payment arrangements, and therefore, would encourage other payers 
to seek Other Payer Advanced APM determinations for their payment 
arrangements.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal, 
without modification, to amend Sec.  414.1420(d)(5)(i) to provide that 
in event that the marginal risk rate varies depending on the amount by 
which actual expenditures exceed expected expenditures, the average 
marginal risk rate across all possible levels of actual expenditures 
will be used for comparison to the marginal risk rate specified in 
paragraph (d)(3)(ii) of this section, while retaining the current 
exceptions for large losses and small losses as described in paragraphs 
(d)(5)(ii) and (d)(5)(iii) of this section.
(iii) Expected Expenditures
    In the CY 2017 Quality Payment Program final rule (81 FR 77551), we 
established the definition of ``expected expenditures'' at Sec.  
414.1420(d)(6) to mean the Other Payer APM benchmark, except for 
episode payment models, for which it is defined as the episode target 
price. We also finalized at Sec.  414.1420(d)(3)(ii) that, except for 
arrangements assessed under the Medicaid Medical Home Model financial 
risk and nominal amount standards, in order to meet the Other Payer 
Advanced APM nominal amount standard, a payment arrangement's level of 
marginal risk must be at least 30 percent of losses in excess of the 
expected expenditures and the total potential risk must be at least 4 
percent (81 FR 77471).
    In the CY 2017 Quality Payment Program proposed rule (81 FR 28332), 
we proposed to measure three dimensions of risk under our generally 
applicable nominal amount standards: (1) Marginal risk, which refers to 
the percentage of the amount by which actual expenditures exceed 
expected expenditures for which an APM Entity would be liable under the 
APM; (2) minimum loss rate (MLR), which is a percentage by which actual 
expenditures may exceed expected expenditures without triggering 
financial risk; and (3) total potential risk, which refers to the 
maximum potential payment for which an APM Entity could be liable under 
the APM. However, based on commenters' concerns regarding technical 
complexity, we finalized only the marginal risk and MLR requirements.
    In the CY 2017 Quality Payment Program proposed rule (81 FR 28333), 
we explained that, to determine whether an APM satisfies the marginal 
risk portion of the nominal risk standard, we would examine the payment 
required under the APM as a percentage of the amount by which actual 
expenditures exceeded expected expenditures. We proposed to require 
that this percentage exceed a required marginal risk percentage of 30 
percent regardless of the amount by which actual expenditures exceeded 
expected expenditures.
    Our rationale for proposing the marginal risk requirement was that 
the inclusion of a marginal risk requirement would be intended to focus 
on maintaining a more than nominal level of likely risk under an 
Advanced APM

[[Page 63097]]

or an Other Payer Advanced APM. However, even with a marginal risk 
requirement, as there is under the Other Payer Advanced APM criteria, 
in the CY 2020 PFS proposed rule (84 FR 40837), we explained that we 
believe there is a need to amend the definition of expected 
expenditures to ensure there are more than nominal levels of average or 
likely risk under Other Payer Advanced APMs that meet the generally 
applicable benchmark-based nominal amount standard. Even with the 
current marginal risk requirement, we believe a more rigorous 
definition of expected expenditures is needed to avoid situations where 
the level of expected expenditures would be set in a manner that 
reduces the losses a participant might incur. For the same general 
reasons, we made a similar proposal to revise our definition of 
expected expenditures under the Advanced APM criteria in the CY 2020 
PFS proposed rule (84 FR 40825). We also believe it is important that 
our definition of expected expenditures is consistent across both the 
Advanced APM and Other Payer Advanced APM criteria. We generally try to 
align the Advanced APM and Other Payer Advanced APM criteria to the 
extent feasible and appropriate.
    We made this parallel proposal for the Other Payer Advanced APM 
criteria to similarly account for scenarios where a payment arrangement 
can have a sufficient total risk potential to meet our standard, and a 
sharing rate that results in adequate marginal risk if actual 
expenditures exceed expected expenditures, but where the level of 
expected expenditures reflected in the payment arrangement's benchmark 
or episode target price could be set in a way that substantially 
reduces the amount of loss a participant in the payment arrangement 
would reasonably expect to incur.
    For a payment arrangement to meet the generally applicable 
benchmark-based nominal amount standard, we believe there should be not 
only the potential for financial losses based on expenditures in excess 
of the benchmark as provided in Sec.  414.1420(d)(6), but also some 
meaningful likelihood that a participant might exceed the benchmark. If 
the benchmark is set in such a way that it is extremely unlikely that 
participants will exceed it, then there is little potential for 
participants to incur financial losses, and the amount of risk is 
essentially illusory.
    Therefore, we proposed to amend the definition of expected 
expenditures in Sec.  414.1420(d)(6). Specifically, we would continue 
to define expected expenditures, for the purposes of this section, as 
the Other Payer APM benchmark. For episode payment arrangements, 
expected expenditures would continue to mean the episode target price. 
However, for purposes of assessing financial risk for Other Payer 
Advanced APM determinations, the expected expenditures under the 
payment arrangement should not exceed the expenditures for a 
participant in the absence of the payment arrangement. The amended 
regulation would specify that if expected expenditures (that is, 
benchmarks) under the payment arrangement exceed the expenditures that 
the participant will be expected to incur in the absence of the payment 
arrangement, such excess expenditures are not considered when CMS 
assesses financial risk under the payment arrangement for Other Payer 
Advanced APM determinations.
    We believe that this change would prevent the expected expenditures 
under the other payer payment arrangement being set in a manner that 
substantially reduces the amount of losses a participant may face while 
otherwise satisfying this Other Payer Advanced APM criterion.
    We clarify that, in general, expected expenditures are expressed as 
a dollar amount, and may be derived from national, regional, APM 
Entity-specific, and/or practice-specific historical expenditures 
during a baseline period, or other comparable expenditures. However, we 
recognize expected expenditures under a payment arrangement are often 
risk-adjusted and trended forward, and may be adjusted to account for 
expenditure changes that are expected to occur as a result of 
participation in the payment arrangement. For the purpose of this 
definition of expected expenditures, we will not consider risk 
adjustments to be excess expenditures when comparing to the costs that 
an APM Entity will be expected to incur in the absence of the payment 
arrangement.
    We believe that this amendment would allow us to ensure that there 
are more-than-nominal amounts of average or likely risk under an other 
payer payment arrangement that meets the generally applicable 
benchmark-based nominal amount standard. We believe that the amended 
definition of expected expenditures, particularly by our not 
considering excess expenditures, will provide a more definite basis for 
us to assess whether an APM Entity will bear more than a nominal amount 
of financial risk for participants under the generally applicable 
benchmark-based nominal amount standard.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters opposed this proposal. A few of these 
commenters asserted that the proposal would add significant 
administrative burden to other payers because other payers would have 
to carry out significant analytical work to demonstrate compliance with 
the requirement. A few of these commenters also stated this additional 
effort would discourage other payers from developing other payer 
payment arrangements that may be Other Payer Advanced APMs. In 
addition, a few of these commenters stated that the proposal does not 
clearly state how CMS would either calculate or assess whether expected 
expenditures under the other payer payment arrangement exceed the 
expenditures that the participant will be expected to incur, or whether 
the other payer would be required to assess whether expected 
expenditures under the other payer payment arrangement exceed the 
expenditures that the participant will be expected to incur. One 
commenter stated the language in the proposal is confusing and does not 
explain how the expenditures that would be expected to occur in the 
absence of the arrangement will be calculated. Another commenter noted 
that the proposal does not provide enough detail on how the assessment 
would be conducted and stated the requirement would require 
``difference-in-difference'' evaluations, which require robust 
evaluations of claims data. Furthermore, some commenters stated that 
the proposed change would result in fewer payment arrangements 
qualifying as Other Payer Advanced APMs.
    Response: In proposing this amendment, we did not intend to place 
an administrative burden on payers and do not expect payers to 
undertake an additional analysis of claims data to demonstrate 
compliance. As part of our Other Payer Advanced APM monitoring and 
program integrity activities, we would expect payers submitting payment 
arrangements for Other Payer Advanced APM determinations to understand 
that they may be subject to random or targeted monitoring as part of 
participation in Quality Payment Program in the form of a request for a 
simple analysis provided by the payer demonstrating that the expected 
expenditures under the payment arrangement should not exceed the 
expenditures for a participants in the absence of the payment 
arrangement. At the time of submissions of other

[[Page 63098]]

payment arrangements from either payers or eligible clinicians, no 
additional analysis would be required. In addition, we are not 
requiring that any payer conduct any ``difference-in-difference'' 
evaluation to comply with this amendment. We are notifying other payers 
that they should take this requirement into account when they design 
new payment arrangements that they intend to satisfy the financial risk 
criterion by way of the benchmark-based nominal amount standard.
    We acknowledge that there may be instances where, even if no 
additional analysis is required, this policy may lead to a payer not to 
make a submission of their payment arrangement for Other Payer Advanced 
APM determinations. However, we believe that this policy monitoring is 
important to the integrity of the program, and that any such impact on 
submissions will be minimal.
    After considering public comments, we are finalizing our proposal 
to amend the definition of expected expenditures at Sec.  
414.1420(d)(6) without modification. We clarify that demonstrating 
compliance with this requirement should require only a minimal amount 
of analysis, if any, on the part of the payer or clinicians.
(iv) Excluded Items and Services Under Full Capitation Arrangements
    In the CY 2017 Quality Payment Program final rule (81 FR 77551), we 
finalized a capitation standard at Sec.  414.1420(d)(7) which provides 
that a capitation arrangement meets the Other Payer Advanced APM 
financial risk criterion. For purposes of Sec.  414.1420(d)(3), we 
defined a capitation arrangement as a payment arrangement in which a 
per capita or otherwise predetermined payment is made under the APM for 
all items and services for which payment is made under the APM for all 
items and services for which payment is made through the APM furnished 
to a population of beneficiaries, and no settlement is performed for 
the purpose of reconciling or sharing losses incurred or savings earned 
by the APM Entity. We clarified that arrangements made directly between 
CMS and Medicare Advantage Organizations under the Medicare Advantage 
program are not considered capitation arrangements for purposes of 
Sec.  414.1420(d)(7).
    In the CY 2019 PFS final rule (83 FR 59939), we made technical 
corrections to the Advanced APM financial risk capitation standard at 
Sec.  414.1420(d)(7). These corrections clarified that our financial 
risk capitation standard applies only to full capitation arrangements 
where a per capita or otherwise predetermined payment is made under the 
APM for all items and services furnished to a population of 
beneficiaries during a fixed period of time, and no settlement or 
reconciliation is performed.
    As we have begun to collect information on other payer payment 
arrangements for purposes of making Other Payer Advanced APM 
determinations, we have noticed that some payment arrangements that are 
submitted for CMS to determine as capitation arrangements consistent 
with Sec.  414.1420(d)(7) include a list of services that have been 
excluded from the capitation rate, such as hospice care, organ 
transplants, or out-of-network emergency room services. In reviewing 
these exclusion lists, we believe that it may be appropriate for 
capitation arrangements to be considered ``full'' capitation 
arrangements even if they categorically exclude certain services from 
payment through the capitation rate. Therefore, in the CY 2020 PFS 
proposed rule (84 FR 40826), we solicited comment on how other payers 
define or determine what, if any, exclusions are reasonable in a given 
capitation arrangement. Specifically, we solicited comment on whether 
there are common industry practices to exclude certain categories of 
items and services from capitated payment rates and, if so, whether 
there are common principles or reasons for excluding those categories 
of services. In addition, we solicited comment on why such items or 
services are excluded.
    We also solicited comment on how non-Medicare payers define or 
prescribe certain categories of services that are excluded with regard 
to global capitation payment arrangements. We also solicited comment on 
whether we should consider a capitation arrangement to be a full 
capitation arrangement even though it excludes certain categories of 
services from the capitation rate.
    We received public comments responding to our solicitation for 
information. We appreciate the comments submitted and will take them 
into consideration for any potential future rulemaking on this issue. 
The comments that we received in response to this solicitation for 
information were applicable to both Advanced APMs and Other Payer 
Advanced APMs. For our responses to these comments, please see section 
III.K.4.c. of this final rule.
(4) Summary
    In this section, we are finalizing the following policies:
     Aligned Other Payer Medical Home Model: We are finalizing 
our proposal to define the term Aligned Other Payer Medical Home Model 
as proposed. In addition, we are finalizing without modification our 
proposals that the CEHRT criterion and the use of quality measures 
criterion will apply to any Aligned Other Payer Medical Home Model for 
which we will make an Other Payer Advanced APM determination. We are 
also finalizing our proposal without modification to conform the 
financial risk and nominal amount standards for Aligned Other Payer 
Medical Home Models to the existing standards for Medicaid Medical Home 
Model financial risk and nominal amount standards, including the 50 
eligible clinician limit.
     Marginal Risk: We are finalizing without modification our 
proposal that when the marginal risk rate in a payment arrangement 
varies depending on the amount by which actual/expenditures exceed 
expected expenditures, we will use the average marginal risk rate 
across all possible levels of actual expenditures for comparison to the 
marginal risk rate requirement, with exceptions for large losses and 
small losses as provided in Sec.  414.1420(d)(5) without modification.
     Expected Expenditures: We are finalizing our proposal 
without modification to amend the definition of expected expenditures 
at Sec.  414.1420(d)(6) to provide that, for assessing financial risk 
for Other Payer Advanced APM determinations for episode payment 
arrangements, the expected expenditures (episode target price) under 
the payment arrangement should not exceed the expenditures for a 
participant in the absence of the payment arrangement.
5. Quality Payment Program Technical Revisions
    In the CY 2020 PFS proposed rule (84 FR 40837), we proposed certain 
technical revisions to our regulations to correct several technical 
errors and to reconcile the text of several of our regulations with the 
final policies we adopted through notice and comment rulemaking.
    We proposed a technical revision to Sec.  414.1405(f) of our 
regulations to specify that the exception for the application of the 
MIPS payment adjustment factors to model-specific payments is 
applicable starting in the 2019 MIPS payment year, not just for the 
2019 MIPS payment year. This revision would align the regulation text 
with our final policy as stated in the preamble of the CY 2019 PFS 
final rule with comment period (83 FR 59887 through 59888) which makes 
clear that the exception begins with the 2019

[[Page 63099]]

MIPS payment year and continues in subsequent years.
    We also proposed technical revisions to Table 59 of the CY 2019 PFS 
final rule with comment period (83 FR 59935) to correct two dates. 
Specifically we proposed to change the date for Medicare Health Plans: 
Guidance made available to ECs, then Submission Period Opens; it is 
currently listed as September 2020, and we proposed to change that date 
to August 2020. Similarly, we proposed to change the date for Remaining 
Other Payers: Guidance made available to ECs, then Submission Period 
Opens; it is currently listed as September 2020, and we proposed to 
change that to August 2020. These changes align with what was 
originally finalized in the CY 2018 Quality Payment Program final rule 
with comment period (82 FR 53864) which stated that the dates were to 
be August 2020, and which we did not propose or intend to change in the 
CY 2019 PFS final rule. Table 66 is included as the corrected Table 59 
from the CY 2019 PFS final rule.
[GRAPHIC] [TIFF OMITTED] TR15NO19.115

    We also proposed technical revisions to Sec. Sec.  414.1415(c)(6) 
and 414.1420(d)(7) to correct the internal citation. The current 
citation, 42 U.S.C. 422, is incorrect. It should instead be 42 CFR part 
422. We also proposed technical revisions to Sec.  414.1420(d)(5). We 
clarify that ``APM'' in Sec.  414.1420(d)(5) should be ``other payer 
payment arrangement.'' In the CY 2019 PFS final rule, we finalized 
deleting Sec.  414.1420(d)(3)(ii)(B) and consolidating Sec.  
414.1420(d)(3)(ii)(A) into Sec.  414.1420(d)(3)(ii), but that change 
was not applied to the regulation. We proposed to revise the regulation 
accordingly. Relatedly, we proposed to amend Sec.  414.1420(d)(5)(i), 
(ii), and (iii) to state in ``paragraph (d)(3)(ii)'' of this section 
instead of ``paragraph (d)(3)(ii)(A)'' of this section. We also 
proposed to clarify that ``Other Payer Advanced APM'' in Sec.  
414.1420(d)(5)(ii) should be ``other payer payment arrangement,'' as 
the marginal risk rate requirements are applied to any other payer 
payment arrangement that CMS assesses against the Other Payer Advanced 
APM criteria. These revisions are technical in nature and do not change 
any substantive policies for the Quality Payment Program.
    We did not receive any comments on these proposed technical 
revisions.
    We are finalizing these technical revisions as proposed.

[[Page 63100]]

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

A. General

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

B. Annual Update to the Code List

1. Background
    In Sec.  411.351, we specify that the entire scope of four DHS 
categories is defined in a list of CPT/HCPCS codes (the Code List), 
which is updated annually to account for changes in the most recent CPT 
and HCPCS Level II publications. The DHS categories defined and updated 
in this manner are:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
    The Code List also identifies those items and services that may 
qualify for either of the following two exceptions to the physician 
self-referral prohibition:
     EPO and other dialysis-related drugs furnished in or by an 
ESRD facility (Sec.  411.355(g)).
     Preventive screening tests, immunizations, or vaccines 
(Sec.  411.355(h)).
    The definition of DHS at Sec.  411.351 excludes services for which 
payment is made by Medicare as part of a composite rate (unless the 
services are specifically identified as DHS and are themselves payable 
through a composite rate, such as home health and inpatient and 
outpatient hospital services). Effective January 1, 2011, EPO and 
dialysis-related drugs furnished in or by an ESRD facility (except 
drugs for which there are no injectable equivalents or other forms of 
administration), have been reimbursed under a composite rate known as 
the ESRD prospective payment system (ESRD PPS) (75 FR 49030). 
Accordingly, EPO and any dialysis-related drugs that are paid for under 
ESRD PPS are not DHS and are not listed among the drugs that could 
qualify for the exception at Sec.  411.355(g) for EPO and other 
dialysis-related drugs furnished by an ESRD facility.
    ESRD-related oral-only drugs, which are drugs or biologicals with 
no injectable equivalents or other forms of administration other than 
an oral form, were scheduled to be paid under ESRD PPS beginning 
January 1, 2014 (75 FR 49044). However, there have been several delays 
of the implementation of payment of these drugs under ESRD PPS. On 
December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a 
Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) was enacted 
and delayed the inclusion of these oral-only drugs under the ESRD PPS 
until 2025. Until that time, such drugs furnished in or by an ESRD 
facility are not paid as part of a composite rate and thus, are DHS.
    The Code List was last updated in Tables 28 and 29 of the CY 2019 
PFS final rule (83 FR 59718).
2. Response to Comments
    We received no comments relating to the Code List that became 
effective January 1, 2019.
3. Revisions Effective for CY 2020
    The updated, comprehensive Code List effective January 1, 2020, is 
available on our website at http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.html.
    Additions and deletions to the Code List conform it to the most 
recent publications of CPT and HCPCS Level II and to changes in 
Medicare coverage policy and payment status.
    Tables 67 and 68 identify the additions and deletions, 
respectively, to the comprehensive Code List that become effective 
January 1, 2020. Tables 67 and 68 also identify the additions and 
deletions to the list of codes used to identify the items and services 
that may qualify for the exception in Sec.  411.355(g) (regarding 
dialysis-related outpatient prescription drugs furnished in or by an 
ESRD facility) and in Sec.  411.355(h) (regarding preventive screening 
tests, immunizations, and vaccines).

[[Page 63101]]

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[[Page 63102]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.117

V. Interim Final Rule With Comment Period [CMS-1715-IFC]

A. Coding and Payment for Evaluation and Management, Observation and 
Provision of Self-Administered Esketamine (HCPCS Codes G2082 and G2083)

    On March 5, 2009, the U.S. Food and Drug Administration (FDA) 
approved SpravatoTM (esketamine) nasal spray, used in 
conjunction with an oral antidepressant, for treatment of depression in 
adults who have tried other antidepressant medicines but have not 
benefited from them (treatment-resistant depression (TRD)).\120\ 
Because of the risk of serious adverse outcomes resulting from sedation 
and dissociation caused by Spravato administration, and the potential 
for abuse and misuse of the product, it is only available through a 
restricted distribution system under a Risk Evaluation and Mitigation 
Strategy (REMS). A REMS is a drug safety program that the FDA can 
require for certain medications with serious safety

[[Page 63103]]

concerns to help ensure the benefit of the medication outweigh its 
risks.\121\
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    \120\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
    \121\ https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
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    Patients with major depression disorder who, despite trying at 
least two antidepressant treatments given at adequate doses for an 
adequate duration in the current episode, have not responded to 
treatment are considered to have TRD.\122\ TRD is especially relevant 
for Medicare beneficiaries. Depression in the elderly is associated 
with suicide more than at any other age; adults 65 or older constitute 
16 percent of all suicide deaths. The decrease in average life 
expectancy for those with depressive illness, including Medicare 
beneficiaries, is 7 to 11 years. Depression is a major predictor of the 
onset of stroke, diabetes, and heart disease; it raises patients' risk 
of developing coronary heart disease and the risk of dying from a heart 
attack nearly threefold.\123\ There has also been a longstanding need 
for additional effective treatment for TRD, a serious and life-
threatening condition.\124\
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    \122\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
    \123\ https://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=105&bc=AAAQAAAAAAAA&.
    \124\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
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    A treatment session of esketamine consists of instructed nasal 
self-administration by the patient, followed by a period of post-
administration observation of the patient under direct supervision of a 
health care professional. Esketamine is a non-competitive N-methyl D-
aspartate (NMDA) receptor antagonist. It is a nasal spray supplied as 
an aqueous solution of esketamine hydrochloride in a vial with a nasal 
spray device. This is the first FDA approval of esketamine for any 
use.\125\ Each device delivers two sprays containing a total of 28 mg 
of esketamine. Patients would require either two (2) devices (for a 
56mg dose) or three (3) devices (for an 84 mg dose) per treatment.
---------------------------------------------------------------------------

    \125\ Ibid.
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    After reviewing the Spravato Prescribing Information, Medication 
Guide, and REMS requirements, we have concluded that effective and 
appropriate treatment of TRD with esketamine requires discrete services 
of a medical professional, meaning those that may furnish and report E/
M services under the PFS, both during an overall course of treatment 
and at the time the drug is administered.\126\ Because of the risk of 
serious adverse outcomes resulting from sedation and dissociation 
caused by Spravato administration, and the potential for abuse and 
misuse of the product: The product is only available through a 
restricted distribution system under a REMS; \127\ patients must be 
monitored by a health care provider for at least 2 hours after 
receiving their Spravato dose; the prescriber and patient must both 
sign a Patient Enrollment Form; and the product will only be 
administered in a certified medical office where the health care 
provider can monitor the patient.\128\ Further information regarding 
certification of medical offices is available at www.SPRAVATOrems.com 
or 1-855-382-6022.
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    \126\ https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211243.
    \127\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
    \128\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
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    Because this newly available treatment regimen addresses a 
particular and urgent need for people with TRD, including Medicare 
beneficiaries, we recognize that it is in the public interest to ensure 
appropriate patients have access to this potentially life-saving 
treatment. We recognize, however, that the services and resources 
involved in furnishing this treatment are not adequately reflected in 
existing coding and payment under the PFS, or otherwise under Medicare 
Part B. Given the FDA approval conditions/requirements including that 
the drug is only available as an integral component of a physicians' 
service, the absence of existing HCPCS coding that would adequately 
describe the service with the provision of the product, and our 
understanding based on review of the Spravato Prescribing Information, 
Medication Guide, and REMS requirements, we do not believe the Medicare 
beneficiaries in the greatest medical need of this treatment would be 
likely to have access to it until such time that Medicare coding and 
payment are updated. Medicare coding and payment policies are generally 
adopted through annual updates to the PFS. Unless we adopt coding and 
payment changes for this treatment beginning January 1, 2020, we 
believe that the next practicable alternative would be either 
standalone rulemaking or PFS rulemaking for 2021. Both of these 
alternatives would risk the lives of Medicare beneficiaries with TRD 
for several months to over a year.
    Therefore, to facilitate prompt beneficiary access to the new, 
potentially life-saving treatment for TRD using esketamine, we are 
creating two new HCPCS G codes, G2082 and G2083, effective January 1, 
2020 on an interim final basis. For CY 2020, we are establishing RVUs 
for these services that reflect the relative resource costs associated 
with the evaluation and management (E/M), observation and provision of 
the self-administered esketamine product using HCPCS G codes. We note 
that we have historically established coding and payment on an interim 
final basis for truly new services when it is in the public interest to 
do so. Like most other truly new services, we expect diffusion of this 
kind of treatment into the market will take place over several years, 
even though we expect some people to benefit immediately. Consequently, 
the expected impact on other PFS services is negligible for 2020, and 
we will consider the public comments we receive on this interim final 
policy as we consider finalizing coding or payment rules for this 
treatment beginning in 2021. 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.
     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 
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 (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

[[Page 63104]]

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 are also incorporating 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 are incorporating 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 note that we are valuing these two HCPCS codes, in part, on the 
basis of a level 2 established patient office/outpatient E/M visit; 
consequently, for purposes of relevant Medicare conditions of payment, 
reporting these codes is similar to reporting a level 2 office/
outpatient E/M visit code. In addition to seeking comment on the 
interim final values we are establishing for HCPCS codes G2082 and 
G2083, we also seek comment on the assigned work RVUs, work times, and 
direct PE inputs.
    Under circumstances where the health care professional supervising 
the self-administration and observation does not also provide the 
esketamine product, the provider 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 service of 
the professional or the clinical staff. CMS will monitor claims data to 
safeguard against duplicative billing for these services and items.
    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 are using the most recent 
available quarter of WAC data for 2020 pricing, but we anticipate using 
either data that is reported for determining payments under section 
1847A of the Act (such as ASP) or compendia pricing information (such 
as WAC) in future years and expect to address this issue in further 
rulemaking. We seek comments on how to best establish input prices for 
the esketamine product, as well as other potential self-administered 
drugs that necessitate concurrent medical services, under PFS 
ratesetting in future years.
    We note that there is a 60-day public comment period following 
publication of this interim final rule for the public to comment on 
these interim final amendments to our regulations. We refer readers to 
the ADDRESSES section of the final rule for instructions on submitting 
public comments. Comments are due by the ``Comment date'' specified in 
the DATES section of this rule.

B. Waiver of Proposed Rulemaking for Provisions

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of the proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. Section 
553(b)(B) of the APA provides for exceptions from the notice and 
comment requirements; in cases in which these exceptions apply, section 
1871(b)(2)(C) of the Act provides for exceptions from the notice and 
60-day comment period requirements of the Act as well. Section 
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an 
agency to dispense with normal rulemaking requirements for good cause 
if the agency makes a finding that the notice and comment process is 
impracticable, unnecessary, or contrary to the public interest.
    We find that there is good cause to waive the notice and comment 
requirements under sections 553(b)(B) of the APA and section 
1871(b)(2)(C) due to the urgent need of some Medicare beneficiaries for 
effective treatment for TRD, a serious and life-threatening condition. 
The U.S. Food and Drug Administration (FDA) approved Spravato 
(esketamine) nasal spray on March 5, 2019, used in conjunction with an 
oral antidepressant, for treatment of adults who have tried other 
antidepressant medications but have not benefited from them. Because of 
the treatment's unique method of delivery, specifically the necessary 
inclusion of a self-administered drug product as part of a uniquely 
identifiable service of a medical professional (as required through a 
restricted distribution system under a Risk Evaluation and Mitigation 
Strategy (REMS),\129\ existing Medicare coding and payment policies 
would not permit appropriate payment for these services. Consequently, 
Medicare beneficiaries' access to this treatment would be impeded 
without Medicare coding and payment policy changes established in this 
final rule with comment period. Given the longstanding need for 
additional effective treatments for patients with TRD and the potential 
risk to the lives of the Medicare beneficiaries with TRD, we believe it 
is in the public interest to adopt these interim final policies to 
ensure access by making available appropriate payment to physicians and 
other practitioners for provision of this service as soon as 
practicable, and that the lack of an appropriate payment mechanism 
would jeopardize or significantly delay access to this treatment 
regimen. We find that it would be impracticable and contrary to the 
public interest to undergo notice and comment procedures before 
finalizing these payment policies on an interim basis. We also find 
that delaying implementation of these policies is unnecessary because 
the impact on other PFS services for 2020 is negligible and the 
practical alternative for this treatment is no payment under Medicare 
Part B. In either case, payments for 2021 and beyond would be informed 
by public comments.
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    \129\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
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    Therefore, we find good cause to waive the notice of proposed 
rulemaking as provided under section

[[Page 63105]]

1871(b)(2)(C) of the Act and section 533(b)(B) of the APA and to issue 
this interim final rule with an opportunity for public comment. We are 
providing a 60-day public comment period as specified in the DATES 
section of this document.

VI. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 
35), we are required to publish a 30-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 the PRA'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.
    Our August 14, 2019 (84 FR 40482) proposed rule solicited public 
comment on each of the required issues under section 3506(c)(2)(A) of 
the PRA for the following information collection requirements. We 
received PRA-related comments pertaining to the Open Payments Program 
and Quality Payment Program. A summary of the comments and our response 
are set out below, under sections V.B.5. and V.B.7.c.(3)(b).

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2018 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 69 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.
[GRAPHIC] [TIFF OMITTED] TR15NO19.118

    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.

B. Information Collection Requirements (ICRs)

1. ICRs Regarding Medicare Coverage for Opioid Use Disorder Treatment 
Services Furnished by Opioid Treatment Programs (OTPs) (Sec. Sec.  
414.800 through 414.806)
    As described in section II.G. of this final rule, section 2005 of 
the SUPPORT for Patients and Communities Act establishes a new Medicare 
Part B benefit for OUD treatment services furnished by OTPs for 
episodes of care beginning on or after January 1, 2020. In this final 
rule we are adopting our proposals to use the payment methodology in 
section 1847A of the Act, which is based on Average Sales Price (ASP), 
to set the payment rates for the ``incident to'' drugs and ASP-based 
payment to set the payment rates for the oral product categories, when 
we receive manufacturers' voluntarily-submitted ASP data for these 
drugs.
    The burden consists of the time/cost for manufacturers of oral 
opioid agonist or antagonist treatment medications (that are approved 
by the Food and Drug Administration under section 505 of the Federal 
Food, Drug, and Cosmetic Act for use in the treatment of OUD) to 
voluntarily prepare and submit their ASP data to CMS.
    The burden for such reporting is currently approved by OMB under 
control number 0938-0921 (CMS-10110) and will remain unchanged (13 
hours per response, 4 responses per year, 180 respondents, and 9,360 
total hours) since our currently approved burden already accounts for 
the voluntary reporting of ASP data. We estimate that there are 
approximately 15 manufacturers of oral drugs used for treatment of 
opioid use disorder (OUD). We believe that approximately 10 of the 15 
manufacturers already report ASP data to CMS for other drugs, and thus 
up to 5 manufacturers may newly report ASP data to CMS. However, we 
note that some of these new respondents may have subsidiary or similar 
relationships with manufacturers that already report ASP data and may 
be able to submit their data with a current respondent. While the 
policies we are adopting in

[[Page 63106]]

this CY 2020 PFS final rule may slightly increase the number of 
respondents, our 180 respondent estimate historically fluctuates over 
time as new Part B drug manufacturers are added while others leave or 
consolidate. The annual fluctuation in respondents in the past has 
typically been +/- 5 to 10 manufacturers per year; over the past few 
years, the annual fluctuation has sometimes been greater, ranging from 
-13 to +11, but over that same period the overall average of the annual 
fluctuation is near zero. As a result, the potential slight increase in 
respondents associated with voluntary reporting for oral drugs used in 
the treatment of OUD, remains unchanged from the currently approved 
burden estimate of 180 respondents. In addition, we believe that 
additional voluntary reporting for oral drugs used for treatment of OUD 
by those manufacturers that currently report ASP data to CMS for other 
drugs will impose minimal additional burden. Consequently, we are not 
making any changes under the aforementioned control number. However, we 
will continue to monitor the number of respondents to account for 
various factors such as a change in the number of voluntary submissions 
from oral OUD drug manufacturers, as well as other issues that may not 
be related to the voluntary reporting for oral drugs used in OTPs, such 
as manufacturer consolidations, and new Part B drug and biological 
manufacturers. We will revise the burden estimate as needed.
    We received no comments in relation to our proposed burden 
estimates.
2. ICRs Regarding the Ground Ambulance Data Collection System
    Section 1834(l)(17)(A) of the Act requires that the Secretary 
develop a ground ambulance data collection system that collects cost, 
revenue, utilization, and other information determined appropriate by 
the Secretary with respect to providers of services and suppliers of 
ground ambulance services (ground ambulance organizations). Section 
1834(l)(17)(I) of the Act states that the PRA does not apply to the 
collection of information required under section 1834(l)(17) of the 
Act. Accordingly, we did not set out in the proposed rule the burden of 
the collection of information under the data collection system, and we 
are similarly not setting out that burden in this final rule. Please 
refer to section VII.F.2. of this final rule for a discussion of the 
impacts associated with the ground ambulance data collection system.
3. ICRs Regarding Intensive Cardiac Rehabilitation (Sec.  410.49)
    Section 410.49(b)(1)(vii) and (viii) of this final rule will expand 
the covered conditions to chronic heart failure and add other cardiac 
conditions as specified through the national coverage determination 
(NCD) process. We do not anticipate the need to use the NCD process to 
add additional covered conditions in the near future. In the unlikely 
event an NCD request is submitted, it will be covered by OMB control 
number 0938-0776 (CMS-R-290), which will not expire until February 29, 
2020. We are not making any changes under that control number since 
this rule does not impose changes to the currently approved submission 
process or burden.
    We did not receive public comments on the ICRs for intensive 
cardiac rehabilitation.
4. 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. Code, 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 section 
VII.F.6. of this final rule for a discussion of the impacts associated 
with the changes to the Shared Savings Program quality reporting 
requirements included in this final rule.
5. ICRs Regarding the Open Payments Program
    Section III.F. of this rule: (1) Expands the definition of 
``covered recipient,'' (2) modifies ``nature of payment'' categories, 
and (3) standardizes data on reported covered drugs, devices, 
biologicals, or medical supplies.
    Expanding the Definition of ``Covered Recipient'' (Sec. Sec.  
403.902, 403.904, and 403.908): This rule expands the definition of a 
``covered recipient'' in accordance with the SUPPORT Act to include 
physician assistants, nurse practitioners, clinical nurse specialists, 
nurse anesthetists, and certified nurse midwifes. The definition 
currently includes certain physicians and teaching hospitals. Section 
6111(c) of the SUPPORT Act provides that chapter 35 of title 44 of the 
U.S. Code, which includes such provisions as the PRA, shall not apply 
to the changes to the definition of a covered recipient included in the 
SUPPORT Act. In this regard we are not setting out burden under the 
authority of the PRA. Such estimates can be found in the RIA under 
section VII.F.7. of this final rule.
    Modification of the ``Nature of Payment'' Categories (Sec. Sec.  
403.902 and 403.904): The following changes will be submitted to OMB 
for approval under control number 0938-1237 (CMS-10495). Subject to 
renewal, the control number is currently set to expire on March 31, 
2021. It was last approved on March 21, 2018, and remains active.
    The changes will modify the ``nature of payment'' categories and 
provide more options for applicable manufacturers and GPOs to capture 
the nature of the payment made to the covered recipient. To accommodate 
this change, we project that reporting entities will need to update 
their system to incorporate the additional categories. We estimate, 
based on the trends in the number of entities that report every year, 
that there are 1,600 reporting entities and estimate, using the number 
of records that these entities report as a proxy for size of the 
entity. The total number of entities that report fluctuates year to 
year but has been close to 1,600 for the last two program years. We 
also estimate that 38 percent (or 611 entities) are small, 29 percent 
(or 457 entities) are medium, and 33 percent (or 532 entities) are 
large. We also estimate that 25 percent of reporting entities (400) 
will need to make minor, one-time updates to their data collection 
processes because they expect to report a transaction with one of the 
new categories. Among the 400 entities, we estimate it will take 
between 5 and 30 hours per entity depending on the size of the entity 
(with large companies requiring more time) at $44.92/hr for support 
staff. For all of these entities, we estimate a subtotal of 5,895 hours 
[(30 hr for a large entity x 133 entities) + (10 hr for a medium entity 
x 114 entities) + (5 hr for a small entity x 153 entities)] at a cost 
of $264,804 (5,895 hr x $44.92/hr).
    We also expect that all entities will need to make minor, one-time 
adjustments to their submission processes. For each entity we estimate 
that this will take 2 to 5 hours at $44.92/hr (with larger entities 
requiring more time) for support staff and 1 hour at $83.70/hr for 
compliance officers. For all entities, we estimate a subtotal of 7,767 
hours [(5 hr for support staff at a large entity x 532 entities) + (5 
hr for support staff at a medium entity x 457 entities) + (2 hr for 
support staff at a small entity x 611 entities) + (1 hr for compliance 
officer at each entity regardless of size x 1,600 entities)] at a cost 
of $410,941 [(2,660 hr for support staff at large entities x $44.92/hr) 
+ (2,285 hr for support staff at medium entities x $44.92/hr) + (1,222 
hr for support staff at small entities x $44.92/

[[Page 63107]]

hr) + (1,600 hr for compliance officers across all entities x $83.70/
hr)].
    In aggregate, we estimate a one-time burden of 13,662 hours (5,895 
hr + 7,767 hr) at a cost of $675,745 ($264,804 + $410,941) to 
implement. After these adjustments are made, we do not anticipate any 
ongoing added burden beyond what is currently approved under the 
aforementioned control number. We are maintaining these burden 
estimates as we believe they are representative of the array of 
potential burden associated with these changes.

         Table 70--Burden To Modify Nature of Payment Categories
------------------------------------------------------------------------
               Description                     Hours           Cost
------------------------------------------------------------------------
Burden to update collection processes              5,895        $264,804
 for entities that expect to report a
 transaction with a new Nature of
 Payment category.......................
Burden to update submission processes              7,767         410,941
 and systems to account for the new
 Nature of Payment categories...........
                                         -------------------------------
    Total...............................          13,662        $675,745
------------------------------------------------------------------------

    Standardizing Data Reporting for Covered Drugs, Devices, 
Biologicals, or Medical Supplies (Sec. Sec.  403.902 and 403.904): The 
following changes will be submitted to OMB for approval under control 
number 0938-1237 (CMS-10495). Subject to renewal, the control number is 
currently set to expire on March 31, 2021. It was last approved on 
March 21, 2018, and remains active.
    Applicable manufacturers and GPOs will need to accommodate the 
reporting of device identifiers. The following estimates may vary 
because the information collection system changes that are needed will 
vary since some entities may already be capturing this information in 
their systems while others may not.
    We estimate, based on an analysis of currently available data, that 
approximately 850 entities (approximately 53 percent of an assumed 
1,600) will need to report at least one record with a device identifier 
and that 450 of those entities do not already collect the device 
identifier. For this analysis we assumed that 38 percent (172 = 450 x 
0.38) of the entities will be small, 29 percent (128 = 450 x 0.29) will 
be medium, and 33 percent (150 = 450 x 0.33) will be large. We 
differentiate because we assume that larger companies will incur more 
burden to make the changes needed to begin reporting device identifiers 
because they have more complex systems and potentially more records to 
report. The number of submitted records will not change, but this rule 
will add a new data element that may need to be reported along with 
some or all of an entity's records. The precise tasks will vary by 
entity, but may include developing processes for gathering device 
identifier information or systems for collecting the data.
    For the 450 entities that will be required to start collecting 
device identifiers, we estimate that this task will take between 20 and 
100 hours for support staff depending on the size of the company (with 
larger companies requiring more time) at $44.92/hr. For all entities, 
we estimate a subtotal of 24,840 hours [(100 hr for a large entity x 
150 entities) + (50 hr for a medium entity x 128 entities) + (20 hr for 
a small entity x 172 entities)] at a cost of $1,115,813 [(15,000 hr for 
support staff at a large entity x $44.92/hr) + (6,400 hr for support 
staff at a medium entity x $44.92/hr) + (3,440 hr for support staff at 
a small entity x $44.92/hr)].
    For the 850 entities that we expect will be required to begin 
reporting a device identifier, we estimate that this would take support 
staff between 10 and 40 hours per entity (with larger companies 
requiring more time) at $44.92/hr and 2 hours at $83.70/hr for 
compliance officers. For all entities, we estimate a subtotal of 21,100 
hours [(40 hr for support staff at a large entity x 282 entities) + (20 
hr for support staff at a medium entity x 244 entities) + (10 hr for 
support staff at a small entity x 324 entities) + (2 hr for compliance 
officers at every entity regardless of size x 850 entities)] at a cost 
of $1,013,740 [(11,280 hr for support staff at large entities x $44.92/
hr) + (4,880 for support staff at medium entities x $44.92/hr) + (3,240 
for support staff at small entities x $44.92/hr) + (1,700 hr for 
compliance officers across all entities regardless of size x $83.70/
hr)].
    We also assume that the remaining 750 entities not planning to 
submit a device identifier will have a small amount of burden 
associated with updating their submission processes. We estimate that 
this will take support staff between 2 and 10 hours per entity (with 
larger entities requiring more time) at $44.92/hr and 2 hours for 
compliance officers at $83.70/hr. For all entities, we estimate a 
subtotal of 5,637 hours [(10 hr for support staff at a large entity x 
249 entities) + (5 hr for support staff at a medium entity x 215 
entities) + (2 hr for support staff at a small entity x 286 entities) + 
(750 hr for compliance officers at all entities regardless of size x 2 
hr)] at a cost of $311,384 [(2,490 hr for support staff at large 
entities x $44.92/hr) + (1,075 hr for support staff at medium entities 
x $44.92/hr) + (572 hr for support staff at small entities x $44.92/hr) 
+ (1,500 hr for compliance officers at all entities regardless of size 
x $83.70/hr)].
    In aggregate, we estimate a one-time burden of 51,577 hours (24,840 
hr + 21,100 hr + 5,637 hr) at a cost of $2,440,937 ($1,115,813 + 
$1,013,740 + $311,384) to implement. After these adjustments are made, 
we do not anticipate there being any ongoing added burden beyond what 
is currently approved under the aforementioned control number. We are 
maintaining these burden estimates as we believe they are 
representative of the array of potential burden associated with these 
changes.

  Table 71--Burden for Changes To Standardize Data on Reported Covered
            Drugs, Devices, Biologicals, or Medical Supplies
------------------------------------------------------------------------
               Description                     Hours           Cost
------------------------------------------------------------------------
First year data collection burden for             24,840      $1,115,813
 entities that do not currently collect
 a device identifier....................
First year submission burden for all              21,100       1,013,740
 entities that will be required to
 report a device identifier.............
One time submission process and system             5,637         311,384
 updates for entities not reporting a
 device identifier......................
                                         -------------------------------

[[Page 63108]]

 
    Total...............................          51,577      $2,440,937
------------------------------------------------------------------------

    Comment: One commenter requested that CMS consider the potential 
additional burden on reporting entities based on the expanded 
definition of covered recipients.
    Response: We recognize that there is an increased data reporting 
requirement associated with implementation of these statutory 
requirements, but the expanded definition is required by statute. The 
estimated burden of Open Payments program is outlined under OMB control 
number 0938-1237. Section VII.F.7.a. of this final rule provides an 
estimate of the anticipated regulatory impact, although section 6111(c) 
of the SUPPORT Act states that chapter 35 of title 44 of the U.S. Code, 
which includes such provisions as the PRA, shall not apply to the 
changes to the definition of a covered recipient. As implementation 
plans are made, we will work to provide guidance, technical assistance, 
and operational efficiencies to help reduce the potential burden as 
much as possible.
    Comment: One commenter further stated that they believe the burden 
estimate to add DI information to the Open Payment dataset is greater 
than CMS assumed. The commenter would like to provide input to CMS on 
the implementation of this requirement.
    Response: When making this burden estimate, we took into account 
all of the current reporting entities and the array of demographics. We 
divided the group into several smaller categories based on entity size 
and made assumptions about the effort needed to make system and process 
changes. We assume that our estimates for each category will be low for 
some entities, but high for others. As we work through implementing 
these changes, we hope stakeholders will continue to provide feedback 
during working sessions to ensure our data collection system is easy to 
use and provides clear information.
6. ICRs Regarding Medicare Enrollment of Opioid Treatment Programs
    The following discusses the burden estimates we proposed regarding 
the enrollment of OTP programs.
    As mentioned in section III.H. of this final rule, OTP providers 
will be required to enroll in Medicare via the paper or internet-based 
version of the Form CMS-855B (or its successor application) and any 
applicable supplement, pay the application fee, submit fingerprints, 
and complete a provider agreement.
    Based on SAMHSA statistics and our internal data, we generally 
estimated that: (1) There are about 1,700 certified and accredited OTPs 
eligible for Medicare enrollment; and (2) 200 OTPs would become 
certified by SAMHSA in the next 3 years (or roughly 67 per year), 
bringing the total amount of OTPs eligible to enroll to approximately 
1,900 over the next 3 years.
    Form Completion (Sec.  424.67(b)): We estimated that it would take 
each OTP an average of 3 hours to obtain and furnish the information on 
the Form CMS-855B (OMB control number: 0938-0685) and a new supplement 
thereto designed to capture information unique to OTPs. Per our 
experience, we believe that the OTP's medical secretary would be 
responsible for securing and reporting data on the Form CMS-855B and 
new accompanying OTP supplement. We estimated that this task would take 
approximately 2.5 hours; of this amount, roughly 30 minutes would 
involve completion of the data on the supplement, though this timeframe 
could be higher or lower depending upon the number of individuals whom 
the OTP must list. Additionally, the form would be reviewed and signed 
by a health diagnosing and treating practitioner of the OTP, a process 
we estimated would take 30 minutes. We project a first-year burden of 
5,301 hours (1,767 entities x 3 hr) at a cost of $244,146 (1,767 
entities x ((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 x $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 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 estimate an annual burden of 
1,900 hours (5,700 hr/3) at a cost of $87,507 ($262,522/3).
    A copy of the draft OTP supplement was made available online, and 
we welcomed public comment on: (1) Its contents; (2) the usefulness of 
the data to be captured thereon; and (3) the anticipated burden of 
completion. We received no comment and are finalizing the supplement as 
well as our burden estimates as proposed.
    Fingerprinting (Sec.  424.518): In this rule, OTPs will be subject 
to high categorical risk level screening under Sec.  424.518, which 
requires the submission of a set of fingerprints for a national 
background check (via FBI Applicant Fingerprint Card FD-258) from all 
individuals who maintain a 5 percent or greater direct or indirect 
ownership interest in the OTP. Since the burden is currently approved 
by OMB as a common form (FD-258) under control number 1110-0046, we are 
not setting out such burden. However, an analysis of the impact of this 
requirement can be found in the RIA section of this rule.
    Application Fee (Sec.  424.514): As already discussed in this rule, 
each OTP will be required to pay an application fee at the time of 
enrollment. The application fee does not meet the definition of a 
``collection of information'' (5 CFR 1320.3(c)) and, as such, is not 
subject to the requirements of the PRA. Although we are not setting out 
such burden under this PRA section, the cost is scored under section 
VII.F.8. of the RIA.
    Provider Agreement (Sec.  424.67(b)(7)): OTPs will also have to 
complete a provider agreement in order to enroll in Medicare. The 
burden for reporting and completing the Provider Agreement Form CMS-
1561 and -1561A (OMB control number 0938-0832) was based on SAMHSA 
statistics. We estimate that there are about 1,700 already certified 
and accredited OTPs eligible for Medicare enrollment initially; 
approximately 200 OTPs would become certified by SAMHSA in the next 3 
years (or roughly 67 per year). We anticipate that it would take the 
OPT 5 minutes at $192.44/hr for a Chief Executive to review and sign 
the CMS-1561 or CMS-1561A, and an additional 5 minutes at $35.66/hr for 
a Medical Secretary to file the document when fully executed.
    In aggregate, we estimate a 3-year burden of 317 hours ([1,767 OPTs 
for year 1 + 67 OTPs for year 2 + 67 OTPs for year 3] x 10 min/60) at a 
cost of $36,154 ([317 hr/2 respondents x

[[Page 63109]]

$192.44/hr] + [317 hr/2 respondents x $35.66/hr]). This results, 
roughly, in a Year 1 burden of 295 hours at a cost of $33,623, a Year 2 
burden of 11 hours at a cost of $1,272, and a Year 3 burden of 11 hours 
at a cost of $1,254. Over the course of OMB's typical 3-year approval 
period, we estimate an average annual burden of 106 hours (317 hr/3 
years) at a cost of $12,051 ($36,154/3 years).
    Total: Table 72 summarizes our foregoing burden estimates.
    [GRAPHIC] [TIFF OMITTED] TR15NO19.119
    
    We received no comments on our proposed requirements and burden 
estimates and are therefore finalizing them without change. The 
requirement and burden estimates will be submitted to OMB for approval 
under control number 0938-0685 (Form CMS-855B; ``Medicare Enrollment 
Application: Clinics/Group Practices and Certain Other Suppliers'') and 
0938-0832 (Form CMS-1561/-1561A; ``Health Insurance Benefit 
Agreement'').
7. The Quality Payment Program (42 CFR Part 414 and Section III.K. of 
This Final Rule)
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 ICRs reflect this final rule's policies, as well as policies in 
the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77008 
and 82 FR 53568, respectively), and the CY 2019 PFS final rule (83 FR 
59452).
(2) Summary of Quality Payment Program Changes: MIPS
(a) Summary of Changes to our Currently Approved Burden Estimates
    As discussed in more detail in section VI.B.7, the MIPS ICRs 
consist of: Registration for virtual groups; qualified registry self-
nomination applications; and QCDR self-nomination applications; CAHPS 
survey vendor applications; Quality Payment Program Identity Management 
Application Process; quality performance category data submission by 
Medicare Part B claims collection type, QCDR and MIPS CQM collection 
type, eCQM collection type, and CMS web interface submission type; 
CAHPS for MIPS survey beneficiary participation; group registration for 
CMS web interface; group registration for CAHPS for MIPS survey; call 
for quality measures; reweighting applications for Promoting 
Interoperability and other performance categories; Promoting 
Interoperability performance category data submission; call for 
Promoting Interoperability measures; improvement activities performance 
category data submission; nomination of improvement activities; and 
opt-out of Physician Compare for voluntary participants.
    Two MIPS ICRs show changes in burden due to finalized policies: 
QCDR self-nomination applications and Call for Quality Measures. For 
the QCDR self-nomination applications ICR, we have decreased our 
estimate of the number of QCDR measures QCDRs will submit for approval 
from 9 to 2 (-7 measures) due to the finalized proposal to require 
measure testing prior to submission for approval. We have also 
increased our estimate of the time required to submit a QCDR measure by 
1.5 hours due to the requirement for QCDRs to link their QCDR measures 
as feasible to at least one cost measure, improvement activity, or MIPS 
Value Pathways starting with the 2021 self-nomination period (+1 hour); 
and the requirement for QCDR measure stewards to submit measure testing 
data as part of the self-nomination process for each QCDR measure (+0.5 
hours). The net effect of these changes is a reduction in burden per 
QCDR to self-nominate from 12 hours to 8 hours (-4 hours). For the Call 
for Quality Measures, we have increased our estimate of the time 
required to nominate a quality measure for consideration by 1 hour due 
to the requirement that MIPS quality measure stewards link their MIPS 
quality measures to existing and related cost measures and improvement 
activities and provide rationale for the linkage.
    The remaining changes to our currently approved burden estimates 
are adjustments to reflect better understanding of the impacts of 
policies finalized in previous rules, as well as the use of updated 
data sources available at the time of publication of this final rule.
    We are not making any changes to the following ICRs: Registration 
for virtual groups, CAHPS survey vendor applications, Quality Payment 
Program Identity Management Application Process, CAHPS for MIPS survey 
beneficiary participation, and group registration for CAHPS for MIPS 
survey. See section VI.B.7.n. of this final rule for a summary of the 
ICRs, the overall burden estimates, and a summary of the assumption and 
data changes affecting each ICR.
    The accuracy of our estimates of the total burden for data 
submission under the quality, Promoting Interoperability, and 
improvement activities performance categories may be impacted due to 
two primary reasons. First, we anticipate the number of QPs to increase 
because of total expected growth in Advanced APM participation as new 
models that are Advanced APMs for which we do not yet have enrollment 
data become available for participation. The additional QPs will be 
excluded from MIPS and likely not report. Second, it is difficult to 
predict what eligible clinicians who may report voluntarily

[[Page 63110]]

will do in the 2020 MIPS performance period compared to the 2018 MIPS 
performance period, and therefore, the actual number of 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.
    The revised requirements and burden estimates for all Quality 
Payment Program ICRs (except for CAHPS for MIPS and virtual groups 
election) will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621). The CAHPS for MIPS Survey is approved under OMB 
control number 0938-1222 (CMS-10450). The Virtual Groups Election is 
approved under OMB control number 0938-1343 (CMS-10652).
(b) Summary of Changes to Burden Estimates Provided in the CY 2020 PFS 
Proposed Rule
    In the CY 2020 PFS proposed rule (84 FR 40838 through 40881), we 
used respondent data from the 2017 MIPS performance period for the 
quality, Promoting Interoperability, and improvement activities 
performance categories with the sole exception of 104 CMS Web Interface 
respondents, which was based on the number of groups who submitted data 
for the quality performance category via the CMS Web Interface for the 
2018 MIPS performance period. For this final rule, we have updated our 
respondent estimates for each of these performance categories with data 
from the 2018 MIPS performance period.
    Our participation estimates are reflected in Tables 78, 79 and 80 
for the quality performance category, Table 96 for the Promoting 
Interoperability performance category, and Table 101 for the 
improvement activities performance category.
(3) Summary of Quality Payment Program Changes: Advanced APMs
    As discussed in more detail in sections VI.B.7. of this final rule, 
ICRs for Advanced APMs consist of: Partial Qualifying APM Participant 
(QP) election; Other Payer Advanced APM identification: Payer Initiated 
and Eligible Clinician Initiated Processes; and submission of data for 
All-Payer QP determinations under the All-Payer Combination Option.
    For these ICRs, the changes to currently approved burden estimates 
are adjustments based on updated projections for the 2020 MIPS 
performance period. We are not making any changes to our per-respondent 
burden estimates and have not made any changes or adjustments to the 
burden estimates provided in the CY 2020 PFS proposed rule. We are also 
not making any changes to the Other Payer Advanced APM identification: 
Eligible Clinician Initiated Process ICR.
(4) Framework for Understanding the Burden of MIPS Data Submission
    Because of the wide range of information collection requirements 
under MIPS, Table 73 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 73, 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 73.
    For MIPS eligible clinicians participating in MIPS APMs, the 
organizations submitting data on behalf of MIPS eligible clinicians 
will vary between performance categories and, in some instances, 
between MIPS APMs. For the 2020 MIPS performance period, the quality 
data submitted by MIPS APM participants reporting through the CMS Web 
Interface on behalf of their participant MIPS eligible clinicians will 
fulfill any MIPS submission requirements for the quality performance 
category. For other MIPS APMs, the quality data submitted by APM 
Entities on behalf of their participant MIPS eligible clinicians will 
fulfill any MIPS submission requirements for the quality performance 
category if that data is available to be scored. However, as finalized 
in section III.K.3.c.(5)(c)(i)(A) of this rule, beginning in the 2020 
MIPS performance period, MIPS eligible clinicians participating in MIPS 
APMs whose APM quality data is not available for MIPS may elect to 
report MIPS quality measures at either the APM entity, individual, or 
TIN-level in a manner similar to our established policy for the 
Promoting Interoperability performance category under the APM scoring 
standard for purposes of the MIPS quality performance category. If we 
determine there are not sufficient measures applicable and available, 
we will assign performance category weights as specified in Sec.  
414.1370(h)(5).
    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.
    Advanced APM participants who are determined to be Partial QPs may 
incur additional burden if they elect to participate in MIPS, which is 
discussed in more detail in the CY 2018 Quality Payment Program final 
rule (82 FR 53841 through 53844), but other than the election to 
participate in MIPS, we do not have data to estimate that burden.
BILLING CODE 4120-01-P

[[Page 63111]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.120


[[Page 63112]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.121


[[Page 63113]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.122

BILLING CODE 4120-01-C
    The policies finalized in the CY 2017 and CY 2018 Quality Payment 
Program final rules, and the CY 2019 PFS final rule and continued in 
this final rule create some additional data collection requirements not 
listed in Table 73. These additional data collections, some of which 
were previously 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
     Self-nomination of new and returning QCDRs (81 FR 77507 
through 77508, 82 FR 53906 through 53908, and 83 FR 59998 through 
60000) (OMB 0938-1314).
     Self-nomination of new and returning registries (81 FR 
77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 through 
59998) (OMB 0938-1314).
     Approval process for new and returning CAHPS for MIPS 
survey vendors (82 FR 53908) (OMB 0938-1222).
Additional ICRs Related to the Data Submission and the Quality 
Performance Category
     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
     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
     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 new quality measures (83 FR 60010 through 60011) 
(OMB 0938-1314).
Additional ICRs Related to MIPS
     Opt out of performance data display on Physician Compare 
for voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR 
60022) (OMB 0938-1314).
Additional ICRs Related to APMs
     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 finalizing 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

[[Page 63114]]

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)
(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. 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.
    The burden associated with qualified registry self-nomination, QCDR 
self-nomination and measure submission, and the CAHPS for MIPS survey 
vendor applications follow: \130\
---------------------------------------------------------------------------

    \130\ 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) Qualified Registry Self-Nomination Applications
    The requirements and burden associated with qualified registries 
and their self-nomination will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    As explained below, this rule will both adjust the number of self-
nomination applications based on current data and revise the number of 
self-nomination applications due to policies promulgated in the CY 2019 
final rule regarding the definition of a QCDR (83 FR 59895) and minimum 
participation requirements (83 FR 59897) which are effective beginning 
in the 2020 MIPS performance period. The adjustment will decrease our 
total burden estimates while keeping our burden per response estimates 
unchanged. We are not making any changes to the self-nomination 
process.
    We refer readers to Sec.  414.1400(a)(2) and (c)(1) which state 
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.
    In the CY 2018 Quality Payment Program final rule (82 FR 53815) and 
as stated in Sec.  414.1400(c)(1), previously approved qualified 
registries in good standing (that is, that are not on probation or 
disqualified) may attest that certain aspects of their previous year's 
approved self-nomination have not changed and will be used for the 
applicable performance period. In the same rule, we stated that 
qualified registries in good standing that would like to make minimal 
changes to their previously approved self-nomination application from 
the previous year, may submit these changes, and attest to no other 
changes from their previously approved qualified registry application 
for CMS review during the self-nomination period (82 FR 53815). The 
self-nomination period is from July 1 to September 1 of the calendar 
year prior to the applicable performance period beginning with the 2020 
MIPS performance period (83 FR 59906).
    For this final rule, we have adjusted the number of self-nominating 
applicants from 150 to 153 based on the number of applications received 
during the 2020 self-nomination period, an increase of 3 from the 
currently approved estimate of 150 (83 FR 59997 through 59998). This is 
a decrease of 137 from the estimate of 290 provided in the CY 2020 PFS 
proposed rule due to availability of more recent data. This estimate 
reflects impacts of revisions to both the definition of a QCDR and 
minimum participation requirements for entities seeking approval as a 
QCDR which were previously finalized in the CY 2019 PFS final rule (83 
FR 59895 through 59897) that may or may not have resulted in some 
entities seeking approval as a qualified registry rather than a QCDR.
    The burden associated with the qualified registry self-nomination 
process varies depending on the number of existing qualified registries 
that elect to use the simplified self-nomination process in lieu of the 
full self-nomination process as described in the CY 2018 Quality 
Payment Program final rule (82 FR 53815). The Quality Payment Program 
Self-Nomination Form is submitted electronically using a web-based 
tool. We will be submitting a revised version of the form for approval 
under OMB control number 0938-1314 (CMS-10621).
    As described in the CY 2017 Quality Payment Program final rule, the 
full self-nomination process requires the submission of basic 
information, a description of the process the qualified registry will 
use for completion of a randomized audit of a subset of data prior to 
submission, and the provision of a data validation plan along with the 
results of the executed data validation plan by May 31 of the year 
following the performance period (81 FR 77383 through 77384). As shown 
in Table 75, we estimate that the staff involved in the qualified 
registry self-nomination process will be mainly computer systems 
analysts or their equivalent, who have an adjusted labor rate of 
$90.02/hr. Consistent with the CY 2019 PFS final rule (83 FR 59998), we 
estimate that the time associated with the self-nomination process 
ranges from a minimum of 0.5 hours (for the simplified self-nomination 
process) to 3 hours (for the full self-nomination process) per 
qualified registry. For the 2019 MIPS performance period, 135 qualified 
registries were approved to submit data out of the total 141 (96 
percent) which submitted nomination forms. For our minimum burden 
estimate, we assume a similar percentage of the 153 qualified 
registries that submitted nomination forms in CY 2019 for the 2020 MIPS 
performance period will be approved and will nominate using the 
simplified process in CY 2020; this results in a total of 147 (153 x 96 
percent) simplified self-nomination applications received. When 
considering this rule's adjusted number of nomination applications 
(153), we estimate that the annual burden will range from 91.5 hours 
([147 simplified self-nominations x 0.5 hr] + [6 full self-nominations 
x 3 hr]) to 459 hours (153 qualified registries x 3 hr) at a cost 
ranging from $8,237 (91.5 hr x $90.02/hr) to $41,319 (459 hr x $90.02/
hr), respectively (see Table 75).
    As shown in Table 74, compared to the currently approved minimum 
estimates of 97.5 hours and $8,777 and the maximum estimates of 450 
hours and $40,509, the increase in the number of respondents will 
adjust our total burden estimates by -6 hours and -$540 [(6 registries 
x 0.5 hr x $90.02/hr) + (-3 registries x 3 hr x $90.02/hr)] and +9 
hours and +$810 (3 registries x 3 hr x $90.02/hr). Although we are 
adjusting our total burden estimates based on more current data, the 
burden per response would remain unchanged. The reason for the decrease 
in minimum burden despite an increase in number of qualified 
registries, is the change in number of simplified and full self-
nominations. In the CY 2019 PFS final rule, we estimate 141 simplified 
self-

[[Page 63115]]

nominations and 9 full self-nominations; for this final rule, we 
estimate 147 simplified self-nominations and 6 full self-nominations.
[GRAPHIC] [TIFF OMITTED] TR15NO19.123

    As finalized in the CY 2017 Quality Payment Program final rule (81 
FR 77363 through 77364) and as further revised in the CY 2019 PFS final 
rule at (83 FR 60088) and in Sec.  414.1400(a)(2), qualified registries 
may submit data for any of the three MIPS performance categories 
quality (except for data on the CAHPS for MIPS survey); improvement 
activities; and Promoting Interoperability. In section 
III.K.3.g.(4)(a)(i) of this rule, we are finalizing changes to Sec.  
414.1400(a)(2) to state that beginning with the 2023 payment year (2021 
performance period), qualified registries must be able to submit data 
for all of the MIPS performance categories identified in the 
regulation. We are also finalizing to amend Sec.  414.1400(a)(2)(iii) 
to state that 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 (9). As part of the 
current self-nomination process, qualified registries are already 
required to attest to the MIPS quality measures, performance 
categories, improvement activities, and/or Promoting Interoperability 
measures and objectives supported. As part of this policy, we are 
requiring qualified registries to attest to the ability to submit data 
for all three of these performance categories at time of self-
nomination. As finalized in the CY 2017 Quality Payment Program final 
rule, qualified registries are required to provide feedback on all of 
the MIPS performance categories at least 4 times a year (81 FR 77367 
through 77386). In section III.K.3.g.(4)(a)(ii), we are finalizing, 
beginning with the 2023 MIPS payment year, to require qualified 
registries to provide the following as a part of the performance 
feedback given at least 4 times (to the extent feasible) a year: 
Feedback to their clinicians and groups on how they compare to other 
clinicians who have submitted data on a given measure within the 
qualified registry. Further, qualified registries will be required to 
attest during the self-nomination process that they can provide 
performance feedback at least 4 times a year, and if not, provide 
sufficient rationale as to why they do not believe they would be able 
to meet this requirement. Because we are not requiring qualified 
registries to provide performance feedback to their clinicians and 
groups at a greater frequency than what has previously been required 
combined with qualified registries only being required to provide 
feedback using data they are already collecting, we do not believe this 
finalized policy creates enough additional burden for qualified 
registries to elect to discontinue participation in the Quality Payment 
Program. Therefore, we are not adjusting our estimates for the number 
of qualified registries that will self-nominate in the 2021 performance 
period or future years as a result of this requirement; if reliable 
information becomes available indicating this assumption is incorrect, 
we will adjust our assumptions and respondent estimates at that time. 
Because qualified registries will only be required to provide 
performance feedback to clinicians and not to CMS, and because 
qualified registries are already required to attest to the performance 
categories they support, we anticipate minimal changes to the self-
nomination process as a result of these requirements and assume there 
will be minimal impact on the time required to complete either the 
simplified or full self-nomination process.
    We are also finalizing in section III.K.3.g.(2) of this final rule 
and at Sec.  414.1400(a)(4) to establish that a condition of approval 
is for the third party intermediary to agree that 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 transition plan. Because of the uncertain, 
but low frequency (less than 10 per year historically) with which third 
party intermediaries have elected to discontinue services during a 
performance period, we are unable to estimate the total burden 
associated with development of CMS approved transition plans. However, 
we anticipate the time involved in developing a transition plan and 
disseminating it to their contracted MIPS eligible clinicians is likely 
to be no more than 10 hours.
    Qualified registries must comply with requirements on the 
submission of MIPS data to CMS. The burden associated with qualified 
registry submission requirements will be the time and effort associated 
with calculating quality measure results from the data submitted to the 
qualified registry by its participants and submitting these results, 
the numerator and denominator data on quality measures, the Promoting 
Interoperability performance category, and improvement activities data 
to us on behalf of their participants. We expect that the time needed 
for a qualified registry to accomplish these tasks will vary along with 
the number of MIPS eligible clinicians submitting data to the qualified 
registry and the number of applicable measures. However, we believe 
that qualified registries already perform many of these activities for 
their participants. Therefore, we believe the estimates discussed 
earlier and shown in Table 75

[[Page 63116]]

represents the upper bound for qualified registry burden, with the 
potential for less additional MIPS burden if the qualified registry 
already provides similar data submission services.
    Based on these assumptions, we estimate the total annual burden 
associated with a qualified registry self-nominating to be considered 
for approval.
[GRAPHIC] [TIFF OMITTED] TR15NO19.124

    Both the minimum and maximum burdens shown in Table 75 reflect 
adjustments to the number of respondents (from 150 to 153) due to 
availability of more recent data (+3 respondents). For purposes of 
calculating total burden associated with this final rule as shown in 
Table 116 only the maximum burden is being submitted to OMB for their 
review and approval.
    We received no public comments related to the burden estimates for 
qualified registry self-nomination. The burden estimates have been 
updated from the CY 2020 PFS proposed rule (84 FR 40848 through 40849) 
due to availability of updated data.
(3) QCDR Self-Nomination Applications
(a) Self-Nomination Process
    The requirements and burden associated with QCDRs and the self-
nomination process will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    As explained below, this rule will adjust the number of self-
nomination applications submitted by QCDRs seeking approval to submit 
data from 200 to 76 based on data from the CY 2019 nomination period 
for the 2020 MIPS performance period. This estimate reflects impacts of 
revisions to both the definition of a QCDR and minimum participation 
requirements for entities seeking approval as a QCDR which were 
previously finalized in the CY 2019 PFS final rule (83 FR 59895 through 
59897) that may or may not have resulted in some entities seeking 
approval as a qualified registry rather than a QCDR. This rule will 
also update the number of QCDR measures submitted for consideration by 
each QCDR seeking to self-nominate (from 9 to 2), as well as the time 
required to submit information (from 1 hour to 2.5 hours) for each QCDR 
measure due to policies being finalized. In addition, our per response 
estimates for the simplified and full self-nomination processes will 
decrease from 9.5 hours to 5.5 hours and from 12 hours to 8 hours, 
respectively due strictly to our adjustment to the average number of 
QCDR measures submitted for approval by each QCDR based on availability 
of more recent data. These changes will decrease our minimum total 
burden estimate (from 2,025 hours to 418 hours) and increase our 
maximum total burden estimate (from 2,400 hours to 608 hours).
    We refer readers to Sec.  414.1400(a)(2) and (b)(1) which state 
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.
    In the CY 2018 Quality Payment Program final rule and Sec.  
414.1400(b)(1), previously approved QCDRs in good standing (that are 
not on probation or disqualified) that wish to self-nominate using the 
simplified process can attest, in whole or in part, that their 
previously approved form is still accurate and applicable (82 FR 
53808). Existing QCDRs in good standing that would like to make minimal 
changes to their previously approved self-nomination application from 
the previous year, may submit these changes, and attest to no other 
changes from their previously approved QCDR application, for CMS review 
during the current self-nomination period, from September 1 to November 
1 (82 FR 53808). The self-nomination period is from July 1 to September 
1 of the calendar year prior to the applicable performance period 
beginning in the 2020 MIPS performance period (83 FR 59898).
    The burden associated with QCDR self-nomination will vary depending 
on the number of existing QCDRs that will elect to use the simplified 
self-nomination process in lieu of the full self-nomination process as 
described in the CY 2018 Quality Payment Program final rule (82 FR 
53808 through 53813). The OPP Self-Nomination Form is submitted 
electronically using a web-based tool. We will be submitting a revised 
version of the form for approval under OMB control number 0938-1314 
(CMS-10621).
    For this final rule, we have adjusted the number of QCDRs self-
nominating for approval to submit data from 200 to 76 based on the 
number of applications received during the CY 2019 self-nomination 
period for the 2020 MIPS performance period, a decrease of 124 from the 
currently approved estimate of 150 (83 FR 59997 through 59998). This is 
a decrease of 15 from the estimate of 91 provided in the CY 2020 PFS 
proposed rule due to availability of more recent data. Given this 
decrease, for our minimum burden estimate we will assume each of the 76 
QCDRs will be approved for the 2020 MIPS performance period and will 
self-nominate using the simplified process during the CY 2020 
nomination period. This estimate reflects impacts of revisions to both 
the definition of a QCDR and minimum participation requirements for 
entities seeking approval as a QCDR which were previously finalized in 
the CY 2019 PFS final rule (83 FR 59895 through 59897) that may or may 
not have resulted in

[[Page 63117]]

some entities seeking approval as a qualified registry rather than a 
QCDR. We were unable to change our estimates in the CY 2019 PFS final 
rule to reflect these policies because we had neither the data to 
support a change nor any notifications of intent by previously approved 
QCDRs indicating they would no longer self-nominate as a QCDR (83 FR 
59999). As a result, we are making the necessary adjustments to our 
respondent estimates in this final rule.
    Based on previously finalized policies in the CY 2017 Quality 
Payment Program final rule (81 FR 77363 through 77364) and as further 
revised in the CY 2019 PFS final rule at Sec.  414.1400(a)(2) (83 FR 
60088), the current policy is that all third party intermediaries may 
submit data for any of the three MIPS performance categories quality 
(except for data on the CAHPS for MIPS survey); improvement activities; 
and Promoting Interoperability. In section III.K.3.g.(3)(a)(i) of this 
rule, we are finalizing changes to Sec.  414.1400(a)(2) to state that 
beginning with the 2023 MIPS payment year (2021 performance period), 
QCDRs must be able to submit data for all of the MIPS performance 
categories identified in the regulation. We are also finalizing to 
amend Sec.  414.1400(a)(2)(iii) to state that for the Promoting 
Interoperability performance category, 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 (9). As finalized in the CY 2018 Quality Payment Program final 
rule, QCDRs are required to provide feedback on all of the MIPS 
performance categories that the QCDR reports at least 4 times a year 
(82 FR 53812). In section III.K.3.g.(3)(a)(iii) we are finalizing, 
beginning with the 2023 MIPS payment year, to require that QCDRs 
provide the following as a part of the performance feedback given at 
least 4 times a year: Feedback to their clinicians and groups on how 
they compare to other clinicians who have submitted data on a given 
measure (MIPS quality measure and/or QCDR measure) within the QCDR. We 
also understand that QCDRs can only provide feedback on data they have 
collected on their clinicians and groups, and realize the comparison 
would be limited to that data and not reflect the larger sample of 
those that have submitted on the measure for MIPS, which the QCDR does 
not have access to. Further, we are also finalizing, beginning with the 
2023 MIPS payment year, to require QCDRs to attest during the self-
nomination process that they can provide performance feedback at least 
4 times a year, and if not, provide sufficient rationale as to why they 
do not believe they will be able to meet this requirement. We do not 
believe these proposals create enough additional burden for QCDRs to 
elect to discontinue participation in the Quality Payment Program 
because we are not requiring QCDRs to provide performance feedback to 
their clinicians and groups at a greater frequency than what has 
previously been required and because QCDRs will only be required to 
provide feedback using data they are already collecting. Therefore, we 
are not adjusting our estimates for the number of QCDRs that will self-
nominate in the 2021 performance period or future years as a result of 
these finalized policies; if reliable information becomes available 
indicating this assumption is incorrect, we will adjust our assumptions 
and respondent estimates at that time. As part of the self-nomination 
process, QCDRs are already required to attest to the MIPS quality 
measures, performance categories, improvement activities, and Promoting 
Interoperability measures and objectives supported and will not be 
required to provide performance feedback to CMS. Therefore, we 
anticipate no additional steps being added to the self-nomination 
process as a result of these finalized policies and assume there will 
be no impact on the time required to complete either the simplified or 
full self-nomination process.
    In the CY 2020 PFS proposed rule, we increased our per-respondent 
burden estimate for completing the full self-nomination process by 15 
minutes (0.25 hours) due to the proposal to require QCDRs to describe 
the quality improvement services they will provide as part of their 
self-nomination (84 FR 40851). Due to this proposal not being 
finalized, we have decreased our burden estimate from the CY 2020 PFS 
proposed rule by 0.25 hours.
    We estimate that the self-nomination process for QCDRs to submit on 
behalf of MIPS eligible clinicians or groups for MIPS will involve 
approximately 3 hours per QCDR to submit information required at the 
time of self-nomination as described in the CY 2017 Quality Payment 
Program final rule including basic information about the QCDR, 
describing the process it will use for completion of a randomized audit 
of a subset of data prior to submission, providing a data validation 
plan, and providing results of the executed data validation plan by May 
31 of the year following the performance period (81 FR 77383 through 
77384). However, for the simplified self-nomination process, we 
estimate 0.5 hours per QCDR to submit this information.
    We are also finalizing in section III.K.3.g.(2) of this final rule 
and at Sec.  414.1400(a)(4) to establish that a condition of approval 
is for the third party intermediary to agree that 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 transition plan. Because of the uncertain, 
but low frequency (less than 10 per year historically) with which third 
party intermediaries have elected to discontinue services during a 
performance period, we are unable to estimate the total burden 
associated with development of CMS approved transition plans. However, 
we anticipate the time involved in developing a transition plan and 
disseminating it to contracted MIPS eligible clinicians is likely to be 
no more than 10 hours.
(b) QCDR Measure Requirements
    As promulgated in the CY 2017 and CY 2018 Quality Payment Plan 
final rules (81 FR 77366 through 77374 and 82 FR 53812 through 53813), 
QCDRs calculate their measure results and also must possess 
benchmarking capabilities (for QCDR measures) that compare the quality 
of care a MIPS eligible clinician provides with other MIPS eligible 
clinicians performing the same quality measures. For QCDR measures, the 
QCDR must provide to us, if available, data from years prior (for 
example, 2017 data for the 2019 MIPS performance period) before the 
start of the performance period. In addition, the QCDR must provide to 
us, if available, the entire distribution of the measure's performance 
broken down by deciles. As an alternative to supplying this information 
to us, the QCDR may post this information on their website prior to the 
start of the performance period, to the extent permitted by applicable 
privacy laws. The time it takes to perform these functions may vary 
depending on the sophistication of the entity, but we estimate that a 
QCDR will spend an additional 1 hour performing these activities per 
measure.
    As discussed in section III.K.3.g.(3)(c)(i)(B)(cc), we are 
finalizing that in order for a QCDR measure to be considered for use in 
the program beginning with the 2021 performance period and future 
years, all QCDR measures submitted for self-nomination

[[Page 63118]]

must be fully developed with completed testing results at the clinician 
level, as defined by the CMS Blueprint for the CMS Measures Management 
System, as used in the testing of MIPS quality measures prior to the 
submission of those measures to the Call for Measures. Beginning with 
the 2021 performance period and future years, we are finalizing in 
section III.K.3.g.(3)(c)(i)(B)(dd) of this final rule, to also require 
QCDRs to collect data on the potential QCDR measure, appropriate to the 
measure type, as defined in the CMS Blueprint for the CMS Measures 
Management System, prior to self-nomination. We estimate the time 
necessary to submit measure testing data as part of the self-nomination 
process will average approximately 0.5 hours per measure, understanding 
that this estimate may be either high or low depending on the type of 
measure and the quantity of data being submitted. We discuss additional 
impacts of this proposal in section VII.C.10.(f) of this rule's RIA.
    In section III.K.3.g.(3)(c)(i)(A)(bb) of this rule, we are 
finalizing to amend Sec.  414.1400 to state that CMS may consider the 
extent to which a QCDR measure is available to MIPS eligible clinicians 
reporting through QCDRs other than the QCDR measure owner for purposes 
of MIPS. If CMS determines that a QCDR measure is not available to MIPS 
eligible clinicians, groups, and virtual groups reporting through other 
QCDRs, CMS may not approve the measure. Because the choice to license a 
QCDR measure is an elective business decision made by individual QCDRs 
and we lack insight into both the specific terms and frequency of 
agreements made between entities, we are not accounting for QCDR 
measure licensing costs as part of our burden estimate. However, if 
information regarding the number of licensing agreements and the 
approximate cost per agreement becomes available, we may adjust our 
assumptions and burden estimates at that time.
    In section III.K.3.g.(3)(c)(i)(B)(ee) of this rule, we are 
finalizing, beginning with the 2020 performance period, that after the 
self-nomination period closes each year, we will review newly self-
nominated and previously approved QCDR measures based on considerations 
as described in the CY 2019 PFS final rule (83 FR 59900 through 59902). 
In instances in which multiple, similar QCDR measures exist that 
warrant approval, we may provisionally approve the individual QCDR 
measures for 1 year with the condition that QCDRs address certain areas 
of duplication with other approved QCDR measures in order to be 
considered for the program in subsequent years. The QCDR could do so by 
harmonizing its measure with, or significantly differentiating its 
measure from, other similar QCDR measures. QCDR measure harmonization 
may require two or more QCDRs to work collaboratively to develop one 
cohesive QCDR measure that is representative of their similar yet, 
individual measures. We are unable to account for measure harmonization 
costs as part of our burden estimate, as the process and outcomes of 
measure harmonization will likely vary substantially depending on a 
number of factors, including: Extent of duplication with other 
measures, number of QCDRs involved in harmonizing toward a single 
measure, and number of measures being harmonized among the same QCDRs. 
We intend to identify only those QCDR measures which are duplicative to 
such an extent as to assume harmonization will not be overly 
burdensome, however, because the harmonization process will occur 
between QCDRs without our involvement, we are unable to predict or 
quantify the associated effort.
    As discussed in section III.K.3.g.(3)(c)(i)(B)(bb) of this final 
rule, beginning with the 2021 performance period and future years, we 
are finalizing that QCDRs are required to link their QCDR measures as 
feasible to at least one of the following, at the time of self-
nomination: (1) Cost measures (as found in section III.K.3.c.(2) of 
this final rule); (2) improvement activities (as found in Appendix 2: 
Improvement Activities Tables); or (3) CMS developed MIPS Value 
Pathways (as described in section III.K.3.a. of this final rule). We 
estimate that a QCDR will spend an additional 1 hour performing these 
activities per measure, on average.
    We are also finalizing to formalize factors we would take into 
consideration for approving and rejecting QCDR measures for the MIPS 
program beginning with the 2022 MIPS payment year (2020 performance 
period). With regard to approving QCDR measures, we are finalizing the 
following: (a) 2-year QCDR measure approval process, and (b) 
participation plan for existing QCDR measures that have failed to reach 
benchmarking thresholds. As discussed in section 
III.K.3.g.(3)(c)(ii)(B) of this rule, we are finalizing to implement, 
beginning with the 2021 performance period, 2-year QCDR measure 
approvals (at our discretion) for QCDR measures that attain approval 
status by meeting the QCDR measure considerations and requirements 
described in section III.K.3.g.(3)(c). The 2-year approvals will be 
subject to the following conditions whereby the multi-year approval 
will no longer apply if the QCDR measure is identified as: Topped out; 
duplicative of a new, more robust measure; reflects an outdated 
clinical guideline; requires measure harmonization, or if the QCDR 
self-nominating the measure is no longer in good standing. We believe 
this could result in reduced burden for QCDRs as they would not 
necessarily be required to submit every measure for approval annually. 
However, because we are unable to predict which previously approved 
QCDR measures will be removed or retained in future years, we are 
likewise unable to predict the total number of measures that will be 
submitted for approval and the resulting impact on future burden. We 
anticipate that the number of QCDR measures submitted in the 2021 
performance period will reflect the impact of this policy; at that time 
we will update our assumptions and burden estimates accordingly.
    We estimate that on average, each QCDR will submit information for 
2 QCDR measures, for a total burden of 2 hours per QCDR (1 hr per 
measure x 2 measures). Based on the number of measures nominated during 
the CY 2019 nomination period for the 2020 MIPS performance period 
(790, or approximately 10.4 measures per QCDR) as well as an analysis 
of currently approved QCDR measures which indicates less than 10 
percent of current measures have completed testing, we believe each 
QCDR is likely to submit 1 previously approved QCDR measure for 
approval during the CY 2020 nomination period. We also believe the 
finalized policy requiring measure testing will result in additional 
measures undergoing testing than in previous years and therefore 
estimate each QCDR will submit 1 additional measure for approval during 
the CY 2020 nomination period, for a total of 2 measures per QCDR. 
Finally, we believe the finalized changes in requirements for QCDR 
measure submission and for QCDRs to harmonize measures we identify as 
duplicative discussed earlier in this section will result in a 
reduction in the number of QCDR measures submitted for approval in 
future years. However, we are unable to quantify the impact these 
changes will have on the number of measures QCDRs will submit for 
approval beyond the impacts previously discussed. As information 
becomes available in future years, we will revisit our assumptions to 
better reflect the impact of these requirements on QCDRs and the 
quantity of measures

[[Page 63119]]

being submitted for consideration annually. When combined with our 
previously stated assumption regarding our inability to predict which 
QCDR measures will maintain approval in future years, we believe the 
estimate of 2 measures per QCDR to be appropriate.
    Beginning with the 2021 performance period, we are finalizing in 
section III.K.3.g.(3)(c)(iii) of this rule that in instances where an 
existing QCDR measure has been in MIPS for 2 years, and has failed to 
reach benchmarking thresholds due to low adoption, where a QCDR 
believes the low-reported QCDR measure is still important and relevant 
to a specialist's practice, that the QCDR may develop and submit to a 
QCDR measure participation plan, to be submitted as part of their self-
nomination. Because we are unable to predict the frequency with which 
existing QCDR measures will meet the finalized criteria for allowing 
QCDRs to submit a measure participation plan or the likelihood of QCDRs 
electing to submit a plan, we are unable to estimate the total 
associated burden. However, we anticipate the time involved in 
developing a measure participation plan is likely to average between 1 
and 2 hours, depending on the QCDR and the level of detail they choose 
to include. In future performance periods we may reassess availability 
of the number of QCDR measure participation plans submitted by QCDRs 
and estimate the associated burden, if possible. In aggregate, we 
estimate a QCDR will require 2.5 hours per QCDR measure, an increase of 
1.5 hours from the currently approved estimate of 1 hour (83 FR 59999). 
As discussed earlier in this section, we estimate each QCDR will submit 
2 QCDR measures for approval, on average. Therefore, we estimate each 
QCDR will require 5 hours (2 measures x 2.5 hr per measure) to submit 
QCDR measures for approval, independent of the selection of the 
simplified or full self-nomination process.
    We are finalizing in section III.K.3.g.3(c)(i)(A)(bb)(BB) of this 
final rule, to amend Sec.  414.1400 to add paragraph (b)(3)(iv)(I) to 
state that we would give greater consideration to measures for which 
QCDRs: (a) Conducted an environmental scan of existing QCDR measures; 
MIPS quality measures; quality measures retired from the legacy 
Physician Quality Reporting System (PQRS) program; and (b) utilized the 
CMS Quality Measure Development Plan Annual Report and the Blueprint 
for the CMS Measures Management System to identify measurement gaps 
prior to measure development. We are also finalizing in section 
III.K.3.g.3(c)(i)(A)(bb)(CC) of this final rule and Sec.  414.1400 to 
add paragraph (b)(3)(iv)(J), to state that, beginning with the 2020 
performance period, we place greater preference on QCDR measures that 
meet case minimum and reporting volumes required for benchmarking after 
being in the program for 2 consecutive CY performance periods. Those 
that do not meet this requirement, may not continue to be approved. 
Lastly, we are finalizing in section III.K.3.g.3(c)(i)(B)(aa) of this 
final rule, beginning with the 2020 performance period, to change both 
of the below listed considerations into requirements and add Sec.  
414.1400(b)(3)(v) to include the following for QCDR measure 
requirements for approval: Measures that are beyond the measure concept 
phase of development; and measures that address significant variation 
in performance. Because these proposals do not impact the amount of 
information QCDRs are required to submit for the nomination of a QCDR 
measure, we are not finalizing any additional changes to our burden 
estimate as result of these policies. We also do not believe these 
policies are likely to result in any additional change in the number of 
measures submitted per QCDR beyond the impacts previously discussed.
    In the CY 2019 PFS final rule, the burden associated with self-
nomination of a QCDR was estimated to range from a minimum of 9.5 hours 
(0.5 hours to submit information for simplified self-nomination process 
and 9 hours for submission of QCDR measures) to a maximum of 12 hours 
(3 hours for the full self-nomination process and 9 hours for the 
submission of QCDR measures) (83 FR 59999). For this rule, we are 
finalizing to increase the burden associated with self-nomination to a 
minimum of 5.5 hours (0.5 hours to submit information for the 
simplified self-nomination process and 5 hours for the submission of 
QCDR measures) to a maximum of 8 hours (3 hours to submit information 
for the full self-nomination process and 5 hours for the submission of 
QCDR measures) to account for our revised estimate of the average 
number of QCDR measures submitted for consideration per QCDR, as well 
as the revised estimate of burden per QCDR measure.
    We assume that the staff involved in the QCDR self-nomination 
process will continue to be computer systems analysts or their 
equivalent, who have an average labor rate of $90.02/hr. Considering 
that the time per QCDR associated with the self-nomination process 
ranges from a minimum of 5.5 hours to a maximum of 8 hours, we estimate 
that the annual burden will range from 418 hours (76 QCDRs x 5.5 hr) to 
608 hours (76 QCDRs x 8 hr) at a cost ranging from $37,628 (418 hr x 
$90.02/hr) and $54,732 (608 hr x $90.02/hr), respectively (see Table 
76).
    Based on the assumptions previously discussed, we provide an 
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures 
results and numerator and denominator data on MIPS eligible clinicians.
[GRAPHIC] [TIFF OMITTED] TR15NO19.125


[[Page 63120]]


    Both the minimum and maximum burden shown in Table 76 reflect 
adjustments to the number of respondents due to availability of more 
recent data, as well as changes resulting from policies finalized in 
the CY 2019 PFS final rule regarding the definition and minimum 
participation requirements for entities seeking approval as QCDRs which 
will be effective beginning with the 2020 MIPS performance period. For 
purposes of calculating total burden associated with the final rule as 
shown in Table 116, only the maximum burden is used.
    Independent of the change to our per response time estimate, the 
decrease in the number of respondents (from 200 to 76) results in an 
adjustment of between -1,303 hours [(-74 QCDRs x 9.5 hr) + (-50 QCDRs x 
12 hr)] at a cost of -$117,297 (-1,303 hr x $90.02) and -1,488 hours (-
124 QCDRs x 12 hr) at a cost of -$133,950 (-1,488 hr x $90.02/hr). 
Accounting for the adjustment in the number of QCDRs, the change in 
time per QCDR to self-nominate results in an change of between -304 
hours (76 QCDRs x -4 hr) at a cost of -$27,366 (-304 hr x $90.02/hr) 
and -304 hours (76 QCDRs x -4 hr) at a cost of -$27,366 (-304 hr x 
$90.02/hr). As shown in Table 77, when these two adjustments are 
combined, the net impact ranges between -1,607 hours (-1,304 hr -304 
hr) at a cost of -$144,663 (-$117,297 -$27,366) and -1,792 hours (-
1,488 hr -304 hr) at a cost of -$161,316 (-$133,950 -$27,366).
[GRAPHIC] [TIFF OMITTED] TR15NO19.126

    QCDRs must comply with requirements on the submission of MIPS data 
to CMS. The burden associated with the QCDR submission requirements 
will be the time and effort associated with calculating quality measure 
results from the data submitted to the QCDR by its participants and 
submitting these results, the numerator and denominator data on quality 
measures, the Promoting Interoperability performance category, and 
improvement activities data to us on behalf of their participants. We 
expect that the time needed for a QCDR to accomplish these tasks will 
vary along with the number of MIPS eligible clinicians submitting data 
to the QCDR and the number of applicable measures. However, we believe 
that QCDRs already perform many of these activities for their 
participants. As stated in section III.K.3.g.(3)(a)(i), based on our 
review of existing 2019 QCDRs through the 2019 QCDR Qualified Posting, 
approximately 92 QCDRs, or about 72 percent of the QCDRs currently 
participating in the program are able to submit data for these three 
performance categories. In addition, through our review of previous 
qualified postings for the 2018 and 2017 MIPS performance periods, we 
have observed that in 2018, 73 percent (approximately 110 QCDRs) and in 
2017, 73 percent (approximately 83 QCDRs) have been able to submit data 
for all three of the quality, Promoting Interoperability, and 
improvement activity performance categories. Given this, we believe it 
is reasonable that all QCDRs have the capacity to submit data for the 
improvement activities and Promoting Interoperability performance 
categories and are not making any further changes to our burden 
estimates. Therefore, we believe the 608 hour estimate noted in this 
section represents the upper bound of QCDR burden, with the potential 
for less additional MIPS burden if the QCDR already provides similar 
data submission services.
    The following is a summary of the public comments received on the 
Quality Payment Program ICRs regarding the burden estimates for QCDR 
self-nomination.
    Comment: A few commenters believe that the scope of proposals in 
the proposed rule increases cost and burden to the point where some 
third-party intermediaries may end their participation in MIPS. One 
commenter stated that several provisions would additionally require it 
to alter business plans, missions, and customer service priorities 
while another commenter cited their belief that CMS is attempting to 
shift costs and burden of administering the MIPS program onto specialty 
societies that create measures and operate QCDRs.
    Response: We believe that our policies are intended to standardize 
and raise the bar on the services and the quality of the third party 
intermediaries we have in the MIPS program. Similar to years past, the 
standards and requirements of QCDRs are higher when compared to that of 
qualified registries, as we expect QCDRs to have extensive experience 
in quality reporting, quality measure development, and clinical 
expertise to not just facilitate reporting, but to also help address 
measurement gaps found within the program. We believe that QCDRs and 
qualified registries should further clinician goals of quality 
improvement by providing meaningful information and services. While we 
estimate increases in the burden for self-nomination, the burden per 
QCDR measure submitted for approval, and the costs associated with 
developing measures and meeting requirements for approval as a QCDR or 
registry, we believe that the increased cost and burden are 
significantly outweighed by the positive impact of the policies for 
MIPS eligible clinicians. We discuss the financial impact of these 
proposals beyond reporting burden further in section VII.F.10.f. of the 
RIA.
    Comment: One commenter believes that the ``true costs'' associated 
with a QCDR application, whether using the simplified or full 
application, must reflect more than the actual time to input the data 
required. The commenter further cited costs such as creating and 
maintaining registries and QCDR

[[Page 63121]]

measures, recruitment of clinicians to develop quality improvement 
initiatives, hiring staff to support and develop content and services 
identified by these clinicians, and technology solutions necessary to 
support the quality improvement services.
    Response: We recognize there are additional costs and 
administrative burdens on respondents associated with self-nominating 
as a QCDR or submitting a QCDR measure beyond the reporting burden 
estimated in the Collection of Information section of this policy which 
only accounts for the time required for record keeping, reporting, and 
third-party disclosures associated with the policy. We discuss the 
financial impact of these proposals beyond reporting burden further in 
section VII.F.10.f. of the RIA. We understand that some respondents may 
require additional time above the 0.5 hours we estimate for the 
simplified self-nomination process and the 3 hours for the full self-
nomination process, but given that we do not include the costs to 
maintain registries or create measures and quality improvement services 
in our burden estimate, we believe this estimate is a reasonable 
average across all respondents based on our review of the nomination 
process, the information required to complete the nomination form, and 
the criteria required to self-nominate as a QCDR.
    After consideration of public comments, we are making no changes to 
our estimates as a result of public comments received, however we have 
decreased our per-respondent burden estimate for completing the full 
self-nomination form by 0.25 hours due to the decision not to finalize 
the proposal to require QCDR to engage in activities that will foster 
improvement in the quality of care. The burden estimates have been 
updated from the CY 2020 PFS proposed rule (84 FR 40850 through 40854) 
due to availability of updated data.
(4) CAHPS for MIPS Survey Vendor
    This rule is not finalizing 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.
d. ICRs Regarding Quality Data Submission (Sec. Sec.  414.1325 and 
414.1335)
(1) Background
    As explained below, this rule will adjust the number of respondents 
based on current data. The adjustment will increase our total burden 
estimates while keeping our ``per response'' estimates unchanged. We 
are not revising any requirements regarding the number of measures to 
be submitted or the manner in which they may be submitted.
    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 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.
    To determine which QPs should be excluded from MIPS, we used the QP 
List for the 2019 predictive file that contains current participation 
in Advanced APMs as of January 15, 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 definition at Sec.  414.1305 for the 2020 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 2020 Medicare 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.
    Using participation data from the 2018 MIPS performance period 
combined with the estimate of QPs for the 2020 performance period, we 
estimate a total of 780,605 clinicians will submit quality data as 
individuals or groups in the 2020 MIPS performance period, a decrease 
of 183,641 clinicians when compared to our estimate of 964,246 
clinicians in the CY 2019 PFS final rule (83 FR 60002).
    In the CY 2017 Quality Payment Program final rule, we assumed that 
any clinician that submits quality data codes to us for the Medicare 
Part B claims collection type is intending to do so for the Quality 
Payment Program to ensure that we fully accounted for any burden that 
may have resulted from our policies (81 FR 77501 through 77504); we 
continued using this assumption in both the CY 2018 Quality Payment 
Program final rule and the CY 2019 PFS final rule. 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). However, we also elected to 
continue using the assumption that all clinicians (except QPs) who 
submitted data via the Medicare Part B claims collection type in the 
2018 MIPS performance period would continue to do so for MIPS to avoid 
overstating the impact of the change as we lacked the data to 
accurately estimate both the number of clinicians who would be impacted 
by the finalized policies and the potential behavioral response of 
those clinicians who would be required to switch to another collection 
type (83 FR 60001). For this final rule, beginning with the 2020 MIPS 
performance period, we assume only clinicians in small practices who 
submitted quality data via Medicare Part B claims in the 2018 MIPS 
performance period will continue to do so for the 2020 MIPS performance 
period. Further, we assume that clinicians in other practices (not 
small practices) who meet at least one of the following criteria will 
not need to find an alternate collection type for submitting quality 
performance category data for the Quality Payment Program for the 2020 
MIPS performance period: (1) Facility-based; (2) submitted quality data 
via Medicare Part B claims and at least one other collection type; or 
(3) were previously scored as part of a group. Finally, we assume 
clinicians in other practices (not small practices) who meet all of the 
following criteria will submit via the MIPS CQM collection type for the 
2020 MIPS performance period because the Medicare Part B claims 
collection type will no longer be available as an option for collecting 
and reporting quality data: (1) Scored as individuals; (2) not 
facility-based; and (3) submitted quality data only via the Medicare 
Part B claims collection type in the 2018 MIPS performance period. 
Because we do not have data to accurately predict what collection type 
each affected clinician would use to collect and report quality data, 
we assume that the affected clinicians will select the MIPS CQM 
collection type because, when compared to Medicare Part B claims, we 
believe this is the next most accessible and least burdensome

[[Page 63122]]

alternative. Our assumptions result 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, as 
shown in Table 78.
    We assume that 100 percent of APM Entities in MIPS APMs will submit 
quality data to CMS as required under their models. Consistent with 
assumptions used in the CY 2019 PFS final rule (83 FR 60000 through 
60001), we include all quality data voluntarily submitted by MIPS APM 
participants made at the individual or TIN-level in our respondent 
estimates. Therefore, we are not finalizing any adjustments to our 
respondent estimates as a result of the policies discussed in section 
III.K.3.c.(5)(c)(i)(A) of this final rule, which allows MIPS eligible 
clinicians participating in MIPS APMs to elect to report MIPS quality 
measures at either the individual or TIN-level under the APM scoring 
standard beginning in the 2020 MIPS performance period. To estimate who 
will be a MIPS APM participant in the 2020 MIPS performance period, we 
used the latest QP List for the first snapshot data of the 2019 QP 
performance period. 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. For clinicians who participated in an APM in 2018, were not in 
an APM in 2019, and did not report MIPS quality data in 2018, we assume 
they will elect to report to MIPS via the MIPS CQM collection type, 
similar to our previously stated assumption regarding clinicians who 
are required to use an alternate reporting option.
    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.\131\ Tables 78, 79 and 
80 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.
---------------------------------------------------------------------------

    \131\ 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 78 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the 2020 MIPS performance period based on data from the 
2018 MIPS performance period.
    For the 2020 MIPS performance period, respondents will have the 
option to submit quality performance category data via Medicare Part B 
claims, direct, and log in and upload submission types, and CMS Web 
Interface. We estimate the burden for collecting data via collection 
type: Claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. We 
believe that, while estimating burden by submission type may be better 
aligned with the way clinicians participate with the Quality Payment 
Program, it is more important to reduce confusion and enable greater 
transparency by maintain consistency with previous rulemaking.
    For an individual, group, or third-party to submit MIPS quality, 
improvement activities, or Promoting Interoperability performance 
category data using either the log in and upload or the log in and 
attest submission type or to access feedback reports, the submitter 
must have a CMS Enterprise Portal user account. Once the user account 
is created using the Identity Management Application Process, 
registration is not required again for future years.
    Table 78 shows that in the 2020 MIPS performance period, an 
estimated 94,846 clinicians will submit data as individuals for the 
Medicare Part B claims collection type; 391,430 clinicians will submit 
data as individuals or as part of groups for the MIPS CQM or QCDR 
collection types; 247,856 clinicians will submit data as individuals or 
as part of groups via eCQM collection types; and 46,473 clinicians will 
submit as part of groups via the CMS Web Interface. In the CY 2020 PFS 
proposed rule, we estimated 109,951 clinicians will submit data as 
individuals for the Medicare Part B claims collection type; 359,621 
clinicians will submit data as individuals or as part of groups for the 
MIPS CQM or QCDR collection types; 247,329 clinicians will submit data 
as individuals or as part of groups via eCQM collection types; and 
116,342 clinicians will submit as part of groups via the CMS Web 
Interface (84 FR 40856). Our updated estimates reflect the availability 
of more recent data.
    Table 78 provides estimates of the number of clinicians to collect 
quality measures data via each collection type, regardless of whether 
they decide to submit as individual clinicians or as part of groups. 
Because our burden estimates for quality data submission assume that 
burden is reduced when clinicians elect to submit as part of a group, 
we also separately estimate the expected number of clinicians to submit 
as individuals or part of groups.

    Table 78--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
                                                       Medicare
                                                        Part B    QCDR/ MIPS     eCQM       CMS web      Total
                                                        claims        CQM                  interface
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect data by collection        94,846     391,430     247,856      46,473     780,605
 type (as individual clinicians or groups) in 2020
 MIPS performance period (excludes QPs) (a).........
* Number of clinicians to collect data by collection     257,260     324,693     243,062     139,231     964,246
 type (as individual clinicians or groups) in 2019
 MIPS performance period (excludes QPs) (b).........
Difference (c) = (a) - (b)..........................    -162,414    + 66,737     + 4,794     -92,758    -183,641
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).


[[Page 63123]]

    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 79 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 2020 MIPS performance period. We estimate 
that approximately 94,846 clinicians will submit data as individuals 
using the Medicare Part B claims collection type; approximately 100,269 
clinicians will submit data as individuals using MIPS CQMs or QCDR 
collection types; and approximately 38,935 clinicians will submit data 
as individuals using eCQMs collection type. In the CY 2020 PFS proposed 
rule, we estimated that 109,951 clinicians will submit data as 
individuals using the Medicare Part B claims collection type; 
approximately 106,039 clinicians will submit data as individuals using 
MIPS CQMs or QCDR collection types; and approximately 47,455 clinicians 
will submit data as individuals using eCQMs collection type (84 FR 
40856 through 40857). Our updated estimates reflect the availability of 
more recent data.

     Table 79--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
                                                 Collection Type
----------------------------------------------------------------------------------------------------------------
                                                       Medicare
                                                        Part B    QCDR/ MIPS     eCQM       CMS web      Total
                                                        claims        CQM                  interface
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit data as individuals        95,846     100,269      38,935           0     234,050
 in 2020 MIPS Performance Period (excludes QPs) (a).
* Number of Clinicians to submit data as individuals     257,260      71,439      47,557           0     376,256
 in 2019 MIPS Performance Period (excludes QPs) (b).
Difference (c) = (a) - (b)..........................    -162,414    + 28,830      -8,622           0    -142,206
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    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 79 are not mutually exclusive.
    Table 80 provides our estimated counts of groups or virtual groups 
that will submit quality data on behalf of clinicians for each 
collection type in the 2020 MIPS performance period and reflects our 
assumption that the formation of virtual groups will reduce burden. 
With the previously discussed exceptions regarding groups who 
experienced a change in APM participation status between the 2018 and 
2019 MIPS performance periods, 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 2020 MIPS performance period. Specifically, we 
estimate that 10,949 groups and virtual groups will submit data for the 
QCDR or MIPS CQM collection types on behalf of 291,161 clinicians; 
4,398 groups and virtual groups will submit for eCQM collection types 
on behalf of 208,921 eligible clinicians; and 104 groups will submit 
data via the CMS Web Interface on behalf of 46,473 clinicians. In the 
CY 2020 PFS proposed rule, we estimated that 10,552 groups and virtual 
groups will submit data for the QCDR or MIPS CQM collection types on 
behalf of 253,582 clinicians; 4,332 groups and virtual groups will 
submit for eCQM collection types on behalf of 199,874 eligible 
clinicians; and 104 groups will submit data via the CMS Web Interface 
on behalf of 116,342 clinicians (84 FR 40857). Our updated estimates 
reflect availability of more recent data. In the CY 2017 and CY 2018 
Quality Payment Program final rules, the CY 2019 PFS final rule, the CY 
2020 PFS proposed rule, we were required to adjust our respondent 
estimates to account for MIPS eligible clinicians who we assumed would 
respond as participants in a virtual group. Because we are now able to 
base our respondent estimates on data from the 2018 MIPS performance 
period, which was the first performance period in which clinicians 
could submit as participants in a virtual group, we are no longer 
making the adjustment for virtual group participation.

     Table 80--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
                                     Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
                                                       Medicare
                                                        Part B    QCDR/ MIPS     eCQM       CMS web      Total
                                                        claims        CQM                  interface
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data by collection type            0      10,949       4,398         104      15,451
 (on behalf of clinicians) in 2020 MIPS performance
 period (excludes QPs) (a)..........................
* Number of groups to collect data by collection               0      10,542       4,304         286      15,132
 type on behalf of clinicians in 2019 MIPS
 performance period (b).............................

[[Page 63124]]

 
Difference (c) = (a) - (b)..........................           0       + 407        + 94        -182         319
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    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 2020 
MIPS performance period, the total number of quality measures will be 
218. The new MIPS quality measures proposed for inclusion in MIPS for 
the 2020 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 81, as 
well as counts of new, removed, and substantively changed measures.

                   Table 81--Summary of Quality Measures for the 2020 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
                                                     Number of       Number of       measures        Number of
                 Collection type                     measures        measures     finalized with     measures
                                                   finalized as    finalized for   a substantive   remaining for
                                                        new           removal         change         CY 2020 *
----------------------------------------------------------------------------------------------------------------
Medicare Part B Claims Specifications...........               0               9              19              55
MIPS CQMs Specifications........................               2              39              72             196
eCQM Specifications.............................               1               4              34              47
Survey--CSV.....................................               0               0               0               1
CMS Web Interface Measure Specifications........               0               0               9              10
Administrative Claims...........................               0               0               0               1
                                                 ---------------------------------------------------------------
    Total.......................................               3              42              83             218
----------------------------------------------------------------------------------------------------------------
* A measure may be specified under multiple collection types but will only be counted once in the total.

    For the 2020 MIPS performance period, there is a net reduction of 
39 quality measures across all collection types compared to the 257 
measures finalized for the 2019 MIPS performance period (83 FR 60003). 
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.
    As discussed in section III.K.3.c.(1)(c)(ii) of this rule, we 
proposed to adopt a higher data completeness threshold (the percentage 
of eligible patients the clinician must check to see whether the 
measure applies to) for the 2020 MIPS performance period, such that 
MIPS eligible clinicians and groups submitting quality measure data on 
QCDR measures, MIPS CQMs, and eCQMs must submit data on at least 70 
percent of the MIPS eligible clinician or group's patients that meet 
the denominator criteria, regardless of payer for the 2020 MIPS 
performance period. We believe this proposal may increase 
administrative burden for some clinicians as it affects the amount of 
data they have to collect, but will have no impact on regulatory burden 
as it affects neither the number of quality measures they are required 
to report nor the amount of data they must report for each quality 
measure once results have been aggregated.
(2) Quality Payment Program Identity Management Application Process
    This rule is not finalizing 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.
(3) Quality Data Submission by Clinicians: Medicare Part B Claims-Based 
Collection Type
    This rule is not finalizing any new or revised collection of 
information

[[Page 63125]]

requirements related to the submission of Medicare Part B claims data 
for the quality performance category. However, we are making 
adjustments to our currently approved burden estimates based on more 
recent data. The requirements and burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    As noted in Table 78, based on 2018 MIPS performance period data, 
we assume that 94,846 individual clinicians will collect and submit 
quality data via the Medicare Part B claims collection type. This rule 
is finalizing to adjust the number of Medicare Part B claims 
respondents from 257,260 to 94,846 (a decrease of 162,414) based on 
more recent data and our updated 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. This is a decrease of 15,105 from the CY 2020 PFS proposed rule 
estimate of 109,951 respondents due to availability of more recent data 
(84 FR 40858 through 40859). We continue to anticipate that the 
Medicare Part B claims submission process for MIPS is operationally 
similar to the way the claims submission process functioned under the 
PQRS. Specifically, clinicians will need to gather the required 
information, select the appropriate QDCs, and include the appropriate 
QDCs on the Medicare Part B claims they submit for payment. Clinicians 
will collect QDCs as additional (optional) line items on the CMS-1500 
claim form or the electronic equivalent HIPAA transaction 837-P, 
approved by OMB under control number 0938-1197. This final rule's 
provisions do not necessitate the revision of either form and we made 
no changes to the associated estimate of reporting burden.
    As shown in Table 82, consistent with our currently approved per 
respondent burden estimates, we estimate that the burden of quality 
data submission using Medicare Part B claims will range from 0.15 hours 
at a cost of $13.50 (0.15 hr x $90.02/hr) to 7.2 hours at a cost of 
$648.14 (7.2 hr x $90.02/hr) per respondent. The burden will involve 
becoming familiar with MIPS data submission requirements. We believe 
that the start-up cost for a clinician's practice to review measure 
specifications is 7 hours, consisting of 3 hours at $109.36/hr for a 
practice administrator, 1 hour at $202.86/hr for a clinician, 1 hour at 
$45.24/hr for an LPN/medical assistant, 1 hour at $90.02/hr for a 
computer systems analyst, and 1 hour at $38.00/hr for a billing clerk. 
We are not revising our currently approved per response burden 
estimates.
    The estimate for reviewing and incorporating measure specifications 
for the claims collection type is higher than that of QCDRs/Registries 
or eCQM collection types due to the more manual, and therefore, more 
burdensome nature of Medicare Part B claims measures.
    Considering both data submission and start-up requirements, the 
estimated time (per clinician) ranges from a minimum of 7.15 hours 
(0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this 
regard the total annual time ranges from 678,149 hours (7.15 hr x 
94,846 clinicians) to 1,346,813 hours (14.2 hr x 94,846 clinicians). 
The estimated annual cost (per clinician) ranges from $717.70 [(0.15 hr 
x $90.02/hr) + (3 hr x $109.36/hr) + (1 hr x $90.02/hr) + (1 hr x 
$45.24/hr) + (1 hr x $38.00/hr + (1 hr x $202.86/hr)] to a maximum of 
$1,352.34 [(7.2 hr x $90.02/hr) + (3 hr x $109.36/hr) + (1 hr x $90.02/
hr) + (1 hr x $45.24/hr) + (1 hr x $38.00/hr + (1 hr x $202.86/hr)]. 
The total annual cost ranges from a minimum of $68,071,259 (94,846 
clinicians x $717.70) to a maximum of $128,264,419 (94,846 clinicians x 
$1,352.34).
    Table 82 summarizes the range of total annual burden associated 
with clinicians submitting quality data via Medicare Part B claims.
BILLING CODE 4120-01-P

[[Page 63126]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.127

    As shown in Table 83, using the unchanged currently approved per 
respondent burden estimates which range from $717.70 to $1,352.34, the 
decrease in number of respondents from 257,260 to 94,846 results in a 
total adjustment of between -1,161,260 hours (-162,414 respondents x 
7.15 hr/respondent) at a cost of -$116,565,015 (-162,414 respondents x 
$717.70/respondent) and -2,306,279 hours (-162,414 respondents x 14.2 
hr/respondent) at a cost of -$219,639,598 (-162,414 respondents x 
$1,352.34/respondent). For purposes of calculating total burden 
associated with the final rule as shown in Table 116, only the maximum 
burden is used.
[GRAPHIC] [TIFF OMITTED] TR15NO19.128

    We received no public comments related to the burden estimates for 
submission of quality performance category data using the Medicare Part 
B claims collection type. The burden estimates have been updated from 
the CY 2020 PFS proposed rule (84 FR 40858 through 40859) due to 
availability of updated data.

[[Page 63127]]

(4) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    This rule is not finalizing any new or revised collection of 
information requirements related to the MIPS CQM or QCDR collection 
types. However, we are making adjustments to our currently approved 
burden estimates based on more recent data. The requirements and burden 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    As noted in Tables 78, 79, and 80, and based on 2018 MIPS 
performance period data, we assume that 391,430 clinicians will submit 
quality data as individuals or groups using MIPS CQM or QCDR collection 
types. Of these, we expect 100,269 clinicians, as shown in Table 79, 
will submit as individuals and 10,949 groups and virtual groups, as 
shown in Table 80, are expected to submit on behalf of the remaining 
291,161 clinicians. This is a decrease of 5,770 individuals and an 
increase of 397 groups from the CY 2020 PFS proposed rule's estimates 
of 106,039 individuals and 10,552 groups due to availability of more 
recent data (84 FR 40860). As previously stated, we assume clinicians 
in other practices (not small practices) who meet all of the following 
criteria will submit via the MIPS CQM collection type for the 2020 MIPS 
performance period because the Medicare Part B claims collection type 
will no longer be available as an option for collecting and reporting 
quality data: (1) Scored as individuals; (2) not facility-based; and 
(3) submitted quality data only via the Medicare Part B claims 
collection type in the 2018 MIPS performance period. As a result of 
this assumption and our use of more recent data, this rule is 
finalizing to adjust the number of QCDR and MIPS CQM respondents from 
81,981 to 111,218 (an increase of 29,237). 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 collection requirements and, in some cases, specialty measure sets 
and QCDR measures. Therefore, we believe that the burden for an 
individual clinician or group to review measure specifications and 
submit quality data total 9.083 hours at $872.37 per individual 
clinician or group. This consists of 3 hours at $90.02/hr for a 
computer systems analyst (or their equivalent) to submit quality data 
along with 2 hours at $109.36/hr for a practice administrator, 1 hour 
at $90.02/hr for a computer systems analyst, 1 hour at $45.24/hr for a 
LPN/medical assistant, 1 hour at $38.00/hr for a billing clerk, and 1 
hour at $202.86/hr for a clinician 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) per clinician or group (respondent) for a cost of $7.50 (0.083 
hr x $90.02/hr for a computer systems analyst).
    In aggregate, we estimate an annual burden of 1,010,193 hours 
(9.083 hr/response x 111,218 groups plus clinicians submitting as 
individuals) at a cost of $97,023,431 (111,218 responses x $872.37/
response). Based on these assumptions, we have estimated in Table 84 
the burden for these submissions.

[[Page 63128]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.129

    As shown in Table 85, using the unchanged currently approved per 
respondent burden estimate, the increase in number of respondents from 
81,981 to 111,218 results in a total increase of 265,560 hours (29,237 
respondents x 9.083 hr/respondent) at a cost of $25,505,530 (29,237 
respondents x $872.37/respondent).
[GRAPHIC] [TIFF OMITTED] TR15NO19.130

    We received no public comments related to the burden estimates for 
submission of quality performance category data using the MIPS CQM/QCDR 
collection type. The burden estimates have been updated from the CY 
2020 PFS proposed rule (84 FR 40860 through 40861) due to availability 
of updated data.
(5) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    This rule is not finalizing any new or revised collection of 
information requirements related to the eCQM

[[Page 63129]]

collection type. However, we are making adjustments to our currently 
approved burden estimates based on more recent data. The requirements 
and burden will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    As noted in Tables 78, 79, and 80, based on 2018 MIPS performance 
period data, we assume that 254,469 clinicians will elect to use the 
eCQM collection type; 38,935 clinicians are expected to submit eCQMs as 
individuals; and 4,398 groups and virtual groups are expected to submit 
eCQMs on behalf of the remaining 208,921 clinicians. This rule 
finalizes to adjust the number of eCQM respondents from 51,861 to 
43,333 (a decrease of 8,528) based on more recent data. This is a 
decrease of 8,520 individuals and an increase of 66 groups from the CY 
2020 PFS proposed rule's estimates of 47,455 individuals and 4,332 
groups due to availability of more recent data (84 FR 40861). We expect 
the burden to be the same for each respondent using the eCQM collection 
type, whether the clinician is participating in MIPS as an individual 
or group.
    Under the eCQM collection type, the individual clinician or group 
may either submit the quality measures data directly to us from their 
eCQM, log in and upload a file, or utilize a third-party intermediary 
to derive data from their CEHRT and submit it to us on the clinician's 
or group's behalf.
    To prepare for the eCQM collection type, the clinician or group 
must review the quality measures on which we will be accepting MIPS 
data extracted from eCQMs, select the appropriate quality measures, 
extract the necessary clinical data from their CEHRT, and submit the 
necessary data to the CMS-designated clinical data warehouse or use a 
health IT vendor to submit the data on behalf of the clinician or 
group. We assume the burden for collecting quality measures data via 
eCQM is similar for clinicians and groups who submit their data 
directly to us from their CEHRT and clinicians and groups who use 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 the CMS-designated clinical data warehouse.
    We estimate that it will take no more than 2 hours at $90.02/hr for 
a computer systems analyst to submit the actual data file. The burden 
will also involve becoming familiar with MIPS submission. In this 
regard, we estimate it will take 6 hours for a clinician or group to 
review measure specifications. Of that time, we estimate 2 hours at 
$109.36/hr for a practice administrator, 1 hour at $202.86/hr for a 
clinician, 1 hour at $90.02/hr for a computer systems analyst, 1 hour 
at $45.24/hr for an LPN/medical assistant, and 1 hour at $38.00/hr for 
a billing clerk.
    In aggregate we estimate an annual burden of 346,664 hours (8 hr x 
43,333 groups and clinicians submitting as individuals) at a cost of 
$33,577,875 (43,333 responses x $774.88/response). Based on these 
assumptions, we have estimated in Table 86 the burden for these 
submissions.
[GRAPHIC] [TIFF OMITTED] TR15NO19.131

    As shown in Table 87, using the unchanged currently approved per 
respondent burden estimate, the decrease in number of respondents from 
51,861 to 43,333 results in a total difference of -68,224 hours (-8,528

[[Page 63130]]

respondents x 8 hr/respondent) at a cost of -$6,608,177 (-8,528 
respondents x $774.88/respondent). 
[GRAPHIC] [TIFF OMITTED] TR15NO19.132

    We received no public comments related to the burden estimates for 
submission of quality performance category data using the eCQM 
collection type. The burden estimates have been updated from the CY 
2020 PFS proposed rule (84 FR 40861 through 40862) due to availability 
of updated data.
(6) Quality Data Submission via CMS Web Interface
    This rule is not finalizing any new or revised collection of 
information requirements related to submission of quality data via the 
CMS Web Interface. However, we are making adjustments to our currently 
approved burden estimates based on more recent data. The requirements 
and burden will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    We assume that 104 groups will submit quality data via the CMS Web 
Interface based on the number of groups who completed 100 percent of 
reporting quality data via the Web Interface in the 2018 MIPS 
performance period. This is a decrease of 182 groups from the currently 
approved number of 286 groups provided in the CY 2019 PFS final rule 
(83 FR 60007) due to receipt of more current data. We estimate that 
46,473 clinicians will submit as part of groups via this method, a 
decrease of 92,758 from our currently approved estimate of 139,231 
clinicians. This is a decrease of 69,869 individuals from the CY 2020 
PFS proposed rule's estimate of 116,342 individuals due to availability 
of more recent data (84 FR 40862).
    The burden associated with the group submission requirements is the 
time and effort associated with submitting data on a sample of the 
organization's beneficiaries that is prepopulated in the CMS Web 
Interface. Our burden estimate for submission includes the time (61.67 
hours) needed for each group to populate data fields in the web 
interface with information on approximately 248 eligible assigned 
Medicare beneficiaries and submit the data (we will partially pre-
populate the CMS Web Interface with claims data from their Medicare 
Part A and Part B beneficiaries). The patient data either can be 
manually entered, uploaded into the CMS Web Interface via a standard 
file format, which can be populated by CEHRT, or submitted directly. 
Each group must provide data on 248 eligible assigned Medicare 
beneficiaries (or all eligible assigned Medicare beneficiaries if the 
pool of eligible assigned beneficiaries is less than 248) for each 
measure. In aggregate, we estimate an annual burden of 6,414 hours (104 
groups x 61.67 hr) at a cost of $577,359 (6,414 hr x $90.02/hr). Based 
on the assumptions discussed in this section, Table 88 summarizes the 
burden for groups submitting to MIPS via the CMS Web Interface.
[GRAPHIC] [TIFF OMITTED] TR15NO19.133

    As shown in Table 89, using our unchanged currently approved per 
respondent burden estimate, the decrease in number of respondents 
results in a total adjustment of -11,224 hours (-182 respondents x 
61.67 hr) at -$1,010,379 (-11,224 hr x $90.02/hr).

[[Page 63131]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.134

    We received no public comments related to the burden estimates for 
submission of quality performance category data using the CMS Web 
Interface. The burden estimates have been updated from the CY 2020 PFS 
proposed rule (84 FR 40862 through 40863) due to availability of 
updated data.
(7) Beneficiary Responses to CAHPS for MIPS Survey
    This rule is not finalizing any new or revised collection of 
information requirements or burden related to 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 MIPS survey vendor changes under 
that control number.
(8) Group Registration for CMS Web Interface
    This rule is not finalizing any new or revised collection of 
information requirements related to the group registration for CMS Web 
Interface. However, we are adjusting our currently approved burden 
estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    Groups interested in participating in MIPS using the CMS Web 
Interface for the first time must complete an online registration 
process. After first time registration, groups will only need to opt 
out if they are not going to continue to submit via the CMS Web 
Interface. In Table 90, we estimate that the registration process for 
groups under MIPS involves approximately 0.25 hours at $90.02/hr for a 
computer systems analyst (or their equivalent) to register the group.
    In this rule, we are adjusting the number of respondents from 67 to 
69 based on more recent data; an increase of 18 from our estimate of 51 
in the CY 2020 PFS proposed rule (84 FR 40863). We assume that 
approximately 69 groups will elect to use the CMS Web Interface for the 
first time during the 2020 MIPS performance period based on the number 
of new registrations received during the CY 2019 registration period; 
an increase of 2 compared to the number of groups currently approved by 
OMB. As shown in Table 90, we estimate a burden of 17.25 hours (69 new 
registrations x 0.25 hr/registration) at a cost of $1,553 (17.255 hr x 
$90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.135

    As shown in Table 91 using our unchanged currently approved per 
respondent burden estimates, the decrease in the number of groups 
registering to submit MIPS data via the CMS Web Interface results in an 
adjustment to the total time burden of 0.5 hours at a cost of $45 (-2 
groups x 0.25 hr x $90.02/hr).

[[Page 63132]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.136

    We received no public comments related to the burden estimates for 
group registrations for the CMS Web Interface. The burden estimates 
have been updated from the CY 2020 PFS proposed rule (84 FR 40863 
through 40864) due to availability of updated data.
(9) Group Registration for CAHPS for MIPS Survey
    This rule is not finalizing 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, are not making any MIPS survey vendor 
changes under that control number.
e. ICRs Regarding the Nomination of Quality Measures
    The requirements and burden associated with this data submission 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    Quality measures are selected annually through a call for quality 
measures under consideration, with a final list of quality measures 
being published in the Federal Register by November 1 of each year. 
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit 
a ``Call for Quality Measures'' each year. Specifically, the Secretary 
must request that eligible clinician organizations and other relevant 
stakeholders identify and submit quality measures to be considered for 
selection in the annual list of MIPS quality measures, as well as 
updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act, 
eligible clinician organizations are professional organizations as 
defined by nationally recognized specialty boards of certification or 
equivalent certification boards.
    As we described in the CY 2017 Quality Payment Program final rule 
(81 FR 77137), we will accept quality measures submissions at any time, 
but only measures submitted during the timeframe provided by us through 
the pre-rulemaking process of each year will be considered for 
inclusion in the annual list of MIPS quality measures for the 
performance period beginning 2 years after the measure is submitted. 
This process is consistent with the pre-rulemaking process and the 
annual call for measures, which are further described at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html.
    To identify and submit a quality measure, eligible clinician 
organizations and other relevant stakeholders use a one-page online 
form that requests information on background, a gap analysis which 
includes evidence for the measure, reliability, validity, endorsement 
and a summary which includes how the proposed measure relates to the 
Quality Payment Program and the rationale for the measure. In addition, 
proposed measures must be accompanied by a completed Peer Review 
Journal Article form. As discussed in section III.K.3.c.(1)(d)(i) of 
this rule, we are finalizing that beginning with the 2020 Call for 
Measures process, MIPS quality measure stewards will be required to 
link their MIPS quality measures to existing and related cost measures 
and improvement activities, as applicable and feasible. MIPS quality 
measure stewards will also be required to provide a rationale as to how 
they believe their measure correlates to other performance category 
measures and activities. We believe this will require approximately 0.6 
hours at $109.36/hr for a practice administrator and 0.4 hours at 
$202.86 for a clinician to research existing measures or activities and 
provide a rationale for the linkage to the new measure. We also 
estimate it will require 0.3 hours at $109.36/hr for a practice 
administrator to make a strategic decision to nominate and submit a 
measure and 0.2 hours at $202.86/hr for clinician review time. We 
recognize there is additional burden on respondents associated with 
development of a new quality measure beyond the 1.5 hour estimate (0.6 
hr + 0.4 hr + 0.3 hr + 0.2 hr) which only accounts for the time 
required for recordkeeping, reporting, and third-party disclosures 
associated with the policy; but we believe this estimate to be 
reasonable to nominate and submit a measure. The 1.5 hour estimate also 
assumes that submitters will have the necessary information to complete 
the nomination form readily available, which we believe is a reasonable 
assumption. Additionally, some submitters familiar with the process or 
who are submitting multiple measures may require significantly less 
time, while other submitters may require more if the opposite is true. 
Representing an average across all respondents based on our review of 
the nomination process, the information required to complete the 
nomination form, and the criteria required to nominate the measure, we 
believe the total estimate of 1.5 hours per measure to be reasonable 
and appropriate.
    As shown in Table 92, we estimate that 28 submissions will be 
received during the 2020 Call for Quality Measures based on the number 
of submissions received during the 2019 Call for Quality Measures 
process; a decrease of 112 compared to the number of submissions 
currently approved by OMB (140 submissions). This is an increase of 2 
from the CY 2020 PFS proposed rule due to availability of more recent 
data (84 FR 40865). In keeping with the focus on clinicians as the 
primary source for recommending new quality measures, we are using

[[Page 63133]]

practice administrators and clinician time for our burden estimates.
    Consistent with the CY 2017 Quality Payment Program final rule, we 
also estimate it will take 4 hours at $202.86/hr for a clinician (or 
equivalent) to complete the Peer Review Journal Article Form (81 FR 
77153 through 77155). This assumes that measure information is 
available and testing is complete in order to have the necessary 
information to complete the form, which we believe is a reasonable 
assumption.
    As shown in Table 92, in aggregate we estimate an annual burden of 
154 hours (28 submissions x 5.5 hr/submission) at a cost of $28,884 {28 
submissions x [(0.9 hr x $109.36/hr) + (4.6 hr x $202.86/hr){time} .
[GRAPHIC] [TIFF OMITTED] TR15NO19.137

    Independent of the decrease in the number of new quality measures 
submitted for consideration, the increase in burden per nominated 
measure results in a difference of 140 hours at a cost of $20,546 {140 
submissions x [(0.6 hr x $109.36/hr) + (0.4 hr x $202.86/hr)]{time} . 
The decrease in the number of new quality measures submitted results in 
an adjustment of -616 hours at -$115,537 (-112 submissions x [(0.9 hr x 
$109.36/hr) + (4.6 hr x $202.86/hr)]). As shown in Table 93, in 
aggregate, the combine impact of these changes is -476 hours (140-616) 
at a cost of -$94,991 ($20,546-$115,537).
[GRAPHIC] [TIFF OMITTED] TR15NO19.138

    We received no public comments related to the burden estimates for 
the Call for Quality Measures. The burden estimates have been updated 
from the CY 2020 PFS proposed rule (84 FR 40864 through 40865) due to 
availability of updated data.
f. ICRs Regarding Promoting Interoperability Data (Sec. Sec.  414.1375 
and 414.1380)
(1) Background
    For the 2020 MIPS performance period, clinicians and groups can 
submit Promoting Interoperability data through direct, log in and 
upload, or log in and attest submission types. We have worked to 
further align the Promoting Interoperability performance category with 
other MIPS performance categories. With the exception of submitters who 
elect to use the log in and attest submission type for the Promoting 
Interoperability performance category, which is not available for the 
quality performance category, we anticipate that 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. In the 2019 and prior MIPS performance periods, 
individuals and groups submitting data for the quality performance 
category via a qualified registry or QCDR that did not also support 
reporting of data for the Promoting Interoperability or improvement 
activity performance categories would be required to submit data for 
these performance categories using an alternate submission type. The 
finalized policies discussed in sections III.K.3.g.(3)(a)(i) and 
III.K.3.g.(4)(a)(i) of this rule requiring qualified registries and 
QCDRs to be able to submit data for the quality, improvement 
activities, and Promoting Interoperability performance categories will 
alleviate this issue. Hence, the following burden estimates

[[Page 63134]]

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
    This rule is not finalizing any new or revised collection of 
information requirements related to the submission of reweighting 
applications for Promoting Interoperability and other performance 
categories. However, we are making adjustments to our currently 
approved burden estimates based on more recent data from the 2019 MIPS 
performance period. The adjusted burden estimates will be submitted to 
OMB for approval under control number 0938-1314 (CMS-10621).
    As established in the CY 2017 and CY 2018 Quality Payment Program 
final rules, MIPS eligible clinicians who meet the criteria for a 
significant hardship or other type of exception may submit an 
application requesting a zero percent weighting for the Promoting 
Interoperability performance category in the following circumstances: 
Insufficient internet connectivity, extreme and uncontrollable 
circumstances, lack of control over the availability of CEHRT, 
clinicians who are in a small practice, and decertified EHR technology 
(81 FR 77240 through 77243 and 82 FR 53680 through 53686, 
respectively). In addition, in the CY 2018 Quality Payment Program 
final rule, we established that MIPS eligible clinicians and groups 
citing extreme and uncontrollable circumstances may also apply for a 
reweighting of the quality, cost, and/or improvement activities 
performance categories (82 FR 53783 through 53785). As discussed in 
section III.K.3.d.(2)(b)(ii)(A), we are finalizing, beginning with the 
2018 MIPS performance period and 2020 MIPS payment year, to reweight 
the performance categories for a MIPS eligible clinician who we 
determine has data for a performance category that are inaccurate, 
unusable or otherwise compromised due to circumstances outside of the 
control of the clinician or its agents if we learn the relevant 
information prior to the beginning of the associated MIPS payment year. 
Because this is a new policy and we believe these occurrences are rare 
based on our experience, we are unable to estimate the number of 
clinicians, groups, or third party intermediaries that may contact us 
regarding a potential data issue. Similarly, the extent and source of 
documentation provided to us for each event may vary considerably. 
Therefore, we are not finalizing any changes to our currently approved 
burden estimates as a result of this policy. Respondents who apply for 
a reweighting for any of these 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 94 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 for the 2018 MIPS performance period, we assume 
30,472 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 148 
respondents will submit a request only to reweight one or more of the 
quality, cost, or improvement activity performance categories, for a 
total of 30,620 reweighting applications submitted. This is an increase 
of 24,447 from our estimate of 6,025 in the CY 2020 PFS proposed rule 
due to availability of more recent data (84 FR 40866). A significant 
portion of this increase is due to 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. Of our total 
respondent estimate of 30,620, we estimate that 24,377 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 6,243 respondents 
will submit a request for reweighting the Promoting Interoperability 
performance category to zero percent as a small practice experiencing a 
significant hardship.
    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 estimate 
it will take 0.25 hours at $90.02/hr for a computer system analyst to 
complete and submit the application. As shown in Table 94, we estimate 
an annual burden of 7,655 hours (30,620 applications x 0.25 hr/
application) at a cost of $689,103 (7,655 hr x $90.02/hr).

[[Page 63135]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.139

    As shown in Table 95, using our unchanged currently approved per 
respondent burden estimate, the increased number of respondents results 
in a total adjustment of 6,145 hours (24,579 respondents x 0.25 hr/
respondent) and $553,150 (24,579 respondents x $22.50/respondent).
[GRAPHIC] [TIFF OMITTED] TR15NO19.140

    We received no public comments related to the burden estimates for 
reweighting applications for Promoting Interoperability and other 
performance categories. The burden estimates have been updated from the 
CY 2020 PFS proposed rule (84 FR 40866 through 40867) due to 
availability of updated data.
(3) Submitting Promoting Interoperability Data
    This rule is not finalizing any new or revised collection of 
information requirements related to the submission of Promoting 
Interoperability data. However, we are making adjustments to our 
currently approved burden estimates based on updated estimates of QPs 
and MIPS APMs for 2020 MIPS performance period. The adjusted burden 
estimates will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    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.
    As shown in Table 96, based on data from the 2018 MIPS performance 
period, we estimate that a total of 74,281 respondents consisting of 
59,865 individual MIPS eligible clinicians and 14,416 groups and 
virtual groups will submit Promoting Interoperability data; this is an 
adjustment to the number of respondents from 93,869 to 74,281 (a 
decrease of 19,588) based on more recent data. This is a decrease of 
21,493 individuals and an increase of 1,911 groups from the CY 2020 PFS 
proposed rule's estimates of 81,358 individuals and 12,505 groups also 
due to availability of more recent data (84 FR 40868). In the CY 2017 
and CY 2018 Quality Payment Program final rules, the CY 2019 PFS final 
rule, the CY 2020 PFS proposed rule, we were required to adjust our 
respondent estimates to account for MIPS eligible clinicians who we 
assumed would respond as participants in a virtual group. Because we 
are now able to base our respondent estimates on data from the 2018 
MIPS performance period, which was the first performance period in 
which clinicians could submit as participants in a virtual group, we 
are no longer making the adjustment for virtual group participation.
    Because our respondent estimates are based on the number of actual 
submissions received for the Promoting Interoperability performance 
category, it is not necessary to account for policies adopted in the CY 
2017 Quality Payment Program final rule regarding reweighting, which 
state that if a clinician submits Promoting Interoperability data, they 
will be scored and the performance category will not be reweighted (81 
FR 77238-77245). This approach is identical to the approach we used in 
the CY 2019 PFS final rule (83 FR 60013 through 60014);

[[Page 63136]]

however, we failed to state the distinction in that final rule that we 
no longer need to make modifications to our estimates due to the use of 
actual MIPS submission data. As established in the CY 2017 and CY 2018 
Quality Payment Program final rules and the CY 2019 PFS final rule, 
certain MIPS eligible clinicians will be eligible for automatic 
reweighting of the Promoting Interoperability performance category to 
zero percent, including MIPS eligible clinicians that are hospital-
based, ambulatory surgical center-based, non-patient facing clinicians, 
physician assistants, nurse practitioners, clinician nurse specialists, 
certified registered nurse anesthetists, physical therapists; 
occupational therapists; qualified speech-language pathologists or 
qualified audiologist; clinical psychologists; and registered 
dieticians or nutrition professionals (81 FR 77238 through 77245, 82 FR 
53680 through 53687, and 83 FR 59819 through 59820, respectively). For 
the same reasons discussed above regarding our use of data reflecting 
the actual number of Promoting Interoperability data submissions 
received, these estimates already account for the reweighting policies 
in the CY 2017 and CY 2018 Quality Payment Program final rules, 
including exceptions for MIPS eligible clinicians who have experienced 
a significant hardship (including clinicians who are in small 
practices), as well as exceptions due to decertification of an EHR (81 
FR 77240 through 77243 and 82 FR 53680 through 53686).
    In section III.K.3.c.(4)(f)(iii) of this rule, we are finalizing to 
revise the definition of a hospital-based MIPS eligible clinician under 
Sec.  414.1305 to include groups and virtual groups. We are finalizing 
that, beginning with the 2022 MIPS payment year, a hospital-based MIPS 
eligible clinician under Sec.  414.1305 means an individual MIPS 
eligible clinician who furnishes 75 percent or more of his or her 
covered professional services in an inpatient hospital, on-campus 
outpatient hospital, off campus outpatient hospital, or emergency room 
setting based on claims for the MIPS determination period, and a group 
or virtual group provided that more than 75 percent of the NPIs billing 
under the group's TIN or virtual group's TINs, as applicable, meet the 
definition of a hospital-based individual MIPS eligible clinician 
during the MIPS determination period. We are also finalizing to revise 
Sec.  414.1380(c)(2)(iii) to specify that for the Promoting 
Interoperability performance category to be reweighted for a MIPS 
eligible clinician who elects to participate in MIPS as part of a group 
or virtual group, all of the MIPS eligible clinicians in the group or 
virtual group must qualify for reweighting, or the group or virtual 
group must meet the finalized revised definition of a hospital-based 
MIPS eligible clinician or the definition of a non-patient facing MIPS 
eligible clinician as defined in Sec.  414.1305. We believe these 
policies could result in a decrease in the number of data submissions 
for the Promoting Interoperability performance category, but we do not 
currently have the data necessary to determine how many groups would 
elect to forego submission. As additional information becomes available 
in future years, we will revisit the impact of this policy and adjust 
our burden estimates accordingly.
    As discussed in section III.K.3.c.(4)(d)(i)(B) of this rule, we are 
finalizing to allow clinicians to satisfy the optional bonus Query of 
PDMP measure by submitting a ``yes/no'' attestation, rather than 
reporting a numerator and denominator. In the CY 2019 PFS final rule, 
we updated our burden assumptions from 3 hours to 2.67 hours to reflect 
the change from 5 base measures, 9 performance measures, and 4 bonus 
measures to the reporting of 4 base measures (83 FR 60013 through 
60014). Due to a lack of data regarding the number of health care 
providers who would submit data for bonus Promoting Interoperability 
measures, we have consistently been unable to estimate burden related 
to the reporting of bonus measures and are therefore unable to account 
for any change in burden due to the proposed change to a ``yes/no'' 
attestation for the Query of PDMP measure. If we have better data in 
the future, we may reassess our burden assumptions and whether we can 
reasonably quantify the burden associated with the reporting of bonus 
measures.
    We assume that MIPS eligible clinicians scored under the APM 
scoring standard, as described in section III.K.3.c.(5) of this rule, 
will continue to submit Promoting Interoperability data the same as in 
2018. 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 59822-59823). Burden estimates 
for this final rule assume group TIN-level reporting as we believe this 
is the most reasonable assumption for the Shared Savings Program, which 
requires that ACOs include full TINs as ACO participants. As we receive 
updated information which reflects the actual number of Promoting 
Interoperability data submissions submitted by Shared Savings Program 
ACO participants, we will update our burden estimates accordingly.

      Table 96--Estimated Number of Respondents To Submit Promoting
        Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                             Number of
                                                            respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting               59,865
 Interoperability (a)...................................
Number of groups to submit Promoting Interoperability             14,416
 (b)....................................................
Total Respondents in 2020 MIPS performance period (CY             74,281
 2020 Final Rule) (c) = (a) + (b).......................
* Total Respondents in 2019 MIPS performance period (CY           93,869
 2019 Final Rule) (d)...................................
Difference (e) = (c)-(d)................................         -19,588
------------------------------------------------------------------------

    We estimate the time required for an individual or group to submit 
Promoting Interoperability data to be 2.67 hours. As previously 
discussed, we are finalizing changes to Sec.  414.1400(a)(2) to state 
that beginning with the 2023 MIPS payment year, QCDRs and qualified 
registries must be able to submit data for all the MIPS performance 
categories identified in the regulation. Based on our review of 2019 
qualified registries and QCDRs, we have determined that 70

[[Page 63137]]

percent and 72 percent of these vendors, respectively, are already able 
to submit data for these performance categories. For clinicians who 
currently utilize qualified registries or QCDRs that have not 
previously offered the ability to report Promoting Interoperability or 
improvement activity data, we believe this will result in a reduction 
of burden as it will simplify MIPS reporting. In order to estimate the 
impact on reporting burden, we would need to correlate the specific 
individual clinicians and groups who submitted quality performance 
category data via the MIPS CQM/QCDR collection type that are required 
to report data for both the quality and Promoting Interoperability 
performance categories with the specific qualified registries or QCDRs 
that are affected by this proposal. Currently, we do not have the 
necessary information to perform this correlation and are therefore 
unable to estimate the resulting impact on burden. If data becomes 
available in the future which enables us to perform this analysis, we 
will update our burden estimates at that time.
    As shown in Table 97, the total burden estimate for submission of 
data on the specified Promoting Interoperability objectives and 
measures is estimated to be 198,083 hours (74,281 respondents x 2.67 
incremental hours for a computer analyst's time above and beyond the 
clinician, practice manager, and computer system's analyst time 
required to submit quality data) at a cost of $17,831,402 (198,083 hr x 
$90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.141

    As shown in Table 98, using our unchanged currently approved per 
respondent burden estimate, the decrease in number of respondents 
results in a total adjustment of -52,235 hours (-19,588 respondents x 
2.67 hr/respondent) at a cost of -$4,702,165 (-52,235 hr x $90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.142

    We received no public comments related to the burden estimates for 
submission of data for the Promoting Interoperability performance 
category. The burden estimates have been updated from the CY 2020 PFS 
proposed rule (84 FR 40867 through 40869) due to availability of 
updated data.
g. ICRs Regarding the Nomination of Promoting Interoperability (PI) 
Measures
    This rule is not finalizing any new or revised collection of 
information requirements related to the nomination of Promoting 
Interoperability measures. However, we are making adjustment to our 
currently approved burden estimates based on data from the 2019 MIPS 
performance period. The adjusted burden estimates will be submitted to 
OMB for approval under control number 0938-1314 (CMS-10621).
    Consistent with our requests for stakeholder input on quality 
measures and improvement activities, we also requested potential 
measures for the Promoting Interoperability performance category that 
measure patient outcomes, emphasize patient safety, support improvement 
activities and the quality performance category, and build on the 
advanced use of CEHRT using 2015 Edition standards and certification 
criteria. Promoting Interoperability measures may be submitted via the 
Call for Promoting Interoperability

[[Page 63138]]

Performance Category Measures Submission Form that includes the measure 
description, measure type (if applicable), reporting requirement, and 
CEHRT functionality used (if applicable). This rule does not propose 
any changes to that form.
    We estimate 10 proposals will be submitted for new Promoting 
Interoperability measures, based on the number of proposals submitted 
during the CY 2019 nomination period. This is a decrease of 37 from the 
estimate currently approved by OMB (47 proposals) under the 
aforementioned control number and a decrease of 18 from the 28 
proposals estimated in the CY 2020 PFS proposed rule due to 
availability of more recent data (84 FR 40869). We estimate it will 
take 0.5 hours per organization to submit an activity to us, consisting 
of 0.3 hours at $109.36/hr for a practice administrator to make a 
strategic decision to nominate that activity and submit an activity to 
us via email and 0.2 hours at $202.86/hr for a clinician to review the 
nomination. As shown in Table 99, we estimate an annual burden of 5 
hours (10 proposals x 0.5 hr/response) at a cost of $734 (10 x [(0.3 h 
x $109.36/hr) + (0.2 hr x $202.86/hr)].
[GRAPHIC] [TIFF OMITTED] TR15NO19.143

    As shown in Table 100, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of respondents 
results in an adjustment of -18.5 hours at a cost of -$2,715 (-37 
respondents x 0.5 hr x $73.38 per respondent).
[GRAPHIC] [TIFF OMITTED] TR15NO19.144

BILLING CODE 4120-01-C
    We received no public comments related to the burden estimates for 
the Call for Promoting Interoperability measures. The burden estimates 
have been updated from the CY 2020 PFS proposed rule (84 FR 40869 
through 40870) due to availability of updated data.
h. ICRs Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    This rule is not finalizing any new or revised collection of 
information requirements related to the submission of Improvement 
Activities data. However, we are making adjustments to our currently 
approved burden estimates based on more recent data. The adjusted 
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621).
    As discussed in section III.K.3.c.(3)(d)(iii) of this rule, after 
consideration of comments received, we are modifying our final policy 
to state that beginning with the 2020 MIPS performance period and for 
future years, each improvement activity for which groups and virtual 
groups submit a ``yes'' response must be performed by at least 50 
percent of the NPIs billing under the group's TIN or virtual group's 
TINs, as applicable; and the NPIs must perform the same activity during 
a continuous 90-day period within the same performance year. Because 
eligible clinicians attest to improvement activities at the group 
level, there is no impact on reporting burden as a result of this 
policy.
    As previously discussed, beginning with the 2023 MIPS payment year 
and for future years, we are finalizing to require QCDRs and qualified 
registries be able to submit data for three performance categories: 
Quality, improvement activities, and Promoting Interoperability; our 
discussion of burden for submitting Promoting Interoperability data in 
section VI.B.7.f.(3) noted our inability to account for the reduction 
in burden associated with the proposal. Consistent with our decision 
not to change our per respondent burden estimate to submit

[[Page 63139]]

Promoting Interoperability data, we are not changing our per respondent 
burden estimate to submit improvement activity data as a result of this 
policy.
    Furthermore, as discussed in section III.K.3.c.(3)(e)(i) of this 
rule, we are finalizing to establish removal factors to consider when 
proposing to remove improvement activities from the Inventory. However, 
we do not believe this will affect reporting burden, because 
respondents will still be required to submit the same number of 
improvement activities and this policy will not require respondents to 
submit any additional information. We are also finalizing for the CY 
2020 performance period and future years to: Add 2 new improvement 
activities, modify 7 existing improvement activities, and remove 15 
existing improvement activities. Because MIPS eligible clinicians are 
still required to submit the same number of activities, we do not 
expect these proposals to affect our currently approved burden 
estimates. In addition, in order for an eligible clinician or group to 
receive credit for being a patient-centered medical home or comparable 
specialty practice, the eligible clinician or group must attest in the 
same manner as any other improvement activity. In In section 
III.K.3.c.(3)(d)(iii) of this final rule, we are also finalizing: (1) 
To modify the definition of rural area; (2) to update Sec.  
414.1380(b)(3)(ii)(A) and (C) remove the reference to the four listed 
accreditation organizations to be recognized as patient-centered 
medical homes and removing the reference to the specific accrediting 
organization for comparable specialty practices; and (3) to conclude 
and remove the CMS Study on Factors Associated with Reporting Quality 
Measures. Because these policies neither impact the number of 
respondents nor the time to submit data for the improvement activities 
performance category, we have made no associated changes to our burden 
estimate. We discuss the cost reduction associated with concluding the 
CMS Study on Factors Associated with Reporting Quality Measures in 
section VII.F.10.d of this final rule
    While these finalized policies do not add additional reporting 
burden, we have adjusted our currently approved burden estimates based 
on more recent data. The adjusted burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    The CY 2018 Quality Payment Program final rule provides: (1) That 
for activities that are performed for at least a continuous 90 days 
during the performance period, MIPS eligible clinicians must submit a 
``yes'' response for activities within the Improvement Activities 
Inventory (82 FR 53651); (2) that the term ``recognized'' is accepted 
as equivalent to the term ``certified'' when referring to the 
requirements for a patient-centered medical home to receive full credit 
for the improvement activities performance category for MIPS (82 FR 
53649); and (3) that for the 2020 MIPS payment year and future years, 
to receive full credit as a certified or recognized patient-centered 
medical home or comparable specialty practice, at least 50 percent of 
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655).
    In the CY 2017 Quality Payment Program final rule, we described how 
we determine MIPS APM scores (81 FR 77185). We compare the requirements 
of the specific MIPS APM with the list of activities in the Improvement 
Activities Inventory and score those activities in the same manner that 
they are otherwise scored for MIPS eligible clinicians (81 FR 77817 
through 77831). If, based on our assessment, the MIPS APM does not 
receive the maximum improvement activities performance category score, 
then the APM Entity can submit additional improvement activities. We 
anticipate that MIPS APMs in the 2020 MIPS performance period will not 
need to submit additional improvement activities as the models will 
already meet the maximum improvement activities performance category 
score.
    A variety of organizations and in some cases, individual 
clinicians, will submit improvement activity performance category data. 
For clinicians who are not part of APMs, we assume that clinicians 
submitting quality data as part of a group through direct, log in and 
upload submission types, and CMS Web Interface will also submit 
improvement activities data. In the 2019 and prior MIPS performance 
periods, individuals and groups submitting data for the quality 
performance category through a MIPS CQM or QCDR that did not also 
support reporting of data for the Promoting Interoperability or 
improvement activity performance categories would be required to submit 
data for these performance categories using an alternate submission 
type, the finalized policies discussed in sections III.K.3.g.(3)(a)(i) 
and III.K.3.g.(4)(a)(i) of this rule requiring qualified registries and 
QCDRs to be able to submit data for all three of the MIPS performance 
categories identified in Sec.  414.1400(a)(2) will help to alleviate 
this issue. As finalized in the CY 2017 Quality Payment Program final 
rule (81 FR 77264), APM Entities only need to report improvement 
activities data if the CMS-assigned improvement activities score is 
below the maximum improvement activities score. Our CY 2018 Quality 
Payment Program final rule burden estimates assumed that all APM 
Entities will receive the maximum CMS-assigned improvement activities 
score (82 FR 53921 through 53922).
    As represented in Table 101, based on 2018 MIPS performance period 
data, we estimate that a total of 103,813 respondents consisting of 
86,935 individual clinicians and 16,878 groups will submit improvement 
activities during the 2020 MIPS performance period; this is an 
adjustment to the number of respondents from 136,004 to 103,813 (a 
decrease of 32,191) based on more recent data. This is a decrease of 
15,819 individuals and an increase of 1,117 groups from the estimates 
of 102,754 individuals and 15,761 groups provided in the CY 2020 PFS 
proposed rule due to availability of more recent data (84 FR 40871). In 
the CY 2017 and CY 2018 Quality Payment Program final rules, the CY 
2019 PFS final rule, the CY 2020 PFS proposed rule, we were required to 
adjust our respondent estimates to account for MIPS eligible clinicians 
who we assumed would respond as participants in a virtual group. 
Because we are now able to base our respondent estimates on data from 
the 2018 MIPS performance period, which was the first performance 
period in which clinicians could submit as participants in a virtual 
group, we are no longer making the adjustment for virtual group 
participation. In addition, as previously discussed 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 APM in the 2018 
MIPS performance period but will be in the 2020 MIPS performance 
period, and will therefore not be required to submit improvement 
activities data.
    Our burden estimates assume there will be no improvement activities 
burden for MIPS APM participants. We will assign the improvement 
activities performance category score at the APM Entity level. We also 
assume that the MIPS APM models for the 2020 MIPS performance period 
will qualify for the maximum improvement activities performance 
category score and, as

[[Page 63140]]

such, APM Entities will not submit any additional improvement 
activities.
[GRAPHIC] [TIFF OMITTED] TR15NO19.145

    Consistent with the CY 2019 PFS final rule, we estimate that the 
per response time required per individual or group is 5 minutes at 
$90.02/hr for a computer system analyst to submit by logging in and 
manually attesting that certain activities were performed in the form 
and manner specified by CMS with a set of authenticated credentials (83 
FR 60016).
    As shown in Table 102, we estimate an annual burden of 8,651 hours 
(103,813 responses x 5 minutes/60) at a cost of $778,771 (8,651 hr x 
$90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.146

    As shown in Table 103, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of respondents 
results in an adjustment of -2,683 hours (-32,191 responses x 5 
minutes/60) at a cost of -$241,486 (-2,683 hr $90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.147

    We received no public comments related to the burden estimates for 
submission of data for the Improvement Activities performance category. 
The burden estimates have been updated from the CY 2020 PFS proposed 
rule (84 FR 40870 through 40872) due to availability of updated data.

[[Page 63141]]

i. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    This rule is not finalizing any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
nomination of improvement activities. However, we are making 
adjustments to our currently approved burden estimates based on data 
from the 2019 MIPS performance period. The adjusted burden estimates 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    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). The 2019 Annual Call for Activities lasted from February 1, 
2019 through July 1, 2019, during which we received 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 2020 Improvement Activities Inventory. Based on the number of 
improvement activity nominations received in the CY 2019 Annual Call 
for Activities, we estimate that we will receive 31 nominations for the 
2020 Annual Call for Activities, which is a decrease of 94 from the 125 
nominations currently approved by OMB and a decrease of 97 from the 
estimate of 128 provided in the CY 2020 PFS proposed rule (84 FR 
40872).
    We estimate 1.2 hours at $109.36/hr for a practice administrator or 
equivalent to make a strategic decision to nominate and submit that 
activity and 0.8 hours at $202.86/hr for a clinician's review. As shown 
in Table 104, we estimate an annual burden of 62 hours (31 nominations 
x 2 hr/nomination) at a cost of $9,099 (31 x [(1.2 hr x $109.36/hr) + 
(0.8 hr x $202.86/hr)]).
[GRAPHIC] [TIFF OMITTED] TR15NO19.148

    As shown in Table 105, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of nominations 
results in an adjustment of -188 hours at a cost of -$27,591 {-94 
activities x [(1.2 hr x $109.36/hr) + (0.8 hr x $202.86/hr)]{time} .
[GRAPHIC] [TIFF OMITTED] TR15NO19.149

    We received no public comments related to the burden estimates for 
nomination of Improvement Activities. The burden estimates have been 
updated from the CY 2020 PFS proposed rule (84 FR 40872 through 40873) 
due to availability of updated data.
j. 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, 
including for the 10 episode-based measures we are finalizing to 
include in the cost performance category as discussed in section 
III.K.3.c.(2)(b)(iii) of this rule. Moreover, the provisions of this 
final rule do not result in the need to add or revise or delete any 
claims data fields. Therefore, we are not finalizing any new or revised 
collection

[[Page 63142]]

of information requirements or burden for MIPS eligible clinicians 
resulting from the cost performance category.
k. Quality Payment Program ICRs Regarding Partial QP Elections 
(Sec. Sec.  414.1310(b)(ii) and 414.1430)
    This rule is not finalizing 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 
making adjustments to our currently approved burden estimates based on 
updated projections for the 2020 MIPS performance period. The adjusted 
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621).
    In section III.K.4.d.(2)(b), we are finalizing that, beginning for 
eligible clinicians who become Partial QPs in the 2021 MIPS performance 
period, Partial QP status will only apply to the TIN/NPI combination 
through which Partial QP status is attained. Any Partial QP election 
will only apply to TIN/NPI combination through which Partial QP status 
is attained so that an eligible clinician who is a Partial QP for only 
one TIN/NPI combination may still report under MIPS for other TIN/NPI 
combinations.
    As shown in Table 106, based on our predictive QP analysis for the 
2020 QP performance period, which accounts for the increase in QP and 
Partial QP thresholds, we estimate that 12 APM Entities and 2,010 
eligible clinicians will make the election to participate as a Partial 
QP in MIPS representing approximately 15,500 Partial QPs, an increase 
of 1,941 from the 81 elections currently approved by OMB under the 
aforementioned control number. We estimate it will take the APM Entity 
representative or eligible clinician 15 minutes (0.25 hr) to make this 
election. In aggregate, we estimate an annual burden of 505.5 hours 
(2,022 respondents x 0.25 hr/election) at a cost of $45,080 (505.5 
hours x $90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.150

    As shown in Table 107, using our unchanged currently approved per 
respondent burden estimate, the increase in the number of Partial QP 
elections results in an adjustment of 485.25 (1,941 elections x 0.25hr) 
at a cost of $43,682 (485.25 hr x $90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.151

    We received no public comments related to the burden estimates for 
Partial QP election. The burden estimates have been updated from the CY 
2020 PFS proposed rule (84 FR 40873 through 40874) due to availability 
of updated data.
l. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1445) and Eligible Clinician Initiated 
Process (Sec.  414.1445)
    As indicated below, the finalized requirements and burden discussed 
under this section 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 finalizing any new or revised collection of 
information requirements related to the Payer-Initiated Process. 
However, we are making adjustments to our currently approved burden 
estimates based on updated projections for the 2020 MIPS performance 
period. As mentioned above, the adjusted burden will be submitted to 
OMB for approval.
    As shown in Table 108, based on the actual number of requests 
received in the 2018 QP performance period, we estimate that in CY 2020 
for the 2021 QP performance period 110 payer-initiated requests for 
Other Payer Advanced APM determinations will be submitted (10 Medicaid 
payers, 50 Medicare Advantage Organizations, and 50 remaining other 
payers), a decrease of 105 from the 215 total requests currently 
approved by OMB under the

[[Page 63143]]

aforementioned control number. We estimate it will take 10 hours at 
$90.02/hr for a computer system analyst per arrangement submission. In 
aggregate, we estimate an annual burden of 1,100 hours (110 submissions 
x 10 hr/submission) at a cost of $99,022 (1,100 hr x $90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.152

    As shown in Table 109, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of payer-
initiated requests from 215 to 110 results in an adjustment of -1,050 
hours (-105 requests x 10 hr) at a cost of -$94,521 (-1,050 hr x 
$90.02/hr).
[GRAPHIC] [TIFF OMITTED] TR15NO19.153

    We received no public comments related to the burden estimates for 
the Other Payer Advanced APM Identification Determinations: Payer-
Initiated Process. The burden estimates have been updated from the CY 
2020 PFS proposed rule (84 FR 40874) due to availability of updated 
data.
(2) Eligible Clinician Initiated Process (Sec.  414.1445)
    This rule is not finalizing 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 finalizing any new or revised collection of 
information requirements related to the Submission of Data for QP 
Determinations under the All-Payer Combination Option. However, we are 
making adjustments to our currently approved burden estimates based on 
updated projections for the 2020 MIPS performance period. The adjusted 
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621).
    The CY 2017 Quality Payment Program final rule provided that either 
APM Entities or individual eligible clinicians must submit by a date 
and in a manner determined by us: (1) Payment arrangement information 
necessary to assess whether each other payer arrangement is an Other 
Payer Advanced APM, including information on financial risk 
arrangements, use of CEHRT, and payment tied to quality measures; (2) 
for each payment arrangement, the amounts of payments for services 
furnished through the arrangement, the total payments from the payer, 
the numbers of patients furnished any service through the arrangement 
(that is, patients for whom the eligible clinician is at risk if actual 
expenditures exceed expected expenditures), and (3) the total number of 
patients furnished any service through the arrangement (81 FR 77480). 
The rule also specified that if we do not receive sufficient 
information to complete our evaluation of another payer arrangement and 
to make QP determinations for an eligible clinician using the All-Payer 
Combination Option, we will not assess the eligible clinicians under 
the All-Payer Combination Option (81 FR 77480).
    In the CY 2018 Quality Payment Program final rule, we explained 
that in order for us to make QP determinations under the All-Payer 
Combination Option using either the payment

[[Page 63144]]

amount or patient count method, we will need to receive all of the 
payment amount and patient count information: (1) Attributable to the 
eligible clinician or APM Entity through every Other Payer Advanced 
APM; and (2) for all other payments or patients, except from excluded 
payers, made or attributed to the eligible clinician during the QP 
performance period (82 FR 53885). We also finalized that eligible 
clinicians and APM Entities will not need to submit Medicare payment or 
patient information for QP determinations under the All-Payer 
Combination Option (82 FR 53885).
    The CY 2018 Quality Payment Program final rule also noted that we 
will need this payment amount and patient count information for the 
periods January 1 through March 31, January 1 through June 30, and 
January 1 through August 31 (82 FR 53885). We noted that the timing may 
be challenging for APM Entities or eligible clinicians to submit 
information for the August 31 snapshot date. If we receive information 
for either the March 31 or June 30 snapshots, but not the August 31 
snapshot, we will use that information to make QP determinations under 
the All-Payer Combination Option. This payment amount and patient count 
information is to be submitted in a way that allows us to distinguish 
information from January 1 through March 31, January 1 through June 30, 
and January 1 through August 31 so that we can make QP determinations 
based on the two finalized snapshot dates (82 FR 30203 through 30204).
    The CY 2018 Quality Payment Program final rule specified that APM 
Entities or eligible clinicians must submit all of the required 
information about the Other Payer Advanced APMs in which they 
participate, including those for which there is a pending request for 
an Other Payer Advanced APM determination, as well as the payment 
amount and patient count information sufficient for us to make QP 
determinations by December 1 of the calendar year that is 2 years to 
prior to the payment year, which we refer to as the QP Determination 
Submission Deadline (82 FR 53886).
    In the CY 2019 PFS final rule, we finalized the addition of a third 
alternative to allow QP determinations at the TIN level in instances 
where all clinicians who have reassigned billing rights to the TIN 
participate in a single (the same) APM Entity (83 FR 59936). This 
option will therefore be available to all TINs participating in Full 
TIN APMs, such as the Medicare Shared Savings Program. It will also be 
available to any other TIN for which all clinicians who have reassigned 
billing rights to the TIN are participating in a single APM Entity. To 
make QP determinations under the All-Payer Combination Option at the 
TIN level as finalized using either the payment amount or patient count 
method, we will need to receive, by December 1 of the calendar year 
that is 2 years to prior to the payment year, all of the payment amount 
and patient count information: (1) Attributable to the eligible 
clinician, TIN, or APM Entity through every Other Payer Advanced APM; 
and (2) for all other payments or patients, except from excluded 
payers, made or attributed to the eligible clinician(s) during the QP 
performance period for the periods January 1 through March 31, January 
1 through June 30, and January 1 through August 31.
    As shown in Table 110, we assume that 20 APM Entities, 448 TINs, 
and 83 eligible clinicians will submit data for QP determinations under 
the All-Payer Combination Option in 2019, and increase of 242 from the 
309 total submissions currently approved by OMB under the 
aforementioned control number. We estimate it will take the APM Entity 
representative, TIN representative, or eligible clinician 5 hours at 
$109.36/hr for a practice administrator to complete this submission. In 
aggregate, we estimate an annual burden of 2,755 hours (551 respondents 
x 5 hr) at a cost of $301,287 (2,755 hr x $109.36/hr).
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    As shown in Table 111, using our unchanged currently approved per 
respondent burden estimate, the increase in the number of data 
submissions from 309 to 551 results in an adjustment of 1,210 hours 
(242 requests x 5 hr) at a cost of $132,326 (1,210 hr x $109.36/hr).

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    We received no public comments related to the burden estimates for 
the submission of data for All-Payer QP Determinations. The burden 
estimates have been updated from the CY 2020 PFS proposed rule (84 FR 
40875 through 40876) due to availability of updated data.
m. ICRs Regarding Voluntary Participants Election To Opt-Out of 
Performance Data Display on Physician Compare (Sec.  414.1395)
    This rule is not finalizing 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 making adjustment to our currently approved burden 
estimates based on data from the 2018 MIPS performance period. The 
adjusted burden will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    We estimate that 10 percent of the total clinicians and groups who 
will voluntarily participate in MIPS will also elect not to participate 
in public reporting. This results in a total of 10,042 (0.10 x 100,415 
voluntary MIPS participants) clinicians and groups, a decrease of 1,575 
from the currently approved estimate of 11,617 and a decrease of 1,474 
from the estimate of 11,516 respondents in the CY 2020 PFS proposed 
rule due to availability of more recent data (84 FR 40876) due to the 
availability of more recent data. 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).
    In section III.K.3.h.(6) of this rule, we are finalizing to 
publicly report (1) an indicator if a MIPS eligible clinician is scored 
using facility-based measurement beginning with Year 3 (2019 
performance information available for public reporting in late 2020) 
and (2) aggregate MIPS data beginning with Year 2 (2018 performance 
information available for public reporting in late 2019). We believe it 
is possible that the percentage of voluntary participants electing not 
to participate in public reporting may change as a result of these 
policies, we lack the ability to predict the behavior of clinicians' 
response to them. Table 112 shows that for these voluntary 
participants, we estimate it will take 0.25 hours at $90.02/hr for a 
computer system analyst to submit a request to opt-out. In aggregate, 
we estimate an annual burden of 2,511 hours (10,042 requests x 0.25 hr/
request) at a cost of $225,995 (2,511 hr x $90.02/hr).
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    As shown in Table 113, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of opt outs by 
voluntary participants from 11,617 to 10,042 results in an adjustment 
of 393.75 hours (-1,575 requests x 0.25 hr) at a cost of -$35,445 (-
393.75 hr x $90.02/hr).

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    We received no public comments related to the burden estimates for 
voluntary participants to opt-out of performance data display on 
Physician Compare. The burden estimates have been updated from the CY 
2020 PFS proposed rule (84 FR 40876 through 40877) due to availability 
of updated data.
n. Summary of Annual Quality Payment Program Burden Estimates
    Table 114 summarizes this final rule's burden estimates for the 
Quality Payment Program. To understand the burden implications of the 
policies finalized in this rule, we have also estimated a baseline 
burden of continuing the policies and information collections set forth 
in the CY 2019 PFS final rule into the 2020 MIPS performance period. 
Our estimated baseline burden estimates reflect the availability of 
more accurate data to account for all potential respondents and 
submissions across all the performance categories, more accurately 
reflect the exclusion of QPs from all MIPS performance categories, and 
better estimate the number of third-parties likely to self-nominate as 
qualified registries and QCDRs, as well as the number of measures 
submitted per QCDR. The baseline burden estimate is 2,932,925 hours at 
a cost of $279,573,747. This baseline burden estimate is lower than the 
burden approved for information collection related to the CY 2019 PFS 
final rule due to updated data and assumptions. The difference of -276 
hours and -$23,257 between this baseline estimate and the total burden 
shown in Tables 114 and 116 is the reduction in burden associated with 
impacts of finalized policies to require QCDRs to perform measure 
testing, partially offset by an increase in burden due to finalized 
policies requiring QCDRs to submit measure testing data and to require 
quality measures and QCDR measures be linked to existing cost measures, 
improvement activities, or MIPS Value Pathways, as feasible and 
applicable at the time of self-nomination.
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    Table 115 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this final rule. We have divided the reasons for our change in burden 
into those related to new policies and those related to adjustments in 
burden from continued Quality Payment Program Year 3 policies that 
reflect updated data and revised methods.

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C. Summary of PRA-Related Requirements and Annual Burden Estimates

    A summary of the PRA-related requirements and annual burden 
estimates is shown in Table 116.

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D. Beneficiary Liability

    Many policy changes could result in a change in beneficiary 
liability as it relates to coinsurance (which is 20 percent of the fee 
schedule amount, if applicable for the particular provision after the 
beneficiary has met the deductible). To illustrate this point, as shown 
in our public use file Impact on Payment for Selected Procedures 
available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2019 national 
payment amount in the nonfacility setting for CPT code 99203 (Office/
outpatient visit, new) was $109.92, which means that in CY 2019, a 
beneficiary would be responsible for 20 percent of this amount, or 
$21.98. Based on this final rule, using the CY 2020 CF, the CY 2020 
national payment amount in the nonfacility setting for CPT code 99203, 
as shown in the Impact on Payment for Selected Procedures public use 
file, is $110.43, which means that, in CY 2020, the final beneficiary 
coinsurance for this service would be $22.09.

VII. Regulatory Impact Analysis

A. Statement of Need

    This final rule makes payment and policy changes under the Medicare 
PFS and implements required statutory changes under the Medicare Access 
and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better 
Life Experience Act (ABLE), the Protecting Access to Medicare Act of 
2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, the 
Consolidated Appropriations Act of 2016, the Bipartisan Budget Act of 
2018, and sections 2005 6063, and 6111 of the SUPPORT for Patients and 
Communities Act of 2018. This final rule also makes changes to payment 
policy and other related policies for Medicare Part B.
    This final rule is necessary to make policy changes under Medicare 
fee-for-service. Therefore, we included a detailed Regulatory Impact 
Analysis (RIA) to assess all costs and benefits of available regulatory 
alternatives and explained the selection of these regulatory approaches 
that we believe adhere to statutory requirements and, to the extent 
feasible, maximize net benefits.

B. Overall Impact

    We examined the impact of this rule as required by Executive Order 
12866 on Regulatory Planning and Review (September 30, 1993), Executive 
Order 13563 on Improving Regulation and Regulatory Review (February 2, 
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 
L. 96-354), section 1102(b) of the Social Security Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the 
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 
on Reducing Regulation and Controlling Regulatory Costs (January 30, 
2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). An RIA 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). We estimated, as discussed in 
this section, that the PFS provisions included in this final rule will 
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.

[[Page 63151]]

    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. The PFS does not 
reimburse for services provided by rural hospitals; the PFS pays for 
physicians' services, which can be furnished by physicians and 
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 
final rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2019, that 
threshold is approximately $154 million. This final rule will impose no 
mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has Federalism 
implications. Since this 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. We 
estimate the rule generates $0.61 million in annualized savings in 2016 
dollars, discounted at 7 percent relative to year 2016 over a perpetual 
time horizon. This final rule is still considered an E.O. 13771 
regulatory action due to potential unquantified cost. Details on the 
estimated costs of this rule can be found in the preceding and 
subsequent analyses.
    For the Quality Payment Program, we estimate that between 210,000 
and 270,000 clinicians will become Qualifying APM Participants (QPs) 
and the total lump sum APM Incentive Payments will be approximately 
$535-685 million in the 2022 Quality Payment Program payment year. We 
estimate that approximately 880,000 clinicians will be MIPS eligible 
clinicians for the 2020 MIPS performance period. We estimate that MIPS 
payment adjustments will be approximately equally distributed between 
negative MIPS payment adjustments and positive MIPS payment adjustments 
($433 million redistributed) to MIPS eligible clinicians, as required 
by the statute to ensure budget neutrality. Up to an additional $500 
million is also available for the 2022 MIPS payment year for additional 
positive MIPS payment adjustments for exceptional performance. Please 
refer to section VII.F.10 of this final rule for the full RIA of the 
Quality Payment Program.
    We prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this final rule; details the costs and benefits of the rule; analyzes 
alternatives; and presents the measures we would use to minimize the 
burden on small entities. As indicated elsewhere in this final rule, we 
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 final rule. We are unaware of any 
relevant federal rules that duplicate, overlap, or conflict with this 
final rule. The relevant sections of this final rule contain a 
description of significant alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compared payment rates for CY 2019 with payment rates for CY 2020 using 
CY 2018 Medicare utilization. The payment impacts in this final rule 
reflect averages by specialty based on Medicare utilization. The 
payment impact for an individual practitioner could vary from the 
average and would depend on the mix of services he or she furnishes. 
The average percentage change in total revenues will be less than the 
impact displayed here because practitioners and other entities 
generally furnish services to both Medicare and non-Medicare patients. 
In addition, practitioners and other entities may receive substantial 
Medicare revenues for services under other Medicare payment systems. 
For instance, independent laboratories receive approximately 83 percent 
of their Medicare revenues from clinical laboratory services that are 
paid under the Clinical Laboratory Fee Schedule (CLFS).
    The 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 2020, as required by 
section 1848(d)(19) of the Act, is 0.00 percent before applying other 
adjustments.

[[Page 63152]]

    To calculate the CY 2020 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 
estimated the CY 2020 PFS CF to be 36.0896 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 2020 anesthesia CF to be 
22.2774, which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments.

       Table 117--Calculation of the CY 2020 PFS Conversion Factor
------------------------------------------------------------------------
     CY 2019 Conversion Factor                                36.0391
------------------------------------------------------------------------
Statutory Update Factor...........  0.00 percent          ..............
                                     (1.0000).
CY 2020 RVU Budget Neutrality       0.14 percent          ..............
 Adjustment.                         (1.0014).
CY 2020 Conversion Factor.........  ....................         36.0896
------------------------------------------------------------------------


   Table 118--Calculation of the CY 2020 Anesthesia Conversion Factor
------------------------------------------------------------------------
     CY 2019 National Average
   Anesthesia Conversion Factor                               22.2730
------------------------------------------------------------------------
Statutory Update Factor...........  0.00 percent          ..............
                                     (1.0000).
CY 2020 RVU Budget Neutrality       0.14 percent          ..............
 Adjustment.                         (1.0014).
CY 2020 Anesthesia Fee Schedule     -0.46 percent         ..............
 Practice Expense and Malpractice    (0.9954).
 Adjustment.
CY 2020 Conversion Factor.........  ....................         22.2016
------------------------------------------------------------------------

    Table 119 shows the payment impact on PFS services of the policies 
contained in this final rule. To the extent that there are year-to-year 
changes in the volume and mix of services provided by practitioners, 
the actual impact on total Medicare revenues will be different from 
those shown in Table 119 (CY 2020 PFS Estimated Impact on Total Allowed 
Charges by Specialty). The following is an explanation of the 
information represented in Table 119.
     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 2018 utilization and CY 
2019 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 2020 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 2020 impact on total allowed charges of the changes in the 
PE RVUs.
     Column E (Impact of MP RVU Changes): This column shows the 
estimated CY 2020 impact on total allowed charges of the changes in the 
MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2020 combined impact on total allowed charges of all the 
changes in the previous columns. Column F may not equal the sum of 
columns C, D, and E due to rounding.
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2. CY 2020 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 clinical social workers, podiatry, urology, and obstetrics/
gynecology reflect increases relative to other physician specialties. 
These increases can largely be attributed to finalized increases in 
value for particular services following the recommendations from the 
American Medical Association (AMA)'s Relative Value Scale Update 
Committee 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.
    The estimated impacts for several specialties, including 
ophthalmology and optometry, reflect decreases in payments relative to 
payment to other physician specialties as a result of revaluation of 
individual procedures reviewed by the AMA's relative value scale update 
committee (RUC) and CMS. The estimated impacts for other specialties, 
including vascular surgery, reflect 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. We also 
note that the estimated impact for the neurology specialty is 
decreasing as compared to the proposed impacts due to the decision to 
finalize contractor pricing for some of the new long term EEG 
monitoring services. 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 1 percent increase for CY 2020 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 119), 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 119 
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 119 displays the estimated CY 2020 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 2020 PFS final rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer readers to 
Addendum A on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
c. Estimated Impacts Related to Changes for Office/Outpatient E/M 
Services for CY 2021
    Although we did not propose changes to E/M coding and payment for 
CY 2020, we proposed certain changes for CY 2021. In the proposed rule, 
we displayed an impact table that illustrated the specialty level 
impact associated with implementing the proposed changes to the office/
outpatient E/M code set in CY 2020, rather than CY 2021. Table 120 
reflects that we are finalizing as proposed.

[[Page 63155]]

We believe these estimates provide insight into the magnitude of 
potential changes for certain physician specialties but note that Table 
120 does not take into account other changes to payment rates finalized 
for CY 2020 and should be considered for illustrative purposes only. 
Furthermore, as the CY 2021 impact of the revalued office/outpatient E/
M code set will be inclusive of policies finalized in that year's 
rulemaking, we believe it would be premature to provide updated impacts 
for CY 2020. Table 120 illustrates the estimated specialty level 
impacts associated with finalizing the work values for the office/
outpatient E/M codes, as well as the revalued HCPCS add-on G-code for 
primary care and certain types of specialty visits as proposed for CY 
2020, exclusive of any other changes finalized for CY 2020.
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    Overall, those specialties that bill higher level established 
patient visits, such as endocrinology or family practice, see the 
greatest increases as those codes were revalued higher relative to the 
rest of the office/outpatient E/M code set. Those specialties that see 
the greatest decreases are those that do not generally bill office/
outpatient E/M visits. Other specialty level impacts are primarily 
driven by the extent to which those specialties bill using the office/
outpatient E/M code set and the relative increases to the particular 
office/outpatient E/M codes predominantly billed by those specialties. 
We note that any potential coding changes and recommendations in 
overall valuation for new and existing codes between the CY 2020 rule 
and the CY 2021 final rule could impact the actual change in overall 
RVUs for office/outpatient visits relative to the rest of the PFS. 
Given the various factors that will be considered by the variety of 
stakeholders involved in the CPT and RUC processes, we do not believe 
we can estimate with any degree of certainty what the impact of 
potential changes might be. We also, note, however, that any changes in 
coding and payment for these services would be subject to notice and 
comment rulemaking.
    As discussed elsewhere in this section of the final rule, we 
estimate this approach would lead to burden reduction for 
practitioners, while allowing a year of preparatory time and time for 
potential refinement over the next year as we take into account any 
feedback from stakeholders on these changes.
    Comment: We received a number of comments on the impact analysis 
conducted to show the estimated specialty level impacts associated with 
implementing the proposed changes to the office/outpatient E/M code 
family for CY 2020, rather than CY 2021. Overall commenters requested 
that CMS provide more details as to how the impacts analysis was 
conducted, particularly the assumptions behind estimated utilization 
for HCPCS code GPC1X.
    Response: For purposes of estimating the specialty level impacts we 
assumed that the following specialties would bill HCPCS code GPC1X with 
100 percent of their office/outpatient E/M visit codes: Family 
practice, general practice, internal medicine, pediatrics, geriatrics, 
nurse practitioner, physician assistant, endocrinology, rheumatology, 
hematology/oncology, urology, neurology, obstetrics/gynecology, 
allergy/immunology, otolaryngology, interventional pain management, 
cardiology, nephrology, infectious disease, psychiatry, and pulmonary 
disease. We want to underscore that this was an assumption regarding 
which specialties are likely to furnish the types of medical care 
services that serve as the continuing focal point for all needed health 
care services or with medical care services that are part of ongoing 
care related to a patient's single, serious, or complex chronic 
condition and is not meant to be prescriptive as to which specialties 
may bill for this service. As stated earlier, there are no specialty 
restrictions for billing HCPCS code GPC1X.
    We encourage the public to submit additional information and 
recommendations regarding utilization for HCPCS code GPC1X prior to the 
February 10th deadline for submission of RUC and stakeholder valuation 
recommendations to be considered in CY 2021 rulemaking.

D. Effect of Changes Related to Telehealth

    As discussed in section II.F. of this final rule, we proposed to 
add three new codes, HCPCS codes G2086, G2087, and G2088, to the list 
of Medicare telehealth services for CY 2020. 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, for services already on the list, they are 
furnished via telehealth, on average, less than 0.1 percent of the time 
they are reported overall. The restrictions placed on Medicare 
telehealth by the statute limit the magnitude of utilization; however, 
we believe there is value in allowing physicians and patients the 
greatest flexibility when appropriate.

E. Effect of Changes Related to Physician Supervision for Physician 
Assistant (PA) Services

    As discussed in section II.I of this final rule, we proposed to 
revise Sec.  410.74(a)(2) such that the statutory physician supervision 
requirement for PA services at section 1861(s)(2)(K)(i) of the Act 
would be met when a PA furnishes their services in accordance with 
state law and state scope of practice rules for PAs in the state in 
which the services are furnished, with medical direction and 
appropriate supervision as required by state law in which the services 
are performed. In the absence of state law governing physician 
supervision of PA services, the physician supervision required by 
Medicare for PA services would be evidenced by documentation in the 
medical record of the PA's approach to

[[Page 63158]]

working with physicians in furnishing their services. This change would 
substantially align the regulation on physician supervision for PA 
services at Sec.  410.74(a)(2) with our current regulations on 
physician collaboration for NP and CNS services at Sec. Sec.  
410.75(c)(3) and 410.76(c)(3). Our finalized policies are responsive to 
practitioner concerns that Medicare requirement for supervision of PA 
services may impose a more stringent standard than state laws governing 
physician supervision of PA services, and suggestions that the current 
regulatory definition of physician supervision as it applies to PAs 
could inappropriately restrict the practice of PAs in delivering their 
professional services to the Medicare population. While we expect that 
our finalized policies may result in increased administrative 
flexibility for PAs as they furnish services to patients, we cannot 
determine the specific impact our revised policies will have on 
practice business plans and demand for certain levels of clinicians 
though we expect that any emerging trends may be indicative of the 
current and expanded role of nonphysician practitioners as members of 
the medical team.

F. Other Provisions of the Regulation

1. Effect of Medicare Coverage for Opioid Use Disorder Treatment 
Services Furnished by Opioid Treatment Programs (OTPs)
    As discussed in section II.G of this final rule, section 2005 of 
the Substance Use-Disorder Prevention that Promotes Opioid Recovery and 
Treatment (SUPPORT) for Patients and Communities Act establishes a new 
Medicare Part B benefit for opioid use disorder (OUD) treatment 
services furnished by opioid treatment programs (OTPs) for episodes of 
care beginning on or after January 1, 2020. The Substance Abuse and 
Mental Health Services Administration (SAMHSA) currently performs 
regulatory certification of OTPs. Currently, SAMHSA certifies about 
1,700 OTPs. They are located predominately in urban areas, tend to be 
freestanding facilities, and provide a range of services, including 
medication-assisted treatment (MAT). The payor mix for OTPs currently 
includes Medicaid, private payors, TRICARE, as well as individual pay 
patients. The updated total estimated net Medicare and Medicaid impact, 
including FFS and Medicare Advantage, over 10 years is $1,484,000,000. 
We note that this estimate has increased compared to the estimate in 
the proposed rule, to reflect changes in the policies being finalized 
compared to the proposed policies, including the adoption of add-on 
codes describing intake activities and periodic assessments. In 
developing this estimate, it was assumed that the average treatment 
length would be 12 months in duration and the average rate per week in 
CY 2020 was assumed to be $220, which is a weighted average of the 
rates we are finalizing for the bundled payments for treatment with 
methadone, buprenorphine, and naltrexone and reflects the payment 
methodology that was finalized for the non-drug component, which sums 
the rates of similar services paid for under Medicare. It also includes 
payment for initial and periodic assessments that were added in this 
final rule. The initial assessment was assumed to be provided once at 
the beginning of treatment for patients new to the program. For the 
purpose of this estimate, it was assumed that periodic assessments 
would occur twice per year. These rates were updated annually by the 
Medicare Economic Index (MEI), based on our finalized policy.
    We assumed that the impact in the first year would be reduced by 50 
percent due to potential delays in provider enrollment and necessary 
investment by providers to transition to Medicare coding and billing 
systems. Additionally, any change to FFS benefits has an associated 
impact on payments to Medicare Advantage plans so an adjustment was 
made to reflect this impact, based on the projected distribution of 
spending in each year. The estimate also accounts for the impact on the 
program due to the change in the monthly Part B premium as a result of 
implementation of this new benefit, which we estimate to increase from 
approximately $0.09 (9 cents) in 2021 to $0.14 (14 cents) in 2029. The 
Part B enrollment and MEI assumptions were based on the President's 
Fiscal Year 2020 Budget baseline that was released in July of 2019. As 
with all estimates, and particularly those for new separately billable 
services, this outcome is highly uncertain because the available 
information on which to base estimates is limited and is not directly 
applicable to a new Medicare payment. The cost and utilization 
estimates are based on Medicare and Medicaid claims data for 
beneficiaries with OUD, together with statistics about the types of 
services typically furnished at OTPs.
    It is difficult for us to predict how coverage of OTP services will 
specifically affect the market. We anticipate current OTPs may expand 
access to care for Medicare beneficiaries since they will be able to 
receive payment from Medicare for services furnished to beneficiaries 
when they previously were unable to do so. Coverage may also create 
financial incentives to establish new OTPs. However, since TRICARE, 
Medicaid, and some private payers already pay for OTP services, it is 
less clear whether the presence of Medicare payment rates will have any 
effect on current rates for OTP services or on new rates should 
additional private coverage be established.
2. Changes to the Ambulance Physician Certification Statement 
Requirement
    This final rule will clarify the requirements at Sec. Sec.  410.40 
and 410.41 regarding the requirements for physician certification and 
non-physician certification statements and expand the list of staff 
members who can sign non-physician certification statements. While we 
believe that clarification of the regulatory provisions associated with 
physician certification and non-physician certification statements is 
needed and would be well received by stakeholders, we do not believe 
that these clarifications would have any substantive monetary or impact 
the amount of time needed to complete the certification statements. We 
believe the primary benefit of the clarification would be for providers 
and suppliers in preparing and submitting the original certification 
statements. It is feasible the clarification could result in fewer 
claims being denied. However, hypothetically, these denials are likely 
a small subset of the ambulance claim denials and those denied for 
technical PCS issues are likely appealed and overturned.
    Moreover, we have examined the impact of expanding the list of 
individuals who may sign the non-physician certification statement. 
This added flexibility in accessing additional individuals to sign a 
non-physician certification statement would be needed only when the 
physician was unavailable. Thus, while we anticipate that some 
providers would use the increased flexibility, the precise impact is 
not calculable.
3. Medicare Ground Ambulance Data Collection System
    As discussed in section III.B.2. of this final rule, section 
50203(b) of the BBA of 2018 added a new paragraph (17) to section 
1834(l) of the Act, which requires the Secretary to develop a data 
collection system to collect cost, revenue, utilization, and other 
information determined appropriate with respect to providers and 
suppliers of ground ambulance services. In

[[Page 63159]]

section III.B.4 through III.B.7. of this final rule, we outline the 
provisions that implement this section, including the data that will be 
collected through the data collection system, sampling methodology, 
requirements for reporting data, payment reductions that will apply to 
ground ambulance providers and suppliers that fail to sufficiently 
report data and that do not qualify for a hardship exemption, informal 
review process that will be available to ground ambulance providers and 
suppliers that are subject to a payment reduction, and our policies for 
making the data available to the public.
    We estimate that ground ambulance providers and suppliers will need 
to engage in two primary activities with respect to these requirements, 
both of which will require them to incur cost and burden: Data 
collection and data reporting. The data collection activity includes: 
(1) Reviewing instructions to understand the data required for 
reporting; (2) accessing existing data systems and reports to obtain 
the required information; (3) obtaining required information from other 
entities where appropriate; and (4) if necessary, developing processes 
and systems to collect data that are not currently collected, but that 
they will be required to report under the data collection system. The 
data reporting activity includes entering the collected information in 
the Medicare Ground Ambulance Data Collection Instrument.
    To estimate the data collection impact, we assumed that each ground 
ambulance organization that is selected to submit data for a year would 
take up to 20 hours to collect the required data, which would include 4 
hours to review the instructions and 16 hours to collect the required 
data. These estimates were informed by our discussions with ambulance 
organizations during stakeholder engagements and through more in-depth 
interviews with nine ambulance organizations for the purpose of 
soliciting feedback on data collection instrument items as described in 
section III.B.3. and III.B.4. of this final rule. Most participants 
indicated that they would be able to provide some of the required 
information with an investment of 1-2 hours and complete information 
with additional hours to collect the missing data. Many participants 
indicated that they would need to reach out to other staff at the 
organization, at contracted organizations (such as billing companies), 
or at other entities (such as municipal government financial staff for 
government ambulance organizations) to collect required information 
that was not in the organization's accounting or billing systems. Some 
participants indicated that their organization would need to adjust 
data collection processes or collect new data over the course of a year 
to ensure that required data was available in the appropriate format 
prior to submission.
    Actual data collection and reporting will vary depending on the mix 
of employees at sampled ambulance organizations, the staff with 
available time to dedicate to data collection and data reporting 
activities at each organization, the staff in different roles that 
already perform similar activities in each organization, and whether 
billing services are contracted out or conducted internally.
    Because we expect that the staff (by category) that will contribute 
to data collection and reporting will be highly variable across ground 
ambulance organizations, we calculated a blended mean wage for the 
purposes of estimating burden. Table 121 lists the Standard 
Occupational Classification (SOC) categories contributing to the 
blended wage, the mean wage for each SOC specific to North American 
Industry Classification System (NAICS) industry code 621910 (Ambulance 
Services), and the relative contribution of each SOC to the blended 
mean. The source mean wage and employment data is from the Bureau of 
Labor Statistics May 2018 Occupational Employment Statistics data 
(available from https://download.bls.gov/pub/time.series/oe/) for the 
indicated SOC and NAICS codes, which was most recently available wage 
and employment data set. We assumed that financial clerks (SOC category 
433000) would account for 25 percent of the total data collection and 
reporting effort, and that six other SOC categories would contribute to 
the remaining 75 percent (see Table 121).
[GRAPHIC] [TIFF OMITTED] TR15NO19.166

    In addition, we calculated the cost of overhead, including fringe 
benefits, at 100 percent of the mean hourly wage. Although we recognize 
that fringe benefits and overhead costs may vary significantly by 
employer, and that there are different accepted methods for estimating 
these costs, doubling the mean blended wage rate to estimate total cost 
is an accepted method to provide a reasonably accurate estimate. 
Therefore, assuming a mean blended wage of $28.91 for data collection, 
and assuming the cost of overhead, including fringe benefits, at 100 
percent of the mean hourly wage, we calculated a wage plus benefits 
estimate of $57.82 per hour of data collection. To calculate at the 
total data collection cost per sampled ground ambulance organization, 
we multiplied the time

[[Page 63160]]

required for data collection by the burdened hourly wage (20 hours * 
$57.82/hour) for a total of $1,156.
    We discussed several sampling options in section III.B.5. of this 
final rule. We finalized our proposed sampling rate of 25 percent that 
would yield an expected 2,690 respondents (based on 2016 data) in the 
first sample, resulting in a total estimated data collection cost of 
$3,110,684 (2,690 respondents * $1,156 per respondent).
    To estimate the cost of data reporting, we assumed it will require 
3 hours to enter, review, and submit information into the proposed web-
based data collection system. The estimate of 3 hours was also informed 
by interviews with nine ambulance organizations to solicit feedback on 
the data instrument items under consideration. We included time for 
staff to review the collected data before entering it into the data 
collection system. We also assumed that staff responsible for reporting 
the data would have the same blended hourly wage used to estimate data 
collection costs above ($28.91) as the staff that collected the data. 
Again, assuming the cost of overhead at 100 percent of the mean hourly 
wage, we calculated at a wage plus benefits estimate of $57.82. 
Therefore, we estimate a per-respondent cost for data submission of 
$173.46 (3 hours * $57.82/hour). To calculate the total cost for data 
reporting under a 25 percent sampling rate, we multiplied the number of 
ground ambulance organizations sampled annually by the time required 
for data entry times the total hourly wage estimate, for a total of 
$466,603 across all respondents (2,690 respondents * 3 hours * $57.82/
hour).
    Adding the total data collection and reporting costs yields a total 
annual impact for ground ambulance organizations of $3,577,287 
($3,110,684 for data collection [2,690 respondents * 20 hours * $57.82/
hour] + $466,603 total cost for data submission [2,690 respondents * 3 
hours * $57.82/hour]) with a 25 percent sampling rate. Our estimate of 
total annual impact would be lower at $1,430,649 ($1,244,042 for data 
collection [1,076 respondents * 20 hours * $57.82/hour] + $186,606 for 
data submission [1,076 respondents * 3 hours * $57.82/hour]) under a 10 
percent sampling rate alternative and higher at $7,153,244 ($6,220,212 
for data collection [5,379 respondents * 20 hours * $57.82/hour] + 
$933,032 for data submission [5,379 respondents * 3 hours * $57.82/
hour]) under a 50 percent sampling rate. In all cases, the estimated 
cost of collecting and reporting data is $1,330 per organization 
sampled ($1,156 for data collection [20 hours * $57.82/hour] + $173.46 
for data submission [3 hours * $57.82/hour]). The per-organization 
estimate reflects an average. Based on discussions with ambulance 
organizations to provide feedback on instrument items, we do not 
anticipate that larger or smaller ambulance organizations in terms of 
transport volume, costs, or revenue will face systematically more or 
less burden in data collection or reporting. While larger organizations 
generally have higher transport volumes, costs, and revenue, and more 
complex financial arrangements that may increase reporting burden, they 
also tend to have existing data collection and reporting processes and 
staff that will reduce the additional effort required to submit the 
required data. On the other hand, while smaller organizations have less 
data to collect and report, they may not have current processes in 
place to begin collecting some required data.
    Comment: Two commenters disagreed with our estimate to complete the 
survey. One commenter stated for smaller organizations, compliance with 
the proposed cost reporting requirements will take considerably longer 
than the 20 hours over the course of 12 months estimated by CMS because 
a lot of the data being sought is not currently collected or sorted. 
The other commenter stated that the proposed estimate of 20 hours is 
not valid and should be 40 hours but would not include the time taken 
by others, such as the dispatcher or medical director, to collect the 
data. According to the commenter, the volunteer services do not collect 
a lot of data that is not directly needed for their operations and thus 
much of this will be new data.
    Response: We understand that the length of time it will take to 
complete the data collection will vary considerably, depending on 
numerous factors including the organizational structure of the 
ambulance organization, the existing accounting and cost reporting 
system, and the size and characteristics of the ambulance organization. 
For some, the amount of time required will be less than the estimate, 
and for others, it will be more. The estimate we provided is based on 
our experience in working with ambulance organizations during the 
development of the survey, and the time generally required by other 
programs with similar data collection requirements. We note that the 
data collection system was designed so that respondents only are 
required to answer the questions that are relevant for their 
organization, so for some organizations, the reporting requirements 
will also be less than for others.
b. Hardship Exemption Process
    As discussed in section III.B.7.b. of this final rule, we proposed 
a process for ground ambulance organizations to request and for CMS to 
grant hardship exemptions from the 10 percent payment reduction. To 
request a hardship exemption, we proposed that a ground ambulance 
organization would be required to complete and submit a request form 
that we would make available on the Ambulances Services Center website 
at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html.
    We estimate that 25 percent of the total number of ground ambulance 
organizations will be selected each year as the representative sample 
to report the required information under the data collection system. 
That is, 25 percent out of the total 10,758 NPIs, or 2,690 ambulance 
providers and suppliers.
    While we expect that few, if any, ground ambulance organizations 
will request a hardship exception, we do not have experience in 
collecting data from ground ambulance organizations that could be used 
to develop an estimate, so we based our estimate on the total number of 
organizations being surveyed. As a result, we estimated that a total of 
2,690 ground ambulance organizations would apply for a hardship 
exemption, and that it would take 15 minutes for each of these ground 
ambulance organizations 15 minutes to complete and submit the request 
form.
    We assumed for purposes of this estimate that the mix of staff 
responsible for completing this form would have the same blended hourly 
wage used to estimate the data collection and data reporting costs. We 
also calculated the cost of overhead, including fringe benefits, at 100 
percent of the mean hourly wage, as we did above. As a result, we 
estimated that the total cost burden associated with the completion and 
submission of the hardship exemption request form would be 
approximately $38,884.
    We did not receive any comments on our estimate to complete the 
hardship exemption form. As we discussed in section III.B.7.b. of this 
final rule, we are finalizing our proposed process for hardship 
exemptions.
c. Informal Review Process
    As discussed in section III.B.7.c. of this final rule, we proposed 
a process for a ground ambulance organization to seek an informal 
review of our determination that it is subject to the 10 percent 
reduction.
    We estimate that a collection of information burden of 15 minutes 
for a

[[Page 63161]]

ground ambulance organization that is requesting an informal review to 
gather the requested information and send an email to our AMBULANCEODF 
mailbox.
    We used the total number of ambulance organizations that will be 
surveyed each year to develop our estimates and estimated a total 
burden of 40,350 minutes (15 x 2,690) or 672.5 hours for 2,690 ground 
ambulance organizations to complete this process. Taking into account 
the same blended mean hourly wage and fringe benefits as we did for our 
other estimates, we estimated that the total for all sampled ground 
ambulance organizations to gather the requested information and submit 
the form would be approximately $38,884.
    We did not receive any comments on our estimate to collect and 
submit the information for an informal review. As we discussed in 
section III.B.7.c. of this final rule, we are finalizing our proposed 
process to request an informal review.
4. Intensive Cardiac Rehabilitation (ICR)
    As discussed in section III.C. of this final rule, we are adding 
stable, chronic heart failure (CHF) (defined as patient with left 
ventricular ejection fraction of 35 percent or less and NYHA class II 
to IV symptoms despite being on optimal heart failure therapy for at 
least 6 weeks) to the list of covered conditions for ICR, as well as, 
the ability for use to use the NCD process to add additional covered 
conditions for ICR. Heart failure impacts approximately 5.7 million 
adults, and approximately 80 percent of individuals over age 65 have 
heart failure. (The majority (86 percent) of Medicare beneficiaries are 
over age 65.) We estimate 4,560,000 beneficiaries over age 65 have 
heart failure.
    The uptake by beneficiaries has historically been low for CR and 
ICR. From February 2014 to 2017, after stable CHF was added to the 
covered conditions for CR, only 439,888 claims were processed for this 
service with a diagnosis code of CHF. Less than 1 percent of 
beneficiaries with heart failure utilized CR. Given that the uptake of 
ICR has been even lower than CR, we expect the same trend (low uptake) 
for intensive cardiac rehabilitation due to the nature of these 
programs which entail rehabilitation through lifestyle modification. We 
conducted a claims analysis that examined claims prior to and after a 
2014 NDC that added stable CHF to the list of covered conditions for 
CR. Prior to the implementation of stable CHF as a covered condition 
for CR, 1.8 percent of claims for CR included a diagnosis code for CHF. 
After implementation, 4.7 percent of claims for CR included a diagnosis 
code for CHF. Therefore, for ICR, which has historically been utilized 
much less than CR (for example, when all CR and ICR claims are 
combined, only 1 percent of the claims are for ICR), we anticipate 
there may be a similar slight percentage increase in claims for ICR for 
treatment of stable CHF. Assuming a 4.7 percent increase in ICR claims 
due to adding stable CHF as a covered condition, we estimate an 
increase of 3,378 claims annually. For 2019, the facility and non-
facility prices for CR and ICR are the same, and the average price is 
$120.93. Therefore, based on our estimated increase in claims, at an 
average price of $120.93, the estimated total cost of adding stable, 
chronic heart failure to the list of covered conditions for ICR is 
estimated at $408,502 annually. From 2010-2017, the median number of 
ICR visits per calendar year was 18 visits per beneficiary. Therefore, 
based on our expected increase in the number of claims (3,378), the 
estimated number of beneficiaries covered would be 187. Based on these 
estimates, we estimate there will only be a negligible impact on 
Medicare expenditures by finalizing this rule.
    Additionally, we do not anticipate providers currently offering ICR 
would need to obtain any specialized technology and equipment to treat 
ICR patients with stable CHF beyond what they would obtain for ICR 
patients seeking treatment for the existing six covered conditions.
    With the finalization of this rule, we now cover the seven cardiac 
conditions that constitute the vast majority of cardiac conditions that 
CR and ICR can treat. Due to the breadth of the covered conditions, we 
do not anticipate the need to use the NCD process to add additional 
covered conditions to CR and ICR in the near future.
    Lastly, while CR and ICR have low utilization at this point in 
time, an increase in the number of CR and/or ICR providers in 
underserved areas could result in an increase in utilization due to 
increased availability/proximity to services. However, we are not able 
to accurately quantify the number of entities that would seek approval 
as CR or ICR programs. Additionally, we acknowledge, that the expansion 
of coverage to ICR could generate attention around the importance of 
CR/ICR and may increase beneficiary utilization.
5. 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 proposed to align the eCQMs available for 
Medicaid EPs in 2020 with those available for MIPS eligible clinicians 
for the CY 2020 performance period. We are finalizing this proposal as 
proposed. We anticipate that this alignment will reduce burden for 
Medicaid EPs by aligning the requirements for multiple reporting 
programs, and that the system changes required for EPs to implement 
this change 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 2020. Not 
implementing this alignment could lead to increased burden because EPs 
might have to report on different eCQMs for the Medicaid Promoting 
Interoperability Program, if they opt to report on newly added eCQMs 
for MIPS. We expect that this policy will have only a minimal impact on 
states, by requiring minor adjustments to state systems for 2020 to 
maintain current eCQM lists and specifications. State expenditures to 
make any systems changes required as a result of this policy will be 
eligible for 90 percent Federal financial participation.
    For 2020, we proposed 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 policy 
would generally align with the MIPS data submission requirement for 
eligible clinicians using the eCQM collection type for the quality 
performance category, which is established 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. We are finalizing this policy as proposed. This policy will 
be a continuation of our policy for 2019 and we believe it will not 
create new burden for EPs or states.
    We also proposed that the 2020 eCQM reporting period for EPs in the 
Medicaid Promoting Interoperability Program who have demonstrated 
meaningful use in a prior year would be a minimum of any continuous 
274-day period within CY

[[Page 63162]]

2020. We proposed to shorten the reporting period from a full calendar 
year to enable states to take attestations for 2020 as early as October 
1, 2020. We noted that we believe this would improve states' 
flexibility as they move toward the end of the Medicaid Promoting 
Interoperability Program and the December 31, 2021 statutory deadline 
to make incentive payments. We explained that we believed that this 
proposal would create no additional burden for EPs or health IT 
vendors, as Certified EHR Technology (CEHRT) should be able to run eCQM 
reports for any number of days and during any time period. The eCQM 
reporting period would be a minimum and EPs could continue to report on 
a full calendar year if they wish. As in previous years, we proposed 
that the 2020 eCQM reporting period for EPs attesting to meaningful use 
for the first time would be any continuous 90-day period within the 
calendar year.
    After considering the comments we received on this proposal, we are 
finalizing a continuous 90-day eCQM reporting period for all Medicaid 
EPs in 2020, rather than requiring a minimum of any continuous 274-day 
period within CY 2020 for EPs in the Medicaid Promoting 
Interoperability Program who have demonstrated meaningful use in a 
prior year. The reporting period is a minimum, and we encourage EPs to 
report on a longer period if they are able to do so. As discussed 
above, at section III.D of this final rule, we believe that finalizing 
a 90-day eCQM reporting period for 2020, as recommended by commenters, 
instead of the 274-day eCQM reporting period we proposed, is more 
likely to reduce burden on EPs, health IT vendors, states, and other 
stakeholders, as compared to a full-year period or the 274-day eCQM 
reporting period we proposed.
    Finally, we proposed to change Medicaid policy for 2021 related to 
EP Meaningful Use Objective 1, Measure 1 (Conduct or review a security 
risk analysis (SRA)). We proposed to allow Medicaid EPs to conduct an 
SRA at any time during CY 2021, even if the EP conducts the SRA after 
attesting to meaningful use of CEHRT to the state. A Medicaid EP who 
has not completed an SRA for CY 2021 by the time he or she attests to 
meaningful use of CEHRT for CY 2021 would be required to attest that he 
or she will complete the required SRA by December 31, 2021. Currently, 
this measure must be completed in the same calendar year as the EHR 
reporting period. This may occur before, during, or after the EHR 
reporting period, though if it occurs after the EHR reporting period it 
must occur before the provider attests to meaningful use of CEHRT or 
before the end of the calendar year, whichever comes first. In 
practice, this means that EPs do not attest to meaningful use of CEHRT 
before completing this measure. However, due to the changes we 
previously made to the EHR and eCQM reporting period timelines for CY 
2021, all Medicaid EPs are expected to attest to meaningful use of 
CEHRT on or before October 31, 2021. Accordingly, if we did not propose 
to change the deadline for conducting the SRA, Medicaid EPs would no 
longer have the option of completing an SRA at the end of the calendar 
year, and would likely have to complete one well before December 2021. 
If an EP typically conducts the security risk analysis at the end of 
each year, this timeline could create burden for the EP, and may not be 
optimal for protecting information security, because it could disrupt 
the intervals between security risk analyses. We have also heard 
feedback from health care providers that SRAs are generally conducted 
for a whole clinic and the current requirement would create burden on 
non-EP health care providers in 2021. We are finalizing this change as 
proposed. As noted in the proposed rule, we believe this policy would 
prevent additional burden for both EPs and non-EP health care 
providers. We acknowledge that some EPs might experience increased 
burden due to the risk of recoupments from what we believe would likely 
be a small minority of EPs who fail to produce sufficient documentation 
for the SRA. However, we believe this potential additional burden is 
clearly outweighed by the reduced burden on what we anticipate would be 
the vast majority of Medicaid EPs that are afforded flexibility to 
conduct the SRA at any point in the calendar year that aligns with 
their operational needs.
    As also discussed in the proposed rule, this policy could create 
burden for states, as they might have to adjust their pre-payment and 
post-payment verification plans and conduct more thorough audits for 
this meaningful use objective. However, states are already required to 
conduct adequate oversight of the Medicaid Promoting Interoperability 
Program, including routine tracking and verification of meaningful use 
attestations (see 42 CFR 495.318(b), 495.332(c), and 495.368), and we 
did not propose to change that requirement for 2021. We have 
established at 42 CFR 495.322(b) that 90 percent federal financial 
participation will be available for state administrative expenditures 
related to Medicaid Promoting Interoperability Program audits and 
appeals that are incurred on or before September 30, 2023.
6. Medicare Shared Savings Program
    In section III.F.1.b. of this final rule, we summarize certain 
modifications to the quality measure set used to assess the quality 
performance of ACOs participating in the Shared Savings Program based 
on changes made to the CMS Web Interface measures under the Quality 
Payment Program in section III.I.3.b.(1). Specifically, (1) revisions 
to the numerator guidance for ACO-17--Preventive Care and Screening: 
Tobacco use: Screening and Cessation Intervention and maintaining the 
measure as pay-for-reporting for performance years 2019; and (2) 
reverting ACO-43--Ambulatory Sensitive Condition Acute Composite (AHRQ 
Prevention Quality Indicator (PQI) #91) to pay-for-reporting for 2 
years (2020 and 2021) to account for a substantive change in the 
measure.
    The net result of these modifications to the Shared Savings Program 
quality measure set will be a measure set of 23 measures for 
performance year 2020. These changes will have no impact on the number 
of measures an ACO is required to report; therefore, there is no 
expected change in reporting burden for ACOs.
7. Open Payments
a. Expanding the Definition of ``Covered Recipient'' (Sec. Sec.  
403.902, 403.904, and 403.908)
    Our initial estimate based on the available information is that 
there will be approximately $10 million dollar per year in increased 
burden to reporting entities and the new covered recipient groups for 
submitting, collecting, retaining, and reviewing data. This estimate is 
based on existing burden calculations. It assumes that there will be 
734,000 new records (~7 percent increase) reported about 205,000 (~33 
percent increase) covered recipients.
    We also believe there will be costs to reporting entities for 
updating their systems and reporting processes. However, we are unable 
to estimate these costs because they will vary depending on the 
reporting entity's individual circumstances.
    As explained in section IV.5. of this final rule, section 6111(c) 
of the SUPPORT Act states that chapter 35 of title 44 of the U.S. Code, 
which includes such provisions as the PRA, shall not apply to the 
changes to the definition of a covered recipient. Therefore, a detailed 
breakdown is not provided in that section. The above estimates

[[Page 63163]]

however, do provide a RIA of this provision.
b. Modification of the ``Nature of Payment'' Categories (Sec. Sec.  
403.902 and 403.904)
    We anticipate minor additional costs for system updates associated 
with our provision to modify the ``nature of payment'' categories. As 
we indicated in section III.F. of this final rule, said provisions are 
intended to add clarity. They will not increase the amount of 
information to be reported. Data already reported to us may simply be 
reported in a different category. We proposed these changes only to be 
made prospectively and did not propose to have manufactures and GPOs to 
make changes to previously reported data. This provision would, 
generally speaking, allow reporting entities to better characterize the 
nature of a payment and would not constitute a new requirement. Hence, 
the expected impact is minimal.
c. Standardizing Data Reporting (Sec. Sec.  403.902 and 403.904)
    Approximately 850 entities (approximately 53 percent), have 
reported a transaction that will require the addition of a device 
identifier when this final rule is implemented. The total cost of the 
addition of this new data element cannot be estimated because it would 
depend on: (1) Whether the entity already tracks this data element and 
(2) the extent to which the entity would need to update their system to 
be able to report this data element.
8. OTP Enrollment and Revocation of Physician/Eligible Professional 
Enrollment for Abusive Part B Prescribing or Patient Harm
i. OTP Enrollment
    As stated previously in this final rule, we proposed that OTP 
providers be required to not only enroll in Medicare, but also to: (1) 
Pay an application fee at the time of enrollment; and (2) submit a set 
of fingerprints for a national background check (via FBI Applicant 
Fingerprint Card FD-258) from all individuals who maintain a 5 percent 
or greater direct or indirect ownership interest in the OTP. The 
following is a discussion of the associated impacts we estimated in the 
proposed rule.
a. Application Fee
    The application fees for each of the past 3 calendar years (CY) 
were or are $560 (CY 2017), $569, (CY 2018), and $586 (CY 2019). 
Consistent with Sec.  424.518, the differing fee amounts were 
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 
could not predict future changes to the CPI, the fee amounts between 
2017 and 2019 increased by an average of $13 per year. We believed this 
was a reasonable barometer with which to establish estimates (strictly 
for purposes of the proposed rule) of the fee amounts in the first 3 
CYs of this rule (that is, 2020, 2021, and 2022). We thus projected a 
fee amount of $599 in 2020, $612 for 2021, and $625 for 2022.
    Applying these prospective fee amounts to the number of projected 
applicants in the rule's first 3 years, we estimated a cost to 
enrollees of $1,058,433 (or 1,767 x $599) in the first year, $41,004 
(or 67 x $612) in the second year, and $41,250 (or 66 x $625) in the 
third year.
b. Fingerprinting
    Based on the experiences of the provider community to date, we 
estimated that it would take each owner (BLS: Top Executives) 
approximately 2 hours at $123.32/hr to obtain and submit fingerprints. 
(According to the most recent BLS wage data for May 2018, the mean 
hourly wage for the general category of ``Top Executives'' is $61.66 
(see http://www.bls.gov/oes/current/oes_nat.htm#43 0000). With fringe 
benefits and overhead, the figure is $123.32.)
    As mentioned in the preamble of this final rule, SAMHSA statistics 
indicate that there are currently about 1,677 active OTPs. Of these, 
approximately 1,585 have full certifications and 92 have provisional 
certifications.
    Although we did not have specific data on the matter, we projected, 
for purposes of our burden estimates, a total of 1,500 direct or 
indirect ownership interests in OTP providers that would require the 
submission of fingerprints over the first 3 years. This 1,500 figure is 
less than the 1,900 projected applicants (discussed in the ICR section 
of this rule) in the first 3 years following the final rule's 
publication because some applicants may have non-profit business 
structures and, thus, would not have owners. Furthermore, our 
estimation of individual owners who would qualify to submit 
fingerprints was based on a sampling of similar provider types, 
including DMEPOS suppliers (high risk), MDPP suppliers (high risk), 
rural health clinics (limited risk) and others.
    As noted in the preamble to this final rule, however, the only OTPs 
that will be assigned to the high-risk level of categorical screening 
(thus requiring the submission of fingerprints) will be those that were 
not fully and continuously certified by SAMHSA since October 23, 2018. 
We believe this group represents about one-quarter of all projected OTP 
applications. Using our previously mentioned per-year projections of 
the number of enrolling OTPs, we believe that there will be 442 high-
risk level applications in the first year, 17 in the second year, and 
17 in the third year. (This results in a total of 476 OTPs.) In 
addition, application of the one-quarter percentage to the above-
mentioned universe of 1,500 ownership interests results in a revised 
figure of 375 (1,500 x 0.25).
    Applying these new figures to the aforementioned per year breakdown 
of applicants, we estimate a first year burden of 698 hours at a cost 
of $86,077 (698/hr x $123.32/hr). We obtained the 698 hour estimate by 
first dividing 442 (the number of first-year applicants) by 476, 
resulting in a figure of 0.93. We then multiplied 0.93 by 375 (the 
number of ownership interests over the 3-year period) and thereafter by 
2 hours.
    Applying this same formula, we projected a second-year time 
estimate of 26 hours (or 0.035 x 375 owners x 2 hr) at a cost of $3,206 
(26 hr x $123.32/hr), and a third-year estimate of 26 hours (or 0.035 x 
375 applicants x 2 hr) at a cost of $3,206 (26 hr x $123.32/hr). In 
aggregate, we estimated a burden of 750 hours (698 hr + 26 hr + 26 hr) 
at a cost of $92,489 ($86,077 + $3,206 + $3,206). When annualized over 
the 3-year period, we estimated an annual burden of 250 hours (750 
hours/3) at a cost of $30,830 ($92,489/3).
c. Conclusion
    We received no comments on our proposed estimates regarding 
application fees and fingerprinting. We are therefore finalizing them, 
subject to the modification of our fingerprinting projections.
ii. Revocation of Physician/Eligible Professional Enrollment for 
Improper Part B Prescribing or Patient Harm
    As previously discussed in the proposed rule and this final rule, 
we proposed the following:
     Under existing Sec.  424.535(a)(14), CMS may revoke a 
physician's or other eligible professional's enrollment if he or she 
has a pattern or practice of prescribing Part D drugs that:
    (i) Is abusive, and/or represents a threat to the health and safety 
of Medicare beneficiaries; or
    (ii) fails to meet Medicare requirements. We proposed to expand the 
scope of Sec.  424.535(a)(14) to include Part B drugs.

[[Page 63164]]

     In new Sec. Sec.  424.530(a)(15) and 424.535(a)(22), 
respectively, we proposed that CMS could deny or revoke a physician's 
or other eligible professional's enrollment if he or she has been 
subject to prior action from a state oversight board, federal or state 
health care program, Independent Review Organization (IRO) 
determination(s), or any other equivalent governmental body or program 
that oversees, regulates, or administers the provision of health care 
with underlying facts reflecting improper physician or other eligible 
professional conduct that led to patient harm.
    Using our current average annual number of revocations for improper 
Part D prescribing as a barometer, we project that approximately 10 
revocations per year will occur due to our expansion of Sec.  
424.535(a)(14) to include Part B drugs. Regarding our patient harm 
provision, we project approximately 5 revocations per year. This is 
based on our statements in section III.H of this final rule that we 
will exercise our authority under this provision only in significant 
and exceptional cases of patient harm. This results in an annual 
estimated total of 15 revocations for these two provisions. Based on 
our internal statistics concerning the average annual amount of 
provider payments, we project a per-revoked provider amount of $50,000. 
We therefore estimate our combined annual projected savings to the 
Trust Funds (specifically, monies that would not otherwise be paid to 
the revoked providers) concerning the abusive Part B prescribing and 
patient harm revocation provisions to be $750,000 (15 revocations X 
$50,000) annually. Over 10 years, this results in a total savings of 
$7.5 million.
9. Deferring to State Scope of Practice Requirements
a. Ambulatory Surgery Centers
    Currently, there are approximately 5,800 Medicare-participating 
ASCs. We are finalizing our proposal with modification at Sec.  
416.42(a)(1) to clarify that there are two components to any pre-
procedure evaluation and require that, immediately before surgery, a 
physician must examine the patient to evaluate the risk of the 
procedure to be performed, and a physician or anesthetist must examine 
the patient to evaluate the risk of anesthesia for that procedure. We 
are finalizing this change to reduce ASC compliance burden and provide 
for patient assessment and care continuity while maintaining patient 
safety and care. At Sec.  416.42(a)(1)(ii), we will allow an 
anesthetist or a physician to perform the required pre-surgical 
anesthesia risk evaluation. We do not believe this modification to the 
proposed policy affects our estimates.
    In total, ASCs provided about 6.4 million services in 2016. We 
assume that 30 percent of all procedures will utilize the services of a 
nurse anesthetist instead of a physician to meet this requirement, 
which reduces the average cost of the examination. We estimate the pre-
surgical anesthesia evaluation to take 15 minutes to complete. We are 
assuming these estimates based on previous experience and conversations 
with stakeholders.
    According to 2018 Bureau of Labor Statistics data, the hourly cost 
for a physician (including fringe benefits and overhead calculated at 
100 percent of the mean hourly wage) is approximately $203 ($51 for 15 
minute evaluation), and the hourly cost for a nurse anesthetist is 
approximately $168 ($42 for 15 minute evaluation). Assuming 1.92 
million procedures annually, we can predict a savings of approximately 
$17.3 million (($51-$42) x 1.92 million). We have used our best 
estimate as to the percentage of pre-surgical evaluations by 
anesthetists overall.
b. Hospice
    We are revising Sec.  418.106 to permit hospices to accept orders 
for drugs from attending physicians who are physician assistants. We do 
not believe that there are any associated financial impacts for 
hospices.
10. Changes Due to Updates to the Quality Payment Program
    In section III.K. of this final rule, we included our policies for 
the Quality Payment Program. In this section of the final rule, we 
present the overall and incremental impacts to the number of expected 
QPs and associated APM Incentive Payments. In MIPS, we estimate the 
total MIPS eligible population and the payment impacts by practice size 
for the 2020 MIPS performance period based on various proposed policies 
to modify the MIPS final score and the proposed new performance 
threshold and additional performance threshold. For this RIA, we 
updated performance period and eligibility data to reflect information 
submitted in the 2018 MIPS performance period.
a. Estimated APM Incentive Payments to QPs in Advanced APMs and Other 
Payer Advanced APMs
    From 2019 through 2024, through the Medicare Option, eligible 
clinicians receiving a sufficient portion of Medicare Part B payments 
for covered professional services or seeing a sufficient number of 
Medicare patients through Advanced APMs as required to become QPs, for 
the applicable performance period, will receive a lump-sum APM 
Incentive Payment equal to 5 percent of their estimated aggregate 
payment amounts for Medicare covered professional services furnished 
during the calendar year immediately preceding the payment year. In 
addition, beginning in payment year 2021, in addition to the Medicare 
Option, eligible clinicians may become QPs through the All-Payer 
Combination Option. The All-Payer Combination Option will allow 
eligible clinicians to become QPs by meeting the QP thresholds through 
a pair of calculations that assess a combination of both Medicare Part 
B covered professional services furnished through Advanced APMs and 
services furnished through Other Payer Advanced APMs.
    The APM Incentive Payment is separate from and in addition to the 
payment for covered professional services furnished by an eligible 
clinician during that year. Eligible clinicians who become QPs for a 
year are exempt from MIPS reporting requirements and payment 
adjustment. 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 2020 QP Performance Period, 
we define Partial QPs to be eligible clinicians in Advanced APMs who 
collectively have at least 40 percent, but less than 50 percent, of 
their payments for Part B covered professional services through an APM 
Entity, or collectively furnish Part B covered professional services to 
at least 25 percent, but less than 35 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, payment rates for services 
furnished by clinicians who achieve QP status for a year would be 
increased each year by 0.75 percent for the year, while payment rates 
for services furnished by clinicians who do not achieve QP status for 
the year would be increased by 0.25

[[Page 63165]]

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 fourth payment year (2022 payment year) of the 
Quality Payment Program.
    In section III.K.4.e.(3)(c)(ii) of this final rule, we amended the 
marginal risk standard finalized in Sec.  414.1420(d)(5) by amending 
paragraph (d)(5)(i) to provide that in event that the marginal risk 
rate varies depending on the amount by which actual expenditures exceed 
expected expenditures, the average marginal risk rate across all 
possible levels of actual expenditures would be used for comparison to 
the marginal risk rate specified in paragraph (d)(3)(ii) of Sec.  
414.1420(d), and we retained the exceptions for large losses and small 
losses as described in that section. We do not yet have experience with 
QP and Partial QP Determinations under the All-Payer Combination 
Option, as the 2019 QP Performance Period is the first year in which 
eligible clinicians can become QPs or Partial QPs under the All-Payer 
Combination Option. To date, we have only determined a modest number of 
payment arrangements from non-Medicare payers that meet the Other Payer 
Advanced APM criteria. However, we expect this policy may increase the 
number of arrangements that may meet the Other Payer Advanced APM 
financial risk criterion.
    Based on our analysis there are 21,000 providers within 5 percent 
of performance year 2020 QP thresholds in Advanced APMs, and therefore, 
could potentially benefit from participation in Other Payer Advanced 
APMs. Assuming a static marketplace, there are between 100-150 eligible 
clinicians that would benefit from the change in the marginal risk 
requirement at this time (that is, in 2020 QP Performance Period). This 
is because there are likely to be only a small number of eligible 
clinicians who both (1) participate in the payment arrangements we 
determined were not Other Payer Advanced APMs, but will become Other 
Payer Advanced APMs under the policy, and (2) have QP scores just below 
the QP threshold. While this number may grow in the future as payers 
adopt payment arrangements designed to reflect the change in the 
marginal risk requirement, we anticipate the incremental impact of this 
policy will have a small impact on the number of clinicians that meet 
the QP threshold and the total number of payment arrangements that are 
determined to be Other Payer Advanced APMs for the 2020 QP Performance 
Period.
    Overall, we estimated that for the 2020 QP Performance Period 
between 210,000 and 270,000 eligible clinicians will become QPs, 
therefore be excluded from MIPS, and qualify for the lump sum APM 
incentive payment in Payment Year 2022 based on 5 percent of their Part 
B allowable charges for covered professional services in the preceding 
year. These allowable charges for QPs are estimated to be between 
approximately $10,700 million and $13,700 million in total for the 2020 
performance year. The analysis for this final rule used the 2019 second 
snapshot participation file, and the 2019 third snapshot participation 
file for the MSSP Basic Level E and MSSP Enhanced models. We estimate 
that the total lump sum APM Incentive Payments will be approximately 
$535-685 million for the 2022 Quality Payment Program payment year.
    In section VII.F.10.b. of this final rule, we projected the number 
of eligible clinicians that will be QPs, and thus excluded from MIPS, 
using several sources of information. First, the projections are 
anchored in the most recently available public information on Advanced 
APMs. The projections reflect Advanced APMs that will be operating 
during the 2020 QP Performance Period, as well as some Advanced APMs 
anticipated to be operational during the 2020 QP Performance Period. 
The projections also reflect an estimated number of eligible clinicians 
that would attain QP status through the All-Payer Combination Option. 
The following APMs are expected to be Advanced APMs for the 2020 QP 
Performance Period:
     Next Generation ACO Model, Comprehensive Primary Care Plus 
(CPC+) Model;
     Comprehensive ESRD Care (CEC) Model (Two-Sided Risk 
Arrangement);
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative);
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track);
     Oncology Care Model (Two-Sided Risk Arrangements);
     Medicare ACO Track 1+ Model;
     Bundled Payments for Care Improvement Advanced;
     Maryland Total Cost of Care Model (Maryland Care Redesign 
Program; Maryland Primary Care Program); and
     Medicare Shared Savings Program (Track 2, Basic Track 
Level E, and the ENHANCED Track).
    We used the APM Participant 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 QPs, total Part B allowed 
charges for covered professional services, and the aggregate total of 
APM incentive payments for the 2020 QP Performance Period. We examined 
the extent to which Advanced APM participants would meet the QP 
Thresholds of having at least 50 percent of their Part B covered 
professional services or at least 35 percent of their Medicare 
beneficiaries furnished Part B covered professional services through 
the APM Entity.
    We received the following comments on the APM estimates:
    Comment: One commenter expressed concern that the RIA estimates 
similar totals for the number of QPs in performance year 2019 and 
performance year 2020, reflecting a relatively flat projected growth of 
QPs in 2020.
    Response: In the CY 2020 PFS proposed rule (84 FR 40732), we 
estimated the number of QPs based on the best data at the time of 
publication. Our current analysis reflects the most recent 
participation data as of August 31, 2019 and as a result our 
projections indicate an increase in the number of QPs for PY2020.
    As a result of the availability of more recent data, we have 
updated our calculations in this final rule and estimate that for the 
2020 QP Performance Period between 210,000 and 270,000 eligible 
clinicians will become QPs.
b. Estimated Number of Clinicians Eligible for MIPS Eligibility
(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 2020 
MIPS performance period in this final 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 several 
eligibility files 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

[[Page 63166]]

MIPS eligible clinicians as we finalized in the CY 2019 PFS final rule 
(83 FR 59727 through 59730). We included 1.6 million clinicians (see 
Table 122) 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.
    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 
those clinicians eligible for MIPS. Due to policy changes the exclusion 
for participants in the Medicare Advantage Qualifying Payment 
Arrangement Incentive (MAQI) has been removed.
    For the estimated MIPS eligible population for the 2022 MIPS 
payment year, we restricted our analysis to clinicians who are a 
physician (as defined in section 1861(r) of the Act); a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5) of the Act); a certified 
registered nurse anesthetist (as defined in section 1861(bb)(2) of the 
Act); a physical therapist, occupational therapist, speech-language 
pathologist, audiologist, clinical psychologist, and registered 
dietitian or nutrition professional as finalized in the CY 2019 PFS 
final rule (83 FR 60076).
    As noted previously, we excluded QPs from our scoring model since 
these clinicians are not MIPS eligible clinicians. To determine which 
clinicians in the initial population of 1.6 million should be excluded 
as QPs, we used the APM Participant List for the first 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 2020 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 163,200. Due to data 
limitations, we could not identify specific clinicians who may become 
QPs in the 2020 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 or APM entity) levels based 
on how data are submitted or at the APM Entity level if the clinician 
is part of a MIPS APM Entity scored under the APM scoring standard. To 
determine who among those in the total initial population of 1.6 
million is a MIPS APM participant, we used those who are APMs in the 
2018 performance period as well as the additional clinicians in the 
first snapshot date of the 2019 QP performance period. To determine who 
is a member of a virtual group we used those who are in a virtual group 
for the 2018 performance period. If a MIPS eligible clinician is 
determined to not be scored as a MIPS APM or virtual group participant, 
then their reporting type, that is, group (TIN) or individual (TIN/NPI) 
is based on their reporting for the CY 2018 MIPS performance period. If 
no data are submitted by a clinician (TIN/NPI) or the clinician's group 
(TIN), and the TIN/NPI is not associated with an APM Entity or virtual 
group during the performance period, then the low-volume threshold is 
applied at the TIN/NPI level to PFS charges and beneficiary count for 
the 2019 first determination period. 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 122 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 2020 MIPS performance 
period after using 2018 MIPS performance period data and applying the 
policies for the 2020 MIPS performance period.
    For the purposes of modeling, we made assumptions on group 
reporting to apply the low-volume threshold. One extreme and unlikely 
assumption is that no practices elect group reporting, virtual group 
reporting, or participate in an APM and the low-volume threshold would 
always be applied at the individual level. Although we believe a 
scenario in which only these clinicians would participate as 
individuals is unlikely, this assumption is important because it 
quantifies the minimum number of MIPS eligible clinicians. For this 
final rule model, we estimate there were approximately 220,000 
clinicians \132\ who would be MIPS eligible because they exceed the low 
volume threshold as individuals and are not otherwise excluded. In 
Table 122, we identify clinicians under this assumption as having 
``required eligibility.''
---------------------------------------------------------------------------

    \132\ The count of 224,082 MIPS eligible clinicians for required 
eligibility includes those who participated in MIPS (206,226 MIPS 
eligible clinicians), as well as those who did not participate 
(17,856 MIPS eligible clinicians).
---------------------------------------------------------------------------

    We anticipate that groups that submitted to MIPS as a group or 
registered as a virtual group for the CY 2018 MIPS performance period 
will continue to do so for the CY 2020 MIPS performance period. Using 
this group assumption and including those identified with MIPS APM 
entities in our scoring model, we identified 639,004 MIPS eligible 
clinicians. In Table 122, we identify these clinicians who do not meet 
the low-volume threshold individually but are anticipated to submit to 
MIPS as a group, virtual group or MIPS APM as having ``group 
eligibility.'' 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.
    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 assumption of 33 percent 
opt-in participation 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

[[Page 63167]]

adjustment based on their performance. This 33 percent participation 
assumption is identified in Table 122 as ``Opt-In eligibility''. In 
this final rule analysis, we estimate an additional 20,644 clinicians 
would be eligible through this policy for a total MIPS eligible 
population of approximately 880,000. The leads to an associated $69 
billion allowed PFS charges estimated to be included in the 2020 MIPS 
performance period.
[GRAPHIC] [TIFF OMITTED] TR15NO19.167

    There are approximately 380,352 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 that the MIPS eligible clinician population 
could be as high as 1.26 million clinicians.

[[Page 63168]]

    Finally, there are some clinicians who would not be MIPS eligible 
either because they or their group are below the low-volume threshold 
on all three criteria (approximately 82,000) or because they are 
excluded for other reasons (approximately 266,000).
    Since eligibility among many clinicians is contingent on submission 
to MIPS as a group, virtual group, APM participation or election to 
opt-in, we will not know the number of MIPS eligible clinicians until 
the submission period for the 2020 MIPS performance period is closed. 
For this impact analysis, we used the estimated population of 879,966 
MIPS eligible clinicians described above.
c. Estimated Impacts on Payments to MIPS Eligible Clinicians
(1) Summary of Approach
    In sections III.K.3.c., III.K.3.d. and III.K.3.e. of this final 
rule, we present several provisions which impact the measures and 
activities that impact the performance category scores, final score 
calculation, and the MIPS payment adjustment. We discuss these changes 
in more detail in section VII.F.10.c.(2) of this RIA as we describe our 
methodology to estimate MIPS payments for the 2022 MIPS payment year. 
We note that many of the MIPS policies from the CY 2019 Quality Payment 
Program final rule were only defined for the 2019 MIPS performance 
period and 2021 MIPS payment year (including the performance threshold, 
the additional performance threshold, the policy for redistributing the 
weights of the performance categories, and many scoring policies for 
the quality performance category) which precludes us from developing a 
baseline for the 2020 MIPS performance period and 2022 MIPS payment 
year if there was no new regulatory action. Therefore, our impact 
analysis looks at the total effect of the finalized MIPS policies on 
the MIPS final score and payment adjustment for CY 2020 MIPS 
performance period/CY 2022 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 in the four MIPS performance categories: Quality, cost, 
improvement activities, and Promoting Interoperability. As discussed in 
section VII.F.10.c.(2) of this final 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 final rule reflect 
averages by practice size based on Medicare utilization. The payment 
impact for a MIPS eligible clinician could vary from the average and 
would depend on the combination of services that the MIPS eligible 
clinician furnishes. The average percentage change in total revenues 
that clinicians earn would be less than the impact displayed here 
because MIPS eligible clinicians generally furnish services to both 
Medicare and non-Medicare patients; this program does not impact 
payment from non-Medicare patients. In addition, MIPS eligible 
clinicians may receive Medicare revenues for services under other 
Medicare payment systems, such as the Medicare Federally Qualified 
Health Center Prospective Payment System, that would not be affected by 
MIPS payment adjustment factors.
(2) Methodology To Assess Impact
    To estimate participation in MIPS for the CY 2020 Quality Payment 
Program for this final rule, we generally used 2018 MIPS performance 
period data. Our scoring model includes the 879,966 estimated number of 
MIPS eligible clinicians as described in section VII.F.10.b.(1)(b) of 
this RIA.
    To estimate the impact of MIPS on 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.\133\ We calculated a 
hypothetical final score for the 2020 MIPS performance period/2022 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.
---------------------------------------------------------------------------

    \133\ 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.
---------------------------------------------------------------------------

    Starting with the 2018 performance period, certain groups could 
apply to be a virtual group and would be scored as a single group. For 
our model, we assumed that clinicians who participated as virtual 
groups for 2018 would continue to be a virtual group for the 2020 
performance period.
(a) Methodology To Estimate the Quality Performance Category Score
    We estimated the quality performance category score using a similar 
methodology described in the CY 2019 PFS final rule (83 FR 60053 
through 60054) with the following modifications that reflect the newly 
finalized policies for the 2020 MIPS performance period and improvement 
to our modeling methodology. As discussed in section 
III.K.3.c.(1)(c)(ii) of this final rule, we increased the data 
completeness requirement for the CY 2020 performance period from 60 
percent to 70 percent. As discussed in section III. K.3.c.(1) of this 
final rule, we finalized a quality performance category weight of 45 
percent for the 2020 MIPS performance period.
    We also applied modifications that were previously finalized 
including the validation process that was finalized in the CY 2017 
Quality Payment Program final rule (81 FR 77289 through 77291), 
applying the topped out scoring cap that was finalized (82 FR 53721 
through 53727) to the measures subject to the scoring cap for the 2019 
MIPS performance period, and the provisions in section 
III.K.3.d.(1)(b)(i)(C) of this final rule for benchmarks based on flat 
percentages to avoid potential inappropriate treatment.
    Finally, our model applied the APM scoring standard policies 
finalized in the CY 2019 PFS final rule (83 FR 59754) as modified by 
the provisions in section III.K.3.c.(5)(c)(i)(B) of this final rule to 
MIPS eligible clinicians identified as being scored as a MIPS APM in 
the eligibility section VII.F.10.b.(1)(b) of this final rule. As 
described in section III.K.3.c.(5)(c)(i)(B) of this final rule, we will 
apply a minimum score of 50 percent, or an `APM Quality Reporting 
Credit', under the MIPS quality performance category for certain APM 
entities participating in MIPS. In our model, this `APM Quality 
Reporting Credit' was implemented for APM Entities that do not use Web 
Interface. As described in section III.K.3.c.(5)(c)(i)(A) of this final 
rule, we calculate an aggregated APM Entity quality performance 
category score from submitted MIPS data by the participants in an APM 
Entity not required to use Web Interface.
    As described in section VII.F.10.b.(1)(b) of this final rule, we 
are using the APM Participant List for the first 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, using all available data to identify

[[Page 63169]]

who is an APM participant. For this analysis, the only MIPS reported 
measures available that are reported by a MIPS APM Entity would be the 
Web Interface measures and CAHPS for ACOs. In the case of MIPS APM 
entities associated with APMs that require participating entities to 
report Web Interface measures and CAHPS for ACOs, if the APM Entity 
existed in 2018, we calculated a score based on the Web Interface 
submission and CAHPS for ACOs from the 2018 performance period. If the 
APM Entity did not submit MIPS quality performance data for the 2018 
performance period and was participating in the Shared Savings Program, 
we calculated an aggregate score based on individual submissions 
similar to how we estimate aggregate scores for MIPS APM entities that 
are not required to utilize the Web Interface. If the APM Entity is new 
for 2019 and is associated with an APM that requires participating 
entities to submit Web Interface measures and CAHPS for ACOs (and 
therefore did not have the ability to submit Web Interface measures for 
the 2018 performance period), and the participating clinician was 
associated with a different APM Entity in 2018 we used the score of the 
2018 associated Entity. If that participating clinician was not 
associated with a different APM Entity in 2018 we used the median Web 
Interface score because we would anticipate the new APM Entities would 
report quality using the Web Interface in the future. For the MIPS APMs 
that do not utilize Web Interface only, we calculated an average 
quality performance category score based on group and individual 
submissions and then applied the APM Quality Reporting Credit policy to 
add 50 percent to the MIPS quality performance category score for APM 
Entities submitting to MIPS as discussed in section 
III.K.3.c.(5)(c)(i)(B) of this final rule. All quality performance 
category scores would be capped at 100 percent after receiving the 50 
percent APM Quality Reporting Credit.
(b) Methodology To Estimate the Cost Performance Category Score
    In section III.K.3.c.(2) of this final rule, we finalized a cost 
performance category weight of 15 percent for the 2020 MIPS performance 
period. In section III.K.3.c(2)(b)(iii) of this final rule, we added 10 
episode-based measures to the cost performance category beginning with 
the 2020 performance period in addition to the 8 episode-based measures 
finalized in the CY 2019 PFS final rule (83 FR 59767). In section 
III.K.3.c.(2)(b)(v) of this rule, we included the revised total per 
capita cost and MSPB clinician measures.
    We estimated the cost performance category score using all measures 
finalized in section III.K.3.c.(2)(b)(viii) of this final rule. The 
total per capita cost measure performance was estimated based on the 
revised measure using claims data from October 2016 through September 
2017. The MSPB clinician measure performance was estimated based on the 
revised measure using claims data from January through December of 
2017. For the episode-based measures, we used the specifications for 
the 8 episode-based measures finalized in the CY 2019 PFS final rule 
(83 FR 35902 through 35903), the specifications for the 10 new episode-
based measures discussed in section III.K.3.c.(2)(b)(iii) of this final 
rule and claims data from January through December of 2017. A 
limitation of this cost data is that it does not overlap with the 2018 
calendar year so we did not have cost measures for clinicians (TIN/
NPIs) that newly bill in 2018. Cost measures are scored if the 
clinicians or groups met or exceed the case volume: 20 For the total 
per capita cost measure, 35 for MSPB clinician, 10 for procedural 
episode-based measures, and 20 for acute inpatient medical condition 
episode-based measures. The cost measures are calculated for both the 
TIN/NPI and the TIN, except for the lower gastrointestinal hemorrhage 
measure, which we discussed in section III.K.3.c.(2)(vi)(B) of this 
final rule to calculate only for groups. For clinicians participating 
as individuals, the TIN/NPI level score was used if available and if 
the minimum case volume was met. For clinicians participating as 
groups, the TIN level score was used, if available, and if the minimum 
case volume was met. For clinicians with no measures meeting the 
minimum case requirement, we did not estimate a score for the cost 
performance category, and the weight for the cost performance category 
was redistributed according to section III.K.3.c.(2) of this final 
rule. The raw cost measure scores were mapped to scores on the scale of 
1-10, using benchmarks based on all measures that met the case minimum 
and if the group or clinician exceeded the low-volume threshold during 
the relevant performance period. For the episode-based cost measures, 
separate benchmarks were developed for TIN/NPI level scores and TIN 
level scores. For each clinician, a cost performance category score was 
calculated as the average of the measure scores available for the 
clinician.
(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 estimate the facility-
based score using the scoring policies finalized in the CY2018 Quality 
Payment Program final rule (82 FR 53763). In section III.K.3.d.(1)(c) 
of this final rule, we finalized technical changes for clarity and 
those changes do not affect the facility-based policies.
    We used data for the first determination period for the 2019 
performance period to attribute clinicians and groups to hospitals and 
assign the specific Hospital VBP Program Total Performance Score. If a 
Hospital VBP Program Total Performance Score could not be assigned to a 
clinician, in instances in which the attributed facility does not 
participate in the Hospital VBP program or no facility could be 
attributed, that clinician was determined as not eligible for facility-
based measurement and assumed to participate in MIPS via other methods. 
We are not requiring eligible clinicians to opt-in to facility-based 
measurement; it is possible that a MIPS eligible clinician or a group 
is automatically eligible for facility-based measurement, but they 
participate in MIPS as an individual or a group. In these cases, we 
used the higher combined quality and cost performance category score, 
as reflected in the final score, from facility-based scoring compared 
to the combined quality and cost performance category score from MIPS 
submission-based scoring.
(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 2019 PFS final rule (83 
FR 60055) with the following modifications that reflect the new 
policies for the 2020 MIPS performance period.
    In section III.K.3.c.(4)(d)(i)(B) of this final rule, we modified 
the Query of PDMP measure to a yes/no response. The Query of PDMP 
measure was not modeled because the measure was not available in the 
2018 MIPS performance period submissions data.

[[Page 63170]]

    In section III.K.3.c.(4)(f)(iii) of this final rule, we revised the 
definition of hospital-based MIPS eligible clinician to include groups 
and virtual groups. We also stated that a hospital-based MIPS eligible 
clinician under Sec.  414.1305 means an individual MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the POS codes 
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, off campus outpatient hospital, or 
emergency room setting based on claims for the MIPS determination 
period, and a group or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or virtual group's TINs, as 
applicable, meet the definition of a hospital-based individual MIPS 
eligible clinician. In section III.K.3.c.(4)(f)(iv) of this final rule, 
we discussed accounting for a group or virtual group that meets the 
definition of a non-patient facing MIPS eligible clinician such that 
the group or virtual group only has to meet a threshold of more than 75 
percent. Also, as described in sections III.K.3.c.(4)(f)(iii) and 
III.K.3.c.(4)(f)(iv) of this final rule, we assigned a zero percent 
weight for the Promoting Interoperability performance category for 
groups defined as hospital-based and non-patient facing, and 
redistribute the points associated with the Promoting Interoperability 
performance category to another performance category or categories. 
Therefore, in our impact analysis model, a group was only assigned a 
zero percent weight for the Promoting Interoperability performance 
category and the points for Promoting Interoperability performance 
category was redistributed if: (1) All the TIN/NPIs were eligible for 
reweighting as established at Sec.  414.1380(c)(2)(iii) for MIPS 
eligible clinicians submitting data as a group or virtual group, or 2) 
the group met the revised definition of a hospital-based MIPS eligible 
clinician as discussed in section III.K.3.c.(4)(f)(iii) of this final 
rule or the definition of a non-patient facing MIPS eligible clinician, 
as discussed in section III.K.3.c.(4)(f)(iv) of this final rule, as 
defined in Sec.  414.1305. We also incorporated into our model the 
policy to continue automatic reweighting for NPs, PAs, CNSs and CRNAs, 
physical therapists, occupational therapist, speech-language 
pathologists, audiologists, clinical psychologists, and registered 
dietitians or nutrition professionals as described in sections 
III.K.3.c.(4)(f)(i) and III.K.3.c.(4)(f)(ii) of this final rule.
    In our model, for the APM participants identified in section 
VII.F.10.b.(1).(b).of this final rule, 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.
    All other policies for the Promoting Interoperability performance 
category described in section III.K.3.c.(4) of this final rule did not 
impact our modeling methodology for this performance category because 
either the data were not available in the 2018 MIPS performance period 
submissions data or the changes reflect the modeling strategy 
previously used and described in the CY 2019 PFS final rule (83 FR 
60055). For example, since the Verify Opioid Treatment Agreement 
measure was not modeled in the CY 2019 PFS final rule (83 FR 60055) 
because the measure was not available in the 2017 MIPS performance 
period submissions data, the removal of this measure did not impact our 
methodology for this final rule.
    This is the first iteration of the model where there are small 
practice hardship applications, therefore, we only reweighted small 
practices if they submitted an application and did not submit Promoting 
Interoperability performance category data.
(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 VII.F.10.b.(1)(b) of this final rule. In section 
III.K.3.c.(3)(d)(iii) of this final rule, we increase the minimum 
number of clinicians in a group or virtual group who are required to 
perform an improvement activity to 50 percent for the improvement 
activities performance category beginning with the CY 2020 performance 
year and future years. We did not incorporate this change into our 
model because we did not have the information to model this provision. 
For the APM participants identified in section VII.F.10.b.(1)(b) of 
this final rule, we assigned an improvement activity performance 
category score of 100 percent.
    Clinicians and groups not participating in a MIPS APM were assigned 
their CY 2018 MIPS performance period improvement activities 
performance category score.
(f) Methodology To Estimate the Complex Patient Bonus
    In section III.K.3.d.(2)(a) of this final rule, we continued the 
complex patient bonus for the 2020 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 III.K.3.c.(1)(b), III.K.3.c.(2)(a), and 
summarized in section III.K.3.d.(2)(b) of this final rule, our model 
assigns a final score for each TIN/NPI by multiplying each performance 
category score by the corresponding performance category weight, adding 
the products together, multiplying the sum by 100 points, and adding 
the complex patient bonus. After adding any applicable bonus for 
complex patients, we reset any final scores that exceeded 100 points 
equal to 100 points. For MIPS eligible clinicians who were assigned a 
weight of zero percent for any performance category, we redistributed 
the weights according to section III.K.3.d.(2)(b)(iii) of this final 
rule.
(h) Methodology To Estimate the MIPS Payment Adjustment
    As described in the CY 2018 Quality Payment Program final rule (82 
FR 53785 through 53787), we applied a hierarchy to determine which 
final score should be used for the payment adjustment for each MIPS 
eligible clinician when more than one final score is available (for 
example if a clinician qualifies for a score for an APM entity and a 
group score, we select the APM entity score).

[[Page 63171]]

    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 a performance 
threshold of 45 points and the additional performance threshold of 85 
points (as discussed in sections III.K.3.e.(2) and III.K.3.e.(3) of 
this final rule). We used these resulting parameters to estimate the 
positive or negative MIPS payment adjustment based on the estimated 
final score and the paid amount for covered professional services 
furnished by the MIPS eligible clinician. We considered other 
performance thresholds which are discussed in section VII.F.2. of this 
RIA.
(3) Impact of Payments by Practice Size
    Using the assumptions provided above, our model estimates that $433 
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 model further 
estimates that the maximum positive payment adjustments are 6.2 percent 
after considering the MIPS payment adjustment and the additional MIPS 
payment adjustment for exceptional performance.
    Table 123 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. In aggregate, the cohort of clinicians in small practices 
participating in MIPS and who submit to MIPS receive a 1.0 percent 
increase in total paid amount, which is lower than the comparative 
payment increases received by the cohort of MIPS eligible clinicians in 
larger-sized practices. Table 123 also shows that 92.5 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 for these 
calculations, and it is likely that there will be changes that we 
cannot account for at this time because the performance thresholds 
increased for the 2020 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 these clinicians do not all receive a final score of zero. 
Indeed, some MIPS eligible clinicians that do not submit data to MIPS 
may receive final scores above zero through performance on 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 (15,993 out of 18,017 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 and that participation 
may change for the 2020 performance period.
[GRAPHIC] [TIFF OMITTED] TR15NO19.168


[[Page 63172]]


    We received the following comments about our MIPS impact analysis:
    Comment: One commenter raised concerns that scoring policies may 
inadvertently disadvantage smaller (but not small) groups and 
individual clinicians, and encouraged CMS to continue analyzing and 
addressing differences that are found.
    Response: We agree on the importance of evaluating the impact of 
scoring policies that affect payment distributions. Table 123 analyzes 
the impact of payment redistribution by differing practice sizes. In 
our analysis, over 80 percent of clinicians in small practices (1-15 
clinicians) that submit data to MIPS would receive a positive or 
neutral adjustment. The table also shows the results for practices of 
16 to 25 clinicians.
    After consideration of public comments, we have not updated our 
approach to the estimating the impact of the MIPS payments, however, we 
did update several data sources.
e. Potential Costs of Compliance With the Promoting Interoperability 
and Improvement Activities and Cost Performance Categories for Eligible 
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability 
Performance Category
    In section III.K.3.c.(4)(d)(i)(B) of this final rule, we allow 
clinicians and groups to satisfy the optional bonus Query of PDMP 
measure by submitting a ``yes/no'' attestation, rather than reporting a 
numerator and denominator. As discussed in the Collection of 
Information section of this final rule, we are not changing our burden 
assumptions to account for this policy due to a lack of information 
regarding the number of clinicians reporting bonus measures combined 
with our currently approved burden estimates being based only on the 
reporting of required measures. However, we do believe that for 
clinicians or groups who report this measure, there will be a reduction 
in reporting burden compared to what would have been required to submit 
the measure without this change related to the elimination of the need 
to perform calculations prior to submitting a numerator and 
denominator. As data availability allows, we will reassess the 
inclusion of this burden in the Collection of Information in the 
future.
    In sections III.K.3.g.(3)(a)(i) and III.K.3.g.(4)(a)(i) of this 
rule, beginning with the 2021 performance period and for future years, 
we require QCDRs and qualified registries to support three performance 
categories: Quality, improvement activities, and Promoting 
Interoperability. In the Collection of Information section, we 
discussed the potential burden reduction associated with simplifying 
MIPS reporting for clinicians who currently utilize qualified 
registries or QCDRs that have not previously offered the ability to 
report Promoting Interoperability or improvement activity data. We 
believe it is also possible that some MIPS eligible clinicians may 
elect to begin utilizing qualified registries or QCDRs as a result this 
policy and its potential for simplifying their MIPS reporting combined 
with the benefits of improving the quality of care provided to their 
patients. We do not have information with which to estimate the number 
of clinicians who may pursue this option, therefore we cannot quantify 
the associated costs, cost savings, and benefits consistent with the CY 
2018 Quality Payment Program final rule (82 FR 53946).
(2) Potential Costs of Compliance With Improvement Activities 
Performance Category
    In section III.K.3.c.(3)(d)(iii) of this final rule, we are: (1) 
Modifying the definition of rural area; (2) updating Sec.  
414.1380(b)(3)(ii)(A) and (C) removing the reference to the four listed 
accreditation organizations to be recognized as patient-centered 
medical homes and removing the reference to the specific accrediting 
organization for comparable specialty practices; (3) increasing the 
group reporting threshold to 50 percent; (4) establishing factors to 
consider for removal of improvement activities from the Inventory; (5) 
removing 15, modifying seven, and adding two new improvement activities 
for the 2020 performance period and future years; and (6) concluding 
and removing the CMS Study on Factors Associated with Reporting Quality 
Measures.
    The finalized proposals to modify the definition of a rural area 
and to remove references to the four listed accreditation organizations 
to be recognized as patient-centered medical homes and to the specific 
accrediting organization for comparable specialty practices will have 
no financial impact due to the nature of the regulatory changes being 
finalized.
    Given groups' familiarity with the improvement activities in the 
Improvement Activities Inventory, we believe that a group would find 
applicable and meaningful activities to complete that are not specific 
to practice size, specialty, or practice setting and would apply to at 
least 50 percent of individual MIPS eligible clinicians in the group. 
Therefore, an increase in the minimum threshold for a group to receive 
credit for the improvement activities performance category should not 
present additional complexity or burden. We also 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 final rule because 
previously finalized improvement activities continue to apply for the 
current and future years unless otherwise modified per rule-making (82 
FR 54175). Most of the improvement activities in the Inventory remain 
unchanged for the 2020 MIPS performance period. Of the activities that 
are being removed, or modified, many were duplicative which means many 
clinicians or groups would be able to continue the activity, but it 
would be reported under a different activity in the Improvement 
Activities Inventory.
    Our provision to establish removal factors for consideration when 
removing improvement activities from the Improvement Activities 
Inventory would provide guidance for clinicians or groups on the 
considerations for the removal of improvement activities and would not 
present additional burden. The changes to the Improvement Activities 
Inventory that include the modification, removal, and addition of 
improvement activities provide clarity, avoid duplication, and provide 
more options for clinicians to select improvement activities that are 
appropriate for their clinical practice and would not present 
additional burden. Furthermore, in this final rule, we end and remove 
the Study on Factors Associated with Reporting Quality Measures 
beginning with the 2020 MIPS performance period. In the CY 2019 PFS 
final rule, we finalized a sample size of 200 clinicians, each of which 
completed a 15-minute survey both prior to and after submitting MIPS 
data (83 FR 60058). As a result of ending the study, we estimate a 
reduction in burden of 100 hours and $20,286 (200 clinicians x 0.5 
hours x $202.86).
(3) Potential Costs of Compliance With the Cost Performance Category
    We state in section VI.B.7.j of the CY 2020 PFS final rule that 
there were no submissions required for the cost performance categories, 
therefore, we did not include any compliance cost associated with that 
performance category; however, we received the following comments on 
administrative costs for the cost performance category proposals.

[[Page 63173]]

    Comment: One commenter noted that in a large multi-specialty 
organization the number of cost measures could increase administrative 
burden on clinicians and organizations, to track measures and work to 
improve performance.
    Response: We acknowledge there are administrative burdens and 
related financial costs associated with each administrative claims 
measure 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.
    As a result of these comments, we are acknowledging that while 
there is no data collection burden, there may be associated costs for 
clinicians and group practices to monitor new cost measures; however, 
we are unable to quantify that impact.
f. Potential Costs of Compliance for Third Party Intermediaries
    Based on previously finalized policies in the CY 2017 Quality 
Payment Program final rule (81 FR 77363 through 77364) and as further 
revised in the CY 2019 PFS final rule at Sec.  414.1400(a)(2) (83 FR 
60088), the current policy is that all third party intermediaries may 
submit data for any of the three MIPS performance categories quality 
(except for data on the CAHPS for MIPS survey); improvement activities; 
and Promoting Interoperability. As previously discussed in section 
III.K.3.g.(3)(a)(i) and III.K.3.g.(4)(a)(i) of this final rule, we are 
finalizing changes to Sec.  414.1400(a)(2) to state that beginning with 
the 2023 MIPS payment year (2021 performance period), QCDRs and 
qualified registries must be able to submit data for all the MIPS 
performance categories identified in the regulation. In section 
III.K.3.g.(1) of this final rule, we further state that we anticipate 
using the QCDR and qualified registry self-nomination vetting process 
to assess which of these entities will be subject to the requirement to 
support reporting the Promoting Interoperability performance category 
and which third parties could 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 (9). Based on our review of 
qualified registries and QCDRs approved to submit data for the 2019 
MIPS performance period, 70 percent of qualified registries and 72 
percent of QCDRs are already able to submit data for the quality, 
improvement activities, and Promoting Interoperability performance 
categories. We believe this provision could result in the remaining 
qualified registries and QCDRs incurring additional costs to upgrade 
information technology systems in order to make this ability available 
to clinicians, with less cost incurred by entities who would be subject 
to an exception for the Promoting Interoperability performance 
category. However, given that each of these entities and their 
information technology systems are unique, and there is no method of 
determining which entities may have already begun the process of 
developing this ability, we are unable to determine the impact of 
transitioning from allowing this ability as an option to requiring it. 
Also, given that the majority of these entities have already begun 
offering the ability to submit data on behalf of the improvement 
activities and Promoting Interoperability performance categories, we 
assume they have done so because they believe the benefits outweigh the 
costs and is therefore, in their best financial interests to do so.
    In section III.K.3.g.(3)(a)(iii) of this final rule, beginning with 
the 2021 performance period, we require qualified registries and QCDRs 
to provide the following as part of the performance feedback given at 
least 4 times a year: Feedback to their clinicians and groups on how 
they compare to other clinicians who have submitted data on a given 
measure (MIPS quality measure and/or QCDR measure) within the QCDR. We 
understand that QCDRs can only provide feedback on data they have 
collected on their clinicians and groups, and realize the comparison 
would be limited to that data and not reflect the larger sample of 
those that have submitted on the measure for MIPS, which the QCDR does 
not have access to. As finalized in the CY 2017 and CY 2018 Quality 
Payment Program final rules (81 FR 77367 through 77386 and 82 FR 
53812), qualified registries and QCDRs are required to provide feedback 
on all of the MIPS performance categories that the qualified registry 
or QCDR reports at least 4 times a year. Given that we did not propose 
a significant change but are instead modifying and strengthening the 
existing policy, we do not anticipate a significant increase in cost or 
effort for Third Party Intermediaries to comply with this provision.
    In section III.K.3.g.(3)(c)(i)(B)(cc), we require that in order for 
a QCDR measure to be considered for use in the program beginning with 
the 2021 performance period and future years, all QCDR measures 
submitted for self-nomination must be fully developed with completed 
testing results at the clinician level, as defined by the CMS Blueprint 
for the CMS Measures Management System, as used in the testing of MIPS 
quality measures prior to the submission of those measures to the Call 
for Measures. Beginning with the 2021 performance period and future 
years, we also require QCDRs to collect data on the potential QCDR 
measure, appropriate to the measure type, as defined in the CMS 
Blueprint for the CMS Measures Management System, prior to self-
nomination. The testing process for quality measures is dependent on 
the measure type (for example, a measure that is specified as an eCQM 
measure has additional steps it must undergo when compared to other 
measure types). The National Quality Forum (NQF) has developed guides 
for measure testing criteria and standards which further illustrate 
these differences based on measure type.\134\ Additionally, the costs 
associated with testing vary based on the complexity of the measure and 
the developing organization. The Journal of the American Medical 
Association states that the costs associated with quality measures are 
generally unknown or unreported.\135\ While we understand the policy 
will result in additional costs for QCDRs to develop measures, given 
the uncertainty regarding the number and types of measures that will be 
proposed in future performance periods coupled with the lack of 
available cost data on measure development and testing, we are unable 
to determine the financial impact of this provision on QCDRs beyond the 
likelihood of it being more than trivial. Likewise, we understand that 
some QCDRs already perform measure testing prior to submission for 
approval while others do not. This variability makes it difficult to 
estimate the incremental impact of this regulation.
---------------------------------------------------------------------------

    \134\ http://www.qualityforum.org/Measuring_Performance/Submitting_Standards.aspx.
    \135\ Schuster, Onorato, and Meltzer. ``Measuring the Cost of 
Quality Measurement: A Missing Link in Quality Strategy'', Journal 
of the American Medical Association. 2017; 318(13):1219-1220. 
https://jamanetwork.com/journals/jama/fullarticle/2653111?resultClick=1.
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    In section III.K.3.g.(3)(c)(i)(A)(bb)(AA) of this rule, we amend 
Sec.  414.1400 to state that CMS may consider the extent

[[Page 63174]]

to which a QCDR measure is available to MIPS eligible clinicians 
reporting through QCDRs other than the QCDR measure owner for purposes 
of MIPS. If CMS determines that a QCDR measure is not available to MIPS 
eligible clinicians, groups, and virtual groups reporting through other 
QCDRs, CMS may not approve the measure. Because the choice to license a 
QCDR measure is an elective business decision made by individual QCDRs 
and we have little insight into both the specific terms and frequency 
of agreements made between entities, we are unable to account for the 
financial impact of licensing QCDR measures for each QCDR. In aggregate 
across all QCDRs, the financial impact would be zero as fees paid by 
one QCDR will be collected by another QCDR.
    In section III.K.3.g.(3)(c)(i)(B)(ee) of this rule, we discuss, 
beginning with the 2020 performance period, that after the self-
nomination period closes each year, we will review newly self-nominated 
and previously approved QCDR measures based on considerations as 
described in the CY 2019 PFS final rule (83 FR 59900 through 59902). In 
instances in which multiple, similar QCDR measures exist that warrant 
approval, we may provisionally approve the individual QCDR measures for 
1 year with the condition that QCDRs address certain areas of 
duplication with other approved QCDR measures in order to be considered 
for the program in subsequent years. The QCDR could do so by 
harmonizing its measure with, or significantly differentiating its 
measure from, other similar QCDR measures. QCDR measure harmonization 
may require two or more QCDRs to work collaboratively to develop one 
cohesive QCDR measure that is representative of their similar yet, 
individual measures. We are unable to account for the financial impact 
of measure harmonization, as the process and outcomes will likely vary 
substantially depending on a number of factors, including: Extent of 
duplication with other measures, number of QCDRs involved in 
harmonizing toward a single measure, and number of measures being 
harmonized among the same QCDRs. We intend to identify only those QCDR 
measures which are duplicative to such an extent as to assume 
harmonization will not be overly burdensome, however, because the 
harmonization process will occur between QCDRs without our involvement, 
we are unable to predict or quantify the associated effort.
    We understand that some QCDRs may believe the provisions to require 
measure harmonization and encourage QCDRs to license their measures to 
other QCDRs as a consideration for measure approval may result in a 
reduced ability for QCDRs to differentiate themselves in the 
marketplace. We note that in addition to the suite of measures offered 
by a QCDR and their relevance to individual clinicians and groups, ease 
of incorporating a QCDR's measures into existing practice workflows, as 
well as integration into broader quality improvement programs are two 
examples of distinguishing characteristics for clinicians to consider 
when selecting a QCDR. In addition, clinicians may also consider cost 
(if any); recommendations, support, or endorsements from specialty 
societies; the number of other users submitting data to the QCDR; the 
specific educational services and quality improvement initiatives 
offered; and the specific performance feedback information provided as 
part of the required reports provided at least 4 times a year. We 
believe that the impact these provisions may have on the perceived 
differentiated value of certain QCDRs is counterbalanced by the need to 
promote more focused quality measure development towards outcomes that 
are meaningful to patients, families and their providers.
    In this final rule, we discussed our policy to formalize a number 
of factors we would take into consideration for approving and rejecting 
QCDR measures for the MIPS program beginning with the 2020 performance 
period and future years. With regard to approving QCDR measures, we are 
implementing the following: (1) 2-year QCDR measure approval process, 
and (2) participation plan for existing QCDR measures that have failed 
to reach benchmarking thresholds.
    As discussed in section III.K.3.g.(3)(c)(ii)(B), we are 
implementing, beginning with the 2021 performance period, 2-year QCDR 
measure approvals (at our discretion) for QCDR measures that attain 
approval status by meeting the QCDR measure considerations and 
requirements described in section III.K.3.g.(3)(c). The 2-year 
approvals would be subject to the following conditions whereby the 
multi-year approval will no longer apply if the QCDR measure is 
identified as: Topped out; duplicative of a new, more robust measure; 
reflects an outdated clinical guideline; requires measure 
harmonization, or if the QCDR self-nominating the measure is no longer 
in good standing. We believe this will result in reduced burden for 
QCDRs as they will no longer be required to submit each measure for 
approval annually. However, because we are unable to predict which 
previously approved QCDR measures will be removed or retained in future 
years, we are likewise unable to predict the impact on future burden 
associated with QCDRs submitting measures for approval. Beginning with 
the 2021 performance period, we require that in instances where an 
existing QCDR measure has been in MIPS for 2 years and has failed to 
reach benchmarking thresholds due to low adoption, where the QCDR 
believes the low-reported QCDR measure is still important and relevant 
to a specialist's practice, that the QCDR may submit to CMS a QCDR 
measure participation plan, to be submitted as part of their self-
nomination. Because we are unable to predict the frequency with which 
existing QCDR measures will meet the criteria for allowing QCDRs to 
submit a measure participation plan or the likelihood of QCDRs electing 
to submit a plan, we are unable to estimate the impact associated with 
this provision.
    As discussed in section III.K.3.g.(3)(c)(i)(B)(bb) of this final 
rule, beginning with the 2021 performance period and future years, 
QCDRs must link their QCDR measures as feasible to the following, at 
the time of self-nomination: (a) Cost measures (as found in section 
III.K.3.c.(3) of this final rule), (b) improvement activities (as found 
in Appendix 2: Improvement Activities Tables), or (c) CMS developed 
MIPS Value Pathways (as described in section III.K.3.a. of this final 
rule). We do not assume any additional impact beyond the 1 hour per 
QCDR measure as discussed in section VI.B.7 of the Collection of 
Information section of this final rule.
    We are also finalizing in section III.K.3.g.(2) of this final rule 
and at Sec.  414.1400(a)(4) to establish that a condition of approval 
is for the third party intermediary to agree that 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 transition plan. Historically, less than 10 
third party intermediaries have elected to discontinue services during 
a performance period and we have no basis to assume this is likely to 
change in future years. We do not assume any additional impact beyond 
the 10 hours per transition plan discussed in section VI.B.7 of this 
final rule.

[[Page 63175]]

    We are finalizing in section III.K.3.g.3(c)(i)(A)(bb)(BB) of this 
final rule to amend Sec.  414.1400 to add paragraph (b)(3)(iv)(I) to 
state that we would give greater consideration to measures for which 
QCDRs: (a) Conducted an environmental scan of existing QCDR measures; 
MIPS quality measures; quality measures retired from the legacy 
Physician Quality Reporting System (PQRS) program; and (b) utilized the 
CMS Quality Measure Development Plan Annual Report and the Blueprint 
for the CMS Measures Management System to identify measurement gaps 
prior to measure development. We are also finalizing in section 
III.K.3.g.3(c)(i)(A)(bb)(CC) of this final rule and Sec.  414.1400 to 
add paragraph (b)(3)(iv)(J), to state that, beginning with the 2020 
performance period, we place greater preference on QCDR measures that 
meet case minimum and reporting volumes required for benchmarking after 
being in the program for 2 consecutive CY performance periods. Those 
that do not meet this requirement, may not continue to be approved. 
Lastly, we are finalizing in section III.K.3.g.3(c)(i)(B)(aa) of this 
final rule, beginning with the 2020 performance period, to change both 
of the below listed considerations into requirements and add paragraph 
(b)(3)(v) to include the following for QCDR measure requirements for 
approval: Measures that are beyond the measure concept phase of 
development; and measures that address significant variation in 
performance. We do not assume any additional impacts beyond those 
previously discussed in this section or in the Collection of 
Information section.
    We received public comments on the compliance costs for third party 
intermediaries. The following is a summary of the comments we received 
and our responses.
    Comment: A few commenters expressed their opinion that the scope of 
proposals in the proposed rule increases cost and burden to the point 
where some third-party vendors may end their participation in MIPS. One 
commenter stated that several provisions would additionally require it 
to alter business plans, missions, and customer service priorities 
while another commenter cited their belief that CMS is attempting to 
shift costs and burden of administering the MIPS program onto specialty 
societies that create measures and operate QCDRs.
    Response: We disagree. We believe that our policies are intended to 
standardize and raise the bar on the services and the quality of the 
third-party intermediaries we have in the MIPS program. Similar to 
years past, the standards and requirements of QCDRs are higher when 
compared to that of qualified registries, as we expect QCDRs to have 
extensive experience in quality reporting, quality measure development, 
and clinical expertise to not just facilitate reporting, but to also 
help address measurement gaps found within the program. We believe that 
QCDRs and qualified registries should further clinician goals of 
quality improvement by providing meaningful information and services. 
We believe that the increased cost and burden are significantly 
outweighed by the positive impact of the policies for MIPS eligible 
clinicians. As a result of the comments, we have not updated our 
estimates.
g. Assumptions & Limitations
    We note several limitations to our estimates of MIPS eligible 
clinicians' eligibility and participation, negative MIPS payment 
adjustments, and positive payment adjustments for the 2022 MIPS payment 
year. We based our analyses on the data prepared to support the 2018 
performance period initial determination of clinician and special 
status eligibility (available via the NPI lookup on qpp.cms.gov),\136\ 
APM Participant List for the first snapshot date for the 2019 QP 
performance period, CY 2018 Quality Payment Program Year 2 data and 
CAHPS for ACOs. The scoring model results presented in this rule assume 
that CY 2018 Quality Payment Program Year 2 data submissions and 
performance are representative of CY 2020 Quality Payment Program data 
submissions and performance. The estimated performance for CY 2020 MIPS 
performance period using Quality Payment Program Year 2 data may be 
underestimated because the performance threshold to avoid a negative 
payment adjustment for the 2018 MIPS performance period/2019 MIPS 
payment year was significantly lower (15 out of 100 points) than the 
performance threshold for the 2020 MIPS performance period/2022 MIPS 
payment year (45 out of 100). We anticipate clinicians may submit more 
performance categories to meet the higher performance threshold to 
avoid a negative payment adjustment.
---------------------------------------------------------------------------

    \136\ The time period for this eligibility file (September 1, 
2016 to August 31, 2017) 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 Year 2 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 finalized policies.
    A limitation of our cost data is that it does not overlap with the 
2018 calendar year so we may not be capturing performance for all 
clinicians.
    There are additional limitations to our estimates: (1) Because we 
used historic data, we assumed participation in the three performance 
categories in MIPS Year 2 would be similar to MIPS Year 4 performance; 
and (2) 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 123. Due to the limitations 
described, there is considerable uncertainty around our estimates that 
is difficult to quantify in detail.

G. Alternatives Considered

    This final rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
exercised, presents rationale for our policies and, where relevant, 
alternatives that were considered. For purposes of the payment impact 
on PFS services of the policies contained in this final rule, we 
presented the estimated impact on total allowed charges by specialty. 
The alternatives we considered, as discussed in the preceding preamble 
sections, would result in different payment rates, and therefore, 
result in different estimates than those shown in Table 119 (CY 2020 
PFS Estimated Impact on Total Allowed Charges by Specialty).
1. Alternatives Considered Related to Medicare Coverage for Opioid Use 
Disorder Treatment Services Furnished by Opioid Treatment Programs
    We considered several possibilities for pricing the oral 
medications, namely methadone and buprenorphine (oral), included in the 
OTP payment bundles. As described in section II.G. of this final rule, 
we finalized the use of ASP-based payment to set the payment rates for 
the oral OTP drug product categories when we receive manufacturer-
submitted ASP data for these drugs and to limit the payment amounts for 
oral drugs to 100 percent of the ASP instead of 106 percent of the ASP. 
When ASP data are not available for the oral OTP drugs, we finalized 
use of the TRICARE rate to set the drug portion of the payment for

[[Page 63176]]

methadone and the NADAC data to set the drug portion of the payment for 
oral buprenorphine. We note that, for the CY 2020 payments, we were 
able to calculate an ASP for methadone because of manufacturer 
reporting. However, we did not receive ASP data from any of the 
buprenorphine oral manufacturers. Therefore, this drug category was 
priced using NADAC survey data.
    In developing the policies for this final rule, we also considered 
several other options for pricing of oral drugs as described in the 
proposed rule, including the methodology under section 1847A of the 
Act; Medicare Part D Prescription Drug Plan Finder data; WAC; and NADAC 
data. In determining which alternative data source to finalize for 
pricing the oral OTP drugs, in the event we did not receive 
manufacturer-submitted ASP pricing data, we considered commenters' 
varied responses to the options presented in the proposed rule. We also 
considered the possibility of using the TRICARE rate for methadone as 
the primary pricing methodology and increasing the payment limits to 
106 percent of the ASP, instead of 100 percent of the ASP, as suggested 
by commenters.
    We did not receive comments that would significantly alter our 
assumptions regarding estimated impacts of these alternatives. For 
methadone, using the methodology under section 1847A of the Act, 
Medicare Part D Prescription Drug Plan Finder data, WAC, TRICARE rates, 
and NADAC data methodologies would have resulted in a slightly 
decreased impact when compared to the reported ASP. For buprenorphine 
(oral), the Medicare Part D Prescription Drug Plan Finder data is very 
similar to NADAC pricing. Therefore, we believe there would be minimal 
changes in the estimated impacts from using this alternative data 
source. Since WAC-based pricing is slightly higher than NADAC pricing, 
we note that using WAC-based pricing would increase the estimated 
impacts marginally. For both oral product categories, increasing the 
payment limit to 106 percent of the ASP, instead of 100 percent of the 
ASP, would have resulted in a correspondingly higher impact.
    While considering whether to finalize the rates that were proposed 
for the non-drug component, we explored a number of alternative 
scenarios based on commenters' responses to our proposals. For example, 
we considered whether to finalize the proposed rate that was based on a 
crosswalk to TRICARE's bundled weekly rate for methadone, whether to 
base the Medicare rate on the rates set by state Medicaid programs, or 
whether to calculate the rate using a building block methodology which 
sums the payment rates for similar services paid under Medicare 
currently. Were we to have finalized the proposed rates that were based 
on a crosswalk to TRICARE's weekly bundled rate, that would have 
resulted in a lower impact compared to the estimated impact of the 
rates we are finalizing, which were calculated using a building block 
methodology, as the TRICARE rate for non-drug services is lower than 
the rate we have finalized using the building block approach. Were we 
to have finalized rates equal to those set by some state Medicaid 
programs, the estimated impact would vary depending on which state 
Medicaid programs were used.
    We note that there is significant variability across the state 
Medicaid programs in terms of the payment rates and what services are 
included in the bundle or billed separately, and that some states have 
payment rates that are higher than our finalized rate. Additionally, we 
considered whether to finalize partial episodes for each of the bundled 
payments. Were we to have finalized partial episodes that would have 
likely resulted in a lower overall impact compared to the rates we are 
finalizing, as the rates that were proposed for the partial episodes 
were calculated by taking one half of the value of the non-drug 
component for the full episodes. As noted in section II.G of this rule, 
we are not finalizing our proposal to create partial episodes for CY 
2020.
    We also considered several alternatives for the update factor used 
in updating the payment rates for the non-drug component of the bundled 
payment for OUD treatment services, including the Bureau of Labor 
Statistics Consumer Price Index for All Items for Urban Consumers (CPI-
U) (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm)) and the IPPS hospital market basket reduced by the 
multifactor productivity adjustment. Based on a CMS forecast of 
projected rates, we believe that the projected MEI and CPI-U rates are 
anticipated to be similar, and thus using the CPI-U as an update factor 
would have minimal effect on estimated impacts. Since the projected 
IPPS hospital market basket rate is generally higher than the projected 
MEI rate, using the IPPS hospital market basket rate would result in 
higher estimated impacts. We received one comment which stated that an 
OTP's cost structure is more similar to a hospital outpatient 
department than a physician's office, so the IPPS annual update factor 
should be used instead of the MEI rate. In considering the appropriate 
update factor to finalize, we considered the medical services being 
provided by the OTP facilities and we believe that conceptually 
physician office services more closely align to OTP services, and 
compositionally the MEI more closely aligns with the services 
associated with the OTP payment system.
2. Alternatives Considered Related to Payment for E/M Services
    In developing our policies for office/outpatient E/M visits 
effective January 1, 2021, we considered a number of alternatives. For 
reasons discussed in section II.P. of this final rule, we did not 
include either the extended office/outpatient E/M HCPCS code GPR01 or 
the single blended payment rates for combined visit levels 2 through 4 
that were finalized in the CY 2019 final rule for CY 2021 in our 
considerations. Our alternatives also did not include the revaluation 
of global surgical services, as recommended by the AMA RUC, which 
incorporated the revised office/outpatient E/M code values. We note 
that in all of the alternatives we considered, the valuation for all 
codes in the office/outpatient E/M code set would increase. Therefore, 
all specialties for whom the office/outpatient codes represent a 
significant portion of their billing would also see payment increases 
while those specialties who do not report those codes would see overall 
payment decreases. Any variation in the magnitude of the increases or 
decreases are a result of a specialties overall billing patterns.
    We did, however, consider proposing to eliminate both add-on codes, 
HCPCS code GCG0X and HCPCS code GPC1X, that were finalized in the CY 
2019 final rule for CY 2021. Our stated rationale in the CY 2019 final 
rule for developing HCPCS code GPC1X (83 FR 59625 through 59653) was to 
more accurately account for the type and intensity of E/M work 
performed in primary care-focused visits beyond the typical resources 
reflected in the single payment rate for the levels 2 through 4 visits. 
The reason for finalizing HCPCS code GCG0X, as stated in the CY 2019 FR 
(83 FR 59625 through 59653) GCG0X was to reflect additional resource 
costs for inherently complex services that are non-procedural. We 
considered whether these two add-on codes would still be necessary in 
the context of the revised descriptors and valuations for office/
outpatient E/M services. We considered an alternative, therefore, in 
which we adopted the RUC's recommended values

[[Page 63177]]

but excluded the two HCPCS add-on G-codes. In reviewing the results of 
this policy option, we observed that our concerns about capturing the 
work associated with visits that are part of ongoing, comprehensive 
primary care and/or care management for patients having a single, 
serious, or complex chronic condition were still present. The specialty 
level impacts associated with this alternative are displayed in Table 
124. The specialties that benefited most from this alternative, such as 
Endocrinology and Rheumatology, are those that primarily bill levels 3-
5 established patient office/outpatient E/M visits, as those visit 
levels had the greatest increases in valuation among the overall 
office/outpatient E/M code set.
BILLING CODE 4120-01-P

[[Page 63178]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.169


[[Page 63179]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.170

    We also considered, as an alternative, proposing CMS refinements to 
the RUC recommendations for two of the CPT codes. Consistent with our 
generally established policies for reviewing work RVUs recommended by 
the RUC, we observed that the increase in work RVU for CPT codes 99212 
and 99214 (levels 2 and 4 for established patients) seemed 
disproportionate to the increase in total time for these services, 
particularly in comparison with the work to time relationships among 
the other seven E/M code revaluations. For CPT code 99212, we observed 
that the total time for furnishing this service increased by 2 minutes 
(13 percent increase), but that the recommended work RVU increased by 
nearly 50 percent from 0.48 to 0.70. We reviewed other CPT codes with 
similar times as the survey code and identified a potential crosswalk 
to CPT code 76536 (Ultrasound, soft tissues of head and neck e.g., 
thyroid, parathyroid, parotid), real time with image documentation), 
with a work RVU of 0.56. We therefore considered decreasing the work 
RVU for CPT code 99212 to 0.56. For CPT code 99214, the total time 
increased from 40 to 49 minutes, which is a 23 percent change, while 
the work RVU increased from 1.50 to 1.92 (28 percent increase). We 
considered a crosswalk to CPT code 73206 (Computed tomographic 
angiography, upper extremity, with contrast material(s), including 
noncontrast images, if performed, and image postprocessing), with a 
work RVU of 1.81 and total time of 50 minutes. The refinements we 
considered for the RUC recommendations are shown in Table 125.
[GRAPHIC] [TIFF OMITTED] TR15NO19.171

    Table 126 illustrates the specialty level impacts of refining the 
RUC recommendations. Under this alternative those specialties who 
frequently bill CPT code 99212 or CPT code 99214, such as dermatology 
and family practice, respectively, experience more modest increases 
relative to other alternatives.

[[Page 63180]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.172


[[Page 63181]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.173

    We also considered an alternative that reflected CMS refinements to 
the three CPT codes as described above and also included the 
consolidated, redefined and revalued HCPCS add-on G code, GPC1X.
    Table 127 illustrates the specialty level impacts associated with 
making refinements to the RUC recommended values for the office/
outpatient E/M code set and also making separate payment for HCPCS add-
on code GPC1X. These impacts are similar to what we proposed, with 
slight less positive impacts for those specialties who bill CPT codes 
99212 or 99214.

[[Page 63182]]

[GRAPHIC] [TIFF OMITTED] TR15NO19.174


[[Page 63183]]


[GRAPHIC] [TIFF OMITTED] TR15NO19.175

BILLING CODE 4120-01-C
    Comment: As discussed previously, some commenters questioned the 
necessity of additional coding to describe 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. Some 
commenters encouraged CMS to work with CPT and the RUC, rather than 
utilize Medicare specific G-codes, to address concerns regarding 
payment for these services. Other commenters rejected the necessity of 
additional payment all together.
    Response: Please see the full discussion in section II.P. of this 
final rule. We continue to believe that the revalued office/outpatient 
E/M visits do not accurately account for the resources associated with 
furnishing primary care and certain types of specialty visits.
    Comment: Overall, commenters did not support CMS' refinements to 
the valuation of CPT codes 99212 and 99214 as reflected in alternatives 
considered, stating that the values recommended to CMS by the RUC were 
more accurate as they were part of a rigorous survey and represented a 
consensus by the medical community.
    Response: As discussed in section II.P. of this final rule, we 
agree with commenters and are finalizing as proposed.
3. Alternatives Considered for the Quality Payment Program
    For purposes of the payment impact on the Quality Payment Program, 
we view the performance threshold and the additional performance 
threshold, as the critical factors affecting the distribution of 
payment adjustments. We ran two separate models with performance 
thresholds of 35 and 50 respectively (as an alternative to the proposed 
performance threshold of 45) to estimate the impact of a more moderate 
and a more aggressive increase in the performance threshold. A lower 
performance threshold would be a more gradual transition and could 
potentially allow more clinicians to meet or exceed the performance 
threshold. The lower performance threshold would lower the amount of 
budget neutral dollars to redistribute and increase the number of 
clinicians with a positive payment adjustment, but the scaling factor 
would be lower. In contrast, a more aggressive increase would likely 
lead to higher positive payment adjustments for clinicians that exceed 
the performance threshold because the budget neutral pool would be 
redistributed among fewer clinicians. We ran each of these models using 
the proposed additional performance threshold of 85. In the model with 
a performance threshold of 35, we estimate that $360 million would be 
redistributed through budget neutrality. There would be a maximum 
payment adjustment of 6.0 percent after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In addition, 5.2 percent of MIPS eligible clinicians would 
receive a negative payment adjustment among those that submit data. In 
the model with a performance threshold of 50, we estimate that $470 
million would be redistributed through budget neutrality, and that 
there would be a maximum payment adjustment of 6.4 percent after 
considering the MIPS payment adjustment and the additional MIPS payment 
adjustment for exceptional performance. In addition, 9.6 percent of 
MIPS eligible clinicians would receive a negative payment adjustment 
among those that submit data. We proposed a performance threshold of 45 
because we believe increasing the performance threshold to 45 points 
was not unreasonable or too steep, but rather a moderate step that 
encourages clinicians to gain experience with all MIPS performance 
categories. We refer readers to section III.K.3.e.(2) of this final 
rule for additional rationale on the selection of the performance 
threshold.
    To evaluate the impact of modifying the additional performance 
threshold, we ran two models with additional performance thresholds of 
75 and 80 as an alternative to the 85 points. We ran each of these 
models using a performance threshold of 45. The benefit of the model 
with the additional performance threshold of 75 would maintain the 
additional performance threshold that was in year 3. In the model with 
the additional performance threshold of 75, we estimate that $433 
million would be redistributed through budget neutrality, and there 
would be a maximum payment adjustment of 3.8 percent after considering 
the MIPS payment adjustment and the additional MIPS payment adjustment 
for exceptional performance. In addition, 7.5 percent of MIPS eligible 
clinicians would receive a negative payment adjustment among those that 
submit data. In the model with an additional performance threshold of 
80, we estimate that $433 million would be redistributed through budget 
neutrality, and that there would be a maximum payment adjustment of 4.5 
percent after considering the MIPS payment adjustment and the 
additional MIPS payment adjustment for exceptional performance among 
those that submit data. Also, that 7.5 percent of MIPS eligible 
clinicians will receive a negative payment adjustment among those that 
submit data. We proposed the additional performance threshold at 85 
points because we believe raising the additional performance threshold 
would

[[Page 63184]]

incentivize continued improved performance while accounting for policy 
changes in the fourth year of the program. We refer readers to section 
III.K.3.e.(3) of this final rule for additional rationale on the 
selection of additional performance threshold.
    In addition, we ran a model with a weight of 20 percent for the 
cost performance category and of 40 percent for the quality performance 
category as an alternate to our finalized weight of 15 percent for the 
cost performance category. The 20 percent weight for the cost 
performance category has a mean score of 76.34 and a median score of 
82.88 where our primary model has a mean score of 76.67 and a median 
score of 83.57.

H. Impact on Beneficiaries

1. Medicare PFS
    There are a number of changes in this final rule that will 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, will have a positive impact and improve the quality and value 
of care provided to Medicare providers and beneficiaries.
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. Similarly, our provisions in section III.K.3.g.(3) of this 
rule will improve the caliber and value of QCDR measures.

I. Burden Reduction Estimates: Payment for E/M Services

    In the CY 2019 PFS final rule, we finalized proposals that we made 
in response to comments received from RFIs released to the public under 
our Patients Over Paperwork Initiative. Specifically, we finalized 
provisions that focused on simplifying the medical documentation 
payment framework for office/outpatient E/M services and allowing 
greater flexibility on the components practitioners could choose to 
document when billing Medicare for office/outpatient E/M visits. In 
that rule we discussed the specific changes to documentation 
requirements and estimated significant reductions in the amount of time 
that practitioners would spend documenting office/outpatient E/M 
visits, furthering our goal of allowing practitioners more time spent 
with patients. As discussed earlier in section II.P. of this final 
rule, we proposed to adopt the revised office/outpatient E/M code set. 
The proposals reflected our ongoing dialog with the practitioner 
community and took into account the significant revisions the AMA/CPT 
Editorial Panel has made to the guidelines for the office/outpatient E/
M code set. We note that as part of its efforts to revise the 
guidelines, the AMA has also estimated a reduction in the amount of 
time practitioners would spend documenting office/outpatient E/M 
visits. The AMA asserts that its revisions to the office/outpatient E/M 
code set will accomplish similar, albeit greater burden reduction in 
comparison with CMS' approach, as finalized in the CY 2019 PFS final 
rule, and is more intuitive and in line with the current practice of 
medicine. We reviewed the AMA's estimates and acknowledge that overall 
the AMA's approach does result in burden reduction that are consistent 
with our broader goals discussed above. In comparison to our estimates 
of burden reduction, as discussed in the CY 2019 final rule, the AMA's 
estimates show less documentation burden to practitioners, the 
difference resulting from CMS' finalized policies that allow use of 
add-on codes to reflect additional resource costs inherent in 
furnishing some kinds of office/outpatient E/M visits that the current 
E/M coding and visit levels do not fully recognize (FR 83 59638). The 
AMA estimates reflect assumptions that the time spent documenting 
appropriate application of the add-on codes may result in additional 
burden to practitioners. We disagree with this assumption. In addition 
to proposing to redefine and revalue HCPCS G code add-on GPC1X to be 
more understandable and easy to report for purposes of medical 
documentation and billing, and proposing to delete HCPCS G-code add-on 
GCG0X, we discussed that we believe that while an initial setup period 
is expected for practices to establish workflows that incorporate 
appropriate use of the add-on code, practices should be able to 
automate the appropriate use of the add-on code in a short period of 
time. Even so, our proposal to adopt the AMA's revised office/
outpatient E/M code set was consistent with our goal of burden 
reduction and aligns with the policy principles that underlay what we 
finalized in the CY 2019 PFS final rule. The AMA's estimates of burden 
reduction as related to office/outpatient E/M documentation and other 
materials pertinent to the AMA/CPT and AMA/RUC's recent efforts to 
revise the office/outpatient E/M code set are available at https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management. 
The burden estimates as discussed above remain the same because we made 
no refinements to our proposals to adopt the AMA's revised office/
outpatient E/M code set.

J. 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 May 2018 BLS for medical and 
health service managers (Code 11-9111), we

[[Page 63185]]

estimate that the cost of reviewing this rule is $109.36 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 
$874.88 (8.0 hours x $109.36). Therefore, we estimated that the total 
cost of reviewing this regulation is $37,997,788 ($874.88 x 43,432 
reviewers).

K. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 128 and 129 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2019 to CY 2020 
based on the FY 2020 President's Budget baseline.

      Table 128--Accounting Statement: Classification of Estimated
                              Expenditures
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2020 Annualized Monetized Transfers.  Estimated increase in
                                          expenditures of $0.3 billion
                                          for PFS CF update.
From Whom To Whom?.....................  Federal Government to
                                          physicians, other
                                          practitioners and providers
                                          and suppliers who receive
                                          payment under Medicare.
------------------------------------------------------------------------


   Table 129--Accounting Statement: Classification of Estimated Costs,
                          Transfer, and Savings
------------------------------------------------------------------------
                Category                             Transfer
------------------------------------------------------------------------
CY 2020 Annualized Monetized Transfers   $0.1 billion.
 of beneficiary cost coinsurance.
From Whom to Whom?.....................  Beneficiaries to Federal
                                          Government.
------------------------------------------------------------------------

L. 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 403

    Grant programs--health, Health insurance, Hospitals, 
Intergovernmental relations, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

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

42 CFR Part 411

    Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

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

42 CFR Part 415

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

42 CFR Part 416

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

42 CFR Part 418

    Health facilities, Hospice care, Medicare, 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.

42 CFR Part 489

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 498

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

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

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 continues to read as follows:

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


0
2. Section 403.902 is amended--
0
a. By adding in alphabetical order the definitions of ``Certified nurse 
midwife'', ``Certified registered nurse anesthetist'', and ``Clinical 
nurse specialist'';
0
b. By revising the definition of ``Covered recipient'';
0
c. By adding in alphabetical order the definitions of ``Device 
identifier'', ``Long term medical supply or device loan'', ``Non-
teaching hospital covered recipient'', ``Nurse practitioner'', 
``Physician assistant'', ``Short term medical supply or device loan'', 
and ``Unique device identifier''.
    The additions and revisions read as follows:


Sec.  403.902   Definitions.

* * * * *
    Certified nurse midwife means a registered nurse who has 
successfully completed a program of study and clinical experience 
meeting guidelines prescribed by the Secretary, or has been certified 
by an organization recognized by the Secretary.
    Certified registered nurse anesthetist means a certified registered 
nurse anesthetist licensed by the State who meets such education, 
training, and other requirements relating to anesthesia services and 
related care as the Secretary may prescribe. In prescribing such 
requirements the

[[Page 63186]]

Secretary may use the same requirements as those established by a 
national organization for the certification of nurse anesthetists. Such 
term also includes, as prescribed by the Secretary, an anesthesiologist 
assistant.
* * * * *
    Clinical nurse specialist means, an individual who--
    (1) Is a registered nurse and is licensed to practice nursing in 
the State in which the clinical nurse specialist services are 
performed; and
    (2) Holds a master's degree in a defined clinical area of nursing 
from an accredited educational institution.
* * * * *
    Covered recipient means--
    (1) Any physician, physician assistant, nurse practitioner, 
clinical nurse specialist, certified registered nurse anesthetist, or 
certified nurse-midwife who is not a bona fide employee of the 
applicable manufacturer that is reporting the payment; or
    Device identifier is the mandatory, fixed portion of a unique 
device identifier (UDI) that identifies the specific version or model 
of a device and the labeler of that device (as described at 21 CFR 
801.3 in paragraph (1) of the definition of ``Unique device 
identifier'').
* * * * *
    Long term medical supply or device loan means the loan of supplies 
or a device for 91 days or longer.
    Non-teaching hospital covered recipient means a person who is one 
or more of the following: Physician; physician assistant; nurse 
practitioner; clinical nurse specialist; certified registered nurse 
anesthetist; or certified nurse-midwife.
* * * * *
    Nurse practitioner means a nurse practitioner who performs such 
services as such individual is legally authorized to perform (in the 
State in which the individual performs such services) in accordance 
with State law (or the State regulatory mechanism provided by State 
law), and who meets such training, education, and experience 
requirements (or any combination thereof) as the Secretary may 
prescribe in regulations.
* * * * *
    Physician assistant means a physician assistant who performs such 
services as such individual is legally authorized to perform (in the 
State in which the individual performs such services) in accordance 
with State law (or the State regulatory mechanism provided by State 
law), and who meets such training, education, and experience 
requirements (or any combination thereof) as the Secretary may 
prescribe in regulations.
* * * * *
    Short term medical supply or device loan means the loan of a 
covered device or a device under development, or the provision of a 
limited quantity of medical supplies for a short-term trial period, not 
to exceed a loan period of 90 days or a quantity of 90 days of average 
daily use, to permit evaluation of the device or medical supply by the 
covered recipient.
* * * * *
    Unique device identifier means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of 21 CFR 801.40 and 830.3.

0
3. Section 403.904 is amended by--
0
a. Revising paragraphs (c)(1), (c)(3) introductory text, (c)(3)(ii) and 
(iii), (c)(8), (e)(2) introductory text and;
0
b. Adding paragraph (e)(2)(xi);
0
c. Revising paragraphs (e)(2)(xiv) and (xv);
0
d. Adding paragraph (e)(2)(xviii); and
0
e. Revising paragraphs (f)(1) introductory text, (f)(1)(i)(A) 
introductory text, (f)(1)(i)(A)(1),(3) and (5), (f)(1)(iv), (f)(1)(v), 
(h)(5), (h)(7), and (h)(13).
    The revisions and addition read as follows:


Sec.  403.904   Reports of payments or other transfers of value to 
covered recipients.

* * * * *
    (c)* * *
    (1) Name of the covered recipient. For non-teaching hospital 
covered recipients, the name must be as listed in the National Plan & 
Provider Enumeration System (NPPES) (if applicable) and include first 
and last name, middle initial, and suffix (for all that apply).
* * * * *
    (3) Identifiers for non-teaching hospital covered recipients. In 
the case of a covered recipient the following identifiers:
* * * * *
    (ii) National Provider Identifier (if applicable and as listed in 
the NPPES). If a National Provider Identifier cannot be identified for 
a non-teaching hospital covered recipient, the field may be left blank, 
indicating that the applicable manufacturer could not find one.
    (iii) State professional license number(s) (for at least one State 
where the non-teaching hospital covered recipient maintains a license), 
and the State(s) in which the license is held.
* * * * *
    (8) Related covered drug, device, biological or medical supply. 
Report the marketed or brand name of the related covered drugs, 
devices, biologicals, or medical supplies, and therapeutic area or 
product category unless the payment or other transfer of value is not 
related to a particular covered drug, device, biological or medical 
supply.
    (i) For drugs and biologicals--
    (A) If the marketed name has not yet been selected, applicable 
manufacturers must indicate the name registered on clinicaltrials.gov.
    (B) Any regularly used identifiers must be reported, including, but 
not limited to, national drug codes.
    (ii) For devices, if the device has a unique device identifier 
(UDI), then the device identifier (DI) portions of it must be reported, 
as applicable.
    (iii) Applicable manufacturers may report the marketed name and 
therapeutic area or product category for payments or other transfers of 
value related to a non-covered drug, device, biological, or medical 
supply.
    (iv) Applicable manufacturers must indicate if the related drug, 
device, biological, or medical supply is covered or non-covered.
    (v) Applicable manufacturers must indicate if the payment or other 
transfer of value is not related to any covered or non-covered drug, 
device, biological or medical supply.
* * * * *
    (e) * * *
    (2) Rules for categorizing natures of payment. An applicable 
manufacturer must categorize each payment or other transfer of value, 
or separable part of that payment or transfer of value, with one of the 
categories listed in paragraphs (e)(2)(i) through (xviii) of this 
section, using the designation that best describes the nature of the 
payment or other transfer of value, or separable part of that payment 
or other transfer of value. If a payment or other transfer of value 
could reasonably be considered as falling within more than one 
category, the applicable manufacturer should select one category that 
it deems to most accurately describe the nature of the payment or 
transfer of value.
* * * * *
    (xi) Debt forgiveness.
* * * * *
    (xiv) Compensation for serving as faculty or as a speaker for a 
medical education program.
    (xv) Long term medical supply or device loan.
* * * * *
    (xviii) Acquisitions.
    (f) * * *
    (1) Research-related payments or other transfers of value to 
covered recipients, including research-related

[[Page 63187]]

payments or other transfers of value made indirectly to a covered 
recipient through a third party, must be reported to CMS separately 
from other payments or transfers of value, and must include the 
following information (in lieu of the information required by Sec.  
403.904(c)):
    (i) * * *
    (A) If paid to a non-teaching hospital covered recipient, all of 
the following must be provided:
    (1) The non-teaching hospital covered recipient's name as listed in 
the NPPES (if applicable).
* * * * *
    (3) State professional license number(s) (for at least one State 
where the non-teaching hospital covered recipient maintains a license) 
and State(s) in which the license is held.
* * * * *
    (5) Primary business address of the non-teaching hospital covered 
recipient(s).
* * * * *
    (iv) Name(s) of any related covered drugs, devices, biologicals, or 
medical supplies (subject to the requirements specified in paragraph 
(c)(8) of this section); for drugs and biologicals, the relevant 
National Drug Code(s), if any; and for devices and medical supplies, 
the relevant device identifier, if any, and the therapeutic area or 
product category if a marketed name is not available.
    (v) Information about each non-teaching hospital covered recipient 
principal investigator (if applicable) set forth in paragraph 
(f)(1)(i)(A) of this section.
* * * * *
    (h) * * *
    (5) Short term medical supply or device loan.
* * * * *
    (7) A transfer of anything of value to a non-teaching hospital 
covered recipient when the covered recipient is a patient, research 
subject or participant in data collection for research, and not acting 
in the professional capacity of a covered recipient.
* * * * *
    (13) In the case of a non-teaching hospital covered recipient, a 
transfer of anything of value to the covered recipient if the transfer 
is payment solely for the services of the covered recipient with 
respect to an administrative proceeding, legal defense, prosecution, or 
settlement or judgment of a civil or criminal action and arbitration.
* * * * *

0
4. Section 403.908 is amended by revising paragraphs (g)(2)(ii) 
introductory text to read as follows:


Sec.  403.908  Procedures for electronic submission of reports.

* * * * *
    (g) * * *
    (2) * * *
    (ii) Covered recipients--
* * * * *

PART 409--HOSPITAL INSURANCE BENEFITS

0
5. The authority citation for part 409 continues to read as follows:

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


Sec.  409.27  [Amended]

0
6. Section 409.27 is amended in paragraph (c) by removing the reference 
``Sec.  410.40(d)(1)'' and adding in its place the reference ``Sec.  
410.40(e)(1)''.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

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

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

0
8. Section 410.20 is amended by adding paragraph (e) to read as 
follows:


Sec.  410.20   Physicians' services.

* * * * *
    (e) Medical record documentation. The physician may review and 
verify (sign/date), rather than re-document, notes in a patient's 
medical record made by physicians; residents; nurses; medical, 
physician assistant, and advanced practice registered nurse students; 
or other members of the medical team including, as applicable, notes 
documenting the physician's presence and participation in the services.

0
9. Section 410.40 is amended--
0
a. By redesignating paragraphs (a) through (f) as paragraphs (b) 
through (g), respectively;
0
b. By adding new paragraph (a);
0
c. In newly redesignated paragraph (b)(1) by removing the reference 
``paragraphs (d) and (e)'' and adding in its place the reference 
``paragraphs (e) and (f)''; and
0
d. By revising newly redesignated paragraphs (e)(2)(i), (e)(3)(i), and 
(e)(3)(iii) through (v).
    The additions and revision reads as follows:


Sec.  410.40   Coverage of ambulance services.

    (a) Definitions. As used in this section, the following definitions 
apply:
    Non-physician certification statement means a statement signed and 
dated by an individual which certifies that the medical necessity 
provisions of paragraph (e)(1) of this section are met and who meets 
all of the criteria in paragraphs (i) through (iii) of this definition. 
The statement need not be a stand-alone document and no specific format 
or title is required.
    (i) Has personal knowledge of the beneficiary's condition at the 
time the ambulance transport is ordered or the service is furnished;
    (ii) Who must be employed:
    (A) By the beneficiary's attending physician; or
    (B) By the hospital or facility where the beneficiary is being 
treated and from which the beneficiary is transported;
    (iii) Is among the following individuals, with respect to whom all 
Medicare regulations and all applicable State licensure laws apply:
    (A) Physician assistant (PA).
    (B) Nurse practitioner (NP).
    (C) Clinical nurse specialist (CNS).
    (D) Registered nurse (RN).
    (E) Licensed practical nurse (LPN).
    (F) Social worker.
    (G) Case manager.
    (H) Discharge planner.
    Physician certification statement means a statement signed and 
dated by the beneficiary's attending physician which certifies that the 
medical necessity provisions of paragraph (e)(1) of this section are 
met. The statement need not be a stand-alone document and no specific 
format or title is required.
* * * * *
    (e) * * *
    (2) * * *
    (i) Medicare covers medically necessary nonemergency, scheduled, 
repetitive ambulance services if the ambulance provider or supplier, 
before furnishing the service to the beneficiary, obtains a physician 
certification statement dated no earlier than 60 days before the date 
the service is furnished.
* * * * *
    (3) * * *
    (i) For a resident of a facility who is under the care of a 
physician if the ambulance provider or supplier obtains a physician 
certification statement within 48 hours after the transport.
* * * * *
    (iii) If the ambulance provider or supplier is unable to obtain a 
signed physician certification statement from the beneficiary's 
attending physician, a non-physician certification statement must be 
obtained.
    (iv) If the ambulance provider or supplier is unable to obtain the 
required physician or non-physician certification statement within 21 
calendar days following the date of the service, the ambulance provider 
or supplier must document its attempts to obtain the

[[Page 63188]]

requested certification and may then submit the claim. Acceptable 
documentation includes a signed return receipt from the U.S. Postal 
Service or other similar service that evidences that the ambulance 
supplier attempted to obtain the required signature from the 
beneficiary's attending physician or other individual named in 
paragraph (e)(3)(iii) of this section.
    (v) In all cases, the provider or supplier must keep appropriate 
documentation on file and, upon request, present it to the contractor. 
The presence of the physician or non-physician certification statement 
or signed return receipt does not alone demonstrate that the ambulance 
transport was medically necessary. All other program criteria must be 
met in order for payment to be made.
* * * * *

0
10. Section 410.41 is amended by revising the section heading and 
paragraph (c)(1) to read as follows:


Sec.  410.41   Requirements for ambulance providers and suppliers.

* * * * *
    (c) * * *
    (1) Bill for ambulance services using CMS-designated procedure 
codes to describe origin and destination and indicate on claims form 
that the physician certification statement or non-physician 
certification statement is on file, if required.
* * * * *

0
11. Section 410.49 is amended by revising paragraph (b)(1)(vii) and 
adding paragraph (b)(1)(viii) to read as follows:


Sec.  410.49  Cardiac rehabilitation program and intensive cardiac 
rehabilitation program: Conditions of coverage.

* * * * *
    (b) * * *
    (1) * * *
    (vii) Stable, chronic heart failure defined as patients with left 
ventricular ejection fraction of 35 percent or less and New York Heart 
Association (NYHA) class II to IV symptoms despite being on optimal 
heart failure therapy for at least 6 weeks, on or after February 18, 
2014 for cardiac rehabilitation and on or after February 9, 2018 for 
intensive cardiac rehabilitation; or
    (viii) Other cardiac conditions as specified through a national 
coverage determination (NCD). The NCD process may also be used to 
specify non-coverage of a cardiac condition for ICR if coverage is not 
supported by clinical evidence.
* * * * *

0
12. Section 410.59 is amended by--
0
a. Adding paragraphs (a)(4) and (e)(1)(v); and
0
b. Revising paragraphs (e)(2) introductory text, (e)(2)(i) and (v), and 
(e)(3).
    The additions and revisions read as follows:


Sec.  410.59  Outpatient occupational therapy services: Conditions.

    (a) * * *
    (4) Effective for dates of service on and after January 1, 2020, 
for occupational therapy services described in paragraph (a)(3)(i) or 
(ii) of this section, as applicable--
    (i) Claims for services furnished in whole or in part by an 
occupational therapy assistant must include the prescribed modifier; 
and
    (ii) Effective for dates of service on or after January 1, 2022, 
claims for such services that include the modifier and for which 
payment is made under sections 1848 or 1834(k) of the Act are paid an 
amount equal to 85 percent of the amount of payment otherwise 
applicable for the service.
    (iii) For purposes of this paragraph, ``furnished in whole or in 
part'' means when the occupational therapy assistant either:
    (A) Furnishes all the minutes of a service exclusive of the 
occupational therapist; or
    (B) Furnishes a portion of a service separately from the part 
furnished by the occupational therapist such that the minutes for that 
portion of a service furnished by the occupational therapy assistant 
exceed 10 percent of the total minutes for that service.
* * * * *
    (e) * * *
    (1) * * *
    (v) Beginning in 2018 and for each successive calendar year, the 
amount described in paragraph (e)(1)(ii) of this section is no longer 
applied as a limitation on incurred expenses for outpatient 
occupational therapy services, but, is instead applied as a threshold 
above which claims for occupational therapy services must include the 
KX modifier (the KX modifier threshold) to indicate that the service is 
medically necessary and justified by appropriate documentation in the 
medical record and claims for services above the KX modifier threshold 
that do not include the KX modifier are denied.
    (2) For purposes of applying the KX modifier threshold, outpatient 
occupational therapy includes:
    (i) Outpatient occupational therapy services furnished under this 
section;
* * * * *
    (v) Outpatient occupational therapy services furnished by a CAH 
directly or under arrangements, included in the amount of annual 
incurred expenses as if such services were furnished under section 
1834(k)(1)(B) of the Act.
* * * * *
    (3) A process for medical review of claims for outpatient 
occupational therapy services applies as follows:
    (i) For 2012 through 2017, medical review applies to claims for 
services at or in excess of $3,700 of recognized incurred expenses as 
described in paragraph (e)(1)(i) of this section.
    (A) For 2012, 2013, and 2014 all claims at and above the $3,700 
medical review threshold are subject to medical review; and
    (B) For 2015, 2016, and 2017 claims at and above the $3,700 medical 
review threshold are subject to a targeted medical review process.
    (ii) For 2018 and subsequent years, a targeted medical review 
process applies when the accrued annual incurred expenses reach the 
following medical review threshold amounts:
    (A) Beginning with 2018 and before 2028, $3,000;
    (B) For 2028 and each year thereafter, the applicable medical 
review threshold is determined by increasing the medical review 
threshold in effect for the previous year (starting with $3,000 in 
2027) by the increase in the Medicare Economic Index for the current 
year.

0
13. Section 410.60 is amended by--
0
a. Adding paragraphs (a)(4) and (e)(1)(v); and
0
b. Revising paragraphs (e)(2) introductory text, (e)(2)(i), (ii) and 
(vi), and (e)(3).
    The additions and revisions read as follows:


Sec.  410.60  Outpatient physical therapy services: Conditions.

    (a) * * *
    (4) Effective for dates of service on and after January 1, 2020, 
for physical therapy services described in paragraphs (a)(3)(i) or (ii) 
of this section, as applicable--
    (i) Claims for services furnished in whole or in part by a physical 
therapist assistant must include the prescribed modifier; and
    (ii) Effective for dates of service on or after January 1, 2022, 
claims for such services that include the modifier and for which 
payment is made under sections 1848 or 1834(k) of the Act are paid an 
amount equal to 85 percent of the amount of payment otherwise 
applicable for the service.
    (iii) For purposes of this paragraph, ``furnished in whole or in 
part'' means when the physical therapist assistant either:

[[Page 63189]]

    (A) Furnishes all the minutes of a service exclusive of the 
physical therapist; or
    (B) Furnishes a portion of a service separately from the part 
furnished by the physical therapist such that the minutes for that 
portion of a service furnished by the physical therapist assistant 
exceed 10 percent of the total minutes for that service.
* * * * *
    (e) * * *
    (1) * * *
    (v) Beginning in 2018 and for each successive calendar year, the 
amount described in paragraph (e)(1)(ii) of this section is not applied 
as a limitation on incurred expenses for outpatient physical therapy 
and outpatient speech-language pathology services, but is instead 
applied as a threshold above which claims for physical therapy and 
speech-language pathology services must include the KX modifier (the KX 
modifier threshold) to indicate that the service is medically necessary 
and justified by appropriate documentation in the medical record; and 
claims for services above the KX modifier threshold that do not include 
the KX modifier are denied.
    (2) For purposes of applying the KX modifier threshold, outpatient 
physical therapy includes:
    (i) Outpatient physical therapy services furnished under this 
section;
    (ii) Outpatient speech-language pathology services furnished under 
Sec.  410.62;
* * * * *
    (vi) Outpatient physical therapy and speech-language pathology 
services furnished by a CAH directly or under arrangements, included in 
the amount of annual incurred expenses as if such services were 
furnished and paid under section 1834(k)(1)(B) of the Act.
    (3) A process for medical review of claims for physical therapy and 
speech-language pathology services applies as follows:
    (i) For 2012 through 2017, medical review applies to claims for 
services at or in excess of $3,700 of recognized incurred expenses as 
described in paragraph (e)(1)(i) of this section.
    (A) For 2012, 2013, and 2014 all claims at and above the $3,700 
medical review threshold are subject to medical review; and
    (B) For 2015, 2016, and 2017 claims at and above the $3,700 medical 
review threshold are subject to a targeted medical review process.
    (ii) For 2018 and subsequent years, a targeted medical review 
process when the accrued annual incurred expenses reach the following 
medical review threshold amounts:
    (A) Beginning with 2018 and before 2028, $3,000;
    (B) For 2028 and each year thereafter, the applicable medical 
review threshold is determined by increasing the medical review 
threshold in effect for the previous year (starting with $3,000 for 
2017) by the increase in the Medicare Economic Index for the current 
year.

0
14. Section 410.67 is added to read as follows:


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

    (a) Basis and scope. (1) Basis. This section implements sections 
1861(jjj), 1861(s)(2)(HH), 1833(a)(1)(CC) and 1834(w) of the Act which 
provide for coverage of opioid use disorder treatment services 
furnished by an opioid treatment program and the payment of a bundled 
payment under Part B to an opioid treatment program for opioid use 
disorder treatment services that are furnished to a beneficiary during 
an episode of care beginning on or after January 1, 2020.
    (2) Scope. This section sets forth the criteria for an opioid 
treatment program, the scope of opioid use disorder treatment services, 
and the methodology for determining the bundled payments to opioid 
treatment programs for furnishing opioid use disorder treatment 
services.
    (b) Definitions. For purposes of this section, the following 
definitions apply:
    Episode of care means a one-week (contiguous 7-day) period.
    Opioid treatment program means an entity that is an opioid 
treatment program (as defined in Sec.  8.2 of this title, or any 
successor regulation) that meets the requirements described in 
paragraph (c) of this section.
    Opioid use disorder treatment service means one of the following 
items or services for the treatment of opioid use disorder that is 
furnished by an opioid treatment program that meets the requirements 
described in paragraph (c) of this section.
    (1) Opioid agonist and antagonist treatment medications (including 
oral, injected, or implanted versions) that are approved by the Food 
and Drug Administration under section 505 of the Federal, Food, Drug, 
and Cosmetic Act for use in treatment of opioid use disorder.
    (2) Dispensing and administration of opioid agonist and antagonist 
treatment medications, if applicable.
    (3) Substance use counseling by a professional to the extent 
authorized under State law to furnish such services including services 
furnished via two-way interactive audio-video communication technology, 
as clinically appropriate, and in compliance with all applicable 
requirements.
    (4) Individual and group therapy with a physician or psychologist 
(or other mental health professional to the extent authorized under 
State law), including services furnished via two-way interactive audio-
video communication technology, as clinically appropriate, and in 
compliance with all applicable requirements.
    (5) Toxicology testing.
    (6) Intake activities, including initial medical examination 
services required under Sec.  8.12(f)(2) of this title and initial 
assessment services required under Sec.  8.12(f)(4) of this title.
    (7) Periodic assessment services required under Sec.  8.12(f)(4) of 
this title.
    (c) Requirements for opioid treatment programs. To participate in 
the Medicare program and receive payment, an opioid treatment program 
must meet all of the following:
    (1) Be enrolled in the Medicare program.
    (2) Have in effect a certification by the Substance Abuse and 
Mental Health Services Administration (SAMHSA) for the opioid treatment 
program.
    (3) Be accredited by an accrediting body approved by the SAMHSA.
    (4) Have in effect a provider agreement under part 489 of this 
title.
    (d) Bundled payments for opioid use disorder treatment services 
furnished by opioid treatment programs.
    (1) CMS will establish categories of bundled payments for opioid 
treatment programs for an episode of care as follows:
    (i) Categories for each type of opioid agonist and antagonist 
treatment medication;
    (ii) A category for medication not otherwise specified, which will 
be used for new FDA-approved opioid agonist or antagonist treatment 
medications for which CMS has not established a category; and
    (iii) A category for episodes of care in which no medication is 
provided.
    (2) The bundled payment for episodes of care in which a medication 
is provided consists of payment for a drug component, reflecting 
payment for the applicable FDA-approved opioid agonist or antagonist 
medication in the patient's treatment plan, and a non-drug component, 
reflecting payment for all other opioid use disorder treatment services 
reflected in the patient's treatment plan (including dispensing/
administration of the medication, if applicable). The payments for the 
drug component and non-drug component are added together to create the 
bundled payment amount. The bundled payment

[[Page 63190]]

for episodes of care in which no medication is provided consists of a 
single payment amount for all opioid use disorder treatment services 
reflected in the patient's treatment plan (excluding medication and 
dispensing/administration of medication).
    (i) Drug component. The payment for the drug component for an 
episode of care will be determined as follows, using the most recent 
data available at time of ratesetting for the applicable calendar year:
    (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 shall be 100 percent of the ASP, if ASP 
is used.
    (B) For oral medications, if ASP data are available, the payment 
amount is 100 percent of ASP, which will be determined based on ASP 
data that have been calculated consistent with the provisions in part 
414, subpart 800 of this chapter and voluntarily submitted by drug 
manufacturers. If ASP data are not available, the payment amount for 
methadone will be based on the TRICARE rate and for buprenorphine will 
be calculated using the National Average Drug Acquisition Cost.
    (C) Exception. For the drug component of bundled payments in the 
medication not otherwise specified category under paragraph (d)(1)(iii) 
of this section, the payment amount is be based on the applicable 
methodology under paragraphs (d)(2)(i)(A) and (B) of this section 
(applying the most recent available data for such new medication), or 
invoice pricing until the necessary data become available.
    (ii) Non-drug component. The payment for CY 2020 for the non-drug 
component of the bundled payment for an episode of care is the sum of:
    (A) The CY 2019 Medicare physician fee schedule non-facility rates 
for the following items and services:
    (1) Psychotherapy, 30 minutes with patient
    (2) Group psychotherapy
    (3) Alcohol and/or substance (other than tobacco) abuse structured 
assessment and brief intervention at the non-physician practitioner 
rate.
    (4) For administration of an injectable medication, if applicable, 
drug administration (Therapeutic, prophylactic).
    (5) For the insertion, removal, or insertion and removal of the 
implantable medication, if applicable, the applicable rate.
    (B) For dispensing oral medication, if applicable, an approximation 
of the average dispensing fees under state Medicaid programs.
    (C) One fourth of the sum of the CY 2019 Clinical Laboratory Fee 
Schedule rate for two drug tests, presumptive, capable of being read by 
direct optical observation only and for a drug test, definitive, 1-7 
drug classes.
    (iii) No medication provided episodes of care. The bundled payment 
amount for CY 2020 for an episode of care in which no medication is 
provided is based on the non-drug component rate for an episode of care 
in which a drug is dispensed or administered, not including any amounts 
reflecting the cost of dispensing or administration of a drug.
    (3) At least one OUD treatment service described in paragraphs 
(b)(1) through (5) of this section must be furnished to bill for the 
bundled payment for an episode of care.
    (4) Adjustments will be made to the bundled payment for the 
following:
    (i) If the opioid treatment program furnishes:
    (A) Counseling or therapy services in excess of the amount 
specified in the beneficiary's treatment plan and for which medical 
necessity is documented in the medical record, an adjustment will be 
made for each additional 30 minutes of counseling or individual therapy 
furnished during the episode of care.
    (B) Intake activities described in paragraph (b)(6) of this 
section, an adjustment will be made when intake activities are 
furnished.
    (C) Periodic assessments described in paragraph (b)(7) of this 
section, an adjustment will be made when this service is furnished.
    (D) Additional take home supply of oral drugs of up to 21 days, in 
increments of 7 days, an adjustment will be made when oral medications 
are dispensed.
    (ii) The payment amounts for the non-drug component of the bundled 
payment for an episode of care, and the adjustments for counseling or 
therapy, intake activities and periodic assessments will be 
geographically adjusted using the Geographic Adjustment Factor 
described in Sec.  414.26 of this chapter.
    (iii) The payment amounts for the non-drug component of the bundled 
payment for an episode of care, and the adjustments for counseling or 
therapy, intake activities and periodic assessments will be updated 
annually using the Medicare Economic Index described in Sec.  
405.504(d) of this chapter.
    (5) Payment for medications delivered, administered or dispensed to 
a beneficiary as part of the bundled payment is considered a 
duplicative payment if a claim for delivery, administration or 
dispensing of the same medications for the same beneficiary on the same 
date of service was also separately paid under Medicare Part B or Part 
D. CMS will recoup the duplicative payment made to the opioid treatment 
program.
    (e) Beneficiary cost-sharing. A beneficiary copayment amount of 
zero will apply.

0
15. Section 410.69 is amended in paragraph (b) by adding paragraph (5) 
to the definition of ``Certified registered nurse anesthetist'' to read 
as follows:


Sec.  410.69   Services of a certified registered nurse anesthetist or 
an anesthesiologist's assistant: Basic rule and definitions.

* * * * *
    (b) * * *
    Certified registered nurse anesthetist * * *
    (5) For certified registered nurse anesthetist services, the 
certified registered nurse anesthetist may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record 
made by physicians; residents; nurses; medical, physician assistant, 
and advanced practice registered nurse students; or other members of 
the medical team, including, as applicable, notes documenting the 
certified registered nurse anesthetist's presence and participation in 
the service.
* * * * *

0
16. Section 410.74 is amended by revising paragraph (a)(2)(iv) and by 
adding paragraph (e) to read as follows:


Sec.  410.74  Physician assistants' services.

    (a) * * *
    (2) * * *
    (iv) Performs the services in accordance with state law and state 
scope of practice rules for physician assistants in the state in which 
the physician assistant's professional services are furnished. Any 
state laws and scope of practice rules that describe the required 
practice relationship between physicians and physician assistants, 
including explicit supervisory or collaborative practice requirements, 
describe a form of supervision for purposes of section 1861(s)(2)(K)(i) 
of the Act. For states with no explicit state law and scope of practice 
rules regarding physician supervision of physician assistant's 
services, physician supervision is a process in which a physician 
assistant has a working relationship with one or more physicians to 
supervise the delivery of their health care services. Such physician 
supervision is evidenced by documenting at the

[[Page 63191]]

practice level the physician assistant's scope of practice and the 
working relationships the physician assistant has with the supervising 
physician/s when furnishing professional services.
* * * * *
    (e) Medical record documentation. For physician assistants' 
services, the physician assistant may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record 
made by physicians; residents; nurses; medical, physician assistant, 
and advanced practice registered nurse students; or other members of 
the medical team, including, as applicable, notes documenting the 
physician assistant's presence and participation in the service.

0
17. Section 410.75 is amended by adding paragraph (f) to read as 
follows:


Sec.  410.75  Nurse practitioners' services.

* * * * *
    (f) Medical record documentation. For nurse practitioners' 
services, the nurse practitioner may review and verify (sign and date), 
rather than re-document, notes in a patient's medical record made by 
physicians; residents; nurses; medical, physician assistant, and 
advanced practice registered nurse students; or other members of the 
medical team, including, as applicable, notes documenting the nurse 
practitioner's presence and participation in the service.

0
18. Section 410.76 is amended by adding paragraph (f) to read as 
follows:


Sec.  410.76   Clinical nurse specialists' services.

* * * * *
    (f) Medical record documentation. For clinical nurse specialists' 
services, the clinical nurse specialist may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record 
made by physicians; residents; nurses; medical, physician assistant, 
and advanced practice registered nurse students; or other members of 
the medical team, including, as applicable, notes documenting the 
clinical nurse specialist's presence and participation in the service.

0
19. Section 410.77 is amended by adding paragraph (e) to read as 
follows:


Sec.  410.77  Certified nurse-midwives' services: Qualifications and 
conditions.

* * * * *
    (e) Medical record documentation. For certified nurse-midwives' 
services, the certified nurse-midwife may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record 
made by physicians; residents; nurses; medical, physician assistant, 
and advanced practice registered nurse students; or other members of 
the medical team, including, as applicable, notes documenting the 
certified nurse-midwife's presence and participation in the service.

0
20. Section 410.105 is amended by adding paragraph (d) to read as 
follows:


Sec.  410.105   Requirements for coverage of CORF services.

* * * * *
    (d) Claims. Effective for dates of service on and after January 1, 
2020 physical therapy or occupational therapy services covered as part 
of a rehabilitation plan of treatment described in paragraph (c) of 
this section, as applicable--
    (1) Claims for such services furnished in whole or in part by a 
physical therapist assistant or an occupational therapy assistant must 
be identified with the inclusion of the respective prescribed modifier; 
and
    (2) Effective for dates of service on and after January 1, 2022, 
such claims are paid an amount equal to 85 percent of the amount of 
payment otherwise applicable for the service as defined at section 
1834(k) of the Act.
    (3) For purposes of this paragraph, ``furnished in whole or in 
part'' means when the physical therapist assistant or occupational 
therapy assistant either--
    (i) Furnishes all the minutes of a service exclusive of the 
respective physical therapist or occupational therapist; or
    (ii) Furnishes a portion of a service separately from the part 
furnished by the physical or occupational therapist such that the 
minutes for that portion of a service exceed 10 percent of the total 
time for that service.

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

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

    Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, 
and 1395nn.

0
22. Section 411.370 is amended--
0
a. In paragraph (b) introductory text, by removing the phrase ``CMS 
determines'' and adding in its place the phrase ``CMS will determine''; 
and
0
b. By revising paragraphs (b)(1), (c) introductory text, (d), and (e).
    The revisions read as follows:


Sec.  411.370  Advisory opinions relating to physician referrals.

* * * * *
    (b) * * *
    (1) The request must relate to an existing arrangement or one into 
which the requestor, in good faith, specifically plans to enter. The 
planned arrangement may be contingent upon the party or parties 
receiving a favorable advisory opinion. CMS does not consider, for 
purposes of an advisory opinion, requests that involve the activities 
of third parties.
* * * * *
    (c) Matters not subject to advisory opinions. CMS will not address 
through an advisory opinion--
* * * * *
    (d) Facts subject to advisory opinions. The requestor must include 
in the advisory opinion request a complete description of the 
arrangement that the requestor is undertaking, or plans to undertake, 
as described in Sec.  411.372.
    (e) Acceptance of requests. (1) CMS does not accept an advisory 
opinion request or issue an advisory opinion if--
    (i) The request is not related to a named individual or entity;
    (ii) The request does not describe the arrangement at issue with a 
level of detail sufficient for CMS to issue an opinion, and the 
requestor does not timely respond to CMS requests for additional 
information;
    (iii) CMS is aware, after consultation with OIG and DOJ, that the 
same course of action is under investigation, or is or has been the 
subject of a proceeding involving the Department of Health and Human 
Services or another governmental agency;
    (iv) CMS believes that it cannot make an informed opinion or could 
only make an informed opinion after extensive investigation, clinical 
study, testing, or collateral inquiry; or
    (v) CMS determines that the arrangement or course of conduct at 
issue is or would be in violation of applicable State or Federal law or 
regulation.
    (2) CMS may elect not to accept an advisory opinion request if it 
determines, after consultation with OIG and DOJ:
    (i) The course of action described is substantially similar to a 
course of conduct that is under investigation or the subject of a 
proceeding involving the Department or other law enforcement agencies; 
and
    (ii) Issuing an advisory opinion could interfere with the 
investigation or proceeding.
* * * * *

0
23. Section 411.372 is amended by--
0
a. Revising paragraphs (b)(4)(i) and (ii), (5), (6), and (8)(ii);
0
b. Removing paragraph (b)(9); and
0
c. Adding paragraph (d).
    The revisions and addition read as follows:

[[Page 63192]]

Sec.  411.372  Procedure for submitting a request.

* * * * *
    (b) * * *
    (4) * * *
    (i) A complete description of the arrangement that the requestor is 
undertaking, or plans to undertake, including:
    (A) The purpose of the arrangement; the nature of each party's 
(including each entity's) contribution to the arrangement; the direct 
or indirect relationships between the parties, with an emphasis on the 
relationships between physicians involved in the arrangement (or their 
immediate family members who are involved); and
    (B) Any entities that provide designated health services; the types 
of services for which a physician wishes to refer, and whether the 
referrals will involve Medicare or Medicaid patients;
    (ii) Complete copies of all relevant documents or relevant portions 
of documents that affect or could affect the arrangement, such as 
personal service or employment contracts, leases, deeds, pension or 
insurance plans, or financial statements (or, if these relevant 
documents do not yet exist, a complete description, to the best of the 
requestor's knowledge, of what these documents are likely to contain);
* * * * *
    (5) The identity of all entities involved either directly or 
indirectly in the arrangement, including their names, addresses, legal 
form, ownership structure, nature of the business (products and 
services) and, if relevant, their Medicare and Medicaid provider 
numbers. The requestor must also include a brief description of any 
other entities that could affect the outcome of the opinion, including 
those with which the requestor, the other parties, or the immediate 
family members of involved physicians, have any financial relationships 
(either direct or indirect, and as defined in section 1877(a)(2) of the 
Act and Sec.  411.354), or in which any of the parties holds an 
ownership or control interest as defined in section 1124(a)(3) of the 
Act.
    (6) At the option of the requestor, a discussion of the specific 
issues or questions to be addressed by CMS including, if possible, a 
discussion of why the requestor believes the referral prohibition in 
section 1877 of the Act might or might not be triggered by the 
arrangement and which, if any, exceptions the requestor believes might 
apply. The requestor should attempt to designate which facts are 
relevant to each issue or question raised in the request and should 
cite the provisions of law under which each issue or question arises.
* * * * *
    (8) * * *
    (ii) The chief executive officer, or other authorized officer, of 
the requestor, if the requestor is a corporation;
* * * * *
    (d) Requests for expedited review. Parties may seek expedited 
review of arrangements under Sec.  411.380(c)(1)(i) for a determination 
as to whether the arrangement or course of conduct is indistinguishable 
in all material aspects from an arrangement or course of conduct that 
was the subject of a prior advisory opinion. Parties seeking such 
expedited review must identify the relevant advisory opinion and 
provide an explanation of why the subject arrangement is 
indistinguishable from the arrangement that was the subject of the 
prior relevant advisory opinion. Requestors should clearly and 
prominently indicate in their submission to CMS that they are seeking 
expedited review.

0
24. Section 411.375 is amended by--
0
a. Revising paragraphs (a);
0
b. Removing paragraph (b); and
0
c. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
    The revision reads as follows:


Sec.  411.375  Fees for the cost of advisory opinions.

    (a) Hourly rate. CMS will charge an hourly rate of $220. Parties 
may request an estimate from CMS after submitting a complete request. 
Before issuing the advisory opinion, CMS will calculate the final fee 
for responding to the request.
* * * * *

0
25. Section 411.379 is amended by revising paragraphs (a), (b), (d) and 
(e) to read as follows:


Sec.  411.379  When CMS accepts a request.

    (a) Upon receiving a request for an advisory opinion, CMS promptly 
makes an initial determination of whether the request contains a level 
of detail sufficient for CMS to process the request.
    (b) If CMS determines that the request submitted lacks details 
necessary for CMS to process the request, CMS will provide notification 
to the requestor within 15 working days of receiving the request.
* * * * *
    (d) CMS formally accepts a request when CMS determines that the 
request (inclusive of any supplemental submissions) describes the 
arrangement at issue with sufficient detail and that the grounds for 
rejection of a request listed at Sec.  411.370(e) do not apply. Upon 
accepting the request, CMS notifies the requestor by regular U.S. mail 
of the date that CMS formally accepts the request.
    (e) The applicable time period that CMS has to issue an advisory 
opinion set forth in Sec.  411.380(c) does not begin until CMS formally 
accepts the request for an advisory opinion.

0
26. Section 411.380 is amended by revising paragraph (c) to read as 
follows:


Sec.  411.380   When CMS issues a formal advisory opinion.

* * * * *
    (c)(1) Except as set forth in paragraph (c)(2) of this section, CMS 
issues an advisory opinion in accordance with the provisions of this 
part within 60 working days after the date on which it formally accepts 
the advisory opinion request.
    (i) In the case of a request for a determination that an 
arrangement or course of conduct is indistinguishable in all material 
aspects from another arrangement or course of conduct that was the 
subject of a prior opinion, CMS issues an advisory opinion within 30 
working days after the date on which it formally accepts the advisory 
opinion request.
    (ii) In the case of a request that CMS determines, in its 
discretion, involves complex legal issues or highly complicated fact 
patterns, CMS issues an advisory opinion within a reasonable time 
period after the date on which it formally accepts the advisory opinion 
request.
    (iii) If the last day of the 60-working day or 30-working day time 
period falls on a Saturday, Sunday, or Federal holiday, CMS may issue 
the advisory opinion at the close of business on the first business day 
following the weekend or holiday.
    (2) The applicable time period for issuing an advisory opinion is 
suspended from the time CMS;
    (i) Notifies the requestor that the costs have reached or are 
likely to exceed the triggering amount as described in Sec.  
411.375(c)(2) until CMS receives written notice from the requestor to 
continue processing the request;
    (ii) Requests additional information from the requestor until CMS 
receives the additional information;
    (iii) Notifies the requestor of the full amount due until CMS 
receives payment of this amount; and
    (iv) Notifies the requestor of the need for expert advice until CMS 
receives the expert advice.
* * * * *

[[Page 63193]]


0
27. Section 411.382 is revised to read as follows:


Sec.  411.382  CMS' right to rescind advisory opinions.

    (a)(1) Any advice CMS gives in an advisory opinion does not 
prejudice its right to reconsider the questions involved in the 
opinion, and CMS may rescind or revoke the opinion if it determines 
that there is good cause to rescind or revoke the opinion.
    (2) Good cause shall exist where--
    (i) There is a material change in the law that affects the 
conclusions reached in an opinion; or
    (ii) A party that has received a negative advisory opinion seeks 
reconsideration based on new facts or law.
    (b) CMS provides advance notice to the requestor and to the public 
of its decision to rescind or revoke the opinion so that the requestor 
and other parties may discontinue any course of action they have taken 
in accordance with, or in good faith reliance on, the advisory opinion.
    (c) CMS does not proceed against the requestor with respect to any 
action the requestor and the involved parties have taken in good faith 
reliance upon CMS' advice under this part, provided--
    (1) The requestor presented to CMS a full, complete and accurate 
description of all the relevant facts; and
    (2) The parties promptly discontinue the action upon receiving 
notice that CMS had rescinded or revoked its approval, or discontinue 
the action within a reasonable ``wind down'' period, as determined by 
CMS.


Sec.  411.384  [Amended]

0
28. Section 411.384 is amended in paragraph (b) by removing the phrase 
``for public inspection during its normal hours of operation and''.

0
29. Section 411.387 is revised to read as follows:


Sec.  411.387  Effect of an advisory opinion.

    (a) An advisory opinion is binding on the Secretary, and a 
favorable advisory opinion shall preclude imposition of sanctions under 
section 1877(g) of the Act with respect to:
    (1) The individuals or entities requesting the opinion; and
    (2) Individuals or entities that are parties to the specific 
arrangement with respect to which such advisory opinion has been 
issued.
    (b) The Secretary will not pursue sanctions under section 1877(g) 
of the Act against any party to an arrangement that CMS determines is 
indistinguishable in all its material aspects from an arrangement with 
respect to which CMS issued a favorable advisory opinion.
    (c) Individuals and entities may rely on an advisory opinion as 
non-binding guidance that illustrates the application of the physician 
self-referral law and regulations to the specific facts and 
circumstances described in the advisory opinion.

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

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

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

0
31. Section 414.601 is amended by adding the following sentence to the 
end of the section:


Sec.  414.601  Purpose.

    * * * Section 1834(l)(17) of the Act requires the development of a 
data collection system to collect cost, revenue, utilization, and other 
information determined appropriate from providers of services and 
suppliers of ground ambulance services.

0
32. Section 414.605 is amended by--
0
a. Adding the definition of ``Ground ambulance organization'' in 
alphabetical order; and
0
b. In the definition of ``Paramedic ALS intercept (PI)'' by removing 
the reference ``Sec.  410.40(c)'' and adding in its place the reference 
``Sec.  410.40(d)''.
    The addition reads as follows:


Sec.  414.605  Definitions.

* * * * *
    Ground ambulance organization means a Medicare provider or supplier 
of ground ambulance services.
* * * * *

0
33. Section 414.610 is amended by adding paragraph (c)(9) to read as 
follows:


Sec.  414.610  Basis of payment.

* * * * *
    (c) * * *
    (9) Payment reduction for failure to report data. In the case of a 
ground ambulance organization (as defined at Sec.  414.605) that is 
selected by CMS under Sec.  414.626(c) for a year that does not 
sufficiently submit data under Sec.  414.626(b) and is not granted a 
hardship exemption under Sec.  414.626(d), the payments made under this 
section are reduced by 10 percent for the applicable period. For 
purposes of this paragraph, the applicable period is the calendar year 
that begins following the date that CMS provided written notification 
to the ground ambulance organization under Sec.  414.626(e)(1) that the 
ground ambulance did not sufficiently submit the required data.
* * * * *

0
34. Section 414.626 is added to subpart H to read as follows:


Sec.  414.626  Data reporting by ground ambulance organizations.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    Data collection period means, with respect to a year, the 12-month 
period that reflects the ground ambulance organization's annual 
accounting period.
    Data reporting period means, with respect to a year, the 5-month 
period that begins the day after the last day of the ground ambulance 
organization's data collection period.
    For a year means one of the calendar years from 2020 through 2024.
    Medicare Ground Ambulance Data Collection Instrument means the 
single survey-based data collection instrument that can be accessed by 
sampled ambulance organizations under this section via a secure web-
based system for reporting data under this section.
    (b) Data collection and submission requirement. Except as provided 
in paragraph (d) of this section, a ground ambulance organization 
selected by CMS under paragraph (c) of this section must do the 
following:
    (1) Within 30 days of the date that CMS notifies a ground ambulance 
organization under paragraph (c)(3) of this section that it has 
selected the ground ambulance organization to report data under this 
section, the ground ambulance must select a data collection period that 
corresponds with its annual accounting period and provide the start 
date of that data collection period to the ground ambulance 
organization's Medicare Administrative Contractor.
    (2) Collect during its selected data collection period the data 
necessary to complete the Medicare Ground Ambulance Data Collection 
Instrument.
    (3) Submit to CMS a completed Medicare Ground Ambulance Data 
Collection Instrument during the data reporting period that corresponds 
to the ground ambulance organization's selected data collection period.
    (c) Representative sample. (1) Random sample. For purposes of the 
data collection described in paragraph (b) of this section, and for a 
year, CMS will select a random sample of 25 percent of eligible ground 
ambulance organizations that is stratified based on:
    (i) Provider versus supplier status and ownership (for-profit, non-
profit, and government);

[[Page 63194]]

    (ii) Service area population density (transports originating in 
primarily urban, rural, and super rural zip codes); and
    (iii) Medicare-billed transport volume categories.
    (2) Selection eligibility. A ground ambulance organization is 
eligible to be selected for data reporting under this section for a 
year if it is enrolled in Medicare and has submitted to CMS at least 
one Medicare ambulance transport claim during the year prior to the 
selection under paragraph (b)(1) of this section.
    (3) Notification of selection for a year. CMS will notify an 
eligible ground ambulance organization that it has been selected to 
report data under this section for a year at least 30 days prior to the 
beginning of the calendar year in which the ground ambulance 
organization must begin to collect data by posting a list of selected 
organizations on the CMS web page and providing written notification to 
each selected ground ambulance organization via email or U.S. mail.
    (4) Limitation. CMS will not select the same ground ambulance 
organization under this paragraph (c) in 2 consecutive years, to the 
extent practicable.
    (d) Hardship exemption. A ground ambulance organization selected 
under paragraph (c) of this section may request and CMS may grant an 
exception to the reporting requirements under paragraph (b) of this 
section in the event of a significant hardship, such as a natural 
disaster, bankruptcy, or similar situation that the Secretary 
determines interfered with the ability of the ground ambulance 
organization to submit such information in a timely manner for the data 
collection period selected by the ground ambulance organization.
    (1) To request a hardship exemption, the ground ambulance 
organization must submit a request form (accessed on the Ambulances 
Services Center website (https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html) to CMS within 90 calendar days of the 
date that CMS notified the ground ambulance organization that it would 
receive a 10 percent payment reduction as a result of not submitting 
sufficient information under the data collection system. The request 
form must include all of the following:
    (i) Ground ambulance organization name.
    (ii) NPI number.
    (iii) Ground ambulance organization address.
    (iv) Chief executive officer and any other designated personnel 
contact information, including name, email address, telephone number 
and mailing address (must include a physical address, a post office box 
address is not acceptable).
    (v) Reason for requesting a hardship exemption.
    (vi) Evidence of the impact of the hardship (such as photographs, 
newspaper or other media articles, financial data, bankruptcy filing, 
etc.).
    (vii) Date when the ground ambulance organization would be able to 
begin collecting data under paragraph (b) of this section.
    (viii) Date and signature of the chief executive officer or other 
designated personnel of the ground ambulance organization.
    (2) CMS will provide a written response to the hardship exemption 
request within 30 days of its receipt of the hardship exemption form.
    (e) Notification of non-compliance and informal review. (1) 
Notification of non-compliance. A ground ambulance organization 
selected under paragraph (c) of this section for a year that does not 
sufficiently report data under paragraph (b) of this section, will 
receive written notification from CMS that it will receive a payment 
reduction under Sec.  414.610(c)(9).
    (2) Informal review. A ground ambulance organization that receives 
a written notification under paragraph (e)(1) of a payment reduction 
under Sec.  414.610(c)(9) may submit a request for an informal review 
within 90 days of the date it received the notification by submitting 
all of the following information:
    (i) Ground ambulance organization name.
    (ii) NPI number.
    (iii) Chief executive officer and any other designated personnel 
contact information, including name, email address, telephone number 
and mailing address with the street location of the ground ambulance 
organization.
    (iv) Ground ambulance organization's selected data collection 
period and data reporting period.
    (v) A statement of the reasons why the ground ambulance 
organization does not agree with CMS' determination and any supporting 
documentation.
    (f) Public availability of data. Beginning in 2022, and at least 
once every 2 years thereafter, CMS will post on its website data that 
it collected under this section, including but not limited to summary 
statistics and ground ambulance organization characteristics.
    (g) Limitations on review. There is no administrative or judicial 
review under section 1869 or section 1878 of the Act, or otherwise of 
the data required for submission under paragraph (b) of this section or 
the selection of ground ambulance organizations under paragraph (c) of 
this section.

0
35. Section 414.1305 is amended by--
0
a. Adding the definition of ``Aligned Other Payer Medical Home Model'' 
in alphabetical order;
0
b. Revising the definition of ``Hospital-based MIPS eligible 
clinician'';
0
c. Adding the definition of ``MIPS Value Pathway'' in alphabetical 
order; and
0
d. Revising the definition of ``Rural area''.
    The additions and revision read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Aligned Other Payer Medical Home Model means an aligned other payer 
payment arrangement (not including a Medicaid payment arrangement) 
operated by a payer formally partnering in a CMS Multi-Payer Model that 
is a Medical Home Model through a written expression of alignment and 
cooperation, such as a memorandum of understanding (MOU) with CMS, and 
is determined by CMS to have the following characteristics:
    (1) The other payer payment arrangement has a primary care focus 
with participants that primarily include primary care practices or 
multispecialty practices that include primary care physicians and 
practitioners and offer primary care services. For the purposes of this 
provision, primary care focus means the inclusion of specific design 
elements related to eligible clinicians practicing under one or more of 
the following Physician Specialty Codes: 01 General Practice; 08 Family 
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 
Clinical Nurse Specialist; and 97 Physician Assistant;
    (2) Empanelment of each patient to a primary clinician; and
    (3) At least four of the following:
    (i) Planned coordination of chronic and preventive care.
    (ii) Patient access and continuity of care.
    (iii) Risk-stratified care management.
    (iv) Coordination of care across the medical neighborhood.
    (v) Patient and caregiver engagement.
    (vi) Shared decision-making.
    (vii) Payment arrangements in addition to, or substituting for, 
fee-for-service payments (for example, shared savings or population-
based payments).
* * * * *

[[Page 63195]]

    Hospital-based MIPS eligible clinician means:
    (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the Place of 
Service (POS) codes used in the HIPAA standard transaction as an 
inpatient hospital, on-campus outpatient hospital, off campus-
outpatient hospital, or emergency room setting based on claims for a 
period prior to the performance period as specified by CMS; and
    (2) For the 2021 MIPS payment year, a MIPS eligible clinician who 
furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the POS codes used in the 
HIPAA standard transaction as an inpatient hospital, on-campus 
outpatient hospital, off campus outpatient hospital, or emergency room 
setting based on claims for the MIPS determination period; and
    (3) Beginning with the 2022 MIPS payment year, an individual MIPS 
eligible clinician who furnishes 75 percent or more of his or her 
covered professional services in sites of service identified by the POS 
codes used in the HIPAA standard transaction as an inpatient hospital, 
on-campus outpatient hospital, off campus outpatient hospital, or 
emergency room setting based on claims for the MIPS determination 
period, and a group or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or virtual group's TINs, as 
applicable, meet the definition of a hospital-based individual MIPS 
eligible clinician during the MIPS determination period.
* * * * *
    MIPS Value Pathway means a subset of measures and activities 
established through rulemaking.
* * * * *
    Rural area means a ZIP code designated as rural by the Federal 
Office of Rural Health Policy (FORHP), using the most recent FORHP 
Eligible ZIP Code file available.
* * * * *

0
36. Section 414.1310 is amended by--
0
a. Revising paragraph (e)(2)(ii); and
0
b. Removing paragraphs (e)(3) through (5).
    The revision reads as follows:


Sec.  414.1310   Applicability.

* * * * *
    (e) * * *
    (2) * * *
    (ii) Individual eligible clinicians that elect to participate in 
MIPS as a group must aggregate their performance data across the 
group's TIN, and for the Promoting Interoperability performance 
category, must aggregate the performance data of all of the MIPS 
eligible clinicians in the group's TIN for whom the group has data in 
CEHRT.
* * * * *

0
37. Section 414.1315 is amended by revising paragraph (d)(2) to read as 
follows:


Sec.  414.1315   Virtual groups.

* * * * *
    (d) * * *
    (2) Solo practitioners and groups of 10 or fewer eligible 
clinicians that elect to participate in MIPS as a virtual group must 
aggregate their performance data across the virtual group's TINs, and 
for the Promoting Interoperability performance category, must aggregate 
the performance data of all of the MIPS eligible clinicians in the 
virtual group's TINs for whom the virtual group has data in CEHRT.
* * * * *

0
38. Section 414.1320 is amended by adding paragraph (f) to read as 
follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (f) For purposes of the 2023 MIPS payment year, the performance 
period for:
    (1) The Promoting Interoperability performance category is a 
minimum of a continuous 90-day period within the calendar year that 
occurs 2 years prior to the applicable MIPS payment year, up to and 
including the full calendar year.
    (2) [Reserved]

0
39. Section 414.1330 is amended by revising paragraphs (b)(3) to read 
as follows:


Sec.  414.1330  Quality performance category.

* * * * *
    (b) * * *
    (3) 45 percent of a MIPS eligible clinician's final score for MIPS 
payment years 2021 and 2022.

0
40. Section 414.1335 is amended by revising paragraph (a)(3)(i) to read 
as follows:


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

    (a) * * *
    (3) * * *
    (i) For the 12-month performance period, a group that participates 
in the CAHPS for MIPS survey must use a survey vendor that is approved 
by CMS for the applicable performance period to transmit survey 
measures data to CMS.
* * * * *

0
41. Section 414.1340 is amended by revising paragraphs (a)(1) and (2) 
and adding paragraphs (a)(3), (b)(3), and (d) to read as follows:


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

    (a) * * *
    (1) At least 50 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for MIPS payment year 2019.
    (2) At least 60 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for MIPS payment years 2020 and 2021.
    (3) At least a 70 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for the 2022 MIPS payment year.
    (b) * * *
    (3) At least a 70 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for the 2022 MIPS payment year.
* * * * *
    (d) If quality data are submitted selectively such that the 
submitted data are unrepresentative of a MIPS eligible clinician or 
group's performance, any such data would not be true, accurate, or 
complete for purposes of Sec.  414.1390(b) or Sec.  414.1400(a)(5).

0
42. Section 414.1350 is amended by revising paragraphs (b), (c)(2) and 
(d)(3) to read as follows:


Sec.  414.1350  Cost performance category.

* * * * *
    (b) Attribution. (1) Cost measures are attributed at the TIN/NPI 
level for the 2017 thorough 2019 performance periods.
    (2) For the total per capita cost measure specified for the 2017 
through 2019 performance periods, beneficiaries are attributed using a 
method generally consistent with the method of assignment of 
beneficiaries under Sec.  425.402 of this chapter.
    (3) For the Medicare Spending per Beneficiary clinician (MSPB 
clinician) measure specified for the 2017 through 2019 performance 
periods, an episode is attributed to the MIPS eligible clinician who 
submitted the plurality of claims (as measured by allowed charges) for 
Medicare Part B services rendered during an inpatient hospitalization 
that is an index admission for the MSPB clinician measure during the 
applicable performance period.
    (4) For the acute condition episode-based measures specified for 
the 2017 performance period, an episode is attributed to each MIPS 
eligible clinician who bills at least 30 percent of

[[Page 63196]]

inpatient evaluation and management (E/M) visits during the trigger 
event for the episode.
    (5) For the procedural episode-based measures specified for the 
2017 performance period, an episode is attributed to each MIPS eligible 
clinician who bills a Medicare Part B claim with a trigger code during 
the trigger event for the episode.
    (6) For the acute inpatient medical condition episode-based 
measures specified for the 2019 performance period, an episode is 
attributed to each MIPS eligible clinician who bills inpatient E/M 
claim lines during a trigger inpatient hospitalization under a TIN that 
renders at least 30 percent of the inpatient E/M claim lines in that 
hospitalization.
    (7) For the procedural episode-based measures specified for the 
2019 performance period, an episode is attributed to each MIPS eligible 
clinician who renders a trigger service as identified by HCPCS/CPT 
procedure codes.
    (8) Beginning with the 2020 performance period, each cost measure 
is attributed according to the measure specifications for the 
applicable performance period.
* * * * *
    (c) * * *
    (2) For the Medicare spending per beneficiary clinician measure, 
the case minimum is 35.
* * * * *
    (d) * * *
    (3) 15 percent of a MIPS eligible clinician's final score for MIPS 
payment years 2021 and 2022.

0
43. Section 414.1360 is amended by adding paragraph (a)(2) to read as 
follows:


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

    (a) * * *
    (2) Groups and virtual groups. Beginning with the 2020 performance 
year, each improvement activity for which groups and virtual groups 
submit a yes response in accordance with paragraph (a)(1) of this 
section must be performed by at least 50 percent of the NPIs billing 
under the group's TIN or virtual group's TINs, as applicable, and the 
NPIs must perform the same activity during any continuous 90-day period 
within the same performance year.
* * * * *

0
44. Section 414.1370 is amended by adding paragraph (e)(2) and revising 
paragraph (g)(1) to read as follows:


Sec.  414.1370  APM scoring standard under MIPS.

* * * * *
    (e) * * *
    (2) For purposes of calculating the APM Entity group score under 
the APM scoring standard, MIPS scores submitted by virtual groups will 
not be included.
* * * * *
    (g) * * *
    (1) Quality. Beginning in the 2020 Performance year--
    (i) MIPS APMs that require APM Entities to submit quality data 
through a MIPS submission mechanism. The MIPS quality performance 
category score for a performance period will be calculated for the APM 
Entity using the data submitted for the APM Entity through a MIPS 
submission mechanism in accordance with Sec.  414.1335.
    (ii) MIPS APMs that do not require APM Entities to submit quality 
data through a MIPS submission mechanism. The APM Entity will be 
assigned an APM Quality Reporting Credit worth 50 percent of the total 
quality performance category score. The APM Quality Reporting Credit 
will be added to the MIPS quality performance category score to 
generate an APM Entity quality performance category score, which in no 
case shall exceed 100. The MIPS quality performance category score for 
a performance period will be calculated for the APM Entity using the 
data submitted for the APM Entity through a MIPS submission mechanism 
in accordance with Sec.  414.1335.
    (iii) Determination of score for each MIPS eligible clinician in an 
APM entity. Regardless of whether a MIPS APM requires APM Entities to 
submit quality data through a MIPS submission mechanism, if data are 
not submitted for an APM Entity through a MIPS submission mechanism in 
accordance with Sec.  414.1335, the score for each MIPS eligible 
clinician in such APM Entity is the higher of either:
    (A) A TIN level score based on the measure data for the quality 
performance category reported by a TIN for the MIPS eligible clinician 
in accordance with Sec.  414.1335; or
    (B) An individual level score based on the measure data for the 
quality performance category reported by the MIPS eligible clinician in 
accordance with Sec.  414.1335.
    (iv) Quality improvement score. For an APM Entity for which CMS 
calculated a total quality performance category score for one or more 
participants in the APM Entity for the preceding MIPS performance 
period, CMS calculates a quality improvement score for the APM Entity 
group as specified in Sec.  414.1380(b)(1)(xvi).
* * * * *

0
45. Section 414.1380 is amended--
0
a. In paragraph (b)(1)(i) introductory text by removing the years 
``2019, 2020, and 2021'' and adding in its place the years ``2019 
through 2022'';
0
b. In paragraph (b)(1)(i)(A)(1) by removing the years ``2019, 2020, and 
2021'' and adding in its place the years ``2019 through 2022'';
0
c. By revising paragraph (b)(1)(ii) introductory text;
0
d. By adding paragraph (b)(1)(ii)(C);
0
e. By revising paragraph (b)(1)(v)(A)(1)(i);
0
f. In paragraph (b)(1)(v)(A)(1)(ii) by removing the years ``2019, 2020, 
and 2021'' and adding in its place the years ``2019 through 2022'';
0
g. In paragraph (b)(1)(v)(B)(1)(i) by removing the years ``2019, 2020, 
and 2021'' and adding in its place the years ``2019 through 2022'';
0
h. In paragraph (b)(1)(vi)(C)(4) by removing the phrase ``2020 and 2021 
MIPS payment year'' and adding in its place the phrase ``2020 through 
2022 MIPS payment years'';
0
i. By revising paragraph (b)(3)(ii)(A) and (C);
0
j. In paragraph (c)(2)(i)(A)(4) by removing the phrase ``beginning with 
the 2021 MIPS payment year'' and adding in its place the phrase ``for 
the 2021 and 2022 MIPS payment years'';
0
k. In paragraph (c)(2)(i)(A)(5) by removing the years ``2019, 2020, and 
2021'' and adding in its place the years ``2019, 2020, 2021, and 
2022'';
0
l. By adding paragraph (c)(2)(i)(A)(9);
0
m. By revising paragraph (c)(2)(i)(C) introductory text;
0
n. By adding paragraphs (c)(2)(i)(C)(10) and (c)(2)(ii)(D);
0
o. By revising paragraph (c)(2)(iii) and (c)(3) introductory text; and
0
p. In paragraph (e)(2)(i)(C) by removing the phrase ``Can be 
attributed'' and adding in its place the phrase ``Can be assigned''.
    The revisions and additions read as follows:


Sec.  414.1380  Scoring.

* * * * *
    (b) * * *
    (1) * * *
    (ii) Benchmarks. Except as provided in paragraphs (b)(1)(ii)(B) and 
(C) of this section, benchmarks will be based on performance by 
collection type, from all available sources, including MIPS eligible 
clinicians and APMs, to the extent feasible, during the applicable 
baseline or performance period.
* * * * *

[[Page 63197]]

    (C) Beginning with the 2022 MIPS payment year, for each measure 
that has a benchmark that CMS determines may have the potential to 
result in inappropriate treatment, CMS will set benchmarks using a flat 
percentage for all collection types where the top decile is higher than 
90 percent under the methodology at paragraph (b)(1)(ii) of this 
section.
* * * * *
    (v) * * *
    (A) * * *
    (1) * * *
    (i) Each high priority measure must meet the case minimum 
requirement at paragraph (b)(1)(iii) of this section, meet the data 
completeness requirement at Sec.  414.1340, and have a performance rate 
that is greater than zero.
* * * * *
    (3) * * *
    (ii) * * *
    (A) The practice has received accreditation from an accreditation 
organization that is nationally recognized.
* * * * *
    (C) The practice is a comparable specialty practice that has 
received recognition through a specialty recognition program offered 
through a nationally recognized accreditation organization; or
* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (A) * * *
    (9) Beginning with the 2020 MIPS payment year, for the quality, 
cost, and improvement activities performance categories, CMS 
determines, based on information known to the agency prior to the 
beginning of the relevant MIPS payment year, that data for a MIPS 
eligible clinician are inaccurate, unusable or otherwise compromised 
due to circumstances outside of the control of the clinician and its 
agents.
* * * * *
    (C) Under section 1848(o)(2)(D) of the Act, a significant hardship 
exception or other type of exception is granted to a MIPS eligible 
clinician based on the following circumstances for the Promoting 
Interoperability performance category. Except as provided in paragraph 
(c)(2)(i)(C)(10) of this section, 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.
* * * * *
    (10) Beginning with the 2020 MIPS payment year, CMS determines, 
based on information known to the agency prior to the beginning of the 
relevant MIPS payment year, that data for a MIPS eligible clinician are 
inaccurate, unusable or otherwise compromised due to circumstances 
outside of the control of the clinician and its agents.
* * * * *
    (ii) * * *
    (D) For the 2022 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
                                                                                                   Promoting
            Reweighting scenario                Quality (%)      Cost (%)       Improvement    interoperability
                                                                              activities (%)          (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    Scores for all four performance                       45              15              15                  25
     categories.............................
Reweight One Performance Category:
    No Cost.................................              55               0              15                  30
    No Promoting Interoperability...........              70              15              15                   0
    No Quality..............................               0              15              15                  70
    No Improvement Activities...............              60              15               0                  25
Reweight Two Performance Categories:
    No Cost and no Promoting                              85               0              15                   0
     Interoperability.......................
    No Cost and no Quality..................               0               0              15                  85
    No Cost and no Improvement Activities...              70               0               0                  30
    No Promoting Interoperability and no                   0              50              50                   0
     Quality................................
    No Promoting Interoperability and no                  85              15               0                   0
     Improvement Activities.................
    No Quality and no Improvement Activities               0              15               0                  85
----------------------------------------------------------------------------------------------------------------

    (iii) For the Promoting Interoperability performance category to be 
reweighted in accordance with paragraph (c)(2)(ii) of this section for 
a MIPS eligible clinician who elects to participate in MIPS as part of 
a group or virtual group, all of the MIPS eligible clinicians in the 
group or virtual group must qualify for reweighting based on the 
circumstances described in paragraph (c)(2)(i) of this section, or the 
group or virtual group must meet the definition of a hospital-based 
MIPS eligible clinician or a non-patient facing MIPS eligible clinician 
as defined in Sec.  414.1305.
    (3) Complex patient bonus. For the 2020, 2021 and 2022 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:
* * * * *


0
46. Section 414.1385 is amended by revising paragraph (a) to read as 
follows:


Sec.  414.1385  Targeted review and review limitations.

    (a) Targeted review. A MIPS eligible clinician or group may request 
a targeted review of the calculation of the MIPS payment adjustment 
factor under section 1848(q)(6)(A) of the Act and, as applicable, the 
calculation of the additional MIPS payment adjustment factor under 
section 1848(q)(6)(C) of the Act (collectively referred to as the MIPS 
payment adjustment factors) applicable to such MIPS eligible clinician 
or group for a year. The process for targeted review is as follows:
    (1) A MIPS eligible clinician or group (including their designated 
support staff), or a third party intermediary as defined at Sec.  
414.1305, may submit a request for a targeted review.
    (2) 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. The targeted review request 
submission period may be extended as specified by CMS.
    (3) A request for a targeted review may be denied if the request is 
duplicative of another request for a targeted review; the request is 
not

[[Page 63198]]

submitted during the targeted review request submission period; or the 
request is outside of the scope of the targeted review, which is 
limited to the calculation of the MIPS payment adjustment factors 
applicable to the MIPS eligible clinician or group for a year. If the 
targeted review request is denied, there will be no change to the MIPS 
final score or associated MIPS payment adjustment factors for the MIPS 
eligible clinician or group. If the targeted review request is 
approved, the MIPS final score and associated MIPS payment adjustment 
factors may be revised, if applicable, for the MIPS eligible clinician 
or group.
    (4) CMS will respond to each request for a targeted review timely 
submitted and determine whether a targeted review is warranted.
    (5) A request for a targeted review may include additional 
information in support of the request at the time it is submitted. If 
CMS requests additional information from the MIPS eligible clinician or 
group that is the subject of a request for a targeted review, it must 
be provided and received by CMS within 30 days of CMS' 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.
    (6) If a request for a targeted review is approved, CMS may 
recalculate, to the extent feasible and applicable, the scores of a 
MIPS eligible clinician or group with regard to measures, activities, 
performance categories, and the final score, as well as the MIPS 
payment adjustment factors.
    (7) Decisions based on the targeted review are final, and there is 
no further review or appeal. CMS will notify the individual or entity 
that submitted the request for a targeted review of the final decision.
    (8) Documentation submitted for a targeted review must be retained 
by the submitter for 6 years from the end of the MIPS performance 
period.
* * * * *

0
47. Section 414.1395 is amended by revising paragraph (a) to read as 
follows:


Sec.  414.1395  Public reporting.

    (a) General. (1) CMS posts on Physician Compare, in an easily 
understandable format, the following:
    (i) Information regarding the performance of MIPS eligible 
clinicians, including, but not limited to, final scores and performance 
category scores for each MIPS eligible clinician; and
    (ii) The names of eligible clinicians in Advanced APMs and, to the 
extent feasible, the names and performance of such Advanced APMs.
    (2) CMS periodically posts on Physician Compare aggregate 
information on the MIPS, including the range of final scores for all 
MIPS eligible clinicians and the range of the performance of all MIPS 
eligible clinicians with respect to each performance category.
    (3) The information made available under this section will 
indicate, where appropriate, that publicized information may not be 
representative of an eligible clinician's entire patient population, 
the variety of services furnished by the eligible clinician, or the 
health conditions of individuals treated.
* * * * *

0
48. Section 414.1400 is amended by--
0
a. Revising paragraphs (a)(2) introductory text and (a)(2)(iii);
0
b. Adding paragraphs (a)(4)(v) and (vi);
0
c. Revising paragraph (b)(1);
0
d. Adding paragraphs (b)(2)(iii), (b)(3)(iv) through (vii), ;
0
e. Revising paragraph (c)(1);
0
f. Adding paragraphs (c)(2)(i) and (ii); and
0
g. Revising paragraphs (f)(1) introductory text and (f)(3) introductory 
text.
    The revision and addition reads as follows:


Sec.  414.1400   Third party intermediaries.

    (a) * * *
    (2) Beginning with the 2023 MIPS payment year, QCDRs and qualified 
registries must be able to submit data for all of the following MIPS 
performance categories, and Health IT vendors must be able to submit 
data for at least one of the following MIPS performance categories:
* * * * *
    (iii) 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)).
* * * * *
    (4) * * *
    (v) The third party intermediary must provide services throughout 
the entire performance period and applicable data submission period.
    (vi) 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.
* * * * *
    (b) * * *
    (1) QCDR self-nomination. For the 2020 and 2021 MIPS payment years, 
entities seeking to qualify as a QCDR must self-nominate September 1 
until November 1 of the CY preceding the applicable performance period. 
For the 2022 MIPS payment year and future years, entities seeking to 
qualify as a QCDR must self-nominate during a 60-day period during the 
CY preceding the applicable performance period (beginning no earlier 
than July 1 and ending no later than September 1). Entities seeking to 
qualify as a QCDR for a performance period must provide all information 
required by CMS at the time of self-nomination and must provide any 
additional information requested by CMS during the review process. For 
the 2021 MIPS payment year and future years, existing QCDRs that are in 
good standing may attest that certain aspects of their previous year's 
approved self-nomination have not changed and will be used for the 
applicable performance period. Beginning with the 2023 payment year, 
QCDRs are required to attest during the self-nomination process that 
they can provide performance feedback at least 4 times a year (as 
specified at paragraph (b)(2)(iv) of this section), and if not, provide 
sufficient rationale as to why they do not believe they would be able 
to meet this requirement. Each QCDR would still be required to submit 
notification to CMS within the reporting period promptly within the 
month of realization of the impending deficiency in order to be 
considered for this exception, as discussed at paragraph (b)(2)(iv) of 
this section.
    (2) * * *
    (iii) Beginning with the 2023 MIPS payment year, require QCDRs to 
provide performance feedback to their clinicians and groups at least 4 
times a year, and provide specific feedback to their clinicians and 
groups on how they compare to other clinicians who have submitted data 
on a given measure within the QCDR. Exceptions to this requirement may 
occur if the QCDR does not receive the data from their clinician until 
the end of the performance period.
    (3) * * *
    (iv) QCDR measure considerations for approval include:

[[Page 63199]]

    (A) Preference for measures that are outcome-based rather than 
clinical process measures.
    (B) Measures that address patient safety and adverse events.
    (C) Measures that identify appropriate use of diagnosis and 
therapeutics.
    (D) Measures that address the domain of care coordination.
    (E) Measures that address the domain for patient and caregiver 
experience.
    (F) Measures that address efficiency, cost, and resource use.
    (G) Beginning with the 2021 performance period--
    (1) That QCDRs link their QCDR measures as feasible to at least one 
of the following at the time of self-nomination:
    (i) Cost measure;
    (ii) Improvement activity; or
    (iii) An MVP.
    (2) In cases where a QCDR measure does not have a clear link to a 
cost measure, improvement activity, or an MVP, we would consider 
exceptions if the potential QCDR measure otherwise meets the QCDR 
measure requirements and considerations.
    (H) Beginning with the 2020 performance period CMS may consider the 
extent to which a QCDR measure is available to MIPS eligible clinicians 
reporting through QCDRs other than the QCDR measure owner for purposes 
of MIPS. If CMS determines that a QCDR measure is not available to MIPS 
eligible clinicians, groups, and virtual groups reporting through other 
QCDRs, CMS may not approve the measure.
    (I) We give greater consideration to measures for which QCDRs:
    (1) Conducted an environmental scan of existing QCDR measures; MIPS 
quality measures; quality measures retired from the legacy Physician 
Quality Reporting System (PQRS) program; and
    (2) Utilized the CMS Quality Measure Development Plan Annual Report 
and the Blueprint for the CMS Measures Management System to identify 
measurement gaps prior to measure development.
    (J) Beginning with the 2020 performance period, we place greater 
preference on QCDR measures that meet case minimum and reporting 
volumes required for benchmarking after being in the program for 2 
consecutive CY performance periods. Those that do not, may not continue 
to be approved.
    (1) Beginning with the 2020 performance period, in instances where 
a QCDR believes the low-reported QCDR measure that did not meet 
benchmarking thresholds is still important and relevant to a 
specialist's practice, that the QCDR may develop and submit a QCDR 
measure participation plan for our consideration. This QCDR measure 
participation plan must include the QCDR's detailed plans and changes 
to encourage eligible clinicians and groups to submit data on the low-
reported QCDR measure for purposes of the MIPS program.
    (2) [Reserved]
    (v) QCDR measure requirements for approval include:
    (A) QCDR Measures that are beyond the measure concept phase of 
development.
    (B) QCDR Measures that address significant variation in 
performance.
    (C) Beginning with the 2021 performance period, all QCDR measures 
must be fully developed and tested, with complete testing results at 
the clinician level, prior to submitting the QCDR measure at the time 
of self-nomination.
    (D) 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.
    (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 in order to be considered for the program in 
subsequent years. If the QCDR measures are not harmonized, CMS may 
reject the duplicative QCDR measure.
    (vi) Beginning with the 2021 performance period, 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 QCDR measure second year approval, if the 
QCDR measure is found to be: Topped out; duplicative of a more robust 
measure; reflects an outdated clinical guideline; requires QCDR measure 
harmonization; or if the QCDR self-nominating the QCDR measure is no 
longer in good standing.
    (vii) Beginning with the 2020 performance period, QCDR measure 
rejection criteria considerations include, but are not limited to, the 
following factors:
    (A) QCDR measures that are duplicative, or identical to other QCDR 
measures or MIPS quality measures that are currently in the program.
    (B) QCDR measures that are duplicative or identical to MIPS quality 
measures that have been removed from MIPS through rulemaking.
    (C) QCDR measures that are duplicative or identical to quality 
measures used under the legacy Physician Quality Reporting System 
(PQRS) program, which have been retired.
    (D) QCDR measures that meet the topped out definition as described 
at Sec.  414.1305.
    (E) QCDR measures that are process-based, with consideration to 
whether the removal of the process measure impacts the number of 
measures available for a specific specialty.
    (F) Whether the QCDR measure has potential unintended consequences 
to a patient's care.
    (G) Considerations and evaluation of the measure's performance 
data, to determine whether performance variance exists.
    (H) Whether the previously identified areas of duplication have 
been addressed as requested.
    (I) QCDR measures that split a single clinical practice or action 
into several QCDR measures.
    (J) QCDR measures that are ``check-box'' with no actionable quality 
action.
    (K) QCDR measures that do not meet the case minimum and reporting 
volumes required for benchmarking after being in the program for 2 
consecutive years.
    (L) 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.
    (M) QCDR measures with clinician attribution issues, where the 
quality action is not under the direct control of the reporting 
clinician.
    (N) QCDR measures that focus on rare events or ``never events'' in 
the measurement period.
    (c) * * *
    (1) Qualified registry self-nomination. For the 2020 and 2021 MIPS 
payment years, entities seeking to qualify as a qualified registry must 
self-nominate from September 1 until November 1 of the CY preceding the 
applicable performance period. For the 2022 MIPS payment year and 
future years, entities seeking to qualify as a qualified registry must 
self-nominate during a 60-day period during the CY preceding the 
applicable performance period (beginning no earlier than July 1 and 
ending no later than September 1). Entities seeking to qualify as a 
qualified registry for a performance period must provide all 
information required by CMS at the time of self-nomination and must 
provide any additional

[[Page 63200]]

information requested by CMS during the review process. For the 2021 
MIPS payment year and future years, existing qualified registries that 
are in good standing may attest that certain aspects of their previous 
year's approved self-nomination have not changed and will be used for 
the applicable performance period. Beginning with the 2023 payment 
year, qualified registries are required to attest during the self-
nomination process that they can provide performance feedback at least 
4 times a year (as specified at Sec.  414.1400(c)(2)(ii)), and if not, 
provide sufficient rationale as to why they do not believe they would 
be able to meet this requirement. Each qualified registry would still 
be required to submit notification to CMS within the reporting period 
promptly within the month of realization of the impending deficiency in 
order to be considered for this exception, as discussed at Sec.  
414.1400(c)(2)(ii).
    (2) * * *
    (i) Beginning with the 2022 MIPS Payment Year, the qualified 
registry must have at least 25 participants by January 1 of the year 
prior to the applicable performance period.
    (ii) Beginning with the 2023 MIPS payment year, require qualified 
registries to provide performance feedback to their clinicians and 
groups at least 4 times a year, and provide specific feedback to their 
clinicians and groups on how they compare to other clinicians who have 
submitted data on a given measure within the qualified registries. 
Exceptions to this requirement may occur if the qualified registries 
does not receive the data from their clinician until the end of the 
performance period.
* * * * *
    (f) * * *
    (1) If CMS determines that a third party intermediary has ceased to 
meet one or more of the applicable criteria for approval, has submitted 
a false certification under paragraph (a)(5) of this section, or has 
submitted data that are inaccurate, unusable, or otherwise compromised, 
CMS may take one or more of the following remedial actions after 
providing written notice to the third party intermediary:
* * * * *
    (3) For purposes of paragraph (f) of this section, CMS may 
determine that submitted data are inaccurate, unusable, or otherwise 
compromised, including but not limited to, if the submitted data:
* * * * *

0
49. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(7) and (8);
0
b. Adding paragraph, (d)(6); and
0
c. Revising paragraph (f) introductory text.
    The additions and revision read as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (7) The performance threshold for the 2022 MIPS payment year is 45 
points.
    (8) The performance threshold for the 2023 MIPS payment year is 60 
points.
* * * * *
    (d) * * *
    (6) The additional performance threshold for the 2022 and 2023 MIPS 
payment years is 85 points.
* * * * *
    (f) Exception to application of MIPS payment adjustment factors to 
model-specific payments under section 1115A APMs. Beginning with the 
2019 MIPS payment year, the payment adjustment factors specified under 
paragraph (e) of this section are not applicable to payments that meet 
all of the following conditions:
* * * * *

0
50. Section 414.1415 is amended by revising paragraph (c)(5) and (6) to 
read as follows:


Sec.  414.1415  Advanced APM criteria.

* * * * *
    (c) * * *
    (5) For the purposes of this section, expected expenditures means 
the beneficiary expenditures for which an APM Entity is responsible 
under an APM. For episode payment models, expected expenditures means 
the episode target price. For purposes of assessing financial risk for 
Advanced APM determinations, the expected expenditures under the terms 
of the APM should not exceed the Medicare Part A and Part B 
expenditures for a participant in the absence of the APM. If the 
expected expenditures under the APM exceed the Medicare Part A and Part 
B expenditures that an APM Entity would be expected to incur in the 
absence of the APM, such excess expenditures are not considered when 
CMS assesses financial risk under the APM for purposes of Advanced APM 
determinations.
    (6) Capitation. A full capitation arrangement meets this Advanced 
APM criterion. For purposes of this part, a full capitation arrangement 
means a payment arrangement in which a per capita or otherwise 
predetermined payment is made under the APM for all items and services 
furnished to a population of beneficiaries during a fixed period of 
time, and no settlement is performed to reconcile or share losses 
incurred or savings earned by the APM Entity. Arrangements between CMS 
and Medicare Advantage Organizations under the Medicare Advantage 
program (part 422 of this title) are not considered capitation 
arrangements for purposes of this paragraph (c)(6).
* * * * *

0
51. Section 414.1420 is amended by revising paragraph (d)(2) 
introductory text, (d)(2)(ii), (d)(3)(ii)), (d)(4) introductory text 
and (d)(5) through (8) to read as follows:


Sec.  414.1420   Other payer advanced APM criteria.

* * * * *
    (d) * * *
    (2) Medicaid Medical Home Model and Aligned Other Payer Medical 
Home Model financial risk standard. The APM Entity participates in a 
Medicaid Medical Home Model or an Aligned Other Payer Medical Home 
Model that, based on the APM Entity's failure to meet or exceed one or 
more specified performance standards, does one or more of the 
following:
* * * * *
    (ii) Require direct payment by the APM Entity to the payer;
* * * * *
    (3) * * *
    (ii) Except for risk arrangements described under paragraph (d)(2) 
of this section, the risk arrangement must have a marginal risk rate of 
at least 30 percent.
    (4) Medicaid Medical Home Model and Aligned Other Payer Medical 
Home Model nominal amount standard. For a Medicaid Medical Home Model 
or an Aligned Other Payer Medical Home Model to meet the Medicaid 
Medical Home Model nominal amount standard, the total annual amount 
that an APM Entity potentially owes a payer or forgoes must be at least 
the following amounts:
* * * * *
    (5) Marginal risk rate. For purposes of this section, the marginal 
risk rate is defined as the percentage of actual expenditures that 
exceed expected expenditures for which an APM Entity is responsible 
under an other payer payment arrangement.
    (i) In the event that the marginal risk rate varies depending on 
the amount by which actual expenditures exceed expected expenditures, 
the average marginal risk rate across all possible levels of actual 
expenditures would be used for comparison to the marginal risk rate 
specified in paragraph (d)(3)(ii) of this section, with exceptions for 
large losses as described in paragraph (d)(5)(ii) of this section and 
small losses

[[Page 63201]]

as described in paragraph (d)(5)(iii) of this section.
    (ii) Allowance for large losses. The determination in paragraph 
(d)(3)(ii) of this section may disregard the marginal risk rates that 
apply in cases when actual expenditures exceed expected expenditures by 
an amount sufficient to require the APM Entity to make financial risk 
payments under the other payer payment arrangement greater than or 
equal to the total risk requirement under paragraph (d)(3)(i) of this 
section.
    (iii) Allowance for minimum loss rate. The determination in 
paragraph (d)(3)(ii) of this section may disregard the marginal risk 
rates that apply in cases when actual expenditures exceed expected 
expenditures by less than 4 percent of expected expenditures.
    (6) Expected expenditures. For the purposes of this section, 
expected expenditures is defined as the Other Payer APM benchmark. For 
episode payment models, expected expenditures means the episode target 
price. For purposes of assessing financial risk for Other Payer 
Advanced APM determinations, the expected expenditures under the 
payment arrangement should not exceed the expenditures for a 
participant in the absence of the payment arrangement. If expected 
expenditures under the payment arrangement exceed the expenditures that 
the participant would be expected to incur in the absence of the 
payment arrangement, such excess expenditures are not considered when 
assessing financial risk under the payment arrangement for Other Payer 
Advanced APM determinations.
    (7) Capitation. A full capitation arrangement meets this Other 
Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this 
section, a full capitation arrangement means a payment arrangement in 
which a per capita or otherwise predetermined payment is made under the 
payment arrangement for all items and services furnished to a 
population of beneficiaries during a fixed period of time, and no 
settlement is performed for the purposes of reconciling or sharing 
losses incurred or savings earned by the participant. Arrangements made 
directly between CMS and Medicare Advantage Organizations under the 
Medicare Advantage program (part 422 of this title) are not considered 
capitation arrangements for purposes of this paragraph.
    (8) Aligned Other Payer Medical Home Model and Medicaid Medical 
Home Model 50 eligible clinician limit. Notwithstanding paragraphs 
(d)(2) and (4) of this section, if an APM Entity participating in an 
Aligned Other Payer Medical Home Model or Medicaid Medical Home Model 
is owned and operated by an organization with 50 or more eligible 
clinicians whose Medicare billing rights have been reassigned to the 
TIN(s) of the organization(s) or any of the organization's subsidiary 
entities, the requirements of paragraphs (d)(1) and (3) of this section 
apply.
* * * * *

0
52. Section 414.1425 is amended by revising paragraphs (c)(5) and (6), 
and (d)(3) and (4) to read as follows:


Sec.  414.1425  Qualifying APM participant determination: In general.

* * * * *
    (c) * * *
    (5) Beginning in the 2020 QP Performance Period, an eligible 
clinician in an APM Entity is not a QP for a year if:
    (i) The APM Entity voluntarily or involuntarily terminates from an 
Advanced APM before the end of the QP Performance Period; or
    (ii) The APM Entity voluntarily or involuntarily terminates from an 
Advanced APM at a date on which the APM Entity would not bear financial 
risk for that QP performance period under the terms of the Advanced 
APM, even if such termination date occurs within such QP Performance 
Period.
    (6) Beginning in the 2020 QP Performance Period, an eligible 
clinician is not a QP for a year if:
    (i) One or more of the APM Entities in which the eligible clinician 
participates voluntarily or involuntarily terminates from the Advanced 
APM before the end of the QP Performance Period, and the eligible 
clinician does not achieve a Threshold Score that meets or exceeds the 
QP payment amount threshold or QP patient count threshold based on 
participation in the remaining non-terminating APM Entities; or
    (ii) One or more of the APM Entities in which the eligible 
clinician participates voluntarily or involuntarily terminates from the 
Advanced APM at a date on which the APM Entity would not bear financial 
risk under the terms of the Advanced APM, and the eligible clinician 
does not achieve a Threshold Score that meets or exceeds the QP payment 
amount threshold or QP patient count threshold based on participation 
in the remaining non-terminating APM Entities.
* * * * *
    (d) * * *
    (3) Beginning in the 2020 QP Performance Period, an eligible 
clinician is not a Partial QP for a year if:
    (i) The APM Entity voluntarily or involuntarily terminates from an 
Advanced APM before the end of the QP Performance Period; or
    (ii) The APM Entity voluntarily or involuntarily terminates from an 
Advanced APM at a date on which the APM Entity would not bear financial 
risk for that performance period under the terms of the Advanced APM.
    (4) Beginning in the 2020 QP Performance Period, an eligible 
clinician is not a Partial QP for a year if:
    (i) One or more of the APM Entities in which the eligible clinician 
participates voluntarily or involuntarily terminates from the Advanced 
APM before the end of the QP Performance Period, and the eligible 
clinician does not achieve a Threshold Score that meets or exceeds the 
Partial QP payment amount threshold or Partial QP patient count 
threshold based on participation in the remaining non-terminating APM 
Entities; or
    (ii) One or more of the APM Entities in which the eligible 
clinician participates voluntarily or involuntarily terminates from the 
Advanced APM at a date on which the APM Entity would not bear financial 
risk under the terms of the Advanced APM, and the eligible clinician 
does not achieve a Threshold Score that meets or exceeds the Partial QP 
payment amount threshold or Partial QP patient count threshold based on 
participation in the remaining non-terminating APM Entities.
* * * * *

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

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

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

0
54. Section 415.172 is amended by revising the section heading and 
paragraph (b) to read as follows:


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

* * * * *
    (b) Documentation. Except for services furnished as set forth in 
Sec. Sec.  415.174 (concerning an exception for services furnished in 
hospital outpatient and certain other ambulatory settings), 415.176 
(concerning renal dialysis services), and 415.184 (concerning 
psychiatric services), the medical records must document the teaching 
physician was present at the time the service is furnished. The 
presence of the teaching physician during procedures

[[Page 63202]]

and evaluation and management services may be demonstrated by the notes 
in the medical records made by the physician or as provided in Sec.  
410.20(e) of this chapter.
* * * * *

0
55. Section 415.174 is amended by--
0
a. Revising paragraph (a)(6); and
0
b. Removing and reserving paragraph (b).
    The revision reads as follows:


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

    (a) * * *
    (6) The medical records must document the extent of the teaching 
physician's participation in the review and direction of services 
furnished to each beneficiary. The extent of the teaching physician's 
participation may be demonstrated by the notes in the medical records 
made by the physician or as provided in Sec.  410.20(e) of this chapter 
to each beneficiary in accordance with the documentation requirements 
at Sec.  415.172(b).
    (b) [Reserved]

PART 416--AMBULATORY SURGICAL CENTERS

0
56. The authority citation for part 416 is revised to read as follows:

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

0
57. Section 416.42 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  416.42  Condition for coverage--Surgical services.

* * * * *
    (a) * * *
    (1) Immediately before surgery--
    (i) A physician must examine the patient to evaluate the risk of 
the procedure to be performed; and
    (ii) A physician or anesthetist as defined at Sec.  410.69(b) of 
this chapter must examine the patient to evaluate the risk of 
anesthesia.
* * * * *

PART 418--HOSPICE CARE

0
58. The authority citation for part 418 continues to read as follows:

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

0
59. Section 418.106 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  418.106  Condition of participation: Drugs and biologicals, 
medical supplies, and durable medical equipment.

* * * * *
    (b) * * *
    (1) Drugs may be ordered by any of the following practitioners:
    (i) A physician as defined by section 1861(r)(1) of the Act.
    (ii) A nurse practitioner in accordance with state scope of 
practice requirements.
    (iii) A physician assistant in accordance with state scope of 
practice requirements and hospice policy who is:
    (A) The patient's attending physician; and
    (B) Not an employee of or under arrangement with the hospice.
* * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

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

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

0
61. Section 424.67 is added to subpart E to read as follows:


Sec.  424.67   Enrollment requirements for opioid treatment programs 
(OTP).

    (a) General enrollment requirement. In order for a program or 
eligible professional (as that term is defined in section 1848(k)(3)(B) 
of the Act) to receive Medicare payment for the provision of opioid use 
disorder treatment services, the provider must qualify as an OTP (as 
that term is defined in Sec.  8.2 of this title) and enroll in the 
Medicare program under the provisions of this section and of subpart P 
of this part.
    (b) Specific requirements and standards for enrollment. To enroll 
in the Medicare program, an OTP must meet all of the following 
requirements and standards:
    (1) Fully complete and submit the Form CMS-855B application (or its 
successor application) and any applicable supplement or attachment 
thereto to its applicable Medicare contractor. This includes, but is 
not limited to, the following:
    (i) Maintain and submit to CMS (via the applicable supplement or 
attachment) a list of all physicians, other eligible professionals, and 
pharmacists (regardless of whether the individual is a W-2 employee of 
the OTP) who are legally authorized to prescribe, order, or dispense 
controlled substances on behalf of the OTP. The list must include the 
physician's, other eligible professional's, or pharmacist's:
    (A) First and last name, and middle initial.
    (B) Social Security Number.
    (C) National Provider Identifier.
    (D) License number (if applicable).
    (ii) Certifying via the Form CMS-855B 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 (d) of this section.
    (2) Comply with the application fee requirements in Sec.  424.514.
    (3) Successfully complete the assigned categorical risk level 
screening required under, as applicable, Sec.  424.518(b) and (c).
    (4)(i) Have a current, valid certification by SAMHSA for an opioid 
treatment program consistent with the provisions and requirements of 
Sec.  8.11 of this title.
    (ii) A provisional certification under Sec.  8.11(e) of this title 
does not meet the requirements of paragraph (b)(4)(i) of this section.
    (5) 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. Such individuals include, but are not limited to, the 
following:
    (i) Medical director (as described in Sec.  8.2 of this title).
    (ii) Program sponsor (as described in Sec.  8.2 of this title).
    (6)(i)(A) Must not employ or contract with a prescribing or 
ordering physician or eligible professional or with any individual 
legally authorized to dispense narcotics who, within the preceding 10 
years, has been convicted (as that term is defined in 42 CFR 1001.2) of 
a Federal or State felony that CMS deems detrimental to the best 
interests of the Medicare program and its beneficiaries based on the 
same categories of detrimental felonies, as well as case by case 
detrimental determinations, found at Sec.  424.535(a)(3).
    (B) Paragraph (b)(6)(i)(A) of this section applies regardless of 
whether the individual in question is:
    (1) Currently dispensing narcotics at or on behalf of the OTP; or
    (2) A W-2 employee of the OTP.
    (ii) Must not employ or contract with any personnel (regardless of 
whether the individual is a W-2 employee of the OTP) who is revoked 
from Medicare under Sec.  424.535 or any other applicable section in 
Title 42, or who is on the preclusion list under Sec.  422.222 or Sec.  
423.120(c)(6) of this chapter.
    (iii) Must not employ or contract with any personnel (regardless of 
whether the individual is a W-2 employee of the OTP) who has a prior 
adverse action by a State oversight board, including, but not limited 
to, a reprimand, fine, or restriction, for a case or situation 
involving patient harm that CMS deems detrimental to the best interests 
of the Medicare program and its beneficiaries. CMS will consider the 
factors enumerated at Sec.  424.535(a)(22) in each

[[Page 63203]]

case of patient harm that potentially applies to this paragraph.
    (7)(i) Sign (and adhere to the term of) a provider agreement in 
accordance with the provisions of part 489 of this chapter.
    (ii) An OTP's appeals under part 498 of a Medicare revocation 
(under Sec.  424.535) and a provider agreement termination (under Sec.  
489.53 of this chapter) must be filed jointly and, as applicable, 
considered jointly by CMS under part 498 of this chapter.
    (8) Comply with all other applicable requirements for enrollment 
specified in this section and in subpart P of this part.
    (c) Denial of enrollment. CMS may deny an OTP's enrollment 
application on any of the following grounds:
    (1)(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 in this section.
    (ii) Any of the denial reasons in Sec.  424.530 applies.
    (2) An OTP may appeal the denial of its enrollment application 
under part 498 of this chapter.
    (d) Continued compliance, standards, and reasons for revocation. 
(1) Upon and after enrollment, an OTP--
    (i) Must remain validly certified by SAMHSA as required under Sec.  
8.11 of this title.
    (ii) Remains subject to, and must remain in full compliance with, 
the provisions of this section and of subpart P of this part. This 
includes, but is not limited to, the provisions of paragraph (b)(6) of 
this section, the revalidation provisions in Sec.  424.515, and the 
deactivation and reactivation provisions in Sec.  424.540.
    (iii) Upon revalidation, successfully complete the moderate 
categorical risk level screening required under Sec.  424.518(b).
    (2) CMS may revoke an OTP's enrollment on any of the following 
grounds:
    (i) The provider does not have a current, valid certification by 
SAMHSA as required under paragraph (b)(4)(i) 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 (d)(1) of this 
section.
    (ii) Any of the revocation reasons in Sec.  424.535 applies.
    (3) An OTP may appeal the revocation of its enrollment under part 
498 of this title.
    (e) Claim payment. For an OTP to receive payment for furnished 
drugs:
    (1) The prescribing or medication ordering physician's or other 
eligible professional's National Provider Identifier must be listed on 
Field 17 of the Form CMS-1500; and
    (2) All other applicable requirements of this section, this part, 
and part 8 of this title must be met.
    (f) Relation to part 8 of this title. Nothing in this section shall 
be construed as:
    (1) Supplanting any of the provisions in part 8 of this title; or
    (2) Eliminating an OTP's obligation to maintain compliance with all 
applicable provisions in part 8 of this title.

0
62. Section 424.502 is amended by adding the definition of ``State 
oversight board'' in alphabetical order to read as follows:


Sec.  424.502   Definitions.

* * * * *
    State oversight board means, for purposes of Sec. Sec.  
424.530(a)(15) and 424.535(a)(22) only, any State administrative body 
or organization, such as (but not limited to) a medical board, 
licensing agency, or accreditation body, that directly or indirectly 
oversees or regulates the provision of health care within the State.
* * * * *

0
63. Section 424.518 is amended by adding paragraphs (b)(1)(xii) and 
(xiii) and (c)(1)(iv) to read as follows:


Sec.  424.518   Screening levels for Medicare providers and suppliers.

* * * * *
    (b) * * *
    (1) * * *
    (xii) Prospective (newly enrolling) opioid treatment programs that 
have been fully and continuously certified by the Substance Abuse and 
Mental Health Services Administration (SAMHSA) since October 23, 2018.
    (xiii) Revalidating opioid treatment programs.
* * * * *
    (c) * * *
    (1) * * *
    (iv) Prospective (newly enrolling) opioid treatment programs that 
have not been fully and continuously certified by SAMHSA since October 
23, 2018.
* * * * *

0
64. Section 424.520 is amended by revising paragraph (d) introductory 
text to read as follows:


Sec.  424.520  Effective date of Medicare billing privileges.

* * * * *
    (d) Physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, and opioid 
treatment programs. The effective date for billing privileges for 
physicians, non-physician practitioners, physician and non-physician 
practitioner organizations, ambulance suppliers, and opioid treatment 
programs is the later of--
* * * * *

0
65. Section 424.521 is amended by revising the section heading and 
paragraph (a) introductory text to read as follows:


Sec.  424.521  Request for payment by physicians, non-physician 
practitioners, physician and non-physician organizations, ambulance 
suppliers, and opioid treatment programs.

    (a) Physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, and opioid 
treatment programs may retrospectively bill for services when the 
physician, non-physician practitioner, physician or non-physician 
organization, ambulance supplier, or opioid treatment program has met 
all program requirements, including State licensure requirements, and 
services were provided at the enrolled practice location for up to--
* * * * *

0
66. Section 424.530 is amended by adding paragraph (a)(15) to read as 
follows:


Sec.  424.530   Denial of enrollment in the Medicare program.

    (a) * * *
    (15) Patient harm. (i) The physician or other eligible professional 
(as that term is defined in 1848(k)(3)(B) of the Act) has been subject 
to prior action from a State oversight board, Federal or State health 
care program, Independent Review Organization (IRO) determination(s), 
or any other equivalent governmental body or program that oversees, 
regulates, or administers the provision of health care with underlying 
facts reflecting improper physician or other eligible professional 
conduct that led to patient harm. In determining whether a denial is 
appropriate, CMS considers the following factors:
    (A) The nature of the patient harm.
    (B) The nature of the physician's or other eligible professional's 
conduct.
    (C) The number and type(s) of sanctions or disciplinary actions 
that have been imposed against the physician or other eligible 
professional by a State oversight board, IRO, Federal or State health 
care program, or any other equivalent governmental body or program that 
oversees, regulates, or administers the provision of health care. Such 
actions include, but are not limited to in scope or degree:

[[Page 63204]]

    (1) License restriction(s) pertaining to certain procedures or 
practices.
    (2) Required compliance appearances before State oversight board 
members.
    (3) License restriction(s) regarding the ability to treat certain 
types of patients (for example, cannot be alone with members of a 
different gender after a sexual offense charge).
    (4) Administrative/monetary penalties.
    (5) Formal reprimand(s).
    (D) If applicable, the nature of the IRO determination(s).
    (E) The number of patients impacted by the physician's or other 
eligible professional's conduct and the degree of harm thereto or 
impact upon.
    (ii) Paragraph (a)(15)(i) of this section does not apply to actions 
or orders pertaining exclusively to either of the following:
    (A) Required participation in rehabilitation or mental/behavioral 
health programs; or
    (B) Required abstinence from drugs or alcohol and random drug 
testing.
* * * * *

0
67. Section 424.535 is amended by--
0
a. In paragraph (a)(14) introductory text, by removing the phrase 
``prescribing Part D drugs'' and adding in its place the phrase 
``prescribing Part B or D drugs''; and
0
b. Adding paragraph (a)(22).
    The addition reads as follows:


Sec.  424.535  Revocation of enrollment in the Medicare program.

    (a) * * *
    (22) Patient harm. (i) The physician or other eligible professional 
(as that term is defined in 1848(k)(3)(B) of the Act) has been subject 
to prior action from a State oversight board, Federal or State health 
care program, Independent Review Organization (IRO) determination(s), 
or any other equivalent governmental body or program that oversees, 
regulates, or administers the provision of health care with underlying 
facts reflecting improper physician or other eligible professional 
conduct that led to patient harm. In determining whether a revocation 
is appropriate, CMS considers the following factors:
    (A) The nature of the patient harm.
    (B) The nature of the physician's or other eligible professional's 
conduct.
    (C) The number and type(s) of sanctions or disciplinary actions 
that have been imposed against the physician or other eligible 
professional by the State oversight board, IRO, Federal or State health 
care program, or any other equivalent governmental body or program that 
oversees, regulates, or administers the provision of health care. Such 
actions include, but are not limited to in scope or degree:
    (1) License restriction(s) pertaining to certain procedures or 
practices.
    (2) Required compliance appearances before State medical board 
members.
    (3) License restriction(s) regarding the ability to treat certain 
types of patients (for example, cannot be alone with members of a 
different gender after a sexual offense charge).
    (4) Administrative or monetary penalties.
    (5) Formal reprimand(s).
    (D) If applicable, the nature of the IRO determination(s).
    (E) The number of patients impacted by the physician's or other 
eligible professional's conduct and the degree of harm thereto or 
impact upon.
    (ii) Paragraph (a)(22)(i) of this section does not apply to actions 
or orders pertaining exclusively to either of the following:
    (A) Required participation in rehabilitation or mental/behavioral 
health programs; or
    (B) Required abstinence from drugs or alcohol and random drug 
testing.
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
68. The authority citation for part 425 continues to read as follows:

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


Sec.  425.612   [Amended]

0
69. Section 425.612 is amended in paragraph (a)(1)(v)(E) introductory 
text by removing the phrase ``paragraph (a)(1)(v)(B)'' and adding in 
its place the phrase ``paragraph (a)(1)(v)(D)''.

PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL

0
70. The authority citation for part 489 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc, 
1395ff, and 1395(hh).

0
71. Section 489.2 is amended by adding paragraphs (b)(10) and (c)(3) to 
read as follows:


Sec.  489.2   Scope of part.

* * * * *
    (b) * * *
    (10) Opioid treatment programs (OTPs).
    (c) * * *
    (3) OTPs may enter into provider agreements only to furnish opioid 
use disorder treatment services.

0
72. Section 489.10 is amended by revising paragraph (a) to read as 
follows:


Sec.  489.10   Basic requirements.

    (a) Any of the providers specified in Sec.  489.2 may request 
participation in Medicare. In order to be accepted, it must meet the 
conditions of participation or requirements (for SNFs) set forth in 
this section and elsewhere in this chapter. The RNHCIs must meet the 
conditions for coverage, conditions for participation and the 
requirements set forth in this section and elsewhere in this chapter. 
The OTPs must meet the requirements set forth in this section and 
elsewhere in this chapter.
* * * * *

0
73. Section 489.13 is amended by adding paragraph (a)(2)(iii) to read 
as follows:


Sec.  489.13   Effective date of agreement or approval.

    (a) * * *
    (2) * * *
    (iii) For an agreement with an opioid treatment program (OTP), the 
effective date is the effective date of billing as established under 
Sec.  424.520(d) or Sec.  424.521(a), as applicable.
* * * * *

0
74. Section 489.53 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  489.53   Termination by CMS.

    (a) * * *
    (3) It no longer meets the appropriate conditions of participation 
or requirements (for SNFs and NFs) set forth elsewhere in this chapter. 
In the case of an RNHCI, it no longer meets the conditions for 
coverage, conditions of participation and requirements set forth 
elsewhere in this chapter. In the case of an OTP, it no longer meets 
the requirements set forth in this section and elsewhere in this 
chapter.
* * * * *

PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT 
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT 
AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE 
MEDICAID PROGRAM

0
75. The authority citation for part 498 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1320a-7j, and 1395hh.

0
76. Section 498.2 is amended in the definition of ``Provider'' by 
revising the introductory text and adding paragraph (3) to read as 
follows:


Sec.  498.2   Definitions.

* * * * *

[[Page 63205]]

    Provider means any of the following:
* * * * *
    (3) An entity that has in effect an agreement to participate in 
Medicare but only to furnish opioid use disorder treatment services.
* * * * *

    Dated: October 24, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: October 28, 2019.
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 final rule, previously 
finalized measures and specialty measure sets will continue to apply 
for the 2022 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
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[FR Doc. 2019-24086 Filed 11-1-19; 4:15 pm]
BILLING CODE 4120-01-C