[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Proposed Rules]
[Pages 40482-41289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16041]



[[Page 40481]]

Vol. 84

Wednesday,

No. 157

August 14, 2019

Part II

Book 2 of 3 Books

Pages 40481-41289





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 403, 410, 415, 416, 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; Proposed Rules

  Federal Register / Vol. 84 , No. 157 / Wednesday, August 14, 2019 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-1715-P]
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

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

ACTION: Proposed rule.

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

DATES: Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on September 27, 2019.

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

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 indicies (GPCIs).
    Larry Chan, (410) 786-6864, for issues related to potentially 
misvalued services under the PFS.
    Lindsey Baldwin, (410) 786-1694, or Emily Yoder, (410) 786-1804, 
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.
    Kathy Bryant, (410) 786-3448, for issues related to coinsurance for 
colorectal cancer screening tests.
    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.
    Kathy Bryant, (410) 786-3448, for issues related to global surgery 
data collection.
    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-BBA of 2018 
requirements for Medicare ground ambulance services 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.
    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).
    Megan Hyde, (410) 786-3247, for inquiries related to Alternative 
Payment Models (APMs).

SUPPLEMENTARY INFORMATION:

Addenda Available Only Through the Internet on the CMS Website

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

[[Page 40483]]

for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html. Click on the link on the left side of the screen titled, 
``PFS Federal Regulations Notices'' for a chronological list of PFS 
Federal Register and other related documents. For the CY 2020 PFS 
proposed rule, refer to item CMS-1715-P. Readers with questions related 
to accessing any of the Addenda or other supporting documents 
referenced in this proposed rule and posted on the CMS website 
identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this proposed rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2019 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major proposed rule proposes to revise payment polices under 
the Medicare PFS and make other policy changes, including proposals to 
implement certain provisions of the Bipartisan Budget Act of 2018 (BBA 
of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment 
(SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L. 
115-271, October 24, 2018), related to Medicare Part B payment, 
applicable to services furnished in CY 2020 and thereafter. In 
addition, this proposed rule includes proposals related to payment 
policy changes that are addressed in section III. of this proposed 
rule. We are requesting public comments on all of the proposals being 
made in this proposed rule.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work; 
practice expense (PE); and malpractice (MP) expense. In addition, the 
statute requires that we establish by regulation each year's payment 
amounts for all physicians' services paid under the PFS, incorporating 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    In this major proposed rule, we are proposing to establish RVUs for 
CY 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 proposed rule also includes 
discussions and proposals 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 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. This proposed 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 Services 
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.)
 Updates to the Quality Payment Program (section III.K.)
2. Summary of Costs and Benefits
    We have determined that this major proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VI. of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

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

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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 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 proposed 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.

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    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 VI. of this proposed rule, the Regulatory 
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of 
the Act, if revisions to the RVUs cause expenditures for the year to 
change by more than $20 million, we make adjustments to ensure that 
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each 
component. Please refer to the CY 2017 PFS final rule with comment 
period for a discussion of the last GPCI update (81 FR 80261 through 
80270).
    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS's Office of 
the Actuary (OACT). The formula for calculating the Medicare PFS 
payment amount for a given service and fee schedule area can be 
expressed as:

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

B. Determination of 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 practice expense 
methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 
PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of

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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 are 
proposing to use proxy PE/HR values for these new specialties, as there 
are no PPIS data for these specialties, by crosswalking the PE/HR as 
follows from specialties that furnish similar services in the Medicare 
claims data:
     Medical Toxicology from Emergency Medicine; and
     Hematopoietic Cell Transplantation and Cellular Therapy 
from Hematology/Oncology.
    These updates are reflected in the ``CY 2020 PFS Proposed Rule PE/
HR'' file available on the CMS website under the supporting data files 
for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Next, 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

[[Page 40487]]

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.
    For CY 2020, we are proposing 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 are 
proposing 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.

             Table 1--Proposed Updates to Expected Specialty
------------------------------------------------------------------------
                         CY 2019 expected       Updated CY 2020 expected
     CPT code               specialty                  specialty
------------------------------------------------------------------------
33414.............  Cardiac Surgery..........  Thoracic Surgery.
33468.............  Cardiac Surgery..........  Thoracic Surgery.
33470.............  Cardiac Surgery..........  Thoracic Surgery.
33471.............  Cardiac Surgery..........  Thoracic Surgery.
33476.............  Cardiac Surgery..........  Thoracic Surgery.
33478.............  Cardiac Surgery..........  Thoracic Surgery.
33502.............  Cardiac Surgery..........  Thoracic Surgery.
33503.............  Cardiac Surgery..........  Thoracic Surgery.
33504.............  Cardiac Surgery..........  Thoracic Surgery.
33505.............  Cardiac Surgery..........  Thoracic Surgery.
33506.............  Cardiac Surgery..........  Thoracic Surgery.
33507.............  Cardiac Surgery..........  Thoracic Surgery.
33600.............  Cardiac Surgery..........  Thoracic Surgery.
33602.............  Cardiac Surgery..........  Thoracic Surgery.
33606.............  Cardiac Surgery..........  Thoracic Surgery.
33608.............  Cardiac Surgery..........  Thoracic Surgery.
33610.............  Cardiac Surgery..........  Thoracic Surgery.
33611.............  Cardiac Surgery..........  Thoracic Surgery.
33612.............  Cardiac Surgery..........  Thoracic Surgery.
33615.............  Cardiac Surgery..........  Thoracic Surgery.
33617.............  Cardiac Surgery..........  Thoracic Surgery.
33619.............  Cardiac Surgery..........  Thoracic Surgery.
33620.............  Cardiac Surgery..........  Thoracic Surgery.
33621.............  Cardiac Surgery..........  Thoracic Surgery.
33622.............  Cardiac Surgery..........  Thoracic Surgery.
33645.............  Cardiac Surgery..........  Thoracic Surgery.
33647.............  Cardiac Surgery..........  Thoracic Surgery.
33660.............  Cardiac Surgery..........  Thoracic Surgery.
33665.............  Cardiac Surgery..........  Thoracic Surgery.
33670.............  Cardiac Surgery..........  Thoracic Surgery.
33675.............  Cardiac Surgery..........  Thoracic Surgery.
33676.............  Cardiac Surgery..........  Thoracic Surgery.
33677.............  Cardiac Surgery..........  Thoracic Surgery.
33684.............  Cardiac Surgery..........  Thoracic Surgery.
33688.............  Cardiac Surgery..........  Thoracic Surgery.
33690.............  Cardiac Surgery..........  Thoracic Surgery.
33692.............  Cardiac Surgery..........  Thoracic Surgery.
33694.............  Cardiac Surgery..........  Thoracic Surgery.
33697.............  Cardiac Surgery..........  Thoracic Surgery.
33702.............  Cardiac Surgery..........  Thoracic Surgery.
33710.............  Cardiac Surgery..........  Thoracic Surgery.
33720.............  Cardiac Surgery..........  Thoracic Surgery.
33722.............  Cardiac Surgery..........  Thoracic Surgery.
33724.............  Cardiac Surgery..........  Thoracic Surgery.
33726.............  Cardiac Surgery..........  Thoracic Surgery.
33730.............  Cardiac Surgery..........  Thoracic Surgery.
33732.............  Cardiac Surgery..........  Thoracic Surgery.
33735.............  Cardiac Surgery..........  Thoracic Surgery.
33736.............  Cardiac Surgery..........  Thoracic Surgery.

[[Page 40488]]

 
33737.............  Cardiac Surgery..........  Thoracic Surgery.
33750.............  Cardiac Surgery..........  Thoracic Surgery.
33755.............  Cardiac Surgery..........  Thoracic Surgery.
33762.............  Cardiac Surgery..........  Thoracic Surgery.
33764.............  Cardiac Surgery..........  Thoracic Surgery.
33766.............  Cardiac Surgery..........  Thoracic Surgery.
33767.............  Cardiac Surgery..........  Thoracic Surgery.
33768.............  Cardiac Surgery..........  Thoracic Surgery.
33770.............  Cardiac Surgery..........  Thoracic Surgery.
33771.............  Cardiac Surgery..........  Thoracic Surgery.
33774.............  Cardiac Surgery..........  Thoracic Surgery.
33775.............  Cardiac Surgery..........  Thoracic Surgery.
33776.............  Cardiac Surgery..........  Thoracic Surgery.
33777.............  Cardiac Surgery..........  Thoracic Surgery.
33778.............  Cardiac Surgery..........  Thoracic Surgery.
33779.............  Cardiac Surgery..........  Thoracic Surgery.
33780.............  Cardiac Surgery..........  Thoracic Surgery.
33781.............  Cardiac Surgery..........  Thoracic Surgery.
33782.............  Cardiac Surgery..........  Thoracic Surgery.
33783.............  Cardiac Surgery..........  Thoracic Surgery.
33786.............  Cardiac Surgery..........  Thoracic Surgery.
33788.............  Cardiac Surgery..........  Thoracic Surgery.
33800.............  Cardiac Surgery..........  Thoracic Surgery.
33802.............  Cardiac Surgery..........  Thoracic Surgery.
33803.............  Cardiac Surgery..........  Thoracic Surgery.
33813.............  Cardiac Surgery..........  Thoracic Surgery.
33814.............  Cardiac Surgery..........  Thoracic Surgery.
33820.............  Cardiac Surgery..........  Thoracic Surgery.
33822.............  Cardiac Surgery..........  Thoracic Surgery.
33824.............  Cardiac Surgery..........  Thoracic Surgery.
33840.............  Cardiac Surgery..........  Thoracic Surgery.
33845.............  Cardiac Surgery..........  Thoracic Surgery.
33851.............  Cardiac Surgery..........  Thoracic Surgery.
33852.............  Cardiac Surgery..........  Thoracic Surgery.
33853.............  Cardiac Surgery..........  Thoracic Surgery.
33917.............  Cardiac Surgery..........  Thoracic Surgery.
33920.............  Cardiac Surgery..........  Thoracic Surgery.
33922.............  Cardiac Surgery..........  Thoracic Surgery.
33924.............  Cardiac Surgery..........  Thoracic Surgery.
33925.............  Cardiac Surgery..........  Thoracic Surgery.
33926.............  Cardiac Surgery..........  Thoracic Surgery.
35182.............  Cardiac Surgery..........  Thoracic Surgery.
------------------------------------------------------------------------

    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 identical MP risk factors for MP valuation. As a 
result, we do not anticipate this proposal having a discernible effect 
on the valuation of the codes listed above. For additional discussion 
on this issue, we refer readers to section II.C of this proposed rule, 
Malpractice. 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 proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: The direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this proposed rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable

[[Page 40489]]

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.

       Table 2--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
     Specialty code                    Specialty description
------------------------------------------------------------------------
49......................  Ambulatory surgical center.
50......................  Nurse practitioner.
51......................  Medical supply company with certified
                           orthotist.
52......................  Medical supply company with certified
                           prosthetist.
53......................  Medical supply company with certified
                           prosthetist[dash]orthotist.
54......................  Medical supply company not included in 51, 52,
                           or 53.
55......................  Individual certified orthotist.
56......................  Individual certified prosthetist.
57......................  Individual certified
                           prosthetist[dash]orthotist.
58......................  Medical supply company with registered
                           pharmacist.
59......................  Ambulance service supplier, e.g., private
                           ambulance companies, funeral homes, etc.
60......................  Public health or welfare agencies.
61......................  Voluntary health or charitable agencies.
73......................  Mass immunization roster biller.
74......................  Radiation therapy centers.
87......................  All other suppliers (e.g., drug and department
                           stores).
88......................  Unknown supplier/provider specialty.
89......................  Certified clinical nurse specialist.
96......................  Optician.
97......................  Physician assistant.
A0......................  Hospital.
A1......................  SNF.
A2......................  Intermediate care nursing facility.
A3......................  Nursing facility, other.
A4......................  HHA.
A5......................  Pharmacy.
A6......................  Medical supply company with respiratory
                           therapist.
A7......................  Department store.
A8......................  Grocery store.
B1......................  Supplier of oxygen and/or oxygen related
                           equipment (eff. 10/2/2007).
B2......................  Pedorthic personnel.
B3......................  Medical supply company with pedorthic
                           personnel.
B4......................  Rehabilitation Agency.
B5......................  Ocularist.
C1......................  Centralized Flu.
C2......................  Indirect Payment Procedure.
C5......................  Dentistry.
------------------------------------------------------------------------

     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).

[[Page 40490]]

     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 3 details the manner in which the 
modifiers are applied.

     Table 3--Application of Payment Modifiers to Utilization Files
------------------------------------------------------------------------
                                             Volume
      Modifier           Description       adjustment    Time adjustment
------------------------------------------------------------------------
80,81,82............  Assistant at      16%............  Intraoperative
                       Surgery.                           portion.
AS..................  Assistant at      14% (85% * 16%)  Intraoperative
                       Surgery--Physic                    portion.
                       ian Assistant.
50 or LT and RT.....  Bilateral         150%...........  150% of work
                       Surgery.                           time.
51..................  Multiple          50%............  Intraoperative
                       Procedure.                         portion.
52..................  Reduced Services  50%............  50%.
53..................  Discontinued      50%............  50%.
                       Procedure.
54..................  Intraoperative    Preoperative +   Preoperative +
                       Care only.        Intraoperative   Intraoperative
                                         Percentages on   portion.
                                         the payment
                                         files used by
                                         Medicare
                                         contractors to
                                         process
                                         Medicare
                                         claims.
55..................  Postoperative     Postoperative    Postoperative
                       Care only.        Percentage on    portion.
                                         the payment
                                         files used by
                                         Medicare
                                         contractors to
                                         process
                                         Medicare
                                         claims.
62..................  Co-surgeons.....  62.5%..........  50%.
66..................  Team Surgeons...  33%............  33%.
------------------------------------------------------------------------

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

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

Where:

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

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that would support an alternative rate.

[[Page 40491]]

    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 do not believe that we have sufficient 
information at present to propose a variable maintenance factor for 
equipment cost per minute pricing. We continue to investigate potential 
avenues for determining equipment maintenance costs across a broad 
range of equipment items.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). We 
are not proposing any changes to these interest rates for CY 2020. The 
Interest rates are listed in Table 4.

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

3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2020 direct PE input public use files, which are 
available 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.
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.

[[Page 40492]]

    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 59463-59464).
    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 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 proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Equipment Recommendations for Scope Systems
    During our routine reviews of direct PE input recommendations, we 
have regularly found unexplained inconsistencies involving the use of 
scopes and the video systems associated with them. Some of the scopes 
include video systems bundled into the equipment item, some of them 
include scope accessories as part of their price, and some of them are 
standalone scopes with no other equipment included. It is not always 
clear which equipment items related to scopes fall into which of these 
categories. We have also frequently found anomalies in the equipment 
recommendations, with equipment items that consist of a scope and video 
system bundle recommended, along with a separate scope video system. 
Based on our review, the variations do not appear to be consistent with 
the different code descriptions.
    To promote appropriate relativity among the services and facilitate 
the transparency of our review process, during the review of the 
recommended direct PE inputs for the CY 2017 PFS proposed rule, we 
developed a structure that separates the scope, the associated video 
system, and any scope accessories that might be typical as distinct 
equipment items for each code. Under this approach, we proposed 
standalone prices for each scope, and separate prices for the video 
systems and accessories that are used with scopes.
(1) Scope Equipment
    Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through 
46177), we proposed standardizing refinements to the way scopes have

[[Page 40493]]

been defined in the direct PE input database. We believe that there are 
four general types of scopes: Non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and 
rigid scopes would typically be paired with one of the scope video 
systems, while the non-video scopes would not. The flexible scopes can 
be further divided into diagnostic (or non-channeled) and therapeutic 
(or channeled) scopes. We proposed to identify for each anatomical 
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video 
flexible scope; (4) a non-channeled flexible video scope; and (5) a 
channeled flexible video scope. We proposed to classify the existing 
scopes in our direct PE database under this classification system, to 
improve the transparency of our review process and improve appropriate 
relativity among the services. We planned to propose input prices for 
these equipment items through future rulemaking.
    We proposed these changes only for the reviewed codes for CY 2017 
that made use of scopes, along with updated prices for the equipment 
items related to scopes utilized by these services. We did not propose 
to apply these policies to codes with inputs reviewed prior to CY 2017. 
We also solicited comment on this separate pricing structure for 
scopes, scope video systems, and scope accessories, which we 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

[[Page 40494]]

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 are proposing to establish 
23 new scope equipment codes (see Table 5).

           Table 5--CY 2020 Proposed New Scope Equipment Codes
------------------------------------------------------------------------
                         Proposed scope
       CMS code            equipment      Proposed price     Number of
                          description                        invoices
------------------------------------------------------------------------
ES070................  rigid scope,       ..............               0
                        cystoscopy.
ES071................  rigid scope,       ..............               0
                        hysteroscopy.
ES072................  rigid scope,       ..............               0
                        otoscopy.
ES073................  rigid scope,       ..............               0
                        nasal/sinus
                        endoscopy.
ES074................  rigid scope,       ..............               0
                        proctosigmoidosc
                        opy.
ES075................  rigid scope,            $3,966.08               5
                        laryngoscopy.
ES076................  rigid scope,            14,500.00               1
                        colposcopy.
ES077................  non-channeled      ..............               0
                        flexible digital
                        scope,
                        hysteroscopy.
ES078................  non-channeled      ..............               0
                        flexible digital
                        scope,
                        nasopharyngoscop
                        y.
ES079................  non-channeled      ..............               0
                        flexible digital
                        scope,
                        bronchoscopy.
ES080................  non-channeled           21,485.51               7
                        flexible digital
                        scope,
                        laryngoscopy.
ES081................  channeled          ..............               0
                        flexible digital
                        scope,
                        cystoscopy.
ES082................  channeled          ..............               0
                        flexible digital
                        scope,
                        hysteroscopy.
ES083................  channeled          ..............               0
                        flexible digital
                        scope,
                        bronchoscopy.
ES084................  channeled               18,694.39               5
                        flexible digital
                        scope,
                        laryngoscopy.
ES085................  multi-channeled         17,360.00               1
                        flexible digital
                        scope, flexible
                        sigmoidoscopy.
ES086................  multi-channeled         38,058.81               6
                        flexible digital
                        scope,
                        colonoscopy.
ES087................  multi-channeled    ..............               0
                        flexible digital
                        scope,
                        esophagoscopy
                        gastroscopy
                        duodenoscopy
                        (EGD).
ES088................  multi-channeled         34,585.35               5
                        flexible digital
                        scope,
                        esophagoscopy.
ES089................  multi-channeled    ..............               0
                        flexible digital
                        scope, ileoscopy.
ES090................  multi-channeled    ..............               0
                        flexible digital
                        scope,
                        pouchoscopy.
ES091................  ultrasound         ..............               0
                        digital scope,
                        endoscopic
                        ultrasound.
ES092................  non-video                5,078.04               4
                        flexible scope,
                        laryngoscopy.
------------------------------------------------------------------------

    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 are proposing 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 are proposing 
to consider these items separately. We are proposing to use the initial 
five invoices to establish a proposed price of $3,966.08 for the rigid 
scope, laryngoscopy (ES075) equipment item. We note 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. 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 believe that these invoices reinforce the value 
established by the market-based pricing update for the stroboscoby 
system carried out last year, and we are not proposing to update the 
price of the ES065 equipment at this time. However, we are 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 have submitted 
invoices for pricing, we are proposing to replace the existing scopes 
with the new scope equipment. We received recommendations from the 
RUC's scope workgroup regarding which HCPCS codes make use of the new 
scope equipment items, and we are proposing to make this scope 
replacement for approximately 100 HCPCS codes in total (see Table 6).
BILLING CODE 4120-01-P

[[Page 40495]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.000


[[Page 40496]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.001


[[Page 40497]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.002


[[Page 40498]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.003

BILLING CODE 4120-01-C
    In all but three cases, we are proposing 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), the current scopes in use 
are the FEES video system (ES027) and the FEESST video system (ES028). 
Since we are proposing the use of a non-channeled flexible digital 
scope that requires a corresponding scope video system, we are adding 
the ES080 equipment at the same equipment time

[[Page 40499]]

to these three procedures rather than replacing the ES027 and ES028 
equipment. In all other cases, we are proposing to replace the current 
scope equipment listed in Table 6 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 are not proposing to add one of the new scope 
equipment items to these procedures.
    We did not receive pricing information along with the workgroup 
recommendations for the other 15 new scope equipment items. For CY 
2020, we are proposing to establish new equipment codes for these 
scopes as detailed in Table 5. However, due to a lack of pricing 
information, we are not proposing 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 welcome additional feedback from 
stakeholders regarding the pricing of these scope equipment items, 
especially the submission of detailed invoices with pricing data. We 
are proposing to transition the scopes for which we do have pricing 
information over to the new equipment items for CY 2020, and we look 
forward to engaging with stakeholders to assist in pricing and then 
transitioning the remaining scopes in future rulemaking.
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 are proposing 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 are proposing 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 agree with the workgroup's 
recommendation, and we are proposing 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 
are proposing to apply the special rule for multiple endoscopic 
procedures to this family of codes beginning in CY 2020. 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 are proposing 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 this proposal are as 
follows (see Table 7).

 Table 7--Proposed Nasal Sinus Endoscopy Codes Subject to Special Rules
                   for Multiple Endoscopic Procedures
------------------------------------------------------------------------
               CPT code                         Short descriptor
------------------------------------------------------------------------
31231................................  Nasal endoscopy dx.
31233................................  Nasal/sinus endoscopy dx.
31235................................  Nasal/sinus endoscopy dx.
31237................................  Nasal/sinus endoscopy surg.
31238................................  Nasal/sinus endoscopy surg.
31239................................  Nasal/sinus endoscopy surg.
31240................................  Nasal/sinus endoscopy surg.
31241................................  Nsl/sins ndsc w/artery lig.
31253................................  Nsl/sins ndsc total.
31254................................  Nsl/sins ndsc w/prtl ethmdct.
31255................................  Nsl/sins ndsc w/tot ethmdct.
31256................................  Exploration maxillary sinus.
31257................................  Nsl/sins ndsc tot w/sphendt.
31259................................  Nsl/sins ndsc sphn tiss rmvl.
31267................................  Endoscopy maxillary sinus.
31276................................  Nsl/sins ndsc frnt tiss rmvl.
31287................................  Nasal/sinus endoscopy surg.
31288................................  Nasal/sinus endoscopy surg.
31290................................  Nasal/sinus endoscopy surg.
31291................................  Nasal/sinus endoscopy surg.
31292................................  Nasal/sinus endoscopy surg.
31293................................  Nasal/sinus endoscopy surg.
31294................................  Nasal/sinus endoscopy surg.
31295................................  Sinus endo w/balloon dil.
31296................................  Sinus endo w/balloon dil.
31297................................  Sinus endo w/balloon dil.
31298................................  Nsl/sins ndsc w/sins dilat.
------------------------------------------------------------------------

    Special rules for multiple endoscopic procedures would apply if any 
of the procedures listed in Table 7 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 
Pub. 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).
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

[[Page 40500]]

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 are proposing the following price 
updates for existing direct PE inputs.
    We are proposing 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 are proposing that the new pricing take effect for CY 2020 
for these items instead of being phased in over 4 years. For the 
details of these proposed price updates, please refer to Table 22, 
Proposed CY 2020 Invoices Received for Existing Direct PE Inputs in 
section II.N., Proposed Valuation of Specific Codes, of this proposed 
rule.
    We are also proposing to update the name of the EP001 equipment 
item from ``DNA/digital image analyzer (ACIS)'' to ``DNA/Digital Image 
Analyzer'' due to 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 1300 supplies and 750 equipment items 
currently used as direct PE inputs. This report is available as a 
public use file displayed on the CMS website under downloads for the CY 
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The StrategyGen team of researchers, attorneys, physicians, and 
health policy experts conducted a market research study of the supply 
and equipment items currently used in the PFS direct PE input database. 
Resources and methodologies included field surveys, aggregate 
databases, vendor resources, market scans, market analysis, physician 
substantiation, and statistical analysis to estimate and validate 
current prices for medical equipment and medical supplies. StrategyGen 
conducted secondary market research on each of the 2,072 DPEI medical 
equipment and supply items that CMS identified from the current DPEI. 
The primary and secondary resources StrategyGen used to gather price 
data and other information were:
     Telephone surveys with vendors for top priority items 
(Vendor Survey).
     Physician panel validation of market research results, 
prioritized by total spending (Physician Panel).
     The General Services Administration system (GSA).
     An aggregate health system buyers database with discounted 
prices (Buyers).
     Publicly available vendor resources, that is, Amazon 
Business, Cardinal Health (Vendors).
     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-

[[Page 40501]]

up'' PE methodology (71 FR 69641). This transition period will not only 
ease the shift to the updated supply and equipment pricing, but will 
also allow interested parties an opportunity to review and respond to 
the new pricing information associated with their services.
    We proposed to implement this phase-in over 4 years so that supply 
and equipment values transition smoothly from the prices we currently 
include to the final updated prices in CY 2022. We proposed to 
implement this pricing transition such that one quarter of the 
difference between the current price and the fully phased-in price is 
implemented for CY 2019, one third of the difference between the CY 
2019 price and the final price is implemented for CY 2020, and one half 
of the difference between the CY 2020 price and the final price is 
implemented for CY 2021, with the new direct PE prices fully 
implemented for CY 2022. An example of the transition from the current 
to the fully-implemented new pricing is provided in Table 8.

            Table 8--Example of Direct PE Pricing Transition
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current Price...............                  $100
Final Price.................                   200  ....................
    Year 1 (CY 2019) Price..                   125  \1/4\ difference
                                                     between $100 and
                                                     $200.
    Year 2 (CY 2020) Price..                   150  \1/3\ difference
                                                     between $125 and
                                                     $200.
    Year 3 (CY 2021) Price..                   175  \1/2\ difference
                                                     between $150 and
                                                     $200.
    Final (CY 2022) Price...                   200  ....................
------------------------------------------------------------------------

    For new supply and equipment codes for which we establish prices 
during the transition years (CYs 2019, 2020 and 2021) based on the 
public submission of invoices, we 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 time frame 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

[[Page 40502]]

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 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 are proposing to update the prices of the following supply 
and equipment items:
BILLING CODE 4120-01-P

[[Page 40503]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.004

BILLING CODE 4120-01-C
    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)

[[Page 40504]]

(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 are proposing 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 are again 
proposing 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 are proposing to update the price of the EM visit pack to 
$5.47 to match the sum of the prices of the component supplies, and 
proposing 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 8. 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.
    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.
(2) Invoice Submission
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 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 are proposing to continue with the third 
year of the transition of this adjustment to the standard process for 
allocating indirect PE.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that 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, we implemented the third review and 
update of MP RVUs. For a comprehensive discussion of the third review 
and update of MP RVUs, see the CY 2015 proposed rule (79 FR 40349 
through 40355) and final rule with comment period (79 FR 67591 through 
67596). In the CY 2018 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

[[Page 40505]]

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 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 GPCI. Therefore, we are 
proposing to align the update of MP premium data with the update to the 
MP GPCIs, that is, we are proposing 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 are proposing to implement the fourth 
comprehensive review and update of MP RVUs for CY 2020 and are seeking 
comment on these proposals.
2. Methodology for the Proposed Revision of Resource-Based Malpractice 
RVUs
a. General Discussion
    We calculated the proposed MP RVUs using updated malpractice 
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 are proposing to incorporate several 
methodological refinements, which are described below in this proposed 
rule. 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. 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: Malpractice 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 
will use 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 malpractice premium data because they 
represent the expense incurred by practitioners to obtain malpractice 
insurance as reported by insurers. For CY 2020, the most current 
malpractice 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 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.
    Malpractice 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. Malpractice 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 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

[[Page 40506]]

the 35 state threshold was not met. In this proposed CY 2020 update, we 
note that the proposed methodological improvement discussed below in 
this proposed rule 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 are proposing 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.
    (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.
    (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 propose 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 are no data corresponding to a CMS specialty in the filing, we 
propose to use total imputation to establish premiums.
    For example, if a specialty of Sleep Medicine is listed on the 
insurer's rate filing, this rate will be matched to the CMS specialty 
Sleep Medicine (C0). 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). In this example, we believe 
General Practice is likely to be consistent with the rate that a Sleep 
Medicine provider would be charged by that insurer. This proposed 
methodological improvement means 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 in an effort to utilize as much of 
the information from the filings as possible.
    We are seeking comment on these proposed methodological 
improvements. Additional technical details 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.
c. Steps for Calculating Malpractice RVUs
    Calculation of the proposed MP RVUs conceptually follows the 
specialty-weighted approach used in the CY 2015 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.
    Step (1): Compute a preliminary national average premium for each 
specialty.
    Insurance rating area malpractice 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 malpractice claims if they occur. To account for the 
presence of different classes in the malpractice 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 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 10. 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. Therefore, we 
calculated a national average surgical premium and non-surgical premium 
for those specialties. For all other specialties (those that are not 
listed in Table 10) 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.

[[Page 40507]]



   Table 10--Proposed Specialties Subdivided Into Service Risk Groups
------------------------------------------------------------------------
      Service risk groups                      Specialties
------------------------------------------------------------------------
Surgery/No Surgery.............  Otolaryngology (04), Cardiology (06),
                                  Dermatology (07), Gastroenterology
                                  (10), Neurology (13), Ophthalmology
                                  (18), Urology (34), Geriatric Medicine
                                  (38), Nephrology (39), Endocrinology
                                  (46), Podiatry (48), Emergency
                                  Medicine (93).
Surgery/No Surgery/OB..........  General Practice (01), Family Practice
                                  (08), OB/GYN (16).
------------------------------------------------------------------------

    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 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 the data for calculating 
the CY 2015 MP RVUs for TC-only services. We declined to utilize the 
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 propose 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 11 shows the proposed risk factors by specialty type and 
service risk group.
BILLING CODE 4120-01-P

[[Page 40508]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.005


[[Page 40509]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.006

BILLING CODE 4120-01-C
    Step (4): Calculate malpractice 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

[[Page 40510]]

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 
malpractice 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 proposed 
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 are soliciting public comment on the list of 
expected specialties. We also note 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 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.
    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 proposed rule, Determination of Practice Expense Relative Value 
Units, we discuss specialties that are excluded from ratesetting for 
the purposes of calculating PE RVUs. We are proposing 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 are proposing to also exclude for 
the purpose of calculating MP RVUs is available in section II.B. of 
this proposed rule, Determination of Practice Expense Relative Value 
Units. The proposed 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 can be found in section VI. of this proposed rule, 
Regulatory Impact Analysis.
    Additional information on our proposed methodology for updating the 
MP RVUs is available in the ``Interim 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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

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, 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 are 
proposing to phase in \1/2\ of the latest GPCI adjustment in CY 2020.

[[Page 40511]]

    We have completed a review of the GPCIs and are proposing new GPCIs 
in this proposed rule. We also calculate a geographic adjustment factor 
(GAF) for each PFS locality. The GAFs are a weighted composite of each 
PFS localities 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 proposed 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 proposed 
rule for the CY 2020 proposed GPCIs and summarized proposed GAFs 
available on the CMS website under the supporting documents section of 
the CY 2020 PFS proposed 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 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 are defined alternatively by 
state boundaries (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 an interim 
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs 
for the Medicare Physician Fee Schedule,'' on our website located under 
the supporting documents section for the CY 2020 PFS proposed 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 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

[[Page 40512]]

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 
proposed 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 proposed 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 proposed 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 to $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 proposed 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 are proposing 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 proposed GPCI cost share weights for CY 2020 are displayed in 
Table 12.

      Table 12--Proposed Cost Share Weights for CY 2020 GPCI Update
------------------------------------------------------------------------
                                                        Proposed CY 2020
         Expense category              Current cost    cost share weight
                                     share weight (%)         (%)
------------------------------------------------------------------------
Work..............................             50.866             50.866
Practice Expense..................             44.839             44.839
    --Employee Compensation.......             16.553             16.553
    --Office Rent.................             10.223             10.223
    --Purchased Services..........              8.095              8.095
    --Equipment, Supplies, Other..              9.968              9.968
Malpractice Insurance.............              4.295              4.295
                                   -------------------------------------
    Total.........................            100.000            100.000
------------------------------------------------------------------------

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

[[Page 40513]]

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 proposed rule. The qualifying 
states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada. 
In accordance with statute, we would 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 current PFS locality structure. 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 
current locality structure, 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 current locality structure. 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 current locality structure. 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 current locality structure. 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 current localities 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\. 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).

[[Page 40514]]

h. Refinements to the GPCI Methodology
    In the process of calculating GPCIs for the purposes of this 
proposed 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 are 
proposing 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 
are also proposing 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 proposed methodological refinements yield 
improved mathematical precision. Additional information on the GPCI 
methodology and the proposed refinements are available in the interim 
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs 
for the Medicare Physician Fee Schedule'' on our website located under 
the supporting documents section of the CY 2020 PFS proposed 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, the periodic 
review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of 
the Act. At each update, the proposed 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 proposed 
CY 2020 updated GPCIs for the first and second year of the 2-year 
transition, along with the GAFs, are displayed in Addenda D and E to 
this proposed rule available on our website under the supporting 
documents section of the CY 2020 PFS proposed rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

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 proposed 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

[[Page 40515]]

same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well. 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 
approximately 1,700 potentially misvalued codes to refine work RVUs and 
direct PE inputs. We have assigned appropriate work RVUs and direct PE 
inputs for these services as a result of these reviews. A more detailed 
discussion of the extensive prior reviews of potentially misvalued 
codes is included in the 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

[[Page 40516]]

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 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 will 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 are proposing the aforementioned public and CMS nominated codes 
as potentially misvalued and welcome public comment on these codes.
    Another commenter provided information to CMS in which they stated 
that the work involved in furnishing services represented by the 
office/outpatient evaluation and management (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

[[Page 40517]]

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.
    We acknowledge the points made by the commenter, and continue to 
consider the best ways to recognize the significant changes in 
healthcare practice as discussed by the commenter. We agree, 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). 
Concurrently, the CPT Editorial Panel, under similar burden reduction 
guiding principles, convened a workgroup and proposed to refine and 
revalue the existing E/M office/outpatient code set. We thank the 
commenter for the views represented in their comment. As stated earlier 
in this section, we agree in principle that the existing set of office/
outpatient E/M CPT codes may not be correctly valued, and therefore, we 
will continue to consider opportunities to revalue these codes, in 
light of their significance to payment for services billed under 
Medicare.
    Table 13 lists the HCPCS and CPT codes that we are proposing as 
potentially misvalued.

     Table 13--HCPCS and CPT Codes Proposed as Potentially Misvalued
------------------------------------------------------------------------
            CPT/HCPCS code                     Short description
------------------------------------------------------------------------
10005................................  Fna bx w/us gdn 1st les.
10021................................  Fna bx w/o img gdn 1st les.
76377................................  3d render w/intrp postproces.
G0166................................  Extrnl counterpulse, per tx.
------------------------------------------------------------------------

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 telehealth services. Our review of these requests 
includes an assessment of whether the service is accurately described 
by the corresponding code when furnished via telehealth and whether the 
use of a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the proposed additions 
described later in this section, can be located on the CMS website at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Historically, requests to add services to the list of Medicare 
telehealth services had to be submitted and received no later than 
December 31 of each calendar year to be considered for the next 
rulemaking cycle. However, 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,

[[Page 40518]]

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, there are three HCPCS G-codes describing new services 
being proposed in section II.H. of this rule for CY 2020 which we 
believe are sufficiently similar to services currently on the 
telehealth list to be added on a Category 1 basis. Therefore, we are 
proposing 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 GYYY1: 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 GYYY2: 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 GYYY3: 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).
    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 GYYY1, GYYY2, and GYYY3 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 
services list. We note that like certain other non-face-to-face PFS 
services, the other components of HCPCS codes GYYY1-3 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 GYYY1-3 
are similar to other telehealth services. Were these components of 
HCPCS codes GYYY1-3 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.
    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 
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 GYYY1, GYYY2, and GYYY3 will complement the existing policies 
related to flexibilities in treating SUDs under Medicare Telehealth.
    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.

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 and most recently, on 
April 19, 2019.\3\
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    \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-19apr2019.aspx.
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    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, including opioid use disorder (42 CFR 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.
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    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

[[Page 40519]]

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 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 
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)) 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 
42 CFR 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.
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    Many payers currently cover MAT services for treatment of OUD. 
Medicaid \7\ is one of the largest payers of medications for substance 
use disorder (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'' proposed rule, many qualified health plans covered MAT 
medications for plan year 2018 (84 FR 285).
---------------------------------------------------------------------------

    \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 are proposing to 
establish rules to govern Medicare coverage of and payment for OUD 
treatment services furnished in OTPs. In the following discussion, we 
propose to establish definitions of OUD treatment services and OTP for 
purposes of the Medicare Program. We also propose a methodology for 
determining Medicare payment for such services provided by OTPs. We are 
proposing to codify these policies in a new section of the regulations 
at Sec.  410.67. For a discussion about Medicare enrollment 
requirements and the proposed program integrity approach for OTPs, we 
refer readers to section III.H. Medicare Enrollment of Opioid Treatment 
Programs, in this proposed rule.
2. Proposed 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,

[[Page 40520]]

injected, and implanted opioid agonist and antagonist medications 
approved by 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.
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    \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 and 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\
---------------------------------------------------------------------------

    \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 in order 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 
milligrams did not suppress opioid abstinence, with clinical stability 
generally achieved at doses between 80 to 120 mg/day.\25\ By law, 
methadone can only be dispensed through an OTP certified by SAMHSA.\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 opioid use disorder.\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\
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    \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.
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    We propose 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 propose 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 propose to codify this definition of OUD treatment services 
furnished by OTPs at Sec.  410.67(b). As part of this definition, we 
also propose 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 seek 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 are 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 understand 
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

[[Page 40521]]

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 would like 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 welcome 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.
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 that 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 proposed rule, Medicare 
Enrollment of Opioid Treatment Programs, for further details on our 
proposed 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 42 CFR 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 42 CFR 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, which is determined by the medical director 
or program physician of the OTP in which the patient is enrolled (42 
CFR 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 
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-

[[Page 40522]]

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 42 CFR part 8, subpart C and 
any regulations regarding the use of opioid agonist treatment 
medications in the treatment of OUD, which 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, including that the person has an OUD, and that the person 
has had an OUD 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 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 substance use disorder 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 substance use 
disorders with MAT (42 CFR 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 (42 CFR 8.11).
    The SAMHSA regulations establish procedures for an entity to apply 
to become a SAMHSA-approved accrediting body (42 CFR 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;
    ++ 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;

[[Page 40523]]

     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 amends section 1866(e) of the 
Act by adding a new paragraph (3) which includes opioid treatment 
programs (but only with respect to the furnishing of opioid use 
disorder 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 implemented at 42 CFR part 489. Therefore, we are 
proposing to amend part 489 to include OTPs (but only with respect to 
the furnishing of opioid use disorder treatment services) as a 
provider. Specifically, we are proposing to add OTPs (but only with 
respect to the furnishing of opioid use disorder treatment services) to 
the list of providers in Sec.  489.2. This addition makes clear that 
the other requirements specified in Section 1866, and implemented in 
part 489, which include the limits on charges to beneficiaries, would 
apply to OTPs (with respect to the furnishing of opioid use disorder 
treatment services). We are also proposing 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 are not proposing any conditions of participation 
for OTPs, we are proposing 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 are proposing 
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. 
Finally, as noted earlier in the preamble, OTPs are required to be 
certified by SAMHSA and accredited by an accrediting body approved by 
SAMHSA. In Sec.  489.53, we are proposing 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 are also proposing 
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 are amending 
the definition of provider in Sec.  498.2 to include OTPs. We are 
continuing to review the application of the provider agreement 
requirements to OTPs and may make further amendments to parts 489 and 
498 as necessary to ensure that the existing provider agreement 
regulations are applied to OTPs consistent with our proposals and 
Section 2005 of the SUPPORT Act.
(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, we 
believe the existing SAMHSA certification and accreditation 
requirements are both 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 
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, 
CMS is not proposing any additional conditions for participation in 
Medicare by OTPs at this time. We welcome public comments on this 
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 propose to define ``opioid treatment program'' at Sec.  
410.67(b) as an entity that is an opioid treatment program as defined 
in 42 CFR 8.2 (or any successor regulation) and meets the applicable 
requirements for an OTP. We propose to codify this definition at Sec.  
410.67(b). In addition, we propose 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 are also proposing that an OTP must have a 
provider agreement as required by section 1866(a) of the Act. We 
propose to codify these requirements at Sec.  410.67(c). We welcome 
public comments on the proposed definition of OTP and the proposed 
Medicare requirements for OTPs.
3. Proposed 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 are 
proposing to establish bundled payments for OUD treatment services 
which, as discussed above, would include the medications approved by 
the FDA under section 505

[[Page 40524]]

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 proposed bundled payments, we propose 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 propose to calculate the full 
bundled payment rate by combining the drug component and the non-drug 
components. Below, we discuss our proposals for determining the bundled 
payments for OUD treatment services. As part of this discussion, we 
address payment rates for these services under the Medicaid and 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 propose to codify 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. We understand that many private 
payers cover services furnished by OTPs, and welcome 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 may consider this information as part of the development 
of the final bundled payment rates for OUD treatment services furnished 
by OTPs in the final rule.
(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 the intake/assessment, drug dispensing and screening and 
integrated psychosocial and medical treatment and supportive services), 
hereafter referred as the non-drug services. We note 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)(S), 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.\36\ Beneficiary cost-sharing consists of a flat copayment that 
may be applied to this weekly rate.
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    \36\ 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 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 fee-for-service 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.\37\ Drugs listed on Medicare's Part B ASP files are paid using 
the ASP.\38\ Drugs not appearing on the Medicare ASP file are paid at 
the lesser of billed charges or 95 percent of the AWP.\39\ 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.\40\
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    \37\ 81 FR 61080.
    \38\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
    \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\ 81 FR 61080.

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[[Page 40525]]

(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 medication-assisted treatment of OUD under 
their Medicaid programs. However, as of 2018, only 42 states covered 
methadone for MAT for OUD under their Medicaid programs.\41\ We note 
that section 1006(b) of the SUPPORT Act amends sections 1902 and 1905 
of the Social Security 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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    \41\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.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,\42\ while the unit of 
payment in Maryland for methadone maintenance is weekly,\43\ and 
Vermont uses a monthly unit \44\ of payment of these OUD treatment 
items and services.
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    \42\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \43\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \44\ 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; \45\ however, fewer than 70 percent 
cover the implanted or extended-release injectable versions of 
buprenorphine.\46\ In addition, all states cover the extended-release 
injectable naltrexone.\47\ We also found that many states pay different 
rates based on the specific type of drug used for MAT.
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    \45\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \46\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \47\ 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,\48\ Texas,\49\ and California) \50\ separately 
reimburse for individual and group counseling services, while other 
states (such as Vermont \51\ and New Mexico) \52\ included these 
services in the OUD bundled payment.
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    \48\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \49\ 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.
    \50\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \51\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
    \52\ 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 are proposing 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). 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 believe a weekly duration 
for an episode of care would be most familiar to OTPs and therefore the 
least disruptive to adopt. We welcome comments on whether we should 
consider a daily or monthly bundled payment. We are proposing to define 
an episode of care at Sec.  410.67(b) as a 1 week (contiguous 7-day) 
period.
    We recognize that patients receiving MAT are often on this 
treatment regimen for an indefinite amount of time and therefore, we 
are not proposing any maximum number of weeks during an overall course 
of treatment for OUD.
(a) Requirements for an Episode
    We note 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 recognize 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 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 propose 
that it could bill for a full weekly bundle. We are proposing 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).
(b) Partial Episode of Care
    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

[[Page 40526]]

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 are proposing 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 propose 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 propose 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 intend to monitor this issue and 
will consider whether we would need to make changes to this policy in 
future rulemaking to ensure that the billing for partial episodes is 
not being abused. We are proposing 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 seek 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 seek 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 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 welcome feedback regarding whether any 
other payers of OTP services allow for billing partial bundles and what 
thresholds they use.
(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 described in detail 
below), we are proposing 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 are proposing to codify this non-drug episode 
of care at Sec.  410.67(d).
(2) Drug and Non-Drug Components
    As discussed above, in establishing the bundled payment rates, we 
propose 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, we believe that the significant 
variation in the cost of these drugs needs 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 propose to base the OTP bundled payment rates, 
in part, on the type of medication used for treatment. Specifically, we 
propose 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 propose to create a category of bundled payment 
describing a drug not otherwise specified to be used for new drugs (as 
discussed further below). We are also proposing a non-drug bundled 
payment to be used when medication is not administered (as discussed 
further below). 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 propose 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).
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 propose that OTPs would bill 
for the episode of care using the medication not otherwise specified 
(NOS) code, HCPCS code GXXX9 (or GXXX19 for a partial episode). In such 
cases, we propose to use the typical or average maintenance dose to 
determine the drug cost for the new bundle. Then, we propose that 
pricing would be determined based on the relevant pricing methodology 
as described later in this section (section II.G.) of the proposed 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 propose 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 propose to use ASP-based payment when we receive 
manufacturer-submitted ASP data for

[[Page 40527]]

these drugs. In the event that we do not receive manufacturer-submitted 
ASP pricing data, we are considering several potential pricing 
mechanisms (as 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 are not proposing a specific pricing mechanism at this 
time for the situation in which we do not receive manufacturer-
submitted ASP pricing data, but are requesting public comment on 
several potential approaches for estimating the acquisition cost and 
payment amounts for these drugs. We will consider the comments received 
in developing our final policy for determining these drug prices. 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 propose to use invoice pricing until either ASP pricing 
data or the information necessary to apply the chosen pricing 
methodology becomes available to price the medication. We are proposing 
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 CMS has the opportunity to consider through 
rulemaking establishing a unique bundled payment for episodes of care 
during which the new drug is furnished. We welcome comments on this 
proposed approach to the treatment of new drugs used for MAT in OTPs.
    As discussed above, we also welcome 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 context of OUD treatment services provided by OTPs. 
We additionally welcome 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.
(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 are proposing 
to define as the FDA-approved opioid agonist and antagonist treatment 
medications, the dispensing and administration of such medications (if 
applicable), substance use disorder 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 SAMSHA 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 SAMSHA 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.
ii. Other Services
    As discussed earlier, we are proposing 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 are seeking 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. 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 are necessary. See below for additional discussion related to 
how we could price these services.
(3) Adjustment to Bundled Payment Rate for Additional Counseling or 
Therapy Services
    In addition to the items and services already included in the 
proposed bundles, we recognize 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. We seek to ensure that patients have access to these needed 
services. Accordingly, we are proposing 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, we assume

[[Page 40528]]

that a typical case might include one substance use counseling session, 
one individual therapy session, and one group therapy session per week. 
We further 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 expect that the medical necessity for billing 
the add-on code would be documented in the medical record. This add-on 
code (HCPCS code GXX19) would describe each additional 30 minutes of 
counseling or group or individual therapy furnished in a week of MAT, 
which could be billed in conjunction with the codes describing the full 
episode of care or the partial episodes. For example, 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. Additionally, we note that there may be situations in which 
the add-on code could be billed in conjunction with the code for a 
partial episode; for example, if a patient requires prolonged 
counseling services on the initial day of treatment, but does not 
return for any of the other services specified in their treatment plan, 
such as daily medication dispensing, for the remainder of that week. We 
acknowledge that an unintended consequence of using the treatment plan 
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 expect that OTPs will 
ensure that treatment plans reflect the full scope of services expected 
to be furnished during an episode of care and that they will update 
treatment plans regularly to reflect changes. We intend to monitor this 
issue and will consider whether we need to make changes to this policy 
through future rulemaking to ensure that this adjustment is not being 
abused. We welcome comments on the proposed add-on code and the 
threshold for billing. We propose to codify this adjustment to the 
bundled payment rate for additional counseling or therapy services in 
Sec.  410.67(d)(3)(i).
(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 are proposing 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 believe this is an appropriate approach because, as 
discussed previously, we expect 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 other health professional shortage areas could 
facilitate treatment through virtual care coming from an urban or other 
external site; however, we note 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 note 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, the 
restrictions of section 1834(m) of the Act would not apply. 
Additionally, we note 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 are proposing to include language in Sec.  410.67(b) in the 
definition of opioid use disorder 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 invite comment 
as to whether this proposal, including whether furnishing these 
services through communication technology is clinically appropriate. We 
also invite public comment on other components of the bundle that may 
be clinically appropriate to be furnished via communication technology, 
while also considering SAMHSA's guidance that OTPs should pay 
exceptional attention to data security and privacy.
(5) Coding
    We are proposing to adopt a coding structure for OUD treatment 
services that varies by the medication administered. To operationalize 
this approach, we are proposing 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 propose to 
establish partial episode G codes to correspond with each of those 
bundles, respectively. Additionally, we propose to create an add-on 
code to describe additional counseling that is furnished beyond the 
amount specified in the patient's treatment plan. As discussed above, 
we are seeking comment on whether to include intake activities and 
periodic assessments in the definition of OUD treatment services. Were 
we to finalize including these activities in the definition of OUD 
treatment services, we welcome feedback on whether we should consider 
modifying the payment associated with the bundle or creating add-on 
codes for services such as the

[[Page 40529]]

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 Clinical Lab 
Fee Schedule (CLFS). For example, 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 welcome 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 note 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 propose that the codes describing the 
bundled payment for an episode of care with a medication not otherwise 
specified, HCPCS codes GXXX9 and GXX18, 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 note 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 potential for misuse of such a 
code, we also welcome comments as to whether this code is needed.
    The codes and long descriptors for the proposed OTP bundled 
services are:
     HCPCS code GXXX1: 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 GXXX2: 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 GXXX3: 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 GXXX4: 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 GXXX5: 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 GXXX6: 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 GXXX7: 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 GXXX8: 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 GXXX9: 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 GXX10: 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); partial episode. Do not report with GXXX1.
     HCPCS code GXX11: 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); partial episode. Do not 
report with GXXX2.
     HCPCS code GXX12: 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); partial episode. Do not 
report with GXXX3.

[[Page 40530]]

     HCPCS code GXX13: 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); partial episode (only 
to be billed once every 6 months). Do not report with GXXX4.
     HCPCS code GXX14: 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); partial episode. Do 
not report with GXXX5.
     HCPCS code GXX15: 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); partial 
episode. Do not report with GXXX6.
     HCPCS code GXX16: 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); partial episode. Do not report with GXXX7.
     HCPCS code GXX17: 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); partial episode. Do not report with GXXX8.
     HCPCS code GXX18: 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); partial 
episode. Do not report with GXXX9.
     HCPCS code GXX19: 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.
    See Table 15 for proposed valuations for HCPCS codes GXXX1-GXX19. 
We propose that only an entity enrolled with Medicare as an OTP could 
bill these codes. Additionally, we propose 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.
(6) Payment Rates
    The codes describing the proposed OTP bundled services (HCPCS codes 
GXXX1-GXX19) would be assigned flat dollar payment amounts, which are 
listed in Table 15. 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 the section 1848 of the Act. Because OUD treatment services are 
not considered physicians' services and are paid outside the PFS, 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 are proposing 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 these 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 propose to use the typical or average maintenance dose, 
as discussed earlier in this section, to determine the drug costs for 
each of the proposed 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 propose 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 invite 
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 seek 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 note that the bundled payment rates are intended to be 
comprehensive with respect to the drugs provided; therefore, we do 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 do not anticipate to be 
significant in the OTP setting.
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 are 
proposing 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 do not believe that a cost-to-charge ratio based on 
such reported information could be available for a significant period 
of time. Furthermore, 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, at this time, we are 
proposing 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

[[Page 40531]]

another more direct assessment of drug acquisition cost, though we 
intend to continue to explore alternate ways to gather this 
information. As described in greater detail below, we propose that the 
payment amounts for the drug component of the bundles be based on CMS 
pricing mechanisms currently in place. We request 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 are proposing to include in the OTP bundled 
payments and for which we do not receive manufacturer-submitted ASP 
data, we are considering several potential approaches for determining 
the payment amounts for the drug component of the bundles. Although we 
are not proposing a specific pricing mechanism at this time, we are 
soliciting comments on several different approaches, and we intend 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 will begin by breaking the 
drugs into two categories based on their current coverage and payment 
by Medicare. First, we discuss the injectable and implantable drugs, 
which are generally covered and paid for under Medicare Part B, and 
then discuss the oral medications, which are generally covered and paid 
for under Medicare Part D.\53\ Buprenorphine (injection), buprenorphine 
(implant), and naltrexone (injection) would fall into the former 
category and methadone and buprenorphine (oral) would fall into the 
latter category.
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    \53\ 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.
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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 example, the Hospital Outpatient 
Prospective Payment System (OPPS) \54\).
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    \54\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
---------------------------------------------------------------------------

    In most cases, determining payment using the methodology in section 
1847A of the Act means payment is 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 \55\ 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 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.
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    \55\ 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 \56\ or average manufacturer price (AMP)-based price substitutions 
as authorized under section 1847A(d) of the Act.\57\ 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.\58\ We 
also use current AWP to make payment under the OPPS for very new drugs 
without an ASP.\59\ 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.\60\
---------------------------------------------------------------------------

    \56\ See 75 FR 73465-73466, the section titled Partial Quarter 
ASP data.
    \57\ See 77 FR 69140.
    \58\ Section 1842(o)(1)(A)(iv) of the Act.
    \59\ 80 FR 70426 and 80 FR 70442-3; Medicare Claims Processing 
Manual 100-04, Chapter 17, Section 20.1.3.
    \60\ Medicare Claims Processing Manual 100-04, Chapter 17, 
Section 20.1.3.
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    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

[[Page 40532]]

for more expensive drugs.\61\ 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.\62\
---------------------------------------------------------------------------

    \61\ See MedPAC Report to the Congress: Medicare and the Health 
Care Delivery System June 2015, pages 65-72.
    \62\ Ibid.
---------------------------------------------------------------------------

    We propose 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 propose 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 believe limiting the add-on will incentivize the use of 
the most clinically appropriate drug for a given patient. In addition, 
we understand that many OTPs purchase directly from drug manufacturers, 
thereby limiting the markup from distribution channels. We also propose 
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. Please note that the 
quarterly ASP Drug Pricing Files include ASP plus 6 percent payment 
amounts.\63\ 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. Proposed payment 
rates are provided below in this section of this proposed rule. A 
discussion of the proposed annual payment update methodology is also 
provided below. We propose to codify the ASP payment methodology for 
the drug component at Sec.  410.67(d)(2). We solicit 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.
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    \63\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
---------------------------------------------------------------------------

iii. Oral Drugs
    We propose 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 believe that using the ASP pricing data 
for oral OTP drugs currently covered under Part D \64\ would facilitate 
the computation of the estimated costs of these drugs. However, we do 
not collect ASP pricing information under section 1927(b) of the Act 
for these drugs. We request 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.
---------------------------------------------------------------------------

    \64\ 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 propose 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 a HCPCS code. We believe 
limiting the add-on will incentivize the use of the most clinically 
appropriate drug for a given patient. In addition, we understand that 
many OTPs purchase directly from drug manufacturers, thereby limiting 
the markup from distribution channels. We propose 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. Please note that the quarterly ASP Drug 
Pricing Files include ASP plus 6 percent payment amounts.\65\ 
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. Proposed payment rates are 
provided below in this section of this proposed rule. A discussion of 
the proposed annual payment update methodology is also provided below. 
We propose to codify the ASP payment methodology for the drug component 
at Sec.  410.67(d)(2). We solicit 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.
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    \65\ 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 are considering several potential 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. We are not proposing a specific pricing 
mechanism for these drugs at this time, but are requesting public 
comment on the following potential approaches for estimating the 
acquisition cost and payment amounts for these drugs and on alternative 
approaches. We will 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 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's 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.\66\ 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,

[[Page 40533]]

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.
---------------------------------------------------------------------------

    \66\ 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, 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. 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 Drug Plan Finder data available at the 
drafting of the CY 2020 PFS final rule. We note 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,\67\ 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.\68\
---------------------------------------------------------------------------

    \67\ 82 FR 50742 through 50745.
    \68\ 75 FR 49142.
---------------------------------------------------------------------------

    We believe that 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.\69\ 
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.
---------------------------------------------------------------------------

    \69\ 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 seek 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 
propose 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 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 
believe that 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. If we select this option to estimate the cost 
of certain drugs, we would develop pricing using the most recent data 
files available at the drafting of the 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 
propose 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

[[Page 40534]]

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), CMS believes 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. 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, 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. If we select this option, we 
would develop pricing using the most recent data files available at the 
drafting of the CY 2020 PFS final rule.
Alternative Methadone Pricing: TRICARE
    We are also considering an approach for estimating the cost of 
methadone using the amount calculated by TRICARE. As discussed above in 
this section of this proposed rule, the TRICARE rates for medications 
used in OTPs to treat opioid use disorder are spelled out in the 2016 
TRICARE final rule (81 FR 61068); in the regulations at Sec.  
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.\70\ 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.\71\
---------------------------------------------------------------------------

    \70\ 81 FR 61079.
    \71\ 81 FR 61079.
---------------------------------------------------------------------------

    This option would only be applicable for methadone because TRICARE 
has developed a fee-for-service payment methodology for buprenorphine 
and naltrexone.\72\ 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.\73\ 
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.\74\
---------------------------------------------------------------------------

    \72\ 81 FR 61080.
    \73\ 81 FR 61080.
    \74\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
---------------------------------------------------------------------------

    We believe that pricing methadone consistent with the TRICARE 
payment rate may 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.'' \75\
---------------------------------------------------------------------------

    \75\ 81 FR 61080.
---------------------------------------------------------------------------

    We are proposing 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). We request public comment 
on the potential alternative approaches set forth above for estimating 
the cost of oral drugs that we propose 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 are set forth 
in Table 14. We will consider the comments received on these different 
potential approaches when deciding on the approach that we will use to 
determine the payment rates for these drugs in the CY 2020 PFS final 
rule. We also invite 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. As noted previously, we welcome 
comments on how new drugs with a novel mechanism of action should be 
priced, and specifically whether pricing for non-opioid agonist and/or 
antagonist medications should be determined using the same pricing 
methodology, including the alternatives discussed above, as would be 
used for medications included in the proposed definition of OUD 
treatment services.

    TABLE 14--Estimated * Initial Drug Payment Rates for Each Pricing
                                Approach
------------------------------------------------------------------------
                                                      Estimated initial
    Pricing approach (or        Estimated initial    weekly drug payment
        alternative)           weekly drug payment        for oral
                                  for methadone         buprenorphine
------------------------------------------------------------------------
Proposal: ASP-Based Payment.  ASPs currently not    ASPs currently not
                               reported.             reported.
Approach 1: The Methodology   $29.61..............  $117.68.
 in Section 1847A of the Act.
Approach 2: Medicare's Part   22.47...............  97.65.
 D Prescription Drug Plan
 Finder Data.
Approach 3: WAC.............  27.93...............  111.02.
Approach 4: NADAC...........  11.76...............  97.02.

[[Page 40535]]

 
Alternative Methadone         22.19...............  N/A.
 Pricing: TRICARE.
------------------------------------------------------------------------
* The estimated payment amounts in this table are based on data files
  posted at the time of the drafting of this proposed rule. We would
  develop the final pricing for CY 2020 using the most recent data files
  available at the drafting of the CY 2020 PFS final rule.

(b) Non-Drug Component
    To price the non-drug component of the bundled payments, we are 
proposing 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 (that is, the Inpatient Prospective Payment System 
update factor) under TRICARE (81 FR 61079). The updated amount for CY 
2019 to $133.15 (of which $22.19 is the methadone cost and the 
remainder, $110.96, is for the non-drug services).\76\ We believe using 
the TRICARE weekly bundled rate is 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 recognize 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, 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 proposed bundled 
payments. We are proposing 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 this proposal, 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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    \76\ 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 includes daily administration 
of methadone, as part of our proposed approach 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 propose 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 understand 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 valued 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 propose 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 accounts for the fact that these injectable drugs are 
not oral drugs that are dispensed daily; we would then instead add 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). We propose to update the amount of this adjustment 
annually using the same methodology that we are proposing to use to 
update the non-drug component of the bundled payments.
    Similarly, 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 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, practice expense (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 HCPCS code GXXX5, 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 HCPCS code GXXX6, 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 HCPCS 
code GXXX7, 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)). The amounts for HCPCS codes 
G0516, G0517 and G0518 under the CY 2019 non-facility Medicare payment 
rate are $111.00, $126.86, and $204.70, respectively.
    In order to determine the payment rates for the code describing a 
non-drug bundled payment, HCPCS code GXXX8, we propose 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 propose that the payment rate for the add-on code, HCPCS code 
GXX19, would be based on 30 minutes of

[[Page 40536]]

substance use counseling and valued based on a crosswalk to the rates 
set by state Medicaid programs for similar services.
i. Medication Not Otherwise Specified
    We would expect the non-drug component for medication not otherwise 
specified bundled payments (HCPCS code GXXX9) to be consistent with the 
pricing methodology for the other bundled payments and therefore, 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 would adjust the 
TRICARE payment rate for non-drug services using the same methodology 
we are proposing for injectable medications above (to subtract an 
amount for daily dispensing and add the non-facility Medicare payment 
rate for administration of the injection). For implantable medications, 
we would also use the same methodology we propose above, with the same 
crosswalked non-facility Medicare payment rates (for insertion, 
removal, and insertion and removal). We welcome comments on all of the 
proposed pricing methodologies described in this section. As noted 
above, we also welcome comments on how new drugs with a novel mechanism 
of action (that is, drugs that are not opioid agonists and/or 
antagonists) should be priced. We additionally welcome 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 propose above for determining the 
payment rate for the non-drug component of an episodes of are 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.
(c) Partial Episode of Care
    For HCPCS codes GXX10 and GXX11 (codes describing partial episodes 
for methadone and oral buprenorphine), we propose 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 above 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 welcome comment on other methods that could be used to 
calculate these payment rates. We propose 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 HCPCS codes GXX12 and GXX16 (codes describing partial episodes 
for injectable buprenorphine and naltrexone), we propose 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 propose 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 HCPCS codes GXX13, GXX14, GXX15 (codes describing partial 
episodes for the buprenorphine implant insertion, removal, and 
insertion and removal, respectively) we propose that the payment rates 
for drug component would be the same as the payment rate for the 
corresponding weekly bundle. For the non-drug component, we propose 
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 $111.00, $126.86, and $204.70, 
respectively).
    For HCPCS code GXX17 (code describing a non-drug partial episode of 
care), we propose that the payment rate would be calculated by taking 
one half of the payment rate for the corresponding weekly bundle.
    We propose that the payment rate for the code describing partial 
episodes for a medication not otherwise specified (HCPCS code GXX18) 
would be calculated based on whether the medication is oral, injectable 
or implantable, following the methodology described above. For oral 
drugs, we would follow the methodology described for HCPCS codes GXX10 
and GXX11. For injectable drugs, we would follow the methodology 
described for HCPCS codes GXX12 and GXX16. For implantable drugs, we 
would follow the methodology described for HCPCS codes GXX13, GXX14, 
and GXX15. We welcome 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.
BILLING CODE 4120-01-P

[[Page 40537]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.007


[[Page 40538]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.008


[[Page 40539]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.009

BILLING CODE 4120-01-C
(8) Place of Service (POS) Code for Services Furnished at OTPs
    We are creating a new POS code specific to OTPs since there are no 
existing POS codes that specifically describe OTPs. Claims for OTP 
services would include this place of service code. We note that POS 
codes are available for use by all payers. We are not proposing to make 
any differential payment based on the use of this new POS code. Further 
guidance will be issued regarding the POS code that should be used by 
OTPs.
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. We 
note that many of the individual items or services provided by OTPs 
that would be included in the bundled payment rates under our proposal 
may also be appropriately available to beneficiaries through other 
Medicare benefits. Although we recognize the potential for significant 
program integrity concerns when similar items or services are payable 
under separate Medicare benefits, we also believe that 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, we 
believe that 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, we believe 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 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 believe 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 propose 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 propose to codify this policy at Sec.  410.67(d)(4). We understand 
that some OTPs negotiate arrangements whereby community pharmacies 
supply MAT-related medications to OTPs. 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 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. CMS intends to monitor for 
duplicative payments, and would take appropriate action as needed when 
such duplicative payments are identified. Therefore, we are proposing 
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 
propose to codify this policy at Sec.  410.67(d)(4). CMS notes 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.

[[Page 40540]]

d. Cost Sharing
    Section 2005(c) of the SUPPORT Act amends 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 are proposing 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 also ensures 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.\77\ We intend to continue to 
monitor the opioid crisis in order to determine at what point in the 
future a copayment may be imposed. At such a time we deem appropriate, 
we would institute cost sharing through future notice and comment 
rulemaking. We welcome feedback from the public 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 proposed 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 recognize that setting the copayment for OUD services at a 
non-zero amount could create a barrier to access to treatment for many 
beneficiaries. We propose to codify the proposed copayment amount of 
zero at Sec.  410.67(e). We welcome 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.
---------------------------------------------------------------------------

    \77\ 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 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 note 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.
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.
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 OTP 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. As we believe OTP treatment services will also 
be subject to varying cost based upon the geographic locality where the 
services are furnished, we propose to apply a geographic locality 
adjustment to the bundled payment rate for OTP treatment services. 
Below, we discuss our proposed approach with respect to 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 reflect national pricing, and because there is no 
geographic adjustment factor applied to the payment of Part B drugs 
under the ASP methodology, we do not believe that it is necessary to 
adjust the drug component of the bundled payment rates for OTP services 
based upon geographic locality. Therefore, we are proposing not to 
apply a geographic locality adjustment to the drug component of the 
bundled payment rate for OTP services.
(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 
treatments 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, we believe it would be appropriate to 
apply a geographic locality adjustment to the non-drug component of the 
bundled payments. We believe that the geographic variation in cost of 
the non-drug services provided by OTPs will 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 are proposing 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

[[Page 40541]]

three fee schedule components (work, PE, and malpractice).
    Although we are proposing to adjust the non-drug component of the 
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 the OTP bundled 
payment is a flat rate payment for all OUD treatment services furnished 
during an episode of care, 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 are proposing to use the 
Geographic Adjustment Factor (GAF) at Sec.  414.26. Specifically, we 
are proposing 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 this 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 the non-drug component of 
OUD treatment services is comprised of work, PE, and malpractice 
expenses, we ultimately decided to propose using the GAF as we believe 
the weighted composite of all three GPCIs reflected in the GAF would be 
the more appropriate geographic adjustment factor to reflect geographic 
variations in the cost of furnishing these services.
    The GAF, which is determined under Sec.  414.26, is further 
discussed earlier in section II.D.1. of this proposed rule and the 
specific GAF values for each payment locality are posted in Addendum D 
to this proposed 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 have opted to propose using the GAF as we believe 
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 propose 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 invite public 
comment on our 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 welcome comments on any 
factors, other than the GAF, that could be used to make this payment 
adjustment.
    Additionally, we note that the majority of OTPs operate in urban 
localities. In light of this fact, we are interested in receiving 
information on whether rural areas have appropriate access to treatment 
for OUD. We are 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 invite public comment on this issue and 
potential solutions we could consider adopting to address this 
potential issue through future rulemaking.
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 are proposing 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 propose 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 are proposing 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 are proposing 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. As an example, if we were to finalize our proposal to price 
the drug component of the bundled payment rate for episodes of care 
that include injectable and implantable drugs generally covered and 
paid under Medicare Part B 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. Similarly, if we finalize our proposal to 
price the drug component of the bundled payment rate for episodes of 
care that include oral drugs using ASP data, if such data are 
available, we would also update the pricing of the drug component using 
the most recently available ASP data at the time of ratesetting for the 
applicable calendar year. Previously, 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 also be updated using the most recently 
available NADAC data at the time of ratesetting for the applicable 
calendar year. We propose to codify this methodology for determining 
the annual update to the payment rate for the drug component at Sec.  
410.67(d)(3)(i).
    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 believe that it is important 
to apply an annual update to the payment rates that recognizes the 
differing rate of growth of drug costs

[[Page 40542]]

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, which measures the average change over time 
in the selling prices received by domestic producers for their output. 
Ultimately we decided against updating 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 believe the proposed approach updated the pricing of the drug 
component of the OUD treatment services payment rate in the manner most 
familiar to stakeholders. We invite public comment on our proposed 
approach to updating the drug component of the bundled payment rates. 
We also seek 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.
(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 are proposing 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' practice expenses, with an adjustment for 
the change in economy-wide, private nonfarm business multifactor 
productivity. 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 considered other potential update factors, such as the Bureau 
of Labor Statistics Consumer Price Index for All Items for Urban 
Consumers (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 Consumer Price Index 
for All Items (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 believe 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 propose 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 propose to codify this proposal at Sec.  
410.67(d)(3)(iii). We invite public comment on this proposal.

H. Bundled Payments Under the PFS for Substance Use Disorders

1. Background and Proposal
    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 are proposing to establish 
bundled payments for the overall treatment of OUD, including 
management, care coordination, psychotherapy, and counseling 
activities. We note that, if a patient's treatment involves MAT, this 
proposed 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 are also proposing in this proposed rule 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 proposed 
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.
    To implement this new bundled payment, we are proposing 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

[[Page 40543]]

implanted buprenorphine) in the office setting compared to the OTP 
setting. Based on feedback we received through the comment 
solicitation, we are proposing 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 welcome comments on 
whether we should consider creating a separately billable 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 are proposing 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 non-physician practitioner 
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 are not proposing to require consultation with a specialist as a 
condition of payment for these codes.
    The codes and descriptors for the proposed services are:
     HCPCS code GYYY1: 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 GYYY2: 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 GYYY3: 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 GYYY1 and GYYY2, 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 GYYY1, GYYY2, and GYYY3 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 are proposing that the add-on code 
(HCPCS code GYYY3) 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 are 
proposing that when the time requirement is met, HCPCS code GYYY3 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 welcome comments on this proposal.
    We are proposing to value HCPCS codes GYYY1, GYYY2, and GYYY3 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 GYYY1, 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

[[Page 40544]]

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 GYYY1 is also based 
on a crosswalk to CPT codes 99492. Additionally, for HCPCS code GYYY1, 
we are proposing 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 practice expense described 
by these crosswalk codes is analogous to the services described in 
HCPCS code GYYY1 because HCPCS code GYYY1 includes similar care 
coordination activities as described in CPT code 99492 and bundles in 
the psychotherapy services described in CPT codes 90832 and 90853.
    We are proposing to value HCPCS code GYYY2 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 GYYY2 is also based on a crosswalk to CPT codes 99493. For HCPCS 
code GYYY2, we are proposing 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 practice expense 
described by these crosswalk codes is analogous to the services 
described in HCPCS code GYYY2 because HCPCS code GYYY2 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 are proposing to value HCPCS code GYYY3 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 GYYY2 is 
also based on a crosswalk to CPT codes 99493. For HCPCS code GYYY3, we 
are proposing to use a crosswalk to the direct PE inputs associated 
with CPT code 99494. We believe that the work and practice expense 
described by this crosswalk code is analogous to the services described 
in HCPCS code GYYY3 because HCPCS code GYYY3 includes similar care 
coordination activities as described in CPT code 99494.
    For additional details on the proposed direct PE inputs for HCPCS 
codes GYYY1-GYYY3, see Table 22.
    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 
are proposing 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 GYYY1, GYYY2, 
and GYYY3. We welcome comments on this proposal.
    We are proposing 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 propose 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 proposed services described by HCPCS codes 
GYYY1-GYYY3. 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 propose that 
these visits could similarly serve as the initiating visit for OUD 
services.
    We are proposing that the counseling, therapy, and care 
coordination described in the proposed 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 are also 
proposing 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,

[[Page 40545]]

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 are proposing 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 are proposing 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 are also proposing to allow any of the individual therapy, group 
therapy and counseling services included in HCPCS codes GYYY1, GYYY2, 
and GYYY3 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 proposed rule regarding Telehealth Services, like 
certain other non-face-to-face PFS services, the components of HCPCS 
codes GYYY1 through GYYY3 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 GYYY1 
through GYYY3 are similar to other telehealth services. If the non-
face-to-face components of HCPCS codes GYYY1 through GYYY3 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 proposed rule, 
Telehealth Services, we are proposing to add HCPCS codes GYYY1, GYYY2, 
and GYYY3 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 proposed services described above (HCPCS codes GYYY1, 
GYYY2, and GYYY3), we seek 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 proposed rule, Medicare 
Coverage for Certain Services Furnished by Opioid Treatment Programs, 
we are proposing 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 new using any 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 are seeking 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 welcome feedback from stakeholders and the public 
on other potential bundles describing services for other substance use 
disorders for our consideration in future rulemaking.
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.

[[Page 40546]]

    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 proposed bundled payment under the PFS for OUD 
treatment furnished by physicians, we reviewed the applicability of 
RHCs and FQHCs 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 GYYY1 and 
GYYY2, beginning on January 1, 2020. The requirements to bill the 
services would be similar to the requirements under the PFS for GYYY1 
and GYYY2, 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 do not believe that adding a new 
and separate code to report a bundle of OUD services is necessary. 
Therefore, we are not proposing to add a new G code for a bundle of OUD 
service.

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 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 for PAs regarding 
physician supervision across some states. According to these 
commenters, some states have already relaxed 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 invite 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 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. Proposal
    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 are proposing to 
revise the regulation at Sec.  410.74 that establishes physician 
supervision requirements for PAs. Specifically, we are proposing to

[[Page 40547]]

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 provided 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 
proposed 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 nonphysician practitioners as members of the medical team. As 
we are informed about transitions in state law and state 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 proposal on this issue largely 
defers to state law and state 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.

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 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).
    We are aware that nonphysician practitioners 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 nonphysician practitioners 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 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 nonphysician practitioner 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

[[Page 40548]]

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. Proposal
    After considering the concerns expressed by these stakeholders, 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 propose 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. This principle would apply across the spectrum of all 
Medicare-covered services paid under the PFS. Because this proposal is 
intended to apply broadly, we propose 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. We invite 
comments on this proposal.
    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 are proposing 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.'' 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 note 
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 does 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 are also proposing 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 invite comments on these proposed amendments to our regulations.

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 practitioner, their clinical staff, 
or both (see Table 16). 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.

           Table 16--Summary of Special Care Management Codes
------------------------------------------------------------------------
                Service                              Summary
------------------------------------------------------------------------
Care Plan Oversight (CPO) (also          Supervision of home health,
 referred to as Home Health               hospice, per month.
 Supervision, Hospice Supervision)
 (HCPCS Codes G0181, G0182).
ESRD Monthly Services (CPT Codes 90951-  ESRD management, with and
 70).                                     without face-to-face visits,
                                          by age, per month.
Transitional Care Management (TCM)       Management of transition from
 (adopted in 2013) (CPT Codes 99495,      acute care or certain
 99496).                                  outpatient stays to a
                                          community setting, with face-
                                          to-face visit, once per
                                          patient within 30 days post-
                                          discharge.
Chronic Care Management (CCM) (adopted   Management of all care for
 in 2015, 2017, 2019) (CPT Codes 99487,   patients with two or more
 99489, 99490, 99491).                    serious chronic conditions,
                                          timed, per month.
Advance Care Planning (ACP) (adopted in  Counseling/discussing advance
 2016) (CPT Codes 99497, 99498).          directives, face-to-face,
                                          timed.
Behavioral Health Integration (BHI)      Management of behavioral health
 (adopted in 2017) (CPT Codes 99484,      conditions(s), timed, per
 99492, 99493, 99494).                    month.
Assessment/Care Planning for Cognitive   Assessment and care planning of
 Impairment (adopted in 2017) (CPT Code   cognitive impairment, face-to-
 99483).                                  face visit.
Prolonged Evaluation & Management (E/M)  Non-face-to-face E&M work
 Without Direct Patient Contact           related to a face-to-face
 (adopted in 2017) (CPT Codes 99358,      visit, timed.
 99359).

[[Page 40549]]

 
Remote Patient Monitoring (adopted in    Review and analysis of patient-
 2019) (CPT Code 99091).                  generated health data, timed,
                                          per 30 days.
Interprofessional Consultation (adopted  Inter-practitioner
 in 2019) (CPT Codes 99446, 99447,        consultation.
 99448, 99449, 99451, 99452).
------------------------------------------------------------------------

    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 proposed rule, we continue our ongoing work in this area through 
code set refinement related to TCM services and CCM services, in 
addition to proposing 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. 
Specifically, 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, based upon an analysis of claims data by Bindman 
and Cox,\78\ utilization of TCM services is low when compared to the 
number of Medicare beneficiaries with eligible discharges. 
Additionally, 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 TCM services could positively affect 
patient outcomes.
---------------------------------------------------------------------------

    \78\ 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 a proposal designed to increase utilization of TCM 
services, we considered possible factors contributing 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 services.
    We focused initially on the requirements for billing TCM services. 
In reviewing the 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 cannot 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 upon their creation. 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; 
although, many of these codes were not separately payable or covered 
under the PFS so even if they were reported for PFS payment, they would 
not be have been separately paid (see, for example, 77 FR 68985). In 
response to those 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 remain either bundled, noncovered by 
Medicare, or invalid for Medicare payment purposes. Table 17 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 this year's CY 2020 proposed 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 may not 
substantially overlap with TCM services and should be separately 
payable alongside 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. CPT code 99091 (Collection 
& interpretation of physiologic data, requiring a minimum of 30 minutes 
each 30 days) would permit the physician or other qualified healthcare 
professional to collect and analyze physiologic parameters associated 
with the patient's chronic disease.
    Thus, after review of the services described by these 14 HCPCS 
codes, we believe these codes, when medically necessary, may complement 
TCM services rather than substantially overlap or duplicate services. 
We also believe removing the billing restrictions associated with these 
codes may increase utilization of TCM services.

  Table 17--14 HCPCS Codes That Currently Cannot Be Billed Concurrently
    With TCM by the Same Practitioner and Are Active Codes Payable by
                              Medicare PFS
------------------------------------------------------------------------
           Code family              HCPCS code         Descriptor
------------------------------------------------------------------------
Prolonged Services without Direct        99358  Prolonged E/M service
 Patient Contact.                                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.
                                         99359  Prolonged E/M service
                                                 before and/or after
                                                 direct patient care;
                                                 each additional 30
                                                 minutes beyond the
                                                 first hour of prolonged
                                                 services.

[[Page 40550]]

 
Home and Outpatient International        93792  Patient/caregiver
 Normalized Ratio (INR)                  93793   training for initiation
 Monitoring Services.                            of home INR monitoring.
                                                Anticoagulant management
                                                 for a patient taking
                                                 warfarin; includes
                                                 review and
                                                 interpretation of a new
                                                 home, office, or lab
                                                 INR test result,
                                                 patient instructions,
                                                 dosage adjustment and
                                                 scheduling of
                                                 additional test(s).
End Stage Renal Disease Services         90960  ESRD related services
 (patients who are 20+ years).                   monthly with 4 or more
                                                 face-to-face visits per
                                                 month; for patients 20
                                                 years and older.
                                         90961  ESRD related services
                                                 monthly with 2-3 face-
                                                 to-face visits per
                                                 month; for patients 20
                                                 years and older.
                                         90962  ESRD related services
                                                 with 1 face-to-face
                                                 visit per month; for
                                                 patients 20 years and
                                                 older.
                                         90966  ESRD related services
                                                 for home dialysis per
                                                 full month; for
                                                 patients 20 years and
                                                 older.
                                         90970  ESRD related services
                                                 for dialysis less than
                                                 a full month of
                                                 service; per day; for
                                                 patient 20 years and
                                                 older.
Interpretation of Physiological          99091  Collection &
 Data.                                           interpretation of
                                                 physiologic data,
                                                 requiring a minimum of
                                                 30 minutes each 30
                                                 days.
Complex Chronic Care Management          99487  Complex Chronic Care
 Services.                               99489   with 60 minutes of
                                                 clinical staff time per
                                                 calendar month.
                                                Complex Chronic Care;
                                                 additional 30 minutes
                                                 of clinical staff time
                                                 per month.
Care Plan Oversight Services.....        G0181  Physician supervision of
                                                 a patient receiving
                                                 Medicare-covered
                                                 services provided by a
                                                 participating home
                                                 health agency (patient
                                                 not present) requiring
                                                 complex and
                                                 multidisciplinary care
                                                 modalities within a
                                                 calendar month; 30+
                                                 minutes.
                                         G0182  Physician supervision of
                                                 a patient receiving
                                                 Medicare-covered
                                                 hospice services (Pt
                                                 not present) requiring
                                                 complex and
                                                 multidisciplinary care
                                                 modalities; within a
                                                 calendar month; 30+
                                                 minutes.
------------------------------------------------------------------------

    Thus, with the goal of increasing medically appropriate use of TCM 
services, we are proposing to revise our billing requirements for TCM 
by allowing TCM codes to be billed concurrently with any of these 
codes. Before we finalize such a rule, however, we seek comment on 
whether overlap of services exists, and if so, which services should be 
restricted from being billed concurrently with TCM. We also seek 
comment on whether any overlap would depend upon whether the same or a 
different practitioner reports the services. We note that CPT reporting 
rules generally apply at the practitioner level, and we are seeking 
input from stakeholders as to whether our policy should differ based on 
whether it is the same or a different practitioner reporting the 
services. We are seeking comment on whether 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) 
overlaps with TCM or should be reportable and separately payable in the 
same service period.
    As part of our analysis of the utilization data for TCM services, 
we also examined how current payment rates for TCM might negatively 
affect the appropriate utilization of TCM services, an idea proposed by 
Bindman and Cox. 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 
during 2018 as part of a regular RUC review of new technologies or 
services. 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 two TCM codes, the RUC recommended a 
slight increase in work RVUs for both codes. We believe the results 
from the new survey will better reflect the work involved in furnishing 
TCM services as care management services. Thus, also for CY 2020, we 
are proposing 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 are not 
proposing any direct PE refinements to the RUC's recommendations for 
this code family.
3. Chronic Care Management (CCM) Services
    CCM services are comprehensive care coordination services per 
calendar month, furnished by a physician or non-physician practitioner 
(NPP) managing overall care and their clinical staff, for patients with 
two or more serious chronic conditions. There are currently two 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). Table 17 provides a high-level 
summary of the CCM service elements.
    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.\79\ 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

[[Page 40551]]

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

    \79\ 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. 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.
    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. Some stakeholders continue to recommend that, in addition to 
separate payment for the complex CCM codes, we should create an add-on 
code for non-complex CCM, such that non-complex CCM would be defined 
and valued in 20-minute increments of time with additional payment for 
each additional 20 minutes, or extra payment for 20 to 40 minutes of 
clinical staff time spent performing care management activities.
    We agree that coding changes that identify additional time 
increments would improve payment accuracy for non-complex CCM. 
Accordingly, we propose 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 describe the initial 20 minutes of 
clinical staff time, and the second G code would describe each 
additional 20 minutes thereafter. We intend 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 would consider adopting any CPT code(s) once the CPT Editorial Panel 
completes its work. We acknowledge 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 are seeking 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 are proposing 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 propose a work RVU of 0.61 for 
HCPCS code GCCC1, which we crosswalked from CPT code 99490. We believe 
these codes have a similar amount of work since they would have the 
same intra-service time of 15 minutes.
    We propose 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 are proposing a work 
RVU of 0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107 
(Incisional biopsy of skin (eg, 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 believe accurately reflects the work associated with each 
additional 20 minutes of CCM services. Both codes have the same 
intraservice time of 15 minutes. We note 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, 
CPT code 11107 shares a similar work intensity to proposed HCPCS code 
GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2 share the same 
intraservice time, add-on codes often have lower intensity than the 
base codes because they describe the continuation of an already 
initiated service.
    We are soliciting public comment on whether we should limit the 
number of times this add-on code (HCPCS code GCCC2) can be reported in 
a given service period for a given beneficiary. It

[[Page 40552]]

is 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 be 
already described under existing coding for complex CCM. 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 note that complex CCM already describes (in part) 60 or 
more minutes of clinical staff time in a service period. We are seeking 
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.
b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes 
GCCC3 and GCCC4)
    Currently, the CPT codes for complex CCM include in the code 
descriptors a requirement for establishment or substantial revision of 
the comprehensive care plan (see above). 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 propose 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 believe 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 
believe it is unnecessary as a means of distinguishing eligible 
patients. Instead of CPT code 99487, we propose 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 are proposing a work RVU of 1.00 for HCPCS code GCCC3, 
which is a crosswalk to CPT code 99487.
    Instead of CPT code 99489, we propose 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 
management services of less than 30 minutes additional to the first 60 
minutes of complex chronic care management services during a calendar 
month)). We are proposing a work RVU of 0.50 for HCPCS code GCCC4, 
which is a crosswalk to CPT code 99489.
    We intend 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 would consider adopting any 
new or revised complex CCM CPT code(s) once the CPT Editorial Panel 
completes its work. We acknowledge 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 are seeking 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.
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 
have 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. We note 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 are proposing 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 believe simpler language would 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

[[Page 40553]]

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.
    Our proposed new language would 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 welcome 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.
    Additional information regarding the existing requirements for 
billing CCM, including links to prior rules, is available on our 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
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 are proposing separate coding and 
payment for Principal Care Management (PCM) services, which describe 
care management services for one serious chronic condition. A 
qualifying condition would typically be expected to last between three 
months and a 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.
    While we are not proposing any restrictions on the specialties that 
could bill for PCM, we expect that most of these services would 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 would 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 would be billed when a single condition is of such complexity 
that it could not 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. While 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 
would still oversee the overall care for the patient while the 
practitioner billing for PCM services would 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 would also be able to bill for PCM services. We are 
proposing 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 
would 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 are proposing to make separate payment for PCM 
services via two new G codes: HCPCS code GPPP1 (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 GPPP2 (Comprehensive care management for a single high-risk 
disease services, e.g., Principal Care Management, at least 30 minutes 
of clinical staff time directed by a physician or other qualified 
health care professional, per calendar month with the following 
elements: One complex chronic condition lasting at least 3 months, 
which is the focus of the care plan, the condition is of sufficient 
severity to place patient at risk of hospitalization or have been cause 
of a recent hospitalization, the condition requires development or 
revision of disease-specific care plan, the condition requires frequent 
adjustments in the medication regimen, and/or the management of the 
condition is unusually complex due to comorbidities). HCPCS code GPPP1 
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

[[Page 40554]]

single high risk disease or complex chronic condition. HCPCS code GPPP2 
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 GPPP1, we are proposing 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 
GPPP1 and the physician work is of similar intensity. Therefore, we are 
proposing a work RVU of 1.28 for HCPCS code GPPP1.
    For HCPCS code GPPP2 we are proposing 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 would be the same. Therefore, we are proposing a work RVU 
of 0.61 for HCPCS code GPPP2.
    While we are proposing 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 are seeking 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 acknowledge that we are concurrently proposing revisions for 
both complex and non-complex CCM services. Were we not to finalize the 
proposed changes for both complex and non-complex CCM services, we 
believe 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 are seeking 
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.
    While 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 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. While we 
are not proposing additional requirements for the proposed 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 are seeking 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.
    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 are proposing that the full CCM scope of service 
requirements apply to PCM, including documenting the patient's verbal 
consent in the medical record. We are seeking 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 18 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 are seeking comment 
on how best to educate practitioners and beneficiaries on the benefits 
of PCM services.
    Additionally, we are proposing to add GPPP2 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). Due 
to the potential for duplicative payment, we are proposing 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 are also proposing that PCM would not be billable by the 
same practitioner for the same patient during a surgical global period, 
as we believe those resource costs would already be included in the 
valuation of the global surgical code.

           Table 18--Chronic Care Management Services Summary
------------------------------------------------------------------------
                          CCM Service Summary *
-------------------------------------------------------------------------
Verbal Consent:
     Inform regarding availability of the service; that only one
     practitioner can bill per month; the right to stop services
     effective at the end of any service period; and that cost sharing
     applies (if no supplemental insurance).
     Document that consent was obtained.
Initiating Visit for New Patients (separately paid).
Certified Electronic Health Record (EHR) Use:
     Structured Recording of Core Patient Information Using
     Certified EHR (demographics, problem list, medications, allergies).

[[Page 40555]]

 
24/7 Access (``On Call'' Service).
Designated Care Team Member.
Comprehensive Care Management:
     Systematic needs assessment (medical and psychosocial).
     Ensure receipt of preventive services.
     Medication reconciliation, management and oversight of self-
     management.
Comprehensive Electronic Care Plan:
     Plan is available timely within and outside the practice
     (can include fax).
     Copy of care plan to patient/caregiver (format not
     prescribed).
     Establish, implement, revise or monitor the plan.
Management of Care Transitions/Referrals (e.g., discharges, ED visit
 follow up, referrals):
     Create/exchange continuity of care document(s) timely
     (format not prescribed).
Home- and Community-Based Care Coordination:
     Coordinate with any home- and community-based clinical
     service providers, and document communication with them regarding
     psychosocial needs and functional deficits.
Enhanced Communication Opportunities:
     Offer asynchronous non-face-to-face methods other than
     telephone, such as secure email.
------------------------------------------------------------------------
* All elements that are medically reasonable and necessary must be
  furnished during the month, but all elements do not necessarily apply
  every month. Consent need only be obtained once, and initiating visits
  are only for new patients or patients not seen within a year prior to
  initiation of CCM.

    We are also seeking comment on any potential for duplicative 
payment between the proposed 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/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)).
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 in 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 994X0 (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 994X0, 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 do 
not agree with the RUC-recommended work RVU of 0.61 for the add-on 
code. Instead, we are proposing a work RVU of 0.50 for the add-on code. 
This value is supported by CPT code 88381 (Microdissection (i.e., 
sample preparation of microscopically identified target); manual), 
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 are proposing the RUC-recommended direct PE 
inputs for CPT code 994X0.
    Finally, we are proposing that RPM services reported with CPT codes 
99457 and 994X0 may be furnished under general supervision rather than 
the currently required direct supervision. Because care management 
services include establishing, implementing, revising, or monitoring 
treatment plans, as well as providing support services, and because RPM 
services (that is, CPT codes 99457 and 994X0) 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 believe that CPT codes 99457 and 994X0 should be included 
as designated care management services. Designated care management 
services can be furnished under general

[[Page 40556]]

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.
6. Comment Solicitation on Consent for Communication Technology-Based 
Services
    In the CY 2019 PFS Final Rule, CMS finalized separate payment for a 
number of services that could be furnished via telecommunications 
technology. Specifically, CMS 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 59490-59491), 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 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, 
we are seeking comment on whether a single advance beneficiary consent 
could be obtained for a number of communication technology-based 
services. During the consent process, the practitioner would make sure 
the beneficiary is aware that utilization of these services will result 
in a cost sharing obligation. We are seeking 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 one year period, or for a set number of services, after which 
a new consent would need to be obtained. We are also seeking comment on 
the potential program integrity concerns associated with allowing 
advance consent and how best to minimize those concerns.
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, or general 
behavioral health services. Payment for this service is set at the 
average of the national, non-facility payment rates for CPT codes 
99490, 99487, and 99484. We are proposing 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 are finalized for practitioners billing under the PFS. We 
note that we are not proposing any changes in the valuation of these 
codes. Upon finalization, the payment for HCPCS code G0511 would be set 
at the average of the national, non-facility payment rates for HCPCS 
codes GCCC1 and GCCC3 and CPT code 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.

[[Page 40557]]

    In addition to screening tests, which typically are furnished to 
patients in the absence of signs or symptoms of illness 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 can be found 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. We invite 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. We specifically invite 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 note that we would consider 
adopting such a requirement in the final rule in accordance with public 
comments. We also invite 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.

[[Page 40558]]

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. 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. 
We are now proposing 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. We propose 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 propose 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 are also proposing 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 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).
2. Proposed 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

[[Page 40559]]

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
    CMS interprets 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.
    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 
propose 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 propose 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 propose 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 propose 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 propose to apply the CQ/CO modifier policies to all 
services that would be billed with the respective GP or GO therapy 
modifier. We believe this is 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.

[[Page 40560]]

    For purposes of deciding whether the 10 percent de minimis standard 
is exceeded, we offer 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 propose 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 is required to be added to the claim for that service. As 
noted above, we propose 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 19 for minutes needed to meet or 
exceed using the ``simple'' method with typical times for the total 
time of a therapy service.

                       Table 19--Simple Method for Determining When CQ/CO Modifiers Apply
----------------------------------------------------------------------------------------------------------------
                        Method Two: simple method to apply 10 percent de minimis standard
-----------------------------------------------------------------------------------------------------------------
                               Determine the 10 percent
Total Time * examples using      standard by dividing      Round 10 percent standard   PTA/OTA Minutes needed to
typical service total times    service Total Time by 10      to next whole integer        exceed--apply CQ/CO
----------------------------------------------------------------------------------------------------------------
                       10                          1.0                         1.0                         2.0
                       15                          1.5                         2.0                         3.0
                       20                          2.0                         2.0                         3.0
                       30                          3.0                         3.0                         4.0
                       45                          4.5                         5.0                         6.0
                       60                          6.0                         6.0                         7.0
                       75                          7.5                         8.0                         9.0
----------------------------------------------------------------------------------------------------------------
Total Time equals total therapist minutes plus any PTA/OTA independent minutes. Concurrent minutes: When PTA/
  OTA's minutes are furnished concurrently with the therapist, total time equals the total minutes of the
  therapist's service. Separate minutes: When PTA/OTA's minutes are furnished separately from the minutes
  furnished by the therapist, total time equals the sum of the minutes of the service furnished by the PT/OT
  plus the minutes of the service furnished separately by the PTA/OTA.

    We want to clarify 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.
    As we indicated in the CY 2019 PFS final rule, we are addressing 
more specifically in this proposed rule the application of the 10 
percent de minimis standard in various clinical scenarios to decide 
when the CQ/CO modifiers apply. We acknowledge that application of the 
10 percent de minimis standard can work differently depending on the 
types of services and scenarios involving both 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. We address our 
proposals for applying the CQ/CO modifiers using the 10 percent de 
minimis standard, along with applicable billing scenarios, by category 
below. In each of these scenarios, we assume 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

[[Page 40561]]

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 19.
     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 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

[[Page 40562]]

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 proposed regulations at 
Sec. Sec.  410.59(a)(4) and 410.60(a)(4), we propose 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 proposal to revise our documentation requirement for the 
daily treatment note extends 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 seek 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 are also interested in hearing 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 proposed 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 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 
anticipate that we will add examples to illustrate when the applicable 
therapy assistant modifiers must be applied, similar to the examples 
provided below.
    We are providing the following 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. 
These examples reflect how the therapist or therapy provider would 
decide whether the CQ or CO therapy assistant modifier should be 
included when billing for one or more service units of the 15-minute 
timed codes. In the following scenarios, ``PT'' is used to represent 
physical therapist and ``OT'' is used to refer to an occupational 
therapist for ease of reference; and, the services of the PTA/OTA are 
assumed to be therapeutic in nature, and not services that a technician 
or aide without the education and training of a PTA/OTA could provide.
     Scenario One: Where only one service, described by a 
single HCPCS code defined in 15-minute increments, is furnished in a 
treatment day:
    (1) The PT/OT and PTA/OTA each separately, that is individually and 
exclusively, furnish minutes of the same therapeutic exercise service 
(HCPCS code 97110) in different time frames: The PT/OT furnishes 7 
minutes and the PTA furnishes 7 minutes for a total of 14 minutes, one 
unit can be billed using the total time minute range of at least 8 
minutes and up to 22 minutes.
    Billing Example: One 15-minute unit of HCPCS code 97110 is reported 
on the claim with the CQ/CO modifier to signal that the time of the 
service furnished by the PTA/OTA (7 minutes) exceeded 10 percent of the 
14-minute total service time (1.4 minutes rounded to 1 minute, so the 
modifier would apply if the PTA/OTA had furnished 2 or more minutes of 
the service).
    (2) The PT/OT and PTA/OTA each separately, exclusive of the other, 
furnish minutes of the same therapeutic exercise service (HCPCS code 
97110) in different time frames: The PT/OT furnishes 20 minutes and the 
PTA/OTA furnishes 25 minutes for a total of 45 minutes, three units can 
be billed using the total time minute range of at least 38 minutes and 
up to 52 minutes.
    Billing Example: All three units of CPT code 97110 are reported on 
the claim with the corresponding CQ/CO modifier because the 25 minutes

[[Page 40563]]

furnished by the PTA/OTA exceeds 10 percent of the 45-minute total 
service time (4.5 minutes rounded to 5 minutes, so the modifier would 
apply if the PTA/OTA had furnished 6 or more minutes of the service).
    (3) The PTA/OTA works concurrently with the respective PT/OT as a 
team to furnish the same neuromuscular reeducation service (HCPCS code 
97112) for a 30-minute session, resulting in 2 billable units of the 
service (at least 23 minutes and up to 37 minutes).
    Billing Example: Both units of HCPCS code 97112 are reported with 
the appropriate CQ or CO modifier because the service time furnished by 
the PTA/OTA (30 minutes) exceeded 10 percent of the 30-minute total 
service time (3 minutes, so the modifier would apply if the PTA/OTA had 
furnished 4 or more minutes of the service).
     Scenario Two: When services that are represented by 
different procedure codes are furnished. Follow our current policy to 
identify the procedure codes to bill and the units to bill for the 
service(s) provided for the most time. We propose that when the PT/OT 
and the PTA/OTA each independently furnish a service defined by a 
different procedure code for the same number of minutes, for example 10 
minutes, for a total time of 20 minutes, qualifying for 1 unit to be 
billed (at least 8 minutes up to 23 minutes), the code for the service 
furnished by the PT/OT is selected to break the tie--one unit of that 
service would be billed without the CQ/CO modifier.
    (1) When only one unit of a service can be billed (requires a 
minimum of 8 minutes but less than 23 minutes):
    (a) The PT/OT independently furnishes 15 minutes of manual therapy 
(HCPCS code 97140) and the PTA/OTA independently furnishes 7 minutes of 
therapeutic exercise (HCPCS code 97110). One unit of HCPCS code 97140 
can be billed (at least 8 minutes and up to 22 minutes).
    Billing Example: One unit of HCPCS code 97140 is billed without the 
CQ/CO modifier because the PT/OT exclusively (without the PTA/OTA) 
furnished a full unit of a service defined by 15-minute time interval 
(current instructions require ``1'' unit to be reported). The 7 minutes 
of a different service delivered solely by the PTA/OTA do not result in 
a billable service. Both services, though, are documented in the 
medical record, noting which services were furnished by the PT/OT or 
PTA/OTA; and, the 7 minutes of HCPCS code 97110 would be included in 
the total minutes of timed codes that are considered when identifying 
the procedure codes and units of each that can be billed on the claim.
    (b) If instead, the PT/OT independently furnished 7 minutes of CPT 
code 97140 and the PTA/OTA independently furnished a full 15-minutes of 
CPT code 97110, one unit of CPT code 97110 is billed and the CQ/CO 
modifier is applied; the 7 minutes of the PT/OT service (CPT code 
97140) do not result in billable service, but all the minutes are 
documented and included in the total minutes of the timed codes that 
are considered when identifying the procedure codes and units of each 
that can be billed on the claim.
    (c) If the PT/OT and PTA/OTA each independently furnish an equal 
number of minutes of CPT codes 97140 and 97110, respectively, that is 
less than the full 15-minute mark, and the total minutes of the timed 
codes qualify for billing one unit of a service, the code furnished by 
the PT/OT would be selected to break the tie and billed without a CQ/CO 
modifier because the PT/OT furnished that service independently of the 
PTA/OTA.
    If instead the PT/OT furnishes an 8-minute service (CPT code 97140) 
and the PTA/OTA delivers a 13-minute service (CPT code 97110), one unit 
of the 13-minute PTA/OTA-delivered service (CPT code 97110) would be 
billed consistent with our current policy to bill the service with the 
greater time; and the service would be billed with a CQ/CO modifier 
because the PTA/OTA furnished the service independently.
    (2) When two or more units can be billed (requires a minimum of 23 
minutes), follow current instructions for billing procedure codes and 
units for each timed code.
    (a) The PT/OT furnishes 20 minutes of neuromuscular reeducation 
(CPT code 97112) and the PTA/OTA furnishes 8 minutes of therapeutic 
exercise (CPT code 97110) for a total of 28 minutes, which permits two 
units of the timed codes to be billed (at least 23 minutes and up to 37 
minutes).
    Billing Example: Following our usual process for billing for the 
procedure codes and units based on services furnished with the most 
minutes, one unit of each procedure code would be billed--one unit of 
CPT code 97112 is billed without a CQ/CO modifier and one unit of CPT 
code 97110 is billed with a CQ/CO modifier. This is because, under our 
current policy, the two billable units of timed codes are allocated 
among procedure codes by assigning the first 15 minutes of service to 
code 97112 (the code with the highest number of minutes), which leaves 
another 13 minutes of timed services: 5 minutes of code 97112 (20 minus 
15) and 8 minutes of code 97110. Since the 8 minutes of code 97110 is 
greater than the remaining 5 minutes of code 97112, the second billable 
unit of service would be assigned to 97110. The CQ/CO modifier would 
not apply to CPT code 97112 because the therapist furnished all minutes 
of that service independently. The CQ/CO modifier would apply to CPT 
code 97110 because the PTA/OTA furnished all minutes of that service 
independently.
    (b) The PT/OT furnishes 32 minutes of neuromuscular reeducation 
(CPT code 97112), the PT/OT and the PTA/OTA each separately furnish 12 
minutes and 14 minutes, respectively, of therapeutic exercise (CPT code 
97110) for a total of 26 minutes, and the PTA/OTA independently 
furnishes 12 minutes of self-care (CPT code 97535) for a total of 70 
minutes of timed code services, permitting five units to be billed (68-
82 minutes). Under our current policy, the five billable units would be 
assigned as follows: Two units to CPT code 97112, two units to CPT code 
97110, and one unit to CPT code 97535.
    Billing Example: The two units of CPT code 97112 would be billed 
without a CQ/CO modifier because all 32 minutes of that service were 
furnished independently by the PT/OT. The two units of CPT code 97110 
would be billed with the CQ/CO modifier because the PTA/OTA's 14 
minutes of the service are greater than 10 percent of the 26 total 
minutes of the service (2.6 minutes which is rounded to 3 minutes, so 
the modifiers would apply if the PTA/OTA furnished 4 or more minutes of 
the service), and the one unit of CPT code 97535 would be billed with a 
CQ/CO modifier because the PTA/OTA independently furnished all minutes 
of that service.
    (c) The PT/OT independently furnishes 12 minutes of neuromuscular 
reeducation activities (CPT code 97112) and the PTA/OTA independently 
furnishes 8 minutes of self-care activities (CPT code 97535) and 7 
minutes of therapeutic exercise (CPT code 97110)--the total treatment 
time of 27 minutes allows for two units of service to be billed (at 
least 23 minutes and up to 37 minutes). Under our current policy, the 
two billable units would be assigned as follows: One unit of CPT code 
97112 and one unit of CPT code 97535.
    Billing Example: The one unit of HCPCS code 97112 would be billed 
without the CQ/CO modifier because it was furnished independently by 
the PT/OT; and, the one unit of CPT code 97535 is billed with the CQ/CO 
modifier because it was independently furnished

[[Page 40564]]

by the PTA/OTA. In this example, CPT code 97110 is not billable; 
however, the minutes for all three codes are documented and counted 
toward the total time of the timed code services furnished to the 
patient on the date of service.
    (d) The PT/OT furnishes 15 minutes of each of two services 
described by CPT codes 97112 and 97535, and is assisted by the PTA/OTA 
who furnishes 3 minutes of each service concurrently with the PT/OT. 
The total time of 30 minutes allows two 15-minute units to be billed--
one unit each of CPT code 97112 and CPT code 97535.
    Billing Example: Both CPT codes 97112 and 97535 are billed with the 
applicable CQ/CO modifier because the time the PTA/OTA spent assisting 
the PT/OT for each service exceeds 10 percent of the 15-minute total 
time for each service (1.5 minutes which is rounded to 2 minutes, so 
that the modifiers apply if the PTA/OTA furnishes 3 or more minutes of 
the service).
c. Proposed Regulatory Provisions
    In accordance with section 1834(v)(2)(B) of the Act, we are 
proposing 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 are proposing 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 note 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 would like to take this 
opportunity to clarify 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.

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 proposed rule, Potentially Misvalued Services under the 
PFS. Historically, when we received RUC recommendations, our process 
had been to establish interim final RVUs for the potentially misvalued 
codes, new codes, and any other codes for which there were coding 
changes in the final rule with comment period for a year. Then, during 
the 60-day period following the publication of the final rule with 
comment period, we accepted public comment about those valuations. For 
services furnished during the calendar year following the publication 
of interim final rates, we paid for services based upon the interim 
final values established in the final rule. In the final rule with 
comment period for the subsequent year, we considered and responded to 
public comments received on the interim final values, and typically 
made any appropriate adjustments and finalized those values.
    In the CY 2015 PFS final rule with comment period (79 FR 67547), we 
finalized a new process for establishing values for new, revised and 
potentially misvalued codes. Under the new process, we include proposed 
values for these services in the proposed rule, rather than 
establishing them as interim final in the final rule with comment 
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the 
new process was applicable to all codes, except for new codes that 
describe truly new services. For CY 2017, we proposed new values in the 
CY 2017 PFS proposed rule for the vast majority of 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 reproposed 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

[[Page 40565]]

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 propose those values as 
recommended. Additionally, we continually engage with stakeholders, 
including the RUC, with regard to our approach for accurately valuing 
codes, and as we prioritize our obligation to value new, revised, and 
potentially misvalued codes. We continue to welcome feedback from all 
interested parties regarding valuation of services for consideration 
through our rulemaking process.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conduct a review that 
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

[[Page 40566]]

a significant portion of codes for which we recently established or 
proposed work RVUs that are based on refinements to the RUC-recommended 
values. When we have adjusted work RVUs to account for significant 
changes in time, we have started by looking at the change in the time 
in the context of the RUC-recommended work RVU. When the recommended 
work RVUs do not appear to account for significant changes in time, we 
have employed the different approaches to identify potential values 
that reconcile the recommended work RVUs with the recommended time 
values. Many of these methodologies, such as survey data, building 
block, crosswalks to key reference or similar codes, and magnitude 
estimation have long been used in developing work RVUs under the PFS. 
In addition to these, we sometimes use the relationship between the old 
time values and the new time values for particular services to identify 
alternative work RVUs based on changes in time components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider these work RVUs as potential 
options relative to the values developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we believe that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC's recommendation has appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned methodologies to identify potential work RVUs, including 
the methodologies intended to account for the changes in the resources 
involved in furnishing the procedure.
    Several stakeholders, including the RUC, have expressed general 
objections to our use of these methodologies and deemed our actions in 
adjusting the recommended work RVUs as inappropriate; other 
stakeholders have also expressed general concerns with CMS refinements 
to RUC-recommended values in general. In the CY 2017 PFS final rule (81 
FR 80272 through 80277), we responded in detail to several comments 
that we received regarding this issue. In the CY 2017 PFS proposed rule 
(81 FR 46162), we requested comments regarding potential alternatives 
to making adjustments that would recognize overall estimates of work in 
the context of changes in the resource of time for particular services; 
however, we did not receive any specific potential alternatives. As 
described earlier in this section, crosswalks to key reference or 
similar codes are one of the many methodological approaches we have 
employed to identify potential values that reconcile the RUC-recommend 
work RVUs with the recommended time values when the RUC-recommended 
work RVUs did not appear to account for significant changes in time. In 
response to comments in the CY 2019 PFS final rule (83 FR 59515), we 
clarify 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 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 proposed 
valuation considered for specific codes. Table 20 contains a list of 
codes and descriptors for which we are proposing work RVUs; this 
includes all codes for which we received RUC recommendations by 
February 10, 2019. The proposed 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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially misvalued codes. 
We review the RUC-recommended direct PE inputs on a code by code basis. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, HCPAC, and other public commenters, 
medical literature, and comparative databases, as well as a comparison 
with other codes within the PFS, and consultation with physicians and 
health care professionals within CMS and the federal government, as 
well as Medicare claims data. We also assess the methodology and data 
used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. When 
we determine that the RUC's recommendations appropriately estimate the 
direct PE inputs (clinical labor, disposable supplies, and medical 
equipment) required for the typical service, are consistent with the 
principles of relativity, and reflect our payment policies, we use 
those direct PE inputs to value a service. If not, we refine the 
recommended PE inputs to better reflect our estimate of the PE 
resources required for the service. We also confirm whether CPT codes 
should have facility and/or nonfacility direct 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 21 details 
our proposed refinements of the RUC's direct PE recommendations at the 
code-specific level. In section II.B. of this proposed rule, 
Determination of Practice Expense Relative Value Units (PE RVUs), we 
address certain proposed refinements that would be common across codes. 
Proposed refinements to particular codes are addressed in the portions 
of this section that are dedicated to particular codes. We note

[[Page 40567]]

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 21 result in 
changes under the $0.35 threshold and are unlikely to result in a 
change to the RVUs.
    We also note that the proposed 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 proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have been used in developing the proposed 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 proposed rule, 
Determination of Practice Expense Relative Value Units (PE RVUs), for 
more information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. However, some recommendations include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2020, we received invoices for several new supply and 
equipment items. Tables 22 and 23 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed rule, Determination of Practice Expense Relative 
Value Units, we encouraged stakeholders to review the prices associated 
with these new and existing items to determine whether these prices 
appear to be accurate. Where prices appear inaccurate, we encouraged 
stakeholders to submit invoices or other information to improve the 
accuracy of pricing for these items in the direct PE database by 
February 10th of the following year for consideration in future 
rulemaking, similar to our process for consideration of RUC 
recommendations.

[[Page 40568]]

    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 22 and 23 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 proposed code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the public use files for the PFS proposed and final 
rules for each year display 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 proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. 
For more information regarding the history of the MPPR policy, we refer 
readers to the CY 2014 PFS final rule with comment period (78 FR 74261 
through 74263). For more information regarding the history of the OPPS 
cap, we refer readers to the CY 2007 PFS final rule with comment period 
(71 FR 69659 through 69662).
4. Proposed Valuation of Specific Codes for CY 2020
(1) Tissue Grafting Procedures (CPT Codes 15X00, 15X01, 15X02, 15X03, 
and 15X04)
    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 are proposing the RUC-recommended work RVUs of 6.68 for CPT code 
15X00 (Grafting of autologous soft tissue, other, harvested by direct 
excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15X01 
(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 15X02 (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 15X03 (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 15X04 (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 are proposing the RUC-recommended direct PE inputs for this code 
family without refinement.
(2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983, 
206X0, 206X1, 206X2, 206X3, 206X4, and 206X5)
    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 also are not proposing 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,

[[Page 40569]]

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 offers 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 offer 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 are proposing a work RVU 
of 1.14, and accept the survey recommended 5 minutes for intraservice 
time and 30 minutes of total time. We are not proposing 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 offer 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 are proposing a work RVU of 1.34, and accept the RUC-
recommended 10 minutes for intraservice time and 33 minutes of total 
time. We are not proposing 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 offer 
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 are 
proposing a work RVU of 1.91, and accept the RUC-recommended 15 minutes 
for intraservice time and 40 minutes of total time. We are not 
proposing any direct PE refinements to CPT code 11983.
    The new proposed add-on CPT codes 206X0-206X5 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 206X0 (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 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 are proposing for CPT code 206X0, a work RVU of 1.32, and 
accept the RUC-recommended 20 minutes of intraservice time and 20 
minutes of total time.
    The specialty society's survey for CPT code 206X1 (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 38 
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

[[Page 40570]]

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 206X1.
    The specialty society's survey for CPT code 206X2 (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 45 
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 are 
proposing the work RVU of 1.80 with the RUC-recommended 30 minutes of 
intraservice time and 37 minutes of total time, for CPT code 206X2.
    The specialty society's survey for CPT code 206X3 (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 are proposing the 
RUC-recommended work RVU of 1.13 with 15 minutes of intraservice time 
and 18 minutes of total time for 206X3.
    The specialty society's survey for CPT code 206X4 (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 28 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 are proposing the RUC-
recommended work RVU of 1.80 with 20 minutes of intraservice time and 
23 minutes of total time for 206X4.
    The specialty society's survey for CPT code 206X5 (Removal of drug 
delivery 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 
are proposing the RUC-recommended work RVU of 2.15 with 25 minutes of 
intraservice time and 28 minutes of total time for 206X5.
(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 are proposing 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

[[Page 40571]]

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 would be 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 are proposing 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 are not proposing 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 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 are 
proposing 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 are proposing 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 are proposing 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.
(4) Trigger Point Dry Needling (CPT Codes 205X1 and 205X2)
    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 205X1 (Needle insertion(s) without injection(s), 1 or 2 muscle(s)) 
and we are proposing 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 205X1, which makes it an appropriate choice for 
a crosswalk. In our review of CPT code 205X1, 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 205X1, 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 
205X1 should be valued at a higher rate, and therefore, we are 
proposing 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 205X2 (Needle insertion(s) without injection(s), 3 or more 
muscle(s)) and we are proposing 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 205X2, 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 are proposing a work RVU of 0.32 for CPT code 
205X1 with 10 minutes of intraservice work time, and a work RVU of 0.48 
for CPT code 205X2 with 15 minutes of intraservice work time. We also 
considered crosswalking the work RVU of CPT code 205X2 to the

[[Page 40572]]

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 205X2 was more intense than CPT 
code 97140.
    We are also proposing to designate CPT codes 205X1 and 205X2 as 
``always therapy'' procedures, and we are soliciting comments on this 
designation. We are proposing the RUC-recommended direct PE inputs for 
all codes in the family.
(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 
disagree with the recommended work RVU of 3.75 because we do not 
believe that this reduction in work RVU from the current value of 3.89 
is commensurate with the RUC-recommended a 33-minute reduction in 
intraservice time and a 105-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 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, 
as we believe that this better accounts for the decrease in the 
surveyed work time.
    For the direct PE inputs, we are proposing to refine the equipment 
time for the power table (EF031) to conform to our established standard 
for non-highly technical equipment.
(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 are proposing 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 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 are 
proposing 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 are proposing 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 are proposing 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.
(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 are proposing to refine the equipment 
time for the power table (EF031) to conform to our established standard 
for non-highly technical equipment.
(8) Arthrodesis--Sacroliliac 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

[[Page 40573]]

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 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 are proposing 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 are 
proposing the RUC-recommended work RVU, we are soliciting 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 are proposing the RUC-recommended direct PE inputs for CPT code 
27279.
(9) Pericardiocentesis and Pericardial Drainage (CPT Code 3X000, 3X001, 
3X002, and 3X003)
    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 periodcardiocentesis 
drainage procedures to differentiate by age and to include imaging 
guidance.
    We are proposing 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 3X000 (Pericardiocentesis, including imaging guidance, when 
performed) and are proposing 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 3X000 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 3X000, 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 3X000 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 3X000 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 
3X001 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including fluoroscopy and/or ultrasound guidance, when 
performed; 6 years and older without congenital cardiac anomaly) and 
are proposing 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 3X001 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 3X001, we noted many of the same issues that we had raised 
with CPT code 3X000, 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 3X000, 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 3X001 based on 
a crosswalk to CPT code 52234 based on the same rationale that we

[[Page 40574]]

detailed with regards to CPT code 3X000.
    We disagree with the RUC-recommended work RVU of 6.00 for CPT code 
3X002 (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 are proposing a work RVU of 5.00 based on the 
survey 25th percentile value. In our review of CPT code 3X002, we noted 
many of the same issues that we had raised with CPT codes 3X000 and 
3X001, 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 3X002 and very similar total time. While we 
agree that CPT code 31603 is a close match to the surveyed work times 
for CPT code 3X002, 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 3X002 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 are proposing a 
work RVU of 5.00 for CPT code 3X002 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 
3X003 (Pericardial drainage with insertion of indwelling catheter, 
percutaneous, including CT guidance) and are proposing a work RVU of 
4.29 based on the survey 25th percentile value. In our review of CPT 
code 3X003, we noted many of the same issues that we had raised with 
CPT codes 3X000-3X002, 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 
3X003) 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 3X003 was overvalued. We also compared CPT code 3X003 to 
the most similar code in the family, CPT code 3X001, and noted that the 
survey respondents indicated that CPT code 3X003 should have a lower 
work RVU at both the survey 25th percentile and survey median values. 
Therefore, we are proposing a work RVU of 4.29 for CPT code 3X003 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 are not proposing any direct PE 
inputs for the codes in this family.
(10) Pericardiotomy (CPT Codes 33020 and 33025)
    CPT code 33020 (Pericardiotomy for removal of clot or foreign body 
(primary procedure)) 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. The RAW 
determined that CPT code 33020 should be surveyed for April 2018; CPT 
code 33025 (Creation of pericardial window or partial resection for 
drainage) was included for review as part of this code family.
    We disagree with the RUC-recommended work RVU of 14.31 (25th 
percentile survey value) for CPT code 33020 and are proposing 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 note 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 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 33020, we 
believe 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 disagree 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 agree 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 are proposing 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,

[[Page 40575]]

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 note that the RUC-recommended 
intraservice time is decreasing from 66 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 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 33025, we 
believe 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 are proposing the RUC-recommended direct PE inputs for all the 
codes in this family.
(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 determined 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 practice expense. 
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 are proposing the RUC-recommended work RVU for all six of the 
codes in this family. We are proposing 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(12) Aortic Graft Procedures (CPT Codes 338XX, 338X1, 33863, 33864, 
338X2, 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 
on an interim basis (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 338XX (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 think a comparison to other 
services of similar time indicates that the RUC's recommended increase 
overstates the work. Instead, we are proposing 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 338X1 (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 are proposing 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

[[Page 40576]]

resurveyed to determine more accurate physician time values, and we are 
proposing 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 are proposing to maintain the current work 
RVU of 60.08 for this service.
    For CPT code 338X2 (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 are 
proposing a less significant increase to 60.88 using the RUC-
recommended difference in work value between CPT code 338X1 and the 
code in question, CPT code 338X2 (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 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 33X01 (Aortic hemiarch graft including isolation 
and control of the arch vessels, beveled open distal aortic anastomosis 
extending under one or more of the arch vessels, and total circulatory 
arrest or isolated cerebral perfusion (List separately in addition to 
code for primary procedure)), we are proposing the RUC-recommended work 
RVU of 17.75.
    For the direct PE inputs, we are proposing to refine the clinical 
labor to align with the number of post-operative visits. Thus, we are 
proposing to add 12 minutes of clinical labor time for ``Discharge day 
management'' for CPT codes 338X1, 33863, 33864, and 338X2, as each of 
these codes include a 99238 discharge visit within their global periods 
that should be reflected in the clinical labor inputs.
(13) Iliac Branched Endograft Placement (CPT Codes 34X00 and 34X01)
    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 are proposing the RUC-recommended work RVU of 9.00 for CPT code 
34X00 (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 34X01 (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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(14) Exploration of Artery (CPT Codes 35701, 35X01, and 35X01)
    CPT code 35701 (Exploration not followed by surgical repair, 
artery; neck (e.g., carotid, subclavian)) was identified via a screen 
for services with a ne.g.ative 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 are proposing the RUC-recommended work RVU for all three codes 
in the family. We are proposing a work RVU of 7.50 for CPT code 35701, 
a work RVU of 7.12 for CPT code 35X00 (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 35X01 (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 are proposing 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 are 
proposing 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 35X00, and from 63 minutes to 27 minutes for 
CPT code 35X01. 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 are proposing 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 35X01 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.
(15) Intravascular Ultrasound (CPT Codes 37252 and 37253)
    In CY 2014, the CPT Editorial Panel deleted CPT codes 37250 
(Ultrasound evaluation of blood vessel during

[[Page 40577]]

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). CPT codes 37252 and 37253 
were reviewed at the January 2015 RUC meeting. The RUC's recommendation 
for these codes were to result in an overall work savings that should 
have been redistributed back to the Medicare conversion factor. The 
codes have had a 44 percent increase in work RVUs over the old codes, 
CPT codes 37250 and 37251, from 2015 to 2016 and the utilization has 
doubled from that of the previous coding structure, not considering the 
radiological activities. In April 2018, the RUC reviewed this code 
family and determined the utilization of the bundling of these services 
was underestimated. 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 ZZZ-
day global codes, and the survey results indicated the intraservice and 
total work times, along with the work RVU should remain the same 
despite the underestimation in utilization.
    We disagreed with the RUC-recommended work RVU of 1.80 for CPT code 
37252 and are proposing 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 stated that bundling this service would achieve savings. 
However, since 2015 observed utilization for CPT code 37252 has greatly 
exceeded proposed estimates, thus we are proposing to restore work 
neutrality to the intravascular ultrasound code family to achieve the 
initial estimated savings.
    For CPT code 37253, we disagreed with the RUC-recommended work RVU 
of 1.44 and we are proposing 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 are proposing 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 are 
proposing 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 are proposing the RUC-
recommended direct PE inputs for all codes in the family.
(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 are proposing 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 are proposing to refine the clinical 
labor time for the ``Prepare room, equipment and supplies'' (CA013) 
activity to 3 minutes and to refine the clinical labor time for the 
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. 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 
standard for non-highly technical equipment.
(18) Transanal Hemorrhoidal Dearterialization (CPT Codes 46945, 46946, 
and 46X48)
    We are proposing the RUC-recommended work RVU for all three codes 
in the family. We are proposing 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 46X48 
(Hemorrhoidectomy, internal, by transanal hemorrhoidal 
dearterialization, 2 or more hemorrhoid columns/groups, including 
ultrasound guidance, with mucopexy when performed).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(19) Preperitoneal Pelvic Packing (CPT Codes 490X1 and 490X2)
    In May 2018, the CPT Editorial Panel approved the addition of two 
codes for preperitoneal pelvic packing, removal

[[Page 40578]]

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 
490X1 (Preperitoneal pelvic packing for hemorrhage associated with 
pelvic trauma, including local exploration) and are proposing 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 490X1, which we investigated by comparing 
this new service against the existing 0-day global codes on the PFS. We 
found that among the roughly 1,100 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 490X1, with an average 
intraservice work time of 111 minutes as compared to the 45 minutes of 
intraservice work time in CPT code 490X1. 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 1,100 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 490X1.
    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 are proposing for CPT code 490X1. 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 490X1 would establish a new maximum value, higher than all of the 
79 other codes that fall into this category. We recognize that CPT code 
490X1 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 
490X2 (Re-exploration of pelvic wound with removal of preperitoneal 
pelvic packing including repacking, when performed) and are proposing 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 are 
proposing 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 are proposing 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family without refinement.
(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 are proposing to maintain the current work RVU of 7.73 as 
recommended by the RUC. We are proposing the RUC-recommended direct PE 
inputs for CPT code 54640 without refinement.
(22) Radiofrequency Neurootomy Sacroiliac Joint (CPT Codes 6XX00, 
6XX01)
    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 are proposing the 
RUC-recommended work RVU of 1.52 for CPT code 6XX00 (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 6XX01 
(Radiofrequency ablation, nerves innervating the sacroiliac joint, with

[[Page 40579]]

image guidance (i.e., fluoroscopy or computed tomography)).
    For the direct PE inputs, we are proposing to refine the quantity 
of the ``needle, 18-26g 1.5-3.5in, spinal'' (SC028) supply from 3 to 1 
for CPT code 6XX00. There are no spinal needles in use in the reference 
code associated with CPT code 6XX00, 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 6XX00 would require a spinal needle, but we do not believe 
that the use of three such needles would be typical.
    We are proposing to refine the quantity of the ``cannula 
(radiofrequency denervation) (SMK-C10)'' (SD011) supply from 4 to 2 for 
CPT code 6XX01. 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 are 
proposing 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 are proposing 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.
(23) Lumbar Puncture (CPT Codes 62270, 622X0, 62272, and 622X1)
    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 are proposing 
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 622X0 (Spinal puncture, lumbar, diagnostic; with 
fluoroscopic or CT guidance), we disagree with the RUC-recommended work 
RVU of 1.95 and we are proposing 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 622X0 is equivalent to 
an interval of 0.51 RVUs. Therefore, we are proposing a work RVU of 
1.73 for CPT code 622X0, 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 are proposing 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 622X0 is 
equivalent to the RUC-recommended interval of 0.36 RVUs. Therefore, we 
are proposing 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 622X1 (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 
are proposing 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 622X1 is equivalent to the recommended 
interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 2.03 
for CPT code 622X1, based on the recommended interval of 0.81 
additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
(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 are not 
proposing to change the current work RVUs.
    For the direct PE inputs, we are proposing 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.
(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 (i.e., 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

[[Page 40580]]

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 (ie 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 do not 
consider the overlap of imaging as noted in the RUC recommendations. We 
note 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 are proposing 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 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 final rule 
(82 FR 53054). Although we are proposing the RUC reaffirmed work RVUs 
for these two codes, as submitted in the RUC recommendations, we note 
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 disagree with the 
RUC-recommended work RVU of 1.00 for CPT code 64400 and are proposing 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 note 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 do not believe the RUC-recommended 
work RVU appropriately accounts for the substantial reductions in the 
surveyed work times for the procedure. Although we do not imply that 
the decrease in time as reflected in survey values must 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 .075 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 note that our proposed work RVU 
maintains rank order in this code family among comparable codes.
    For CPT code 64408, we disagree with the RUC-recommended work RVU 
of 0.90 and are proposing 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 note 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 accounts for the substantial reductions in the surveyed 
work times for the procedure. Although we do not imply that the 
decrease in time as reflected in survey values must 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 .075, based on a crosswalk CPT code 64450,

[[Page 40581]]

to account for these decrease in the surveyed work times. We further 
note that our proposed work RVU maintains rank order in this code 
family among comparable codes.
    For CPT code 64415, we disagree with the RUC-recommended work RVU 
of 1.42 and are proposing a work RVU of 1.35, based on our 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 note 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 do not believe the RUC-recommended work RVU appropriately 
accounts for the substantial reductions in the surveyed work times for 
the procedure. Although we do not imply that the decrease in time as 
reflected in survey values must 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 
believe 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 disagree with the RUC-recommended work RVU 
of 1.81 and are proposing a work RVU of 1.48, based on our 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 note 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 accounts for the substantial 
reductions in the surveyed total time for the procedure. Although we do 
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 64416, we believe that it would be more accurate to 
propose a work RVU of 1.48, based on our time ratios methodology and a 
bracket of CPT code 62270 and CPT code 91035, to account for these 
decreases in the surveyed work times.
    For CPT code 64420, we disagree with the RUC-recommended work RVU 
of 1.18 and are proposing 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 note 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 accounts for the 
substantial reductions in the surveyed work times for the procedure. 
Although we do not imply that the decrease in time as reflected in 
survey values must 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 believe 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 disagree with the RUC-recommended work RVU 
of 0.60 and are proposing a work RVU of 0.50, based on our 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 note that our time ratio methodology suggests the code is better 
valued at 0.50. Furthermore, the RUC-recommended work RVU of 0.60 
creates a rank order anomaly in the code family. In the case of CPT 
code 64421, we believe 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 disagree with the RUC-recommended work RVU 
of 1.19 and are proposing 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.
    We note 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 
believe 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 disagree with the RUC-recommended work RVU 
of 1.15 and are proposing 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

[[Page 40582]]

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 note 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 accounts 
for the substantial reductions in the surveyed intraservice work time 
for the procedure. Although we do 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 
believe 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 disagree with the RUC-recommended work RVU 
of 1.18 and are proposing 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 note 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 accounts 
for the substantial reductions in the surveyed intraservice work time 
for the procedure. Although we do 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 
believe 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 disagree with the RUC-recommended work RVU 
of 1.54 and are proposing a work RVU of 1.36 based on our 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 note 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 accounts for 
the substantial reductions in the surveyed intraservice work time for 
the procedure. Although we do 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 
believe 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 disagree with the RUC-recommended work RVU 
of 1.55 and are proposing a work RVU of 1.41, based our 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 note 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 accounts for the substantial reductions in the surveyed 
intraservice work time for the procedure. Although we do 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 64448, we believe 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 disagree with the RUC-recommended work RVU 
of 1.55 and are proposing a work RVU of 1.27, based our time ratio 
methodology and a reference to CPT code 11755 (Biopsy of nail unit (eg, 
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 note 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 accounts for 
the substantial reductions in the surveyed intraservice work time for 
the procedure. Although we do 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

[[Page 40583]]

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 are proposing 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 are proposing 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.
(26) Genicular Injection and RFA (CPT Codes 64640, 64XX0, and 64XX1)
    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 the 
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), 64XX0 
(Injection(s), anesthetic agent(s) and/or steroid; genicular nerve 
branches including imaging guidance, when performed), and 64XX1 
(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 are proposing the RUC-recommended work RVUs for two 
of the three codes in this family. We are proposing 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 64XX0.
    For CPT code 64XX1, we disagree with the RUC-recommended work RVU 
of 2.62, which is higher than the 25th percentile survey value, a work 
RVU 2.50, and are proposing 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 64XX1.
    In our review of CPT code 64XX1, we examined the intraservice time 
ratio for the new code, CPT code 64XX1, in relation to an existing code 
in this family of services, CPT code 64640. CPT code 64XX1 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 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 64XX1, 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 are proposing 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 64XX1), 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 are 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 25 to 20 minutes for CPT code 64640, 
to match the intraservice work time. We are also proposing to refine 
the equipment times in accordance with our standard equipment time 
formulas for CPT code 64640.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
64XX0 without refinement.
    For CPT code 64XX1, we are proposing to refine the quantity of the 
``cannula (radiofrequency denervation) (SMK-C10)'' (SD011) supply from 
3 to 1. We do not believe that the use of 3 of this supply item would 
be typical for the procedure. We note that the RUC recommendations for 
another code in this family, CPT code 64640 only contains 1 of this 
supply item. We believe 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 are 
proposing 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 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 are refining 
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.

[[Page 40584]]

(27) Cyclophotocoagulation (CPT Codes 66711, 66982, 66983, 66984, 
66X01, and 66X02)
    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 66X01 
(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 66X02 (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 are proposing 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 
disagree with the RUC recommendations for CPT codes 66711, 66X01, and 
66X02.
    For CPT code 66711, we disagree with the RUC-recommended work RVU 
of 6.36 and are proposing 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 note 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 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 66711, we 
believe 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 66X01, the RUC recommended a work RVU of 13.15, we 
disagree with the RUC-recommended work RVU and are proposing 
contractor-pricing for this code. In reviewing this code, we note that 
the RUC recommendation survey values do not support the RUC-recommended 
work RVU of 13.15 and furthermore, the RUC recommendations do 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 believe it is more 
appropriate to propose contractor-pricing for CPT code 66X01. We also 
note that the RUC recommended contractor-pricing for another code in 
this family, CPT code 66983, which we are proposing for CY 2020.
    For CPT code 66X02, the RUC recommended a work RVU of 10.25, we 
disagree with the RUC-recommended work RVU and are proposing 
contractor-pricing for this code. In reviewing this code, we note that 
the RUC recommendation survey values do not support the RUC-recommended 
work RVU of 10.25. Furthermore, we are 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 66X02, 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 66X02. However, the RUC is recommending the same work 
RVU of 10.25 for CPT codes 66982 and 66X02, supported by the same 
crosswalk to CPT code 67110.
    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 66X02, we believe it is appropriate to propose contractor-
pricing for CPT code 66X02. We also note that the RUC recommended 
contractor-pricing for another code in this family, CPT code 66983, 
which we are prosing for CY 2020.
    We are proposing to remove all the direct PE inputs for CPT codes 
66X01 and 66X02, given our proposal for contractor-pricing for these 
codes. We are proposing the RUC-recommended direct PE inputs for the 
other codes in this family.
(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

[[Page 40585]]

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.
    The RUC recommended a work RVU for CPT code 70210 of 0.20, which is 
a slight increase over the current work RVU for this code (0.17). 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 one 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 disagree 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 do are not convinced that the work RVU for this code 
should increase. In addition, we note 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. We are proposing to maintain the work RVU for CPT code 
70210 of 0.17 work RVUs, bracketed by two services. On the upper side, 
we identified CPT code 73501 (Radiologic examination, hip, unilateral, 
with pelvis when performed; 1 view) with a work RVU of 0.18, and on the 
lower side, we identified CPT code 73560 (Radiologic examination, knee; 
1 or 2 views) with a work RVU of 0.16. For CPT code 70220, we are 
proposing the RUC-recommended work RVU of 0.22.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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.
    The RUC-recommended work RVU for CPT code 70250 is 0.20, which is a 
slight decrease from the current work RVU for this code (0.24). The 
decrease, according to the RUC, reflects a slightly lower total time 
required to furnish the service (from 7 minutes to 5 minutes) and is 
consistent with the 25th percentile work RVU from the survey results. 
The RUC-recommended work RVU is bracketed by two CPT codes: 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 disagree with the 
recommended work RVU of 0.20 for CPT code 70250. 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 
(0.17 work RVU) might 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. We believe that a crosswalk to CPT 
code 73501 (Radiologic examination, hip, unilateral, with pelvis when 
performed; 1 view) with a work RVU of 0.18, 3 minutes of intraservice 
time, and 5 minutes of total time, accurately reflects both the time 
and intensity of furnishing the service described by CPT code 70250. 
Therefore, we are proposing a work RVU of 0.18 for CPT code 70250.
    The RUC recommended a work RVU of 0.29 for CPT code 70260, which is 
lower than the current work RVU of 0.34. 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. Moreover, since we are proposing 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 work RVU of 
0.28. We believe that applying this increment is a better reflection of 
the work time and intensity involved in furnishing CPT code 70260. We 
are proposing a work RVU for CPT code 70260 of 0.28.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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.
    The RUC recommended a work RVU of 0.20 for CPT code 70360, which is 
an increase over the current work RVU

[[Page 40586]]

(0.17). 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 one 
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, 
we do not agree 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. When we looked at CPT codes with identical times to the survey 
code for a crosswalk, we identified CPT code 73552 (Radiologic 
examination, femur; minimum 2 views), with a work RVU of 0.18. We 
believe this is a more appropriate valuation for CPT code 70360 and we 
are proposing a work RVU for this CPT code of 0.18.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
70360.
(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 are proposing the RUC-recommended work RVU for all 12 CPT 
codes in this family as follows: CPT code 72020 (work RVU = 0.16); CPT 
code 72040 (work RVU = 0.22); CPT code 72050 (work RVU = 0.27); CPT 
code 72052 (work RVU = 0.30); CPT code 72070 (work RVU = 0.20); CPT 
code 72072 (work RVU = 0.23); CPT code 72074 (work RVU = 0.25); 72080 
(work RVU = 0.21); CPT code 72100 (work RVU = 0.22); CPT code 72110 
(work RVU =0.26); CPT code 72114 (work RVU = 0.30); and CPT code 72120 
(work RVU = 0.22).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 disagree with the RUC-recommended work RVU 
of 1.28 and propose instead a work RVU of 1.13. We are proposing a 
lower work RVU because 1.13 represents the commensurate 12 percent 
decrease in work time reflected in survey values. We reference 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 disagree with the RUC-recommended work RVU of 1.13 for CPT 
code 70481. Instead, we are proposing a work RVU of 1.06 for CPT code 
70481. As with CPT code 70840, we are proposing 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 are proposing 
the RUC-recommended work RVU of 1.27.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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

[[Page 40587]]

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 are proposing the RUC-recommended work RVU for eight of the nine 
codes in the family. We are proposing 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 are proposing 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 want to reiterate that we believe it would be 
irresponsible to ignore changes in time based on the best data 
available and that we are statutorily obligated to consider both time 
and intensity in establishing work RVUs for PFS services. For 
additional information regarding the use of 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 
(0.21). We are proposing the RUC-recommended values for these two CPT 
codes.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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.
    For CPT code 72200, the RUC is recommending a work RVU of 0.20, 
which is higher than the current work RVU (0.17). 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 one 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 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

[[Page 40588]]

RUC supported their recommendation of a work RVU for CPT code 72200 of 
0.20 with two bracketing codes: CPT code 93042 (Rhythm ECG, 1-3 leads; 
interpretation and report only) with work RVU of 0.15, and CPT code 
70355 (Orthopantogram (e.g. panoramic x-ray)) with 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). A work RVU of 0.20 
is consistent with the work RVU estimated by the TTR and reflects the 
25th percentile of survey results. Nevertheless, we do not agree that 
there is sufficient justification for an increase in work RVU for CPT 
code 72200. We are 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. We also note that the 25th 
percentile of survey results are based on the overall survey total 
time, which is 8 minutes, rather than the RUC's recommended 6 minutes. 
The time parameters for furnishing the service affect all other points 
of comparison for purpose of valuing the code, including TTR, 
identification of potential crosswalks, and increment calculations. 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 are proposing to maintain the current 
work RVU for CPT code 72200 at 0.17.
    For CPT code 72202, the RUC recommended a work RVU of 0.26, which 
is considerably higher than the current work RUV for this code of 0.19. 
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 note 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 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 justifies a higher work RVU for the survey code. We 
disagree 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 of 0.07 work RVUs is warranted. The TTR calculation yields 
a work RVU of .019, suggesting that a value closer to the current work 
RVU would be more appropriate. In addition, since we consider the RUC-
recommended work RVU for this code as an incremental change from the 
prior code in this family, we believe that an increase of 0.06 over the 
proposed work RVU of 0.18 for CPT code 72200, which yields a work RVU 
of 0.23, is a better reflection of the time and intensity required to 
furnish CPT code 72202. Our proposed value work RVU of 0.23 is 
bracketed by CPT code 73521 (Radiologic examination, hips, bilateral, 
with pelvis when performed; 2 views) on the lower end (work RVU = .22), 
and CPT code 74021 (Radiologic examination, abdomen; 3 or more views), 
on the higher end (work RVU = 0.27). CPT code 73521 has the same times 
as the survey code but describes a bilateral service with 2 views, 
which is slightly less intense. CPT code 74021 also has identical times 
but involves X-ray of the abdomen with 3 views, a slightly higher 
intensity than the survey code.
    The RUC-recommended work RVU for CPT code 72220 is 0.20, which 
reflects an increase over the current work RVU for this code (0.17). 
The key reference service from the survey results is CPT code 73522 
(Radiologic examination, hips, bilateral, with pelvis when performed, 
2-4 views), with a work RVU of 0.29, 5 minutes intraservice time, and 7 
minutes total time. The RUC noted that the 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 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 notes 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. We also note 
that a work 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). Instead, we are proposing to 
maintain the work RVU for this service at 0.17, which is consistent 
with our proposal to maintain the current work RVU for CPT code 72200 
at 0.17 as well.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 are proposing the RUC-
recommended work RVUs for all five codes in this family as follows: CPT 
code 73000 (work RVU = 0.16); CPT code 73010 (work RVU = 0.17); CPT 
code 73020 (work RVU = 0.15); CPT code 73030 (work RVU = 0.18); and CPT 
code 73050 (work RVU = 0.18).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 are proposing the RUC-recommended work RVU for all three codes 
in this family. We are proposing 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).

[[Page 40589]]

    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 are proposing 
the RUC-recommended work RVU for all three codes in this family as 
follows: CPT code 73070 (work RVU = 0. 16); CPT code 73080 (work RVU = 
0.17); and CPT code 73090 (work RVU = 0.16).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(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 
are proposing the RUC-recommended work RVU of 0.16. We are also 
proposing the RUC-recommended direct PE inputs for CPT code 73650.
(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 are proposing the RUC-recommended 
work RVU for this code of 0.13 for CPT code 73660. We are also 
proposing the RUC-recommended direct PE inputs for CPT code 73660.
(41) Upper Gastrointestinal Tract Imaging (CPT Codes 74210, 74220, 
74230, 74X00, 74240, 74246, and 74X01)
    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 are proposing 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 74X00 (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 74X01 (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, 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 note that no 
rationale was given for the RUC-recommended times for these codes, and 
we are requesting 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, 74X00, 74230, 74240, and 74246, respectively. In 
addition, for CPT code 74230, we are proposing 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.
(42) Lower Gastrointestinal Tract Imaging (CPT Codes 74250, 74251, 
74270, and 74280)
    These services were identified through a list CMS/Other codes with 
Medicare utilization of 30,000 or more. We are proposing 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).

[[Page 40590]]

    For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we note that no 
rationale was given for the recommended times for these codes, and we 
are requesting 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 are proposing 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.
(43) Urography (CPT Code 74425)
    The physician time and work described by CPT code 74425 (Urography, 
antegrade (pyelostogram, nephrostogram, loopogram), radiological 
supervision and interpretation) was combined with services describing 
genitourinary catheter procedures in CY 2016, resulting in CPT codes 
50431 (Injection procedure for antegrade nephrostogram and/or 
ureterogram, complete diagnostic procedure including imaging guidance 
(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 are 
proposing the RUC-recommended work RVU of 0.51 for CPT code 74425.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
74425.
(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 are proposing the RUC-recommended 
value of 2.00 RVUs.
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(45) Angiography (CPT Codes 75726 and 75774)
    We are proposing the RUC-recommend work RVU for both codes in this 
family. We are proposing 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 are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(46) X-Ray Exam Specimen (CPT Code 76098)
    CPT code 70098 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 through 19288 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 the CPT code (CPT code 76098) again in October 2018.
    The RUC recommended a work RVU, based on the October 2018 meeting, 
of 0.31 for CPT code 76098, 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

[[Page 40591]]

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 are 
proposing the RUC-recommended work RVU for CPT code 76098 of 0.31.
    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 are proposing the RUC-recommended direct PE inputs for CPT code 
76098.
(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 are proposing 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.
(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 are proposing 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.
(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 are proposing the RUC-recommended work RVUs for all five CPT 
codes in this family as follows: CPT code 77073 (work RVU = 0.26); CPT 
code 77074 (work RVU = 0.44); CPT code 77075 (work RVU = 0.55); CPT 
code 77076 (work RVU = 0.70); and CPT code 77077 (work RVU = 0.33).
    We are proposing the RUC-recommended direct PE inputs for all codes 
in the family.
(50) SPECT-CT Procedures (CPT Codes 78800, 78801, 78802, 78803, 78804, 
788X0, 788X1, 788X2, and 788X3)
    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 are proposing 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 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 are proposing 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 are 
proposing a work RVU of 0.80 based on the RUC-recommended incremental

[[Page 40592]]

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 are proposing 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 are proposing 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 788X0 (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 are proposing a work RVU of 1.49 for CPT code 788X0 
based on the RUC-recommended incremental relationship between CPT code 
788X0 and CPT code 78803 (a difference of 1.09 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 788X1 (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 are proposing 
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, 788X0: 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 788X2 (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, 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 are proposing 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 788X3 (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 wish 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 
788X2, depending on the type of service described by the code. For CPT 
code 788X0, which describes a single day of imaging and is thus 
analagous to CPT code 788X3 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

[[Page 40593]]

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 788X3.
    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, 788X0, 788X1, 
and 788X2, 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, 788X0, 
788X1, and 788X2, we are proposing 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 are refining these supplies to 
quantities of 5 each for CPT codes 78801, 78804, and 788X2 to conform 
with other codes in the family.
(51) Myocardial PET (CPT Codes 78459, 78X29, 78491, 78X31, 78492, 
78X32, 78X33, 78X34, and 78X35)
    CPT code 78492 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 disagree with the RUC-
recommended work RVU of 1.56, which is the survey 25th percentile 
value, as we believe 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 believe that the significance of the 
reductions in recommended physician time values warrants a reduction in 
work RVU. We are proposing 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 78X31 (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 disagree with the RUC recommendation 
of 1.67 based on the survey 25th percentile, as we do 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 
are proposing 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 note 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, 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 disagree with the RUC recommendation to increase the work 
RVU to 1.61 based on the survey 25th percentile. We believe 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 with similar time values. We are proposing 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 apply 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 disagree with the RUC's recommended valuation of 1.76 for CPT 
code 78X29 (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 believe a work RVU that 
is greater than those of all other services of similar intraservice 
time values is not appropriate. We are proposing a work RVU of 1.20 for 
CPT code 78X29. We are proposing to value CPT code 78X29 with an 
incremental methodology, which preserves the RUC-recommended 
relationship among the codes in this family; the RUC

[[Page 40594]]

recommends an increment of 0.20 between CPT code 78X29 and CPT code 
78491. We are proposing to apply this increment to our proposed value 
of 1.00 for CPT code 78491 to arrive at our value of 1.20.
    We disagree 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 are proposing 
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 
reference CPT code 95908 (Nerve conduction studies; 3-4 studies), with 
a work RVU of 1.25, similar physician time values.
    We disagree with the RUC's recommendation of 1.90 for CPT code 
78X32 (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 
that is greater than those of all other services of similar 
intraservice time values suggests that it is an overestimate. Instead 
we are proposing a work RVU of 1.34 for CPT code 78X32, based on an 
incremental methodology. We apply the RUC-recommended increment between 
78491 and CPT code 78X32, a difference of 0.34, to our proposed value 
of 1.00 for CPT code 78491, for a value of 1.34. We support 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 disagree with the RUC's recommendation of 2.07 for CPT code 
78X33 (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 believe 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 are proposing a work RVU of 1.51 for CPT code 78X33, based on an 
incremental methodology. We apply the RUC-recommended increment between 
78491 and CPT code 78X33, 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 78X34 (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 
disagree 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 believe the fact that this work RVU is among the 
highest among services of similar intraservice time values suggests 
that it is an overestimate. We are proposing a work RVU of 1.70 by 
applying the RUC-recommended increment between CPT code 78X34 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 support 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.
    For CPT code 78X35 (Absolute quantitation of myocardial blood flow 
(AQMBF), positron emission tomography, rest and pharmacologic stress 
(List separately in addition to code for primary procedure)), we 
disagree with the RUC recommendation to assign a work RVU of 0.63 to 
this code based on the survey 25th percentile, because we believe a 
comparison to other codes with a global period of ZZZ suggests that 
this is somewhat overvalued, and because we wish 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 think is warranted from the RUC value for 
CPT code 78491 to CPT code 78X35 will maintain consistency in value 
among these services. We believe 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 
are proposing to refine the equipment times to conform to our 
established policies for non-highly, as well as for highly technical 
equipment. In addition, we are proposing 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 are proposing 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 are refining these supplies to quantities 
of 5 each for CPT codes 78X33 and 78X34 to conform with other codes in 
the family. We are proposing that we will

[[Page 40595]]

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.
(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 disagree with the RUC-recommended work RVU and are proposing 
a work RVU of 0.26 for all four codes in this family, based on our time 
ratio methodology and a crosswalk to CPT code 93313 (Echocardiography, 
transesophageal, real-time with image 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 note 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 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 88141 and HCPCS codes G0124, G0141, and P3001, we believe that it 
would be more accurate to propose a work RVU of 0.26, based on our 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 are proposing 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 believe that these quality assurance activities 
would not typically take 7 minutes to perform, given that similar 
federally mandated 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 are proposing 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 proposing 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 are proposing 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.
(53) Biofeedback Training (CPT Codes 908XX and 909XX)
    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 are proposing the RUC-recommended work RVU of 0.90 for CPT code 
908XX (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 909XX (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 are proposing to refine 
the equipment time for the power table (EF031) equipment in CPT code 
908XX to conform to our established standard for non-highly technical 
equipment.
    We are also proposing to designate CPT codes 908XX and 909XX as 
``sometimes therapy'' procedures which means that an appropriate 
therapy modifier is always required when this service is furnished by 
therapists. For 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.
(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

[[Page 40596]]

utilization is continuing to increase for this service. This code was 
surveyed and reviewed for the January 2019 RUC meeting.
    We are proposing the work RVU of 0.10 as recommended by the RUC. We 
are also proposing the RUC-recommended direct PE inputs for CPT code 
92145 without refinement.
(55) Computerized Dynamic Posturography (CPT Codes 92548 and 92XX0)
    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 92XX0 
(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 are 
proposing 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 are proposing to maintain relativity between these two codes by 
valuing CPT code 92XX0 by applying the RUC-recommended incremental 
difference between the two codes, a difference of 0.20, to our proposed 
value of 0.66 for CPT code 93316; therefore, we are proposing a work 
RVU of 0.87 for CPT code 92XX0. 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 are proposing the RUC-recommended direct PE inputs for these 
codes without refinement.
(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 are proposing the HCPAC-recommended work RVU of 
1.40 for CPT code 92626, which is identical to its current RVU. We are 
also proposing the HCPAC-recommended work RVU of 0.33 for the add-on 
code, CPT code 92627. We are proposing the RUC-recommended direct PE 
inputs for all codes in the family.
(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 are proposing 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 are 
also proposing a change from 90-day to 0-day global period status for 
these two procedures, also as recommended by the RUC.
(58) Opthalmoscopy (CPT Codes 92X18 and 92X19)
    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 are proposing the RUC-recommended work RVUs of 0.40 for CPT code 
92X18 (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 92X19 (Ophthalmoscopy, 
extended, with drawing of optic nerve or macula (e.g., for glaucoma, 
macular pathology, tumor) with interpretation and report, unilateral or 
bilateral).
    We are proposing the RUC-recommended direct PE inputs for this code 
family without refinement.
(59) Remote Interrogation Device Evaluation (CPT Codes 93297, 93298, 
93299, and HCPCS Code GTTT1)
    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 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

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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 practice expense 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. Stating 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 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 note 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 are 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 are proposing 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 are not proposing to allocate direct PE inputs for CPT 
codes 93297 and 93298, we are seeking 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 are proposing 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 are proposing to create a G-code to describe 
the services previously furnished under CPT code 93299. We are 
proposing to create HCPCS code GTTT1 (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.
(60) Duplex Scan Arterial Inflow-Venous Outflow (CPT Codes 93X00 and 
93X01)
    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 are proposing the RUC-recommended 
work RVU of 0.80 for CPT code 93X00 (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 93X01 (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 are proposing 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 are proposing 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.
(61) Myocardial Strain Imaging (CPT Code 933X0)
    The CPT Editorial Panel deleted one Category III code and created 
one new Category I add-on code CPT code 933X0 to describe the work of 
myocardial strain imaging performed in supplement to transthoracic 
echocardiography services. We are proposing the RUC-recommended work 
RVU of 0.24.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
933X0. However, we note that no rationale was given for the RUC-
recommended 12 minutes of clinical labor time for the activity CA021

[[Page 40598]]

``Perform procedure/service,'' and we are requesting comment on the 
appropriateness of this allocated time value.
(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 are proposing 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 
are proposing the RUC-recommended 0.05, we are soliciting public 
comment on this stakeholder-recommended potential alternative value.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
94200 without refinement.
(63) Long-Term EEG Monitoring (CPT Codes 95X01, 95X02, 95X03, 95X04, 
95X05, 95X06, 95X07, 95X08, 95X09, 95X10, 95X11, 95X12, 95X13, 95X14, 
95X15, 95X16, 95X17, 95X18, 95X19, 95X20, 95X21, 95X22, and 95X23)
    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 proposing the RUC-recommended work RVU for six of the 
professional component codes in this family. We are proposing a work 
RVU of 3.86 for CPT code 95X18 (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 
95X19 (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 95X20 (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 95X21 (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 95X22 
(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 95X23 (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 are also proposing the RUC-recommended work RVU of 0.00 for the 
13 technical component codes in the family: CPT code 95X01 
(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 95X02 (Electroencephalogram (EEG) without video, review of data, 
technical description by EEG technologist, 2-12 hours; unmonitored), 
CPT code 95X03 (Electroencephalogram (EEG) without video, review of 
data, technical description by EEG technologist, 2-12 hours; with 
intermittent monitoring and maintenance), CPT code 95X04 
(Electroencephalogram (EEG) without video, review of data, technical 
description by EEG technologist, 2-12 hours; with continuous, real-time 
monitoring and maintenance), CPT code 95X05 (Electroencephalogram (EEG) 
without video, review of data, technical description by EEG 
technologist, each increment of 12-26 hours; unmonitored), CPT code 
95X06 (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 95X07 
(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 95X08 
(Electroencephalogram with video (VEEG), review of data, technical 
description by EEG technologist, 2-12 hours; unmonitored), CPT code 
95X09 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, 2-12 hours; with 
intermittent monitoring and maintenance), CPT code 95X10 
(Electroencephalogram with video (VEEG), review of data, technical 
description by EEG technologist, 2-12 hours; with continuous, real-time 
monitoring and maintenance), CPT code 95X11 (Electroencephalogram with 
video (VEEG), review of data, technical description by EEG 
technologist, each increment of 12-26 hours; unmonitored), CPT code 
95X12 (Electroencephalogram with video (VEEG), review of data, 
technical description by EEG technologist, each increment of 12-26 
hours; with intermittent monitoring and

[[Page 40599]]

maintenance), and CPT code 95X13 (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 disagree with the RUC-recommended work RVU of 2.00 for CPT code 
95X14 (Electroencephalogram, continuous recording, physician or other 
qualified health care professional review of recorded events, 2-12 
hours of EEG recording; without video) and we are proposing 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 95X14. When considering the work RVU for CPT code 
95X14, 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 95X14, yet has a work RVU of 1.98, lower than the 
recommended work RVU of 2.00. These time values suggested that CPT code 
95X14 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 95X14 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 are proposing a work RVU of 1.85 
for CPT code 95X14 based on the aforementioned crosswalk to CPT code 
93314.
    We disagree with the RUC-recommended work RVU of 2.50 for CPT code 
95X15 (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 are proposing a work RVU of 
2.35. Although we disagree with the RUC-recommended work RVU, we concur 
that the relative difference in work between CPT codes 95X14 and 95X15 
is equivalent to the recommended interval of 0.50 RVUs. Therefore, we 
are proposing a work RVU of 2.35 for CPT code 95X15, based on the 
recommended interval of 0.50 additional RVUs above our proposed work 
RVU of 1.85 for CPT code 95X14. We are supporting 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 95X15.
    We disagree with the RUC-recommended work RVU of 3.00 for CPT code 
95X16 (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 are proposing 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 
95X16. We also note that the observation care described by CPT code 
99219 shares some clinical similarities to the long term EEG monitoring 
described by CPT code 95X16, although we note 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 believe that the proposed crosswalk to CPT code 
99219 at a work RVU of 2.60 more accurately captures the intensity of 
CPT code 95X16. At the recommended work RVU of 3.00, the intensity of 
CPT code 95X16 is anomalously high in comparison to the rest of the 
family, higher than any of the other professional component codes. We 
have no reason to believe that the 24-hour EEG monitoring done without 
video as described in CPT code 95X16 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 
95X16, 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 95X16 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 95X17.
    We disagree with the RUC-recommended work RVU of 3.86 for CPT code 
95X17 (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 are proposing 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 95X17, at 90 minutes as compared to 75 
minutes. We disagree with the use of this crosswalk, as the 15 minutes 
of additional total time in CPT code 99223 result in a higher work 
valuation that overstates the work RVU of CPT code 95X17. 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 results 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 95X17 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 do 
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 are proposing a work RVU of 3.50 for CPT code 95X17 
based on the

[[Page 40600]]

survey 25th percentile value. We note 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) has 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 95X17, but does support 
the proposed work RVU of 3.50 at the slightly lower newly surveyed work 
times. We also note that at the recommended work RVU of 3.86, the 
intensity of CPT code 95X17 was anomalously high in comparison to the 
rest of the family, the second-highest intensity as compared to the 
other professional component codes. We have no reason to believe that 
the 24 hour EEG monitoring done with video as described in CPT code 
95X17 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 
95X17 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 95X16.
    For the direct PE inputs, we are proposing to make a series of 
refinements to the clinical labor times of CPT code 95X01. 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 for recommended 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 95X01, 
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 are proposing 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 
agree that additional clinical labor time would be required to carry 
out these activities for CPT code 95X01, we do not believe that the 
survey median times would be typical. We are proposing 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 are also proposing 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 95X01. This is 
another situation where we are proposing 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 believe that the RUC-
recommended survey median clinical labor time of 10 minutes overstates 
the amount of direct clinical labor taking place. We believe that it is 
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 are also proposing to refine the quantity of the non-sterile 
gloves (SB022) supply from 3 to 2 for CPT code 95X01. 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 do 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 are not proposing to refine many of the other 
clinical labor times for CPT code 95X01, 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 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 95X02-95X13, we are proposing 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 95X02-95X13, we are 
proposing 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 95X04, 
95X07, 95X10, and 95X13, we are proposing to refine the equipment time 
for the

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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 do 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 do not believe that each monitor would require its own 
review station, and that the equipment time should not be equal to four 
times the clinical labor of the ``Perform procedure/service'' (CA021) 
activity. As a result, we are proposing to refine the ambulatory EEG 
review station equipment time from 510 minutes to 150 minutes for CPT 
code 95X04, from 1,480 minutes to 400 minutes for CPT code 95X07, from 
514 minutes to 154 minutes for CPT code 95X10, and from 1,495 minutes 
to 415 minutes for CPT code 95X13.
    For the 10 professional component procedures, CPT codes 95X14-
95X23, we are again proposing 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 are proposing to refine the equipment times 
for these 10 procedures to match our standard equipment time formula 
for the professional PACS workstation. Therefore, we are proposing 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 95X14 through 95X23. We believe that this equipment time is 
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 95X14-95X23 make no mention of the ambulatory EEG review station 
in the postservice work period.
    Finally, we are proposing 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.
(64) Health and Behavioral Assessment and Intervention (CPT Codes 
961X0, 961X1, 961X2, 961X3, 961X4, 961X5, 961X6, 961X7, and 961X8)
    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 961X0 (Health 
behavior assessment, including re-assessment (i.e., health-focused 
clinical interview, behavioral observations, clinical decision 
making)), CPT code 961X1 (Health behavior intervention, individual, 
face-to-face; initial 30 minutes), CPT code 961X2 (Health behavior 
intervention, individual, face-to-face; each additional 15 minutes 
(list separately in addition to code for primary service)), CPT code 
961X3 (Health behavior intervention, group (2 or more patients), face-
to-face; initial 30 minutes), CPT code 961X4 (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 961X5 (Health behavior intervention, family (with the patient 
present), face-to-face; initial 30 minutes), CPT code 961X6 (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 961X7 (Health behavior intervention, family 
(without the patient present), face-to-face; initial 30 minutes), CPT 
code 961X8 (Health behavior intervention, family (without the patient 
present), face-to-face; each additional 15 minutes (list separately in 
addition to code for primary service)).
    We are proposing the RUC-recommended work RVUs for each of the 
codes in this family as follows.
     For CPT code 961X0, we are proposing a work RVU of 2.10.
     For CPT code 961X1, we are proposing a work RVU of 1.45.
     For CPT code 961X2, we are proposing a work RVU of 0.50.
     For CPT code 961X3, we are proposing a work RVU of 0.21.
     For CPT code 961X4, we are proposing a work RVU of 0.10.
     For CPT code 961X5, we are proposing a work RVU of 1.55.
     For CPT code 961X6, we are proposing a work RVU of 0.55.
     For CPT code 961X7, we are proposing a work RVU of 1.50 
(but this code will be non-covered by Medicare).
     For CPT code 961X8, we are proposing a work RVU of 0.54 
(but this code will be non-covered by Medicare).
    We are proposing the RUC-recommended direct PE inputs for all of 
the CPT codes in this family without refinement.
(66) Cognitive Function Intervention (CPT Codes 971XX and 9XXX0)
    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

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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 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 971XX 
(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 9XXX0 (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; each additional 15 minutes (list separately in 
addition to code for primary procedure)).
    We are proposing the RUC-recommended work RVUs of 0.50 for CPT code 
971XX and 0.48 for CPT code 9XXX0. We are proposing the RUC-recommended 
direct PE inputs for all codes in the family. We are also proposing to 
designate CPT codes 971XX and 9XXX0 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.
(67) 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 are proposing 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, one 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 are proposing 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.
(68) 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 Final Rule (80 FR 
71005),

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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 
comment 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 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 are 
proposing to assign an active status to CPT codes 97607 and 97608 and 
we are proposing the work RVUs as recommended by the RUC that we 
received for CY 2015 when the CPT Editorial Panel created these codes. 
Thus, we are proposing a work RVU of 0.41 for CPT code 97607 and a work 
RVU of 0.46 for CPT code 97608. Similarly, we are proposing 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.'' A 
search of publicly available commercial pricing data indicates that a 
unit price of approximately $100 is appropriate, and therefore, we are 
proposing this price for this supply item. If more accurate invoices 
are available, we are soliciting such invoices to more accurately price 
it.
(69) 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 practice expense for the January 2019 RUC meeting.
    We are proposing the RUC-recommend work 0.40 for CPT code 97610. We 
are also proposing the RUC-recommended direct PE inputs for CPT code 
97610.
(70) Online Digital Evaluation Service (e-Visit) (CPT Codes 98X00, 
98X01, and 98X02)
    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 98X00 (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 98X01 
(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 98X02 (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 9X0X1-9X0X3 are for practitioners 
who can independently bill E/M services while CPT codes 98X00-98X02 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 that there are qualified non-
physician health care professionals who will likely perform these 
services. Therefore, for CY 2020, we are proposing separate payment for 
online digital assessments via three HCPCS G-codes that mirror the RUC 
recommendations for CPT codes 98X00-98X02. The proposed HCPCS G codes 
and descriptors are as follows:
     HCPCS code GNPP1 (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 GNPP2 (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 GNPP3 (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 are proposing a work RVU of 0.25 for CPT code 
GNPP1, which reflects the RUC-recommended work RVU for CPT code 98X00. 
For HCPCS codes GNPP2 and GNPP3, we believe that the 25th percentile 
work RVU associated with CPT codes 98X01 and 98X02 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 are proposing a work 
RVU of 0.44 for HCPCS code GNPP1 and a work RVU of 0.69 for HCPCS code 
GNPP2.
    We are proposing the direct PE inputs associated with CPT codes 
98X00, 98X01, and 98X02 for GNPP1, GNPP2, and GNPP3 respectively.
(71) 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 are proposing 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 are not proposing any direct PE 
inputs for the codes in this family.

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(72) Self-Measured Blood Pressure Monitoring (CPT Codes 99X01, 99X02, 
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 99X01 (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 99X02 (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 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 are proposing the RUC-recommended work RVU of 0.18 for CPT code 
99X02, 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 are proposing 
the RUC-recommended work RVU of 0.00 for CPT codes 93786, 93788, and 
99X01. We are also proposing the RUC-recommended direct PE inputs for 
all codes in the family.
(73) Online Digital Evaluation Service (e-Visit) (CPT Codes 9X0X1, 
9X0X2, and 9X0X3)
    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 9X0X1 (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 
9X0X2 (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 9X0X3 (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 are proposing the RUC-recommended work RVUs of 0.25 
for CPT code 9X0X1, 0.50 for CPT code 9X0X2, and 0.80 for CPT code 
9X0X3. We are proposing the RUC-recommended direct PE inputs for all 
codes in the family.
(74) 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 are proposing 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.''
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

O. 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 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 evaluation and management 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. 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.
    We are seeking public comments 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's 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.

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).\80\
---------------------------------------------------------------------------

    \80\ 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.\81\ 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.\82\
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    \81\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
    \82\ 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), 
practice expense, 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

[[Page 40671]]

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).\83\ 
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 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 25.
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    \83\ See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; 
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the 
Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.

                 Table 25--Key Component Documentation Requirements for Level 2 vs. 3 E/M Visit
----------------------------------------------------------------------------------------------------------------
         Key component *            Level 2 (1995)      Level 3 (1995)      Level 2 (1997)      Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present       Review of Systems   Problem Pertinent   No change from      No change from
 Illness or HPI).                  (ROS) n/a.          ROS: Inquires       1995.               1995.
                                                       about the system
                                                       directly related
                                                       to the problem(s)
                                                       identified in the
                                                       HPI.
Physical Examination (Exam).....  A limited           A limited           General multi-      General multi-
                                   examination of      examination of      system exam:        system exam:
                                   the affected body   the affected body   Performance and     Performance and
                                   area or organ       area or organ       documentation of    documentation of
                                   system.             system and other    one to five         at least six
                                                       symptomatic or      elements in one     elements in one
                                                       related organ       or more organ       or more organ
                                                       system(s).          system(s) or body   system(s) or body
                                                                           area(s).            area(s).
                                                                          Single organ        Single organ
                                                                           system exam:        system exam:
                                                                           Performance and     Performance and
                                                                           documentation of    documentation of
                                                                           one to five         at least six
                                                                           elements.           elements.
 
Medical Decision Making (MDM).    Straightforward:    Low complexity:              No change from 1995.
 Measured by: **
    1. Problem--Number of            1. Minimal.....  1. Limited.
     diagnoses/treatment options.
    2. Data--Amount and/or           2. Minimal or    2. Limited data
     complexity of data to be         no data review.  review.
     reviewed.
    3. Risk--Risk of                 3. Minimal risk  3. Low risk.
     complications and/or
     morbidity or mortality.
----------------------------------------------------------------------------------------------------------------
 * For certain settings and patient types, each of these three key components must be met or exceeded (for
  example, new patients; initial hospital visits). For others, only two of the three key components must be met
  or exceeded (for example, established patients, subsequent hospital or other visits).
** Two of three met or exceeded.

    According to both Medicare claims processing manual instructions 
and CPT coding rules, when counseling and/or coordination of care 
accounts for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time) 
the duration of the visit can be used as an alternative basis to select 
the appropriate E/M visit level (Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 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

[[Page 40672]]

upon the content of the service. The duration of the visit is an 
ancillary factor and does not control the level of the service to be 
billed unless more than 50 percent of the face-to-face time (for non-
inpatient services) or more than 50 percent of the floor time (for 
inpatient services) is spent providing counseling or coordination of 
care as described in subsection C.'' Subsection C states that ``the 
physician may document time spent with the patient in conjunction with 
the medical decision-making involved and a description of the 
coordination of care or counseling provided. Documentation must be in 
sufficient detail to support the claim.'' The example included in 
subsection C further states, ``The code selection is based on the total 
time of the face-to-face encounter or floor time, not just the 
counseling time. The medical record must be documented in sufficient 
detail to justify the selection of the specific code if time is the 
basis for selection of the code.''
    Both the 1995 and 1997 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.'' \84\ 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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    \84\ 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 evaluation and management service when a lower level of service is 
warranted. The volume of documentation should not be the primary 
influence upon which a specific level of service is billed. 
Documentation should support the level of service reported.''
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

[[Page 40673]]

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 AMA's 
website at https://www.ama-assn.org/cpt-evaluation-and-management.
    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, available at https://www.ama-assn.org/cpt-evaluation-and-management.
    Given the CPT coding changes that will take effect in 2021, the AMA 
RUC has conducted a resurvey and revaluation of the office/outpatient 
E/M visit codes, and provided us with its recommendations. We discuss 
our proposal to adopt the CPT coding for office/outpatient E/M visits 
below, noting that the CPT coding changes will also necessitate some 
changes to CMS' policies for CY 2021, due to forthcoming changes in 
code descriptors. In addition, we address revaluation of the codes, 
proposing new values for the codes as revised by CPT. We propose 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 propose to delete the HCPCS add-on code we finalized last year for 
CY 2021 for extended visits (GPRO1). We propose 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 new 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 believe our 
proposed policies will 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.
3. Proposed Policies for CY 2021 for Office/Outpatient E/M Visits
a. Office/Outpatient E/M Visit Coding and Documentation
    For CY 2021, for office/outpatient E/M visits (CPT codes 99201-
99215) we are proposing 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 
believe 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 note 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 select 
the level of code selection 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.
    For levels 2 through 5 office/outpatient E/M visits, the code level 
reported would be decided based on

[[Page 40674]]

either the level of MDM (as redefined in 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 finalized 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. We interpret 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) that would only be reported when time is used for code 
level 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. The long descriptor for CPT code 99XXX is 
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). We demonstrate below how prolonged office/outpatient E/M 
visit time would be reported:

  Table 26--Total Proposed Practitioner Times for Office/Outpatient E/M
             Visits When Time Is Used To Select Visit Level
------------------------------------------------------------------------
Established patient office/outpatient E/
 M visit (total practitioner time, when
   time is used to select code level)                CPT code
               (minutes)
------------------------------------------------------------------------
40-54..................................  99215.
55-69..................................  99215x1 and 99XXXx1.
70-84..................................  99215x1 and 99XXXx2.
85 or more.............................  99215x1 and 99XXXx3 or more for
                                          each additional 15 mintues.
------------------------------------------------------------------------


 
New patient office/outpatient E/M visit
 (total practitioner time, when time is              CPT code
  used to select code level) (minutes)
------------------------------------------------------------------------
60-74..................................  99205.
75-89..................................  99205x1 and 99XXXx1.
90-104.................................  99205x1 and 99XXXx2.
105 or more............................  99205x1 and 99XXXx3 or more for
                                          each additional 15 minutes.
------------------------------------------------------------------------

    We are proposing 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 towards 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 note that CPT codes 
99358-9 describe time spent beyond the ``usual'' time (CPT prefatory 
language), and it is 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 do 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 
be used to report practitioner time spent on any date (the date of the 
visit or any other day), the CPT reporting instruction ``see 99358, 
99359'' seems circular. The new prefatory language seems 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 are seeking public input on this proposal and whether it 
would be appropriate to interpret the CPT reporting instructions for 
CPT codes 99358-9 as proposed, as well as how this interpretation may 
impact valuation. We believe CPT codes 99358 and 99359 may need to be 
redefined, resurveyed and revalued. After internal review, we believe 
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 propose to 
delete HCPCS code GPRO1 for CY 2021. We propose 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.

[[Page 40675]]

b. Office/Outpatient E/M Visit Revaluation (CPT Codes 99201 Through 
99215)
    We have received valuation recommendations from the AMA RUC for the 
revised office/outpatient E/M 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 
believe that it is appropriate to follow our usual process of 
addressing the valuation of the revised office/outpatient E/M 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 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, practice expense inputs and physician 
time (number of minutes) for the revised office/outpatient E/M code 
set. Please note that these proposed changes in coding and values are 
for the revised office/outpatient E/M code set and a new 15-minute 
prolonged services code. That code set is effective beginning in CY 
2021, and the proposed values would go into effect with those codes as 
of January 1, 2021.
    We are proposing to adopt the RUC-recommended work RVUs for all of 
the office/outpatient E/M codes and the new prolonged services add-on 
code. Specifically, we are proposing 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 practice expense inputs for 
these codes, we are proposing 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.
    The information we reviewed on the RUC valuation exercise was based 
on an extensive survey the RUC conducted of over 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 time frame 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 time frame. 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 results in two conflicting sets of times: The 
component times as surveyed and the total time as surveyed. Although we 
are proposing to adopt the RUC-recommended times as explained below, we 
are seeking comment on how CMS should address the discrepancies in 
times, which have implications both for 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

[[Page 40676]]

component times sum to the total time. Specifically, we request comment 
on which times should CMS use, and how we should resolve differences 
between the component and total times when they conflict. Table 27A 
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.

  Table 27A--RUC-Recommended Pre-, Intra-, Post-Service Times, RUC-Recommended Total Times for CPT Codes 99202-
                                           99215 and Actual Total Time
----------------------------------------------------------------------------------------------------------------
                                                                                                       RUC-
              HCPCS                 Pre-service    Intra-service  Immediate post-  Actual total     recommended
                                       time            time        service time        time         total time
----------------------------------------------------------------------------------------------------------------
99202...........................               2              15               3              20              22
99203...........................               5              25               5              35              40
99204...........................              10              40              10              60              60
99205...........................              14              59              15              88              85
99211...........................  ..............               5               2               7               7
99212...........................               2              11               3              16              18
99213...........................               5              20               5              30              30
99214...........................               7              30              10              47              49
99215...........................              10              45              15              70              70
----------------------------------------------------------------------------------------------------------------

    Table 27B summarizes the current office/outpatient E/M services 
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.

 Table 27B--Side by Side Comparison of Work RVUs and Physician Time for the Office/Outpatient E/M Services Code Set, and the New Prolonged Services Code
                                                                [Current versus revised]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Current total   Current work    CY 2021 total   CY 2021 work    RUC rec total   RUC rec work
                       HCPCS code                           time (mins)         RVU         time (mins)         RVU         time (mins)         RVU
--------------------------------------------------------------------------------------------------------------------------------------------------------
99201...................................................              17            0.48              17            0.48             N/A             N/A
99202...................................................              22            0.93              22            1.76              22            0.93
99203...................................................              29            1.42              29            1.76              40             1.6
99204...................................................              45            2.43              45            1.76              60             2.6
99205...................................................              67            3.17              67            3.17              85             3.5
99211...................................................               7            0.18               7            0.18               7            0.18
99212...................................................              16            0.48              16            1.18              18             0.7
99213...................................................              23            0.97              23            1.18              30             1.3
99214...................................................              40             1.5              40            1.18              49            1.92
99215...................................................              55            2.11              55            2.11              70             2.8
99XXX...................................................             N/A             N/A             N/A             N/A              15            0.61
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The RUC recommendations reflect a rigorous 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 are 
proposing to establish separate values for Levels 2-4 office/outpatient 
E/M visits for both new and established patients rather than continue 
with the blended rate. We are proposing to accept the RUC-recommended 
work and time values for the revised office/outpatient E/M codes 
without refinement for CY 2021. With regard to the RUC's 
recommendations for practice expense inputs, we are proposing 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.
c. 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 would more accurately reflect the 
resources involved in furnishing a typical office/outpatient E/M visit, 
we believe that the revalued office/outpatient E/M 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

[[Page 40677]]

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 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 an 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 visits and certain types of specialty office/
outpatient 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 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 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 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 want to make it clear 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 are proposing 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 are proposing to revise the descriptor for HCPCS code GPC1X and 
delete HCPCS code GCG0X. The proposed descriptor for GPC1X appears in 
Table 28. We are seeking comment from the public and stakeholders 
regarding these 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 
service code set and proposed values. Upon further review and in light 
of the other proposed changes to the office/outpatient E/M service 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 services, we believe its work and time 
values are the most appropriate crosswalk for the revised HCPCS code 
GPC1X. Therefore, we are proposing to value HCPCS code GPC1X at 100 
percent of the work and time values for CPT code 90785, and proposing a 
work RVU of 0.33 and a physician time of 11 minutes. We are also 
proposing that this HCPCS add-on G code could be billed as applicable 
with every level of office and outpatient E/M visit, and that we would 
revise the code descriptor to reflect that change. See Table 28 for the 
proposed changes to the code descriptor. We note that if the CPT 
Editorial Panel makes any further changes to the office and outpatient 
E/M 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.

[[Page 40678]]



                   Table 28--Proposed Revaluation of HCPCS Add-On G Code Finalized for CY 2021
----------------------------------------------------------------------------------------------------------------
                          Proposed code        FR 2019 total     FR 2019 work    Proposed total   Proposed work
     HCPCS code        descriptor revisions     time (mins)          RVU          time (mins)          RVU
----------------------------------------------------------------------------------------------------------------
GPC1X..............  Visit complexity                   8.25             0.25               11             0.33
                      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).
----------------------------------------------------------------------------------------------------------------

d. Valuation of CPT Code 99xxx (Prolonged Office/Outpatient E/M)
    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. We are proposing to delete to the HCPCS add-on code we 
finalized last year for CY 2021 for extended visits (GPRO1) and adopt 
the new CPT code 99XXX. Further, as discussed above we are proposing to 
accept the RUC recommended values for CPT code 99XXX without 
refinement.
    We are seeking comment on these proposals, as well as any 
additional information stakeholders can provide on the appropriate 
valuation for these services.
e. Implementation Timeframe
    We propose that these policy changes for office/outpatient E/M 
visits would be effective for services furnished starting January 1, 
2021. We believe this would allow sufficient time for practitioner and 
provider 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 propose 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 medical decision making to decide the 
level of office/outpatient E/M visit (using the revised CPT 
interpretive guidelines for medical decision making);
     Payment for prolonged office/outpatient E/M visits using 
the revised CPT code for such services, including separate payment for 
new CPT code 99xxx and deletion of HCPCS code GPRO1 (extended office/
outpatient E/M visit) that we previously finalized for 2021;
     Revise the descriptor for HCPCS code GPC1X and delete 
HCPCS code GCG0X; and
     Increase in value for HCPCS code GCG1X and allowing it to 
be reported with all office/outpatient E/M visit levels.
f. Global Surgical Packages
    In addition to their recommendations regarding physician work, 
time, and practice expense for office/outpatient E/M visits, the AMA 
RUC also recommended adjusting the office/outpatient E/M visits for 
codes with a global period to reflect the changes made to the values 
for office/outpatient E/M visits. Procedures with a 10- and 90-day 
global period have post-operative visits included in their valuation. 
These post-operative visits are valued with reference to values for the 
E/M visits and each procedure has at least a half of an E/M visit 
included the global period. However, these visits are not directly 
included in the valuation. Rather, work RVUs for procedures with a 
global period are generally valued using magnitude estimation.
    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 follow-up 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 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 MACRA added section 1848(c)(8)(A) of the Act, 
which

[[Page 40679]]

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-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 shifted the study 
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 the Time File for cataract surgery and hip 
replacement and somewhat different for complex wound repair. (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 
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 will give the public and 
stakeholders time to study the reports we are making available along 
with this rule and consider an appropriate approach to revaluing global 
surgical procedures. We also note that the Office of the Inspector 
General (OIG) has published a number of reports on this topic. We will 
continue to study and consider alternative ways to address the values 
for these services.
g. Comment Solicitation on Revaluing the Office/Outpatient E/M Visit 
Within TCM, Cognitive Impairment Assessment/Care Planning and Similar 
Services
    We recognize 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). In future rulemaking, we 
may consider adjusting the RVUs for these services and are seeking 
public input on such a policy. We note that unlike the global surgical 
codes, these services always include an office/outpatient E/M visit(s) 
furnished by the reporting practitioner as part of the service, and it 
may therefore be appropriate to adjust their valuation commensurate 
with any

[[Page 40680]]

changes to the values for the revised codes for office/outpatient E/M 
visits. While some of these services do not involve an 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 are also seeking 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 are 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 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 evaluation and management 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). In 
order 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 are seeking 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.

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 are proposing to revise Sec. Sec.  410.40 
and 410.41. Importantly, we first clarify that these requirements apply 
to ambulance providers, as well as suppliers. The proposed 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 nonrepetitive 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)
    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 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 it has 
been requested that we incorporate additional exceptions into the 
regulatory framework.
    Upon reviewing the need for a PCS and non-physician certification

[[Page 40681]]

statement, stakeholders' concerns, and our commitment to reducing the 
burden placed on providers and suppliers, we have determined that 
instead of incorporating additional exceptions, our efforts would be 
better served by minorly altering the structure of the existing 
regulatory framework. 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 are proposing to add a new paragraph (a) in 
Sec.  410.40 in which we would define both PSCs, as well as non-
physician certification statements. Therefore, we are proposing 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).
    For new proposed 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 proposed 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. Since the two 
definitions incorporate the requirement to obtain a certification of 
medical necessity, we are proposing a conforming change to newly 
redesignated paragraph (e)(2) to remove the language requiring that an 
order certifying medical necessity be obtained.
    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 can 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. 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. The precise form or format by which 
that information is conveyed has never been prescribed. We aim here 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.
    The definition of non-physician certification statement in proposed 
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 
requirements; and (3) the specific staff that can sign in lieu of the 
attending physician. Included within the proposed 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 proposed at 
Sec.  410.40(a), we are proposing 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 have proposed changes to refer to the 
newly redesignated paragraph (e) and in paragraph (e)(3)(v) we have 
proposed changes to refer to the newly defined terms in paragraph (a), 
specifically the physician or non-physician certification statement. 
Lastly, we are also proposing 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 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 do not anticipate that this clarification will 
alter the frequency of claim denials.
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.
    In that final rule with comment period, however, 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 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 therefore 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

[[Page 40682]]

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.
    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 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 are proposing as part of the new proposed 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 request comments on whether other staff should be 
included in this regulation, and request that commenters identify such 
staff's licensure and position and the reason it would be appropriate 
for such staff to sign a certification statement.

B. Proposal To Establish a Medicare Ground Ambulance Services 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 geographic adjustment factor, and other 
applicable adjustment factors as set forth at section 1834(l) of the 
Act and 42 CFR 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 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

[[Page 40683]]

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) 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 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 HHS, in consultation 
with the Secretary of Transportation, to establish an advisory 
committee that includes HHS, DOT, and others to 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 welcome 
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.
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 (collectively referred to in this proposed 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:
     The Moran Company Statistical and Financial Data Survey 
(the ``Moran

[[Page 40684]]

survey'').\85\ In 2012, American Ambulance Association (AAA) 
commissioned a study with the goal of developing a data collection 
instrument 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.
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    \85\ 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.\86\ 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 instrument is geared toward 
government entities, as private ambulance providers and suppliers do 
not qualify for the supplemental payments.
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    \86\ 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.
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     The Emergency Medical Services Cost Analysis Project 
(EMSCAP) framework.\87\ 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 instrument 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.
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    \87\ 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.\88\ 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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    \88\ 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.\89\ 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.
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    \89\ 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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    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 time frame 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 \90\ report'') which is referenced 
throughout this proposed 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. This report, in addition to 
other considerations we describe below, informed our proposals for the 
data collection instrument.
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    \90\ CMS Alliance to Modernize Healthcare.
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4. Proposals for the Data Collection Instrument
a. Proposed Format
    We considered several options for collecting the data including a 
survey, a cost report spreadsheet like 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 note 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. For these reasons, we do not believe that these 
tools could be used by all ground ambulance organizations for Medicare 
payment purposes without significant revision.
    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 agree 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

[[Page 40685]]

on volunteer services, which would exclude a large percentage of ground 
ambulance organizations from our sample. It would also not take into 
account the unique differences of government run ground ambulance 
entities, and specifically ground ambulance entities that provide other 
emergency services such as fire services, 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. Although we agree that standardization is 
important for data analysis, many smaller ground ambulance 
organizations have said they would have difficulty complying with 
complex cost reporting guidelines. We believe 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.
    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 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 are not proposing this approach because we 
believe 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. We will discuss this more 
in the options we considered for sampling section of this proposed 
rule.
    Based on our analysis of the existing or previously used data 
collection instruments described above, we do not believe that any of 
them would be sufficient to adequately capture the data required by 
section 1834(l) of the Act. Therefore, we are proposing to collect 
ground ambulance organization data using a survey that we developed 
specifically for this purpose, which we will refer to from this point 
forward in this proposed rule as the data collection instrument, and 
which we would make available via a secure web-based system. We believe 
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. The proposed data collection 
instrument includes 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 also believe that 
the proposed data collection instrument is easier to navigate and less 
time consuming to complete than a cost report spreadsheet. The proposed 
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. We are also proposing to codify these 
policies at Sec.  414.626.
b. Proposed 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.
    We considered several options regarding the scope of collecting 
data on ground ambulance cost, revenue, and utilization. One option 
would be 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. This approach would consider all ground ambulance costs, 
revenue, and utilization, regardless of whether the service was 
billable to Medicare or related to a Medicare beneficiary. The 
advantage of this approach is that ground ambulance organizations 
already track information at their organizational level on total costs, 
revenue, and utilization for their own internal budgeting and planning. 
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'',\91\ 
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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    \91\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
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    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,'' \92\ 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

[[Page 40686]]

(HCPCS) codes because the available cost data in both studies did not 
support that level of analysis.
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    \92\ This report is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Report-To-Congress-September-2015.pdf.
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    Another option would be to consider only those costs that are 
relevant to ground ambulance services furnished to Medicare 
beneficiaries. 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 believe 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 would be to consider only those costs that are 
related to the specific ground ambulance transport services that are 
paid under the AFS. 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). We believe this 
option would also be overly burdensome and complex.
    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, and 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 propose the first option as discussed above, 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. This approach would consider 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 are proposing to collect a ground ambulance 
organization's total costs and total revenues, we are aware that many 
ground ambulance organizations share operational costs with fire 
departments, other public service organizations, air ambulance 
services, hospitals, and other entities. 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 are also aware that some ground ambulance 
suppliers deploy emergency medical technicians (EMTs) in fire trucks, 
which would make it difficult to determine whether the fire truck costs 
should be factored into the total ground ambulance costs, and if so, 
how that would be calculated.
    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. However, we do 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. 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 are 
proposing an approach where the data collection instrument instructions 
would separately address three further refined proposed categories of 
total ground ambulance costs and revenues:
     Cost and revenue components completely unrelated to ground 
ambulance services. These costs and revenues would be unrelated to this 
data collection and not reported. Examples include 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. These costs and revenue would be reported in full, 
but respondents would report additional information that can be used to 
allocate a portion of the costs to ground ambulance services. Depending 
on how the data would be utilized, certain costs could be included or 
excluded from an analysis after data are collected. Examples include 
EMTs who are also firefighters and facilities with both ground 
ambulance and fire department functions. (We considered an alternative 
where respondents would allocate costs and report only costs associated 
with ground ambulance services but believe 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. These costs are reported in full. Examples include 
EMTs with only ground ambulance responsibilities and ground ambulance 
vehicles.
    We believe that this approach would 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. 
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. For example, 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 believe that under our 
proposed approach, the collected data would be available to estimate 
total costs and revenue relevant to ground ambulance services.
c. Proposed Data Collection Elements
    The draft data collection instrument is available on the CMS 
website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html. An overview of the elements of the data 
collection instrument we are proposing is in Table 29, including 
information on costs, revenues, utilization (which we define for the 
purposes of the instrument as service volume and service mix), as well 
as the characteristics of ground ambulance organizations.
    To help structure the data collection instrument, we organized 
costs by category (for example, labor, vehicles, and facilities), which 
is the approach

[[Page 40687]]

used in the GEMT and the AAA/Moran survey.

    Table 29--Proposed Components for the Data Collection Instrument
------------------------------------------------------------------------
  Component (data collection
     instrument section)                   Broad description
------------------------------------------------------------------------
Ground ambulance organization  Information regarding the identity of the
 characteristics (2-4).         organization and respondent(s), service
                                area, ownership, response time, and
                                other characteristics; broad questions
                                about offered services to serve as
                                screening questions.
Utilization: Ground ambulance  Number of responses and transports, level
 service volume and service     of services reported by HCPCS code.
 mix (5 and 6).
Costs (7-12).................  Information on all costs partially or
                                entirely related to ground ambulance
                                services.
     Staffing and      Number and costs associated with EMTs
     Labor Costs (7).           administrative staff, and facilities
                                staff; separate reporting of volunteer
                                staff and associated costs.
     Facilities Costs  Number of facilities; rent and mortgage
     (8).                       payments, insurance, maintenance, and
                                utility costs.
     Vehicle Costs     Number of ground ambulances; number of
     (9).                       other vehicles used in ground ambulance
                                responses; annual depreciation; total
                                fuel, maintenance, and insurance costs.
     Equipment &       Capital medical and non-medical
     Supply Costs (10).         equipment; medical and non-medical
                                supplies and other equipment.
     Other Costs (11)  All other costs not reported elsewhere.
     Total Cost (12).  Total costs for the ground ambulance
                                organization included as a way to cross-
                                check costs reported in the instrument.
Revenue (13).................  Revenue from health insurers (including
                                Medicare); revenue from all other
                                sources including communities served.
------------------------------------------------------------------------

    The following sections describe our proposed approach for data 
collection in each of these categories.
(1) Collecting Data on Ground Ambulance Provider and Supplier 
Characteristics
    CMS is 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. We also 
recognize 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. Research 
conducted for this proposal indicates 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 believe it is important for ground ambulance 
organizations to report additional characterictics, as described below, 
to adequately analyze the differences in costs and revenue among 
different types of ambulance providers and suppliers. We also believe 
collecting this information directly through the proposed data 
collection instrument will improve data quality with minimal burden on 
the respondents because the proposed data collection instrument is 
designed to tailor later sections and questions based on respondents' 
characteristics through programmed ``skip patterns''. 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 believe that data accuracy would be more 
robust if reported directly by respondents for the specific purpose of 
this data collection.
    The proposed data collection questions related to organizational 
characteristics and service area are in sections 2, 3, and 4 of the 
data collection instrument. We are proposing to collect information on 
ownership and organization type through a sequence of questions in 
section 2 of the data collection instrument. Some of the questions in 
this section are 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, asks 
about the organizations' ownership status. This item aligns closely 
with a similar question on the Medicare enrollment form CMS 855B for 
ambulance suppliers. Question 7 asks whether the respondent's 
organization uses any volunteer labor. While this question could have 
been asked later in the data collection instrument around the 
collection of labor data, 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 asks respondents to select a category that best describes 
their ambulance organization. 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 ask whether the respondent has shared operational 
costs with an entity of another type, including a fire department, 
hospital, or other entity. We are proposing 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

[[Page 40688]]

operational costs with another entity type. 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.
    Other proposed questions regarding organizational characteristics 
are necessary to tailor later parts of the data collection instrument 
to the respondent. These include proposed 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. 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. The 
area served by ambulance providers and suppliers is an important 
characteristic and we are proposing to collect information on the 
geographic area served by each ambulance provider and supplier in 
section 3 of the data collection instrument.
    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). We considered several alternatives to collect information 
on service area. One option would be to utilize Medicare claims data, 
but this would limit the information to Medicare billed transports only 
and would also not differentiate between primary and other service 
areas. Another option would be to allow respondents to write in a 
description of their primary and other service areas, but this would 
require converting written responses to a format that can be used for 
analysis. A third option would be for respondents to report the ZIP 
codes that constitute their primary and other service area. This 
approach aligns with the Medicare enrollment process requirement to 
submit ZIP codes where the ground ambulance organization operates. It 
would also collect ZIP code-based information on service area that can 
be easily linked to the ZIP Code to Carrier Locality file \93\ that 
lists each ZIP code and its designation as urban; rural; or super-
rural. This file is used by the MACs to determine if the temporary add-
on payments should apply to a transport under the AFS. 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.
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    \93\ Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html.
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    We are proposing 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 are also 
proposing to require respondents to specify whether they have a 
``secondary'' service area, which 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). 
Mutual aid agreements are joint agreements with neighboring areas in 
which they can ask each other for assistance. Auto-aid arrangements 
allow a central dispatch to send the closest ambulance to the scene. We 
are not proposing 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 believe reporting on rarely-served 
areas would involve significant additional burden and would add to 
instrument complexity without generating data that would be useful for 
analysis.
    The proposed approach distinguishes between primary and secondary 
service areas. This would 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 believe 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 are proposing to ask the following questions in sections 3 and 4 
of the 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:
     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).
    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

[[Page 40689]]

long average trip times even though mileage may be more modest due to 
terrain, the quality of roads, and other factors. We believe 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.
(2) Collecting Data on Ground Ambulance Utilization
    CMS is required to collect information on the utilization of ground 
ambulance services. 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. 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). 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. 
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. The number of 
responses that did not result in a transport can be separately tallied. 
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). Another utilization category 
would include information on ambulance providers and suppliers that 
furnish paramedic intercept services or provide paramedic-level staff 
in the course of a BLS response where another organization provides the 
ground ambulance transport.
    We believe 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. Collecting utilization information related to transports but 
not other services could omit important cost information. 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. 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 are 
proposing a two-pronged approach to collect data on the volume and the 
mix of services. First, we are proposing to collect total volume of 
services for each of the categories listed below in section 5 of the 
proposed 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). 
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. 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 are proposing 
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 are not proposing 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 are proposing 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 
are not proposing 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 believe, 
based on discussions with stakeholders, that it is reasonable to assume 
that the distribution of transports across categories would be the 
same.
(3) Collecting Data on Costs
    Section 1834(l)(17)(A) of the Act requires CMS to collect cost 
information from ground ambulance organizations, and we previously 
discussed our proposal to collect data on a ground ambulance 
organization's total costs. This part of the proposed rule describes 
the data in each cost category that we are proposing to collect, as 
well as alternatives that we considered.
    The costs reported separately in the categories of costs we are 
proposing to collect would sum to an organization's total ground 
ambulance costs. In addition to ground ambulance costs, we are 
proposing to ask all respondents in the proposed data collection 
instrument

[[Page 40690]]

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 instrument, and we can compare the reported total to the 
sum of costs across categories. Such a 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 believe that this cross-check will improve data quality 
and is consistent with existing survey-based data collection tools. 
This approach will also provide a better understanding of the overall 
size and scope of ground ambulance organizations, including activities 
other than providing ground ambulance services. 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, there are 
instructions and reminders throughout the proposed data collection 
instrument to avoid double-counting of costs. From a design 
perspective, we believe it is less important where a particular cost is 
reported on the survey data collection instrument and more important 
that the cost is reported only once.
    We are making two proposals that have important implications for 
reporting in all cost sections in the proposed 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 propose 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 are proposing to allow the 
respondent to report an allocated amount directly for these questions 
using an allocation approach they regularly use for this purpose. We 
believe that while proposing a specific allocation approach would yield 
more uniform and transparent data, we believe that these benefits are 
not worth the additional respondent burden.
    Second, we are proposing 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. Examples 
include 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. Although we recognize 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 considered asking respondents to 
report fair market values for these vehicles and buildings. However, we 
are aware that while the lack of reported cost data in one of these 
major categories could affect calculated total cost, 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 
propose instead 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 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 are also proposing not to collect 
an estimate of fair market value for donated equipment, supplies, and 
costs collected in the ``other costs'' section of the instrument. As 
noted above, for those 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.
    The following sections describe each cost category, alternative for 
data collection, and our proposals related to each category of costs 
separately.
(i.) Collecting Data on Staffing and Labor Costs
    In interviews with ambulance providers and suppliers, they stated 
that labor is one the largest contributors to total ground ambulance 
costs (especially medical staff such as EMTs, paramedics, and medical 
directors) and that they use a broad mix of labor types and hiring 
arrangements. There is also significant variation in tracking staffing 
and labor cost inputs that are needed to calculate costs. We were also 
informed by ambulance providers and suppliers 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.).
    We agree that labor costs are an important component of total costs 
and believe 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 would not be able to gauge whether differences in 
labor costs are due to compensation or different levels of staffing. 
Collecting information on staffing levels also allows the use of 
imputed labor rates from other sources (such as the Bureau of Labor 
Statistics). We also acknowledge 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 are 
proposing to collect information in the proposed data collection 
instrument on the number of staff and labor costs for several detailed 
categories of response staff (for example, EMT-basic, EMT-intermediate, 
and EMT-paramedic) (section 7.1), and for a single category for paid 
administrative and facilities

[[Page 40691]]

staff (for example, executives, billing staff, and maintenance staff) 
(section 7.2), and (c) separately for medical directors (section 7.2). 
We believe 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 believe 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.
    The main limitation of the proposed approach is that we would not 
collect detailed information on specific paid administration and 
facilities labor categories. Therefore, we are also proposing 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). This question also serves as a screening question to determine 
which response options appear to the respondent in several other 
questions in this section of the proposed data collection instrument. 
We also propose 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).
Reporting Staffing Levels
    In reporting staffing levels in the proposed data collection 
instrument, 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 believe 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. 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. 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. 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. 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 are proposing 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 
proposed data collection instrument ask 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 are 
proposing 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 refer 
to these costs as fully-burdened costs. 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 providers and suppliers to report fully burdened costs 
may be limited. Despite this limitation, due to the importance of labor 
costs as a component of total ground ambulance costs, we believe that 
information on fully burdened costs (sections 7.1 and 7.2) must be 
reported so that all relevant ground ambulance transport costs are 
collected. Ambulance providers and suppliers 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
    Ground ambulance organizations have also informed CMS that a 
significant share of ambulance providers and suppliers 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 are proposing 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 (section 7.3, questions 1-5). Although some 
suggested that assigning a value to volunteer labor hours may be 
important, the proposed 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 believe reported hours 
can be converted, if necessary, to market rates using data from other 
sources. We are also proposing 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 
are proposing 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). We believe 
this information can be used to subtract a portion of associated labor 
costs when calculating ground ambulance labor costs. We believe our 
proposed 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 are proposing to ask respondents to 
report the total hours in a typical week unrelated to ground ambulance 
or fire/police response duties (which are

[[Page 40692]]

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 believe this 
proposed 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.
(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.
    We considered proposing to require respondents to report facilities 
costs aggregated across all facilities. We believe this approach would 
minimize burden on the respondent by eliminating the need to break 
costs down by facility; however, it may also increase the risk for 
inconsistencies in how respondents report total facilities costs. 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 proposing to require respondents to report all 
costs on a per-facility basis. We believe this approach would allow the 
most flexibility in reporting complex facility arrangements from ground 
ambulance organizations operating out of multiple facilities. However, 
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 are proposing a hybrid approach involving both per-facility and 
aggregate reporting of different information. 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). Third, respondents report facilities-
related insurance, maintenance, utilities, and property taxes 
aggregated across all facilities (section 8.3).
    We believe this proposed 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. 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. The proposed 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 
expect that 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 do not 
believe this information would be difficult to collect.
(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 are proposing 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.
    Ambulance providers and suppliers 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. For example, a fire truck staffed with fire 
personnel cross-trained as EMTs may respond with a ground ambulance to 
an emergency call. 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. One 
alternative would be to only include the costs for ambulances and 
exclude other certain non-ambulance response vehicles from reported 
costs. 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 would be 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 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 believe 
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 are proposing to collect data on vehicle costs in the proposed 
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 are 
proposing 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 are 
proposing to allow respondents with owned vehicles to use their own 
accounting approach to calculate annual depreciated value per vehicle. 
We believe that allowing flexibility for respondents to use their 
standard approach for this calculation would result in more accurate 
data and less reporting burden.
    We are also proposing 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). The proposed instructions in section 9.2 of the data 
collection instrument specify that reported vehicles must support 
ground ambulance services. We are proposing to collect the type of each 
vehicle in broad categories in addition

[[Page 40693]]

to the annual depreciated value or lease payment amount for each 
vehicle.
    In addition to the above costs, we also are proposing 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 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, a share of 
vehicle costs reported via the 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 believe 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. The main limitation of this approach is that 
maintenance and fuel costs could vary significantly across vehicle 
categories. For example, maintenance and fuel costs may be 
significantly different for ground ambulance than for other types of 
vehicles. As a result, we are proposing 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 propose 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.
(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.
    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, many ground ambulance 
organizations may not keep detailed records of all their individual 
equipment and supply costs. Taking those factors into account, we are 
proposing 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). 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 believe 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 are proposing 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 are proposing 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 can vary depending on the expected service 
life of the specific good. 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 are proposing 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 can report 
annual depreciated costs for capital equipment and total annual costs 
otherwise. We also are proposing 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 are proposing to allow respondents to use their own 
standard accounting practice to categorize equipment as capital or non-
capital. While we believe it would be possible to ask respondents to 
use a standard approach, we believe this would require respondents with 
another practice to recalculate annual depreciated cost and potentially 
increase respondent burden and reporting errors.
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 believe 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 are proposing 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). 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.

[[Page 40694]]

(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.
    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 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 believed this approach may be less burdensome for 
organizations that track miscellaneous costs in aggregate, we believe 
this would introduce a large amount of reporting bias and inconsistency 
in reporting across organizations. Our proposals related to reporting 
contracted services and miscellaneous costs are described below.
Reporting Contracted Services
    For contracted services, we are proposing 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 proposed data collection instrument 
would provide 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 are proposing 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. 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 are proposing 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. 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.
d. Proposed 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. We view total revenue as the sum of payments 
from health care payers and all other sources of revenue, including 
those listed above.
    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 also considered what level of data to request 
in this section. We are proposing 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 are proposing this 
level of detail because we believe understanding payer mix would be 
helpful to assess Medicare's contributions to total revenue. Based on 
information provided by ambulance providers and suppliers, there is 
variation in how patient-paid amounts were recorded in ambulance 
billing systems. We are proposing 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 are proposing to request information on additional revenue 
in predetermined categories and using write-in fields if necessary 
(section 13, question 5).
    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 are proposing 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 do not believe it would not 
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 are proposing to collect information on both 
total and paid transports. These two measures of volume can be used to 
provide insight into the share of transports that are not paid. The 
proposed 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). 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

[[Page 40695]]

not believe it is necessary to directly collect information on 
uncompensated care in the revenue section of the data collection 
instrument.
    We invite comments regarding all the proposals for data collection 
described in this section, including our proposals on the format, 
scope, elements (characteristics, utilization, and costs), collection 
of equipment and supply costs, and other costs.
5. Proposals 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 addition to meeting the requirements set 
forth in the statute, including developing a representative sample, our 
proposals around sampling aim to balance our need for statistical 
precision with reporting burden. Our proposals to meet these statutory 
requirements are described below, and were developed with the intention 
of obtaining statistical precision with the least amount of reporting 
burden.
    Eligible Organizations. 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 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 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 are proposing 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. 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 considered 
sampling at a broader parent organization level for those that bill 
Medicare under more than one NPI, 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 are proposing to 
select the sample at the NPI level and to include the specific NPI 
selected to report information. Furthermore, we propose 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 acknowledge 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. 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 are proposing 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 believe 
reported hours can 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 report 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 are proposing that 
ambulance providers and suppliers that use any amount of volunteer 
labor be included in sampling. We invite comments as to whether 
organanizations that rely on volunteer labor should be exempt from 
sampling.
    Sampling file. The organizational characteristics being proposed 
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) can be obtained 
from available Medicare data. We are proposing to develop sampling 
files using the most recent full year of data available. For the first 
sample notified in 2019 and reporting in 2020, we are proposing to use 
2017 claims and enrollment data. Another alternative we considered was 
using 2018 data, however we are not proposing 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 invite 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. 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

[[Page 40696]]

time data reporting begins. Similarily, we expect that some new ground 
ambulance organizations would start operating between the time the 
sample was pulled and when reporting begins. Since we propose to 
collect a full 12 continous months of data, these organizations would 
not have the data we are proposing to collect. Therefore, we are 
proposing that ground ambulance providers and suppliers organizations 
selected for the sample that were not in business 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 did have a full continuous 12 
months of data.
    We believe the above scenerios are inevitable given the significant 
amount of time between sampling and data reporting and invite comments 
on our proposed approach regarding exempting ground ambulance 
organizations who do not have a full 12-month continuous period of 
data.
    Sampling rate: We are also proposing 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 are 
proposing a 25 percent sampling rate because if a lower sampling rate 
is used, estimates of cost, revenue, and utilization from the data 
collected via the instrument for subgroups of ground ambulance 
suppliers would be of inadequate precision as described in the 
following section. Furthermore, our analyses illustrated that using 50 
percent sampling rate yielded only marginal gains in precision over a 
corresponding strategy that involves sampling NPIs at a 25 percent rate 
while doubling the response burden. In our view, these gains are not 
sufficient to merit the increased burden that would be imposed by 
implementing a higher sampling rate. Our proposal was informed by 
analyses regarding the alternative sampling rates in Chapter 7 of the 
CAMH report. We invite comments on the proposed sampling rate of 25 
percent each year.
    We are also proposing 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 providing 
written notification to each selected ground ambulance organization via 
email or U.S. mail. Notification on the CMS website would be provided 
at least 30 days prior to the time the selected ambulance organization 
would be required to begin collecting data. For purposes of CY 2020, we 
will post such information on the website when the CY 2020 PFS final 
rule is issued. A discussion of the proposed collection and reporting 
requirements can be found in the next section. We are also proposing to 
codify the representative sample requirements in Sec.  414.626(c).
    Approach for Sampling: 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 to sample ground ambulance organizations in 
proportion to their volume of Medicare-billed ground ambulance 
services. Under this approach, 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. Specifically, the top 10 percent of 
ground ambulance organizations by volume accounted for nearly 70 
percent of total Medicare ground ambulance transports. In contrast, 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, the ambulance providers and suppliers 
in the top 10 percent by volume would therefore be much more likely to 
be sampled compared to those in the bottom 50 percent by volume. 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 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 include simple and 
stratified random samples of ground ambulance organizations. A simple 
random sample would include a fixed share of all ground ambulance 
organizations, regardless of any differences in characteristics, in 
each year's sample. Unlike sampling in proportion to Medicare-billed 
ground ambulance services, 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. 
The rate at which these organizations are sampled would be the same for 
organizations in the same stratum; however, 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, the 
sample can be considered representative.
    Stratified random sampling has several advantages in that it is 
easy to implement and it meets the requirement that the sample be 
representative. 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 a government organziation and the 
geographic locations in which ground ambulance services are funished 
(such as urban, rural, and low population density areas). 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, the flexibility to vary sampling rates across strata allows the 
ability to account for anticipated and unanticipated rates of 
nonresponse.
    We believe that use of a stratified random sample would comport 
with the statutory requirements. Therefore, we are proposing a 
stratified random

[[Page 40697]]

sample approach. Specifically, we are proposing to sample from each 
strata at the same rate (25 percent, as described above). 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 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 
believe 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). As discussed above, we are proposing 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 believe 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) \94\ and 
HHS (2015) \95\ reports found much higher per-transport costs for 
ambulance providers than those of ambulance suppliers. This suggests 
that the ground ambulance cost structures for ambulance providers and 
suppliers are fundamentally different.
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    \94\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
    \95\ 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. 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. 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. Our analysis found that the volume 
distribution is highly skewed. In other words, 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. 
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. Conceptually, for-profit organizations maximize profit and 
operate only in markets and service lines with positive margins. 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 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. For-
profit suppliers are more likely than others to specialize in non-
emergency scheduled transports. 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. 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. 
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. 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. This extra 
time affects the availability of the ambulance and the staff for 
subsequent trips, potentially increasing response times.
    As previously discussed, we are not aware of any existing data 
source that lists all ground ambulance organzations or one that 
encompasses all the characteristics that impact costs and revenues 
described above. Medicare claims and enrollment data is the only source 
of data for which we are aware that has all the providers and suppliers 
that bill Medicare in a given year. 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 are proposing 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,

[[Page 40698]]

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 are proposing 
volume categories of 1 to 200, 201 to 800, 801 to 2,500, and 2,501 or 
more paid Medicare transports. The proposed 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 2,500 Medicare transports per year) into 
a separate category. We would expect that these highest-volume ground 
ambulance organizations may face different costs than lower-volume 
organizations due to economies of scale.
    We are proposing 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). Also, 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. 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. 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 
propose to stratify ground ambulance providers, which account for only 
6 percent of ground ambulance organizations combined, based on service 
area population density only. We are proposing 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 are also proposing 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. 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.
    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). A 25 percent 
sampling rate will also 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 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 invite comments on all our proposals for sampling as described 
in this section, 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 invite comments on our proposals to collect data from 
ground ambulance organizations that bill Medicare, and the use of a 
stratified random sample.
6. Proposals for 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 are proposing to define the data collection period and the 
data reporting period. In determining when the proposed 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 
are proposing 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 are proposing 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 are proposing 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 are proposing that the first data collection period 
be January 1, 2020 through December 31, 2021, with

[[Page 40699]]

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 propose that respondents 
would additionally confirm the data collection period when reporting 
data via the data collection instrument (section 2, question 5).
    We also propose 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 also provide 
adequate time for ground ambulance organizations to report information 
under the data collection system to CMS. This proposal 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 propose to codify the data collection and reporting requirements 
for selected ground organizations at Sec.  414.626(b).
    Tables 30 and 31 illustrate various examples of data collection 
periods and the data reporting periods under our proposal. 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 the tables.

Table 30--Example of a Data Collection and Reporting Period for a Ground
      Ambulance Organization With a Calendar Year Accounting Period
------------------------------------------------------------------------
                                     Data collection     Data reporting
               Year                       period             period
------------------------------------------------------------------------
1.................................  01/01/2020-12/31/  01/01/2021-05/31/
                                                 2020               2021
2.................................  01/01/2021-12/31/  01/01/2022-05/31/
                                                 2021               2022
3.................................  01/01/2022-12/31/  01/01/2023-05/31/
                                                 2022               2023
4.................................  01/01/2023-12/31/  01/01/2024-05/31/
                                                 2023               2024
------------------------------------------------------------------------


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

    We invite comments on our proposal to use a 12-month data 
collection period. We also invite 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 invite 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 plan on addressing section 1834(l)(17)(E) of 
the Act, ongoing data collection, in future rulemaking.
7. Proposed 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 are proposing to define the data 
collection and data reporting periods based on the ground ambulance 
organization's annual accounting period (either calendar year 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 are proposing 
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,

[[Page 40700]]

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 propose 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 are proposing 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 would 
apply to claims for dates of service during the applicable calendar 
year and would be applied to the final ambulance fee schedule payment, 
after all other adjustments have been applied under Sec.  414.610(c). 
We are proposing to codify the payment reduction by adding a new 
paragraph (c)(9) in Sec.  414.610.
b. Proposed 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 are proposing that ground ambulance organizations in these or 
other similar situations could request that CMS grant a hardship 
exemption, and CMS could 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 propose 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 are proposing 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 of 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 propose that the 
request form be submitted to the Ambulance ODF mailbox at 
[email protected]. Following receipt of the request form, we are 
proposing 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 are 
also proposing to codify the hardship exemption requirement at Sec.  
414.626(d).
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 propose 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's determination and any supporting 
documentation.
    We propose 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 are proposing 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 are proposing that the request be submitted to the Ambulance 
ODF mailbox at [email protected]. Following receipt of the 
request for informal review, we would 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 are 
seeking comments on our proposed

[[Page 40701]]

informal review process. We are also proposing to codify the informal 
review process in Sec.  414.610(e).
    We invite comments regarding all the proposals on the payment 
reduction for failure to report, including the applicable period, 
hardship exemption, and informal review.
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 are proposing 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 are also proposing that the data proposed 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 are proposing 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 invite 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 invite comments regarding our proposals for public availability 
of the data.
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 are proposing to codify the limitations on review at 
Sec.  414.626(g).

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 proposed rule includes our 
proposals for implementing this expansion of coverage through revisions 
to Sec.  410.49(b)(1).
1. Background
    Cardiac rehabilitation (CR) was developed in the 1950s from the 
concept of early mobilization after acute myocardial infarction (heart 
attack).\96\ The standard of care prior to the widespread adoption of 
CR was bed-rest and inactivity after acute myocardial infarction.\97\ 
In the 1970s, cardiac rehabilitation developed into highly structured, 
physician supervised, electrocardiographically-monitored exercise 
programs. However, the programs consisted almost solely of exercise 
alone.\98\ Referencing 1998 guidelines \99\ from the American 
Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), 
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.''
---------------------------------------------------------------------------

    \96\ Pashkow, FJ. Issues in Contemporary Cardiac Rehabilitation: 
A Historical Perspective. JACC 1993 Mar 1;21(3):822-34.
    \97\ Forman DE. Cardiac rehabilitation and secondary prevention 
programs for elderly cardiac patients. Clin Geriatr Med. 2000 
Aug;16(3):619-29.
    \98\ 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.
    \99\ AACWR Guidelines for Cardiac Rehabilitation and Secondary 
Prevention Programs, ed 3. Windsor, ON, Human Kinetics, 1998.
---------------------------------------------------------------------------

    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 proposed

[[Page 40702]]

rule is specific to CR and ICR for cardiac conditions. As such, this 
proposed rule could not 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 propose to amend Sec.  410.49(b) to expand the covered 
conditions for ICR. We propose 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 propose 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 propose 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 our proposal would 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. Summary
    In summary, we are proposing modifications to existing requirements 
under Sec.  410.49(b) to implement the coverage changes specific to 
ICR. The proposals involve 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. We invite the public to provide comments 
on these proposals.

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

1. Background
    Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory 
basis for the incentive payments made to Medicaid EPs and eligible 
hospitals for the adoption, implementation, upgrade, and meaningful use 
of 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 
6 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 6 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 proposed rule, we propose to 
amend the list of available eCQMs for the CY 2020 performance period. 
To keep eCQM specifications current and minimize complexity, we propose 
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 propose 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 help 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 anticipate that this proposal would reduce burden for Medicaid 
EPs by aligning the requirements for multiple reporting programs, and 
that the system changes required for EPs to implement this change would 
not be significant, particularly in light of our belief that many EPs 
would report eCQMs to meet the quality performance category of MIPS and 
therefore should be prepared to report on the available eCQMs for 2020. 
We expect 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 propose to again require (as we did for 2019) that 
Medicaid EPs report on any 6 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 6 
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

[[Page 40703]]

eligible clinicians who elect to submit eCQMs must generally submit 
data on at least 6 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 propose 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 propose that if no outcome or high priority 
measures are relevant to a Medicaid EP's scope of practice, the 
clinician may report on any 6 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. We propose 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 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 would be considered high priority measures under our 
proposal are: CMS2, ``Preventive Care and Screening: Screening for 
Depression and Follow-Up Plan''; CMS122, ``Diabetes: Hemoglobin A1c 
(HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening''; 
CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up 
Care for Children Prescribed ADHD Medication (ADD)''; CMS137, 
``Initiation and Engagement of Alcohol and Other Drug Dependence 
Treatment''; CMS153, ``Chlamydia Screening for Women''; CMS155, 
``Weight Assessment and Counseling for Nutrition and Physical Activity 
for Children and Adolescents''; and CMS165, ``Controlling High Blood 
Pressure.''
     Through an amendment to Sec.  495.332(f), we gave each 
state the flexibility to identify which of the eCQMs available for 
reporting in the Medicaid Promoting Interoperability Program are high 
priority measures for Medicaid EPs in that state, with review and 
approval by CMS, through the State Medicaid HIT Plan (SMHP). States are 
thus able to identify high priority measures that align with their 
state health goals or other programs within the state.
    All eCQMs identified via any of these three methods are high 
priority measures for EPs participating in the Medicaid Promoting 
Interoperability Program for 2019. As noted above, we propose to use 
the same three methods for identifying high priority eCQMs for the 
Medicaid Promoting Interoperability Program for 2020. We invite 
comments as to whether any of these methods should be altered or 
removed, or whether any additional methods should be considered for 
2021.
    We also propose that the 2020 eCQM reporting period for Medicaid 
EPs who have demonstrated meaningful use in a prior year 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. 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. Medicaid EPs could also use a longer eCQM 
reporting period in CY 2020, up to the full calendar year. In addition, 
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 are proposing 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 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 longer reporting 
periods create more useful data for quality measurement and improvement 
because they give states a broader picture of a health care provider's 
care and patient outcomes. However, we agree that a full-year eCQM 
reporting period in 2020 might unnecessarily burden states as they 
would need to issue incentive payments and implement systems changes 
for 2021 in a timely manner.
    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. 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 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 alternative 274-day eCQM reporting period. We also

[[Page 40704]]

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 seek 
comment, especially from states and Medicaid EPs, about whether either 
of these alternatives might be preferable to our proposal.
    We note that states submit their attestation deadlines to CMS each 
year as part of their SMHPs. We do not believe that this proposal would 
create any additional burden on EPs or CEHRT vendors, as CEHRT should 
be able to report eCQM data from any length of time.
    We propose 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.
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 therefore 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 given 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 are proposing 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. If this 
proposal is finalized as proposed, we would work with states to develop 
post-payment verification and audit processes that meet CMS due 
diligence requirements, including those in Sec. Sec.  495.318 and 
495.368, and generally to ensure that incentive payments are made 
properly. We remind states that as a condition of receiving enhanced 
federal financial participation (FFP), they are required to demonstrate 
to the satisfaction of HHS that they are conducting adequate

[[Page 40705]]

oversight of the program, including routine tracking of meaningful use 
attestations (See Sec.  495.318(b)). States are also reminded 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.
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). The final rule establishing the Shared Savings 
Program appeared in the November 2, 2011 Federal Register (Medicare 
Program; Medicare Shared Savings Program: Accountable Care 
Organizations; final rule (76 FR 67802) (hereinafter referred to as the 
``November 2011 final rule'')). A subsequent major update to the 
program rules appeared in the June 9, 2015 Federal Register (Medicare 
Program; Medicare Shared Savings Program: Accountable Care 
Organizations; final rule (80 FR 32692) (hereinafter referred to as the 
``June 2015 final rule'')). The final rule entitled, ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Revised Benchmark Rebasing Methodology, Facilitating 
Transition to Performance-Based Risk, and Administrative Finality of 
Financial Calculations,'' which addressed changes related to the 
program's financial benchmark methodology, appeared in the June 9, 2016 
Federal Register (81 FR 37950) (hereinafter referred to as the ``June 
2016 final rule'')). A final rule redesigning the Shared Savings 
Program appeared in the December 31, 2018 Federal Register (Medicare 
Program: Medicare Shared Savings Program; Accountable Care 
Organizations-Pathways to Success; final rule) (83 FR 67816) 
(hereinafter referred to as the ``December 2018 final rule''). In the 
December 2018 final rule, we finalized a number of policies including 
redesign of the participation options available under the program to 
encourage ACOs to transition to two-sided models; new tools to support 
coordination of care across settings and strengthen beneficiary 
engagement; and revisions to ensure rigorous benchmarking.
    We have also made use of the annual CY PFS rules to address quality 
reporting for the Shared Savings Program and certain other issues. In 
the CY 2019 PFS final rule, we finalized a voluntary 6-month extension 
for existing ACOs whose participation agreements would otherwise expire 
on December 31, 2018; allowed beneficiaries greater flexibility in 
selecting their primary care provider and in the use of that selection 
for purposes of assigning the beneficiary to an ACO if the clinician 
they align with is participating in an ACO; revised the definition of 
primary care services used in beneficiary assignment; provided relief 
for ACOs and their clinicians impacted by extreme and uncontrollable 
circumstances in performance year 2018 and subsequent years; 
established a new Certified Electronic Health Record Technology (CEHRT) 
threshold requirement; and reduced the Shared Savings Program quality 
measure set from 31 to 23 measures (83 FR 59940 through 59990 and 59707 
through 59715). In the CY 2018 PFS final rule (82 FR 53209 through 
53226), we finalized revisions to several different policies under the 
Shared Savings Program, including the assignment methodology, quality 
measure validation audit process, use of the skilled nursing facility 
(SNF) 3-day waiver, and handling of demonstration payments for purposes 
of financial reconciliation and establishing historical benchmarks. In 
addition, in the CY 2017 and CY 2018 Quality Payment Program final 
rules (81 FR 77255 through 77260, and 82 FR 53688 through 53706, 
respectively), we finalized policies related to the Alternative Payment 
Model (APM) scoring standard under the Merit-Based Incentive Payment 
System (MIPS), which reduced the reporting burden for MIPS eligible 
clinicians who participate in MIPS APMs, such as the Shared Savings 
Program.
    As a general summary, in this CY 2020 PFS proposed rule, we:
     Discuss aligning the Shared Savings Program quality 
measure set with proposed changes to the Web Interface measure set 
under MIPS per previously-finalized policy;
     Propose a change to the claims-based measures;
     Solicit comment on aligning the Shared Savings Program 
quality score with the MIPS quality performance category score; and
     Propose 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 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 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 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 establishing the 
Shared Savings Program (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 year 2019, 
23 quality measures will be used to determine ACO quality performance 
(83 FR 59707 through

[[Page 40706]]

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. Proposed Changes to the 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 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 are not making any specific proposals related to 
changes in CMS Web Interface measures reported under the Shared Savings 
Program. Rather, we refer readers to Appendix 1, Table C (Existing 
Quality Measures Proposed for Removal Beginning with the 2022 MIPS 
Payment Year) and Table Group A (New Quality Measures Proposed for 
Addition Beginning with the 2022 MIPS Payment Year) of this proposed 
rule for a complete discussion of the proposed changes to the CMS Web 
Interface measures for performance year 2020 (2022 MIPS Payment Year). 
Based on the changes being proposed in Appendix 1, Table C of this 
proposed rule, ACOs would no longer be responsible for reporting the 
following measure for purposes of the Shared Savings Program starting 
with reporting for performance year 2020:
 ACO-14 Preventive Care and Screening Influenza Immunization
    In the event we do not finalize the removal of this measure, we 
would maintain the measure with the ``substantive'' change described in 
Appendix 1, Table C (Previously Finalized Quality Measures Proposed for 
Removal in the 2022 Payment Year and Future Years) of this proposed 
rule. We have reviewed the proposed ``substantive'' change and we do 
not believe that this change to the measure would require that we 
revert the measure to pay-for-reporting for the 2020 performance year 
as we could create a historical benchmark.
    Additionally, in section III.I.3.B.(1) of this proposed rule, we 
are proposing to add the following measure to the CMS Web Interface for 
purposes of the Quality Payment Program:
 ACO-47 Adult Immunization Status
    Based on the policies being proposed for purposes of MIPS in 
Appendix 1, Table Group A of this proposed rule, Shared Savings Program 
ACOs would be responsible for reporting the Adult Immunization Status 
measure (ACO-47) starting with quality reporting for performance year 
2020. Consistent with our existing policy regarding the scoring of 
newly introduced quality measures, this measure would be pay-for-
reporting for all ACOs for 2 years (performance years 2020 and 
performance year 2021). The measure would then phase into pay-for-
performance beginning in performance year 2022 (Sec.  425.502(a)(4)).
    In section III.J.3.c.(1)(d) of this rule, we note that as discussed 
in Table DD (Previously Finalized Quality Measures with Substantive 
Changes Proposed for the 2021 MIPS Payment Year), 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 (ACO-17) 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 performance year we are 
designating the measure pay-for-reporting in accordance with Sec.  
425.502(a)(5). Additionally, in section III.J.3.c.(1)(d) of this 
proposed rule, we are proposing to update the CMS Web Interface measure 
numerator guidance for purposes of the Quality Payment Program. To the 
extent that this proposed change constitutes a change to the Shared 
Savings Program measure set after the start of the 2019 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 modify the 
measure as proposed in Table DD because the current guidance is 
inconsistent with the intent of the CMS Web Interface version of this 
measure,

[[Page 40707]]

as modified in the CY 2018 QPP final rule, and unduly burdensome on 
clinicians. If this modification is finalized as proposed, consistent 
with our discussion in the CY 2018 PFS final rule, we expect 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 year 2019 and subsequent year.
    In addition, we note 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.\100\ 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 propose 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 measure. However, we believe that changes to 
measures 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, our 
proposal to revert the measure to pay-for-reporting for 2 years will 
give ACOs time to refine care processes and educate clinicians while 
also gaining experience with the refined composite measure and 
understanding of performance under revised benchmarks prior to the 
start of a pay for performance year.
---------------------------------------------------------------------------

    \100\ https://www.qualityindicators.ahrq.gov/News/Retirement%20Notice_v2019_Indicators.pdf.
---------------------------------------------------------------------------

    We seek comment on this proposal and the alternative approach 
considered.
    Table 32 shows the Shared Savings Program quality measure set for 
performance year 2020 and subsequent performance years that would 
result if the proposals in section III.I.3.B.(1) of this proposed rule 
are finalized, including the phase-in schedule for the proposed Adult 
Immunization Status measure (ACO-47).
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[[Page 40708]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.075


[[Page 40709]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.076

BILLING CODE 4120-01-C
    The net result, if the proposals in section III.I.3.b.(1) of this 
proposed rule are finalized, would be a set of 23 measures on which 
ACOs' quality performance would be assessed for performance year 2020 
and subsequent performance years. The 4 domains would include the 
following numbers of quality measures (See Table 33):
     Patient/Caregiver Experience of Care-10 measures.
     Care Coordination/Patient Safety-4 measures.
     Preventive Health-6 measures.
     At Risk Populations-3 measures.
    Table 33 provides a summary of the number of measures by domain and 
the total points and domain weights that would be used for scoring 
purposes.
[GRAPHIC] [TIFF OMITTED] TP14AU19.077

c. Seeking 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 
percentile benchmark for P4P measures) on at least one measure in each 
domain

[[Page 40710]]

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 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) 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.
    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.
    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 are soliciting comment 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.

[[Page 40711]]

    First, we are requesting 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 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). 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 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. We note that 
for performance year 2017 (the only year from which we have complete 
data available), 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 
45.01 and the weighted median MIPS quality performance score for these 
ACOs was 46.8, 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 ACO under the Shared Savings Program quality scoring 
methodology. As an alternative, given that we currently collect the 
necessary data from these ACOs, 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 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 the 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 welcome comment 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. We also welcome comment on potential alternative 
approaches for scoring Shared Savings Program quality performance in a 
way that more closely aligns with MIPS.
    In addition, we note that we are also soliciting comment on 
simplifying MIPS by implementing a core measure set using 
administrative claims-based measures that can be broadly applied to 
communities or populations and developing measure set tracks 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 proposed rule for more information on these 
approaches.
    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 this proposed rule, we are 
proposing to add the MIPS All-Cause Unplanned Admission for Patients 
with Multiple Chronic Conditions (MCC) measure to the MIPS quality 
performance category. 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 as explained in section 
III.I.3.B.(1)(ii). 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. 
These MIPS claims-based measures are similar to those currently used to 
assess ACO quality under the Shared Savings Program. The proposed 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 proposed 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. For more detailed information on the MIPS MCC measure please 
refer to Appendix 1 Table AA (New Quality Measures Proposed for 
Addition for the 2023 Payment Year and Future Years) of this proposed 
rule. 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

[[Page 40712]]

difference among the measures is only the entity that is accountable--
either an ACO or a MIPS-eligible clinician--but the specifications are 
otherwise aligned. We also welcome comment on potentially including all 
of the MIPS claims-based measures in the MIPS quality performance 
category score for ACOs (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 note 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.
    In addition, we are soliciting 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. As we look to more closely align 
with MIPS quality performance category scoring in future years, we are 
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 recognize 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 is 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 welcome comment on these 
potential approaches or other approaches for determining Shared Savings 
Program quality minimum attainment using MIPS data.
    We are also seeking 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 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 welcome 
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 are considering an option 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 note that currently, for ACOs in the 
first year of their first agreement period,

[[Page 40713]]

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 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 believe that 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 welcome comment on this alternative for 
determining the MIPS quality performance category score.
    Lastly, we are seeking 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. If we were to adopt 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 welcome 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 are seeking stakeholder feedback on the approaches discussed in 
this section of the proposed rule and any other recommendations 
regarding the potential alignment of the Shared Savings Program quality 
performance standard with the MIPS quality performance category in the 
assessment of ACO quality performance in the future for purposes of the 
Shared Savings Program.
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).''

F. Open Payments

1. Background
a. Open Payments Policies
    The Open Payments program is a statutorily-mandated program that 
promotes transparency by providing information about the financial 
relationships between the pharmaceutical and medical device industry 
and certain types of health care providers and makes the information 
available to the public. Section 1128G of the Act requires 
manufacturers of covered drugs, devices, biologicals, or medical 
supplies (referred to as ``applicable manufacturers'') 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 under section 1128G 
of the Act. 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 transparency that provides 
information to the general public that may influence their health care 
decision-making and choice of providers, as well as information that 
researchers looking into potential correlations between financial 
relationships and provider behaviors may use. More than 51 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 FAQs, 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 manufacturers of 
covered drugs, devices, biologicals, or medical supplies (referred to 
as ``applicable manufacturers'') to submit information annually about 
certain payments or other transfers of value made to ``covered 
recipients,'' currently defined as physicians and teaching hospitals, 
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 or a State plan under 
Medicaid or the CHIP

[[Page 40714]]

(or a waiver of such a plan); and requires applicable manufacturers and 
applicable GPOs to disclose any ownership or investment 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, and sought 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. This rule proposes to 
codify the Open Payments provisions from the SUPPORT Act, proposes 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 proposes 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 proposed provisions:
     Sections 1102 and 1871, which provide general authority 
for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.
     Section 1861, which defines providers and suppliers.
     Section 1128G, 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. Proposed Changes
    In this rule, we propose to revise several Open Payments 
regulations at 42 CFR part 403. We are proposing 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 are also proposing a correction to the national drug codes (NDCs) 
reporting requirements for drugs and biologicals that, should the rule 
be finalized as proposed, would be effective 60 days following the 
publication of the final rule. We believe this would 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, though at section 1128G(e)(7) of the 
Act it excepts 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, applicable manufacturers will be required 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 are proposing to revise Sec.  403.902 to align with the 
statutory requirements in sections 1128G(e)(6)(A) and (B) of the Act. 
Specifically, we are proposing to revise the definition of ``covered 
recipient'' in Sec.  403.902 to include PAs, NPs, CNSs, CRNAs, and 
CNMs. In addition, we are proposing at Sec.  403.902 to reference the 
definitions of these additional provider types as defined in sections 
1861(aa)(5)(A), 1861(aa)(5)(B), 1861(bb)(2), and 1861(gg)(2) of the 
Act.
    We are also proposing 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 propose 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''

[[Page 40715]]

with the phrase ``non-teaching hospital.''
     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.''
(2) Nature of Payment Categories
    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 are proposing 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 are proposing 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. At proposed revised Sec.  
403.904(e)(2)(xv), we are proposing 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. 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 addition, we are proposing 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 (proposed Sec.  403.904(e)(2)(xi)): This 
would 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 (proposed 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 would be used 
to characterize the loans of covered devices or medical supplies for 
longer than 90 days. (Note: We are proposing 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 (proposed Sec.  403.904(e)(2)(xviii)): This 
addition would 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 are proposing 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 propose 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 are proposing a new Sec.  403.904(h)(5) to be 
``short-term medical supply or device loan.''
(3) Standardizing Data on Reported Covered Drugs, Devices, Biologicals, 
or Medical Supplies
    When applicable manufacturers or applicable GPOs report payments or 
transfers of value related to specific drugs and biologicals, we 
currently require names and NDCs to be reported to the Open Payments 
program. However, based upon the lack of federally-recognized 
identifiers when we started the Open Payments program, we have not 
required analogous reporting for medical devices from the 
manufacturers. 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 HHS Office of the National Coordinator's requirement that UDIs 
form part of the Common Clinical Data Set (45 CFR part 170), we believe 
that the use of UDIs and device identifiers (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).
    With the standardization and typical use of UDIs and based upon 
OIG's recommendation, we propose 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 do not propose to require a full UDI. We 
believe such a step would substantially aid in enhancing the quality of 
the Open Payments data because the identifiers can be used to validate 
submitted device information. This effort would 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 are proposing 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.

[[Page 40716]]

    We also seek 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 propose 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 propose 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 propose to reincorporate language that specifically requires 
reporting of NDCs.
    As a result of the proposed changes to Sec.  403.904(c)(8), we are 
also proposing 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.

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 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 
that establishes the payment and related requirements for home infusion 
therapy under this benefit.
    Specifically, 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 described in section 1861(iii)(1) of the Act 
for the individual 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 records 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 are soliciting comments 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 under Medicare Part B as required under section 
1834(u)(6) of the Act. We also invite comments on any additional 
interpretations of this notification requirement.

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 more detail in this proposed 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. The SUPPORT Act attempts to fulfill these objectives, in part, 
by establishing a new Medicare benefit category for opioid treatment 
programs (OTPs) pursuant to section 2005 thereof. 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). 
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 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 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 in current 
regulations referenced in 42 CFR 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 outlined in 42 CFR 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;
     Compliance with all pertinent state laws and regulations, 
as stated in Sec.  8.11(f)(1);
     Per Sec.  8.11(f)(6), compliance with all regulations 
enforced by the Drug Enforcement Administration (DEA)

[[Page 40717]]

under 21 CFR chapter II; this includes registration by the DEA before 
administering or dispensing opioid agonist treatment medications; and
     As stated in Sec.  8.11(a)(2), compliance with all other 
conditions for certification established by SAMHSA.
    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. Under Sec.  8.11(e)(1), an OTP 
that has no current certification from SAMHSA but has applied for 
accreditation with an accreditation body may obtain a provisional 
certification for up to 1 year.
    At the time of application for certification or any time 
thereafter, an OTP may request from SAMHSA an exemption from the 
regulatory requirements of Sec. Sec.  8.11 and 8.12. Section 8.11(h), 
which governs the exemption process, cites an example of a private 
practitioner who wishes to treat a limited number of patients in a non-
metropolitan area with few physicians and no rehabilitative services 
geographically accessible; he or she may choose to seek an exemption 
from some of the staffing and service standards.
    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
    Most pertinent to the discussion and proposals below, 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 qualify as an OTP and to bill and 
receive payment from Medicare for opioid use disorder treatment 
services. Per section 1861(jjj)(2)(A) of the Act, the provisions of 
this proposed rule would establish requirements that OTPs must meet in 
order 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. As further explained below, 
CMS and its 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. 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. In the April 21, 2006 
final rule, we cited 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 providers 
and suppliers: (1) Engaging (or potentially engaging) in fraudulent or 
abusive behavior; (2) presenting a risk of harm to Medicare 
beneficiaries or the Medicare Trust Funds; or (3) that are otherwise 
unqualified to furnish Medicare services or items.
    One of the provider enrollment regulations was the ``Medicare, 
Medicaid, and Children's Health Insurance Programs; Additional 
Screening Requirements, Application Fees, Temporary Enrollment 
Moratoria, Payment Suspensions and Compliance Plans for Providers and 
Suppliers'' final rule published in the February 2, 2011 Federal 
Register (76 FR 5862). This final rule implemented various provisions 
of the Affordable Care Act, including the following:
     Added a new Sec.  424.514 that required submission of 
application fees by institutional providers (as that term is defined in 
Sec.  424.502) as part of the Medicare, Medicaid, and Children's Health 
Insurance Program (CHIP) provider enrollment processes.
     Added a new Sec.  424.518 that established Medicare, 
Medicaid, and CHIP provider enrollment screening categories and 
requirements based on the CMS-assessed level of risk of fraud, waste, 
and abuse posed by a particular category of provider or supplier.
    We also published the ``Medicare Program; Requirements for the 
Medicare Incentive Reward Program and Provider Enrollment'' final rule 
in the December 5, 2014 Federal Register (79 FR 72499) wherein we 
addressed several vulnerabilities in the provider enrollment process. 
As part of the December 2014 final rule--
     We expanded the number of reasons for which we can: (1) 
deny a prospective provider's or supplier's enrollment in the Medicare 
program under Sec.  424.530; or (2) revoke the Medicare enrollment of 
an existing provider or supplier under Sec.  424.535.
     We supplemented the existing denial reason in Sec.  
424.530(a)(3) such that we could deny a prospective provider's or 
supplier's Medicare enrollment if a managing employee (as that term is 
defined in Sec.  424.502) of the provider or supplier has, within the 
10 years preceding enrollment or revalidation of enrollment, been 
convicted of a federal or state felony offense that we determined to be 
detrimental to the best interests of the Medicare program and its 
beneficiaries.
     We expanded the existing revocation reason in Sec.  
424.535(a)(8) to allow us to revoke a provider's or supplier's 
enrollment if we determine that the provider or supplier has a pattern 
or practice of submitting claims that fail to meet Medicare 
requirements.
    In addition to these final rules, we have also made several other 
regulatory changes to 42 CFR part 424, subpart P to address various 
program integrity issues that have arisen.
(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, 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

[[Page 40718]]

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:
     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.
     As applicable, information about the provider's or 
supplier's use of a billing agency.
    The Form CMS-855 application is used for a number of provider 
enrollment transactions, such as:
     Initial enrollment: The provider or supplier is enrolling 
in Medicare for the first time, enrolling in another MAC's 
jurisdiction, or seeking to enroll in Medicare after having previously 
been enrolled.
     Change of ownership: The provider or supplier is reporting 
a change in its ownership.
     Revalidation: The provider or supplier is revalidating its 
Medicare enrollment information in accordance with Sec.  424.515.
     Reactivation: The provider or supplier is seeking to 
reactivate its Medicare billing privileges after being deactivated 
under Sec.  424.540.
     Change of information: The provider or supplier is 
reporting a change in its existing enrollment information in accordance 
with Sec.  424.516.
    After receiving a provider's or supplier's initial enrollment 
application, 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 applicable); or (2) deny enrollment 
under Sec.  424.530.
d. Proposed OTP Enrollment Provisions
(1) Legal Basis and Necessity
    As mentioned earlier, section 1861(jjj)(2)(A) of the Act requires 
OTPs to enroll in Medicare to bill and receive payment. In the 
proposals discussed in this section III.I.3. of this proposed rule, we 
outline the proposed requirements and procedures with which OTPs must 
comply to enroll and remain enrolled in Medicare. In doing so, we are 
relying 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 screened 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 are 
endangered, and billions of Trust Fund dollars may be paid to 
unqualified or fraudulent parties.
    Nor, we add, are our general concerns restricted to the mere need 
and desire to establish provider enrollment requirements for OTPs. 
Though a very critical one, provider enrollment is only a single 
component of CMS' much broader program integrity efforts. We emphasize 
that in establishing and implementing an overall Medicare OTP process 
per the SUPPORT Act and implementing an overall program integrity 
strategy, our objectives will 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 actually applies to many other 
types of payment safeguards as well.
(2) OTP Enrollment Requirements
(a) Addition of 42 CFR 424.67 and General OTP Requirement To Enroll
    We propose to establish a new 42 CFR 424.67 that would include most 
of our proposed OTP provisions. In paragraph (a), we are proposing that 
in order for a program 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 subpart P of this part and this 
section. As previously indicated, subpart P outlines the requirements 
and procedures of the enrollment process. All providers and suppliers 
that seek to bill Medicare must enroll in Medicare and adhere to all 
enrollment requirements in subpart P. Proposed Sec.  424.67 would 
implement the above-mentioned requirement stated in section 
1861(jjj)(2)(A) of the Act.
(b) OTPs--Procedures and Compliance
    In paragraph (b) of Sec.  424.67, we are proposing 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 propose 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. While we 
recognize that the Form CMS-855B is typically completed by suppliers 
rather than providers, we believe that certain unique characteristics 
of OTPs (for example, OTPs would only bill Medicare Part B) make the 
Form CMS-855B the most suitable enrollment application for OTPs. 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 CMS-855 form 
completion, we propose two subsidiary requirements as part of the 
aforementioned supplement/attachment.
    First, in Sec.  424.67(b)(1)(i), we propose that the OTP must 
maintain and submit to CMS (via the applicable supplement or 
attachment) a list of all physicians and other eligible professionals 
(as the

[[Page 40719]]

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 (4) license number (if applicable). This requirement, in our view, 
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 propose 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). This is to help ensure that the 
OTP fully understands its obligation to maintain constant compliance 
with the requirements associated with OTP enrollment.
    We do not believe that the requirements addressed in proposed Sec.  
424.67(b)(1) duplicate any other information collection effort 
involving OTPs. Indeed, the OTP enrollment process will capture various 
data elements not collected via other means, such as the SAMHSA 
certification process. Such data elements include the name, social 
security number (SSN) and National Provider Identification (NPI) number 
of all eligible professionals at the OTP who are legally authorized to 
prescribe, order, or dispense controlled substances. While SAMHSA's 
approved accreditation bodies do verify that these individuals have 
appropriate licensure, they do not collect this information on a form, 
screen against federal databases, or have a database that keeps this 
information. CMS, however, intends to conduct these activities.
(ii) OTPs: Application Fee
    As mentioned previously in our discussion of the February 2, 2011 
final rule, under Sec.  424.514, prospective and revalidating 
institutional providers that are submitting an enrollment application 
generally must pay the applicable 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 non-physician practitioner organizations, which are 
exempt from the fee requirement if they are enrolling as a physician or 
non-physician practitioner organization), Form CMS-855S, Form CMS-
20134, or an associated internet-based PECOS enrollment application. 
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 and non-physician organization), we believe 
that an OTP would meet the definition of an institutional provider 
under Sec.  424.502. It would therefore be required to pay an 
application fee consistent with Sec.  424.514; we are proposing to 
clarify this requirement to pay the fee in new Sec.  424.67(b)(2).
(c) OTPs: Categorical Risk Designation
    We previously referenced Sec.  424.518, which outlines 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. Irrespective of which category a provider or 
supplier type falls within, the MAC performs the following screening 
functions upon receipt of an initial enrollment application, a 
revalidation application, or an application to add a new practice 
location:
     Verifies that a provider or supplier meets all applicable 
federal regulations and state requirements for their provider or 
supplier type.
     Conducts state license verifications.
     Conducts database checks on a pre- and post-enrollment 
basis to ensure that providers and suppliers continue to meet the 
enrollment criteria for their provider or supplier type.
    However, providers and suppliers at the moderate and high 
categorical risk levels must also undergo a site visit. Furthermore, 
for those in the high categorical risk level, the MAC performs two 
additional functions under Sec.  424.518(c)(2). First, the MAC requires 
the submission of a set of fingerprints for a national background check 
from all individuals who maintain a 5 percent or greater direct or 
indirect ownership interest in the provider or supplier. Second, it 
conducts a fingerprint-based criminal history record check of the 
Federal Bureau of Investigation's Integrated Automated Fingerprint 
Identification System on all individuals who maintain a 5 percent or 
greater direct or indirect ownership interest in the provider or 
supplier. These additional verification activities are intended to 
correspond to the heightened risk involved.
    There currently are only three provider or supplier types that fall 
within the high categorical risk level under Sec.  424.518(c)(1): 
Newly/initially enrolling home health agencies (HHAs); newly/initially 
enrolling suppliers of durable medical equipment, prosthetics, 
orthotics, and supplies (DMEPOS); and newly/initially enrolling 
Medicare Diabetes Prevention Program (MDPP) suppliers. We are now 
proposing to assign newly enrolling OTPs to the high categorical risk 
level.
    A principal concern is that, as indicated previously, 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. This is because OTP services are an 
entirely new Medicare benefit. We expressed similar concerns regarding 
our inclusion of MDPP suppliers in Sec.  424.518(c)(1). That is, in the 
CY 2017 PFS proposed rule (81 FR 46162), we proposed to assign MDPP 
suppliers to the high categorical risk level because the MDPP could 
bring organization types that are entirely new to Medicare.
    Our concerns about OTPs go well beyond the above-referenced lack of 
historical information, though. The opioid epidemic has, in our view, 
increased the potential for unscrupulous providers to take advantage of 
Medicare beneficiaries through fraudulent billing schemes and abusive 
prescribing practices; recent examples include ``patient brokers'' in 
Massachusetts, as well as excessive stays in ``sober homes'' in 
Florida. Furthermore, there is a heightened risk in OTP facilities 
compared to other types of providers due to: (1) The core service 
provided at the facilities--the prescribing and dispensing of methadone 
and other opioids as part of medication-assisted treatment for opioid 
addiction; and (2) the nature of the patients at the facilities, that 
is, individuals grappling with opioid addiction. By assigning OTPs to 
the ``high-risk'' screening level--thereby capturing fingerprints of 
all 5 percent or greater owners and conducting site visits--we would be 
taking a preventative approach to stopping fraudulent billing and 
prescribing practices and keeping Medicare beneficiaries safe.
    Given the foregoing, we are proposing four regulatory provisions. 
First, we are

[[Page 40720]]

proposing to state in new Sec.  424.67(b)(3) that newly enrolling OTP 
providers will be screened at the high categorical risk level in 
accordance with the requirements of Sec.  424.518(c). Second, we are 
proposing to add a new paragraph (iv) to Sec.  424.518(c)(1) that would 
add newly enrolling OTPs to the types of providers and suppliers 
screened at the high categorical risk level. Third, we are proposing 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 DMEPOS suppliers, HHAs, and MDPPs, 
which are screened at the high categorical risk level when newly 
enrolling and at the moderate level when revalidating. Fourth, and 
consistent with the addition of new Sec.  424.518(b)(1)(xii), we 
propose to require that, upon revalidation, the OTP 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); as 
discussed below, proposed paragraph (d) addresses ongoing obligations 
and standards with which enrolled OTPs must comply.
(d) OTPs: Certification
    We are proposing in new Sec.  424.67(b)(4) that to enroll in 
Medicare, an OTP must have in effect a current, valid certification by 
SAMHSA for such a program. This requirement is consistent with both 
section 1861(jjj)(2)(B) of the Act and Sec.  8.11. We consider SAMHSA 
certification to be extremely important because it would: (1) Assist us 
in ensuring that the provider is qualified to furnish OTP services; and 
(2) help confirm that the provider is in compliance with the relevant 
provisions of part 8 and other applicable requirements (such as federal 
opioid treatment standards).
    We noted earlier that, under Sec.  8.11(e), OTPs with no current 
SAMHSA certification that have applied for accreditation with an 
accreditation body are eligible to receive a provisional certification 
for up to 1 year. To receive a provisional certification, an OTP must 
submit to SAMHSA certain information required under Sec.  8.11(e), 
along with:
     A statement identifying the accreditation body to which 
the OTP has applied for accreditation;
     The date on which the OTP applied for accreditation;
     The dates of any accreditation surveys that have taken 
place or are expected to take place; and
     The expected schedule for completing the accreditation 
process.
    Under proposed Sec.  424.67(b)(4)(ii), we state that we would not 
accept a provisional certification under Sec.  8.11(e) in lieu of the 
certification described in Sec.  8.11(a). As already mentioned, section 
1861(jjj)(2)(B) of the Act states that an OTP must have in effect a 
certification by SAMHSA, a requirement we interpret to mean full SAMHSA 
certification rather than provisional certification. Indeed, 
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 body. Section 1861(jjj)(2)(C) of 
the Act, however, requires actual accreditation rather than the mere 
application for accreditation. Thus, we believe that full certification 
should be required.
(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. Section 424.502 of our regulations defines a 
managing employee as a general manager, business manager, 
administrator, director, or other individual that exercises operational 
or managerial control over (or who directly or indirectly conducts) the 
day-to-day operation of the provider or supplier, either under contract 
or through some other arrangement, whether or not the individual is a 
W-2 employee of the provider or supplier. We are proposing in new Sec.  
424.67(b)(5) that all of the OTP's staff that meet the regulatory 
definition of managing employee 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
    Given 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 believe that OTPs should 
adhere to certain standards unique to the services they provide. In 
particular, we wish to ensure that problematic providers and personnel 
are not prescribing or dispensing drugs on behalf of the OTP. To this 
end, we propose the following additional requirements with which OTPs 
must comply in order to enroll in Medicare.
    In new Sec.  424.67(b)(6)(i), we propose 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, found at 42 CFR 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. We note that SAMHSA recognizes the importance of 
dispensing personnel in an OTP's operations by requiring, as part of 
the certification process, disclosure of the names and state license 
numbers of all OTP personnel (other than program physicians) who 
legally dispense narcotic drugs even if they are not, at present, 
responsible for administering or dispensing methadone at the program. 
Such individuals include pharmacists, registered nurses, and licensed 
practical nurses. (See https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-programs.apply.) We, too, acknowledge the 
crucial roles of such persons in ensuring the safe dispensing of 
medicines and believe that those with felonious histories pose a 
potential risk to the health and safety of Medicare beneficiaries.
    This overarching concern regarding possible patient harm also lies 
behind our proposed standards in new Sec.  424.67(b)(6)(ii) and (iii). 
In the former paragraph, we propose 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. Sec.  422.222 or 423.120(c)(6). In Sec.  
424.67(b)(6)(iii), we propose 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 current or 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

[[Page 40721]]

factors enumerated at Sec.  424.535(a)(22) in each case of patient harm 
that potentially applies to this provision.
    Concerning Sec.  424.67(b)(6)(ii), we believe that OTP personnel 
who are revoked from Medicare for problematic behavior present a 
potential threat to the OTP's patients. We hold a similar view 
regarding persons on the preclusion list (as that term is defined in 
Sec. Sec.  422.2 and 423.100). Indeed, such individuals are precluded 
from receiving payment for Medicare Advantage (MA) items and services 
or Part D drugs furnished or prescribed to Medicare beneficiaries 
under, respectively, Sec. Sec.  422.222 or 423.120(c)(6), due to, in 
general, a prior felony conviction, a current revocation, or behavior 
that would warrant a revocation if the person were enrolled in 
Medicare. As for Sec.  424.67(b)(6)(iii), we discuss in detail our 
proposed new revocation reason at Sec.  424.535(a)(22) in section 
III.H.2. of this proposed rule. This proposed new revocation ground 
pertains to improper conduct that led to patient harm. In light of the 
aforementioned and critical need to preserve the safety of Medicare 
beneficiaries, we believe that Sec.  424.67(b)(6)(iii) is an 
appropriate requirement.
(g) Provider Agreement
(i) General Requirement
    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) outlines required terms of the provider 
agreement, such as allowed charges for furnished services.
    Consistent with these requirements, and as previously discussed in 
more detail in this proposed rule, we are proposing to revise various 
sections of 42 CFR part 489 to include OTPs within the category of 
providers that must sign a provider agreement in order to participate 
in Medicare. To incorporate this requirement into Sec.  424.67 as a 
prerequisite for enrollment, we propose to state in new Sec.  
424.67(b)(7)(i) 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.
(ii) Appeals
    Under Sec.  489.53, we may terminate a provider agreement if any of 
the circumstances outlined in that section apply (for example, the 
provider under Sec.  489.53(a)(1) fails to comply with the provisions 
of Title XVIII of the Act). The provider may, however, appeal any such 
termination pursuant to 42 CFR part 498. This process is akin to what 
occurs with Medicare revocations, whereby: (1) Medicare may revoke a 
provider's or supplier's Medicare enrollment for any of the reasons 
identified in Sec.  424.535; and (2) the provider or supplier may 
appeal said revocation under part 498. There is, though, an additional 
important result of the revocation process; under Sec.  424.535(b), 
when a provider's or supplier's billing privileges are revoked, any 
provider agreement in effect at the time of revocation is terminated 
effective with the date of revocation.
    Given this linkage in Sec.  424.535(b) between a revocation of 
enrollment and the termination of a provider agreement, we are 
concerned about the potential for duplicate appeals processes (that is, 
one for the revocation and the other for the provider agreement 
termination) involving a revoked OTP. The same concern, of course, 
would apply in the reverse situation, in which a termination of the 
provider agreement under Sec.  489.53 led to a revocation under Sec.  
424.535 because a provider agreement is a requirement for enrollment 
pursuant to proposed Sec.  424.67(b)(7)(i). We believe that having dual 
appeals processes for OTPs would impose unnecessary administrative 
burdens on OTPs and CMS. A single appeals process would, in our view, 
be more efficient. To this end, we propose in new Sec.  
424.67(b)(7)(ii) that an OTP's appeals under 498 of a Medicare 
revocation (under Sec.  424.535) and a provider agreement termination 
(under Sec.  489.53) must be filed jointly and, as applicable, 
considered jointly by CMS under part 498 of this chapter. We note that 
there is precedence for such a consolidated approach. Under Sec. Sec.  
422.222(a)(2)(ii)(B) and 423.120(c)(6)(v)(B)(2) (which apply to 
Medicare Part C and D, respectively), if a provider's or prescriber's 
inclusion on the preclusion list (see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html for background information on the preclusion list) 
is based on a contemporaneous Medicare revocation under Sec.  
[thinsp]424.535, the appeals of the preclusion list inclusion and the 
revocation must be filed jointly and considered jointly under part 498.
    We would appreciate comment on our proposed consolidated appeals 
process, including suggestions of alternative processes and the 
potential operational components thereof.
(h) OTPs: Other Applicable Requirements
    To ensure that the OTP meets all other applicable requirements for 
enrollment, we are proposing at Sec.  424.67(b)(8)) that the OTP must 
comply with all other applicable requirements for enrollment specified 
in Sec.  424.67 and in part 424, subpart P.
(i) OTPs: Denial of Enrollment and Appeals Thereof
    We are proposing to state in new Sec.  424.67(c)(1)(i) and (ii) 
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.
    In new Sec.  424.67(c)(2), we are proposing that an OTP may appeal 
the denial of its enrollment application under part 498.
    We believe that Sec.  424.67(c)(1)(i) is necessary so as to comply 
with the previously mentioned statutory and regulatory requirements 
that an OTP be SAMHSA-certified. Concerning paragraphs (c)(1)(ii) and 
(2), we note that because an OTP is a Medicare provider, it must be 
treated in the same manner as any other provider or supplier for 
purposes of enrollment and appeal rights; that is, subpart P and the 
appeals provisions in part 498 apply to OTPs to the same extent they do 
to all other providers and suppliers. We accordingly believe it is 
appropriate to include paragraphs (c)(1)(ii) and (2) in this proposed 
rule.
(j) OTPs: Continued Compliance, Standards, and Reasons for Revocation
    For reasons identical to those behind our proposed addition of 
paragraph (c), we propose several provisions in new Sec.  424.67(d).
    In paragraph (d)(1), we are proposing 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 and

[[Page 40722]]

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 are proposing 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 are proposing that an OTP may 
appeal the revocation of its enrollment under part 498.
(k) OTPs: Prescribing Individuals
    We believe it is important for us to be able to monitor the 
prescribing and dispensing practices occurring at an OTP. We have an 
obligation to ensure that beneficiary safety is maintained and the 
Trust Funds are protected. Accordingly, we propose under new Sec.  
424.67(e)(1) (and with respect to payment to OTP providers for 
furnished drugs) 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 note that our use of the term 
``medication ordering'' is merely intended to reiterate that our 
proposed provision applies to any physician or other eligible 
professional who prescribes or orders drugs in the OTP arena.
    Section 424.67(e)(1), in our view, 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. So as to avoid the impression, however, that this is the only 
requirement necessary for claim payment, we propose 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 propose 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 of Title 42 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, non-physician practitioners, physician and non-
physician practitioner 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 In a similar vein, Sec.  424.521(a) 
states that physicians, non-physician practitioners, physician and non-
physician practitioner 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, 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 propose to include newly 
enrolling OTPs within the scope of both Sec.  424.520(d) and Sec.  
424.521(a). We believe that the effective and retrospective billing 
dates addressed therein achieves a proper balance between the need for 
the prompt provision of OTP services and the importance of ensuring 
that each prospective OTP enrollee is carefully and closely screened 
for compliance with all applicable requirements.
2. Revision(s) and Addition(s) to Denial and Revocation Reasons in 
Sec. Sec.  424.530 and 424.535
a. Improper Prescribing
    Under 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 was finalized in the ``Medicare Program; 
Contract Year 2015 Policy and Technical Changes to the Medicare 
Advantage and the Medicare Prescription Drug Benefit Programs'' final 
rule that was published in the May 23, 2014 Federal Register (79 FR 
29844). It was designed to address situations, which we discussed in 
that final rule, 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 practitioners who have engaged in a variety of improper 
prescribing practices. We believe these administrative actions have 
helped to shield beneficiaries and the program at large from improper 
prescribing practices.
    The dispensing of drugs in the treatment of opioid use disorder is, 
as indicated previously, an important component of an OTP's function. 
Akin to our rationale for the establishment of Sec.  424.535(a)(14) in 
2014, we are concerned about potential instances where OTP physicians 
and other eligible professionals prescribe drugs in an improper 
fashion. This is an especially important consideration given the 
nationwide opioid epidemic and the need to reduce opioid abuse. Given 
this, we believe 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. Improper prescribing in the Part B context is 
no less troubling or potentially dangerous than prescribing in the Part 
D context. Thus, only through such an expansion can we, on a much 
broader and necessary scale, further deter parties from improper 
Medicare prescribing practices.
    In the introductory text of Sec.  424.535(a)(14), we currently 
state that CMS determines that the physician or other eligible 
professional has a pattern or practice of prescribing Part D drugs. 
Consistent with the above discussion,

[[Page 40723]]

we are proposing to revise this paragraph to include Part B drugs so we 
would specify the prescribing of ``Part B or D drugs.'' We note 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 are also proposing 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 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.
    We currently lack the legal basis to take administrative action 
against a physician or other eligible professional for a matter related 
to patient harm based solely on an IRO determination or an 
administrative action (excluding a state medical license suspension or 
revocation) imposed by a state oversight board, a federal or state 
health care program, or any other equivalent governmental body or 
program that oversees, regulates, or administers the provision of 
health care. We believe, however, that our general rulemaking authority 
under sections 1102, 1866(j)(1)(A), and 1871 of the Act gives us the 
ability to establish such legal grounds. As alluded to in this proposed 
rule and in previous rulemaking efforts, we have long been concerned 
about instances of physician or other eligible professional misconduct, 
and we believe our authority to take action to stem such behavior 
should be expanded to include the scenarios identified in proposed 
Sec.  424.530(a)(15) and Sec.  424.535(a)(22). Indeed, 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. IRO determinations, too, 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 believe 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 recognize that situations could arise where a state oversight 
board has chosen to impose a relatively minor sanction on physician or 
other eligible professional for conduct that we deem more serious. We 
note, however, that we, rather than state boards, is ultimately 
responsible for the administration of the Medicare program and the 
protection of its beneficiaries. State oversight of licensed physicians 
or practitioners is, in short, a function entirely different from 
federal oversight of Medicare. We accordingly believe that we should 
have the discretion to review such cases to determine whether, in the 
agency's view, the physician's or other eligible professional's conduct 
warrants revocation or denial. Yet it should in no way be assumed, on 
the other hand, that a very modest sanction would automatically result 
in revocation or denial action. We emphasize that we would only take 
such a measure after the most careful consideration of all of the 
factors outlined above.
    A number of these factors, we add, are not altogether dissimilar 
from those which we presently use for determining whether a revocation 
under Sec.  424.535(a)(14) is appropriate (for example, general 
frequency and degree of the behavior in question, number of prior 
sanctions). We have found them to be useful in our Sec.  424.535(a)(14) 
determinations and, for this reason, believe they will prove likewise 
with respect to Sec.  424.530(a)(15) and Sec.  424.535(a)(22). Certain 
of our other proposed criteria are designed to pertain to the unique 
facts addressed in these two provisions (for example, the extent of 
patient harm) and, in our view, would help ensure a thorough review of 
the case at hand.
    Sections 424.530(a)(15) and 424.535(a)(22) would apply to 
physicians and other eligible professionals in OTP and non-OTP 
settings. Revocation or denial action could be taken against physicians 
and other eligible professionals in solo practice or who are part of a 
group or any other provider or supplier type.
    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 propose to 
define this term in Sec.  424.502. Specifically, we would state that, 
for purposes of Sec. Sec.  424.530(a)(15) and 424.535(a)(22) only, 
``state oversight board'' means ``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 welcome comment not only on our proposed definition of ``state 
oversight board'' but also on our proposed revocation and denial 
authorities. We are especially interested in securing public feedback 
on additional means of preventing fraud, waste, and abuse in OTP 
setting; for instance, 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.

[[Page 40724]]

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 non-physician practitioners (NPPs). 
Medicare policies and regulations have been updated over recent years 
to make changes to allow 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 
an admission. The surgical services performed at ASCs are scheduled, 
primarily elective, non-life-threatening procedures that can be safely 
performed in an ambulatory setting. Currently, there are approximately 
5,767 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, 
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), which 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 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.\101\ 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.
---------------------------------------------------------------------------

    \101\ Paul F. Hogan et al., ``Cost Effectiveness Analysis of 
Anesthesia Providers.'' Nursing Economic$. 2010; 28:159-169.
---------------------------------------------------------------------------

b. Proposed Provisions
    We are proposing 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 would be making ASC patient 
evaluations more consistent by allowing the option for the same 
clinician to complete both pre- and post-procedure anesthesia 
evaluations.
    This proposed change is a continuation of our efforts to reduce 
regulatory burden. This change would increase supplier flexibility and 
reduce burden, while allowing qualified clinicians to focus on 
providing high-quality healthcare to their patients. We are also 
requesting 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.
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,

[[Page 40725]]

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. Proposed 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.
    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 propose to revise Sec.  418.106(b)(1) to permit a 
hospice to accept drug orders from a physician, NP, or PA. We propose 
that the PA must be an individual acting within his or her state scope 
of practice requirements and hospice policy. We also propose 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. 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.
    The role of a PA is not defined in the hospice CoPs because the 
statute does not include PA services as being part of the Medicare 
hospice benefit. As such, there are no provisions in the hospice CoPs 
to address specific PA issues such as personnel requirements, 
descriptions of whether such services would be considered core or non-
core, or provisions to address issues of co-signatures. To more fully 
understand the current and future role of NPPs, including PAs, in 
hospice care and the hospice CoPs, we request 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?

[[Page 40726]]

     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 time frames 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?

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 CMS advisory opinions 
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, the Office of Inspector General (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 
CMS advisory opinions 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 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) 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 Congress' directive to take into account 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 CMS 
advisory opinions 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. Proposed Revisions to the CMS 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 CMS 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 stated also 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

[[Page 40727]]

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 CMS 
advisory opinions apply only to the specific circumstances of the 
requestor. These commenters asserted that the OIG's advisory opinion 
process, upon which the CMS advisory opinion process is modeled, is 
inappropriate for a payment statute. These commenters noted that OIG 
opines on matters related to a felony criminal statute, whereas the 
physician self-referral law, by contrast, is a payment rule. The 
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 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 CMS advisory opinion 
regulations were issued. In those 20 years, we have issued 30 advisory 
opinions,\102\ 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 have undertaken a fresh review of the CMS 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, and we recognize that our current advisory opinion process 
has not been utilized by stakeholders or resulted in a significant 
number of issued opinions to date. Accordingly, we have 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.
---------------------------------------------------------------------------

    \102\ 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.
---------------------------------------------------------------------------

    Failure to satisfy the requirements of an exception to the 
physician self-referral law carries significant consequences, 
regardless of a party's intent.\103\ 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 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.
---------------------------------------------------------------------------

    \103\ 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. But we believe that the risk of such misuse is 
acceptably low with respect to the section 1877 of the Act advisory 
opinion process 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 
meets an 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 built-in safeguard against 
protecting an arrangement that the law would not otherwise protect. 
Furthermore, a favorable advisory opinion from CMS does not immunize 
parties from liability under the anti-kickback statute.
a. 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 the rules in 
paragraphs (b)(3) and (4) of section 1128D of the Act, which prohibit 
the 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 statutory 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 (Id.).
    Under our current regulations, CMS accepts requests for advisory 
opinions that involve existing arrangements, as well as requests that 
involve arrangements into which the requestor plans to enter. Some 
commenters on the June 2018 CMS RFI suggested that CMS expand the scope 
of the requests that it will consider for an advisory opinion to 
include requests that involve hypothetical fact patterns and general 
questions of interpretation. It is our position that some requests are 
not appropriate for an advisory opinion.

[[Page 40728]]

Further, although we are proposing a number of changes to improve the 
advisory opinion process for stakeholders, we believe that expanding 
the process to include questions regarding hypothetical fact patterns 
or general interpretation could overwhelm the agency. Thus, we are not 
proposing an expansion of the scope of requests at this time; however, 
we are soliciting comments on whether we should do so in the future. We 
are proposing minor clarifications to Sec.  411.370(b) regarding 
matters that qualify for advisory opinions and the parties that may 
request them. Specifically, we are proposing 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 are also proposing revisions to the 
regulation text for grammatical purposes.
    We note that CMS currently responds to questions pertaining to the 
physician self-referral law through the CMS Physician Self-Referral 
Call Center. Although we are unable to provide formal guidance or an 
opinion regarding whether a specific referral is permissible or whether 
a financial relationship satisfies the requirements of an exception, we 
are able to assist parties with identifying relevant guidance. The CMS 
Physician Self-Referral Call Center 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. CMS also responds to frequently 
asked questions (FAQs) regarding the physician self-referral law from 
time to time. FAQs issued to date may be found on our website at 
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/FAQs.html.
    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 are proposing changes to this regulation. First, we are 
proposing to add to the reasons that CMS will not accept an advisory 
opinion request or issue an advisory opinion. Specifically, we are 
proposing that CMS will reject 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 are proposing 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 are proposing to ease the restriction at 
Sec.  411.370(e)(2) that prohibits the acceptance of an advisory 
opinion request or issuance of an advisory opinion if CMS is aware of 
pending or past investigations or proceedings involving a course of 
action that is ``substantially the same'' as the arrangement or 
proposed arrangement between or among the parties requesting an 
advisory opinion, and instead 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 propose 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 is the subject of a proceeding involving 
HHS or other law enforcement agencies, and issuing an advisory opinion 
could interfere with the investigation or proceeding. We propose to 
retain at renumbered Sec.  411.370(e)(1)(iii) the restriction on 
accepting requests if CMS is aware that the specific course of action 
(involving the same specific parties) is under investigation or is, or 
has been the subject of a proceeding involving the Department or 
another governmental agency. We also propose 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 seek comments on this approach.
    Although we are not proposing changes to Sec.  411.370(f) which 
describes the effects of an advisory opinion on other government 
authority, we note that a determination regarding whether a referral is 
prohibited by section 1877 of the Act is a determination that rests 
solely and exclusively with the Secretary (and, in this case, the 
Administrator, to whom the Secretary has delegated this authority). 
Under section 1877(g)(6) of the Act, an advisory opinion is binding on 
the Secretary, and if the Secretary determines that a particular fact 
pattern does not trigger liability under section 1877 of the Act, that 
determination is binding on the Secretary, as well as any component of 
HHS that exercised the authority delegated by the Secretary. Such a 
determination would preclude the imposition of sanctions under section 
1877(g) of the Act.\104\ A favorable advisory opinion would not, 
however, insulate parties from liability under the anti-kickback 
statute or any other laws or regulations outside of section 1877 of the 
Act. It would also not preclude OIG from exercising its authority under 
the Inspector General Act of 1978 (Pub. L. 95-452, as amended by Pub. 
L. 115-254, enacted October 05, 2018). In a physician self-referral law 
advisory opinion, CMS may opine on whether an arrangement is 
``commercially reasonable'' as defined by the physician-self-referral 
law regulations. Such a determination by CMS may not apply in the 
context of the anti-kickback statute and should not be interpreted as 
such. A CMS determination that an arrangement is or is not a 
``financial relationship,'' as defined at section 1877(a)(2) of the Act 
and Sec.  411.354(a), or that an arrangement satisfies a specific 
requirement of an exception to the physician self-referral law (for 
example, whether a compensation arrangement is ``commercially 
reasonable''), would be a separate and distinct inquiry from any 
determination by law enforcement that the arrangement does or does not 
violate the anti-kickback statute.
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    \104\ The Secretary has delegated the civil monetary penalty 
authority under section 1877 of the Act to the OIG.
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b. Timeline for Issuing an Advisory Opinion (Sec.  411.380)
    Section 1877(g)(6) of the Act does not impose any deadlines by 
which the

[[Page 40729]]

agency must respond to an advisory opinion request, but 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 
determine, 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 on the volume and complexity of expected requests, 
and based upon our then-current staffing situation.
    We are proposing to modify this time period and establish a 60-day 
timeframe for issuing advisory opinions. The 60-day 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 also considering 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 seek comment on the proposed 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.
c. 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 are proposing 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. We are 
also considering 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 
seek comment on whether the existing certification requirement creates 
undue burden for requestors, and whether the requirement is necessary 
given Section 1001.
d. 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 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). We believe it is 
appropriate to adopt an hourly fee of $220 for preparation of an 
advisory opinion. We believe this amount reflects the costs incurred by 
the agency in processing an advisory opinion request. We are also 
considering adding a provision establishing an expedited pathway for 
requestors that seek an advisory opinion within 30 days of the request. 
If we establish such a pathway, we would consider charging $440 an hour 
to process the request, reflecting the extra resources necessary to 
produce an advisory opinion within the abbreviated timeframe. We 
request 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 are considering promulgating a cap on the 
amount of fees charged for an advisory opinion. We solicit comments on 
the amount of the cap. We also request comments on whether CMS should 
eliminate the initial $250 fee.
e. Reliance on an Advisory Opinion (Sec.  411.387)
    As we consider improvements to the advisory opinion process, we are 
also considering regulatory changes to clarify current CMS policies and 
practices, and make our advisory opinions more useful compliance tools 
for stakeholders. Specifically, we are soliciting 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 believe it may be unduly 
restrictive in the context of a strict liability payment rule that 
applies regardless of a party's intent.
    In practice, CMS does anticipate that parties to an arrangement 
that is subject to 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 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

[[Page 40730]]

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 are 
proposing changes to Sec.  411.387 to reflect this view. Specifically, 
we are proposing 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 are proposing 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. Even though 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 would not consider 
using 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 the anti-kickback statute or 
any other law. 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). 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 to query whether a referral is prohibited under section 1877 of 
the Act because the arrangement is materially indistinguishable from an 
arrangement that received a favorable advisory opinion. We seek comment 
on this approach.
    Finally, we are also proposing 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 
self-referral law and regulations to specific facts and circumstances. 
We believe that stakeholders already look to advisory opinions issued 
by OIG and CMS to inform their decision-making, and these proposed 
changes would make clear that CMS acknowledges that such reliance is 
permissible and reasonable. We request comments on all aspects of these 
proposals.
f. Rescission (Sec.  411.382)
    Under current Sec.  411.382, CMS may rescind or revoke an advisory 
opinion after it is issued. 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 are again requesting comment on this issue. 
Specifically, we are soliciting 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.
g. Other Modifications to Procedural Requirements
    We are proposing minor modifications to Sec.  411.372 to improve 
readability and clarity. We are also proposing 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 are requesting 
comments on these and other updates to the procedure for submitting an 
advisory opinion request that will improve the efficiency of the review 
process.

K. CY 2020 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This section of the proposed 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 should 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 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)--have increased from 2017 to 
2018.\105\ 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. 
Beginning with the 2024 MIPS payment year, the cost performance 
category will be weighted at 30 percent, which has been gradually 
increased in the last few years, 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. 
Beginning in the 2022 performance period, there will no longer be the 
same flexibility in establishing the weight of the cost performance 
category or in establishing the performance threshold. Refer readers to 
sections III.K.3.c.(2)(a) and III.K.3.e.(2) of this proposed rule for 
more information about the statutory requirements related to these 
provisions.
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    \105\ Quality Payment Program (QPP) Participation in 2018: 
Results at a Glance https://qpp-cm-prod-content.s3.amazonaws.com/uploads/586/2018%20QPP%20Participation%20Results%20Infographic.pdf.
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b. Summary of Major Proposals
(1) MIPS Value Pathways Request for Information
    CMS is committed to the transformation of MIPS, which will allow 
for: More streamlined and cohesive reporting; enhanced and timely 
feedback; and the creation of MIPS Value Pathways (MVPs) of integrated 
measures and activities that are meaningful to all clinicians from 
specialists to primary care clinicians and patients. The new MVPs would 
remove barriers to APM participation and promote value by focusing on 
quality, interoperability, and cost. Additionally, MVPs would create a 
cohesive and meaningful participation experience for clinicians by 
moving away from siloed activities and measures and towards an aligned 
set of measures that are more relevant to a clinician's scope of 
practice, while further reducing reporting burden and

[[Page 40731]]

easing the transition to APMs. MVPs are described in greater detail at 
section III.K.1.b.(2) and the full Request for Information at section 
III.K.3.a. of this proposed rule.
(2) Major MIPS Proposals
    The major MIPS proposals in this year's proposed rule include a 
focus on a strategic vision to further transform MIPS by empowering 
patients and simplifying MIPS to improve value and reduce burden. We 
envision a future state of the program where patients have the 
information needed to make informed decisions about their healthcare, 
clinicians improve health outcomes and quality of care for their 
patients in alignment with the Meaningful Measures initiative,\106\ and 
the data collection burden is limited in alignment with the Patients 
over Paperwork initiative.\107\ Hence, we are proposing to apply a new 
MVPs framework to future proposals beginning with the 2021 MIPS 
Performance Year. MVPs would utilize sets of measures and activities 
that incorporate a foundation of promoting interoperability and 
administrative claims-based population health measures and layered with 
specialty/condition specific clinical quality measures to create both 
more uniformity and simplicity in measure reporting. The MVP framework 
will also connect quality, cost, and improvement activities performance 
categories to drive toward value; integrate the voice of patients; and 
reduce clinician barriers to movement into Advanced APMs. Further, the 
MVP framework would reduce the number of performance measures and 
activities clinicians may select. Ultimately, we believe this would 
decrease clinician burden and improve performance data quality, while 
still accounting for different types of specialties and practices. In 
addition to comments requested on the framework, we are seeking 
feedback on several implementation elements within section III.K.3.a. 
of this proposed rule. Within this section, we describe our vision that 
includes the following:
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    \106\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    \107\ https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.html.
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     Furthering the application of the Meaningful Measures 
framework.
     Implementing a measure set using additional administrative 
claims-based quality measures.
     Developing MVPs, using an approach which connects measures 
and activities from the quality, cost, and improvement activities 
performance categories; requiring completion of the Promoting 
Interoperability performance category to maintain alignment with 
hospitals; and focusing on a specialty or condition to standardize and 
provide more cohesive reporting and participation.
     Providing timely quality and cost performance data 
feedback using administrative claims, registry, and electronically 
submitted data to enhance a clinician self-tracking to facilitate care 
improvements.
     Enhancing information available to patients to inform 
decision making, including increasing the patient reported measures in 
MVPs.
    This vision will ultimately help us to better measure and 
incentivize value, ensure participation is more meaningful to 
clinicians and their patients, provide information to patients to 
assist with clinician selection, reduce clinician reporting burden, 
respond to program concerns, and increase alignment with APMs, and 
increase alignment with APMs. The RFI solicits comment on the types of 
information that would be useful to patients (Medicare beneficiaries) 
and individual clinicians reporting data for purposes of sharing on CMS 
public websites. We have assessed new opportunities, such as, 
implementation of a foundational claims-based population health core 
measure set using administrative claims-based quality measures that can 
be broadly applied to communities or populations, development of MVP 
measure tracks to provide uniformity in measure reporting and to unify 
performance categories, and enhancement of the patient voice, to 
increase simplicity, reduce burden, and increase the value of MIPS 
performance data. We strongly encourage feedback on how we can best 
realize our path to value vision of MIPS Value Pathways.
    In addition to this framework, we are making two significant 
proposals for the 2020 MIPS performance period:
     As discussed in section III.K.3.g.(2) of this proposed 
rule, we are proposing 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 
proposed rule, we are proposing to add new episode-based measures in 
the cost performance category to more accurately reflect the cost of 
care that specialists provide. Further, we are proposing to revise the 
total per capita cost and the Medicare Spending Per Beneficiary (MSPB) 
measures in response to stakeholders' feedback suggestions.
    While we continue efforts to strengthen the Quality Payment 
Program, we remain interested in clinician participation and engagement 
in the program. Finally, as the Bipartisan Budget Act of 2018 (BBA of 
2018) (Pub. L. 115-123, enacted February 9, 2018) extended the 
flexibility and transition years within the Quality Payment Program, we 
believe these proposed policies for Year 4 and our strategic vision 
will assist us in working towards a more robust program in the future.
(3) Major APM Proposals
(a) Aligned Other Payer Medical Home Models
    We are proposing to add the defined term, Aligned Other Payer 
Medical Home Model, to Sec.  414.1305. 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. 
We believe that structuring this proposed 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 proposal to define the term Aligned Other Payer 
Medical Home Model, we are proposing to amend Sec.  414.1420(d)(2), 
(d)(4), and (d)(8) of our regulations to also apply the 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 proposing to modify our definition of marginal risk when 
determining whether a payment arrangement is an Other Payer Advanced 
APM. We propose 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

[[Page 40732]]

expenditures would be used for comparison to the marginal risk rate 
specified in with exceptions for large losses and small losses as 
described in Sec.  414.1420(d). Average marginal risk would be computed 
by adding the marginal risk rate at each percentage of level to 
determine to determine participants' losses, and dividing it by the 
percentage above the benchmark to get the average marginal risk. 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 VI.E.10.a. of this proposed rule, for the 
2022 payment year and based on estimated Advanced APM participation 
during the 2020 QP Performance Period, we estimate that between 175,000 
and 225,000 clinicians will become Qualifying APM Participants (QPs). 
As a QP for the 2022 payment year, an eligible clinician is excluded 
from the MIPS reporting requirements and payment adjustment and 
qualifies for 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 $500-600 million for the 
2022 Quality Payment Program payment year.
    We estimate that approximately 818,000 clinicians would be MIPS 
eligible clinicians for the 2020 MIPS performance period in section 
VI.E.10.b.(1)(b) of this proposed 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 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 ($584 million) and positive MIPS payment adjustments ($584 
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 80 points that we are proposing in section 
III.K.3.e.(3) of this proposed 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 proposing to define the following terms:
     Aligned Other Payer Medical Home Model.
     Hospital-based MIPS eligible clinician.
     MIPS Value Pathway.
    We are additionally proposing to revise at Sec.  414.1305 the 
following term:
     Rural area.
    These terms and definitions are discussed in detail in relevant 
sections of this proposed rule.
3. MIPS Program Details
a. Transforming MIPS: MIPS Value Pathways Request for Information
(1) Overview
    In this proposed rule, we are proposing to apply a new MIPS Value 
Pathways (MVP) framework to 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. 
As discussed in section III.K.3.a.(3)(a) of this proposed rule, the MVP 
framework would be implemented as early as feasible to produce a MIPS 
program that more effectively meets the 7 strategic objectives 
described in the CY 2018 QPP final rule (82 FR 53570) and drives 
continued progress and improvement. The MVP framework would connect 
measures and activities across the 4 MIPS performance categories, 
incorporate a set of administrative claims-based quality measures that 
focus on population health, provide data and feedback to clinicians, 
and enhance information provided to patients. As discussed in section 
III.K.3.a.(3)(a) of this proposed rule, we are proposing to apply this 
MVP framework to future proposals beginning with the 2021 MIPS 
performance period rather than the 2020 MIPS performance period, so 
that we can seek necessary feedback on the details of implementing this 
transformative approach and address additional details of the 
methodology in next year's rulemaking cycle. We understand that 
clinicians want timely performance feedback data on quality and cost to 
track their performance and prepare to take on risk, as required in 
Advanced APMs, and we intend to provide enhanced feedback and data 
analysis information to clinicians in the future. We plan to engage 
with clinician professional organizations and front-line clinicians to 
develop the MVPs.
(2) MVP Framework
(a) MVP Overview
    We believe the MVPs will reduce the complexity of the MIPS program 
and the burden to participate. We intend to simplify MIPS while 
continuing to reward high value clinicians and help all clinicians 
improve care and engage patients. While we emphasized flexibility 
during the initial years of MIPS, we believe we must balance 
flexibility with a degree of standardization to hold clinicians 
accountable for the quality of care, identify and reward high value 
care, and limit clinician burden. Any solution to improving MIPS 
performance measurement data must account for the large variation in 
specialty, size, and composition of clinician practices. MVPs allow for 
a more cohesive participation experience by connecting activities and 
measures from the 4 MIPS performance categories that are relevant to 
the population they are caring for, a specialty or medical condition.
    The MIPS program aims to drive quality and value through the 
collection, assessment, and public reporting of data that informs and 
rewards the delivery of high-value care. For purposes of this 
discussion, we define ``value'' as a measurement of quality as related 
to cost, ``value-based care'' as paying for health care services in a 
manner that directly links performance on cost, quality, and the 
patient's experience of care, and ``high value clinicians'' as 
clinicians that perform well on applicable measures of quality and 
cost. We believe implementing a ``path to value'' framework will 
transform the MIPS program by better informing and empowering patients 
to make decisions about their healthcare and helping clinicians to 
achieve better outcomes, and also by promoting robust and accessible 
healthcare data, and interoperability.
    We are targeting policies that remove APM participation barriers as 
clinicians

[[Page 40733]]

and practices prepare to take on and successfully manage risk as 
practices build out their quality infrastructures with components that 
align with the MIPS performance categories. Critical practice 
infrastructure components that support higher value care and readiness 
to join APMs include performance measurement tracking, performance 
improvement processes, interoperability, and data information systems 
that assist clinicians and practices in monitoring performance and 
adopting new workflows and care delivery methods. Performance measure 
reporting for specific populations encourages practices to build an 
infrastructure with capabilities to compile and analyze population 
health data, a critical capability in assuming and managing risk. For 
example, quality measurement can bolster the development of a practice 
infrastructure that rapidly integrates evidence-based best practices 
into the structure and execution of care delivery, to leverage a value-
based payment, and to produce achievement of better health outcomes. 
Improvement Activities add a continuous clinical practice improvement 
component, that can help clinicians use the experiences and 
perspectives of front-line staff and beneficiaries to constantly 
assess, reconfigure, and innovate processes and systems of care 
delivery to better manage revenue and risk expenditure. Sensitivity to 
cost and experience with cost measures within a practice infrastructure 
is critical to managing value based payment and APM risk, while 
awareness of and sensitivity to cost from the beneficiary perspective 
(out-of-pocket cost, cost of time off from work for the patient and/or 
caregiver, cost of disruption of normal activities/relationships) can 
help support shared decision-making. An interoperability infrastructure 
component supports the development of a practice infrastructure that 
recognizes the critical role of information exchange in supporting 
safe, effective, and efficient coordination and transitions of care 
through a complex health care system, and better management of costs 
and risk. We believe that experience with MVPs, in which there is 
measurement of quality (of care and of experience of care) and cost-
efficiency, continuous improvement/innovation within the practice, and 
efficient management and transfers of information, will remove barriers 
to APM participation.
    We believe it is important to transform the MIPS program. We must 
change the current program to move along the path to value and enter a 
future state of MIPS, which includes a more cohesive and simplified 
participation experience for clinicians, increased voice of the 
patient, increased CMS provided data and feedback to clinicians to 
reduce reporting burden, and facilitated movement to Alternative 
Payment Models. 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.
    We have built the MIPS program recognizing the large variation in 
specialty, size, and composition of clinician practices, providing 
broad flexibility for clinician choice of measures and activities, data 
submission types, and individual or group level participation. Although 
we believe this flexibility contributed to Year 1 participation of 95 
percent of MIPS eligible clinicians, including 94 percent of rural 
practices and 81 percent of small practices,\108\ and the increase in 
Year 2 participation to 98 percent of MIPS eligible clinicians.\109\ we 
also believe there is room to improve upon the program. Specifically, 
we believe this flexibility has inadvertently resulted in a complex 
MIPS program that is not producing the level of robust clinician 
performance information we envision providing to meet patient needs and 
spur clinician care improvements.
---------------------------------------------------------------------------

    \108\ 2017 Quality Payment Program Reporting Experience, March 
20, 2019 (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/491/2017%20QPP%20Experience%20Report.pdf).
    \109\ Quality Payment Program (QPP) Participation in 2018: 
Results at a Glance, https://qpp-cm-prod-content.s3.amazonaws.com/uploads/586/2018%20QPP%20Participation%20Results%20Infographic.pdf.
---------------------------------------------------------------------------

    Although we have been reducing the numbers of MIPS quality measures 
in accordance with the Meaningful Measures initiative (see 83 FR 59763 
through 59765), we have heard concerns from some stakeholders that MIPS 
presents clinicians with too much complexity and choice (for example, 
of several hundred MIPS and QCDR quality measures), causing unnecessary 
burden. As noted in the CY 2019 PFS final rule (83 FR 59720), we have 
received feedback that some clinicians find the performance 
requirements confusing, and that it is difficult for them to choose 
measures that are meaningful to their practices and have a direct 
benefit to beneficiaries.
    We have also heard concerns from stakeholders that MIPS does not 
allow for sufficient differentiation of performance across practices 
due to clinician quality measures selection bias. This detracts from 
the program's ability to effectively measure and compare performance, 
provide meaningful feedback, and incentivize quality. For example, in 
its June 2017 Report to Congress, MedPAC documented the need for 
changes to the MIPS program to increase clarity, reduce complexity, and 
make the burden of data submission worthwhile through higher impact. 
MedPAC recommended in their March 2018 Report to Congress using a 
uniform set of population-based measures for clinicians paid by 
Medicare who are not participating in an advanced APM, and provided an 
illustrative voluntary value model that used administrative claims and 
patient experience surveys. The MedPAC model did not include any 
specific clinical specialty or practice level measures.
    We believe a hybrid approach is warranted--where clinicians are 
measured on a unified set of measures and activities around a clinician 
condition or specialty, layered on top of a base of population health 
measures, which would be included in virtually all of the MVPs. Over 
time, the information clinicians and groups are required to submit will 
be less burdensome and more meaningful to clinicians and patients. At 
the same time, we intend to analyze Medicare information to provide to 
clinicians and patients more information to improve the health of the 
Medicare beneficiaries. Finally, we anticipate capturing additional 
information important to patients. We envision applying this framework 
to future proposals beginning with the 2021 MIPS performance period/
2023 MIPS payment year as we integrate new MVPs, so that eventually, 
all MIPS eligible clinicians would have to participate through an MVP 
or a MIPS APM. We seek feedback on numerous elements related to the 
MVPs in sections III.K.3.a.(3)(a)(i) through III.K.3.a.(3)(a)(iv) of 
this proposed rule.
(b) Clinician Data Feedback
    Clinicians have expressed an interest in leveraging data, such as 
timely claims data, to track performance and inform care improvements. 
We understand that performance data feedback on administrative claims-
based quality and cost measures would potentially assist clinicians in 
understanding their performance and preparing to take on risk as 
required in Advanced APMs. We see the critical need for data feedback 
and intend to provide enhanced clinician driven data feedback and 
analysis information under the future MVP approach. We are interested 
in

[[Page 40734]]

whether clinicians would like to see outlier analysis or other types of 
actionable data feedback and are seeking comments on clinician data 
feedback content and timing needs in section III.K.3.a.(6) of this 
proposed rule.
(c) Enhancing Information for Patients
    The MIPS program aims to drive quality and value through the 
collection, assessment, and public reporting of data that informs and 
rewards the delivery of high-value care. We believe that our 
performance measurement should focus more on patient reported measures, 
including patient experience and satisfaction measures and clinical 
outcomes measures, as we believe that clinicians can use feedback from 
the patient perspective to inform care improvement efforts. We believe 
that MVPs should include patient reported measures when feasible. We 
believe implementing an MVP framework will transform the MIPS program 
by better informing and empowering patients to make decisions about 
their healthcare and helping clinicians achieve better outcomes, and 
also by promoting robust and accessible healthcare data and 
interoperability.
    We are dedicated to putting patients first and providing the 
information they need to be engaged and active decision-makers in their 
care. We believe that whenever feasible the MIPS program should provide 
meaningful information at the individual clinician level. We believe we 
need specific specialty information from multispecialty groups and are 
considering approaches to use the MVPs to require reporting relevant to 
multiple specialty types within a group to provide more comprehensive 
information for patients. We seek comment, as discussed in section 
III.K.3.a.(3)(b) of this proposed rule, on the best ways to identify 
which MVPs should be reported by multispecialty groups and how we 
should balance the need for information at the individual clinician 
level with the burden of reporting.
    We are also looking at ways that we can gather and display 
information that is useful to patients. We are considering approaches, 
as discussed in section III.K.3.a.(6) of this proposed rule, to 
developing and reporting on Physician Compare a ``value indicator'' 
representing each clinician's performance on cost, quality, and the 
patient's experience of care. We are committed to learning more about 
the types of information patients use in making decisions and 
determining what information can be derived from the data reported or 
gathered as part of MIPS.
(3) Implementing MVPs
(a) MVP Definition, Development, Specification, Assignment, and 
Examples
    We are seeking comments on the development and structure of MVPs, 
which would connect measures and activities across the quality, cost, 
and improvement activities performance categories. We believe that 
interoperability is a foundational element and thus would generally 
apply to all clinicians, regardless of the specific MVP, for whom the 
Promoting Interoperability performance category is required. MVPs would 
support our vision to measure value, reduce burden, simplify the MIPS 
performance measurement and scoring approaches, and ensure strong 
alignment of quality and cost measures. The four guiding principles we 
would use to define MVPs are:
    1. MVPs should consist of limited sets of measures and activities 
that are meaningful to clinicians, which will reduce or eliminate 
clinician burden related to selection of measures and activities, 
simplify scoring, and lead to sufficient comparative data.
    2. MVPs should include measures and activities that would result in 
providing comparative performance data that is valuable to patients and 
caregivers in evaluating clinician performance and making choices about 
their care.
    3. MVPs should include measures that encourage performance 
improvements in high priority areas.
    4. MVPs should reduce barriers to APM participation by including 
measures that are part of APMs where feasible, and by linking cost and 
quality measurement.
    We request public comments on the MVP guiding principles noted 
above. We also request public comments on how to best develop MVPs to 
allow for the development of better comparative data, reduce burden, 
and provide valuable information to patients and clinicians.
    MVPs would be organized around clinician specialty or health 
condition and encompass a set of related measures and activities. We 
intend to ensure equity in MVPs so that clinicians are not advantaged 
by reporting one MVP over another (for example, in terms of reporting 
burden and scoring), but also want to include measures that have 
opportunities for improvement. Bundling quality and cost measures and 
improvement activities that are highly correlated in addition to the 
measures from the Promoting Interoperability performance category will 
strengthen clinical improvement and streamline reporting. As an initial 
step, we are proposing to require that beginning with the 2020 Call for 
measures process, MIPS quality measure stewards must link their MIPS 
quality measures to existing and related cost measures and improvement 
activities, as applicable and feasible. We refer readers to section 
III.K.3.c.(1)(d)(i) of this proposed rule for further discussion of our 
proposal.
    We believe that MVPs can be created with significant input from 
clinicians and specialty societies, to ensure that measures and 
activities within MVPs are relevant and important to clinician 
practices. The most significant change with MVPs is that eventually all 
MIPS eligible clinicians would no longer be able to 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 condition (see examples of potential MVPs in section 
III.K.3.a.(3)(a) of this proposed rule). We also intend that a 
population health measure/administrative claims-based measures would be 
layered into measuring the quality performance category, applied 
whenever there is a sufficient case minimum. Cost measures would be 
specific to the MVP and applied only when a clinician or group meets 
the case minimum. MVPs could potentially also allow for the use of 
multi-category measures, should they be developed, as clinician 
feedback has indicated there is an interest in the development of these 
performance measures that simultaneously address two or three of the 
MIPS performance categories (83 FR 35932).
    As outlined in our goals for the Promoting Interoperability 
performance category in section III.K.3.c.(4)(b), we look to continue 
MIPS alignment with the Medicare Promoting Interoperability Program for 
eligible hospitals and CAHs, where appropriate. We envision Promoting 
Interoperability performance category measures, which focus on the 
meaningful use of certified EHR technology to support care coordination 
and electronic health information exchange, to be a key structural part 
of any MVP. Initially, there would be a uniform set of Promoting 
Interoperability measures in each MVP, though in future years we may 
consider customizing the Promoting Interoperability measures in each 
MVP. At this time, we are not considering making modifications to the 
Promoting Interoperability performance category as it becomes 
incorporated into the MVP framework. We believe that interoperability 
is a foundational element and thus would apply to all

[[Page 40735]]

clinicians, regardless of MVP, for whom the Promoting Interoperability 
performance category is required. However, we are seeking comment on 
how the Promoting Interoperability performance category could evolve in 
the future to meet our goal of greater cohesion between the MIPS 
performance categories. We believe that eligible clinicians could 
benefit from more targeted approaches to assessing the meaningful use 
of health IT which aligns with clinically relevant MVPs cutting across 
the MIPS performance categories. One approach we could consider is 
exploring which measures for the Promoting Interoperability performance 
category would be directly aligned with measures in other MIPS 
performance categories. For instance, many improvement activities are 
enabled by, or could be enabled by, the use of certified health IT 
including care coordination and patient engagement through health 
information exchange. We could develop Promoting Interoperability 
measures which measure the use of health IT in conducting these 
improvement activities, while relevant quality measures for a given MVP 
could assess quality outcomes associated with these activities. We 
invite comment on these concepts, as well as other suggestions for how 
the Promoting Interoperability performance category can be better 
integrated into MVPs.
    We also believe that improvement activities can be closely linked 
to the quality and cost measures, to encourage improvement on 
performance of those measures. As clinicians report on a stable set of 
measures, there is an inherent incentive to change practice patterns to 
increase performance on required quality and cost measures. We are 
seeking feedback in section III.K.3.a.(3)(a)(ii) of this proposed rule 
on how many improvement activities should be included in an MVP and how 
much flexibility there should be in selecting improvement activities. 
We also seek feedback on the extent to which improvement activities in 
MVPs should be specialty-specific, condition-focused improvement 
activities, versus other areas relevant to the practice such as patient 
experience and engagement, team-based care, and care coordination. More 
generally, we would like to understand how improvement activities are 
used to improve quality measure performance within clinical practices.
    Our goal in using MVPs is to standardize which measures and 
activities are reported, both to reduce clinician burden and better 
measure performance among comparable clinicians while appropriately 
recognizing the variability of clinician practices and potentially 
reducing barriers to moving into APMs, which generally measure quality 
for their respective participants using the same quality measures. We 
can also look to APMs for methods of linking quality and value 
measurement as APMs are designed around value, and address quality, 
cost, and care redesign for a specific population.
    We realize that there are numerous issues on which we need 
stakeholder feedback to fully implement MVPs, but we believe the basic 
approach could start in the 2021 MIPS performance period/2023 MIPS 
payment year. We are requesting public comments on the following 
issues:
     How to construct MVPs, including approach, definition, 
development, specification, and examples referenced at 
III.K.3.a.(3)(a)(i) of this proposed rule;
     How to select measures and activities for MVPs, referenced 
at III.K.3.a.(3)(a)(ii) of this proposed rule;
     How to determine MVP assignment, referenced at 
III.K.3.a.(3)(a)(iii) of this proposed rule; and
     How to transition to MVPs, referenced at 
III.K.3.a.(3)(a)(iv) of this proposed rule.
    To begin implementing MVPs, we are proposing to define a MIPS Value 
Pathway at Sec.  414.1305 as a subset of measures and activities 
specified by CMS. We anticipate that MVPs may include, but would 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. MVPs would include a population 
health quality measure set, and measures and activities such that all 4 
MIPS performance categories are addressed, and each performance 
category would be scored according to its current methodology. Under 
MVPs, the current MIPS performance measure collection types would 
continue to be used to the extent possible, but these details need to 
be worked out and would be addressed in next year's rulemaking cycle. 
We request comment on performance measure collection types for MVPs in 
section III.K.3.a.(3)(a)(ii) of this proposed rule.
    We provide 4 illustrative examples of MVPs in Table 34. The 
examples demonstrate how MVPs could be constructed and show the types 
of measures and activities that might be assigned to each MVP. We 
present 2 example MVPs for primary care and general medicine, which 
includes preventive health and diabetes prevention and treatment, as 
well as two example MVPs for procedural specialties, which include 
major surgery and general ophthalmology. Within our sample MVPs, we 
present no more than 4 quality or cost measures or improvement 
activities for each performance category. However, the exact number of 
measures and activities could vary across MVPs. We envision that we 
would no longer require the same number of measures or activities for 
all clinicians but focus on what is needed to best assess the quality 
and value of care within a particular specialty or condition. To assign 
quality measures in these examples, we prioritized outcome and patient 
reported measures, non-topped out measures, and eCQMs. To assign cost 
measures, we reviewed existing measures and selected those that fit 
into the MVP topic. We also included population health measures, which 
are described in section III.K.3.a.(4) of this proposed rule. We 
reviewed and selected relevant improvement activities that align with 
the quality and cost measures in the MVPs. We are interested in 
feedback on whether improvement activities should focus on improving 
the quality and cost measures within an MVP or be much broader 
including any improvement activities that are relevant to the practice. 
We are interested in exploring approaches to leverage participation in 
specialty accreditation programs, such as the American College of 
Surgeons' Commission on Cancer accreditation program. Since specialty 
accreditation programs may promote the evaluation and improvement of 
clinical processes and care, we believe it may be appropriate to 
incorporate attestation to participation in such programs as an 
approach to satisfy the requirements of the improvement activities 
performance category, for example, by proposing to specify such 
participation as an improvement activity for all MVPs or specific MVPs 
in future rulemaking. To align with the statutory requirement that a 
practice that is certified or recognized as a patient-centered medical 
home or comparable specialty practice be given the highest potential 
score for the improvement activities performance category, we have also 
included an illustrative example under the Preventive Health MVP to 
depict how patient-centered medical homes or comparable specialty 
practices would receive credit under the improvement activities 
performance category. We anticipate that all measures in the Promoting 
Interoperability performance category would initially be applicable to

[[Page 40736]]

each MVP unless an exclusion applies; thus, we assigned all Promoting 
Interoperability measures to all MVPs. We welcome comments on the 
examples of possible MVPs and on options for encouraging 
interoperability to promote improvements in care and performance 
measurement results.
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    The examples in Table 34 are illustrative only, but we envision 
that we would start building MVPs by reviewing the existing specialty 
measure sets for the quality performance category. However, some 
specialty measure sets contain multiple conditions or concepts, so we 
do not envision a one-to-one correlation between the specialty measure 
sets and MVPs.
    We anticipate that eventually many clinicians would have at least 
one relevant MVP, while other clinicians may have several. In 
particular, we believe that multispecialty groups will have more than 
one relevant MVP. If technically feasible, we would like to establish a 
methodology that allows us to identify and assign in advance the 
relevant MVP(s) for MIPS eligible clinicians or groups and require the 
clinician or groups to report on those MVPs. In addition, we would 
consider folding MIPS APM measures and activities into MVPs and develop 
an assignment process as described in the CY 2018 Quality Payment 
Program final rule (82 FR 53785 through 53787), applying a hierarchy 
which applies APM entity final scores over any other final score.
    We are interested in feedback on the level of choice that should be 
provided to clinicians for MVP selection or selection of measures and 
activities within an MVP. We have heard from some clinicians that they 
would prefer a clear list of what specific measures and activities they 
have to perform versus various options of measures and activities to 
report. We believe a methodology in which clinicians are informed of 
the potential MVP(s) that are available for a clinician or group to 
report on would be simpler to communicate and allow for both clinicians 
and CMS to better understand what measures and activities should be 
submitted. We are considering assigning MVPs to clinicians and groups, 
if technically feasible, starting with the 2021 MIPS performance period 
as MVPs become available and would propose the MVP assignment process 
in next year's rulemaking cycle. We are considering the feasibility of 
potential data sources or methods to use to assign clinicians to an 
MVP, such as the specialty reported on Part B claims or use of Medicare 
Provider Enrollment, Chain, and Ownership System (PECOS) data. We seek 
comment on circumstances when we should allow clinicians and groups to 
select an alternative MVP, rather than the one or more MVP(s) assigned. 
Those clinicians and groups who would not have an applicable MVP for 
the 2021 MIPS performance period would continue the current process of 
reporting MIPS measures and activities for the 4 performance 
categories. As an alternate option, we could consider self-assignment 
of MVPs for the 2021 MIPS performance year period with the intention of 
assigning MVPs to clinicians starting in the 2022 MIPS performance 
period. Clinicians have had flexibility in choosing MIPS quality 
measures to date, and we expect retaining a degree of choice will be 
welcome by some clinicians as we transition to MVPs. We anticipate that 
the number of available MVPs would increase in the 2022 MIPS 
performance period and subsequent years, which would allow for MVP 
assignment for all clinicians and groups. We are requesting public 
comments on whether clinicians and groups should be able to self-select 
an MVP or if an MVP should be assigned. If assigned, we are requesting 
comments on the best way to assign an MVP--should it be based on place 
of service codes, specialty designation on Part B claims, or in the 
case of groups, should the assigned MVP(s) be based on the specialty 
designation of the majority of clinicians in the group, specific 
services, or other factors?
    We are considering approaches to assigning MVPs to multispecialty 
groups to be inclusive of the different specialties providing care to 
patients. Alternatively, we are also considering approaches that would 
allow for self-assignment of MVPs where multispecialty groups would 
select one or more MVPs that are most relevant to the specialty mix 
within the group.
    We believe the approach to MVPs must find the right balance between 
having a sufficient number of MVPs to allow clinicians to report on 
measures and activities relevant to their practices, without developing 
so many MVPs that reporting is diluted and developing benchmarks is 
hampered. For example, we would not want to have several MVPs for the 
same specialty or condition because then only a portion of the MIPS 
eligible clinicians are reporting on the quality measures, which limits 
the ability to develop benchmarks and to make meaningful comparisons of 
clinicians.
    In addition, due to differences in collection types for many 
quality measures, we can have multiple benchmarks for each measure, 
which further complicates the ability to make meaningful comparisons. 
The diversity of MVPs and collection types of quality measures may 
hamper MIPS in meeting its vision of effectively measuring and 
comparing performance, providing meaningful feedback, incentivizing 
quality, and providing patients with enhanced information for making 
clinician selection choices.
    We believe Electronic Clinical Quality Measures (eCQMs) have the 
potential to decrease reporting burden within MVPs. Stakeholders have 
previously supported eCQMs and the associated reduction in information 
collection burden under a variety of CMS programs and have made 
recommendations for improving eCQMs (83 FR 41593). While we support the 
reporting of eCQMs through the MIPS program, we have identified certain 
eCQMs for removal. We may propose to remove measures that are extremely 
topped out, duplicative of a new measure, or are low-adopted measures 
that have been in the program for 2 or more years. We refer readers to 
Table Group C of Appendix 1 for the list of previously finalized 
quality measures proposed for removal in the 2022

[[Page 40739]]

payment year. Through our Call for Measures process, and related 
measure development resources, such as the CMS BluePrint at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf and the CMS Measure Development 
Plan at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/2018-MDP-annual-report.PDF, we encourage stakeholders to 
submit electronically specified measures for CMS consideration. We 
recognize that there are challenges related to development of new eCQMs 
and technical aspects, however, we are interested in eCQMs and their 
potential use in MVPs to reduce reporting burden. For further 
discussion of strategies for reducing burden associated with reporting 
eCQMs, refer to the Office of the National Coordinator for Health 
Information Technology draft report, Strategy of Reducing Regulatory 
and Administrative Burden Relating to the Use of Health IT and EHRs 
(https://www.healthit.gov/sites/default/files/page/2018-11/Draft%20Strategy%20on%20Reducing%20Regulatory%20and%20Administrative%20Burden%20Relating.pdf).
    We are interested in feedback on our timeframe for transitioning 
into MVPs. We anticipate that we will have a number of MVPs proposed 
for the 2021 MIPS performance period. However, we understand that there 
are many operational considerations that should be taken into account. 
We request comment on approaches to accelerate the development and 
implementation of MVPs, as well as any comments on the optimal timeline 
for transition.
    Over the next year, we may consider convening public forum 
listening sessions, webinars, and office hours, or use additional 
opportunities such as the pre-rulemaking measures process to understand 
what is important to clinicians, patients, and stakeholders, as we 
develop MVPs.
(i) Request for Feedback on MVP Approach, Definition, Development, 
Specification, Assignment, and Examples
    We are requesting public comments on how MVPs are developed.
     We have stated MVP guiding principles regarding reducing 
burden, providing comparative performance data to patients and 
caregivers, encouraging improvements in high priority areas, and 
reducing barriers to APM participation. Should we consider other 
guiding principles as we define and develop MVPs?
     In addition to gathering feedback from this proposed rule, 
how do we best engage stakeholders in the development of MVPs?
    ++ How would stakeholders like to be engaged in MVP development? 
What type of outreach would be the most effective in gathering the 
voice of the patient in the MVP concept and the selection of measures?
    ++ For quality measures, should we initiate a ``Call for MVPs'' 
that aligns with policies developed for the Call for Measures and 
Measure Selection Process, described in section III.K.3.c.(1)(d)(i) of 
this proposed rule, or should we use an approach similar to the process 
used to solicit recommendations for new specialty measure sets and 
revisions to existing specialty measure sets, as described in section 
III.K.3.c.(1)(d)(i) of this proposed rule?
     How should MVPs be organized, for example, around 
specialties and areas of practice? Alternatively, should MVPs be 
organized to address a small number of public health priorities, for 
example, HIV care or healthcare-associated infections? Please refer to 
Table 34 for examples of specialty MVPs.
     How can we ensure the right number of MVPs that result in 
comparable and comprehensive information that is meaningful for the 
clinicians, patients, and the Medicare program? How should we limit the 
number of MVPs? Should each specialty have a single MVP?
     How should we build on Promoting Interoperability, a 
foundational component of MVPs, as we link the 4 categories within 
MVPs? How could we best promote the use of health information 
technology and interoperability in practices not yet using electronic 
health records?
     How can MVPs effectively reduce barriers to clinician 
movement into APMs, such as practice inexperience with cost measurement 
and lack of readiness to take on financial risk?
(ii) Request for Feedback on Selection of Measures and Activities for 
MVPs
    We are requesting public comments on the selection of measures and 
activities in MVPs.
     Please provide feedback on the Example MVPs in Table 34 
that might help us in our development of additional MVPs. In the 
example, there is a list of required quality measures and improvement 
activities. Should MVPs include only required measures and activities, 
or a small list of quality measures and activities from which 
clinicians could choose what to report?
     What criteria should be used for determining which 
measures and activities should be included in an MVP, such as 
prioritizing outcome, high priority and patient-reported measures; 
limiting the number of quality measures to 4, including only cost 
measures that align with quality measures, etc.? How should performance 
categories and associated measures and activities be linked (e.g., 
quality measures aligned with cost measures)?
     For the quality measures, should clinicians and groups be 
required to use a certain collection type (eCQMs, MIPS Clinical Quality 
Measures [MIPS CQMs], CMS Web Interface, or QCDR measures) in order to 
have a comparable data set in the MVPs? What will clinicians' 
administrative burden be for changing to a new, specific collection 
type for a measure, for example, changing from MIPS CQM to an eCQM?
     Currently we have similar measures addressing the same 
clinical topic, with different collection types (for example, eCQMs, 
MIPS CQMs, QCDR measures, etc.) that have different specifications and 
separate benchmarks. What methodology could be used to develop a single 
benchmark when multiple collection types are used? Another solution we 
may consider to ensure comparable measure data and request feedback on 
is to require a single collection type. Please also refer to section 
III.K.3.a.(3)(c) of this proposed rule for more about QCDR measures in 
MVP.
     Should improvement activities in MVPs be restricted to 
activities directly related to the clinical outcomes of the quality and 
cost measures in the MVP, for example, IA_PM_4 ``Glycemic Management 
Services'' for a Diabetes MVP, or should the selection of improvement 
activities include cross-cutting activities, for example, IA_EPA_1 
Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have 
Real-Time Access to Patient's Medical Record? Should attestation to 
participation in a specialty accreditation program satisfy the 
improvement activities performance category requirements for an MVP? 
Should this option be available for all MVPs or limited to specific 
MVPs, such as particular specialties for which accreditation programs 
are available? What criteria should we use to identify such programs?
(iii) Request for Feedback on MVP Assignment
    We are requesting public comments on how we determine the most 
relevant MVP for clinicians and groups.

[[Page 40740]]

     How should we identify which MVP(s) are most appropriate 
for a clinician? Would it be based on the clinician specialty as 
identified in PECOS or the specialty reported on claims? If we assign 
an MVP, how would we be able to verify the applicability of the 
assigned MVP?
     Should we provide clinicians and groups more than one 
applicable MVP and allow clinicians to select their MVP(s) from those 
identified? What tools would be helpful for clinicians to understand 
what MVP(s) might be applicable, for example NPI lookup, measure 
shopping cart, etc.?
(iv) Request for Feedback on Transition to MVPs
    We are requesting public comments on how we transition to MVPs 
beginning with the 2021 MIPS performance period/2023 MIPS payment year.
     What practice level operational considerations do we need 
to account for in the timeline for implementing MVPs?
(b) Adjusting MVPs for Different Practice Characteristics
(i) Small and Rural Practices Participation in MVPs
    We realize that reporting burden associated with MIPS can vary by 
the size of the practice. Under current quality performance category 
submission requirements, the same number of measures and activities are 
reported regardless of group size, which may impose a high burden on 
small practices, given their very limited resources to address program 
requirements. Another challenge for small and rural group practices is 
the lack of a sufficient case mix to report measures that can be 
reliably scored, which makes the use of a set of administrative claims-
based quality and cost measures especially challenging. Policies for 
submission of measures and scoring for MVPs may need to account for 
these challenges. As we move towards MVPs, we will be evaluating other 
policies (such as eligibility requirements, including the low-volume 
threshold (Sec.  414.1305), submission requirements (Sec.  414.1325), 
scoring (Sec.  414.1380), etc.) for further modification.
    We also want to adopt policies that reduce barriers for small 
practices transitioning into APMs where available. We have seen that 
there are innovative small groups including over 83,000 clinicians (in 
small practices with less than 4 clinicians) that joined the 
Transforming Clinical Practice Initiative (TCPI) Practice 
Transformation Networks (PTNs), who followed tailored, targeted and 
disciplined practices, and transitioned into advanced practices, for 
example, practices that met APM readiness milestones in their practice 
assessments and considers itself ready for migrating into an 
alternative based payment arrangement. Presently, there are a total of 
60,311 clinicians that have transitioned to APMs. Within TCPI, these 
APMs, in alignment with the CMS Healthcare Payment Learning and Action 
Network APM Framework, are Category 3 (APMs Built on Fee For-Service 
Architecture) and Category 4 (Population-Based Payment) payment 
arrangements.\110\ We understand that there are certain factors that 
enable clinicians to make the transition into APMs, including the 
readiness to take on additional risk, the ability to use timely 
feedback to make practice changes, willingness to engage in peer-to-
peer learning and community of practices, accessing technical 
assistance, and an ability to invest in infrastructure to enable care 
improvement and efficiencies. Developing MVPs in alignment with APM 
measures may assist small practices by providing experience with some 
APM requirements, and enhanced CMS feedback data on quality and cost 
performance can help clinicians make practice improvements and increase 
readiness to participate in Advanced APMs.
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    \110\ http://hcp-lan.org/workproducts/apm-framework-onepager.pdf.
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(A) Request for Feedback on Small and Rural Practices Participation in 
MVPs
    We are requesting public comments on policies to support small 
practices.
     How should we structure the MVPs to provide flexibility 
for small and rural practices and reduce participation burden? What MVP 
related policies could best assist small and/or rural groups when 
submitting measures and activities? Should we have alternate measures 
and activities submission requirements for small and/or rural 
practices? For example, should small and/or rural practices be allowed 
to report fewer measures and activities within an MVP?
     How can we mitigate challenges small and/or rural 
practices have in reporting? What types of technical assistance would 
be most helpful to help small and/or rural practices to have successful 
participation in MVPs?
     How can we reduce barriers to small and/or rural groups to 
transitioning into APMs, such as lack of information on performance on 
quality and cost measures and limited resources? What approaches could 
help small practices transition to MVPs?
(ii) Multispecialty Practices Participation in MVPs
    At Sec.  414.1305, a group is defined as a single TIN with two or 
more eligible clinicians (including at least one MIPS eligible 
clinician), as identified by their individual NPI, who have reassigned 
their billing rights to the TIN. Section 1848(q)(1)(D)(ii) of the Act 
requires that the MIPS process, for assessing group practices, must to 
the extent practicable reflect the range of items and services 
furnished by the MIPS eligible clinicians in the group practice 
involved. Multispecialty groups, especially those groups with a large 
number of clinicians, often provide an array of services that may not 
be captured in a single set of measures or in a single MVP. We have 
also heard similar concerns from stakeholders. In the CY 2019 PFS 
proposed rule (83 FR 35891), we acknowledged one of the overarching 
themes we have heard from stakeholders is that we make an option 
available to groups that would allow a portion of a group to report as 
a separate sub-group on measures and activities that are more 
applicable to the sub-group and be assessed and scored accordingly 
based on the performance of the sub-group. We solicited comment on 
specific options and questions for implementation of sub-group level 
reporting in future years in response to some stakeholders who 
requested the ability to report quality data for a portion of a TIN so 
that they can report measures and activities more relevant to their 
practice. However, as we noted in the CY 2019 PFS final rule (83 FR 
59742), because there are numerous operational challenges with 
implementing such a sub-group option, we did not propose any such 
changes to our established reporting policies regarding the use of a 
sub-group identifier. In the CY 2018 Quality Payment Program final rule 
(82 FR 53593), we stated that in future rulemaking we intend to explore 
the feasibility of establishing group-related policies that would 
permit participation in MIPS at a sub-group level and create such 
functionality through a new identifier.
    As we consider this transition to MVPs, we are seeking public 
comment on whether we can use the MVP approach as an alternative to 
sub-group reporting to more comprehensively capture the range of the 
items and services furnished by the group practice. This approach could 
address

[[Page 40741]]

stakeholder concerns about reporting on meaningful measures which are 
related to their practice without adding undue operational and data 
collection burden associated with creating and maintaining identifiers 
for sub-groups. Under this approach, multispecialty groups would report 
on multiple assigned or selected MVPs, where assignment or selection of 
MVPs would be proposed in future rulemaking, at the group level. 
Depending on how the MVPs are then combined and scored at the group 
level, this may eliminate the need for groups to create sub-TIN 
identifiers and apply eligibility criteria at the sub-TIN level.
    We are interested in developing criteria to identify which MVPs are 
applicable to multispecialty groups and whether or not we should 
require the reporting of multiple MVPs. Such an approach would provide 
patients with better information about care and services provided by 
multispecialty groups. If we require reporting on more than one MVP, we 
may consider putting a cap on the number of MVPs, measures, and 
activities to ensure there is no undue burden for multispecialty 
practices. We are interested in how to improve both large and small 
multispecialty group reporting of MIPS performance measures and 
activities.
(A) Request for Feedback on Multispecialty Practices Participation in 
MVPs
    We are requesting public comments on MVP policies for 
multispecialty practices.
     We are considering a requirement in future years that 
multiple specialty types within a group report relevant MVPs to provide 
more comprehensive information for patients. We are seeking comment on 
whether we can use the MVP approach as an alternative to sub-group 
reporting to more comprehensively capture the range of the items and 
services furnished by the group practice. For example, would it better 
for multispecialty groups to report and be scored on multiple MVPs to 
offer patients a more comprehensive picture of group practice 
performance or for multispecialty groups to create sub-groups which 
would break the overall group into smaller units which would 
independently report MVPs? How should we balance the need for 
information for patients on clinicians within the multispecialty 
practice with the clinician burden of reporting?
     What criteria should be used to identify which MVPs are 
applicable to multispecialty groups? For example, should it be based on 
the number or percentage of clinicians from the same specialty in the 
group? Should a group be able to identify which clinicians will report 
which MVP?
     Should there be a limit on the number of MVPs that could 
be reported by a multispecialty group?
     What mechanisms should be used to assess a group's 
specialty composition to determine which MVPs are applicable? For 
example, would groups need to submit identifying information to assure 
that measure MVPs aligned with the number or percent of clinicians of 
different specialties within a group? Is there information (such as 
specialty as identified in PECOS or the specialty reported on claims) 
we could leverage to ensure the appropriateness of MVPs for groups?
     In section III.E.1.c. of this proposed rule, we seek 
public comment on whether to align Shared Savings Program quality 
reporting requirements and quality scoring methodology with MIPS. As 
MIPS transitions to MVPs and addresses multispecialty practices, What 
MVP policies should be applied to MIPS APM participants?
(c) Incorporating QCDR Measures Into MVPs
    As part of our path to value focus, we want participation in MIPS 
to become more meaningful to patients and clinicians. QCDR measures are 
not included in our proposals for annual rulemaking and are separate 
from MIPS measures, which are finalized through the rulemaking process. 
We refer readers to section III.K.3.g.(2)(c) of this rule for 
discussion of proposals to strengthen QCDR measures.
    Both QCDR and MIPS measures are currently available for clinicians 
to choose from to fulfill the requirements under the quality 
performance category. We have been encouraged by clinician adoption of 
QCDRs and their measures in the time since the Quality Payment Program 
became operational. Clinicians are interested and dedicated to quality 
improvement and have worked with QCDRs to foster an innovative and 
flexible approach to quality measurement and improvement. We continue 
to believe that participation in these QCDR quality improvement 
programs is a strong sign of a commitment to quality and improvement.
    While this environment has encouraged a flexible approach to 
quality improvement, we believe it has also contributed to confusion 
and lack of consistency in measurement as our list of MIPS measures is 
greatly outpaced by the number of QCDR measures.
    As noted in section III.K.3.a.(3)(a) of this rule, we are 
considering a major change in the submission requirements for MIPS 
eligible clinicians beginning with the 2021 MIPS performance period. We 
believe that a smaller and more focused set of quality measures 
assembled into an MVP, integrated with cost measures and improvement 
activities, will better serve the program by reducing the complexity of 
identifying how to participate in the program for clinicians, improving 
our ability to compare clinicians, and improving beneficiaries' ability 
to identify high quality practices. A proliferation of measures that 
are different for every modest variation in practice is contrary to 
such a goal. Therefore, we need to consider the role of QCDR measures 
in such an environment.
(i) Request for Feedback on Incorporating QCDR Measures Into MVPs
    We are requesting public comments on policies for how QCDR measures 
would be used in MVPs:
     Should QCDR measures be integrated into MVPs along with 
MIPS measures, or should they be limited to specific MVPs consisting of 
only QCDR measures? How do we continue to encourage clinicians to use 
QCDRs under MVPs?
(d) Scoring MVP Performance
    As we are proposing to apply the MVP framework to future proposals 
beginning with the 2021 MIPS performance period/2023 MIPS payment year, 
we may propose scoring changes in future rulemaking. We anticipate that 
our basic approach to scoring measures and activities would remain 
stable with MVPs. In particular, we believe that both quality and cost 
performance category measures within MVPs would be scored using a scale 
of 0 to 10 and performance assessed by comparing to a benchmark, using 
the current approach to calculate benchmarks. We refer readers to 
sections III.K.3.c.(1)(b) and III.K.3.c.(2)(a) of this proposed rule 
for further discussion on how the quality and cost performance 
categories respectively contribute to the final score. For quality 
measures, we anticipate, when possible, that MVPs would use a single 
benchmark for each measure and that all clinicians and groups in the 
MVP would be compared against the same standard. In addition, we would 
no longer need special scoring policies and bonuses to incent selection 
of certain measures because clinicians would be required to report

[[Page 40742]]

all measures and activities in the MVP. Finally, we could align 
improvement scoring for quality and cost performance measures, because 
clinicians would use a stable set of measures, allowing for comparison 
year-to-year at the measure level. We believe the standardized sets of 
measures in MVPs would enable us to smoothly integrate new measures and 
collect data to develop robust benchmarks before scoring these measures 
on performance. We believe that scoring under the MVPs will potentially 
reduce barriers to clinicians' movement into APMs, which generally 
score their respective participants using the same quality measures and 
strongly align quality and cost measures.
    We believe that small practices will continue to face challenges 
with meeting case minimums that allow reliable scoring of quality 
measures. Our scoring policies will need to take into account that not 
all measures reported by small practices can be scored based on the 
case mix available for reporting.
    We anticipate that the underlying scoring framework for scoring 
improvement activities referenced in III.K.3.d.(1)(d) of this proposed 
rule would not change for clinicians; however, there could be the 
potential to better link cost and quality measures and the associated 
improvement activities. We do not anticipate that the underlying 
framework for scoring Promoting Interoperability measures referenced in 
III.K.3.d.(1)(e) of this proposed rule would change because of the 
introduction of the MVP framework. Promoting Interoperability is a 
foundational component of MVPs. Scoring policies may be developed as 
more details of the implementation of MVPs are developed.
    We would also consider proposing scoring policies to evaluate MVPs 
holistically, making sure that scoring across MVPs is equitable and 
that clinicians are not unfairly advantaged by reporting a specific 
MVP. We seek feedback on scoring policies that will help us create 
level comparability across MVPs.
    Additionally, if we propose in the future to allow or require 
multispecialty groups to submit more than a single MVP of measures and 
activities, we would need to develop scoring policies to fairly score 
such groups.
(i) Request for Feedback on Scoring MVP Performance
    We are requesting comments on the following:
     What scoring policies can be simplified or eliminated with 
the introduction of MVPs? For example, we may consider eliminating 
scoring available for 2021 MIPS performance period providing a 3-point 
floor for each submitted measure that can be reliably scored (83 FR 
59842). Additionally, we may consider eliminating the scoring bonuses 
available for the 2021 MIPS performance period for submitting high-
priority measures and use of CEHRT to support quality performance 
category submissions (83 FR 59850 to 59852). Are there other scoring 
policies that could be simplified or eliminated?
     We seek feedback on scoring policies that will help us 
create level comparability across MVPs. Are there approaches we should 
take to create equity across MVPs and across clinician types, for 
example, that regardless of the number of measures and activity, no 
single MVP would ``outperform'' others? For example, should there be an 
MVP adjustment added to the performance category scores?
     How should we score multispecialty groups reporting 
multiple MVPs? Should scores be consolidated for a single group score 
or scored separately (and with separate MIPS payment adjustments) for 
specialists within the group? Alternatively, should we have an 
aggregate score for the multispecialty group?
(4) MVP Population Health Quality Measure Set
    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 MIPS quality performance 
category. Currently, the MIPS program has one administrative claims-
based quality measure, the all-cause readmission measure, which is 
calculated and scored for groups with 16 or more clinicians that meet a 
200-patient case minimum (81 FR 77300). In the CY 2019 PFS proposed 
rule (83 FR 59719), we discussed our intent to use the Meaningful 
Measures Initiative within the Quality Payment Program to help address 
clinician reporting burden and improve patient outcomes through MIPS 
performance measurement. The Meaningful Measures Initiative represents 
an approach to quality measures that fosters operational efficiencies, 
reduces costs associated with collection and reporting burden, and 
produces quality measurement focused on meaningful outcomes. As we 
apply the Meaningful Measures framework within MIPS to reduce reporting 
burden and strengthen the use of measures that matter to patients and 
clinicians, we are considering how to implement a population health 
administrative claims-based quality measure set.
    Global or population quality measures calculated from 
administrative claims-based quality data can be used as a foundational 
measure set to help improve patient outcomes, reduce data reporting 
burden and costs, better align clinician quality improvement efforts, 
and increase alignment with APMs and other payer performance 
measurement. The April 2019 Health Care Payment Learning & Action 
Network's Roadmap for Driving High Performance in Alternative Payment 
Models (https://hcp-lan.org/workproducts/roadmap-final.pdf), intended 
as a tool to begin identifying promising practices for implementing 
successful APMs, points out that:
     Payers use HEDIS[supreg] quality measures along with 
administrative claims-based quality measures, such as preventable 
admissions and readmissions, in designing ACOs and primary care model 
APMs
     Providers are more likely to participate in APMs if the 
required measures align with measures they already track (see Roadmap 
page 19), and
     There is room for improvement in the area of quality 
measurement to meaningfully assess health and quality-of-life outcomes 
(see Roadmap page 60).
    We believe an administrative claims-based quality measure set 
consisting of a small number of quality measures focused on outcomes 
and intermediate outcomes can move MIPS towards population health 
measurement.
    We have heard from some stakeholders that we should drive quality 
measurement towards a set of population-based outcome measures. We 
believe increasing the number of population health measures that 
utilize administrative claims data in the MIPS program while reducing 
the number of required condition and specialty specific measures would 
reduce the burden associated with quality reporting. However, we 
recognize that the use of an administrative claims-based quality 
measure set would entail certain tradeoffs. These measures historically 
have been applicable to primary care clinicians, with less relevance 
for some specialists. They have also been limited to Medicare fee for 
service patients, excluding other payer patients, and therefore, have 
not provided a picture of a clinician's entire practice and patient 
base. In addition, administrative claims-based quality measures require 
a large sample to produce reliable results, which presents challenges 
in a clinician program that allows for participation by individuals

[[Page 40743]]

and groups with relatively few patients in a specific measure 
denominator. However, given the opportunity to reduce burden (because 
clinicians do not need to report the administrative claims-based 
quality measures themselves), apply measures across different clinician 
types, focus on important public health priorities, and reduce barriers 
to APM participation, we want to find ways to effectively use 
administrative claims-based population health quality measures in MIPS.
    We are working on multiple fronts to find the best and most 
appropriate measures for the MIPS program. For example, we are working 
with measure stewards on technical specifications to ensure the 
measures are reliable and broadly applicable to MIPS eligible 
clinicians. We intend to have the measures reviewed by a consensus-
based entity, for example, the National Quality Forum (NQF) Measure 
Applications Partnership (MAP). We have looked at the use of 
administrative claims-based quality measures in the Shared Savings 
Program and the Comprehensive Primary Care Plus (CPC+) model to 
identify examples of measures that could be included as MIPS measures. 
As one example, in addition to an all-cause readmission measure 
(similar to the one currently used in MIPS), the Shared Savings Program 
has a measure (ACO--38), the All-Cause Unplanned Admissions for 
Patients with Multiple Chronic Conditions, that we are in the process 
of adapting and testing for the MIPS program. In section 
III.K.3.c.(1)(d)(ii) of this proposed rule, we are proposing to add 
All-Cause Unplanned Admissions for Patients with Multiple Chronic 
Conditions measure to MIPS for the 2021 MIPS performance period. The 
Shared Savings Program also has a risk adjusted measure, (ACO--43), the 
Ambulatory Sensitive Condition Acute Composite (AHRQ Prevention Quality 
Indicator (PQI) #91), which assesses the risk adjusted rate of hospital 
discharges for acute PQI conditions with a principal diagnosis of 
dehydration, bacterial pneumonia, or urinary tract infection among ACO 
assigned Medicare fee-for-service (FFS) beneficiaries 18 years and 
older. In section III.E.1.b., we recognize that the measure steward, 
AHRQ, has made ``substantive'' change to the measure and propose to 
redesignate ACO--43 to a pay-for-reporting measure for the 2020 and 
2021 performance years, while seeking comment on other approaches 
including developing historic benchmarks.
    As we work to improve and develop a foundational population health 
quality measure set, we are reviewing measures that we could propose in 
future rulemaking. We are reviewing whether it would be appropriate to 
add a measure similar to the ACO--43 Ambulatory Sensitive Condition 
Acute Composite (AHRQ Prevention Quality Indicator (PQI) #91) to MIPS. 
We are also reviewing two risk adjusted utilization measures that are 
included in the CPC+ Model Quality and Utilization Measure Set for the 
2019 Performance Period for potential inclusion in the MIPS program: 
The HEDIS[supreg] Acute Hospital Utilization (AHU) (this is the 
inpatient hospital utilization measure in CPC+ Model that was updated 
by NCQA in 2018); and the HEDIS[supreg] Emergency Department 
Utilization (EDU).\111\ These measures assess the risk-adjusted ratio 
of observed-to-expected acute inpatient and observation stay discharges 
during the measurement year reported by surgery, medicine and total 
among members 18 years of age and older. These measures are currently 
specified for health plans, but we intend to work with the measure 
steward, NCQA, for appropriateness for the MIPS program.
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    \111\ The Acute Hospital Utilization and Emergency Department 
Utilization measures and specifications were developed by the 
National Committee for Quality Assurance (``NCQA'') under the 
Performance Measurements contract (HHSM-500-2006-00060C) with CMS 
and are included in HEDIS[supreg] with permission of CMS. HEDIS is a 
registered trademark of NCQA.
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    Clinicians raised concerns in response to previously proposed 
administrative claims-based quality measures. These concerns included 
measure reliability and applicability case size, attribution, risk 
adjustment, application at the clinician or group level, and degree of 
actionable feedback for improvements (81 FR 77130 through 77136). We 
finalized use of the all-cause readmission measure but limited its 
applicability to groups of 16 or more clinicians with a minimum of 200 
cases to mitigate some of the concerns. We did not finalize the 
proposed AHRQ Acute Conditions Composite and Chronic Conditions 
Composite measures (81 FR 28192 and 28447). Our intention is to address 
the technical challenges as we test the Ambulatory Sensitive Condition 
Acute Composite measure and present to a consensus-based entity (for 
example NQF) to ensure the measure is reliable. We seek feedback on 
additional steps to ensure the measure addresses the concerns noted 
above.
    Clinician feedback also called for the examination of potential 
sociodemographic status risk adjustment for administrative claims-based 
quality measures. Please refer to section III.K.3.d.(2)(a) of this 
proposed rule for information on our approach to accounting for risk 
factors in MIPS, including the complex patient bonus which was 
finalized for the 2020 MIPS payment year (82 FR 53771 through 53776), 
as well as plans to take into consideration a second report by ASPE 
expected in October 2019 on accounting for risk factors in quality, 
resource use and other measures in Medicare. We are proposing to 
continue the complex patient bonus in MIPS and would continue to assess 
the need for and effectiveness of such a scoring adjustment to ensure 
fair performance comparisons between clinicians.
    In summary, we plan to increase the use of global and population 
based administrative claims-based quality measures as we develop a 
population health quality measure set and are outlining our proposal to 
add at least one additional administrative claims-based quality measure 
starting in the 2021 MIPS performance period in section 
III.K.3.c.(1)(d)(ii) of this proposed rule.
(a) Request for Feedback on Population Health Quality Measure Set
    We are requesting public comments on the use of a population health 
quality measure set.
     In addition to the quality measures described above, are 
there specific administrative claims-based quality measures we should 
consider, including, but not limited to, any that assess specialty care 
that are specified and/or tested at the clinician/group practice level?
     We would like to balance the desire for quality measures 
specific to a clinical practice with a reduction in administrative 
burden for submission. Should administrative claims-based quality 
measures be used to replace some of the reporting requirements in the 
quality performance category? For example, if two additional 
administrative claims-based quality measures were added to MVPs should 
we reduce the required quality measures by 1 measure for each of the 
MVPs?
     In addition to testing, what other information or methods 
should be used to mitigate concerns about administrative claims-based 
quality measure reliability, applicability, and degree of actionable 
feedback for clinician performance improvement? What concerns should be 
prioritized?
(5) Clinician Data Feedback
    Clinicians have expressed an interest in leveraging data to track 
performance and inform care improvements. We see the critical need for 
data feedback and

[[Page 40744]]

intend to provide enhanced clinician driven data feedback and analysis 
information under the future MVP approach. We understand that 
performance data feedback on administrative claims-based quality and 
cost measures would potentially assist clinicians in understanding 
their performance and preparing to take on risk as required in Advanced 
APMs. We are interested in whether clinicians would benefit from 
receiving feedback on administrative data that is available to us, such 
as information on the services that their patients receive or 
information on the clinician's volume of services in comparison to 
their peers to determine if the clinician is an outlier. Clinicians may 
also benefit from timely actionable clinical data feedback from 
registries, and we have proposed to enhance data feedback requirements 
for QCDRs and registries in sections III.K.3.g.(2)(a)(iii) and 
III.K.3.g.(3)(a)(ii) respectively of this proposed rule. We also 
understand the need for timely data feedback and are seeking comments 
on clinician data feedback content and timing needs.
(a) Request for Feedback on Clinician Data Feedback
    We are requesting public comments on the Clinician Feedback.
     We would like to provide meaningful clinician feedback on 
administrative claims-based quality and cost measures. As clinicians 
and groups move towards joining APMs, is there particular data from 
quality and cost measures that would be helpful?
     Would it be useful to clinicians to have feedback based on 
an analysis of administrative claims data that includes outlier 
analysis or other types of actionable data feedback? What type of 
information about practice variation, such as the number of procedures 
performed compared to other clinicians within the same specialty or 
clinicians treating the same type of patients, would be most useful? 
What level of granularity (for example, individual clinician or group 
performance) would be appropriate?
(6) Enhanced Information for Patients
(a) Patient Reported Measures
    We intend to incorporate more patient reported outcomes and care 
experience measures into MVPs. We want to learn how patient reported 
information is being effectively used in the field to improve care to 
assist patients with clinician selection and to incentivize high value 
care. We believe that feedback from the patient perspective can inform 
care improvement efforts as clinicians assess patient reported feedback 
to identify ways to elevate quality of care.
    MIPS currently includes patient reported measures, including 
optimal asthma control and measures for functional status assessment 
following hip and knee replacements, and other patient reported 
measures are being added. We recognize current limitations with the 
availability of patient reported measures. Patient reported measures 
are often specific to a clinical condition or procedure, and we do not 
have measures that are available or applicable to the majority of 
clinicians in the MIPS program. The Consumer Assessments of Healthcare 
Providers and Systems (CAHPS) for MIPS survey, a patient experience 
survey, is offered to group practices as an optional quality measure 
and is a high-weighted improvement activity. Section 
III.K.3.c.(1)(c)(i) of this proposed rule discusses initiatives to 
expand the information collected in the CAHPS for MIPS survey.
    We have assessed additional approaches to gathering information on 
experience and satisfaction from work both within and outside of the 
health care environment. The Robert Wood Johnson Foundation working 
with Patients Like Me, a health information sharing website for 
patients, has provided guidance on what should be measured through a 
publication entitled ``Development of a Conceptual Framework of ``Good 
Healthcare'' from The Patient's Perspective'' \112\ We understand that 
some organizations such as Patients Like Me are working with patients 
throughout the measure development process to enhance their ability to 
capture information that is useful to patients. Outside of healthcare, 
many industries are approaching the measurement of satisfaction as a 
business priority. Service industries have pioneered single question 
``surveys'' asked at each encounter to learn if they are meeting 
customer expectations and satisfying their customers, that could 
include a question about the service provided or whether the assistance 
provided addressed their problems. We are interested in how information 
from single question or brief surveys to measure the quality of patient 
experience and satisfaction with health care delivery could be better 
incorporated into MVPs.
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    \112\ https://patientslikeme_posters.s3.amazonaws.com/2017_Development%20of%20a%20Conceptual%20Framework%20of%20%E2%80%9CGood%20Healthcare%E2%80%9D%20from%20The%20Patient%E2%80%99s%20Perspective.pdf.
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(i) Request for Feedback on Patient Reported Measures
    We are requesting public comments on enhancing the patient voice in 
MVPs. Specifically, we seek comment on:
     What patient experience/satisfaction measurement tools or 
approaches to capturing information would be appropriate for inclusion 
in MVPs? How could current commercial approaches for measuring the 
customer experience outside of the health care sector (for example, 
single measures of satisfaction or experience) be developed and 
incorporated into MVPs to capture patient experience and satisfaction 
information?
     What approaches should we take to get reliable performance 
information for patients using patient reported data, in particular at 
the individual clinician level? Given the current TIN reporting 
structure, are there recommendations for ensuring clinician level 
specific information in MVPs? Should clinicians be incentivized to 
report patient experience measures at the individual clinician level to 
facilitate patients making informed decisions when selecting a 
clinician, and, if so, how?
     How should patient-reported measures be included in MVPs? 
How can the patient voice be better incorporated into public reporting 
under the MVP framework, in particular at the individual clinician 
level?
(b) Publicly Reporting MVP Performance Information
    We believe implementing a path to value will transform our 
healthcare system by empowering well-informed patients to make 
decisions about their healthcare and helping clinicians achieve better 
outcomes. As we consider publicly reporting MVP performance 
information, we want to ensure that patients have information that is 
important and useful, which we believe includes information on 
clinician performance on cost, quality, patient experience, and 
satisfaction with care.
    Currently, all MIPS quality measure information is displayed on 
Physician Compare clinician and group profile pages at the individual 
quality measure level. User testing with patients and caregivers has 
shown that performance on certain individual quality measures is 
particularly useful for selecting clinicians for their healthcare 
needs. However, testing has also shown that patients and caregivers are 
interested in a single overall rating called a ``value indicator'' for 
a clinician or group when making comparisons across groups or 
clinicians. To date, a ``value indicator'' to compare the performance 
of a

[[Page 40745]]

clinician or group has not been possible due to the current approach in 
which clinicians can select from an inventory of measures across a 
variety of collection types and activities. Since clinicians are not 
all reporting on the same quality measures, we have been unable to 
develop direct overall comparisons under our public reporting 
standards. However, we believe that MVPs, in which clinicians of a 
particular specialty are held accountable for a uniform set of quality 
and cost measures, would better allow for such comparisons.
    Related to the MVP approach, we seek comment on the types of 
clinician performance information we should include in the display for 
a single ``value indicator''. As we think about value and information 
that is important to patients, we want to incorporate measurement of 
cost, quality, and patient experience and satisfaction in a way that is 
meaningful to patients. We have heard that Medicare patients and 
caregivers greatly desire information such as a value indicator, to 
help make decisions about their healthcare. We seek comment on whether 
displaying an overall indicator for the MVP for a clinician or group 
would be useful for patients' making healthcare decisions. We refer 
readers to the Public Reporting on Physician Compare at section 
III.K.3.h.(4) of this proposed rule for additional considerations for 
publicly reporting these types of information such as a value 
indicator, patient narratives, and patient reported outcome measures.
(i) Request for Feedback on Publicly Reporting MVP Performance 
Information
    We seek feedback on approaches to publicly reporting MVP 
performance information:
     What considerations should be taken into account if we 
publicly report a value indicator, as well as corresponding measures 
and activities included in the MVPs?
     If we develop a value indicator, what data elements should 
be included? For example, should all reported measures and activities 
be aggregated into the value indicator?
     How would a value indicator, based on information from 
MVPs, be useful for patients making health care decisions?
     What methods of displaying MVP performance information 
should we consider other than our current approach to using star 
ratings for quality measure information on clinician profile pages?
     What factors should be considered to ensure publicly 
reported MVP information is comparable across relevant clinicians and 
groups?
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).
    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 are proposing 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 are proposing to revise 
Sec. Sec.  414.1310(e)(2)(ii) and 414.1315(d)(2. Specifically, we are 
proposing 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 are proposing 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.
    We request comments on these proposals.
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, we seek to:
     Propose 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 proposed rule;
     Seek comment on adding narratives to the CAHPS for MIPS 
survey and on whether the survey should collect data at the individual 
eligible clinician level;
     Propose to increase the data completeness criteria to 70 
percent for the 2022 MIPS payment year as described in Sec.  
414.1340(b)(3);
     Propose 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;
     Seek comment as to whether we should consider realigning 
the MIPS quality measure update cycle with that of the eCQM annual 
update process;
     Propose 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.
     Seek 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;
     Propose to remove MIPS quality measures that do not meet 
case minimum and reporting volumes required for benchmarking after 
being in

[[Page 40746]]

the program for 2 consecutive CY performance periods;
     Propose 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
     Request 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 
proposed rule, we propose 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 are proposing 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 
are proposing 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 are 
proposing 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 seek comment on our proposals to incrementally reduce the 
weight of the quality performance category as we gradually increase the 
weight of the cost performance category. Specifically, the quality 
performance category will comprise 40 percent of a MIPS eligible 
clinician's final score for the 2022 MIPS payment year, 35 percent for 
the 2023 MIPS payment year, and 30 percent for the 2024 MIPS payment 
year and future years.
(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 are not proposing 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 are not making any proposals in regard to the CAHPS for 
MIPS survey this year, we are interested in feedback to add to the 
survey, in future years, specific to a solicitation of comments we 
previously requested to expand the survey to add narratives in the CY 
2018 Quality Payment Program final rule (82 FR 53630). Currently, the 
CAHPS for MIPS survey is available for only groups to report under the 
MIPS. The patient experience survey data that is available on Physician 
Compare is highly valued by patients and their caregivers as they 
evaluate their health care options. However, in user testing with 
patients and caregivers over the last several years, the users 
regularly request more information from patients like them in their own 
words, and to publicly report narrative reviews of individual 
clinicians and groups. User testing further indicates that patients 
want patient-generated information when selecting a clinician. Since 
the CAHPS for MIPS survey is only at the group level, we are also 
interested in feedback related to collection of data on patient 
experiences from individual clinicians, which would be new data for CMS 
and consequently new data to publicly report to patients and 
caregivers. Including data at the individual level is of interest to 
CMS as we have heard this is valuable to patients and caregivers in 
making decisions related to their health care. See section III.K.3.h. 
of this proposed rule where we are seeking comment on public reporting 
considerations on the Physician Compare website for adding patient 
narratives in future rulemaking.
    Through efforts such as the Patients Over Paperwork initiative and 
MyHealthEData initiative (https://www.cms.gov/newsroom/press-releases/trump-administration-announces-myhealthedata-initiative-put-patients-center-us-healthcare-system), we are dedicated to putting patients 
first and empowering patients to have the information they need to be 
engaged and active decision-makers in their care. We are also mindful 
that a patient is a health care consumer for whom aspects of the health 
care delivery experience, such as wait times or how a clinician 
interacts with patients, may factor into a patient's decision to select 
a clinician. We believe that measuring patient experience can help 
inform patient decision-making and considered previous government 
efforts to measure experience, such as the President's Management 
Agenda--OMB Circular No. A-11 section 280--Managing Customer Experience 
and Improving Service Delivery (https://www.whitehouse.gov/wp-content/uploads/2018/06/s280.pdf). Specifically, the OMB Circular No. A-11 
section 280.7 references how should customer experience be measured in 
the federal government. At a minimum, the federal government customer 
experience should be measured in seven domains: \113\
---------------------------------------------------------------------------

    \113\ President's Management Agenda (2018)--OMB Circular No. A-
11 section 280--Managing Customer Experience and Improving Service 
Delivery (https://www.whitehouse.gov/wp-content/uploads/2018/06/s280.pdf).
---------------------------------------------------------------------------

     Overall: (1) Satisfaction; (2) Confidence/Trust.
     Service: (3) Quality.
     Process: (4) Ease/Simplicity; (5) Efficiency/Speed; (6) 
Equity/Transparency.
     People: (7) Employee Helpfulness.
    While the CAHPS for MIPS survey is an assessment of clinicians 
within a group, we are looking at ways to enhance that feedback to 
ensure the customer (patient) experience is being measured in such a 
way that data from the CAHPS for MIPS survey can be used in healthcare 
decision making. We are seeking comments on the above referenced seven 
domains and if additional elements, questions, or context should be 
added to the current CAHPS for MIPS survey (available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/459/2019%20CAHPS%20for%20MIPS%20Survey_Sample%20Copy.pdf), or if these 
domains should be used to measure individual clinicians if a new 
instrument was developed to gather that data and share the feedback 
with

[[Page 40747]]

patients to make decisions about their healthcare.
    For considerations as we prepare for future policies and 
rulemaking, we are also seeking comment on:
     Measures that would expand the information collected in 
the CAHPS for MIPS survey, including a question regarding the patients' 
overall experience and satisfaction rating with a recent health care 
encounter. Patients value the ``voice'' of other patients and want 
information that helps to choose their clinicians, and whether they 
would recommend the clinician, group, office or facility to their 
family and friends, as detailed in section III.K.3.a. of this rule. 
Several versions of the CAHPS survey, including the CAHPS Clinician & 
Group Survey 3.0, do have a question regarding the patients' rating of 
a clinician. We refer readers to the Agency for Healthcare Research and 
Quality's website on CAHPS Clinician and Group Survey for additional 
information at https://www.ahrq.gov/cahps/surveys-guidance/cg/index.html. We currently do not collect and display information from a 
single question about the patients' satisfaction or experience. Patient 
experience measures provide a more objective assessment of health care 
quality, since satisfaction may change frequently based on subjective 
expectations. The CAHPS for MIPS survey has traditionally focused on 
measures of patient experience.
     Method for collecting this type of information from 
patients and caregivers and if a web, paper, phone, or email based 
survey would be preferred? Currently the CAHPS for MIPS survey is only 
administered through paper and phone based methods.
     Should a tool be developed to collect information about 
individual clinicians? Or should this information be kept at the group 
level only? Currently patient experience data is only available through 
the CAHPS for MIPS survey, and this survey does not collect information 
on individual clinicians.
     Should this data be collected at a pilot level first, 
provided that such an approach is consistent with our statutory 
authority, so that we learn from this data before fully implementing 
broader across the program? If so, we seek comments regarding the 
framework and implementation criteria of a pilot.
    In addition, we are seeking comment on the value of using narrative 
questions, inviting patients to respond to a series of questions in 
free text responding to open ended questions and describing their 
experience with care. Patients can write a response in their own words. 
We would build from work done by AHRQ to develop a Narrative 
Elicitation Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html), which is a set of open-ended questions 
that prompt patients to tell a clear and comprehensive story about 
their experience with a clinician. Narratives from patients about their 
health care experiences can provide a valuable complement to 
standardized survey scores, both to help clinicians understand what 
they can do to improve their care and to engage and inform patients 
about differences among clinicians. Five questions underwent initial 
item development for the Clinician & Group CAHPS Survey, focusing on 
the patient's relationship with the clinician, patient expectations, 
how the expectations were met, what went well, and what could have been 
better. We believe patients will be interested in this information to 
make informed decisions about their healthcare. In section 
III.K.3.c.(1), we seek comment on how the free text questions might be 
scored as part of the Quality Payment Program. We seek comment on the 
value of collecting and displaying information from narrative 
questions, and whether stakeholders have concerns with the potential 
burden involved with drafting narrative responses. We also are 
interested in understanding whether clinicians would find this 
information useful in improving the care they provide to beneficiaries
    As we continue learning about what patient experience data and 
format is most usable to patients, caregivers, and clinicians we plan 
to conduct additional item development and testing of implementation 
processes at CMS. Information gathered from these activities, along 
with comments received from this rule will be taken into consideration 
as we consider future policies for future rulemaking, using a human-
centered design approach where applicable.
(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 data completeness threshold was finalized at 60 percent.
    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 35, we believe that it is feasible for eligible 
clinicians and groups to achieve a higher data completeness threshold.

 Table 35--CY 2017 Data Completeness Rates for MIPS Individual Eligible
                 Clinicians, Groups, and Small Practices
------------------------------------------------------------------------
                                                           Average data
    Average data completeness rate--       Average data    completeness
      individual eligible clinician        completeness    rate-- small
                                           rate-- groups     practices
------------------------------------------------------------------------
76.14...................................           85.27           74.76
------------------------------------------------------------------------


[[Page 40748]]

    With the support of the data in Table 35, we propose 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. 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 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 are requesting 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 have received inquiries regarding perceived opportunities to 
selectively submit 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 propose to further amend Sec.  414.1340 to add a new 
subsection (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 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.
    We continue to strongly urge all MIPS eligible clinicians to report 
on quality measures where they have performed the quality actions with 
respect to all applicable patients.
    We would like to note that we are not proposing 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 36 describes the data 
completeness requirements by collection type.

 Table 36--Summary of Data Completeness Requirements and Performance Period by Collection Type for the 2020 MIPS
                                               Performance Period
----------------------------------------------------------------------------------------------------------------
           Collection type                Performance period                    Data completeness
----------------------------------------------------------------------------------------------------------------
Medicare Part B claims measures......  Jan 1-Dec 31...........  70 percent sample of individual MIPS eligible
                                                                 clinician's, or group's Medicare Part B
                                                                 patients for the performance period.
QCDR measures, MIPS CQMs, and eCQMs..  Jan 1-Dec 31...........  70 percent sample of individual MIPS eligible
                                                                 clinician's, or group's patients across all
                                                                 payers for the performance period.
CMS Web Interface measures...........  Jan 1-Dec 31...........  Sampling requirements for the group's Medicare
                                                                 Part B patients: populate data fields for the
                                                                 first 248 consecutively ranked and assigned
                                                                 Medicare beneficiaries in the order in which
                                                                 they appear in the group's sample for each
                                                                 module/measure. If the pool of eligible
                                                                 assigned beneficiaries is less than 248, then
                                                                 the group would report on 100 percent of
                                                                 assigned beneficiaries.
CAHPS for MIPS survey measure........  Jan 1-Dec 31...........  Sampling requirements for the group's Medicare
                                                                 Part B patients.
----------------------------------------------------------------------------------------------------------------

(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

[[Page 40749]]

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.
     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 strongly 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 are proposing 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. 
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. We seek comments on 
this proposal.
    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. The following specialty measure sets have been 
excluded from this proposed rule because we did not propose any changes 
to these specialty measure sets: Pathology, Electro-Physiology Cardiac 
Specialist, and Interventional Radiology. Therefore, for the finalized 
Pathology specialty measure set, we refer readers to the CY 2019 PFS 
final rule corrections notice (84 FR 566). In addition, we refer 
readers to the CY 2018 Quality Payment Program final rule for the 
finalized Electro-Physiology Cardiac Specialist specialty measure set 
(82 FR 53990) and the finalized Interventional Radiology specialty 
measure set (82 FR 54098 through 54099). Our proposals for 
modifications to existing specialty sets and new specialty sets can be 
found in Table Group B of Appendix 1 of this proposed rule. Specialty 
sets may include: New measures, previously finalized measures with 
modifications, previously finalized measures with no modifications, the 
removal of certain previously finalized quality measures, or the 
addition of existing MIPS quality measures. Please note that the 
proposed 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 are being 
proposed within this 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 proposed substantive 
changes can be found in Table Groups D and DD of Appendix 1 of this 
proposed rule. As discussed in Table DD of this proposed 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 are proposing in Table DD of this proposed rule to update the CMS 
Web Interface measure numerator guidance. To the extent that this 
proposed 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 modify the measure as proposed in Table DD of this 
proposed 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 QPP final rule, and unduly burdensome on clinicians. If 
this modification is finalized as proposed, we expect that we would be

[[Page 40750]]

able to benchmark and score the CMS Web Interface version of this 
measure for the 2019 MIPS performance period and 2021 MIPS payment 
adjustment.
    As discussed in section III.E.1.b of this proposed 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 proposed rule, we propose to add 1 new measure 
to the CMS Web Interface in MIPS. Furthermore, as discussed in Table 
Group C of Appendix 1 of this proposed rule, we are proposing to remove 
1 measure from the CMS Web Interface in MIPS. If finalized, groups 
reporting CMS Web Interface measures for MIPS would be responsible for 
reporting the finalized measure set, inclusive of any finalized measure 
removals and/or additions. We refer readers to the Appendix 1 of this 
proposed 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 seek stakeholder comment as to whether we 
should consider realigning the measure update cycle with that of the 
eCQM annual update process. We note if the update cycles were to align, 
quality measure specifications updates would be gathered earlier in the 
year, which may pose an issue when considerations need to be given, but 
not limited to: Updates to clinical guidelines and changes in NQF 
endorsement status.
    In addition, we refer readers to the CY 2019 PFS final rule (83 FR 
59759) for additional details on reporting requirements of eCQM 
measures. Furthermore, in section III.D. of this proposed rule, we 
propose 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 proposed 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, in Table Group AA of Appendix 1 of 
this proposed rule, we are proposing 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 are proposing 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.(4) of this 
proposed 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.
(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.
    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).
    As an example, four of the five quality measures within the 
pathology specialty set have been identified as extremely topped out in 
the 2019 benchmarking file. However, we believe that it is important to 
retain these pathology specific measures in the MIPS quality measure 
set to ensure that pathologists have a sufficient number of quality 
measures to report. 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

[[Page 40751]]

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 seek 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 seek comment on potential alternative solutions in 
addressing 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 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 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 refer 
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 are proposing 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 
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 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. We seek 
comments on this proposal. In addition, we refer readers to Table Group 
C of Appendix 1 of this proposed 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 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 seek 
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 request feedback on which quality measure's removal 
should be delayed for a year, and why.
    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 propose 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

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MIPS eligible clinicians. We seek comments on this proposal.
(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. The Potential Opioid Overuse measure captures 
the proportion of patients aged 18 years or older who receive opioid 
therapy for 90 days or more with no more than a 7-day gap between 
prescriptions with a daily dosage of 90 morphine milligram equivalents 
(MME) or higher. It is intended to report the extent of long-term, 
high-dose opioid prescribing with the goal of improving patient safety 
by reducing the potential for opioid-related harms and encouraging the 
use of alternative pain management. The measure was field tested in 
2017. The testing population included 3 test sites, consisting of 19 
practices representing 87 clinicians, for CY 2016. Initial results from 
measure testing indicated that this measure is important, feasible, 
reliable, valid, and usable. Stakeholders supported the measure 
concept's importance in addressing a quality improvement opportunity in 
a priority population.
    Through interviews primarily with EHR vendors, we have identified 
potential challenges for implementing the Potential Opioid Overuse 
measure. The human readable CQL-based specification is more than 200 
pages long in order to accommodate a library providing more information 
on opioid medications than is currently available to export for the 
Value Set Authority Center (VSAC). Vendors expressed concerns about the 
feasibility of accurately capturing some of the medication-specific 
data elements within the measure, such as medication start and end 
dates and times, because these are not consistently captured during 
typical workflows.
    We seek to mitigate the usability and feasibility issues for the 
measure by gathering information from a wider audience of technical 
implementers to strengthen the potential for measure adoption. We 
invite public comment on the Potential Opioid Overuse CQL-based 
specifications in this section. Specifically, we seek comment on the 
following questions:
     Would you select this measure to support your quality 
measure initiatives? Why?
     Would you implement this measure in its current state? 
Why?
     How can we improve the usability of this measure?
     This measure performs medication calculations, to 
calculate MME, which helps compare different opioids and opioid 
dosages. Are there any workflow, mapping, or other implementation 
factors to consider related to the required medication related data 
elements needed to perform the MME calculations in this measure? 
Specifically related to: Use of the opioid data library, which clearly 
lists the required medication information directly in the measure 
specification; Use of medication end dates, to calculate medication 
durations; Use of coded medication frequencies, such as ``3 times 
daily'' or ``every 6 hours,'' required to calculate daily medication 
dosages.
     Are there any other foreseeable challenges to implementing 
this 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 this year's rule, we are proposing 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
     Seek comments on the future inclusion of an additional 
episode-based measure.
    These proposals are discussed in more detail in the following 
sections of this proposed 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). 
Several commenters noted that the increased flexibility provided by the 
BBA of 2018 should be used to maintain the weight at 10 percent for 
MIPS payment year 2021 and in future years. A few commenters were 
concerned about increasing the weight of the cost performance category 
because of the challenges with the existing attribution and risk-
adjustment methodologies. Some commenters recommended that the cost 
performance category weight should be increased to 30 percent as soon 
as possible. We considered these comments when we developed our 
proposals for setting the weight of the cost performance category in 
this proposed rule.
    We are proposing 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 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 recognize 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 recognize that there may be 
greater understanding of the measures in the cost performance category 
as clinicians gain more experience with them.
    We are proposing 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. We plan to increase the weight of 
the cost performance category at standard increments of 5 percent each 
year until

[[Page 40753]]

MIPS payment year 2024. Therefore, we propose at Sec.  414.1350(d)(5) 
to weight the cost performance category at 25 percent for the 2023 MIPS 
payment year and propose 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. 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 
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 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 
invite comments on whether we should consider an alternative weight for 
the 2022 and/or 2023 MIPS payment years.
    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 proposed rule, we are proposing to add 10 
episode-based measures to the cost performance category beginning with 
the 2020 MIPS performance period. 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 would allow more clinicians to be measured in 
this performance category, with an increasing focus on costs associated 
with services provided by clinicians for specific episodes of care. In 
section III.K.3.c.(2)(b)(v) of this proposed rule, in efforts to ensure 
that our existing cost measures hold clinicians appropriately 
accountable, we propose modifications to both the total per capita cost 
and MSPB measures.
(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. For the CY 2020 
performance period and future performance periods, we propose to add 10 
newly developed episode-based measures to the cost performance category 
in section III.K.3.c.(2)(b)(iii) of the proposed rule and propose 
modifications to both the total per capita cost and MSPB measures in 
section III.K.3.c.(2)(b)(v) of this proposed rule. In section 
III.K.3.c.(2)(b)(viii) of this proposed rule, we summarize all new and 
existing measures that would be included in the cost performance 
category starting with the CY 2020 performance period. Some 
modifications to measures used in the cost performance category may 
incorporate changes that would not substantively change the measure. 
Examples of such non-substantive changes may include updated diagnosis 
or procedure codes or changes to exclusions to the patient population 
or definitions. While we address such changes on a case-by-case basis, 
we generally believe these types of maintenance changes are distinct 
from substantive changes to measures that result in what are considered 
new or different measures. However, as described in section 3 of the 
Blueprint for the CMS Measures Management System Version 14.1 (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 this proposed rule, we have 
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.
(ii) Attribution
    In this section of the proposed 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 trigger 
inpatient hospitalization under a TIN that renders at least 30 percent 
of the inpatient E/M claim lines in that

[[Page 40754]]

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 this proposed rule, 
we have reevaluated the total per capita cost and MSPB measures. In the 
process of evaluating these measures, the TEP identified areas for 
potential refinement within the attribution methodology, and the 
revised measures that we propose include substantial changes to the 
attribution methodology. As we explain in section III.K.3.c.(2)(b)(v), 
we believe these new attribution methodologies better establish the 
relationship between the clinician and the patients. In general, for 
the cost performance category, 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 performance category measures in the preamble and included 
those methodologies in the regulation text, we intend to take a 
different approach going forward and address attribution as part of the 
measure logic and specifications. For this proposed rule and in future 
rulemaking, we will include the attribution methodology for each cost 
performance category measure in the measure specifications, which are 
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 the 
final rule is published. 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 could 
be implemented without undertaking rulemaking, and align with the 
approach taken for measures in the quality performance category. 
Therefore, we propose 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. We also propose 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.
    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 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. For this proposed rule 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 propose 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. 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 are not proposing additional regulation 
text. We note that in section III.K.3.c.(2)(b)(vi)(B) of this proposed 
rule, we propose 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. 
Although this is not directly related to attribution, it does limit the 
assessment of certain measures for MIPS eligible clinicians who report 
as individuals.
(iii) Episode-Based Measures for the 2020 and Future Performance 
Periods
    In this section of the proposed 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 patient and provided during the episode's 
timeframe. Specifically, we define cost based on the allowed amounts on 
Medicare claims, which include both Medicare payments and beneficiary 
deductible and coinsurance amounts. 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). These processes included convening a TEP and clinical 
subcommittees to solicit expert and clinical input for measure 
development, conducting national field testing on the episode-based 
measures developed, and seeking input from clinicians and stakeholders 
through engagement activities.
    To gather input on the 10 episode-based measures that we are 
proposing, the measure development contractor convened 10 clinical 
subcommittees composed of more than 260 clinicians affiliated with 120 
specialty societies through an open call for nominations between 
February 6, 2018 and March 20, 2018. Applicants who submitted materials 
after the March 20, 2018 deadline were added to a standing pool of 
nominees and considered for membership in the measure-specific 
workgroups. The clinical subcommittees met during an in-person meeting 
in April 2018 to select episode group(s) for development and provide 
input on the composition of measure-specific workgroups. The smaller 
measure-specific workgroups were introduced as a refinement to the 
measure development process based on feedback from members of the first 
set of clinical subcommittees. The small group size was intended to 
facilitate more focused discussions. The workgroups--one for each 
measure--met through in-person meetings and webinars between June and 
December 2018 to provide detailed clinical input on each component of 
the episode-based measures. These components include episode triggers 
and windows (to limit the timing of services included in the episode), 
item and service assignment, exclusions,

[[Page 40755]]

attribution, and risk adjustment variables.
    In addition, the 10 episode-based measures we are proposing were 
developed with input from the Person and Family Committee, a body of 
patients and their family members and caregivers who provide input 
iteratively during the measure development process. Discussions 
regarding patient and caregiver perspectives on the types of episodes 
that should be prioritized informed the clinical subcommittees' 
considerations for episode selection. Throughout measure development, 
the workgroups engaged in bidirectional conversations with the Person 
and Family Committee to inform measure specifications. For example, 
patient perspectives on services perceived as aiding recovery or 
helping to avoid unnecessary costs and complications helped the 
workgroup provide recommendations for service assignment, and in turn, 
the workgroup provided questions to the Person and Family Committee, 
which helped guide their in-depth interviews. After considering each 
round of input, clinicians had multiple opportunities to solicit 
additional information and feedback from Person and Family Committee 
members. In total, the measure developer conducted 84 interviews with 
65-70 Person and Family Committee members via one-on-one interviews 
during development of the 10 episode-based measures.
    Finally, as with the measures finalized in the CY 2019 PFS final 
rule (83 FR 59767), the 10 episode-based measures we are proposing 
underwent a measure development process based on high level guidance 
provided to the measure development contractor by a standing TEP. This 
TEP provided oversight and cross-cutting guidance to the measure 
development contractor for development of episode-based measures 
through four meetings between August 2016 and August 2017.
    Further detail can 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 propose to add the 10 episode-based measures listed in 
Table 37 as cost measures for the 2020 performance period and future 
performance periods.
    The detailed specifications for these 10 episode-based measures 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. These specifications documents consist 
of (i) methodology for constructing each measure, and (ii) 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 
(i) methodology and (ii) 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. In addition, 
measure justification forms containing testing results for these 
measures are available at 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.

   Table 37--Episode-Based Measures Proposed for the 2020 Performance
                  Period and Future Performance Periods
------------------------------------------------------------------------
                Measure topic                     Episode measure type
------------------------------------------------------------------------
Acute Kidney Injury Requiring New Inpatient    Procedural
 Dialysis.
Elective Primary Hip Arthroplasty............  Procedural.
Femoral or Inguinal Hernia Repair............  Procedural.
Hemodialysis Access Creation.................  Procedural.
Inpatient Chronic Obstructive Pulmonary        Acute inpatient medical
 Disease (COPD) Exacerbation.                   condition.
Lower Gastrointestinal Hemorrhage *..........  Acute inpatient medical
                                                condition.
Lumbar Spine Fusion for Degenerative Disease,  Procedural.
 1-3 Levels.
Lumpectomy Partial Mastectomy, Simple          Procedural.
 Mastectomy.
Non-Emergent Coronary Artery Bypass Graft      Procedural.
 (CABG).

[[Page 40756]]

 
Renal or Ureteral Stone Surgical Treatment...  Procedural.
------------------------------------------------------------------------
* This measure is being proposed only for groups. Please reference
  section III.K.3.c.(2)(b)(vi)(B) of the proposed rule.

(iv) Proposed 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 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 proposed 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 resources 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 
eight 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 propose 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. 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 proposed rule. Our proposed 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 
are proposing in section III.K.3.c.(2)(b)(iii) of this proposed rule 
for the cost performance category.
(v) Revised Cost Measures
(A) 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 
are proposing to modify both of these measures based on stakeholder 
input from prior public comment periods and recommendations from the 
TEP. We also propose 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 propose to change 
the name from MSPB to MSPB clinician at Sec. Sec.  414.1350(b)(3) and 
414.1350(c)(2).
    The measure development contractor convened the TEP for two in-
person meetings in August 2017 and May 2018 to provide input on 
potential refinements to both measures and for a webinar in November 
2018 to determine additional refinements to the measures based on 
feedback received from field testing. The TEP's discussion from the May 
2018 meeting can be found in the TEP Summary Report at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/TEP-Current-Panels.html#a0913. In addition, the measure 
development contractor convened the MSPB Service Refinement Workgroup, 
an expert workgroup that the TEP recommended to provide detailed 
clinical input on service assignment rules for the revised MSPB 
clinician measure. The MSPB Service Refinement Workgroup convened twice 
during summer 2018 to develop the service exclusion list. The service 
exclusion list contains the service codes and logic for services that 
are

[[Page 40757]]

considered clinically unrelated to the index admission of the revised 
MSPB clinician episodes and are removed from the episodes and measure 
calculation. The revised measures underwent field testing in fall of 
October 2018 during which we sought feedback on the refined measure 
specifications and supplemental documentation through an online form. 
At the end of field testing, the measure development contractor shared 
feedback with the standing TEP, which considered the feedback in 
determining further measure refinements for the total per capita cost 
measure. The TEP also discussed the MSPB clinician measure after field 
testing and had the opportunity to provide input on further refinements 
to this measure. A field-testing feedback summary report 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).
(B) 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 Value Modifier 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 would 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 would 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 are proposing for the total per capita cost 
measure.
    First, we are proposing to change the attribution methodology to 
more accurately identify a beneficiary's primary care relationships. 
This is done by identifying a combination of services that occur within 
a short period of time 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 four-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 would 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 would occur concurrently and would 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 are providing 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. 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

[[Page 40758]]

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 at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-TPCC-measure-specs.zip. 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 would be 
attributed the beneficiary and the TIN/NPI within this practice that 
provides the most primary care E/M services that initiate candidate 
events would be attributed the beneficiary. Under the current total per 
capita cost measure, the TIN and TIN/NPI would 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 are proposing 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. Specifically, candidate events are excluded if they are 
performed by clinicians who (i) frequently perform non-primary care 
services (for example, global surgery, chemotherapy, anesthesia, 
radiation therapy) or (ii) 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 do not propose to change the adjustment for specialty; as 
such, the measure would continue to adjust for specialty to account for 
variation in cost across clinician specialties and in clinician groups 
with diverse specialty compositions.
    Third, we are proposing 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. This methodology would 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 are proposing to add an institutional risk 
model to improve risk adjustment for clinicians treating 
institutionalized beneficiaries.
    Fourth, we are proposing to change the measure to evaluate 
beneficiaries' costs on a monthly basis rather than an annual basis. 
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 would 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 proposed 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 at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-TPCC-measure-specs.zip.
    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. 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 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 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 believe 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 are 
proposing to include the total per capita cost measure with these 
revised specifications in the cost performance category beginning with 
the CY 2020 performance period.
(C) 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 Value 
Modifier 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 would 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

[[Page 40759]]

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 are proposing as part of the re-evaluation of this measure.
    First, we are proposing 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). 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 at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/mspb-clinician-zip-file.zip. 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 are proposing 
to add service exclusions to the measure to remove costs that are 
unlikely to be influenced by the clinician's care decisions. 
Specifically, we are proposing to exclude unrelated services specific 
to groups of MS-DRGs aggregated by major diagnostic 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 proposed changes to the measure is 
included in the measure specifications documents, which are available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/mspb-clinician-zip-file.zip. This includes a comparison of the proposed changes 
against the MSPB clinician measure as currently specified. A measure 
justification form containing testing results for this measure with the 
proposed 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 are proposing to include the revised MSPB clinician 
measure with these specifications in the cost performance category 
beginning with the CY 2020 performance period.
(vi) Reliability
(A) Reliability for Episode-Based Measures
    In the CY 2017 QPP 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 proposed 10 episode-based measures 
listed in Table 38 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 proposed 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 this 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.

                   Table 38--Percent of TINs and TIN/NPIs That Meet 0.4 Reliability Threshold
----------------------------------------------------------------------------------------------------------------
                                                  % TINs meeting                    % TIN/NPIs
                                                        0.4            Mean         meeting 0.4        Mean
                  Measure name                      reliability     reliability     reliability     reliability
                                                     threshold       for TINs        threshold     for TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Acute Kidney Injury Requiring New Inpatient                100.0            0.58            85.3            0.48
 Dialysis.......................................
Elective Primary Hip Arthroplasty...............           100.0            0.85           100.0            0.78
Femoral or Inguinal Hernia Repair...............           100.0            0.86           100.0            0.81
Hemodialysis Access Creation....................            93.1            0.63            70.1            0.48
Inpatient Chronic Obstructive Pulmonary Disease            100.0            0.69            68.0            0.46
 (COPD) Exacerbation............................
Lower Gastrointestinal Hemorrhage *.............            74.6            0.51             0.0            0.20
Lumbar Spine Fusion for Degenerative Disease, 1-           100.0            0.77           100.0            0.69
 3 Levels.......................................
Lumpectomy Partial Mastectomy, Simple Mastectomy           100.0            0.64           100.0            0.60
Non-Emergent Coronary Artery Bypass Graft (CABG)           100.0            0.82           100.0            0.74
Renal or Ureteral Stone Surgical Treatment......           100.0            0.77           100.0            0.65
----------------------------------------------------------------------------------------------------------------
* This measure is being proposed only for groups. Please reference section III.K.3.c.(2)(b)(vi)(B) of the
  proposed rule.


[[Page 40760]]

(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 proposed 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 propose to include the measure in the cost 
performance category only for MIPS eligible clinicians who report as a 
group or virtual group. 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 would again consider limiting the 
assessment of the measure to groups.
(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 felt best balanced our interest in ensuring 
moderate reliability without limiting participation. Given the 
significant changes to these measures that we are proposing in section 
III.K.3.c.(2)(b)(v), 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 39.

  TABLE 39--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                    % TIN/NPIs
                                                        0.4            Mean         meeting 0.4        Mean
                  Measure name                      reliability     reliability     reliability     reliability
                                                     threshold       for TINs        threshold     for TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Medicare Spending Per Beneficiary Clinician.....           100.0            0.77           100.0            0.69
Total Per Capita Cost...........................           100.0            0.82           100.0            0.89
----------------------------------------------------------------------------------------------------------------

    Based on this analysis, in this proposed rule we are not proposing 
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.
(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 proposed in section 
III.K.3.c.(2)(b)(vii) of this proposed rule. 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 opportunity to incentivize improvement in the 
field of mental health, a CMS priority area.
    The Psychoses/Related Conditions episode-based measure was reviewed 
by the MAP Clinician Workgroup in December 2018 as part of a group with 
the 10 episode-based measures in Table 40 that we are proposing and 
received a preliminary recommendation of ``Conditional support for 
rulemaking,'' on the condition of NQF endorsement. In January 2019, The 
MAP Coordinating Committee pulled this measure for separate discussion 
from the other 10 episode-based measures and voted to finalize a 
recommendation of ``Do not support for rulemaking.'' The MAP's concerns 
with this measure related to: (i) The attribution model and its 
potential to hold clinicians responsible for costs outside of their 
influence; (ii) geographic variation in community resource 
availability; (iii) effects of physical comorbidities on measure score; 
and (iv) the potential to exacerbate access issues in mental health 
care. More detail is available in the 2019 MAP Clinician Workgroup 
final report at http://www.qualityforum.org/Publications/2019/03/MAP_Clinicians_2019_Considerations_for_Implementing_Measures_Final_Report.aspx.
    We appreciate the feedback from the MAP but believe that the 
measure already accounts for these concerns. The expert workgroup 
convened by the measure development contractor to provide input on the 
specifications carefully considered these and other issues unique to 
mental health care throughout the development process and field 
testing. The expert workgroup, which reconvened to consider the MAP's 
concerns, noted that they had addressed each of the MAP's concerns 
during development activities and that this measure could be a 
significant step towards mental health parity by including psychiatry 
with other specialties in a MIPS episode-based measure. In addition, 
the measure provides opportunities for innovation in care coordination, 
which the Person and Family Committee expressed as an improvement need. 
We are now seeking

[[Page 40761]]

comments on the Psychoses/Related Conditions episode-based measure. In 
future years, we may propose the use of this measure.
    Regarding the MAP's first concern about clinician accountability, 
the Psychoses/Related Conditions measure is constructed to only capture 
costs within an attributed clinician's influence through judicious 
service assignment rules. That is, services are only included in the 
cost of an episode when they meet specific conditions defined by 
procedure, diagnosis, and timing within the episode window. Members of 
the expert workgroup also noted that the measure can incentivize 
improved care coordination across care settings by holding clinicians 
accountable for certain post-discharge care. This recognition of the 
potential for measures to incentivize systems care coordination aligns 
with the rationale for quality measures currently available for 
reporting in MIPS, which acknowledge the goal of promoting shared 
accountability and collaboration with patients, families, and 
providers. For example, NQF #0576/Quality #391 Follow-Up After 
Hospitalization for Mental Illness (81 FR 77645) holds clinicians 
accountable for certain follow-up care.
    Regarding the MAP's second concern about geographic variation, 
empirical analyses indicate the impact of geographic variation has 
limited effect on measure score and is similar across episode-based 
measures. The measure development contractor conducted empirical 
analyses to examine the effect of adding variables to the current risk 
adjustment model to account for state differences to assess the impact 
of geographic variation. The analyses indicated that there is a high 
correlation between the measure using the current risk adjustment model 
and the model accounting for state differences. At the TIN level, the 
correlation between the Psychoses/Related Conditions base measure and 
state-augmented measure is 0.838. At the TIN-NPI level, the correlation 
between the Psychoses/Related Conditions base measure and state-
augmented measure is 0.835.
    Regarding the MAP's third concern about physical comorbidities, the 
measure's risk adjustment model includes variables to account for 
patient comorbidities, including variables for patient history of other 
physical or mental health issues that might affect outcomes for 
patients captured under this measure.
    Regarding the MAP's fourth concern about mental healthcare access, 
the large number of beneficiaries covered by this measure mitigates the 
potential for clinicians to limit access for Medicare patients. The 
potential coverage of beneficiaries is high, as there are approximately 
102,000 beneficiaries with at least one episode (for episodes ending 
between January 1, 2017 and December 31, 2017). Additionally, the 
measure is designed to account for complex case mix to preserve access 
to care: The patient cohort is divided into sub-groups to ensure 
meaningful clinical comparisons between homogenous patient populations. 
We believe that this measure has the potential to incentivize improved 
care coordination and team-based care, and encourage the use of use 
community resources, which would improve access to care.
    The Psychoses/Related Conditions episode-based measure would bridge 
the measurement gap in the MIPS cost performance category by providing 
mental health clinicians an episode-based measure as a complement to 
the two broader, population cost measures currently in MIPS. Based on 
episodes ending between January 1, 2017 and December 31, 2017, 
approximately 97 percent of MIPS eligible TINs and 36 percent of MIPS 
eligible TIN/NPIs meeting the 20 episode-case minimum for the 
Psychoses/Related Conditions measure also meet the case minimum for the 
revised MSPB clinician measure. Similarly, approximately, 98 percent of 
MIPS eligible TINs and 23 percent of MIPS eligible TIN/NPIs meeting the 
case minimum for the Psychoses/Related Conditions measure also meet the 
case minimum for the revised total per capita cost measure. We believe 
that this measure accurately reflects cost associated with inpatient 
psychiatrists' care and can provide information about cost performance 
that is actionable for mental health clinical practice as they provide 
clinicians with feedback on the cost of services within their 
reasonable influence.
    A key goal for cost measures is to assess provider variation due to 
practice differences rather than chance, which can be determined by the 
measure's reliability. The Psychoses/Related Conditions measure tests 
well for reliability. The measure has a mean reliability over 0.7, 
generally considered the threshold for high reliability, at both TIN 
and TIN-NPI levels at the 10, 20, and 30-episode case minima. At the 
20-epsiode case minimum imposed for acute inpatient medical condition 
episode-based measures, mean reliability is 0.83 for TIN and 0.88 for 
TIN-NPI level reporting, with 100.0 percent of TINs and 100.0 percent 
of TIN-NPIs meeting or exceeding the 0.4 threshold for moderate 
reliability. A measure justification form with additional testing 
results for this measure is available at 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 are seeking 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.
(viii) Summary of Previously Established and Proposed Measures for the 
Cost Performance Category for the 2020 and Future Performance Periods

Table 40--Summary Table of Cost Measures for the 2020 Performance Period
                     and Future Performance Periods
------------------------------------------------------------------------
        Measure topic             Measure type         Measure Status
------------------------------------------------------------------------
Total Per Capita Cost.......  Population-Based....  Revised and proposed
                                                     for 2020
                                                     performance period
                                                     and beyond.
Medicare Spending Per         Population-Based....  Revised and proposed
 Beneficiary Clinician.                              for 2020
                                                     performance period
                                                     and beyond.
Elective Outpatient           Procedural episode-   Currently in use for
 Percutaneous Coronary         based.                2019 Performance
 Intervention (PCI).                                 Period and Beyond.
Knee Arthroplasty...........  Procedural episode-   Currently in use for
                               based.                2019 Performance
                                                     Period and Beyond.
Revascularization for Lower   Procedural episode-   Currently in use for
 Extremity Chronic Critical    based.                2019 Performance
 Limb Ischemia.                                      Period and Beyond.

[[Page 40762]]

 
Routine Cataract Removal      Procedural episode-   Currently in use for
 with Intraocular Lens (IOL)   based.                2019 Performance
 Implantation.                                       Period and Beyond.
Screening/Surveillance        Procedural episode-   Currently in use for
 Colonoscopy.                  based.                2019 Performance
                                                     Period and Beyond.
Intracranial Hemorrhage or    Acute inpatient       Currently in use for
 Cerebral Infarction.          medical condition     2019 Performance
                               episode-based.        Period and Beyond.
Simple Pneumonia with         Acute inpatient       Currently in use for
 Hospitalization.              medical condition     2019 Performance
                               episode-based.        Period and Beyond.
ST-Elevation Myocardial       Acute inpatient       Currently in use for
 Infarction (STEMI) with       medical condition     2019 Performance
 Percutaneous Coronary         episode-based.        Period and Beyond.
 Intervention (PCI).
Acute Kidney Injury           Procedural episode-   Proposed for 2020
 Requiring New Inpatient       based.                Performance Period
 Dialysis.                                           and Beyond.
Elective Primary Hip          Procedural episode-   Proposed for 2020
 Arthroplasty.                 based.                Performance Period
                                                     and Beyond.
Femoral or Inguinal Hernia    Procedural episode-   Proposed for 2020
 Repair.                       based.                Performance Period
                                                     and Beyond.
Hemodialysis Access Creation  Procedural episode-   Proposed for 2020
                               based.                Performance Period
                                                     and Beyond.
Inpatient Chronic             Acute inpatient       Proposed for 2020
 Obstructive Pulmonary         medical condition     Performance Period
 Disease (COPD) Exacerbation.  episode-based.        and Beyond.
Lower Gastrointestinal        Acute inpatient       Proposed for 2020
 Hemorrhage (at group level    medical condition     Performance Period
 only).                        episode-based.        and Beyond.
Lumbar Spine Fusion for       Procedural episode-   Proposed for 2020
 Degenerative Disease, 1-3     based.                Performance Period
 Levels.                                             and Beyond.
Lumpectomy, Partial           Procedural episode-   Proposed for 2020
 Mastectomy, Simple            based.                Performance Period
 Mastectomy.                                         and Beyond.
Non-Emergent Coronary Artery  Procedural episode-   Proposed for 2020
 Bypass Graft (CABG).          based.                Performance Period
                                                     and Beyond.
Renal or Ureteral Stone       Procedural episode-   Proposed for 2020
 Surgical Treatment.           based.                Performance Period
                                                     and Beyond.
------------------------------------------------------------------------

(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 proposed rule, we are proposing to: (1) Modify the 
definition of rural area; (2) update Sec.  414.1380(b)(3)(ii)(A) and 
(C) to remove the reference to the four listed accreditation 
organizations in order to be recognized as patient-centered medical 
homes and to remove the reference to the specific accrediting 
organization for comparable specialty practices; (3) increase the group 
reporting threshold to 50 percent; (4) establish factors to consider 
for removal of improvement activities from the Inventory; (5) remove 
15, modify seven, and add two new improvement activities for the 2020 
performance period and future years; and (6) conclude and remove the 
CMS Study on Factors Associated with Reporting Quality Measures. These 
proposals are discussed in more detail in this proposed 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, we are proposing 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

[[Page 40763]]

Commuting Area (RUCA) codes. 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 
are proposing 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. We invite public comment on our proposal as discussed 
in this proposed rule.
---------------------------------------------------------------------------

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

(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; (A)(1) through (A)(4) lists 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 do not want to exclude 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, we request comments on our proposal to update 
Sec.  414.1380(b)(3)(ii)(A) and (C) to remove specific entity names.
(d) Improvement Activities Data Submission
    We are proposing 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 are not proposing 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 are not proposing any changes to these policies.
(iii) Group Reporting
    In this proposed rule, we are making two proposals with respect to 
group reporting: (a) Increasing 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 in order 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 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 or specialty or practice setting, we believe that a group should 
be able to find applicable and meaningful activities to complete that 
would apply to at least 50 percent of individual MIPS eligible 
clinicians in a group.
    Therefore, we are proposing 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 would like to note that if finalized the proposed 
changes to the group threshold would 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

[[Page 40764]]

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 in order 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 would 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 practice or TIN to perform an improvement activity for the same 
continuous 90-day performance period would 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 
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 are requesting 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 
would remain the same. In other words, each TIN would 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 would 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 would 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.
    We invite public comments on our proposal as discussed above, as 
well as the alternatives considered.
(e) Improvement Activities Inventory
    We are proposing changes to the Improvement Activities Inventory 
to: (1) Establish removal factors to consider when proposing to remove 
improvement activities from the Inventory; (2) remove 15 improvement 
activities for the 2020 performance period and future years contingent 
on our proposed removal factors being finalized; (3) modify seven 
existing improvement activities for the 2020 performance period and 
future years; and (4) add two new improvement activities for the 2020 
performance period and future years. These proposals are discussed in 
more detail in this proposed rule.
(i) Proposed 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 
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 practices have made financial investments to perform these 
activities and that no activities should be removed. Some commenters 
suggested that we should remove 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 that we appreciate the commenters input. In addition, we 
understand that many practices may have made financial investments to 
perform these 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 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 are 
proposing to adopt the following factors for our consideration when

[[Page 40765]]

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, would 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 invite public comments on our proposal to implement 
factors to consider in removing improvement activities from the 
Inventory. In conjunction with this proposal, we are proposing a number 
of improvement activity removals as discussed in the next section and 
in Appendix 2 of this proposed rule. Those removals are contingent upon 
finalization of these removal factors.
(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 proposed rule, we 
invite comments on our proposals to: (1) Remove 15 improvement 
activities from the Inventory beginning with the 2020 performance 
period, (2) modify seven existing improvement activities for 2020 
performance period and future years, and (3) add two new improvement 
activities for 2020 performance period and future years. We refer 
readers to Appendix 2 of this proposed rule for further details. Our 
proposals to remove improvement activities are being made in 
conjunction with our proposal to adopt removal factors and are 
contingent upon finalization of that proposal.
(f) CMS Study on Factors Associated With Reporting Quality Measures
    In this proposed rule, we are proposing 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 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) Proposal To End and Remove Study
    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, we request comments on our 
proposal to conclude this study at the end of the CY 2019 performance 
period. In conjunction with our proposal to end the study, we are also 
proposing to remove the study and the incentive provided towards the 
improvement activity performance category beginning with the 2020 
performance period. If the study is ended as proposed above, we are 
proposing to remove this activity because it would be obsolete 
(proposed 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 77195-77197), would no longer be 
available starting with the 2020 performance period.
(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 learnt 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

[[Page 40766]]

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 include: (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 non-physician practitioner 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.
    These proposals are discussed in more detail in this proposed rule.
    We are also seeking input through Requests for Information as 
follows: (1) Potential Opioid Measures for Future Inclusion in the 
Promoting Interoperability performance category, (2) NQF and CDC Opioid 
Quality Measures, (3) a Metric to Improve Efficiency of Providers 
within EHRs, (4) the Provider to Patient Exchange Objective, (5) 
Integration of Patient-Generated Health Data into EHRs Using CEHRT, and 
(6) Engaging in Activities that Promote the Safety of the EHR.
(b) Goals of Proposed Changes to the Promoting Interoperability 
Performance Category
    As we look toward the future of the Promoting Interoperability 
performance category, the general goals of our proposals in this 
proposed 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 the 2015 Edition CEHRT; (4) improving 
patient access to their EHRs 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 are proposing 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). This proposal aligns with the proposed EHR 
reporting period in CY 2021 for the Medicare Promoting Interoperability 
Program for eligible hospitals and CAHs (84 FR 19554). 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 are requesting comments on this proposal.
(d) Promoting Interoperability Performance Category Measures for MIPS 
Eligible Clinicians
(i) Proposed Changes to Measures for the e-Prescribing Objective
(A) Background
    Beginning with the MIPS performance period in 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). These measures built upon the meaningful use of CEHRT, as well 
as the security of electronic prescribing of Schedule II controlled 
substances while preventing diversion. For both measures, we defined 
opioids as Schedule II controlled substances under 21 CFR 1308.12, as 
they are recognized as having a high potential for abuse with potential 
for severe psychological or physical dependence. Additionally, we noted 
the intent of the new measures was not to dissuade the prescribing or 
use of opioids for patients with medical diagnoses or conditions that 
benefit from their use, such as patients diagnosed with cancer or those 
receiving hospice.
    During the comment period for the CY 2019 PFS proposed rule (83 FR 
35921 through 35925), and subsequently through public forums and 
correspondence, we received extensive comments from stakeholders 
regarding the Query of PDMP measure and the Verify Opioid Treatment 
Agreement measure. While this feedback is the main catalyst for our 
proposals, there have also been significant legislative changes that 
have the potential to

[[Page 40767]]

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). This legislation was 
enacted to address the opioid crisis and affects a wide range of HHS 
programs and policies. While this legislation is not the main reason 
for our proposals, 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.
    In this proposed rule, we are aiming to be responsive to the 
comments that we have received from stakeholders since the CY 2019 PFS 
final rule was published and to take into account certain aspects of 
the SUPPORT Act that may have implications for the policy goals of the 
Promoting Interoperability performance category.
    As explained in further detail below, we are proposing to make the 
Query of PDMP measure optional in CY 2020, remove the numerator and 
denominator that we established for the Query of PDMP measure and 
instead require a ``yes/no'' response beginning in CY 2019, and remove 
the Verify Opioid Treatment Agreement measure beginning in CY 2020. In 
section III.K.3.c.(4)(d)(i) of this proposed rule, we are also 
requesting information on potential new opioid use disorder (OUD) 
prevention and treatment-related measures. We believe the requests for 
information will help to inform future rulemaking and not only help 
prevent and treat substance use disorder, but allow us to adopt 
measures that enable flexibility without added burden for clinicians. 
We value stakeholders' continued interest in and support for combating 
the nation's opioid epidemic.
(B) Query of Prescription Drug Monitoring Program (PDMP) Measure
(aa) Query of PDMP Measure
    As we stated in the CY 2019 PFS final rule (83 FR 59800 through 
59803), the Query of PDMP measure is optional and available for bonus 
points for the 2019 performance period, and we will propose our policy 
for the Query of a PDMP measure for the 2020 performance period in 
future rulemaking. We afforded MIPS eligible clinicians' flexibility 
for implementing this measure, including the flexibility to query the 
PDMP in any manner allowed under their State law.
    However, we have received substantial feedback from health IT 
vendors and specialty societies that this flexibility 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. During the CY 2019 PFS proposed rule comment 
period (83 FR 35922 through 35925) and after the final rule was 
published, these stakeholders stated that it is premature to require 
the Query of PDMP measure in the 2020 performance period especially 
given the maturation needed in PDMP development.
    We agree with stakeholders that PDMPs are still maturing in their 
development and use. In addition there is considerable variation among 
state PDMP programs as many only operate within a state and are not 
linked to larger systems. For more information, we refer readers to the 
following: The National Alliance of Model State Drug Laws (https://namsdl.org/topics/pdmp/) and PDMP Training and Technical Assistance 
Center (https://www.pdmpassist.org/content/pdmp-maps-and-tables).
    Stakeholders also mentioned the challenge posed by the current lack 
of integration of PDMPs into the EHR workflow. Historically, health 
care providers have had to go outside of the EHR workflow in order to 
separately log in to and access the State PDMP. In addition, 
stakeholders noted the wide variation in whether PDMP data can be 
stored in the EHR. By integrating PDMP data into the health record, 
health care providers can improve clinical decision making by utilizing 
this information to identify potential opioid use disorders, inform the 
development of care plans, and develop effective interventions. ONC is 
currently engaged in an assessment to better understand the current 
state of policy and technical factors impacting PDMP integration across 
States. This assessment is exploring factors like PDMP data 
integration, standards and hubs used to facilitate interstate PMDP data 
exchange, access permissions, and laws and regulations governing PDMP 
data storage.
    In October 2018, the SUPPORT Act became law, signifying an 
important investment and approach for our nation in combating the 
opioid epidemic. The provisions of this law aim to provide for opioid 
use disorder prevention, recovery, and treatment and aim to increase 
access to evidence-based treatment and follow-up care included through 
legislative changes specific to the Medicare and Medicaid programs. 
Specifically, with respect to PDMPs, 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, in an effort to help reduce opioid misuse and 
overprescribing, and in an effort to help promote the overall effective 
prevention and treatment of opioid use disorder.
    Section 5042(a) of the SUPPORT Act added section 1944 to the Act, 
titled ``Requirements relating to qualified prescription drug 
monitoring programs and prescribing certain controlled substances.'' 
This section increases federal Medicaid matching rates during FY 2019 
and 2020 for certain state expenditures relating to qualified PDMPs 
administered by states. Under section 1944(b)(1) of the Act, to be a 
qualified PDMP, a PDMP must facilitate access by a covered provider to, 
at a minimum, the following information with respect to a covered 
individual, in as close to real-time as possible: Information regarding 
the prescription drug history of a covered individual with respect to 
controlled substances; the number and type of controlled substances 
prescribed to and filled for the covered individual during at least the 
most recent 12-month period; and the name, location, and contact 
information of each covered provider who prescribed a controlled 
substance to the covered individual during at the least the most recent 
12-month period. Under section 1944(b)(2) of the Act, a qualified PDMP 
must also facilitate the integration of the information described in 
section 1944(b)(1) of the Act into the workflow of a covered provider, 
which may include the electronic system used by the covered provider 
for prescribing controlled substances.
    Section 1944(f) of the Act establishes, for FY 2019 and FY 2020, a 
100 percent federal Medicaid matching rate for state expenditures to 
design, develop, or implement a PDMP that meets the requirements 
outlined in section 1944(b)(1) and (2) of the Act, and to make 
connections to that PDMP. Section 1944(f)(2) of the Act specifies that, 
to qualify for the 100 percent federal matching rate, a state must have 
in place agreements with all contiguous states that, when combined, 
enable covered providers in all the contiguous states to access, 
through the PDMP, all information described in 1944(b)(1) of the Act.
    Section 5042(b) of the SUPPORT Act requires CMS, in consultation 
with the Centers for Disease Control and Prevention (CDC), to issue 
guidance not later than October 1, 2019 on best practices on the uses 
of PDMPs required of prescribers and on protecting the

[[Page 40768]]

privacy of Medicaid beneficiary information maintained in and accessed 
through PDMPs. Furthermore, section 5042(c) of the SUPPORT Act requires 
that HHS develop and publish, not later than October 1, 2020, model 
practices to assist State Medicaid program operations in identifying 
and implementing strategies to utilize data-sharing agreements 
described in section 1944(b) of the Act for the following purposes: 
Monitoring and preventing fraud, waste, and abuse; and improving health 
care for individuals enrolled in Medicaid who transition in and out of 
Medicaid coverage, who may have sources of health care coverage in 
addition to Medicaid coverage, or who pay for prescription drugs with 
cash. We note that section 7162 of the SUPPORT Act also supports PDMP 
integration as part of the CDC's grant programs aimed at efficiency and 
enhancement by states, including improvement in the intrastate and 
interstate interoperability of PDMPs.
    In addition, the explanatory statement that accompanied Title II of 
Division H of the Consolidated Appropriations Act, 2018 (Pub. L. 115-
141),\116\ encouraged the CDC to work with the ONC to enhance the 
integration of PDMPs and EHRs. As part of this effort, the CDC and ONC 
are collaborating to expand upon previous and leverage input from 
current federal efforts to advance and scale PDMP integration with 
health IT systems. This collaboration includes testing and refining 
standard-based approaches to enable effective integration into clinical 
workflows, exploring emerging technical solutions to enhance access and 
use of PDMP data, providing technical resources to a variety of 
stakeholders to advance and scale the interoperability of health IT 
systems and PDMPs, and incorporating policy considerations, as 
relevant, to inform the implementation and success of integration 
approaches.
---------------------------------------------------------------------------

    \116\ https://www.govinfo.gov/content/pkg/CREC-2018-03-22/html/CREC-2018-03-22-pt3-PgH2697.htm.
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    We understand that there is wide variation across the country in 
how health care providers are implementing and integrating PDMP queries 
into health IT and clinical workflows, and that it could be burdensome 
for health care providers if we were to narrow the measure to allow 
only a single workflow. At the same time, we have heard extensive 
feedback from EHR developers that incorporating the ability to count 
the number of PDMP queries in CEHRT would require more robust 
certification specifications and standards. These stakeholders state 
that health IT developers may face significant cost burdens under the 
current flexibility allowed for health care providers if they fully 
develop numerator and denominator calculations for all the potential 
use cases and are required to change the specification at a later date. 
Developers have indicated that the costs of additional development will 
likely be passed on to health care providers without additional benefit 
as this development would be solely for the purpose of calculating the 
measure rather than furthering the clinical goal of the measure.
    Given the stakeholder concerns discussed above regarding the lack 
of integration, the recent enactment of the SUPPORT Act (in particular, 
its provisions specific to Medicaid providers and qualified PDMPs), and 
the activities funded by the CDC, we believe that additional time is 
needed to evaluate the changing PDMP landscape prior to requiring a 
Query of PDMP measure, or introducing requirements related to EHR-PDMP 
integration.
    Therefore, we are proposing to make the Query of PDMP measure 
optional and eligible for 5 bonus points for the Electronic 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 are proposing 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 2019 performance period, we are 
proposing to remove the numerator and denominator that we 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. Under 
this proposal, the measure description would remain the same (83 FR 
59803), but instead of submitting numerator and denominator information 
for the measure, MIPS eligible clinicians would submit a ``yes/no'' 
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 used data from CEHRT to 
conduct a query of a PDMP for prescription drug history, except where 
prohibited and in accordance with applicable law. We are proposing this 
change to give us more time to restructure the measure and develop a 
robust measure that meets the needs of both health care providers and 
other stakeholders. Because currently there are not standards-based 
interfaces between CEHRT and PDMPs, health care providers must manually 
track the number of times that they query a PDMP outside of CEHRT. We 
are proposing this change to reduce the burden on health care providers 
of having to manually keep track of information related to the measure 
and to mitigate the burden on health IT developers who would otherwise 
have to develop the measure's numerator and denominator calculations 
when we expect to propose changes to the measure in the near future. 
Therefore, health care providers and health IT developers have 
suggested that, given the current state, there would be a significant 
reduction in burden by allowing health care providers to satisfy the 
measure by submitting a ``yes/no'' response, rather than reporting a 
numerator and denominator. In addition, for the 2019 performance 
period, the Query of PDMP measure is not scored based on a clinician's 
performance as determined by a numerator and denominator; instead, it 
is an optional measure that is eligible for a full five bonus points 
regardless of how a clinician performs (83 FR 59794 through 59795). 
Thus, because the measure is not scored based on performance, requiring 
a ``yes/no'' response instead of a numerator and denominator would not 
affect the potential number of points that a clinician could earn by 
reporting on the measure.
    We do not believe that these changes would result in additional 
costs (time or money) for health care providers, and instead would 
reduce the burden of manually tracking information needed to report on 
this measure in its current form. For CY 2019, we did not provide 
exclusions for the Query of PDMP and Verify Opioid Treatment Agreement 
measures because they were optional and eligible for bonus points, and 
similarly, we do not believe exclusions would be necessary for the 
Query of PDMP measure if we finalize our proposal to make the measure 
optional and eligible for bonus points in CY 2020.
    We also welcome comments on future timing for requiring a measure 
that includes EHR-PDMP integration and on the value of the measure for 
advancing the effective prevention and treatment of opioid use disorder 
especially in relation to the requirements of the SUPPORT Act described 
above.
    We also note that some stakeholders have requested that we define a 
value set for controlled substances for the opioid-related measures, 
Query of

[[Page 40769]]

PDMP and Verify Opioid Treatment Agreement. In the CY 2019 PFS final 
rule (83 FR 59803), for the Query of PDMP and Verify Opioid Treatment 
Agreement measures, we defined opioids as Schedule II controlled 
substances under 21 CFR 1308.12. We recognize that some challenges 
remain related to electronic prescribing of controlled substances, 
including more restrictive state laws and lack of products both for 
health care providers and pharmacies that include the necessary 
functionalities. We anticipate working closely with the Drug 
Enforcement Administration (DEA) on future technical requirements that 
can better support measurement of adoption and use of electronic 
prescribing of controlled substances, which may include the definition 
of a value set related to such measures. As more information on 
developing technical requirements becomes available, we will provide 
additional information.
    As we seek comment and continue to advance this measure, we are 
excited about future innovations that may help improve PDMPs and 
support the electronic prescribing of controlled substances. We 
envision a future state where PDMP data is integrated into the clinical 
workflow and where clinicians do not have to access multiple systems to 
find and reconcile the information. While we may have a long distance 
to go to get to this state, we believe that it is an achievable goal 
for the future of the Promoting Interoperability performance category.
    We are inviting comments on these proposals.
(C) 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 
received feedback from stakeholders that this measure has presented 
significant implementation challenges and an increase in burden, and 
does not further interoperability. Below, we outline some of the 
ongoing concerns we heard since the measure was finalized in the CY 
2019 PFS final rule (83 FR 59803 through 59806).
(aa) Lack of Certification Standards and Criteria
    Stakeholders have continually expressed concern regarding the lack 
of defined data elements, structure, standards and criteria for the 
electronic exchange of opioid treatment agreements and how this impacts 
verifying whether there is an opioid treatment agreement to meet this 
measure. We acknowledged these concerns in the CY 2019 PFS final rule 
(83 FR 59803 through 59806).
    In the CY 2019 PFS final rule (83 FR 59803 through 59806), we 
stated that there are a number of ways that certified health IT may be 
able to support the electronic exchange of opioid abuse-related 
treatment data such as the care plan template within the Consolidated-
Clinical Document Architecture (C-CDA). We stated this information 
could be considered as part of an opioid treatment agreement, even 
though we did not define the elements of one. However, we understand 
that while such standards may include relevant information, the lack of 
clarity around a specific standard to support incorporation of an 
opioid treatment agreement presents an additional source of burden to 
clinicians seeking to report on the measure.
(bb) Calculating 30 Cumulative Day Look-Back Period
    Another area where stakeholders have expressed concern is how to 
calculate 30 cumulative days of opioid prescriptions in a 6-month 
period. One possible solution we offered was to utilize the NCPDP 10.6 
Medication History query. In the CY 2019 PFS final rule (83 FR 59803 
through 59806), we noted that the Medication History query does not 
contain a discrete field for prescription days and relies on third 
party data that may not be discrete. Since the CY 2019 PFS final rule 
was published, stakeholders have continued to express this concern and 
impress upon us that the 30-cumulative day total in a 6-month look-back 
period cannot be automatically calculated, requiring health care 
providers to engage in a burdensome, manual calculation process if they 
wish to report on this measure.
    In addition, we have heard concerns over which medications should 
be used to determine the 30-cumulative day threshold. For example, 
stakeholders were unsure if medications given while a patient is 
admitted to the hospital should count towards the 30 cumulative days 
and also how as needed, or PRN, medications should be addressed.
    Stakeholders have also indicated that this measure could present 
timing challenges. For example, it may cause patients being discharged 
on opioids to be delayed in their discharge to account for the possible 
time-consuming nature of having to search for an opioid treatment 
agreement.
(cc) Unintended Burden Caused by Flexibility
    In the CY 2019 PFS final rule (83 FR 59803 through 59806), we chose 
not to define what constitutes an opioid treatment agreement. While we 
believed that this would allow flexibility for health care providers to 
determine which elements they believed were most important to an opioid 
treatment agreement, we have heard from stakeholders that the lack of 
definition and standards around what would constitute an opioid 
treatment agreement has created an unintended burden. Specifically, 
some stakeholders indicated that we should define an opioid treatment 
agreement so that MIPS eligible clinicians would have a standardized 
definition of an opioid treatment agreement and the criteria to make up 
an opioid treatment agreement. However, other stakeholders indicated 
that given the lack of consensus within the industry on what should or 
should not be included in an opioid treatment agreement and on the 
clinical efficacy of various options for such agreements, that it would 
be inappropriate for us to define what should constitute an opioid 
treatment agreement at this time.
    We have heard from stakeholders that the challenges described above 
result in a measure that is vague, burdensome to measure and does not 
necessarily offer a clinical value to the health care providers or 
support the clinical goal of supporting OUD treatment. Therefore, we 
are proposing to remove the Verify Opioid Treatment Agreement measure 
from the Promoting Interoperability performance category beginning with 
the performance period in CY 2020.
    While we are proposing to remove the Verify Opioid Treatment 
Agreement measure, we believe there may be other opioid measures that 
would be more effective in combatting the opioid epidemic, offer value 
for health care providers in measuring the impacts of health IT-enabled 
resources on OUD prevention and treatment, and engage patients in care 
coordination and planning. We are seeking public comment on a series of 
question in requests for information regarding new opioid measures in 
section III.K.3.c(4)(d)(i) of this proposed rule.
    We invite comments on this proposal.
(ii) Health Information Exchange Objective
    There are two measures under the Health Information Exchange 
objective: The Support Electronic Referral Loops by Sending Health 
Information measure and the Support Electronic Referral Loops by 
Receiving and Incorporating

[[Page 40770]]

Health Information Measure. We are proposing minor modifications to 
both measures.
(A) Proposed 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 the exclusion is 
claimed, and stated that we intended to propose a redistribution policy 
in next year's rulemaking (83 FR 59795). Accordingly, we are proposing 
to redistribute 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. We have 
chosen to redistribute the points to the Provide Patients Access to 
Their Health Information measure because we believe that many MIPS 
eligible clinicians may be eligible to claim exclusions for both 
measures under the Health Information Exchange objective. Under our 
existing policy (83 FR 59788), if an exclusion is claimed for the 
Support Electronic Referral Loops by Receiving and Incorporating Health 
Information measure, the 20 points associated with it will be 
redistributed to the Support Electronic Referral Loops by Sending 
Health Information measure. Under our proposal, 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 40 points 
associated with these measures would be redistributed to the Provide 
Patients Access to Their Health Information measure. We are proposing 
that this redistribution policy would be applicable beginning with the 
2019 performance period/2021 MIPS payment year.
    We invite comments on this proposal.
(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. We established the following exclusion for the new 
measure: 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). We are proposing to revise 
this description of the exclusion to more clearly and precisely capture 
our intended policy. The Request/Accept Summary of Care measure, which 
as noted previously was replaced by the new Support Electronic Referral 
Loops by Receiving and Incorporating Health Information measure, 
included the following exclusion: Any MIPS eligible clinician who 
receives transitions of care or referrals or has patient encounters in 
which the MIPS eligible clinician has never before encountered the 
patient fewer than 100 times during the performance period (83 FR 
59798, 82 FR 53679 through 53680). Our intention was to use that same 
exclusion from the Request/Accept Summary of Care measure for the new 
Support Electronic Referral Loops by Receiving and Incorporating Health 
Information measure. Instead, the description of the exclusion that we 
included in the CY 2019 PFS final rule (83 FR 59812) did not precisely 
track the description of the Request/Accept Summary of Care measure 
exclusion, and 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: Receiving fewer than 100 transitions of care or 
referrals; or having fewer than 100 encounters with patients never 
before encountered. This was not our intention. Rather, as with the 
Request/Accept Summary of Care measure exclusion, our intention was 
that a combination of the two criteria must occur fewer than 100 times 
during the performance period for the exclusion to be applicable to a 
MIPS eligible clinician. Thus, we are proposing to revise the 
description of the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure exclusion to track the 
description of the Request/Accept Summary of Care measure exclusion (83 
FR 59798, 82 FR 53679 through 53680): 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. For 
example, during the performance period, if a MIPS eligible clinician 
received 50 transitions of care, 50 referrals, and 50 patient 
encounters in which they have never before encountered the patient, the 
total sum of 150 would be above the threshold of fewer than 100 times, 
and therefore the MIPS eligible clinician would not be eligible for 
this exclusion. We are proposing that the revised description of the 
exclusion would be applicable beginning with the 2019 performance 
period/2021 MIPS payment year.
    For ease of reference, Table 41 lists the objectives and measures 
for the Promoting Interoperability performance category for the 2020 
performance period as revised to reflect the proposals made in this 
proposed 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).
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(e) Scoring Methodology
(i) Proposed 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 proposed rule, we are proposing 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, in the 
event we finalize the proposal for the Query of PDMP measure; and (3) 
remove the Verify Opioid Treatment Agreement measure beginning in 2020. 
Table 42 reflects these proposals, although the maximum points 
available do not include points that would be redistributed in the 
event that an exclusion is claimed. 
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[[Page 40776]]

(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 are unable to determine, at 
this time, 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 beyond this first year 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.
    Thus, we are proposing to continue the existing policy of 
reweighting the Promoting Interoperability performance category for 
NPs, PAs, CRNAs, and CNSs for the performance period in 2020, and to 
revise Sec.  414.1380(c)(2)(i)(A)(5) to reflect this proposal. We are 
requesting public comments on this proposal.
(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 
policy we adopted for NPs, PAs, CNSs, and CRNAs for the performance 
periods in 2017-2019 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 Program, we have little evidence as to 
whether there are sufficient measures applicable and available to them 
under the Promoting Interoperability performance category.
    For the reasons discussed in section III.K.3.c.(4)(f)(i), for the 
performance period in 2020, we are proposing to continue the existing 
policy of reweighting the Promoting Interoperability performance 
category for physical therapists, occupational therapists, qualified 
speech-language pathologist, qualified audiologists, clinical 
psychologists, and registered dieticians or nutrition professionals, 
and to revise Sec.  414.1380(c)(2)(i)(A)(4) to reflect this proposal. 
We invite comments on this proposal.
(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,

[[Page 40777]]

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 non-physician practitioners (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 
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. We agree 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 are proposing to revise 
the definition of a hospital-based MIPS eligible clinician under Sec.  
414.1305 to include groups and virtual groups. We are proposing 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 believe 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 are proposing 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, as proposed in section III.K.3.c.(4)(f)(iv), 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 section III.K.3.c.(4)(f)(iii) of the proposed rule in 
connection with our discussion of hospital-based MIPS eligible 
clinicians in groups, under Sec.  414.1380(c)(2)(iii), 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. In that section, we are proposing 
to revise Sec.  414.1380(c)(2)(iii) to account for groups and virtual 
groups that meet the proposed 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 are proposing 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.
(g) Future Direction of the Promoting Interoperability Performance 
Category
(i) Request for Information (RFI) on Potential Opioid Measures for 
Future Inclusion in the Promoting Interoperability Performance Category
    In the past, the Promoting Interoperability performance category 
measures focused on very general process focused actions supported by 
health IT. In the Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program--Stage 3 and Modifications to Meaningful Use 
in 2015 through 2017 final rule (80 FR 62766 through 62768), we sought 
to expand the potential for Medicare and Medicaid Promoting 
Interoperability Program measures to include more complex measures and 
closer relationships to high priority health outcomes.
    In this RFI, we are seeking comment on Promoting Interoperability 
performance category measures that might be relevant to specific 
clinical priorities or goals related to addressing OUD prevention and 
treatment. As the Query of PDMP measure matures, we believe it will be 
essential in improving

[[Page 40778]]

prescribing practices. As outlined in section III.K.3.c.(4)(d).(i) of 
this proposed rule, stakeholders indicated that the Verify Opioid 
Treatment Agreement measure presented significant implementation 
challenges for MIPS eligible clinicians. Therefore, we are seeking 
comment on potential new measures for OUD prevention and treatment that 
could be included in future years of the Promoting Interoperability 
performance category. We welcome all comments, but we are seeking 
comment specifically on possible OUD prevention and treatment measures 
that include the following characteristics:
     Include evidence of positive impact on outcome-focused 
improvement activities, and the opioid crisis overall;
     Leverage the capabilities of CEHRT where possible, 
including: near-automatic calculation and reporting of numerator, 
denominator, exclusions and exceptions to minimize manual documentation 
required of the provider; and timing elements to reduce quality 
measurement and reporting burdens to the greatest extent possible;
     Are based on well-defined clinical concepts, measure logic 
and timing elements that can be captured by CEHRT in standard clinical 
workflow and/or routine business operations. Well-defined clinical 
concepts include those that can be discretely represented by available 
clinical and/or claims vocabularies such as SNOMED CT, LOINC, RxNorm, 
ICD-10 or CPT;
     Align with clinical workflows in such a way that data used 
in the calculation of the measure is collected as part of a standard 
workflow and does not require any additional steps or actions by the 
health care provider;
     Are applicable to all clinicians (for example, clinicians 
participating as individuals or as a group, or clinicians located in a 
rural area, designated health professional shortage area (HPSA), 
designated medically-underserved area (MUA), or urban area);
     Could potentially align with other MIPS performance 
categories; and
     Are represented by a measure description, numerator/
denominator or yes/no attestation statement, and possible exclusions.
(ii) Request for Information (RFI) on NQF and CDC Opioid Quality 
Measures
    We also are specifically seeking public comment on the development 
of potential measures for consideration for the Promoting 
Interoperability performance category that are based on existing 
efforts to measure clinical and process improvements specifically 
related to the opioid epidemic, including the opioid quality measures 
endorsed by the National Quality Forum (NQF) and the CDC Quality 
Improvement (QI) opioid measures discussed below. The NQF measures 
represent a reference point for evaluating opioid prescribing behaviors 
based on measures that have undergone the rigorous NQF measure 
endorsement process. The CDC guidelines ``encourage careful and 
selective use of opioid therapy in the context of managing chronic pain 
through . . . an evidence-based prescribing guideline.'' \117\ The 
guidelines have led to the development of CDC measures on prescribing 
practices on which we are seeking comment. We believe these measures 
may help participants understand the relationship between the measure 
description and the use of health IT to support the actions of the 
measures.
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    \117\ https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
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    For example, the measures may describe a clinical concept, such as 
the CDC Measure 12: Counsel on Risks and Benefits Annually. The actions 
for this activity can be supported by CEHRT through the use of 
standards to record key health information for the patient and to 
identify which patients should be included in the denominator based on 
information in the medication list, information gained through 
medication reconciliation of data received through health information 
exchange with another health provider of care, and/or information 
incorporated after a query of a PDMP is completed. The actions for the 
numerator could include leveraging CEHRT to provide patient-specific 
education, to capture or record Patient Generated Health Data (PGHD), 
to engage in secure messaging with the patient and ensure the patient 
is engaging with their record through a patient portal or an 
Application Programming Interface (API).
    We believe that the clinical actions identified within both the NQF 
quality measures and the CDC QI opioid measures, can be supported by 
the standards and functionalities of certified health IT and we welcome 
public comment on the specific use cases for health IT implementation 
for the potential measure actions. We recognize that modifications to 
the NQF and CDC measures may be necessary to make the measures as 
applicable as possible to all participants of the Promoting 
Interoperability performance category, and are seeking comment on any 
modifications that would be necessary. In addition, we note that there 
is some overlap between some of the NQF quality measures and the CDC QI 
opioid measures and are seeking comment on whether there are ways in 
which the two sets of measures could be correlated to support potential 
new measures of the meaningful use of health IT for the Promoting 
Interoperability performance category. Finally, we are seeking comment 
on which measures might best advance the implementation and use of 
interoperable health IT and encourage information exchange between care 
teams and with patients.
(A) NQF Quality Measures
    Three NQF-endorsed quality measures that were stewarded by the 
Pharmacy Quality Alliance (PQA) evaluate patients with prescriptions 
for opioids in combination with benzodiazepines, at high-dosage, or 
from multiple prescribers and pharmacies. Each measure was evaluated 
and recommended for endorsement by the NQF's Patient Safety Standing 
Committee \118\ and endorsed by the Consensus Standards Approval 
Committee. These measures, NQF #2940, #2950, and #2951, were 
recommended by the NQF Measure Application Partnership for inclusion on 
the December 2018 Measures Under Consideration List for the Medicare 
Shared Savings Program.
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    \118\ https://www.qualityforum.org/News_And_Resources/Press_Releases/2017/NQF_Statement_on_Endorsement_of_Opioid_Patient_Safety_Measures.aspx.
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    We are seeking public comment on the development of potential 
measures for consideration for the Promoting Interoperability 
performance category that are based on existing efforts to measure 
clinical and process improvements specifically related to the opioid 
epidemic, including the opioid quality measures endorsed by the NQF 
above and the CDC QI opioid measures discussed below. The NQF measures 
represent a reference point for evaluating opioid prescribing behaviors 
based on measures that have undergone the rigorous NQF measure 
endorsement process. The CDC guidelines ``encourage careful and 
selective use of opioid therapy in the context of managing chronic pain 
through . . . an evidence-based prescribing guideline.'' \119\ The 
guidelines have led to the development of CDC measures on prescribing 
practices on which are seeking comment. We are seeking comment on the 
following three NQF measures for possible inclusion in the Promoting 
Interoperability performance category and any modifications that may be

[[Page 40779]]

necessary to maximize their use in the Promoting Interoperability 
performance category:
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    \119\ https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
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     Use of Opioids at High Dosage in Persons Without Cancer 
(NQF #2940).
     Use of Opioids from Multiple Providers in Persons Without 
Cancer (NQF #2950).
     Use of Opioids from Multiple Providers and at High Dosage 
in Persons Without Cancer (NQF #2951).
    We believe these measures relate to activities that hold promise in 
combatting the opioid epidemic and can be supported using CEHRT to 
complete the actions of the measures. Therefore, we are seeking comment 
on how the Promoting Interoperability performance category can 
incorporate the description of the use of technology into measure 
guidance if these measures were considered for use by MIPS eligible 
clinicians. For example, the actions related to the Use of Opioids from 
Multiple Providers in Persons Without Cancer (NQF #2950) measure could 
include using health IT to electronically prescribe the medication, to 
query a PDMP, to identify other care team members, to conduct 
medication reconciliation based on information received through health 
information exchange with other providers of care, and recording key 
health information in a structured format. Additional information 
regarding each measure is available using NQF's Quality Positioning 
System at http://www.qualityforum.org/QPS/QPSTool.aspx.
(B) CDC Quality Improvement Opioid Measures
    We believe there may be promise in the CDC QI opioid measures based 
on the prescribing best practices found in Appendix B in the CDC 
document, ``Quality Improvement and Care Coordination: Implementing the 
CDC Guideline for Prescribing Opioids for Chronic Pain'' (Implementing 
the CDC Prescribing Guideline).\120\ CDC developed the ``Implementing 
the CDC Prescribing Guideline'' document to help healthcare providers 
and systems integrate the CDC Prescribing Guideline \121\ and the 
associated QI opioid measures found in the Implementing the CDC 
Prescribing Guideline document into their clinical practices. The CDC 
developed 16 QI opioid measures to align with the recommendations in 
the CDC Prescribing Guideline and to improve opioid prescribing. These 
measures are intended to measure implementation of the recommended 
practices.
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    \120\ https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
    \121\ https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.
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    Generally, we believe these guidelines and measures are consistent 
with the objective and measure concept of the Promoting 
Interoperability performance category where the recommendation in the 
CDC Prescribing Guideline is the overarching objective and an 
associated QI opioid measure is a description of the patient population 
focus (denominator) and the desired action (numerator). The 
``Implementing the CDC Prescribing Guideline'' document, also, includes 
practice-level strategies to help organize and improve the management 
and coordination of long-term opioid therapy:
     Using an interdisciplinary team approach.
     Establishing practice policies and standards.
     Using EHR data to develop registries and track QI opioid 
measures.
    These following measures address treatment guidelines for initial 
treatment practices and long-term treatment and outcomes. Examples of 
measures related to short term OUD prevention and treatment activities 
include:
     CDC Measure 2: Check PDMP Before Prescribing Opioids.
     CDC Measure 4: Evaluate Within Four Weeks of Starting 
Opioids.
    Examples of measures related to long term OUD prevention and 
treatment activities include:
     CDC Measure 11: Check PDMP Quarterly.
     CDC Measure 12: Counsel On Risks and Benefits Annually.
    The data sources from these measures include State PDMP data or the 
practice EHR data field.
    The CDC and the Agency for Healthcare Research and Quality (AHRQ) 
are also developing electronic clinical decision support tools that can 
provide real-time clinical decision support for some of the best 
practices included in the Implementing the CDC Prescribing Guideline 
document based on well-defined clinical concepts.\122\ Well-defined 
clinical concepts are those that can be discretely represented by 
available content standards or vocabularies such as SNOMED CT or LOINC. 
In the context of QI measures, these well-defined clinical concepts 
that are part of the clinical decision support artifacts, including the 
clinical conditions or prescribed medications that trigger the decision 
support, could also be used to develop measures for the Promoting 
Interoperability performance category related to OUD prevention and 
treatment. This can create a tight linkage between the guidelines, the 
recommended clinical actions based on the guidelines, and the improved 
outcomes based on the recommended clinical actions.
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    \122\ https://cds.ahrq.gov/cdsconnect/topic/opioids-and-pain-management.
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    Therefore, we are seeking comment on which of the 16 CDC QI opioid 
measures have value for potential consideration for the Promoting 
Interoperability performance category. We are further seeking comment 
on whether we should consider a different type of measurement concept 
for OUD prevention and treatment, such as reporting on a set of cross-
cutting activities and measures to earn credit in the Promoting 
Interoperability performance category (for example, a set of one 
clinical decision support, the related CDC QI opioid measure, and a 
potentially relevant clinical quality measure). While the CDC quality 
measures could be implemented for the Quality category, they are 
highlighted as under consideration for the PI category as they have 
been linked in the CDC work to the use of CDS artifacts through health 
IT, as discussed.
    We refer readers to the ``Implementing the CDC Prescribing 
Guideline'' document, and the related measures, in Appendix B of that 
document, which is available at https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
(iii) Request for Information (RFI) on a Metric To Improve Efficiency 
of Providers Within EHRs
    One of the benefits of adopting EHRs is increasing the efficiency 
of health care processes and generating cost savings by eliminating 
time-consuming paper-based processes. Through the use of EHRs, health 
care providers are able to automate administrative aspects of delivery 
system management, such as coding and scheduling, easily locate patient 
information in electronic charts, and streamline communications with 
other health care providers through electronic means.
    However, research, also, points to variable results from the 
implementation of health IT across practice settings, suggesting that 
health IT adoption is not a universal remedy for inefficient practice. 
Stakeholders continue to describe ways in which the potential benefits 
of EHRs have not been fully realized, and are pointing to non-optimized 
electronic workflows and poor system design that can increase, rather 
than reduce, administrative burden, which contributes to physician

[[Page 40780]]

burnout.\123\ For instance, in many systems, stakeholders have 
identified EHR functionality associated with clinical documentation, 
order entry, and messaging as cumbersome. It is our understanding that 
in order to achieve true EHR efficiency gains in today's healthcare 
environment, the way forward must include reductions in the persistent 
sources of technology-related burden, an increased allowance for 
ancillary medical staff to assist in medical documentation, and through 
the more effective use of technology.
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    \123\ https://www.ahrq.gov/professionals/clinicians-providers/ahrq-works/burnout/index.html.
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    In November 2018, the Office of the National Coordinator for Health 
Information Technology (ONC) released the draft report ``Strategy on 
Reducing Regulatory and Administrative Burden Relating to the Use of 
Health IT and EHRs,'' \124\ as required by section 4001 of the 21st 
Century Cures Act (Pub. L. 114-255, enacted December 13, 2016). In the 
draft report, ONC described a variety of factors that may contribute to 
EHR-related burden, and provided draft recommendations for how HHS, as 
well as other stakeholders may be able to address these factors. 
Specifically, the draft report discussed processes where adoption of 
improved electronic processes could reduce the EHR-related burden, such 
as processes related to prior authorization requests. The draft report, 
also, discussed EHR usability and design challenges which may 
contribute to EHR-related burden, and identified best practices for 
design, as well as a variety of emerging system features which may 
improve efficiency in health IT usage. We believe further adoption of 
more efficient workflows and technologies, such as those identified in 
the draft report, will help health care providers with overall 
improvements in patient care and interoperability, and we are seeking 
comment on how such implementation of such processes can be effectively 
measured and encouraged as part of the Promoting Interoperability 
performance category.
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    \124\ https://www.healthit.gov/sites/default/files/page/2018-11/Draft%20Strategy%20on%20Reducing%20Regulatory%20and%20Administrative%20Burden%20Relating.pdf.
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    We also are interested in how to measure and incentivize efficiency 
as it relates to the meaningful use of CEHRT and the furthering of 
interoperability. In 2017, the NQF released, ``A Measurement Framework 
to Assess Nationwide Progress Related to Interoperable Health 
Information Exchange to Support the National Quality Strategy,'' \125\ 
which included discussion of measure concepts of productivity and 
efficiency that can result from the use of health IT, specifically the 
health information exchange. For instance, the NQF report identifies a 
measure concept for the ``percentage of reduction of duplicate labs and 
imaging over time,'' which can capture the impact of electronic 
availability of imaging studies on duplicative studies that are often 
conducted when health care providers do not have the ability to locate 
an existing study. However, we recognize that there are challenges 
associated with tying such measures of economic efficiency to a single 
factor, such as electronic workflow improvements.\126\
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    \125\ https://www.qualityforum.org/Publications/2017/09/Interoperability_2016-2017_Final _Report.aspx.
    \126\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699907/.
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    Consistent with our commitment to reducing administrative burden, 
increasing efficiencies, and improving beneficiary experience via the 
``Patients over Paperwork initiative,'' \127\ we are seeking 
stakeholder feedback on a potential metric to evaluate health care 
provider efficiency using EHRs. Specifically, we are requesting 
information on the following questions:
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    \127\ https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.html.
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     What do stakeholders believe would be useful ways to 
measure the efficiency of health care processes due to the use of 
health IT? What are measurable outcomes demonstrating greater 
efficiency in costs or resource use that can be linked to the use of 
health IT-enabled processes? This includes measure description, 
numerator/denominator or yes/no reporting, and exclusions.
     What do stakeholders believe may be hindering their 
ability to achieve greater efficiency (for example, product, measures, 
CMS regulations)? Please, provide examples.
     What are specific technologies, capabilities, or system 
features (beyond those currently addressed in the Promoting 
Interoperability performance category) that can increase the efficiency 
of provider interactions with technology systems; for instance, 
alternate authentication technologies that can simplify provider logon? 
How could we reward providers for adoption and use of these 
technologies?
     What are key administrative processes that can benefit 
from more efficient electronic workflows; for instance, conducting 
prior authorization requests? How can we measure and reward providers 
for their uptake of more efficient electronic workflows?
     Could CMS successfully incentivize efficiency? What role 
should CMS play in improving efficiency in the practice of medicine? 
The underlying goal is to move to a more streamlined, efficient, easier 
user experience, whereby providers can input and access a patient's 
data in a reliable, timely manner. Having not yet reached this point, 
we are seeking feedback on the best way(s) to get there.
(iv) Request for Information (RFI) on the Provider to Patient Exchange 
Objective
    In March 2018, the White House Office of American Innovation and 
the CMS Administrator announced the launch of MyHealthEData and CMS' 
role in improving patient access and advancing interoperability. As 
part of the MyHealthEData initiative, we are taking a patient-centered 
approach to health information access and moving to a system in which 
patients have immediate access to their computable health information 
and can be assured that their health information will follow them as 
they move throughout the health care system from provider to provider, 
payer to payer. To accomplish this, we have launched several 
initiatives related to data sharing and interoperability to empower 
patients and encourage plan and provider competition. One example is 
our overhaul of the Advancing Care Information performance category 
under MIPS to transform it into the new Promoting Interoperability 
performance category, which put a heavy emphasis on patient access to 
their health information through the Provide Patients Electronic Access 
to Their Health Information measure.
    Through the Provide Patients Electronic Access to Their Health 
Information measure, we are ensuring that patients have access to their 
information through any application of their choice that is configured 
to meet the technical specifications of the API in the MIPS eligible 
clinician's CEHRT. To make these APIs fully useful to patients, they 
should provide immediate access to updated information whenever the 
patient needs that information, should be always available, configured 
using standardized technology and contain the information a patient 
needs to make informed decisions about their care.
    In the CY 2019 PFS proposed rule (83 FR 35932), we introduced a 
potential future Promoting Interoperability performance category 
concept that explored creating a set of priority health IT activities 
that would serve as alternatives to the traditional Promoting

[[Page 40781]]

Interoperability performance category measures. We requested public 
comment on whether MIPS eligible clinicians should earn credit in the 
Promoting Interoperability performance category by attesting to health 
IT or interoperability activities in lieu of reporting on specific 
measures. We identified specific health IT activities and sought public 
comment on those and additional activities that would add value for 
patients and health care providers, are relevant to patient care and 
clinical workflows, support alignment with existing objectives, promote 
flexibility, are feasible for implementation, are innovative in the use 
of health IT, and promote interoperability. We received feedback in 
support of this future concept.
    One such activity that we specifically requested comment on was a 
health IT activity in which MIPS eligible clinicians may obtain credit 
in the Promoting Interoperability performance category if they maintain 
an ``open API,'' or standards-based API, which allows patients to 
access their health information through a preferred third-party 
application. An API can be thought of as a set of commands, functions, 
protocols, or tools published by one software developer (``Developer 
A'') that enables other software developers to create programs 
(applications or ``apps'') that can interact with developer A's 
software without needing to know the internal workings of developer A's 
software, all while maintaining consumer privacy data standards. This 
is how API technology creates a seamless user experience that is, 
typically, associated with other applications that are used in more 
common aspects of consumers' daily lives, such as travel and personal 
finance. Standardized, transparent, and pro-competitive API technology 
can enable similar benefits to consumers of health care services.\128\
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    \128\ ONC has made available a succinct, non-technical overview 
of APIs in context of consumers' access to their own medical 
information across multiple providers' EHR systems, which is 
available at the HealthIT.gov website at https://www.healthit.gov/api-education-module/story_html5.html.
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    We received feedback from several commenters regarding concerns 
that an ``open'' API may open the door to patient data without 
security, leaving MIPS eligible clinicians' EHR systems open for cyber-
attacks. However, we wish to note that the term ``open API'' does not 
imply that any and all applications or application developers would 
have unfettered access to individuals' personal or sensitive 
information nor would it allow for any reduction in the required 
protections for privacy and security of patient health information. 
Additionally, with respect to patient access, a patient will need to 
authenticate him/herself to a health care organization that is the 
steward of their data (for example, username and password) and the 
access provided to an app will be for that one patient. The overall 
HIPAA Security Rule, HIPAA Privacy Rule, and other cybersecurity 
obligations that apply to HIPAA covered entities remain the same and 
would need to be applied to an API in the same way they are currently 
applied to any and all other interfaces a health care organization 
deploys in production.
    ONC's 21st Century Cures Act proposed rule (84 FR 7424 through 
7610) includes new proposals that focus on how certified health IT can 
use APIs to allow health information to be accessed, exchanged, and 
used without special effort through the use of APIs or successor 
technology or standards, as provided for under applicable law. For 
instance, ONC has proposed to adopt a new criterion for a standards-
based API at Sec.  170.315(g)(10). This standards-based API criterion 
would replace the existing API criterion with one that requires the use 
of the HL7 Fast Healthcare Interoperability Resources (FHIR[supreg]) 
standard. ONC has also proposed a series of requirements for the 
standards-based API that would improve interoperability by focusing on 
standardized, transparent, and pro-competitive API practices.
    ONC has proposed to make the standards-based API criterion part of 
the 2015 Edition base EHR definition (84 FR 7427), which would ensure 
that this functionality is ultimately included in the CEHRT definition 
required for participation in the Promoting Interoperability 
performance category. If finalized, health IT developers would have 24 
months from the publication of the final rule to implement these 
changes to certified health IT products.
(A) Immediate Access
    The existing Provide Patients Electronic Access to Their Health 
Information measure specifies that the MIPS eligible clinicians provide 
the patient timely access to view online, download, and transmit his or 
her health information, and further specifies that patient health 
information must be made available to the patient within 4 business 
days of its availability to the MIPS eligible clinicians. We believe it 
is critical for patients to have access to their health information 
when making decisions about their care. In the recently published 
proposed rule titled, ``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'' (84 FR 7610 through 
7680) (hereinafter referred to as the ``CMS Interoperability and 
Patient Access proposed rule''), we proposed that certain health plans 
and payers be required to make patient health information available 
through an open, standards-based API no later than one business day 
after it is received by the health plan or payer.
    Recognizing the importance of patients having access to their 
complete health information, including clinical information from the 
MIPS eligible clinicians' CEHRT, and appreciating the new technical 
flexibility a standards-based API would provide, we are seeking comment 
on whether MIPS eligible clinicians should make patient health 
information available immediately through an open, standards-based API, 
no later than one business day after it is available to the MIPS 
eligible clinicians in their CEHRT. We seek comment on the barriers to 
more immediate access to patient information. Additionally, we seek 
comment on whether there are specific data elements that may be more or 
less feasible to share no later than one business day. We also seek 
comment as to when implementation of such a requirement is feasible.
(B) Persistent Access and Standards-Based APIs
    As discussed above, the ONC 21st Century Cures Act proposed rule 
(84 FR 7479) includes a proposal for adoption of API conditions of 
certification that ensure a standards-based API is implemented in a 
manner that provides unimpeded access to technical documentation, is 
non-discriminatory, preserves rights of access, and minimizes costs or 
other burdens that could result in special effort. The ONC 21st Century 
Cures Act proposed rule (84 FR 7575), also, includes requirements for 
the standardized API related to privacy and security to ensure that 
patient health information is protected.
    The existing Provide Patients Electronic Access to Their Health 
Information measure does not specify the overall operational 
expectations associated with enabling patients' access to their health 
information. For instance, the measure only specifies that

[[Page 40782]]

access must be ``timely.'' As a result, we request public comment on 
whether we should revise the measure to be more specific with respect 
to the experience patients should have regarding their access. For 
instance, in the ONC 21st Century Cures Act proposed rule (84 FR 7481 
through 7484), there is a proposal regarding requirements around 
persistent access to APIs, which would accommodate a patient's routine 
access to their health information without needing to reauthorize their 
application and re-authenticate themselves. We seek comment on whether 
the Promoting Interoperability performance category measure should be 
updated to accommodate this proposed technical requirement for 
persistent access.
    As we work to advance interoperability and empower patients through 
access to their health information, we continue to explore the role of 
APIs. We support the ONC 21st Century Cures Act proposed rule (84 FR 
7424) proposal to move to an HL7 FHIR[supreg]-based API under 2015 
Edition certification (84 FR 7479). Health care providers committed to 
a standards-based API could benefit from joining in on the industry's 
new FHIR standards framework to reduce burden in, and improve on, 
quality measurement through automation and simplification. Use of FHIR-
based APIs could help push forward interoperability regardless of EHR 
systems used providing standardized way to share information.
    Understanding this, we are, specifically, seeking public comments 
on the following question:
     If ONC's proposed FHIR-based API certification criteria is 
finalized, would stakeholders support a possible bonus under the 
Promoting Interoperability performance category for early adoption of a 
certified FHIR-based API in the intermediate time before ONC's final 
rule's compliance date for implementation of a FHIR standard for 
certified APIs?
(C) Available Data
    Recognizing the overall burden that switching EHR systems places on 
health care providers, ONC has introduced a new proposal that seeks to 
minimize that burden. In the ONC 21st Century Cures Act proposed rule, 
ONC proposed to adopt a new 2015 Edition certification criterion for 
the EHI export at 45 CFR 170.315(b)(10). The purpose of this criterion 
is to provide patients and health IT users the ability to securely 
export the entire EHR for a single patient, or all patients, in a 
computable, electronic format, and facilitate receiving the health IT 
system's interpretation, and use of the EHI, to the extent that is 
reasonably practicable using the existing technology of developers. 
This patient-focused export capability complements other provisions of 
the proposed rule that support patients' access to their EHI, including 
information that may eventually be accessible via the proposed 
standardized API in 45 CFR 170.215. It is also complementary to the 
proposals in the CMS Interoperability and Patient Access proposed rule, 
which proposed to require certain health plans and issuers to provide 
patients access to their health data through a standardized API.
    Building on these proposals, we are seeking comment on an 
alternative measure under the Provider to Patient Exchange objective 
that would require clinicians to use technology certified to the EHI 
criterion to provide the patient(s) their complete electronic health 
data contained within an EHR.
    Specifically, we are seeking comment on the following questions:
     Do stakeholders believe that incorporating this 
alternative measure into the Provider to Patient Exchange objective 
will be effective in encouraging the availability of all data stored in 
health IT systems?
     In relation to the Provider to Patient Exchange objective, 
as a whole, how should a required measure focused on using the proposed 
total EHI export function in CEHRT be scored?
     If this certification criterion is finalized and 
implemented, should a measure based on the criterion be established as 
a bonus measure? Should this measure be established as an attestation 
measure?
     In the long term, how do stakeholders believe such an 
alternative measure would impact burden?
     If stakeholders do not believe this will have a positive 
impact on burden, in what other way(s) might an alternative measure be 
implemented that may result in burden reduction? Please, be specific.
     Which data elements do stakeholders believe are of 
greatest clinical value or would be of most use to health care 
providers to share in a standardized electronic format if the complete 
record was not immediately available?
    In addition to the above questions, we have some general questions 
that are related to health IT activities, for which we are, also, 
seeking public comment:
     Do stakeholders believe that we should consider including 
a health IT activity that promotes engagement in the health information 
exchange across the care continuum that would encourage bi-directional 
exchange of health information with community partners, such as post-
acute care, long-term care, behavioral health, and home and community 
based services to promote better care coordination for patients with 
chronic conditions and complex care needs? If so, what criteria should 
we consider when implementing a health information exchange across the 
care continuum health IT activity in the Promoting Interoperability 
performance category?
     What criteria should we employ, such as specific goals or 
areas of focus, to identify high priority health IT activities for the 
future of the performance category?
     Are there additional health IT activities we should 
consider recognizing in lieu of reporting on existing measures and 
objectives that would most effectively advance priorities for 
nationwide interoperability and spur innovation?
(D) Patient Matching
    ONC has stated that patient matching is critically important to 
interoperability and the nation's health IT infrastructure as health 
care providers must be able to share patient health information and 
accurately match a patient to his or her data from a different health 
care provider in order for many anticipated interoperability benefits 
to be realized. We continue to support ONC's work promoting the 
development of patient matching initiatives. Per Congress' guidance, 
ONC is looking at innovative ways to provide technical assistance to 
private sector-led initiatives to further develop accurate patient 
matching solutions in order to promote interoperability without 
requiring a unique patient identifier (UPI). We understand the 
significant health information privacy and security concerns raised 
around the development of a UPI standard and the current prohibition 
against using HHS funds to adopt a UPI standard (84 FR 7656).
    Recognizing Congress' statement regarding patient matching and 
stakeholder comments stating that a patient matching solution would 
accomplish the goals of a UPI, we are seeking comment for future 
consideration on ways for ONC and CMS to continue to facilitate private 
sector efforts on a workable and scalable patient matching strategy so 
that the lack of a specific UPI does not impede the free flow of 
information. We are also seeking comment on how we may leverage our 
authority to provide support to those working to improve patient 
matching. We note that we intend to use comments we receive for

[[Page 40783]]

the development of policy and future rulemaking.
     Do stakeholders believe that CMS and ONC patient matching 
efforts impact burden? Please, explain.
     If stakeholders believe that patient matching is leading 
to increased burden, what suggestions might stakeholders have to 
promote interoperability securely and accurately, without the 
requirement of a UPI, that may result in burden reduction? Please, be 
specific.
(v) Request for Information (RFI) on Integration of Patient-Generated 
Health Data Into EHRs Using CEHRT
    The Promoting Interoperability performance category is continuously 
seeking ways to prioritize the advanced use of CEHRT functionalities, 
encourage movement away from paper-based processes that increase health 
care provider burden, and empower individual beneficiaries to take a 
more impactful role in managing their health to achieve their goals. 
Increased availability of patient-generated health data (PGHD) \129\ 
offers providers an opportunity to monitor and track a patient's 
health-related data from information that is provided by the patient 
and not the provider. Increasingly affordable wearable devices, 
sensors, and other technologies capture PGHD, providing new ways to 
monitor and track a patient's healthcare experience. Capturing 
important health information through devices and other tools between 
medical visits could help improve care management and patient outcomes, 
potentially resulting in increased cost savings. Although many types of 
PGHD are being used in clinical settings today, the continuous 
collection and integration of patients' health-data into EHRs to inform 
clinical care has not been widely achieved across the health care 
system.
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    \129\ For more information, we refer readers to https://www.healthit.gov/topic/scientific-initiatives/patient-generated-health-data.
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    In the 2015 Edition Health IT Certification Criteria final rule (80 
FR 62661; 45 CFR 170.315(e)(3)), ONC finalized a criterion for patient 
health information capture functionality within certified health IT 
that allows a user to identify, record, and access information directly 
and electronically shared by a patient. We finalized a PGHD measure 
requiring health care providers to incorporate PGHD or data from a 
nonclinical setting into CEHRT (80 FR 62851). However, we removed this 
measure in the CY 2019 PFS final rule (83 FR 59813), due to concerns 
that the measure was not fully health IT-based and could include paper-
based actions, an approach which did not align with program priorities 
to advance the use of CEHRT. Stakeholder comments regarding this 
measure also noted that manual processes to conduct actions associated 
with the measure could increase health care provider reporting burden 
and that there was confusion over which types of data would be 
applicable and the situations in which the patient data would apply. At 
the same time, there was ample support from the public for ONC and CMS 
to continue to advance certified health IT capabilities to capture 
PGHD.
    However, we continue to believe that it is important for the 
Promoting Interoperability performance category to explore new ways to 
incentivize health care providers who take proactive steps to advance 
the emerging use of PGHD. As relevant technologies and standards 
continue to evolve, there may be new approaches through which we can 
address challenges related to emerging standards for PGHD capture, 
appropriate clinical workflows for receiving and reviewing PGHD, and 
advance the technical architecture needed to support PGHD use.
    In 2018, ONC released the white paper, ``Conceptualizing a Data 
Infrastructure for the Capture, Use, and Sharing of Patient-Generated 
Health Data in Care Delivery and Research through 2024,'' \130\ which 
described key challenges, opportunities and enabling actions for 
different stakeholders, including clinicians, to advance the use of 
PGHD. For instance, the report identified an enabling action around 
supporting ``clinicians to work within and across organizations to 
incorporate prioritized PGHD use cases into their workflows.'' This 
action urges clinicians and care teams to identify priority use cases 
and relevant PGHD types that would be valuable to improving care 
delivery for patient populations. It, also, highlights the importance 
of developing clinical workflows that avoid overwhelming the care team 
with extraneous data by encouraging care teams to develop management 
strategies for shared responsibilities around collecting, verifying, 
and analyzing PGHD. A second enabling action the white paper identifies 
for clinicians is, ``collaboration between clinicians and developers to 
advance technologies supporting PGHD interpretation and use.'' This 
enabling action highlights feedback for developers about prioritized 
use cases and application features as critical to ensuring that the 
necessary refinements are made to technology solutions to effectively 
support the capture and use of PGHD. Finally, the report encourages 
``clinicians in providing patient education to encourage PGHD capture 
and use in ways that maximize data quality,'' recognizing the important 
role that clinicians can play in helping patients understand how to 
share PGHD, the differences between solicited and unsolicited PGHD, and 
how PGHD are relevant for the patient's care.
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    \130\ https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf.
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    Considering the enabling actions for clinicians identified in the 
white paper, we are interested in ways that the Promoting 
Interoperability performance category could adopt new elements related 
to PGHD that: (1) Represent clearly defined uses of health IT; (2) are 
linked to positive outcomes for patients; and (3) advance the capture, 
use, and sharing of PGHD. In considering how the Promoting 
Interoperability performance category could continue to advance the use 
of PGHD, we also note that a future element related to PGHD would not 
necessarily need to be implemented as a traditional measure requiring 
reporting of a numerator and denominator. For instance, in the CY 2019 
PFS proposed rule (83 FR 35932), we requested comment on the concept of 
``health IT'' or ``interoperability'' activities to which a health care 
provider could attest, potentially in lieu of reporting on measures 
associated with certain objectives. By addressing the use of PGHD 
through such a concept, rather than traditional measure reporting, we 
could potentially reduce the reporting burden associated with a new 
PGHD-related element.
    We are inviting stakeholder comment on these concepts, and the 
specific questions below:
     What specific use cases for capture of PGHD as part of 
treatment and care coordination across clinical conditions and care 
settings are most promising for improving patient outcomes? For 
instance, use of PGHD for capturing advanced directives and pre/post-
operation instructions in surgery units.
     Should the Promoting Interoperability performance category 
explore ways to reward providers for engaging in activities that pilot 
promising technical solutions or approaches for capturing PGHD and 
incorporating it into CEHRT using standards-based approaches?
     Should health care providers be expected to collect 
information from their patients outside of scheduled appointments or 
procedures? What are the benefits and concerns about doing so?
     Should the Promoting Interoperability performance category

[[Page 40784]]

explore ways to reward health care providers for implementing best 
practices associated with optimizing clinical workflows for obtaining, 
reviewing, and analyzing PGHD?
    We believe the bi-directional availability of data, meaning that 
both patients and their health care providers have real-time access to 
the patient's electronic health record, is critical. This includes 
patients being able to import their health data into their medical 
record and have it be available to health care providers. We welcome 
input on how we can encourage, enable, and reward health care providers 
to advance capture, exchange, and use of PGHD.
(vi) Request for Information (RFI) on Engaging in Activities That 
Promote the Safety of the EHR
    The widespread adoption of EHRs has transformed the way health care 
is delivered, offering improved availability of patient health 
information, supporting more informed clinical decision making, and 
reduce medical errors.\131\ However, many stakeholders have identified 
risks to patient safety as one of the unintended consequences that may 
result from the implementation of EHRs. By disrupting established 
workflows and presenting clinicians with new challenges, EHR 
implementation may increase the incidence of certain errors, resulting 
in harm to patients.
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    \131\ https://www.healthit.gov/topic/health-it-basics/improved-patient-care-using-ehrs.
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    As we continue to advance the use of CEHRT in health care, we are 
seeking comment on how to further mitigate the specific safety risks 
that may arise from technology implementation. Specifically, we are 
seeking comment on ways that the Promoting Interoperability performance 
category may reward MIPS eligible clinicians for engaging in activities 
that can help to reduce the errors associated with EHR implementation.
    For instance, we are requesting comment on a potential future 
change to the performance category under which MIPS eligible clinicians 
would receive points towards their Promoting Interoperability 
performance category score for attesting to performance of an 
assessment based on one of the ONC SAFER Guides. The SAFER Guides 
(available at https://www.healthit.gov/topic/safety/safer-guides) are 
designed to help healthcare organizations conduct self-assessments to 
optimize the safety and safe use of EHRs in nine different areas: High 
Priority Practices, Organizational Responsibilities, Contingency 
Planning, System Configuration, System Interfaces, Patient 
Identification, Computerized Provider Order Entry, Test Results 
Reporting and Follow-Up, and Clinician Communication.
    Each of the SAFER Guides is based on the best evidence available, 
including a literature review, expert opinion, and field testing at a 
wide range of healthcare organizations, from small ambulatory practices 
to large health systems. A number of EHR developers currently utilize 
the SAFER Guides as part of their health care provider training 
modules.
    Specifically, we might consider offering points towards the 
Promoting Interoperability performance category score to MIPS eligible 
clinicians that attest to conducting an assessment based on the High 
Priority Practices \132\ and/or the Organizational Responsibilities 
\133\ SAFER Guides which cover many foundational concepts from across 
the guides. Alternatively we might consider awarding points for review 
of all nine of the SAFER Guides. We are also inviting comments on 
alternatives to the SAFER Guides, including appropriate assessments 
related to patient safety, which should also be considered as part of 
any future bonus option.
---------------------------------------------------------------------------

    \132\ https://www.healthit.gov/sites/default/files/safer/guides/safer_high_priority_practices.pdf.
    \133\ https://www.healthit.gov/sites/default/files/safer/guides/safer_organizational_responsibilities.pdf.
---------------------------------------------------------------------------

    We are requesting comment on the ideas above, as well as inviting 
stakeholders to suggest other approaches we may take to rewarding 
activities that promote reduction of safety risks associated with EHR 
implementation as part of 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 of an APM Entity 
participating in a MIPS APM for the applicable MIPS performance period.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77246), the APM scoring standard is designed to reduce reporting 
burden for such 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).

[[Page 40785]]

     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).
     Primary Care First (All Tracks).
    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 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 propose 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 only 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 request comment on this proposal.
(B) APM Quality Reporting Credit
    We are also proposing 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, where 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 that do not elect to participate in MIPS from the 
definition of a MIPS eligible clinician. In addition, section 
1848(q)(5)(C)(ii) of the Act requires that participation by a MIPS 
eligible clinician in an APM (as defined in section 1833(z)(3)(C) of 
the Act) earn 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 are proposing to apply a similar approach to quality 
performance category scoring under the APM scoring standard. 
Specifically, we are proposing that APM Entity groups participating in 
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 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

[[Page 40786]]

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 request comment on this proposal.
(i) Exceptions From APM Quality Reporting Credit
    Under this proposal, 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 mechanism 
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 mechanism 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 in they would in any 
Other MIPS APM in accordance with Sec.  414.1370(g)(1)(ii). However, as 
in these cases no burden of duplicative reporting would exist, they 
would remain ineligible for the APM Quality Reporting credit.
(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 
entity. Likewise, we recognize that some APMs, such as the CMS Web 
Interface reporters already require reporting on MIPS quality measures 
as part of participation in the APM. Therefore, we are proposing that, 
in instances where an APM Entity has reported quality measures to MIPS 
through a MIPS submission type and using MIPS 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 request comment on this proposal.
(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 
proposals discussed in section[s] III.J.3.d.(1)(b) of this proposed 
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 
believe it would be inappropriate 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 would 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.
    We request comment on this proposal.
(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 section III.J.3.c.(5)(c)(i)(c) of this proposed 
rule, we are proposing 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. 
In light of this proposal, we believe that the same extreme and 
uncontrollable circumstances policies that apply to other MIPS eligible 
clinicians with regard to the quality performance category should also 
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 propose 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). We would limit the proposed application 
of these policies to the quality performance category because our 
proposal in section III.J.3.c.(5)(c)(i) 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 propose 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 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 was a 
solo practitioner and qualified for a zero percent weighting, if the 
MIPS eligible clinician's TIN did not report at the group level and the 
MIPS eligible

[[Page 40787]]

clinician was 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 welcome 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.
    We request comment on this proposal.
(d) Request for Comment on APM Scoring Beyond 2020
    We are also seeking comment on potential policies to be included in 
next year's rulemaking to further address the changing incentives for 
APM participation under MACRA. We want the design of the APM scoring 
standard to continue to encourage appropriate shifts of MIPS eligible 
clinicians into MIPS APMs and eventually into Advanced APMs while 
ensuring fair treatment for all MIPS eligible clinicians.
    We note 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.
(F) 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 now are proposing 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.
(i) Sunsetting the APM Quality Reporting Credit for APM Entities
    One proposal 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 believe that this proposal 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. This proposal 
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.
(ii) Sunsetting the APM Quality Reporting Credit for Non-Advanced APMs
    Similar to the first proposal, 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 tracks.
    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).
    Alternatively 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 Advanced 
APM tracks of an APM after the initial agreement period after the start 
of the APM.
(iii) 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 proposal 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.
(iv) 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 by the MIPS APM. For example, the 
maximum 50 percent credit may continue to be available to APM Entities 
in Advanced APM tracks while the value of the credit may be limited to 
25 percent for participants in one-sided risk tracks. We are soliciting 
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.
(v) Other Options
    We seek 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.
(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

[[Page 40788]]

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, whereas 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.
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 MIPS Value Pathways (MVP) Framework as 
discussed in section III.K.3.a. of this proposed 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 this proposed rule, we are proposing 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.(2) of this proposed 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 propose to transform the MIPS program through MVPs, 
our goal is to incorporate ways to address these issues without 
developing special scoring policies. We refer readers to section 
III.K.3.a.(3)(d) of this proposed rule, for further discussion on 
scoring of MVPs.
    In section III.K.3.d.(1) of this proposed rule, we discuss the 
limited proposals for our scoring policies as we anticipate future 
changes as we work to transform MIPS through MVPs. Specifically, we are 
proposing 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 are requesting comment on future approaches to scoring the 
CAHPS for MIPS survey measure if new questions are added to the survey. 
These proposals are discussed in more detail in this section of the 
proposed rule.
(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.
(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 are proposing 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 proposed 
MVPs discussed in section III.K.3.a. of this proposed 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 proposed framework before proposing to remove the 
3-point floor. Accordingly, we are proposing 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.

[[Page 40789]]

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.
(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 proposed policies for the CY 2020 MIPS performance 
period is provided in Table 43.

   Table 43--Quality Performance Category: Proposed Scoring Policies for the CY 2020 MIPS Performance Period *
----------------------------------------------------------------------------------------------------------------
            Measure type                               Description                           Scoring rules
----------------------------------------------------------------------------------------------------------------
Class 1............................  For the 2020 MIPS performance period:               For the 2020 MIPS
                                     Measures that can be scored based on                 performance period: 3
                                      performance..                                       to 10 points based on
                                     Measures that are submitted or calculated that       performance compared
                                      meet all the following criteria:.                   to the benchmark.
                                     (1) Has a benchmark;...........................
                                     (2) Has at least 20 cases; and.................
                                     (3) Meets the data completeness standard
                                      (generally 70 percent for 2020.) **.
                                     ** We refer readers to section III.K.3.c.(1)(c)
                                      for our proposal to increase data
                                      completeness..
Class 2............................  For the 2020 MIPS performance period:            For the 2020 MIPS
                                     Measures that are submitted and meet data         performance period:
                                      completeness, but do not have either of the     3 points.
                                      following:.
                                     (1) A benchmark................................
                                     (2) At least 20 cases..........................
Class 3............................  For the 2020 MIPS performance period:            Beginning with the 2020
                                     Measures that are submitted, but do not meet      MIPS performance period:
                                      data completeness threshold, even if they have  MIPS eligible clinicians
                                      a measure benchmark and/or meet the case         other than small
                                      minimum.                                         practices will receive
                                                                                       zero measure achievement
                                                                                       points. Small practices
                                                                                       will continue to receive
                                                                                       3 points.
----------------------------------------------------------------------------------------------------------------
* The Class 2 and 3 measure scoring policies are not applicable to CMS Web Interface measures or administrative
  claims-based measures.

    For the 2022 MIPS payment year, we are proposing 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 are proposing to amend Sec.  
414.1380(b)(1)(i)(A)(1) to remove the years 2019, 2020, and 2021 and 
adding 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.
(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 
are proposing to establish benchmarks based on flat percentages in 
specific cases where we determine the measure's

[[Page 40790]]

otherwise applicable benchmark could potentially incentivize treatment 
that could be inappropriate for a particular patient type. Rather than 
develop benchmarks based on the distribution of scores we would base 
them on flat percentages such that any performance rate at or above 90 
percent would be in the top decile and any performance rate above 80 
percent would be in the second highest decile, and this would continue 
for the remaining deciles. We believe the measures that would 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 are proposing 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 
would be applying the flat percentages to ensure that the benchmark 
does not result in inappropriate and potentially harmful patient 
treatment. We believe this adjustment would provide additional 
protection to patients and reduce the potential incentive for 
inappropriate treatment of patients.
    We propose 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 would 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 would propose the modified benchmark for 
the applicable MIPS payment year through rulemaking. This policy would 
be effective beginning with the CY 2020 MIPS performance period (and 
thus the 2022 MIPS payment adjustment year). We also seek 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. 
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 are proposing 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). 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 seek 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 are proposing to modify, we would 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 would 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 would add 
complexity to the program overall. We seek 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 are proposing 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, 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 Sec.  414.1380(b)(1)(ii). We also 
propose 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.

[[Page 40791]]

(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 this proposed rule, we are not proposing 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 are considering expanding the information 
collected in the CAHPS for MIPS survey measure, described in section 
III.K.3.c.(1) of this proposed rule, and seek 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 section III.K.3.c.(1)(c)(i) of this proposed rule. In 
addition, we are interested in learning from organizations with 
experience scoring narrative information, including methodologies. We 
would work with stakeholders on user testing before proposing any such 
methodology in future rulemaking. We are also considering 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 section III.I.3.a.(1) of this proposed rule. 
We are interested in feedback regarding how to score this measure. The 
new questions could potentially be added to the calculation for a score 
for the CAHPS for MIPS survey measure. We would consider any changes 
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 this proposed rule, we do not propose any changes to this 
policy. However, we refer readers to section III.K.3.d.(2)(b)(ii)(A) of 
this proposed 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 proposed 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 propose 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 (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.
    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 this proposed rule, we propose to maintain the cap on measure 
points for reporting high priority measures for the 2022 MIPS payment 
year. Accordingly, we propose 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.
(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 this proposed rule, we propose to continue to assign and 
maintain the cap on measure bonus points for end-to-end electronic 
reporting for the 2022 MIPS payment year. We believe with the proposed 
framework for transforming MIPS through the MVPs discussed in section 
III.K.3.a. of this proposed rule, 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 proposed framework before 
proposing to remove our policy of assigning bonus points for end-to-end 
electronic reporting. Accordingly, we propose 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.
(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 this proposed rule, we propose to continue our previously 
established

[[Page 40792]]

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. 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.
(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-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 are not proposing 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 do not propose any changes to the eligibility of 
facility-based measurement for individuals or groups, we are proposing 
to amend Sec.  414.1380(e)(2)(i)(C) to improve clarity. Specifically, 
we propose 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 are proposing 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.
(iii) Facility-Based Measures for CY 2020 MIPS Performance Period/2022 
MIPS Payment Year
    For informational purposes, we are providing in Table 44 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).
BILLING CODE 4120-01-P

[[Page 40793]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.086

BILLING CODE 4120-01-C
(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 
proposed rule, where we discuss our proposals 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 proposed rule, 
where we discuss our proposals for the Promoting Interoperability 
performance category.
(2) Calculating the Final Score
    For a description of the statutory basis and our policies for 
calculating the final score for MIPS eligible clinicians, we refer 
readers to Sec.  414.1380(c) 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 53769 through 53785), and CY 2019 PFS 
final rule (83 FR 59868 through 59878). In this proposed rule, we are 
proposing to continue the complex patient bonus for the 2022 MIPS 
payment year and to establish performance category reweighting policies 
for the 2022, 2023, and 2024 MIPS payment years.
(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

[[Page 40794]]

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 
propose 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. Although we intend to maintain 
the complex patient bonus as a short-term solution, we do not believe 
we have sufficient information available at this time to develop a 
long-term solution to account for patient risk factors in MIPS such 
that we would be able to include a different approach in this proposed 
rule. 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 \134\ 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. The second ASPE report is expected in October 2019 as 
required by the IMPACT Act, and will examine additional risk factors 
and data. We expect the second report will build on the analyses 
included in initial report and may provide additional insight for a 
long-term solution to addressing risk factors in MIPS. At this time, we 
do not believe additional data sources are available that would be 
feasible to use as the basis for a different approach to account for 
patient risk factors in MIPS. We 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.
---------------------------------------------------------------------------

    \134\ 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.
---------------------------------------------------------------------------

    With newly available data from the Quality Payment Program, we 
considered whether the data still support the complex patient bonus at 
the final score level. We have replicated analyses similar to the ones 
presented in Table 27 of the CY 2018 Quality Payment Program final rule 
(82 FR 53776). However, our latest analyses use the data submitted for 
the Quality Payment Program for the 2017 MIPS performance period and 
assess eligibility and final scores based on the proposals we are 
making for the 2020 MIPS performance period/2022 MIPS payment year 
using the methodology described in the Regulatory Impact Analysis in 
section VI. of this proposed rule.
    In the CY 2018 Quality Payment Program final rule (82 FR 53771 
through 53776), when considering approaches for a complex patient 
bonus, we reviewed evidence to identify how indicators of patient 
complexity have an impact on performance under MIPS, as well as 
availability of data to implement the bonus. Specifically, we 
identified two potential indicators for complexity: Medical complexity 
as measured through Hierarchical Condition Category (HCC) risk scores; 
and social risk as measured through the proportion of patients with 
dual eligible status.
    We identified these indicators because they are common indicators 
of patient complexity in the Medicare program and the data is readily 
available. Both of these indicators have been used in CMS programs to 
account for risk and both data elements are already publicly available 
for individual NPIs in the Medicare Physician and Other Supplier Public 
Use File (referred to as the Physician and Other Supplier PUF).
    We divided clinicians and groups into quartiles based on average 
HCC risk score and percentage of dual eligible patients. To assess 
whether there was a difference in MIPS simulated scores by these two 
variables, we analyzed the effect of average HCC risk score and dual 
eligible ratio separately for groups and individuals. When looking at 
individuals, we focused on individuals that reported 6 or more measures 
(removing individuals who reported no measures or who reported less 
than 6 measures). We restricted our analysis to individuals who 
reported 6 or more measures because we wanted to look at differences in 
performance for those who reported the 6 measures which are generally 
required under MIPS if there are six measures that apply to the MIPS 
eligible clinician, rather than differences in scores due to MIPS 
eligible clinicians not fully reporting for MIPS.
    We also ranked MIPS eligible clinicians by proportion of patients 
with dual eligibility as previously done in Table 27 of the CY 2018 
Quality Payment Program final rule (82 FR 53776). We have updated the 
analysis by using the components of the complex patient bonus and 
dividing clinicians into quartiles. The preliminary results are shown 
in Table 45.

[[Page 40795]]



 Table 45--MIPS Simulated Average Final Score * by HCC Risk Quartile and
                      Dual Eligible Ratio Quartile
------------------------------------------------------------------------
                                            Estimated 2022 MIPS payment
                                           year final scores using data
                                             submitted for the quality
                                           payment program for the 2017
             HCC risk score                   MIPS performance period
                                         -------------------------------
                                            Individuals
                                              with 6+         Groups
                                            measures *
------------------------------------------------------------------------
Quartile 1--Lowest Average HCC..........           72.32            70.3
Quartile 2..............................           72.58           77.59
Quartile 3..............................            73.2           73.93
Quartile 4--Highest Average HCC.........           72.68           67.66
           Dual Eligible Ratio
Quartile 1--Low Proportion of Dual                 73.51           73.04
 Status.................................
Quartile 2..............................           72.37           76.28
Quartile 3..............................           72.16           72.21
Quartile 4--Highest Proportion of Dual              70.7           68.79
 Status.................................
------------------------------------------------------------------------
* We restricted our analysis to individuals who reported 6 or more
  measures because we wanted to look at differences in performance for
  those who reported the 6 measures which are generally required under
  MIPS if there are six measures that apply to the MIPS eligible
  clinician, rather than differences in scores due to MIPS eligible
  clinicians not fully reporting for MIPS.

    Table 45 illustrates the average estimated MIPS final scores for 
individual MIPS eligible clinicians who submitted at least 6 measures 
(generally, those who fully report for MIPS quality) and for group 
reporters, stratified by the average HCC risk score and dual eligible 
ratio quartiles. For more detail on the original analysis, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 
53776).\135\
---------------------------------------------------------------------------

    \135\ Data submitted for 2017 MIPS performance period was 
subject to different policies than later years of MIPS (due to the 
``pick-your-pace'' approach in the first year of MIPS and the much 
lower performance threshold of 3 points).
---------------------------------------------------------------------------

    Overall, the analysis of preliminary data 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 see 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 have only 1 year of data and more recent data 
may bring different results. In addition, we are awaiting a second 
report from ASPE in October 2019 that we expect will provide more 
direction for our approach to accounting for risk factors in MIPS. We 
are 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 at this time.
(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). Under our proposals in 
section III.K.3.c.(2)(a) of this proposed rule, the cost performance 
category would make up 20 percent of a MIPS eligible clinician's final 
score for the 2022 MIPS payment year, 25 percent for the 2023 MIPS 
payment year, and 30 percent for the 2024 MIPS payment year. Under our 
proposals in section III.K.3.c.(1)(b) of this proposed rule, the 
quality performance category would thus make up 40 percent of a MIPS 
eligible clinician's final score the 2022 MIPS payment year, 35 percent 
for the 2023 MIPS payment year, and 30 percent for the 2024 MIPS 
payment year. Table 46 summarizes the weights proposed for each 
performance category.

      Table 46--Proposed Weights by MIPS Performance Category for the 2022 Through 2024 MIPS Payment Years
----------------------------------------------------------------------------------------------------------------
                                                                                     2023 MIPS       2024 MIPS
                                                                     2022 MIPS     payment year    payment year
                      Performance category                         payment year     (proposed)      (proposed)
                                                                    (proposed)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Quality.........................................................              40              35              30
Cost............................................................              20              25              30
Improvement Activities..........................................              15              15              15
Promoting Interoperability......................................              25              25              25
----------------------------------------------------------------------------------------------------------------


[[Page 40796]]

(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 would 
receive a score of zero for the measure or activity, which would 
contribute to the final score for that MIPS eligible clinician. 
Assigning a scoring weight of zero percent and redistributing the 
weight to the other performance categories differs from the scenario of 
a MIPS eligible clinician failing to report on an applicable measure or 
activity that is required to be reported. 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
    Under current regulations at Sec.  414.1380(c)(2), we assign 
different weights to the performance categories and redistribute weight 
from one category to another under specified circumstances where we 
have determined reweighting is appropriate. These circumstances do not 
currently include cases where a MIPS eligible clinician submits data 
that are inaccurate, unusable, or otherwise compromised (referred to in 
this section as ``compromised data''). If we determine a MIPS eligible 
clinician has submitted compromised data, we assign the clinician a 
score of zero for the performance category. Because compromised data is 
not currently a basis for reweighting, the determination that data are 
inaccurate, unusable or otherwise compromised is likely to reduce the 
clinician's final score and therefore may reduce the clinician's 
payment adjustments. However, we believe that reweighting of the 
applicable performance categories may be appropriate in rare cases. 
Specifically, we believe reweighting may be appropriate when a MIPS 
eligible clinician's data are inaccurate, unusable or otherwise 
compromised due to circumstances that are outside of the control of the 
MIPS eligible clinician or its agents.
    In the CY 2018 Quality Payment Program final rule, we discussed our 
belief that extreme and uncontrollable circumstances, such as natural 
disasters, could cause the MIPS measures and activities to be 
unavailable to a MIPS eligible clinician (82 FR 53780 through 53783). 
For similar reasons, we believe that the 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 believe 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. Therefore, we are proposing 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 purposes of this reweighting policy, we propose that 
reweighting take into account both what control the clinician had 
directly over the circumstances and what control the clinician had 
indirectly through its agents. The term agent as used in this proposal 
is intended 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 believe that 
reweighting is not appropriate if a clinician could exert influence 
over a third party intermediary or another party to prevent or 
remediate compromised data and does not do so. However, we believe 
reweighting is appropriate in certain circumstances that may be within 
the control of the clinician's third party intermediary if the 
clinician cannot alter that party's conduct. Such circumstances would 
exist if a clinician's third party intermediary could correct the 
clinician's compromised data and despite requests from the clinician 
the third party intermediary chose not to do so. In this example, the 
decision by the third party intermediary not to make the correction 
would demonstrate that the third party intermediary was not acting as 
an agent of the clinician and the third party intermediary's conduct 
would not preclude reweighting. We solicit 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 propose that our determination of whether reweighing will be 
applied under this policy can take into account any information known 
to the agency and we will consider the information we obtain on a case-
by-case basis for reweighting. We anticipate 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 
request 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 encourage 
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 manner. We also 
encourage 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 recognize 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 
solicit comment on whether and how our proposed reweighting policy 
should apply to these circumstances. 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

[[Page 40797]]

data may result in remedial action against the submitter. 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 propose 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 propose 
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 solicit 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 propose 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 emphasize 
that this 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 proposed 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 are proposing 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 are concerned 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 are 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 seek 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 emphasize 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 sum, under the authority in sections 1848(q)(5)(F) and 
1848(o)(2)(D) of the Act, we are proposing 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 
are proposing 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 solicit comment in 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 note that we previously finalized at Sec.  414.1380(c) that if a 
MIPS eligible clinician is scored on fewer than two performance 
categories, he or she will receive a final score equal to the 
performance threshold (81 FR 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.
    Because the cost performance category was zero percent of a MIPS 
eligible clinician's final score for the 2017 MIPS performance period, 
we stated in the CY 2019 PFS proposed rule (83 FR 35970) that it is not 
appropriate to redistribute weight to the cost performance category for 
the 2019 MIPS performance period because MIPS eligible clinicians have 
limited experience being scored on cost measures for purposes of MIPS. 
In addition, we were concerned that there would be limited measures in 
the cost performance category under our proposals for the 2019 MIPS 
performance period and stated that it

[[Page 40798]]

may be appropriate to delay shifting additional weight to the cost 
performance category until additional measures are developed. However, 
we also noted that cost is a critical component of the Quality Payment 
Program and believe placing additional emphasis on the cost performance 
category in future years may be appropriate. Therefore, we solicited 
comment on redistributing weight to the cost performance category in 
future years.
    Several commenters expressed the belief that the weight of other 
performance categories should not be redistributed to the cost 
performance category. One commenter stated that the cost performance 
category weight should not be increased until additional cost measures 
are available and additional results of the episode-based cost measures 
are available. Another commenter expressed the belief that the cost 
performance category does not yet accurately assess the impact of a 
clinician's care on the total cost of care for a patient.
    We do not believe it would 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. As described in section III.K.3.c.(2)(b)(v) of 
this proposed rule, we are proposing substantial changes to the MSPB 
and total per capital cost measures, as well as proposing to add 10 new 
episode-based measures. We believe 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 are making in this proposed rule, 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 are proposing.
    Under our existing policies, we redistribute weight from the other 
performance categories to the improvement activities performance 
category in certain scenarios. However, we have generally redistributed 
performance category weights more to the quality performance category 
to incentivize reporting on quality measures, and because MIPS eligible 
clinicians have had more experience with quality measure reporting from 
other CMS programs. Beginning with the 2022 MIPS payment year, we 
propose to not redistribute performance category weights to the 
improvement activities performance category in any scenario. 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 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 believe it is no longer appropriate to 
increase the weight of the improvement activities performance category 
above 15 percent under our redistribution policies. We note 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 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 propose 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 47. First, we have adjusted 
our redistribution policies to account for a cost performance category 
weight of 20 percent for the 2022 MIPS payment year. We are also 
proposing, 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 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 propose 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 47). 
This proposed change would emphasize the importance of interoperability 
without overwhelming the contribution of the quality performance 
category to the final score. We also propose 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.

         Table 47--Performance Category Redistribution Policies Proposed for the 2022 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                                                  Improvement       Promoting
             Reweighting scenario                   Quality     Cost (percent)    activities    interoperability
                                                   (percent)                       (percent)        (percent)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       40              20              15               25
     categories...............................
Reweight One Performance Category:
    --No Cost.................................              55               0              15               30
    --No Promoting Interoperability...........              65              20              15                0
    --No Quality..............................               0              20              15               65

[[Page 40799]]

 
    --No Improvement Activities...............              55              20               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              85              15                0
     Quality..................................
    --No Promoting Interoperability and no                  80              20               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              20               0               80
----------------------------------------------------------------------------------------------------------------

    In section III.K.3.c.(2)(a) of this proposed rule, we have proposed 
weights for the cost performance category of 25 and 30 percent for the 
2023 and 2024 MIPS payment years, respectively. Because MIPS eligible 
clinicians will have had more experience being scored on cost measures, 
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 have 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 believe that we should 
redistribute weight to the cost performance category in other scenarios 
beginning with the 2023 MIPS payment year. 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 believe that redistributing weight equally to quality and cost 
is consistent with our goal of greater alignment between the quality 
and cost performance categories as described in section III.K.3.c.(2) 
of this proposed rule. We would also continue to redistribute weight to 
the Promoting Interoperability 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 propose to codify at 
Sec. Sec.  414.1380(c)(2)(ii)(E) and (F), are presented in Tables 47 
and 48.
BILLING CODE 4120-01-P

[[Page 40800]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.087

BILLING CODE 4120-01-C
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).
    We are proposing 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

[[Page 40801]]

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 50.

 Table 50--Performance Thresholds for the 2019 MIPS Payment Year, 2020 MIPS Payment Year, and 2021 MIPS Payment
                                                      Year
----------------------------------------------------------------------------------------------------------------
                                                      2019 MIPS  payment  2020 MIPS  payment  2021 MIPS  payment
                                                         year (points)       year (points)       year (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), we are again relying 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 1848(q)(6)(D)(i) of the Act, the performance threshold for the 
2024 MIPS payment year would be either the mean or median of the final 
scores for all MIPS eligible clinicians for a prior period specified by 
the Secretary.
    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. As 
referenced in the CY 2019 PFS final rule, 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 (83 FR 59881). In the Regulatory Impact Analysis (RIA) 
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 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). 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 this proposed rule (although we intend to 
include those results in the final rule if available). We believe the 
data points based on actual data from the 2017 MIPS performance period/
2019 MIPS payment year would be appropriate to use in our analysis in 
projecting the estimated performance threshold for the 2024 MIPS 
payment year. However, 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 would consider modifying our 
estimation of the performance threshold for the 2024 MIPS payment year 
accordingly.
    We refer readers to Table 51 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.

[[Page 40802]]



 Table 51--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; and 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                             2019 MIPS          2020 MIPS          2021 MIPS
                                                           payment year *    payment year **    payment year ***
                                                              (points)           (points)           (points)
----------------------------------------------------------------------------------------------------------------
Mean Final Score.......................................              74.01              80.30              69.53
Median Final Score.....................................              88.97              90.91              78.72
----------------------------------------------------------------------------------------------------------------
Source: CY 2019 PFS final rule RIA * *** (83 FR 60048); CY 2018 Quality Payment Program final rule RIA ** (82 FR
  53926 through 53950).
* Mean and median final scores based on actual final scores for 2019 MIPS payment year.
** Mean and median final scores based on information available in the RIA because actual final scores for the
  2020 MIPS payment year were not available in time for this proposed rule.
*** Mean and median final scores based on estimated final scores from 2021 MIPS payment year.

    We are choosing 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 2019 PFS 
proposed rule, we 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 (83 FR 35972). A 
few commenters supported the use of the mean rather than the median for 
determining the performance threshold because they believed this 
approach and the statutory requirement of a gradual and incremental 
transition to the performance threshold for the 2024 MIPS payment year 
would provide a clear path and certainty and would allow for clinicians 
to budget, plan, and develop a long-term strategy for successful 
participation in MIPS.
    We note 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 are proposing to use data from 
the 2019 MIPS payment year because it is the only MIPS final score data 
available and usable in time for the publication of this proposed rule. 
We acknowledge that via the 2020 MIPS payment year performance 
feedback, we have provided to MIPS eligible clinicians their calculated 
final scores. However, the mean and median of final scores for the 2020 
MIPS payment year are not yet published. We anticipate that the mean 
and median data points for the 2020 MIPS payment year will be available 
for consideration prior to publication of the final rule and seek 
comment on whether and how we should use this information to update our 
estimates. We understand 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. 
Eligibility and scoring policies changed in the initial years of the 
program. 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. As illustrated in Table 51, we estimated 
that the mean and median final scores for the 2020 MIPS payment year 
will be higher than for the 2019 MIPS payment year; however, we 
anticipate the final scores for the 2021 MIPS payment year will be 
lower. Recognizing the limitations of data for the 2019 MIPS payment 
year and the 2020 MIPS payment year, we are requesting comments on 
whether we should update or modify our estimates. We will propose the 
actual performance threshold for the 2024 MIPS payment year in future 
rulemaking.
    Based on these analyses, we are proposing 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 have estimated to be 
74.01 points.
    For example, 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 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.
    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. In section III.K.3.e.(4) of this proposed rule, we provide 
examples of the ways clinicians can meet or exceed the proposed 
performance threshold for the 2022 MIPS payment year.

[[Page 40803]]

    We recognize 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. We also recognize the unique challenges for small practices 
and rural clinicians that could prevent them from meeting or exceeding 
the proposed performance thresholds and refer readers to sections 
III.K.3.a.(3)(b)(i) and III.K.3.a.(3)(b)(i)(A) of this proposed rule 
for a discussion of the participation of small and rural practices in 
MVPs and a request for feedback on small and rural practices 
participation in MVPs, respectively.
    We invite 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 seek comment on whether we should adopt a different performance 
threshold in the 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. For example, if the actual mean or median final score 
for the 2020 MIPS payment year is closer to 85 points, should we 
finalize a higher performance threshold than currently proposed? Or if 
the mean or median values are lower, should we finalize a lower 
performance threshold? We anticipate the data will change over time and 
that the distribution of final scores will differ from one year to the 
next. We also seek 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 seek 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 seek comment on alternative numerical values for the 
performance threshold for the 2023 MIPS payment year.
(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 section III.K.3.e.(2) of this proposed rule, we 
are relying 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. As we also discussed in section 
III.K.3.e.(2) of this proposed rule, for the initial 5 years of MIPS, 
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 2022 MIPS payment year and the 2023 MIPS 
payment year, we are relying on the discretion afforded by the special 
rule and proposing to again 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 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. 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 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.
    We are relying on the special rule under section 1848(q)(6)(D)(iii) 
of the Act to propose at Sec.  414.1405(d)(6) to set the additional 
performance threshold for the 2022 MIPS payment year at 80 points and 
to propose 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 proposed 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 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. We also believe it is appropriate to raise 
the bar on what is rewarded as exceptional performance for Year 4 and 
for Year 5 of the MIPS program 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.
    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 proposed 
performance category weights for the 2022 MIPS payment year discussed 
as section III.K.3.d.(2)(b) of this proposed rule, 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

[[Page 40804]]

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.
    For example, if a MIPS eligible clinician gets a perfect score for 
the improvement activities (15 percent), cost (20 percent), and 
Promoting Interoperability (25 percent) performance categories, but 
does not submit quality measures data, then the MIPS eligible clinician 
would only receive 60 points (0 points for quality performance category 
+ 20 points for the cost performance category + 15 points for 
improvement activities performance category + 25 points for Promoting 
Interoperability performance category), which is below the proposed 
additional performance thresholds. 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.
    We note 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. 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. We recognize that setting a higher additional performance 
threshold may result in fewer clinicians receiving additional MIPS 
payment adjustments. We also note 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.
    We invite 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 seek comment on alternative 
numerical values for the additional performance threshold for the 2022 
MIPS payment year. We refer readers to sections VI.E.10.c.(3) and 
VI.F.2. of the RIA 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 seek 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 section III.K.3.e.(2) of 
this proposed rule, we seek comment on whether we should adopt 
different numerical values for the additional performance threshold and 
how we should set those values. We also seek 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 remind 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.
(4) Example of Adjustment Factors
    In the CY 2019 PFS proposed rule (83 FR 35978 through 35981) and 
the CY 2019 PFS final rule (83 FR 59891 through 59894), 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 2021 MIPS 
payment year. We are updating the figure and tables based on the 
policies we are proposing in this proposed rule.
    Figure 1 provides an example of how various final scores would be 
converted to a MIPS payment adjustment factor, and potentially an 
additional MIPS payment adjustment factor, using the statutory formula 
and based on the policies proposed for the 2022 MIPS payment year in 
this proposed 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 resulting in 
the lowest payment adjustment, and 100 being the highest possible score 
which receives the highest positive applicable percentage and resulting 
in the highest payment adjustment. However, there are two modifications 
to this linear sliding scale. First, there is an exception for a final 
score between zero and one-fourth of the performance threshold (zero 
and 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 would 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 would 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 would 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) would 
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 would be less than 1 and the MIPS payment adjustment factor for 
each MIPS eligible clinician with a final score of 100 points would be 
less than 9 percent.
    Figure 1 illustrates an example of the slope of the line for the 
linear adjustments for the 2022 MIPS payment year, but it could change 
considerably as new information becomes available. In this example, the 
scaling factor for the MIPS payment adjustment factor is 0.203. In this 
example, MIPS eligible clinicians with a final score equal to 100 would 
have a MIPS payment adjustment factor of 1.823 percent (9 percent x

[[Page 40805]]

0.2026). (Note that this is prior to adding the additional payment 
adjustment for exceptional performance, which is explained below.)
    The proposed additional performance threshold for the 2022 MIPS 
payment year is 80 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 
0.395. Therefore, MIPS eligible clinicians with a final score of 100 
would have an additional MIPS payment adjustment factor of 3.95 percent 
(10 percent x 0.395). The total adjustment for a MIPS eligible 
clinician with a final score equal to 100 would be 1 + 0.0182 + 0.0395 
= 0.0578, for a total positive MIPS payment adjustment of 5.78 percent.
BILLING CODE 4120-01-P
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    The final MIPS payment adjustments will be determined by the 
distribution of final scores across MIPS eligible clinicians and the 
performance threshold. More MIPS eligible clinicians above the 
performance threshold means the scaling factors would decrease because 
more MIPS eligible clinicians receive a positive MIPS payment 
adjustment factor. More MIPS eligible clinicians below the performance 
threshold means the scaling factors would increase because more MIPS 
eligible clinicians would receive a negative MIPS payment adjustment 
factor and relatively fewer MIPS eligible clinicians would receive a 
positive MIPS payment adjustment factor.
    Table 52 illustrates the changes in payment adjustments based on 
the final policies for the 2020 and 2021 MIPS payment years, and the 
proposed policies for the 2022 and 2023 MIPS payment years discussed in 
this proposed rule, as well as the statutorily required increase in the 
applicable percent as required by section 1848(q)(6)(B) of the Act.

[[Page 40806]]

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[[Page 40807]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.090

BILLING CODE 4120-01-C
    We have provided updated examples below with the policies proposed 
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 53, 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 40808]]

category is redistributed to the quality performance category under the 
proposed reweighting policies discussed 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 65 percent of the final 
score. We refer readers to section III.K.3.d.(2)(b)(iii) of this 
proposed 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 53.

                    Table 53--Scoring Example 1, MIPS Eligible Clinician in a Small Practice
----------------------------------------------------------------------------------------------------------------
                  [A]                              [B]                       [C]                     [D]
Performance category                    Performance score.......  Category weight.........         Earned points
                                                                                               ([B] * [C] * 100)
----------------------------------------------------------------------------------------------------------------
Quality...............................  60%.....................  65%.....................                    39
Cost..................................  50%.....................  20%.....................                    10
Improvement Activities................  20 out of 40 points--50%  15%.....................                   7.5
Promoting Interoperability............  N/A.....................  0% (redistributed to                         0
                                                                   quality).
                                                                                           ---------------------
    Subtotal (Before Bonuses).........  ........................  ........................                  56.5
    Complex Patient Bonus.............  ........................  ........................                     3
                                                                                           ---------------------
        Final Score (not to exceed      ........................  ........................                  59.5
         100).
----------------------------------------------------------------------------------------------------------------

Example 2: Group Submission Not in a Small Practice
    In the example illustrated in Table 54, a MIPS eligible clinician 
in a medium size practice participating in MIPS as a group receives 
performance category scores of 75 percent for the quality performance 
category, 50 percent for the cost performance category, and 100 percent 
for the Promoting Interoperability and improvement activities 
performance categories. There are many paths for a practice to receive 
a 75 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 83 points, and both the 
performance threshold of 45 and the additional performance threshold of 
80 are exceeded. In this example, the group practice exceeds the 
additional performance threshold and will receive the additional MIPS 
payment adjustment.

                    Table 54--Scoring Example 2, MIPS Eligible Clinician in a Medium Practice
----------------------------------------------------------------------------------------------------------------
                   [A]                                [B]                      [C]                   [D]
Performance category                      Performance score.........       Category weight         Earned points
                                                                                       (%)     ([B] * [C] * 100)
----------------------------------------------------------------------------------------------------------------
Quality.................................  75%.......................                    40                    30
Cost....................................  50%.......................                    20                    10
Improvement Activities..................  40 out of 40 points--100%.                    15                    15
Promoting Interoperability..............  100%......................                    25                    25
                                                                                           ---------------------
    Subtotal (Before Bonuses)...........  ..........................  ....................                    80
    Complex Patient Bonus...............  ..........................  ....................                     3
                                                                                           ---------------------
        Final Score (not to exceed 100).  ..........................  ....................                    83
----------------------------------------------------------------------------------------------------------------


[[Page 40809]]

Example 3: Non-Patient Facing MIPS Eligible Clinician
    In the example illustrated in Table 55, 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 and the performance 
threshold of 45 points is exceeded while the additional performance 
threshold of 80 points is not.

                     Table 55--Scoring Example 3, Non-Patient Facing MIPS Eligible Clinician
----------------------------------------------------------------------------------------------------------------
                 [A]                              [B]                       [C]                     [D]
Performance category                   Performance score.......  Category weight.........         Earned points
                                                                                                       ([B] * [C] * 100)
----------------------------------------------------------------------------------------------------------------
Quality..............................  50%.....................  65%.....................                  32.5
Cost.................................  50%.....................  20%.....................                    10
Improvement Activities...............  20 out of 40 points for   15%.....................                   7.5
                                        1 medium weight
                                        activity--50%.
Promoting Interoperability...........  0%......................  0% (redistributed to                         0
                                                                  quality).
    Subtotal (Before Bonuses)........  ........................  ........................                    50
    Complex Patient Bonus............  ........................  ........................                     3
                                                                                          ----------------------
        Final Score (not to exceed     ........................  ........................                    53
         100).
----------------------------------------------------------------------------------------------------------------

    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).
    We are proposing 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 proposed 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). In our efforts to minimize burden on MIPS eligible 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 are proposing 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 QPP 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 CMS will respond to each 
request for targeted review timely submitted and determine whether a 
targeted review is warranted (81 FR 77353). We are proposing to 
redesignate this provision as Sec.  414.1385(a)(4).
(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. We 
believe it is important to ensure MIPS eligible clinicians and groups 
have an opportunity to review their revised

[[Page 40810]]

performance feedback prior to the application of the MIPS payment 
adjustment factors. 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 
are proposing 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 are proposing 
this change would 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 
are proposing 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. Notification will 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.
(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 each targeted review request is reviewed individually 
and by category. Therefore, we are proposing 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's request. Non-responsiveness to CMS's 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.
     QPP Service Center ticket numbers.
     Signed contracts or agreements between a MIPS eligible 
clinician/group and a third party intermediary.
(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 are 
proposing to renumber this provision 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 
are also proposing 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.
(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 are proposing 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.
(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 performance. Accordingly, a clinician or 
group that submits a certification under Sec.  414.1390(b) in 
connection with the

[[Page 40811]]

submission of data they know is 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 
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).
g. Third Party Intermediaries
    We refer readers to Sec. Sec.  414.1305 and 414.1400, the CY 17 
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 this proposed rule, we propose to make several changes. We 
propose to establish new requirements for MIPS performance categories 
that must be supported by QCDRs, qualified registries, and Health IT 
vendors. We are proposing 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 
are also proposing 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 are also proposing to update considerations for 
QCDR measures. With respect to qualified registries, we are also 
proposing to require enhanced performance feedback requirements. 
Finally, we are clarifying 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 proposals discussed 
in this section justify the collection of information and regulatory 
impact burden estimates discussed in sections IV. and VI. of this 
proposed rule, respectively, for additional information on the costs 
and benefits.
(1) Proposed 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 sum, 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 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 
propose to amend Sec.  414.1400(a)(2) to state that beginning with the 
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. We solicit 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.
    However, we recognize the need to create an exception to allow 
QCDRs and qualified registries that only represent MIPS eligible 
clinicians 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 are proposing 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). We refer 
readers to section III.K.3.c.(4) of this proposed rule for additional 
information on the clinician types that are eligible for reweighting 
the Promoting Interoperability performance category. We anticipate 
using the self-nomination vetting process to assess whether the QCDR or 
qualified registry is subject to our proposed requirement to support 
reporting the Promoting Interoperability performance category. We 
solicit comments on this proposal, including the scope of the proposed 
exception from the Promoting Interoperability reporting requirement for 
certain types of QCDRs and qualified registries. Specifically, we 
solicit 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.
(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 
this proposed rule we are proposing 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 are 
proposing two

[[Page 40812]]

changes to help prevent these disruptions. First, we are proposing 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. In addition, we are proposing at 
Sec.  414.1400(a)(4) to add a new paragraph (vi) to establish that a 
condition of approval is for 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 a 
transition plan. 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 new 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. 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 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. We note that under this proposal, 
if CMS determines that a third party intermediary has ceased to meet 
either of these proposed new criteria for approval, CMS may take 
remedial action or terminate the third party intermediary in accordance 
with Sec.  414.1400(f). We also refer readers to sections III.K.3.g.(3) 
and III.K.3.g.(4) where we discuss these proposals for QCDRs and 
qualified registries specifically.
(3) Qualified Clinical Data Registries (QCDRs)
    In this proposed rule, we propose to update: (a) QCDR approval 
criteria; and (b) various policies related to QCDR measures. These 
proposals 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 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 this proposed rule, we are proposing 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
    We also refer readers to section III.K.3.g.(1) above, where we 
propose 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 section 
III.K.3.a., Transforming MIPS: MIPS Value Pathways Framework, we 
believe this proposal will assist clinicians in that transition.
    Based on our review of existing 2019 QCDRs through the 2019 QCDR 
Qualified Posting, approximately 92

[[Page 40813]]

QCDRs, or about 72 percent of the QCDRs currently participating in the 
program are supporting all three performance categories. The 2019 QCDR 
qualified posting is available in the QPP Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/347/2019%20QCDR%20Qualified%20Posting_Final_v3.xlsx. 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. Based on this 
data, we believe it is reasonable to want to continue to strengthen our 
policies at Sec.  414.1400(a)(2), to require 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 propose to require QCDRs to support three performance 
categories: Quality, improvement activities, and Promoting 
Interoperability. Additionally, for reasons, as discussed above, we 
propose to amend Sec.  414.1400(a)(2) to state beginning with the 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 section III.K.3.g.(1) of this proposed rule, 
we are proposing that based on the proposed 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 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 would 
require QCDRs 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 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 this proposed rule, we are proposing 
policies with regards to ``foster improvement in the quality of care.''
    Therefore, we are proposing 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. 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 are proposing 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.

[[Page 40814]]

(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 \136\ 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.
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    \136\ Quality Payment Program Overview. https://qpp.cms.gov/about/qpp-overview.
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    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.
    Therefore, we are proposing a change so that QCDRs structure 
feedback in a similar manner. We propose 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. 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 are also 
soliciting 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 are also proposing 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)(iv)).
    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, we are also seeking 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 are also seeking 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. This would allow QCDRs some time to provide enhanced and 
actionable feedback to MIPS eligible clinicians prior to the data 
submission deadline.
(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 this proposed rule, we are 
proposing 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.
(c) QCDR Measure Requirements
(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 this proposed rule, 
we are proposing to codify established QCDR measure considerations and 
propose, 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 section 
III.K.3.c.(1) of this proposed rule.

[[Page 40815]]

(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 this proposed rule, we propose to codify a number of those 
previously finalized QCDR measure considerations (83 FR 59902). We are 
proposing to amend Sec.  414.1400 by adding Sec.  414.1400(b)(3)(iv) to 
include the following previously finalized 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.
    More information on QCDR measure approval criteria can be found in 
the QCDR/Qualified Registry Self-Nomination Tool-Kit in the QPP 
Resource Library. We refer readers to section III.K.3.g.(3)(c)(i)(B) of 
this rule where we are proposing to change the following previously 
finalized considerations into requirements:
     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 propose 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, CMS 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. We propose 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

[[Page 40816]]

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 QPP Resource Library, which is available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/342/2019%20MIPS%20Quality%20Benchmarks.zip); production submission data 
submitted from the previous year's data submission period; and data 
provided to us by the QCDRs themselves.
    As discussed in our QCDR measure rejection considerations proposal 
below, we propose 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 approved in the 
future if our proposal is finalized as proposed. We note that this 
factor is parallel to what is being proposed for MIPS quality measures 
in section III.K.3.c.(1) of this proposed 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 propose 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. Those that do not, may not continue to be 
approved. We refer readers to section III.K.3.g.(3)(c)(ii) below in 
this proposed 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. We also refer readers to Sec.  414.1330 for additional 
information.
(B) QCDR Measure Requirements
(aa) Previously Finalized Requirements Considerations Codified as 
Requirements
    As mentioned above, in this proposed rule, we propose to change two 
previously finalized measure considerations into requirements and 
codify those requirements. 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) where we are 
proposing to codify the majority as measure considerations. However, 
for two of those previously finalized consideration, we are proposing 
them as requirements:
     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 are 
proposing to change both of those considerations into requirements and 
are proposing to amend Sec.  414.1400 by adding Sec.  414.1400(b)(3)(v) 
to include the following:
     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 Transforming MIPS: MIPS Value Pathways Framework, see 
section III.K.3.a. of this proposed rule) 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, beginning with the 2021 performance period and future 
years, we propose 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 section III.K.3.c.(2) of this proposed rule); (b) 
Improvement Activity (as found in Appendix 2: Improvement Activities 
Tables); or (c) CMS developed MVPs (as described in Table C-B1 of 
section III.K.3.a. of this proposed rule). 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 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 to the following at the 
time of self-nomination: (a) Cost measure; (b) improvement activity; 
and (c) an MVP. 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.
    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 to the following at the time of 
self-nomination: (a) Cost measure; (b) improvement activity; and (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.
(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 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 are moving forward with a proposal 
in this proposed rule.
    Beginning with the 2021 performance period and future years, we 
propose,

[[Page 40817]]

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. 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 are also proposing to amend Sec.  414.1400 to add 
paragraph (b)(3)(v)(C) to reflect this proposal. At Sec.  
414.1400(b)(3)(v)(C), we propose 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 note 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.\137\ 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 VI the Regulatory Impact Analysis 
of this rule for additional details.
---------------------------------------------------------------------------

    \137\ 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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(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, we are proposing to require QCDRs to collect data on the 
potential QCDR measure. For a QCDR measure to be considered for use in 
the program, beginning with the 2021 performance period and future 
years, we are proposing 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. 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 strongly 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.
(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 are moving forward 
with a proposal in this rule.
    Therefore, we propose, 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

[[Page 40818]]

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 propose to amend Sec.  414.1400 to add paragraph 
(b)(3)(v)(E) to state beginning with the 2022 MIPS payment year, CMS 
may provisionally approve the individual QCDR measures for 1 year with 
the condition that QCDRs address certain areas of duplication with 
other approved QCDR measures 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) below.
(C) QCDR Measure Rejections
    We are proposing QCDR measure rejection criteria that generally 
aligns 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 this proposal, 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 propose to amend Sec.  414.1400 to add paragraph (b)(3)(vii) to 
state that beginning with the 2020 performance period, we propose to 
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 QPP 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) above.)
     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) below).
     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 this proposed 
rule, we are proposing the addition of a multi-year approval process.
(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 moving forward with a proposal in this rule.
    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), we 
are proposing 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 part of this proposal, 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 QPP final rule (81 FR 77282 through 77283));
     Duplicative of a more robust measure (this proposal aligns 
with our

[[Page 40819]]

proposal at section III.K.3.g.(3)(c) above);
     Reflects an outdated clinical guideline;
     Requires measure harmonization (this proposal aligns with 
our proposal at section III.K.3.g.(3)(c)(i)(B) above); 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.
(iii) Participation Plan for Existing QCDR Measures That Have Failed To 
Reach Benchmarking Thresholds
    We refer readers to section III.K.3.g.(3)(c)(i), above in this 
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.
    However, we understand that there are instances where measures that 
are low-reported may still be considered important to a respective 
specialty. Therefore, beginning with the 2020 performance period, we 
propose to amend Sec.  414.1400 to add paragraph (b)(3)(iv)(J)(aa) 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. 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.
(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 this proposed 
rule, we propose to update qualified registry required services. These 
proposals 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 Act for statutory 
authority. We also refer readers to section III.K.3.g.(3) above, where 
we propose to require QCDRs and qualified registries to support three 
performance categories: Quality, improvement activities, and Promoting 
Interoperability. In addition, we refer readers to section 
III.K.3.g.(3)(a)(i) where we discuss a parallel requirement for QCDRs. 
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. The qualified posting of 
approved 2019 qualified registries can be found on the QPP resource 
library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/348/2019%20Qualified%20Registry%20Posting_Final_v1.0.xlsx. 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 section 
III.K.3.a. of this proposed rule, Transforming MIPS Path to Value, we 
believe this proposal will assist clinicians in that transition.
    Therefore, as discussed above beginning with the 2021 performance 
period and for future years, we propose 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 section III.K.3.g.(1) of this rule, we are 
proposing that based on the proposed 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 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 would require qualified registries to attest to the 
ability to submit data for

[[Page 40820]]

these performance categories, as applicable, at time of self-
nomination. We are also proposing this same requirement for QCDRs in 
section III.K.3.g.(3) of this proposed rule.
(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 \138\ 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.
---------------------------------------------------------------------------

    \138\ 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 are proposing to add a new paragraph at Sec.  
414.1400(c)(2) to require (i) and (ii). We are simply proposing 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. Additionally, we are 
proposing to add a new paragraph, Sec.  414.1400(c)(2)(ii), beginning 
with the 2023 MIPS payment year, to require that qualifed registries 
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 within the qualified registry. We understand that there would 
be instances in which the qualified registry cannot meet this 
requirement; and therefore, we are also proposing 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 soliciting 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, we are also proposing 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) 
where we are proposing a parallel requirement for QCDRs; we intend to 
have the same requirements for both QCDRs and qualifies registries.
    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 qualified registry 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, we are also seeking comment for future notice-and-
comment rulemaking on whether we should require MIPS eligible 
clinicians, groups, and virtual groups who utilize a qualfied registry 
to submit data throughout the performance period, and prior to the 
close of the performance period (that is, December 31st). We are also 
seeking 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.
(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.
    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.

[[Page 40821]]

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 are not representative of the 
clinician's or group's performance. As described in section 
III.K.3.c.(1) of this proposed rule, we proposed to further amend Sec.  
414.1340(a)(3) to clarify that the submitted data should be reflective 
of a 70 percent random sample. 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. 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).
    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 within 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.
    In this proposed rule, we propose two changes to more expressly 
emphasize CMS enforcement authority. First, we propose to clarify in 
this proposed rule 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, as discussed below, we propose to clarify in this proposed rule 
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). With these revisions and a grammatical correction 
described below, the proposed Sec.  414.1400(f)(1) 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. We 
anticipate that these proposed revisions will emphasize to third party 
intermediaries the sanctions they may face from CMS if they submit 
improper data to CMS. 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.
    As noted above, we are proposing revisions to Sec.  414.1400(f)(3) 
to clarify the intent of this provision. We 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 this proposed rule, we propose 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 propose grammatically corrections related to the use of 
the plural term ``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 are proposing 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

[[Page 40822]]

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. These 
proposals are discussed in more detail in this proposed 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;
     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 propose to amend Sec.  
414.1395(a) by adding paragraph (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 proposed rule, we 
are also proposing to amend Sec.  414.1395(a) by adding paragraph (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 propose to amend Sec.  414.1395(a) by adding paragraph (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 
propose 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 proposed policy at Sec.  414.1395(a). We 
wish to 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 seek comment on any other aggregate information 
that stakeholders would find useful for future public reporting on 
Physician Compare.
(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 are not making any proposals regarding publicly 
reporting quality performance category information, we are seeking 
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 would expect to find such information on the 
Physician Compare website already, based on their experiences with 
other consumer-oriented websites. We currently do not

[[Page 40823]]

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 are 
seeking 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). We refer readers to 
section III.K.3.c.(1)(c)(i) of this proposed 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 would 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 seek comment on the 
value of collecting and publicly reporting information from narrative 
questions and other 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 note 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.
(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 are not making any proposals regarding publicly 
reporting Promoting Interoperability category information, we do want 
to 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).
    We note that addressing comments on this proposed policy is outside 
of the scope of this proposed rule and instead direct readers to review 
that proposed rule, available at https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-and, for more 
information.
(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 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

[[Page 40824]]

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 are proposing 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 proposing 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 proposing 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 request comment on this 
proposal.
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 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 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 proposed rule, we discuss proposals 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 have sought 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 section III.I.4.d.(2)(a) of this proposed rule, we 
propose 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).
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:

[[Page 40825]]

     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 Sec.  414.1415(b)(3), effective January 1, 
2020, to provide that at least one outcome measure, for which measure 
results are included as a factor when determining payment to 
participants under the terms of the APM must either be finalized on the 
MIPS final list of measures as described in Sec.  414.1330, endorsed by 
a consensus-based entity; or determined by CMS to be evidence-based, 
reliable, and valid.
    Bearing Financial Risk for Monetary Losses:
     We 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 proposed 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 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 purpose 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 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 the marginal 
risk and MLR components were not necessary to explicitly include 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 that this percentage 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 more importantly, 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

[[Page 40826]]

Advanced APM would actually be more than nominal for participants.
    However, based on our experience to date, we are 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 now 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 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 Sec.  414.1415(c)(5), we are proposing to amend the 
definition of expected expenditures. Specifically, we are proposing to 
define expected expenditure as, for the purposes of this section, 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 
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, we 
recognize 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 this proposed definition of expected expenditures, 
we would not consider risk adjustments to be excess expenditures when 
comparing to the costs that an APM Entity would be expected to incur in 
the absence of the APM.
    We believe that this proposed amendment would 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 believe that the proposed amended 
definition of expected expenditures, particularly by our not 
considering excess expenditures when determining whether an APM meets 
the benchmark-based nominal amount standard, would provide a more 
definite 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 are also proposing a similar amendment to the definition of 
expected expenditures applicable to the Other Payer Advanced APM 
criteria in section III.I.4.d.(2)(b)(i) of this proposed rule.
    We seek comment on this proposal.
(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 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 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 
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, we are seeking comment 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 
seek 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 seek 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 seek

[[Page 40827]]

comment on how non-Medicare payers define or prescribe certain 
categories of services that are excluded with regards to global 
capitation payment arrangements.
    In addition, we are seeking comment on whether a capitation 
arrangement should be considered to be a full capitation arrangement 
even though it excludes certain categories of services from the 
capitation rate under the full capitation standard for Other Payer 
Advanced APMs as discussed in section III.I.4.d.(2)(c)(ii) of this 
proposed rule.
(3) Summary of Proposals
    In this section, we are proposing the following policy:
     Expected Expenditures: We are proposing to amend the 
definition of expected expenditures codified at Sec.  414.1415(c)(5) to 
state, 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 mean 
the episode target price. In addition, for purposes of assessing 
financial risk for Advanced APM determinations, the expected 
expenditures under the APM should not exceed the expected Medicare 
Parts A and B expenditures (including model-specific risk-adjustments 
and trend adjustments), for the APM Entity in the absence of the APM. 
If expected expenditures under the APM exceed the Medicare Parts A and 
B expenditures that the APM Entity would be expected to incur in the 
absence of the APM, such excess expenditures would not be considered 
when CMS assesses financial risk under the APM for Advanced APM 
determinations.
d. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
    We finalized policies relating to QP and Partial QP determinations 
in the CY 2017 Quality Payment Program final rule (81 FR 77433 through 
77450). In the CY 2019 PFS final rule (83 FR 59923 through 59925), we 
finalized additional policies relating to QP determinations and 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 would apply to all the individual 
eligible clinicians who are identified as part of the APM Entity 
participating in an Advanced APM. If that 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 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, upon further consideration, and based on our experience 
implementing the Quality Payment Program to date, we no longer believe 
we should apply Partial QP status at the individual clinician (NPI) 
level across all TIN/NPI combinations, as we have and do for QP status. 
Partial QPs are excluded from MIPS 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. When this MIPS exclusion is applied at the NPI level, it 
does not always provide a similar net positive outcome across an 
individual clinician's TIN/NPI combinations when compared to the APM 
Incentive Payment that QPs receive. The MIPS exclusion is different 
from QP status as Partial QPs do not receive an APM Incentive Payment, 
Partial QPs are only relieved of the MIPS reporting requirements and 
not subject to a MIPS payment adjustment. As such, while a Partial QP 
might wish to be excluded from the MIPS reporting requirements and 
payment adjustment with respect to the TIN/NPI combination that relates 
to an APM Entity in an Advanced APM, that same Partial QP might benefit 
from reporting to MIPS and receiving a MIPS payment adjustment with 
respect to some or all of their other TIN/NPI combinations because they 
anticipate receiving an upward MIPS payment adjustment.
    So, while the current policy excludes Partial QPs from MIPS 
reporting requirements and allows Partial QPs to avoid any potential 
downward MIPS payment adjustment, we have heard from stakeholders, 
including some clinicians, that this policy has prevented eligible 
clinicians from receiving a positive MIPS payment adjustment earned 
through a different TIN/NPI combination not associated with the APM 
Entity through which they attained Partial QP status. Furthermore, in 
many circumstances, the election to be excluded from MIPS for an 
eligible clinician is made outside their control at the APM Entity 
level. In such scenarios, an eligible clinician may have reported to 
MIPS as part of a group or as an individual under a separate TIN/NPI 
combination, but would not receive any MIPS payment adjustment based on 
that reporting. If eligible clinicians who would have received a 
positive MIPS adjustment are excluded from MIPS because of their 
Partial QP status, it could potentially discourage eligible clinicians 
from participating in Advanced APMs. Additionally, in future years of 
the Quality Payment Program, we anticipate that it will become harder 
to attain QP and Partial QP status because the QP and Partial QP 
payment amount and patient count thresholds will rise, as set forth in 
Sec.  414.1430. As a result, a greater number of Advanced APM 
participants may attain Partial QP status, which we

[[Page 40828]]

believe increases the importance of removing the potential disincentive 
for Advanced APM participation based on the way the MIPS exclusion for 
Partial QPs is applied.
    Therefore, we are proposing 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 report under MIPS for other TIN/
NPI combinations.
    We seek comment on this proposal.
(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 
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.  414.1425(c)(5) and Sec.  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.  414.1425(c)(6) and Sec.  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 individually 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. We acknowledge 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, 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, we are proposing to revise Sec.  
414.1425(c)(5) and add Sec. Sec.  414.1425(c)(5)(i) and 
414.1425(c)(5)(ii) which states, beginning in the 2020 QP Performance 
Period, 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 are proposing to revise Sec.  414.1425(c)(6) 
and add Sec. Sec.  414.1425(c)(6)(i) and Sec.  414.1425(c)(6)(ii), 
which states, beginning in the 2020 QP Performance Period, 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 individually 
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 individually 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, we are also proposing to revise Sec.  
414.1425(d)(3) and add Sec. Sec.  414.1425(d)(3)(i) and 
414.1425(d)(3)(ii), which states, beginning in the 2020 QP Performance 
Period, 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 are also proposing to revise Sec.  414.1425(d)(4) and add 
Sec. Sec.  414.1425(d)(4)(i) and 414.1425(d)(4)(ii), which states, 
beginning in the 2020 QP Performance Period, 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

[[Page 40829]]

voluntarily or involuntarily terminates from the Advanced APM before 
the end of the QP Performance Period, and the eligible clinician does 
not individually 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 
individually 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 additions account for the scenarios in which 
an APM Entity terminates 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 seek comment on this proposal.
(4) Summary of Proposals
    In this section, we are proposing the following policies:
     Application of Partial QP Status: We propose 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. We propose to amend Sec.  
414.1425(d)(5) to reflect this change.
     APM Entity Termination: We propose to revise Sec. Sec.  
414.1425(c)(5), 414.1425(c)(6), 414.1425(d)(3), and 414.1425(d)(4) to 
state that an eligible clinician is not a QP or a Partial QP for the 
year when an APM Entity 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.
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). 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).
BILLING CODE 4120-01-P

[[Page 40830]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.091


[[Page 40831]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.092

BILLING CODE 4120-01-C
    Unlike the Medicare Option, where we have access to all of the 
information necessary to determine whether an APM meets the criteria to 
be an Advanced APM, we cannot determine whether 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.

[[Page 40832]]

     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, whether or not CEHRT use is explicitly 
required under the terms of the payment arrangement.
     We clarified 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 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 proposed rule, we address our proposal to 
define the term Aligned Other Payer Medical Home Model, and our 
proposals regarding bearing financial risk for monetary losses, 
specifically the Medicaid Medical Home Model financial risk standard 
and the definition of expected expenditures. We also discuss 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) 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 proposed rule, we are 
proposing to add the defined term ``Aligned Other Payer Medical Home 
Model'' to Sec.  414.1305, 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

[[Page 40833]]

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. We believe that structuring this proposed 
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 are proposing to exclude Medicaid payment arrangements from this 
proposed 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 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 are proposing 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 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 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 seek comment on this proposal.
(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, we propose that the 
CEHRT criterion codified in Sec.  414.1420(b) and the use of quality 
measures criterion codified in Sec.  414.1420(c) would apply to any 
Aligned Other Payer Medical Home Model for which we would make an Other 
Payer Advanced APM determination. Further, we propose 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 propose that the Aligned Other Payer Medical Home Model 
financial risk and nominal amount standards would be the same as the 
Medicaid Medical Home Model financial risk and nominal amount 
standards. We are proposing corresponding amendments to Sec.  
414.1420(d)(2) and (4) so that those sections note, 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 believe 
that this proposal, as described in section III.I.3.b. of this proposed 
rule, is appropriate because the same expectation of ability to bear a 
more than nominal amount of financial risk applies to participants in 
these models as Medical Home Models and Medicaid Medical Home Models 
because the arrangements are already aligned and the participants are 
the same.
(c) Determination of Aligned Other Payer Medical Home Model and Other 
Payer Advanced APM Status
    We propose 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 proposal would be effective January 1, 2020 for the 2021 
performance year. 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 would be required to 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 propose 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 seek comment on these proposals.
(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

[[Page 40834]]

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 do not apply to similar arrangements with 
other payers for purposes of Other Payer Advanced APM determinations. 
Consistent with our proposal to define the term Aligned Other Payer 
Medical Home Model, we are proposing to amend Sec.  414.1420(d)(2) and 
(d)(4) of our regulations to also include that 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. Consistent 
with recognizing the similar characteristics of these payment 
arrangements and the same participants, we believe that the same 
financial risk and nominal amount standards should be applied to 
Aligned Other Payer Medical Home Models.
    Further, we are proposing a corresponding amendment to Sec.  
414.1420(d)(2)(ii) to state that an Aligned Other Payer Medical Home 
Model or Medicaid Medical Home Model require the direct payment by the 
APM Entity to the payer, which meaning either the other payer or the 
Medicaid agency.
    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 not being aligned with a CMS Multi-Payer Model that 
is a Medical Home Model, we might create gaming opportunities amongst 
other payers where medical homes are developed solely to take advantage 
of the unique nominal amount standard, particularly because we would 
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 propose that the 50 eligible clinician limit apply to 
Aligned Other Payer Medical Home Models by amending Sec.  
414.1420(d)(8).
    We seek comment on these proposals.
(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 for the purposes of this section, expected 
expenditures is defined as the Other Payer Advanced APM benchmark, 
except for episode payment models, for which it is defined 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

[[Page 40835]]

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, we propose to amend 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 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 would calculate the average marginal risk rate in two steps. An 
example of such a calculation is presented in Table 58. This example 
uses a model relying on a Total Cost of Care (TCOC) benchmark. This 
methodology can also be applied to other types of other payer payment 
arrangements. In this example, 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) equals 1.50 percent. Second, 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 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.

                               Table 58--Example Average Marginal Risk Calculation
----------------------------------------------------------------------------------------------------------------
 Performance (% above TCOC
         benchmark)               Marginal risk (%)         Participant losses (%)     Average marginal risk (%)
----------------------------------------------------------------------------------------------------------------
                        1                           50                        0.50                          50
                        2                           50                        1.00                          50
                        3                           50                        1.50                          50
                        4                           25                        1.75                          44
                        5                           25                        2.00                          40
                        6                           25                        2.25                          38
                        7                           25                        2.50                          36
                        8                           25                        2.75                          34
                        9                           25                        3.00                          33
----------------------------------------------------------------------------------------------------------------

    Through this 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 or exceed 30 percent, while 
recognizing that such risk can be demonstrated with some variation in 
the application of marginal risk rates, allowing for continued 
innovation in the marketplace. This proposed policy ensures that all 
Other Payer Advanced APMs have 30 percent of marginal risk up until the 
participant owes 3 percent of losses, which is the intended effect of 
the standard without excluding certain payment arrangement that have 
strong financial risk designs. When considering average marginal risk 
in the context of total risk, as we 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 believe this proposed change is consistent with the statute and 
the use of guardrails to maintain financially strong models, and note 
that in making this change we are not lowering the standard for the 
applicable marginal risk rate but rather allowing for a new 
demonstration of how it can be met. We clarify that the proposed 
amendment would also continue to maintain 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 clarify that the exception for small losses 
described in paragraph (d)(5)(iii) would also be maintained.
    We seek comment on this proposal.
(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.

[[Page 40836]]

    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 that we would 
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 or an Other Payer Advanced APM. However, even with a 
marginal risk requirement, as there is under the Other Payer Advanced 
APM criteria, 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 meets the 
generally applicable benchmark-based nominal amount standard. Even with 
the current marginal risk requirement, 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. 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.
    As discussed in section III.I.4.c.(2)(c) of this proposed rule, 
this proposal is intended to account for scenarios where a payment 
arrangement could 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; however, the level of 
expected expenditures reflected in the payment arrangements benchmark 
or episode target price could be set in a manner which 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 would exceed it, then there is little potential for 
participants to incur financial losses, and the amount of risk is 
essentially illusory.
    Therefore, in Sec.  414.1420(d)(6), we are proposing to amend the 
definition of expected expenditures. Specifically, we would define 
expected expenditures as, for the purposes of this section, as the 
Other Payer APM benchmark. For episode payment models, expected 
expenditures mean 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 (that is, benchmarks) 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 CMS assesses financial risk 
under the payment arrangement for Other Payer Advanced APM 
determinations.
    We believe that this proposed change would prevent the expected 
expenditures under the other payer payment arrangement being set in a 
manner which 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 payment 
arrangement participation. For the purpose of this proposed definition 
of expected expenditures, we would not consider risk adjustments to be 
excess expenditures when comparing to the costs that an APM Entity 
would be expected to incur in the absence of the payment arrangement.
    We believe that this proposed 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 
proposed amended definition of expected expenditures, particularly by 
our not considering excess expenditures, would provide a more definite 
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 seek comment on this proposal.
(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 
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

[[Page 40837]]

these exclusion lists, we believe that it may be appropriate for CMS to 
allow certain capitation arrangement to be considered ``full'' 
capitation arrangements even if they categorically exclude certain 
services from payment through the capitation rate. Therefore, we are 
seeking comment on how other payers define or determine what, if any, 
exclusions are reasonable in a given capitation arrangement. 
Specifically, we seek 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 
seek comment on why such items or services are excluded.
    We also seek comment on how non-Medicare payers define or prescribe 
certain categories of services that are excluded with regards to global 
capitation payment arrangements. We also seek comment on whether a 
capitation arrangement should be considered to be a full capitation 
arrangement even though it excludes certain categories of services from 
the capitation rate under a full capitation arrangement.
(4) Summary of Proposals
    In this section, we are proposing the following policies:
     Aligned Other Payer Medical Home Model: We proposed to 
define the term Aligned Other Payer Medical Home Model. We also propose 
to apply the existing Medicaid Medical Home Model financial risk and 
nominal amount standards, including the 50 eligible clinician limit, to 
Aligned Other Payer Medical Home Models.
     Marginal Risk: We propose that when 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 requirement, with exceptions for large losses 
and small losses as provided in Sec.  414.1420(d)(5).
     Expected Expenditures: We are proposing to amend the 
definition of expected expenditures codified at Sec.  414.1420(d)(6) to 
define expected expenditures as the Other Payer Advanced APM benchmark, 
and, for episode payment models, expected expenditures means the 
episode target price.
5. Quality Payment Program Technical Revisions
    We are proposing 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 are proposing 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 proposed 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 MIPS payment 
year and continues in subsequent years.
    We are also proposing technical revisions to Table 59 of the CY 
2019 PFS final rule with comment period (83 FR 59935) to correct two 
dates. Specifically we propose 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 propose to change that 
date to August 2020. Similarly, we propose 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 propose 
to change that to August 2020. These changes align with what was 
originally finalized in the CY 2018 QPP final rule with comment period 
(82 FR 53864) which stated that the dates were to be August 2020, and 
which we did not intend to change in the CY 2019 PFS final rule. Table 
59 is included as the corrected Table 59 from the CY 2019 PFS final 
rule.
BILLING CODE 4120-01-P

[[Page 40838]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.093

BILLING CODE 4120-01-C
    We are also proposing 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 are proposing 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 are proposing to revise 
the regulation accordingly in this proposed rule. Relatedly, we propose 
to amend Sec.  414.1420(d)(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 are also proposing 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 proposed revisions 
are technical in nature and do not change any substantive policies for 
the Quality Payment Program.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 
35), we are required to publish a 60-day notice in the Federal Register 
and solicit public comment before a ``collection of information'' 
requirement is submitted to the Office of Management and Budget (OMB) 
for review and approval. 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.
    We are soliciting public comment on each of the required issues 
under section 3506(c)(2)(A) of the PRA for the following information 
collection requirements (ICRs).

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/

[[Page 40839]]

oes/current/oes_nat.htm). In this regard, Table 60 presents the mean 
hourly wage, the cost of fringe benefits and overhead (calculated at 
100 percent of salary), and the adjusted hourly wage.

                          Table 60--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code         wage ($/hr)    overhead ($/   hourly wage ($/
                                                                                        hr)             hr)
----------------------------------------------------------------------------------------------------------------
Billing and Posting Clerks......................         43-3021           19.00           19.00           38.00
Bookkeeping, Accounting, and Auditing Clerks....         43-3031           22.46           22.46           44.92
Chief Executive.................................         11-1011           96.22           96.22          192.44
Compliance Officer..............................         13-1041           41.85           41.85           83.70
Computer Systems Analysts.......................         15-1121           45.01           45.01           90.02
Health Diagnosing and Treating Practitioners....         29-1000           49.02           49.02           98.04
Licensed Practical Nurse (LPN)..................         29-2061           22.62           22.62           45.24
Medical Secretary...............................         43-6013           17.83           17.83           35.66
Physicians......................................         29-1060          101.43          101.43          202.86
Practice Administrator (Medical and Health               11-9111           54.68           54.68          109.36
 Services Managers).............................
----------------------------------------------------------------------------------------------------------------

    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. Proposed 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 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 rule, 
CMS proposes 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 proposed 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 would 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 this 
rule's proposed requirements may slightly increase the number of 
respondents, our 180 respondent per quarter 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 several year period the overall 
average of the annual fluctuation is near 0. As a result, the potential 
slight increase in respondents associated with voluntary reporting from 
oral OUD drug manufacturers is well within the range of recent 
fluctuations in the number or respondents, and the net figure, taking 
into account voluntary OTP reporting, remains unchanged from the 
currently approved burden estimate at 180 respondents. In addition, we 
believe that additional voluntary reporting for oral drugs used for 
treatment of OUD for those manufacturers that currently report ASP data 
to CMS would 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.
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 are not setting out the burden of the proposed 
collection of information under the data collection system. Please 
refer to section VI.F.2. of this proposed rule for a discussion of the 
estimated impacts associated with the ground ambulance data collection 
system.

[[Page 40840]]

3. ICRs Regarding Intensive Cardiac Rehabilitation (Sec.  410.49)
    Section 410.49(b)(1)(vii) and (viii) of this proposed rule would 
expand the covered conditions to chronic heart failure and add other 
cardiac conditions as specified through the national coverage 
determination (NCD) process. The proposed rule would expand covered 
conditions, but, due to the breadth of the proposed and existing 
covered conditions, 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 was submitted, it would be covered by OMB 
control number 0938-0776 (CMS-R-290), which will not expire until 
February 29, 2020. We are not proposing any changes under that control 
number since we are not proposing any changes to the submission process 
or burden.
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 
VI.E.6. of this proposed rule for a discussion of the impacts 
associated with the proposed changes to the Shared Savings Program 
quality reporting requirements included in this proposed rule.
5. ICRs Regarding the Open Payments Program
    As described in section III.F. of this rule, we propose to: (1) 
Expand the definition of ``covered recipient,'' (2) modify ``nature of 
payment'' categories, and (3) standardize 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): In this rule we propose to expand 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. . We do, however, 
provide a brief estimate in section V.8 of this proposed rule.
    Modification of the ``Nature of Payment'' Categories (Sec. Sec.  
403.902 and 403.904): The following proposed 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 proposed changes would 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 would need to update their system to incorporate the proposed 
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. While 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) would 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 would 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 hrs for a large entity x 133 entities) + 
(10 hrs for a medium entity x 114 entities) + (5 hrs for a small entity 
x 153 entities)] at a cost of $264,804 (5,895 hrs x $44.92/hr).
    We also expect that all entities would need to make minor, one-time 
adjustments to their submission processes. For each entity we estimate 
that this would 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 hrs for support staff at a large entity x 532 entities) + (5 
hrs for support staff at a medium entity x 457 entities) + (2 hrs for 
support staff at a small entity x 611 entities) + (1 hr for compliance 
officer at each entity regardless of size x 1600 entities)] at a cost 
of $410,941 [(2,660 hrs for support staff at large entities x $44.92/
hr) + (2,285 hrs for support staff at medium entities x $44.92/hr) + 
(1,222 hrs for support staff at small entities x $44.92/hr) + (1,600 
hrs for compliance officers across all entities x $83.70/hr)].
    In aggregate, we estimate a one-time burden of 13,662 hours (5,895 
hrs + 7,767 hrs) 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.

         Table 61--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 proposed 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. We have made some estimates below, but 
we recognize that these estimates may vary because the information 
collection system

[[Page 40841]]

changes that are needed will vary since some entities may already be 
capturing this information in their systems while others may not. 
Nevertheless, we have made some assumptions below, but we welcome 
feedback from stakeholders regarding the potential burden associated 
with this proposal and the extent to which device identifiers are 
already tracked by reporting entities.
    We estimate, based on an analysis of currently available data, that 
approximately 850 entities (approximately 53 percent of an assumed 
1,600) would 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 of the 
entities would be small, 29 percent would be medium, and 33 percent 
would be large. We differentiate because we assume that larger 
companies would 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 records submissions 
would not change, but this rule would add a new data element that may 
need to be reported along with some or all of an entity's records. The 
precise tasks would vary by entity, but may include developing 
processes for gathering device identifier information or systems for 
collecting the data.
    For the 450 entities that would be required to start collecting 
device identifiers, we estimate that this task would 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 hrs for a large 
entity x 150 entities) + (50 hrs for a medium entity x 128 entities) + 
(20 hrs for a small entity x 172 entities)] at a cost of $1,115,813 
[(15,000 hrs for support staff at a large entity x $44.92/hr) + (6,400 
hrs for support staff at a medium entity x $44.92/hr) + (3,440 hrs for 
support staff at a small entity x $44.92/hr)].
    For the 850 entities that we expect would 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 hrs for support staff at a large entity x 282 entities) + 
(20 hrs for support staff at a medium entity x 244 entities) + (10 hrs 
for support staff at a small entity x 324 entities) + (2 hrs for 
compliance officers at every entity regardless of size x 850 entities)] 
at a cost of $1,013,740 [(11,280 hrs 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 hrs 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 would have a small amount of burden 
associated with updating their submission processes. We estimate that 
this would 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 hrs for support staff at a large entity x 
249 entities) + (5 hrs for support staff at a medium entity x 215 
entities) + (2 hrs for support staff at a small entity x 286 entities) 
+ (750 hrs for compliance officers at all entities regardless of size x 
2 hrs)] at a cost of $311,384 [(2,490 hrs for support staff at large 
entities x $44.92/hr) + (1,075 hrs for support staff at medium entities 
x $44.92/hr) + (572 hrs for support staff at small entities x $44.92/
hr) + (1,500 hrs 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 
hrs + 21,100 hrs + 5,637 hrs) 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.

  Table 62--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 would 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......................
                                         -------------------------------
    Total...............................          51,577       2,440,937
------------------------------------------------------------------------

6. ICRs Regarding Medicare Enrollment of Opioid Treatment Programs
    Except as noted otherwise, the following proposed changes will be 
submitted to OMB for approval under control number 0938-0685 (CMS-855B; 
``Medicare Enrollment Application: Clinics/Group Practices and Certain 
Other Suppliers'').
    As discussed previously in this rule, we propose that OTP providers 
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 
estimate 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: We estimate that it would take each OTP an average 
of 3 hours to obtain and furnish the information on the Form CMS-855B 
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 estimate 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 estimate would take 0.5 hours. We thus project a 
first-year burden of 5,301 hours (1,767 entities x 3 hr) at a cost of 
$732,439 (5,301 hr x ((2.5 hr x $35.66/

[[Page 40842]]

hr) + (0.5 hr x $98.04/hr)), a second-year burden of 201 hours (67 
entities x 3 hr) at a cost of $27,772 (201 hr 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 $27,358 (198 hr x((2.5 hr x $35.66/hr) + 
(0.5 hr x $98.04/hr)). In aggregate, we estimate a burden of 5,700 
hours (5,301 hr + 201 hr + 198 hr) at a cost of $787,569 ($732,439 + 
$27,772 + $27,358). When annualized over the 3-year period, we estimate 
an annual burden of 1,900 hours (5,700 hours/3) at a cost of $262,523 
($787,569/3).
    A copy of the draft OTP supplement will be available on-line, and 
we welcome public comment on: (1) Its contents; (2) the usefulness of 
the data to be captured thereon; and (3) the anticipated burden of 
completion.
    Fingerprinting: As we are proposing that OTPs be subject to high 
categorical risk level screening under Sec.  424.518, we would require 
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. The burden is currently approved by OMB under control 
number 1110-0046. An analysis of the impact of this proposed 
requirement can be found in the RIA section of this rule.
    Application Fee: As already discussed in this rule, each OTP would 
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'' and, as such, is not subject to the requirements of the 
PRA. Although we are not setting out such burden under this section of 
the preamble, the cost is scored under the RIA section.
    Provider Agreement: As mentioned in the preamble of this proposed 
rule, OTPs would have to complete a provider agreement in order to 
enroll in Medicare. The burden for reporting and completing the 
Provider Agreement--CMS Form 1561 and 1561A (OMB control number 0938-
0832) are based on SAMHSA statistics. We generally estimate that there 
are about 1,700 already certified and accredited OTPs eligible for 
Medicare enrollment initially; and approximately 200 OTPs would become 
certified by SAMHSA in the next 3 years (or roughly 67 per year). We 
anticipate 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 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 $192.44/hr] + [317 hr/2 
respondents x $35.66/hr]). This results, roughly, in a Year 1 burden of 
295 hours at $33,623, a Year 2 burden of 11 hours at $1,272, and a Year 
3 burden of 11 hours at a cost of $1,254. Annually, over the course of 
OMB's typical 3-year approval period, we estimate a burden of 106 hours 
317 hr/3 years) at a cost of $12,051 ($36,154/3 years).
    Total: Table 63 summarizes our foregoing burden estimates.

                             Table 63--Combined Burden Related to Enrollment of OTPs
                                 [Completion of CMS-855B and provider agreement]
----------------------------------------------------------------------------------------------------------------
                                                                                                    Annualized
                                      Year 1          Year 2          Year 3           Total      average over 3-
                                                                                                    year period
----------------------------------------------------------------------------------------------------------------
Time (Hours)....................           5,596             212             209           6,017           2,006
Cost ($)........................         766,062          29,044          28,612         823,718         274,572
----------------------------------------------------------------------------------------------------------------

7. The Quality Payment Program (Part 414 and Section III.K. of This 
Proposed Rule)
a. Background
(1) Information Collection Requirements 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 proposed 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
    As discussed in more detail in section IV.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 an increase in burden due to proposed changes in 
policies: QCDR self-nomination applications and Call for Quality 
Measures. For the QCDR self-nomination applications ICR, we have 
increased our estimate of the time required to submit a QCDR measure by 
1.5 hour due to the proposal to require QCDRs to identify a linkage 
between their QCDR measures to related cost measures, Improvement 
Activities, and MIPS Value Pathways starting with the 2021 self-
nomination period (+1 hour); and the proposal to require QCDR measure 
stewards to submit measure testing data as part of the self-nomination 
process for each QCDR measure (+0.5 hours). For this same ICR, we have 
increased our estimate of the time required for a QCDR to submit their 
self-nomination by 0.25 due to the proposal to require QCDRs to include 
a description of the quality improvement services they intend to 
support. 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 proposal to require that MIPS 
quality measure stewards link their MIPS quality measures to existing 
and related cost measures and improvement

[[Page 40843]]

activities and provide rationale for the linkage. The remaining changes 
to 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 proposed rule. We are not proposing 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 
IV.B.7.(n) of this proposed rule for a summary of the ICRs, the overall 
burden estimates, and a summary of the assumption and data changes 
affecting each ICR.
    The 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).
    Respondent estimates for the quality, Promoting Interoperability, 
and improvement activities performance categories are modeled using 
data from the 2017 MIPS performance period with the sole exception of 
104 CMS Web Interface respondents, which is 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. Although we are 
using data from the 2017 MIPS performance period as we did in the CY 
2019 PFS final rule, our respondent estimates have been updated to 
reflect revised assumptions regarding QPs and APM participants. 
Respondent data from the 2018 MIPS performance period was unavailable 
in time for publication for this proposed rule as was the number of 
groups and virtual groups registering to submit quality performance 
category data using the CMS Web Interface. Assuming updated information 
is available, we intend to update these estimates in the final rule.
    Our participation estimates are reflected in Tables 69, 70, and 71 
for the quality performance category, Table 87 for the Promoting 
Interoperability performance category, and Table 92 for the improvement 
activities performance category.
    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 will do in 
the 2020 MIPS performance period compared to the 2017 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.
(3) Summary of Quality Payment Program Changes: Advanced APMs
    As discussed in more detail in sections IV.B.7. of this 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 proposed changes to currently approved burden 
estimates are adjustments based on updated projections for the 2020 
MIPS performance period. We are not proposing any changes to our per-
respondent burden estimates. We are also not proposing 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 64 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 64, 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 64.
    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 proposed 
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

[[Page 40844]]

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

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[GRAPHIC] [TIFF OMITTED] TP14AU19.095


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[GRAPHIC] [TIFF OMITTED] TP14AU19.096

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 proposed rule create some additional data collection requirements 
not listed in Table 64. 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 Approved 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).

[[Page 40848]]

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 does not propose any new or revised collection of 
information requirements or burden related to the virtual group 
election. The virtual group election requirements and burden are 
currently approved by OMB under control number 0938-1343 (CMS-10652). 
Consequently, we are not making any virtual group election changes 
under that control number.
c. ICRs Regarding Third-Party Intermediaries (Sec.  414.1400)
(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 one quality performance category measure, or can be used for 
completion of 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 
submit QCDR measures for the quality performance category. 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: \139\
---------------------------------------------------------------------------

    \139\ 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 proposed 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 would 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 would increase our 
total burden estimates while keeping our burden per response estimates 
unchanged. We are not proposing 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 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 (82 FR 53815). 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 proposed rule, we have adjusted the number of self-
nominating applicants from 150 to 290 based on more recent data and the 
assumption that any entity which self-nominated for approval as a QCDR 
in previous years and that no longer qualifies as a result of policies 
finalized in the CY 2019 PFS final rule, effective beginning with the 
2020 MIPS performance period could elect to self-nominate for approval 
as a qualified registry. The policies revised both the definition of a 
QCDR (83 FR 59895) and minimum participation requirements for entities 
seeking approval as a QCDR (83 FR 59897). Entities which no longer meet 
the criteria for approval as QCDRs may seek other options such as 
collaborating with another entity to meet the new requirements or to 
end their participation in the Quality Payment Program, however, we 
believe the assumption that these entities will instead elect to self-
nominate as a qualified registry is both appropriate and conservative. 
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 
respondents' estimates in this proposed rule.
    For the 2019 MIPS performance period, we received 198 applications 
for nomination to be a qualified registry, 135 of which were approved 
to submit data, a reduction of 6 from the currently approved estimate 
of 141 (83 FR 59997 through 59998). Based on the number of self-
nominations received for the 2019 MIPS performance period, we estimate 
200 entities will self-nominate as a qualified registry for the 2020 
MIPS performance period, not considering

[[Page 40849]]

nominations from entities which previously qualified as QCDRs. Based on 
our analysis of the QCDRs approved for the CY 2019 performance period, 
63 of the 127 approved QCDRs (49.6 percent) would not meet the criteria 
for approval for the CY 2020 performance period. For the 2019 MIPS 
performance period, 181 entities self-nominated for approval as QCDRs, 
therefore we assume that 90 (49.6 percent) of these entities will self-
nominate for approval as qualified registries for the 2020 MIPS 
performance period. In total, we estimate 290 nomination applications 
(200 entities + 90 entities) will be received from entities seeking 
approval to report MIPS data as qualified registries, an increase of 
140 from the currently approved estimate of 150 (83 FR 59997 through 
59998). As previously stated, this increase is comprised of both an 
adjustment to due updated data (+50 self-nominations) and a revision 
due to policies promulgated in the CY 2019 PFS final rule (+90 self-
nominations). Assuming updated data is available, we will update our 
estimates in the final rule to reflect the actual number of nomination 
applications received for the 2020 MIPS performance period.
    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 QPP 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 66, 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. When considering this rule's adjusted number of 
nomination applications (290) we estimate that the annual burden will 
range from 532.5 hours ([135 simplified self-nominations x 0.5 hr] + 
[155 full self-nominations x 3 hr]) to 870 hours (290 qualified 
registries x 3 hr) at a cost ranging from $47,936 (532.5 hr x $90.02/
hr) to $78,317 (870 hr x $90.02/hr), respectively (see Table 66).
    As shown in Table 65, 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 would 
adjust our total burden estimates by 435 hours and $39,159 [(-6 
registries x 0.5 hr x $90.02/hr) + (146 registries x 3 hr x $90.02/hr)] 
and 420 hours and $37,808 (140 registries x 3 hr x $90.02/hr). While we 
are proposing to adjust our total burden estimates based on more 
current data, the burden per response would remain unchanged.

    Table 65--Change in Estimated Burden for Qualified Registry Self-
                               Nomination
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
Total Annual Hours for Qualified                    97.5             450
 Registries in CY 2019 Final Rule (a)...
Total Annual Hours for Qualified                   532.5             870
 Registries in CY 2020 Proposed Rule (b)
                                         -------------------------------
    Difference Between CY 2020 Proposed              435             870
     Rule and CY 2019 Final Rule (c) =
     (b)-(a)............................
------------------------------------------------------------------------
Total Annual Cost for Qualified                   $8,777         $40,509
 Registries in CY 2019 Final Rule (d)...
Total Annual Cost for Qualified                  $47,936         $78,317
 Registries in CY 2020 Proposed Rule (e)
                                         -------------------------------
    Difference Between CY 2020 Proposed          $39,159         $37,808
     Rule and CY 2019 Final Rule (f) =
     (e)-(d)............................
------------------------------------------------------------------------

    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, beginning with the 2021 performance 
period and for future years, we propose to require that qualified 
registries support the reporting of improvement activities and 
Promoting Interoperability measures in addition to the quality 
performance category. 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 
propose, beginning with the 2023 MIPS payment period, 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 the 
proposal 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

[[Page 40850]]

period or future years as a result of this proposal; 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 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. In section 
III.K.3.g.(4)(a)(i) of this proposed rule, beginning with the 2021 
performance period, we are proposing to require qualified registries to 
support all three performance categories: Quality, improvement 
activities, and Promoting Interoperability with the proviso that based 
on the proposed amendment to Sec.  414.1400(a)(2)(iii) the requirement 
to support submission of Promoting Interoperability data would be 
inapplicable to the third party intermediary if the clinician, group or 
virtual group is exempt from this reporting requirement. As part of 
this proposal, we would require qualified registries to attest to the 
ability to submit data for all three of these performance categories at 
time of self-nomination. 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 proposals and assume 
there will be minimal impact on the time required to complete either 
the simplified or full self-nomination process.
    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 66 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.

    Table 66--Estimated Burden for Qualified Registry Self-Nomination
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
# of Qualified Registry Simplified Self-             135               0
 Nomination Applications submitted (a)..
# of Qualified Registry Full Self-                   155             290
 Nomination Applications submitted (b)..
Total Annual Hours Per Qualified                     0.5             0.5
 Registry for Simplified Process (c)....
Total Annual Hours Per Qualified                       3               3
 Registry for Full Process (d)..........
                                         -------------------------------
    Total Annual Hours for Qualified               532.5             870
     Registries (e) = (a) * (c) + (b) *
     (d)................................
------------------------------------------------------------------------
Cost Per Simplified Process Per Registry          $45.01          $45.01
 (@computer systems analyst's labor rate
 of $90.02/hr.) (f).....................
Cost Per Full Process Per Registry               $270.06         $270.06
 (@computer systems analyst's labor rate
 of $90.02/hr.) (g).....................
                                         -------------------------------
    Total Annual Cost for Qualified              $47,936         $78,317
     Registries (h) = (a) * (f) + (b) *
     (g)................................
------------------------------------------------------------------------

    Both the minimum and maximum burdens shown in Table 66 reflect 
adjustments to the number of respondents (from 150 to 290) due to 
availability of more recent data (+50 respondents) and revisions due to 
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 (+90 respondents). For purposes of calculating total 
burden associated with this proposed rule as shown in Table 90, only 
the maximum burden is being submitted to OMB for their review and 
approval.
(3) QCDR Self-Nomination Applications
(a) Self-Nomination Process
    The proposed 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 would 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. These changes result in a decrease 
from 200 to 91 self-nomination applications in the 2020 MIPS 
performance period. This rule would also adjust the number of QCDR 
measures submitted for consideration by each QCDR seeking to self-
nominate (from 9 to 11.5), as well as the time required to submit 
information (from 1 hour to 2.5 hours) for each QCDR measure. These 
changes would increase our minimum total burden estimate (from 2,025 
hours to 2,729.25 hours) and increase our maximum total burden estimate 
(from 2,400 hours to 2,889.25 hours). In addition, our per response 
estimates for the simplified and full self-nomination processes would 
increase from 9.5 hours to 29.25 hours and from 12 hours to 31.75 
hours, respectively.
    We refer readers to Sec.  414.1400(a)(2) and (b)(1) which states 
that QCDRs interested in submitting MIPS data to us on behalf of a MIPS 
eligible clinician, group, or virtual group will need to complete a 
self-nomination process to be considered for approval to do so.
    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

[[Page 40851]]

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 the 2019 MIPS performance period, we received 181 self-
nomination applications from entities seeking approval as QCDRs, 127 of 
which were approved to submit data. Based on our analysis of the QCDRs 
approved for the CY 2019 performance period, 63 of the 127 approved 
QCDRs (49.6 percent) would not meet the criteria for approval for the 
CY 2020 performance period. We project that 90 (49.6 percent) of the 
181 entities will not self-nominate for approval as QCDRs for the 2020 
MIPS performance period but will instead self-nominate to be qualified 
registries. Entities which no longer meet criteria for approval as 
QCDRs may seek other options as well, including collaborating with 
another entity to meet the new requirements or to end their 
participation in the Quality Payment Program; however, we believe the 
assumption that these entities will instead elect self-nomination as a 
qualified registry is both appropriate and conservative. We also 
project the remaining 91 entities will submit nomination applications 
for approval to report MIPS data as QCDRs for the MIPS 2020 performance 
period, a decrease of 109 from the currently approved estimate of 200. 
This decrease of 109 is a result of both an adjustment due to use of 
more recent data accounts (decrease of 19 self-nominations) and a 
change due to previously finalized policies regarding the definition of 
a QCDR (83 FR 59895) and minimum participation requirements (83 FR 
59897) (decrease of 90 self-nominations). 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 proposed rule. We further estimate that the 64 QCDRs approved to 
submit data in the 2019 MIPS performance period that would also qualify 
as QCDRs for the 2020 MIPS performance period will use the simplified 
self-nomination process. Assuming updated data is available, we will 
update our estimates in the final rule to reflect the actual number of 
nomination applications received for the 2020 MIPS performance period.
    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 proposing, beginning with the 2021 performance period and 
future years, to require that QCDRs support three performance 
categories: Quality, improvement activities, and Promoting 
Interoperability. We are also proposing in section 
III.K.3.g.(3)(a)(ii), beginning with the 2023 MIPS payment year and 
future years, QCDRs would be required to provide services to clinicians 
and groups to foster improvement in the quality of care provided to 
patients, by providing educational services in quality improvement and 
leading quality improvement initiatives and to describe the quality 
improvement services they intend to support in their self-nomination 
for CMS review and approval. 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 
propose, 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 proposing, 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 would 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 for 
multiple reasons: We are not requiring QCDRs to provide performance 
feedback to their clinicians and groups at a greater frequency than 
what has previously been required, QCDRs will only being required to 
provide feedback using data they are already collecting, and we are 
giving QCDRs significant flexibility to provide broad quality 
improvement services that are tailorable to the specific QCDR and the 
clinicians they support. 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 this proposal; 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 proposals and 
assume there will be no impact on the time required to complete either 
the simplified or full self-nomination process. With regard to the 
proposal to require QCDRs to describe the quality improvement services 
they will provide as part of their self-nomination, we estimate this 
will require approximately 15 minutes to complete.
    We estimate that the self-nomination process for QCDRs to submit on 
behalf of MIPS eligible clinicians or groups for MIPS will involve 
approximately 3.25 hours per QCDR to submit information

[[Page 40852]]

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.
(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 
proposing 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 are proposing in section 
III.K.3.g.(3)(c)(i)(B)(dd) 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 VI.C.10.(f) of this rule's Regulatory Impact 
Analysis.
    In section III.K.3.g.(3)(c)(i)(A)(bb) of this rule, we are 
proposing 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)(cc) of this rule, we propose, 
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 proposed 
rule, beginning with the 2021 performance period and future years, we 
are proposing that QCDRs must identify a linkage between their QCDR 
measures to the following, at the time of self-nomination: (a) Cost 
measures (as found in section III.K.3.c.(2) of this proposed 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 proposed rule). We estimate that a QCDR will 
spend an additional 1 hour performing these activities per measure, on 
average.
    We are also proposing to formalize 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 proposing 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 proposing 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 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 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

[[Page 40853]]

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. If this policy is finalized, 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 
11.5 QCDR measures, for a total burden of 11.5 hours per QCDR (1 hr per 
measure x 11.5 measures). The estimated average of 11.5 measures per 
QCDR is based on an analysis of the QCDR measures submitted for 
consideration and QCDR measures approved for the 2019 MIPS performance 
period, as well as the measures for QCDRs approved for the CY 2019 
performance period that would not meet criteria for approval for the CY 
2020 performance period. For the 2019 MIPS performance period, 1,123 
QCDR measures were submitted for consideration and 762 were approved; 
an approval rate of 68 percent. Of these approved measures, 264 are for 
the 63 QCDRs which would not meet criteria for approval for the 2020 
MIPS performance period. Averaging the remaining 498 approved QCDR 
measures by the 64 QCDRs that would meet the criteria for approval for 
the 2020 MIPS performance period results in approximately 7.8 approved 
measures per QCDR (498 approved measures / 64 QCDRs). Assuming an 
identical 68 percent QCDR measure approval rate for measures submitted 
for consideration for the 2020 MIPS performance period, this results in 
approximately 11.5 measures submitted for consideration for each QCDR 
(7.8 approved measures / 0.68 approval rate). We believe the proposals 
to change requirements for QCDR measure submission and to require 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 proposed changes will have on the number of 
measures QCDRs will submit for approval. As information becomes 
available in future years, we will revisit our assumptions to better 
reflect the impact of these proposals on QCDRs and the quantity of 
measures 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 11.5 measures per QCDR to be both conservative and 
appropriate, as well as an overall decrease of 76 QCDR measures 
compared to the 1,123 QCDR measures submitted for consideration in the 
CY2019 performance period (1,123 QCDR measures-[91 QCDRs x 11.5 
measures per QCDR]).
    Beginning with the 2021 performance period, we are proposing in 
section III.K.3.g.(3)(c)(iii) of this proposed 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 proposed 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 
burden associated with this proposal. 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 11.5 QCDR measures for approval, on average. 
Therefore, we estimate each QCDR will require 28.75 hours (11.5 
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.
    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 propose 
to increase the burden associated with self-nomination to a minimum of 
29.25 hours (0.5 hours to submit information for the simplified self-
nomination process and 28.75 hours for the submission of QCDR measures) 
to a maximum of 32 hours (3.25 hours to submit information for the full 
self-nomination process and 28.75 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 29.25 hours to a maximum of 32 hours, we 
estimate that the annual burden will range from 2,736 hours ([64 QCDRs 
x 29.25 hr] + [27 QCDRs x 32 hr]) to 2,912 hours (91 QCDRs x 32 hr) at 
a cost ranging from $246,295 (2,736 hr x $90.02/hr) and $262,138 (2,912 
hr x $90.02/hr), respectively (see Table 67).
    Based on the assumptions previously discussed, we provide an 
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures 
results and numerator and denominator data on MIPS eligible clinicians.

  Table 67--Estimated Burden for QCDR Self-Nomination and QCDR Measure
                               Submission
------------------------------------------------------------------------
                                              Minimum         Maximum
------------------------------------------------------------------------
# of QCDR Simplified Self-Nomination                  64               0
 Applications submitted (a).............
# of QCDR Full Self-Nomination                        27              91
 Applications submitted (b).............
Total Annual Hours Per QCDR for                    29.25           29.25
 Simplified Process (c).................
Total Annual Hours Per QCDR for Full               32.00           32.00
 Process (d)............................
                                         -------------------------------

[[Page 40854]]

 
    Total Annual Hours for QCDRs (e) =             2,736           2,912
     (a) *(c) + (b) * (d)...............
------------------------------------------------------------------------
Cost Per Simplified Process Per QCDR           $2,633.09       $2,633.09
 (@computer systems analyst's labor rate
 of $90.02/hr) (f)......................
Cost Per Full Process Per QCDR                 $2,880.64       $2,880.64
 (@computer systems analyst's labor rate
 of $90.02/hr) (g)......................
                                         -------------------------------
    Total Annual Cost for QCDRs (h) =           $246,295        $262,138
     (a) * (f) + (b) * (g)..............
------------------------------------------------------------------------

    Both the minimum and maximum burden shown in Table 67 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 proposed rule 
as shown in Table 90, 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 91) results in an 
adjustment of between -1,093 hours [(-86 QCDRs x 9.5 hr) + (-23 QCDRs x 
12 hr)] at a cost of -$98,392 (-1,093 hr x $90.02) and -1,308 hours (-
109 QCDRs x 12 hr) at a cost of -$117,746 (-1,308 hr x $90.02/hr). 
Accounting for the change in the number of QCDRs, the change in time 
per QCDR to self-nominate results in an adjustment of 1,820 hours (91 
QCDRs x 20 hr) at a cost of $163,836 (1,820 hr x $90.02/hr). As shown 
in Table 68, when these two adjustments are combined, the net impact 
ranges between 727 hours (-1,093 hr + 1,820 hr) hours at a cost of 
$65,444 (-$98,392 + $163,836) and 512 hours (-1,308 hr + 1,820 hr) 
hours at a cost of $46,090 (-$117,746 + $163,836).

 Table 68--Change in Estimated Burden for QCDR Self-Nomination and QCDR
                           Measure Submission
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
Total Annual Hours for QCDRs in CY 2019            2,025           2,400
 Final Rule (a).........................
Total Annual Hours for QCDRs in CY 2020            2,736           2,912
 Proposed Rule (b)......................
                                         -------------------------------
    Difference Between CY 2020 Proposed              711             512
     Rule and CY 2019 Final Rule (c) =
     (b)-(a)............................
------------------------------------------------------------------------
Total Annual Cost for QCDRs in CY 2019          $182,291        $216,048
 Final Rule (d).........................
Total Annual Cost for QCDRs in CY 2020          $246,295        $262,138
 Proposed Rule (e)......................
                                         -------------------------------
    Difference Between CY 2020 Proposed          $64,004         $46,090
     Rule and CY 2019 Final Rule (f) =
     (e)-(d)............................
------------------------------------------------------------------------

    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 supporting 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 supported 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 support the improvement activities and 
Promoting Interoperability performance categories and are not making 
any further changes to our burden estimates. Therefore, we believe the 
2,912-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.
(4) CAHPS for MIPS Survey Vendor
    This rule does not propose 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 would adjust the number of 
respondents based on current data. The adjustment would 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 be subject to 
MIPS payment adjustments.

[[Page 40855]]

    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 would 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 would no longer need to submit data to MIPS); hence, our 
model may under estimate or overestimate the number of respondents.
    Using participation data from the 2017 MIPS performance period 
combined with the estimate of QPs for the 2020 performance period, we 
estimate a total of 833,243 clinicians will submit quality data as 
individuals or groups in the 2020 MIPS performance period, a decrease 
of 131,003 clinicians when compared to our estimate of 964,246 
clinicians in the CY 2019 PFS final rule (83 FR 60002). As previously 
stated in section IV.B.7.(a.(2), respondent data from the 2018 MIPS 
performance period was unavailable at the time of publication of this 
proposed rule. Assuming that updated respondent data becomes available 
before the publication of the CMS-1715-F final rule, we will revise our 
burden estimates in that rule.
    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 
2017 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 proposed 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 2017 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 2017 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 
alternative. Our assumptions result in a 121,858 decrease in the 
estimated number of clinicians who will submit quality data via 
Medicare Part B claims and a 15,556 increase in the number of 
clinicians who will submit via the QCDR/MIPS CQM collection type, as 
shown in Table 69.
    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 making any adjustments to our 
respondent estimates as a result of the proposal discussed in section 
III.K.3.c.(5)(c)(i)(A) of this proposed 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 2019 predictive file that 
contains current participation in MIPS APMs as of January 15, 2019, 
using all available data. 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 2017 MIPS performance 
period. For clinicians who participated in an APM in 2017, were not in 
an APM in 2019, and did not report MIPS quality data in 2017, 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. In addition, we 
assume that the 80 TINs that elect to form 16 virtual groups will 
continue to collect and submit MIPS data using the same collection and 
submission types as they did during the 2017 MIPS performance period, 
but the submission will be at the virtual group, rather than group 
level.
    Our burden estimates for the quality performance category do not 
include the burden for the quality data that APM Entities submit to 
fulfill the requirements of their 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.\140\ Tables 69, 70, 
and 71 explain our

[[Page 40856]]

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.
---------------------------------------------------------------------------

    \140\ 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 69 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 
2017 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 69 shows that in the 2020 MIPS performance period, an 
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.
    Table 69 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 69--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
                                   Medicare Part                                      CMS web
                                     B claims      QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect          109,951         359,621         247,329         116,342         833,243
 data by collection type (as
 individual clinicians or
 groups) in 2020 MIPS
 performance period (excludes
 QPs) (a).......................
* Number of clinicians to                257,260         324,693         243,062         139,231         964,246
 collect data by collection type
 (as individual clinicians or
 groups) in 2019 MIPS
 performance period (excludes
 QPs) (b).......................
Difference between 2020 MIPS            -147,309          34,928           4,267         -22,889        -131,003
 performance period (CY 2020
 Proposed Rule) and 2019 MIPS
 performance period (CY 2019
 Final Rule) (c) = (a)-(b)......
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    In the CY 2018 Quality Payment Program final rule (82 FR 53625 
through 53626), beginning with the 2019 MIPS performance period, we 
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 2017 MIPS 
performance period.
    Table 70 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 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.

     Table 70--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
                                                 Collection Type
----------------------------------------------------------------------------------------------------------------
                                   Medicare Part                                      CMS web
                                     B claims      QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit           109,951         106,039          47,455               0         263,445
 data as individuals in 2020
 MIPS Performance Period
 (excludes QPs) (a).............
* Number of Clinicians to submit         257,260          71,439          47,557               0         376,256
 data as individuals in 2019
 MIPS Performance Period
 (excludes QPs) (b).............

[[Page 40857]]

 
Difference between 2020 MIPS            -147,309         +34,600            -102               0        -112,811
 Performance Period (CY 2020
 proposed rule) and 2019 MIPS
 performance period (CY 2019
 final rule) (c) = (a)-(b)......
----------------------------------------------------------------------------------------------------------------
* 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 70 are not mutually exclusive.
    Table 71 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 2017 and 
2019 MIPS performance periods, we assume that groups that submitted 
quality data as groups in the 2017 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. First, we estimated 
the number of groups or virtual groups that will collect data via each 
collection type during the 2020 MIPS performance period using data from 
the 2017 MIPS performance period. The second and third steps in Table 
71 reflect our currently approved assumption that virtual groups will 
reduce the burden for quality data submission by reducing the number of 
organizations that will submit quality data on behalf of clinicians. We 
assume that 40 groups that previously collected on behalf of clinicians 
via QCDR or MIPS CQM collection types will elect to form 8 virtual 
groups that will collect via QCDR and MIPS CQM collection types. We 
assume that another 40 groups that previously collected on behalf of 
clinicians via eCQM collection types will elect to form another 8 
virtual groups that will collect via eCQM collection types. Hence, the 
second step in Table 71 is to subtract out the estimated number of 
groups under each collection type that will elect to form virtual 
groups, and the third step in Table 71 is to add in the estimated 
number of virtual groups that will submit on behalf of clinicians for 
each collection type.
    Specifically, we assume 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.

     Table 71--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
                                     Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
                                   Medicare Part                                      CMS web
                                     B claims      QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data               0          10,584           4,364             104          15,052
 by collection type (on behalf
 of clinicians) in 2020 MIPS
 performance period (excludes
 QPs) (a).......................
Subtract out: Number of groups                 0              40              40               0              80
 to collect data by collection
 type on behalf of clinicians in
 2020 MIPS performance period
 that will submit as virtual
 groups (b).....................
Add in: Number of virtual groups               0               8               8               0              16
 to collect data by collection
 type on behalf of clinicians in
 2020 MIPS performance period
 (c)............................
Number of groups to collect data               0          10,552           4,332             104          14,988
 by collection type on behalf of
 clinicians in 2020 MIPS
 performance period (d) = (a)-
 (b) + (c)......................
* Number of groups to collect                  0          10,542           4,304             286          15,132
 data by collection type on
 behalf of clinicians in 2019
 MIPS performance period (e)....
Difference between 2020 MIPS                   0              10              28            -182            -144
 performance period (CY 2020
 proposed rule) and 2019 MIPS
 performance period (CY 2019
 final rule) (f) = (d)-(e)......
----------------------------------------------------------------------------------------------------------------
* 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

[[Page 40858]]

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 
206. 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 72, as 
well as counts of new, removed, and substantively changed measures.

                   Table 72--Summary of Quality Measures for the 2020 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                                      Number
                                                      Number          Number         measures         Number
                 Collection type                     measures        measures      proposed with     measures
                                                    proposed as    proposed for    a substantive   remaining for
                                                        new           removal        change *         CY 2020
----------------------------------------------------------------------------------------------------------------
Medicare Part B Claims Specifications...........               0              17              22              47
MIPS CQMs Specifications........................               3              52              77             184
eCQM Specifications.............................               1               6              33              45
Survey--CSV.....................................               0               0               0               1
CMS Web Interface Measure Specifications........               1               1               9              10
Administrative Claims...........................               0               0               0               1
                                                 ---------------------------------------------------------------
    Total **....................................               4              55              95             206
----------------------------------------------------------------------------------------------------------------
* This column includes all measures that have a requested substantive change from the measure stewards. The
  total of 95 substantive changes reflects both measures that will continue and a subset of measures that have
  been proposed for removal for PY2020. There are 73 substantive changes that are proposed in Appendix 1 for
  measures not being proposed for removal.
** 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 
51 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. Likewise, we 
do not anticipate a change in reporting burden as a result of the one 
proposed administrative claims measure (The All-Cause Unplanned 
Admissions for Patients with Multiple Chronic Conditions measure) which 
is being proposed for the 2021 MIPS performance period as discussed in 
section III.K.3.c.(1)(d)(ii) of this rule.
    As discussed in section III.K.3.c.(1)(c)(ii) of this rule, we are 
proposing 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 does not propose 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 does not propose any new or revised collection of 
information requirements related to the submission of Medicare Part B 
claims data for the quality performance category. However, we are 
proposing adjustments to our currently approved burden estimates based 
on more recent data. The proposed requirements and burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    As noted in Table 69, based on 2017 MIPS performance period data, 
we assume that 109,951 individual clinicians will collect and submit 
quality data via the Medicare Part B claims collection type. This rule 
proposes to adjust the number of Medicare Part B claims respondents 
from 257,260 to 109,951 (a decrease of 147,309) based on more recent 
data and our updated methodology of accounting only for clinicians in 
small practices who submitted such claims data in the 2017 MIPS 
performance period rather than all clinicians who submitted quality 
data codes to us for the Medicare Part B claims collection type. 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

[[Page 40859]]

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 
proposed rule's provisions do not necessitate the revision of either 
form and we are making no changes to the associated estimate of 
reporting burden.
    As shown in Table 73, 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 proposing revisions to 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 786,150 hours (7.15 hr x 
109,951 clinicians) to 1,561,304 hours (14.2 hr x 109,951 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 $78,912,163 (109,951 
clinicians x $717.70) to a maximum of $148,691,575 (109,951 clinicians 
x $1,352.34).
    Table 73 summarizes the range of total annual burden associated 
with clinicians submitting quality data via Medicare Part B claims.

    Table 73--Estimated Burden for Quality Performance Category: Clinicians Using the Medicare Part B Claims
                                                 Collection Type
----------------------------------------------------------------------------------------------------------------
                                                                  Minimum burden   Median burden  Maximum burden
----------------------------------------------------------------------------------------------------------------
# of Clinicians (a).............................................         109,951         109,951         109,951
Hours Per Clinician to Submit Quality Data (b)..................            0.15            1.05             7.2
# of Hours Practice Administrator Review Measure Specifications                3               3               3
 (c)............................................................
# of Hours Computer Systems Analyst Review Measure                             1               1               1
 Specifications (d).............................................
# of Hours LPN Review Measure Specifications (e)................               1               1               1
# of Hours Billing Clerk Review Measure Specifications (f)......               1               1               1
# of Hours Clinician Review Measure Specifications (g)..........               1               1               1
Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) +              7.15            8.05            14.2
 (g)............................................................
                                                                 -----------------------------------------------
    Total Annual Hours (i) = (a) * (h)..........................         786,150         885,106       1,561,304
                                                                 -----------------------------------------------
Cost to Submit Quality Data (@computer systems analyst's labor            $13.50          $94.52         $648.14
 rate of $90.02/hr) (j).........................................
Cost to Review Measure Specifications (@practice administrator's         $328.08         $328.08         $328.08
 labor rate of $109.36/hr) (k)..................................
Cost to Review Measure Specifications (@computer systems                  $90.02          $90.02          $90.02
 analyst's labor rate of $90.02/hr) (l).........................
Cost to Review Measure Specifications (@LPN's labor rate of               $45.24          $45.24          $45.24
 $45.24/hr) (m).................................................
Cost to Review Measure Specifications (@billing clerk's labor             $38.00          $38.00          $38.00
 rate of $38.00/hr) (n).........................................
Cost to Review Measure Specifications (@physician's labor rate           $202.86         $202.86         $202.86
 of $202.86/hr) (o).............................................
                                                                 -----------------------------------------------
    Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m)          $717.70         $798.72       $1,352.34
     + (n) + (o)................................................
                                                                 -----------------------------------------------
        Total Annual Cost (q) = (a) * (p).......................     $78,912,163     $87,820,173    $148,691,575
----------------------------------------------------------------------------------------------------------------

    As shown in Table 74, 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 109,951 results in a 
total adjustment of between -1,053,259 hours (-147,309 respondents x 
7.15 hr/respondent) at a cost of -$105,724,111 (-147,309 respondents x 
$717.70/respondent) and -2,091,788 hours (-147,309 respondents x 14.2 
hr/respondent) at a cost of -$199,212,442 (-147,309 respondents x 
$1,352.34/respondent).

   Table 74--Change in Estimated Burden for Quality Performance Category: Clinicians Using the Medicare Part B
                                             Claims Collection Type
----------------------------------------------------------------------------------------------------------------
                                                           Minimum burden     Median burden      Maximum burden
----------------------------------------------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final              1,839,409          2,070,943          3,653,092
 Rule (a)..............................................
Total Annual Hours for Respondents in CY 2020 Proposed             786,150            885,106          1,561,304
 Rule (b)..............................................
                                                        --------------------------------------------------------

[[Page 40860]]

 
    Difference Between CY 2020 Proposed Rule and CY             -1,053,259         -1,185,837         -2,091,788
     2019 Final Rule (c) = (b)-(a).....................
Total Annual Cost for Respondents in CY 2019 Final Rule       $184,636,274       $205,478,964       $347,904,017
 (d)...................................................
Total Annual Cost for Respondents in CY 2020 Proposed          $78,912,163        $87,820,173       $148,691,575
 Rule (e)..............................................
                                                        --------------------------------------------------------
    Difference Between CY 2020 Proposed Rule and CY          -$105,724,111      -$117,658,791      -$199,212,442
     2019 Final Rule (f) = (e)-(d).....................
----------------------------------------------------------------------------------------------------------------

(4) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    This rule does not propose any new or revised collection of 
information requirements related to the MIPS CQM or QCDR collection 
types. However, we are proposing adjustments to our currently approved 
burden estimates based on more recent data. The proposed requirements 
and burden will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    As noted in Tables 69, 70, and 71, and based on 2017 MIPS 
performance period data, we assume that 359,621 clinicians will submit 
quality data as individuals or groups using MIPS CQM or QCDR collection 
types. Of these, we expect 106,039 clinicians, as shown in Table 70, 
will submit as individuals and 10,552 groups and virtual groups, as 
shown in Table 71, are expected to submit on behalf of the remaining 
253,582 clinicians. 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 2017 MIPS performance period. As a result of 
this assumption and our use of more recent data, this rule proposes to 
adjust the number of QCDR and MIPS CQM respondents from 81,981 to 
116,591 (an increase of 34,610). 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 1,058,996 hours 
(9.083 hr/response x 116,591 groups plus clinicians submitting as 
individuals) at a cost of $101,710,684 (116,591 responses x $872.37/
response). The increase in number of respondents from 81,981 to 116,591 
results in a total adjustment of 314,363 hours (34,610 respondents x 
9.083 hr/respondent) at a cost of $30,192,783 (34,610 respondents x 
$872.37/respondent). Based on these assumptions, we have estimated in 
Table 75 the burden for these submissions.

 Table 75--Estimated Burden for Quality Performance Category: Clinicians
 (Participating Individually or as Part of a Group) Using the MIPS CQM/
                          QCDR Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of clinicians submitting as individuals (a)...........         106,039
# of groups submitting via QCDR or MIPS CQM on behalf of          10,552
 individual clinicians (b)..............................
# of Respondents (groups plus clinicians submitting as           116,591
 individuals) (c) = (a) + (b)...........................
Hours Per Respondent to Report Quality Data (d).........               3
# of Hours Practice Administrator Review Measure                       2
 Specifications (e).....................................
# of Hours Computer Systems Analyst Review Measure                     1
 Specifications (f).....................................
# of Hours LPN Review Measure Specifications (g)........               1
# of Hours Billing Clerk Review Measure Specifications                 1
 (h)....................................................
# of Hours Clinician Review Measure Specifications (i)..               1

[[Page 40861]]

 
# of Hours Per Respondent to Authorize Qualified                   0.083
 Registry to Report on Respondent's Behalf (j)..........
Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g)            9.083
 + (h) + (i) + (j)......................................
                                                         ---------------
    Total Annual Hours (l) = (c) * (k)..................       1,058,996
                                                         ---------------
Cost Per Respondent to Submit Quality Data (@computer            $270.06
 systems analyst's labor rate of $90.02/hr) (m).........
Cost to Review Measure Specifications (@practice                 $218.72
 administrator's labor rate of $109.36/hr) (n)..........
Cost Computer System's Analyst Review Measure                     $90.02
 Specifications (@computer systems analyst's labor rate
 of $90.02/hr) (o)......................................
Cost LPN Review Measure Specifications (@LPN's labor              $45.24
 rate of $45.24/hr) (p).................................
Cost Billing Clerk Review Measure Specifications                  $38.00
 (@clerk's labor rate of $38.00/hr) (q).................
Cost Clinician Review Measure Specifications                     $202.86
 (@physician's labor rate of $202.86/hr) (r)............
Cost for Respondent to Authorize Qualified Registry/QCDR           $7.50
 to Report on Respondent's Behalf (@computer systems
 analyst's labor rate of $90.02/hr) (s).................
                                                         ---------------
    Total Annual Cost Per Respondent (t) = (m) + (n) +           $872.37
     (o) + (p) + (q) + (r) + (s)........................
                                                         ---------------
    Total Annual Cost (u) = (c) * (t)...................    $101,710,684
------------------------------------------------------------------------

    As shown in Table 76, using the unchanged currently approved per 
respondent burden estimate, the increase in number of respondents from 
81,981 to 116,591 results in a total difference of 314,363 hours 
(34,610 respondents x 9.083 hr/respondent) at a cost of $30,192,783 
(34,610 respondents x $872.37/respondent).

 Table 76--Change in Estimated Burden for Quality Performance Category:
 Clinicians (Participating Individually or as Part of a Group) Using the
                      MIPS CQM/QCDR Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule         744,633
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed         1,058,996
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019         314,363
     Final Rule (c) = (b)-(a)...........................
------------------------------------------------------------------------
Total Annual Cost for Respondents in CY 2019 Final Rule      $71,517,901
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed       $101,710,684
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019     $30,192,783
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

(5) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    This rule does not propose any new or revised collection of 
information requirements related to the eCQM collection type. However, 
we are proposing to adjust our currently approved burden estimates 
based on more recent data. The proposed requirements and burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    As noted in Tables 69, 70, and 71, based on 2017 MIPS performance 
period data, we assume that 247,329 clinicians will elect to use the 
eCQM collection type; 47,455 clinicians are expected to submit eCQMs as 
individuals; and 4,332 groups and virtual groups are expected to submit 
eCQMs on behalf of the remaining 199,874 clinicians. This rule proposes 
to adjust the number of eCQM respondents from 51,861 to 51,787 (a 
decrease of 74) based on more recent data. 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

[[Page 40862]]

a LPN/medical assistant, and 1 hour at $38.00/hr for a billing clerk.
    In aggregate we estimate an annual burden of 414,296 hours (8 hr x 
51,787 groups and clinicians submitting as individuals) at a cost of 
$40,128,711 (51,787 responses x $774.88/response). Based on these 
assumptions, we have estimated in Table 77 the burden for these 
submissions.

 Table 77--Estimated Burden for Quality Performance Category: Clinicians
     (Submitting Individually or as Part of a Group) Using the eCQM
                             Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of clinicians submitting as individuals (a)...........          47,455
# of Groups submitting via EHR on behalf of individual             4,332
 clinicians (b).........................................
# of Respondents (groups and clinicians submitting as             51,787
 individuals) (c) = (a) + (b)...........................
Hours Per Respondent to Submit MIPS Quality Data File to               2
 CMS (d)................................................
# of Hours Practice Administrator Review Measure                       2
 Specifications (e).....................................
# of Hours Computer Systems Analyst Review Measure                     1
 Specifications (f).....................................
# of Hours LPN Review Measure Specifications (g)........               1
# of Hours Billing Clerk Review Measure Specifications                 1
 (h)....................................................
# of Hours Clinicians Review Measure Specifications (i).               1
Annual Hours Per Respondent (j) = (d) + (e) + (f) + (g)                8
 + (h) + (i)............................................
                                                         ---------------
    Total Annual Hours (k) = (c) * (j)..................         414,296
                                                         ---------------
Cost Per Respondent to Submit Quality Data (@computer            $180.04
 systems analyst's labor rate of $90.02/hr) (l).........
Cost to Review Measure Specifications (@practice                 $218.72
 administrator's labor rate of $109.36/hr) (m)..........
Cost to Review Measure Specifications (@computer systems          $90.02
 analyst's labor rate of $90.02/hr) (n).................
Cost to Review Measure Specifications (@LPN's labor rate          $45.24
 of $45.24/hr) (o)......................................
Cost to Review Measure Specifications (@clerk's labor             $38.00
 rate of $38.00/hr) (p).................................
Cost to D21Review Measure Specifications (@physician's           $202.86
 labor rate of $202.86/hr) (q)..........................
                                                         ---------------
    Total Cost Per Respondent (r) = (l) + (m) + (n) +            $774.88
     (o) + (p) + (q)....................................
                                                         ---------------
        Total Annual Cost (s) = (c) * (r)...............     $40,128,711
------------------------------------------------------------------------

    As shown in Table 78, using the unchanged currently approved per 
respondent burden estimate, the decrease in number of respondents from 
51,861 to 51,787 results in a total difference of -592 hours (-74 
respondents x 8 hr/respondent) at a cost of -$57,341 (-74 respondents x 
$774.88/respondent).

 Table 78--Change in Estimated Burden for Quality Performance Category:
 Clinicians (Participating Individually or as Part of a Group) Using the
                          eCQM Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule         414,888
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed           414,296
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019            -592
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule      $40,186,052
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed        $40,128,711
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019        -$57,341
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

(6) Quality Data Submission via CMS Web Interface
    This rule does not propose any new or revised collection of 
information requirements related to submission of quality data via the 
CMS Web Interface. However, we are proposing adjustments to our 
currently approved burden estimates based on more recent data. The 
proposed 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 
116,342 clinicians will submit as part of groups via this method, a 
decrease of 22,889 from our currently approved estimate of 139,231 
clinicians.
    The burden associated with the group submission requirements is the 
time and effort associated with submitting data on a sample of the 
organization's beneficiaries that is prepopulated in the CMS Web 
Interface. Our burden estimate for submission includes the time (61.67 
hours) needed for each group to populate data fields in the web 
interface with information on approximately 248 eligible assigned 
Medicare beneficiaries and submit the data (we will partially pre-
populate the CMS Web Interface with claims data from their Medicare 
Part A and B beneficiaries). The patient data either can be manually 
entered, uploaded into

[[Page 40863]]

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 79 summarizes the burden for groups 
submitting to MIPS via the CMS Web Interface.

 Table 79--Estimated Burden for Quality Data Submission via the CMS Web
                                Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Eligible Group Practices (a).......................             104
Total Annual Hours Per Group to Submit (b)..............           61.67
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................           6,414
                                                         ---------------
Cost Per Group to Report (@computer systems analyst's          $5,551.53
 labor rate of $90.02/hr.) (d)..........................
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................        $577,359
------------------------------------------------------------------------

    As shown in Table 80, 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).

Table 80--Change in Estimated Burden for Quality Data Submission via the
                            CMS Web Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule          17,637
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             6,413
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019         -11,224
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule       $1,587,739
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed           $577,359
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019     -$1,010,379
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

(7) Beneficiary Responses to CAHPS for MIPS Survey
    This rule does not propose 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 does not propose any new or revised collection of 
information requirements related to the group registration for CMS Web 
Interface. However, we propose to adjust 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 on-line registration 
process. After first time registration, groups will only need to opt 
out if they are not going to continue to submit via the CMS Web 
Interface. In Table 81, 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 propose to adjust the number of respondents from 
67 to 51 based on more recent data. We assume that approximately 51 
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 2018 registration period; a 
decrease of 16 compared to the number of groups currently approved by 
OMB. The registration period for the CY 2019 MIPS performance period 
ends on June 30, 2019; assuming updated information is available, we 
will update our respondent estimates in the final rule. As shown in 
Table 81, we estimate a burden of 12.75 hours (51 new registrations x 
0.25 hr/registration) at a cost of $1,148 (12.75 hr x $90.02/hr).

 Table 81--Estimated Burden for Group Registration for CMS Web Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of New Groups Registering for CMS Web Interface                51
 (a)....................................................
Annual Hours Per Group (b)..............................            0.25
                                                         ---------------

[[Page 40864]]

 
    Total Annual Hours (c) = (a) * (b)..................           12.75
                                                         ---------------
Labor rate for a computer systems analyst (d)...........       $90.02/hr
                                                         ---------------
    Total Annual Cost for CMS Web Interface Group                 $1,148
     Registration (e) = (a) * (d).......................
------------------------------------------------------------------------

    As shown in Table 82 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 4 hours at a cost of $360 (-16 
groups x 0.25 hr x $90.02/hr).

Table 82--Change in Estimated Burden for Group Registrations for the CMS
                              Web Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule           16.75
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             12.75
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019              -4
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule           $1,508
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed             $1,148
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019           -$360
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

(9) Group Registration for CAHPS for MIPS Survey
    This rule does not propose 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 proposed 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 proposing 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. MIPS quality 
measure stewards would 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 would 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 would 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,

[[Page 40865]]

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 83, we estimate that 26 submissions will be 
received during the 2019 Call for Quality Measures based on the number 
of submissions received during the 2018 Call for Quality Measures 
process; a decrease of 114 compared to the number of submissions 
currently approved by OMB (140 submissions). The 2019 Call for Quality 
Measures process ends on June 3, 2019; assuming updated information is 
available, we will update our estimate in the final rule. In keeping 
with the focus on clinicians as the primary source for recommending new 
quality measures, we are using practice administrators and clinician 
time for our burden estimates.
    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 83, in aggregate we estimate an annual burden of 
143 hours (26 submissions x 5.5 hr/submission) at a cost of $26,821 {26 
submissions x [(0.9 hr x $109.36/hr) + (4.6 hr x $202.86/hr{time} .

        Table 83--Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of New Quality Measures Submitted for Consideration                 26
 (a)....................................................
# of Hours Per Practice Administrator to Identify,                   0.9
 Propose, and Link Measure (b)..........................
# of Hours Per Clinician to Identify and Link Measure                0.6
 (c)....................................................
# of Hours Per Clinician to Complete Peer Review Article            4.00
 Form (d)...............................................
                                                         ---------------
    Annual Hours Per Response (e) = (b) + (c) + (d).....            5.50
                                                         ---------------
        Total Annual Hours (f) = (a) * (e)..............             143
                                                         ---------------
Cost to Identify and Submit Measure (@practice                    $98.42
 administrator's labor rate of $109.36/hr.) (g).........
Cost to Identify Quality Measure and Complete Peer               $933.16
 Review Article Form (@physician's labor rate of $202.86/
 hr.) (h)...............................................
                                                         ---------------
    Total Annual Cost Per Respondent (i) = (g) + (h)....       $1,031.58
                                                         ---------------
        Total Annual Cost (j) = (a) * (i)...............         $26,821
------------------------------------------------------------------------

    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 -627 hours at -$117,600 (-114 submissions x [(0.9 hr x 
$109.36/hr) + (4.6 hr x $202.86/hr)]). As shown in Table 84, in 
aggregate, the combine impact of these changes is -487 hours (140-627) 
at a cost of -$97,054 ($20,546-$117,600).

   Table 84--Change in Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule             630
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed               143
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019            -487
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule         $123,875
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed            $26,821
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019        -$97,054
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

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

[[Page 40866]]

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 proposals discussed in sections 
III.K.3.g.(3)(a)(i) and III.K.3.g.(4)(a)(i) requiring qualified 
registries and QCDRs to support the reporting of quality, improvement 
activities, and Promoting Interoperability performance categories would 
alleviate this issue. Hence, the following burden estimates show only 
incremental hours required above and beyond the time already accounted 
for in the quality data submission process. Although this analysis 
assesses burden by performance category and submission type, we 
emphasize that MIPS is a consolidated program and submission analysis 
and decisions are expected to be made for the program as a whole.
(2) Reweighting Applications for Promoting Interoperability and Other 
Performance Categories
    This rule does not propose any new or revised collection of 
information requirements related to the submission of reweighting 
applications for Promoting Interoperability and other performance 
categories. However, we propose to adjust our currently approved burden 
estimates based on an updated analysis of individuals and groups who 
submitted reweighting applications for the 2017 MIPS performance period 
but likely would not submit such applications for 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 proposing, 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 proposing any changes to our currently approved 
burden estimates as a result of this proposal. 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. Data on the number of reweighting 
applications submitted for the 2018 MIPS performance period is 
unavailable for this proposed rule. Assuming updated information is 
available for the final rule, we will assess the utility of using this 
information to estimate burden for future performance periods and will 
make a determination at that time as to the most appropriate data to 
use in estimating future burden.
    Table 85 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 2017 MIPS performance period, we assume 
6,025 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. Of that amount we estimate that 
3,365 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 2,660 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 would take 0.25 hours at $90.02/hr for a computer system analyst to 
complete and submit the application. As shown in Table 85, we estimate 
an annual burden of 1,506.25 hours (6,025 applications x 0.25 hr/
application) at a cost of $135,593 (1,506.25 hr x $90.02/hr).

[[Page 40867]]



  Table 85--Estimated Burden for Reweighting Applications for Promoting
            Interoperability and Other Performance Categories
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Eligible Clinicians or Groups Applying Due to                 3,365
 Significant Hardship and Other Exceptions (a)..........
# of Eligible Clinicians or Groups Applying Due to                 2,660
 Significant Hardship for Small Practice (b)............
Total Respondents Due to Hardships, Other Exceptions and           6,025
 Hardships for Small Practices (c)......................
Hours Per Applicant per application submission (d)......            0.25
                                                         ---------------
    Total Annual Hours (e) = (a) * (c)..................        1,506.25
                                                         ---------------
Labor Rate for a computer systems analyst (f)...........       $90.02/hr
                                                         ---------------
    Total Annual Cost (g) = (a) * (f)...................        $135,593
------------------------------------------------------------------------

    As shown in Table 86, using our unchanged currently approved per 
respondent burden estimate, the decreased number of respondents results 
in a total adjustment of -4 hours (-16 respondents x 0.25 hr/
respondent) and -$360 (-16 respondents x $22.50/respondent).

  Table 86--Change in Estimated Burden for Reweighting Applications for
       Promoting Interoperability and Other Performance Categories
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule           1,510
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             1,506
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019              -4
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule         $135,953
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed           $135,593
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019           -$360
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

(3) Submitting Promoting Interoperability Data
    This rule does not propose any new or revised collection of 
information requirements related to the submission of Promoting 
Interoperability data. However, we propose to adjust our currently 
approved burden estimates based on updated estimates of QPs and MIPS 
APMs for 2019 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 87, based on data from the 2017 MIPS performance 
period, we estimate that a total of 93,863 respondents consisting of 
81,358 individual MIPS eligible clinicians and 12,505 groups and 
virtual groups will submit Promoting Interoperability data. Similar to 
the process shown in Table 71 for groups reporting via QCDR/MIPS CQM 
and eCQM collection types, we have adjusted the group reporting data 
from the 2017 MIPS performance period to account for virtual groups, as 
the option to submit data as a virtual group was not available until 
the 2018 MIPS performance period.
    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), 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,

[[Page 40868]]

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), we propose to revise the 
definition of a hospital-based MIPS eligible clinician under Sec.  
414.1305 to include groups and virtual groups. We propose 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 also propose 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 as 
defined in Sec.  414.1305. We believe these proposals 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 
propose 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, 
would continue to submit Promoting Interoperability data the same as in 
2017. Each MIPS eligible clinician in an APM Entity reports data for 
the Promoting Interoperability performance category through either 
their group TIN or individual reporting. 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 proposed 
rule assume group TIN-level reporting as we believe this is the most 
reasonable assumption for the Shared Savings Program, which requires 
that ACOs include full TIN 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 87--Estimated Number of Respondents To Submit Promoting
        Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                             Number of
                                                            respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting               81,358
 Interoperability (a)...................................
Number of groups to submit Promoting Interoperability             12,569
 (b)....................................................
Subtract: Number of groups to submit Promoting                        80
 Interoperability on behalf of clinicians in 2020 MIPS
 performance period that will submit as virtual groups
 (c)....................................................
Add in: Number of virtual groups to submit Promoting                  16
 Interoperability on behalf of clinicians in 2020 MIPS
 performance period (d).................................
Number of groups to submit Promoting Interoperability on          12,505
 behalf of clinicians in 2020 MIPS performance period
 (e) = (b)-(c) + (d)....................................
                                                         ---------------
    Total Respondents in 2020 MIPS performance period             93,863
     (CY 2020 Proposed Rule) (f) = (a) + (e)............
    * Total Respondents in 2019 MIPS performance period           93,869
     (CY 2019 Final Rule) (g)...........................
                                                         ---------------
        Difference between CY 2020 Proposed Rule and CY               -6
         2019 Final Rule (h) = (f)-(g)..................
------------------------------------------------------------------------

    We estimate the time required for an individual or group to submit 
Promoting Interoperability data to be 2.67 hours. As previously 
discussed, beginning with the 2021 performance period and for future 
years, we propose to require that QCDRs and qualified registries 
support three performance categories: Quality, improvement activities, 
and Promoting Interoperability. Based on our review of 2019 qualified 
registries and QCDRs, we have determined that 70 percent and 72 percent 
of these vendors, respectively, already support reporting 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 would result in a reduction of burden as it would 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

[[Page 40869]]

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 88, the total burden estimate for submission of 
data on the specified Promoting Interoperability objectives and 
measures is estimated to be 250,301 hours (93,853 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 $22,532,126 (250,301 hr x 
$90.02/hr).

  Table 88--Estimated Burden for Promoting Interoperability Performance
                        Category Data Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting               81,358
 Interoperability (a)...................................
Number of groups to submit Promoting Interoperability             12,505
 (b)....................................................
Total (c) = (a) + (b)...................................          93,863
Total Annual Hours Per Respondent (b)...................            2.67
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................         250,301
                                                         ---------------
Labor rate for a computer systems analyst to submit            $90.02/hr
 Promoting Interoperability data (d)....................
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................     $22,532,126
------------------------------------------------------------------------

    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 -16 hours (-6 respondents x 2.67 hr/
respondent) at a cost of -$1,440 (-16 hr x $90.02/hr).

   Table 89--Change in Estimated Burden for Promoting Interoperability
                  Performance Category Data Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule         250,317
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed           250,301
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019             -16
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule      $22,533,566
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed        $22,532,126
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019         -$1,440
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

g. ICRs Regarding the Nomination of Promoting Interoperability (PI) 
Measures
    This rule does not propose any new or revised collection of 
information requirements related to the nomination of Promoting 
Interoperability measures. However, we propose to adjusted our 
currently approved burden estimates based on data from the 2018 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 request 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 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 28 proposals will be submitted for new Promoting 
Interoperability measures, based on the number of proposals submitted 
during the CY 2018 nomination period. This is a decrease of 19 from the 
estimate currently approved by OMB (47 proposals) under the 
aforementioned control number. The 2019 Call for Promoting 
Interoperability Measures process ends on July 1, 2019; assuming 
updated information is available, we will update our estimate in the 
final rule. 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 
90, we estimate an annual burden of 14 hours (28 proposals x 0.5 hr/
response) at a cost of $2,055 (28 x [(0.3 hr x $109.36/hr) + (0.2 hr x 
$202.86/hr)].

[[Page 40870]]



   Table 90--Estimated Burden for Call for Promoting Interoperability
                                Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Promoting Interoperability Measure Nominations (a).              28
# of Hours Per Practice Administrator to Identify and               0.30
 Propose Measure (b)....................................
# of Hours Per Clinician to Identify Measure (c)........            0.20
Annual Hours Per Respondent (d) = (b) + (c).............            0.50
                                                         ---------------
    Total Annual Hours (e) = (a) * (d)..................              14
                                                         ---------------
Cost to Identify and Submit Measure (@practice                    $32.81
 administrator's labor rate of $109.36/hr) (f)..........
Cost to Identify Improvement Measure (@physician's labor          $40.57
 rate of $202.86/hr) (g)................................
                                                         ---------------
    Total Annual Cost Per Respondent (h) = (f) + (g)....          $73.38
                                                         ---------------
        Total Annual Cost (i) = (a) * (h)...............          $2,055
------------------------------------------------------------------------

    As shown in Table 91, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of respondents 
results in an adjustment of -9.5 hours at a cost of -$1,394 (-19 
respondents x 0.5 hr x $73.38 per respondent).

       Table 91--Change in Estimated Burden for Call for Promoting
                        Interoperability Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule            23.5
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed                14
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019            -9.5
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule           $3,449
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed             $2.055
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019         -$1,394
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

h. ICRs Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    This rule does not propose any new or revised collection of 
information requirements related to the submission of Improvement 
Activities data. However, we propose to adjust 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, we are 
proposing, beginning with the 2020 MIPS performance period and for 
future years, to increase the minimum number of clinicians in a group 
or virtual group who are required to perform an improvement activity 
from at least one clinician to 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. Because eligible clinicians are able to attest 
to improvement activity measures at the group level, there is no impact 
on reporting burden as a result of this proposal.
    As previously discussed, beginning with the 2021 performance period 
and for future years, we are proposing to require QCDRs and qualified 
registries to support three performance categories: Quality, 
improvement activities, and Promoting Interoperability; our discussion 
of burden for submitting Promoting Interoperability data in section 
IV.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 Promoting 
Interoperability data, we are not changing our per respondent burden 
estimate to submit improvement activity data as a result of this 
proposal.
    Furthermore, as discussed in section III.K.3.c.(3)(e)(i) of this 
rule, we are proposing to establish removal factors to consider when 
proposing to remove improvement activities from the Inventory. However, 
we do not believe this would affect reporting burden, because 
respondents would still be required submit the same number of 
improvement activities and this proposal would not require respondents 
to submit any additional information. We are also proposing 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.
    While our proposals 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

[[Page 40871]]

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 2019 MIPS performance period will not 
need to submit additional improvement activities as the models will 
already meet the maximum improvement activities performance category 
score.
    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 proposals 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 support the reporting of quality, improvement activities, and 
Promoting Interoperability performance categories would 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 92, based on 2017 MIPS performance period 
data, we estimate that 102,754 clinicians will submit improvement 
activities as individuals during the 2020 MIPS performance period and 
15,761 groups will submit improvement activities on behalf of 
clinicians. Similar to the process shown in Table 87 for groups 
submitting Promoting Interoperability data, we have adjusted the group 
reporting data from the 2017 MIPS performance period to account for 
virtual groups, as the option to submit data as a virtual group was not 
available until the 2018 MIPS performance period. 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 2017 MIPS performance period but will 
be in the 2019 MIPS performance period, and would 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 such, APM Entities will not submit any 
additional improvement activities.

   Table 92--Estimated Numbers of Organizations Submitting Improvement
      Activities Performance Category Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                               Count
------------------------------------------------------------------------
# of clinicians to participate in improvement activities         102,754
 data submission as individuals during the 2020 MIPS
 performance period (a).................................
# of Groups to submit improvement activities on behalf            15,825
 of clinicians during the 2020 MIPS performance period
 (b)....................................................
Subtract: # of groups to submit improvement activities                80
 on behalf of clinicians in 2020 MIPS performance period
 that will submit as virtual groups (c).................
Add in: # of Virtual Groups to submit improvement                     16
 activities on behalf of clinicians during the 2020 MIPS
 performance period (d).................................
# of Groups and Virtual Groups to submit improvement              15,761
 activities on behalf of clinicians during the 2020 MIPS
 performance period (e).................................
                                                         ---------------
    Total # of Respondents (Groups, Virtual Groups, and          118,515
     Individual Clinicians) to submit improvement
     activities data on behalf of clinicians during the
     2020 MIPS performance period (CY 2020 Proposed
     Rule) (f) = (a) + (b) + (e)........................
                                                         ---------------
    * Total # of Respondents (Groups, Virtual Groups,            136,004
     and Individual Clinicians) to submit improvement
     activities data on behalf of clinicians during the
     2019 MIPS performance period (CY 2019 Final Rule)
     (g)................................................
                                                         ---------------
        Difference between CY 2020 Proposed Rule and CY          -17,489
         2019 Final Rule (h) = (g)-(f)..................
------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    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

[[Page 40872]]

of authenticated credentials (83 FR 60016).
    As shown in Table 93, we estimate an annual burden of 9,876 hours 
(118,515 responses x 5 minutes/60) at a cost of $889,060 (9,876.25 hr x 
$90.02/hr).

    Table 93--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
                                                  Burden estimate
------------------------------------------------------------------------
Total # of Respondents (Groups, Virtual    118,515.
 Groups, and Individual Clinicians) to
 submit improvement activities data on
 behalf of clinicians during the 2019
 MIPS performance period (a).
Total Annual Hours Per Respondent (b)....  5 minutes.
Total Annual Hours (c)...................  9,876.25.
Labor rate for a computer systems analyst  $90.02/hr.
 to submit improvement activities (d).
                                          ------------------------------
    Total Annual Cost (e) = (a) * (d)....  $889,060.
------------------------------------------------------------------------

    As shown in Table 94, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of respondents 
results in an adjustment of -1,457 hours (-17,489 responses x 5 
minutes/60) at a cost of -$131,197 (-1,457 hr $90.02/hr).

     Table 94--Change in Estimated Burden for Improvement Activities
                               Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule          11,334
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             9,876
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019          -1,457
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule       $1,020,257
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed           $889,060
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019       -$131,197
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

i. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    This rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
nomination of improvement activities. However, we have adjusted our 
currently approved burden estimates based on data from the 2018 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 2018 Annual Call for Activities lasted from February 1, 
2018 through March 1, 2018, during which we received 128 nominations of 
activities which were evaluated for the Improvement Activities Under 
Consideration (IAUC) list for possible inclusion in the CY 2019 
Improvement Activities Inventory. Based on the number of improvement 
activity nominations received in the CY 2018 Annual Call for 
Activities, we estimate that we will receive 128 nominations for the 
2020 Annual Call for Activities, which is an increase of 3 from the 125 
nominations currently approved by OMB. The 2019 Annual Call for 
Activities ends on July 1, 2019; assuming updated information is 
available, we will update our estimate in the final rule.
    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 95, we estimate an annual burden of 256 hours (128 nominations 
x 2 hr/nomination) at a cost of $37,571 (128 x [(1.2 hr x $109.36/hr) + 
(0.8 hr x $202.86/hr)]).

   Table 95--Estimated Burden for Nomination of Improvement Activities
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Nominations of New Improvement Activities (a)......             128
# of Hours Per Practice Administrator to Identify and                1.2
 Propose Activity (b)...................................
# of Hours Per Clinician to Identify Activity (c).......             0.8
Annual Hours Per Respondent (d) = (b) + (c).............               2
                                                         ---------------
    Total Annual Hours (e) = (a) * (d)..................             256
                                                         ---------------
Cost to Identify and Submit Activity (@practice                  $131.23
 administrator's labor rate of $109.36/hr) (f)..........
Cost to Identify Improvement Activity (@physician's              $162.29
 labor rate of $202.86/hr) (g)..........................
                                                         ---------------

[[Page 40873]]

 
    Total Annual Cost Per Respondent (h) = (f) + (g)....         $293.52
                                                         ---------------
        Total Annual Cost (i) = (a) * (h)...............         $37,571
------------------------------------------------------------------------

    As shown in Table 96, using our unchanged currently approved per 
respondent burden estimate, the increase in the number of nominations 
results in an adjustment of 6 hours at a cost of $881 {3 activities x 
[(1.2 hr x $109.36/hr) + (0.8 hr x $202.86/hr)]{time} .

   Table 96--Change in Estimated Burden for Nomination of Improvement
                               Activities
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule             250
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed               256
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019               6
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule          $36,690
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed            $37,571
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019            $881
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

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 proposing 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 
proposed rule do not result in the need to add or revise or delete any 
claims data fields. Therefore, we are not proposing any new or revised 
collection 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 does not propose any new or revised collection of 
information requirements related to the Partial QP Elections to 
participate in MIPS as a MIPS eligible clinician. However, we propose 
to adjust 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 propose that, beginning for 
eligible clinicians who become Partial QPs in the 2020 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. This proposal will potentially increase the total number 
of Partial QP elections to participate in MIPS if clinicians achieve 
Partial QP status under multiple TIN/NPI combinations.
    As shown in Table 97, 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 .25 hr/election) at a cost of $45,080 (505.5 hours 
x $90.02/hr).

           Table 97--Estimated Burden for Partial QP Election
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of respondents making Partial QP election (6 APM                 2,022
 Entities, 75 eligible clinicians) (a)..................
Total Hours Per Respondent to Elect to Participate as               0.25
 Partial QP (b).........................................
Total Annual Hours (c) = (a) * (b)......................           505.5
Labor rate for computer systems analyst (d).............       $90.02/hr
                                                         ---------------
    Total Annual Cost (d) = (c) * (d)...................         $45,505
------------------------------------------------------------------------


[[Page 40874]]

    As shown in Table 98, 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).

      Table 98--Change in Estimated Burden for Partial QP Election
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule           20.25
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             505.5
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019          485.25
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule           $1,823
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed            $45,505
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019         $43,682
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

l. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1440) and Eligible Clinician Initiated 
Process (Sec.  414.1445)
    As indicated below, the proposed requirements and burden discussed 
under this section will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
(1) Payer Initiated Process (Sec.  414.1440)
    This rule does not propose any new or revised collection of 
information requirements related to the Payer-Initiated Process. 
However, we propose to adjust 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 99, 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 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).

 Table 99--Estimated Burden for Other Payer Advanced APM Identification
                 Determinations: Payer-Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of other payer payment arrangements (15 Medicaid, 100              110
 Medicare Advantage Organizations, 100 remaining other
 payers) (a)............................................
Total Annual Hours Per other payer payment arrangement                10
 (b)....................................................
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................           1,100
                                                         ---------------
Labor rate for a computer systems analyst (d)...........       $90.02/hr
                                                         ---------------
    Total Annual Cost for Other Payer Advanced APM               $99,022
     determinations (e) = (a) * (d).....................
------------------------------------------------------------------------

    As shown in Table 100, 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).

   Table 100--Change in Estimated Burden for Other Payer Advanced APM
         Identification Determinations: Payer-Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule           2,150
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             1,100
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019          -1,050
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule         $193,543
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed            $99,022
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019        -$94,521
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------


[[Page 40875]]

(2) Eligible Clinician Initiated Process (Sec.  414.1445)
    This rule does not propose 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 proposing any changes to under that control number.
(3) Submission of Data for QP Determinations Under the All-Payer 
Combination Option (Sec.  414.1440)
    This rule does not propose 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 
propose to adjust 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 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 101, 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).

 Table 101--Estimated Burden for the Submission of Data for All-Payer QP
                             Determinations
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of APM Entities submitting data for All-Payer QP                    20
 Determinations (a).....................................
# of TINs submitting data for All-Payer QP                           448
 Determinations (b).....................................
# of eligible submitting data for All-Payer QP                        83
 Determinations (c).....................................
Hours Per respondent QP Determinations (d)..............               5
Total Hours (g) = [(a) *(d)] + [(b) * (d)] + [(c) * (d)]           2,755

[[Page 40876]]

 
Labor rate for a Practice Administrator (h).............      $109.36/hr
                                                         ---------------
    Total Annual Cost for Submission of Data for All-           $301,287
     Payer QP Determinations (i) = (g) * (h)............
------------------------------------------------------------------------

    As shown in Table 102, 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).

Table 102--Change in Estimated Burden for the Submission of Data for All-
                         Payer QP Determinations
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule           1,545
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed             2,755
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019           1,210
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule         $168,961
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed           $301,287
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019        $132,326
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

m. ICRs Regarding Voluntary Participants Election To Opt-Out of 
Performance Data Display on Physician Compare (Sec.  414.1395)
    This rule does not propose 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 propose to adjust 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). Subject to renewal, the control number is currently 
set to expire on January 31, 2022. It was last approved on January 29, 
2019, and remains active.
    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 11,516 (0.10 x 115,163 
voluntary MIPS participants) clinicians and groups, a decrease of 101 
from the currently approved estimate of 11,617. This decrease is due to 
the availability of updated estimates of QPs and APM participation for 
the 2020 performance period. 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 
Regulatory Impact Analysis 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 propose 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 this 
proposals, we lack the ability to predict the behavior of clinicians' 
response to this proposal. Table 103 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 2,879 hours (11,516 requests x 0.25 hr/
request) at a cost of $259,168 (2,879 hr x $90.02/hr).

 Table 103--Estimated Burden for Voluntary Participants To Elect Opt Out
            of Performance Data Display on Physician Compare
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Voluntary Participants Opting Out of Physician               11,516
 Compare (a)............................................
Total Annual Hours per Opt-out Requester (b)............            0.25
                                                         ---------------
    Total Annual Hours for Opt-out Requester (c) = (a) *           2,879
     (b)................................................
                                                         ---------------
Labor rate for a computer systems analyst (d)...........       $90.02/hr
                                                         ---------------
    Total Annual Cost for Opt-out Requests (e) = (a) *          $259,168
     (d)................................................
------------------------------------------------------------------------


[[Page 40877]]

    As shown in Table 104, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of opt outs by 
voluntary participants from 11,617 to 11,516 results in an adjustment 
of 25.25 hours (101 requests x 0.25 hr) at a cost of -$2,273 (25.25 hr 
x $90.02/hr).

   Table 104--Change in Estimated Burden for Voluntary Participants To
     Elect Opt Out of Performance Data Display on Physician Compare
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule        2,904.25
 (a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed          2,879.00
 Rule (b)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019          -25.25
     Final Rule (c) = (b)-(a)...........................
                                                         ---------------
Total Annual Cost for Respondents in CY 2019 Final Rule         $261,441
 (d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed           $259,168
 Rule (e)...............................................
                                                         ---------------
    Difference Between CY 2020 Proposed Rule and CY 2019         -$2,273
     Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------

n. Summary of Annual Quality Payment Program Burden Estimates
    Table 105 summarizes this proposed rule's burden estimates for the 
Quality Payment Program. To understand the burden implications of the 
policies proposed in this rule, we have also estimated a baseline 
burden of continuing the policies and information collections set forth 
in the CY 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 3,312,523 hours at 
a cost of $315,630,967. 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 1,619 
hours and $147,173 between this baseline estimate and the total burden 
shown in Tables 105 and 107 is the burden associated with the proposals 
to require QCDRs to submit measure testing data to require proposed 
quality measures and QCDR measures to be linked to existing cost 
measures, improvement activities, and MIPS Value Pathways, if possible 
at the time of self-nomination and to describe the quality improvements 
services they intend to support.

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    Table 106 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this proposed rule. We have divided the reasons for our change in 
burden into those related to new policies and those related to 
adjustments in burden from continued Quality Payment Program Year 3 
policies that reflect updated data and revised methods.
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C. Summary of Annual Burden Estimates for Proposed Requirements

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D. Submission of Comments

    We have submitted a copy of this rule to OMB for its review of the 
rule's proposed information collection requirements and burden. The 
requirements are not effective until they have been approved by OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections previously discussed, please visit CMS's 
website at https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports 
Clearance Office at (410) 786-1326.
    We invite public comments on the proposed information collection 
requirements and burden. If you wish to comment, please submit your 
comments electronically as specified in the DATES and ADDRESSES 
sections of this proposed rule and identify the rule (CMS-1715-P) and 
where applicable the ICR's CFR citation, CMS ID number, and OMB control 
number.

V. Response to Comments

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

VI. Regulatory Impact Analysis

A. Statement of Need

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

B. Overall Impact

    We examined the impact of this rule as required by Executive Order 
12866 on Regulatory Planning and Review (September 30, 1993), Executive 
Order 13563 on Improving Regulation and Regulatory Review (February 2, 
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 
L. 96-354), section 1102(b) of the Social Security Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the 
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 
on Reducing Regulation and Controlling Regulatory Costs (January 30, 
2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). An RIA 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). We estimated, as discussed in 
this section, that the PFS provisions included in this proposed rule 
would redistribute more than $100 million in 1 year. Therefore, we 
estimate that this rulemaking is ``economically significant'' as 
measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we prepared an RIA 
that, to the best of our ability, presents the costs and benefits of 
the rulemaking. The RFA requires agencies to analyze options for 
regulatory relief of small entities. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and small 
governmental jurisdictions. Most hospitals, practitioners and most 
other

[[Page 40882]]

providers and suppliers are small entities, either by nonprofit status 
or by having annual revenues that qualify for small business status 
under the Small Business Administration standards. (For details, see 
the SBA's website at http://www.sba.gov/content/table-small-business-size-standards (refer to the 620000 series)). Individuals and states 
are not included in the definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
proposed rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. The PFS does not 
reimburse for services provided by rural hospitals; the PFS pays for 
physicians' services, which can be furnished by physicians and non-
physician practitioners in a variety of settings, including rural 
hospitals. We did not prepare an analysis for section 1102(b) of the 
Act because we determined, and the Secretary certified, that this 
proposed rule would not have a significant impact on the operations of 
a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2019, that 
threshold is approximately $154 million. This proposed rule will impose 
no mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017 and 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' 
This proposed rule, if finalized, is considered an E.O. 13771 
regulatory action. We estimate the rule generates $3.46 million in 
annualized costs in 2016 dollars, discounted at 7 percent relative to 
year 2016 over a perpetual time horizon. Details on the estimated costs 
of this rule can be found in the preceding and subsequent analyses.
    We prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this proposed rule; details the costs and benefits of the rule; 
analyzes alternatives; and presents the measures we would use to 
minimize the burden on small entities. As indicated elsewhere in this 
proposed rule, we are proposing a variety of changes to our 
regulations, payments, or payment policies to ensure that our payment 
systems reflect changes in medical practice and the relative value of 
services, and implementing statutory provisions. We provide information 
for each of the policy changes in the relevant sections of this 
proposed rule. We are unaware of any relevant federal rules that 
duplicate, overlap, or conflict with this proposed rule. The relevant 
sections of this proposed rule contain a description of significant 
alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compared payment rates for CY 2019 with payment rates for CY 2020 using 
CY 2018 Medicare utilization. The payment impacts in this proposed rule 
reflect averages by specialty based on Medicare utilization. The 
payment impact for an individual practitioner could vary from the 
average and would depend on the mix of services he or she furnishes. 
The average percentage change in total revenues will be less than the 
impact displayed here because practitioners and other entities 
generally furnish services to both Medicare and non-Medicare patients. 
In addition, practitioners and other entities may receive substantial 
Medicare revenues for services under other Medicare payment systems. 
For instance, independent laboratories receive approximately 83 percent 
of their Medicare revenues from clinical laboratory services that are 
paid under the Clinical Laboratory Fee Schedule (CLFS).
    The annual update to the PFS conversion factor (CF) was previously 
calculated based on a statutory formula; for details about this 
formula, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67741 through 67742). Section 101(a) of the MACRA 
repealed the previous statutory update formula and amended section 
1848(d) of the Act to specify the update adjustment factors for CY 2015 
and beyond. The update adjustment factor for CY 2020, as required by 
section 53106 of the Bipartisan Budget Act of 2018, is 0.00 percent 
before applying other adjustments.
    To calculate the proposed 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

[[Page 40883]]

section 1848(d)(18) 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 108--Calculation of the Proposed 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 (1.0014)..  ..............
 Adjustment.
                                                         ---------------
    CY 2020 Conversion Factor..  .......................         36.0896
------------------------------------------------------------------------


  Table 109--Calculation of the Proposed CY 2020 Anesthesia Conversion
                                 Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2019 National Average         .......................         22.2730
 Anesthesia Conversion Factor.
Statutory Update Factor........  0.00 percent (1.0000)..  ..............
CY 2020 RVU Budget Neutrality    0.14 percent (1.0014)..  ..............
 Adjustment.
CY 2020 Anesthesia Fee Schedule  -0.12 percent (0.9988).  ..............
 Practice Expense and
 Malpractice Adjustment.
                                                         ---------------
    CY 2020 Conversion Factor..  .......................         22.2774
------------------------------------------------------------------------

    Table 110 shows the payment impact on PFS services of the policies 
contained in this proposed rule. To the extent that there are year-to-
year changes in the volume and mix of services provided by 
practitioners, the actual impact on total Medicare revenues would be 
different from those shown in Table 110 (CY 2020 PFS Estimated Impact 
on Total Allowed Charges by Specialty). The following is an explanation 
of the information represented in Table 110.
     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, neurology, emergency medicine, and 
podiatry 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. 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 110), 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 110 
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 110 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 proposed rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer readers to 
Addendum A on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
c. Estimated Impacts Related to Proposed Changes for Office/Outpatient 
E/M Services for CY 2021
    Although we are not proposing changes to E/M coding and payment for 
CY 2020, we are proposing certain changes for CY 2021. We provide the 
following impact estimate only for illustrative purposes. We believe 
these estimates provide insight into the magnitude of potential changes 
for certain physician specialties. Table 111 illustrates the estimated 
specialty level impacts associated with implementing the RUC-
recommended work values for the office/outpatient E/M codes, as well as 
the revalued HCPCS add-on G-codes for primary care and certain types of 
specialty visits in 2020, rather than delaying until CY 2021.

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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 
proposed 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 proposed 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 proposed changes.

D. Effect of Proposed Changes Related to Telehealth

    As discussed in section II.F. of this proposed rule, we are 
proposing to add three new codes, HCPCS codes GYYY1, GYYY2, and GYYY3, 
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 proposed 
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. Other Provisions of the Proposed 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 proposed 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 
free-standing 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 total estimated Part B net impact, including FFS and 
Medicare Advantage, over 10 years is $1,024,000,000. 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 $148, which is a weighted average of the rates we are proposing 
for the bundled payments for treatment with methadone, buprenorphine, 
and naltrexone. These rates were assumed to be updated annually by the 
Medicare Economic Index (MEI). We assumed that the impact in the first 
year would be reduced by 50 percent due to potential delays in provider 
certification and system modifications. Additionally, any change to 
fee-for-service benefits has an associated impact on payments to 
Medicare Advantage plans so an adjustment was made to reflect this, 
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 Part B premium as a result of this provision. The Part B 
enrollment and MEI assumptions were based on the President's Fiscal 
Year 2020 Budget baseline that was released in March 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

[[Page 40888]]

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 OTPs 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 proposed rule would 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 Services Data Collection System
    As discussed in section III.B.2. of this proposed 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 section III.B.4 through 
III.B.7. of this proposed rule, we describe our proposals that would 
implement this section, including the data that would be collected 
through the data collection system, sampling methodology, requirements 
for reporting data, payment reductions that would 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 would 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 would 
need to engage in two primary activities with respect to these 
proposals, both of which would 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 would be required to report under the data collection 
system. The data reporting activity includes entering the collected 
information in CMS's proposed web-based data collection system.
    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 proposed 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 112 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 112).

[[Page 40889]]



 Table 112--Estimated Mean Hourly Wages for Occupations Involved in Data
                               Collection
------------------------------------------------------------------------
                                            Mean hourly      Weight (%
                   D-6                       wage ($)        effort) *
------------------------------------------------------------------------
Top Executives (111000).................           51.49              17
Other Management Occupations (119000)...           39.23              12
Business and Financial Operations                  28.60              15
 Occupations (130000)...................
Secretaries and Administrative                     18.11              10
 Assistants (436010)....................
Other Office and Administrative Support            16.20              10
 Workers (439000).......................
Financial Clerks (433000)...............           18.51              25
First-Line Supervisors of Office and               27.92              10
 Administrative Support Workers (431011)
                                         -------------------------------
    Blended Mean Hourly Wage............           28.91             100
------------------------------------------------------------------------
* Note: Weights may not sum to 100 percent due to rounding. Source:
  Bureau of Labor Statistics Occupational Employment Statistics, May
  2018, available from https://download.bls.gov/pub/time.series/oe/.

    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 at 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 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 
proposed rule. Our proposed sampling rate of 25 percent would yield an 
expected 2,690 respondents 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.
b. Hardship Exemption Process
    As discussed in section III.B.7.b. of this proposed rule, we are 
proposing a process for ground ambulance organizations to request and 
for CMS to grant significant hardship exemptions from the 10 percent 
payment reduction. To request a significant hardship exemption, we are 
proposing 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 are basing our estimate on the total 
number of organizations being surveyed. As a result, we estimate 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.

[[Page 40890]]

    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.
c. Informal Review Process
    As discussed in section III.B.7.c. of this proposed rule, we are 
proposing a process in which a ground ambulance organization may 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 ground ambulance provider or supplier who is requesting an 
informal review to gather the requested information and send an email 
to our AMBULANCEODF mailbox.
    Again, we are using the total number of ambulance organizations 
survey each year to develop our estimates. Therefore, a total of 40,350 
minutes (15 x 2,690) or 672.5 hours for 2,690 ambulance providers and 
suppliers to complete this form. Taking into account the same blended 
mean hourly wage and fringe benefits as we did for our other estimates, 
we estimate that the total for all sampled ambulance providers and 
suppliers to submit the form would be approximately $38,884.
4. Intensive Cardiac Rehabilitation (ICR)
    As discussed in section III.C. of this proposed 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,\141\ and approximately 80 percent of individuals over age 65 
have heart failure.\142\ (The majority (86 percent) of Medicare 
beneficiaries are over age 65.\143\) We estimate 4,560,000 
beneficiaries over age 65 have heart failure.
---------------------------------------------------------------------------

    \141\ Centers for Disease Control, Heart Failure Fact Sheet, 
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
    \142\ Vigen, Rebecca et al. ``Aging of the United States 
population: impact on heart failure.'' Current heart failure reports 
vol. 9,4 (2012): 369-74. doi:10.1007/s11897-012-0114-8.
    \143\ CMS, 2019 Fast Facts, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts/index.html.
---------------------------------------------------------------------------

    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 from this proposed change.
    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.
    When this proposed rule is finalized, we will 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 
proposed and existing 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 propose to align the eCQMs available for 
Medicaid EPs in 2020 with those available for MIPS eligible clinicians 
for the CY 2020 performance period. We anticipate that this proposal 
would reduce burden for Medicaid EPs by aligning the requirements for 
multiple reporting programs, and that the system changes required for 
EPs to implement this change would not be significant, as many EPs are 
expected to report eCQMs to meet the quality performance category of 
MIPS and therefore should be prepared to report on those eCQMs for 
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 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. 
State expenditures to make any systems changes required as a result of 
this proposal would be eligible for 90 percent Federal financial 
participation.
    For 2020, we propose to require that Medicaid EPs report on any six 
eCQMs that are relevant to the EP's scope of practice, including at 
least one outcome

[[Page 40891]]

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. This proposal would be 
a continuation of our policy for 2019 and we believe it would create no 
new burden for EPs or states.
    We also propose 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 2020. We are proposing 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 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. This should add no 
additional burden for EPs or CEHRT vendors, as Certified EHR Technology 
(CEHRT) should be able to run eCQM reports for any number of days and 
during any time period. The proposed 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, 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.
    Finally, we are proposing to change Medicaid policy for 2021 
related to EP Meaningful Use Objective 1, Measure 1 (Conduct or review 
a security risk analysis (SRA)). We are proposing 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 believe our proposal would prevent additional burden for both 
EPs and non-EP health care providers.
    This proposal 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 are not proposing 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 proposed 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 proposed changes made to the CMS Web Interface measures under the 
Quality Payment Program in section III.I.3.b.(1). Specifically, we are 
proposing: (1) The addition of one CMS Web Interface measure; (2) the 
removal of one CMS Web Interface Measure; (3) revisions to the 
numerator guidance for ACO-17--Preventive Care and Screening: Tobacco 
use: Screening and Cessation Intervention; and (4) reverting ACO-43--
Ambulatory Sensitive Condition Acute Composite (AHRQ Prevention Quality 
Indicator (PQI) #91) to pay-for-reporting for 2 years to account for a 
substantive change in the measure.
    The net result of these proposed modifications to the Shared 
Savings Program quality measure set would be a measure set of 23 
measures. These proposed changes would 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 proposed 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 
however, do provide a regulatory impact analysis 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 proposed provision to modify the ``nature of payment'' 
categories. As we indicated in section III.F. of this proposed 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 propose these changes

[[Page 40892]]

only to be made prospectively and do 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 could require the addition of a device 
identifier if this proposed rule becomes final. 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. Medicare Enrollment of Opioid Treatment Programs
    As stated previously in this proposed rule, we propose that OTP 
providers be required to not only enroll in Medicare, but also (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.
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. While we 
cannot predict future changes to the CPI, we note that the fee amounts 
between 2017 and 2019 increased by an average of $13 per year. We 
believe this is a reasonable barometer with which to establish 
estimates (strictly for purposes of this proposed rule) of the fee 
amounts in the first 3 CYs of this rule (that is, 2020, 2021, and 
2022). We thus project 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 estimate 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 
estimate that it would take each owner (BLS: Top Executives) 
approximately 2 hours at $123.32/hr to obtain and submit the 
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 proposed 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 do not have specific data on the matter, we project, 
for purposes of our proposed burden estimates, a total of 1,500 such 
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 is based on a sampling of similar provider types, 
including DMEPOS suppliers (high risk), MDPP suppliers (high risk), 
rural health clinics (limited risk) and others.
    Applying this figure to the aforementioned per year breakdown of 
applicants, we estimate a first year burden of 2,790 hours at a cost of 
$344,063 (2,790 hr x $123.32/hr). We obtained the 2,790 hour estimate 
by first dividing 1,767 (the number of first-year applicants) by 1,900, 
resulting in a figure of 0.93. We then multiplied 0.93 by 1,500 (the 
number of ownership interests over the 3-year period) and thereafter by 
2 hours.
    Applying this same formula, we project a second-year time estimate 
of 106 hours (or 0.0353 x 1,500 applicants x 2 hr) at a cost of $13,072 
(106 hr x $123.32/hr), and a third-year estimate of 104 hours (or 
0.0347 x 1,500 applicants x 2 hr) at a cost of $12,825 (104 hr x 
$123.32/hr). In aggregate, we estimate a burden of 3,000 hours (2,790 
hr + 106 hr + 104 hr) at a cost of $369,960 ($344,063 + $13,072 + 
$12,825). When annualized over the 3-year period, we estimate an annual 
burden of 1,000 hours (3,000 hours/3) at a cost of $123,320 ($369,960/
3).
9. Deferring to State Scope of Practice Requirements
a. Ambulatory Surgery Centers
    As of May 2019 there were 5,767 Medicare-participating ASCs. We are 
proposing to revise Sec.  416.42 to allow an anesthetist, or a 
physician, to perform the required examination before surgery for 
anesthesia risk and of the procedure to be performed. We proposed this 
revision 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), we propose to allow an anesthetist, in 
addition to a physician, to perform the required pre-surgical risk and 
evaluation examination. This change would provide flexibility and allow 
either a physician or an anesthetist to perform the pre-surgical 
examination. In total, ASCs provided about 6.4 million services in 
2016.\144\ We assume that 30 percent of all procedures would utilize 
the services of a nurse anesthetist instead of a physician for this 
requirement, which would reduce the cost of the examination. We 
estimate the pre-surgical evaluation to take 15 minutes to complete. We 
are assuming these estimates based on previous experience and 
conversations with stakeholders. We acknowledge the uncertainty with 
these estimates and invite public comment on our assumptions to 
articulate the most accurate information in the final rule 
calculations. 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, however, we welcome any comments and evidence-
based information that would inform our ability to provide the most 
accurate cost savings estimates.
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    \144\ MEDPAC, Ambulatory surgical centers services 2017, p. 136.
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b. Hospice
    We are proposing to revise Sec.  418.106 to permit hospices to 
accept orders for drugs from attending physicians who are physician 
assistants. We do not

[[Page 40893]]

believe that are any associated financial impacts for hospices.
10. Changes Due to Updates to the Quality Payment Program
    In section III.K. of this proposed rule, we included our proposed 
policies for the Quality Payment Program. In this section of the 
proposed rule, we present the overall and incremental impacts to the 
number of expected QPs and associated APM Incentive Payments. In MIPS, 
we estimate the total MIPS eligible population and the payment impacts 
by practice size for the 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.
    Although the submission period for the second MIPS performance 
period ended in early 2019, the final data sets were not available in 
time to incorporate into the CY 2020 PFS proposed rule analysis. We 
intend to use data from the 2018 MIPS performance period for the final 
rule.
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 would not need to report to MIPS and would not receive a MIPS 
payment adjustment to their Part B PFS payments. 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 will not 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. If the Partial 
QP elects to be scored under MIPS, they would be subject to all MIPS 
requirements and would receive a MIPS payment adjustment. This 
adjustment may be positive, negative, or neutral. If an eligible 
clinician does not 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 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 detail.
    In section III.K.4.e.(3)(b)(ii) of this proposed rule, we propose 
to amend 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 with exceptions 
for large losses and small losses as described in 414.1420(d). We do 
not yet have experience with QP and Partial QP Determinations under the 
All-Payer Combination Option as it will be operational for the first 
time this fall. 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 added flexibility in the 
marketplace may increase the number of arrangements in this category. 
Based on our analysis there are 12,000 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 50-100 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 models we determined were 
not Other Payer Advanced APMs, but would become Other Payer Advanced 
APMs under the proposed 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 proposal 
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.
    Overall, we estimated that between 175,000 and 225,000 eligible 
clinicians will become QPs, therefore be excluded from MIPS, and 
qualify for the lump sum APM incentive payment 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 $9,000 million and $12,000 million in total for 
the 2020 performance year. The analysis for this proposed rule used the 
APM Participation Lists for the Predictive QP determination file for 
2019. We estimate that the total lump sum APM Incentive Payments will 
be approximately $500-600 million for the 2022 Quality Payment Program 
payment year.
    In section VI.E.10., 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

[[Page 40894]]

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);
     Primary Care First; 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 examine 
the extent to which Advanced APM participants would meet the QP 
Thresholds of having at least 50 percent of their Part B covered 
professional services or at least 35 percent of their Medicare 
beneficiaries furnished Part B covered professional services through 
the APM Entity.
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 proposed rule, our scoring model used 
the first determination period from the 2018 MIPS performance period 
eligibility file as described in the CY 2018 Quality Payment Program 
final rule (82 FR 53587 through 53592). The first determination period 
from the 2018 MIPS performance period eligibility file was selected to 
maximize the overlap with the performance period data used in the 
model. In addition, since the low-volume threshold was finalized in the 
CY 2019 PFS final rule (83 FR 60075) to be based on covered 
professional services (services for which payment is made under, or is 
based on, the PFS and that are furnished by an eligible clinician), 
this eligibility file provided the information to base the low-volume 
threshold on covered professional services rather than all items and 
services under Part B. We included 1.5 million clinicians (see Table 
113) who had PFS claims from September 1, 2016 to August 31, 2017 and 
included a 30-day claim run-out. We excluded from our analysis 
individual clinicians who were affected by the automatic extreme and 
uncontrollable policy finalized for the 2017 MIPS performance period/
2019 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. We also excluded clinicians 
participating in the Medicare Advantage Qualifying Payment Arrangement 
Incentive (MAQI) Demonstration for whom the waivers of MIPS reporting 
requirements and the associated payment consequences are applicable, as 
finalized in the CY 2019 PFS final rule (83 FR 59890).
    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 
QPs should be excluded, we used the QP List for the 2019 predictive 
file that contains current participation in Advanced APMs as of January 
15, 2019, using all available data because these data were available by 
TIN and NPI, could be merged into our model 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 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 124,413 for the 2019 
QP performance period due to the expected growth in APM participation. 
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 indicator 
that was used for the 2017 MIPS performance period/2019 MIPS payment 
year. Finally, we excluded the MAQI participants with a MIPS exclusion 
for the 2019 MIPS performance period.
(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 is a MIPS APM participant, we used the latest 2019 
predictive file that contains current participation in MIPS APMs as of 
January 15, 2019, using all available data. We identified all 
clinicians in our eligible population who are in the 2019 predictive 
file and evaluated them as an APM Entity. We also evaluated clinicians 
as APM Entities if they are in our eligible population and associated 
with an APM Entity for the 2017 performance period but are no longer 
billing for Medicare (because they may have changed practices).\145\ If 
a MIPS

[[Page 40895]]

eligible clinician is determined to not be scored as a MIPS APM, then 
their reporting assumption is based on their reporting for the CY 2017 
MIPS performance period. If no data are submitted and the TIN/NPI is 
not associated with an APM Entity during the performance period, then 
the low-volume threshold is applied at the TIN/NPI level. 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.
---------------------------------------------------------------------------

    \145\ A total of approximately 222,000 clinicians were included 
in our model and scored using the APM scoring standard. These 
clinicians are represented in the individual and group eligibility 
rows in Table 113 depending on whether they would have exceeded the 
low volume threshold as an individual or because they were part of 
an APM entity group submission.
---------------------------------------------------------------------------

    Table 113 presents the estimated MIPS eligibility status and the 
associated PFS allowed charges for the 2020 MIPS performance period 
after using Quality Payment Program Year 1 data and applying the 
proposed 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 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 proposed rule model, we estimate there were approximately 
221,000 clinicians \146\ who would be MIPS eligible because they exceed 
the low volume threshold as individuals and are not otherwise excluded. 
In Table 113, we identify clinicians under this assumption as having 
``required eligibility.''
---------------------------------------------------------------------------

    \146\ The count of 220,981 MIPS eligible clinicians for required 
eligibility includes those who participated in MIPS (203,027 MIPS 
eligible clinicians), as well as those who did not participate 
(17,954 MIPS eligible clinicians).
---------------------------------------------------------------------------

    We anticipate that groups that submitted to MIPS as a group 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 increased the number of MIPS eligible 
clinicians by 566,000 clinicians. In Table 113, we identify these 
clinicians who do not meet the low-volume threshold individually but 
are anticipated to submit to MIPS as a group or MIPS APM as having 
``group eligibility.'' With the availability of CY 2017 Quality Payment 
Program Year 1 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 2017 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 adjustment based on their 
performance. This 33 percent participation assumption is identified in 
Table 113 as ``Opt-In eligibility''. In this proposed rule analysis, we 
estimate an additional 31,000 clinicians would be eligible through this 
policy for a total MIPS eligible population of approximately 818,000. 
The leads to an associated $68 billion allowed PFS charges estimated to 
be included in the 2020 MIPS performance period.
BILLING CODE 4120-01-P

[[Page 40896]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.105

BILLING CODE 4120-01-C
    There are approximately 386,000 clinicians who are not MIPS 
eligible, but could be if their practice decides to participate or they 
elect to opt-in. We describe this group as ``Potentially MIPS 
eligible''. These clinicians would be included as MIPS eligible in the 
unlikely scenario in which all group practices elect to submit data as 
a group and all clinicians that could elect to opt-into MIPS do elect 
to opt-in. This assumption is important because it quantifies the 
maximum number of MIPS eligible clinicians. When this unlikely scenario 
is modeled, we estimate that the MIPS eligible clinician population 
could be as high as 1.2 million clinicians.
    Finally, there are some clinicians who would not be MIPS eligible 
either

[[Page 40897]]

because they or their group are below the low-volume threshold on all 
three criteria (approximately 77,000) or because they are excluded for 
other reasons (approximately 203,000).
    Since eligibility among many clinicians is contingent on submission 
to MIPS as a 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 818,391 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 proposed 
rule, we present several proposals which impact the measures and 
activities that impact the performance category scores, final score 
calculation, and the MIPS payment adjustment. We discuss these changes 
in more detail in section VI.E.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 proposed MIPS policy changes 
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 VI.E.10.c.(2) of this proposed rule, we used the most recently 
available data from the Quality Payment Program which is generally data 
submitted for the 2017 MIPS performance period. We will use 2018 MIPS 
performance period data for the impact analysis in the final rule 
should that data become available.
    The estimated payment impacts presented in this proposed rule 
reflect averages by practice size based on Medicare utilization. The 
payment impact for a MIPS eligible clinician could vary from the 
average and would depend on the combination of services that the MIPS 
eligible clinician furnishes. The average percentage change in total 
revenues 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 proposed rule, we used CY 2017 Quality Payment Program 
Year 1 performance period data. Our scoring model includes the 818,391 
estimated number of MIPS eligible clinicians as described in section 
VI.E.10.b.(1)(b) of this RIA.
    To estimate the impact of MIPS on eligible clinicians, we generally 
used the Quality Payment Program Year 1 submission data, 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, CAHPS for MIPS 
and CAHPS for ACOs, the total per capita cost measure, Medicare 
Spending Per Beneficiary (MSPB) clinician measure and other data 
sets.\147\ 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.
---------------------------------------------------------------------------

    \147\ 2016 PQRS and Value Modifier 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.
---------------------------------------------------------------------------

    We did not model virtual groups since we had fewer than 10 virtual 
groups register for the 2019 performance period, which was not a 
sufficiently large number of virtual groups to model separately for 
this RIA. We will revisit modeling virtual groups separately once we 
receive virtual group submissions in future years.
(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 
proposed policies for the 2020 MIPS performance period and improvement 
to our modeling methodology. As proposed in section 
III.K.3.c.(1)(c)(ii) of this proposed rule, we increased the data 
completeness requirement for the CY 2020 performance period from 60 
percent to 70 percent.
    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) and 
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.
    Finally, our model applied the APM scoring standard policies 
finalized in the CY 2019 PFS final rule (83 FR 59754) as modified by 
the proposals in section III.K.3.c.(5)(c)(i)(B) of this proposed rule 
to MIPS eligible clinicians identified as being scored as a MIPS APM in 
the eligibility section VI.E.10.b.(1)(b) of this proposed rule. As 
described in section III.K.3.c.(5)(c)(i)(B) of this proposed rule, we 
are proposing 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. In our model, this 
proposed `APM Quality Reporting Credit' was implemented for APM 
Entities that do not use Web Interface. We also propose in sections 
III.K.3.c.(5)(c)(i)(A) of this proposed rule to calculate an aggregated 
APM Entity quality score from submitted MIPS data by the participants 
in an APM Entity if the APM quality data cannot be used.
    As described in section VI.E.10.b.(1).(b). of this proposed rule, 
we are using the 2019 predictive file that contains current 
participation in MIPS APMs as of January 15, 2019, using all available 
data to identify who is an APM participant. In the case of MIPS APM 
entities that report Web Interface, if the APM Entity existed in 2017, 
we calculated a score based on the Web Interface submission from the 
2017 performance period. If the APM Entity did submit Web Interface 
data for the 2017 performance period, we calculated an aggregate score 
based on individual

[[Page 40898]]

submissions similar to how we estimate aggregate scores for MIPS APM 
entities that do not utilize Web Interface. If the APM Entity is new 
for 2019 (and therefore did not have the ability to submit Web 
Interface for the 2017 performance period), we used the average Web 
Interface score because we would anticipate the new APM Entities would 
report quality using Web Interface in the future. For MIPS APMs that do 
not utilize the Web Interface, we estimated the APM Entity quality 
performance category score by taking the higher of the group and 
individual quality scores for the clinicians in the APM Entity and 
calculating the average for the APM Entity. Clinicians were assigned a 
score of 0 if they did not submit quality data to MIPS. For the MIPS 
APMs that do not utilize Web Interface only, we then applied the 
proposed APM Quality Reporting Credit policy to add 50 percent to the 
MIPS quality score for APM Entities submitting to MIPS as proposed in 
section III.K.3.c.(5)(c)(i)(B) of this proposed 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)(b)(iii) of this proposed rule, we propose 
to add 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 propose to 
revise the total per capita cost and MSPB clinician measures.
    We estimated the cost performance category score using all measures 
included in section III.K.3.c.(2)(b)(viii) of this proposed rule. The 
total per capita cost measure performance was estimated based on the 
proposed revised measure using claims data from October 2016 through 
September 2017. The MSPB clinician measure performance was estimated 
based on the proposed 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 proposed 
specifications for the 10 new episode-based measures discussed in 
section III.K.3.c.(2)(b)(iii) of this proposed rule and claims data 
from January through December of 2017. Cost measures 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 propose in section III.K.3.c.(2)(vi)(B) of this 
proposed 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 reassigned to the quality performance category. 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 proposed rule, we are only proposing technical changes for 
clarity and those changes do not affect the facility-based policies. In 
the CY 2019 PFS final rule (83 FR 60054 through 60055), we were unable 
to incorporate the facility-based logic fully into our model. For this 
proposed rule, we have new datasets that allow us to more completely 
model facility-based measurement.
    We used data from the feedback reports for the first determination 
period for the 2019 performance period, which is from October 1, 2017 
to September 30, 2018 to attribute clinicians and groups to hospitals 
and assign the specific Hospital VBP Program Total Performance Score. 
Although the time period for facility-based eligibility does not align 
with the MIPS eligibility and performance period data, these facility-
based eligibility data were used because we did not have attribution 
data available for the matching performance period and the use of 
actual attribution data was preferable to using proxy data. 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, that clinician was determined 
as not eligible for facility-based measurement and assumed to 
participate in MIPS via other methods. In some cases, a group or 
clinician may have changed practices and would not have an associated 
facility-based indicator in the feedback reports (because the feedback 
reports used a different time period). In those cases, if the TIN or 
TIN-NPI was facility-based in the 2017 MIPS performance period, we 
estimated a facility-based score by taking the median MIPS quality and 
cost performance score. 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 newly 
proposed policies for the 2020 MIPS performance period.
    In section III.K.3.c.(4)(d)(i)(B)(aa) of this proposed rule, we 
proposed to modify 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 2017 MIPS performance period submissions data.
    In section III.K.3.c.(4)(f)(iii) of this proposed rule, we proposed 
to revise the definition of hospital-based MIPS eligible clinician to 
include groups and virtual groups. We also proposed that a

[[Page 40899]]

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 proposed rule, we proposed revisions to also account 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 
proposed rule, we proposed to assign 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 proposed revised 
definition of a hospital-based MIPS eligible clinician as proposed in 
section III.K.3.c.(4)(f)(iii) of this proposed rule or the definition 
of a non-patient facing MIPS eligible clinician, as proposed in section 
III.K.3.c.(4)(f)(iv) of this proposed rule, as defined in Sec.  
414.1305. We also incorporated into our model the proposed 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 proposed rule.
    In our model, for the APM participants identified in section 
VI.E.10.b.(1).(b).of this proposed 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 proposed policies for the Promoting Interoperability 
performance category described in section III.K.3.c.(4) of this 
proposed rule did not impact our modeling methodology for this 
performance category because either the data were not available in the 
2017 MIPS performance period submissions data or the proposed 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 proposed removal of this 
measure did not impact our impact analysis methodology for this 
proposed rule.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    We modeled the improvement activities performance category score 
based on CY 2017 Quality Payment Period Year 1 data and APM 
participation in the 2017 MIPS performance period. In section 
III.K.3.c.(3)(d)(iii) of this proposed rule, we are proposing 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 CY 
2020 performance year and future years. We did not incorporate this 
proposed change into our model because we did not have the information 
to model this proposal. For the APM participants identified in section 
VI.E.10.b.(1)(b) of this proposed 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 2017 Quality Payment Program Year 1 improvement activities 
performance category score.
(f) Methodology To Estimate the Complex Patient Bonus
    In section III.K.3.d.(2)(a) of this proposed rule, we are proposing 
to continue the complex patient bonus. Consistent with the policy to 
define complex patients as those with high medical risk or with dual 
eligibility, our scoring model used the complex patient bonus 
information calculated for the 2018 performance period data, because 
this variable was available in time for the publication of this 
proposed rule. If the clinician did not have a complex patient bonus 
score from the 2018 performance period data (because the bonus was from 
a different performance period), we proxied a score using the methods 
described in the CY 2019 PFS final rule (83 FR 59869) to supplement the 
gap in data.
(g) Methodology To Estimate the Final Score
    As proposed 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 proposed rule, our model 
assigns a final score for each TIN/NPI by multiplying each performance 
category score by the corresponding performance category weight, adding 
the products together, multiplying the sum by 100 points, and adding 
the complex patient bonus. After adding any applicable bonus for 
complex patients, we reset any final scores that exceeded 100 points 
equal to 100 points. For MIPS eligible clinicians who were assigned a 
weight of zero percent for the Promoting Interoperability due to a 
significant hardship or other type of exception, the weight for the 
Promoting Interoperability performance category was redistributed to 
the quality performance category. For MIPS eligible clinicians who did 
not have a cost performance category score, the weight for the cost 
performance category was redistributed to the quality and Promoting 
Interoperability performance categories.
    In our scoring model, we did not address scenarios where a zero 
percent weight would be assigned to the quality performance category or 
the improvement activities performance category. We applied the 
remaining reweighting scenarios described in detail in section 
III.K.3.d.(2)(b)(ii) of this proposed rule and in the CY 2019 PFS Final 
Rule (83 FR 59871 through 83 FR 59878).
(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).
    We then calculated the parameters of an exchange function in 
accordance

[[Page 40900]]

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 80 points (as proposed in 
sections III.K.3.e.(2) and III.K.3.e.(3) of this proposed rule). We 
used these resulting parameters to estimate the positive or negative 
MIPS payment adjustment based on the estimated final score and the paid 
amount for covered professional services furnished by the MIPS eligible 
clinician. We considered other performance thresholds which are 
discussed in section VI.F.2. of this RIA.
(3) Impact of Payments by Practice Size
    Using the assumptions provided above, our model estimates that $586 
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 5.8 percent 
after considering the MIPS payment adjustment and the additional MIPS 
payment adjustment for exceptional performance.
    Table 114 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 0.9 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 114 also shows that 87.3 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 2017 performance period submissions data for these 
calculations, and it is likely that there will be changes that we 
cannot account for at this time. For example, the 2017 performance 
period was the first year of the program, and it was considered a 
``Pick Your Pace'' year of participation. With ``Pick Your Pace'', 
clinicians could begin slowly participating in MIPS at their own pace 
by determining how much data to submit and their level of 
participation. Specifically, the performance threshold was set at 3 
points, and submission of one quality measure or attesting to one 
improvement activity would allow a clinician to meet or exceed the 
performance threshold. In the second and third years of the program, 
the performance thresholds increased, along with the data submission 
requirements to avoid a negative payment adjustment. At this time, we 
are not able to estimate the impact of these policy changes using Year 
1 performance period data, but we anticipate having additional 
information based on 2018 (year 2) data submissions when conducting the 
impact analysis for the final rule.
    The combined impact of negative and positive adjustments and the 
additional positive adjustments for exceptional performance as a 
percent of paid amount among those that do not submit data to MIPS was 
not the maximum negative payment adjustment of 9 percent possible 
because 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, 90 percent are in small 
practices (16,116 out of 17,954 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 2017 performance period and that participation 
may change for the 2020 performance period. As stated above, the 2017 
performance period was the first year of MIPS, which was a ``Pick Your 
Pace'' year, and we believe that the level of participation and amount 
of data submitted will likely change in ensuing years. For example, we 
note in section III.K.1.a. of this proposed rule that we have published 
participation rates for the 2018 performance period and those rates 
differ from the 2017 performance period participation rates, where a 
slight increase in participation was observed. We did not have the 
submission data in time for this analysis, but we intend to update our 
data for the final rule.
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[GRAPHIC] [TIFF OMITTED] TP14AU19.106

BILLING CODE 4120-01-C
e. Potential Costs of Compliance With the Promoting Interoperability 
and Improvement Activities Performance Categories for Eligible 
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability 
Performance Category
    In section III.K.3.c.(4)(d)(i)(B)(aa) of this proposed rule, we 
propose to 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 proposed rule, we are not 
changing our burden assumptions to account for this proposal 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 proposed 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 are proposing to 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 
proposed 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 proposed rule, we are 
proposing, beginning with the 2020 MIPS performance period and for 
future years, to increase the minimum number of clinicians in a group 
or virtual group who are required to perform an improvement activity 
from at least one clinician to 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. In addition, we are proposing changes to the

[[Page 40902]]

Improvement Activities Inventory to: (1) Establish removal factors to 
consider when proposing to remove improvement activities from the 
Inventory; (2) remove 15 improvement activities for the CY 2020 
performance period and future years contingent on our proposed removal 
factors being finalized; (3) modify 7 existing improvement activities 
for the CY 2020 performance period and future years; and (4) add two 
new improvement activities for the CY 2020 performance period and 
future years.
    Given groups' familiarity with the improvement activities in the 
Improvement Activities Inventory, we assume 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 proposed 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 Improvement Activities 
Inventory remain unchanged for the 2020 MIPS performance period and 
most clinicians are likely to have selected improvement activities that 
were unaffected by the changes. Of the activities that were removed, 
modified, or added, 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 proposal to establish removal factors when proposing to remove 
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 proposed 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 proposed rule, we are proposing to 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).
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 proposed rule, 
beginning with the 2021 performance period and for future years, we are 
proposing to require QCDRs and qualified registries to support three 
performance categories: Quality, improvement activities, and Promoting 
Interoperability. In section III.K.3.g.(1), 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 proposed requirement to support reporting the Promoting 
Interoperability performance category and which entities would be 
subject to an exception based on which clinician types they serve and 
whether those clinician types are eligible for reweighting of the 
Promoting Interoperability performance category as discussed in section 
III.K.3.c.(4). 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 already offer 
support for the quality, improvement activities, and Promoting 
Interoperability performance categories. We believe this proposal 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.
    We are also proposing in section III.K.3.g.(3)(a)(ii) of this 
proposed rule, beginning with the 2021 performance period, to 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 are not proposing a significant change but are instead 
proposing to modify and strengthen the existing policy, we do not 
anticipate a significant increase in cost or effort for Third Party 
Intermediaries to comply with this proposal. In alignment with our 
proposal above, we are also proposing to require QCDRs to provide 
services to clinicians and groups to foster improvement in the quality 
of care provided to patients, by providing educational services in 
quality improvement and leading quality improvement initiatives. 
Similar to the requirement to support submission of Promoting 
Interoperability and improvement activity data, we believe this 
proposal could result in QCDRs incurring additional costs. We are 
unable to create a baseline of current service offerings for each QCDR, 
which would be needed in order to determine

[[Page 40903]]

the incremental costs associated with providing any additional services 
required by this proposal. We believe that by offering these services, 
additional MIPS eligible clinicians may be encouraged to utilize these 
entities, thereby increasing membership and potentially offsetting some 
of the costs the QCDR would have to incur.
    In section III.K.3.g.(3)(c)(i)(B)(cc), we are proposing 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 are proposing in section 
III.K.3.g.(3)(c)(i)(B)(dd) 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. 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.\148\ 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.\149\ 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.
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    \148\ http://www.qualityforum.org/Measuring_Performance/Submitting_Standards.aspx.
    \149\ 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) of this rule, we are 
proposing 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 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 propose, 
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 proposals 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 proposals 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 proposed rule, we are proposing 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 
proposing 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 proposing 
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 would be subject to the following conditions whereby the 
multi-year approval will no longer apply if the QCDR measure is 
identified as: Topped

[[Page 40904]]

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 
are proposing 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 
proposed 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 proposal.
    As discussed in section III.K.3.g.(3)(c)(i)(B)(bb) of this proposed 
rule, beginning with the 2021 performance period and future years, we 
are proposing that QCDRs must identify a linkage between their QCDR 
measures to the following, at the time of self-nomination: (a) Cost 
measures (as found in section III.K.3.c.(3) of this proposed 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 proposed rule). We do not assume any 
additional impact beyond the 1 hour per QCDR measure discussed in the 
Collection of Information section.
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),\150\ 
participant lists using the 2019 predictive APM Participation List, 
which contains the 2018 fourth snapshot and any additional TIN/NPIs 
until January 15, 2019, CY 2017 Quality Payment Program Year 1 data and 
CAHPS for ACOs. The scoring model results presented in this proposed 
rule assume that CY 2017 Quality Payment Program Year 1 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 1 data may be underestimated because the performance 
threshold to avoid a negative payment adjustment for the 2017 MIPS 
performance period/2019 MIPS payment year was significantly lower (3 
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.
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    \150\ The time period for this eligibility file (September 1, 
2016 to August 31, 2017) maximizes the overlap with the performance 
data in our model.
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    In our MIPS eligible clinician assumptions, we assumed that 33 
percent of the opt-in eligible clinicians that participated in the CY 
2017 Quality Payment Program Year 1 would elect to opt-in to the MIPS 
program. It is difficult to predict whether clinicians will elect to 
opt-in to participate in MIPS with the proposed policies.
    There are additional limitations to our estimates: (1) Because we 
used historic data, we assumed participation in the three performance 
categories in MIPS Year 1 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 114. Due to the limitations 
described, there is considerable uncertainty around our estimates that 
is difficult to quantify in detail.

F. Alternatives Considered

    This proposed rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
exercised, presents rationale for our proposed policies and, where 
relevant, alternatives that were considered. For purposes of the 
payment impact on PFS services of the policies contained in this 
proposed rule, we presented the estimated impact on total allowed 
charges by specialty. The alternatives we considered, as discussed in 
the preceding preamble sections, would result in different payment 
rates, and therefore, result in different estimates than those shown in 
Table 110 (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 proposed 
rule, we are proposing to use ASP-based payment for oral OTP drugs; 
however, in the event we do not receive manufacturer-submitted ASP 
pricing data for these drugs, we are also considering several other 
alternative pricing mechanisms to determine the pricing of the drug 
components of the bundles that include these medications, including the 
methodology under Section 1847A of the Act; Medicare Part D 
Prescription Drug Plan Finder data; WAC; and NADAC data. For methadone, 
we also consider an alternative using the TRICARE payment rate for 
methadone in its OTP bundled payment. In Table 14, we display the 
estimated initial drug payment rates for the proposed pricing approach 
for the oral drugs and each of the alternatives, based on data files 
posted at the time of the drafting of this proposed rule. We used the 
TRICARE payment rate for methadone to estimate the payment rates for 
the methadone payment bundles and NADAC data to estimate the payment 
rates for the buprenorphine (oral) payment bundles, and to derive the 
impact estimates.
    For methadone, we believe using Medicare Part D Prescription Drug 
Plan Finder Data to price the medication would have minimal impact on 
the RIA estimate since the rate is very close to the TRICARE payment 
rate. Using WAC-based pricing for methadone would likely increase the 
impact estimate marginally since WAC-based pricing is slightly higher 
than the TRICARE payment rate. Since NADAC pricing for methadone is 
significantly less than the TRICARE payment rate, using NADAC pricing 
would significantly decrease the impact estimates, especially because 
the

[[Page 40905]]

vast majority of patients receiving OUD treatment services at OTPs are 
receiving methadone.
    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.
    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.
2. Alternatives Considered Related to Payment for E/M Services
    In developing our proposed 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 proposed 
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 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 115. 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 40906]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.107


[[Page 40907]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.108

    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 (eg, 
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 116.

               Table 116--Current, RUC Recommended and CMS Refined Office/Outpatient E/M Work RVUs
----------------------------------------------------------------------------------------------------------------
                                                                                       Alternative: CMS-refined
         CPT/HCPCS            Current work RVU (current)   RUC-recommended work RVU            work RVU
----------------------------------------------------------------------------------------------------------------
                    99201                         0.48                          NA                          NA
                    99202                         0.93                        0.93                        0.93
                    99203                         1.42                         1.6                         1.6
                    99204                         2.43                         2.6                         2.6
                    99205                         3.17                         3.5                         3.5
                    99211                         0.18                        0.18                        0.18
                    99212                         0.48                         0.7                        0.56
                    99213                         0.97                         1.3                         1.3
                    99214                          1.5                        1.92                        1.81
                    99215                         2.11                         2.8                         2.8
                    99XXX                           NA                        0.61                         0.5
                       GPC1X                      0.25                          NA                        0.33
                        GCG0X                     0.25                          NA                        0.33
----------------------------------------------------------------------------------------------------------------

    Table 117 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 40908]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.109


[[Page 40909]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.110

    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 118 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 are proposing, with 
slight less positive impacts for those specialties who bill CPT codes 
99212 or 99214.

[[Page 40910]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.111


[[Page 40911]]


[GRAPHIC] [TIFF OMITTED] TP14AU19.112

BILLING CODE 4120-01-C
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 80. In the model with 
a performance threshold of 35, we estimate that $466 million would be 
redistributed through budget neutrality. There would be a maximum 
payment adjustment of 5.3 percent after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In addition, 8.2 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 $644 
million would be redistributed through budget neutrality, and that 
there would be a maximum payment adjustment of 6.1 percent after 
considering the MIPS payment adjustment and the additional MIPS payment 
adjustment for exceptional performance. In addition, 15.5 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 proposed 
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 85 as an alternative to the proposed 80 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 $586 
million would be redistributed through budget neutrality, and there 
would be a maximum payment adjustment of 4.8 percent after considering 
the MIPS payment adjustment and the additional MIPS payment adjustment 
for exceptional performance. In addition, 12.7 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 
85, we estimate that $586 million would be redistributed through budget 
neutrality, and that there would be a maximum payment adjustment of 8.3 
percent after considering the MIPS payment adjustment and the 
additional MIPS payment adjustment for exceptional performance among 
those that submit data. Also, that 12.7 percent of MIPS eligible 
clinicians will receive a negative payment adjustment among those that 
submit data. We proposed the additional performance threshold at 80 
points because we believe raising the additional performance threshold 
would 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 proposed rule for additional rationale on 
the selection of additional performance threshold.

G. Impact on Beneficiaries

1. Medicare PFS
    There are a number of changes in this proposed 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

[[Page 40912]]

proposed measures include patient-reported outcomes, which may be used 
to help patients make more informed decisions about treatment options. 
Patient-reported outcome measures provide information on a patient's 
health status from the patient's point of view and may also provide 
valuable insights on factors such as quality of life, functional 
status, and overall disease experience, which may not otherwise be 
available through routine clinical data collection. Patient-reported 
outcomes are factors frequently of interest to patients when making 
decisions about treatment. Similarly, our proposals in section 
III.K.3.g.(2) of this rule will improve the caliber and value of QCDR 
measures.

H. Burden Reduction Estimates

1. 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 
proposals 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 proposed rule, 
we are proposing to adopt the revised office/outpatient E/M code set. 
Our new proposals reflect our ongoing dialog with the practitioner 
community and take 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 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 is 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/RUCs 
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.
2. Beneficiary Liability
    Many proposed policy changes could result in a change in 
beneficiary liability as it relates to coinsurance (which is 20 percent 
of the fee schedule amount, if applicable for the particular provision 
after the beneficiary has met the deductible). To illustrate this 
point, as shown in our public use file Impact on Payment for Selected 
Procedures available on the CMS website at 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 proposed 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.

I. Estimating Regulatory Familiarization Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this rule, we should 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's rule will be the number of reviewers of this 
rule. We acknowledge that this assumption may understate or overstate 
the costs of reviewing this rule. It is possible that not all 
commenters reviewed last year's rule in detail, and it is also possible 
that some reviewers chose not to comment on the rule. For these reasons 
we thought that the number of past commenters would be a fair estimate 
of the number of reviewers of this rule. We welcomed any comments on 
the approach in estimating the number of entities which will review 
this rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this rule, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule. We sought comments on this 
assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $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 $13,399,662 ($874.88 x 15,316 reviewers).

J. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse 
.gov/omb/circulars/a004/a-4.pdf), in Tables 119 and 120 (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.

[[Page 40913]]



      Table 119--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 120--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.
------------------------------------------------------------------------

K. 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 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.

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

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 is revised 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 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

[[Page 40914]]

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 830.20 (mirrored from 21 CFR 801.3).
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, (e)(2)(xiv);
0
b. Adding paragraph (e)(2)(xi);
0
c. Revising paragraph (e)(2)(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), (f)(1)(i)(A)(3), (f)(1)(i)(A)(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 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.
* * * * *

[[Page 40915]]

    (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 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

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

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

0
6. 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, students, or 
other members of the medical team including, as applicable, notes 
documenting the physician's presence and participation in the services.
0
7. 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 (e)(3)(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, certifying 
that the medical necessity requirements of paragraph (e)(1) of this 
section are met.
* * * * *
    (iii) If the ambulance provider or supplier is unable to obtain a 
signed physician certification statement from the beneficiary's 
attending physician, or 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 supplier 
must document its attempts to obtain the 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
8. 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 is on file, if required.
* * * * *
0
9. 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

[[Page 40916]]

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
10. 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 
(a)(3)(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--either concurrently with or 
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
11. 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 paragraph (a)(3)(i) or 
(a)(3)(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:
    (A) Furnishes all the minutes of a service exclusive of the 
physical therapist; or
    (B) Furnishes a portion of a service either concurrently with or 
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

[[Page 40917]]

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
12. 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.
    Partial episode of care means an episode of care in which at least 
one opioid use disorder treatment service, but less than a majority of 
the opioid use disorder treatment services identified in the patient's 
current treatment plan (including any changes noted in the patient's 
medical record), is furnished.
    (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 as follows:
    (i) Categories for each type of opioid agonist and antagonist 
treatment medication;
    (ii) A category for medication not otherwise specified, which must 
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 no medication provided. Each category of 
bundled payment must consist of a payment amount for a full episode of 
care and a payment amount for a partial episode of care.
    (2) The bundled payment for episodes of care in which a medication 
is provided must consist 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 must be added together to create 
the bundled payment amount. The bundled payment for episodes of care in 
which no medication is provided shall consist of a single payment 
amount for all opioid use disorder treatment services reflected in the 
patient's treatment plan (not including medication or dispensing/
administration of such medication).
    (i) Drug component for full episodes of care. For full episodes of 
care, the payment for the drug component 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 must be 
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, the payment amount must be 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 must be based on an 
alternative methodology as determined by the Secretary.
    (C) Exception. For the drug component of bundled payments in the 
medication not otherwise specified category under paragraph (d)(1)(B) 
of this section, the payment amount must be based on the applicable 
methodology under paragraphs (d)(2)(i)(A) and (d)(2)(i)(B) of this 
section (applying the most recent available data for such new 
medication), or invoice pricing until the necessary data become 
available.
    (ii) Drug component for partial episodes of care. For partial 
episodes of care, the payment for the drug

[[Page 40918]]

component will be determined as follows:
    (A) For oral medications, the amount will be half of the payment 
amount for the full episode of care.
    (B) For injectable and implantable medications, the amount will be 
the same as the payment amount for the full episode of care.
    (iii) Non-drug component for full episodes of care. For full 
episodes of care, the payment for CY 2020 for the non-drug components 
of the bundled payments will be based on the CY 2019 TRICARE weekly 
bundled rate for items and services furnished when a patient is 
prescribed methadone, minus the methadone cost, and adjusted as 
follows:
    (A) For oral medications, no further adjustment.
    (B) For injectable medications, to subtract an amount reflecting 
the cost of dispensing methadone and to add an amount reflecting the CY 
2019 non-facility Medicare payment rate for the administration of an 
injection.
    (C) For implantable medications, to subtract an amount reflecting 
the cost of dispensing methadone and to add an amount reflecting the CY 
2019 non-facility Medicare payment rate for insertion, removal, or 
insertion and removal of the implant, as applicable.
    (iv) Non-drug component for partial episodes of care. For partial 
episodes of care, the payment for CY 2020 for the non-drug components 
of the bundled payments will be based on the CY 2019 TRICARE weekly 
bundled rate for items and services furnished when a patient is 
prescribed methadone, minus the methadone cost, adjusted as follows:
    (A) For oral medications, to halve the amount.
    (B) For injectable medications, to subtract an amount reflecting 
the cost of dispensing methadone and then to halve the remaining 
amount. The resulting amount will be added to an amount reflecting the 
CY 2019 non-facility Medicare payment rate for the administration of an 
injection.
    (C) For implantable medications, to subtract an amount reflecting 
the cost of dispensing methadone and then to halve the remaining 
amount. The resulting amount will be added to an amount reflecting the 
CY 2019 non-facility Medicare payment rate for insertion, removal, or 
insertion and removal of the implant, as applicable.
    (v) No medication provided, full and partial episodes of care. The 
bundled payment amount for CY 2020 for a full episode of care in which 
no medication is provided will be based on the CY 2019 TRICARE weekly 
bundled rate for items and services furnished when a patient is 
prescribed methadone, minus the methadone cost, and minus an amount 
reflecting the cost of dispensing methadone. The bundled payment amount 
for CY 2020 for a partial episode of care in which no medication is 
provided will be half the payment amount for a full episode of care in 
which no medication is provided.
    (3) Adjustments will be made to the bundled payment for the 
following:
    (i) If the opioid treatment program furnishes 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 or partial episode of care.
    (ii) The payment amount for the non-drug component and the full 
bundled payment for an episode of care or partial episode of care in 
which no medication is provided will be geographically adjusted using 
the Geographic Adjustment Factor described in Sec.  414.26.
    (iii) The payment amount for the non-drug component and the full 
bundled payment for an episode of care or partial episode of care in 
which no medication is provided will be updated annually using the 
Medicare Economic Index described in Sec.  405.504(d).
    (4) Payment for medications delivered, administered or dispensed to 
a beneficiary as part of the bundled payment must be considered a 
duplicative payment if delivery, administration or dispensing of the 
same medications was also separately paid under Medicare Parts B or 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
13. Section 410.74 is amended by revising paragraph (a)(2)(iv), and 
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 PAs in the State in which the physician 
assistant's professional services are furnished, with medical direction 
and appropriate supervision as provided 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 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, students, or other members of 
the medical team, including, as applicable, notes documenting the 
physician assistant's presence and participation in the service.
0
14. 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, students, or other members of the 
medical team, including, as applicable, notes documenting the nurse 
practitioner's presence and participation in the service.
0
15. 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, 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
16. 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, 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
17. Section 410.105 is amended by adding paragraph (d) to read as 
follows:

[[Page 40919]]

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--either concurrently with or 
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
18. 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
19. 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. Requests that present a general 
question of interpretation, pose a hypothetical situation, or involve 
the activities of third parties are not appropriate for an advisory 
opinion.
* * * * *
    (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; or
    (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.
    (2) CMS may elect not to accept an advisory opinion request if it 
determines, after consultation with OIG and DOJ, that the course of 
action described is substantially similar to a course of conduct that 
is under investigation or is the subject of a proceeding involving the 
Department or other law enforcement agencies, and issuing an advisory 
opinion could interfere with the investigation or proceeding.
* * * * *
0
20. Section 411.372 is amended by revising paragraphs (b)(4)(i) and 
(ii), (5), (6), and (8)(ii) to read as follows:


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) 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;
* * * * *
0
21. Section 411.375 is amended by revising paragraphs (a) and (b) to 
read as follows:

[[Page 40920]]

Sec.  411.375  Fees for the cost of advisory opinions.

    (a) Initial payment. Parties must include with each request for an 
advisory opinion a check or money order payable to CMS for $250. This 
initial payment is nonrefundable.
    (b) How costs are calculated. In addition to the initial payment, 
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 calculates the fee for responding to the request.
* * * * *


Sec.  411.379  [Amended]

0
22. Section 411.379(e) is amended by removing the phrase ``The 90-day 
period'' and adding in its place the phrase ``The 60-day period''.


Sec.  411.380  [Amended]

0
23. Section 411.380 is amended--
0
a. In paragraph (c)(1), by removing the phrase ``within 90 days'' and 
adding in its place the phrase ``within 60 days''.
0
b. In paragraph (c)(2), by removing the phrase ``If the 90th day'' and 
adding in its place the phrase ``If the 60th day''.
0
c. In paragraph (c)(3) introductory text, by removing the phrase ``The 
90-day period'' and adding in its place the phrase ``The 60-day 
period''.


Sec.  411.384  [Amended]

0
24. Section 411.384(b) is amended by removing the phrase ``for public 
inspection during its normal hours of operation and''.
0
25. 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 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
26. The authority for part 414 continues to read as follows:

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


Sec.  414.601  [Amended]

0
27. Section 41.601 is amended by adding the sentence ``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.'' to to the end of the section.
0
28. Section 414.605 is amended by adding the definition of ``ground 
ambulance organization'' in alphabetical order to read as follows:


Sec.  414.605  Definitions.

* * * * *
    Ground ambulance organization means a Medicare provider or supplier 
of ground ambulance services.
* * * * *
0
29. 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
30. Section 414.626 is added 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.
    (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 ambulance organization's 
Medicare Administrative Contractor in accordance with CMS instructions 
on reporting the data collection period.
    (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, ownership (for-profit, non-
profit, and government);
    (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

[[Page 40921]]

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, and that 
is not granted a hardship exemption under paragraph (d) 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's 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
31. 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).
* * * * *
    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

[[Page 40922]]

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 
specified by CMS.
* * * * *
    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
32. 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
33. 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
34. 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
35. Section 414.1330 is amended by adding paragraphs (b)(4), (5), and 
(6) to read as follows:


Sec.  414.1330  Quality performance category.

* * * * *
    (b) * * *
    (4) 40 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2022.
    (5) 35 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2023.
    (6) 30 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2024 and future years.
0
36. 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
37. Section 414.1340 is amended by adding paragraph (d) to read as 
follows:


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

* * * * *
    (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
38. Section 414.1350 is amended by--
0
a. Revising paragraphs (b) and (c)(2); and
0
b. Adding paragraphs (d)(4), (5), and (6).
    The revisions and additions 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 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) * * *

[[Page 40923]]

    (2) For the Medicare spending per beneficiary clinician measure, 
the case minimum is 35.
* * * * *
    (d) * * *
    (4) 20 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2022.
    (5) 25 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2023.
    (6) 30 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2024 and each subsequent MIPS payment year.
0
39. 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 for the same continuous 90 days in 
the performance period.
* * * * *
0
40. Section 414.1370 is amended by amending paragraph (e)(2) 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.
* * * * *
0
41. 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), (E), and 
(F);
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.
* * * * *
    (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:
BILLING CODE 4120-01-P

[[Page 40924]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.113

    (E) For the 2023 MIPS payment year:
    [GRAPHIC] [TIFF OMITTED] TP14AU19.114
    
    (F) For the 2024 MIPS payment year:

[[Page 40925]]

[GRAPHIC] [TIFF OMITTED] TP14AU19.115

BILLING CODE 4120-01-C
    (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
42. 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 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's request. Non-
responsiveness to CMS's 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.
    (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
43. 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

[[Page 40926]]

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
44. 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) and (iv), (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 2021 performance period and all future 
years, for the following MIPS performance categories, QCDRs and 
qualified registries must be able to submit data for all categories, 
and Health IT vendors must be able to submit data for at least one 
category:
* * * * *
    (iii) Promoting Interoperability, 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) 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 data 
submission mechanism or third party intermediary 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, the QCDR 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.
    (iv) 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:
    (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 to the following at the 
time of self-nomination:
    (i) Cost measure,
    (ii) Improvement activity,
    (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) QCDRs should conduct an environmental scan of existing QCDR 
measures; MIPS quality measures; quality measures retired from the 
legacy Physician Quality Reporting System (PQRS) program; and utilize 
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

[[Page 40927]]

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 2020 performance period, areas of 
duplication identified by CMS should be addressed within a year of the 
request. 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, that 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.
    (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 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
45. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(7) and (8);
0
b. Adding paragraph, (d)(6) and (7); and
0
c. Revising paragraph (f) introductory text.
    The additions and revisions read as follows:

[[Page 40928]]

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 MIPS payment 
year is 80 points.
    (7) The additional performance threshold for the 2023 MIPS payment 
year 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
46. 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 B expenditures for 
a participant in the absence of the APM. If the expected expenditures 
under the APM exceed the Medicare Part 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 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 (42 CFR part 422) are not considered capitation arrangements 
for purposes of this paragraph (c)(6).
* * * * *
0
47. Section 414.1420 is amended by revising paragraph (d)(2) 
introductory text, (d)(2)(ii), (d)(3)(ii)), (d)(4) introductory text, 
(d)(5), (6), (7) and (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 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 (that is, benchmarks) 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 (42 CFR part 422) 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

[[Page 40929]]

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
48. Section 414.1425 is amended by--
0
a. Revising paragraph (c)(5) and (6), (d)(3) and (4); and
0
b. Adding paragraph (d)(5).
    The revision and addition reads as follows:


Sec.  414.1425  Qualifying APM participant determination: In general.

* * * * *
    (c) * * *
    (5) Beginning in the 2020 QP Performance Period, an eligible 
clinician 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 performance period under the terms of the Advanced APM.
    (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 individually 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 individually 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 individually 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 individually 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.
    (5) Beginning in the 2020 QP Performance Period, Partial QP status 
applies only to the TIN/NPI combination(s) through which Partial QP 
status is attained.
* * * * *

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

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

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

0
50. 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 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
51. 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
52. The authority citation for part 416 is revised to read as follows:

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


Sec.  416.42  [Amended]

0
53. Section 416.42 is amended in paragraph (a)(1), by removing the 
phrase ``A physician must'' and by adding in its place the phrase ``A 
physician or an anesthetist as defined at Sec.  410.69(b) of this 
chapter must''.

PART 418--HOSPICE CARE

0
54. The authority citation for part 418 is revised to read as follows:

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

0
55. 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.

[[Page 40930]]

    (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
56. The authority citation for part 424 continues to read as follows:

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

0
57. 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 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 subpart P of this part and 
this section.
    (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 and eligible professionals who are 
legally authorized to prescribe, order, or dispense controlled 
substances on behalf of the OTP. The list must include the physician's 
or eligible professional'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 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. application) and any applicable 
supplement thereto to its applicable Medicare contractor.
    (2) Comply with the application fee requirements in Sec.  424.514.
    (3) Successfully complete the high categorical risk level screening 
required under Sec.  424.518(c).
    (4)(i) Have a current, valid certification by SAMHSA for an opioid 
treatment program consistent with the provisions and requirements Sec.  
8.11 of this title.
    (ii) A provisional certification under Sec.  8.11(e) of this title 
does not meet the requirements of the paragraph (b)(4)(i) of this 
section.
    (5) Report on the Form CMS-855 and/or any applicable supplement all 
OTP staff that 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 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 42 CFR part 489.
    (ii) An OTP's appeals under 498 of a Medicare revocation (under 
Sec.  424.535) and a provider agreement termination (under Sec.  
489.53(a)(1)) 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) 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.
    (2) Any of the denial reasons in Sec.  424.530 applies.
    (3) 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 subpart P of this Part and of this section. 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 
SAMSHA 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 paragraph (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.

[[Page 40931]]

    (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
58. 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
59. Section 424.518 is amended by adding paragraphs (b)(1)(xii) and 
(c)(1)(iv) to read as follows:


Sec.  424.518  Screening levels for Medicare providers and suppliers.

* * * * *
    (b) * * *
    (1) * * *
    (xii) Revalidating opioid treatment programs.
* * * * *
    (c) * * *
    (1) * * *
    (iv) Prospective (newly enrolling) opioid treatment programs.
* * * * *
0
60. 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
61. 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
62. Section 424.530 is amended by reserving paragraphs (a)(12),(13) and 
(14) and adding paragraph (a)(15) to read as follows:


Sec.  424.530  Denial of enrollment in the Medicare program.

* * * * *
    (a) * * *
    (15) Patient Harm. The physician or eligible professional (as that 
term is defined in 1848(k)(3)(B) of the Act) has been subject to prior 
action from 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 eligible professional conduct that led 
to patient harm. In determining whether a denial is appropriate, CMS 
considers the following factors:
    (i) The nature of the patient harm.
    (ii) The nature of the physician's or eligible professional's 
conduct.
    (iii) The number and type(s) of sanctions or disciplinary actions 
that have been imposed against the physician or 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:
    (A) License restriction(s) pertaining to certain procedures or 
practices.
    (B) Required compliance appearances before State oversight board 
members.
    (C) Required participation in rehabilitation or mental/behavioral 
health programs.
    (D) Required abstinence from drugs or alcohol and random drug 
testing.
    (E) 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).
    (F) Administrative/monetary penalties.
    (G) Formal reprimand(s).
    (iv) If applicable, the nature of the IRO determination(s).
    (v) The number of patients impacted by the physician's or eligible 
professional's conduct and the degree of harm thereto or impact upon.
    (vi) Any other information that CMS deems relevant to its 
determination.
* * * * *
0
63. 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. Reserving paragraphs (a)(15) through (21).
0
c. Adding paragraph (a)(22).
    The addition reads as follows:


Sec.  424.535  Revocation of enrollment in the Medicare programs.

    (a) * * *
    (22) Patient Harm. The physician or 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 eligible professional conduct that led 
to patient harm. In determining whether a revocation is appropriate, 
CMS considers the following factors:
    (i) The nature of the patient harm.
    (ii) The nature of the physician's or eligible professional's 
conduct.
    (iii) The number and type(s) of sanctions or disciplinary actions 
that have been imposed against the physician or 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:
    (A) License restriction(s) pertaining to certain procedures or 
practices.
    (B) Required compliance appearances before State medical board 
members.
    (C) Required participation in rehabilitation or mental/behavioral 
health programs.
    (D) Required abstinence from drugs or alcohol and random drug 
testing.
    (E) License restriction(s) regarding the ability to treat certain 
types of patients

[[Page 40932]]

(for example, cannot be alone with members of a different gender after 
a sexual offense charge).
    (F) Administrative or monetary penalties.
    (G) Formal reprimand(s).
    (iv) If applicable, the nature of the IRO determination(s).
    (v) The number of patients impacted by the physician's or eligible 
professional's conduct and the degree of harm thereto or impact upon.

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
64. 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
65. 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
66. 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
67. 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
68. 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
69. Section 489.13 is amended by revising paragraph (a)(2)(i) to read 
as follows:


Sec.  489.13  Effective date of agreement or approval.

    (a) * * *
    (2) * * *
    (i) For an agreement with a community mental health center (CMHC), 
opioid treatment program (OTP), or a federally qualified health center 
(FQHC), the effective date is the date on which CMS accepts a signed 
agreement which assures that the CMHC, OTP or FQHC meets all Federal 
requirements.
* * * * *
0
70. 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
71. The authority citation for part 498 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1320a-7j, and 1395hh.

0
72. 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.

    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: June 21, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: July 18, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
 BILLING CODE 4120-01-P

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[FR Doc. 2019-16041 Filed 7-29-19; 4:15 pm]
BILLING CODE 4120-01-C