[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Proposed Rules]
[Pages 50074-50665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17127]
[[Page 50073]]
Vol. 85
Monday,
No. 159
August 17, 2020
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 410, 414 et al.
Medicare Program; CY 2021 Payment Policies Under the Physician Fee
Schedule and Other Changes to Part B Payment Policies; Medicare Shared
Savings Program Requirements; Medicaid Promoting Interoperability
Program Requirements for Eligible Professionals; Quality Payment
Program; Coverage of Opioid Use Disorder Services Furnished by Opioid
Treatment Programs; Medicare Enrollment of Opioid Treatment Programs;
Electronic Prescribing for Controlled Substances for a Covered Part D
Drug Under a Prescription Drug Plan or an MA-PD Plan; Payment for
Office/Outpatient Evaluation and Management Services; Hospital IQR
Program; Establish New Code Categories; and Medicare Diabetes
Prevention Program (MDPP) Expanded Model Emergency Policy; Proposed
Rule
Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 /
Proposed Rules
[[Page 50074]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410, 414, 415, 423, 424, and 425
[CMS-1734-P]
RIN 0938-AU10
Medicare Program; CY 2021 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Medicaid Promoting
Interoperability Program Requirements for Eligible Professionals;
Quality Payment Program; Coverage of Opioid Use Disorder Services
Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid
Treatment Programs; Electronic Prescribing for Controlled Substances
for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD
Plan; Payment for Office/Outpatient Evaluation and Management Services;
Hospital IQR Program; Establish New Code Categories; and Medicare
Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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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 requirements; Medicaid
Promoting Interoperability Program requirements for Eligible
Professionals; updates to the Quality Payment Program; Medicare
coverage of opioid use disorder services furnished by opioid treatment
programs; Medicare enrollment of Opioid Treatment Programs; payment for
office/outpatient evaluation and management services; Requirement for
Electronic Prescribing for Controlled Substances for a Covered Part D
drug under a prescription drug plan or an MA-PD plan and Medicare
Diabetes Prevention Program (MDPP) expanded model Emergency Policy.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on October 5, 2020.
(See the SUPPLEMENTARY INFORMATION section of this proposed rule for a
list of provisions open for comment.)
ADDRESSES: In commenting, please refer to file code CMS-1734-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed).
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1734-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1734-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT:
Jamie Hermansen, (410) 786-2064, for any issues not identified
below.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and specialty-specific impacts
of PFS proposals.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Emily Yoder, (410) 786-1804, Donta Henson, (410) 786-1947, and
Patrick Sartini, (410) 786-9252, for issues related to telehealth and
other services involving communications technology.
Liane Grayson, (410) 786-6583, for issues related to care
management services and remote physiologic monitoring services.
Emily Yoder, (410) 786-1804, Christiane LaBonte, (410) 786-7237,
Ann Marshall, (410) 786-3059, and Patrick Sartini, (410) 786-9252, for
issues related to payment for office/outpatient evaluation and
management visits.
Christiane LaBonte, (410) 786-7237, for issues related to teaching
physician services.
Roberta Epps, (410) 786-4503, and Regina Walker-Wren, (410) 786-
9160, for issues related to supervision of diagnostic tests.
Ann Marshall, (410) 786-3059, for issues related to incident to
pharmacist services.
Pamela West, (410) 786-2302, for issues related to therapy
services.
Sarah Leipnik, (410) 786-3933, for issues related to medical record
documentation.
Lindsey Baldwin, (410) 786-1694 and Terry Simananda, (410) 786-
8144, for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs.
Laura Ashbaugh, (410) 786-1113, for issues related to Clinical
Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of
Payment Reductions.
Joseph Schultz, (410) 786-2656, for issues related to opioid
treatment program provider enrollment regulation updates for
institutional claim submissions.
Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs,
primary care management services, and the FQHC market basket.
Rachel Katonak, (410) 786-8564, for issues related to comprehensive
screenings for seniors: Section 2002 of the Substance Use-Disorder
Prevention that Promote Opioid Recovery and Treatment for Patients and
Communities Act (SUPPORT Act).
David Koppel, (303) 844-2883, or Elizabeth LeBreton, (202) 615-
3816, for issues related to the Medicaid Promoting Interoperability
Program.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) Quality performance
standard and quality reporting requirements.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment and repayment mechanism
requirements.
Cheryl Gilbreath, (410) 786-5919, for issues related to home
infusion therapy benefit.
Heather Hostetler, (410) 786-4515, for issues related to removal of
selected national coverage determinations.
Joella Roland, (410) 786-7638, for issues related to requirement
for electronic prescribing for controlled substances for a covered Part
D drug under a prescription drug plan or an MA-PD plan.
Edmund Kasaitis, (410) 786-0477, for issues related to Part B drug
payment and Food Drug & Cosmetic Act section 505(b)(2) drug products.
Elizabeth Holland, (410) 786-1309, for issues related to updates to
certified electronic health record technology due to the 21st Century
Cures Act.
Julia Venanzi, (410) 786-1471, for issues related to the Hospital
Inpatient Quality Reporting (IQR) Program
Irina Akelaitis, (410) 786-4602, for issues related to HCPCS Level
II codes.
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Amanda Rhee, (410) 786-3888, for the Medicare Diabetes Prevention
Program (MDPP) expanded model emergency policy.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Brittany LaCouture, (410) 786-0481, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that website to view
public comments.
Addenda Available Only Through the Internet on the CMS Website: The
PFS Addenda along with other supporting documents and tables referenced
in this proposed rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2021 PFS proposed rule, refer to item CMS-1734-P. Readers with
questions related to accessing any of the Addenda or other supporting
documents referenced in this proposed rule and posted on the CMS
website identified above should contact Jamie Hermansen at (410) 786-
2064.
CPT (Current Procedural Terminology) Copyright Notice: Throughout
this proposed rule, we use CPT codes and descriptions to refer to a
variety of services. We note that CPT codes and descriptions are
copyright 2019 American Medical Association. All Rights Reserved. CPT
is a registered trademark of the American Medical Association (AMA).
Applicable Federal Acquisition Regulations (FAR) and Defense Federal
Acquisition Regulations (DFAR) apply.
I. Executive Summary
A. Purpose
This major proposed rule proposes to revise payment polices under
the Medicare PFS and makes other policy changes, including proposals to
implement certain provisions of the Bipartisan Budget Act of 2018 (BBA
of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L.
115-271, October 24, 2018), related to Medicare Part B payment. In
addition, this proposed rule includes provisions related to other
payment policy changes that are addressed in section III. of this
proposed rule.
1. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work;
practice expense (PE); and malpractice (MP) expense. In addition, the
statute requires that we establish by regulation each year's payment
amounts for all physicians' services paid under the PFS, incorporating
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major proposed rule, we are proposing to establish RVUs for
CY 2021 for the PFS to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. This proposed rule also includes
discussions and provisions regarding several other Medicare Part B
payment policies.
Specifically, this proposed rule addresses:
Practice Expense RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section II.C.)
Telehealth and Other Services Involving Communications
Technology (section II.D.)
Care Management Services and Remote Physiologic Monitoring
Services (section II.E.)
Refinements to Values for Certain Services to Reflect
Revisions to Payment for Office/Outpatient Evaluation and Management
(E/M) Visits and Promote Payment Stability during the COVID-19 Pandemic
(section II.F.)
Scopes of Practice and Related Issues (section II.G.)
Valuation of Specific Codes (section II.H.)
Modifications related to Medicare Coverage for Opioid Use
Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs)
(section II.I.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions, and a Comment Solicitation
on Payment for Specimen Collection for Covid-19 Tests (section III.A.)
Opioid Treatment Program Provider Enrollment Regulation
Updates for Institutional Claim Submissions (section III.B.)
Payment for Primary Care Management Services in RHCs and FQHCs
(section III.C.)
Changes to the Federally Qualified Health Center Prospective
Payment System (FQHC PPS) for CY 2021: Proposed Rebasing and Revising
of the FQHC Market Basket (section III.D.)
Comprehensive Screenings for Seniors: Section 2002 of the
Substance Use-Disorder Prevention that Promote Opioid Recovery and
Treatment for Patients and Communities Act (SUPPORT Act) (section
III.E.)
Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Notification of Infusion Therapy Options Available Prior to
Furnishing Home Infusion Therapy Services (section III.H.)
Modifications to Quality Reporting Requirements and Comment
Solicitation on Modifications to the Extreme and Uncontrollable
Circumstances Policy for Performance Year 2020 (section III.I.)
Proposal to Remove Selected National Coverage Determinations
(section III.J.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D drug under a prescription drug plan or
an MA-PD plan (section III.K.)
Medicare Part B Drug Payment for Drugs Approved Through the
Pathway Established Under Section 505(b)(2) of the Food, Drug, and
Cosmetic Act (section III.L.)
Updates to Certified Electronic Health Record Technology due
to the 21st Century Cures Act Final Rule (section III.M.)
Proposal to Establish New Code Categories (section III.N.)
Medicare Diabetes Prevention Program (MDPP) expanded model
Emergency Policy (section III.O.)
CY 2021 Updates to the Quality Payment Program (section IV.)
Planned 30-day Delayed Effective Date for the Final Rule
(section V.)
Collection of Information Requirements (section VI.)
Response to Comments (section VII.)
Regulatory Impact Analysis (section VIII.)
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2. Summary of Costs and Benefits
We have determined that this proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VIII. of this proposed rule.
3. Waiver of the 60-Day Delayed Effective Date for the Final Rule
The United States is responding to an outbreak of respiratory
disease caused by a novel (new) coronavirus that has now been detected
in more than 190 locations internationally, including in all 50 States
and the District of Columbia. The virus has been named ``SARS CoV 2''
and the disease it causes has been named ``Coronavirus disease 2019''
(abbreviated ``COVID-19'').
Due to the significant devotion of resources to the COVID-19
response, as discussed in section V. of the preamble of this proposed
rule, we are hereby waiving the 60-day delay in the effective date of
the final rule, and replacing it with a 30-day delay in the effective
date of the final rule.
II. Provisions of the Proposed Rule for the PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Act, ``Payment for Physicians' Services.''
The PFS relies on national relative values that are established for
work, practice expense (PE), and malpractice (MP), which are adjusted
for geographic cost variations. These values are multiplied by a
conversion factor (CF) to convert the relative value units (RVUs) into
payment rates. The concepts and methodology underlying the PFS were
enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub.
L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November
5, 1990) (OBRA '90). The final rule published in the November 25, 1991
Federal Register (56 FR 59502) set forth the first fee schedule used
for payment for physicians' services.
We note that throughout this proposed rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Scale
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the federal government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or similar
codes, and magnitude estimation. More information on these issues is
available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended by section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding MP expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA '97) delayed implementation of
the resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA '97 provided for a 4-year transition period
from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in the November 2, 1998 final rule (63 FR 58814), effective for
services furnished in CY 1999. Based on the requirement to transition
to a resource-based system for PE over a 4-year period, payment rates
were not fully based upon resource-based PE RVUs until CY 2002. This
resource-based system was based on two significant sources of actual PE
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
Socioeconomic Monitoring System (SMS) data. These data sources are
described in greater detail in the CY 2012 PFS final rule with comment
period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some resource costs are borne by the
facility. Medicare's payment to the facility (such as the outpatient
prospective payment system (OPPS) payment to the HOPD) would reflect
costs typically incurred by the facility. Thus, payment associated with
those specific facility resource costs is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR
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25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA '97 amended section 1848(c) of the Act
to require that we implement resource-based MP RVUs for services
furnished on or after CY 2000. The resource-based MP RVUs were
implemented in the PFS final rule with comment period published
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and
physician-owned insurers' MP insurance premium data from all the
states, the District of Columbia, and Puerto Rico.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed 5-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC identified and reviewed a number of potentially misvalued codes
on an annual basis based on various identification screens. This annual
review of work and PE RVUs for potentially misvalued codes was
supplemented by the amendments to section 1848 of the Act, as enacted
by section 3134 of the Affordable Care Act, that require the agency to
periodically identify, review and adjust values for potentially
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VII. of this proposed rule, the Regulatory
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of
the Act, if revisions to the RVUs cause expenditures for the year to
change by more than $20 million, we make adjustments to ensure that
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component. Please refer to the CY 2020 PFS final rule for a discussion
of the last GPCI update (84 FR 62615 through 62623).
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS' Office of
the Actuary (OACT). The formula for calculating the Medicare PFS
payment amount for a given service and fee schedule area can be
expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia CF, in a
manner to ensure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value.
Therefore, there is a separate fee schedule methodology for anesthesia
services. Specifically, we establish a separate CF for anesthesia
services and we utilize the uniform relative value guide, or base
units, as well as time units, to calculate the fee schedule amounts for
anesthesia services. Since anesthesia services are not valued using
RVUs, a separate methodology for locality adjustments is also
necessary. This involves an adjustment to the national anesthesia CF
for each payment locality.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding MP expenses, as specified in section 1848(c)(1)(B) of the
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work relative value
units under the PFS and proposed changes to the PE methodology CY 2007
PFS proposed
[[Page 50078]]
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file titled ``CY 2021 PFS Proposed Rule PE/HR'' on the
CMS website under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
As noted above, we have established PE/HR values for various
specialties without SMS or PPIS survey data by crosswalking them to
other similar specialties to estimate a proxy PE/HR. On this note,
stakeholders have raised concerns regarding the appropriate specialty
crosswalk used for home PT/INR monitoring services. These services are
currently classified under the independent diagnostic testing
facilities specialty for PE/HR purposes, due to a lack of survey data
for these services, and stakeholders have suggested to CMS that this
specialty does not reflect the indirect costs associated with
furnishing these services. Stakeholders have raised concerns that the
practice pattern of PT/INR monitoring services are markedly different
from that of the dominant parent specialty as most of the services are
furnished remotely and require long-term relationship with
beneficiaries similar to chronic therapy. Stakeholders also stated that
this is a unique request due to the lack of home PT/INR monitoring
supplier involvement in the last PPIS, and that payments for these
services are derived from previously used supplemental survey data from
the Association for Quality Imaging (AQI), blended with supplementary
survey data from the American College of Radiology (ACR)--neither of
which reflect indirect cost inputs for home PT/INR monitoring.
Therefore, we are soliciting comment from the public regarding the
most accurate specialty crosswalk to use for indirect PE when it comes
to home PT/INR monitoring services. We are seeking information on any
additional costs associated with these services that are not reflected
in our currently assigned PE/HR for independent diagnostic testing
facilities, as well as which specialties would best capture these costs
through the use of a crosswalk.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level on the basis of
the direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is
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calculated so that the direct costs equal the average percentage of
direct costs of those specialties furnishing the service. For example,
if the direct portion of the PE RVUs for a given service is 2.00 and
direct costs, on average, represent 25 percent of total costs for the
specialties that furnish the service, the initial indirect allocator
would be calculated so that it equals 75 percent of the total PE RVUs.
Thus, in this example, the initial indirect allocator would equal 6.00,
resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and
6.00 is 75 percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Then, we incorporate the specialty-specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this proposed rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we
instead use the expected specialty that we identify on a list developed
based on medical review and input from expert stakeholders. We display
this list of expected specialty assignments as part of the annual set
of data files we make available as part of notice and comment
rulemaking and consider recommendations from the RUC and
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other stakeholders on changes to this list on an annual basis. Services
for which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) are unaffected by the list of expected
specialty assignments. We also finalized in the CY 2018 PFS final rule
(82 FR 52982 through 59283) a policy to apply these service-level
overrides for both PE and MP, rather than one or the other category.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this proposed rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low-volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 1.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the manner in which the
modifiers are applied.
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We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
proposed rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate) [caret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed
rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different types of equipment, the vast
majority of which fall in the range of 5 to 10 years, and none of which
are lower than 2 years in duration. We believe that the updated
editions of this reference material remain the most accurate source for
estimating the useful life of depreciable medical equipment.
We note that stakeholders including the RUC, specialty societies,
and other commenters suggested a useful life of less than 1 year for
several of the new equipment items for CY 2021, and as low as three
months in one case. We have rarely, if ever, received requests for
equipment useful life of less than one year in duration and note that
these very short useful life durations are significantly lower than
anything in our current equipment database, and if finalized would
represent major outliers when compared to the rest of the equipment.
Table 3 details the distribution of useful life durations of the
equipment currently in our database:
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As Table 3 demonstrates, the vast majority of equipment items have
a useful life duration of 5 to 10 years, and only 4 out of the 777
equipment codes have a useful life duration of less than 3 years. We
also note that due to the formula used to calculate the equipment cost
per minute, decreasing the useful life of any equipment item from 5
years to 3 months has the same effect as increasing the price of the
equipment 20 times over. In other words, decreasing the useful life
from 5 years to 0.25 years has the same multiplicative effect as
increasing the price of the equipment from $5,000 to 100,000 due to the
formula listed above. Since we currently do not have any equipment
items in our database with a useful life of less than one year, we are
proposing a clarification on how to address these cases.
We disagree that assigning a useful life at these very short
durations would be typical for new equipment, especially in light of
the data provided by the AHA's ``Estimated Useful Lives of Depreciable
Hospital Assets'' reference. The equipment life durations listed in
Table 3 were finalized over the last 15 years through the use of this
reference material. We have concerns that assigning very low useful
life durations to equipment items would fail to maintain relativity
with other equipment on the PFS, effectively assigning a much higher
price than other equipment items with more typical useful life
durations. We believe that equipment items with very low useful life
durations represent outlier cases that are not handled appropriately by
the current equipment methodology and which we seek to clarify through
this rulemaking. We also note that the equipment cost per minute
formula was designed under the assumption that each equipment item
would remain in use for a period of several years and depreciate over
that span of time. Our current equipment formula is not designed to
address cases in which equipment is replaced multiple times per year,
and we believe that applying a multi-year depreciation in these
situations would not be reflective of market pricing. We do not believe
that items which are replaced on a monthly basis can be accurately
priced using a formula which assumes they will be in use for years at a
time, and that the use of such a formula would distort relativity with
the overwhelming majority of equipment items which are in use for 5-10
years.
Therefore, we proposing to treat equipment life durations of less
than 1 year as having a duration of 1 year for the purpose of our
equipment price per minute formula. We believe that this is the most
accurate way to incorporate these short equipment life durations within
the framework of our current methodology. In the rare cases where items
are replaced every few months, we believe that it is more accurate to
treat these items as disposable supplies with a fractional supply
quantity as opposed to equipment items with very short equipment life
durations. For example, we are proposing to establish the EECP
compression equipment package (SD341) and the EECP electrical equipment
package (SD342) as disposable supplies instead of equipment items as
described in the Valuation of Specific Codes (section II.H. of this
proposed rule) portion of the preamble. We expect these situations to
occur only rarely, and we will evaluate them on an individual case-by-
case basis. Our criteria will be based on whether or not the item in
question could be more accurately classified as a disposable supply
while maintaining overall relativity within our PE methodology. We
welcome additional comments from stakeholders regarding the subject of
useful life durations for new equipment items with unique useful life
durations as described above and any additional suggestions on
alternative ways to incorporate these items into our methodology or
potential wider changes to the equipment cost per minute formula more
broadly.
Maintenance: This factor for maintenance was finalized in
the CY 1998 PFS final rule with comment period (62 FR 33164). As we
previously stated in the CY 2016 PFS final rule with comment period (80
FR 70897), we do not believe the annual maintenance factor for all
equipment is precisely 5 percent, and we concur that the current rate
likely understates the true cost of maintaining some equipment. We also
believe it likely overstates the maintenance costs for other equipment.
When we solicited comments regarding sources of data containing
equipment maintenance rates, commenters were unable to identify an
auditable, robust data source that could be used by CMS on a wide
scale. We do not believe that voluntary submissions regarding the
maintenance costs of individual equipment items would be an appropriate
methodology for determining costs. As a result, in the absence of
publicly available datasets regarding equipment maintenance costs or
another systematic data collection methodology for determining a
different maintenance factor, we are not proposing a variable
maintenance factor for equipment cost per minute pricing as we do not
believe that we have sufficient information at present. We continue to
investigate potential avenues for determining equipment maintenance
costs across a broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment
period (77 FR 68902), we updated the interest rates used in developing
an equipment cost per minute calculation (see 77 FR 68902 for a
thorough discussion of this issue). The interest rate was based on the
Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The Interest rates are listed in Table 4.
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We are not proposing any changes to the equipment interest rates
for CY 2021.
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2020 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2020 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640 through 67641), we continue to make improvements to the direct
PE input database to provide the number of clinical labor minutes
assigned for each task for every code in the database instead of only
including the number of clinical labor minutes for the preservice,
service, and post service periods for each code. In addition to
increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184
through 80186), we finalized a policy to establish a range of
appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page.'' These standard minutes will be applied to new and
revised codes that make use of this clinical labor activity when they
are reviewed by us for valuation. We finalized a policy to establish 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, 4 minutes as the standard for the complex
case, and 5 minutes as the standard for the highly complex case. These
values were based upon a review of the existing minutes assigned for
this clinical labor activity; we determined that 2 minutes is the
duration for most services and a small number of codes with more
complex forms of digital imaging have higher values. We also finalized
standard times for a series of clinical labor tasks associated with
pathology services in the CY 2016 PFS final rule with comment period
(80 FR 70902). We do not believe these activities would be dependent on
number of blocks or batch size, and we believe that the finalized
standard values accurately reflect the typical time it takes to perform
these clinical labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (``Review patient clinical extant information and
questionnaire'') in the preservice period, and CA014 (``Confirm order,
protocol exam'') in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the CA007
and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did
[[Page 50085]]
not contain any clinical labor for the CA007 activity. In these
situations, we continue to believe that in these cases the 3 total
minutes of clinical staff time would be more accurately described by
the CA013 ``Prepare room, equipment and supplies'' activity code, and
we finalized these clinical labor refinements. For additional details,
we direct readers to the discussion in the CY 2019 PFS final rule (83
FR 59463 and 59464).
Following the publication of the CY 2020 PFS proposed rule, a
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2021, we are continuing to display two versions of
the Labor Task Detail public use file: One version with the old listing
of clinical labor tasks, and one with the same tasks crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2021 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the equipment item, some of them
include scope accessories as part of their price, and some of them are
standalone scopes with no other equipment included. It is not always
clear which equipment items related to scopes fall into which of these
categories. We have also frequently found anomalies in the equipment
recommendations, with equipment items that consist of a scope and video
system bundle recommended, along with a separate scope video system.
Based on our review, the variations do not appear to be consistent with
the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during the review of the
recommended direct PE inputs for the CY 2017 PFS proposed rule, we
developed a structure that separates the scope, the associated video
system, and any scope accessories that might be typical as distinct
equipment items for each code. Under this approach, we proposed
standalone prices for each scope, and separate prices for the video
systems and accessories that are used with scopes.
(1) Scope Equipment
Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through
46177), we proposed standardizing refinements to the way scopes have
been defined in the direct PE input database. We believe that there are
four general types of scopes: Non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and
rigid scopes would typically be paired with one of the scope video
systems, while the non-video scopes would not. The flexible scopes can
be further divided into diagnostic (or non-channeled) and therapeutic
(or channeled) scopes. We proposed to identify for each anatomical
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
flexible scope; (4) a non-channeled flexible video scope; and (5) a
channeled flexible video scope. We proposed to classify the existing
scopes in our direct PE database under this classification system, to
improve the transparency of our review process and improve appropriate
relativity among the services. We planned to propose input prices for
these equipment items through future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017
that made use of scopes, along with updated prices for the equipment
items related to scopes utilized by these services. We did not propose
to apply these policies to codes with inputs reviewed prior to CY 2017.
We also solicited comment on this separate pricing structure for
scopes, scope video systems, and scope accessories, which we noted we
could consider proposing to apply to other codes in future rulemaking.
We did not finalize price increases for a series of other scopes and
scope accessories, as the invoices submitted for these components
indicated that they are different forms of equipment with different
product IDs and different prices. We did not receive any data to
indicate that the equipment on the newly submitted invoices was more
typical in its use than the equipment that we were currently using for
pricing.
We did not make further changes to existing scope equipment in CY
2017 to allow the RUC's PE Subcommittee the opportunity to provide
feedback. However, we believed there was some miscommunication on this
point, as the RUC's PE Subcommittee workgroup that was created to
address scope systems stated that no further action was required
following the finalization of our proposal. Therefore, we made further
proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962)
to continue clarifying scope equipment inputs, and sought comments
regarding the new set of scope proposals. We considered creating a
single scope equipment code for each of the five categories detailed in
this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
flexible scope; (4) a non-channeled flexible video scope; and (5) a
channeled flexible video scope. Under the current classification
system, there are many different scopes in each category depending on
the medical specialty furnishing the service and the part of the body
affected. We
[[Page 50086]]
stated our belief that the variation between these scopes was not
significant enough to warrant maintaining these distinctions, and we
believed that creating and pricing a single scope equipment code for
each category would help provide additional clarity. We sought public
comment on the merits of this potential scope organization, as well as
any pricing information regarding these five new scope categories.
After considering the comments on the CY 2018 PFS proposed rule, we
did not finalize our proposal to create and price a single scope
equipment code for each of the five categories previously identified.
Instead, we supported the recommendation from the commenters to create
scope equipment codes on a per-specialty basis for six categories of
scopes as applicable, including the addition of a new sixth category of
multi-channeled flexible video scopes. Our goal was to create an
administratively simple scheme that would be easier to maintain and
help to reduce administrative burden. In 2018, the RUC convened a Scope
Equipment Reorganization Workgroup to incorporate feedback from expert
stakeholders with the intention of making recommendations to us on
scope organization and scope pricing. Since the workgroup was not
convened in time to submit recommendations for the CY 2019 PFS
rulemaking cycle, we delayed proposals for any further changes to scope
equipment until CY 2020 in order to incorporate the feedback from the
aforementioned workgroup.
(2) Scope Video System
We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through
46177) to define the scope video system as including: (1) A monitor;
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a
printer. We believe that these equipment components represent the
typical case for a scope video system. Our model for this system was
the ``video system, endoscopy (processor, digital capture, monitor,
printer, cart)'' equipment item (ES031), which we proposed to re-price
as part of this separate pricing approach. We obtained current pricing
invoices for the endoscopy video system as part of our investigation of
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a
digital capture device to the endoscopy video system (ES031) in the CY
2017 PFS final rule (81 FR 80188). We finalized our proposal to price
the system at $33,391, based on component prices of $9,000 for the
processor, $18,346 for the digital capture device, $2,000 for the
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did
not finalize, a proposal to add an LED light source into the cost of
the scope video system (ES031), which would remove the need for a
separate light source in these procedures. We also described a proposal
to increase the price of the scope video system by $1,000 to cover the
expense of miscellaneous small equipment associated with the system
that falls below the threshold of individual equipment pricing as scope
accessories (such as cables, microphones, foot pedals, etc.). With the
addition of the LED light (equipment code EQ382 at a price of $1,915),
the updated total price of the scope video system would be set at
$36,306.
We did not finalize this updated pricing to the scope video system
in CY 2018, but we did propose and finalize the updated pricing for CY
2019 to $36,306 along with changing the name of the ES031 equipment
item to ``scope video system (monitor, processor, digital capture,
cart, printer, LED light)'' to reflect the fact that the use of the
ES031 scope video system is not limited to endoscopy procedures.
(3) Scope Accessories
We understand that there may be other accessories associated with
the use of scopes. We finalized a proposal in the CY 2017 PFS final
rule (81 FR 80188) to separately price any scope accessories outside
the use of the scope video system, and individually evaluate their
inclusion or exclusion as direct PE inputs for particular codes as
usual under our current policy based on whether they are typically used
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2020
The Scope Equipment Reorganization Workgroup organized by the RUC
submitted detailed recommendations to CMS for consideration in the CY
2020 rule cycle, describing 23 different types of scope equipment, the
HCPCS codes associated with each scope type, and a series of invoices
for scope pricing. Based on the recommendations from the workgroup, we
proposed to establish 23 new scope equipment codes. For the eight new
scope equipment items where we received submitted invoices for pricing,
we proposed to replace the existing scopes with the new scope equipment
at the same amount of equipment time. This scope replacement involved
approximately 100 HCPCS codes in total and was detailed in a table
published in the CY 2020 proposed rule (84 FR 40495 through 40498). We
noted that we did not receive pricing information along with the
workgroup recommendations for the other 15 new scope equipment items.
Therefore, although we proposed to establish new equipment codes for
these scopes, we did not propose to replace existing scope equipment
with the new equipment items as we did for the other eight new scope
equipment items for CY 2020.
Following the publication of the CY 2020 PFS proposed rule,
commenters provided additional information regarding pricing for the
new scope equipment and their associated HCPCS codes. Based on this
information provided by the commenters, we finalized a price for eight
additional new scope equipment items and finalized the replacement of
the existing scopes with the new scope equipment at the same amount of
equipment time for approximately two dozen additional HCPCS codes (84
FR 62593 through 62595). Table 5 lists the CY 2020 finalized price for
the new scope equipment codes:
[[Page 50087]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.005
We noted that although we updated the scope equipment pricing for
CY 2020 such that the ES087 and ES089 scopes shared the same price with
the ES088 scope, and the ES090 scope shared the same price with the
ES085 scope, we did not mean to suggest that these scopes that shared
pricing were identical with one another. We assigned the same price to
these scopes because they replaced the same current scope equipment
codes, and because we did not have individual pricing information for
them. We remain open to the submission of additional invoices to
establish individual pricing for these scopes, and we continue to
welcome more data to help identify pricing for the remaining seven
scope equipment codes that still lack invoices.
(5) Scope Proposals for CY 2021
We did not receive further recommendations from the Scope Equipment
Reorganization Workgroup organized by the RUC following the publication
of the CY 2020 final rule. However, we did receive invoices associated
with the pricing of the scope video system (monitor, processor, digital
capture, cart, printer, LED light) (ES031) equipment item as part of
the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the
Colonoscopy code families. We previously finalized a price of $36,306
for the ES031 equipment based on the sum of component prices of $9,000
for the processor, $18,346 for the digital capture device, $2,000 for
the monitor, $2,295 for the printer, $1,750 for the cart, $1,915 for
the LED light, and $1,000 to cover the expense of miscellaneous small
equipment associated with the system that falls below the threshold of
individual equipment pricing as scope accessories (such as cables,
microphones, foot pedals, etc.) We received 37 invoices associated with
the components of the ES031 scope video system, which averaged out to
prices of $21,988.89 for the processor, $16,175.87 for the digital
capture device, $6,987.56 for the monitor, $7,922.80 for the printer,
$4,945.45 for the cart, and $12,652.82 for the LED light. Based on the
sum of these component prices, we are proposing to update the price the
ES031 scope video system equipment to $70,673.38. We are not proposing
to include an additional $1,000 to cover the expense of miscellaneous
small equipment as the products listed on the component invoices
indicated that cost of cables were already included in this
significantly higher equipment pricing. We are soliciting additional
comments from stakeholders regarding the pricing of the full ES031
scope equipment system as well as its components.
As part of our market-based supply and equipment pricing
transition, we finalized a policy in CY 2019 to phase in any updated
pricing established during the 4-year transition period for very
commonly used supplies and equipment that are included in 100 or more
codes, even if invoices are provided as part of the formal review of a
code family (83 FR 59473 through 59475). Because the ES031 scope
equipment system is utilized by more than 250 HCPCS codes, we are
proposing to transition this pricing increase over the remaining two
years of the pricing update, such that the CY 2021 equipment price will
be $53,489.69 before moving to its destination price of $70,673.38 in
CY 2022. We note that this transition policy also applies to the price
of the suction machine (Gomco) (EQ235) equipment, which, although it is
not a scope, is utilized by approximately 360 HCPCS codes, and
therefore, is another example of this pricing transition policy. We are
proposing to transition the EQ235 pricing increase over the remaining 2
years of the pricing update, such that the CY 2021 equipment price will
be $1,981.66 before moving to its destination price of $ $3,195.85 in
CY 2022. As we stated previously, this
[[Page 50088]]
policy is intended to minimize any potential disruptive effects during
the pricing transition period due to the high number of services that
make use of these very common supply and equipment items included in
100 or more HCPCS codes.
We also received invoices for the colonoscopy videoscope (ES033)
and gastroscopy videoscopy (ES034) as part of the review of the
Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code
families. We finalized the replacement of both of these scope equipment
items in the CY 2020 final rule (84 FR 62588 through 62590), replacing
the colonoscopy videoscope (ES033) with the multi-channeled flexible
digital scope, colonoscopy (ES086) equipment item and the gastroscopy
videoscopy (ES034) with the multi-channeled flexible digital scope,
esophagoscopy gastroscopy duodenoscopy (EGD) (ES087) equipment item. In
both cases, the submitted invoices were nearly identical to the
finalized prices for the ES086 ($38,058.81) and ES087 ($34,585.35)
equipment. We believe that these invoices reinforce the prices
finalized through rulemaking last year, and therefore, we are not
proposing to further update the prices of these scopes.
We remain open to further comments regarding the pricing of the
remaining seven scope equipment codes that still lack invoices, as well
as additional data regarding the pricing of the scope equipment codes
that currently share the same price.
c. Technical Corrections to Direct PE Input Database and Supporting
Files
For CY 2021, we are proposing to address the following
inconsistencies:
Following the publication of the CY 2020 PFS final rule,
stakeholders contacted CMS and clarified that CPT code 0466T (Insertion
of chest wall respiratory sensor electrode or electrode array,
including connection to pulse generator) is always performed on an add-
on basis and would never be used as a standalone code. Therefore, we
are proposing to update the global period for CPT code 0466T to add-on
status (ZZZ) to more accurately reflect the way in which this service
is performed.
d. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2021,
we are proposing to update the price of one supply and four equipment
items in response to the public submission of invoices. As these
pricing updates were each part of the formal review for a code family,
we are proposing that the new pricing take effect for CY 2021 for these
items instead of being phased in over 4 years. These supply and
equipment items with updated prices associated with the formal review
of a code family are listed in the valuation of specific codes section
of the preamble under Table 27: CY 2021 Invoices Received for Existing
Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
Section 220(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted April 1, 2014) provides that the
Secretary may collect or obtain information from any eligible
professional or any other source on the resources directly or
indirectly related to furnishing services for which payment is made
under the PFS, and that such information may be used in the
determination of relative values for services under the PFS. Such
information may include the time involved in furnishing services; the
amounts, types and prices of PE inputs; overhead and accounting
information for practices of physicians and other suppliers, and any
other elements that would improve the valuation of services under the
PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, we
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE
inputs (DPEI) for supply and equipment pricing for CY 2019. These
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing
recommendations for approximately 1300 supplies and 750 equipment items
currently used as direct PE inputs. This report is available as a
public use file displayed on the CMS website under downloads for the CY
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The StrategyGen team of researchers, attorneys, physicians, and
health policy experts conducted a market research study of the supply
and equipment items currently used in the PFS direct PE input database.
Resources and methodologies included field surveys, aggregate
databases, vendor resources, market scans, market analysis, physician
substantiation, and statistical analysis to estimate and validate
current prices for medical equipment and medical supplies. StrategyGen
conducted secondary market research on each of the 2,072 DPEI medical
equipment and supply items that CMS identified from the current DPEI.
The primary and secondary resources StrategyGen used to gather price
data and other information were:
Telephone surveys with vendors for top priority items
(Vendor Survey).
Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
The General Services Administration system (GSA).
An aggregate health system buyers database with discounted
prices (Buyers).
Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
The Federal Register, current DPEI data, historical
proposed and final rules prior to CY 2018, and other resources; that
is, AMA RUC reports (References).
StrategyGen prioritized the equipment and supply research based on
current share of PE RVUs attributable by item provided by CMS.
StrategyGen developed the preliminary Recommended Price (RP)
methodology based on the following rules in hierarchical order
considering both data representativeness and reliability.
(1) If the market share, as well as the sample size, for the top
three commercial products were available, the weighted average price
(weighted by percent market share) was the reported RP. Commercial
price, as a weighted average of market share, represents a more robust
estimate for each piece of equipment and a more precise reference for
the RP.
(2) If no data were available for commercial products, the current
CMS prices were used as the RP.
GSA prices were not used to calculate the StrategyGen recommended
prices, due to our concern that the GSA system curtails the number and
type of suppliers whose products may be accessed on the GSA Advantage
website, and that the GSA prices may often be lower than prices that
are available to non-governmental purchasers. After reviewing the
StrategyGen report, we proposed to adopt the updated direct PE input
prices for supplies and equipment as recommended by StrategyGen.
StrategyGen found that despite technological advancements, the
average commercial price for medical equipment and supplies has
remained relatively consistent with the current
[[Page 50089]]
CMS price. Specifically, preliminary data indicated that there was no
statistically significant difference between the estimated commercial
prices and the current CMS prices for both equipment and supplies. This
cumulative stable pricing for medical equipment and supplies appears
similar to the pricing impacts of non-medical technology advancements
where some historically high-priced equipment (that is, desktop PCs)
has been increasingly substituted with current technology (that is,
laptops and tablets) at similar or lower price points. However, while
there were no statistically significant differences in pricing at the
aggregate level, medical specialties would experience increases or
decreases in their Medicare payments if we were to adopt the pricing
updates recommended by StrategyGen. At the service level, there may be
large shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, in the CY 2019 PFS proposed rule we proposed to phase in our use
of the new direct PE input pricing over a 4-year period using a 25/75
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021),
and 100/0 percent (CY 2022) split between new and old pricing. This
approach is consistent with how we have previously incorporated
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment
period when changing to the ``bottom-up'' PE methodology (71 FR 69641).
This transition period will not only ease the shift to the updated
supply and equipment pricing, but will also allow interested parties an
opportunity to review and respond to the new pricing information
associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased-in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the transition from the current
to the fully-implemented new pricing is provided in Table 6.
[GRAPHIC] [TIFF OMITTED] TP17AU20.006
For new supply and equipment codes for which we establish prices
during the transition years (CYs 2019, 2020 and 2021) based on the
public submission of invoices, we proposed to fully implement those
prices with no transition since there are no current prices for these
supply and equipment items. These new supply and equipment codes would
immediately be priced at their newly established values. We also
proposed that, for existing supply and equipment codes, when we
establish prices based on invoices that are submitted as part of a
revaluation or comprehensive review of a code or code family, they will
be fully implemented for the year they are adopted without being phased
in over the 4-year pricing transition. The formal review process for a
HCPCS code includes a review of pricing of the supplies and equipment
included in the code. When we find that the price on the submitted
invoice is typical for the item in question, we believe it would be
appropriate to finalize the new pricing immediately along with any
other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a
comprehensive review and valuation of a code family and for which we
establish prices based on invoices submitted by the public, we proposed
to implement the established invoice price as the updated price and to
phase in the new price over the remaining years of the proposed 4-year
pricing transition. During the proposed transition period, where price
changes for supplies and equipment are adopted without a formal review
of the HCPCS codes that include them (as is the case for the many
updated prices we proposed to phase in over the 4-year transition
period), we believe it is important to include them in the remaining
transition toward the updated price. We also proposed to phase in any
updated pricing we establish during the 4-year transition period for
very commonly used supplies and equipment that are included in 100 or
more codes, such as sterile gloves (SB024) or exam tables (EF023), even
if invoices are provided as part of the formal review of a code family.
We would implement the new prices for any such supplies and equipment
over the remaining years of the proposed 4-year transition period. Our
proposal was intended to minimize any potential disruptive effects
during the proposed transition period that could be caused by other
sudden shifts in RVUs due to the high number of services that make use
of these very common supply and equipment items (meaning that these
items are included in 100 or more codes).
We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer timeframe will allow more opportunities for public
[[Page 50090]]
comment and submission of additional, applicable data. We welcomed
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration.
We received many comments regarding the market-based supply and
equipment pricing proposal following the publication of the CY 2019 PFS
proposed rule. For a full discussion of these comments, we direct
readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In
each instance in which a commenter raised questions about the accuracy
of a supply or equipment code's recommended price, the StrategyGen
contractor conducted further research on the item and its price with
special attention to ensuring that the recommended price was based on
the correct item in question and the clarified unit of measure. Based
on the commenters' requests, the StrategyGen contractor conducted an
extensive examination of the pricing of any supply or equipment items
that any commenter identified as requiring additional review. Invoices
submitted by multiple commenters were greatly appreciated and ensured
that medical equipment and supplies were re-examined and clarified.
Multiple researchers reviewed these specified supply and equipment
codes for accuracy and proper pricing. In most cases, the contractor
also reached out to a team of nurses and their physician panel to
further validate the accuracy of the data and pricing information. In
some cases, the pricing for individual items needed further
clarification due to a lack of information or due to significant
variation in packaged items. After consideration of the comments and
this additional price research, we updated the recommended prices for
approximately 70 supply and equipment codes identified by the
commenters. Table 9 in the CY 2019 PFS final rule lists the supply and
equipment codes with price changes based on feedback from the
commenters and the resulting additional research into pricing (83 FR
59479 through 59480).
After consideration of the public comments, we finalized our
proposals associated with the market research study to update the PFS
direct PE inputs for supply and equipment pricing. We continue to
believe that implementing the proposed updated prices with a 4-year
phase-in will improve payment accuracy, while maintaining stability and
allowing stakeholders the opportunity to address potential concerns
about changes in payment for particular items. We continue to welcome
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration.
For CY 2021, we received invoice submissions for approximately a
dozen supply and equipment codes from stakeholders as part of the third
year of the market-based supply and equipment pricing update. The
submitted invoices were used in many cases to supplement the pricing
originally proposed for the CY 2019 PFS rule cycle. We reviewed the
invoices as well as prior data for the relevant supply/equipment codes
to make sure the item in the invoice was representative of the supply/
equipment item in question and aligned with past research. Based on
this research, we are proposing to update the prices of the supply and
equipment items listed in Table 7 of the CY 2021 PFS proposed rule.
We finalized a policy in CY 2019 to phase in the new supply and
equipment pricing over 4 years so that supply and equipment values
transition smoothly from their current prices to the final updated
prices in CY 2022. We finalized our proposal to implement this pricing
transition such that one quarter of the difference between the current
price and the fully phased in price was implemented for CY 2019, one
third of the difference between the CY 2019 price and the final price
is implemented for CY 2020, and one half of the difference between the
CY 2020 price and the final price is implemented for CY 2021, with the
new direct PE prices fully implemented for CY 2022. An example of the
transition from the current to the fully-implemented new pricing is
provided in Table 6. For CY 2021, one half of the difference between
the CY 2020 price and the final price will be implemented as per the
previously finalized policy. Table 7 contains the list of proposed CY
2021 market-based supply and equipment pricing updates:
[GRAPHIC] [TIFF OMITTED] TP17AU20.007
The proposed prices for the supply and equipment items listed in
Table 7 were calculated based on averaging together the prices on the
submitted invoices. In the case of the vascular sheath (SD136) and RF
endovenous occlusion catheter (SD155) supplies, the proposed price was
determined by removing the sheath or catheter from the eight submitted
kit invoices and then averaging the resulting price together with the
single standalone sheath/catheter invoice.
In addition to submitting invoices with information updating the
price of
[[Page 50091]]
the ``Vmax 22d and 62j (PFT equip, autobox, computer system)'' (EQ041)
equipment, stakeholders also clarified that the ``Vmax 229 (spirometry
testing equip, computer system)'' (EQ040) and ``Vmax 29s (spirometry
testing equip, computer system)'' (EQ043) equipment items have become
obsolete and are no longer typically used in any HCPCS codes. Based on
the information supplied by the stakeholders, we are proposing to
remove the EQ040 and EQ043 equipment items, replacing them with the
EQ041 equipment at the same number of minutes in the six HCPCS codes
where they are utilized.
We are not proposing to update the price of additional supply and
equipment items for which invoices were submitted following the
publication of the CY 2020 PFS final rule. We are not proposing to
update the price for the ``pipette, transfer 23ml'' (SL109), ``slide
specimen mailer (1-5 microscope slides)'' (SL121), ``stain,
hematoxylin'' (SL135), ``stain, eosin'' (SL201), and ``stain, PAP OG-
6'' (SL491) supplies. In each case we received a single invoice for
these five supplies detailing price increases ranging from 82 percent
to 160 percent above the current pricing. These supplies are commonly
used in cytopathology procedures and we disagree that the typical price
for these supplies has more than doubled since being reviewed by the
StrategyGen contractor two years ago for CY 2019.
We are also not proposing to update the price for the ``embedding
mold'' (SL060) supply or the ``microscope, compound'' (EP060) equipment
based on the same rationale. The submitted invoices represent pricing
increases of 339 percent for the compound microscope and 7800 percent
for the embedding mold and, based on the recent review of the pricing
of these items by our contractor, we do not believe that the submitted
invoices reflect typical market-based pricing. The same stakeholder
also submitted an invoice to update the price of the surgical mask
(SB033) supply by 617 percent over the current price. However, the
invoice in question contains the price for a surgical mask with face
shield, which is described by the SB034 supply code, not the SB033
supply code. Therefore, we are not proposing to update the price of the
surgical mask (SB033) supply based on this invoice. Finally, we
received an invoice for a ClosureFast Procedure Pack (CFP) but it was
unclear what supply or equipment item this invoice was intended to
update. As a result, we were unable to use this invoice to make a
pricing proposal.
(2) Invoice Submission
The full list of updated supply and equipment pricing as it will be
implemented over the 4-year transition period will be made available as
a public use file displayed on the CMS website under downloads for the
CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. To be included in a given
year's proposed rule, we generally need to receive invoices by the same
February 10th deadline we noted for consideration of RUC
recommendations. However, we will consider invoices submitted as public
comments during the comment period following the publication of the PFS
proposed rule, and would consider any invoices received after February
10th or outside of the public comment process as part of our
established annual process for requests to update supply and equipment
prices. Stakeholders are encouraged to submit invoices as part of their
public comments or, if outside the public comment process, via email at
[email protected].
(3) Updated Supply Pricing for Venous and Arterial Stenting Services
Following the publication of the CY 2020 PFS final rule,
stakeholders contacted CMS and presented additional information
regarding supply pricing for certain venous and arterial stenting
services. These stakeholders stated that the use of the ``stent,
vascular, deployment system, Cordis SMART'' (SA103) supply was no
longer typical in CPT codes 37238 (Transcatheter placement of an
intravascular stent(s), open or percutaneous, including radiological
supervision and interpretation and including angioplasty within the
same vessel, when performed; initial vein) and 37239 (Transcatheter
placement of an intravascular stent(s), open or percutaneous, including
radiological supervision and interpretation and including angioplasty
within the same vessel, when performed; each additional vein). The
stakeholders stated that a new venous stent system had become the
typical standard of care for these services, and they supplied ten
invoices for use in pricing this supply.
The stakeholders also requested additional information regarding
the nature of the ``stent, balloon, implantable'' (SD299) supply
included in CPT codes 37236 (Transcatheter placement of an
intravascular stent(s) (except lower extremity artery(s) for occlusive
disease, cervical carotid, extracranial vertebral or intrathoracic
carotid, intracranial, or coronary), open or percutaneous, including
radiological supervision and interpretation and including all
angioplasty within the same vessel, when performed; initial artery) and
37237 (Transcatheter placement of an intravascular stent(s) (except
lower extremity artery(s) for occlusive disease, cervical carotid,
extracranial vertebral or intrathoracic carotid, intracranial, or
coronary), open or percutaneous, including radiological supervision and
interpretation and including all angioplasty within the same vessel,
when performed; each additional artery). The stakeholders specifically
were unclear what the implantable stent balloon represented and sought
guidance on whether pricing involved a stent, a balloon, or a
combination of both.
In response to the additional information provided by the
stakeholders, we are proposing to remove the SA103 supply item from CPT
codes 37238 and 37239. We are proposing to replace it with a newly
created ``venous stent system'' (SD340) supply at the same supply
quantity. We are proposing a price of $1,750.00 for the venous stent
system based on the median price of the ten invoices supplied by the
stakeholders. We are proposing the use of the median price due to the
presence of several invoices that appear to be outliers which are not
reflective of market pricing for the venous stent system. With regards
to the request for additional information regarding the nature of the
``stent, balloon, implantable'' (SD299) supply, the original invoice
used to price this supply during the CY 2015 rule cycle listed an item
named ``Renal and Biliary Stent System 7.0 mm x 15 mm x 135 cm''. We
welcome additional information from stakeholders regarding the nature
and pricing of this supply item.
(4) Myocardial PET Equipment Inputs
Following the publication of the CY 2020 PFS final rule,
stakeholders contacted CMS and presented additional information
regarding the direct PE inputs for several codes associated with
Myocardial PET services. The stakeholders stated that the nuclide rod
source set (ER044) equipment was inadvertently excluded
[[Page 50092]]
from the direct PE recommendations for CPT codes 78432 (Myocardial
imaging, positron emission tomography (PET), combined perfusion with
metabolic evaluation study (including ventricular wall motion[s] and/or
ejection fraction[s], when performed), dual radiotracer (e.g.,
myocardial viability);), 78459 (Myocardial imaging, positron emission
tomography (PET), metabolic evaluation study (including ventricular
wall motion[s] and/or ejection fraction[s], when performed), single
study;), 78491 (Myocardial imaging, positron emission tomography (PET),
perfusion study (including ventricular wall motion[s] and/or ejection
fraction[s], when performed); single study, at rest or stress (exercise
or pharmacologic)), and 78492 (Myocardial imaging, positron emission
tomography (PET), perfusion study (including ventricular wall motion[s]
and/or ejection fraction[s], when performed); multiple studies at rest
and stress (exercise or pharmacologic)), and requested that CMS add
this equipment to the direct inputs for this group of CPT codes. The
stakeholders also stated that the current useful life of 5 years for
the ER044 equipment was incorrect as these sources are replaced every 9
months to 1 year. The stakeholders requested that CMS update the useful
life of ER044 to 0.75 years. Finally, the stakeholders stated that the
costs for the purchase of the Rubidium PET Generator (ER114) equipment
are captured elsewhere through the billing of HCPCS supply code A9555,
and the stakeholders recommended that we remove equipment item ER114 to
avoid incorrect billing duplication.
We appreciate the additional information submitted by the
stakeholders regarding the direct PE inputs for these Myocardial PET
services. In response to this new information, we are proposing to
update the price for the nuclide rod source set (ER044) equipment to
$2,081.17 based on averaging together the price of the three submitted
invoices after removing the shipping and delivery costs according to
our standard pricing methodology. We are also proposing to add the
ER044 equipment to CPT codes 78432, 78459, 78491, and 78492 as
requested, assigning the same equipment time utilized by the ``PET
Refurbished Imaging Cardiac Configuration'' (ER110) equipment in each
service. We are proposing to update the useful life of the ER044
equipment to one year in accordance with our proposed policy to treat
equipment useful life durations of less than 1 year as having a
duration of one year. As we stated previously in section II.B we have
concerns that assigning very low useful life durations of less than 1
year would fail to maintain relativity with other equipment on the PFS,
and the equipment cost per minute formula was designed under the
assumption that each equipment item would remain in use for a period of
several years and depreciate over that span of time. We direct readers
to the previous discussion regarding equipment cost per minute
methodology earlier in section II.B. of this proposed rule. Finally, we
are removing the ``PET Generator (Rubidium)'' (ER114) equipment from
our database as requested by the stakeholders. We note that since the
technical components for CPT codes 78432, 78459, 78491, and 78492 are
all contractor-priced, there will be no change to the national pricing
of these codes.
(5) Adjustment to Allocation of Indirect PE for Some Office-Based
Services
In the CY 2018 PFS final rule (82 FR 52999 through 53000), we
established criteria for identifying the services most affected by the
indirect PE allocation anomaly that does not allow for a site of
service differential that accurately reflects the relative indirect
costs involved in furnishing services in nonfacility settings. We also
finalized a modification in the PE methodology for allocating indirect
PE RVUs to better reflect the relative indirect PE resources involved
in furnishing these services. The methodology, as described, is based
on the difference between the ratio of indirect PE to work RVUs for
each of the codes meeting eligibility criteria and the ratio of
indirect PE to work RVU for the most commonly reported visit code. We
refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000)
for a discussion of our process for selecting services subject to the
revised methodology, as well as a description of the methodology, which
we began implementing for CY 2018 as the first year of a 4-year
transition.
For CY 2021, we are proposing to continue with the fourth and final
year of the transition of this adjustment to the standard process for
allocating indirect PE.
e. Update on Technical Expert Panel Related to Practice Expense
The RAND Corporation is currently studying potential improvements
to CMS' PE allocation methodology and the data that underlie it. As we
noted earlier in this section, our current system for setting PE RVUs
relies in part on data collected in the Physician Practice Information
Survey (PPIS), which was administered by the AMA in CY 2007 and 2008.
RAND, in its first phase of research, available at https://www.rand.org/pubs/research_reports/RR2166.html, found that the PPIS
data are outdated and may no longer reflect the resource allocation,
staffing arrangements, and cost structures that describe practitioners'
resource requirements in furnishing services to Medicare beneficiaries,
and consequently may not accurately capture the indirect PE resources
required to furnish services to Medicare FFS beneficiaries. For
example, the PPIS preceded the widespread adoption of electronic health
records, quality reporting programs, billing codes that promote team-
based care, and hospital acquisition of physician practices. Notably,
RAND found that practice ownership was strongly associated with
indirect PE, with physician-owned practices requiring 190% higher
indirect PE compared to facility-owned practices, suggesting a need to
potentially update demographic information. Additionally, RAND found
that aggregating Medicare provider specialties into broader categories
resulted in small specialty-level impacts relative to the current
system, suggesting that specialty-specific inputs may not be required
to accurately reflect resource costs.
To follow up on these and other issues raised in the first phase of
RAND's research, in the CY 2020 PFS, we announced that RAND was
convening a technical expert panel (TEP) to obtain input from
stakeholders including physicians, practice and health system managers,
health care accountants, and health policy experts. The TEP occurred on
January 10, 2020 and its report is available at https://www.rand.org/pubs/working_papers/WR1334.html. Topics discussed included identifying
issues with the current system; changes in medicine that have affected
PE; how PE inputs could be updated, including through a potential new
survey instrument; how best to aggregate PE categories if there were to
be new survey instrument; ways to maximize response rates in a
potential new survey; and using existing data to inform PFS PE rates.
In addition, RAND has issued the results of its subsequent phase of
research, available at www.rand.org/t/RR3248. This report is also
available as a public use file displayed on the CMS website under
downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
[[Page 50093]]
Based on the results of the TEP and RAND's other ongoing research,
we are interested in potentially refining the PE methodology and
updating the data used to make payments under the PFS. We believe that
potential refinements could improve payment accuracy and strengthen
Medicare. Our goals are to balance obtaining the data as soon as
practicable and in a way that would allow stakeholders and CMS to
collectively examine many of the issues the TEP and RAND's research
identified. We are thinking through several questions, including how to
best incorporate market-based information, which could be similar to
the market research that we recently conducted to update supply and
equipment pricing used to determine direct PE inputs under the PFS
payment methodology. For example, stakeholders have expressed an
interest in updating the clinical labor data that we use for direct PE
inputs based on current salaries and compensation for the health care
workforce. We are soliciting comment regarding how we might update the
clinical labor data. Historically, we have used data from the Bureau of
Labor Statistics and are seeking comment to determine if this is the
best data source or if there is an alternative. We are also interested
in hosting a Town Hall meeting at a date to be determined to provide an
open forum for discussion with stakeholders on our ongoing research to
potentially update the PE methodology and the underlying inputs.
Finally, we welcome feedback from all interested parties regarding
RAND's report and we are not making any proposals based on this report
at this time. Stakeholders are encouraged to submit feedback as part of
their public comments or, if outside the public comment process, via
email at [email protected].
C. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) of the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.H. of this proposed rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association Resource-Based Relative Value Scale (RVS) Update
Committee (RUC), Medicare Payment Advisory Commission (MedPAC), and
other stakeholders. For many years, the RUC has provided us with
recommendations on the appropriate relative values for new, revised,
and potentially misvalued PFS services. We review these recommendations
on a code-by-code basis and consider these recommendations in
conjunction with analyses of other data, such as claims data, to inform
the decision-making process as authorized by law. We may also consider
analyses of work time, work RVUs, or direct PE inputs using other data
sources, such as Department of Veteran Affairs (VA), National Surgical
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons
(STS), and the Merit-based Incentive Payment System (MIPS) data. In
addition to considering the most recently available data, we assess the
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also consider information provided by
other stakeholders. We conduct a review to assess the appropriate RVUs
in the context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE costs decline.
This can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE costs rises.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is
[[Page 50094]]
furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well. Individuals and stakeholder groups may submit codes for review
under the potentially misvalued codes initiative to CMS in one of two
ways. Nominations may be submitted to CMS via email or through postal
mail. Email submissions should be sent to the CMS emailbox
[email protected], with the phrase ``Potentially
Misvalued Codes'' and the referencing CPT code number(s) and/or the CPT
descriptor(s) in the subject line. Physical letters for nominations
should be sent via the U.S. Postal Service to the Centers for Medicare
& Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd.,
Baltimore, Maryland 21244. Envelopes containing the nomination letters
must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes''. Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed over 1,700
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior reviews of potentially misvalued codes is included
in the Medicare Program; Payment Policies Under the Physician Fee
Schedule, Five-Year Review of Work Relative Value Units, Clinical
Laboratory Fee Schedule: Signature on Requisition, and Other Revisions
to Part B for CY 2012; final rule (76 FR 73052 through 73055)
(hereinafter referred to as the ``CY 2012 PFS final rule with comment
period''). In the CY 2012 PFS final rule with comment period (76 FR
73055 through 73958), we finalized our policy to consolidate the review
of physician work and PE at the same time, and established a process
for the annual public nomination of potentially misvalued services.
In the Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the
Requirement for Termination of Non-Random Prepayment Complex Medical
Review and Other Revisions to Part B for CY 2013 (77 FR 68892)
(hereinafter referred to as the ``CY 2013 PFS final rule with comment
period''), we built upon the work we began in CY 2009 to review
potentially misvalued codes that have not been reviewed since the
implementation of the PFS (so-called ``Harvard-valued codes''). In the
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2009; and Revisions to
the Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter
referred to as the ``CY 2009 PFS proposed rule''), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services.
In the CY 2013 PFS final rule with comment period, we identified
specific Harvard-valued services with annual allowed charges that total
at least $10,000,000 as potentially misvalued. In addition to the
Harvard-valued codes, in the CY 2013 PFS final rule with comment period
we finalized for review a list of potentially misvalued codes that have
stand-alone PE (codes with physician work and no listed work time and
codes with no physician work that have listed work time). We have
continued each year to consider and finalize a list of potentially
misvalued codes that have or will be reviewed and revised as
appropriate in future rulemaking.
3. CY 2021 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
through 67608), we modified this process whereby the public and
stakeholders may nominate potentially misvalued codes for review by
submitting the code with supporting documentation by February 10th of
each year. Supporting documentation for codes nominated for the annual
review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
[[Page 50095]]
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In that year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
We received submissions nominating codes for review under the
potentially misvalued code initiative, and several requests for review
of practice expense related inputs prior to our February 10, 2020
deadline. We refer readers to section II.B. of this proposed rule,
Determination of Practice Expense RVUs, for further discussion on the
PE-related submissions. Our summary of the submissions reviewed under
the potentially misvalued code initiative is discussed below.
We received multiple submissions requesting that CMS consider CPT
code 22867 (Insertion of interlaminar/interspinous process
stabilization/distraction device, without fusion, including image
guidance when performed, with open decompression, lumbar; single level)
for nomination as potentially misvalued. In their request, the
submitters suggested that the physician work assigned to this code
significantly undervalues the procedure relative to the value of CPT
code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s], [eg, spinal or lateral recess stenosis]), single vertebral
segment; lumbar). The submitters stated that the work performed during
the surgical steps to perform a laminectomy for both procedures is
generally similar except for the additional intensity and complexity
involved in CPT code 22867 to implant the interspinous stabilization
device. The submitters also requested that the malpractice RVUs
assigned to this code be increased to better align with similar spine
procedures, in terms of specialty level and service level risk factors,
in addition to the intensity and complexity of the procedure. After
considering the information provided by the submitter, which suggests
that the current valuation for the service may not reflect the level of
intensity inherent in furnishing the service relative to other similar
services with inputs that exceed those for the nominated service we are
proposing to nominate CPT code 22867 as potentially misvalued and
welcome public comment on this code.
D. Telehealth and Other Services Involving Communications Technology
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in this proposed rule and in prior rulemaking, several
conditions must be met for Medicare to make payment for telehealth
services under the PFS. For further details, see the full discussion of
the scope of Medicare telehealth services in the CY 2018 PFS final rule
(82 FR 53006) and in 42 CFR 410.78 and 414.65.
a. Adding Services to the Medicare Telehealth Services List
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a process for adding services to or deleting services from
the Medicare telehealth services list in accordance with section
1834(m)(4)(F)(ii) of the Act. This process provides the public with an
ongoing opportunity to submit requests for adding services, which are
then reviewed by us. Under this process, we assign any submitted
request to add to the Medicare telehealth services list to one of the
following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on Medicare telehealth services list. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current Medicare telehealth services list. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
The Medicare telehealth services list, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
For CY 2021, requests to add services to the Medicare telehealth
services list must have been submitted and received by February 10,
2020. Each request to add a service to the Medicare telehealth services
list must include any supporting documentation the requester wishes us
to consider as we review the request. Because we use the annual PFS
rulemaking process as the vehicle to
[[Page 50096]]
make changes to the Medicare telehealth services list, requesters
should be advised that any information submitted as part of a request
is subject to public disclosure for this purpose. For more information
on submitting a request to add services to the Medicare telehealth
services list, including where to mail these requests, see our website
at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2021
Under our current policy, we add services to the Medicare
telehealth services list on a Category 1 basis when we determine that
they are similar to services on the existing Medicare telehealth
services list for the roles of, and interactions among, the
beneficiary, physician (or other practitioner) at the distant site and,
if necessary, the telepresenter. As we stated in the CY 2012 PFS final
rule with comment period (76 FR 73098), we believe that the Category 1
criteria not only streamline our review process for publicly requested
services that fall into this category, but also expedite our ability to
identify codes for the Medicare telehealth services list that resemble
those services already on the Medicare telehealth services list. We
received several requests to add various services as Medicare
telehealth services effective for CY 2021. We also conducted an
internal review of potential services to add to the Medicare telehealth
services list.
In response to the PHE for the COVID-19 pandemic, CMS undertook
emergency rulemaking to add a number of services to the Medicare
telehealth services list on an interim final basis. In the ``Medicare
and Medicaid Programs; Policy and Regulatory Revisions in Response to
the COVID-19 Public Health Emergency'' interim final rule with comment
period (IFC), (85 FR 19230, 19234 through 19241, March 31, 2020)
(hereinafter referred to as the ``March 31st COVID-19 IFC''), on an
interim final basis for the duration of the PHE for the COVID-19
pandemic, we also finalized the addition of a number of services to the
Medicare telehealth services list on a Category 2 basis. The following
is a list of those services:
Emergency Department (ED) Visits, Levels 1-5 (CPT codes
99281-99285).
Initial and Subsequent Observation and Observation
Discharge Day Management (CPT codes 99217-99220; CPT codes 99224-99226;
CPT codes 99234-99236).
Initial hospital care and hospital discharge day
management (CPT codes 99221-99223; CPT codes 99238-99239).
Initial nursing facility visits, All levels (Low,
Moderate, and High Complexity) and nursing facility discharge day
management (CPT codes 99304-99306; CPT codes 99315-99316).
Critical Care Services (CPT codes 99291-99292).
Domiciliary, Rest Home, or Custodial Care services, New
and Established patients (CPT codes 99327-99328; CPT codes 99334-
99337).
Home Visits, New and Established Patient, All levels (CPT
codes 99341-99345; CPT codes 99347-99350).
Inpatient Neonatal and Pediatric Critical Care, Initial
and Subsequent (CPT codes 99468-99473; CPT codes 99475-99476).
Initial and Continuing Intensive Care Services (CPT code
99477-994780).
Assessment and Care Planning for Patients with Cognitive
Impairment (CPT code 99483).
Group Psychotherapy (CPT code 90853).
End-Stage Renal Disease (ESRD) Services (CPT codes 90952,
90953, 90959, and 90962).
Psychological and Neuropsychological Testing (CPT codes
96130-96133; CPT codes 96136-96139).
Therapy Services, Physical and Occupational Therapy, All
levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535,
97750, 97755, 97760, 97761, 92521-92524, 92507).
Radiation Treatment Management Services (CPT codes 77427).
When we previously considered adding these services to the Medicare
telehealth services list, either through a public request or through
our own internal review, we considered whether these services met the
Category 1 or Category 2 criteria. In many cases, we reviewed requests
to add these services on a Category 1 basis, but did not receive or
identify information that allowed us to review the services on a
Category 2 basis. While we stated in the March 31st COVID-19 IFC that
we did not believe the context of the PHE for the COVID-19 pandemic
changes the assessment of these services as Category 1, we did reassess
all of these services on a Category 2 basis in the context of the
widespread presence of COVID-19 in the community. Given the exposure
risks for beneficiaries, the health care work force, and the community
at large, we stated that in-person interaction between professionals
and patients poses an immediate potential risk that would not have been
present when we previously reviewed these services. We were concerned
that this new risk created a unique circumstance where health care
professionals might have to choose between the best means to mitigate
exposure risk for themselves and for their patients or seeking Medicare
payment for the service. For example, certain persons, especially older
adults who are particularly vulnerable to complications from this
specific viral infection; those considered at risk because of
underlying health conditions; and those known to be recently exposed or
diagnosed, and therefore, likely to spread the virus to others, were
often being directed by local public health officials to self-isolate
as much as possible. At the same time, we noted that the risk to
medical professionals treating patients is high and we considered it
likely that medical professionals would try to treat patients as
effectively as possible without exposing themselves or their patients
unnecessarily. We explained that, in some cases, the use of
telecommunication technology could mitigate the exposure risk; and in
such cases, there is a clear clinical benefit of using such technology
in furnishing the service. In other words, patients who should not be
seen by a professional in-person due to the exposure risk were highly
likely to be without access to clinically appropriate treatment or
diagnostic options unless they have access to services furnished
through interactive communication technology. Therefore, in the context
of the PHE for the COVID-19 pandemic, we believed that all of the
services we added met the Category 2 criteria to be added to the
Medicare telehealth services list on the basis that there was a patient
population that would otherwise not have access to clinically
appropriate treatment. We noted that, as with other services on the
Medicare telehealth services list, it may not be clinically appropriate
or possible to use telecommunications technology to furnish these
particular services to every person or in every circumstance. However,
in the context of the PHE for the COVID-19 pandemic with specific
regard to the exposure risks noted above, we recognized the clinical
benefit of access to medically reasonable and necessary services
furnished using telecommunications technology as opposed to the
potential lack of access that could occur to mitigate the risk of
disease exposure.
In addition to considering public requests and services identified
through internal review for additions to the Medicare telehealth
services list, we have also considered which of the services added to
the Medicare
[[Page 50097]]
telehealth services list on an interim basis should remain on the
Medicare telehealth services list permanently or on an interim basis
after the end of the PHE. The following presents a discussion of these
services and related proposals.
After reviewing the requests we received, the services we
identified, and the services we added to the Medicare telehealth
services list on an interim basis for the duration of the PHE, we
identified the services we have listed in Table 8 as being sufficiently
similar to services currently on the Medicare telehealth services list
to be added on a Category 1 basis. Therefore, we are proposing to add
the services in Table 8 to the Medicare telehealth services list on a
Category 1 basis for CY 2021.
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[[Page 50098]]
We believe the services described by the HCPCS codes in Table 8 are
similar to services currently on the Medicare telehealth services list.
The add-on codes to the office/outpatient E/M services are, by
definition, part of the office/outpatient E/M services since they
cannot be billed with any other codes. The Assessment of and Care
Planning for Patients with Cognitive Impairment was defined as a
service meant to be billed in specific clinical scenarios in lieu of a
level 5 office/outpatient E/M visit. As such, these services fall
within the Category 1 criteria because they are similar to the office
visits that are already on the Medicare telehealth services list. As it
describes group therapy, CPT code 90853 is similar to the other group
therapy services currently on the Medicare telehealth services list.
While the patient's home cannot serve as an originating site (where
the patient is located) for purposes of most Medicare telehealth
services, the SUPPORT for Patients and Communities Act amended section
1834(m)(4)(C) of the Act and added a new paragraph at section
1834(m)(7) of the Act to remove geographic limitations and authorize
the patient's home to serve as a telehealth originating site for
purposes of treatment of a substance use disorder or a co-occurring
mental health disorder, furnished on or after July 1, 2019, to an
individual with a substance use disorder diagnosis. These domiciliary/
home visits contain the same elements and similar descriptors to the
office/outpatient E/M visits, and therefore, we believe there is
sufficient justification to add them to the Medicare telehealth
services list on a Category 1 basis. Additionally, we believe that, due
to the vulnerability of this particular patient population, who are
receiving treatment for a diagnosed substance use disorder or co-
occurring mental health disorder, we should maximize the availability
of telehealth services for the treatment of substance use disorders and
co-occurring mental health disorders. We note that, because the home is
not generally a permissible telehealth originating site, these services
could be billed when furnished as telehealth services only for
treatment of a substance use disorder or co-occurring mental health
disorder.
Finally, we received a request to add CPT code 96121
(Neurobehavioral status exam (clinical assessment of thinking,
reasoning and judgment, [e.g., acquired knowledge, attention, language,
memory, planning and problem solving, and visual spatial abilities]),
by physician or other qualified health care professional, both face-to-
face time with the patient and time interpreting test results and
preparing the report; each additional hour (List separately in addition
to code for primary procedure)) on the basis that this is an add-on
code to CPT code 96116 (Neurobehavioral status exam (clinical
assessment of thinking, reasoning and judgment, [e.g., acquired
knowledge, attention, language, memory, planning and problem solving,
and visual spatial abilities]), by physician or other qualified health
care professional, both face-to-face time with the patient and time
interpreting test results and preparing the report; first hour) which
is currently on the Medicare telehealth services list. In the past we
have added services to the Medicare telehealth services list that are
add-on codes that describe a continuation or additional elements of
services currently on the Medicare telehealth services list since the
services would only be considered telehealth services when billed as an
add-on to codes already on the Medicare telehealth services list (82 FR
53008). Therefore, we are proposing to add CPT code 96121 to the
Medicare telehealth services list.
We also received a request to add services to the Medicare
telehealth services list that do not meet our criteria for addition to
the Medicare telehealth services list, as explained below. We are not
proposing to add the services listed in Table 9 to the Medicare
telehealth services list.
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We received a request to add Medical Genetics services to the
Medicare telehealth services list. We note that CPT code 96040 is
considered bundled into office/outpatient E/M visits, which are already
on the Medicare telehealth services list. Therefore, we do not believe
it is necessary to add CPT code 96040. As we stated in the CY 2012 PFS
final rule with comment period (76 FR 73096 through 73097), physicians
and nonphysician practitioners who may independently bill Medicare for
their services and who are counseling individuals would generally
report office or other outpatient evaluation and management (E/M) CPT
codes for office visits that involve significant counseling, including
genetic counseling, and these office visit CPT codes are already on the
Medicare telehealth services list. CPT code 96040 would only be
reported by genetic counselors for genetic counseling services. Genetic
counselors are not among the practitioners who can bill Medicare
directly for their professional services, and they are also not
practitioners who can furnish telehealth services as specified in
section 1834(m)(4)(E) of the Act. As such, we do not believe that it
would be necessary or appropriate to add CPT code 96040 to the Medicare
telehealth services list.
HCPCS code S0265 is a Medication, Supplies, and Services code; and
there is no separate payment under the PFS for this category of codes.
Therefore, we are not proposing to add this service to the Medicare
telehealth services list.
c. Proposed Temporary Addition of a Category 3 Basis for Adding to or
Deleting Services From the Medicare Telehealth Services List
Recently enacted legislation to address the COVID-19 pandemic
provided the Secretary with new authorities under section 1135(b)(8) of
the Act, as added by section 102 of the Coronavirus Preparedness and
Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March
6, 2020) and subsequently amended by section 6010 of the Families First
Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section
3703 of the
[[Page 50099]]
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L.
116-136, March 27, 2020)), to waive or modify Medicare telehealth
payment requirements during the PHE for the COVID-19 pandemic. Due to
the circumstances of the COVID-19 pandemic, particularly the need to
maintain physical distance to avoid exposure to the virus, we
anticipate that health care practitioners are developing new approaches
to providing care using various forms of technology when they are not
physically present with the patient. We have established several
flexibilities to accommodate these changes in the delivery of care.
Through waiver authority under section 1135(b)(8) of the Act, in
response to the PHE for the COVID-19 pandemic, we have removed the
geographic and site of service originating site restrictions in section
1834(m)(4)(C) of the Act, as well as the restrictions in section
1834(m)(4)(E) of the Act on the types of practitioners who may furnish
telehealth services, for the duration of the PHE for the COVID-19
pandemic. We also used waiver authority to allow certain telehealth
services to be furnished via audio-only communication technology. In
the March 31st COVID-19 IFC, we added to the Medicare telehealth
services list on an interim basis the services identified at the
beginning of this section. Through the May 1st COVID-19 IFC, on an
interim basis, we removed the requirement that we undertake rulemaking
to add or delete services on the Medicare telehealth services list so
that we could consider the addition of services on a subregulatory
basis as they were recommended by the public or identified internally.
On a subregulatory basis, we simultaneously added several more
additional services to the Medicare telehealth services list when we
issued the May 1st COVID-19 IFC. At the conclusion of the PHE, these
waivers and interim policies will expire, payment for Medicare
telehealth services will once again be limited by the requirements of
section 1834(m) of the Act, and we will return to the policies
established through the regular notice and comment rulemaking process,
including the previously established Medicare telehealth services list.
We believe that the experiences of clinicians who are furnishing
telehealth services during the PHE will be useful to inform decisions
about which of the services we added temporarily to the Medicare
telehealth services list might be appropriate to add on a permanent
basis. However, we also recognize that the annual PFS rulemaking
schedule may not align perfectly with the expiration of the PHE, and
that the clinicians providing services via telehealth during the PHE
may not have the opportunity to conduct the kinds of review or develop
the kind of evidence we usually consider when adding services to the
Medicare telehealth services list on a permanent basis. In the event
that the PHE ends prior to the end of calendar year 2021, stakeholders
might not have the opportunity to use our current consideration process
for telehealth services to request permanent additions to the Medicare
telehealth services list prior to those services being removed from the
Medicare telehealth services list. This is especially true for those
services that might need to be considered on a Category 2 basis, which
involves providing supporting documentation to illustrate the clinical
benefit of such services. Recognizing the extent to which practice
patterns are shifting as a result of the PHE from a model of care based
on in-person services to one that relies on a combination of in-person
services and virtual care, we believe that it would be disruptive to
both clinical practice and beneficiary access to abruptly eliminate
Medicare payment for these services when furnished via telehealth as
soon as the PHE ends without first providing an opportunity to use
information developed during the PHE to support requests for permanent
changes to the Medicare telehealth services list.
As previously noted, in response to the PHE for the COVID-19
pandemic, we have added a broad range of services to the Medicare
telehealth services list. Before eliminating the full range of these
services from the Medicare telehealth services list and potentially
jeopardizing beneficiary access to those services that have been
clinically beneficial, based primarily on the timing of annual
rulemaking, we believe it would be prudent to collect information from
the public regarding which, where and how various telehealth services
have been in use in various communities during the COVID-19 response.
Feedback from patients and clinicians is essential to help CMS
understand how the use of telehealth services may have contributed
positively to, or negatively affected, the quality of care provided to
beneficiaries during the PHE for the COVID-19 pandemic so that we can
understand which services should be retained on the Medicare telehealth
services list until we can give them full consideration under our
established rulemaking process.
Therefore, we are proposing to create a third category of criteria
for adding services to the Medicare telehealth services list on a
temporary basis. This new category would describe services that would
be included on the Medicare telehealth services list on a temporary
basis. We would include in this category the services that were added
during the PHE for which there is likely to be clinical benefit when
furnished via telehealth, but for which there is not yet sufficient
evidence available to consider the services as permanent additions
under Category 1 or Category 2 criteria. Recognizing that the services
we would add on a temporary basis under Category 3 would ultimately
need to meet the criteria under categories 1 or 2 in order to be
permanently added to the Medicare telehealth services list, and the
potential for evidence development that could continue through the
Category 3 temporary addition period, we considered each of the
services we added on an interim final basis during the PHE. In
developing the proposal to add specific services on a Category 3 basis,
we conducted a clinical assessment to identify those services for which
we could foresee a reasonable potential likelihood of clinical benefit
when furnished via telehealth outside the circumstances of the PHE and
that we anticipate would be able to demonstrate that clinical benefit
in such a way as to meet our Category 2 criteria in full. Any service
added under the proposed Category 3 would remain on the Medicare
telehealth services list through the calendar year in which the PHE
ends. When assessing whether there was a potential likelihood of
clinical benefit for a service such that it should be added to the
Medicare telehealth services list on a Category 3 basis, we considered
the following factors:
Whether, outside of the circumstances of the PHE, there
are increased concerns for patient safety if the service is furnished
as a telehealth service.
Whether, outside of the circumstances of the PHE, there
are concerns about whether the provision of the service via telehealth
is likely to jeopardize quality of care.
Whether all elements of the service could fully and
effectively be performed by a remotely located clinician using two-way,
audio/video telecommunications technology.
We recognize that the circumstances of the PHE have provided
clinicians with the opportunity to use telecommunications technology in
health care delivery in a scope and manner far surpassing the
telehealth services described under section 1834(m) of the Act,
particularly as a
[[Page 50100]]
result of the removal of geographic and site of service restrictions,
and the addition of many services to the Medicare telehealth services
list. When adding services to the Medicare telehealth services list on
an interim basis during the PHE, we reassessed services on a Category 2
basis in the context of the widespread presence of COVID-19 in the
community. We recognized that healthcare access issues could arise due
to the immediate potential exposure risks to patients and healthcare
workers, and that the use of telecommunication technology could
mitigate risk and facilitate clinically appropriate treatment. In the
context of the PHE for the COVID-19 pandemic, we found that the added
services met the Category 2 criteria on the basis that there is a
patient population that would otherwise not have access to clinically
appropriate care (85 FR 19234). While the interim addition of a broad
swath of services to the Medicare telehealth services list is
responsive to critical needs during the COVID-19 PHE, the impact of
adding these services to the Medicare telehealth services list on a
permanent basis is currently unknown. Specifically, although it is
possible to assess the uptake among health care practitioners of the
added telehealth services, the extent to which service delivery via
telehealth demonstrates clinical benefit outside the conditions of the
PHE is not known at this time. Adding services to the Medicare
telehealth services list on a Category 3 basis will give the public the
opportunity to gather data and generate requests to add certain
services to the Medicare telehealth services list permanently, which
would be adjudicated on a Category 1 or Category 2 basis during future
PFS annual rulemaking, while maintaining access to telehealth services
with potential likelihood of clinical benefit. We are also proposing
that the Category 3 criteria and basis for considering additions to the
Medicare telehealth services list would be temporary, to expire at the
end of the calendar year in which the PHE expires.
We have identified a number of services that we believe, based on
our clinical assessment, fit the Category 3 criteria enumerated above
in that we did not identify significant concerns over patient safety,
quality of care, or the ability of clinicians to provide all elements
of the service remotely if these services were to remain on the
Medicare telehealth services list for an additional period beyond the
PHE. Therefore we are proposing to continue including these services on
the Medicare telehealth services list through the calendar year in
which the PHE ends. These services are listed in Table 10. We invite
public comment on the services we identified for temporary addition to
the Medicare telehealth services list through the Category 3 criteria--
including whether some should not be considered as Category 3 temporary
additions to the Medicare telehealth services list, or whether services
currently not proposed as Category 3 additions to the Medicare
telehealth services list should be considered as such. While our
clinical assessment indicated that the services in Table 10 demonstrate
potential likelihood of clinical benefit when furnished as telehealth
services and, as such, the potential to meet the Category 1 or Category
2 criteria for permanent addition to the Medicare telehealth services
list with the development of additional evidence, we are seeking
information from the public that would supplement our clinical
assessment and assist us in consideration of our proposals regarding
the Category 3 addition of services, even though we recognize that
formal analyses may not yet be available. The following are examples of
the kinds of information we are seeking from the public to help inform
our decisions about proposed additions under Category 3:
By whom and for whom are the services being delivered via
telehealth during the PHE;
What practical safeguards are being employed to maintain
safety and clinical effectiveness of services delivered via telehealth;
and how are practices quickly and efficiently transitioning patients
from telehealth to in-person care as needed;
What specific health outcomes data are being or are
capable of being gathered to demonstrate clinical benefit;
How is technology being used to facilitate the acquisition
of clinical information that would otherwise be obtained by a hands-on
physical examination if the service was furnished in person. Certain
services on the Medicare telehealth services list prior to the PHE,
specifically the office/outpatient E/M code set, involve a physical
exam. With the telehealth expansions during the PHE, clinicians may
have had valuable experience providing other telehealth services to
patients in higher acuity settings of care, such as an emergency
department, that involve a hands-on physical examination when furnished
in person.
Whether patient outcomes are improved by the addition of
one or more services to the Medicare telehealth services list,
including whether inclusion on the Medicare telehealth services list
increases access, safety, patient satisfaction, and overall quality of
care;
Whether furnishing this service or services via
telecommunication technology promotes prudent use of resources;
Whether the permanent addition of specific, individual
services or categories of services to the Medicare telehealth services
list supports quick responses to the spread of infectious disease or
other emergent circumstances that may require widespread use of
telehealth; and
What is the impact on the health care workforce of the
inclusion of one or more services or categories of services on the
Medicare telehealth services list (for example, whether the health care
workforce and its capabilities to provide care are expanded).
In addition, we note that CMS is committed to the following broad
goals, and these weigh heavily in our decision-making around the
addition, whether temporary or permanent, of a service or services to
the Medicare telehealth services list. We request that commenters
consider these goals in conjunction with their comments on our
proposals for the treatment of the telehealth services we added on an
interim basis during the PHE for the COVID-19 pandemic:
Maintaining the capacity to enable rapid assessment of
patterns of care, safety, and outcomes in the Medicare, Medicaid, CHIP
and Marketplace populations;
Establishing system safeguards to detect and avert
unintended patient harms that result from policy adjustments;
Ensuring high quality care is maintained;
Demonstrating ongoing quality improvement efforts by
Medicare participating providers, while maintaining access to necessary
care;
Establishing protections for vulnerable beneficiary
populations (those with multiple chronic conditions, functional
limitations, heart failure, COPD, diabetes, dementia), and sites of
heightened vulnerability (such as nursing homes, rural communities)
with high risk of adverse outcomes;
Ensuring appropriate resource utilization and supporting
cost efficiency;
Supporting emergency preparedness and maintaining capacity
to surge for potential coronavirus resurgence or other healthcare
issues; and
Considering timing and pace of policy corrections in light
of local and
[[Page 50101]]
regional variations in systems of care and the impact of the COVID-19
pandemic.
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d. Comment Solicitation on Medicare Telehealth Services Added on an
Interim Basis During the PHE for the COVID-19 Pandemic That CMS Is Not
Proposing To Retain After the PHE Ends
In the March 31st COVID-19 IFC and the May 1st COVID-19 IFC, we
finalized on an interim basis during the PHE for the COVID-19 pandemic
the addition of a number of services to the Medicare telehealth
services list. While a number of these services were previously
requested and reviewed for addition by external stakeholders as part of
our standard process for updating the Medicare telehealth services
list, a few were identified through internal review. As discussed
above, we conducted a clinical assessment of each of the services added
to the Medicare telehealth services list to identify those for which we
could foresee a reasonable potential likelihood of clinical benefit
when furnished via telehealth outside the circumstances of the PHE. In
our clinical review of these services, we did not identify sufficient
information to suggest there is a potential likelihood of clinical
benefit for these services such that they could meet the Category 1 or
Category 2 criteria outside the circumstances of the PHE. We
specifically considered the potential for these services to be
furnished, outside the circumstances of the PHE, without increased
concerns for patient safety or jeopardizing quality of care; and
furnished fully and effectively, including all elements of the service,
by a remotely located clinician via two-way, audio/video
telecommunications technology. Due to these concerns, we did not find a
potential likelihood that the services could meet Category 2 criteria
even with development of additional evidence. However, we are inviting
public comment on whether any service added to the Medicare telehealth
services list for the duration of the PHE for the COVID-19 pandemic
should be added to the Medicare telehealth services list on a
temporary, Category 3 basis, based on the criteria outlined above. We
welcome additional information from commenters about these services, as
outlined in our request for comment for services we are proposing to
add to the Medicare telehealth services list on a Category 3 basis.
We are also seeking specific comment on the following
considerations associated with particular services. Comments on these
specific concerns will also inform our final decisions on whether these
services should be added to the Medicare telehealth services list on a
temporary, Category 3 basis:
Initial and final/discharge interactions (CPT codes 99234-
99236 and 99238-99239): We believe that the potential acuity of the
patient described by these codes would require an in-person physical
exam in order to fulfill the requirements of the service. We have
concerns that without an in-person physical examination the need for
the physician or health care provider to fully understand the health
status of the person with whom they are establishing a clinical and
therapeutic relationship would be compromised. We believe that the need
for an in-person interaction would rise beyond any specific diagnosis,
and serves as the foundation upon which any and all clinical decisions
are based for these services. We are concerned that, without an in-
person interaction, care planning that includes risk-benefit
considerations and clinical decision-making will be less well-informed
and create risk of patient harm.
Higher level emergency department visits (CPT codes 99284-
99285): We are concerned that the full scope of service elements of
these codes cannot be met via two-way, audio/video telecommunications
technology as higher levels are indicated by patient characteristics,
clinical complexity, urgency for care, and require complex decision-
making. We also believe, due to the acuity of the patient described by
these codes, that an in-person physical examination is necessary to
fulfill the service requirements.
Hospital, Intensive Care Unit, Emergency care, Observation
stays (CPT
[[Page 50103]]
codes CPT 99217-99220; 99221-99226; 99484-99485, 99468-99472, 99475-
99476, and 99477-99480): These codes describe visits that are furnished
to patients who are ill enough to require hospital evaluation and care.
We believe that the codes describe an evaluation for these potentially
high acuity patients that is comprehensive and includes an in-person
physical examination. Our view that in-person care is necessary to
fulfill the requirements of the code is driven by the need for the
physician or health provider to fully understand the health status of
the person with whom they are establishing a clinical and therapeutic
relationship. We believe that the need for an in-person interaction
would rise above any specific diagnosis, and serves as the foundation
upon which any and all clinical decisions are based for these services.
We are concerned that, without an in-person interaction, care planning
that includes risk-benefit considerations and clinical decision-making
will be less well-informed and create risk of patient harm.
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With regard to the physical therapy, occupational therapy, and
speech-language pathology services in Table Creceived a number of
requests that we add therapy services to the Medicare telehealth
services list. In the CY 2018 PFS final rule, we noted that section
1834(m)(4)(E) of the Act specifies the types of practitioners who may
furnish and bill for Medicare telehealth services as those
practitioners under section 1842(b)(18)(C) of the Act. Physical
therapists (PTs), occupational therapists (OTs) and speech-language
pathologists (SLPs) are not among the practitioners identified in
section 1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final
rule (81 FR 80198) that because these services are predominantly
furnished by PTs, OTs, and SLPs, we did not believe it would be
appropriate to add them to the Medicare telehealth services list at
this time. In a subsequent request to consider adding these services
for 2018, the original requester suggested that we might propose these
services to be added to the Medicare telehealth services list so that
payment can be made for them when furnished via telehealth by
physicians or practitioners who can serve as distant site
practitioners. We stated that since the majority of the codes are
furnished over 90 percent of the time by therapy professionals who are
not included on the statutory list of eligible distant site
practitioners, we believed that adding therapy services to the Medicare
telehealth services list could result in confusion about who is
authorized to furnish and bill for these services when furnished via
telehealth. While we continue to believe this is generally the case,
and we are not proposing to add these services permanently to the
Medicare telehealth services list, we are seeking comment on whether
these services should be added to the Medicare telehealth services list
so that, in instances when a practitioner who is eligible to bill for
telehealth services furnishes these services via telehealth, they could
bill and receive payment for them. We are also seeking comment on
whether all aspects of these services can be fully and effectively
furnished via two-way, audio/video telecommunications technology. We
also note that given our clarification regarding telehealth services
furnished incident to the professional services of a physician or
practitioner (85 FR 27562), if these services were added to the
Medicare telehealth services list, they could be furnished by a
therapist and billed by a physician or practitioner who can furnish and
bill for telehealth services provided that all of the ``incident to''
requirements are met.
With regard to the critical care services listed in Table 11, we
have received a number of requests in prior years to add these services
to the Medicare telehealth services list. In response to one such
request, we finalized creation of two HCPCS G codes, G0508 (Telehealth
consultation, critical care, initial, physicians typically spend 60
minutes communicating with the patient and providers via telehealth)
and G0509 (Telehealth consultation, critical care, subsequent,
physicians typically spend 50 minutes communicating with the patient
and providers via telehealth), to describe the work associated with
furnishing consultation services via Medicare telehealth to critically
ill patients in the CY 2017 PFS final rule. We stated that CPT guidance
makes clear that a variety of other services are bundled into the
payment rates for critical care, including gastric intubations and
vascular access procedures, among others. While we continue to believe
that the full range of care for critically ill patients cannot be
performed via two-way, audio/video telecommunications technology for
the reasons articulated above, we are seeking comment on whether
current coding (either through the CPT codes describing in-person
critical care or the HCPCS G codes describing critical care consults
furnished via telehealth) does not reflect additional models of
critical care delivery, specifically, models of care delivery that
utilize a combination of remote monitoring and clinical staff at the
location of the beneficiary to allow, when an onsite practitioner is
not available, for a practitioner at a distant site to monitor vital
signs and direct in-person care as needed.
We are seeking comment on the definition, potential coding and
valuation for this kind of remote service. We are also seeking comment
on the following concerns:
How to distinguish the technical component of the remote
monitoring portion of the service from the diagnosis-related group
(DRG) payment already being provided to the hospital.
How to provide payment only for monitoring and
interventions furnished to Medicare beneficiaries when the remote
intensivist is monitoring multiple patients, some of which may not be
Medicare beneficiaries.
How this service intersects with both the critical care
consult G codes and the in-person critical care services.
BILLING CODE 4120-01-P
[[Page 50110]]
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BILLING CODE 4120-01-C
2. Technical Refinement to the Medicare Telehealth Services List To
Reflect Current Coding
For CY 2020, the CPT Editorial Panel deleted the six existing
Health and Behavior Assessment and Intervention procedure CPT codes and
replaced them with nine new CPT codes. The six deleted CPT codes
include CPT code 96150 (Health and behavior assessment (e.g., health-
focused clinical interview, behavioral observations,
psychophysiological monitoring, health oriented questionnaires), each
15 minutes face-to-face with the patient; initial assessment), CPT code
96151 (Health and behavior assessment (e.g., health-focused clinical
interview, behavioral observations, psychophysiological monitoring,
health oriented questionnaires), each 15 minutes face-to-face with the
patient; reassessment), CPT code 96152 (Health and behavior
intervention, each 15 minutes, face-to-face; individual), CPT code
96153 (Health and behavior intervention, each 15 minutes, face-to-face;
group (2 or more patients)), CPT code 96154 (Health and behavior
intervention, each 15 minutes, face-to-face; family (with the patient
present)), and CPT code 96155 (Health and behavior intervention, each
15 minutes, face-to-face; family (without the patient present)).
However, we inadvertently neglected to make the corresponding update to
reflect these coding changes on the Medicare telehealth services list
in CY 2020 PFS rulemaking. Therefore, we are proposing to delete CPT
codes 96150-96155 from the Medicare telehealth services list and
replace them with the following successor codes: CPT code 96156 (Health
behavior assessment, including reassessment (i.e., health-focused
clinical interview,
[[Page 50111]]
behavioral observations, clinical decision making)); CPT code 96158
(Health behavior intervention, individual, face-to-face; initial 30
minutes); CPT code 96159 (Health behavior intervention, individual,
face-to-face; each additional 15 minutes (list separately in addition
to code for primary service)); CPT code 96164 (Health behavior
intervention, group (2 or more patients), face-to-face; initial 30
minutes); CPT code 96165 (Health behavior intervention, group (2 or
more patients), face-to-face; each additional 15 minutes (list
separately in addition to code for primary service)); CPT code 96167
(Health behavior intervention, family (with the patient present), face-
to-face; initial 30 minutes); CPT code 96168 (Health behavior
intervention, family (with the patient present), face-to-face each
additional 15 minutes (list separately in addition to code for primary
service)); CPT code 96170 (Health behavior intervention, family
(without the patient present), face-to-face; initial 30 minutes); and
CPT code 96171 (Health behavior intervention, family (without the
patient present), face-to-face; each additional 15 minutes (list
separately in addition to code for primary service).
We are also proposing to amend our regulations to stipulate that
when new codes are issued to replace codes that describe the same
clinical services that are currently on the Medicare telehealth
services list, we will consider those new codes to be successor codes
to those that are on the Medicare telehealth services list, and will
update the Medicare telehealth services list accordingly. At Sec.
410.78(f), we are proposing to revise the final sentence of the
paragraph to read: CMS maintains on the CMS website the Medicare
telehealth services list under this section, including the current
HCPCS codes that describe the services.
3. Furnishing Telehealth Visits in Inpatient and Nursing Facility
Settings, and Critical Care Consultations
The long term care facility regulations at Sec. 483.30(c) require
that residents of SNFs receive an initial visit from a physician, and
periodic personal visits subsequently by either a physician or other
nonphysician practitioner (NPP). In the CY 2010 PFS final rule with
comment period (74 FR 61762) we stated that these regulations ensure
that at least a minimal degree of personal contact between a physician
or a qualified NPP and a resident is maintained, both at the point of
admission to the facility and periodically during the course of the
resident's stay. In that rule we stated that we believe that these
federally-mandated visits should be conducted in-person, and not as
Medicare telehealth services. We therefore revised Sec. 410.78 to
restrict physicians and practitioners from using telehealth to furnish
the physician visits required under Sec. 483.30(c).
During the PHE for the COVID-19 pandemic, we waived the requirement
in 42 CFR 483.30 for physicians and nonphysician practitioners to
personally perform required visits for nursing home residents, and
allowed visits to be conducted via telehealth (https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf).
We are seeking public comment on whether it would be appropriate to
maintain this flexibility on a permanent basis outside of the PHE for
the COVID-19 pandemic. We invite public comment on whether the in-
person visit requirement is necessary, or whether two-way, audio/video
telecommunications technology would be sufficient in instances when,
due to continued exposure risk, workforce capacity, or other factors,
the clinician determines an in-person visit is not necessary.
We have also received requests to revise our frequency limitations
for telehealth subsequent inpatient and nursing facility visits.
Currently, we limit the provision of subsequent inpatient visits via
Medicare telehealth to once every 3 days and subsequent nursing
facility visits to once every 30 days. We received a request to remove
the frequency limitation on the subsequent inpatient services and a
separate request to revise the subsequent nursing facility visits to
once every 3 days, rather than 30 days.
As we stated in the CY 2019 PFS final rule, we believed the
potential acuity of illness of hospital inpatients is greater than that
of patients who are likely to receive services that were on the
Medicare telehealth services list at that time. We also stated that it
would be appropriate to permit some subsequent hospital care services
to be furnished through telehealth to ensure that hospitalized patients
have frequent encounters with their admitting practitioner. In
addition, we expressed our belief that the majority of these visits
should be furnished in person to facilitate the comprehensive,
coordinated, and personal care that medically volatile, acutely ill
patients require on an ongoing basis. Because of our concerns regarding
the potential acuity of illness of hospital inpatients, we finalized
the addition of CPT codes 99231-99233 to the Medicare telehealth
services list, but limited the provision of these subsequent hospital
care services through telehealth to once every 3 days. We continue to
believe that admitting practitioners should continue to make
appropriate in-person visits to all patients who need such care during
their hospitalization. Our concerns with, and position on, the
provision of subsequent hospital care services via telehealth have not
changed (83 FR 59493). Therefore, we are not proposing to modify our
current policy.
In the CY 2018 PFS final rule, we reiterated that we believed it
would be appropriate to permit some subsequent nursing facility (NF)
care services to be furnished through telehealth to ensure that complex
nursing facility patients have frequent encounters with their admitting
practitioner, but because of our concerns regarding the potential
acuity and complexity of NF inpatients, we limited the provision of
subsequent NF care services furnished through telehealth to once every
30 days. We also stated that we continued to have concerns regarding
more routine use of telehealth given the potential acuity and
complexity of NF inpatients, and therefore, we were not proposing to
remove the frequency limitation for subsequent NF care services (83 FR
59494). We have received comments from stakeholders who stated that the
once every 30-day frequency limitation for subsequent NF visits
furnished via Medicare telehealth limits access to care for Medicare
beneficiaries in the NF setting. Stakeholders stated that the use of
Medicare telehealth is crucial to maintaining a continuum of care in
this setting and that CMS should leave it up to clinicians to decide
how frequently a visit may be furnished as a Medicare telehealth
service rather than in person depending on the needs of specific
patients. We are persuaded by the comments from these stakeholders, and
therefore, are proposing to revise the frequency limitation from one
visit every 30 days to one visit every 3 days. We believe this interval
strikes the right balance between requiring in-person visits and
allowing flexibility to furnish services via telehealth when clinically
appropriate to do so. We are also seeking comment on whether frequency
limitations broadly are burdensome and limit access to necessary care
when services are available only through telehealth, and how best to
ensure that patients are receiving necessary in-person care.
[[Page 50112]]
4. Proposed Technical Amendment To Remove References to Specific
Technology
The final sentence of our regulation at Sec. 410.78(a)(3)
prohibits the use of telephones, facsimile machines, and electronic
mail systems for purposes of furnishing Medicare telehealth services.
In the March 31st COVID-19 IFC, we added a new Sec. 410.78(a)(3)(i)
(and reserved Sec. 410.78(a)(3)(ii) for later use) to provide for an
exception that removes application of that sentence during the PHE for
the COVID-19 pandemic. We added the new section on an interim final
basis because we believe that the first sentence of Sec. 410.78(a)(3)
adequately describes the technology requirements for an interactive
telecommunication system that may be used to furnish a Medicare
telehealth service. That sentence defines interactive telecommunication
system as ``multimedia communications equipment that includes, at a
minimum, audio and video equipment permitting two-way, real-time
interactive communication.'' We were also concerned that the reference
to ``telephones'' in the second sentence of the regulation as
impermissible technology could cause confusion in instances where an
otherwise eligible device, such as a smart phone, may also be used as a
telephone. Because these concerns are not situation- or time-limited to
the PHE for COVID-19, we are proposing to remove the second sentence of
the regulation at Sec. 410.78(a)(3) which specifies that
``[t]elephones, facsimile machines, and electronic mail systems do not
meet the definition of an interactive telecommunications system.'' As
we are proposing to adopt this change on a permanent basis, we are also
proposing to delete the subparagraphs at Sec. 410.78(a)(3)(i) and
410.78(a)(3)(ii). We believe these amendments to our regulations would
remove outdated references to specific types of technology and provide
a clearer statement of our policy.
5. Communication Technology-Based Services (CTBS)
In the CY 2019 PFS final rule, we finalized separate payment for a
number of services that could be furnished via telecommunications
technology, but that are not considered Medicare telehealth services.
Specifically, we finalized HCPCS code G2010 (Remote evaluation of
recorded video and/or images submitted by an established patient (e.g.,
store and forward), including interpretation with follow-up with the
patient within 24 business hours, not originating from a related E/M
service provided within the previous 7 days nor leading to an E/M
service or procedure within the next 24 hours or soonest available
appointment), and HCPCS code G2012 (Brief communication technology-
based service, e.g. virtual check-in, by a physician or other qualified
health care professional who can report evaluation and management
services, provided to an established patient, not originating from a
related E/M service provided within the previous 7 days nor leading to
an E/M service or procedure within the next 24 hours or soonest
available appointment; 5-10 minutes of medical discussion). We
finalized maintenance of these codes as part of the set of codes that
is only reportable by those practitioners that can furnish E/M
services. We stated that we believed this was appropriate since the
service describes a check-in directly with the billing practitioner to
assess whether an office visit is needed. However, we did note that
similar check-ins provided by nurses and other clinical staff can be
important aspects of coordinated patient care (83 FR 59486).
In the CY 2020 PFS final rule, we finalized separate payment for
HCPCS codes G2061 (Qualified nonphysician healthcare professional
online assessment and management, for an established patient, for up to
seven days, cumulative time during the 7 days; 5-10 minutes), G2062
(Qualified nonphysician healthcare professional online assessment and
management service, for an established patient, for up to seven days,
cumulative time during the 7 days; 11-20 minutes), and G2063 (Qualified
nonphysician qualified healthcare professional assessment and
management service, for an established patient, for up to seven days,
cumulative time during the 7 days; 21 or more minutes). In that rule,
we stated that these codes may be billed by nonphysician practitioners
(NPPs) consistent with the definition of their respective benefit
category, although we did not provide specific examples (84 FR 62796).
We have received a number of questions regarding which benefit
categories HCPCS codes G2061 through G2063 fall under. In the March
31st COVID-19 IFC (85 FR 19244-19245) we established on an interim
basis for the duration of the PHE for the COVID-19 pandemic that these
services could be billed for example, by licensed clinical social
workers and clinical psychologists, as well as PTs, OTs, and SLPs who
bill Medicare directly for their services when the service furnished
falls within the scope of these practitioner's benefit categories. We
are proposing to adopt that policy on a permanent basis. We note that
this is not an exhaustive list and we are seeking comment on other
benefit categories into which these services fall.
We are also proposing to allow billing of other CTBS by certain
nonphysician practitioners, consistent with the scope of these
practitioners' benefit categories through the creation of two
additional HCPCS G codes that can be billed by practitioners who cannot
independently bill for E/M services:
G20X0 (Remote assessment of recorded video and/or images
submitted by an established patient (e.g., store and forward),
including interpretation with follow-up with the patient within 24
business hours, not originating from a related service provided within
the previous 7 days nor leading to a service or procedure within the
next 24 hours or soonest available appointment.)
G20X2 (Brief communication technology-based service, e.g.
virtual check-in, by a qualified health care professional who cannot
report evaluation and management services, provided to an established
patient, not originating from a related e/m service provided within the
previous 7 days nor leading to a service or procedure within the next
24 hours or soonest available appointment; 5-10 minutes of medical
discussion).
We are proposing to value these services identically to HCPCS codes
G2010 and G2012, respectively. We acknowledge that it has been agency
policy, in general, to differentially value similar services that are
performed by practitioners who can and cannot, respectively, bill
independently for E/M services, with higher values for the service
performed by practitioners who can independently bill E/M services.
However, given the relatively low values for HCPCS codes G2010 and
G2012, we do not think that there is a significant differential in
resource costs to warrant different values, but are seeking comment on
whether we should value these services differentially, including
potentially increasing the valuation of HCPCS codes G2010 and G2012.
Further, to facilitate billing of the CTBS by therapists, we are
proposing to designate HCPCS codes G20X0, G20X2, G2061, G2062, and
G2063 as ``sometimes therapy'' services. When billed by a private
practice PT, OT, or SLP, the codes would need to include the
corresponding GO, GP, or GN therapy modifier to signify that the CTB
are furnished as therapy services furnished under an OT, PT, or SLP
plan of care.
[[Page 50113]]
We also note that in section II.K. of this proposed rule we are
proposing for CY 2021 to replace the eVisit G codes with corresponding
CPT codes, and that this policy would also apply to those codes.
For all of these CTBS, we are also making clear that the consent
from the patient to receive these services can be documented by
auxiliary staff under general supervision, as well as by the billing
practitioner. While we continue to believe that beneficiary consent is
necessary so that the beneficiary is notified of cost sharing when
receiving these services, we do not believe that the timing or manner
in which beneficiary consent is acquired should interfere with the
provision of one of these services. We are retaining the requirement
that, in instances when the brief communication technology-based
service originates from a related E/M service (including one furnished
as a telehealth service) provided within the previous 7 days by the
same physician or other qualified health care professional, this
service would be considered bundled into that previous E/M service and
would not be separately billable.
6. Comment Solicitation on Continuation of Payment for Audio-Only
Visits
In the March 31st COVID-19 IFC, we established separate payment for
audio-only telephone evaluation and management (E/M) services (85 FR
19264 through 19266). The telephone E/M services are CPT codes 99441
(Telephone evaluation and management service by a physician or other
qualified health care professional who may report evaluation and
management services provided to an established patient, parent, or
guardian not originating from a related E/M service provided within the
previous 7 days nor leading to an E/M service or procedure within the
next 24 hours or soonest available appointment; 5-10 minutes of medical
discussion); 99442 (Telephone evaluation and management service by a
physician or other qualified health care professional who may report
evaluation and management services provided to an established patient,
parent, or guardian not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment; 11-20
minutes of medical discussion); and 99443 (Telephone evaluation and
management service by a physician or other qualified health care
professional who may report evaluation and management services provided
to an established patient, parent, or guardian not originating from a
related E/M service provided within the previous 7 days nor leading to
an E/M service or procedure within the next 24 hours or soonest
available appointment; 21-30 minutes of medical discussion). We noted
that, although these services were previously considered non-covered
under the PFS, in the context of the PHE and with the goal of reducing
exposure risks associated with the COVID-19 pandemic, especially in the
case that two-way, audio and video technology is not available to
furnish a Medicare telehealth service, we believed there are
circumstances where prolonged, audio-only communication between the
practitioner and the patient could be clinically appropriate, yet not
fully replace a face-to-face visit. For example, an established patient
who was experiencing an exacerbation of their condition could have a
25-minute phone conversation with their physician during which the
physician determines that an adjustment to the patient's medication
would alleviate their symptoms. The use of CPT code 99443 in this
situation prevents a similar in-person service as the evaluation of the
patient's symptoms and determination to adjust medication could be
conducted without patient and the practitioner being in the same
location. We stated our belief that these telephone E/M codes, with
their established description and valuation, were the best way to
recognize the relative resource costs of these kinds of services and
make payment for them under the PFS. For these codes, we initially
finalized on an interim basis during the PHE for the COVID-19 pandemic,
work relative value units (RVUs) as recommended by the American Medical
Association (AMA) Relative Value Scale Update Committee (RUC), as
discussed in the CY 2008 PFS final rule with comment period (72 FR
66371), of 0.25 for CPT code 99441, 0.50 for CPT code 99442, and 0.75
for CPT code 99443. We also finalized the RUC-recommended direct
practice expense (PE) inputs which consist of 3 minutes of post-service
Registered Nurse/Licensed Practical Nurse/Medical Technical Assistant
clinical labor time for each code.
In the May 1st COVID-19 IFC, we noted that in the time since we
established these payment amounts, stakeholders had informed us that
use of audio-only services was more prevalent than we had previously
considered, especially because many beneficiaries were not utilizing
video-enabled communication technology from their homes. In other
words, there were many cases where practitioners would under ordinary
circumstances utilize telehealth or in-person visits to evaluate and
manage patients' medical concerns, but were instead using audio-only
interactions to manage more complex care (85 FR 27589 through 27590).
While we had previously acknowledged the likelihood that, under the
circumstances of the PHE, more time would be spent interacting with the
patient via audio-only technology, we stated that the intensity of
furnishing an audio-only visit to a beneficiary during the unique
circumstances of the COVID-19 pandemic was not accurately captured by
the valuation of these services we established in the March 31st COVID-
19 IFC. This would be particularly true to the extent that these audio-
only services are actually serving as a substitute for office/
outpatient Medicare telehealth visits for beneficiaries not using
video-enabled telecommunications technology contrary to the situation
we anticipated when establishing payment for them in the March 31st
COVID-19 IFC. We stated that, given our understanding that these audio-
only services were being furnished primarily as a replacement for care
that would otherwise be reported as an in-person or telehealth visit
using the office/outpatient E/M codes, we established new RVUs for the
telephone E/M services based on crosswalks to the most analogous
office/outpatient E/M codes, based on the time requirements for the
telephone codes and the times assumed for valuation for purposes of the
office/outpatient E/M codes. Specifically, we crosswalked CPT codes
99212, 99213, and 99214 to CPT codes 99441, 99442, and 99443,
respectively. We therefore finalized, on an interim basis and for the
duration of the COVID-19 PHE, the following work RVUs: 0.48 for CPT
code 99441; 0.97 for CPT code 99442; and 1.50 for CPT code 99443. We
also finalized the direct PE inputs associated with CPT code 99212 for
CPT code 99441, the direct PE inputs associated with CPT code 99213 for
CPT code 99442, and the direct PE inputs associated with CPT code 99214
for CPT code 99443. We did not finalize increased payment rates for CPT
codes 98966-98968 as these codes describe services furnished by
practitioners who cannot independently bill for E/M services and so
these telephone assessment and management services, by definition, are
not being furnished in lieu of an office/outpatient E/M service. We
noted that to the extent that these extended phone services are taking
[[Page 50114]]
place instead of office/outpatient E/M visits (either in-person or via
telehealth), the direct crosswalk of RVUs also better maintains overall
budget neutrality and relativity under the PFS. We stated that we
believed that the resources required to furnish these services during
the PHE for the COVID-19 pandemic are better captured by the RVUs
associated with the level 2-4 established patient office/outpatient E/M
visits. Additionally, we stated that, given our understanding that
these audio-only services were being furnished as substitutes for
office/outpatient E/M services, we recognized that they should be
considered as telehealth services, and added them to the Medicare
telehealth services list for the duration of the PHE. For these audio-
only E/M services, we separately issued a waiver under section
1135(b)(8) of the Act, as amended by section 3703 of the CARES Act, of
the requirements under section 1834(m) of the Act and our regulation at
Sec. 410.78 that Medicare telehealth services must be furnished using
video technology.
We are not proposing to continue to recognize these codes for
payment under the PFS after conclusion of the PHE for the COVID-19
pandemic because, outside of the circumstances of the PHE, we are not
able to waive the requirement that telehealth services be furnished
using an interactive telecommunications system that includes two-way,
audio/video communication technology. However, we recognize that the
need for audio-only interaction could remain as beneficiaries continue
to try to avoid sources of potential infection, such as a doctor's
office; and in that circumstance, a longer phone conversation may be
needed to determine if an in-person visit is necessary than what is
described by the virtual check-in. We are seeking comment on whether
CMS should develop coding and payment for a service similar to the
virtual check-in but for a longer unit of time and with an accordingly
higher value. We are seeking input from the public on the appropriate
duration interval for such services and the resources in both work and
PE that would be associated with furnishing them. We are also seeking
comment on whether separate payment for such telephone-only services
should be a provisional policy to remain in effect until a year or some
other period after the end of the PHE or if it should be PFS payment
policy permanently.
7. Comment Solicitation on Coding and Payment for Virtual Services
The health care community uses the term ``telehealth'' broadly to
refer to medical services furnished via communications technology.
Under current PFS payment rules, Medicare routinely pays for many of
these kinds of services. This includes some kinds of remote patient
monitoring (either as separate services or as parts of bundled
services), interpretations of diagnostic tests when furnished remotely
and, under conditions specified in section 1834(m) of the Act, services
that would otherwise be furnished in person but are instead furnished
via real-time, interactive communication technology. Over the past
several years, we have also established several PFS policies to make
separate payment for non-face-to-face services included as part of
ongoing care management. Although all of the kinds of services stated
above might be called ``telehealth'' by patients, other payers and
health care providers, we have generally used the term ``Medicare
telehealth services'' to refer to the subset of services defined in
section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare
telehealth services and specifies the payment amounts and circumstances
under which Medicare makes payment for a discrete set of services, all
of which must ordinarily be furnished in-person, when they are instead
furnished using interactive, real time telecommunication technology.
We believe that the provisions in section 1834(m) of the Act apply
particularly to the kinds of professional services explicitly
enumerated in the statutory provisions, like professional
consultations, office visits, and office psychiatry services.
Generally, the services we have added to the Medicare telehealth
services list are similar to these kinds of services. As has long been
the case, certain other kinds of services that are furnished remotely
using communications technology are not considered ``Medicare
telehealth services'' and are not subject to the restrictions
articulated in section 1834(m) of the Act. This is true for services
that were routinely paid separately prior to the enactment of the
provisions in section 1834(m) of the Act and do not usually include
patient interaction (such as remote interpretation of diagnostic
imaging tests), and for services that were not discretely defined or
separately paid for at the time of enactment and that do include
patient interaction (such as chronic care management services).
In recent years, we have begun making separate payment for a number
of services that use telecommunications technology but are not
considered Medicare telehealth services. These CTB services include,
for example, certain kinds of remote patient monitoring (either as
separate services or as parts of bundled services), a virtual check-in,
and a remote asynchronous service. These services are different than
the kinds of services specified in section 1834(m) of the Act, in that
they are not the kind of services that are ordinarily furnished in
person but are routinely furnished using a telecommunications system.
In the past, we have received requests to add certain services,
such as chronic care management or remote physiologic monitoring to the
Medicare telehealth services list. However, as these services fall
outside the scope of services addressed, and the enumerated list of
services included in section 1834(m) of the Act, they are not
considered telehealth services and, therefore, are not subject to the
same restrictions. We are seeking comment on whether there are
additional services that fall outside the scope of telehealth services
under section 1834(m) of the Act where it would be helpful for us to
clarify that the services are inherently non-face-to-face, so do not
need to be on the Medicare telehealth services list in order to be
billed and paid when furnished using telecommunications technology
rather than in person with the patient present. We are also seeking
comment on physicians' services that use evolving technologies to
improve patient care that may not be fully recognized by current PFS
coding and payment, including, for example, additional or more specific
coding for care management services. Finally, we are broadly seeking
comment on any impediments that contribute to healthcare provider
burden and that may result in practitioners being reluctant to bill for
CTBS. We appreciate the ongoing engagement and additional information
from stakeholders as we work to improve coding and payment for these
services that utilize telecommunications technology.
8. Proposed Clarification of Existing PFS Policies for Telehealth
Services
In response to the waiver of statutory requirements and the
relaxation of regulatory requirements for telehealth during the PHE for
the COVID-19 pandemic, we received a number of requests to clarify
existing PFS policy for telehealth. For example, we received questions
as to whether Medicare allows incident-to billing for telehealth
services, particularly for practitioners such as counselors who are
supervised
[[Page 50115]]
by a physician in private practice. We note that there are no Medicare
regulations that explicitly prohibit eligible distant site
practitioners from billing for telehealth services provided incident to
their services. However, we also note that our existing definition of
direct supervision requires on-site presence of the billing clinician
when the service is provided. That requirement could make it difficult
for a billing clinician to provide the direct supervision of services
provided via telehealth incident to their professional services by
auxiliary personnel. Under our proposed amendment to the definition of
direct supervision to permit virtual presence, we acknowledge that
billing practitioners could more easily meet the direct supervision
requirements for telehealth services provided incident to their
services. Consequently, we believe that services provided incident to
the professional services of an eligible distant site physician or
practitioner could be reported when they meet direct supervision
requirements at both the originating and distant site through the
virtual presence of the billing physician or practitioner. Therefore,
we are proposing to clarify that services that may be billed incident-
to may be provided via telehealth incident to a physicians' service and
under the direct supervision of the billing professional. This is
consistent with a policy clarification that we made through the May 1st
COVID-19 IFC (85 FR 27562).
We have also received questions as to whether services should be
reported as telehealth services when the individual physician or
practitioner furnishing the service is in the same location as the
beneficiary; for example, if the physician or practitioner furnishing
the service is in the same institutional setting but is utilizing
telecommunications technology to furnish the service due to exposure
risks. We are clarifying, as we did in the May 1st COVID-19 IFC (85 FR
27562) that if audio/video technology is used in furnishing a service
when the beneficiary and the practitioner are in the same institutional
or office setting, then the practitioner should bill for the service
furnished as if it was furnished in person, and the service would not
be subject to any of the telehealth requirements under section 1834(m)
of the Act or Sec. 410.78 of our regulations.
9. Direct Supervision by Interactive Telecommunications Technology
Many services for which payment is made under the PFS can be
furnished under a level of physician or NPP supervision rather than
being performed directly by the billing practitioner. In many cases,
the supervision requirements necessitate the presence of the physician
or NPP in a particular location, usually in the same location as the
beneficiary when the service is provided. For example, as described at
Sec. 410.26, services furnished by auxiliary personnel incident to a
physician's or NPP's professional service usually require the direct
supervision of the physician or NPP. In addition to these ``incident
to'' services, there are a number of diagnostic services under the PFS
that also must be furnished under direct supervision. As currently
defined in Sec. Sec. 410.26 and 410.32(b)(3)(ii), direct supervision
means that the physician or NPP must be present in the office suite and
immediately available to furnish assistance and direction throughout
the performance of the procedure. Direct supervision does not require
the physician or NPP to be present in the room when the service or
procedure is performed.
For the duration of the PHE for the COVID-19 pandemic, for purposes
of limiting exposure to COVID-19, we adopted an interim final policy
revising the definition of direct supervision to include virtual
presence of the supervising physician or practitioner using interactive
audio/video real-time communications technology (85 FR 19245). We
recognized that in some cases, the physical proximity of the physician
or practitioner might present additional infection exposure risk to the
patient and/or practitioner. In the context of the PHE for the COVID-19
pandemic, given the risks of exposure, the immediate risk of foregone
medical care, the increased demand for healthcare professionals, and
the widespread use of telecommunications technology, we believed that
individual practitioners were in the best position to make decisions
about how to meet the requirement to provide appropriate direct
supervision based on their clinical judgment in particular
circumstances.
We are proposing to extend this policy until the later of the end
of the calendar year in which the PHE ends or December 31, 2021, to
recognize the different and unique circumstances faced by individual
communities that may continue after the PHE ends, and provide time to
solicit public input on circumstances where the flexibility to use
interactive audio/video real-time communications technology to provide
virtual direct supervision could still be needed and appropriate. The
extension of this flexibility would allow time for clinicians to make
adjustments and for us to obtain public input on services and
circumstances for which this policy might be appropriate on a permanent
basis. We note that if we finalize this proposal and the PHE ends
before the CY 2021 PFS final rule takes effect, the interim policy
adopted during the PHE to allow direct supervision using real-time,
interactive audio and video technology would no longer be in effect
during the period between expiration of the PHE and the date the final
policy takes effect.
Given our continued interaction with practitioners during the PHE
and our growing understanding of how services may be furnished remotely
and safely, we now have a better understanding of how, in some cases,
depending upon the unique circumstances of individual patients and
billing practitioners or physicians, telecommunications technology
could safely allow the practitioner or physician's immediate
availability to furnish assistance and direction without necessarily
requiring the supervising practitioner's or physician's physical
presence in the location where the service is being furnished. In such
cases, the use of real-time, audio and video telecommunications
technology may allow the supervising practitioner or physician to
observe the beneficiary and the auxiliary staff performing the service
or be engaged (Direct supervision does not require the physician or NPP
to be present in the room when the service or procedure is performed)
to provide assistance and direction of the service through virtual
means, and without the supervising practitioner or physician being
physically present.
Consequently, we are proposing to revise Sec. 410.32(b)(3)(ii) to
allow direct supervision to be provided using real-time, interactive
audio and video technology through the later of the end of the calendar
year in which the PHE ends or December 31, 2021. Specifically, we
propose to continue our current rule that ``Direct supervision'' in the
office setting means the physician (or other supervising practitioner)
must be present in the office suite and immediately available to
furnish assistance and direction throughout the performance of the
procedure. It does not mean that the physician (or other supervising
practitioner) must be present in the room when the procedure is
performed. We propose to add that, until the later of the end of the
calendar year in which the PHE ends or December 31, 2021, the presence
of the physician (or other practitioner) may include virtual presence
through audio/video real-time communications technology (excluding
audio-only) subject to the clinical judgement of the
[[Page 50116]]
supervising physician or (other supervising practitioner). In response
to questions received since we issued our interim policy for the PHE,
we are clarifying that, to the extent our policy allows direct
supervision through virtual presence using audio/video real-time
communications technology, the requirement could be met by the
supervising physician (or other practitioner) being immediately
available to engage via audio/video technology (excluding audio-only),
and would not require real-time presence or observation of the service
via interactive audio and video technology throughout the performance
of the procedure.
While flexibility to provide direct supervision through audio/video
real-time communications technology was adopted to be responsive to
critical needs during the PHE to ensure beneficiary access to care,
reduce exposure risk and to increase the capacity of practitioners and
physicians to respond to COVID-19, we are concerned that direct
supervision through virtual presence may not be sufficient to support
PFS payment on a permanent basis, beyond the PHE, due to issues of
patient safety. For instance, in complex, high-risk, surgical,
interventional, or endoscopic procedures, or anesthesia procedures, a
patient's clinical status can quickly change and we believe it is
necessary for such services to be furnished or supervised in person to
allow for rapid on-site decision-making in the event of an adverse
clinical situation. For example, there could be a case in which a
practitioner or physician uses audio/video interactive communications
to virtually supervise a nurse performing a post-op evaluation
following surgery for hip fracture, and the nurse might note that the
patient is uncooperative. In this scenario, had a full exam been
performed directly by the practitioner or physician, or under the in-
person supervision of a practitioner or physician who was physically or
immediately available in the clinic to provide the necessary direction,
the physician or practitioner would have recognized that the patient
exhibited signs of crystal-mediated acute arthritis, and that the
patient's lack of cooperation was likely due to hypoactive delirium.
Instead, the supervising practitioner or physician may not have been
able to identify this clinical issue as a result of being available
only via audio/video interactive communications technology. In this
case, the presence of the supervising practitioner or physician through
audio/video interactive communications technology would have been
insufficient. There also may be certain patient populations that
require greater clinical attentiveness and skill than the supervising
practitioner or physician could provide via audio/video interactive
communications technology. For example, patients with cognitive
impairment or dementia, or patients with communication disabilities,
may require the experience and skill of a physically present
supervising practitioner or physician to recognize needs such as the
need for specialized testing. It may not be possible for a supervising
practitioner or physician to recognize or meet these clinical needs
while being present for the service only through audio/video
interactive communications technology. Moreover, the virtual connection
between the individual performing the service and the supervising
practitioner or physician could be disrupted, making it challenging for
the supervising practitioner or physician to remain immediately
available to provide assistance and direction to the physically present
clinical staff or auxiliary personnel to furnish appropriate care to
the patient.
We are seeking information from commenters as to whether there
should be any additional ``guardrails'' or limitations to ensure
patient safety/clinical appropriateness, beyond typical clinical
standards, as well as restrictions to prevent fraud or inappropriate
use if we were to finalize a policy to permit direct supervision
through audio/video interactive communications technology, with
consideration of relevant patient safety, clinical appropriateness
criteria or other restrictions, on a temporary basis through the later
of the end of the calendar year in which the PHE ends or December 31,
2021, or consider it beyond the time specified. We are also seeking
information on what risks this policy might introduce to beneficiaries
as they receive care from practitioners that would supervise care
virtually in this way. Further we are seeking comment on potential
concerns around induced utilization and fraud, waste, and abuse and how
those concerns might be addressed. We also invite commenters to provide
data and information about their implementation experience with direct
supervision using virtual presence during the PHE, and are interested
in comments on the degree of aging and disability competency training
that is required for effective use of audio/video real-time
communications technology.
10. Comment Solicitation on PFS Payment for Specimen Collection for
COVID-19 Tests
When physicians and other practitioners collect specimens for
clinical diagnostic laboratory tests as part of their professional
services, Medicare generally makes payment for the services under the
PFS, though often that payment is bundled into the payment rate for
other services, including office and outpatient visits. Typically,
collection of a specimen via nasal swab or other method during the
provision of a service might be reported as part of (bundled with) an
office/outpatient E/M visit (CPT codes 99201 through 99205, 99211
through 99215). In visits where a patient has a face-to-face
interaction with a billing professional with whom they have an
established relationship, these services are generally reported with a
level 2 through a level 5 visit (CPT codes 99212 through 99215). In
cases where the specimen is collected during a visit where the face-to-
face interaction only involves clinical staff of the billing
professional with whom the patient has an established relationship,
these services are generally reported using CPT code 99211.
In the May 1st COVID-19 IFC (85 FR 27604-27605), we finalized on an
interim basis that physicians and NPPs may use CPT code 99211 to bill
for services furnished incident to their professional services, for
both new and established patients, when clinical staff assess symptoms
and collect specimens for purposes of COVID-19 testing, if the billing
practitioner does not also furnish a higher level E/M service to the
patient on the same day. We are considering whether to extend or make
permanent the policy to allow physicians and NPPs to use CPT code 99211
to bill for services furnished incident to their professional services,
for both new and established patients, when clinical staff assess
symptoms and collect specimens for purposes of COVID-19 testing, and
are soliciting public comments on whether we should continue this
policy for a period of time, or permanently, after the COVID-19 PHE
ends.
E. Care Management Services and Remote Physiologic Monitoring Services
1. Background
In recent years, we have updated PFS policies to improve payment
for care management and coordination. Working with the CPT Editorial
Panel and other clinicians, we have expanded the suite of codes
describing these services. New CPT codes were created that describe
services that involve direct patient
[[Page 50117]]
contact (for some services, in-person) or do not involve direct patient
contact; represent a single encounter, monthly service, or both; are
timed services; address specific conditions; and represent the work of
the billing practitioner, auxiliary personnel (specifically, clinical
staff), or both (see Table 13). In this proposed rule for CY 2021, we
continue our work to improve payment for care management services
through proposed code refinements related to remote physiologic
monitoring (RPM), transitional care management (TCM), and psychiatric
collaborative care model (CoCM) services.
[GRAPHIC] [TIFF OMITTED] TP17AU20.019
2. Digitally Stored Data Services/Remote Physiologic Monitoring/
Treatment Management Services (RPM)
RPM involves the collection and analysis of patient physiologic
data that are used to develop and manage a treatment plan related to a
chronic and/or acute health illness or condition. In recent years, we
have finalized payment for seven CPT codes in the RPM code family. Five
of the seven codes have been the focus of frequent questions from
stakeholders.
In response to proposals in the CY 2019 PFS proposed rule (83 FR
35771) and the CY 2020 PFS proposed rule (84 FR 40555 through 40556),
stakeholders requested that we clarify how we interpret aspects of the
RPM code descriptors for CPT codes 99453, 99454, 99091, and 99457.
Commenters asked us, for example, to identify who can furnish RPM
services, what kinds of medical devices can be used to collect data,
how data should be collected, and how ``interactive communication'' is
defined. We stated in the CY 2020 PFS final rule (84 FR 62697) that we
would provide guidance in the future about the codes. For CY 2021, we
are clarifying how we read CPT code descriptors and instructions
associated with CPT codes 99453, 99454, 99091, and 99457 (and the add-
on code, CPT code 99458) and their use to describe remote monitoring of
physiologic parameters of a patient's health.
The RPM process begins with two practice expense (PE) only codes,
CPT codes 99453 and 99454, finalized in the CY 2019 PFS final rule (83
FR 39574 through 39576). As PE only codes they are valued to include
clinical staff time, supplies, and equipment, including the medical
device for the typical case of remote monitoring. CPT code 99453
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood
pressure, pulse oximetry, respiratory flow rate), initial; set-up and
patient education on use of equipment) is
[[Page 50118]]
valued to reflect clinical staff time that includes instructing a
patient and/or caregiver about using one or more medical devices. CPT
code 99454 (Remote monitoring of physiologic parameter(s) (e.g.,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; device(s) supply with daily recording(s) or programmed
alert(s) transmission, each 30 days) is valued to include the medical
device or devices supplied to the patient and the programming of the
medical device for repeated monitoring. We reviewed the PE inputs for
CPT code 99454 for purposes of this proposal, and are clarifying that
the medical device or devices that are supplied to the patient and used
to collect physiologic data are considered equipment and as such are
direct PE inputs for the code.
Review of CPT prefatory language (CPT[supreg] 2020 Professional
Codebook (hereafter, CPT Codebook), p. 42) provides additional
information about the two PE only codes. For example, the CPT prefatory
language indicates that monitoring must occur over at least 16 days of
a 30-day period in order for CPT codes 99453 and 99454 to be billed.
Additionally, these two codes are not to be reported for a patient more
than once during a 30-day period. This language suggests that even when
multiple medical devices are provided to a patient, the services
associated with all the medical devices can be billed only once per
patient per 30-day period and only when at least 16 days of data have
been collected. We also note that CPT 99453 can be billed only once per
episode of care where an episode of care is defined as ``beginning when
the remote physiologic monitoring service is initiated and ends with
attainment of targeted treatment goals'' (CPT Codebook, p. 42).
Other stakeholder inquiries about CPT codes 99453 and 99454 focus
upon the kinds of medical devices that can be used to collect the
patient's physiologic data. Prefatory language in the CPT Codebook
states that ``the device must be a medical device as defined by the
FDA.'' CPT simply specifies that the device must meet the FDA's
definition of a medical device as described in section 201(h) of the
Federal, Food, Drug and Cosmetic Act (FFDCA). We have found no language
in the CPT Codebook indicating that a medical device must be FDA
cleared as some stakeholders have suggested although such clearance may
be appropriate. Nor have we found information that suggests a medical
device must be prescribed by a physician, although this could be
possible depending upon the medical device. Beyond acknowledging the
CPT specification that the medical device supplied for CPT code 99454
must meet the FDA definition of a medical device, we are clarifying
that the medical device should digitally (that is, automatically)
upload patient physiologic data (that is, data are not patient self-
recorded and/or self-reported). We note also that use of the medical
device or devices that digitally collect and transmit a patient's
physiologic data must, as usual for most Medicare covered services, be
reasonable and necessary for the diagnosis or treatment of the
patient's illness or injury or to improve the functioning of a
malformed body member. Further, the device must be used to collect and
transmit reliable and valid physiologic data that allow understanding
of a patient's health status to develop and manage a plan of treatment.
The CPT Codebook lists the RPM codes under the main heading
Evaluation and Management (E/M). We are clarifying that as E/M codes,
CPT codes 99453, 99454, 99091, 99457, and 99458, can be ordered and
billed only by physicians or nonphysician practitioners (NPPs) who are
eligible to bill Medicare for E/M services.
Although we initially described RPM services in the CY 2019 PFS
final rule (83 FR 35771) as services furnished to patients with chronic
conditions, we are also clarifying that practitioners may furnish these
services to remotely collect and analyze physiologic data from patients
with acute conditions, as well as from patients with chronic
conditions.
After the 30-day data collection period for CPT codes 99453 and
99454, the physiologic data that are collected and transmitted are
analyzed and interpreted by the physician or practitioner as described
by CPT code 99091, a code that includes only professional work, that
is, there are no direct PE inputs. We finalized payment for CPT code
99091 (Collection and interpretation of physiologic data digitally
stored and/or transmitted by the patient and/or caregiver to the
physician or other qualified health care professional, qualified by
education, training, licensure/regulation requiring a minimum of 30
minutes of time, each 30 days) in the CY 2018 PFS final rule (82 FR
59473). The valuation for CPT code 99091 includes a total time of 40
minutes of physician or nonphysician practitioner work broken down as
follows: 5 minutes of preservice work (for example, chart review); 30
minutes of intra-service work (for example, data analysis and
interpretation, report based upon the physiologic data, as well as a
possible phone call to the patient); and 5 minutes of post-service work
(that is, chart documentation). We note that stakeholders have
expressed confusion about the specification in the code descriptor for
CPT code 99091 that the service is furnished by a ``physician or other
qualified health care professional, qualified by education, training,
licensure/regulation.'' The phrase ``physician or other qualified
healthcare professional'' is defined by CPT as, ``an individual who is
qualified by education, training, licensure/regulation (when
applicable) and facility privileging (when applicable) who performs a
professional service within his/her scope of practice and independently
reports that professional service. These professionals are distinct
from ``clinical staff . . . [which refers to] a person who works under
the supervision of a physician or other qualified healthcare
professional and who is allowed by law, regulation, and facility policy
to perform or assist in the performance of a specified professional
service but does not individually report that professional service.''
\1\ Accordingly, when referring to a particular service described by a
CPT code for Medicare purposes, a physician or other qualified
healthcare professional is an individual whose scope of practice and
Medicare benefit category includes the service and who is authorized to
independently bill Medicare for the service. See our previous
discussion of this in the CY 2016 PFS final rule at 80 FR 70957.
Medicare also covers and makes payment for certain services performed
by auxiliary personnel (which includes clinical staff) ``incident to''
the professional services of the billing practitioner. Our regulation
at Sec. 410.26(a) defines auxiliary personnel (a term that includes
clinical staff) and delineates the conditions for payment for
``incident to'' services.
---------------------------------------------------------------------------
\1\ CPT Codebook, p.xiii.
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After analyzing and interpreting a patient's remotely collected
physiologic data, the next step in the process of RPM is the
development of a treatment plan that is informed by the analysis and
interpretation of the patient's data. It is at this point that the
physician or nonphysician practitioner develops a treatment plan with
the patient and/or caregiver (that is, patient-centered care) and then
manages the plan until the targeted goals of the treatment plan are
attained, which signals the end of the episode of care. CPT code 99457
(Remote physiologic monitoring treatment management services, clinical
staff/physician/other qualified health care professional time in a
calendar
[[Page 50119]]
month requiring interactive communication with the patient/caregiver
during the month; first 20 minutes) and its add-on code, CPT code 99458
(Remote physiologic monitoring treatment management services, clinical
staff/physician/other qualified health care professional time in a
calendar month requiring interactive communication with the patient/
caregiver during the month; each additional 20 minutes) describe the
treatment and management services associated with RPM. Medicare
stakeholders have requested that we clarify aspects of these two codes.
The two most frequently asked questions include, ``Who can furnish the
services described by CPT codes 99457 and 99458? '' and ``What does it
mean to have an `interactive communication' with a patient? ''
We addressed who can furnish CPT codes 99457 and 99458 in the CY
2020 PFS final rule (84 FR 62697 through 62698) when we designated both
codes as care management services. We explained that, like other care
management services, CPT codes 99457 and 99458 can be furnished by
clinical staff under the general supervision of the physician or NPP.
We note that RPM services are not considered to be diagnostic tests;
that is, they cannot be furnished and billed by an Independent
Diagnostic Testing Facility on the order of a physician or NPP.
The services described by CPT codes 99457 and 99458 are services
that are typically furnished remotely using communications technologies
that allow ``interactive communication,'' which we read as real-time
interaction, between a patient and the physician, nonphysician
practitioner, or clinical staff who provide the services. Stakeholders
have requested that we define ``interactive communication'' as used in
the code descriptors for CPT codes 99457 and 99458. We see this remote,
non-face-to-face exchange as being similar to the exchange that occurs
in providing services described by HCPCS code G2012, Brief
Communication Technology Based Service, which we finalized in the CY
2019 final rule (83 FR 59483 through 59486). Thus, we are clarifying
that ``interactive communication'' for purposes of CPT codes 99457 and
99458 involves, at a minimum, a real-time synchronous, two-way audio
interaction that is capable of being enhanced with video or other kinds
of data transmission. As indicated in the code descriptor for CPT code
99457, the interactive communication must total at least 20 minutes of
interactive time with the patient over the course of a calendar month
for CPT code 99457 to be reported. Each additional 20 minutes of
interactive communication between the patient and the physician/
nonphysician practitioner/clinical staff is reported using CPT code
99458. The CPT Codebook states that unless there are code- or code-
range specific instructions, parenthetical instructions, or code
descriptors to the contrary, time is considered to be the ``face-to-
face'' time with the patient or patient's caregiver/medical decision-
maker. See the CPT Codebook, page xvii, as well as pages 10, 13, and 16
for more information about measuring time. Where, as here, the services
are not typically furnished in person with the patient, we interpret
time in the code descriptor to mean the time spent in direct, real-time
interactive communication with the patient.
Lastly, we are proposing to establish as permanent policy two of
the changes we made on an interim basis to the requirements for
furnishing RPM services in response to the PHE for the COVID-19
pandemic. (See 85 FR 19264 and 85 FR 27605 through 27606 for the
interim modifications and clarifications to RPM services in response to
the PHE for the COVID-19 pandemic).
Our goals during the PHE for the COVID-19 pandemic have been to
reduce exposure risks to the Novel Coronavirus for practitioners and
patients while also increasing access to health care services. We
eliminated as many obstacles as possible to allow timely delivery of
reasonable and necessary health care. We wanted patients to be able to
access services quickly and without barriers. With the goals of
reducing exposure and increasing access to services, we finalized that
RPM services could be furnished to new patients, as well as established
patients. We also finalized on an interim basis for the duration of the
PHE for the COVID-19 pandemic policies to allow consent to be obtained
at the time services are furnished, and by individuals providing RPM
services under contract with the billing physician or practitioner; and
to allow RPM codes to be billed for a minimum of 2 days of data
collection over a 30-day period, rather than the required 16 days of
data collection over a 30-day period as provided in the CPT code
descriptors.
For CY 2021, we are proposing on a permanent basis to allow consent
to be obtained at the time that RPM services are furnished. Because the
CPT code descriptors do not specify that clinical staff must perform
RPM services, we are also proposing to allow auxiliary personnel (which
includes other individuals who are not clinical staff but are
employees, or leased or contracted employees) to furnish services
described by CPT codes 99453 and 99454 under the general supervision of
the billing physician or practitioner.
When the PHE for the COVID-19 pandemic ends, we again will require
that RPM services must be furnished only to an established patient. We
believe that a physician or practitioner who has an established
relationship with a patient would likely have had an opportunity to
provide a new patient E/M service. During the new patient E/M service,
the physician or practitioner would have collected relevant patient
history and conducted a physical exam, as appropriate. As a result, the
physician or practitioner would possess information needed to
understand the current medical status and needs of the patient prior to
ordering RPM services to collect and analyze the patient's physiologic
data and to develop a treatment plan. Additionally, and in keeping with
the CPT prefatory language for CPT codes 99453 and 99454, when the PHE
for the COVID-19 pandemic ends, we will once again require that 16 days
of data be collected within 30 days to meet the requirements to bill
CPT codes 99453 and 99454.
Finally, in response to the May 19, 2020 Executive Order 13924,
``Regulatory Relief To Support Economic Recovery,'' (85 FR 31353
through 31356), we are seeking comment from the medical community and
other members of the public on whether the current RPM coding
accurately and adequately describes the full range of clinical
scenarios where RPM services may be of benefit to patients. For
example, CPT codes 99453 and 99454 currently require use of a medical
device (as defined by the FDA) that digitally collects and transmits 16
or more days of data every 30 days in order for the codes to be billed.
However, some patients may not require remote monitoring for 16 or more
days in a 30-day period. For some patients, continuous short-term
monitoring might be more appropriate. For example, a post-surgical
patient who is recovering at home might benefit from remote monitoring
of his or her body temperature as a means of assessing infection and
managing medications or dosage. In some situations, monitoring several
times throughout a day, over a period of 10 days, may be reasonable and
necessary. Sixteen or more days might be unnecessary. We are asking for
information that would help us to understand whether it would be
beneficial to consider establishing
[[Page 50120]]
coding and payment rules that would allow practitioners to bill and be
paid for RPM services with shorter monitoring periods. Specifically, we
are interested in understanding whether one or more codes that describe
a shorter duration, for example, 8 or more days of remote monitoring
within 30 days, might be useful. We welcome comments including any
additional information that the medical community and other members of
the public believe may provide further clarification on how RPM
services are used in clinical practice, and how they might be coded,
billed and valued under the Medicare PFS.
3. Transitional Care Management (TCM)
Payment for TCM CPT codes 99495 (Transitional Care Management
services with the following required elements: Communication (direct
contact, telephone, electronic) with the patient and/or caregiver
within two business days of discharge; medical decision making of at
least moderate complexity during the service period; face-to-face visit
within 14 calendar days of discharge) and 99496 (Transitional Care
Management services with the following required elements: Communication
(direct contact, telephone, electronic) with the patient and/or
caregiver within two business days of discharge; medical decision
making of at least high complexity during the service period; face-to-
face visit within 7 calendar days of discharge) was finalized in the CY
2013 PFS final rule (77 FR 68979 through 68993). At that time, we
identified a list of 57 HCPCS codes (see 77 FR 68990 for the original
guidance) that we stated could not be billed concurrently with TCM
services because of potential duplication of services.
For CY 2020, recognizing that use of TCM services was low when
compared to the number of Medicare beneficiaries with eligible
discharges and that increased utilization of medically necessary TCM
services could improve patient outcomes, one of our proposals included
modifying our prior rule that prohibited the billing of TCM services
with many other services that we had viewed as duplicative (77 FR
68990). In the CY 2020 PFS final rule (84 FR 40549 through 40550), we
finalized a policy to allow concurrent billing of TCM services, when
reasonable and necessary, with 16 actively priced (that is, not bundled
or non-covered) codes during the 30-day period covered by TCM services.
We stated at the time that we would continue to refine our billing
policies for TCM through future notice and comment rulemaking.
We are proposing now for CY 2021 to remove 14 additional actively
priced (not bundled or non-covered) HCPCS codes from the list of
remaining HCPCS codes that cannot be billed concurrently with TCM. We
believe that no overlap exists that would warrant preventing concurrent
reporting between TCM and the services of these 14 codes. We are also
proposing to allow the new Chronic Care Management code HCPCS code
G2058 to be billed concurrently with TCM when reasonable and necessary.
We note that the minutes counted for TCM services cannot also be
counted towards other services. See Table 14 for the list of 15 codes
that we are proposing could be billed concurrently with TCM services
when reasonable and necessary. We welcome comment on our proposal to
allow these additional services to billed concurrently with the TCM
service.
[GRAPHIC] [TIFF OMITTED] TP17AU20.020
[[Page 50121]]
4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code
GCOL1)
In the CY 2017 PFS final rule (81 FR 80230), we established G-codes
used to bill for monthly services furnished using the Psychiatric
Collaborative Care Model (CoCM), an evidence-based approach to
behavioral health integration that enhances ``usual'' primary care by
adding care management support and regular psychiatric inter-specialty
consultation. These G-codes were replaced by CPT codes 99492-99494,
which we established for payment under the PFS in the CY 2018 PFS final
rule (82 FR 53077).
Stakeholders have requested additional coding to capture shorter
increments of time spent, for example, when a patient is seen for
services, but is then hospitalized or referred for specialized care,
and the number of minutes required to bill for services using the
current coding is not met. To accurately account for these resources
costs, we are proposing to establish a G-code to describe 30 minutes of
behavioral health care manager time. Since this code would describe one
half of the time described by the existing code that describes
subsequent months of CoCM services, we are proposing to price this code
based on one half the work and direct PE inputs for CPT code 99493
(Subsequent psychiatric collaborative care management, first 60 minutes
in a subsequent month of behavioral health care manager activities, in
consultation with a psychiatric consultant, and directed by the
treating physician or other qualified health care professional, with
the following required elements:
Tracking patient follow-up and progress using the
registry, with appropriate documentation; participation in weekly
caseload consultation with the psychiatric consultant;
Ongoing collaboration with and coordination of the
patient's mental health care with the treating physician or other
qualified health care professional and any other treating mental health
practitioners;
Additional review of progress and recommendations for
changes in treatment, as indicated, including medications, based on
recommendations provided by the psychiatric consultant;
Provision of brief interventions using evidence-based
techniques such as behavioral activation, motivational interviewing,
and other focused treatment strategies;
Monitoring of patient outcomes using validated rating
scales; and
Relapse prevention planning with patients as they achieve
remission of symptoms and/or other treatment goals and are prepared for
discharge from active treatment.), which is assigned a work RVU of
1.53.
Therefore, the proposed work RVU for the new proposed code is 0.77.
We are proposing that this code could be used for either the initial
month or subsequent months. We note that the existing CPT time rules
for the CoCM services would apply. The proposed code is:
GCOL1: Initial or subsequent psychiatric collaborative
care management, first 30 minutes in a month of behavioral health care
manager activities, in consultation with a psychiatric consultant, and
directed by the treating physician or other qualified health care
professional.
We are proposing that the required elements listed for CPT code
99493 would also be required elements for billing HCPCS cod GCOL1.
Additionally, we propose that CPT time rules would apply, consistent
with the guidance in the CPT codebook for CPT codes 99492-99494.
In the CY 2017 PFS final rule (81 FR 80235), we finalized that CCM
and BHI services could be billed during the same month for the same
beneficiary if all the requirements to bill each service are separately
met. We are also proposing that HCPCS code GCOL1 could be billed during
the same month as CCM and TCM services, provided that all requirements
to report each service are met and time and effort are not counted more
than once. We note that the patient consent requirement would apply to
each service independently.
In the CY 2017 PFS final rule (81 FR 80235), we finalized that the
psychiatric CoCM services may be furnished under general supervision
because we do not believe it is clinically necessary that the
professionals on the team who provide services other than the treating
practitioner (namely, the behavioral health care manager and the
psychiatric consultant) must have the billing practitioner immediately
available to them at all times, as would be required under a higher
level of supervision. Therefore, consistent with the other codes in
this code family (CPT codes 99492-99494), we propose to add HCPCS code
GCOL1 to the list of designated care management services for which we
allow general supervision.
We welcome comments on the proposal to create this new code, as
well as the proposed valuation.
F. Refinements to Values for Certain Services To Reflect Revisions to
Payment for Office/Outpatient Evaluation and Management (E/M) Visits
and Promote Payment Stability During the COVID-19 Pandemic
1. Background
a. Evaluation and Management (E/M) Visits Overview
Physicians and other practitioners who are paid under the PFS bill
for common office visits for evaluation and management (E/M) visits
using a relatively generic set of CPT codes (Level I HCPCS codes) that
distinguish visits based on the level of complexity, site of service,
and whether the patient is new or established. These CPT codes are
broadly referred to as E/M visit codes and historically have included
three key components within their code descriptors: History of present
illness (history), physical examination (exam), and medical decision-
making (MDM).\2\
---------------------------------------------------------------------------
\2\ 2019 CPT Codebook, Evaluation and Management, pages 6
through 13.
---------------------------------------------------------------------------
Currently, there are five levels of office/outpatient E/M visits.
There are five codes representing each level for new patients (CPT
codes 99201 through 99205), and five codes representing each level for
established patients (CPT codes 99211 through 99215). CPT code 99211
(Level 1 established patient) is the only code in the office/outpatient
E/M visit code set that describes a visit that may be performed by the
billing practitioner or by clinical staff under supervision, and that
has no specified history, exam or MDM (see Table 15).
In total, E/M visits billed using these CPT codes comprise
approximately 40 percent of allowed charges for PFS services; and
office/outpatient E/M visits, in particular, comprise approximately 20
percent of allowed charges for PFS services. Within the E/M visits
represented in these percentages, there is wide variation in the volume
and level of E/M visits billed by different specialties. According to
Medicare claims data, E/M visits are furnished by nearly all
specialties, but represent a greater share of total allowed charges for
physicians and other practitioners who do not routinely furnish
procedural interventions or diagnostic tests. Generally, these
practitioners include primary care practitioners and certain other
specialists such as neurologists, endocrinologists and rheumatologists.
Certain specialties, such as podiatry, tend to furnish lower level E/M
visits more often than higher level E/M visits. Some specialties, such
as dermatology,
[[Page 50122]]
tend to bill more E/M visits on the same day as they bill minor
procedures.
b. Overview of Policies Finalized in CY 2020 for CY 2021
In the CY 2020 PFS final rule (84 FR 62844 through 62860), for the
office/outpatient E/M visit code set (CPT codes 99201 through 99215),
we finalized a policy to generally adopt the new coding, prefatory
language, and interpretive guidance framework that has been issued by
the AMA's CPT Editorial Panel (see https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management) and will be effective
January 1, 2021. Under this new CPT coding framework, history and exam
will no longer be used to select the level of code for office/
outpatient E/M visits. Instead, an office/outpatient E/M visit will
include a medically appropriate history and exam, when performed. The
clinically outdated system for number of body systems/areas reviewed
and examined under history and exam will no longer apply, and the
history and exam components will only be performed when, and to the
extent, reasonable and necessary, and clinically appropriate.
As indicated in Table 15, the changes will include deletion of CPT
code 99201 (Level 1 office/outpatient visit, new patient), which the
CPT Editorial Panel decided to eliminate because CPT codes 99201 and
99202 are both straightforward MDM and currently largely differentiated
by history and exam elements. Table 15 provides an overview of how the
level 1 and level 2 office/outpatient E/M visits are currently
structured, demonstrating this current overlap.
[GRAPHIC] [TIFF OMITTED] TP17AU20.021
For levels 2 through 5 office/outpatient E/M visits, selection of
the code level to report will be based on either the level of MDM (as
redefined in the new AMA/CPT guidance framework, also available on the
AMA website at https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management or the total time personally spent by the
reporting practitioner on the day of the visit (including face-to-face
and non-face-to-face time). We continue to believe these policies will
further our ongoing effort to reduce administrative burden, improve
payment accuracy, and update the office/outpatient E/M visit code set
to better reflect the current practice of medicine.
Regarding prolonged visits, we finalized separate payment for a new
prolonged visit add-on CPT code (CPT code 99XXX), and discontinued the
use of CPT codes 99358 and 99359 (prolonged E/M visit without direct
patient contact) to report prolonged time associated with office/
outpatient E/M visits. We refer readers to the CY 2020 PFS final rule
for a detailed discussion of this policy (84 FR 62849 through 62850).
Also we finalized separate payment for HCPCS code GPC1X, to provide
payment for visit complexity inherent to evaluation and management
associated with medical care services that serve as the continuing
focal point for all needed health care services and/or with medical
care services that are part of ongoing care related to a patient's
single, serious, or complex chronic condition.
The AMA RUC resurveyed and revalued the revised office/outpatient
E/M visit code set, concurrent with the CPT Editorial Panel redefining
the services and associated interpretive guidance, and provided us with
its recommendations. In the CY 2020 PFS final rule, we also addressed
and responded to the AMA RUC recommendations. We finalized new values
for CPT codes 99202 through 99215, and assigned RVUs to the new office/
outpatient E/M prolonged visit CPT code 99XXX, as well as the new HCPCS
code GPC1X. These valuations were finalized with an effective date of
January 1, 2021. In Table 16, we provide a summary of the codes and
work RVUs finalized in the CY 2020 PFS final rule for CY 2021.
[[Page 50123]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.022
c. Continuing Stakeholder Feedback
Since issuing the CY 2020 PFS final rule, we have continued to
engage with the stakeholder community on the issues addressed in this
section of our proposed rule. In the CY 2020 PFS final rule (84 FR
62859 through 62860), we discussed public comments we received in
response to our request for comment about whether it would be
appropriate to revalue certain services, other than the global surgical
codes which we addressed separately, for which the values are closely
tied to the values of the office/outpatient E/M visit codes in order to
improve payment accuracy and maintain relativity within the PFS. We
responded that we would consider the commenters' recommendations for
future rulemaking. Since publication of the CY 2020 PFS final rule, we
have received additional feedback from stakeholders, in the form of
written requests and in-person meetings, indicating that certain other
services on which we did not seek comment in the CY 2020 PFS proposed
rule, but which are similar to the office/outpatient E/M visits, have
values that were established relative to values for the office/
outpatient E/M visits or contain office/outpatient E/M visits as
constituent parts of the bundled services included in the code for the
service. We address many of these requests in the following section,
and are seeking comment on whether there are additional, similarly
situated services for which we should consider similar adjustment or
revaluation through future rulemaking. We have also received questions
about the definition and utilization assumptions for the HCPCS add on
code GPC1X.
2. Proposals for CY 2021
a. Time Values for Levels 2-5 Office/Outpatient E/M Visit Codes
In the CY 2020 PFS proposed rule (84 FR 62568), we sought comment
on the times associated with the office/outpatient E/M visits as
recommended by the AMA RUC. When surveying these services for purposes
of valuation, the AMA RUC requested that survey respondents consider
the total time spent on the day of the visit, as well as any pre- and
post-service time occurring within a timeframe of 3 days prior to the
visit and 7 days after, respectively. In developing its recommendations
to us, the AMA RUC then separately averaged the survey results for pre-
service, day of service, and post-service times, and the survey results
for total time, with the result that, for some of the codes, the sum of
the times associated with the three service periods does not match the
RUC-recommended total time. The approach used by the AMA RUC to develop
recommendations sometimes resulted in two conflicting sets of times:
The component times as surveyed and the total time as surveyed. In the
CY 2020 PFS final rule, we finalized adoption of the RUC-recommended
times as explained below, but stated that we would continue to consider
whether this issue has implications for the PFS broadly. When we
establish pre-, intra-, and post-service times for a service under the
PFS, these times always sum to the total time. We believe it would be
illogical for component times not to sum to the total, and this idea is
reflected in our ratesetting system which requires component times to
sum to the total time. Commenters on the CY 2020 PFS proposed rule (84
FR 62849) stated that we should adopt the times as recommended by the
RUC, and did not provide any additional details on the times they
believed we should use when the total time is not the sum of the
component times. Table 17 illustrates the AMA RUC surveyed times for
each service period and the surveyed total time. It also shows the
actual total time calculated as the sum of the component times.
[[Page 50124]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.023
Given the lack of clarity provided by commenters on the CY 2020 PFS
proposed rule about why the sum of minutes in the components would
differ from the total minutes, and our view and systems requirement
that total time must equal the mathematical total of component times,
we are proposing beginning for CY 2021 to adopt the actual total times
(defined as the sum of the component times) rather than the total times
recommended by the RUC for CPT codes 99202 through 99215.
b. Revaluing Services That Are Analogous to Office/Outpatient E/M
Visits
In the CY 2020 PFS proposed rule, we recognized that there are
services other than the global surgical codes for which the values are
closely tied to the values of the office/outpatient E/M visit codes. We
specifically identified transitional care management (TCM) services
(CPT codes 99495, 99496); cognitive impairment assessment and care
planning (CPT code 99483); certain end-stage renal disease (ESRD)
services (CPT codes 90951 through 90970); and the annual wellness visit
(AWV) and initial preventive physical exam (IPPE) (HCPCS codes G0402,
G0438, G0439). Many of these services were valued via a building block
methodology and have office/outpatient E/M visits explicitly built into
their definition or valuation. We stated that we may consider adjusting
the RVUs for these services in future rulemaking, and we sought public
input on such a policy. We noted that, unlike the global surgical
codes, some of these services always include an office/outpatient E/M
visit(s) furnished by the reporting practitioner as part of the
service, and therefore, it may be appropriate to adjust their
valuations commensurate with any changes made to the values for office/
outpatient E/M visits. Some of these services do not actually include
an E/M visit, but we valued them using a direct crosswalk to the RVUs
assigned to an office/outpatient E/M visit(s), and for this reason they
are closely tied to values for office/outpatient E/M visits. Overall,
we believe that the magnitude of the changes to the values of the
office/outpatient E/M visit codes and the associated redefinitions of
the codes themselves are significant enough to warrant an assessment of
the accuracy of the values of services containing, or closely analogous
to, office/outpatient E/M visits. These proposals take into account
input from the public and our own internal review.
We received public comments in support of revaluing certain
services relative to the new office/outpatient E/M visit values. There
was particular support for revaluing the ESRD monthly capitation
payment (MCP) services, TCM services, cognitive impairment assessment
and care planning services, and the emergency department (ED) visits.
Based on input provided since publication of the CY 2020 PFS final rule
by the American College of Obstetricians and Gynecologists (ACOG), we
have also considered the maternity surgical packages which, unlike
other global surgery services, were valued using a methodology,
described in more detail below, that allowed the valuation of the
composite parts of the package to sum to the total value. Additionally,
unlike the 10- and 90-day global surgical services codes (referred to
in this section as 10- and 90-day globals), we have never expressed
concerns as to the accuracy of the values of the maternity packages,
and these services were not part of the policy we adopted to transition
all 10- and 90-day globals to 0-day globals (79 FR 67591), though that
policy was overridden by statutory amendments before it took effect.
(1) End-Stage Renal Disease Monthly Capitation Payment Services
In the CY 2004 PFS final rule with comment period (68 FR 63216), we
established new Level II HCPCS G codes for ESRD services and
established MCP rates for them as specified under section
1881(b)(3)(A)(ii) of the Act. For ESRD center-based patients, payment
for the G codes varied based on the age of the beneficiary and the
number of face-to-face visits furnished each month (for example, 1
visit, 2-3 visits and 4 or more visits). We believed that many
physicians would provide 4 or more visits to center-based ESRD
patients, and a small proportion would provide 2-3 visits or only one
visit per month. Under the MCP methodology, to receive the highest
payment, a physician would have to furnish at least 4 ESRD-related
visits per month. In contrast, payment for home dialysis MCP services
only varied by the age of beneficiary. Although we did not initially
specify a frequency of required visits for home dialysis MCP services,
we stated that we expect physicians to provide clinically appropriate
care to manage the home dialysis patient.
The CPT Editorial Panel created new CPT codes to replace the G
codes for monthly ESRD-related services, and we finalized the new codes
for use under the PFS in CY 2009 (73 FR 69898). The codes created were
CPT codes 90951 through 90962 for monthly ESRD-related services with a
specified number of visits; CPT codes 90963 through 90966 for monthly
ESRD-related services for home dialysis patients; and CPT codes 90967
through 90970 for home dialysis patients with less than a full month of
services. The latter set of codes are billed per encounter and valued
to be 1/30 of the value of CPT codes 90965 and 90966.
In response to our comment solicitation in the CY 2020 PFS final
rule and interim final rule regarding
[[Page 50125]]
whether to adjust the values of the ESRD MCP codes to reflect the
increased values of the office/outpatient E/M visit codes, we received
a number of supportive comments, particularly from specialty societies
representing nephrologists. These commenters pointed out that the MCP
bundled payments for all ESRD-related care for a month were constructed
using a building block methodology and a number of office/outpatient E/
M visits were component parts of those bundles; and that the specified
number of visits in the code descriptor must be furnished in order to
bill for the service. Commenters also noted that although the values of
office/outpatient E/M visit codes have been increased once since the
creation of the MCP G codes and once after adoption of the MCP CPT
codes, the valuation of the ESRD MCP codes was never adjusted to
account for increases to the office/outpatient E/M visit codes. In
Table 18, we provide a summary of the visits bundled into each ESRD MCP
service.
[GRAPHIC] [TIFF OMITTED] TP17AU20.024
In the past, we have not updated the valuation of this code set to
reflect updates to the valuation of the office/outpatient E/M visit
code set and so over time, the values of the ESRD MCP codes have become
out of step with valuation of their constituent visits. We believe
there is sufficient reason to revalue these services to take into
account the changes in valuation for the office/outpatient E/M visits.
These services were initially valued using a building block methodology
which summed the value of the individual service from its components,
and for some of the codes in this code set, a specified number of
visits must be furnished in order to bill for the respective ESRD MCP
code because they are included in the code descriptor.
Therefore, we believe that the ESRD MCP codes should be updated to
more accurately account for the associated office/outpatient E/M
visits. We are proposing to increase the work, physician time, and PE
inputs in the form of clinical staff time of the ESRD MCP codes based
on the marginal difference between the 2020 and 2021 office/outpatient
E/M visit work, physician time, and PE inputs built into each code, as
summarized in Tables 19 and 20. By improving payment accuracy for the
ESRD MCP codes, we would also be supporting broader efforts at
advancing kidney health.\3\ We believe the majority of the visits
included in the ESRD MCP bundles are being furnished, but are seeking
comment on whether there are instances where the number and level of
visits being furnished are not consistent with the number and level of
visits built into the valuation of the code.
---------------------------------------------------------------------------
\3\ HHS Launches President Trump's `Advancing American Kidney
Health' Initiative: https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html.
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3. TCM Services (CPT Codes 99495 and 99496)
The goal of TCM services is to improve the health outcomes of
patients recently discharged from inpatient and certain outpatient
facility stays. We began making separate payment for TCM services in CY
2013. At that time, CPT code 99495 (Transitional Care Management
Services with the following required elements: Communication (direct
contact, telephone, electronic)
[[Page 50126]]
with the patient and/or caregiver with 2 business days of discharge;
medical decision making of at least moderate complexity during the
service period; face-to-face visit within 14 calendar days of
discharge) was valued to include one, level 4 established patient
office/outpatient visit, while CPT code 99496 (Transitional Care
Management Services with the following required elements: Communication
(direct contact, telephone, electronic) with the patient and/or
caregiver with 2 business days of discharge; medical decision making of
at least high complexity during the service period; face-to-face visit
within 7 calendar days of discharge) was valued to include one, level 5
established patient office/outpatient visit (77 FR 68991). In the CY
2020 PFS final rule (84 FR 62687), we finalized the RUC-recommended
work and direct PE inputs for the TCM codes which resulted in small RVU
increases for both codes.
Because both TCM codes include a required face-to-face E/M visit
(either a level 4 or 5 office/outpatient E/M visit), we are proposing
to increase the work RVUs associated with the TCM codes commensurate
with the new valuations for the level 4 (CPT code 99214) and level 5
(CPT code 99215) office/outpatient E/M visits for established patients.
Please see Tables 19 and 20 for long descriptors, as well as current
and proposed work RVUs, physician time, and clinical staff time, for
the TCM codes.
4. Maternity Services
In the CY 2002 PFS final rule with comment period (66 FR 55393), we
finalized separate payment for maternity care services. The maternity
packages are unlike other services for which payment is made under the
PFS in that they are the only global codes that provide a single
payment for almost 12 months of services, including visits, surgical
services, and imaging (among other services); and were valued using a
building-block methodology as opposed to the magnitude estimation
method that is commonly used to value the 10- and 90-day global
services. There are 17 CPT codes that are used for billing delivery,
antepartum, and postpartum maternity care services, and these codes are
all designated with a unique global period indicator ``MMM.''
For CY 2021, the AMA RUC made a recommendation to revalue these
services, along with their recommendations to revalue the 10- and 90-
day global surgical packages, to account for increases in the values of
office/outpatient E/M visits. In the CY 2020 PFS final rule, we decided
not to make changes to the valuation of 10- and 90-day global surgical
packages to reflect changes made to values for the office/outpatient E/
M visit codes while we continue to collect and analyze the data on the
number and level of office/outpatient E/M visits that are actually
being performed as part of these services.
The 10- and 90-day global surgical packages are commonly valued
using a methodology known as magnitude estimation. Magnitude estimation
refers to a methodology for valuing work that identifies the
appropriate work RVU for a service by gauging the total amount of work
for that service relative to the work for a similar service across the
PFS, without explicitly valuing the components of that work. Since its
inception, the AMA RUC has worked under the prevailing assumption that
magnitude estimation is the standard for valuation of all physicians'
services, including those with global surgical packages. Consequently,
the work values associated with expected typical E/M visits within a
code's global period are not necessarily added to the physician work
value for the code to determine the final work RVU. The postoperative
visits in the 10- or 90-day global surgical code periods are often
valued with reference to RVUs for separately-billed E/M visits, but the
bundled post-operative visit RVUs do not directly contribute a certain
number of RVUs to the valuation of the procedures. However, the MMM
codes are unique in both the length of the global period and the
methodology under which they were valued. When CMS established values
for the maternity packages, we based them on RUC recommendations
developed by the relevant specialty societies using the building block
methodology. When it is used for a CPT code representing a bundle of
services, the building block methodology components are the CPT codes
that make up the bundled code and the inputs associated with those
codes. Therefore, when the maternity packages were valued, the work
(and other inputs) associated with the office/outpatient E/M visits in
each package were explicitly accounted for.
In addition, unlike the global surgical codes, we have reason to
believe the visits included in the maternity codes are actually
furnished given the evidence-based standards and professional
guidelines for obstetrical care. For example, The Guidelines for
Perinatal Care state that ``a woman with an uncomplicated first
pregnancy is examined every 4 weeks for the first 28 weeks of
gestation, every 2 weeks until 36 weeks of gestation, and weekly
thereafter.'' \4\ For this reason, we excluded the maternity codes from
our recent global surgery data collection.
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\4\ Kilpatrick SJ, Papile L, and Macones GA, eds. AAP Committee
on Fetus and Newborn and ACOG Committee on Obstetric Practice.
Guidelines for Perinatal Care. Eighth Edition. 2017. Page 150.
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Given the valuation methodology and expectations for office/
outpatient E/M visits in the maternity package codes, and the
revaluation recommendation developed by the AMA RUC, we believe that
the maternity packages should be updated to more accurately reflect the
values of the office/outpatient E/M visits included in the packages. We
believe that, due to the use of the building block valuation
methodology rather than magnitude estimation, and the likelihood that
the bundled visits are actually being furnished, the valuations
recommended to us by the AMA RUC more accurately reflect the resource
costs associated with furnishing these services. In the past, the work,
physician time, and PE for these services have not been revalued to
reflect changes to the office/outpatient E/M visits that are included
as part of the package and therefore, the valuation of the MMM surgical
packages have become misaligned with the valuation of their constituent
office visits.
When revaluing the maternity packages, the AMA RUC used a
methodology similar to what we used when revaluing the ESRD MCP codes
and TCM by adding in the marginal differences in work, physician time,
and practice expense (PE) in the form of clinical staff time between
the current and 2021 E/M values. We believe that this method accurately
accounts for the increase in valuation relative to the office/
outpatient E/M visits, and therefore, we are proposing to increase the
work RVUs, physician time, and PE inputs in the form of clinical staff
time associated with the maternity packages by accepting the
revaluation recommendation from the AMA RUC as detailed in Tables 19
and 20.
We would also note that, in addition to appropriately reflecting
changes to values of the office and outpatient E/M visits, increases
made to the valuation of the maternity package codes would be
consistent with our broader focus on improving maternal health and
birth outcomes. The proposed changes would account for additional
resources involved with additional work that is needed on the part of
practitioners to improve care for this patient population, such as risk
identification and ensuring appropriate interventions and referrals.\5\
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\5\ https://www.hhs.gov/blog/2020/01/29/achieving-better-health-mothers-and-babies.html; https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/rural-health/21-Maternal-Health-Forum-Improving-Maternal-Health-for-Our-Communities.pdf; https://innovation.cms.gov/innovation-models/maternal-opioid-misuse-model.
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[[Page 50127]]
5. Assessment and Care Planning for Patients With Cognitive Impairment
(CPT Code 99483)
In CY 2017, we established payment for HCPCS code G0505 (Assessment
and care planning for patients with cognitive impairment) to provide
payment for cognitive impairment assessment and care planning,
believing that the CPT Editorial Panel was developing new coding for
that service. In response to the CY 2017 PFS proposed rule, the AMA RUC
submitted recommended values for this code, which we adopted in the CY
2017 PFS final rule. In CY 2018, the CPT Editorial Panel created CPT
code 99483 for reporting of this service and in CY 2018, CMS adopted
CPT code 99483 (deleting HCPCS code G0505) without changing the service
valuation. Based on input from commenters and the AMA RUC, the
valuation of this service reflected the complexity involved in
assessment and care planning for patients with cognitive impairment by
including resource costs that are greater than the highest valued
office/outpatient E/M visit (CPT code 99205, new patient level 5 visit)
(81 FR 80352). Specifically, the service includes a cognition-focused
evaluation including a pertinent history and examination, and medical
decision making of moderate or high complexity, in addition to many
functional and other assessments specific to cognitive status. With the
revaluation we finalized in the CY 2020 PFS final rule for CPT code
99205 effective beginning in CY 2021, the current work RVU for CPT code
99483 would have a lower work RVU than a new patient level 5 office/
outpatient E/M visit, which would create a rank order anomaly between
the two codes that, given the way the code was valued, we do not
believe would be appropriate. Rather, because CPT code 99483 was valued
in relation to a level 5 office/outpatient E/M visit, we believe that
an adjustment to the work, physician time, and PE for this service to
reflect the marginal difference between the value of the level 5 new
patient office/outpatient E/M visit in CY 2020 and CY 2021 would be
appropriate to maintain payment accuracy. Therefore, we are proposing
to adjust the work, time, and PE in the form of clinical staff time for
CPT code 99483 as shown in Tables 19 and 20.
6. Initial Preventive Physical Examination (IPPE) and Initial and
Subsequent Annual Wellness (AWV) Visits
In the CY 2011 PFS final rule with comment period, we finalized
separate payment for HCPCS codes G0438 (Annual wellness visit; includes
a personalized prevention plan of service (pps), initial visit) and
G0439 (Annual wellness visit, includes a personalized prevention plan
of service (pps), subsequent visit). These services were valued via a
direct crosswalk to the work, time, and direct PE inputs associated
with CPT codes 99204 and 99214, respectively. In that same rule, we
stated that the HCPCS code G0402 (Initial preventive physical
examination; face-to-face visit, services limited to new beneficiary
during the first 12 months of Medicare enrollment) was also valued
based on a direct crosswalk to the work, time, and direct PE inputs for
CPT code 99204 (75 FR 73408-73411).
Because these codes are valued using direct crosswalks to office/
outpatient E/M visits, and based on the principles articulated above,
we believe that to maintain payment accuracy for the IPPE and the AWV,
their values should be adjusted to reflect the changes in value for CPT
codes 99204 and 99214. Therefore, we are proposing to revise the work,
physician time, and direct PE inputs for these codes as shown in Tables
19 and 20.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
7. Emergency Department Visits
The ED visit codes have been revalued under the PFS three times- in
1997, 2007, and most recently in 2018 as part of the misvalued code
initiative for CY 2020 rulemaking. Each subsequent revaluation was done
in part to maintain relativity with the office/outpatient E/M visit
codes. Specifically, when these services were revalued in prior
rulemaking, the principle was that levels 1 through 3 of the ED visits
should have the same value as the level 1 through 3 new patient office/
outpatient E/M visits and that the levels 4 and 5 ED visits should be
valued higher than the levels 4 and 5 new patient office/outpatient E/M
visits to reflect higher typical intensity in the ED setting. In the CY
2018 PFS final rule, we finalized a proposal to nominate the level 1
through level 5 ED visit codes (CPT codes 99281-99285, see Table 21 for
long descriptors) as potentially misvalued based on information
suggesting that the work RVUs for ED visits may not appropriately
reflect the full resources involved in furnishing these services.
Specifically, stakeholders expressed concerns that the work RVUs for
these services have been undervalued given the increased acuity of the
patient population and the heterogeneity of the sites, such as
freestanding and off-campus EDs, where ED visits are furnished (82 FR
53018). The AMA RUC surveyed and reviewed five of these codes for the
April 2018 RUC meeting and provided a recommendation to CMS for
consideration in CY 2020 rulemaking. In the CY 2020 PFS final rule, we
finalized the RUC-recommended work RVUs of 0.48 for CPT code 99281, a
work RVU of 0.93 for CPT code 99282, a work RVU of 1.42 for 99283, a
work RVU of 2.60 for 99284, and a work RVU of 3.80 for CPT code 99285.
The RUC did not recommend, and we did not finalize, any direct PE
inputs for the codes in this family. The AMA RUC submitted these
recommended values to CMS prior to the submission of the RUC-
recommended revaluation of the office/outpatient E/M visit code family.
In response to our comment solicitation in CY 2020 PFS rulemaking
regarding whether certain services should be revalued to maintain
relativity with office/outpatient E/M visits, the American College of
Emergency Physicians submitted a public comment stating that relativity
between the ED visits and office/outpatient E/M visits should be
maintained, and provided CMS with a specific recommendation for CPT
codes 99283-99285. The association believed we should continue to
preserve the same relationship between the ED and office/outpatient E/M
visit code sets that was established in prior years and would have
likely been maintained had the office/outpatient E/M visits been
revalued prior to the ED visits. They have also submitted a subsequent
letter to this effect. We agree with the society, particularly since
the justification provided by the AMA RUC recommendations we accepted
for the CY 2020 revaluation was, in part, to maintain relativity with
the office/outpatient E/M visits, and that relativity would be
disrupted if they were to remain unadjusted. The proposed values are
consistent with the principle that the levels 1-3 ED visits should
remain the same as the levels 1-3 new patient office visits but the
levels 4-5 ED visits should have a higher value than the corresponding
office visits, due to the complexity of the patients requiring that
level of emergency care. Therefore, we are proposing the values
recommended by ACEP as shown in Table 21.
8. Therapy Evaluations
There are a number of services paid under the PFS that are similar
in many respects to the office/outpatient E/M visit code set, but do
not specifically include, were not valued to include, and were not
necessarily valued relative to,
[[Page 50134]]
office/outpatient E/M visits. These codes inherently include work
associated with assessment and work associated with management, similar
to the work included in the office/outpatient E/M visits, which involve
time spent face-to-face assessing and treating the patient. These
services include therapy evaluation services and psychiatric diagnostic
evaluation services. The practitioners who furnish these services are
prohibited by CMS from billing E/M services due to the limitations of
their Medicare benefit categories. As such, the CPT Editorial Panel has
created specific coding to describe the services furnished by these
practitioners. Although these services are billed using specific,
distinct codes relating to therapy evaluations and psychiatric
diagnostic evaluations, we believe that a significant portion of the
overall work in the codes is for assessment and management of patients,
as it is for the office/outpatient E/M visit codes.
Therefore, we are proposing to adjust the work RVUs for these
services based on a broad-based estimate of the overall change in the
work associated with assessment and management to mirror the overall
increase in the work of the office/outpatient E/M visits. We calculated
this adjustment based on a volume-weighted average of the increases to
the office/outpatient E/M visit work RVUs from CY 2020 to CY 2021.
Details on this calculation are available as a public use file on the
CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices. We are
proposing to apply that percentage increase, which we estimate to be
approximately 28 percent, to the work RVUs for the therapy evaluation
and psychiatric diagnostic evaluation services codes. We believe that
it is important to the relativity of the PFS to revalue these services
to reflect the overall increase in value associated with spending time
assessing and managing patients, as reflected in the changes to work
values for the office/outpatient E/M visits, particularly in
recognition of the value of the clinicians' time which is spent
treating a growing number of patients with greater needs and multiple
medical conditions. We recognize that this is not the methodology
typically used to value services under the PFS and are seeking comment
on potential alternative methodologies or specific values for these
services, particularly about whether commenters believe it would be
better to develop values using comparator codes from the office/
outpatient E/M visit code set, and if so, why.
9. Behavioral Healthcare Services
The psychotherapy code set is divided into psychotherapy that can
be furnished as a standalone service and psychotherapy furnished in
conjunction with an office/outpatient E/M visit. The standalone
psychotherapy services are CPT codes 90832, 90834, and 90837 (See Table
21 for long descriptors). The CPT codes describing psychotherapy
furnished in conjunction with an office/outpatient E/M visit are CPT
codes 90833 (Psychotherapy, 30 minutes with patient when performed with
an evaluation and management service (List separately in addition to
the code for primary procedure)), 90836 (Psychotherapy, 45 minutes with
patient when performed with an evaluation and management service (List
separately in addition to the code for primary procedure)) and 90838
(Psychotherapy, 60 minutes with patient when performed with an
evaluation and management service (List separately in addition to the
code for primary procedure)). As the values for the office/outpatient
E/M visits are increasing, there will necessarily be an increase in the
overall value for psychotherapy furnished in conjunction with office/
outpatient E/M visits. We believe that it is important, both in terms
of supporting access to behavioral health services through appropriate
payment and maintaining relativity within this code family, to increase
the values for the standalone psychotherapy services to reflect changes
to the value of the office/outpatient E/M visits which are most
commonly furnished with the add-on psychotherapy services with
equivalent times. For example, under the finalized revaluation of the
office/outpatient E/M visits, the proportional work value of the
standalone psychotherapy CPT code 90834 (Psytx w pt 45 minutes) would
decrease relative to the combined work RVUs for CPT code 99214 (Level 4
Office/outpatient visit est) when billed with CPT code 90836 (Psytx w
pt w e/m 45 min). The current combined work RVU for CPT code 99214 when
reported with CPT code 90836 is 3.40 (1.90 + 1.50) and the current work
RVU for CPT code 90834 is 2.0. With the revaluation of the office/
outpatient E/M visits beginning for CY 2021, the combined work RVU for
CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92), while the
current work RVU for 90834 would remain at 2.0, resulting in a change
to relativity between these services.
To maintain the current relativity, which we believe to be
appropriate based on the proportionate difference between these
services, we are proposing to increase the work RVU for CPT code 90834
from 2.00 to 2.25 based on the marginal increase in work value for CPT
code 99214 from CY 2020 to CY 2021. Similarly, for CPT code 90832,
which describes 30 minutes of psychotherapy, we are proposing to
increase its work RVU based on the increase to CPT code 99213, which is
most commonly billed with the 30 minutes of psychotherapy add-on, CPT
code 90833. For CPT code 90837, which describes 60 minutes of
psychotherapy, we propose to increase the work RVU based on the
proportional increase to CPT codes 99214 and 90838, which is the
office/outpatient E/M visit code most frequently billed with the 60
minutes of psychotherapy add-on. Table 21 provides a summary of the
current and proposed RVUs for these services.
[[Page 50135]]
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10. Ophthalmological Services
We received a request to revalue the following ophthalmological
services which we are not proposing to revalue:
CPT code 92002: Ophthalmological services: medical
examination and evaluation with initiation of diagnostic and treatment
program; intermediate, new patient.
CPT code 92004: Ophthalmological services:
medical examination and evaluation with initiation of diagnostic and
treatment program; comprehensive, new patient, 1 or more visits.
CPT code 92012: Ophthalmological services:
medical examination and evaluation, with initiation or continuation of
diagnostic and treatment program; intermediate, established patient.
CPT code 92014: Ophthalmological services:
medical examination and evaluation, with initiation or continuation of
diagnostic and treatment program; comprehensive, established patient, 1
or more visits.
We are not proposing to revalue these services because they are not
sufficiently analogous or connected to the office/outpatient E/M visit
codes. While these ophthalmological services have historically been
valued relative to office/outpatient E/M visits, they have not been
reviewed by the RUC since 2007. Two of these ophthalmological services
can include more than one visit, and the number of visits included in
the package is uncertain and therefore are not so closely tied to
office and outpatient E/M services which describe a single visit. In
addition, starting in 2021, the office/outpatient E/M visit codes will
be substantially redefined to allow time or medical decision-making for
code level selection, concepts that do not apply in these
ophthalmological visits which rely on criteria specific to evaluation,
examination, specified technical procedures, and treatment of ocular
conditions for purposes of level selection.\6\ The number of levels
within the two code sets differs, and the number of levels has changed
for office/outpatient E/M visits. Given the revised code set and
framework for level selection for office/outpatient E/M visits, the
level of office/outpatient E/M visits to which the ophthalmological
visits might be analogous is no longer clear. We are also aware that
ophthalmologists report office/outpatient E/M visits as well these
ophthalmologic-specific evaluation codes. The relationship between the
two separate code sets and the reason for relying on both of them is
unclear.
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\6\ CPT Codebook pp. 656-7.
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In addition, the four ophthalmological evaluation codes are
reported with modifier -25 (significant, separately identifiable E/M
service by the same physician on the same day of the procedure or other
service) approximately 4 to 14 percent of the time (depending on the
code in question). Similarly, ED visits are reported with modifier -25
approximately 4 to 12 percent of the time (depending on the code in
question). In contrast, the office/outpatient E/M visit codes are
reported with modifier -25 approximately 18 to 35 percent of the time
(depending on the code in question). We are in the process of analyzing
these data further to assess how often the accompanying service is a
minor procedure rather than a visit. We believe that visit/evaluation
codes furnished the same day as a minor procedure are not closely
analogous to stand-alone office/outpatient E/M visits, and therefore
should not be revalued commensurate with the increase to stand-alone
office/outpatient E/M visits for 2021. As we discussed in prior PFS
rules, we continue to believe that separately identifiable visits
occurring on the same day as minor procedures (such as zero-day global
procedures) have resources that are sufficiently distinct from the
costs associated with furnishing office/outpatient E/M visits to
warrant different payment (see, for example, the CY 2019 PFS final
rule, 83 FR 59639)). As we continue our analysis, we are seeking public
comment on whether visits/evaluations that are furnished frequently
with same-day procedures should be revalued commensurate with increases
to the office/outpatient E/M visits, or whether they are substantially
different enough to warrant independent valuation. We note that the
stand-alone psychotherapy services would be revalued to maintain
relativity with the psychotherapy services that can be performed in
conjunction with an E/M visit. Standalone psychotherapy services cannot
be billed with office/outpatient E/M visits while ophthalmological
visits can, as well as with a separate procedure.
[[Page 50138]]
c. Comment Solicitation on the Definition of HCPCS Code GPC1X
Although we believe that the RUC-recommended values for the revised
office/outpatient E/M visit codes will more accurately reflect the
resources involved in furnishing a typical office/outpatient E/M visit,
we continue to believe that the typical visit described by the revised
and revalued office/outpatient E/M visit code set still does not
adequately describe or reflect the resources associated with primary
care and certain types of specialty visits. Therefore, in the CY 2020
PFS final rule (84 FR 62856), we finalized the HCPCS add-on code GPC1X
which describes the ``visit complexity inherent to evaluation and
management associated with medical care services that serve as the
continuing focal point for all needed health care services and/or with
medical care services that are part of ongoing care related to a
patient's single, serious, or complex condition.'' We stated that we
were not restricting billing based on specialty, but that we did assume
that certain specialties furnished these types of visits more than
others.
Since the publication of the CY 2020 PFS final rule, some specialty
societies have stated that our definition of this service, as
articulated in the code descriptor and the associated preamble
discussion, is unclear. For example, some stakeholders have suggested
that HCPCS add-on code GPC1X, as currently described, could be
applicable for every office/outpatient E/M visit. They have also
expressed concerns regarding our utilization assumptions, since we
assumed that specialties that predominantly furnish the kind of care
described by the code would bill it with every visit. Therefore, we are
soliciting from the public comments providing additional, more specific
information regarding what aspects of the definition of HCPCS add-on
code GPC1X are unclear, how we might address those concerns, and how we
might refine our utilization assumptions for the code.
We continue to believe that the time, intensity, and PE involved in
furnishing services to patients on an ongoing basis that result in a
comprehensive, longitudinal, and continuous relationship with the
patient and involves delivery of team-based care that is accessible,
coordinated with other practitioners and providers, and integrated with
the broader health care landscape, are not adequately described by the
revised office/outpatient E/M visit code set. We believe the inclusion
of HCPCS add-on code GPC1X appropriately recognizes the resources
involved when practitioners furnish services that are best-suited to
patients' ongoing care needs and potentially evolving illness. We also
believe the work reflected in HCPCS add-on code GPC1X is inherently
distinct from existing coding that describes preventive and care
management services. For example, the AWV describes and pays for a
static annual health assessment rather than the time, intensity, and PE
involved in furnishing services to patients on an ongoing basis.
Similarly, TCM service codes are focused on care management for 30 days
following a discharge rather than the time, intensity, and PE involved
in furnishing services to patients on an ongoing basis. Chronic care
management and principal care management service codes are limited to
patients with chronic condition(s). Under chronic care management
codes, patients have two or more chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, whereas principal care
management services are for patients who have a single high-risk
disease of sufficient severity to place the patient at risk of
hospitalization or have been the cause of recent hospitalization. In
contrast, we believe HCPCS add-on code GPC1X reflects the time,
intensity, and PE when practitioners furnish services that enable them
to build longitudinal relationships with all patients (that is, not
only those patients who have a chronic condition or single-high risk
disease) and to address the majority of patients' health care needs
with consistency and continuity over longer periods of time. For
example, in the context of primary care, HCPCS add-on code GPC1X could
recognize the resources inherent in holistic, patient-centered care
that integrates the treatment of illness or injury, management of acute
and chronic health conditions, and coordination of specialty care in a
collaborative relationship with the clinical care team. In the context
of specialty care, HCPCS add-on code GPC1X could recognize the
resources inherent in engaging the patient in a continuous and active
collaborative plan of care related to an identified health condition
the management of which requires the direction of a clinician with
specialized clinical knowledge, skill and experience. Such
collaborative care includes patient education, expectations and
responsibilities, shared decision-making around therapeutic goals, and
shared commitments to achieve those goals. In both examples, HCPCS add-
on code GPC1X reflects the time, intensity, and PE associated with
providing services that result in care that is personalized to the
patient. Finally, we believe that the HCPCS add-on code GPC1X could
bolster the efforts of practitioners in rural communities, including
NPPs, to deliver the comprehensive and longitudinal care that HCPCS
add-on code GPC1X describes.
d. Prolonged Office/Outpatient E/M Visits (CPT Code 99XXX)
We reviewed our final policy for 2021 regarding the reporting of
prolonged office/outpatient E/M visits finalized in the CY 2020 PFS
final rule (84 FR 62848 through 62850). To report these visits
beginning in 2021, we finalized CPT code 99XXX (Prolonged office or
other outpatient evaluation and management service(s) (beyond the total
time of the primary procedure which has been selected using total
time), requiring total time with or without direct patient contact
beyond the usual service, on the date of the primary service; each
additional 15 minutes (List separately in addition to CPT codes 99205,
99215 for office or other outpatient evaluation and management
services)). CPT code 99XXX is only reported when time is used to select
the visit level, and only time of the physician or qualified healthcare
professional is counted. In the CY 2020 PFS final rule, we stated that
our interpretation of revised CPT prefatory language and reporting
instructions would mean that CPT code 99XXX could be reported when the
physician's (or NPP's) time is used for code level selection and the
time for a level 5 office/outpatient E/M visit (the floor of the level
5 time range) is exceeded by 15 minutes or more on the date of service
(84 FR 62848 through 62849). The intent of the CPT Editorial Panel was
unclear because of the use of the terms ``total time'' and ``usual
service'' in the CPT code descriptor (``requiring total time with or
without direct patient contact beyond the usual service.'') The term
``total time'' is unclear because office/outpatient E/M visits now
represent a range of time, and ``total'' time could be interpreted as
including prolonged time. Further, the term, ``usual service'' is
undefined. There is no longer a typical time in the code descriptor
that could be used as point of reference for when the ``usual time'' is
exceeded for all practitioners, and there would be variation (as well
as potential double counting of time) if applied at the individual
practitioner level.
Having reviewed the policy we finalized last year, we believe that
allowing reporting of CPT code 99XXX
[[Page 50139]]
after the minimum time for the level 5 visit is exceeded by at least 15
minutes would result in double counting time. As a specific example,
the time range for CPT code 99215 is 40-54 minutes. If the reporting
practitioner spent 55 minutes of time, 14 of those minutes are included
in the services described by CPT code 99215. Therefore, only 1 minute
should be counted towards the additional 15 minutes needed to report
CPT code 99XXX and prolonged services should not be reportable as we
finalized last year (see Table 33 of the CY 2020 PFS final rule (84 FR
62849)). Therefore, we are proposing that when the time of the
reporting physician or NPP is used to select office/outpatient E/M
visit level, CPT code 99XXX could be reported when the maximum time for
the level 5 office/outpatient E/M visit is exceeded by at least 15
minutes on the date of service. In Tables 22 and 23, we provide
examples.
[GRAPHIC] [TIFF OMITTED] TP17AU20.034
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G. Scope of Practice and Related Issues
We are proposing several policies consistent with the President's
Executive Order 13890 on ``Protecting and Improving Medicare for Our
Nation's Seniors'' to modify supervision and other requirements of the
Medicare program that limit healthcare professionals from practicing at
the top of their license (84 FR 53573, October 8, 2019, Executive Order
#13890). In December 2019, we requested feedback in response to part of
this Executive Order seeking the public's help in identifying
additional Medicare regulations which contain more restrictive
supervision requirements than existing state scope of practice laws, or
which limit health professionals from practicing at the top of their
license (the request for feedback is available at https://www.cms.gov/files/document/request-information-reducing-scope-practice-burden.pdf).
Through review of the feedback we received, we identified the policies
in this section to address in the PFS proposed rule. We believe that
physicians, NPPs, and other professionals should be able to furnish
services to Medicare beneficiaries in accordance with their scope of
practice and state licensure, including education and training, to the
extent permitted under the Medicare statute, as long as it is not
likely to result in fraud, waste or abuse. These proposed policies may
also help ensure an adequate number of clinicians, in addition to
physicians are able to furnish critical services including primary care
services in areas where there is a shortage of physicians.\7\ Some of
the proposals may also help alleviate the opioid crisis.
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\7\ Zhang et al. Physician workforce in the United States of
America: forecasting nationwide shortages. Human Resources for
Health (2020); 18:8. Published online February 6, 2020 and available
online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006215/.
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We note that the responses to our request for feedback on the
topics in this section did not indicate the number of states that have
more flexible scope of practice rules than our federal regulations, or
whether facilities (such as hospitals or nursing facilities) have
relevant policies that limit the ability of the impacted professionals
to perform certain services. For example, if Medicare payment policy
provided for payment of diagnostic tests supervised by NPPs, there may
still be facility- or state-specific policies in place that limit NPPs'
ability to supervise some or all diagnostic tests, and those
limitations would inform the potential impact of changing our policy.
While our proposed flexibility may increase the capacity and
availability of practitioners who can supervise diagnostic tests, which
would alleviate some of the demand on physicians as the only source to
perform this particular function, we have not located information
indicating the degree to which NPP scope of practice includes
supervision of auxiliary staff, especially for the subset of services
that are diagnostic tests. There is a wide range of diagnostic tests,
from a simple strep throat swab to more sophisticated and/or invasive
tests such as x-rays and cardiology procedures. We would need to
understand the scope of practice for many types of auxiliary staff
(some of whom are not licensed) who could potentially provide these
tests under the supervision of an NPP, including RNs, LPNs, medical
assistants, radiologic technicians, and many others. To the extent
practice patterns change, there
[[Page 50140]]
could be induced utilization that would increase costs, but this might
be offset by reduced payment rates because direct payment to NPPs is at
a lower rate than payment to physicians. Therefore, in this proposed
rule, we are also seeking information about the number and names of
states that have licensure or scope of practice laws in place, as well
as any facility-specific policies, that would impact the ability of
clinicians to exercise the flexibilities we are proposing, to help us
assess the potential impact of, or challenges for, our proposed
changes. Information about specific services (service-level
information) would be especially helpful. We are seeking public comment
on whether applicable state laws, scope of practice, and facility
policies would permit practitioners to exercise the proposed
flexibilities if CMS were to adopt the policies proposed in this
section, and to what extent practitioners would be permitted to
exercise these proposed flexibilities, such as for all diagnostic tests
or only a subset.
1. Teaching Physician and Resident Moonlighting Policies
a. Background
In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the
May 1st COVID-19 IFC (85 FR 27550 through 27629), we implemented
several policies on an interim final basis related to PFS payment for
the services of teaching physicians involving residents and resident
moonlighting regulations. The comment periods for both the March 31st
COVID-19 IFC (85 FR 19230) and the May 1st COVID-19 IFC (85 FR 27550)
have closed. Therefore, we plan to address the IFC comments for issues
in which we have proposals in this proposed rule when we publish the
PFS final rule. We are considering whether these policies should be
extended on a temporary basis (that is, if the PHE ends in 2021, these
policies could be extended to December 31, 2021 to allow for a
transition period before reverting to status quo policy) or be made
permanent, and are soliciting public comments on whether these policies
should continue once the PHE ends. We believe public comment will
assist us in identifying appropriate policy continuation decisions that
we would consider finalizing in the CY 2021 PFS final rule.
For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act
specifies that in the case of physicians' services furnished to a
patient in a hospital with a teaching program, the Secretary shall not
provide payment for such services unless the physician renders
sufficient personal and identifiable physicians' services to the
patient to exercise full, personal control over the management of the
portion of the case for which payment is sought.
Regulations regarding PFS payment for teaching physician services
and services of moonlighting residents are codified in 42 CFR part 415.
In general, under Sec. 415.170, payment is made under the PFS for
services furnished in a teaching hospital setting if the services are
personally furnished by a physician who is not a resident, or the
services are furnished by a resident in the presence of a teaching
physician, with exceptions as specified in subsequent regulatory
provisions in part 415. Under Sec. 415.172, if a resident participates
in a service furnished in a teaching setting, PFS payment is made only
if the teaching physician is present during the key portion of any
service or procedure for which payment is sought. The regulation at
Sec. 415.180 states that, for the interpretation of diagnostic
radiology and other diagnostic tests, PFS payment is made if the
interpretation is performed or reviewed by a physician other than a
resident. Under Sec. 415.184, PFS payment is made for psychiatric
services furnished under an approved graduate medical education (GME)
program if the requirements of Sec. Sec. 415.170 and 415.172 are met,
except that the requirement for the presence of the teaching physician
during psychiatric services in which a resident is involved may be met
by observation of the service by use of a one-way mirror, video
equipment, or similar device.
b. Supervision of Residents in Teaching Settings Through Audio/Video
Real-Time Communications Technology
In both the March 31st COVID-19 IFC (85 FR 19258 through 19261) and
the May 1st COVID-19 IFC (85 FR 27550 through 27629), we adopted a
policy on an interim basis during the COVID-19 PHE that, under Sec.
415.172, the requirement for the presence of a teaching physician
during the key portion of the service furnished with the involvement of
a resident can be met using audio/video real-time communications
technology. In other words, the teaching physician must be present,
either in person or virtually through audio/video real-time
communications technology, during the key portion of the service. This
policy generally requires real-time observation (not mere availability)
by the teaching physician through audio and video technology, and does
not include audio-only technology (for example, telephone without
video). For the primary care exception under Sec. 415.174(c), we
adopted a policy on an interim final basis for the duration of the
COVID-19 PHE to allow the teaching physician to direct the care
furnished by the resident, and to review the services furnished by the
resident during or immediately after the visit, remotely using audio/
video real-time communications technology.
Under Sec. 415.180, we adopted a policy on an interim basis for
the duration of the COVID-19 PHE to allow PFS payment to be made for
the interpretation of diagnostic radiology and other diagnostic tests
if the interpretation is performed by a resident when the teaching
physician is present through audio/video real-time communications
technology. A physician other than the resident must still review the
resident's interpretation. Under Sec. 415.184, we adopted a policy on
an interim basis during the COVID-19 PHE that the requirement for the
presence of the teaching physician during the psychiatric service in
which a resident is involved may be met by the teaching physician's
direct supervision using audio/video real-time communications
technology.
We are considering whether the flexibilities described above that
we implemented on an interim basis during PHE under Sec. Sec. 415.172,
415.174, 415.180, and 415.184 should be extended on a temporary basis
(that is, if the PHE ends in 2021, these policies could be extended to
December 31, 2021 to allow for a transition period before reverting to
status quo policy) or be made permanent, and are soliciting public
comments on whether these policies should continue once the PHE ends.
We believe public comment will assist us in identifying appropriate
policy continuation decisions that we would consider finalizing in the
CY 2021 PFS final rule. In addition, we are proposing to make a
technical edit to the regulation text at Sec. 415.184 to eliminate the
term ``direct supervision'' to conform with the language in sections
Sec. Sec. 415.172, 415.174, and 415.180 regarding the presence of the
teaching physician via audio/video real-time communications technology.
While we believe it was appropriate to permit teaching physicians
to be involved in services furnished with residents through audio/video
real-time communications technology to respond to critical needs during
the PHE to reduce exposure risk and to increase the capacity of
teaching settings to respond to COVID-19, we are concerned that
continuing to permit teaching physicians to be involved through their
virtual presence may not be sufficient to warrant PFS payment to the
teaching
[[Page 50141]]
physician on a temporary or permanent basis. Absent the circumstances
of the PHE, the physical, in-person presence of the teaching physician
may be necessary to provide oversight to ensure that care furnished to
Medicare beneficiaries is medically reasonable and necessary, and to
ensure that the teaching physician renders sufficient personal services
to exercise full, personal control of the key portion of the case.
We also have some concerns about patient safety when the teaching
physician is only virtually present. For example, in the March 31st
COVID-19 IFC, we excluded the surgical, high risk, interventional,
endoscopic, or other complex procedures identified under Sec.
415.172(a)(1), and anesthesia services under Sec. 415.178 from the
policy to allow the teaching physician to be present using audio-video
real-time communications technology because we believe the requirement
for the physical, in-person presence of the teaching physician for
either the entire procedure or the key portion of the service with
immediate availability throughout the procedure, as applicable, is
necessary for patient safety given the risks associated with these
services. In complex, high-risk, surgical, interventional, or
endoscopic procedures, or anesthesia procedures, a patient's clinical
status can quickly change. To permit payment under the PFS for these
teaching physician services, we believe the services must be furnished
with a certain level of personal oversight and involvement of the
teaching physician who has the experience and judgment that is
necessary for rapid on-site decision-making during these procedures.
There may be circumstances in which virtual presence of the
teaching physician, considered in light of the potential risks to
patient safety and absent exposure risk concerns due to COVID-19, does
not demonstrate sufficient personal involvement in the service to the
patient to warrant payment to the teaching physician under the PFS. For
example, a resident could evaluate a patient for change in mental
status following surgery for hip fracture, perform a physical exam and
report it as unrevealing, and note that the patient is uncooperative
with a full exam. If a full exam had been performed by the teaching
physician or with the physical presence of the teaching physician (or
with the teaching physician immediately available in the clinic to
provide the necessary direction, under the primary care exception) to
render personal and identifiable physicians' services to the patient,
the exam would likely have revealed crystal-mediated acute arthritis,
and that the patient's lack of cooperation was due to hypoactive
delirium. However, the teaching physician may not have been able to
identify this concern through the use of audio/video interactive
communications technology. In this case, the presence of the teaching
physician through audio/video interactive communications technology
might have been insufficient to allow the teaching physician to render
personal and identifiable physicians' services to exercise full,
personal control over the key portion of the encounter.
There also may be certain patient populations that require greater
clinical attentiveness and skill than the teaching physician could
provide via audio/video interactive communications technology. For
example, patients with cognitive impairment or dementia may require the
experience and skill to recognize a need for specialized testing, and
patients with communication disabilities may require more experience
and skill to recognize specialized needs. It may not be possible for
the teaching physician to meet these clinical needs and exercise full,
personal control while being present for the key portion of the service
through audio/video interactive communications technology. Moreover,
the virtual connection between the teaching physician and the resident
who is with the patient could be disrupted (as with any virtual
supervision scenario), rendering it impossible for the teaching
physician to provide necessary direction for the resident to furnish
appropriate care to the patient, thus foreclosing the ability of the
teaching physician to exercise full, personal control over the key
portion of the services, and potentially putting the patient's safety
at risk.
While we have significant concerns about extending our interim
policy to permit virtual presence of the teaching physician, whether on
a temporary or permanent basis, we believe public comment would be
helpful as we further consider the status of this policy. For example,
because COVID-19 may continue to persist in some communities after the
expiration of the PHE, we are considering extending our policy to
permit the teaching physician to be present through audio/video
interactive communications technology on a temporary basis until the
end of the calendar year in which the PHE ends. The presence of COVID-
19 may result in a need for some teaching settings to continue to limit
exposure risks, especially for high risk patients isolated for their
own protection or in cases where the teaching physician has been
exposed to the virus and must be under quarantine. If the teaching
physician is under quarantine, termination of the policy to permit
virtual presence of the teaching physician could unintentionally limit
the number of licensed practitioners available to furnish services to
Medicare patients in some communities, and could have the unintended
consequence of limiting access to services for Medicare patients. Some
communities may experience a resurgence of COVID-19, and extending our
policy until the end of the calendar year in which the PHE ends to
permit PFS payment when the teaching physician is present through
audio/video real-time communications technology could temporarily help
teaching settings remain prepared with surge capacity.
Based on the clinical experience gained during the PHE, we might
identify circumstances or procedures for which the teaching physician
can routinely render sufficient personal and identifiable services to
the patient to exercise full, personal control over the management of
the key portion of the case when the services are furnished by a
resident with the teaching physician present through audio/video real-
time communications technology. For example, under ordinary
circumstances for the primary care exception at Sec. 415.174, we
permit PFS payment to the teaching physician when a resident furnishes
office/outpatient evaluation and management (E/M) visit codes of lower
and mid-level complexity and annual wellness visits without the
presence of a teaching physician (these codes are discussed in section
II.F. of this proposed rule). Additionally, the teaching physician may
be able to provide sufficient involvement for simple procedures such as
CPT code 36410 (Venipuncture, age 3 years or older, necessitating the
skill of a physician or other qualified health care professional
(separate procedure), for diagnostic or therapeutic purposes (not to be
used for routine venipuncture) or CPT code 51701 (Insertion of non-
indwelling bladder catheter (e.g., straight catheterization for
residual urine). For such circumstances and procedures, it may be
appropriate to continue the virtual presence policy on a temporary or
permanent basis.
We note that having the virtual presence policy in place
temporarily or permanently would not preclude teaching physicians from
providing a greater degree of involvement in services furnished with
residents, and teaching physicians would still have discretion to
determine whether, and if
[[Page 50142]]
so, when it is appropriate to be present virtually rather than in
person depending on the services being furnished and the experience of
the particular residents involved. We seek comment to help us
understand how the option to provide for teaching physician presence
using audio/video real-time communications technology would support
patient safety for all patients and particularly for at-risk patients
(for example, patients who are aged and/or who have a disability);
ensure burden reduction without creating risks to patient care or
increasing fraud; avoid duplicative payment between the PFS and the
IPPS for GME programs; and support emergency preparedness. We also
invite commenters to provide data and other information on their
experiences implementing this policy during the PHE.
c. Virtual Teaching Physician Presence During Medicare Telehealth
Services
In the March 31st COVID-19 IFC (85 FR 19260), we adopted a policy
on an interim basis to allow Medicare to make payment under the PFS for
teaching physician services when a resident furnishes Medicare
telehealth services to beneficiaries while a teaching physician is
present using audio/video real-time communications technology. We are
considering whether this policy should be extended on a temporary basis
(that is, if the PHE ends in 2021, this policy could be extended to
December 31, 2021 to allow for a transition period before reverting to
status quo policy) or be made permanent, and are soliciting public
comments on whether this policy should continue once the PHE ends. We
believe public comment will assist us in identifying appropriate policy
continuation decisions that we would consider finalizing in the CY 2021
PFS final rule. Outside the circumstances of the PHE, under the
requirements at section 1834(m) of the Act that discuss payment for
telehealth services, the patient would be located at a telehealth
originating site, and the teaching physician would be furnishing the
service as the distant site practitioner with the involvement of the
resident.
While teaching physician presence through audio/video real-time
communications technology when a resident furnishes Medicare telehealth
services was responsive to critical needs during the PHE to reduce
exposure risk and to increase the capacity of teaching settings to
respond to COVID-19, we are concerned that the policy to permit virtual
presence of the teaching physician may not allow for sufficient
personal and identifiable physicians' services to exercise full,
personal control over the services such that PFS payment to the
teaching physician would be appropriate outside the circumstances of
the PHE on a temporary or permanent basis. We are concerned that if the
resident was furnishing the service at the distant site and the
teaching physician was at a third site and present with the resident
through audio/video real-time communications technology, the teaching
physician may not be able to render sufficient personal and
identifiable physicians' services to the patient to exercise full,
personal control over the service to warrant separate payment on the
PFS.
Absent the need to reduce exposure risk to COVID-19 during the PHE,
we also have some concerns about patient safety when the teaching
physician is present only virtually during a telehealth service
furnished by a resident. For example, the virtual connection between
the teaching physician and the resident who is with the patient could
be disrupted (as with any virtual supervision scenario), rendering it
impossible for the teaching physician to provide necessary direction
for the resident to furnish appropriate care to the patient, thus
foreclosing the ability of the teaching physician to exercise full,
personal control over the key portion of the service, and potentially
putting the patient's safety at risk.
However, because COVID-19 may continue to persist in some
communities and some communities may experience a resurgence of COVID-
19 after the expiration of the PHE, we are seeking comment about
whether it would be appropriate to extend this policy on a temporary
basis until the end of the calendar year in which the PHE ends. The
presence of COVID-19 may result in a need to continue to limit exposure
risks. In cases where the teaching physician has been exposed to the
virus and is under quarantine, termination of the policy to permit
virtual presence of the teaching physician could unintentionally limit
the number of licensed practitioners available to furnish services to
Medicare patients in some communities, and could have the unintended
consequence of limiting access for Medicare patients. Finally, based on
experience gained during the PHE, we might identify circumstances for
which the teaching physician can routinely render sufficient personal
and identifiable services to the patient to exercise full, personal
control over the management of the key portion of the case while
providing virtual presence during Medicare telehealth services
furnished by a resident on a permanent basis. For example, under
ordinary circumstances for the primary care exception at Sec. 415.174,
we permit PFS payment to the teaching physician when a resident
furnishes office/outpatient E/M visit codes of lower and mid-level
complexity and annual wellness visits without the presence of a
teaching physician (these codes are discussed in section II.F. of this
proposed rule). For such services, it may be appropriate to continue
the virtual presence policy on a temporary or permanent basis. We seek
comment to help us understand how the option to allow teaching
physician presence using audio/video real-time communications
technology could support patient safety for all patients and
particularly for at-risk patients (for example, patients who are aged
and/or who have a disability), ensure burden reduction without creating
risks to patient care or increasing fraud, avoid duplicative payment
between the PFS and the IPPS for GME programs, and support emergency
preparedness. We also invite commenters to provide data and other
information on their experiences implementing this policy during the
PHE.
d. Resident Moonlighting in the Inpatient Setting
Under certain conditions, the services of a licensed resident
physician who is ``moonlighting'' are considered to be furnished by the
individual in their capacity as a physician, rather than as a resident
in an approved GME program. As specified in the regulation at Sec.
415.208, except during the PHE, as defined in the regulation at Sec.
400.200, the services of residents to inpatients of hospitals in which
the residents have their approved GME program are not considered
separately billable as physicians' services and instead are payable
under Sec. Sec. 413.75 through 413.83 regarding direct GME payments,
whether or not the services are related to the approved GME training
program. When a resident furnishes services that are not related to
their approved GME programs in an outpatient department or emergency
department of a hospital in which they have their training program,
those services can be billed separately as physicians' services and
payable under the PFS if they meet the criteria described in our
regulation at Sec. 415.208(b)(2) (i) through (iii). In addition, under
Sec. 415.208(c), services of a licensed resident furnished outside the
scope of an approved GME program when moonlighting in a hospital or
other setting that does not participate in
[[Page 50143]]
the approved GME program are payable under the PFS when the resident is
fully licensed to practice in the state where the services are
furnished, and the resident's time spent in patient care activities in
that setting is not counted for the purpose of Medicare direct GME
payments.
In the March 31st COVID-19 IFC, we amended our regulation at Sec.
415.208 to state that, during the PHE for COVID-19, the services of
residents that are not related to their approved GME programs and are
furnished to inpatients of a hospital in which they have their training
program are separately billable physicians' services for which payment
can be made under the PFS provided that the services are identifiable
physicians' services and meet the conditions for payment of physicians'
services to beneficiaries in providers in Sec. 415.102(a), the
resident is fully licensed to practice medicine, osteopathy, dentistry,
or podiatry by the state in which the services are performed, and the
services can be separately identified from those services that are
required as part of the approved GME program.
We are considering whether this flexibility that we implemented on
an interim basis should be extended on a temporary basis (that is, if
the PHE ends in 2021, these policies could be extended to December 31,
2021 to allow for a transition period before reverting to status quo
policy) or be made permanent, and are soliciting public comments on
whether this policy should continue once the PHE ends. We are concerned
that there may be risks to program integrity in allowing residents to
furnish separately billable physicians' services to inpatients in the
teaching hospitals where they are training when the services are
outside the scope of their approved GME program. For example, there
could be a risk of duplicate Medicare payment for the resident's
services under the IPPS for GME and the PFS if the physicians' services
furnished by residents were not adequately separately identified from
those services that are required as part of the GME program. However,
because COVID-19 may continue to persist in some communities or some
communities may experience a resurgence of COVID-19 after the
expiration of the PHE, it may be appropriate for us to extend this
policy on a temporary basis to meet the needs of teaching hospitals to
ensure that there are as many qualified practitioners available as
possible. We believe public comment will assist us in identifying
appropriate policy continuation decisions that we would consider
finalizing in the CY 2021 PFS final rule. We also invite commenters to
provide data and other information on their experiences implementing
this policy during the PHE.
e. Primary Care Exception Policies
The regulation at Sec. 415.174 sets forth an exception to the
conditions for PFS payment for services furnished in teaching settings
in the case of certain E/M services furnished in certain centers. Under
the so-called ``primary care exception,'' Medicare makes PFS payment in
certain teaching hospital primary care centers for certain services of
lower and mid-level complexity furnished by a resident without the
physical presence of a teaching physician. Section 415.174(a)(3)
requires that the teaching physician must not direct the care of more
than four residents at a time, and must direct the care from such
proximity as to constitute immediate availability (that is, provide
direct supervision) and must review with each resident during or
immediately after each visit, the beneficiary's medical history,
physical examination, diagnosis, and record of tests and therapies.
Section 415.174(a)(3) also requires that the teaching physician must
have no other responsibilities at the time, assume management
responsibility for the beneficiaries seen by the residents, and ensure
that the services furnished are appropriate.
As provided in the regulation at Sec. 415.174(a), the codes of
lower and mid-level complexity that can be furnished under the primary
care exception are specified in section 100 of chapter 12 of the
Medicare Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). They are the
following:
CPT code 99201 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: A problem focused history; A problem focused examination;
Straightforward medical decision making. Counseling and/or coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are self-limited or minor. Typically, 10 minutes
are spent face-to-face with the patient and/or family);
CPT code 99202 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: An expanded problem focused history; An expanded problem
focused examination; Straightforward medical decision making.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are of low to
moderate severity. Typically, 20 minutes are spent face-to-face with
the patient and/or family);
CPT code 99203 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: A detailed history; A detailed examination; Medical
decision making of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the presenting
problem(s) are of moderate severity. Typically, 30 minutes are spent
face-to-face with the patient and/or family);
CPT code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient, that may not
require the presence of a physician or other qualified health care
professional. Usually, the presenting problem(s) are minimal.
Typically, 5 minutes are spent performing or supervising these
services);
CPT code 99212 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A problem focused history; A problem
focused examination; Straightforward medical decision making.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are self-limited or
minor. Typically, 10 minutes are spent face-to-face with the patient
and/or family);
CPT code 99213 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: An expanded problem focused history;
An expanded problem focused examination; Medical decision making of low
complexity. Counseling and coordination of care with other physicians,
other qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
[[Page 50144]]
family's needs. Usually, the presenting problem(s) are of low to
moderate severity. Typically, 15 minutes are spent face-to-face with
the patient and/or family);
HCPCS code G0402 (Initial preventive physical examination;
face-to-face visit, services limited to new beneficiary during the
first 12 months of Medicare enrollment);
HCPCS code G0438 (Annual wellness visit; includes a
personalized prevention plan of service (PPS), initial visit); and
HCPCS code G0439 (Annual wellness visit, includes a
personalized prevention plan of service (PPS), subsequent visit).
In the March 31st COVID-19 IFC, we amended Sec. 415.174 of our
regulations to allow, during the PHE for COVID-19, all levels of
office/outpatient E/M visits to be furnished by the resident and billed
by the teaching physician under the primary care exception. In the May
1st COVID-19 IFC (85 FR 27550 through 27629), we further expanded the
list of services included in the primary care exception during the PHE
for COVID-19. We also allowed PFS payment to the teaching physician for
services furnished by residents via telehealth under the primary care
exception if the services were also on the list of Medicare telehealth
services.
We are considering whether these policies should be extended on a
temporary basis (that is, if the PHE ends in 2021, these policies could
be extended to December 31, 2021 to allow for a transition period
before reverting to status quo policy) or be made permanent, and are
soliciting public comments on whether these policies should continue
once the PHE ends. We believe public comment will assist us in
identifying appropriate policy continuation decisions that we would
consider finalizing in the CY 2021 PFS final rule. We are also
considering whether specific services added under the primary care
exception should be extended temporarily or made permanent and are
soliciting public comment on whether these services should continue as
part of the primary care exception once the PHE ends. These services
are the following:
CPT code 99204 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination;
Medical decision making of moderate complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are of moderate to high severity. Typically, 45
minutes are spent face-to-face with the patient and/or family);
CPT code 99205 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination;
Medical decision making of high complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are of moderate to high severity. Typically, 60
minutes are spent face-to-face with the patient and/or family);
CPT code 99214 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A detailed history; A detailed
examination; Medical decision making of moderate complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the presenting problem(s) are of moderate to high severity.
Typically, 25 minutes are spent face-to-face with the patient and/or
family);
CPT code 99215 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A comprehensive history; A
comprehensive examination; Medical decision making of high complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are of moderate to
high severity. Typically, 40 minutes are spent face-to-face with the
patient and/or family);
CPT code 99495 (Transitional Care Management services with
the following required elements: Communication (direct contact,
telephone, electronic) with the patient and/or caregiver within two
business days of discharge; medical decision making of at least
moderate complexity during the service period; face-to-face visit
within 14 calendar days of discharge);
CPT code 99496 (Transitional Care Management services with
the following required elements: Communication (direct contact,
telephone, electronic) with the patient and/or caregiver within two
business days of discharge; medical decision making of at least high
complexity during the service period; face-to-face visit within 7
calendar days of discharge);
CPT code 99421 (Online digital evaluation and management
service, for an established patient, for up to 7 days, cumulative time
during the 7 days; 5-10 minutes);
CPT code 99422 (Online digital evaluation and management
service, for an established patient, for up to 7 days, cumulative time
during the 7 days; 11-20 minutes);
CPT code 99423 (Online digital evaluation and management
service, for an established patient, for up to 7 days, cumulative time
during the 7 days; 21 or more minutes);
CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30
minutes);
CPT code G2012 (Brief communication technology-based
service, e.g. virtual check-in, by a physician or other qualified
health care professional who can report evaluation and management
services, provided to an established patient, not originating from a
related E/M service provided within the previous 7 days nor leading to
an E/M service or procedure within the next 24 hours or soonest
available appointment; 5-10 minutes of medical discussion); and
HCPCS code G2010 (Remote evaluation of recorded video and/
or images submitted by an established patient (e.g., store and
forward), including interpretation with follow-up with the patient
within 24 business hours, not originating from a related E/M service
provided within the previous 7 days nor leading to an E/M service or
procedure within the next 24 hours or soonest available appointment).
Expanding the array of services for which Medicare may make PFS
payment to the teaching physician when furnished by a resident under
the primary care exception was responsive to critical needs during the
PHE for patients who may be quarantined at home or who may need to be
isolated for purposes of minimizing exposure risk based on presumed or
confirmed COVID-19 infection. Because COVID-19 may continue to persist
in some communities or some communities may experience a resurgence of
COVID-19
[[Page 50145]]
after the expiration of the PHE, it may be appropriate for us to extend
all of these services on a temporary basis (that is, until the end of
the calendar year in which the PHE ends).
However, we are concerned that it may be inappropriate to extend
all of these services on a temporary basis or add them to the primary
care exception permanently. The intent of the primary care exception as
described in Sec. 415.174 is that E/M visits of lower and mid-level
complexity furnished by residents are simple enough for a teaching
physician to be able to direct and manage the care of up to four
residents at any given time and direct the care from such proximity as
to constitute immediate availability. While CPT code 99421 and HCPCS
code G2012 may be simple services, others such as levels 4 and 5
office/outpatient E/M visits (CPT codes 99204 through 99205 and CPT
codes 99214 through 99215) and transitional care management codes (CPT
codes 99495 through 99496) require medical decision making that is of
at least moderate complexity. We are concerned that the teaching
physician may not be able to maintain sufficient personal involvement
in all of the care to warrant PFS payment for the services being
furnished by up to four residents when some or all of the residents
might be furnishing services that are more than lower and mid-level
complexity. We are also concerned that when the teaching physician is
directing the care of a patient that requires moderate or higher
medical decision making, the ability to be immediately available to
other residents could be compromised, potentially putting patients at
risk. Thus, we are considering whether, upon expiration of the PHE, we
should extend on a temporary basis some or all of the services we added
to the primary care exception list during the PHE and are soliciting
public comments on whether these services should continue as part of
the primary care exception after the PHE ends. We also invite
commenters to provide data and other information on their experiences
implementing this policy during the PHE.
We are also considering whether our interim final policy that PFS
payment could be made to the teaching physician when residents furnish
telehealth services under the primary care exception should be extended
on a temporary basis or be made permanent, and are soliciting public
comments on whether this policy should continue once the PHE ends. In
these cases, outside the circumstances of the PHE, the patient would be
at the originating site and the resident furnishing the care, along
with the teaching physician billing for it, would be located at the
primary care center as the distant site practitioner. If we were to
temporarily extend or add permanently to the primary care exception
services such as e-visits or communication technology-based services,
it may also make sense to permit PFS payment to the teaching physician
when the resident furnishes an office/outpatient E/M visit via
telehealth, on the basis that the patient is not physically in the
clinic and that these services all involve the use of virtual
technology (for example, patient portals for e-visits,
telecommunications technology for the office/outpatient E/M visit) to
facilitate care delivery. If we were to remove the services that we
added to the primary care exception on an interim basis, we could
separately consider continuing to permit PFS payment to the teaching
physician when the resident furnishes an office/outpatient E/M visit
via telehealth because the teaching physician would be immediately
available in the distant site clinic with the resident to direct and
manage the care.
f. Conclusion
In summary, we remind stakeholders that during the PHE we
implemented these policies on an interim basis to support our goals of
ensuring beneficiary access to necessary services and maintenance of
sufficient workforce capacity through flexibilities afforded to
providers to safely furnish services to patients. While we anticipate
reverting to our previous teaching physician policy that was in place
prior to the PHE for the reasons discussed above, we are considering
whether the teaching physician and resident moonlighting policies that
we implemented on an interim basis should be extended on a temporary
basis (that is, if the PHE ends in 2021, these policies could be
extended to December 31, 2021 to allow for a transition period before
reverting to status quo policy) or be made permanent policy for CY
2021. We are soliciting public comments on whether these policies
should be continued, and if so, whether they should be made permanent,
or temporarily extended and the appropriate scope of the extension. As
discussed above, we are concerned that the teaching physician may not
be able to maintain sufficient personal involvement in all of the care
to warrant PFS payment for the services being furnished by up to four
residents when some or all of the residents might be furnishing
services that are more than lower and mid-level complexity. We are also
concerned that when the teaching physician is directing the care of a
patient that requires moderate or higher medical decision making, the
ability to be immediately available to other residents could be
compromised, potentially putting patients at risk. We will also
consider under which scenarios our policies for moonlighting or virtual
presence as discussed above, should apply, if any. As discussed for our
moonlighting policy, we are concerned that there may be risks to
program integrity in allowing residents to furnish separately billable
physicians' services to inpatients in the teaching hospitals where they
are training when the services are outside the scope of their approved
GME program. For example, there could be a risk of duplicate Medicare
payment for the resident's services under the IPPS for GME and the PFS
if the physicians' services furnished by residents were not adequately
separately identified from those services that are required as part of
the GME program. Under our discussion of virtual presence, we
highlighted concerns about how continuing to permit teaching physicians
to be involved through their virtual presence may not be sufficient to
warrant PFS payment to the teaching physician on a temporary or
permanent basis. Absent the circumstances of the PHE, the physical, in-
person presence of the teaching physician may be necessary to provide
oversight to ensure that care furnished to Medicare beneficiaries is
medically reasonable and necessary, and to ensure that the teaching
physician renders sufficient personal services to exercise full,
personal control of the key portion of the case. We also discussed
concerns about patient safety when the teaching physician is only
virtually present.
We believe public comment, especially those that focus on the
variables we identify above regarding the specific services included on
the primary exception list, clinical scenarios under which residents
could moonlight or furnish certain types of services under the
supervision of a teaching physician via virtual presence, will assist
us in identifying the appropriate policy continuation decisions after
the end of the PHE, which we will consider finalizing in the CY 2021
PFS final rule. As part of our review of public comments, we will weigh
and make decisions based on the potential benefits and risks associated
with the potential temporary or permanent continuation, in whole or in
part, of these policies. The benefits of continuation may include
limiting COVID-19 exposure risk for practitioners and patients,
increasing workforce capacity of teaching settings
[[Page 50146]]
to respond to continuing effects following the PHE as practitioners may
be asked to assist with the response, and increasing access so that we
do not unintentionally limit the number of licensed practitioners
available to furnish services to Medicare beneficiaries, which could
have the unintended consequence of limiting access to services paid
under the PFS. The risks may include the potential for duplicative
payment with Medicare Part A reimbursement for graduate medical
education training programs, the potential for increases to cost-
sharing for Medicare beneficiaries that could result from additional
Part B claims for services furnished by the teaching physician with the
involvement of residents, and potential risks to patient safety.
2. Supervision of Diagnostic Tests by Certain NPPs
In response to Executive Order #13890 discussed above, we sought
assistance from stakeholders in identifying Medicare regulations that
contain more restrictive supervision requirements than existing state
scope of practice laws, or that limit health professionals from
practicing at the top of their license. In response to our request for
feedback discussed above, physician assistants (PAs) and nurse
practitioners (NPs) recommended regulatory changes that would allow
them to supervise the performance of diagnostic tests because they are
currently authorized to do so under their state scope of practice rules
in many states. In the May 1st COVID-19 IFC (85 FR 27550 through
27629), we established on an interim basis during the COVID-19 PHE, a
policy to permit these and certain other NPPs to supervise diagnostic
tests. We now propose to make those changes permanent by making
modifications to the regulations at Sec. 410.32. We are planning to
address comments we receive on our proposals included in this proposed
rule and comments received on the May 1st COVID-19 IFC (85 FR 27550
through 27629) simultaneously in the final rule since the comment
period for the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629)
recently closed on July 7, 2020.
Prior to the COVID-19 PHE, under Sec. 410.32(a)(2), physicians,
NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical psychologists
(CPs), and clinical social workers (CSWs) who are treating a
beneficiary for a specific medical problem may order diagnostic tests
when they use the results of the tests in the management of the
beneficiary's specific medical problem. However, generally only
physicians were permitted to supervise diagnostic tests. The regulation
at Sec. 410.32(b)(1) provided as a basic general rule that all
diagnostic tests paid under the PFS must be furnished under an
appropriate level of supervision by a physician as defined in section
1861(r) of the Act. Section 410.32(b)(2) then provided for certain
exceptions to which this basic rule did not apply. For instance, under
Sec. 410.32(b)(2)(v), the requirement that diagnostic tests must be
furnished under the appropriate level of supervision by a physician did
not apply for tests performed by an NP or CNS authorized under
applicable state law to furnish the test. (We note that, as for all
services furnished by a NP or CNS, they would have to be furnished
working in collaboration with a physician as provided in regulations at
Sec. Sec. 410.75 and 410.76, respectively). Similarly, under the
regulation at Sec. 410.32(b)(2)(vii), the requirement that diagnostic
tests must be furnished under the appropriate level of supervision by a
physician did not apply for tests performed by a CNM authorized under
applicable state law to furnish the test. This exception is in place
because the Medicare statute does not include any physician supervision
requirement for CNM services. Thus, while NPs, CNSs, PAs, and CNMs were
permitted to furnish diagnostic tests to the extent they were
authorized under state law and their scope of practice to do so, the
regulations at Sec. 410.32 did not address whether these practitioners
could supervise others who furnished diagnostic tests.
In light of stakeholder feedback to CMS on identifying additional
Medicare regulations that contain more restrictive supervision
requirements than existing state scope of practice laws, or that limit
health professionals from practicing at the top of their license,
effective January 1, 2021, we are proposing to amend the basic rule
under the regulation at Sec. 410.32(b)(1) to allow NPs, CNSs, PAs or
CNMs to supervise diagnostic tests on a permanent basis as allowed by
state law and scope of practice. These NPPs have separately enumerated
benefit categories under Medicare law that permit them to furnish
services that would be physician's services if furnished by a
physician, and are authorized to receive payment under Medicare Part B
for the professional services they furnish either directly or
``incident to'' their own professional services, to the extent
authorized under state law and scope of practice.
We are proposing to amend the regulation at Sec.
410.32(b)(2)(iii)(B) on a permanent basis to specify that supervision
of diagnostic psychological and neuropsychological testing services can
be done by NPs, CNS's, PAs or CNMs to the extent that they are
authorized to perform the tests under applicable State law and scope of
practice, in addition to physicians and CPs who are currently
authorized to supervise these tests. We are also proposing to amend on
a permanent basis, the regulation at Sec. 410.32 to add paragraph
(b)(2)(ix) to specify that diagnostic tests performed by a PA in
accordance with their scope of practice and State law do not require
the specified level of supervision assigned to individual tests,
because the relationship of PAs with physicians under Sec. 410.74
would continue to apply. We are also proposing to make permanent the
removal of the parenthetical, previously made as part of the May 1,
2020 COVID-19 IFC (85 FR 27550 through 27629), at Sec. 410.32(b)(3)
that required a general level of physician supervision for diagnostic
tests performed by a PA.
3. Pharmacists Providing Services Incident to Physicians' Services
Stakeholders have asked us to clarify that pharmacists can provide
services incident to the professional services of a physician or other
NPP just as other clinical staff may do. These stakeholders have asked
us, in particular, about pharmacists who provide medication management
services. Medication management is covered under both Medicare Part B
and Part D. We are reiterating the clarification we provided in the May
1st COVID-19 IFC (85 FR 27550 through 27629), that pharmacists fall
within the regulatory definition of auxiliary personnel under our
regulations at Sec. 410.26. As such, pharmacists may provide services
incident to the services, and under the appropriate level of
supervision, of the billing physician or NPP, if payment for the
services is not made under the Medicare Part D benefit. This includes
providing the services incident to the services of the billing
physician or NPP and in accordance with the pharmacist's state scope of
practice and applicable state law.
We note that when a pharmacist provides services that are paid
under the Part D benefit, the services are not also reportable or paid
for under Part B. In addition to circumstances where medication
management is offered as part of the Part D benefit, Part B payment is
also not available for services included in the Medicare Part D
dispensing fees, such as a pharmacist's time in checking the computer
for information about an individual's coverage, measurement or
[[Page 50147]]
mixing of the covered Part D drug, filling the container, physically
providing or delivering the completed prescription to the Part D
enrollee. Similarly, performing required quality assurance activities
consistent with Sec. 423.153(c)(2), such as screening for potential
drug therapy problems due to therapeutic duplication, age/gender-
related contraindications, potential over-utilization and under-
utilization, drug-drug interactions, incorrect drug dosage or duration
of drug therapy, drug-allergy contraindications, and clinical abuse/
misuse are considered part of dispensing fees under Part D and are not
separately reportable services under Part B. Additionally, services and
supplies paid under the incident to benefit must be an integral, though
incidental, part of the service of a physician (or other practitioner)
in the course of diagnosis or treatment of an injury or illness (Sec.
410.26). We also note that our manual provisions specify that
``incident to'' services must be of a type that are medically
appropriate to provide in the office setting; and that where a
physician supervises auxiliary personnel to assist him or her in
rendering services to patients and includes the charges for their
services in his or her own bills, the services of such personnel are
considered incident to the physicians' service if there is a
physicians' service rendered to which the services of such personnel
are an incidental part and there is direct supervision by the physician
(section 60.1 of chapter 15 of the Medicare Benefit Policy Manual (Pub.
100-02) available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf).
Although it is fully consistent with current CMS policy for
pharmacists to provide services incident to the services of the billing
physician or NPP, we believe this clarification may encourage
pharmacists to work with physicians and NPPs in new ways where
pharmacists are working at the top of their training, licensure and
scope of practice. It may free up the time of physicians and NPPs for
other work and increase access to medication management services, for
individuals with chronic conditions and other conditions. As an
example, we found that this clarification was helpful in recently
addressing in the May 1st COVID-19 IFC (85 FR 27550 through 27629), the
ability of pharmacies to enroll as laboratories and work with
physicians in the assessment of clinical information, specimen
collection and reporting results of COVID-19 clinical diagnostic
laboratory tests.
4. Provision of Maintenance Therapy by Therapy Assistants
In response to our request for feedback on scope of practice (noted
above), consistent with Executive Order #13890, respondents requested
that we allow physical therapist assistants (PTAs) and occupational
therapy assistants (OTAs) to furnish maintenance therapy services
associated with a maintenance program. The respondents said that our
Part B therapy policy is not consistent with policies for these
services when provided to patients in the skilled nursing facility
(SNF) and home health (HH) settings paid under Part A. Other
respondents told us that because the therapist is responsible for a
patient's care over an episode, that this should include assigning
responsibilities for maintenance therapy to an assistant when it is
clinically appropriate. Some respondents stated that permitting PTAs
and OTAs to furnish maintenance therapy services would give Medicare
patients greater access to care and permit therapists and therapy
providers more flexibility for resource utilization.
After considering respondents' concerns about the incongruity
between our Part B and Part A maintenance therapy policy, and to
provide flexibility to increase the availability of needed health care
services during the COVID-19 PHE, we amended our policy on an interim
final basis in the May 1st COVID-19 IFC (85 FR 27550 through 27629) to
allow the physical therapist (PT) or occupational therapist (OT) who
established the maintenance program to assign the duties to a PTA or
OTA, as clinically appropriate, to perform maintenance therapy
services.
We explained that making this change could free-up the PT or OT to
furnish other services, particularly those related to the COVID-19 PHE
that require a therapist's assessment and evaluation skills, and
including the CTBS, that is, e-visits, virtual visits, remote
evaluations, and phone evaluations--that were added as ``sometimes
therapy'' services in the March 31st COVID-19 IFC for PTs, OTs and
speech-language pathologists (SLPs). We stated explicitly that the
maintenance therapy services furnished by therapist-supervised OTAs and
PTAs will be paid in the same manner as those we already pay for as
rehabilitative therapy services, and referred the reader to regulatory
payment conditions for Part B outpatient occupational and physical
therapy services (Sec. Sec. 410.59 and 410.60, respectively) that
require, as a basic rule, that the services be provided by an
individual meeting qualifications in 42 CFR part 484 for an OT or PT,
or an appropriately supervised OTA or PTA.
In this proposed rule, we are proposing to make permanent our Part
B policy for maintenance therapy services effective January 1, 2021 in
order to create greater conformity in payment policy for maintenance
therapy services that are furnished and paid under Part B with those in
SNF and HH settings under Part A. If adopted, our policy would dovetail
with our amended policy set forth in the May 1st COVID-19 IFC (85 FR
27550 through 27629) that grants PTs and OTs the discretion to delegate
maintenance therapy services to the PTAs and OTAs, as clinically
appropriate, for the duration of the PHE. If the PHE is ended prior to
January 1, 2021, the therapist would need to personally furnish the
maintenance therapy services until the proposed policy change takes
effect. We plan to address comments from the May 1st COVID-19 IFC in
conjunction with the comments from this proposed rule in the final
rule, given the comment period has only just closed on that IFC.
Our policy for maintenance therapy services is explained in section
220.2 of chapter 15 of the Medicare Benefit Policy Manual (see https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf) in cases where rehabilitative services, requiring the
improvement in the patient's functional status, are no longer or were
not previously covered. This manual section explains that skilled
therapy services related to a reasonable and necessary maintenance
program are available for the establishment or design of the
maintenance program and the delivery of the maintenance program, that
is, maintenance therapy, when it needs to be carried out as maintenance
therapy services. Maintenance programs that can be carried out by the
patient alone or with the assistance of caregivers, are not covered.
Sections 230.1 and 230.2 of chapter 15 of the Medicare Benefit Policy
Manual specify that a PTA or OTA may not provide skilled maintenance
program services.
In considering our proposal, we reviewed regulatory requirements
for conditions of payment for outpatient occupational therapy, physical
therapy, and speech-language pathology services at Sec. Sec. 410.59,
410.60 and 410.62; the regulation for therapy treatment plans at Sec.
410.61, and the regulations specifying treatment plan certification and
recertification requirements at Sec. 424.24 for Part B occupational
therapy, physical therapy, and speech-language
[[Page 50148]]
pathology services, in addition to the above mentioned manual
provisions.
Given that we already make payment for rehabilitative services
requiring improvement in the patient's functional status when they are
furnished by PTAs and OTAs at the discretion of the supervising
therapist treating the patient in accordance with the therapist-
established plan of care, we believe that it would be appropriate for
the therapist to use that same judgement in deciding whether to
delegate to the PTA or OTA the performance of maintenance therapy
services under the associated plan of care. We believe that there is
little difference between the rehabilitative therapy services furnished
to improve a patient's functional status and those for maintenance
therapy services other than the goals set by the therapist in the
therapy plan that are aimed to maintain, slow or prevent further
decline of a patient's condition. We do not believe that the therapist-
only maintenance therapy requirement is needed in the case of
outpatient physical or occupational therapy services, and instead
believe that it would be appropriate for an OT or PT to be permitted to
use their professional judgement to assign the performance of
maintenance therapy services to an OTA or PTA when it is clinically
appropriate to do so.
As such, we propose to allow, on a permanent basis, therapists to
delegate performance of maintenance therapy services to an OTA or PTA
for outpatient occupational and physical therapy services in Part B
settings beginning January 1, 2021. This proposal would better align
our Part B policy with that in SNFs and HH paid under Part A where
maintenance therapy services may be performed by a therapist or a
therapy assistant. Since our regulations at Sec. Sec. 410.59, 410.60,
410.61, 410.62 and 424.24, do not now distinguish between
rehabilitative and maintenance therapy services, we are not proposing
to amend them. Instead, we propose to revise sections 220.2, 230.1 and
230.2 of chapter 15 of the Medicare Benefit Policy Manual to clarify
that PTs and OTs no longer need to personally perform maintenance
therapy services and to specifically remove the prohibitions on PTAs
and OTAs from furnishing such services. Therefore, we believe our
proposal to allow PTs and OTs to delegate maintenance therapy services
to their supervised assistants is in keeping with Executive Order
#13890 and appeals by respondents to our request for feedback on scope
of practice that followed, rather than the alternative option of
maintaining the pre-COVID-19 policy of requiring PTs and OTs to
personally furnish them, after the COVID-19 PHE is ended.
We note that therapists and therapy providers should consult the CQ
and CO modifier policies to consider whether these modifiers should be
applied to claims for services furnished in whole or in part by PTAs
and OTAs which will, beginning January 1, 2022, be paid at 85 percent
of the amount that would otherwise apply for the service, as required
by section 1834(v) of the Act which was added by section 53107 of the
Bipartisan Budget Act of 2018. See the CY 2020 PFS rulemaking for
policies related to the application of CQ and CO modifiers and the
associated regulatory requirements (84 FR 40558 through 40564 (proposed
rule) and 84 FR 62702 through 60708 (final rule)).
5. Medical Record Documentation
As we established in the CY 2020 PFS final rule (84 FR 62681
through 62684), and similarly expressed in the May 1st COVID-19 IFC (85
FR 27556 through 27557), any individual who is authorized under
Medicare law to furnish and bill for their professional services,
whether or not they are acting in a teaching role, may review and
verify (sign and date) the medical record for the services they bill,
rather than re-document, notes in the medical record made by
physicians, residents, nurses, and students (including students in
therapy or other clinical disciplines), or other members of the medical
team. We note that although there are currently no documentation
requirements that would impact payment for PTs, OTs, or SLPs when
documentation is added to the medical record by persons other than the
therapist, we are responding in this proposed rule to stakeholder
requests for clarification. Specifically, we are clarifying that the
broad policy principle that allows billing clinicians to review and
verify documentation added to the medical record for their services by
other members of the medical team also applies to therapists. This will
help ensure that therapists are able to spend more time furnishing
therapy services, including pain management therapies to patients that
may minimize the use of opioids and other medications, rather than
spending time documenting in the medical record. We emphasize that,
while any member of the medical team may enter information into the
medical record, only the reporting clinician may review and verify
notes made in the record by others for the services the reporting
clinician furnishes and bills. We also emphasize that information
entered into the medical record should document that the furnished
services are reasonable and necessary.
H. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
review process, revisions in RVUs were proposed and finalized via
rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
CMS and the RUC identified a number of potentially misvalued codes each
year using various identification screens, as discussed in section
II.C. of this proposed rule, Potentially Misvalued Services under the
PFS. Historically, when we received RUC recommendations, our process
had been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule. In the final rule with
comment period for the subsequent year, we considered and responded to
public comments received on the interim final values, and typically
made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly
[[Page 50149]]
new services. For CY 2017, we proposed new values in the CY 2017 PFS
proposed rule for the vast majority of new, revised, and potentially
misvalued codes for which we received complete RUC recommendations by
February 10, 2016. To complete the transition to this new process, for
codes for which we established interim final values in the CY 2016 PFS
final rule with comment period (81 FR 80170), we reviewed the comments
received during the 60-day public comment period following release of
the CY 2016 PFS final rule with comment period (80 FR 70886), and re-
proposed values for those codes in the CY 2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
federal government as part of our process for establishing valuations.
Where we concur that the RUC's recommendations, or recommendations from
other commenters, are reasonable and appropriate and are consistent
with the time and intensity paradigm of physician work, we proposed
those values as recommended. Additionally, we continually engage with
stakeholders, including the RUC, with regard to our approach for
accurately valuing codes, and as we prioritize our obligation to value
new, revised, and potentially misvalued codes. We continue to welcome
feedback from all interested parties regarding valuation of services
for consideration through our rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conduct a review that
includes the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the federal
government, as well as Medicare claims data. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we use in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could include the CPT codes that make up the bundled code
and the inputs associated with those codes. We use the building block
methodology to construct, or deconstruct, the work RVU for a CPT code
based on component pieces of the code. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilize an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refine the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an evaluation and management (E/M) service, we believe that there is
overlap between the two services in some of the activities furnished
during the preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
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The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. When they exist we also include a summary of
stakeholder reactions to our approach. We note that many commenters and
stakeholders have expressed concerns over the years with our ongoing
adjustment of work RVUs based on changes in the best information we had
regarding the time resources involved in furnishing individual
services. We have been particularly concerned with the RUC's and
various specialty societies' objections to our approach given the
significance of their recommendations to our process for valuing
services and since much of the information we used to make the
adjustments is derived from their survey process. We are obligated
under the statute to consider both time and intensity in establishing
work RVUs for PFS services. As explained in the CY 2016 PFS final rule
with comment period (80 FR 70933), we recognize that adjusting work
RVUs for changes in time is not always a straightforward process, so we
have applied various methodologies to identify several potential work
values for individual codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have started by looking at the change
in the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
magnitude estimation have long been used in developing work RVUs under
the PFS. In addition to these, we sometimes use the relationship
between the old time values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believe that such changes in time are
already accounted for in the RUC's recommendation, then we do not make
such adjustments. Likewise, we do not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We use the ratios to
identify potential work RVUs and consider these work RVUs as potential
options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we believe that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC's recommendation has appeared to
disregard or dismiss the changes in time, without a persuasive
explanation of why such a change should not be accounted for in the
overall work of the service, then we have generally used one of the
aforementioned methodologies to identify potential work RVUs, including
the methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several stakeholders, including the RUC, have expressed general
objections to our use of these methodologies and deemed our actions in
adjusting the recommended work RVUs as inappropriate; other
stakeholders have also expressed general concerns with CMS refinements
to RUC-recommended values in general. In the CY 2017 PFS final rule (81
FR 80272 through 80277), we responded in detail to several comments
that we received regarding this issue. In the CY 2017 PFS proposed rule
(81 FR 46162), we requested comments regarding potential alternatives
to making adjustments that would recognize overall estimates of work in
the context of changes in the resource of time for particular services;
however, we did not receive any specific potential alternatives. As
described earlier in this section, crosswalks to key reference or
similar codes are one of the many methodological approaches we have
employed to identify potential values that reconcile the RUC-recommend
work RVUs with the recommended time values when the RUC-recommended
work RVUs did not appear to account for significant changes in time.
We look forward to continuing to engage with stakeholders and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the valuation
considered for specific codes. Table 24 contains a list of codes and
descriptors for which we are proposing work RVUs; this includes all
codes for which we received RUC recommendations by February 10, 2020.
The proposed work RVUs, work time and other payment information for all
CY 2021 payable codes are available on the CMS website under downloads
for the CY 2021 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct
[[Page 50151]]
PE inputs and refine the inputs accordingly.
Our review and refinement of the RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 25 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this proposed rule, Determination
of Practice Expense Relative Value Units (PE RVUs), we address certain
refinements that would be common across codes. Refinements to
particular codes are addressed in the portions of this section that are
dedicated to particular codes. We note that for each refinement, we
indicate the impact on direct costs for that service. We note that, on
average, in any case where the impact on the direct cost for a
particular refinement is $0.35 or less, the refinement has no impact on
the PE RVUs. This calculation considers both the impact on the direct
portion of the PE RVU, as well as the impact on the indirect allocator
for the average service. We also note that approximately half of the
refinements listed in Table 25 result in changes under the $0.35
threshold and are unlikely to result in a change to the RVUs.
We also note that the direct PE inputs for CY 2021 are displayed in
the CY 2021 direct PE input files, available on the CMS website under
the downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been
used in developing the CY 2021 PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this proposed rule,
Determination of Practice Expense Relative Value Units (PE RVUs), for
more information regarding the collaborative work of CMS and the RUC in
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the
[[Page 50152]]
specialty societies to provide us copies of sales invoices. For CY 2021
we received invoices for several new supply and equipment items. Tables
27 and 28 detail the invoices received for new and existing items in
the direct PE database. As discussed in section II.B. of this proposed
rule, Determination of Practice Expense Relative Value Units, we
encouraged stakeholders to review the prices associated with these new
and existing items to determine whether these prices appear to be
accurate. Where prices appear inaccurate, we encouraged stakeholders to
submit invoices or other information to improve the accuracy of pricing
for these items in the direct PE database by February 10th of the
following year for consideration in future rulemaking, similar to our
process for consideration of RUC recommendations.
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 27 and 28 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that stakeholders will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that stakeholders are
more likely to have better pricing information for items used more
frequently. A single invoice may not be reflective of typical costs and
we encourage stakeholders to provide additional invoices so that we
might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we included the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display the services subject to the MPPR for
diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services, and therapy services. We also
include a list of procedures that meet the definition of imaging under
section 1848(b)(4)(B) of the Act, and therefore, are subject to the
OPPS cap for the upcoming calendar year. The public use files for CY
2021 are available on the CMS website under downloads for the CY 2021
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For more information regarding the history of the MPPR policy, we refer
readers to the CY 2014 PFS final rule with comment period (78 FR 74261
through 74263). For more information regarding the history of the OPPS
cap, we refer readers to the CY 2007 PFS final rule with comment period
(71 FR 69659 through 69662).
4. Proposed Valuation of Specific Codes for CY 2021
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006,
10007, 10008, 10009, 10010, 10011, and 10012)
In June 2017, the CPT Editorial Panel deleted CPT code 10022,
revised CPT code 10021, and created nine new codes to describe fine
needle aspiration procedures with and without imaging guidance. These
ten codes were surveyed and reviewed for the October 2017 and January
2018 RUC meetings. In the CY 2019 final rule, we finalized the RUC-
recommended work RVU for seven of the ten codes in the family, while
finalizing a lower work RVU for CPT codes 10005 (Fine needle aspiration
biopsy, including ultrasound guidance; first lesion), 10009 (Fine
needle aspiration biopsy, including CT guidance; first lesion), and
10021 (Fine needle aspiration biopsy, without imaging guidance; first
lesion). For a full discussion of this review, we refer readers to the
CY 2019 PFS final rule (83 FR 59517 through 59521).
Following the publication of the CY 2019 final rule, RUC staff
stated that CMS erroneously double-counted the utilization for new
codes that had image guidance bundled. We disagreed that this
constituted a technical error and communicated to the RUC in
conversations following the publication of the rule that the surveying
specialties could instead nominate the affected codes from these
families as being potentially misvalued. At the January 2020 RUC
meeting, the RUC reaffirmed its CY 2019 recommendations for physician
work and direct practice expense (PE) for the ten codes in the Fine
Needle Aspiration code family.
In discussing this group of codes, we would like to clarify again
that we disagree with the RUC and do not believe that utilization was
erroneously double-counted for this code family. We publish our
proposed utilization crosswalk each year as a public use file available
on the CMS website; the current such file is available under downloads
for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. During the CY 2019 rule cycle, we proposed the
utilization crosswalk for the Fine Needle Aspiration family as it was
recommended to CMS by the RUC, and we did not receive any comments on
this subject until after the valuation of these codes had been
finalized. We proposed and finalized the utilization crosswalk for this
code family as recommended by the RUC without receiving any comments
from the RUC or other stakeholders. If the RUC or other stakeholders
believed that what CMS had proposed was incorrect or misunderstood what
the RUC had recommended, there was an opportunity to comment during the
60 days following the publication of the proposed rule. We disagree
that the utilization crosswalk was erroneous, and we did not make a
technical correction following the publication of the CY 2019 final
rule for this reason.
We also disagree with the RUC that the utilization crosswalk was
``the
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principle reason CMS rejected the RUC recommendations'' for the codes
in the Fine Needle Aspiration family, as stated in the RUC's CY 2021
recommendations for this code family. As we stated in the CY 2019
proposed rule and restated in the CY 2019 final rule, our refinements
to the work RVUs of CPT codes 10021, 10005, and 10009 were primarily
based on changes in surveyed work time and the relationship between the
codes in the family. For example, this was our rationale for refining
the work RVU of CPT code 10021 from the RUC-recommended value of 1.20
to the finalized value of 1.03: In reviewing CPT code 10021, we noted
that the recommended intraservice time is decreasing from 17 minutes to
15 minutes (12 percent reduction), and the recommended total time is
decreasing from 48 minutes to 33 minutes (32 percent reduction);
however, the RUC-recommended work RVU is only decreasing from 1.27 to
1.20, which is a reduction of just over 5 percent. In the case of CPT
code 10021, we believed that it was more accurate to propose a work RVU
of 1.03 based on a crosswalk to CPT code 36440 to account for these
decreases in the surveyed work time (83 FR 59518). We note that this
primary rationale for refining the work RVU did not mention the
utilization crosswalk at all.
When we communicated to the RUC following the publication of the CY
2019 final rule that the codes in the Fine Needle Aspiration family
could be nominated as potentially misvalued, we indicated that we were
open to receiving new information about the valuation of these codes.
In reaffirming its recommendations from CY 2019, however, the RUC has
not provided any new information that was not already presented for the
previous CMS review of these codes. Therefore, we are not proposing any
changes to the codes in the Fine Needle Aspiration family, as the
reaffirmed CY 2021 RUC recommendations are identical to the CY 2019 RUC
recommendations that already went through notice and comment
rulemaking. We welcome the submission of new information regarding
these services that was not part of the previous CY 2019 review of the
code family.
(2) Tissue Expander Other Than Breast (CPT Code 11960)
This service was included in a larger group of similarly related
codes that were recommended for review for the October 2019 RUC
meeting. The RUC recommended to re-review this code at a more granular
level for the January 2020 RUC meeting.
We disagree with the RUC-recommended work RVU of 12.40 for CPT code
11960 (tissue expander other than breast). We are proposing to maintain
the current work RVU of 11.49 supported by a reference code, CPT code
45560 (repair of rectocele (separate procedure)), which has a work RVU
of 11.50. CPT code 45560 shares the same intraservice time of 90
minutes with CPT code 11960 and has a slightly higher total time of 367
minutes. The recommended total time for CPT code 11960 decreased from
444 minutes to 357 minutes, with a slight increase in intraservice time
of 78 minutes to 90 minutes. We believe the similar work RVU of the
reference CPT code 45560, as well as the reduction in total time,
supports maintaining the current work RVU of 11.49 for CPT code 11960.
We are proposing the RUC-recommended direct PE inputs for CPT code
11960 without refinements.
(3) Breast Implant-Expander Placement (CPT Codes 11970, 19325, 19340,
19342, and 19357)
These services were included in a larger group of 22 breast
reconstruction and similarly related codes that were recommend for
survey for the October 2019 RUC meeting. At the October 2019 RUC
meeting, these codes were recommended for a more granular review for
the January 2020 RUC meeting.
We disagree with the RUC-recommended work RVU of 8.01 for CPT code
11970 (replacement of tissue expander with permanent implant). We are
proposing a work RVU of 7.49 supported by a reference code CPT code
35701 (exploration not followed by surgical repair, artery; neck (e.g.,
carotid, subclavian)), which has a work RVU of 7.50. CPT code 35701
shares the same intraservice time of 60 minutes with CPT code 11970 and
has a slightly higher total time of 229 minutes as compared to 216
minutes. In addition, during our review of CPT code 11970, we noted
that the recommended intraservice time is decreasing from 78 minutes to
60 minutes and the recommended total time of 231 minutes is decreasing
to 216 minutes. We also note that our proposed work RVU of 7.49 for CPT
code 11970 is equal to the total time ratio amount, which is the
current total time compared to the RUC-recommended total time. We are
proposing the RUC-recommended direct PE inputs for CPT code 11970.
We disagree with the RUC-recommended work RVU of 8.64 for CPT code
19325 (breast augmentation with implant). Although we disagree with the
RUC-recommended work RVU, we concur that the relative difference in
work between CPT codes 11970 and 19325 is equivalent to the RUC-
recommended interval of 0.63 RVUs. Therefore, we are proposing a work
RVU of 8.12 for CPT code 19325, based on the recommended interval of
0.63 additional RVUs above our proposed work RVU of 7.49 for CPT code
11970. We believe the use of an incremental difference between these
CPT codes is a valid methodology for setting values, especially in
valuing services within a family of revised codes where it is important
to maintain appropriate intra-family relativity. We are also supporting
our proposed work RVU of 8.12 based on a reference code, CPT code 25652
(open treatment of ulnar styloid fracture). CPT code 25652 shares the
same intraservice time of 60 minutes and the same total time of 225
minutes with a lower work RVU of 8.06. In addition, during our review
of CPT code 19325, we noted that the total time has decreased from 244
minutes to 225 minutes and the intraservice time has decreased from 90
minutes to 60 minutes. We are proposing the RUC-recommended direct PE
inputs for CPT code 19325.
We disagree with the RUC-recommended work RVU of 11.00 for CPT code
19340 (insertion of breast implant on same day of mastectomy (i.e.
immediate)). Although we disagree with the RUC-recommended work RVU, we
concur that the relative difference in work between CPT codes 19325 and
19340 is equivalent to the RUC-recommended interval of 2.36 RVUs.
Therefore, we are proposing a work RVU of 10.48 for CPT code 19340,
based on the recommended interval of 2.36 additional RVUs above our
proposed work RVU of 8.12 for CPT code 19325. We are also supporting
our proposed work RVU of 10.48 based on a reference code, CPT code
47562 (laparoscopy, surgical; cholecystectomy). CPT code 47562 shares
the same intraservice time of 80 minutes and only a slightly lower
total time of 251 minutes with a similar work RVU of 10.47. In
addition, during our review of CPT code 19340, we noted that the total
time has decreased from 366 minutes to 261 minutes and the intraservice
time has decreased from 120 minutes to 80 minutes. We are proposing the
RUC-recommended direct PE inputs for CPT code 19340.
We disagree with the RUC-recommended work RVU of 11.00 for CPT code
19342 (insertion or replacement of breast implant on different day from
mastectomy). Although we disagree with the RUC-recommended work RVU, we
concur that the relative difference in work
[[Page 50154]]
between CPT codes 19325 and 19342 is equivalent to the RUC-recommended
interval of 2.36 RVUs. Therefore, we are proposing a work RVU of 10.48
for CPT code 19342, based on the recommended interval of 2.36
additional RVUs above our proposed work RVU of 8.12 for CPT code 19325.
We also note that the RUC-recommended work RVU of 11.00 is equal to the
RUC-recommended work RVU for CPT code 19340 because they have stated
that both services involve an identical amount of physician work and
similar times. We are also supporting our proposed work RVU of 10.48
based on a reference code, CPT code 47562 (laparoscopy, surgical;
cholecystectomy). CPT code 47562 shares the same intraservice time of
80 minutes and only a slightly lower total time of 251 minutes with a
similar work RVU of 10.47. The total time for CPT code 19342 has
decreased from 320 minutes to 252 minutes and the intraservice time has
decreased from 115 minutes to 80 minutes. We are proposing the RUC-
recommended direct PE inputs for CPT code 19342.
We disagree with the RUC-recommended work RVU of 15.36 for CPT code
19357 (tissue expander placement in breast reconstruction, including
subsequent expansion). Although we disagree with the RUC-recommended
work RVU, we concur that the relative difference in work between CPT
codes 11970 and 19357 is equivalent to the RUC-recommended interval of
7.35 RVUs. Therefore, we are proposing a work RVU of 14.84 for CPT code
19357, based on the recommended interval of 7.35 additional RVUs above
our proposed work RVU of 7.49 for CPT code 11970. We are also
supporting our proposed work RVU of 14.84 based on a reference code,
CPT code 37605 (ligation; internal or common carotid artery). CPT code
37605 shares the same intraservice time of 90 minutes and only a
slightly lower total time of 342 minutes with a lower work RVU of
14.28. In addition, during our review of CPT code 19357, we noted that
the total time has decreased from 468 minutes to 344 minutes and the
intraservice time has decreased from 110 minutes to 90 minutes. We are
proposing the RUC-recommended direct PE inputs for CPT code 19357.
(4) Breast Implant-Expander Removal (CPT Codes 11971, 19328, and 19330)
These services were included in a group of codes that were
recommended for survey for the October 2019 RUC meeting as part of a
large group of 22 breast reconstruction and similarly related services.
At the October 2019 RUC meeting, they agreed that a 22 code family was
too expansive. They recommended these codes be re-reviewed as part of a
smaller and more granular code family for the January 2020 RUC meeting.
We disagree with the RUC-recommended work RVU of 7.02 for CPT code
11971 (removal of tissue expander w/out insertion of implant). Although
we disagree with the RUC-recommended work RVU, we concur that the
relative difference in work between CPT codes 11970 and 11971 is
equivalent to the RUC recommended interval of 0.99 RVUs. Therefore, we
are proposing a work RVU of 6.50 for CPT code 11971, based on the
recommended interval of 0.99 RVUs below our proposed work RVU of 7.49
for CPT code 11970. We note that as stated previously, we believe the
use of an incremental difference between these CPT codes is a valid
methodology for setting values, especially in valuing services within
families of similarly revised codes. We are also supporting our
proposed work RVU of 6.50 based on a reference code, CPT code 25671
(percutaneous skeletal fixation of distal radioulnar dislocation). CPT
code 25671 shares the same intraservice time of 45 minutes and a
slightly less total time of 210 minutes with a very similar work RVU of
6.46. In addition, during our review of CPT code 11971, we noted that
the total time has decreased from 303 minutes to 215 minutes and the
intraservice time has decreased from 90 to 45 minutes. We are proposing
the RUC-recommended direct PE inputs for CPT code 11971.
We disagree with the RUC-recommended work RVU of 7.44 for CPT code
19328 (removal of intact breast implant). Although we disagree with the
RUC-recommended work RVU, we propose increasing the current work RVU
from 6.48 to 6.92 to account for the increases in total and
intraservice time. We also concur that the relative difference in work
between CPT codes 11971 and 19328 is equivalent to the RUC recommended
interval of 0.42 RVUs. Therefore, we are proposing a work RVU of 6.92
for CPT code 19328, based on the recommended interval of 0.42
additional RVUs above our proposed work RVU of 6.50 for CPT code 11970.
We are also supporting our proposed work RVU of 6.92 based on a
reference code, CPT code 28289 (Hallux rigidus correction with
cheilectomy, debridement and capsular release of the first
metatarsophalangeal joint; without implant). CPT code 28289 shares the
same intraservice time of 45 minutes and a slightly higher total time
of 210 minutes with a very similar work RVU of 6.90. The total time for
CPT code 19328 has increased from 173 minutes to 199 minutes and the
intraservice time has increased from 38 to 45 minutes. We are proposing
the RUC-recommended direct PE inputs for CPT code 19328.
We are proposing the RUC-recommended work RVU of 9.00 for CPT code
19330 (removal of ruptured breast implant, including implant contents).
The survey total time for CPT code 19330 has increased from 218 minutes
to 229 minutes and the intraservice time has increased from 62 minutes
to 75 minutes. We are also proposing the RUC-recommended direct PE
inputs for this code without refinements.
(5) Modified Radical Mastectomy (CPT Code 19307)
The RUC recommended that CPT code 19307 (Mastectomy, modified
radical, including axillary lymph nodes, with or without pectoralis
minor muscle, but excluding pectoralis major muscle) be surveyed for
the January 2020 RUC meeting for site of service anomaly. The
Relativity Assessment Workgroup identified services performed less than
50 percent of the time in the inpatient setting yet included inpatient
hospital E/M services within the global period and with 2018 Medicare
utilization over 5,000. The RUC recommended lowering the work RVU to
17.99 which is the survey 25th percentile.
We are proposing the RUC-recommended work RVUs of 17.99 for CPT
code 19307. We are also proposing the RUC-recommended direct PE inputs
for this code.
(6) Breast Lift-Reduction (CPT Codes 19316 and 19318)
These services were included in a larger code group of similarly
related services that were recommended for review for the October 2019
RUC meeting. CPT code 19316 (mastopexy) and CPT code 19318 (Breast
reduction) were then recommended for a more granular review for the
January 2020 RUC meeting.
We are proposing the RUC-recommended work RVU of 11.09 for CPT code
19316 (mastopexy) and 16.03 for CPT code 19318 (Breast reduction). We
are proposing the RUC-recommended direct PE inputs for this code family
without refinements.
(7) Secondary Breast Mound Procedure (CPT Codes 19370, 19371, and
19380)
These services were included in a large group of breast
reconstruction codes that were recommended to be surveyed for the
October 2019 RUC meeting. At the October 2019 RUC meeting, the RUC
concurred with the
[[Page 50155]]
more granular code families but recommended these codes be re-surveyed
for the January 2020 RUC meeting.
We disagree with the RUC-recommended work RVU of 10.0 for CPT code
19370 (Revision of peri-implant capsule, breast, including
capsulorrhaphy, and/or partial capsulectomy). We are proposing to
maintain the current work RVU of 9.17 based on a supporting reference
code, CPT code 28299 (Correction, hallux valgus (bunionectomy), with
sesamoidectomy, when performed; with double osteotomy, any method),
which has a work RVU of 9.29. CPT code 28299 shares a similar
intraservice time of 75 minutes with CPT code 19370 and has a slightly
higher total time of 256 minutes. In addition, we noted during our
review of CPT code 19370 that the recommended total time has increased
minimally from 253 minutes to 255 minutes, with a slight decrease in
intraservice time of 82 minutes to 78 minutes. We believe the similar
work RVU of the supporting CPT code 28299, as well as the minimal
changes in physician work time for CPT code 19370, supports maintaining
the current work RVU of 9.17. We are proposing the RUC-recommended
direct PE inputs for CPT code 19370 without refinements.
We disagree with the RUC-recommended work RVU of 10.81 for CPT code
19371 (Peri-implant capsulectomy, breast, complete, including removal
of all intra-capsular contents). Although we disagree with the RUC-
recommended work RVU, we concur that the relative difference in work
between CPT codes 19370 and 19371 is equivalent to the RUC recommended
interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 9.98
for CPT code 19371, based on the recommended interval of 0.81
additional RVUs above our proposed work RVU of 9.17 for CPT code 19370.
We note that as stated previously, we believe the use of an incremental
difference between these CPT codes is a valid methodology for setting
values, especially in valuing services within a family of revised codes
where it is important to maintain appropriate intra-family relativity.
We are also supporting our proposed work RVU of 9.98 based on a
reference code, CPT code 25628 (Open treatment of carpal scaphoid
(navicular) fracture, includes internal fixation, when performed). CPT
code 25628 shares the same intraservice time of 90 minutes and a
slightly higher total time of 277 minutes with a work RVU of 9.67. In
addition, during our review of CPT code 19371, we noted that the total
time for CPT code 19371 has decreased from 306 minutes to 261 minutes
and the intraservice time has decreased from 117 to 90 minutes. We are
proposing the RUC-recommended direct PE inputs for CPT code 19371.
We disagree with the RUC-recommended work RVU of 12.00 for CPT code
19380 (Revision of reconstructed breast (eg, significant removal of
tissue, re-advancement and/or re-inset of flaps in autologous
reconstruction or significant capsular revision combined with soft
tissue excision in implant-based reconstruction)). Although we disagree
with the RUC-recommended work RVU, we concur that the relative
difference in work between CPT codes 19371 and 19380 is equivalent to
the RUC recommended interval of 1.19 RVUs. Therefore, we are proposing
a work RVU of 11.17 for CPT code 19380, based on the recommended
interval of 1.19 additional RVUs above our proposed work RVU of 9.98
for CPT code 19371. We are also supporting our proposed work RVU of
11.17 based on a reference code, CPT code 64569 (Revision or
replacement of cranial nerve (eg, vagus nerve) neurostimulator
electrode array, including connection to existing pulse generato). CPT
code 64569 shares the same intraservice time of 120 minutes and only a
slightly higher total time of 312 minutes with a work RVU of 11.0. The
total time increased from 277 minutes to 307 minutes and the
intraservice time has increased from 89 minutes to 120 minutes. We are
proposing the RUC-recommended direct PE inputs for CPT code 19380.
(8) Hip-Knee Arthroplasty (CPT Codes 27130 and 27447)
CPT codes 27130 (Arthroplasty, acetabular and proximal femoral
prosthetic replacement (total hip arthroplasty), with or without
autograft or allograft) and 27447 (Arthroplasty, knee, condyle and
plateau; medial AND lateral compartments with or without patella
resurfacing (total knee arthroplasty)) were identified as potentially
misvalued codes under the CMS high expenditure procedural code screen
in the CY 2014 final rule with comment period (78 FR 74334). These
codes were reviewed by the AMA RUC who provided recommendations for
work RVUs and physician time for these services for CY 2014. We agreed
with the RUC recommendation to value CPT code 27130 and CPT code 27447
equally and thus established the same CY 2014 interim final work RVUs
for these two procedures (78 FR 74334). This change resulted in a 1.12
work RVU increase for the visits in the global period. We added the
additional work to the AMA RUC-recommended work RVU of 19.60 for CPT
codes 27130 and 27447, resulting in an interim final work RVU of 20.72
for both services.
In the CY 2015 final rule with comment period (79 FR 67632), we
discussed how in the CY 2014 final rule with comment period, we sought
public comment regarding the appropriate work RVUs for these services
and the most appropriate reconciliation for the conflicting information
regarding time values for these services as presented to us by the
physician community. We did not find the rationales provided for
modifying the interim final work values established in CY 2014
compelling, and thus we finalized the CY 2014 interim final values for
these procedures based upon the best data we had available and to
preserve appropriate relativity with other codes.
In the CY 2019 final rule (83 FR 59500 through 595303), CPT code
27130 and CPT code 27447 were added to the list of potentially
misvalued codes. A stakeholder submitted information requesting that
CMS nominate these codes as potentially misvalued. The stakeholder
stated that there were substantial overestimates in pre-service and
post-service time including follow-up inpatient and outpatient visits
that do not take place included in the valuation of the service. As a
result the codes were resurveyed for the October 2019 RUC meeting.
We are proposing the RUC-recommended work RVU of 19.60 for CPT code
27130 and the RUC-recommended work RVU of 19.60 for CPT code 27447. We
are also proposing the RUC-recommended direct PE inputs for both codes.
Additionally, we are seeking comment from the medical community on how
to consider and/or include pre-optimization time (pre-service work and/
or activities to improve surgical outcomes) going forward. We are also
interested in stakeholders' thoughts on what codes could be used to
capture these pre-optimization activities that could be billed in
conjunction with the services discussed previously. Overall, we are
interested in continuing our ongoing dialog with stakeholders about how
CMS might pay more accurately for improved clinical outcomes that may
result from increased efficiency in furnishing care through activities,
such as pre-optimization and are appreciative of information provided
by the medical community. We invite the medical community to continue
to engage with CMS on this and other topics.
[[Page 50156]]
(9) Toe Amputation (CPT Codes 28820 and 28825)
These services were identified by the RUC Relativity Assessment
Workgroup through a site of service anomaly screen based on the review
of 3 years of data (2015, 2016 and 2017) for services with utilization
over 10,000 in which a service is typically performed in the inpatient
hospital setting, yet only a half discharge day management identified
by CPT code 99238 is included. Prior to conducting the RUC survey, the
specialty societies recommended that it would be appropriate for these
services to have their global period changed from 090-day to 000-day so
the site of service is less of a contributing factor to the codes'
valuation. These codes were surveyed as a 000-day global service, and
we are proposing them as 000-day global services.
We disagree with the RUC-recommended work RVU of 4.10 for CPT code
28820 (Amputation, toe; metatarsophalangeal joint). We believe that it
would be more accurate to propose a work RVU of 3.51, and we are
supporting this value with a crosswalk to CPT code 33958
(Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support
(ECLS) provided by physician; reposition peripheral (arterial and/or
venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed)), which has a work RVU of 3.51,
to account for the decrease in the surveyed work time. We do not
believe the RUC-recommended reduction in work RVU from the current
value of 5.82 is commensurate with the RUC-recommended 102-minute
reduction in total time. We believe that a further reduction in work
RVUs is warranted given the significant reduction in RUC-recommended
physician time.
We disagree with the RUC-recommended work RVU of 4.00 for CPT code
28825 (Amputation, toe; interphalangeal joint). We are proposing a work
RVU of 3.41 based on the RUC-recommended increment relationship between
this code and CPT 28820 (a difference of -0.10), which we apply to our
proposed value for the latter code. We do not believe the RUC-
recommended reduction in work RVU from the current value of 5.37 is
commensurate with the RUC-recommended 97-minute reduction in total
time. We believe that a further reduction in work RVUs is warranted
given the significance of RUC-recommended reduction in physician time.
For the direct PE inputs, we are proposing to refine the pre-
service clinical labor times to conform to the 000-day global period
standards for both codes in the family for CPT codes 28820 and 28825.
We are also proposing to refine the clinical labor times for the
``Provide education/obtain consent'' (CA011) and the ``Prepare room,
equipment and supplies'' (CA013) activities to conform to our
established standard time of 2 minutes each in the non-facility setting
for CPT codes 28820 and 28825. We are also proposing to refine the
equipment time to conform to these changes in the clinical labor time
for both codes.
(10) Shoulder Debridement (CPT Codes 29822 and 29823)
In September 2019, the CPT Editorial Panel approved revision of CPT
code 29822 (Arthroscopy, shoulder, surgical; debridement, limited, 1 or
2 discrete structures (eg, humeral bone, humeral articular cartilage,
glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor
complex, labrum, articular capsule, articular side of the rotator cuff,
bursal side of the rotator cuff, subacromial bursa, foreign body[ies]))
and CPT code 29823 (Arthroscopy, shoulder, surgical; debridement,
extensive, 3 or more discrete structures (eg, humeral bone, humeral
articular cartilage, glenoid bone, glenoid articular cartilage, biceps
tendon, biceps anchor complex, labrum, articular capsule, articular
side of the rotator cuff, bursal side of the rotator cuff, subacromial
bursa, foreign body[ies])) to clarify limited and extensive debridement
by specifying the number of discrete structures debrided and providing
examples of the structures.
We are proposing the RUC-recommended work RVU of 7.03 for CPT code
29822 and 7.98 for CPT code 29823 without refinement.
For the direct PE inputs, we are proposing the RUC recommendations
CPT codes 29822 and 29823 without refinement.
(11) Absorbable Nasal Implant Repair (CPT Codes 30XX0)
In September 2019, the CPT Editorial Panel approved the addition of
CPT code 30XX0 (Repair of nasal valve collapse with subcutaneous/
submucosal lateral wall implant(s)) to report repair of nasal valve
collapse with subcutaneous/submucosal lateral wall implant(s)).
We are proposing the RUC-recommended value of 2.80 work RVUs
without refinement for CPT code 30XX0.
For the direct PE inputs, were also proposing the RUC-recommended
values without refinement.
(12) Lung Biopsy-CT Guidance Bundle (CPT Code 324X0)
CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle)
and 77012 (Computed tomography guidance for needle placement (eg,
biopsy, aspiration, injection, localization device), radiological
supervision and interpretation) were identified by the AMA through a
screen of code pairs that are reported on the same day, same patient
and same NPI number at or more than 75 percent of the time. The CPT
Editorial Panel deleted CPT code 32405 and replaced it with 324X0 (Core
needle biopsy, lung or mediastinum, percutaneous, including imaging
guidance, when performed).
We are not proposing the RUC-recommended work RVU of 4.00, which is
the survey median, because we believe this value somewhat overstates
the increase in intensity. Although we do not imply that the decrease
in time, when considering the aggregate time values for CPT codes 32405
and 77012, as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, significant
decreases in time should be appropriately reflected in the work RVU.
Intraservice and total time ratios using the aggregate time values of
current CPT codes 32405 and 77012 suggest a significantly lower work
RVU; however, we do not believe a decrease from the current aggregate
value of 32405 and 77012 is warranted. We believe there is some overlap
in physician work and time for the two current services, and that the
recommended increase to 4.00 does not appropriately recognize this
overlap. Therefore, we are proposing a work RVU of 3.18, which is the
sum of the work RVUs of the two base codes.
We are proposing the RUC-recommended direct PE inputs without
refinement.
(13) Atrial Septostomy (CPT Codes 33XX0, 33XX1, 33XX2)
Septostomy procedures are performed on extremely small newborns and
neonates with severe forms of congenital heart disease and are
lifesaving/temporizing procedures that do not provide definitive
therapy to these critically ill patients. These procedures are not
typical of the Medicare population and are of low volume. CPT code
92992 (Atrial septectomy or septostomy; transvenous
[[Page 50157]]
method, balloon (eg, Rashkind type) (includes cardiac catheterization))
and CPT code 92993 (Atrial septectomy or septostomy; blade method (Park
septostomy) (includes cardiac catheterization)), are carrier-priced
codes. These services were not formally designated as potentially
misvalued in the CY 2019 PFS final rule (83 FR 59500), but we did make
mention that the RUC had signaled their intention to review these two
codes. Both services were referred to the CPT Editorial Panel by the
specialty societies who indicated that CPT code 92992 may not have
included related imaging guidance, and also commented that CPT code
92993 was antiquated and rarely performed, so both CPT codes were
deleted and are now being replaced with the following proposed CPT
codes.
CPT code 33XX0 (Transcatheter atrial septostomy (TAS) for
congenital cardiac anomalies to create effective atrial flow, including
all imaging guidance by the proceduralist, when performed, any method
(eg, Rashkind, Sang-Park, balloon, cutting balloon, blade)), is one of
three codes intending to replace the two deleted Septostomy codes. For
CPT code 33XX0, the RUC recommends an RVU only crosswalk to CPT code
33340 (Percutaneous transcatheter closure of the left atrial appendage
with endocardial implant, including fluoroscopy, transseptal puncture,
catheter placement(s), left atrial angiography, left atrial appendage
angiography, when performed, and radiological supervision and
interpretation), which has a work RVU of 14.00. The RUC recommends 20
minutes of preservice evaluation time, 15 minutes of preservice
positioning time, 15 minutes preservice scrub/dress/wait time, 55
minutes intraservice time and 45 minutes immediate postservice time,
for 150 minutes total time. We are proposing the RUC recommended work
RVU of 14.00 and physician times without refinement.
CPT code 33XX1 (Transcatheter intracardiac shunt (TIS) creation by
stent placement for congenital cardiac anomalies to establish effective
intracardiac flow, all imaging guidance by the proceduralist when
performed, left and right heart diagnostic cardiac catherization for
congenital cardiac anomalies, and target zone angioplasty, when
performed (eg, atrial septum, Fontan fenestration, right ventricular
outflow tract, Mustard/Senning/Warden baffles); initial intracardiac
shunt) is another proposed new procedure currently performed on neonate
infants to children with severe forms of congenital heart disease, by
having a stent implanted inside of an infant's beating heart (and not
within a blood vessel). This stent replaces the methods in the old
atrial septostomy codes utilizing the balloon and blade method. The RUC
recommends 25 minutes preservice evaluation time, 15 minutes preservice
positioning time, 15 minutes preservice scrub/dress/wait time, 92
minutes intraservice time and 60 minutes immediate postservice time,
for 207 minutes total time. The RUC recommends 20.00 work RVUs for CPT
code 33XX1. We are proposing the RUC recommended work RVUs and their
recommended physician times.
CPT code 33XX2, (Transcatheter intracardiac shunt (TIS) creation by
stent placement for congenital cardiac anomalies to establish effective
intracardiac flow, all imaging guidance by the proceduralist when
performed, left and right heart diagnostic cardiac catherization for
congenital cardiac anomalies, and target zone angioplasty, when
performed (eg, atrial septum, Fontan fenestration, right ventricular
outflow tract, Mustard/Senning/Warden baffles); each additional
intracardiac shunt location (List separately in addition to code for
primary procedure)), is the add-on code to the proposed new procedure
CPT code 33XX1, for 60 minutes of physician intraservice time. The RUC
recommends a work RVU of 10.50 for CPT code 33XX2. This value for the
add-on code, in comparison to the recommended work value of 20.00 RVUs
with 92 minutes/intraservice time and 207 minutes of total time for CPT
code 33XX1 appears to be unsupportable given the 60 minutes of
additional physician intraservice time. We are instead proposing a work
RVU of 8.00 for add-on CPT code 33XX2, which is the 25th percentile
value from the survey and of similar valuation from reference CPT code
93592 (Percutaneous transcatheter closure of paravalvular leak; each
additional occlusion device (List separately in addition to code for
primary procedure)).
This family of CPT codes are facility-only services and have no
direct PE inputs.
(14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 339X1,
33990, 33991, 33992, 339X2, and 33993)
In May 2019, the CPT Editorial Panel approved the revision of four
codes to clarify the insertion and removal of right and left heart
percutaneous ventricular assist devices (PVAD), and the addition of two
codes to report insertion of PVAD venous access and removal of right
heart PVAD. These codes were surveyed with 000-day global periods and
reviewed at the October 2019 RUC meeting.
We are proposing the RUC-recommended work RVUs for all six codes in
the family. We are proposing a work RVU of 6.75 for CPT code 33990
(Insertion of ventricular assist device, percutaneous, including
radiological supervision and interpretation; left heart, arterial
access only), a work RVU of 6.75 for CPT code 339X1 (Insertion of
ventricular assist device, percutaneous, including radiological
supervision and interpretation; right heart, venous access only), a
work RVU of 8.84 for CPT code 33991 (Insertion of ventricular assist
device, percutaneous, including radiological supervision and
interpretation; left heart, both arterial and venous access, with
transseptal puncture), a work RVU of 3.55 for CPT code 33992 (Removal
of percutaneous left heart ventricular assist device, arterial or
arterial and venous cannula(s), separate and distinct session from
insertion), a work RVU of 3.00 for CPT code 339X2 (Removal of
percutaneous right heart ventricular assist device, venous cannula,
separate and distinct session from insertion), and a work RVU of 3.10
for CPT code 33993 (Repositioning of percutaneous right or left heart
ventricular assist device, with imaging guidance, at separate and
distinct session from insertion).
Stakeholders contacted CMS regarding the valuation of the codes in
this family following the arrival of the RUC recommendations. They
stated that the RUC recommendations did not accurately reflect the work
time of these procedures, which they stated to be increasing due to the
adoption of new technology. The stakeholders requested that CMS propose
to maintain the current work RVUs for the codes in this family and to
crosswalk the work RVU of the new codes to existing codes.
We disagree with the stakeholders and are proposing the RUC-
recommended work RVUs for each code in this family as noted previously.
We note that in this case where the surveyed work times for the
existing codes are decreasing and the utilization of CPT code 33990 is
increasing significantly (quadrupling in the last 5 years), we have
reason to believe that practitioners are becoming more efficient at
performing the procedure, which, under the resource-based nature of the
RVU system, lends support for proposing the RUC's recommended work
RVUs. Although the incorporation of new technology can sometimes make
services more complex and difficult to perform, it can also have the
opposite effect by making services less reliant on manual skill and
technique. We disagree
[[Page 50158]]
with the stakeholders that the incorporation of this new technology
would necessarily be grounds for maintaining the current work RVU, as
improvements in technology are commonplace across many different
services and are not specific to this procedure. As detailed earlier,
we also have reason to believe that the improved technology has led to
greater efficiencies in the procedure which, under the resource-based
nature of the RVU system, lends further support for proposing a lower
work RVU for the existing CPT codes.
The RUC did not recommend and we are not proposing any direct PE
inputs for this facility only code family. We are proposing a 000-day
global period for all six codes as surveyed by the RUC.
(15) Esophagogastroduodenoscopy (EGD) With Biopsy (CPT Code 43239)
In the CY 2019 PFS final rule (83 FR 59500), CPT code 43239
(Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single
or multiple) was publicly nominated for review under the potentially
misvalued code initiative. As requested, the specialty societies
conducted a survey for the April 2019 RUC meeting. The RUC survey
results showed that the current work RVU of 2.39, which is below the
survey 25th percentile work RVU of 2.50, accurately reflects the
physician work for CPT code 43239.
We are proposing to maintain the current work RVU of 2.39 as
recommended by the RUC. We are proposing the RUC-recommended direct PE
inputs for CPT code 43239 without refinement.
(16) Colonoscopy (CPT Code 45385)
In the CY 2019 final rule (83 FR 59500), CPT code 45385
(Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other
lesion(s) by snare technique) was publicly nominated for review under
the potentially misvalued code initiative. As requested, the specialty
societies conducted a survey for the April 2019 RUC meeting. The RUC
survey results showed that the current work RVU of 4.57, which is
slightly above the survey 25th percentile work RVU of 4.50, accurately
reflects the physician work for CPT code 45385.
We are proposing to maintain the current work RVU of 4.57 as
recommended by the RUC. We are proposing the RUC-recommended direct PE
inputs for CPT code 45385 without refinement.
(17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes
558XX)
In May 2019, the CPT Editorial Panel established a new code to
report ablation of malignant prostate tissue with high intensity
focused ultrasound (HIFU), including ultrasound guidance. For CPT code
558XX, we are not proposing the RUC recommendation to use the survey
median work RVU of 20.00 to value this service because we believe total
time ratios to the two key reference codes, CPT codes 55840
(Prostatectomy, retropubic radical, with or without nerve sparing) and
55873 (Cryosurgical ablation of the prostate (includes ultrasonic
guidance and monitoring)) indicate that this value is somewhat
overstated and does not accurately reflect the physician time, and
because an analysis of all 090-global period codes with similar time
values indicates that this service is overvalued. We are proposing a
work RVU of 17.73 based on a crosswalk to CPT code 69930 (Cochlear
device implantation, with or without mastoidectomy) which has similar
total time and identical intraservice time values and is more
consistent with other codes of similar time. We are proposing the RUC-
recommended PE inputs without refinement.
(18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57XX0)
In September 2019, the addition of CPT code 57XX0 (Computer-aided
mapping of cervix uteri during colposcopy, including optical dynamic
spectral imaging and algorithmic quantification of the acetowhitening
effect (List separately in addition to code for primary procedure)) was
approved by the CPT Editorial Panel to report computer-aided mapping of
cervix uteri during colposcopy. The RUC recommended the survey median
work RVU of 0.81 for this service. We are proposing the RUC-recommended
value of 0.81 for CPT code 57XX0. We are also proposing the RUC-
recommended direct PE inputs for this code.
We are seeking comment on a new medical supply indicated on the PE
spreadsheet submitted by the RUC. A ``computer aided spectral imaging
system (colposcopy) disposal speculum'' was noted in the RUC PE meeting
materials. This name suggests it is digital. However, on the actual
invoice submitted, the supply item in question was listed as a
``disposable medium speculum'' with no mention of a spectral imaging
system or a digital component. We researched this speculum and could
not find any evidence that it has a digital component. Therefore, we
are proposing to change the name of this new supply item to
``disposable speculum, medium'' (SD337) to reflect the actual product
on the invoice submitted. We are seeking clarification as to what
aspect of the speculum is digital or if a cheaper, non-digital speculum
would suffice. We note for example that the vaginal specula (SD118)
supply has a CY 2021 price of $1.12 and we were able to find disposable
medium specula readily available online for a price of roughly $1.00.
We are proposing the new SD337 supply at the $5.80 price as listed on
the invoice submitted in the RUC materials and are seeking comment as
to why other disposable speculums at a lower price would not be typical
for this procedure.
(19) Colpopexy (CPT Codes 57282 and 57283)
The CPT codes 57282 (Colpopexy, vaginal; extra-peritoneal approach
(sacrospinous, iliococcygeus)) and 57283 (Colpopexy, vaginal; intra-
peritoneal approach (uterosacral, levator myorrhaphy)) were identified
by the RUC Relativity Assessment Workgroup as services performed less
than 50 percent of the time in the inpatient setting yet include
inpatient hospital E/M services within the global period and the 2018
Medicare utilization is over 5,000. This code family was surveyed and
reviewed for the January 2020 RUC meeting. For CY 2021, the RUC
recommended a work RVU of 13.48 for CPT code 57282, and a work RVU of
13.51 for CPT code 57283.
We disagree with the RUC-recommended work RVUs for the CPT code
family of 57282 and 57283. We are proposing a work RVU of 11.63 for CPT
code 57282, and are also proposing to maintain the current work RVU of
11.66 for CPT code 57283. For CPT code 57283, we based our disagreement
on the total time ratio between the current time of 349 minutes and the
recommended time established by the survey of 231 minutes. This ratio
equals 66 percent, and 66 percent of the current work RVU of 11.66 for
CPT code 57283 equals a work RVU of 7.70. When we reviewed CPT code
57283, we found that the recommended work RVU was higher than other
codes with similar time values. This is supported by the reference CPT
codes we compared to CPT code 57283 with 90 minutes of intraservice
time; reference CPT code 19350 (Nipple/areola reconstruction) has a
work RVU of 9.11 with 229 minutes of total time, and reference CPT
[[Page 50159]]
code 47563 (Laparoscopy, surgical; cholecystectomy with
cholangiography) which has a work RVU of 11.47 with 238 minutes of
total time. Although we do not imply that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs. The recommendation
from the RUC acknowledged that the time had decreased for CPT code
57283, and also noted that there has been an increase in intensity due
to a change in technique and knowledge necessary to perform the
service. In the case of CPT code 57283, we believe it would be more
accurate to propose maintaining the current work RVU of 11.66 instead
of the RUC-recommended work RVU of 13.51 to account for these decreases
in the surveyed work time while still accounting for the increase in
intensity. We also note that the intensity of CPT code 57283 would
nearly double by maintaining the proposed work RVU of 11.66, due to the
significant decreases in surveyed work time, which we believe supports
the RUC's contention that the intensity of this code has increased over
time.
For CPT code 57282, we disagree with the RUC-recommended RVU of
13.48. We note that the significant decrease in total time for code
57282 suggests an RVU lower than 13.48. Although we disagree with the
RUC-recommended work RVU, we concur that the relative difference in
work between CPT codes 57282 and 57283 is equivalent to the RUC-
recommended interval of 0.03 RVUs. We believe the use of an incremental
difference between these CPT codes is a valid methodology for setting
values, especially in valuing services within a family of revised codes
where it is important to maintain appropriate intra-family relativity.
Therefore, we are proposing a work RVU of 11.63 for CPT code 57282,
based on the RUC recommended interval of 0.03 RVUs below our proposed
work RVU of 11.66 for CPT code 57283.
We are proposing the RUC-recommended direct PE inputs for the CPT
code family of 57282 and 57283 without refinement.
(20) Laparoscopic Colpopexy (CPT Code 57425)
The CPT code 57425 (Laparoscopy, surgical, colpopexy (suspension of
vaginal apex)) was identified by the RUC Relativity Assessment
Workgroup as a service performed less than 50 percent of the time in
the inpatient setting yet includes inpatient hospital E/M services
within the global period and the 2018 Medicare utilization is over
5,000. This service was surveyed and reviewed for the January 2020 RUC
meeting.
We disagree with the RUC-recommended work RVU of 18.02 for CPT code
57425 and propose to maintain the current RVU of 17.03 based on the
total time ratio between the current time of 404 minutes and the
recommended time established by the survey of 351 minutes. This is
supported by the reference CPT codes we compared to CPT code 57425 with
the same intraservice time; reference CPT code 26587 (Reconstruction of
polydactylous digit, soft tissue and bone) which has a work RVU of
14.50, and reference CPT code 20696 (Application of multiplane (pins or
wires in more than 1 plane), unilateral, external fixation with
stereotactic computer-assisted adjustment (e.g., spatial frame),
including imaging; initial and subsequent alignment(s), assessment(s),
and computation(s) of adjustment schedule(s)) which has a work RVU of
17.56. Both CPT codes 26587 and 20696 have 180 minutes of intraservice
time, which is equal to the 180 minutes of intraservice time in the RUC
recommendation for CPT code 57425, and over 400 minutes of total time.
The total time for CPT code 57425 decreased from 404 to 351 minutes and
the RUC did not appear to take this into account. Therefore, we are
proposing to maintain the current work RVU of 17.03.
We are proposing the RUC-recommended direct PE inputs for CPT code
57425 without refinement.
(21) Intravitreal Injection (CPT Code 67028)
CPT code 67028 (Intravitreal injection of a pharmacologic agent)
was identified via the RUC's Relativity Assessment Workgroup as a code
where the original valuation was based on a crosswalk code that had
since been revalued. The RUC recommended that CPT code 67028 should be
surveyed for the April 2019 RUC meeting. We are proposing the RUC-
recommended work RVU of 1.44 for CPT code 67028.
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Clean room/equipment by clinical staff'' (CA024)
activity from the RUC-recommended 5 minutes to 3 minutes for CPT code
67028, because 3 minutes is the standard time for this clinical labor
activity code, and we disagree that there would typically be a need for
2 additional minutes for cleaning, sterilizing, and re-packaging a
reusable eyelid speculum in a sterile package to prepare for its next
case. Additionally, 3 minutes is the standard time for cleaning the
room and cleaning the equipment; although we agree that these cleaning
tasks would take place, we do not believe that the removal of the same
day E/M visit would result in the need for 2 additional minutes of
cleaning time. We note that we are proposing to maintain the current
time for this clinical labor activity, which was previously finalized
in the CY 2011 PFS final rule at the standard value of 3 minutes (75 FR
73353). We are also proposing to refine the equipment times to match
the change in clinical labor time.
(22) Dilation of Eustachian Tube (CPT Codes 697XX and 697X1)
In September 2019, the CPT Editorial Panel created two new codes
CPT code 697XX (Nasopharyngoscopy, surgical, with dilation of
eustachian tube (ie, balloon dilation); unilateral) and CPT code
697X1(Nasopharyngoscopy, surgical, with dilation of eustachian tube
(ie, balloon dilation); bilateral)) to describe the dilation of the
eustachian tube via surgical nasopharyngoscopy, unilateral and
bilateral. We are proposing the RUC-recommended work RVUs of 3.00 and
4.27 for CPT codes 697XX and 697X1, respectively. For the direct PE
inputs, we are proposing the RUC-recommended values without refinement.
(23) X-Ray of Eye (CPT Code 70030)
CPT code 70030 (Radiologic examination, eye, for detection of
foreign body) was identified through an updated screen of CMS/Other
source codes with Medicare utilization over 20,000. We are proposing
the RUC-recommended work RVU of 0.18 for this service. We are proposing
the RUC-recommended direct PE inputs without refinement.
(24) CT Head-Brain (CPT Codes 70450, 70460, and 70470)
In the CY 2019 PFS final rule (83 FR 59500 through 59503), a
stakeholder nominated CPT code 70450 (Computed tomography, head or
brain; without contrast material) as potentially misvalued, citing GAO
and MedPAC reports that suggest that work RVUs are overstated for
procedures such as these, and the specialty society surveyed family
codes 70460 (Computed tomography, head or brain; with contrast
material(s)) and 70470 (Computed tomography, head or brain; without
contrast material, followed by contrast material(s) and further
sections). We are proposing the RUC
[[Page 50160]]
recommendation to maintain the current work RVUs of 0.85, 1.13, and
1.27 for CPT codes 70450, 70460, and 70470, respectively. For CPT code
70450, we note that the surveyed times are nearly identical to the
current times for these services, and we believe that the RUC's
reference to CPT code 70486 (Computed tomography, maxillofacial area;
without contrast material), which has similar physician time and the
same work RVU, is appropriate. For CPT code 70460, we note that the
surveyed times are nearly identical to the current times for these
services, and we believe that the RUC's reference to CPT code 70487
(Computed tomography, maxillofacial area; with contrast material(s)),
which has similar physician time and the same work RVU is appropriate.
Similarly, for CPT code 70470, we note that the surveyed times are
nearly identical to the current times for these services, and we
believe that the RUC's reference to CPT code 70488 (Computed
tomography, maxillofacial area; without contrast material, followed by
contrast material(s) and further sections)), which has similar
physician time and the same work RVU, is appropriate. We also note that
these codes are relatively consistently valued compared to other codes
with similar time values and a global period of XXX. We are proposing
the RUC-recommended direct PE inputs without refinement.
(25) Screening CT of Thorax (CPT Codes 71250, 71260, 71270, and 712X0)
In October 2018, AMA staff identified the CMS/Other Source codes
with 2017 Medicare utilization over 30,000. HCPCS code G0297 (Low dose
ct scan (ldct) for lung cancer screening) was identified. In January
2019, the RUC recommended to refer to CPT Editorial Panel to establish
a permanent code for this procedure. In May 2019, the CPT Editorial
Panel revised three codes and added one code to distinguish diagnostic
computed tomography, thorax from computed tomography, thorax, low dose
for lung cancer screening.
For CPT code 71250 (Computed tomography, thorax; without contrast
material), we are not proposing the RUC recommendation to maintain the
current work RVU of 1.16 as we believe this does not accurately reflect
the reduction in physician work time, and because an analysis of all
XXX-global period codes with similar time values indicates that this
service is overvalued. We are instead recommending to propose a work
RVU of 1.08 based on the ratio of current to RUC-recommended
intraservice time. As support for this value, we note that it falls
slightly below CPT code 76391 (Magnetic resonance (eg, vibration)
elastography), which has a work RVU of 1.10 and also has higher
physician time values.
Similarly, for CPT code 71260 (Computed tomography, thorax; with
contrast material(s)), we are not proposing the RUC recommendation to
maintain the current work RVU of 1.24 as we believe this does not
accurately reflect the reduction in physician time, and we are instead
proposing a work RVU of 1.16 based the ratio of current to RUC-
recommended intraservice time. Although we disagree with the RUC-
recommended work RVU, we concur that the relative difference between
CPT codes 71250 and 71260 is equivalent to the RUC-recommended interval
of 0.08 RVUs. As stated previously, we believe the use of an
incremental difference between these CPT codes is a valid methodology
for setting values, especially in valuing services within a family of
revised codes where it is important to maintain appropriate intra-
family relativity. We note that that the proposed work RVU of 1.16
maintains the RUC-recommended interval of 0.08 additional RVUs above
our proposed work RVU of 1.08 for CPT code 71250.
For CPT code 71270 (Computed tomography, thorax; without contrast
material, followed by contrast material(s) and further sections)), we
are not proposing the RUC recommendation to maintain the current work
RVU of 1.38 as we believe this does not accurately reflect the
reduction in physician time, and we are instead proposing a work RVU of
1.25 with a crosswalk to CPT code 93284 (Programming device evaluation
(in person) with iterative adjustment of the implantable device to test
the function of the device and select optimal permanent programmed
values with analysis, review and report by a physician or other
qualified health care professional; multiple lead transvenous
implantable defibrillator system) and we support this value by noting
that it is slightly higher than values suggested by the ratio of
current to RUC-recommended intraservice time For CPT code 712X0
(Computed tomography, thorax, low dose for lung cancer screening,
without contrast material(s)), we are not proposing the RUC-recommended
work RVU of 1.16, and we are instead proposing a work RVU of 1.08 so
that the value of this code is consistent with that of CPT code 71250
as current code G0297 is valued based on the value of CPT code 71250,
and to maintain the relative relationship among these codes. In the CY
2016 PFS final rule (80 FR 70974) we finalized that CPT code G0297
should be identically valued to CPT code 71250.
We are proposing the RUC-recommended direct PE inputs without
refinement for CPT codes 71250, 71260, and 71270. For the direct PE
inputs for CPT code 712X0, we are proposing 2 minutes for the clinical
labor activity CA011: ``Provide education/obtain consent'' rather than
the RUC-recommended 3 minutes to be consistent with other non-contrast
screening codes, and we are proposing 4 minutes for the clinical labor
activity CA038 ``Coordinate post-procedure services'' rather than the
RUC-recommended 6 minutes to be consistent with other screening
services, and because we do not see any compelling evidence that this
service has changed significantly since G0297 was implemented for CY
2015 to warrant the recommended 2 additional minutes.
(26) X-Ray Bile Ducts (CPT Codes 74300, 74328, 74329, and 74330)
CPT codes 74300 (Cholangiography and/or pancreatography;
intraoperative, radiological supervision and interpretation) and 74328
(Endoscopic catheterization of the biliary ductal system, radiological
supervision and interpretation) were identified through a screen of
CMS/Other Source codes with 2017 Medicare utilization over 30,000. CPT
codes 74329 (Endoscopic catheterization of the pancreatic ductal
system, radiological supervision and interpretation) and 74330
(Combined endoscopic catheterization of the biliary and pancreatic
ductal systems, radiological supervision and interpretation) were
included as part of the same code family and the family was surveyed.
The codes describe x-rays of the liver, pancreas, and bile ducts. They
are performed in facilities and have no direct PE inputs.
We disagree with the RUC-recommended work RVU of 0.32 for CPT code
74300. We are proposing a work RVU of 0.27 based on a crosswalk to CPT
code 74021 (Radiologic examination, abdomen; 3 or more views), one of
the reference services from the RUC survey and that has an intraservice
time of 4 minutes, nearly identical to the RUC's recommendation of 5
minutes of intraservice time for CPT code 74300. Our proposal is
supported by CPT code 93922 (Limited bilateral noninvasive physiologic
studies of upper or lower extremity arteries) with a work RVU of 0.25
and an intraservice time of 5 minutes and a total time of 10 minutes.
These times are nearly identical to the RUC's recommended
[[Page 50161]]
intraservice of 5 minutes and total time of 10 minutes for CPT code
74300.
We are proposing the RUC-recommended work RVU of 0.47 for CPT code
74328 (Endoscopic catheterization of the biliary ductal system,
radiological supervision and interpretation), with an intraservice time
of 10 minutes and a total time of 20 minutes.
We disagree with the RUC's recommended work RVU of 0.50 for CPT
code 74329 (Endoscopic catheterization of the pancreatic ductal system,
radiological supervision and interpretation). We are proposing a
crosswalk to CPT code 74328 at a work RVU of 0.47 because the
intraservice and total times for both codes are identical and we
believe the work involved in the biliary ductal and pancreatic ductal
systems is similar.
We disagree with the RUC's recommended work RVU of 0.70 for CPT
code 74330 (Combined endoscopic catheterization of the biliary and
pancreatic ductal systems, radiological supervision and interpretation)
and we are proposing a work RVU of 0.56 based on our proposal of the
RUC's recommendation for CPT code 74328 to create internal consistency
within the code family, based on our time ratio methodology and further
supported by a reference to CPT code 93228 (External mobile
cardiovascular telemetry with electrocardiographic recording,
concurrent computerized real time data analysis and greater than 24
hours of accessible ECG data storage (retrievable with query) with ECG
triggered and patient selected events transmitted to a remote attended
surveillance center for up to 30 days; review and interpretation with
report by a physician or other qualified health care professional) with
nearly identical and total time values to CPT code 74330.
The RUC did not recommend and we are not proposing any direct PE
inputs for these codes.
(27) Venography (CPT Codes 75820 and 75822)
The review of CPT code 75820 (Venography, extremity, unilateral,
radiological supervision and interpretation) was prompted by the
Relativity Assessment Workgroup Medicare utilization screen of over
20,000 claims in a year. CPT code 75820 currently has a work RVU of
0.70 with 14 minutes of total time. This service involves the
supervision and interpretation of a contrast injection and imaging of
either the upper or lower extremity. For CPT code 75820, the RUC
recommends 12 minutes preservice time, 20 minutes intraservice time, 10
minutes postservice time and 42 minutes of total time. The specialty
societies' survey at the 25th percentile yielded a 1.05 work RVU, and
it is the RUC's recommended work value. We are proposing the RUC
recommended value for CPT code 75820.
CPT code 75822 (Venography, extremity, bilateral, radiological
supervision and interpretation) is reviewed as part of the family of
codes included with CPT code 75820. CPT code 75822 has a current 1.06
work RVU and 21 minutes of total time. The RUC recommends 15 minutes
preservice time, 30 minutes intraservice time, 12 minutes postservice
time and 57 minutes of total time, and the survey's 25th percentile
work RVU of 1.48. The service is similar to CPT 75820, except that this
CPT code is bilateral, involving the supervision and interpretation of
a contrast injection and imaging of both of either the upper or lower
extremities. The RUC recommends 1.48 work RVU and 57 minutes of total
time for CPT code 75822. We are proposing these RUC recommended values
for CPT code 75822.
(28) Introduction of Catheter or Stent (CPT Code 75984)
The RUC recommended reviewing CPT code 75984 (Change of
percutaneous tube or drainage catheter with contrast monitoring (e.g.,
genitourinary system, abscess) radiological supervision and
interpretation) after more utilization data was available, which
resulted in this service being surveyed and reviewed for the April 2019
RUC meeting. We are proposing the work RVU of 0.83 as recommended by
the RUC. We are proposing the RUC-recommended direct PE inputs for CPT
code 75984 without refinement.
(29) Medical Physics Dose Evaluation (CPT Code 7615X)
The CPT Editorial Panel created CPT code 7615X (Medical physics
dose evaluation for radiation exposure that exceeds institutional
review threshold, including report), which is a new PE-only code.
Because of the high amount of clinical staff time and the fact that
there are not analogous services, the PE Subcommittee requested that
the specialty societies conduct a PE survey. In addition, they stated
that the service is stand-alone, meaning that the medical physicist
works independently from a physician and there are no elements of the
PE that are informed by time from a physician work survey. Following
the meeting, the specialty societies developed a PE survey which was
reviewed and approved by the Research Subcommittee. We are proposing
the RUC-recommended direct PE inputs for CPT code 7615X without
refinement.
(30) Ophthalmic Ultrasound Anterior Segment (CPT Code 76513)
CPT code 76513 (Ophthalmic ultrasound, diagnostic; anterior segment
ultrasound, immersion (water bath) B-scan or high resolution
biomicroscopy) was identified by the RUC due to volume growth,
attributed to improved equipment. The CPT Editorial Panel has since
revised this code to clarify that it is either unilateral or bilateral
(it was previously unilateral). It was then surveyed. The code
describes a test for glaucoma and is performed on the same day as an
office/outpatient evaluation and management (O/O E/M) visit. The CPT
and RUC removed CPT code 76513 from its former code family, creating a
family of 1 service.
In reviewing this code, we noted that the recommended total time is
decreasing from 19 minutes to 15 minutes (21 percent) while the RUC-
recommended work RVU is decreasing from 0.66 to 0.60 (9 percent). We do
not believe the RUC-recommended work RVU appropriately accounts for the
substantial reductions in the surveyed work times for the procedure.
Although we do not imply that the decrease in time as reflected in
survey values must equate to a one-to-one or linear decrease in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, significant decreases in time should be
appropriately reflected in decreases to work RVUs. In the case of CPT
code 76513, we believe that it would be more accurate to propose a work
RVU of 0.53 based on a crosswalk to CPT code 74230 (Radiologic
examination, swallowing function, with cineradiography/
videoradiography, including scout neck radiograph(s) and delayed
image(s), when performed, contrast (eg, barium) study) with identical
intraservice and total times.
For the direct PE inputs, we are proposing to make two refinements
to the clinical labor times of CPT code 76513. We are proposing a
reduction of 1 minute for the clinical labor task CA009: ``Greet
patient, provide gowning, ensure appropriate medical records are
available'' because the EHR information should already be linked from
the preceding O/O E/M visit and the entry of information would be
redundant and paid under indirect PE. We are also proposing a reduction
of 1 minute for the clinical labor task CA011: ``Provide education/
obtain consent'' to be consistent with the time for this
[[Page 50162]]
clinical labor task for the services in CPT code 76513's former code
family.
(31) Radiation Treatment Delivery (CPT Code 77401)
CPT code 77401 (Radiation treatment delivery, superficial and/or
ortho voltage, per day) was identified by the RUC Relativity Assessment
Workgroup through a screen of high-volume growth, for services with
2017 Medicare utilization of 10,000 or more that has increased by at
least 100 percent from 2012 through 2017. In January 2019, the RUC
recommended to refer to this service to the CPT Editorial Panel to
better define the set of services associated with delivery of
superficial radiation therapy (SRT).
We are proposing the following direct PE refinements: A reduction
of 2 minutes for the clinical labor task CA024: ``Clean room/equipment
by clinical staff,'' to the standard 3 minutes, and we are not
proposing to include the new equipment item ER119 ``Lead Room,'' as we
do not have enough information on what this equipment item contains,
and we are requesting more information to allow us to determine if it
is more accurately priced as direct or indirect PE. CPT code 77401 is a
PE only code and we are proposing to maintain the current work RVU of
0.00.
(32) Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and
77525)
In April 2018, the RUC's Relativity Assessment Workgroup (RAW)
identified CPT code 77522 (Proton treatment delivery; simple, with
compensation) and CPT code 77523 (Proton treatment delivery;
intermediate) as contractor-priced Category I CPT codes with 2017
estimated Medicare utilization over 10,000 services. Although the RAW
agreed with the specialty society that this family of codes should
remain contractor priced, the RUC determined that these services should
be surveyed for PE. CPT codes 77520 (Proton treatment delivery; simple,
without compensation) and 77525 (Proton treatment delivery; complex)
were added to the family and the group was surveyed for PE for the
April 2019 RUC meeting.
We encountered significant difficulties in reviewing the
recommended direct PE inputs for the codes in the Proton Beam Treatment
Delivery family. These difficulties were largely associated with
determining a price for the two new equipment items in the code family,
the Proton Treatment Vault (ER115) and the Proton Treatment Delivery
System (ER116). These equipment items had extraordinarily high prices
of $19,001,914 and $30,400,000 respectively on the invoices submitted
with the code family. By way of comparison, the highest equipment price
currently existing in our database for CY 2021 is the ``SRS system,
Linac'' (ER082) equipment item at $4,233,825. We have concerns that
establishing equipment pricing for the proton treatment vault and
delivery system at a rate that is so much higher than anything else in
our equipment database could distort relativity.
We also have concerns about the information provided on the
submitted invoices used for the pricing of these two new equipment
items. The invoices for both the Proton Treatment Vault and the Proton
Treatment Delivery System contained building construction costs such as
asphalt paving, masonry and carpentry expenses, drywall packaging, and
the installation of electrical systems. We understand that these proton
treatment equipment items are extremely capital-intensive and require
the construction of custom-built offices to house the equipment.
However, the expenses associated with constructing new office
facilities fall outside of our direct PE methodology, and would be more
accurately classified as a form of building maintenance or office rent
under indirect PE. We do not agree that construction costs should be
included as a form of direct PE because they are not individually
allocable to a particular patient for a particular service. Although we
agree that the provider does need to bear the costs associated with the
storage of this equipment, this is a form of indirect PE under our
methodology. We do not believe that it would serve the interests of
relativity to include these building construction costs for the proton
treatment equipment as a type of direct PE expense.
As a result, we are proposing to maintain contractor pricing for
CPT codes 77520, 77522, 77523, and 77525 instead of proposing active
pricing for these services. We believe that maintaining contractor
pricing will allow the limited providers of these very expensive
services to adapt more quickly to shifts in the market-based costs
associated with the proton treatment equipment. The RUC similarly
expressed concern in its recommendations about the extremely high cost
of this equipment, agreed that these services were extremely hard to
value, and noted the difficulties that had taken place in surveying the
family of codes. The recommendations from the RUC also noted that
proton treatment is a rapidly changing technology and the change in the
treatment equipment often requires extensive modification to the vault.
We believe that these frequent changes can be more accurately captured
through contractor pricing as opposed to the need to update the pricing
of the proton treatment equipment on an annual basis.
If we were to propose active pricing for the codes in this family,
we believe that we would need to remove the building construction costs
from the Proton Treatment Vault and the Proton Treatment Delivery
System as forms of indirect PE, which would substantially lower their
overall equipment prices. We would also refine the equipment times to
the standard formula for highly technical equipment, which would result
in 3 minutes less time for each equipment item (such as 14 minutes for
all three equipment items in CPT code 77522).
(33) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472,
90473, and 90474 and HCPCS codes G0008, G0009, and G0010)
Especially in the context of the current Public Health Emergency
(PHE) related to the COVID-19 pandemic, it is evident that consistent
beneficiary access to vaccinations is vital to public health. Many
stakeholders have raised concerns regarding the reductions in payment
rates for vaccine administration services over the past several years.
The codes that describe these services have generally been valued based
on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or
diagnostic injection (specify substance or drug); subcutaneous or
intramuscular). Because we proposed and finalized reductions in
valuation for that code for CY 2018 and because the reductions in
overall valuation have been subject to the multi-year phase-in of
significant reductions in RVUs, the payment rate for the vaccine
administration codes has been concurrently reduced.
In the CY 2020 PFS final rule, we acknowledged that it is in the
public interest to ensure appropriate resource cost are reflected in
the valuation of the immunization administration services that are used
to deliver vaccines and noted that we planned to review the valuations
for these services in future rulemaking. For CY 2020, we maintained the
CY 2019 national payment amount for immunization administration
services described by HCPCS codes G0008 (Administration of influenza
virus vaccine), G0009 (Administration of pneumococcal
[[Page 50163]]
vaccine), and G0010 (Administration of hepatitis b vaccine) in the
interim.
The RUC has recently re-submitted recommendations from 2009
regarding the appropriate valuation for the broader range of vaccine
administration services, including CPT codes 90460 (Immunization
administration through 18 years of age via any route of administration,
with counseling by physician or other qualified health care
professional; first or only component of each vaccine or toxoid
administered), 90471 (Immunization administration (includes
percutaneous, intradermal, subcutaneous, or intramuscular injections);
1 vaccine (single or combination vaccine/toxoid)), and 90473
(Immunization administration by intranasal or oral route; 1 vaccine
(single or combination vaccine/toxoid)). In its recommendation, the RUC
noted that the current RVUs assigned are directly crosswalked from CPT
code 96372 (like the vaccine administration G-codes had been) and the
resulting payment rates are substantially lower than current Centers
for Disease Control and Prevention (CDC) regional maximum charges. The
RUC also pointed out that that appropriate payment for immunization
administration that reflects resource cost is critical in maintaining
high immunization rates in the United States, as well as having the
capacity to respond quickly to vaccinate against preventable disease
outbreaks.
We agree with the RUC's assertions regarding the importance of
appropriate resource based valuations for vaccine administration
services. We also recognize that the importance of these services is
increased in the context of the current PHE related to the COVID-19
pandemic, especially should there be a vaccine for this particular
disease.
We reviewed and considered the 2009 RUC-recommended direct PE
inputs for CPT codes 90460-90474 (as well as the related G-codes) in
place of the existing policy based on a crosswalk to CPT code 96372.
However, the RUC-recommended direct PE inputs from 2009 would result in
significant decreases in valuation for these 6 CPT codes even compared
to the current crosswalk. At this time, we do not believe that either
the existing crosswalk or the RUC recommendations from over a decade
ago reflect the relative resource costs associated with these services.
Without updated information to use in developing rates specific to
these codes based on direct PE inputs, and in consideration of the
import of these services for Medicare beneficiaries, as well as the
public health concerns raised by commenters, we believe that it would
be most appropriate to value these services using a crosswalk
methodology that better reflects the relative resources involved in
furnishing all of these services.
Therefore, we are proposing to crosswalk the valuation of CPT codes
90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT
code 36000 (Introduction of needle or intracatheter, vein). CPT code
36000 is a service with a nearly identical work RVU (0.18 as compared
to 0.17 for CPT codes 90460, 90471, and 90473) and a similar clinical
vignette. We believe that the additional clinical labor, supply, and
equipment resources associated with the furnishing of CPT code 36000
more accurately capture the costs associated with these immunization
codes. We also note that this crosswalk will result in payment rates
for vaccine administration services at approximately the same CY 2017
rates that were paid prior to the revaluation of CPT code 96372, which
had previously served as the basis of the crosswalk. We believe that
the proposed crosswalk is the most accurate valuation of these services
and will also serve to ensure the appropriate relative resources
involved in furnishing all of these services is reflected in the
payment for these critical immunization and vaccination services in the
context of the health needs of Medicare beneficiaries.
Regarding the add-on codes associated with these services, CPT
codes 90461 (Immunization administration through 18 years of age via
any route of administration, with counseling by physician or other
qualified health care professional; each additional vaccine or toxoid
component administered), 90472 (Immunization administration (includes
percutaneous, intradermal, subcutaneous, or intramuscular injections);
each additional vaccine (single or combination vaccine/toxoid)), and
90474 (Immunization administration by intranasal or oral route; each
additional vaccine (single or combination vaccine/toxoid)), we note
that the previous valuation methodology set their RVUs at approximately
half of the valuation for the associated base codes, described above.
Absent additional information, we are proposing to maintain that
approach by valuing the three add-on codes at half of the RVUs of the
aforementioned crosswalk to CPT code 36000.
Finally, we are proposing this valuation to apply to all of these
existing vaccine administration codes, using the valuation of CPT code
90471 for base codes and CPT code 90472 for add-on codes. Should a
vaccine for COVID-19 or other infectious disease become available
during CY 2021, we would anticipate applying the same approach to
valuing the administration of such vaccines, regardless of whether
separate coding for such services would need to be introduced.
(34) Liver Elastography (CPT Code 91200)
CPT code 91200 (Liver elastography, mechanically induced shear wave
(eg, vibration), without imaging, with interpretation and report) was
targeted for review through the RUC's new technology/new services
screen. The RUC reviewed 3 years of available Medicare claims data
(2016, 2017 and 2018) and surveyed the code for the January 2020
meeting.
We are proposing the RUC-recommended work RVU of 0.21. We are also
proposing the RUC-recommended direct PE inputs for CPT code 91200
without refinement.
(35) Remote Retinal Imaging (CPT Codes 92227, 92228, and 9225X)
The AMA CPT Editorial Panel revised CPT code 92227 (Imaging of
retina for detection or monitoring of disease; with remote clinical
staff review and report, unilateral or bilateral) and CPT code 92228
(Imaging of retina for detection or monitoring of disease; with remote
physician or qualified health professional review and report,
unilateral or bilateral) that are reported for the treatment of
diabetic retinopathy. Two practice sites are involved in these
services: The acquiring site (for example, a primary care practice) and
the reading site (for example, the ophthalmology practice). Both codes
can be used to report diagnostic and monitoring services and the
distinction is in whom provides the service: Physician (CPT code 92228)
or clinical staff only (CPT code 92227). Thus, only CPT code 92228
includes work, accounting for the physician at the reading site. For
both CPT codes 92227 and 92228, direct PE pays for the clinical staff
at both sites.
The AMA CPT Editorial Panel also created CPT code 9225X (Imaging of
retina for detection or monitoring of disease; with point-of-care
automated analysis with diagnostic report; unilateral or bilateral) for
point-of-care automated analysis that uses innovative artificial
intelligence technology to perform the interpretation of the eye exam,
without requiring that an ophthalmologist interpret the results. CPT
code 9225X can be used at a primary care practice site and the
artificial intelligence technology
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interprets the test instead of a remotely located ophthalmologist.
Because no physician is involved, this service is PE only. We are
considering CPT code 9225X to be a diagnostic service under the PFS and
are creating separate payment for it.
For CPT code 92228, we are proposing the RUC's recommended work RVU
of 0.32. CPT codes 92227 and 9225X are PE only codes, and we are
proposing a work RVU of 0.00 for both codes.
For both CPT codes 92227 and 92228, we are proposing the AMA RUC's
recommended direct PE inputs. We are proposing two refinements to the
direct PE inputs for CPT code 9225X. We are proposing a reduction of 1
minute for the clinical labor task CA009, ``Greet patient, provide
gowning, ensure appropriate medical records are available,'' to be
consistent with the amount of clinical labor for this task in CPT codes
92228 and 92227. We are also not proposing the RUC's recommendation of
a $25 analysis fee for remote imaging because we consider this a
service fee that constitutes a form of indirect PE and that this cost
is appropriately captured via the indirect PE methodology as opposed to
being included as a separate direct PE input. We do not believe that
the analysis fee would be allocated to the use of an individual patient
for an individual service, and can be better understood as an indirect
cost similar to other administrative expenses.
(36) Auditory Evoked Potentials (CPT Codes 92584, 92X51, 92X52, 92X53,
and 92X54)
CPT codes 92585 (Auditory evoked potentials for evoked response
audiometry and/or testing of the central nervous system; comprehensive)
and 92586 (Auditory evoked potentials for evoked response audiometry
and/or testing of the central nervous system; limited) were identified
through a RAW requested screen of CMS/Other Source codes with 2017
Medicare utilization over 30,000. Since these codes were last valued,
audiologists, the primary reporter of these services, can now report
Medicare services independently. As a result, the audiologist work for
these services is moving from PE to work.
To better describe tests of auditory function, the CPT created CPT
code 92584 (Electrocochleography) and replaced CPT codes 92585 and
92586 with four new services. We are proposing the RUC-recommended work
RVUs of 1.00 for CPT code 92584, 1.00 for CPT code 92X52 (Auditory
evoked potentials; for hearing status determination, broadband stimuli,
with interpretation and report), 1.50 for CPT code 92X53 (Auditory
evoked potentials; for threshold estimation at multiple frequencies,
with interpretation and report), and 1.05 for CPT code 92X54 (Auditory
evoked potentials; neurodiagnostic, with interpretation and report).
CPT code 92X51 (Auditory evoked potentials; screening of auditory
potential with broadband stimuli, automated analysis) is a screening
service and is not payable by Medicare. Therefore, we are not proposing
a valuation for this code; however, we will display the RUC-recommended
work RVU of 0.25.
We are proposing the RUC-recommended direct PE inputs for this code
family without refinement.
(37) Vestibular Evoked Myogenic Potential Testing (CPT Codes 925X1,
925X2, and 925X3)
In response to a 2017 RAW request, AMA staff compiled a list of
CMS/Other codes with Medicare Utilization of 30,000 or more. CPT code
92585 (Auditory evoked potentials for evoked response audiometry and/or
testing of the central nervous system; comprehensive) was identified as
one of the codes. In 2018, the AMA/RUC referred CPT code 92585 and its
family member CPT code 92586 (Auditory evoked potentials for evoked
response audiometry and/or testing of the central nervous system;
limited) to the February 2019 CPT Editorial Panel meeting to clarify
code descriptors and define the terms ``limited'' and ``comprehensive''
auditory evoked potentials.
During the discussion of CPT codes 92585 and 92586 at the February
2019 CPT Editorial Panel meeting, specialty societies introduced a new
procedure, Vestibular Evoked Myogenic Potential (VEMP), and suggested
new coding. As a result, the CPT Editorial Panel created 3 new codes:
CPT code 925X1 (Vestibular evoked myogenic potential testing, with
interpretation and report; cervical (cVEMP)); CPT code 925X2
(Vestibular evoked myogenic potential testing, with interpretation and
report; ocular (oVEMP)); and CPT code 925X3 (Vestibular evoked myogenic
potential testing, with interpretation and report; cervical and
ocular). The RUC reviewed the three codes at its April 2019 meeting.
We are proposing the RUC-recommended work RVU of 0.80 for CPT codes
925X1 and 925X2. For CPT code 925X3, we are proposing the RUC-
recommended work RVU of 1.20. We also are proposing the RUC-recommended
direct PE inputs without refinement for these three VEMP codes.
(38) Complete Electrocardiogram (CPT Codes 93000, 93005, and 93010)
In the CY 2019 PFS final rule (83 FR 59452), CPT code 93000 was
nominated for review under the potentially misvalued code initiative.
The RUC reviewed these services at the April 2019 meeting where the
specialty societies explained that the family of electrocardiogram
(ECG) codes were relatively unique in that CPT code 93000
(Electrocardiogram, routine ECG with at least 12 leads; with
interpretation and report) is the global service which is billed in the
hospital setting, CPT 93005 (Electrocardiogram, routine ECG with at
least 12 leads; tracing only, without interpretation and report) is the
technical component and CPT 93010 is the professional component.
We are proposing the RUC-recommended work RVU of 0.17, which is the
current value for both codes, for CPT codes 93000 and 93010. CPT code
93005 is a PE only technical component code, and we are proposing to
maintain the current work RVU of 0.00.
For the direct PE inputs, we are also proposing the RUC-recommended
values without refinement.
(39) External Extended ECG Monitoring (CPT Codes 93224, 93225, 93226,
93227, 93XX0, 93XX1, 93XX2, 93XX3, 93XX4, 93XX5, 93XX6, and 93XX7)
In September 2019, the CPT Editorial Panel replaced four Category
III codes with 8 new Category I codes to report external
electrocardiographic (ECG) recording by continuous rhythm recording and
storage for periods longer than 48 hours. The existing Holter monitor
codes (CPT codes 93224 through 93227) that include up to 48 hours of
continuous recording were also reviewed as part of this family of
services at the January 2020 RUC meeting.
We are proposing the RUC-recommended work RVU for all 12 codes in
the family. We are proposing a work RVU of 0.39 for CPT codes 93224
(External electrocardiographic recording up to 48 hours by continuous
rhythm recording and storage; includes recording, scanning analysis
with report, review and interpretation by a physician or other
qualified health care professional) and 93227 (External
electrocardiographic recording up to 48 hours by continuous rhythm
recording and storage; review and interpretation by a physician or
other qualified health care professional); a work RVU of 0.50 for CPT
codes 93XX0 (External electrocardiographic recording for more than 48
hours up to 7 days by
[[Page 50165]]
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation) and 93XX3 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; review and interpretation);
and a work RVU of 0.55 for CPT codes 93XX4 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation) and 93XX7 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; review and interpretation).
The other six codes in the family are technical component codes
that do not have a work RVU; we are proposing a work RVU of 0.00 for
CPT codes 93225 (External electrocardiographic recording up to 48 hours
by continuous rhythm recording and storage; recording (includes
connection, recording, and disconnection)), 93226 (External
electrocardiographic recording up to 48 hours by continuous rhythm
recording and storage; scanning analysis with report), 93XX1 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), 93XX2 (External electrocardiographic recording
for more than 48 hours up to 7 days by continuous rhythm recording and
storage; scanning analysis with report), 93XX5 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), and 93XX6 (External electrocardiographic
recording for more than 7 days up to 15 days by continuous rhythm
recording and storage; scanning analysis with report).
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Perform procedure/service--NOT directly related to
physician work time'' (CA021) activity for CPT codes 93XX0, 93XX2,
93XX4, and 93XX6. We are proposing to reduce the clinical labor time by
5 minutes for each code as the description of the tasks taking place in
the recommended materials includes activities that are considered to be
indirect PE under our methodology. The recommended materials stated
that ``incoming patch deliveries are sorted and distributed to work
queues. The return box is opened, diary book removed, top housing is
removed using a custom tool to expose USB connection, and device is
plugged in to extract serial number and diagnostic logs.'' These
unboxing and filing activities are classified as administrative
expenses under our PE methodology, and therefore, do not constitute
clinical labor as a direct expense. We are proposing to remove 5
minutes from the clinical labor to reflect these activities which are
indirect as opposed to direct costs. We are also proposing to refine
the equipment time for the desktop computer (ED021) to reflect these
changes in the clinical labor time.
We noted an inconsistency in the RUC-recommended direct PE inputs
for CPT codes 93XX0 and 93XX4. Both of these codes are the ``global
component'' for their respective group of codes, such that the direct
costs for CPT codes 93XX1-93XX3 must sum up to the direct cost of CPT
code 93XX0 and the direct costs for CPT codes 93XX5 through 93XX7 must
sum up to the direct cost of CPT code 93XX4. However, CPT codes 93XX0
and 93XX4 each contained 2 pairs of non-sterile gloves (SB022) whereas
their constituent technical component codes (93XX1 and 93XX5
respectively) only contained a single pair of non-sterile gloves.
Therefore, we are proposing to refine the quantity of the non-sterile
gloves down to 1 pair for CPT codes 93XX0 and 93XX4 to correct this
inconsistency. We also considered increasing the quantity of the gloves
to 2 as in CPT codes 93224 through 93227. However, we believe that only
1 pair of gloves would typically be needed to attach the ECGs, as the
patient does not return to have the ECGs removed in CPT codes 93XX0
through 93XX7 as opposed to CPT codes 93224 through 93227 where the
patient does return for ECG removal.
We are proposing the RUC-recommended equipment time of 1474 minutes
for the Holter monitor (EQ127) equipment included in CPT codes 93224
and 93226, based on an equipment time of 34 minutes during the
procedure along with 1440 minutes (24 hours) of equipment time
thereafter. We note that an external stakeholder wrote to request that
the number of minutes of equipment time for the Holter monitor be
increased from 1440 minutes (24 hours) to 2160 minutes (36 hours) to
reflect the average length of equipment time. The stakeholder wrote
that the 24-hour and 48-hour test were each performed approximately 50
percent of the time and stated that the most accurate number of
equipment minutes would be the average time. The RUC disagreed with the
stakeholder's request in its review because it concluded that there was
insufficient evidence to warrant a change from the current 24 hours of
equipment time; the RUC-recommended equipment time for the Holter
monitor was based on the typical rather than the average service. We
are proposing the RUC-recommended equipment time of 1474 minutes
because our PE methodology is indeed based on the typical case,
specifically what would be typical and reasonable and necessary for the
procedure in question. Although we appreciate the feedback from the
stakeholder, our previously finalized PE methodology establishes
pricing based on the typical case. For a detailed explanation of the
direct PE methodology, including examples, we refer readers to the 5-
year review of work RVUs under the PFS and proposed changes to the PE
methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007
PFS final rule with comment period (71 FR 69629).
The recommendations for this family of codes contain one new supply
item, the ``extended external ECG patch, medical magnetic tape
recorder'' (SD339). We did not receive a traditional invoice to
establish a price for this supply item, instead receiving pricing
information from two sources: A weighted median of claims data with the
cost of the other direct PE inputs removed, and a top-down approach
calculating the cost of the supply per service based on summing the
total costs of the provider and dividing by the total number of tests
furnished. The former methodology yielded a supply price of
approximately $440 while the latter methodology produced an estimated
supply price of $416.85. Stakeholders also submitted a series of
invoices from the clinical study marketplace with a price of $595.
Although we are appreciative of the data provided by the stakeholder,
we require an invoice representative of commercial market pricing to
establish a national price for a new supply or equipment item. Although
we are aware of the unusual circumstances surrounding the ``extended
external ECG patch, medical magnetic tape recorder'' in terms of how it
uploads data to the provider, we cannot establish supply pricing based
on an analysis of claims data and in absence of a representative
invoice.
Therefore, we are proposing to employ a crosswalk to an existing
supply for use as a proxy price until we have an invoice to use for the
``extended external ECG patch, medical magnetic tape recorder'' item.
We are proposing to use the ``kit, percutaneous neuro test
stimulation'' (SA022) supply as our proxy item at a price of $413.24.
[[Page 50166]]
Although this kit is not clinically similar to the extended external
ECG patch, we believe that it is the closest match from a pricing
perspective to employ as a proxy until we are able to arrive at an
invoice that is representative of commercial market pricing. We welcome
the submission of invoices or other additional information for use in
pricing the ``extended external ECG patch, medical magnetic tape
recorder'' supply.
(40) Complete Transthoracic Echocardiography (TTE) With Doppler (CPT
Code 93306)
In the CY 2019 PFS final rule (83 FR 59500), a submitter nominated
CPT code 93306 (Echocardiography, transthoracic, real-time with image
documentation (2D), includes M-mode recording, when performed,
complete, with spectral Doppler echocardiography, and with color flow
Doppler echocardiography) as potentially misvalued, citing GAO, MedPAC,
and Urban Institute reports that suggest the work RVUs are overstated.
Although the code was most recently surveyed in 2016, the specialty
societies and the RUC stated that there has been a change in the
technique and technology used to perform the procedure, so they
resurveyed the code. The RUC recommended decreasing the work RVU from
1.50 to 1.46 and we are proposing this value.
Although we are proposing the RUC's recommended direct PE inputs
without refinement we note that the RUC's recommendation included both
25 mL and 50 mL of ultrasound transmission gel. We are proposing a
supply quantity of 25 mL and seeking clarification on the correct
amount.
(41) Pacing Heart Stimulation (CPT Code 93623)
Review of CPT code 93623 (Programmed stimulation and pacing after
intravenous drug infusion (List separately in addition to code for
primary procedure)), was prompted by the Relativity Assessment
Workgroup Medicare utilization screen of over 30,000 claims in a year.
This service is to create an arrhythmia by an intravenous drug infusion
and it is an add-on code with 60 minutes of total time and a current
work RVU of 2.85.
The RUC recommends the 25th percentile survey value of 2.04 work
RVUs and 20 minutes of intraservice time.
The revision of CPT code 93623 physician's time adjusting from the
current 60 minutes to 20 minutes is a significant change. We do not
believe the RUC-recommended work RVU appropriately accounts for the
substantial reductions in the surveyed work times for the procedure.
Although we do not imply that the decrease in time as reflected in
survey values must equate to a one-to-one or linear decrease in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, significant decreases in time should be
appropriately reflected in decreases to work RVUs. In the case of CPT
code 93623, we believe that it would be more accurate to propose a work
RVU of 0.98 based on CPT code 76810 (Ultrasound, pregnant uterus, real
time with image documentation, fetal and maternal evaluation, after
first trimester ( or = 14 weeks 0 days), transabdominal
approach; each additional gestation (list separately in addition to
code for primary procedure)) with 20 minutes of intraservice time. We
are proposing a work RVU of 0.98 with 20 minutes of intraservice time
for CPT code 93623.
This CPT code is a facility-only service and has no direct PE
inputs.
(42) Intracardiac Echocardiography (ECG) (CPT Code 93662)
The review of CPT code 93662 (Intracardiac echocardiography during
therapeutic/diagnostic intervention, including imaging supervision and
interpretation (List separately in addition to code for primary
procedure), was prompted by the Relativity Assessment Workgroup
Medicare utilization screen of over 10,000 claims in a year that had an
increase in volume by 100 percent between the 2012 to 2017. This
procedure has since changed from its last review, in its reduced use of
fluoroscopy, now replaced with ultrasound that create arrhythmia
mapping systems with intracardiac echo images processed to produce 3-
dimensional electroanatomical maps. The physician can now visualize
better and have more accurate details for more effective catheter
ablation for a wide range of arrhythmias. CPT code 93662 currently has
a work RVU of 2.80 with 5 minutes of preservice evaluation time, 55
minutes of intraservice time, 10 minutes of immediate postservice time,
and 70 minutes of total time.
The survey resulted in a median intraservice time of 25 minutes, a
significant shift from the current intraservice time of 55 minutes. The
RUC recommends a work RVU of 2.53 and 25 minutes of intraservice time
for add-on CPT code 93662. We do not believe the RUC-recommended work
RVU appropriately accounts for the substantial reductions in the
surveyed work times for the procedure. Although we do not imply that
the decrease in time as reflected in survey values must equate to a
one-to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity,
significant decreases in time should be appropriately reflected in
decreases to work RVUs. CPT code 92979 (Endoluminal imaging of coronary
vessel or graft using intravascular ultrasound (ivus) or optical
coherence tomography (oct) during diagnostic evaluation and/or
therapeutic intervention including imaging supervision, interpretation
and report; each additional vessel (list separately in addition to code
for primary procedure)), with 1.44 work RVUs and 25 minutes of
intraservice time, is a good equivalent comparator code in light of the
significant physician time reduction from 55 minutes. A similarly
proportioned reduction of physician intraservice time from the current
55 minutes to the surveyed 25 minutes, if applied to the current work
RVU would result in a value much lower than our reference CPT code
92979's work RVU, so we are proposing a work RVU of 1.44 and 25 minutes
of intraservice time for add-on CPT code 93662.
This CPT code is a facility only service and has no direct PE
inputs.
(43) Ventricular Assist Device (VAD) Interrogation (CPT Code 93750)
The review of CPT code 93750, (Interrogation of ventricular assist
device (VAD), in person, with physician or other qualified health care
professional analysis of device parameters (eg, drivelines, alarms,
power surges), review of device function (eg, flow and volume status,
septum status, recovery), with programming, if performed, and report)
was prompted by the Relativity Assessment Workgroup Medicare
utilization screen of over 10,000 claims in a year and had had an
increased in volume by 100 percent between the 2012 to 2017. CPT code
93750 currently has a work RVU of 0.92 with 30 minutes of intraservice
time.
For physician times, the societies' survey for CPT code 93750
yielded 6 minutes preservice time, 10 minutes intraservice time, 7
minutes immediate post-service time, and 23 minutes of total time. The
25th percentile surveyed work RVU was 0.96. The RUC compared the survey
code to CPT code 78598 (Quantitative differential pulmonary perfusion
and ventilation (eg, aerosol or gas), including imaging when performed)
(0.85 work RVU and 5 minutes of preservice time, 10 minutes of
intraservice time, 9 minutes of immediate postservice time, and total
time of 24 minutes). The RUC
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recommends crosswalking the work RVU of 0.85 from CPT code 78598 to
93750.
CPT code 93289 (Interrogation device evaluation (in person) with
analysis, review and report by a physician or other qualified health
care professional, includes connection, recording and disconnection per
patient encounter; single, dual, or multiple lead transvenous
implantable defibrillator system, including analysis of heart rhythm
derived data elements), with 0.75 work RVUs and 5 minutes of preservice
time, 10 minutes of intraservice time, 8.5 minutes of immediate
postservice time, and total time of 23.5 minutes, we believe is a more
precise comparator code. CPT code 93289's intraservice times, pre and
post times, and total times are almost identical to CPT code 93750's
survey times, so we are proposing a work RVU of 0.75 and 23 minutes of
total time for CPT code 93750.
The PE Subcommittee corrected the equipment times based on the
formulas as provided by CMS. In addition, the PE Subcommittee changed
the clinical staff type for direct labor item ID CA013 Prepare Room,
Equipment and Supplies, from an RN to the RN/LPN/MTA blend and the
direct equipment item ID EQ168 light, exam was removed from CPT code
93750. We are proposing to accept the RUC-recommended direct PE inputs.
(44) Spirometry (CPT Codes 94010 and 94060)
CPT code 94010 (spirometry, including graphic record, total and
timed vital capacity, expiratory flow rate measurement(s), with or
without maximal voluntary ventilation) and CPT code 94060
(Bronchodilation responsiveness, spirometry as in 94010, pre- and post-
bronchodilator administration) were identified as part of a Relativity
Assessment Workgroup (RAW) review of action plans on the status of
services that were RUC referrals to develop CPT Assistant articles.
These codes were recommended to be surveyed.
We are proposing the RUC-recommended work RVU of 0.17 for CPT code
94010 (spirometry, including graphic record, total and timed vital
capacity, expiratory flow rate measurement(s), with or without maximal
voluntary ventilation) and the RUC-recommended work RVU of 0.22 for CPT
code 94060 (Bronchodilation responsiveness, spirometry as in 94010,
pre- and post-bronchodilator administration). We are proposing the RUC-
recommended direct PE inputs for this code family without refinements.
(45) Exercise Test for Bronchospasm (CPT Codes 946X0, 94617, 94618, and
94621)
In 2018, the CPT Editorial Panel created CPT code 94617 (Exercise
test for bronchospasm, including pre- and post-spirometry,
electrocardiographic recording(s), and pulse oximetry), and CPT code
94618 (Pulmonary stress testing (eg, 6-minute walk test), including
measurement of heart rate, oximetry, and oxygen titration, when
performed) from the now deleted CPT code 94620 (Pulmonary stress
testing; simple (eg, 6-minute walk test, prolonged exercise test for
bronchospasm with pre- and post-spirometry and oximetry)), and revised
CPT code 94621 (Cardiopulmonary exercise testing, including
measurements of minute ventilation, co2 production, o2 uptake, and
electrocardiographic recordings) to better describe the specialty's
pulmonary exercise test. Shortly after the creation and revision of
these codes, the specialty society became aware of some providers
performing CPT code 94617 without ECG monitoring, so to more accurately
account for this work without the ECG monitoring, The CPT Editorial
Panel proposed to establish CPT code 946X0 with the descriptor,
(Exercise test for bronchospasm, including pre- and post-spirometry and
pulse oximetry; without electrocardiographic recording(s)). For the
October 2019 RUC meeting, the specialty societies surveyed CPT code
946X0, and included a request to reaffirm the values of the rest of the
codes in the code family.
For CPT code 946X0, the surveyed physician time yielded 5 minutes
of preservice time, 9 minutes of intraservice time, followed by 10
minutes of immediate post-service time, for a total time of 24 minutes.
This distribution of physician times is of course very similar to the
times for CPT code 94617, total time of 26 minutes, except without the
task of including an electrocardiographic recording. The RUC recommends
the survey's median work RVU of 0.49 for CPT code 946X0.
We are proposing the RUC's recommendation of a work RVU of 0.49 and
a total physician time of 24 minutes for CPT code 946X0.
This CPT family of codes that includes CPT code 946X0, are CPT
codes 94617, 94618, and 94621 and there are no changes to their
physician service times, no change to their descriptors, nor their work
RVUs, and remain as they currently are. The specialty societies
reaffirmed these current valuations and we propose to accept them
without change.
We are proposing the RUC-recommended PE changes without refinement.
(46) Evaluation of Wheezing (CPT Codes 94640, 94667, 94668, and 94669)
At the April 2019 RUC meeting, four PE only CPT codes from the
Evaluation of Wheezing code family were reviewed. The codes included
CPT codes 94640 (Pressurized or nonpressurized inhalation treatment for
acute airway obstruction for therapeutic purposes and/or for diagnostic
purposes such as sputum induction with an aerosol generator, nebulizer,
metered dose inhaler or intermittent positive pressure breathing (IPPB)
device), 94667 (Manipulation chest wall, such as cupping, percussing,
and vibration to facilitate lung function; initial demonstration and/or
evaluation), 94668 (Manipulation chest wall, such as cupping,
percussing, and vibration to facilitate lunch function; subsequent),
and 94669 (Mechanical chest wall oscillation to facilitate lung
function, per session).
We are proposing the RUC-recommended direct PE inputs for the four
PE only codes. The RUC did not recommend work RVUs and we are proposing
to maintain the current work RVU of 0.00 for all four codes.
(47) Exhaled Nitric Oxide Measurement (CPT Code 95012)
In January 2019, the RAW reviewed services with 2017 Medicare
utilization of 10,000 or more that had increased by at least 100
percent from 2012 through 2017. The RUC recommended that CPT code 95012
(Nitric oxide expired gas determination) be surveyed for the April 2019
meeting. We are proposing the direct PE inputs for CPT code 95012
without refinement. CPT code 95012 is a PE-only code with no work RVU,
and we are proposing to maintain the current work RVU of 0.00.
(48) Acupuncture Services (CPT Codes 97810, 97811, 97813, and 97814)
The CPT Editorial Panel created two new codes and two new add-on
codes in 2004 to describe the appropriate time or additional time and
levels of service that can be performed using acupuncture and
electroacupuncture, acupuncture therapy with electrical stimulation.
These codes were designated as noncovered services since Medicare did
not reimburse for acupuncture services at the time. In January 2020, we
issued a decision memo stating that Medicare will cover acupuncture for
chronic low back pain
[[Page 50168]]
under section 1862(a)(1)(A) of the Act (CAG-00452N). This was reflected
in the April 2020 PFS Quarterly Update which changed CPT codes 97810
through 97814 to active payment status (CMS Change Request 11661).
Because we had never conducted a review of these four acupuncture
codes, the CY 2020 payment rate consisted of the work RVUs recommended
by the RUC in 2004.
For CY 2021, we are proposing to establish work RVUs for these four
acupuncture codes based on a pair of crosswalks to two recently
reviewed codes in the Dry Needling family. We are proposing a work RVU
of 0.48 for CPT codes 97810 (Acupuncture, 1 or more needles; without
electrical stimulation, initial 15 minutes of personal one-on-one
contact with the patient) and 97813 (Acupuncture, 1 or more needles;
with electrical stimulation, initial 15 minutes of personal one-on-one
contact with the patient) based on a crosswalk to CPT code 20561
(Needle insertion(s) without injection(s); 3 or more muscles). We are
proposing a work RVU of 0.32 for CPT codes 97811 (Acupuncture, 1 or
more needles; without electrical stimulation, each additional 15
minutes of personal one-on-one contact with the patient, with re-
insertion of needle(s)) and 97814 (Acupuncture, 1 or more needles; with
electrical stimulation, each additional 15 minutes of personal one-on-
one contact with the patient, with re-insertion of needle(s)) based on
a crosswalk to CPT code 20560 (Needle insertion(s) without
injection(s); 1 or 2 muscle(s)).
CPT codes 20560 and 20561 are clinically similar services
associated with dry needling that were reviewed last year for CY 2020.
We finalized work RVUs of 0.32 and 0.48 respectively for these two
codes following our review of their associated RUC recommendations,
while noting that dry needling services were non-covered by Medicare
unless otherwise specified through a national coverage determination
(NCD) (84 FR 62722 through 62724). Like the acupuncture codes, CPT
codes 20560 and 20561 were updated to active payment status in the
April 2020 PFS Quarterly Update to reflect the Medicare coverage of
acupuncture for chronic low back pain. We note that CPT codes 97810 and
97813 share the identical work time values with CPT code 20561, and
that CPT codes 97811 and 97814 differ from CPT code 20560 by only 1
minute of work time, 15 minutes as compared to 16 minutes. Although we
do not imply that codes with similar work times must equate to a one-
to-one or linear relationship in the valuation of work RVUs, we believe
that, since the two components of work are time and intensity,
clinically related services with similar intensities and work times
should, generally speaking, be valued similarly. Due to the similar
clinical nature of these services and their nearly identical work
times, we believe that it is more accurate to propose crosswalking CPT
codes 97810 through 97814 to the work RVUs of the Dry Needling codes,
which were finalized last year, as opposed to proposing work RVUs from
2004, which were never reviewed by CMS.
The RUC did not make any recommendations and we are not proposing
any changes to the direct PE inputs for CPT codes 97810 through 97814.
(49) Chronic Care Management Services (CPT Code 994XX and HCPCS Code
G2058)
We established payment for HCPCS code G2058 (Chronic care
management services, each additional 20 minutes of clinical staff time
directed by a physician or other qualified healthcare professional, per
calendar month) in the CY 2020 PFS final rule (84 FR 62690). At the
January 2020 RUC meeting, specialty societies requested a temporary
crosswalk through CY 2021 between the value established by CMS for
HCPCS code G2058 and the value of new CPT code 994XX (with a descriptor
identical to G2058). The Chronic Care Management code family will be
resurveyed during CY 2020 and is expected to be presented for review as
part of the 2022 RUC review process.
For CY 2021, we are proposing the RUC-recommended work RVU of 0.54
and the RUC-recommended direct PE inputs for CPT code 994XX.
(50) External Counterpulsation (HCPCS Code G0166)
In the CY 2020 PFS proposed rule (84 FR 40516), an external
stakeholder nominated HCPCS code G0166 as potentially misvalued due to
concerns that the PE RVUs for this code did not fully reflect the total
resources required to deliver the service and CMS proposed G0166 as
potentially misvalued. The RUC reviewed the direct PE inputs for HCPCS
code G0166 at the October 2019 RUC meeting.
We are proposing the RUC-recommended preservice period, service
period and postservice period with refinements. We propose to replace
CA010 (obtain vital signs) during the postservice of service period
with CA023 (monitor patient following procedure/service, no
multitasking).
For the equipment items, we are proposing to update the price of
the ``EECP, external counterpulsation system'' (EQ012) equipment to
$101,247.50 based on an average of the five invoices submitted along
with the recommendations. We note that the EQ012 equipment is the only
current equipment item in our direct PE database with an equipment
utilization rate of 25 percent and the only equipment item with a
utilization rate under 50 percent. Although we are not proposing to
change the equipment utilization rate, we are soliciting feedback from
commenters regarding the utilization rate for the EQ012 equipment to
help us understand why it should differ from all other medical
equipment.
We also received invoices for a series of additional equipment
items: An EECP service contract, an EECP compression equipment package,
and an EECP electrical equipment package. We are not proposing to
establish a price for the EECP service contract, as service contracts
are considered to be an administrative expense and a form of indirect
PE under our methodology. As for the two equipment packages, there were
a number of unusual factors involving these items that created
difficulties for our equipment methodology. Both equipment packages had
a suggested utilization rate of 25 percent, half of our typical
utilization rate of 50 percent, and both had a suggested useful life
duration of only 3 months. As we stated in section II.B. of this
proposed rule, Determination of Practice Expense RVUs, we have concerns
that assigning very low useful life durations to this type of equipment
would fail to maintain relativity with other equipment on the PFS. We
also noted that the equipment cost per minute formula was designed
under the assumption that each equipment item would remain in use for a
period of several years and depreciate over that span of time. Our
current equipment formula is not designed to address cases in which
equipment is replaced multiple times per year, and we believe that
applying a multi-year depreciation in these situations would not be
reflective of market pricing. Although we agree that these costs should
be reflected in the pricing of HCPCS code G0166, we believe that the
very frequent replacement of the items in the two equipment packages
makes them a poor fit under our equipment methodology.
Therefore, we are proposing to treat the two EECP equipment
packages as supplies instead of treating them as equipment. We are
proposing to establish the EECP compression
[[Page 50169]]
equipment package (SD341) as a supply with a cost of $645 based on an
average of the submitted invoices, and proposing to establish the EECP
electrical equipment package (SD342) as a supply with a cost of $500
again based on an average of the submitted invoices. Based on
information provided by stakeholders, we are proposing a supply
quantity of 1/325 for these two items (0.00308) based on the supply
being used on average five times per day and replaced every 3 months (5
uses * 5 days * 13 weeks = 325). We believe that assigning these two
items as supplies rather than equipment more accurately captures the
unusual circumstances associated with providing this service.
(51) Molecular Pathology Interpretation (HCPCS Code G0452)
At the October 2018 RUC meeting, the Relativity Assessment
Workgroup (RAW) identified HCPCS code G0452 (Molecular pathology
procedure; physician interpretation and report) as potentially
misvalued on a CMS/Other screen. The RUC had never reviewed HCPCS code
G0452 and assumptions regarding work and time were based upon a 1995
vignette. In addition, the specialty society noted that the technology
available for furnishing the service, as well as the patient population
receiving the service, had changed since the code was valued by CMS.
The RUC requested a physician work survey be completed for the
October 2019 RUC meeting. It was during the October meeting that the
work and PE values for HCPCS code G0452 were reviewed and recommended.
For CY 2021, we are proposing the RUC-recommended work RVU of 0.93
and the RUC-recommended direct PE inputs for HCPCS code G0452.
(52) Evaluation and Management, Observation and Provision of Self-
Administered Esketamine (HCPCS Codes G2082 and G2083)
In the CY 2020 PFS final rule (84 FR 63102 through 63104), we
issued an interim final rule with comment period (IFC) to establish
coding and payment for E/M, observation, and the provision of self-
administered Esketamine to facilitate beneficiary access to care for
treatment-resistant depression as efficiently as possible. We created
two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an
interim final basis. For CY 2020, we established RVUs for these
services that reflect the relative resource costs associated with the
E/M, observation and provision of the self-administered esketamine
product. The HCPCS G-codes are described as follows: HCPCS code G2082
(Office or other outpatient visit for the evaluation and management of
an established patient that requires the supervision of a physician or
other qualified health care professional and provision of up to 56 mg
of esketamine nasal self-administration, includes 2 hours post-
administration observation) and HCPCS code G2083 (Office or other
outpatient visit for the evaluation and management of an established
patient that requires the supervision of a physician or other qualified
health care professional and provision of greater than 56 mg esketamine
nasal self-administration, includes 2 hours post-administration
observation).
In developing the interim final values for these codes, we used a
building block methodology that sums the values associated with several
codes. For the overall E/M and observation elements of the services, we
incorporated the work RVUs, work time and direct PE inputs associated
with a level two office/outpatient visit for an established patient,
CPT code 99212 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A problem focused history; A problem focused
examination; Straightforward medical decision making. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are self limited or minor. Typically, 10 minutes
are spent face-to-face with the patient and/or family), which has a
work RVU of 0.48 and a total work time of 16 minutes, which is based on
a pre-service evaluation time of 2 minutes, an intraservice time of 10
minutes, and a postservice time of 4 minutes.
We also incorporated CPT codes 99415 (Prolonged clinical staff
service (the service beyond the typical service time) during an
evaluation and management service in the office or outpatient setting,
direct patient contact with physician supervision; first hour (List
separately in addition to code for outpatient Evaluation and Management
service)) and 99416 (Prolonged clinical staff service (the service
beyond the typical service time) during an evaluation and management
service in the office or outpatient setting, direct patient contact
with physician supervision; each additional 30 minutes (List separately
in addition to code for prolonged service)) in which neither code has a
work RVU, but includes direct PE inputs reflecting the prolonged time
for clinical staff under the direct supervision of the billing
practitioner.
Additionally, to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we incorporated the
wholesale acquisition cost (WAC) data from the most recent available
quarter. For HCPCS code G2082, we are using a price of $590.02 for the
supply input that describes 56 mg (supply code SH109) and for HCPCS
code G2083, we are using a price of $885.02 for the supply input
describing 84 mg of esketamine (supply code SH110).
We sought comment on the interim final values we established for
HCPCS codes G2082 and G2083, including the assigned work RVUs, work
times, and direct PE inputs. We received public comments on this
policy. The following is a summary of the comments we received and our
responses.
Comment: Overall, commenters were supportive of CMS establishing
coding and payment for E/M, observation and the provision of self-
administered esketamine. However, a few commenters were not in support
of the proposal, noting that IV ketamine is cheaper and has been proven
to be more effective than esketamine.
Response: We appreciate the support for our interim final rule with
comment period. We continue to believe that it is in the public
interest to ensure beneficiaries have access to new, potentially life-
saving treatment for treatment-resistant depression (TRD) using
esketamine. Therefore, we are proposing to maintain HCPCS codes G2082
and G2083 that describe E/M, observation and the provision of self-
administered esketamine.
Comment: Several commenters suggested including psychotherapy, CPT
codes 90833 and 90836, in the valuation of HCPCS codes G2083 and G2083.
Response: We disagree that psychotherapy should be included in the
valuation of HCPCS codes G2082 and G2083. HCPCS codes G2082 and G2083
were created to establish coding and payment for E/M, observation and
the provision of self-administered esketamine to facilitate beneficiary
access to care for treatment-resistant depression as efficiently as
possible. However, practitioners who furnish other allowable, billable
services, including psychotherapy, on the same day as an E/M,
observation and provision of self-administered esketamine service can
bill separately for those services using other codes.
Comment: Some commenters recommended that esketamine should
[[Page 50170]]
have its own J code in addition to the G codes.
Response: HCPCS codes G2082 and G2083 are bundled services that
include, as discussed previously, the E/M, observation and the
provision of self-administered esketamine. The self-administered
esketamine is considered a supply item for this bundled service.
Therefore, esketamine cannot be billed separately along with HCPCS
codes G2082 and G2033 under the PFS.
Comment: Several commenters disagreed with the use of 99212 to
establish codes G2082 and G2083. Commenters suggested using 99213,
99214, and/or 99215 instead of 99212. Some commenters indicated that
the intraservice work time of 10 minutes is insufficient, and one
commenter stated a minimum of 20 minutes would be more appropriate.
Another commenter suggested unbundling the code and, in part, indicated
that face-to-face visits with the psychiatrist are not required at each
visit.
Response: We appreciate the feedback received from the commenters
regarding the E/M elements of the service. We have considered the wide
range of recommendations that were received from commenters regarding
the E/M elements of the service. One commenter indicated that there is
variability in performance and level of E/M services associated with
the service (in which self-administered esketamine is provided and
observed). Another commenter noted that a face-to face visit with the
psychiatrist is not required at each visit, while other commenters
recommended using E/M CPT codes up to 99215. We continue to believe
that the building block methodology we used incorporating CPT code
99212 is appropriate for valuing this service. Therefore, we are not
proposing to change the E/M element of the service by incorporating the
work RVUs, work time and direct PE input associated with a level two
office/outpatient visit for an established patient, CPT code 99212.
Comment: Many commenters urged CMS to ensure PFS payment rates are
sufficient to capture the complexity and time for the provision of
esketamine.
A commenter recommended unbundling all the services. The commenter
stated that the way the bundled payments are currently constructed
fails to recognize the possible variability of E/M services that may be
required, the time and effort required of clinical staff to monitor the
patient during the lengthy observation period, and the amount of pre-
and post-service work required. The commenter also stated that bundling
the physician E/M services and the observation services performed by
clinical staff is problematic and including the medication in the
bundle is problematic because in many instances the psychiatrist may
not be incurring the cost of the medication. The commenter stated that
clinical staff time and effort comprise a significant and separate
service, including not only the time spent observing and actively
monitoring the patient's condition for possible adverse side-effects
(that is, nausea, vomiting, escalation in blood pressure), but also
extensive pre- and post-service preparation that does not appear to
have been included as part of the bundled payment and is not described
by existing CPT codes.
The commenter recommended increasing the proposed valuation of
clinical staff time to more appropriately account for the clinical
staff time and the effort required for pre-, intra-, and post- service
work. This includes acquisition of the drug, delivery of the medication
to the patient, and the observation of the self-administration,
followed by active monitoring of the patient's condition (vitals, etc.)
for a minimum of 2 hours, the commenter suggested that the more
appropriate comparison for the clinical staff time related to the 2-
hour observation period is 95076, Ingestion challenge test (sequential
and incremental ingestion of test items, e.g., food, drug or other
substance); initial 120 minutes of testing (110 minutes intra service
time; PE RVU 1.81). Both services, the G2082 and G2083 codes and the
95076, require a lengthy observation time (minimum of 2 hours) with
clinical staff monitoring for adverse side-effects. The total PE RVU of
the 95076 is 1.81 RVUs versus 0.51 RVUs (99415 x 1, 99416 x 2 or 0.27 +
(0.12 x 2) = 0.51 RVUs) of the combined 99415 and 99416. The associated
add-on code for 95076 is 95079, Ingestion challenge test (sequential
and incremental ingestion of test items, e.g., food, drug or other
substance); each additional 60 minutes of testing (List separately in
addition to code for primary procedure) (40 minutes intra-service time;
PE RVU 0.99), which would account for additional time for this service
when required. Procedurally these services are similar in staff time,
staff type and effort, and both are reported separately from the E/M
service. The commenter requested that we use the PE RVUs for the 95076
and the 95079 in lieu of the 99415 and 99416 in calculating the values
for the clinical staff component, to more accurately reflect the time
and effort of the clinical staff in the observation of the patient.
Response: After consideration of comments requesting that we
reconsider aspects of our current valuation for these services,
including at least 2 hours of post-administration observation, we
believe some of the refinements discussed by stakeholders may be
appropriate to improve payment accuracy and help ensure that
beneficiaries who need esketamine for treatment have access to it.
Based on our review of the Spravato Prescribing Information, Medication
Guide and REMS requirements, the FDA-approved conditions/requirements
indicate that the drug is only available as an integral component of a
physician's service.\8\ \9\ \10\ Spravato is only dispensed and
administered to patients in a medically supervised healthcare setting
that monitors these patients.\11\ Therefore, we continue to believe
this treatment should be paid for as a bundled service. In
consideration of the comment urging us to account for clinical staff
time spent observing and actively monitoring the patient for possible
side-effects, along with pre- and post-service preparation, we are
proposing to refine the direct PE inputs of HCPCS codes G2082 and
G2083, in part, by using the clinical labor time for CPT codes 95076
and the 95079 in lieu of the clinical labor time of CPT codes 99415 and
99416. We are specifically proposing 150 minutes of observation time
for HCPCS codes G2082 and G2083 based on the sum of the clinical labor
for CPT code 95076 (110 minutes) and CPT code 95079 (40 minutes). This
would replace our previous interim final valuation of 30 minutes of
observation time based on the sum of the clinical labor for CPT code
99415 (15 minutes) and two billings of CPT code 99416 (8 minutes). We
are seeking comment on this proposal. Additionally, under circumstances
where the health care professional supervising the self-administration
and observation does not also provide the esketamine product, the
physician or practitioner cannot report HCPCS codes G2082 or G2083.
Rather, the visit and the extended observation (by either the billing
professional or clinical staff) could be reported using the existing E/
M codes that describe the visit and the prolonged
[[Page 50171]]
service of the professional or the clinical staff.
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\8\ https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=386.
\9\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf.
\10\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf#page=38.
\11\ https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=386.
---------------------------------------------------------------------------
Comment: One commenter urged CMS to align the HCPCS codes G2082 and
G2083 for a visit for the provision of esketamine with prescribing
recommendations from the drug manufacturer that include at least 2
hours of post-administration observation until a patient is safe to
leave the facility. Another commenter questioned whether the codes
should be valued using CPT codes 99213, 99214 and even 99215, with
99354 (Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; first hour (List separately in addition to
code for office or other outpatient Evaluation and Management or
psychotherapy service)) and 99355 (Prolonged evaluation and management
or psychotherapy service(s) (beyond the typical service time of the
primary procedure) in the office or other outpatient setting requiring
direct patient contact beyond the usual service; each additional 30
minutes (List separately in addition to code for prolonged service)).
Response: As previously stated, we are proposing to continue
valuing HCPCS codes G2082 and G2083, in part, on the basis of a level 2
established patient office/outpatient E/M visit. However, as previously
stated, after considering comments regarding the esketamine post-
administration observation time, we are proposing to refine the direct
PE inputs of HCPCS codes G2082 and G2083, in part, by using the
clinical labor time for CPT codes 95076 and the 95079, specifically
proposing 150 minutes of observation time. We are seeking comment on
this proposal.
Comment: Some commenters indicated that the proposed PE inputs do
not reflect the costs of, and overall drug cycle management needed to
safely administer, esketamine. One commenter indicated that, after
conducting an analysis associated with each patient encounter to
include: Physician time and technician time, reception time, rent,
furniture, monitoring, electronic health record (EHR), supplies, waste
management, etc., their direct overhead cost is $1000 per patient per
encounter, not including direct cost and management of the drug.
Therefore, the commenter recommends we revise payment by adding 20
percent to the direct expense and mandatory overhead costs of $1000 per
patient encounter. Some commenters indicated that the proposed PE
inputs do not reflect the costs of initial capital requirements for
ongoing resources, maintaining the Risk Evaluation and Mitigation
Strategy (REMS) standards with the FDA and overall drug cycle
management needed to safely administer esketamine. Specifically, one
commenter indicated that Spravato will need to be delivered in the
community setting. A typical community psychiatry practice does not
have a large enough physical plant to accommodate a 2 hour monitoring
period, requiring a lease or purchase of additional space. In addition,
Spravato requires administrative support for medication procurement,
appropriate storage equipment (for example, Pyxis machine or similar)
to mitigate abuse and diversion potential, medically appropriate
staffing (for the required observation of self-administration, multiple
vital signs checks, completion of REMS monitoring forms and other
administrative requirements of the REMS, and discharge assessment), and
equipment and services including a chair that can recline and
controlled substance waste removal compliance. One commenter indicated
that the pricing methodology used for esketamine, whether WAC, ASP or
compendia pricing, does not take into account the costs associated with
full-management of the drug cycle including ordering, storage,
inventory tracking, billing, etc. Therefore, the commenter recommends
valuing the bundled esketamine by adding 20 percent to ASP.
Response: Under our PE methodology, the costs identified by the
commenter for reception time, rent, furniture, electronic health
records (EHRs), and waste management are all types of indirect costs.
This means that they are not individually allocable to a particular
patient for a particular service, and therefore they are not summed up
as separate itemized direct costs for codes such as HCPCS codes G2082
and G2083. CMS is still paying practitioners for these costs through
our indirect PE methodology; we note that for a typical HCPCS code,
indirect costs make up roughly 75 percent of the total PE. If we were
to itemize administrative costs such as rent and furniture as direct
costs, we would be double counting them in violation of our standard PE
methodology. As previously discussed, we are proposing to refine the
direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the
clinical labor time for CPT codes 95076 and 95079, in lieu of the
clinical labor time of CPT codes 99415 and 99416 to account for the
clinical staff time, such that the proposed refinements would increase
the clinical labor time from 30 minutes to 150 minutes. We believe this
refinement would account for the clinical staff time and efforts
including the acquisition and delivery of the medication to the patient
as required by the REMS.
Comment: One commenter requested clarification on whether payment
is fixed for 2020 or whether the payment will be adjusted to reflect
2020 changes in WAC, for example updated data made available from the
most recent quarter. The commenter also questioned whether regulatory
changes made under the PFS to values of the component services would
also be applied to the G codes, for example, whether changes to values
of the E/M codes would also be incorporated into the RVU inputs for G
codes. For instance the outpatient E/M values are set to increase in
2021, and the commenter asked whether that increase would automatically
be included in the valuation of the bundle, and whether the payment
currently ascribed to the bundle for the cost of the medication be
updated if the input prices for the services change over time.
Response: Historically, supply input prices are updated on a code-
by-code basis and periodically through annual notice and comment
rulemaking. The prices, including for a variety of pharmaceutical
products, are not routinely updated like Part B drugs paid under the
ASP methodologies. For the supply inputs for the esketamine product
used in developing rates for HCPCS codes G2082 and G2083, we used the
most recent available quarter of WAC data for 2020 pricing, but we
anticipate using either data reported for purposes of determining
payments under section 1847A of the Act (such as ASP) or compendia
pricing information (such as WAC) in future years. Since we reviewed
and are proposing refinements to HCPCS codes G2082 and G2083 for the CY
2021 rulemaking cycle, we propose to update the payment to reflect the
most recent available quarter of WAC data for CY 2021 pricing, and
propose to update the payment to reflect the E/M values (CPT code
99212) for CY 2021. Therefore, to account for the cost of the provision
of the self-administered esketamine as a direct PE input, we
incorporated the wholesale acquisition cost (WAC) data from the most
recent available quarter. For HCPCS code G2082, we propose to update
the supply input that describes 56 mg (supply code SH109) from a price
of $590.02 to $616.93 and for HCPCS code G2083, we propose to update
the price from $885.02 to $928.38 for the supply input
[[Page 50172]]
describing 84 mg of esketamine (supply code SH110).
Comment: One commenter indicated that the CMS approach to the E/M
component of the interim G codes includes inputs associated with an
established patient for the first visit or any subsequent treatment,
and requested clarification that, if reasonable and necessary, the
health care provider could complete an E/M service that is distinct
from the E/M services necessary for esketamine administration, and in
such an event, separate E/M service would be eligible to be paid
separately with E/M codes.
Response: Given that HCPCS codes G2082 and G2083 already take into
account E/M services in their valuations, it would be duplicative to
bill for a separate E/M code along with HCPCS codes G2082 and G2083.
However, other reasonable and necessary E/M services may be furnished
and billed for a patient on dates before and after HCPCS code G2082 or
G2083, for example, when the services are furnished in the course of
treating and diagnosing treatment-resistant depression.
After considering the comments we received, we are proposing to
refine the values for HCPCS codes G2082 and G2083 using a building
block methodology that sums the values associated with several codes.
For the overall E/M and observation elements of the services, we are
incorporating the work RVUs, work time and direct PE inputs associated
with a level two office/outpatient visit for an established patient,
CPT code 99212. We are also proposing to include the clinical labor for
CPT 95076 and 95079 (in lieu of CPT codes 99415 and 99416 as detailed
earlier); and to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we are proposing to
incorporate the wholesale acquisition cost (WAC) data from the most
recent available quarter. We are seeking comment on this updated
payment proposal and valuation of HCPCS code G2082 and G2083.
(53) Bundled Payments Under the PFS for Substance Use Disorders (HCPCS
Codes G2086, G2087, and G2088)
In the CY 2020 PFS final rule (84 FR 62673), we finalized the
creation of new coding and payment describing a bundled episode of care
for the treatment of Opioid Use Disorder (OUD). The codes and
descriptors we finalized for CY 2020 were:
HCPCS code G2086: Office-based treatment for opioid use
disorder, including development of the treatment plan, care
coordination, individual therapy and group therapy and counseling; at
least 70 minutes in the first calendar month.
HCPCS code G2087: Office-based treatment for opioid use
disorder, including care coordination, individual therapy and group
therapy and counseling; at least 60 minutes in a subsequent calendar
month.
HCPCS code G2088: Office-based treatment for opioid use
disorder, including care coordination, individual therapy and group
therapy and counseling; each additional 30 minutes beyond the first 120
minutes (List separately in addition to code for primary procedure).
As noted in the CY 2020 PFS final rule (84 FR 62673), if a
patient's treatment involves MAT, this bundled payment would not
include payment for the medication itself. Billing and payment for
medications under Medicare Part B or Part D would remain unchanged.
We have received requests to expand these bundled payments to be
inclusive of other SUDs, not just OUD. We agree that doing so could
expand access to needed care. We are proposing to expand these bundled
payments to be inclusive of all SUDs. To accomplish this, we are
proposing to revise the code descriptors for HCPCS codes G2086, G2087,
and G2088 by replacing ``opioid use disorder'' with ``a substance use
disorder.'' The payment and billing rules would otherwise remain
unchanged. We note that HCPCS codes G2086, G2087, and G2088 were added
to the Medicare Telehealth list in the CY 2020 PFS final rule (84 FR
62628). The proposed revised code descriptors are:
HCPCS code G2086: Office-based treatment for a substance
use disorder, including development of the treatment plan, care
coordination, individual therapy and group therapy and counseling; at
least 70 minutes in the first calendar month.
HCPCS code G2087: Office-based treatment for a substance
use disorder, including care coordination, individual therapy and group
therapy and counseling; at least 60 minutes in a subsequent calendar
month.
HCPCS code G2088: Office-based treatment for a substance
use disorder, including care coordination, individual therapy and group
therapy and counseling; each additional 30 minutes beyond the first 120
minutes (List separately in addition to code for primary procedure).
Additionally, in the CY 2020 PFS final rule we stated that we
anticipate that the services described by HCPCS codes G2086, G2087, and
G2088 would often be billed by addiction specialty practitioners, but
note that these codes are not limited to any particular physician or
nonphysician practitioner (NPP) specialty. We also noted that
consultation was not a required condition of payment for these codes,
but that consultation with a specialist could be counted toward the
minutes required for billing HCPCS codes G2086, G2087, and G2088 (84 FR
62674). Although it is not a requirement for billing the code, we
encourage that practitioners consult with specialists in cases where it
is warranted and refer the patient to specialty care as needed.
We note that while these codes describe treatment for any SUD,
information about which specific SUDs are being treated would provide
valuable information that can help assess local, state, and national
trends and needs. We believe it is important that the diagnosis codes
listed on the claim form reflect all SUDs being treated, however, we
also do not wish to add any additional burden on practitioners related
to claims submission, therefore, we are seeking information on whether
there are sources of data we could explore in order to provide this
information. We are also seeking information on whether there are
differences in the resource costs associated with furnishing services
for the various SUDs, and accordingly whether there is a need for more
stratified coding to describe these services. We note that in some
instances, the CPT Editorial Panel has created CPT codes to replace G
codes created by CMS, and that we would welcome such input on these
services. We look forward to receiving public comments on this proposal
in order to help evaluate whether more granular coding is needed.
(54) Initiation of Medication Assisted Treatment (MAT) in the Emergency
Department (HCPCS Code GMAT1)
In the CY 2020 PFS proposed rule (84 FR 40545), we sought comment
on the use of medication assisted treatment (MAT) in the emergency
department (ED) setting, including initiation of MAT and the potential
for either referral or follow-up care, to better understand typical
practice patterns to help inform whether we should consider making
separate payment for such services in future rulemaking. We note that
the term MAT generally refers to treatment of OUD that includes both an
FDA-approved medication for the treatment of OUD and behavioral/
psychosocial treatment, but that care provided in the ED typically
would include medication for the treatment of OUD and referral or
linkage to primary care or a hospital-
[[Page 50173]]
based bridge clinic for continuation of medication and potentially
other services, including counseling and other psychosocial services.
The public comments received in response to the comment
solicitation were supportive of us making a proposal, several citing
research that indicates improved outcomes for patients who initiate
medications for the treatment of OUD in the ED. One commenter noted
that by implementing this treatment regimen, practitioners can address
a patient's immediate withdrawal symptoms, which allows time to
coordinate care and provide a referral to substance use disorder
specialists and other community resources who can appropriately carry
out long-term treatment. Another commenter cited that the national rate
of overdose-related visits seen in EDs nearly doubled between 2005 and
2014 and noted that hospital-based care represents a critical
opportunity to initiate treatment and connect patients with OUD to
care, noting that patients who receive information about drug treatment
in the hospital post-overdose are more likely to seek treatment.\12\
The commenter also cited a randomized clinical trial that showed that
more patients were engaged in treatment 30 days after buprenorphine was
initiated in the ED and coupled with a referral, compared to
interventions that did not include buprenorphine.\13\ Another study
found that ED induction of buprenorphine was more cost-effective than
either brief intervention or referral upon discharge.\14\ One commenter
suggested that CMS institute a G-code to address this coding gap in the
short term, while a more permanent solution is pursued to address this
site-of-service specification.
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\12\ Agency for Healthcare Research and Quality, ``Statistical
Brief #219: Opioid-Related Inpatient Stays and Emergency Department
Visits by State, 2009-2014,'' (2017), https://www.hcup-us.ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf.
\13\ Gail D'Onofrio et al., ``Emergency Department-Initiated
Buprenorphine/Naloxone Treatment for Opioid Dependence Randomized
Clinical Trial,'' JAMA 16, no. 313 (2015): 2002-2010, https://www.ncbi.nlm.nih.gov/pubmed/25919527.
\14\ Susan Busch et al., ``Cost Effectiveness of Emergency
Department-Initiated Treatment for Opioid Dependence'', Journal of
Addiction 11, no. 112 (2017), https://www.ncbi.nlm.nih.gov/pubmed/28815789.
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We are persuaded by the comments received in response to our
comment solicitation that this work is not currently accounted for in
the existing code set. To account for the resource costs involved with
initiation of medication for the treatment of opioid use disorder in
the ED and referral for follow-up care, we are proposing to create one
add-on G-code to be billed with E/M visit codes used in the ED setting.
This code would include payment for assessment, referral to ongoing
care, follow-up after treatment begins, and arranging access to
supportive services, but we note that the drug itself would be paid
separately. The proposed code is:
HCPCS code GMAT1: Initiation of medication for the
treatment of opioid use disorder in the emergency department setting,
including assessment, referral to ongoing care, and arranging access to
supportive services (List separately in addition to code for primary
procedure).
To price this service, we are proposing to use a direct crosswalk
to the work and direct PE inputs for HCPCS code G0397 (Alcohol/subs
interv 30 min), which is assigned a work RVU of 1.30. We
believe that the work and PE described by this crosswalk code is
similar in nature and magnitude to the services described in HCPCS code
GMAT1. We note that unlike the requirements for reference code, we are
not proposing a required number of minutes to bill HCPCS code GMAT1. We
welcome comment on this proposal and whether we should consider a
different valuation to account for the resource costs involved with
these services.
(55) Percutaneous Creation of an Arteriovenous Fistula (AVF) (HCPCS
Code G2170 and G2171)
We received a comment in response to the CY 2020 PFS proposed rule
(84 FR 40481), as well as inquiries from stakeholders, requesting that
we establish new coding for the percutaneous creation of an
arteriovenous fistula (AVF) used for dialysis access.
For CY 2019, based on two new technology applications for
arteriovenous fistula creation, we established two new HCPCS codes to
describe the two modalities of this service. Specifically, we
established HCPCS code C9754 (Creation of arteriovenous fistula,
percutaneous; direct, any site, including all imaging and radiologic
supervision and interpretation, when performed and secondary procedures
to redirect blood flow (e.g., transluminal balloon angioplasty, coil
embolization, when performed)) and HCPCS code C9755 (Creation of
arteriovenous fistula, percutaneous using magnetic-guided arterial and
venous catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, when performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with radiologic supervision
and interpretation, when performed). The HCPCS codes were created for
institutional payment systems, and thus do not allow for payment for
the physician's work portion of the service. Stakeholders have stated
that the lack of proper coding to report the physician work associated
with these procedures is problematic, as physicians are either billing
an unlisted procedure code, or are billing other CPT codes that do not
appropriately reflect the resource cost associated with the physician
work portion of the service. Stakeholders stated that separate coding
for physician payment will allow billing when the procedures are
furnished in either a physician office or an institutional setting, and
be paid under the respective payment systems, as appropriate. We have
recognized that the lack of appropriate coding for this critical
physician's service has become an even greater burden given the PHE
that was declared effective January 27, 2020 for the COVID-19 epidemic.
In order to mitigate potential health risks to beneficiaries,
physicians and practitioners as a result of having this procedure
performed in an institutional setting, we have created two HCPCS G
codes for percutaneous creation of an arteriovenous fistula (AVF). The
codes are contractor priced and effective July 1, 2020. This will allow
for more accurate billing and coding of a crucial physician service
that could then be performed in both institutional and office settings,
thus mitigating unnecessary risk to beneficiaries, physicians and
practitioners caused by disease transmission. The HCPCS G codes are
described as follows:
HCPCS G code G2170 (Percutaneous arteriovenous fistula
creation (AVF), direct, any site, by tissue approximation using thermal
resistance energy, and secondary procedures to redirect blood flow
(e.g., transluminal balloon angioplasty, coil embolization) when
performed, and includes all imaging and radiologic guidance,
supervision and interpretation, when performed.)
HCPCS G code G2171 (Percutaneous arteriovenous fistula
creation (AVF), direct, any site, using magnetic-guided arterial and
venous catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, wen performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with
[[Page 50174]]
radiologic supervision and interpretation, when performed.)
We are proposing to maintain contractor pricing for these HCPCS
codes for CY 2021, however, we are also seeking information from
stakeholders on the resource costs involved in furnishing the services
described by HCPCS codes G2170 and G2171 to ensure proper payment for
these physician's services, for consideration in future rulemaking. We
note that under the Outpatient Prospective Payment System (OPPS) these
services are assigned to APC 5193, which for CY 2020 has an assigned
payment rate of $15,938.20.
(56) Insertion, Removal, and Removal and Insertion of Implantable
Interstitial Glucose Sensor System (Category III CPT Codes 0446T,
0447T, and 0448T)
Category III CPT codes 0446T, 0447T, and 0448T describe the
services related to the insertion, removal, and removal and insertion
of an implantable interstitial glucose sensor from subcutaneous pocket,
in a subcutaneous pocket via incision. The implantable interstitial
glucose sensors are part of systems that can allow real-time glucose
monitoring, provides glucose trend information, and signal alerts for
detection and prediction of episodes of low blood glucose
(hypoglycemia) and high blood glucose (hyperglycemia). The codes that
describe the implantation, removal, and removal and implantation of
implantable interstitial glucose sensors are currently contractor-
priced.
Category III CPT code 0446T (Creation of subcutaneous
pocket with insertion of implantable interstitial glucose sensor,
including system activation and patient training);
Category III CPT code 0447T (Removal of implantable
interstitial glucose sensor from subcutaneous pocket via incision); and
Category III CPT code 0448T (Removal of implantable
interstitial glucose sensor with creation of subcutaneous pocket at
different anatomic site and insertion of new implantable sensor,
including system activation).
In the CY 2020 PFS final rule (84 FR 62627), we requested
information from stakeholders to ensure proper payment for this
important physician's service and welcomed recommendations on
appropriate valuation for these services to be considered in future
rulemaking.
We are proposing to establish national payment amounts for the
codes describing the insertion, removal, and removal and insertion of
an implantable interstitial glucose sensor, effective January 1, 2021.
We are proposing a work RVU of 1.14 for Category III CPT code 0446T, a
work RVU of 1.34 for Category III CPT code 0447T, and work RVU of 1.91
for Category III CPT code 0448T based on a crosswalk to the work RVUs,
work time, and direct PE inputs of CPT codes 11981 (Insertion, non-
biodegradable drug delivery implant), 11982 (Removal, non-biodegradable
drug delivery implant), and 11983 (Removal with reinsertion, non-
biodegradable drug delivery implant), respectively, due to the similar
clinical nature of these procedures.
We are also proposing to include one supply and one equipment item
to the direct PE inputs crosswalked from CPT codes 11981-11983. We are
adding a new ``implantable interstitial glucose sensor'' (supply code
SD334) for Category III CPT codes 0446T and 0448T to include the supply
costs of the ``implantable interstitial glucose sensor'' (supply code
SD334) included in these procedures, which we propose to price at
$1,500.00, based on information we received from stakeholders. We are
also proposing to include the smart transmitter associated with the use
of this implantable interstitial glucose sensor. We propose to price
the smart transmitter involved in furnishing this service by using a
similar equipment item finalized in the CY 2019 PFS final rule (83 FR
59624) as a proxy, the ``heart failure patient physiologic monitoring
equipment package'' (EQ392); the EQ392 has a price of $1,000.00, and is
similarly used for long term remote monitoring of patients. We are
proposing to use the EQ392 equipment as a proxy for the valuation of
the smart transmitter associated with the implantable interstitial
glucose sensor, to which we are assigning a time of 25,920 minutes for
EQ392 in Category III CPT codes 0446T and 0448T. This time is derived
from 60 minutes per hour times 24 hours per day times 90 days per
billing quarter, divided by 1 minute of equipment use out of every 5
minutes of time. We are not including either the implantable
interstitial glucose sensor or the EQ392 equipment proxy for Category
III CPT code 0447T, as it describes only a removal procedure.
We are seeking comment on the proposed values for these Category
III CPT codes (0446T, 0447T, and 0448T), and we are seeking comment on
the appropriateness and accuracy of the proposed work RVUs, work times,
and direct PE inputs.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
I. Modifications Related to Medicare Coverage for Opioid Use Disorder
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
1. Background
Section 2005 of the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities (SUPPORT)
Act established a new Medicare Part B benefit category for OUD
treatment services furnished by OTPs during an episode of care
beginning on or after January 1, 2020. In the CY 2020 PFS final rule
(84 FR 62630 through 62677), we implemented coverage requirements and
established new codes describing the bundled payments for episodes of
care for the treatment of OUD furnished by OTPs. We established new
codes for and finalized bundled payments for weekly episodes of care
that include methadone, oral buprenorphine, implantable buprenorphine,
injectable buprenorphine or naltrexone, and non-drug episodes of care,
as well as add-on codes for intake and periodic assessments, take-home
dosages for methadone and oral buprenorphine, and additional
counseling. We are monitoring Medicare enrollment by OTPs and
utilization of the new benefit to ensure that Medicare beneficiaries
have appropriate access to care. For CY 2021, we are proposing several
refinements and seek to provide clarification on certain issues that
stakeholders have brought to our attention.
2. Definition of OUD Treatment Services
In the CY 2020 PFS final rule (84 FR 62631 through 62635), we
finalized a definition of ``OUD treatment services'' that reflects the
statutory definition in section 1861(jjj)(1)(A) of the Act, which
defines covered OUD treatment services to include oral, injected, and
implanted opioid agonist and antagonist treatment
[[Page 50203]]
medications approved by the Food and Drug Administration (FDA) under
section 505 of the FFDCA for use in the treatment of OUD. There are
three drugs currently approved by FDA for the treatment of opioid
dependence: Buprenorphine; methadone; and naltrexone. In the CY 2020
PFS final rule, we noted that we had received comments supporting the
proposed definition of OUD treatment services but also requesting that
CMS include naloxone to treat opioid overdose in that definition as a
medication used in treatment of OUD. Although we did not finalize
including naloxone in the definition of OUD treatment services in that
final rule, we indicated that as we continue to work on refining this
new Medicare benefit, we would consider including additional drugs in
the definition of OUD treatment services under our discretionary
authority in section 1861(jjj)(1)(F) of the Act to include other items
and services the Secretary determines are appropriate. After further
consideration, we have determined that it is appropriate to propose to
extend the definition of OUD treatment services to include opioid
antagonist medications, such as naloxone, that are approved by FDA
under section 505 of the FFDCA for emergency treatment of opioid
overdose.
Naloxone is an opioid antagonist indicated for the emergency
treatment of known or suspected opioid overdose, as manifested by
respiratory and/or central nervous system depression.\15\ \16\ Naloxone
should be given to a person who shows signs of an opioid overdose or
when an overdose is suspected. FDA-approved naloxone products for
overdose reversal are effective in reversing opioid overdose, including
fentanyl-involved opioid overdoses, although overdoses involving potent
(for example, fentanyl) or large quantities of opioids may require
higher-than-normal doses of naloxone or repeated administration to
reverse overdose.\17\
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\15\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
\16\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
\17\ https://store.samhsa.gov/system/files/sma18-4742.pdf.
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Naloxone attaches to opioid receptors and reverses and blocks the
effects of other opioids.\18\ FDA has approved injectable naloxone,
intranasal naloxone, and naloxone auto-injector as emergency treatments
for opioid overdose. The nasal spray is a prefilled, needle-free device
that requires no assembly and can deliver a single dose into each
nostril with two sprays. The auto-injector is injected into the outer
thigh to deliver naloxone to the muscle (intramuscular). These forms of
naloxone can easily be administered by persons who do not have medical
training and they may be prescribed to a patient who is receiving
medication-assisted treatment (MAT) for OUD, especially if the patient
is considered to be at risk for opioid overdose.\19\ Both the nasal
spray and naloxone auto-injector are packaged in a carton containing
two doses to allow for repeat dosing if needed.20 21
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\18\ https://www.drugabuse.gov/publications/drugfacts/naloxone.
\19\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone.
\20\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
\21\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
\22\ https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.
\23\ http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
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The U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. has released
a public health advisory stating that, ``Research shows that when
naloxone and overdose education are available to community members,
overdose deaths decrease in those communities. Therefore, increasing
the availability and targeted distribution of naloxone is a critical
component of our efforts to reduce opioid-related overdose deaths and,
when combined with the availability of effective treatment, to ending
the opioid epidemic.'' \22\
We are proposing to add naloxone to the definition of OUD treatment
services in order to increase access to this important emergency
treatment and to allow OTPs to be paid under Medicare for dispensing
naloxone to Medicare beneficiaries who are receiving other OUD
treatment services from the OTP. Under this proposal, beneficiaries
receiving OUD treatment services from the OTP would be able to receive
naloxone from the OTP under the OUD treatment services benefit, to the
extent it is medically reasonable and necessary as part of their OUD
treatment. We note that naloxone is already covered under Medicare Part
D. In 2017, 72.5 percent of all Medicare beneficiaries were enrolled in
Medicare Part D plans.\23\ However, we believe allowing beneficiaries
to access this important emergency treatment at the OTP may help
decrease barriers to access because there currently are no copayments
for services furnished by OTPs and beneficiaries would not need to
visit a separate provider to access naloxone.
Accordingly, to align with efforts to end the opioid epidemic,
under the discretionary authority in section 1861(jjj)(1)(F) of the
Act, we propose to amend the definition of OUD treatment services at
Sec. 410.67(b) by adding Sec. 410.67(b)(8) to include opioid
antagonist medications that are approved by FDA under section 505 of
the FFDCA for the emergency treatment of known or suspected opioid
overdose. We are proposing to amend the definition of OUD treatment
services under the discretionary authority in section 1861(jjj)(1)(F)
of the Act rather than the authority under section 1861(jjj)(1)(A) of
the Act because section 1861(jjj)(1)(A) of the Act pertains to opioid
agonist and antagonist treatment medications (including oral, injected,
or implanted versions) that are approved by FDA under section 505 of
the FFDCA for use in the treatment of opioid use disorder. Naloxone is
not one of the three drugs currently approved by FDA for the treatment
of opioid dependence (buprenorphine, methadone, and naltrexone); and,
as a result, we do not believe naloxone fits the criteria of section
1861(jjj)(1)(A) of the Act. We seek comment on our proposal to expand
the definition of OUD treatment services.
Additionally, we agree with the public health advisory quoted
previously that community education related to overdose prevention is
needed to address the opioid crisis. We believe that prevention and
community education efforts would increase awareness of treatment
options and could play a role in decreasing opioid overdose deaths. We
welcome comments on whether the definition of OUD treatment services
should be further revised to include overdose education. Additionally,
we welcome comments on whether payment for providing overdose education
to the beneficiary and/or the beneficiary's family or partner should be
considered to be included in the current weekly bundled payments for
episodes of care or whether we should consider establishing an add-on
payment for education related to overdose prevention when such services
are furnished by OTPs. We are specifically seeking information related
to what inputs we might consider in developing the payment rate for
such a service, such as payment amounts for similar services under the
PFS, if we were to include this type of education as part of the
proposed new add-on codes for naloxone discussed later in this section
(HCPCS codes GOTP1 and GOTP2). For example, in order to establish a
payment rate for education related to overdose prevention for the
beneficiary and/or
[[Page 50204]]
beneficiary's family or partner, we could consider a crosswalk to the
Medicare payment rate for CPT code 96161 (Administration of caregiver-
focused health risk assessment instrument (e.g, depression inventory)
for the benefit of the patient, with scoring and documentation, per
standardized instrument). The current non-facility payment rate under
the PFS for CPT code 96161 is $2.53.
a. Proposed Adjustment Made to the Bundled Payments for OUD Treatment
Services
Consistent with our proposal to expand the definition of OUD
treatment services to include opioid antagonist medications indicated
for the emergency treatment of known or suspected opioid overdose, we
believe it is appropriate to propose changes to the payment rates for
the bundled payments to reflect the costs of these medications.
Therefore, we propose to adjust the bundled payment rates through the
use of add-on codes to account for instances in which OTPs provide
Medicare beneficiaries with naloxone. We believe that beneficiaries
receiving naloxone will need a supply at the start of treatment and
would only require refills later if the supply is used in an emergency.
As a result, we would not expect naloxone to be provided weekly to all
patients, but only on an as-needed basis. Accordingly, we believe that
making payment for naloxone through the use of an add-on code is the
most accurate approach to pricing rather than including the costs of
these medications as part of the bundled payment rates for all episodes
of care.
We propose to adopt the following add-on G codes:
HCPCS code GOTP1: Take-home supply of nasal naloxone
(provision of the services by a Medicare-enrolled Opioid Treatment
Program); List separately in addition to code for primary procedure.
HCPCS code GOTP2: Take-home supply of auto-injector
naloxone (provision of the services by a Medicare-enrolled Opioid
Treatment Program); List separately in addition to code for primary
procedure.
We are proposing to adopt an approach similar to the pricing
methodology that was used to price the drug component of the bundled
payments in the CY 2020 PFS final rule to determine the payment rate
for these proposed new add-on codes for naloxone. In the CY 2020 PFS
proposed rule (84 FR 40530), we explained that payment structures that
are closely tailored to the provider's actual acquisition cost reduce
the likelihood that a drug will be chosen primarily for a reason that
is unrelated to the clinical care of the patient, such as the drug's
profit margin for a provider. Therefore, we believe it is appropriate
to use a similar methodology to determine the payment rates for the
add-on codes for naloxone as we adopted in the CY 2020 PFS final rule
for purposes of determining the payment rate for the drug component of
the bundled payments because it provides our best estimate of an OTP's
cost in dispensing naloxone.
In the CY 2020 PFS final rule, we adopted a policy under which we
apply the methodology set forth in section 1847A of the Act to
determine the payment amount for the drug component of the bundled
payment for an episode of care that includes implantable or injectable
medications, except that the payment amount shall be 100 percent of the
average sales price (ASP), if ASP is used. For oral medications, the
payment for the drug component is based on 100 percent of ASP, if ASP
data are available. However, if ASP is not available, the payment
amount for methadone will be based on the TRICARE rate and the payment
amount for oral buprenorphine is calculated using the national average
drug acquisition cost (NADAC).
Drug Pricing for Nasal Naloxone
Consistent with the approach that we adopted for pricing the drug
component of the weekly bundled payments, we are proposing to price the
add-on code describing the take home supply of nasal naloxone, HCPCS
code GOTP1, using the same methodology we previously adopted for
pricing the drug component of an episode of care that include
implantable or injectable medications. Accordingly, the payment
methodology would be based upon the methodology set forth in section
1847A of the Act, except that payment amounts determined based on ASP
and wholesale acquisition cost (WAC) would not include any add-on
percentages. We recognize that nasal naloxone is not an oral,
implantable or injectable medication; however, ASP data are available.
As noted in the CY 2020 PFS final rule (84 FR 62653), we believe using
ASP provides a transparent and public benchmark for manufacturers'
pricing as it reflects the manufacturers' actual sales prices to all
purchasers (with limited exceptions as noted in section 1847A(c)(2) of
the Act) and is the only pricing methodology that includes off-invoice
rebates and discounts as described in section 1847A(c)(3) of the Act.
Therefore, we believe ASP to be the most market-based approach to set
drug prices. We seek public comment on our proposal to use ASP+0 to
price the add-on payment for nasal naloxone and other potential sources
of pricing data for nasal naloxone either generally or specifically
with respect to acquisition by OTPs.
Drug Pricing for Auto-Injector Naloxone
We are proposing to price the add-on code describing the take-home
supply of auto-injector naloxone, HCPCS code GOTP2, using the lowest
pricing available (the lower of ASP + 0, WAC + 0, or NADAC). Currently,
there is no ASP or NADAC reported or calculated for auto-injector
naloxone. Accordingly, we propose to use WAC + 0 to determine the
pricing for the add-on payment for auto-injector naloxone. We believe
100 percent of WAC is a closer estimate of the actual acquisition cost
for OTPs compared to WAC with an add-on percentage because, as defined
in section 1847A(c)(6)(B) of the Act, WAC does not include prompt pay
discounts, rebates or reductions in price. Thus, there should be no
need to pay an add-on percentage to ensure OTPs are reimbursed for
their acquisition costs for auto-injector naloxone. However, in the
future, we believe using the lowest pricing available for auto-injector
naloxone may be most appropriate, because if ASP and/or NADAC pricing
were to become available for auto-injector naloxone, they would be more
reflective of actual costs than a list price.
[[Page 50205]]
We note that auto-injector naloxone is available in both a generic
and brand name version. We considered comparing the Medicare Part D
utilization for each formulation to determine the frequency with which
the generic and brand name versions might dispensed by OTPs. However,
because the generic auto-injector naloxone is rather new to the
marketplace,\24\ there are limited utilization data available for the
generic product. Based on historical information reflecting a trend of
increased generic utilization uptake,\25\ we believe that in most cases
where the auto-injector naloxone is prescribed and dispensed by OTPs to
beneficiaries, it will be the generic formulation of the product.
Therefore, we believe using the price for the generic formulation is a
reasonable approach to pricing the proposed add-on code for auto-
injector naloxone and will ensure that beneficiaries who need this drug
as part of their treatment for OUD have access to it and that OTPs
receive a reasonable payment for dispensing the drug. Accordingly, we
are proposing to use the price of the generic formulation, determined
as WAC + 0, to pay for auto-injector naloxone when the drug is provided
by an OTP as part of an episode of care. We seek comment on our
proposed pricing methodology to pay for auto-injector naloxone and
other potential sources of pricing data for auto-injector naloxone
either generally or specifically with respect to acquisition by OTPs.
Frequency Limit
We note that Medicare Part D allows prescription drug plans to
place quantity limits (QL) on most drugs, including on naloxone. While
most Part D plans do not limit the amount of naloxone a beneficiary is
able to receive in a given month, when they do, they most frequently
allow a plan enrollee a maximum of 4 units per 30 days (2 boxes of 2
units). In the current contract year (2020) only 22 percent of Medicare
Part D formularies apply a QL to naloxone (115/535 formularies), while
for the 2021 contract year only 19 percent of Part D formularies plan
to apply a QL to this product (106/564 formularies). However, a review
of Part D claims data shows that beneficiaries who use naloxone most
frequently use only one box (2 units) within a 30-day period even
though nearly all plans would have permitted additional doses. Under
TRICARE, auto-injector naloxone is covered for a maximum quantity of
one carton at retail network pharmacies for up to a 30-day supply.\26\
We believe it would be appropriate to apply a similar limit on the
frequency of the add-on payment for naloxone dispensed by OTPs. We
believe that applying a frequency limit would assist in enhancing
patient safety and discourage misuse, waste and abuse. Furthermore, we
believe such a limitation is reasonable because there are other
services that OTPs should already be performing, and which are already
included in the weekly bundled payments for episodes of care, such as
counseling and individual and group therapy, that should limit the need
for this emergency treatment. However, we do not want to limit access
to naloxone when it is a medically reasonable and necessary part of the
treatment for OUD. Therefore, we propose to limit Medicare payment to
OTPs for naloxone to one add-on code (HCPCS code GOTP1 or GOTP2) every
30 days to the extent that it is medically reasonable and necessary. We
seek comment on whether this proposed limit is reasonable and whether
special circumstances may arise under which more frequent payment is
medically reasonable and necessary and the types of circumstances that
should qualify for more frequent payment. However, we note that we also
expect OTPs and their treating practitioners will use their clinical
judgment as to whether there may be cases in which a referral to a
higher level of care may be needed for some beneficiaries in order to
reduce the risk of overdose and the need for more frequent emergency
treatment. We propose to add Sec. 410.67(d)(4)(i)(E) to describe
payment for a take-home supply of opioid antagonist medications that
are approved by FDA under section 505 of the FFDCA for the emergency
treatment of known or suspected opioid overdose.
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\24\ https://kaleo.com/in-the-news/authorized-generic-for-evzio-naloxone-hcl-injection-to-be-available-at-a-reduced-list-price-of-178/.
\25\ In 2015, approximately 87 percent of prescriptions filled
under Part D were for generic drugs, compared with 61 percent in
2007. http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
\26\ https://www.express-scripts.com/static/formularySearch/2.9.6/#/formularySearch/drugSearch.
---------------------------------------------------------------------------
We invite public comments on the proposed pricing for nasal
naloxone and auto-injector naloxone. We also seek comment on our
proposal to limit payment for the proposed add-on codes for take-home
supplies of these medications to once every 30 days to the extent that
it is medically reasonable and necessary.
Additionally, we seek comment on whether we should consider
creating a code and establishing an add-on payment for injectable
naloxone. We note that all three forms of naloxone (injectable, auto-
injector, and nasal spray) are FDA-approved and may be considered as
options for community distribution and use by individuals with or
without medical training to stop or reverse the effects of an opioid
overdose.\27\ If we were to establish an add-on payment for injectable
naloxone, we would consider using the same methodology we adopted for
pricing the drug component of an episode of care that includes
implantable or injectable medications, as described in Sec.
410.67(d)(2)(i)(A).
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\27\ https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all-forms-naloxone-help-reduce-opioid-overdose.
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Table 30 details the proposed coding and summarizes the proposed
payment amounts for nasal naloxone and auto-injector naloxone.
[[Page 50206]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.064
Duplicative Payment
Section 1834(w)(1) of the Act, added by section 2005(c) of the
SUPPORT Act, requires the Secretary to ensure, as determined
appropriate by the Secretary, that no duplicative payments are made
under Part B or Part D for items and services furnished by an OTP. We
note that under our proposal, OTPs would be able to provide naloxone to
Medicare beneficiaries and bill for it as an add-on to the bundled
payment. Consistent with Sec. 410.67(e), the beneficiary's copayment
amount would remain zero. We also realize that naloxone may also be
appropriately available to beneficiaries through other Medicare
benefits, including, for example, Medicare Part D, under which the
beneficiary would be responsible for the applicable cost sharing. As
discussed in the CY 2020 PFS final rule (84 FR 62664) and codified at
Sec. 410.67(d)(5), we define duplicative payment to involve only those
circumstances where medications that are delivered, administered or
dispensed to a beneficiary are paid as part of the OTP bundled payment,
and where the delivery, administration or dispensing of the same
medication (that is, same drug, dosage and formulation) is also
separately paid under Medicare Part B or Part D for the same
beneficiary on the same date of service. Because we are proposing to
pay for naloxone as an add-on to the weekly bundled payment, any
payment to an OTP for naloxone would be duplicative if the same
medication is separately paid under Medicare Part B or Part D for the
same beneficiary on the same date of service. Consistent with Sec.
410.67(d)(5), CMS would recoup any duplicative payment made to an OTP
for naloxone.
Additionally, we understand that some OTPs negotiate arrangements
whereby community pharmacies supply MAT-related medications to OTPs.
However, as we stated in the CY 2020 PFS final rule, if the OTP
provides reasonable and necessary MAT-related medications as part of an
episode of care, we would expect the OTP to take measures to ensure
that there is no claim for payment for these drugs other than as part
of the OTP bundled payment. Thus, naloxone billed by an OTP as an add-
on to the bundled payment should not be reported to or paid under a
Part D plan. We expect that OTPs will take reasonable steps to prevent
duplicative payment for naloxone furnished under their care by ensuring
it is not reported or billed under a different Medicare benefit. We
intend to monitor for duplicative payments, and would take appropriate
action as needed when and if such duplicative payments are identified.
3. WAC Pricing
Section 1834(w) of the Act gives the Secretary significant
discretion to establish bundled payment rates for OUD treatment
services. In the CY 2020 PFS final rule, we finalized a payment
methodology for the drug component of the bundled payment rates for OUD
treatment services, under which we use the payment methodology set
forth in section 1847A of the Act (which bases most payment on ASP) to
set the payment rates for implantable and injectable drugs and limited
the payment amount for these drugs to 100 percent of the volume-
weighted ASP for a drug category or code, if ASP is used. We codified
this payment methodology at Sec. 410.67(d)(2)(i)(A).
Section 1847A of the Act provides for the use of other payment
methodologies when ASP is not available, including WAC and average
manufacturer price (AMP). In the CY 2020 PFS final rule, we limited
payments to OTPs for injectable and implantable drugs to 100 percent of
ASP, but did not otherwise diverge from the payment methodology that
would apply under section 1847A of the Act. In this proposed rule, we
believe that it is necessary to amend the OTP drug pricing methodology
in order to limit WAC-based payments to 100 percent of WAC. As
discussed previously, we are proposing to use WAC pricing to determine
the payment rate for the add-on code for the auto-injector naloxone.
Although none of the drugs that are currently included in the drug
component of an episode of care is currently paid based on WAC, we
believe it is possible that we may use WAC to determine the payment for
the drug component of an episode of care in the future, and want to
establish, in advance, the methodology that would apply for purposes of
determining the payment rate.
As authorized under section 1847A of the Act, some Part B drugs are
paid based on WAC. For example, for single source drugs, payment is 106
percent of the lesser of WAC or ASP (section 1847A(b)(4) of the Act),
and in cases where ASP is unavailable during the first quarter of sales
(section 1847A(c)(4) of the Act), 103 percent of WAC is used.
Additionally, there are some instances where drugs lack ASP data for
reasons other than being new, for example, in cases where the
manufacturer had no sales in a reporting quarter. In those situations,
the Medicare payment method varies, but in some cases, the payment may
be 106 percent of the WAC.\28\ As we stated in the CY 2020 PFS final
rule (84 FR 62651), payment structures that are closely tailored to the
provider's actual acquisition cost reduce the likelihood that a drug
will be chosen primarily for a reason that is unrelated
[[Page 50207]]
to the clinical care of the patient, such as the drug's profit margin
for a provider. The WAC is defined in section 1847A(c)(6)(B) as the
manufacturer's list price for a drug to wholesalers or direct
purchasers in the United States, not including prompt pay or other
discounts, rebates, or reductions in price. A drug's WAC is ultimately
controlled by the manufacturer. Unlike ASP, a drug's WAC does not
incorporate prompt-pay or other discounts. If discounts are available
on drugs reimbursed by Medicare at 106 percent of WAC, then Medicare is
paying more for drugs than it otherwise would under the ASP-based
formula.\29\ Therefore, consistent with our existing policy to set the
payment amount at 100 percent of the ASP, if ASP is used to determine
the payment for the drug component of an episode of care, we are
proposing that when WAC-based pricing is used, the payment amount shall
be WAC + 0. We are proposing to amend the provision at Sec.
410.67(d)(2)(i)(A) to reflect this limitation.
---------------------------------------------------------------------------
\28\ http://www.medpac.gov/-blog-/requiring-reporting-of-sales-price-data/2019/06/14/payment-for-part-b-drugs.
\29\ http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf.
---------------------------------------------------------------------------
We welcome comments on this proposed alternative pricing
methodology when the payment for an implantable or injectable
medication included in the drug component of an episode of care is
determined using the methodology set forth in section 1847A of the Act,
and ASP pricing data are not available.
4. Billing and Payment Policies
a. Institutional Claim Forms
We have received several requests to allow OTPs to bill on an
institutional claim form. We were informed by representatives from the
state of New York that all OTPs in New York state bill on institutional
claim forms, not just those that are part of a hospital system. Given
the public health need related to the opioid epidemic, we are exploring
claims processing flexibilities requested by some OTPs that would allow
them to bill services on institutional claims. See also section III.B.
of this proposed rule, OTP Provider Enrollment Regulation Updates for
Institutional Claim Submissions, for a discussion related to OTP
enrollment as it relates to institutional claims. There would be no
differences in coverage or payment between services billed on the
institutional claim form versus the professional claim form. We note
that the National Uniform Billing Committee (NUBC) approved a new Type
Of Bill (087x) for Freestanding Non-residential Opioid Treatment
Program provider billing, as well as a new condition code (89) for
Opioid Treatment Program/Indicates claim for opioid treatment program
services, to be used on hospital based OTP claims (TOB 013x and 085x).
We are seeking information on the reasons this flexibility is necessary
for OTPs, and will address any changes to provider billing policies in
subsequent claims processing instructions.
b. Periodic Assessments
In the CY 2020 PFS final rule (84 FR 62634), we stated that we
understood that intake activities and periodic assessments are integral
services for the establishment and maintenance of OUD treatment for a
beneficiary at an OTP, and therefore, we believed it was reasonable to
include these services in the definition of OUD treatment services.
Accordingly, we finalized a definition of OUD treatment services in
Sec. 410.67(b) that reflected the required intake activities and
periodic assessments. We stated it was our understanding that these
services are furnished much less frequently than the other services
included in the weekly bundled payments; therefore, we created add-on G
codes to describe these services, which would allow us to make more
targeted payments for these services. We noted that the add-on code
describing intake activities should only be billed for new patients
(that is, patients starting treatment at the OTP). We agreed with the
commenters that the level 4 office/outpatient E/M visits for new and
established patients are a good approximation of the services provided
at intake and during periodic assessments at OTPs based on the expected
acuity of patients with OUD receiving services at OTPs, who are likely
to have multiple co-morbidities and present with problems that are of
moderate to high severity and require medical decision making of
moderate complexity. The finalized add-on codes are HCPCS code G2076
(Intake activities; including initial medical examination that is a
complete, fully documented physical evaluation and initial assessment
conducted by a program physician or a primary care physician, or an
authorized health care professional under the supervision of a program
physician or qualified personnel that includes preparation of a
treatment plan that includes the patient's short-term goals and the
tasks the patient must perform to complete the short-term goals; the
patient's requirements for education, vocational rehabilitation, and
employment; and the medical, psycho-social, economic, legal, or other
supportive services that a patient needs, conducted by qualified
personnel) and HCPCS code G2077 (Periodic assessment; assessing
periodically by qualified personnel to determine the most appropriate
combination of services and treatment). The medical services described
by these add-on codes can be furnished by a program physician, a
primary care physician or an authorized healthcare professional under
the supervision of a program physician or qualified personnel such as
nurse practitioners (NPs) and physician assistants (PAs). The other
assessments, including psychosocial assessments can be furnished by
practitioners who are eligible to do so under state law and their scope
of licensure. We noted that to bill for the add-on code, the services
need to be medically reasonable and necessary and that OTPs should
document the rationale for billing the add-on code in the patient's
medical record (84 FR 62647).
We have received inquiries from stakeholders related to what
activities would qualify to bill the add-on code for periodic
assessments, HCPCS code G2077. In the CY 2020 PFS final rule (84 FR
62647), we noted that the add-on code describing periodic assessments
can be billed for each periodic assessment performed for patients that
require multiple assessments during an episode of care, such as
patients who are pregnant or postpartum. We noted that in order to bill
for the add-on code, the services would need to be medically reasonable
and necessary and that OTPs should document the rationale for billing
the add-on code in the patient's medical record. Based on our
understanding of the typical resources costs involved in furnishing
periodic assessments, we priced HCPCS code G2077 based on a crosswalk
to a level 4 office/outpatient E/M visit. Consistent with our
understanding of the expected acuity of patients with OUD receiving
services at OTPs, including the likelihood of the patient having
multiple co-morbidities and presenting with problems that are of
moderate to high severity and requiring medical decision making of
moderate complexity, as well as the associated payment rate assigned to
this code, we believe it is important for the clinician to be able to
visually assess the patient as part of any periodic assessment.
Therefore, for CY 2021, we are proposing that in order to bill for
HCPCS code G2077, a face-to-face medical exam or biopsychosocial
assessment would need to have been performed. Accordingly, we are
proposing to amend the definition of periodic assessment in Sec.
410.67(b)(7) to
[[Page 50208]]
provide that the definition is limited to a face-to-face encounter.
Additionally, we note that in the May 8th COVID-19 IFC, CMS revised
Sec. 410.67(b)(7) on an interim final basis to allow periodic
assessments to be furnished during the PHE for the COVID-19 pandemic
via two-way interactive audio-video communication technology and, in
cases where beneficiaries do not have access to two-way audio-video
communication technology, to permit the periodic assessments to be
furnished using audio-only telephone calls rather than via two-way
interactive audio-video communication technology, provided all other
applicable requirements are met. We believe that allowing periodic
assessments to be furnished via two-way interactive audio-video
communication technology beyond the conclusion of the PHE for the
COVID-19 pandemic would help to expand access to care for patients who
may have a difficult time getting to the OTP in person. Therefore, in
this proposed rule, we are proposing to revise Sec. 410.67(b)(7) to
allow periodic assessments to be furnished via two-way interactive
audio-video communication technology, provided all other applicable
requirements are met. We note that we are currently permitting the use
of audio-only telephone calls to furnish these services during the PHE
for the COVID-19 pandemic, because we believe it is important to
maintain access to these services while the public is following
infection control guidelines to stay at home and practice social
distancing, and not all beneficiaries receiving OUD treatment services
from OTPs may have access to interactive audio-video communication
technology. However, we do not believe this flexibility will be needed
in order to ensure access after the PHE ends. Therefore, under this
proposal, the flexibility to use audio-only telephone services to
furnish periodic assessments would not be permitted once the PHE for
the COVID-19 pandemic has ended. We note that we would consider payment
for any periodic assessment-related services furnished via audio-only
telephone calls to be included in the bundled payment, but that audio-
only telephone services would not qualify for billing HCPCS code G2077
after the end of the PHE for the COVID-19 pandemic. We are seeking
input from the public on whether we should consider continuing to make
add-on payments for audio-only periodic assessments furnished by OTPs
after the conclusion of the PHE for the COVID-19 pandemic, and if so,
whether the payment rate for audio-only services should reflect any
differences in resource costs.
c. Date of Service
In the CY 2020 PFS final rule (84 FR 62641), we defined an episode
of care as a 1-week (contiguous 7-day) period at Sec. 410.67(b). We
have received inquiries related to the date of service used on claims
for the weekly bundles and add-on codes, particularly related to an
approach that many providers informed us they use, which is to
establish a ``standard billing cycle'' in which episodes of care for
all patients at that OTP begin on the same day of the week. We do not
believe that the definition of an episode of care that was finalized
for CY 2020 precludes the use of a ``standard billing cycle.''
Therefore, OTPs may choose to apply a standard billing cycle by setting
a particular day of the week to begin all episodes of care. In this
case, the date of service would be the first day of the OTP's billing
cycle. If a beneficiary starts treatment at the OTP on a day that is in
the middle of the OTP's standard weekly billing cycle, the OTP may
still bill the applicable code for that episode of care provided that
the threshold to bill for the code has been met. Alternatively, OTPs
may choose to adopt weekly billing cycles that vary across patients.
Under this approach, the initial date of service will depend upon the
day of the week when the patient was first admitted to the program or
when Medicare billing began. Therefore, under this approach of adopting
weekly billing cycles that vary across patients, when a patient is
beginning treatment or re-starting treatment after a break in
treatment, the date of service would reflect the first day the patient
was seen and the date of service for subsequent consecutive episodes of
care would be the first day after the previous 7-day period ends. For
the codes describing add-on services (HCPCS codes G2076-G2080), the
date of service should reflect the date that service was furnished;
however, if the OTP has chosen to apply a standard weekly billing
cycle, the date of service for codes describing add-on services may be
the same as the first day in the weekly billing cycle.
We note that this approach is consistent with earlier guidance that
was issued in the OTP Billing and Payment Fact sheet that is posted on
the CMS OTP web page (https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf).
d. Coding
We recognize the importance of allowing OTPs to become accustomed
to billing Medicare using the coding that was established in the CY
2020 PFS final rule; however, we remain interested in refining the code
set through future rulemaking, including stratifying the coding and
associated payment amounts to account for significant differences in
resource costs among patients, especially in relation to amounts of
expected counseling. In the CY 2020 PFS final rule (84 FR 62645), we
finalized an add-on code to describe an adjustment to the bundled
payment when additional counseling or therapy services are furnished,
HCPCS code G2080. This add-on code may be billed when counseling or
therapy services are furnished that substantially exceed the amount
specified in the patient's individualized treatment plan. We have
received feedback from stakeholders noting a range of OTP attendance
patterns that represent a continuum of care and service intensity,
noting significant differences in services received during the
induction phase versus the maintenance phase. We also understand that
patients' needs for service may fluctuate over time, depending on a
variety of factors and circumstances. We welcome comments on how we
might better account for differences in resource costs among patients
over the course of treatment. We will consider the comments received in
developing any proposed refinements to our coding policies in future
rulemaking.
5. Annual Updates
In the CY 2020 PFS final rule (84 FR 62667 through 62669), we
finalized a policy under which the payment for the drug component of
episodes of care will be determined using the most recent data
available at the time of ratesetting for the applicable calendar year.
The payment for the non-drug component of the bundled payment for OUD
treatment services will be updated annually based upon the Medicare
Economic Index. The list of the payment rates for OUD treatment
services furnished by OTPs, with the annual update applied for CY 2021,
is available in the file called CY 2021 OTP Proposed Payment Rates on
the CMS website under downloads for the CY 2021 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html. Additionally, we
note that the current rates, as finalized in the CY 2020 PFS final
rule, both with and without locality adjustments, can be found on the
CMS OTP web page under Billing and Payment at https://www.cms.gov/
Medicare/Medicare-Fee-for-Service-
[[Page 50209]]
Payment/Opioid-Treatment-Program/billing-payment.
III. Other Provisions of the Proposed Rule
A. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and
Phase-in of Payment Reductions, and a Comment Solicitation on Payment
for Specimen Collection for Covid-19 Tests
1. Background on the Clinical Laboratory Fee Schedule
Prior to January 1, 2018, Medicare paid for clinical diagnostic
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule
(CLFS), with certain exceptions, under section 1833(a), (b), and (h) of
the Act. Under the previous payment system, CDLTs were paid based on
the lesser of: (1) The amount billed; (2) the local fee schedule amount
established by the Medicare Administrative Contractor (MAC); or (3) a
national limitation amount (NLA), which is a percentage of the median
of all the local fee schedule amounts (or 100 percent of the median for
new tests furnished on or after January 1, 2001). In practice, most
tests were paid at the NLA. Under the previous payment system, the CLFS
amounts were updated for inflation based on the percentage change in
the Consumer Price Index for All Urban Consumers (CPI-U), and reduced
by a multi-factor productivity adjustment and other statutory
adjustments, but were not otherwise updated or changed. Coinsurance and
deductibles generally do not apply to CDLTs paid under the CLFS.
Section 1834A of the Act, as established by section 216(a) of the
Protecting Access to Medicare Act of 2014 (PAMA), required significant
changes to how Medicare pays for CDLTs under the CLFS. In the June 23,
2016 Federal Register (81 FR 41036), we published a final rule entitled
Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS
final rule), that implemented section 1834A of the Act at 42 CFR part
414, subpart G.
Under the CLFS final rule, ``reporting entities'' must report to
CMS during a ``data reporting period'' ``applicable information''
collected during a ``data collection period'' for their component
``applicable laboratories.'' The first data collection period occurred
from January 1, 2016 through June 30, 2016. The first data reporting
period occurred from January 1, 2017 through March 31, 2017. On March
30, 2017, we announced a 60-day period of enforcement discretion for
the application of the Secretary's potential assessment of Civil
Monetary Penalties (CMPs) for failure to report applicable information
with respect to the initial data reporting period. This announcement is
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we
solicited public comments from applicable laboratories and reporting
entities to better understand the applicable laboratories' experiences
with data reporting, data collection, and other compliance requirements
for the first data collection and reporting periods. We discussed these
comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and
stated that we would consider the comments for potential future
rulemaking or guidance.
As part of the CY 2019 Medicare PFS rulemaking, we finalized two
changes to the definition of ``applicable laboratory'' at Sec. 414.502
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850; 83 FR
35855 through 35862). First, we excluded Medicare Advantage (MA) plan
payments under Part C from the denominator of the Medicare revenues
threshold calculation, in an effort to broaden the types of
laboratories qualifying as an applicable laboratory. Specifically,
excluding MA plan payments could allow additional laboratories of all
types serving a significant population of beneficiaries enrolled in
Medicare Part C to meet the majority of Medicare revenues threshold and
potentially qualify as an applicable laboratory (if they also meet the
low expenditure threshold) and report data to CMS during the data
reporting period. Because MA plan payments are now excluded from the
total Medicare revenues calculation, the denominator amount (total
Medicare revenues) would decrease. If the denominator amount decreases,
the likelihood increases that a laboratory would qualify as an
applicable laboratory. This is because the laboratory's PFS and CLFS
revenues are being compared to a lower total Medicare payment amount
(than what they would have been compared to if MA plan payments
remained in the denominator). Second, consistent with our goal of
obtaining a broader representation of laboratories that could
potentially qualify as an applicable laboratory and report data we also
amended the definition of applicable laboratory to include hospital
outreach laboratories that bill Medicare Part B using the CMS-1450 14x
Type of Bill.
2. Payment Requirements for Clinical Diagnostic Laboratory Tests
In general, under section 1834A of the Act, the payment amount for
each CDLT on the CLFS furnished beginning January 1, 2018, is based on
the applicable information collected during the data collection period
and reported to CMS during the data reporting period, and is equal to
the weighted median of the private payor rates for the test. The
weighted median is calculated by arraying the distribution of all
private payor rates, weighted by the volume for each payor and each
laboratory. The payment amounts established under the CLFS are not
subject to any other adjustment, such as geographic, budget neutrality,
or annual update, as required by section 1834A(b)(4)(B) of the Act.
Additionally, section 1834A(b)(3) of the Act, implemented at Sec.
414.507(d), provides for a phase-in of payment reductions, limiting the
amounts the CLFS rates for each CDLT (that is not a new advanced
diagnostic laboratory test (ADLT) or new CDLT) can be reduced as
compared to the payment rates for the preceding year. Under the
provisions enacted by section 216(a) of PAMA, for the first 3 years
after implementation (CY 2018 through CY 2020), the reduction cannot be
more than 10 percent per year, and for the next 3 years (CY 2021
through CY 2023), the reduction cannot be more than 15 percent per
year. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA,
for CDLTs that are not ADLTs, the data collection period, data
reporting period, and payment rate update occur every 3 years. As such,
the second data collection period for CDLTs that are not ADLTs occurred
from January 1, 2019 through June 30, 2019, and the next data reporting
period was scheduled to take place from January 1, 2020 through March
31, 2020, with the next update to the Medicare payment rates for these
tests based on that reported applicable information scheduled to take
effect as of January 1, 2021.
Section 216(a) of PAMA established a new subcategory of CDLTs known
as ADLTs, with separate reporting and payment requirements under
section 1834A of the Act. As defined in Sec. 414.502, an ADLT is a
CDLT covered under Medicare Part B that is offered and furnished only
by a single laboratory, and cannot be sold for use by a laboratory
other than the single laboratory that designed the test or a successor
owner. Also, an ADLT must meet either Criterion (A), which implements
section 1834A(d)(5)(A) of the Act, or Criterion (B), which
[[Page 50210]]
implements section 1834A(d)(5)(B) of the Act, as follows:
Criterion (A): The test is an analysis of multiple
biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or
proteins; when combined with an empirically derived algorithm, yields a
result that predicts the probability a specific individual patient will
develop a certain condition(s) or respond to a particular therapy(ies);
provides new clinical diagnostic information that cannot be obtained
from any other test or combination of tests; and may include other
assays; or:
Criterion (B): The test is cleared or approved by FDA.
Generally, under section 1834A(d) of the Act, the Medicare payment
rate for a new ADLT is equal to its actual list charge during an
initial period of 3 calendar quarters. After the new ADLT initial
period, ADLTs are paid using the same methodology based on the weighted
median of private payor rates as other CDLTs. However, under section
1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs
occur annually instead of every 3 years.
Additional information on the private payor rate-based CLFS is
detailed in the CLFS final rule (81 FR 41036 through 41101) and is
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.html.
3. Statutory Revisions to the Data Reporting Period and Phase-In of
Payment Reductions
Section 105(a) of the Further Consolidated Appropriations Act, 2020
(FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718
of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES
Act) (Pub. L. 116-136, enacted on March 27, 2020), made revisions to
the CLFS requirements for the next data reporting period for CDLTs that
are not ADLTs under section 1834A of the Act. Additionally, the CARES
Act made revisions to the phase-in of payment reductions under section
1834A of the Act. Specifically, section 105(a)(1) of the FCAA amended
the data reporting requirements in section 1834A(a) of the Act to delay
the next data reporting period for CDLTs that are not ADLTs by 1 year,
so that data reporting would be required during the period of January
1, 2021 through March 31, 2021; the 3-year data reporting cycle for
CDLTs that are not ADLTs would resume after that data reporting period.
Section 105(a)(1) of the FCAA also specified that the data collection
period that applies to the data reporting period of January 1, 2021
through March 30, 2021 would be the period of January 1, 2019 through
June 30, 2019, which is the same data collection period that would have
applied absent the amendments. In addition, section 105(a)(2) of the
FCAA amended section 1834A(b)(3) of the Act regarding the phase-in of
payment reductions to provide that payments may not be reduced by more
than 10 percent as compared to the amount established for the preceding
year through CY 2020, and for CYs 2021 through 2023, payment may not be
reduced by more than 15 percent as compared to the amount established
for the preceding year. These statutory changes were consistent with
our regulations implementing the private payor rate-based CLFS (81 FR
41036; Sec. 414.507(d)).
Subsequently, section 3718 of the CARES Act further amended the
data reporting requirements for CDLTs that are not ADLTs and the phase-
in of payment reductions under the CLFS. Specifically, section 3718(a)
of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the
next data reporting period for CDLTs that are not ADLTs by one
additional year, to require data reporting during the period of January
1, 2022 through March 31, 2022. As amended by the CARES Act, section
1834A(a)(1)(B) of the Act now provides that in the case of reporting
with respect to CDLTs that are not ADLTs, the Secretary shall revise
the reporting period under subparagraph (A) such that--(i) no reporting
is required during the period beginning January 1, 2020, and ending
December 31, 2021; (ii) reporting is required during the period
beginning January 1, 2022, and ending March 31, 2022; and (iii)
reporting is required every 3 years after the period described in
clause (ii).
The CARES Act does not modify the data collection period that
applies to the next data reporting period for these tests. Thus, under
section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of
the FCAA, the next data reporting period for CDLTs that are not ADLTs
(January 1, 2022 through March 31, 2022) will be based on the data
collection period of January 1, 2019 through June 30, 2019. In Sec.
414.502, the current definition of data collection period is defined as
the 6 months from January 1 through June 30 during which applicable
information is collected and that precedes the data reporting period.
Additionally, in Sec. 414.502 the data reporting period is defined as
the 3-month period, January 1 through March 31, during which a
reporting entity reports applicable information to CMS and that follows
the preceding data collection period. Unless we revise our current
definitions of data collection period and data reporting period, the
definitions will be incorrect with regard to the data collection period
that applies to the next data reporting period. Therefore, in section
III.A.4. of this proposed rule, ``Proposed Conforming Regulatory
Changes,'' we are proposing to revise the definitions of data
collection period and data reporting period in Sec. 414.502 to reflect
that the data collection period will be January 1, 2019 through June
30, 2019 for the data reporting period of January 1, 2022 through March
31, 2022.
Section 3718(b) of the CARES Act further amends the provisions in
section 1834A(b)(3) of the Act regarding the phase-in of payment
reductions under the CLFS. First, it extends the statutory phase-in of
payment reductions resulting from private payor rate implementation by
an additional year, that is, through CY 2024. It further amends section
1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent
for CY 2021 is 0 percent, meaning that the payment amount determined
for a CDLT for CY 2021 shall not result in any reduction in payment as
compared to the payment amount for that test for CY 2020. Section
3718(b) of the CARES Act further amends section 1834A(b)(3)(B)(iii) of
the Act to state that the applicable percent of 15 percent will apply
for CYs 2022 through 2024, instead of CYs 2021 through 2023.
4. Proposed Conforming Regulatory Changes
In accordance with section 105(a) of the FCAA and section 3718 of
the CARES Act, we are proposing to make certain conforming changes to
the data reporting and payment requirements at 42 CFR part 414, subpart
G. Specifically, we are proposing to revise Sec. 414.502 to update the
definitions of both the data collection period and data reporting
period, specifying that for the data reporting period of January 1,
2022 through March 31, 2022, the data collection period is January 1,
2019 through June 30, 2019. We are also proposing to revise Sec.
414.504(a)(1) to indicate that initially, data reporting begins January
1, 2017 and is required every 3 years beginning January 2022. In
addition, we are proposing to make conforming changes to our
requirements for the phase-in of payment reductions to reflect the
CARES Act amendments. Specifically, we are proposing to revise Sec.
414.507(d) to indicate that for CY 2021, payment may not be reduced by
[[Page 50211]]
more than 0.0 percent as compared to the amount established for CY
2020, and for CYs 2022 through 2024, payment may not be reduced by more
than 15 percent as compared to the amount established for the preceding
year.
5. Comment Solicitation on Payment for Specimen Collection for COVID-19
Clinical Diagnostic Tests
In the ``Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' interim
final with comment period (IFC) (85 FR 19256 through 19258), which
published in the April 6, 2020 Federal Register, we established that
Medicare will pay a nominal specimen collection fee and associated
travel allowance to independent laboratories for the collection of
specimens for COVID-19 clinical diagnostic laboratory testing for
homebound and non-hospital inpatients. This policy provides independent
laboratories with additional resources to provide COVID-19 testing and
helps with efforts to limit patients' exposure to the general
population and alleviate patients' unease with leaving the home. To
identify specimen collection for COVID-19 testing specifically, we
established two new level II HCPCS codes, Code G2023 (specimen
collection for severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) (Coronavirus disease [COVID-19]), any specimen source); and
G2024 (specimen collection for severe acute respiratory syndrome
coronavirus 2 (SARS-Cov-2) (Coronavirus disease [COVID-19]), from an
individual in a SNF or by a laboratory on behalf of a HHA, any specimen
source), for independent laboratories to use when billing Medicare for
the nominal specimen collection fee for COVID-19 testing for the
duration of the COVID-19 PHE.
We indicated in the April 6, 2020 IFC that this specimen collection
fee policy was established for the duration of the Public Health
Emergency (PHE) for the COVID-19 pandemic (85 FR 19256). We are
requesting comments on whether we should delete HCPCS Codes G2023 and
G2024 once the COVID-19 PHE ends. Comments received may inform a future
proposal. Specifically, we are seeking public input on why these codes,
and their corresponding payment amounts, which are higher than the
nominal fees for specimen collection for other conditions, would be
necessary or useful outside of the context of the PHE. We are
particularly interested in why separate, increased payment for specimen
collection specifically for COVID-19 tests, in contrast to other tests,
might be needed following the end of the PHE.
B. OTP Provider Enrollment Regulation Updates for Institutional Claim
Submissions
1. Modifications to OTP Enrollment Process
a. Background
Under 42 CFR 424.510, a provider or supplier must complete, sign,
and submit to its assigned Medicare Administrative Contractor (MAC) the
Form CMS-855 (OMB Control No. 0938-0685) application to enroll in the
Medicare program and obtain Medicare billing privileges. The Form CMS-
855, which can be submitted via paper or electronically through the
internet-based Provider Enrollment, Chain, and Ownership System (PECOS)
process (SORN: 09-70-0532, Provider Enrollment, Chain, and Ownership
System), captures information about the provider or supplier that CMS
or its MACs reviews and verifies to determine whether the provider or
supplier meets all Medicare requirements. (The specific Form CMS-855
application (of which there are several variations) to be completed
will depend upon the type of provider or supplier submitting said
application.) This process of enrollment helps ensure that: (1) All
prospective providers and suppliers are carefully screened and vetted;
and (2) unqualified providers and suppliers are kept out of the
Medicare program, which helps protect the Trust Funds and Medicare
beneficiaries. Indeed, without this process, billions of taxpayer
dollars might be paid to fraudulent or otherwise non-compliant parties.
b. Completion of Form CMS-855
Existing Sec. 424.67 outlines a number of enrollment requirements
for OTPs. One requirement, addressed in Sec. 424.67(b)(1), is that
OTPs must complete the Form CMS-855B application (Medicare Enrollment
Application: Clinics/Group Practices and Certain Other Suppliers; OMB
#0938-0685) to enroll in Medicare. The reference to the Form CMS-855B
in Sec. 424.67(b)(1) was predicated in part on the assumption that
OTPs would generally submit the CMS-1500 claim form (Health Insurance
Claim Form; OMB Control No.: 0938-1197) to receive payment for their
services. However, as mentioned previously in section II.I.4. of this
proposed rule, we have received requests to allow OTPs to bill for
services on an institutional claim form (specifically, the 837I). To do
so, these OTPs would have to enroll in Medicare via the Form CMS-855A
(Medicare Enrollment Application for Institutional Providers (OMB
#0938-0685)). To account for circumstances where an OTP wishes to
pursue Form CMS-855A enrollment for the reason stated above, we propose
the following revisions to Sec. 424.67:
Current Sec. 424.67(b)(1) states that a newly enrolling
OTP must fully complete and submit the Form CMS-855B application (or
its successor application). We propose to revise this paragraph to
state that the newly enrolling OTP must fully complete and submit, as
applicable, the Form CMS-855A or Form CMS-855B application (or their
successor applications).
Existing Sec. 424.67(b)(1)(ii) requires the OTP to
certify compliance with the requirements and standards described in
paragraphs Sec. 424.67(b) and (d) via the Form CMS-855B and/or the
applicable supplement or attachment thereto. We propose to revise this
paragraph such that the OTP must certify compliance with the above-
referenced requirements and standards via the Form CMS-855A or Form
CMS-855B (as applicable) and/or the applicable supplement or attachment
thereto.
Existing Sec. 424.67(b)(5) requires the OTP to report on
the Form CMS-855B and/or any applicable supplement all OTP staff who
meet the definition of ``managing employee'' in Sec. 424.502. We
propose to change this to state that the OTP must report on the Form
CMS-855A or Form CMS-855B (as applicable) and/or any applicable
supplement all OTP staff who meet the said definition.
We believe these revisions would accomplish two objectives. First,
they would permit OTPs to submit a Form CMS-855A in lieu of a Form CMS-
855B based on their preferred method of billing. Second, they would
confirm that the requirements of Sec. 424.67 apply to all OTPs
regardless of whether they complete the Form CMS-855A or the Form CMS-
855B.
c. Screening Activities Associated With Risk Designation
Section 424.518 outlines provider enrollment screening categories
and requirements based on our assessment of the degree of risk of
fraud, waste, and abuse posed by a particular category of provider or
supplier. In general, the higher the level of risk that a certain
provider or supplier type presents, the greater the degree of scrutiny
with which we will screen and review enrollment applications submitted
by providers or suppliers within that category. There are three levels
of screening addressed in Sec. 424.518: Limited; moderate; and high.
[[Page 50212]]
Irrespective of which level a provider or supplier type falls within,
the MAC performs certain minimum screening functions upon receipt of an
initial enrollment application, a revalidation application, or an
application to add a new practice location. These include:
Verification that the provider or supplier meets all
applicable federal regulations and state requirements for their
provider or supplier type.
State license verifications.
Database reviews on a pre- and post-enrollment basis to
ensure that providers and suppliers continue to meet the enrollment
criteria for their provider or supplier type.
Providers and suppliers at the moderate and high categorical risk
levels must also undergo a site visit. Moreover, for those in the high
categorical risk level, the MAC performs two additional functions under
Sec. 424.518(c)(2). First, the MAC requires the submission of a set of
fingerprints for a national background check from all individuals who
maintain a 5 percent or greater direct or indirect ownership interest
in the provider or supplier. Second, it conducts a fingerprint-based
criminal history record check of the Federal Bureau of Investigation's
(FBI) Integrated Automated Fingerprint Identification System on all
individuals who maintain a 5 percent or greater direct or indirect
ownership interest in the provider or supplier. These additional
verification activities are intended to correspond to the heightened
risk involved with such provider or supplier types.
For newly enrolling OTPs, those that have been fully and
continuously certified by the Substance Abuse and Mental Health
Services Administration (SAMHSA) since October 23, 2018 fall within the
moderate level of categorical screening. OTPs that have not been so
certified since the aforementioned date are subject to the high
screening level. We recognize that certain providers and suppliers have
already enrolled as OTPs via the Form CMS-855B--and, accordingly,
undergone a site visit and, if applicable, fingerprinting--but would
seek to newly enroll via the Form CMS-855A should our proposals be
finalized. (Said enrollment would be considered ``new'' for purposes of
enrollment because the OTP would be enrolling via a different variation
of the Form CMS-855.) While not seeking to minimize the importance of
the enhanced screening activities associated with the moderate and high
categorical levels, we do not wish to unduly burden currently enrolled
OTPs that would pursue Form CMS-855A enrollment as an OTP. More
specifically, we do not believe such OTPs should have to undergo
another site visit and, if applicable, fingerprinting when they
previously did so as an OTP via their original Form CMS-855B
enrollment. This, in our view, would constitute an unnecessary
expenditure of CMS, MAC, and OTP resources. We add that the same would
hold true if, in the future, an OTP that is enrolled via the Form CMS-
855A under revised Sec. 424.67(b) decides to change to a Form CMS-855B
enrollment. In both cases, we believe a duplication of effort should be
avoided to the extent consistent with safeguarding the integrity of the
Medicare program.
Existing Sec. 424.67(b)(3) states that an enrolling OTP must
successfully complete the assigned categorical risk level screening
required under, as applicable, Sec. 424.518(b) and (c) (which outline
the screening requirements for newly enrolling parties in,
respectively, the moderate and high categorical levels). Given the
foregoing discussion, we propose several changes to Sec. 424.67(b)(3).
First, we would re-designate existing Sec. 424.67(b)(3) as new Sec.
424.67(b)(3)(i), though with an exception to its requirements. Second,
new paragraph (b)(3)(ii) (which would address this exception) would
state that currently enrolled OTPs that are changing their OTP
enrollment from a Form CMS-855B to a Form CMS-855A, or vice versa, must
successfully complete the limited level of categorical screening under
Sec. 424.518(a) if the OTP has already completed, as applicable, the
moderate or high level of categorical screening under Sec. 424.518(b)
or (c), respectively. Third, we propose to redesignate existing Sec.
424.518(a)(1)(xii) through (xvii) as Sec. 424.518(a)(1)(xiii) through
(xviii). Fourth, new Sec. 424.518(a)(1)(xii) would add OTPs that fall
within the purview of new paragraph (b)(3)(ii) to the provider and
supplier types subject to limited risk categorical screening.
d. Additional OTP Enrollment Clarifications Regarding the Form CMS-855A
We propose three additional clarifications related to our
previously mentioned OTP enrollment provisions. To incorporate these
into Sec. 424.67, we would redesignate existing paragraphs (c), (d),
(e), and (f) as paragraphs (d), (e), (f), and (g), respectively. The
three clarifications would be included in new paragraph (c).
With the redesignation of existing paragraph (d) as paragraph (e),
we also propose to change the reference to:
Paragraph (d) in existing paragraph (b)(1)(ii) to
paragraph (e).
Paragraph (d)(1) in existing paragraph (d)(2)(i) to
paragraph (e)(1) in redesignated paragraph (e)(2)(i).)
(1) Single Enrollment
We propose in new Sec. 424.67(c)(1) that an OTP may only be
enrolled as such via the Form CMS-855A or the Form CMS-855B but not
both. The OTP, in other words, must opt for either Form CMS-855A
enrollment or Form CMS-855B enrollment. This is to help ensure that the
OTP does not bill twice for the same service via separate claim
vehicles (specifically, the CMS-1500 and the 837I).
(2) Effective Date of Billing
Section 424.520(d) outlines the effective date of billing
privileges for newly enrolling OTPs (and certain other provider and
supplier types). This date is the later of: (1) The date of the OTP's
filing of a Medicare enrollment application that was subsequently
approved by a Medicare contractor; or (2) the date that the OTP first
began furnishing services at a new practice location. In a similar
vein, Sec. 424.521(a) states that OTPs (and certain other provider and
supplier types) may retrospectively bill for services when the OTP has
met all program requirements (including state licensure requirements),
and services were provided at the enrolled practice location for up
to--
30 days prior to their effective date if circumstances
precluded enrollment in advance of providing services to Medicare
beneficiaries; or
90 days prior to their effective date if a Presidentially-
declared disaster under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 through 5206 (Stafford Act)
precluded enrollment in advance of providing services to Medicare
beneficiaries.
In light of proposed Sec. 424.67(c)(1) (and as further explained
in the collection of information section of this proposed rule), we
anticipate that a number of OTPs would end their existing enrollment
and apply as a new OTP via, as applicable, the Form CMS-855A or Form
CMS-855B. Given this, we believe it is important to clarify for
stakeholders the new enrollment's effective date of billing.
Accordingly, at Sec. 424.67, we propose in new paragraph (c)(2) that
if a Form CMS-855B-enrolled OTP changes to a Form CMS-855A enrollment,
or vice versa, the effective date of billing that was established for
the OTP's prior enrollment under Sec. Sec. 424.520(d) and 424.521(a)
would be applied to the OTP's new enrollment. This would allow OTPs
that have been
[[Page 50213]]
unable to bill for furnished services via their preferred claim form
(and have consequently chosen to delay the submission of these claims
for services) to do so retroactive to the effective billing date of its
prior enrollment. To illustrate, suppose an OTP initially enrolled via
the Form CMS-855B in 2020. The effective date of billing was April 1,
2020. Wishing to submit an 837I claim form for the services it has
provided since April 1, 2020 the OTP elects to end its Form CMS-855B
enrollment and enroll via the Form CMS-855A pursuant to revised Sec.
424.67. It successfully does the latter in March 2021. Under Sec.
424.67(c)(2), the billing effective date of the Form CMS-855A
enrollment would be retroactive to April 1, 2020. We note, however,
that the time limits for filing claims found in Sec. 424.44 would
continue to apply. Specifically, all Medicare Part A and Part B claims
must be filed within 1 calendar year after the date of service unless
one of a very limited number of exceptions applies. Switching from a
Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa,
is not grounds for an exception.
We recognize, of course, that not every OTP that seeks to change
its enrollment will have chosen to withhold submission of all of its
claims under its prior enrollment. (Using our example in the previous
paragraph, the OTP may have submitted some claims via the CMS-1500
while planning to eventually submit the remaining ones via the 837I.)
Irrespective of this, CMS has long had operational safeguards in place
to prevent double-billing for the same service. Said protections would
be used in the scenario described in proposed Sec. 424.67(c)(2) so
that claims submitted under the prior enrollment could not be
resubmitted under the new one.
(3) Application Fee
As stated in Sec. 424.514, prospective and revalidating
institutional providers that are submitting a Medicare enrollment
application generally must pay the applicable application fee in
accordance with Sec. 424.514. (For CY 2020, the fee amount is $595.)
We define the term ``institutional provider'' in Sec. 424.502 as any
provider or supplier that submits a paper Medicare enrollment
application using the Form CMS-855A, Form CMS-855B (not including
physician and non-physician practitioner organizations, which are
exempt from the fee requirement if they are enrolling as a physician or
non-physician practitioner organization), Form CMS-855S, Form CMS-
20134, or an associated internet-based PECOS enrollment application.
We have already noted that OTPs currently complete the Form CMS-
855B to enroll in Medicare. They are considered ``institutional
providers'' (as defined in Sec. 424.502) and must pay an application
fee, a requirement addressed in existing Sec. 424.67(b)(2). Since the
existing OTPs referenced in new paragraph (c)(2) would, as stated
previously, be enrolling as new providers via the Form CMS-855A or Form
CMS-855B (as applicable), we believe they would fall within the scope
of both (1) the aforementioned definition of ``institutional provider''
and (2) Sec. 424.514(a)(1); as described therein, Sec. 424.514(a)(1)
applies to prospective institutional providers that are submitting an
initial application. To clarify this issue for the OTP community, we
propose to add language to Sec. 424.67(b)(2) stating that compliance
with the application fee requirements in Sec. 424.514 would also apply
to those OTPs enrolling under the circumstances described in Sec.
424.67(c)(2).
We emphasize that the flexibilities described in this section
III.B. are complementary to those in section II.I. (``Medicare Coverage
for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid
Treatment Programs (OTPs))'' regarding OTP billing via the 837I. Our
OTP enrollment revisions are intended to facilitate greater flexibility
for OTPs should the proposals in section II.I. be finalized.
C. Payment for Principal Care Management (PCM) Services in Rural Health
Centers (RHCs) and Federally Qualified Health Centers (FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
RHC and FQHC visits generally are face-to-face encounters between a
patient and one or more RHC or FQHC practitioners during which time one
or more RHC or FQHC qualifying services are furnished. RHC and FQHC
practitioners are physicians, nurse practitioners (NPs), physician
assistants (PA), certified nurse midwives (CNMs), clinical
psychologists (CPs), and clinical social workers, and under certain
conditions, a registered nurse or licensed practical nurse furnishing
care to a homebound RHC or FQHC patient. A Transitional Care Management
(TCM) service can also be an RHC or FQHC visit. In addition, a Diabetes
Self-Management Training (DSMT) service or a Medical Nutrition Therapy
(MNT) service furnished by a certified DSMT or MNT program may also
count as an FQHC visit. Only medically necessary medical, mental
health, or qualified preventive health services that require the skill
level of an RHC or FQHC practitioner are RHC or FQHC billable visits.
Services furnished by auxiliary personnel (for example, nurses, medical
assistants, or other clinical personnel acting under the supervision of
the RHC or FQHC practitioner) are considered incident to the visit and
are included in the per visit payment.
RHCs are paid an all-inclusive rate (AIR) for all medically
necessary medical and mental health services and qualified preventive
health services furnished on the same day (with some exceptions). In
general, the A/B Medicare Administrative Contractor (MAC) calculates
the AIR for the year for each RHC by dividing total allowable costs by
the total number of visits for all patients. Productivity, payment
limits, and other factors are also considered in the calculation.
Allowable costs must be reasonable and necessary and may include
practitioner compensation, overhead, equipment, space, supplies,
personnel, and other costs incident to the delivery of RHC services.
The AIR is subject to a payment limit, except for certain provider-
based RHCs that have an exception to the payment limit.
FQHCs were paid under the same AIR methodology until October 1,
2014, when, in accordance with section 1834(o) of the Act (as added by
section 10501(i)(3) of the Affordable Care Act), they began to
transition to an FQHC PPS system in which they are paid based on the
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate
is adjusted for geographic differences in the cost of services by the
FQHC PPS geographic adjustment factor (GAF).
b. Care Management Services in RHCs and FQHCs
In the CY 2018 final rule with comment period (83 FR 59683), we
finalized revisions to the payment methodology for Chronic Care
Management (CCM) services furnished by RHCs and FQHCs and established
requirements for general Behavioral Health Integration (BHI) and
psychiatric Collaborative Care Management (CoCM) services furnished in
RHCs and FQHCs, beginning on January 1, 2019. Specifically, we revised
Sec. 405.2464(c) to permit RHCs and FQHCs to bill for care management
services (HCPCS codes G0511 and G0512).
HCPCS code, G0511, is a General Care Management code for use by
RHCs or FQHCs when at least 20 minutes of qualified CCM or general BHI
services are furnished to a patient in a calendar month.
[[Page 50214]]
The payment amount for HCPCS code G0511 is set at the average of
the 3 national non-facility PFS payment rates for the CCM and general
BHI codes and updated annually based on the PFS amounts. The 3 codes
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60
minutes or more of complex CCM services), and CPT 99484 (20 minutes or
more of BHI services).
In the CY 2019 final rule with comment period, we added CPT code
99491 (30 minutes or more of CCM furnished by a physician or other
qualified health care professional) as a general care management
service and included it in the calculation of HCPCS code G0511.
Beginning January 1, 2019, the payment for HCPCS code G0511 is set at
the average of the national non-facility PFS payment rates for CPT
codes 99490, 99487, 99484, and 99491 and is updated annually based on
the PFS amounts. Additional information on CCM requirements is
available on the CMS Care Management web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html, and on the CMS RHC and FQHC web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and
https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
2. Proposed Requirements for PCM Services in RHCs and FQHCs
In the CY 2020 PFS final rule with comment (84 FR 62692), we
established a separate payment for PCM services. PCM services include
comprehensive care management services for a single high-risk disease
or complex condition, typically expected to last at least 3 months and
may have led to a recent hospitalization, and/or placed the patient at
significant risk of death. Beginning January 1, 2020, practitioners
billing under the PFS can bill for PCM services using HCPCS codes G2064
or G2065.
HCPCS code G2064 is for at least 30 minutes of PCM services
furnished by physicians or non-physicians during a calendar month with
the following elements: One complex chronic condition lasting at least
3 months, which is the focus of the care plan, the condition is of
sufficient severity to place patient at risk of hospitalization or have
been the cause of a recent hospitalization, the condition requires
development or revision of disease-specific care plan, the condition
requires frequent adjustments in the medication regimen, and/or the
management of the condition is unusually complex due to comorbidities.
HCPCS code G2065 is for at least 30 minutes of PCM services
furnished by clinical staff under the direct supervision of a physician
or non-physician practitioner with the following elements: One complex
chronic condition lasting at least 3 months, which is the focus of the
care plan, the condition is of sufficient severity to place patient at
risk of hospitalization or have been cause of a recent hospitalization,
the condition requires development or revision of disease-specific care
plan, the condition requires frequent adjustments in the medication
regimen, and/or the management of the condition is unusually complex
due to comorbidities.
A national stakeholder organization representing rural health
clinics has requested that RHCs be allowed to furnish and bill for PCM
services. We agree that there can be significant resources involved in
care management for a single high risk disease or complex chronic
condition, and that the requirements for the new PCM codes are similar
to the requirements for the care management services described by HCPCS
code G0511. These are services that do not currently meet the
requirements for an RHC or FQHC billable visit, and they provide an
array of care management services that are not generally included in
the RHC AIR or the FQHC PPS. Therefore, we are proposing to add HCPCS
codes G2064 and G2065 to G0511 as a comprehensive care management
service for RHCs and FQHCs starting January 1, 2021. The payment rate
for HCPCS G0511 is the average of the national non-facility PFS payment
rate for the RHC and FQHC care management and general behavioral health
codes (CPT codes 99490, 99487, 99484, and 99491), and we propose that
these 2 new codes be added to the calculation of the G0511 payment
rate.
3. Other Options Considered
We also considered creating a separate G code for PCM services. We
did not choose this approach because PCM and CCM are similar services
and grouping them together is consistent with an integrated approach to
care with reduced reporting requirements. As we stated in the CY 2018
PFS final rule, if a new care management code is proposed and
subsequently finalized for practitioners billing under the PFS, we
would review the new code to determine if it should be included in the
calculation of the RHC and FQHC General Care Management Code. The
determination of whether a new care management code should be added to
the codes used to determine the payment rate is based on the
applicability of the service in RHCs and FQHCs, and may result in
either an increase or decrease in the payment amount for HCPCS code
G0511.
4. Implementation
If this proposal is finalized as proposed, RHCs and FQHCs that
furnish qualified PCM services would also be able to bill the services
using HCPCS code G0511, either alone or with other payable services on
an RHC or FQHC claim for dates of service on or after January 1, 2021.
The payment rate for HCPCS code G0511 would continue to be the average
of the national non-facility PFS payment rates for the RHC/FQHC care
management and general behavioral health codes (CPT codes 99484, 99487,
99490, and 99491). HCPCS G2064 and G2065 would be added to G0511 to
calculate a new average for the national non-facility PFS payment rate.
The payment rate for HCPCS code G0511 would be updated annually based
on the PFS amounts for these codes.
D. Changes to the Federally Qualified Health Center Prospective Payment
System (FQHC PPS) for CY 2021: Proposed Rebasing and Revising of the
FQHC Market Basket
1. Background
Section 10501(i)(3)(A) of the Affordable Care Act added section
1834(o) of the Act to establish a payment system for the costs of FQHC
services under Medicare Part B based on prospectively set rates. In the
Prospective Payment System (PPS) for FQHC final rule published in the
May 2, 2014 Federal Register (79 FR 25436), we implemented a
methodology and payment rates for the FQHC PPS. Beginning on October 1,
2014, FQHCs began to transition to the FQHC PPS based on their cost
reporting periods, and as of January 1, 2016, all FQHCs are paid under
the FQHC PPS.
Section 1834(o)(2)(B)(ii) of the Act requires that the payment for
the first year after the implementation year be increased by the
percentage increase in the Medicare Economic Index (MEI). Therefore, in
CY 2016, the FQHC PPS base payment rate was increased by the MEI. The
MEI is based on 2006 data from the American Medical Association (AMA)
for self-employed physicians and was used in the PFS sustainable growth
rate (SGR) formula to determine the conversion factor for physician
service payments. (See the CY 2014 PFS
[[Page 50215]]
final rule (78 FR 74264) for a complete discussion of the 2006-based
MEI). Section 1834(o)(2)(B)(ii) of the Act also requires that beginning
in CY 2017, the FQHC PPS base payment rate will be increased by the
percentage increase in a market basket of FQHC goods and services, or
if such an index is not available, by the percentage increase in the
MEI.
Beginning with CY 2017, FQHC PPS payments were updated using a
2013-based market basket reflecting the operating and capital cost
structures for freestanding FQHC facilities (hereafter referred to as
the FQHC market basket). A complete discussion of the 2013-based FQHC
market basket can be found in the CY 2017 PFS final rule (81 FR 80393
through 80403).
For this CY 2021 PFS/FQHC proposed rule, we propose to rebase and
revise the 2013-based FQHC market basket to reflect a 2017 base year.
The proposed 2017-based FQHC market basket is primarily based on
Medicare cost report data for FQHCs for 2017, which are for cost
reporting periods beginning on and after October 1, 2016, and prior to
September 31, 2017. We propose to use data from cost reports beginning
in FY 2017 because these data are the latest available complete data
for purposes of calculating cost weights for the market basket at the
time of rulemaking.
In the following discussion, we provide an overview of the proposed
FQHC market basket, describe the proposed methodologies for developing
the operating and capital portions of the 2017-based FQHC market
basket, and provide information on the proposed price proxies. We then
present the CY 2021 market basket update based on the proposed 2017-
based FQHC market basket.
2. Overview of the 2017-Based FQHC Market Basket
Similar to the 2013-based FQHC market basket, the proposed 2017-
based FQHC market basket is a fixed-weight, Laspeyres-type price index.
A Laspeyres price index measures the change in price, over time, of the
same mix of goods and services purchased in the base period. Any
changes in the quantity or mix (that is, intensity) of goods and
services purchased over time are not measured. The index itself is
constructed using three steps. First, a base period is selected (in
this proposed rule, we propose to use 2017 as the base period) and
total base period expenditures are estimated for a set of mutually
exclusive and exhaustive spending categories, with the proportion of
total costs that each category represents being calculated. These
proportions are called ``cost weights'' or ``expenditure weights.''
Second, each expenditure category is matched to an appropriate price or
wage variable, referred to as a ``price proxy.'' In almost every
instance, these price proxies are derived from publicly available
statistical series that are published on a consistent schedule
(preferably at least on a quarterly basis). Finally, the expenditure
weight for each cost category is multiplied by the level of its
respective price proxy. The sum of these products (that is, the
expenditure weights multiplied by their price levels) for all cost
categories yields the composite index level of the market basket in a
given period. Repeating this step for other periods produces a series
of market basket levels over time. Dividing an index level for a given
period by an index level for an earlier period produces a rate of
growth in the input price index over that timeframe. As noted above,
the market basket is described as a fixed-weight index because it
represents the change in price over time of a constant mix (quantity
and intensity) of goods and services needed to furnish FQHC services.
The effects on total expenditures resulting from changes in the mix of
goods and services purchased subsequent to the base period are not
measured. For example, a FQHC hiring more nurse practitioners to
accommodate the needs of patients would increase the volume of goods
and services purchased by the FQHC, but would not be factored into the
price change measured by a fixed-weight FQHC market basket. Only when
the index is rebased would changes in the quantity and intensity be
captured, with those changes being reflected in the cost weights.
Therefore, we rebase the market basket periodically so that the cost
weights reflect a recent mix of goods and services that FQHCs purchase
(FQHC inputs) to furnish inpatient care.
3. Development of the 2017-Based FQHC Market Basket Cost Categories and
Weights
We are inviting public comments on our proposed methodology,
discussed below, for deriving the proposed 2017-based FQHC market
basket.
a. Use of Medicare Cost Report Data
We are proposing a 2017-based FQHC market basket that consists of
eleven major cost categories and a residual derived from the 2017
Medicare cost reports (CMS Form 224-14, OMB Control Number 0938-1298)
for FQHCs, hereafter referred to as the 2014 Medicare Cost Report form.
The eleven cost categories are FQHC Practitioner Wages and Salaries,
FQHC Practitioner Employee Benefits, FQHC Practitioner Contract Labor,
Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits,
Clinical Staff Contract Labor, Non-Health Staff Compensation, Medical
Supplies, Pharmaceuticals, Fixed Capital and Moveable Capital. The
residual category reflects all remaining costs not captured in the 11
cost categories such as non-medical supplies and utilities for example.
We note that for the 2013-based FQHC market basket, we estimated six
cost categories from the Medicare cost reports (CMS Form 222-92, OMB
Control Number 0938-0107), hereafter referred to as the 1992 Medicare
cost report form: FQHC Practitioner Compensation, Clinical Staff
Compensation, Non-Health Staff Compensation, Pharmaceuticals, Fixed
Capital and Moveable Capital.
The resulting 2017-based FQHC market basket cost weights reflect
Medicare allowable costs. We define Medicare allowable costs for
freestanding FQHC facilities as the total expenses reported on:
Worksheet A, Columns 1 and 2, lines 1 through 7 and lines 9 through 12;
Worksheet A, Column 1, lines 23 through 36; and Worksheet S3 Part II,
Columns 1 and 2, lines 2 through 14. We note that we continue to
exclude Professional Liability Insurance (PLI) costs from the total
Medicare allowable costs because FQHCs that receive section 330 grant
funds also are eligible to apply for medical malpractice coverage under
Federally Supported Health Centers Assistance Act (FSHCAA) of 1992
(Pub. L. 102-501) and FSHCAA of 1995 (Pub. L. 104-73 amending section
224 of the Public Health Service Act).
Below, we summarize how we derive the eleven major cost category
weights. Prior to estimating any costs, we remove any providers that
did not report any total gross patient revenues as reported on the FQHC
cost report Worksheet F-1, line 1, column 4.
(1) FQHC Practitioner Wages and Salaries Costs
A FQHC practitioner is defined as one of the following occupations:
Physicians; nurse practitioners (NPs); physician assistants (PAs);
certified-nurse midwife (CNMs); clinical psychologist (CPs); and
clinical social workers (CSWs). We propose to derive FQHC Practitioner
Wages and Salaries costs as the sum of direct care costs salaries as
reported on Worksheet A, column 1, lines 23, 25, 26, 29, 30, and 31.
These lines represent the wages and salaries costs for physicians, PAs,
NPs, CNMs, CPs, and CSWs. For the 2013-based FQHC market basket, we
[[Page 50216]]
estimated FQHC Practitioner Total Compensation costs based on a similar
methodology using cost data reported on Worksheet A of the 1992
Medicare cost report form (81 FR 80394) for specific details on the
prior methodology.
(2) FQHC Practitioner Employee Benefits Costs
Effective with the implementation of the 2014 Medicare cost report
form, we began collecting Employee Benefits and Contract Labor data on
Worksheet S-3, part II and propose to derive FQHC Practitioner Employee
Benefits costs using data obtained from that worksheet. Approximately
66 percent of FQHCs included in the sample of FQHCs reporting Salary
costs also reported data on Worksheet S-3, part II for 2017. We
continue to encourage all providers to report these data on the
Medicare cost report. Therefore, we propose to calculate FQHC
Practitioner Employee Benefits costs using Worksheet S-3, part II data.
Specifically, we propose to use data from Worksheet S-3, part II,
column 2, lines 2, 3, 4, 7, 8, and 9 to derive FQHC Practitioner
Employee Benefits costs. These lines represent the employee benefits
costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. Our analysis of
the Worksheet S-3, part II data submitted by these FQHCs indicates that
we had a large enough sample to enable us to produce a reasonable
Employee Benefits cost weight.
For the 2013-based FQHC market basket, we did not have data at the
level of detail to separately estimate FQHC Practitioner Employee
Benefits costs, and instead computed FQHC Practitioner Total
Compensation costs, which reflected costs for wages and salaries,
employee benefits, and contract labor together. Anytime direct costs
can be obtained for a cost category directly from the Medicare Cost
Reports we consider that to be a technical improvement to the market
basket weight methodology as it allows the index to reflect the
relative shares specific to the provider type. Therefore, we believe
this proposed method of separately estimating FQHC Practitioner
Employee Benefits is a technical improvement over the 2013-based FQHC
market basket.
(3) FQHC Practitioner Contract Labor Costs
FQHC Practitioner Contract labor costs are primarily associated
with direct patient care services. Contract labor costs for services
such as accounting, billing, and legal are estimated using other
government data sources as described below. Approximately 60 percent of
FQHCs reported contract labor costs on Worksheet S-3, part II, which we
believe is an adequate sample size to enable us to produce a reasonable
FQHC Practitioner Contract Labor cost weight. Therefore, we propose to
derive the FQHC Practitioner Contract Labor costs for the proposed
2017-based FQHC market basket from data reported on Worksheet S-3, part
II, column 1, lines 2, 3, 4, 7, 8, and 9. These lines represent the
contract labor costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. We
also add in the costs for physician services under agreement as
reported on Worksheet A, column 2, line 24 to derive the total FQHC
Practitioner Contract Labor cost weight in the proposed 2017-based FQHC
market basket.
For the 2013-based FQHC market basket, we did not have data at the
level of detail to separately estimate FQHC Practitioner Contract Labor
costs and instead computed FQHC Practitioner Total Compensation costs,
which reflected costs for wages and salaries, employee benefits, and
contract labor together. As noted previously, anytime direct costs can
be obtained for a cost category directly from the Medicare Cost Reports
we consider that to be a technical improvement to the market basket
weight methodology as it allows the index to reflect the relative
shares specific to the provider type. Therefore, we believe this
proposed method of separately estimating FQHC Practitioner Contract
Labor is a technical improvement over the 2013-based FQHC market
basket.
(4) Clinical Staff Wages and Salaries Costs
Clinical Compensation includes any health-related clinical staff
who does not fall under the definition of a FQHC Practitioner described
in paragraph. We propose to derive Clinical Staff Wages and Salaries
costs as the sum of direct care costs salaries as reported on Worksheet
A, column 1, lines 27, 28, 32, 33, 34, 35, and 36. These lines
represent the wages and salaries costs for visiting registered nurses
(RNs), visiting licensed practical nurses (LPNs), laboratory
technicians, registered dietician/Certified DSMT/MNT educators,
physical therapists (PTs), occupational therapists (OTs), and other
allied health personnel.
For the 2013-based FQHC market basket, we estimated a
clinical staff total compensation cost based on a similar methodology
using cost data reported on Worksheet A of Medicare Cost Report form
CMS-222-92, (see 81 FR 80394 for specific details on the prior
methodology).
(5) Clinical Staff Employee Benefits Costs
Effective with the implementation of the 2014 Medicare cost report
form, we began collecting employee benefits and contract labor data on
Worksheet S-3, part II and propose to derive clinical staff employee
benefits costs using data obtained from that worksheet. Approximately
64 percent of FQHCs included in the sample of FQHCs reporting salary
expenses also reported data on Worksheet S-3, part II for 2017. We
continue to encourage all providers to report these data on the
Medicare cost report. Therefore, we propose to calculate clinical staff
employee benefits costs using Worksheet S-3, part II, column 2, lines
5, 6, 10, 11, 12, 13, and 14. These lines represent the employee
benefits costs for visiting RNs, visiting LPNs, laboratory technicians,
registered dietician/Certified DSMT/MNT educators, PTs, OTs, and other
allied health personnel.
For the 2013-based FQHC market basket, we did not have
data at the level of detail to separately estimate clinical staff
employee benefits costs and instead computed clinical staff total
compensation costs, which reflected costs for wages and salaries,
employee benefits, and contract labor together. We believe this
proposed method of separately estimating clinical staff employee
benefits is a technical improvement over the 2013-based FQHC market
basket.
(6) Clinical Staff Contract Labor Costs
We propose to derive the clinical staff contract labor costs for
the proposed 2017-based FQHC market basket from data reported on
Worksheet S-3, part II, column 1, lines 5, 6, 10, 11, 12, 13, and 14 to
derive clinical staff contract labor costs. These lines represent the
contract labor costs for visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel.
For the 2013-based FQHC market basket, we did not have data at the
level of detail to separately estimate clinical staff contract labor
costs and instead computed clinical staff total compensation costs,
which reflected costs for wages and salaries, employee benefits, and
contract labor together. We believe this proposed method of separately
estimating FQHC clinical staff contract labor is a technical
improvement over the 2013-based FQHC market basket.
[[Page 50217]]
(7) Non-Health Staff Compensation Costs
Non-Health Staff Compensation includes wage and salary costs for
personnel in general service cost centers including: Employee Benefits
department; Administrative & General; Plant Operation & Maintenance;
Janitorial; Medical Records; Pharmacy; Transportation; and Other
General Services. Specifically, non-health staff compensation costs are
derived as the sum of compensation costs as reported on Worksheet A,
column 1 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12. Additionally, we
add a portion of employee benefit costs reported on Worksheet A, line
3, column 2 accounting for the non-health staff. We estimate the ratio
of non-health staff related wages and salaries as a percentage of total
wages and salaries. We then apply the percentage of non-health staff
related wages and salary costs to the total employee benefits costs
(Worksheet A, line 3, column 2) for each FQHC. We believe this is a
reasonable estimate of non-health staff employee benefits. We propose
to only use the costs from column 1 for most of the general service
cost centers other than employee benefits since we believe that there
are noncompensation costs reported in column 2 (such as maintenance and
janitorial supplies). The remaining other costs for the general service
categories are reflected in the remaining proposed cost categories as
explained in more detail below.
(8) Pharmaceuticals Costs
We propose to calculate pharmaceuticals costs using the non-salary
costs for the pharmacy cost center reported on Worksheet A, column 2,
line 9. We propose to exclude the costs for drugs charged to patients
as reported on Worksheet A, line 67 since these drugs are not included
in the Medicare allowable costs for the FQHC PPS and are separately
reimbursed. For the 2013-based FQHC market basket we were not able to
exclude non-reimbursable drug costs (such as drugs charged to patient
costs) from the pharmacy cost weight as the 1992 Medicare cost report
form did not capture these costs separately. We believe our proposed
methodology is a technical improvement as it is more consistent with
the FQHC PPS reimbursement.
(9) Medical Supplies
We propose to calculate medical supplies costs using the non-salary
costs for the medical supplies cost center reported on Worksheet A,
column 2, line 10. The medical supplies cost weight for the 2013-based
FQHC market basket was derived based on the relative share of the
medical supply costs in the MEI since these costs were not separately
reported on the 1992 Medicare cost report form (81 FR 80395 through
80396). Since these costs are now directly reported by FQHC providers
we believe the proposed method is a technical improvement to the method
used in the 2013-based FQHC market basket.
(10) Fixed Capital
We propose that fixed capital costs be equal to costs reported on
Worksheet A, line 1, column 2 of the Medicare Cost Report. A similar
methodology was used for the 2013-based FQHC market basket.
(11) Moveable Capital Costs
We propose that moveable capital costs be equal to the capital
costs as reported on Worksheet A, line 2, column 2. A similar
methodology was used for the 2013-based FQHC market basket.
b. Proposed Major Cost Category Computation
After we derive costs for the major cost categories for each
provider using the Medicare cost report data as previously described,
we propose to trim the data for outliers. For each of the eleven major
cost categories, we first are proposing to divide the calculated costs
for the category by total Medicare allowable costs calculated for the
provider to obtain cost weights for the universe of FQHC providers. For
the 2017-based FQHC market basket (similar to the 2013-based FQHC
market basket), we propose that total Medicare allowable costs would be
equal to the total costs as reported on Worksheet A, Columns 1 and 2,
lines 1 through 7 and lines 9 through 12; Worksheet A, Column 1, lines
23 through 36; and Worksheet S3 Part II, Columns 1 and 2, lines 2
through 14.
For the FQHC Practitioner Wages and Salaries, FQHC Practitioner
Employee Benefits, FQHC Practitioner Contract Labor, Clinical Staff
Wages and Salaries, Clinical Staff Employee Benefits, Clinical Staff
Contract Labor, Non-Health Staff Compensation, Pharmaceuticals, Medical
Supplies, Fixed Capital, and Moveable Capital cost weights, after
excluding cost weights that are less than or equal to zero, we propose
to then remove those providers whose derived cost weights fall in the
top and bottom 5 percent of provider-specific derived cost weights to
ensure the exclusion of outliers. A 5 percent trim is the standard trim
applied to the mean cost weights in all CMS market baskets and is
consistent with the trimming used in the 2013-based FQHC market basket.
After the outliers have been excluded, we sum the costs for each
category across all remaining providers. We then are proposing to
divide this by the sum of total Medicare allowable costs across all
remaining providers to obtain a cost weight for the 2017-based FQHC
market basket for the given category. This trimming process is done for
each cost weight separately.
Finally, we propose to calculate the residual ``All Other'' cost
weight that reflects all remaining costs that are not captured in the
eleven major cost categories listed. We refer readers to Table 31 for
the resulting proposed cost weights for these major cost categories.
[[Page 50218]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.065
The total compensation cost weight of 71.6 percent (sum of FQHC
Practitioner Compensation, Clinical Compensation, Non-health Staff
Compensation) calculated from the Medicare cost reports for the
proposed 2017-based FQHC market basket is approximately 3.0 percentage
point higher than the total compensation cost weight for the 2013-based
FQHC market basket (68.6 percent). The 2017-based cost weight for FQHC
Practitioners and Non-Health Staff are each about 2 percentage points
lower compared to the 2013-based FQHC market basket, while the clinical
staff compensation cost weight is about 7 percentage points higher.
Part of the reason for the shift in the weights between compensation
categories may be due to the change to the FQHC Medicare cost report
form. On the 1992 Medicare cost report form (used for the 2013-based
FQHC market basket), there were four open ended ``fill-in'' categories
for healthcare staff costs and costs under agreement. Since we were
unable to determine what specific category the ``other health care
staff'' costs should be allocated to (that is, either FQHC
practitioner, or clinical staff) we used a methodology where we applied
the expenses for the ``other health care staff costs'' between the
categories for FQHC practitioner and clinical staff, based on the
relative shares of expenses for both categories, excluding the open-
ended fill in lines of Worksheet A, lines 9-11 and line 15. This may
have resulted in an over allocation of some of the 2013 expenses to the
FQHC Practitioner category relative to the clinical staff. On the 2014
Medicare cost report form, there is no longer an ambiguous category for
other direct patient care staff costs.
The proposed 2017-based Pharmaceuticals cost weight is roughly 1.2
percentage points lower than the cost weight in the 2013-based FQHC
market basket. The pharmaceutical costs included in the weight for
2017-based FQHC market basket includes only non-salary costs reported
in Pharmacy (under general services) (Worksheet A, line 9, column 2 on
the 2014 Medicare cost report form). We believe the cost share is lower
with the new data because there is more specificity on where to report
reimbursable and non-reimbursable drugs.
As we did for the 2013-based FQHC market basket, we propose to
allocate the contract labor cost weight to the Wages and Salaries and
Employee Benefits cost weights based on their relative proportions
under the assumption that contract labor costs comprise both Wages and
Salaries and Employee Benefits for both FQHC Practitioners and Clinical
Staff. The contract labor allocation proportion for Wages and Salaries
is equal to the Wages and Salaries cost weight as a percent of the sum
of the Wages and Salaries cost weight and the Employee Benefits cost
weight. This rounded percentage is 82 percent for FQHC Practitioners
and 80 percent for clinical staff. Therefore, we propose to allocate 82
percent of the FQHC Practitioner Contract Labor cost weight to the FQHC
Practitioner Wages and Salaries cost weight and 18 percent to the FQHC
Practitioner Employee Benefits cost weight. Similarly, we propose to
allocate 80 percent of the clinical staff contract labor cost weight to
the Clinical Staff Wages and Salaries cost weight and 20 percent to the
clinical staff employee benefits cost weight. We refer readers to Table
32 that shows the proposed Wages and Salaries and Employee Benefits
cost weights after Contract Labor cost weight allocation for the
proposed 2017-based FQHC market basket.
[[Page 50219]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.066
c. Derivation of the Detailed Operating Cost Weights
To further divide the ``All Other'' residual cost weight of 15.5
percent estimated from the 2017 Medicare cost report data into more
detailed cost categories, we propose to use the 2012 Benchmark Input-
Output (I-O) ``Use Tables/Before Redefinitions/Purchaser Value'' for
NAICS 621100, Offices of Physicians, published by the Bureau of
Economic Analysis (BEA). We note that the BEA benchmark I-O data is
used to further disaggregate residual expenses in other CMS market
baskets. Therefore, we believe the data from this industry are the most
technically appropriate for disaggregation of the residual expenses
since both physician offices and FQHCs provide similar types of care.
These data are publicly available at https://www.bea.gov/industry/input-output-accounts-data. For the 2013-based FQHC market basket, we
used the relative shares of certain categories from the 2006-based MEI
(81 FR 80396).
The BEA Benchmark I-O data are scheduled for publication every 5
years with the most recent data available for 2012. The 2012 Benchmark
I-O data are derived from the 2012 Economic Census and are the building
blocks for BEA's economic accounts. Therefore, they represent the most
comprehensive and complete set of data on the economic processes or
mechanisms by which output is produced and distributed.\30\ BEA also
produces Annual I-O estimates. However, while based on a similar
methodology, these estimates reflect less comprehensive and less
detailed data sources and are subject to revision when benchmark data
becomes available. Instead of using the less detailed Annual I-O data,
we propose to inflate the 2012 Benchmark I-O data forward to 2017 by
applying the annual price changes from the respective price proxies to
the appropriate market basket cost categories that are obtained from
the 2012 Benchmark I-O data. We repeated this practice for each year.
We then calculated the cost shares that each cost category represents
of the 2012 data inflated to 2017. These resulting 2017 cost shares
were applied to the ``All Other'' residual cost weight to obtain the
detailed cost weights for the proposed 2017-based FQHC market basket.
For example, the cost for Medical Equipment represents 7.2 percent of
the sum of the ``All Other'' 2012 Benchmark I-O Offices of Physicians
Expenditures inflated to 2017. Therefore, the Medical Equipment cost
weight represents 7.2 percent of the proposed 2017-based FQHC market
basket's ``All Other'' cost category (15.5 percent), yielding a Medical
Equipment cost weight of 1.1 percent in the proposed 2017-based FQHC
market basket (0.072 x 15.5 percent = 1.1 percent).
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\30\ http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.
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Using this methodology, we propose to derive six detailed FQHC
market basket cost category weights from the proposed 2017-based FQHC
market basket residual cost weight (15.5 percent). These categories
are: (1) Utilities; (2) Medical Equipment; (3) Miscellaneous Products;
(4) Professional, Scientific, and Technical Services; (5)
Administrative Support and Waste Management Services; (6) All Other
Services. We note that for the 2013-based FQHC market basket, we had
Telephone and Postage cost weights. For the proposed 2017-based FQHC
market basket, we propose to include Telephone and Postage costs in the
Miscellaneous Products cost weight due to the small amount of costs in
this category (each were less than .05 percent).
d. Proposed 2017-Based FQHC Market Basket Cost Categories and Weights
Table 33 shows the proposed cost categories and weights for the
proposed 2017-based FQHC market basket compared to the 2013-based FQHC
market basket.
[[Page 50220]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.067
4. Selection of Price Proxies
After developing the cost weights for the proposed 2017-based FQHC
market basket, we selected the most appropriate wage and price proxies
currently available to represent the rate of price change for each
expenditure category. For the majority of the cost weights, we base the
price proxies on U.S. Bureau of Labor Statistics (BLS) data, as they
produce indexes that best meet the criteria of reliability, timeliness,
availability, and relevance, and group them into one of the following
BLS categories:
Employment Cost Indexes. Employment Cost Indexes (ECIs)
measure the rate of change in employment wage rates and employer costs
for employee benefits per hour worked. These indexes are fixed-weight
indexes and strictly measure the change in wage rates and employee
benefits per hour. ECIs are superior to Average Hourly Earnings (AHE)
as price proxies for input price indexes because they are not affected
by shifts in occupation or industry mix, and because they measure pure
price change and are available by both occupational group and by
industry. The industry ECIs are based on the North American Industry
Classification System (NAICS) and the occupational ECIs are based on
the Standard Occupational Classification System (SOC).
Producer Price Indexes. Producer Price Indexes (PPIs)
measure the average change over time in the selling prices received by
domestic producers for their output. The prices included in the PPI are
from the first commercial transaction for many products and some
services (https://www.bls.gov/ppi/).
Consumer Price Indexes. Consumer Price Indexes (CPIs)
measure the average change over time in the prices paid by urban
consumers for a market basket of consumer goods and services (https://www.bls.gov/cpi/). CPIs are only used when the purchases are similar to
those of retail consumers rather than purchases at the producer level,
or if no appropriate PPIs are available.
We evaluate the price proxies using the criteria of reliability,
timeliness, availability, and relevance:
Reliability. Reliability indicates that the index is based
on valid statistical methods and has low sampling variability. Widely
accepted statistical methods ensure that the data were collected and
aggregated in a way that can be replicated. Low sampling variability is
desirable because it indicates that the sample reflects the typical
members of the population. (Sampling variability is variation that
occurs by chance because only a sample was surveyed rather than the
entire population.)
Timeliness. Timeliness implies that the proxy is published
regularly, preferably at least once a quarter. The market baskets are
updated quarterly, and therefore, it is important for the underlying
price proxies to be up-to-date, reflecting the most recent data
available. We believe that using proxies that are published regularly
(at least quarterly, whenever possible) helps to ensure that we are
using the most recent data available to update the market basket. We
strive to use publications that are disseminated frequently, because we
believe that this is an
[[Page 50221]]
optimal way to stay abreast of the most current data available.
Availability. Availability means that the proxy is
publicly available. We prefer that our proxies are publicly available
because this will help ensure that our market basket updates are as
transparent to the public as possible. In addition, this enables the
public to be able to obtain the price proxy data on a regular basis.
Relevance. Relevance means that the proxy is applicable
and representative of the cost category weight to which it is applied.
The CPIs, PPIs, and ECIs that we have selected meet these criteria.
Therefore, we believe that they continue to be the best measure of
price changes for the cost categories to which they would be applied.
Table 34 lists all price proxies that used in the proposed 2017-
based FQHC market basket. Below is a detailed explanation of the price
proxies we are proposing for each cost category weight, many of which
are the same as those used for the 2013-based FQHC market basket.
a. Price Proxies for the Proposed 2017-Based FQHC Market Basket
(1) FQHC Practitioner Wages and Salaries
We propose to use the ECI for Wages and Salaries for Private
Industry Workers in Professional and Related (BLS series code
CIU2010000120000I) to measure price growth of this category. There is
no specific ECI for physicians or FQHC Practitioners and, therefore, we
propose to use an index that is based on professionals that receive
advanced training similar to those performing at the FQHC Practitioner
level of care. This index is consistent with the price proxy used to
measure wages and salaries inflation pressure for physicians own time
in the Medicare Economic Index (MEI) and is based on the MEI technical
panel recommendation from 2012 (78 FR 74266 through 74271)).
Additionally, this price proxy is consistent with the proxy used for
FQHC practitioner compensation in the 2013-based FQHC market basket (81
FR 80397). We note that the 2013-based FQHC market basket has a single
cost category for Total Compensation reflecting both wages and salaries
and employee benefits costs for FQHC Practitioners and this single
compensation category uses the similar price proxy, the ECI Total
Compensation for Private Industry Workers in Professional and Related,
reflecting both types of compensation costs together rather than
separately (81 FR 80397).
(2) FQHC Practitioner Employee Benefits
We propose to use the ECI for Total Benefits for Private Industry
Workers in Professional and Related to measure price growth of this
category. This ECI is calculated using the ECI for Total Compensation
for Private Industry Workers in Professional and Related (BLS series
code CIU1016220000000I) and the relative importance of wages and
salaries within total compensation. The 2013-based FQHC market basket
did not include a separate category for FQHC Practitioner employee
benefit costs.
(3) Clinical Staff Wages and Salaries
We propose to use the ECI for Wages and Salaries for all Civilian
Workers in Health Care and Social Assistance (BLS series code
CIU1026200000000I) to measure the price growth of this cost category.
This cost category consists of wage and salary costs for Nurses,
Laboratory Technicians, and all other healthcare staff not included in
the FQHC Practitioner compensation categories. Based on the clinical
staff composition of these workers, we believe that the ECI for health-
related workers is an appropriate proxy to measure wage and salary
price pressures for these workers. We note that the 2013-based FQHC
market basket has a single cost category for Total Compensation
reflecting both wages and salaries and employee benefits costs for
Clinical Staff and this single compensation category uses the similar
price proxy, the ECI Total Compensation for all Civilian Workers in
Health Care and Social Assistance, reflecting both types of
compensation costs together rather than separately (81 FR 80398).
(4) Clinical Staff Employee Benefits
We propose to use the ECI for Total Benefits for all Civilian
Workers in Health Care and Social Assistance to measure price growth of
this category. This ECI is calculated using the ECI for Total
Compensation for all Civilian Workers in Health Care and Social
Assistance (BLS series code CIU1016220000000I) and the relative
importance of wages and salaries within total compensation. The 2013-
based FQHC market basket did not include a separate category for
Clinical Staff employee benefit costs.
(5) Non-Health Staff Compensation
We propose to continue to use the ECI for Total Compensation for
Private Industry Workers in Office and Administrative Support (BLS
series code CIU2010000220000I) to measure the price growth of this cost
category. The Non-health Staff Compensation cost weight is
predominately attributable to administrative and facility type
occupations, as reported in the data from the Medicare cost reports.
This is the same price proxy used in the 2013-based FQHC market basket
(81 FR 80398).
(6) Pharmaceuticals
We propose to continue to use the PPI Commodities for
Pharmaceuticals for Human Use, Prescription (BLS series code
WPUSI07003) to measure the price growth of this cost category. This
price proxy is used to measure prices of Pharmaceuticals in other CMS
market baskets, such as 2014-based Inpatient Prospective Payment System
and 2014-based Skilled Nursing Facility market baskets. This is the
same proxy used in the 2013-based FQHC market basket (81 FR 80398).
(7) Utilities
We propose to continue to use the CPI for Fuel and Utilities (BLS
series code CUUR0000SAH2) to measure the price growth of this cost
category. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
(8) Medical Equipment
We propose to continue to use the PPI Commodities for Surgical and
Medical Instruments (BLS series code WPU1562) as the price proxy for
this category. This is the same proxy used in the 2013-based FQHC
market basket (81 FR 80398).
(9) Medical Supplies
We propose to continue to use a 50/50 blended index that comprises
the PPI Commodities for Medical and Surgical Appliances and Supplies
(BLS series code WPU156301) and the CPI-U for Medical Equipment and
Supplies (BLS series code CUUR0000SEMG). The 50/50 blend is used in all
market baskets where we do not have an accurate split available. We
believe FQHCs purchase the types of supplies contained within these
proxies, including such items as bandages, dressings, catheters,
intravenous equipment, syringes, and other general disposable medical
supplies, via wholesale purchase, as well as at the retail level.
Consequently, we propose to combine the two aforementioned indexes to
reflect those modes of purchase. This is the same blended price proxy
used in the 2013-based FQHC market basket (81 FR 80398).
[[Page 50222]]
(10) Miscellaneous Products
We propose to use the CPI for All Items Less Food and Energy (BLS
series code CUUR0000SA0L1E) to measure the price growth of this cost
category. We believe that using the CPI for All Items Less Food and
Energy is appropriate as it reflects a general level of inflation. This
is the same proxy used in the 2013-based FQHC market basket (81 FR
80398).
(11) Professional, Scientific, and Technical Services
We propose to continue to use the ECI for Total Compensation for
Private Industry Workers in Professional, Scientific, and Technical
Services (BLS series code CIU2015400000000I) to measure the price
growth of this cost category. This is the same proxy used in the 2013-
based FQHC market basket (81 FR 80398).
(12) Administrative and Facilities Support Services
We propose to continue to use the ECI Total Compensation for
Private Industry Workers in Office and Administrative Support (BLS
series code CIU2010000220000I) to measure the price growth of this cost
category. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
(13) All Other Services
We propose to continue to use the ECI for Total Compensation for
Private Industry Workers in Service Occupations (BLS series code
CIU2010000300000I) to measure the price growth of this cost category.
This is the same proxy used in the 2013-based FQHC market basket (81 FR
80398).
(14) Fixed Capital
We propose to continue to use the PPI Industry for Lessors of
Nonresidential Buildings (BLS series code PCU531120531120) to measure
the price growth of this cost category (81 FR 80398). This is the same
price proxy used in the 2013-based FQHC market basket. We believe this
continues to be the most appropriate price proxy since fixed capital
expenses in FQHCs should reflect inflation for the rental and purchase
of business office space.
(15) Moveable Capital
We propose to continue to use the PPI Commodities for Machinery and
Equipment (BLS series code WPU11) to measure the price growth of this
cost category as this cost category represents nonmedical moveable
equipment. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
c. Summary of Price Proxies of the Proposed 2017-Based FQHC Market
Basket
Table 34 shows the cost categories and associated price proxies for
the proposed 2017-based FQHC market basket.
[GRAPHIC] [TIFF OMITTED] TP17AU20.068
[[Page 50223]]
5. Proposed CY 2021 Productivity Adjusted Market Basket Update for
FQHCs
For CY 2021 (that is, January 1, 2021 through December 31, 2021),
we are proposing to use the proposed 2017-based FQHC market basket
increase factor to update the PPS payments to FQHCs. Consistent with
CMS practice, we estimated the market basket update for the FQHC PPS
based on the most recent forecast from IGI. IGI is a nationally
recognized economic and financial forecasting firm with which we
contract to forecast the components of the market baskets and
multifactor productivity (MFP). We are proposing to use the update
based on the most recent historical data available at the time of
publication of the final rule. For example, the final CY 2021 FQHC
update would be based on the four-quarter moving-average percent change
of the 2017-based FQHC market basket through the second quarter of 2020
(based on the final rule's statutory publication schedule). For the
proposed rule, we do not have the second quarter of 2020 historical
data and, therefore, we will use the most recent projection available.
Based on IGI's first quarter 2020 forecast with historical data
through the fourth quarter of 2019, the projected proposed 2017-based
FQHC market basket increase factor for CY 2021 would be 2.5 percent.
For comparison, the 2013-based FQHC market basket update is also
projected to be 2.5 percent in CY 2021; this estimate is based on IGI's
first quarter 2020 forecast (with historical data through the fourth
quarter of 2019). The proposed 2017-based FQHC market basket and the
2013-based FQHC market basket are both projected to grow at the same
rate for CY 2021, the difference in the average update factor over the
last five historical years (2016-2020) is 0.0 percent.
Table 35 compares the proposed 2017-based FQHC market basket
updates and the 2013-based FQHC market basket updates for CY 2016
through CY 2023.
[GRAPHIC] [TIFF OMITTED] TP17AU20.069
Section 1834(o)(2)(B)(ii) of the Act describes the methods for
determining updates to FQHC PPS payment. We have included a
productivity adjustment to the FQHC PPS annual payment update since
implementation of the FQHC PPS (81 FR 80393) and we propose to continue
to include a productivity adjustment to the proposed 2017-based FQHC
market basket. We propose to use the most recent estimate of the 10-
year moving average of changes in annual private nonfarm business
(economy-wide) multifactor productivity (MFP), which is the same
measure of MFP applied to other CMS Market Basket updates including the
MEI. The BLS publishes the official measure of private nonfarm business
MFP. (See http://www.bls.gov/mfp for the published BLS historical MFP
data). For the final FQHC market basket update, we propose to use the
most recent historical estimate of annual MFP as published by the BLS.
Generally, the most recent historical MFP estimate is lagged two years
from the payment year.
Therefore, we propose to use the 2019 MFP as published by BLS in
the CY 2021 FQHC market basket update. We note that MFP is derived by
subtracting the contribution of labor and capital input growth from
output growth. Since at the time of development of the proposed rule
the 2019 MFP was not yet published by BLS, we are proposing to use
IGI's first quarter 2020 forecast of MFP. A complete description of the
MFP projection methodology is available at http://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html.
Using IGI's first quarter 2020 forecast, the productivity
adjustment for CY 2021 (the 10-year moving average of MFP for the
period ending CY 2019) is projected to be 0.6 percent. Therefore, the
proposed CY 2021 productivity-adjusted FQHC Market basket update is 1.9
percent, based on IGI's first quarter 2020 forecast with historical
data through the fourth quarter of 2019. This reflects a 2.5-percent
increase in the proposed 2017-based FQHC market basket and a 0.6-
percent adjustment for productivity. For comparison, if we continue to
use the 2013-based FQHC market basket, then the CY 2021 productivity-
adjusted FQHC market basket update would also be 1.9 percent (2.5
percent FQHC market basket update less 0.6 percent MFP adjustment).
Finally, we are proposing that if more recent data subsequently become
available, we would use such data, if appropriate, to determine the CY
2021 market basket update and the MFP adjustment for the final rule.
[[Page 50224]]
E. Comprehensive Screenings for Seniors: Section 2002 of the Substance
Use-Disorder Prevention That Promote Opioid Recovery and Treatment for
Patients and Communities Act (SUPPORT Act)
Opioid overdose deaths continue to impact communities across the
United States. In 2018, about 47,000 Americans died as a result of an
opioid overdose, where 32 percent of these deaths involved a
prescription opioid.\31\ In addition to the risk of death from
overdose, opioids carry a number of other health risks, including
respiratory depression, drowsiness, confusion, nausea, increased drug
tolerance, and physical dependence. An estimated 1.7 million people in
the United States have substance use disorders involving prescription
opioid pain relievers.\32\
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\31\ Wilson N, Kariisa M, Seth P, et al. Drug and Opioid-
Involved Overdose Deaths--United States, 2017-2018. MMWR Morb Mortal
Wkly Rep 2020;69:290-297.
\32\ Substance Abuse and Mental Health Services Administration.
(2019). Key substance use and mental health indicators in the United
States: Results from the 2018 National Survey on Drug Use and Health
(HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD:
Center for Behavioral Health Statistics and Quality, Substance Abuse
and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf.
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CMS has a vital role in addressing opioid use disorder prevention,
treatment and recovery. The intent of the SUPPORT Act (Pub. L. 115-271,
enacted on October 24, 2018) is to provide for opioid use disorder
prevention, treatment and recovery. In section 2002 of the SUPPORT Act,
Comprehensive Screening for Seniors, the Congress required the Initial
Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV)
to include screening for potential substance use disorders (SUDs) and a
review of any current opioid prescriptions. We believe that these
provisions are complementary to the existing components of the IPPE and
AWV. We are proposing to add these new elements to the IPPE and AWV
regulations, to draw attention to their importance and fulfil the
section 2002 SUPPORT Act requirements. In this proposed rule, we
provide background on the IPPE and AWV, discuss how the requirements of
the SUPPORT Act are related to the IPPE and AWV, and make proposals to
implement these provisions.
1. Background: IPPE and AWV
a. IPPE Required Elements
The IPPE is defined in section 1861(ww) of the Act and codified in
regulations at Sec. 410.16. The IPPE must be performed within 1 year
after the effective date of a beneficiary's first Medicare Part B
coverage period as stated in section 1861(hhh)(4)(G) of the Act. The
IPPE includes all of the following services furnished to an eligible
beneficiary by a physician or other qualified nonphysician practitioner
(NPP) with the goal of health promotion and disease detection:
Review of the beneficiary's medical and social history
with attention to modifiable risk factors for disease, as those terms
are defined in Sec. 410.16.
Review of the beneficiary's potential (risk factors) for
depression, including current or past experiences with depression or
other mood disorders, based on the use of an appropriate screening
instrument for persons without a current diagnosis of depression, which
the physician or other qualified NPP may select from various available
standardized screening tests designed for this purpose and recognized
by national professional medical organizations.
Review of the beneficiary's functional ability, and level
of safety as those terms are defined in Sec. 410.16 based on the use
of appropriate screening questions or a screening questionnaire, which
the physician or other qualified NPP may select from various available
screening questions or standardized questionnaires designed for this
purpose and recognized by national professional medical organizations.
An examination to include measurement of the beneficiary's
height, weight, body mass index, blood pressure, a visual acuity
screen, and other factors as deemed appropriate, based on the
beneficiary's medical and social history, and current clinical
standards.
End-of-life planning upon agreement with the individual.
Education, counseling, and referral, as deemed appropriate
by the physician or qualified NPP, based on the results of the review
and evaluation services described in Sec. 410.16.
Education, counseling, and referral, including a brief
written plan such as a checklist provided to the individual for
obtaining an electrocardiogram, as appropriate, and the appropriate
screening and other preventive services that are covered as separate
Medicare Part B benefits.
b. AWV Required Elements
Section 1861(hhh) of the Act expanded Medicare coverage under Part
B to include an AWV effective for services furnished on or after
January 1, 2011. We codified the AWV at Sec. 410.15.
The AWV is a wellness visit that focuses on identification of
certain risk factors, personalized health advice, and referral for
additional preventive services and lifestyle interventions (which may
or may not be covered by Medicare). The elements included in the AWV
differ from comprehensive physical examination protocols with which
some providers may be familiar since it is a visit that is specifically
designed to provide personalized prevention plan services as defined in
the Act. The AWV includes a health risk assessment (HRA) and the AWV
takes into account the results of the HRA.
The AWV may be performed when the beneficiary is no longer within
12 months after the effective date of his or her first Medicare Part B
coverage period and when the beneficiary has not received either an
IPPE or AWV within the past 12 months. The AWV may be performed by a
physician, NPP (physician assistant, nurse practitioner, or clinical
nurse specialist), medical professional (including a health educator, a
registered dietitian, or nutrition professional, or other licensed
practitioner) or a team of such medical professionals, working under
the direct supervision of a physician. In summary, the first AWV
includes the following:
Review (and administration if needed) of a health risk
assessment (as defined in Sec. 410.15).
Establishment of an individual's medical and family
history.
Establishment of a list of current providers and suppliers
that are regularly involved in providing medical care to the
individual.
Measurement of an individual's height, weight, body-mass
index (or waist circumference, if appropriate), blood pressure, and
other routine measurements as deemed appropriate, based on the
beneficiary's medical and family history.
Detection of any cognitive impairment that the individual
may have, as that term is defined in Sec. 410.15.
Review of the individual's potential (risk factors) for
depression, including current or past experiences with depression or
other mood disorders, based on the use of an appropriate screening
instrument for persons without a current diagnosis of depression, which
the health professional may select from various available standardized
screening tests
[[Page 50225]]
designed for this purpose and recognized by national medical
professional organizations.
Review of the individual's functional ability and level of
safety, based on direct observation or the use of appropriate screening
questions or a screening questionnaire, which the health professional
as defined in Sec. 410.15 may select from various available screening
questions or standardized questionnaires designed for this purpose and
recognized by national professional medical organizations.
Establishment of the following:
++ A written screening schedule for the individual such as a
checklist for the next 5 to 10 years, as appropriate, based on
recommendations of the United States Preventive Services Task Force
(USPSTF) and the Advisory Committee on Immunization Practices, and the
individual's health risk assessment (as that term is defined in Sec.
410.15), health status, screening history, and age-appropriate
preventive services covered by Medicare.
++ A list of risk factors and conditions for which primary,
secondary or tertiary interventions are recommended or are underway for
the individual, including any mental health conditions or any such risk
factors or conditions that have been identified through an initial
preventive physical examination (as described under Sec. 410.16), and
a list of treatment options and their associated risks and benefits.
++ Furnishing of personalized health advice to the individual and a
referral, as appropriate, to health education or preventive counseling
services or programs aimed at reducing identified risk factors and
improving self-management, or community-based lifestyle interventions
to reduce health risks and promote self-management and wellness,
including weight loss, physical activity, smoking cessation, fall
prevention, and nutrition.
++ At the discretion of the beneficiary, furnish advance care
planning services to include discussion about future care decisions
that may need to be made, how the beneficiary can let others know about
care preferences, and explanation of advance directives which may
involve the completion of standard forms.
++ Any other element determined appropriate through the national
coverage determination process.
In summary, subsequent AWVs include the following:
Review (and administration, if needed) of an updated
health risk assessment (as defined in Sec. 410.15).
An update of the individual's medical and family history.
An update of the list of current providers and suppliers
that are regularly involved in providing medical care to the individual
as that list was developed for the first AWV providing personalized
prevention plan services or the previous subsequent AWV providing
personalized prevention plan services.
Measurement of an individual's weight (or waist
circumference), blood pressure and other routine measurements as deemed
appropriate, based on the individual's medical and family history.
Detection of any cognitive impairment that the individual
may have, as that term is defined in Sec. 410.15.
An update to the following:
++ The written screening schedule for the individual as that
schedule is defined in paragraph (a) of Sec. 410.15 for the first AWV
providing personalized prevention plan services.
++ The list of risk factors and conditions for which primary,
secondary or tertiary interventions are recommended or are underway for
the individual as that list was developed at the first AWV providing
personalized prevention plan services or the previous subsequent AWV
providing personalized prevention plan services.
++ Furnishing of personalized health advice to the individual and a
referral, as appropriate, to health education or preventive counseling
services or programs as that advice and related services are defined in
paragraph (a) of Sec. 410.15.
++ At the discretion of the beneficiary, furnish advance care
planning services to include discussion about future care decisions
that may need to be made, how the beneficiary can let others know about
care preferences, and explanation of advance directives which may
involve the completion of standard forms.
++ Any other element determined appropriate through the national
coverage determination process.
2. Section 2002 of the SUPPORT Act Requirement
In section 2002 of the SUPPORT Act, sections 1861(ww) and
1861(hhh)(2) of the Act were amended to include a review of any current
opioid prescriptions and screening for potential substance use
disorders (SUD) as elements of the IPPE and AWV, effective January 1,
2020.
3. Proposal on Section 2002 of the SUPPORT Act Requirements
We are proposing to add the requirements of section 2002 of the
SUPPORT Act to our regulations at Sec. 410.15 and 410.16 for the AWV
and IPPE, respectively.
Section 2002 of the SUPPORT Act, requires a review of any current
opioid prescriptions as part of the IPPE and AWV. Such review includes
a review of the potential risk factors to the individual for opioid use
disorder, an evaluation of the individual's severity of pain and
current treatment plan, educational information on non-opioid treatment
options, and a referral to a specialist, as appropriate. Section 2002
of the SUPPORT Act also requires adding an element to the IPPE and AWV
to include screening for potential SUDs. Along with the screening for
SUD, a referral for treatment, as appropriate, was added to the AWV.
The definitions and conditions for and limitations on coverage of
the IPPE outlined in Sec. 410.16 includes a review of the
beneficiary's medical and social history. The medical history is
defined to include a review of current medications, which would include
a review of current opioid prescriptions. Furthermore, social history
is defined to include, at a minimum, a history of alcohol, tobacco, and
illicit drug use. Illicit drug use may include the non-medical use of
prescription drugs. The physician or other qualified health
professional may then provide education, counseling, and referral, as
deemed appropriate, based on the results of the review and evaluation
services provided during the IPPE.
The definitions and conditions for and limitations on coverage of
the AWV in Sec. 410.15 includes a health risk assessment, which
entails an evaluation of psychosocial risks, including but not limited
to, depression/life satisfaction, stress, anger, loneliness/social
isolation, pain, and fatigue. The patient's substance use, if
applicable, could be reviewed as part of the health risk assessment.
The AWV also covers establishment of, or an update to the individual's
medical and family history. The medical history includes medication
use, and may have included a review of any opioid prescriptions. The
health professional may also establish or update a list of risk factors
and conditions for which primary, secondary or tertiary interventions
are recommended or are underway for the individual, including any
mental health conditions or any such risk factors or conditions that
have been identified through the initial or subsequent AWV
[[Page 50226]]
or IPPE, and a list of treatment options and their associated risks and
benefits. If the clinician detected, through the above methods for
screening, that a patient was at high-risk for substance use disorder
in the course of the visit, it would have been appropriate to note in
the patient's IPPE written plan or the AWV personalized prevention plan
and to have referred the patient for further assessment and treatment.
Awareness of a patient's use of substances, including nonmedical
use of prescription drugs and illicit drug use, is an important aspect
of the IPPE and AWV. In general, screening for potential SUDs may
include screening questions, the use of a specific tool, screening for
licit and/or illicit drugs (for example, alcohol, non-medical use of
prescription opioids, methamphetamine, heroin, cocaine, and other
substances), review of the beneficiary's medical and social history and
medical records, or prescription drug monitoring program query when
clinically indicated. Given the existing elements of the IPPE and AWV,
we do not expect the new regulatory elements to add significant burdens
on physicians and practitioners who furnish these services because
review of medical and social history, risk factor identification,
education, counseling, and referrals are already fundamental parts of
the IPPE and AWV. The new regulatory elements elevate the importance of
physicians' and other qualified health professionals' vigilance in
identifying and addressing opioid risks and SUDs in Medicare
beneficiaries.
4. Proposed Regulatory Text Changes
We are proposing to add elements to our regulations to reflect the
provisions of section 2002 of the SUPPORT Act. Consistent with sections
1861(ww) and 1861(hhh)(2) of the Act, we propose to amend 42 CFR 410.15
and 410.16 by: (1) Adding the term ``screening for potential substance
use disorders''; (2) Adding the term ``a review of any current opioid
prescriptions'' and its definition; and (3) revising the ``Initial
Preventive Physical Examination,'' ``first annual wellness visit
providing personalized prevention plan services,'' and ``subsequent
annual wellness visit providing personalized prevention plan
services''.
(1) ``Screening for Potential Substance Use Disorders''
We propose to revise Sec. Sec. 410.15 and 410.16 by adding the
element ``Screening for Potential Substance Use Disorders'' and
describing the proposed requirement as a review of the individual's
potential risk factors for substance use disorder and referral for
treatment as appropriate.
(2) Definition of ``A Review of Any Current Opioid Prescriptions''
We propose to revise Sec. Sec. 410.15 and 410.16 by adding the
element ``a review of any current opioid prescriptions'' and defining
such term, consistent with section 1861(ww)(4) of the Act, as a review
of any current opioid prescriptions, including a review of the
potential risk factors to the individual for opioid use disorder, an
evaluation of the individuals' severity of pain and current treatment
plan, the provision of information on non-opioid treatment options, and
a referral to a specialist, as appropriate.
(3) Proposed Changes to the ``Initial Preventive Physical
Examination,'' ``First Annual Wellness Visit'' and ``Subsequent Annual
Wellness Visit''
In Sec. Sec. 410.15 and 410.16, we adopted the components of the
IPPE and AWV, consistent with the statutory elements described in
sections 1861(ww) and 1861(hhh)(2) of the Act. The initial preventive
physical examination, first and subsequent annual wellness visits are
meant to represent a beneficiary visit focused on prevention. Among
other things, the IPPE and AWV encourages beneficiaries to obtain the
preventive services covered by Medicare that are appropriate for them.
First and subsequent AWVs also include elements that focus on the
furnishing of personalized health advice and referral, as appropriate,
to health education, preventive counseling services, or programs aimed
at reducing identified risk factors and improving self-management, or
community-based lifestyle interventions.
We are proposing to revise ``initial preventive physical
examination,'' ``first annual wellness visit providing personalized
prevention plan services,'' and ``subsequent annual wellness visit
providing personalized prevention plan services'' by adding:
In Sec. 410.15(a):
++ A revised paragraph (xi) to the definition of the term ``First
annual wellness visit providing personalized prevention plan
services,'' and a revised paragraph (ix) to the definition of the term
``Subsequent annual wellness visit'' that would add furnishing of a
review of any current opioid prescriptions as that term is defined in
this section.
++ A new paragraph (xii) to the definition of ``First annual
wellness visit providing personalized prevention plan services,'' and a
new paragraph (x) to the definition of ``Subsequent annual wellness
visit'' that would add screening for potential substance use disorders
including a review of the individual's potential risk factors for
substance use disorder and referral for treatment as appropriate.
++ A new paragraph (xiii) to the definition of ``First annual
wellness visit providing personalized prevention plan services,'' and a
new paragraph (xi) to the definition of ``Subsequent annual wellness
visit'' that would add any other element determined appropriate through
the national coverage determination process.
In Sec. 410.16:
++ A revised paragraph (a)(6) to the definition of ``Initial
preventive physical examination'' that would include a review of any
current opioid prescriptions as that term is defined in this section.
++ A revised paragraph (a)(7) to the definition of ``Initial
preventive physical examination'' that would add screening for
potential substance use disorders to include a review of the
individual's potential risk factors for substance use disorder and
referral for treatment as appropriate.
++ A new paragraph (a)(8) to the definition of ``Initial preventive
physical examination'' that would add, education, counseling, and
referral, as deemed appropriate by the physician or qualified
nonphysician practitioner, based on the results of the review and
evaluation services described in this section.
++ A new paragraph (a)(9) to the definition of ``Initial preventive
physical examination'' that would include, education, counseling, and
referral, including a brief written plan such as a checklist provided
to the individual for obtaining an electrocardiogram, as appropriate,
and the appropriate screening and other preventive services that are
covered as separate Medicare Part B benefits as described in sections
1861(s)(10), (jj), (nn), (oo), (pp), (qq)(1), (rr), (uu), (vv),
(xx)(1), (yy), (bbb), and (ddd) of the Act.
5. Summary
The initial preventive physical examination, first and subsequent
annual wellness visits are designed to help prevent disease and
disability based on the beneficiary's current health and risk factors.
Increased payment values for the IPPE and AWV in alignment with
increases to E/M services are being proposed in section II.F. of this
proposed rule. Our proposals seek to incorporate the new AWV and IPPE
requirements of section 2002 of the SUPPORT Act in a manner that is
flexible for clinicians to provide
[[Page 50227]]
the care that is most appropriate for their patients. We look forward
to receiving public comment on these proposals.
F. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs)
1. Background
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory
basis for incentive payments made to Medicaid EPs and eligible
hospitals for the adoption, implementation, upgrade, and meaningful use
of Certified EHR Technology (CEHRT). We have implemented these
statutory provisions in prior rulemakings to establish the Medicaid
Promoting Interoperability Program.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the
Act, and the definition of ``meaningful EHR user'' in regulations at
Sec. 495.4, one of the requirements of being a meaningful EHR user is
to successfully report the clinical quality measures selected by CMS to
CMS or a state, as applicable, in the form and manner specified by CMS
or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting electronic clinical quality measures (eCQMs)
for EPs to report under the Promoting Interoperability Program, and in
establishing the form and manner of reporting, the Secretary shall seek
to avoid redundant or duplicative reporting otherwise required. We have
taken steps to align various quality reporting and payment programs
that include the submission of eCQMs.
In the CY 2020 PFS final rule (84 FR 62568, 62900), we established
for 2020 that Medicaid EPs are required to report on any six eCQMs that
are relevant to the EP's scope of practice, regardless of whether they
report via attestation or electronically. We also adopted the Merit-
based Incentive Payment System (MIPS) requirement that EPs report on at
least one outcome measure (or, if an applicable outcome measure is not
available or relevant, one other high priority measure). We explained
that if no outcome or high priority measure is relevant to a Medicaid
EP's scope of practice, the EP may report on any six eCQMs that are
relevant.
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting
Interoperability Program for 2020
We annually review and revise the list of eCQMs for each MIPS
performance year to reflect updated clinical standards and guidelines.
In Appendix 1 of this proposed rule, we propose to amend the list of
available eCQMs for the CY 2021 performance period. To keep eCQM
specifications current and minimize complexity, we propose to align the
eCQMs available for Medicaid EPs in 2021 with those available for MIPS
eligible clinicians for the CY 2021 performance period. Specifically,
we propose that the eCQMs available for Medicaid EPs in 2021 would
consist of the list of quality measures available under the eCQM
collection type on the final list of quality measures established for
the MIPS CY 2021 performance period.
In previous years, CMS proposals to align the list of eCQMs for
MIPS and the Medicaid Promoting Interoperability Program for EPs
received positive comments that indicated that alignment between these
two programs would help reduce health care provider reporting burden
(84 FR 62900; see also 83 FR 59452, 59702). These comments thus suggest
that aligning the eCQM lists might encourage EP participation in the
Medicaid Promoting Interoperability Program by giving Medicaid EPs that
are also MIPS eligible clinicians the ability to report the same eCQMs
for both programs. Not aligning the eCQM lists could lead to increased
burden, because EPs might have to report on different eCQMs for the
Medicaid Promoting Interoperability Program if they opt to report on
newly added eCQMs for MIPS. In addition, we believe that aligning the
eCQMs available in each program would help to ensure the most uniform
application of up-to-date clinical standards and guidelines possible.
We anticipate that this proposal would reduce burden for Medicaid
EPs by aligning the requirements for multiple reporting programs, and
that the system changes required for EPs to implement this change would
not be significant, particularly in light of our belief that many EPs
would report eCQMs to meet the quality performance category of MIPS and
therefore should be prepared to report on the available eCQMs for 2021.
We expect that this proposal would have only a minimal impact on
states, by requiring minor adjustments to state systems for 2021 to
maintain current eCQM lists and specifications.
For 2021, we propose to again require (as we did for 2020) that
Medicaid EPs report on any six eCQMs that are relevant to their scope
of practice, regardless of whether they report via attestation or
electronically. This policy of allowing Medicaid EPs to report on any
six measures relevant to their scope of practice would generally align
with the MIPS data submission requirement for eligible clinicians using
the eCQM collection type for the quality performance category, which is
established at Sec. 414.1335(a)(1). MIPS eligible clinicians who elect
to submit eCQMs must generally submit data on at least six quality
measures, including at least one outcome measure (or, if an applicable
outcome measure is not available, one other high priority measure). We
refer readers to Sec. 414.1335(a) for the data submission criteria
that apply to individual MIPS eligible clinicians and groups that elect
to submit data with other collection types.
In addition, as we did for 2020, we propose that for 2021, EPs in
the Medicaid Promoting Interoperability Program would be required to
report on at least one outcome measure (or, if an outcome measure is
not available or relevant, one other high priority measure). This
policy would improve alignment with the MIPS quality performance
category requirements for eligible clinicians using the eCQM collection
type. We also propose that if no outcome or high priority measures are
relevant to a Medicaid EP's scope of practice, the clinician may report
on any six eCQMs that are relevant, as was the policy in 2020.
In the CY 2020 PFS final rule (84 FR 62899-62900), we established
the following three methods to identify which of the available measures
are high priority measures for EPs participating in the Medicaid
Promoting Interoperability Program. We propose to use the same three
methods for identifying high priority eCQMs for the Medicaid Promoting
Interoperability Program for 2021:
The same set of measures that are identified as high
priority measures for reporting on the quality performance category for
eligible clinicians participating in MIPS.
All e-specified measures from the previous year's core set
of quality measures for Medicaid and the Children's Health Insurance
Program (CHIP) (Child Core Set) or the core set of health care quality
measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter
together referred to as ``Core Sets'') that are also included on the
MIPS list of eCQMs.
Sections 1139A and 1139B of the Act require the Secretary to
identify and publish core sets of health care quality measures for
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries.
These measure sets are required by statute to be updated annually and
are voluntarily reported by states to CMS. These Core Sets are composed
of measures that specifically focus on populations served by the
[[Page 50228]]
Medicaid and CHIP programs and are of particular importance to their
care. The MIPS eCQM list includes several, but not all, of the measures
in the Core Sets. Because the Core Sets are released at the beginning
of each year, it is not possible to update the list of high-priority
eCQMs with those added to the current year's Core Sets.
The eCQMs that would be available for Medicaid EPs to report in
2021, that are both part of the Core Sets and on the MIPS list of
eCQMs, and that would be considered high priority measures under our
proposal are: CMS2, ``Preventive Care and Screening: Screening for
Depression and Follow-Up Plan''; CMS122, ``Diabetes: Hemoglobin A1c
(HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening'';
CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up
Care for Children Prescribed ADHD Medication (ADD)''; CMS137,
``Initiation and Engagement of Alcohol and Other Drug Dependence
Treatment''; CMS153, ``Chlamydia Screening for Women''; CMS155,
``Weight Assessment and Counseling for Nutrition and Physical Activity
for Children and Adolescents''; and CMS165, ``Controlling High Blood
Pressure.''
Through an amendment to Sec. 495.332(f), we gave each
state the flexibility to identify which of the eCQMs available for
reporting in the Medicaid Promoting Interoperability Program are high
priority measures for Medicaid EPs in that state, with review and
approval by CMS, through the State Medicaid HIT Plan (SMHP). States are
thus able to identify high priority measures that align with their
state health goals or other programs within the state.
All eCQMs identified via any of these three methods are high
priority measures for EPs participating in the Medicaid Promoting
Interoperability Program for 2020. As noted above, we propose to use
the same three methods for identifying high priority eCQMs for the
Medicaid Promoting Interoperability Program for 2021. We invite
comments as to whether any of these methods should be altered or
removed, or whether any additional methods should be considered for
2021.
Finally, we note that the eCQM reporting period in 2021 for EPs in
the Medicaid Promoting Interoperability Program is a minimum of any
continuous 90-day period within CY 2021, provided that the end date for
this period falls before October 31, 2021, or falls before a state-
specific alternative date prior to October 31, 2021 that is specified
in the SMHP, as described in Sec. 495.332(f)(4). This 2021 eCQM
reporting period will help ensure that states can issue all Medicaid
Promoting Interoperability Program payments on or before December 31,
2021. (See 83 FR 59452, 59704 through 59706).
G. Medicare Shared Savings Program
On March 23, 2010, the Patient Protection and Affordable Care Act
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30,
2010, which amended certain provisions of the Patient Protection and
Affordable Care Act (hereinafter collectively referred to as ``the
Affordable Care Act''). Section 3022 of the Affordable Care Act amended
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899
to the Act to establish the Medicare Shared Savings Program (Shared
Savings Program) to facilitate coordination and cooperation among
health care providers to improve the quality of care for Medicare fee-
for-service (FFS) beneficiaries and reduce the rate of growth in
expenditures under Medicare Parts A and B. (See 42 U.S.C. 1395jjj.)
Eligible groups of providers and suppliers, including physicians,
hospitals, and other health care providers, may participate in the
Shared Savings Program by forming or participating in an Accountable
Care Organization (ACO). Under the Shared Savings Program, providers of
services and suppliers that participate in an ACO continue to receive
traditional Medicare FFS payments under Parts A and B, but the ACO may
be eligible to receive a shared savings payment if it meets specified
quality and savings requirements.
Section 1899 of the Act has been amended through subsequent
legislation. The requirements for assignment of Medicare FFS
beneficiaries to ACOs participating under the program were amended by
the 21st Century Cures Act (Pub. L. 114-255). The Bipartisan Budget Act
of 2018 (Pub. L. 115-123, enacted on February 9, 2018), further amended
section 1899 of the Act to provide for the following: Expanded use of
telehealth services by physicians or practitioners participating in an
applicable ACO to furnish services to prospectively assigned
beneficiaries, greater flexibility in the assignment of Medicare FFS
beneficiaries to ACOs by allowing ACOs in tracks under retrospective
beneficiary assignment a choice of prospective assignment for the
agreement period; permitting Medicare FFS beneficiaries to voluntarily
identify an ACO professional as their primary care provider and
requiring that such beneficiaries be notified of the ability to make
and change such identification, and mandating that any such voluntary
identification will supersede claims-based assignment; and allowing
ACOs under certain two-sided models to establish CMS-approved
beneficiary incentive programs.
The Shared Savings Program regulations are codified at 42 CFR part
425. The final rule establishing the Shared Savings Program appeared in
the November 2, 2011 Federal Register (Medicare Program; Medicare
Shared Savings Program: Accountable Care Organizations; final rule (76
FR 67802) (hereinafter referred to as the ``November 2011 final
rule'')). A subsequent major update to the program rules appeared in
the June 9, 2015 Federal Register (Medicare Program; Medicare Shared
Savings Program: Accountable Care Organizations; final rule (80 FR
32692) (hereinafter referred to as the ``June 2015 final rule'')). The
final rule entitled, ``Medicare Program; Medicare Shared Savings
Program; Accountable Care Organizations--Revised Benchmark Rebasing
Methodology, Facilitating Transition to Performance-Based Risk, and
Administrative Finality of Financial Calculations,'' which addressed
changes related to the program's financial benchmark methodology,
appeared in the June 10, 2016 Federal Register (81 FR 37950)
(hereinafter referred to as the ``June 2016 final rule'')). A final
rule, ``Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2019;
Medicare Shared Savings Program Requirements; Quality Payment Program;
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the
Use of Telehealth Services for the Treatment of Opioid Use Disorder
Under the Substance Use-Disorder Prevention That Promotes Opioid
Recovery and Treatment (SUPPORT) for Patients and Communities Act'',
appeared in the November 23, 2018 Federal Register (83 FR 59452)
(herein referred to as the ``November 2018 final rule'' or the ``CY
2019 PFS final rule''). In the November 2018 final rule, we finalized a
voluntary 6-month extension for existing ACOs whose participation
agreements would otherwise expire on December 31, 2018; allowed
beneficiaries greater flexibility in designating their primary care
[[Page 50229]]
provider and in the use of that designation for purposes of assigning
the beneficiary to an ACO if the clinician they align with is
participating in an ACO; revised the definition of primary care
services used in beneficiary assignment; provided relief for ACOs and
their clinicians impacted by extreme and uncontrollable circumstances
in performance year 2018 and subsequent years; established a new
Certified Electronic Health Record Technology (CEHRT) use threshold
requirement; and reduced the Shared Savings Program quality measure set
from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through
59715).
A final rule redesigning the Shared Savings Program appeared in the
December 31, 2018 Federal Register (Medicare Program: Medicare Shared
Savings Program; Accountable Care Organizations-Pathways to Success and
Uncontrollable Circumstances Policies for Performance Year 2017; final
rule) (83 FR 67816) (hereinafter referred to as the ``December 2018
final rule''). In the December 2018 final rule, we finalized a number
of policies for the Shared Savings Program, including a redesign of the
participation options available under the program to encourage ACOs to
transition to two-sided models; new tools to support coordination of
care across settings and strengthen beneficiary engagement; and
revisions to ensure rigorous benchmarking.
In the interim final rule with comment period (IFC) entitled
``Medicare and Medicaid Programs; Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency'', which appeared in
the April 6, 2020 Federal Register (85 FR 19230) (hereinafter referred
to as the ``March 31st COVID-19 IFC''), we removed the restriction
which prevented the application of the Shared Savings Program extreme
and uncontrollable circumstances policy for disasters that occur during
the quality reporting period if the reporting period is extended, to
offer relief under the Shared Savings Program to all ACOs that may be
unable to completely and accurately report quality data for 2019 due to
the public health emergency (PHE) for the COVID-19 pandemic (85 FR
19267 and 19268). In the IFC entitled ``Medicare and Medicaid Programs;
Basic Health Program, and Exchanges; Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency and Delay
of Certain Reporting Requirements for the Skilled Nursing Facility
Quality Reporting Program'' which appeared in the May 8, 2020 Federal
Register (85 FR 27573 through 27587) (hereinafter referred to as the
``May 8th COVID-19 IFC''), we modified Shared Savings Program policies
to: (1) Allow ACOs whose current agreement periods expire on December
31, 2020, the option to extend their existing agreement period by 1-
year, and allow ACOs in the BASIC track's glide path the option to
elect to maintain their current level of participation for performance
year 2021; (2) adjust program calculations to remove payment amounts
for episodes of care for treatment of COVID-19; and (3) expand the
definition of primary care services for purposes of determining
beneficiary assignment to include telehealth codes for virtual check-
ins, e-visits, and telephonic communication. We also clarified the
applicability of the program's extreme and uncontrollable circumstances
policy to mitigate shared losses for the period of the COVID-19 PHE
starting in January 2020.
We have also made use of the annual CY PFS rules to address quality
reporting for the Shared Savings Program and certain other issues.
Refer to the CY 2020 PFS proposed rule for a summary of policies
finalized in prior rules (84 FR 40705).
Policies applicable to Shared Savings Program ACOs for purposes of
reporting for other programs have also continued to evolve based on
changes in the law. The Medicare Access and CHIP Reauthorization Act of
2015 (MACRA) established the Quality Payment Program (Pub. L. 114-10).
In the CY 2017 Quality Payment Program final rule with comment period
(81 FR 77008), we established regulations for the Merit-Based Incentive
Payment System (MIPS) and Advanced Alternative Payment Models (APMs)
and related policies applicable to eligible clinicians who participate
in the Shared Savings Program. These policies included requirements for
Shared Savings Program ACOs regarding reporting for the MIPS Quality
performance category and a policy that gives ACOs full credit for the
MIPS Improvement Activities performance category based on their
participation in the Shared Savings Program. We believe that the
proposed changes would reduce ACO burden by establishing a smaller
measure set, out of which ACO would only be required to actively report
3 measures. This would represent a significant reduction in reporting
requirements from the 10 measures on which ACOs are currently required
to actively report. Reporting for these measures would begin in January
2022, for the 2021 performance year. We believe this timeline would
allow organizations sufficient time to prepare to report on the new
measure set. In addition, the reporting options for the three ACO-
reported measures would leverage existing MIPS collection types and
more closely align existing CEHRT and registries used by ACOs and their
clinicians, including use of APIs to submit data.
As a general summary, in this proposed rule, we are proposing to:
Modify the approach to measuring ACO quality performance
under the Shared Savings Program which includes:
++ Applying the Alternative Payment Model (APM) Performance Pathway
(APP) to Shared Savings Program ACOs.
++ Revising the Shared Savings Program Quality Performance
Standard.
++ Changing the methodology for determining shared savings and
shared losses based on ACO quality performance.
++ Revising the approach to monitoring ACO quality performance and
addressing ACOs that fail to meet the Quality Performance Standard.
++ Updating the process used to validate ACO Quality Data
Reporting.
++ Updating the extreme and uncontrollable circumstances policy as
it relates to quality performance.
Update the definition of primary care services used in
beneficiary assignment, and codify in regulations the adjustment that
is made to an ACO's historical benchmark to reflect any changes to the
beneficiary assignment methodology specified in 42 CFR part 425,
subpart E, during an ACO's agreement period, including revisions to the
definition of primary care services at Sec. 425.402(c).
Revise the policy for determining the amount of repayment
mechanism arrangements for certain ACOs renewing to continue their
participation under a two-sided model.
1. Quality and Other Reporting Requirements
a. Background
Section 1899(b)(3)(C) of the Act states that the Secretary shall
establish quality performance standards to assess the quality of care
furnished by ACOs and seek to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both.
In the November 2011 final rule establishing the Shared Savings
Program, we adopted a quality measure set spanning four domains:
Patient experience of care, care coordination/patient safety,
preventative health, and at-risk population (76 FR 67872 through
[[Page 50230]]
67891). Since then, we have updated the measures that comprise the
quality performance measure set for the Shared Savings Program through
rulemaking in the CY 2015, 2016, 2017, and 2019 PFS final rules (79 FR
67907 through 67920, 80 FR 71263 through 71268, 81 FR 80484 through
80489, and 83 FR 59707 through 59715 respectively).
As we stated in the November 2011 final rule (76 FR 67872), our
principal goal in selecting quality measures for ACOs has been to
identify measures of success in the delivery of high-quality health
care at the individual and population levels, with a focus on outcomes.
In the CY 2019 PFS final rule, we finalized that for performance years
(or a performance period) starting in 2019 and subsequent years, 23
quality measures would be used to determine ACO quality performance (83
FR 59707 through 59715). The information used to determine ACO
performance on these quality measures is submitted by the ACO through
the CMS Web Interface, calculated by us from administrative claims
data, and collected via a patient experience of care survey referred to
as the Consumer Assessment of Healthcare Provider and Systems (CAHPS)
for ACOs Survey.
Eligible clinicians who are participating in an ACO and who are
subject to MIPS (MIPS eligible clinicians) are currently scored under
the APM scoring standard under MIPS (81 FR 77260). These MIPS eligible
clinicians include any eligible clinicians who are participating in an
ACO in a track, or payment model within a track (Track 1 and Levels A
through D of the BASIC track) of the Shared Savings Program that is not
an Advanced APM, as well as those MIPS eligible clinicians
participating in an ACO in a track, or payment model within a track
(Track 2, Level E of the BASIC track, and the ENHANCED track, or the
Medicare ACO Track 1+ Model (Track 1+ Model)) that is an Advanced APM,
but who do not become Qualifying APM Participants (QPs) as specified in
Sec. 414.1425, and are not otherwise excluded from MIPS.
b. Applying the Alternative Payment Model (APM) Performance Pathway
(APP) to Shared Savings Program ACOs
As provided in section 1899(d)(2) of the Act and Sec. 425.502(a)
of the Shared Savings Program regulations, ACOs must meet a quality
performance standard to qualify to share in savings. In the CY 2017 PFS
final rule, we finalized revisions to Sec. 425.502 related to the
quality performance standard and minimum attainment, including
clarifying that the quality performance standard is the overall
standard the ACO must meet to qualify to share in savings; defining the
minimum attainment level for pay for performance measures at the 30th
percent or 30th percentile of the quality performance benchmark and for
pay for reporting measures at the level of complete and accurate
reporting; specifying that only pay for performance measures are
assessed on a sliding scale while pay for reporting measures earn the
maximum number of points for a measure when the minimum attainment
level is met (81 FR 80492 through 80494).
Currently, the quality performance standard is based on an ACO's
experience in the program rather than its financial track. The quality
performance standard is currently defined at the level of full and
complete reporting (pay-for-reporting (P4R)) for the first performance
year of an ACO's first agreement period under the Shared Savings
Program. In the second or subsequent years of the ACO's first agreement
period and all years of subsequent agreement periods, quality measures
are scored as pay-for-performance (P4P) according to the phase-in
schedule for the specific measure and the ACO's performance year in the
Shared Savings Program:
For all performance years, ACOs must completely and
accurately report all quality data used to calculate and assess their
quality performance.
CMS designates a performance benchmark and minimum
attainment level for each P4P measure and establishes a point scale for
the measure. An ACO's quality performance for a measure is evaluated
using the appropriate point scale, and these measure-specific scores
are used to calculate the final quality score for the ACO.
ACOs must meet minimum attainment (defined as 30 percent
or the 30th percentile of the performance benchmark for P4P measures)
on at least one measure in each domain to be eligible to share in any
savings generated (Sec. 425.502(d)(2)(iii)(A)).
In the CY 2020 PFS proposed rule (84 FR 40709 through 40713), we
sought comment on how we might align the Shared Savings Program quality
reporting requirements and scoring methodology more closely with the
MIPS quality reporting and scoring methodology. We discussed utilizing
the MIPS Quality performance category score to adjust shared savings
and shared losses under the Shared Savings Program, as applicable. We
also sought comment on a possible new approach to determining the
threshold for minimum attainment. Under this potential policy, minimum
attainment would continue to be defined as complete and accurate
reporting for ACOs in their first performance year of their first
agreement period, while a MIPS Quality performance category score at or
above the 4th decile across all MIPS Quality performance category
scores would be required for ACOs in all other performance years under
the Shared Savings Program. ACOs with MIPS Quality performance category
scores below the 4th decile of all MIPS Quality performance category
scores would not meet the quality performance standard for the Shared
Savings Program, and thus, would not be eligible to share in savings or
would owe the maximum shared losses, if applicable. In addition, we
sought comment on a potential policy under which ACOs with quality
scores below the 4th decile of all MIPS Quality performance category
scores would be subject to compliance actions and possible termination.
The majority of feedback received in response to our comment
solicitation did not support this approach as it would hold ACOs to a
higher standard to be eligible to share in savings, if earned. In
addition, commenters that opposed aligning the Shared Savings Program
quality score with the MIPS Quality performance category score, stated
that significant restructuring of the Shared Savings Program quality
performance requirements would introduce more confusion for ACOs that
are also transitioning into new tracks under the December 2018 final
rule. Commenters also expressed concern regarding the uncertainty
associated with such an approach, as we had also proposed extensive
revisions to MIPS as the program transitions to MIPS Value Pathways.
Furthermore, commenters noted that ACOs are unique in that they are
responsible for the total cost of care of their beneficiaries and
should not be compared to clinicians in MIPS who are not participating
in total cost of care programs.
Although we acknowledge the commenters' concerns, we note that
section 1899(b)(3)(C) of the Act not only gives us discretion to
establish quality performance standards for the Shared Savings Program,
but also indicates that we should seek to improve the quality of care
furnished by ACOs over time by specifying higher standards, new
measures, or both for purposes of assessing quality of care. The Shared
Savings Program is now in its eighth performance year, and 85 percent
of ACOs participating in the program are considered PY3 ACOs for
purposes of quality reporting, with 65 percent of those ACOs
participating in a second or subsequent agreement period. In light of
[[Page 50231]]
the maturity of the program and consistent with section 1899(b)(3)(C)
of the Act, we believe that it is appropriate to require a higher
standard of care in order for ACOs to continue to share in any savings
they achieve. In addition, holding ACOs to a higher standard is in line
with CMS' goals of incentivizing value-based care and driving the
Medicare system to greater value and quality. However, after taking
into consideration the stakeholder feedback, we also considered ways to
reduce reporting burden, offer more flexibility in the way quality data
can be reported and submitted, and create a more meaningful measure set
that would focus on population health measures and be more outcome-
oriented, while also including patient experience of care metrics.
The Alternative Payment Model Performance Pathway (APP) was
designed for all MIPS APMs; but, it is also responsive to the concerns
raised by commenters in their responses to our solicitation in the CY
2020 PFS proposed rule, while still taking into consideration the
maturity of the Shared Savings Program, ACOs' quality performance over
time, and the intent of section 1899(b)(3)(C) of the Act. The APP
contains a narrower measure set than has previously been used for
Shared Savings Program quality measurement, 6 measures versus the
current 23 scored measures, and is specifically intended for use in
APMs and population health. The design of the APP aligns with
stakeholder interests expressed through comments on our solicitation
about aligning the Shared Savings Program with MIPS in the CY 2020 PFS
proposed rule. These comments suggested adopting a smaller, more
focused measure set in recognition of the fact that APM Entities are
incentivized through the terms of the respective APMs to improve value.
The measure set proposed for the APP aligns with the Meaningful
Measures framework by identifying measures that address the highest
priorities for quality measurement and improvement, while also reducing
reporting burden, promoting alignment of measures and consolidation of
reporting requirements across CMS programs moving payment toward value,
and identifying for consumers' key quality performance metrics. The
measures proposed for inclusion in this set encompass the meaningful
measure domains of patient voice, wellness and prevention, seamless
communication, chronic disease management, and behavioral health. For
these reasons, we believe that the proposed APP, along with the
narrower measure set, which comprises it, would be appropriate to
assess the quality performance of Shared Savings Program ACOs.
The construction of the proposed APP and the proposed measures
within it are described in more detail later in this section. A
detailed discussion of the proposal for use of the APP for MIPS APMs
more generally is found at section III.C.3.b. of this proposed rule.
(1) APM Performance Pathway for Shared Savings Program ACOs
In response to stakeholder feedback and in order to improve
alignment and integration with the Quality Payment Program policies and
operations, align with CMS' Meaningful Measure Framework, increase
participation in APMs and Advanced APMs by reducing reporting burden,
and raise the quality performance standard under the Shared Savings
Program, we are proposing to revise the Shared Savings Program quality
performance standard effective for performance year 2021 and subsequent
performance years. This proposed revision would align the Shared
Savings Program quality performance standard with the proposed APP
under the Quality Payment Program as participants in the Shared Savings
Program would be required to report quality for purposes of the Shared
Savings Program via the APP, which is described in more detail in
section III.C.3.b. of this proposed rule. At a high level, the APP
would replace the current Shared Savings Program quality measure set to
streamline reporting requirements for Shared Savings Program ACOs and
would be a complementary path to the MIPS Value Pathways. The APP is
designed to reduce reporting burden, create new scoring opportunities
for participants in MIPS APMs, and encourage participation in APMs.
Under this new approach, ACOs would only need to report one set of
quality metrics that would satisfy the reporting requirements under
both MIPS and the Shared Savings Program. There would not be separate
quality reporting requirements under the Shared Savings Program, as
under this proposed new approach the quality measures reported for
purposes of the APP would be used to determine the quality performance
of the ACO for purposes of the Shared Savings Program, which is used
for purposes of calculating shared savings and also shared losses,
where applicable. We believe this approach of streamlining the quality
reporting requirements under the Shared Savings Program while
maintaining alignment with the Quality Payment Program will help ACOs
and their participating providers and suppliers dedicate their finite
resources to engaging in efforts to improve quality and reduce costs
for their assigned beneficiary population. In addition, we believe that
using a single methodology to measure quality performance under both
the Shared Savings Program and MIPS would allow ACOs to better focus on
increasing the value of healthcare, improving care, and engaging
patients. It would also reduce burden as ACOs would be able to track to
a smaller set of measures under a unified scoring methodology.
Under the APP proposed in section III.C.3.b. of this proposed rule,
eligible clinicians in Shared Savings Program ACOs would continue to
receive full credit for the improvement activities performance category
in 2021 based on their performance of activities required under Sec.
425.112 of the Shared Savings Program regulations, as they do under
current MIPS scoring policy. Eligible clinicians participating in the
Shared Savings Program are not currently assessed on the MIPS Cost
performance category as these eligible clinicians are already subject
to cost and utilization performance assessments as part of the Shared
Savings Program. Therefore, the cost performance category would
continue to be weighted at zero percent. The four categories in the
proposed APP framework would be weighted as follows: Quality: 50
percent; PI: 30 percent; IA: 20 percent; and Cost: 0 percent.
Under the APP proposed in section III.C.3.b. of this proposed rule,
the MIPS Quality performance category score would be calculated for
ACOs based on MIPS benchmarks, which are used for other non-ACO group
and individual reporters and reflect the method of data submission (for
example, eCQM measures have benchmarks calculated using EHR data). ACOs
would be scored on the measures they report and would receive zero
points for those measures they do not report. For example, if an ACO
reported all three measures it is actively required to report but did
not field a CAHPS for MIPS survey measure, the ACO would receive zero
points for the CAHPS for MIPS survey measure, and that zero would be
included in its MIPS Quality performance category score, along with its
performance rates on the three measures it did actively report as well
as the two claims-based measures included in the APP measure set. This
approach aligns with scoring under MIPS, rather than the current Shared
Savings Program quality performance scoring methodology, which uses
quality benchmarks established specifically for the Shared
[[Page 50232]]
Savings Program and awards zero points for quality for ACOs that report
some but not all of the required measures. We believe that this
approach would be less punitive for ACOs than the current quality
performance standard, under which ACOs that fail to completely report
all quality measures receive a zero score for quality. We also believe
that alignment with the MIPS scoring methodology would reduce the
burden on ACOs of tracking to two different scoring methodologies.
However, if an ACO does not report any of the three APP measures it is
required to actively report and does not field a CAHPS for MIPS survey
the ACO would not meet the quality performance standard for purposes of
the Shared Savings Program and would not be able to share in savings
and would owe maximum losses, if applicable. If an ACO does not report
any of the three measures it is required to actively report and does
not field a CAHPS for MIPS survey, we do not believe that the remaining
two claims-based measures in the APP core measure set would be
sufficient to assess the quality of care provided by an ACO to its
assigned beneficiaries and would likely not allow the ACO to achieve a
MIPS Quality performance category score at or above the 40th
percentile. Under this proposal, there would be no quality ``phase
in.'' All ACOs, regardless of performance year and agreement period,
would be scored on all the measures in the APP for purposes of the
Shared Savings Program quality performance standard.
For MIPS scoring purposes, an ACO that fails to report via the APP
would receive a zero in the Quality performance category under MIPS. If
an ACO fails to report via the APP on behalf of its ACO participants
then the ACO participants could report outside the ACO, on behalf of
the MIPS eligible clinicians who bill through the TIN of the ACO
participant and receive a MIPS Quality performance category score
calculated at the ACO participant level. If ACO participants report
outside the ACO via the APP, they would continue to get full credit for
IA based on ACO participation. If ACO participants choose to report
outside the ACO via a different MIPS reporting option, then regular
MIPS scoring rules would apply (that is, automatic full credit for I.A.
and zero cost category weight would not be applied).
Under this proposal, for performance year 2021 and subsequent
performance years, ACOs would be assessed on a smaller measure set. The
measures ACOs would be scored on would decrease from 23 measures to 6
measures and the number of measures on which ACOs would be required to
actively report would be reduced from 10 to 3.
ACOs would report under the APP on the following 3 measures:
Quality ID#: 001: Diabetes: Hemoglobin A1c (HbA1c) Poor
Control (>9%);
Quality ID#: 134 Preventive Care and Screening: Screening
for Depression and Follow-Up Plan; and
Quality ID#: 236 Controlling High Blood Pressure.
ACOs would report these measures via a submission method of their
choice that aligns with the MIPS data submission types for groups at
Sec. 414.1325(c) (direct, login and upload, or a third-party
intermediary, described at Sec. 414.1400, submitting on behalf of the
ACO). As discussed in section IV.A.3.c.(1) of this proposed rule, we
are proposing to remove the CMS Web Interface from the MIPS data
submission types for groups beginning with the 2021 MIPS performance
year. Medicare Part B claims is not an available submission type for
ACOs as it is limited to TINs consisting of 15 or fewer eligible
clinicians. ACOs would receive a score of between 3 to 10 points for
each measure that meets the data completeness and case minimum
requirements, which would be determined by comparing measure
performance to established benchmarks. In addition, ACOs would need to
field a CAHPS for MIPS survey and would be measured on two claims-based
measures: The Hospital-Wide, 30-day, All-Cause Unplanned Readmission
(HWR) Rate for the Merit-Based Incentive Payment Program (MIPS)
Eligible Clinician Groups; and the All-Cause Unplanned Admissions for
Patients with Multiple Chronic Conditions (MCC). Please see Table 36
and section III.C.3.b. of this proposed rule for full details on the
measures proposed under the APP framework.
[[Page 50233]]
[GRAPHIC] [TIFF OMITTED] TP17AU20.070
As noted above, the measures proposed for inclusion in the measure
set for the APP align with the Meaningful Measures framework by
identifying the highest priorities for quality measurement and
improvement with the goals of reducing burden, promoting alignment,
moving payment toward value, and identifying key quality performance
metrics for consumers. The proposed measures encompass the meaningful
measure domains of patient voice, wellness and prevention, seamless
communication, chronic disease management, and behavioral health. We
also believe that the measures included in the APP are appropriate to
assess the quality performance of Shared Savings Program ACOs as they
focus on the management of chronic health conditions that are high
priority and have high prevalence among the population of Medicare
beneficiaries assigned to ACOs. We also believe that the measure set
chosen for inclusion within the APP would move the quality measure set
used in the Shared Savings Program toward a more outcome based, primary
care focused measure set. In addition to creating a pathway that would
reduce reporting burden for ACOs and allow their participating MIPS
eligible clinicians to meet requirements under MIPS through a smaller
measure set, requiring ACOs to report through the APP would also
eliminate differences in the way ACOs are scored under the Shared
Savings Program, as compared to the way their MIPS eligible clinicians
are scored under MIPS.
We note that under the current Shared Savings Program quality
scoring methodology, the CAHPS for ACOs survey is counted as ten
separate measures, while under the APP, the CAHPS for MIPS survey would
be counted as one. We continue to value the patient voice and believe
it should play a significant role in quality scoring. Using the CAHPS
for MIPS survey would achieve that goal while further aligning the way
in which the quality performance of ACOs and their MIPS eligible
clinicians is scored under the Shared Savings Program and under MIPS,
respectively. Under the current Shared Savings quality scoring
methodology, the 10 CAHPS for ACOs survey measures are scored as one
domain, which makes up 25 percent of the Shared Savings Program quality
score. In contrast, under our proposed approach, the CAHPS for MIPS
survey would be counted as one measure out of the 6 measures that would
be included in the calculation of the ACO's quality score under the
APP. Both of these approaches have a similar weighting, which maintains
the relevance of patient voice. We believe that the proposed approach
under the APP of combining the CAHPS survey measures into a single
measure for quality scoring purposes would allow Shared Savings Program
ACOs to effectively target resources toward improving their assigned
beneficiaries' experience of care in the areas for improvement on which
they choose to focus, rather than having to track to ten separate
survey measures, as is currently required by the CAHPS for ACOs used
under the Shared Savings Program. We believe this approach strikes the
right balance in reducing burden on ACOs and their participating
providers and suppliers while preserving the patient's voice.
Shared Savings Program ACOs are currently required to report on a
set of ten measures via the CMS Web Interface. While these measures
were appropriate for use in the program in the past because they are
primary care focused, we now recognize that the majority of the
measures have highly clustered performance. This means that they cannot
meaningfully distinguish quality performance across groups or ACOs. We
recognize the value in the use of primary care-focused measures and in
developing the proposed measure set for use under the APP, we have
sought to preserve the measures we believe most reflect high priority
quality measurement areas while also placing more emphasis on outcome-
based claims measures, which minimize
[[Page 50234]]
reporting burden and reflect greater opportunity for improvement.
In addition to the measures listed in Table 36, based on
recommendations from MedPAC in its 2015 Report to Congress: Medicare
and the Health Care Delivery System,\33\ we are considering adding a
``Days at Home'' measure that is currently under development, to the
APP core measure set in future years, once it has been through the MAP
pre-rulemaking process. Any future additions to the measure set,
including to add a ``Days at Home'' measure would be proposed and
finalized through notice and comment rulemaking.
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\33\ http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf.
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We welcome public comment on our proposal to apply the APP
framework to determine the quality performance of Shared Savings
Program ACOs.
In addition, we note that we have received feedback from a few
ACOs, including ACOs that have a significant number of beneficiaries in
long-term care facilities or who are chronically ill or high-risk home
bound patients, that the measures ACOs are required to report are not
always applicable to their patient population. Although we are
proposing to require ACOs to report via the APP, we are also seeking
comment on an alternative approach that could be used in the event the
three measures ACOs are required to actively report on are not
applicable to their beneficiary population and there are more
appropriate measure available under MIPS. Under this alternate
approach, ACOs could opt out of the APP and report to MIPS as an APM
entity. If the ACO decides to report as an APM entity to MIPS outside
of the APP, CAHPS for MIPS would become optional; however, the ACO
would be required to report PI and IA and would also be subject to cost
under MIPS. In the event an ACO decides to report as an APM entity to
MIPS outside the APP, we would use the ACO's MIPS Quality performance
category score to determine if the ACO met the Shared Savings Program
quality performance standard.
We seek comment on this alternative reporting approach for ACOs in
the event the three measures ACOs are required to actively report are
not applicable to their beneficiary population.
c. Shared Savings Program Quality Performance Standard
The quality performance standard is the minimum performance level
ACOs must achieve in order to share in any savings earned, avoid
maximum losses under certain payment tracks, and avoid quality-related
compliance actions. We are proposing to increase the level of quality
performance that would be required for all ACOs to meet the Shared
Savings Program quality performance standard. We believe the proposed
changes would simplify the Shared Savings Program quality performance
standard and are also consistent with the statutory requirement that we
seek to improve the quality of care furnished by ACOs over time by
specifying higher standards, new measures or both (section
1899(b)(3)(C) of the Act). We are proposing to increase the quality
performance standard for all ACOs to achievement of a quality
performance score equivalent to the 40th percentile or above across all
MIPS Quality performance category scores, excluding entities/providers
eligible for facility-based scoring. We are excluding entities/
providers eligible for facility-based scoring from the overall MIPS
quality score because facility-based scoring is determined using the
Hospital Value Based Purchasing (HVBP) Total Performance Score (TPS)
which includes quality and cost.
Given that the statute requires that we seek to increase the
quality performance standard over time, we believe changing the quality
performance standard from the 30th percentile on one measure in each
domain to a requirement that ACOs achieve a quality performance score
equivalent to the 40th percentile or above across all MIPS Quality
performance category scores, excluding entities/providers eligible for
facility-based scoring, is the next incremental step in increasing the
quality performance standard. Under the current Shared Savings Program
quality measurement methodology, 99.6 percent or 546 ACOs participating
in the program in 2018 met the quality performance standard of complete
and accurate reporting for ACOs in the first year of their first
agreement period or the 30th percentile on one measure in each domain,
for ACOs in their second or subsequent years of participation in the
program. Of these ACOs, 425 were ACOs in second or subsequent years of
participation in the program for which most quality measures were
scored as pay-for-performance (P4P). We analyzed quality measure data
from 2018 to simulate how many ACOs would achieve a quality performance
score that was at or above the 40th percentile of MIPS Quality
performance category scores. Based on our analysis using 2018 data to
simulate 2021 MIPS Quality performance category scores, we estimate 95
percent of ACOs would achieve a quality performance score at or above
the 40th percentile across all MIPS Quality performance category
scores, excluding entities/providers eligible for facility-based
scores. We recognize that this impact could change if the 40th
percentile across all MIPS Quality performance category scores improves
relative to ACOs' quality performance scores, or alternatively if ACOs,
particularly ACOs at risk of failing, respond to the methodology change
by boosting their performance. The impact could range from 98 percent
of ACOs achieving a quality performance score at or above the 40th
percentile to 92 percent of ACOs reflecting the respective extreme
scenarios assumed in the previous sentence.
Eligible clinicians participating in Shared Savings Program ACOs
who obtain QP status would continue to be exempt from MIPS, and
therefore, would not be subject to APP scoring under MIPS. For eligible
clinicians in an ACO that is participating in a track (or payment model
within a track) that is an Advanced APM who do not meet the threshold
to earn QP status but do meet the lower payment and patient count
threshold to achieve Partial QP status, the ACO can elect to report on
behalf of the Partial QPs, and the Partial QPs would be subject to a
MIPS payment adjustment under the APP framework. Conversely, if an ACO
does not elect to report for the Partial QPs, they would not receive a
MIPS score or payment adjustment and would have no reporting
responsibilities for MIPS. Utilizing the MIPS Quality performance
category scoring methodology to assess the quality performance for
purposes of the Shared Savings Program of ACOs participating in tracks
(or payment models within a track) that qualify as an Advanced APM
would not change whether the eligible clinicians participating in the
ACO obtain QP status and are excluded from MIPS, nor would it change
the ACO participant TINs' eligibility to receive Advanced APM incentive
payments.
We propose to specify in a new section of the Shared Savings
Program regulations at Sec. 425.510, policies on the application of
the APP to Shared Savings Program ACOs for performance years beginning
on or after January 1, 2021. This new section would include a general
provision specifying that CMS establishes quality performance measures
to assess the quality of care furnished by the ACO. If the ACO
demonstrates to CMS that it has satisfied the quality performance
[[Page 50235]]
requirements, and meets all other applicable requirements, the ACO is
eligible to receive shared savings. This general provision also
indicates that CMS seeks to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both.
This new section of the regulations would also specify the requirement
that ACOs must report quality data via the APP established under Sec.
414.1367 according to the method of submission established by CMS. In
addition, this new section of the regulation would also specify that
CMS retains the right to audit and validate quality data reported by an
ACO according to Sec. 414.1390 of this chapter.
We also propose to specify in a new section of the Shared Savings
Program regulations at Sec. 425.512 provisions for determining the ACO
quality performance standard for performance years beginning on or
after January 1, 2021. We propose to specify that the quality
performance standard is the overall standard the ACO must meet in order
to be eligible to receive shared savings for a performance year.
Further, we propose to specify that for all ACOs, CMS designates the
quality performance standard as the ACO reporting quality data via the
APP established under Sec. 414.1367, according to the method of
submission established by CMS and achievement of a quality performance
score equivalent to the 40th percentile or above across all MIPS
Quality performance category scores, excluding entities/providers
eligible for facility-based scoring. In addition, we propose to specify
that if an ACO does not report any of the three of the measures ACOs
are actively required to report and does not field a CAHPS survey, the
ACO would not meet the quality performance standard.
In addition, we propose to modify the existing Shared Savings
Program regulation at Sec. 425.508, on incorporating quality reporting
requirements related to the Quality Payment Program. We propose to add
a provision applicable to 2021 and subsequent performance years, which
specifies that ACOs must submit quality data via the APP established
under Sec. 414.1367 to satisfactorily report on behalf of the eligible
clinicians who bill under the TIN of an ACO participant for purposes of
the MIPS Quality performance category. We also propose related
technical and conforming modifications to Sec. 425.508.
We seek comment on our proposal to revise the Shared Savings
Program quality performance standard.
d. Use of ACO Quality Performance in Determining Shared Savings and
Shared Losses
Section 1899(d)(1)(A) of the Act specifies an ACO is eligible to
receive a shared savings payment for a portion of the savings generated
for Medicare, provided that the ACO meets both the quality performance
standards established by the Secretary and achieves the required level
of savings against its historical benchmark. Section 1899(d)(2) of the
Act provides the authority for the actual payments for shared savings
under the Shared Savings Program. Specifically, if an ACO meets the
quality performance standards established by the Secretary (according
to section 1899(b)(3) of the Act), and meets the savings requirements,
a percent (as determined appropriate by the Secretary) of the
difference between the estimated average per capita Medicare
expenditures in the year, adjusted for beneficiary characteristics, and
the benchmark for the ACO, may be paid to the ACO as shared savings and
the remainder of the difference shall be retained by the Medicare
program. The Secretary is required to establish limits on the total
amount of shared savings paid to an ACO. We have also incorporated
performance-based risk in the form of shared losses into certain
financial models using the authority under section 1899(i)(3) of the
Act to use other payment models.
The Shared Savings Program's one-sided shared savings only models,
and two-sided shared savings and shared losses models are specified in
subpart G of the Shared Savings Program regulations. For agreement
periods beginning on July 1, 2019, and in subsequent years, eligible
ACOs may participate under either: (1) The BASIC track, which includes
a glide path consisting of five levels (Levels A through E) that allows
eligible ACOs to begin under a one-sided model (Level A or Level B) and
incrementally phases-in higher levels of risk and potential reward
(Levels C, D, or E) (Sec. 425.605); or (2) the ENHANCED track, a two-
sided model with the highest level of risk and potential reward (Sec.
425.610). Further, according to the May 8th COVID-19 IFC (85 FR 27574
and 27575), ACOs that entered a first or second agreement period with a
start date of January 1, 2018, whose participation agreements expire
December 31, 2020, may elect to extend their agreement period for an
optional fourth performance year, spanning January 1, 2021, to December
31, 2021. This includes ACOs that entered agreement periods under Track
1 (a one-sided model), Track 2 (a two-sided model), and the ENHANCED
track. Further, this option to elect a 12-month extension of the
agreement period also applies to ACOs participating in the Track 1+
Model whose participation agreements expire December 31, 2020.
Under the Shared Savings Program regulations, for both one-sided
models and two-sided models, CMS uses the ACO's quality performance to
determine the ACO's eligibility to receive shared savings, and the rate
at which ACOs share in these savings. We base the final shared savings
rate on the ACO's quality performance. For ACOs meeting the quality
performance standard, the final shared savings rate is equal to the
product of the ACO's quality score and the maximum sharing rate. The
maximum sharing rate is specific to the ACO's track/level of
participation as follows: 50 percent for ACOs participating in Track 1;
\34\ 60 percent for ACOs participating in Track 2; \35\ 40 percent for
ACOs participating in Level A or Level B of the BASIC track; \36\ and
50 percent for ACOs participating in Levels C, D, or E of the BASIC
track; \37\ and 75 percent for ACOs participating in the ENHANCED
track.\38\ The upside of the Track 1+ Model is based on Shared Savings
Program Track 1; therefore, a maximum sharing rate of 50 percent
applies to Track 1+ Model ACOs.\39\
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\34\ Refer to Sec. 425.604(d).
\35\ Refer to Sec. 425.606(d).
\36\ Refer to Sec. 425.605(d)(1)(i)(A), (d)(1)(ii)(A).
\37\ Refer to Sec. 425.605(d)(1)(iii)(A), (d)(1)(iv)(A),
(d)(1)(v)(A).
\38\ Refer to Sec. 425.610(d).
\39\ Refer to the Track 1+ Model Participation Agreement,
available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf.
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Depending on the track, the ACO's quality performance may also be
used to determine the amount of the ACO's shared losses, for ACOs under
two-sided models. ACOs participating in the Track 1+ Model, and Level
C, D, or E of the BASIC track are subject to a fixed shared loss rate
(also referred to as the loss sharing rate) of 30 percent regardless of
quality performance.\40\ Under Track 2 and the ENHANCED track, the
shared loss rate is calculated as one minus the ACO's final shared
savings rate based on quality performance, up to a maximum of 60
percent or 75 percent, respectively, and the shared loss rate
[[Page 50236]]
may not be less than 40 percent for both tracks.\41\ For ENHANCED track
ACOs, this 40 percent minimum shared loss rate is expressly stated in
the current regulations, whereas for Track 2 ACOs, it is the implicit
minimum shared loss rate as calculated based on the inverse of the
maximum final shared savings rate for the track. Track 2 and ENHANCED
track ACOs that do not meet the quality performance standard for the
performance year will be accountable for shared losses based on the
highest shared loss rate for their track.
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\40\ Provisions specifying the shared loss rate for two-sided
models of the BASIC track are specified in Sec.
425.605(d)(1)(iii)(C), (d)(1)(iv)(C), (d)(1)(v)(C). The shared loss
rate applicable to Track 1+ Model ACOs is specified in the Track 1+
Model Participation Agreement.
\41\ Refer to Sec. Sec. 425.606(f), 425.610(f).
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In light of the proposed changes to the Shared Savings Program's
quality performance standard addressed elsewhere in section III.G.1. of
this proposed rule, we also propose modifications to the regulations
that specify the circumstances under which an ACO will qualify for a
shared savings payment based on its quality performance and the
determination of the rate at which the ACO will share in savings based
on its quality performance.
For all tracks, we propose to specify, in revisions to the
regulations, the requirements that must be met for an ACO to qualify
for a shared savings payment for performance years beginning on or
after January 1, 2021. We propose that to qualify for shared savings,
an ACO must meet the minimum savings rate requirements established for
the track/level, meet the proposed quality performance standard
described in section III.G.1.c. of this proposed rule, and otherwise
maintain its eligibility to participate in the Shared Savings Program
under part 425. We propose to revise Sec. Sec. 425.604(c) (Track 1),
425.605(c) (BASIC track), 425.606(c) (Track 2), and 425.610(c)
(ENHANCED track) to reflect these requirements.
We also propose revisions to the provisions establishing the final
sharing rate for all tracks. We propose that for performance years
beginning on or after January 1, 2021, if an ACO that is otherwise
eligible to share in savings meets the proposed quality performance
standard as described in section III.G.1.c. of this proposed rule, the
ACO will share in savings at the maximum sharing rate according to the
applicable financial model, up to the performance payment limit. We
propose that if the ACO fails to meet the proposed quality performance
standard, the ACO would be ineligible to share in savings. We propose
to specify these policies in revisions to the provisions governing
Track 1 (Sec. 425.604(d)), the BASIC track (Sec. 425.605(d)(1)(i)(A)
(Level A), (d)(1)(ii)(A) (Level B), (d)(1)(iii)(A) (Level C),
(d)(1)(iv)(A) (Level D), (d)(1)(v)(A) (Level E)), Track 2 (Sec.
425.606(d)), and the ENHANCED track (Sec. 425.610(d)).
We also propose modifications to the methodology for determining
shared losses under Track 2 and the ENHANCED track, for performance
years beginning on or after January 1, 2021, to account for the
proposed revisions to the quality performance standard. If the ACO
meets the quality performance standard as proposed (see section
III.G.1.c. of this proposed rule), we would determine the shared loss
rate as follows:
Step 1: Calculate the quotient of the MIPS quality
performance category points earned divided by the total MIPS quality
performance category points available.
Step 2: Calculate the product of the quotient described in
step 1 and the sharing rate for the relevant track, either 60 percent
for Track 2 or 75 percent for the ENHANCED track.
Step 3: Calculate the shared loss rate as 1 minus the
product determined in step 2. Consistent with the existing structure of
the financial models: Under Track 2, the shared loss rate may not
exceed 60 percent, and may not be less than 40 percent; under the
ENHANCED track, the shared loss rate may not exceed 75 percent, and may
not be less than 40 percent.
Under this proposed approach, for an ACO that meets the quality
performance standard we would take into consideration the ACO's quality
score when determining the ACO's share of losses. An ACO with a higher
quality score would owe a lower amount of losses compared to an ACO
with an equivalent amount of losses but a lower quality score, so long
as the ACO's quality score results in a shared loss rate within the
range between the minimum shared loss rate (40 percent) and the maximum
shared loss rate (60 percent under Track 2, or 75 percent under the
ENHANCED track). To the extent the ACO's quality score results in a
shared loss rate outside these limits, the shared loss rate is set to
the minimum or maximum rate (as applicable). We also propose to revise
the regulation at Sec. 425.606(f) to expressly state both the minimum
and maximum shared loss rates for Track 2.
We propose that if the ACO fails to meet the quality performance
standard as proposed (see section III.G.1.c. of this proposed rule),
the shared loss rate would be 60 percent under Track 2 or 75 percent
under the ENHANCED track. We believe this approach would maintain
symmetry with the proposed approach to determining shared savings under
Track 2 and the ENHANCED track based on quality performance. Thus, an
ACO that fails to meet the quality performance standard would be
ineligible to share in savings and would owe the maximum amount of
shared losses.
We propose to specify these provisions for determining the shared
loss rate under Track 2 and the ENHANCED track, for performance years
beginning on or after January 1, 2021, through modifications to the
regulations at Sec. Sec. 425.606(f) and 425.610(f). We also propose
technical and conforming changes to these provisions for clarity, and
to specify that the current policy would continue to apply for purposes
of determining the shared loss rate for Track 2 ACOs and ENHANCED track
ACOs for performance years (or a performance period) beginning on or
before January 1, 2020.
e. Compliance With the Quality Performance Standard
(1) Background
As discussed in more detail in section III.G.1.c. of this proposed
rule, the quality performance standard is the minimum performance level
ACOs must achieve in order to share in any savings earned, avoid
maximum losses under certain payment tracks, and avoid quality-related
compliance actions. Section 1899(d)(4) of the Act authorizes the
Secretary to terminate an agreement with an ACO that does not meet the
established quality performance standards. Through earlier rulemaking
we established an approach to enforce ACO compliance with the quality
performance standards, as specified in the Shared Savings Program
regulations at Sec. 425.316 (see 76 FR 67951, 80 FR 32818 and 32819,
81 FR 80492 through 80494).
To identify ACOs that do not meet the established quality
performance standards, we review the ACO's quality data submission.
Under our current policies, as specified in Sec. 425.316(c), if an ACO
does not meet quality performance standards or fails to report on one
or more quality measures, in addition to actions set forth at
Sec. Sec. 425.216 and 425.218, we will take the following actions:
The ACO may be given a warning for the first time it fails
to meet the minimum attainment level on at least 70 percent of the
measures, as determined under Sec. 425.502, in one or more domains and
may be subject to a corrective action plan (CAP). CMS may forgo the
issuance of the warning letter
[[Page 50237]]
depending on the nature and severity of the noncompliance and instead
subject the ACO to actions set forth at Sec. 425.216 or immediately
terminate the ACO's participation agreement under Sec. 425.218.
The ACO's compliance with the quality performance
standards will be re-evaluated the following year. If the ACO continues
to fail to meet the quality performance standards in the following
year, the agreement will be terminated.
An ACO will not qualify to share in savings in any year it
fails to report accurately, completely, and timely on the quality
performance measures.
Further, according to Sec. 425.224(b), in evaluating the
eligibility of a renewing ACO or re-entering ACO to enter a new
participation agreement with CMS for participation in the Shared
Savings Program, we consider the ACO's history of noncompliance with
the program's quality performance standard. For evaluating ACOs that
entered into a participation agreement for a 3-year period, we consider
whether the ACO failed to meet the quality performance standard during
1 of the first 2 performance years of the previous agreement period.
For evaluating ACOs that entered into a participation agreement for a
period longer than 3 years, we consider whether the ACO failed to meet
the quality performance standard for 2 consecutive performance years
and was terminated as specified in Sec. 425.316(c)(2), or whether the
ACO failed to meet the quality performance standard for 2 or more
performance years of the previous agreement period, regardless of
whether the years were consecutive.
The terms ``renewing ACO'' and ``re-entering ACO'' are defined in
the regulations at Sec. 425.20. We define renewing ACO to mean an ACO
that continues its participation in the program for a consecutive
agreement period, without a break in participation, because it is
either: (1) An ACO whose participation agreement expired and that
immediately enters a new agreement period to continue its participation
in the program; or (2) an ACO that terminated its current participation
agreement under Sec. 425.220 and immediately enters a new agreement
period to continue its participation in the program. We define re-
entering ACO to mean an ACO that does not meet the definition of a
renewing ACO and meets either of the following conditions: (1) Is the
same legal entity as an ACO that previously participated in the program
and is applying to participate in the program after a break in
participation, because the ACO's participation agreement expired
without having been renewed, or the ACO's participation agreement was
terminated under Sec. 425.218 or Sec. 425.220; or (2) is a new legal
entity that has never participated in the Shared Savings Program and is
applying to participate in the program and more than 50 percent of its
ACO participants were included on the ACO participant list under Sec.
425.118, of the same ACO in any of the 5 most recent performance years
prior to the agreement start date.
(2) Proposed Revisions
We have revisited the provisions of Sec. 425.316(c) on monitoring
compliance with quality reporting and performance requirements in light
of our proposed modifications to the quality performance standard. We
propose to modify the introductory text at Sec. 425.316(c) to state
that we will review an ACO's submission of quality measurement data to
identify ACOs that are not meeting the applicable quality performance
standard under Sec. Sec. 425.500 or 425.512. Under the provision, as
revised, we would retain the discretion to request additional
documentation from an ACO, ACO participants, or ACO providers/
suppliers. Further, we believe that in conjunction with our proposed
changes to the quality performance standard, it is appropriate to
strengthen our policies for compliance with the quality performance
standard by broadening the conditions under which CMS may terminate an
ACO's participation agreement when the ACO demonstrates a pattern of
failure to meet the quality performance standard.
As currently structured, the regulation at Sec. 425.316 does not
specify what actions CMS will take when an ACO fails to meet the
quality performance standard for multiple, nonconsecutive performance
years, or 2 consecutive performance years that span 2 agreement periods
(that is, the last performance year of an agreement period and the
first performance year of the subsequent agreement period).
Accordingly, we are proposing a new approach that CMS would follow to
monitor for and address an ACO's continued noncompliance with the
applicable quality performance standard for performance years beginning
on or after January 1, 2021. Noncompliance with the quality performance
standard during earlier performance years would continue to be subject
to the rules currently set forth at Sec. 425.316(c)(1) through (3),
which we propose would be consolidated at Sec. 425.316(c)(1). For
performance years beginning on or after January 1, 2021, we propose
that when CMS determines an ACO fails to meet the quality performance
standard (as described in section III.G.1.c. of this proposed rule),
CMS may take the actions prior to termination set forth at Sec.
425.216, and may terminate the ACO's participation agreement according
to Sec. 425.218. In addition to the actions set forth at Sec. Sec.
425.216 and 425.218, we propose to adopt a specific approach that CMS
would follow to monitor for and address an ACO's continued
noncompliance with the quality performance standard.
We propose that ACOs exhibiting a pattern of failure to meet the
quality performance standard will be terminated from the program.
Specifically, we propose to terminate an ACO's participation agreement
when the ACO fails to meet the quality performance standard for 2
consecutive performance years within an agreement period or fails to
meet the quality performance standard for any 3 performance years
within an agreement period, regardless of whether the years are in
consecutive order. We also propose that we will terminate the
participation agreement of a renewing ACO or a re-entering ACO if the
ACO fails to meet the quality performance standard for 2 consecutive
performance years across 2 agreement periods, specifically the last
performance year of the ACO's previous agreement period and the first
performance year of the ACO's new agreement period. In addition, we
propose that we will terminate the participation agreement of a
renewing ACO or a re-entering ACO if the ACO fails to meet the quality
performance standard for the last performance year of the ACO's
previous agreement period and this occurrence was either the second
consecutive performance year of failed quality performance or the third
nonconsecutive performance year of failed quality performance during
the previous agreement period. We propose to amend Sec. 425.316(c)(2)
to reflect this new approach.
Our proposal to terminate an ACO if it fails to meet the quality
performance standard for 2 consecutive performance years within an
agreement period is consistent with our current approach. However, we
also propose to terminate an ACO's participation agreement if the ACO
fails to meet the quality performance standard for any 3 performance
years within an agreement period, regardless of whether these years are
in consecutive order. In the December 2018 final rule (83 FR 67831), we
extended participation agreements from 3-years to 5-years. ACOs
participating under a 5-year agreement period may show a pattern of
failure to
[[Page 50238]]
meet the quality performance standard in performance years that are not
consecutive. Therefore, we believe it is important to continue to
monitor ACOs throughout their 5-year agreement period and if an ACO
fails to meet the quality performance standard for 3 nonconsecutive
performance years we propose to terminate their participation
agreement.
Additionally, we are concerned that a renewing ACO's quality
performance results for the last performance year of the current
agreement period will not be available for us to consider in reviewing
the ACO's application to renew its agreement, as currently provided in
Sec. 425.224(b)(1)(ii)(A). We have a similar concern with respect to
some re-entering ACOs (particularly, an ACO that notifies CMS of its
decision to terminate its participation agreement and subsequently
submits an application to re-enter the program for the next start date
following the effective date of its termination). To prevent these ACOs
from remaining in the program, despite a pattern of noncompliance with
the quality performance standard, we propose that if we determine that
the last performance year of the ACO's previous agreement period was
either the second consecutive performance year of failed quality
performance or the third nonconsecutive performance year of failed
quality performance during the prior agreement period, CMS would
terminate the ACO's new participation agreement. For example, if an ACO
failed to meet the quality performance standard in the first, third and
fifth performance years of a 5-year agreement period, or failed to meet
the quality performance standard in the fourth and fifth performance
years of a 5-year agreement period, results for the fifth performance
year would not be available until after the ACO has renewed and entered
a new agreement period. In both examples, we would anticipate
determining during the first performance year of the ACO's new
agreement period that the ACO had failed to meet the quality
performance standard for the last performance year of its previous
agreement period. Therefore, CMS would terminate the ACO's new
participation agreement during the first performance year of that
agreement period.
Furthermore, we are concerned an ACO could have a pattern of
failing to meet the quality performance standard for consecutive years
spanning 2 agreement periods. Therefore, if a renewing or re-entering
ACO fails to meet the quality performance standard for 2 consecutive
performance years across 2 agreement periods (the last performance year
of the ACO's previous agreement period and the first performance year
of the ACO's new agreement period), we propose to terminate the ACO's
participation agreement. We would anticipate that quality performance
results for the ACO's first performance year of its new agreement
period would be available during the second performance year of the
ACO's new agreement period. Therefore, CMS would terminate the ACO's
new participation agreement during the second performance year of the
new agreement period.
We recognize there is additional complexity in the application of
these policies to a new ACO that is identified as a re-entering ACO
because of its ACO participants' prior participation in another Shared
Savings Program ACO. Under the proposed approach, we would apply to the
re-entering ACO the other ACO's quality performance for previous years
(prior to the start of the re-entering ACO's agreement period) and
would terminate the re-entering ACO if the other ACO is determined to
have failed to meet the quality performance standard in 2 consecutive
performance years within an agreement period, or if the other ACO is
determined to have failed to meet the quality performance standard for
3 performance years (in nonconsecutive order) within an agreement
period. Consistent with the proposed approach, this could occur in
circumstances when the other ACO's most recent performance year of
failed quality performance is determined after the start of the new,
re-entering ACO's agreement period. Further, under the proposed
approach, we would also consider whether the other ACO failed to meet
the quality performance standard in the most recent performance year
prior to the start of the new, re-entering ACO's agreement period, and
whether the new, re-entering ACO also fails to meet the quality
performance standard for its first performance year. Because these 2
performance years of failed quality performance would be consecutive,
we would terminate the participation of the new, re-entering ACO.
Because a significant percentage of the ACO participants in the
new, re-entering ACO were previously participating in this other ACO,
we believe it is appropriate to hold the new, re-entering ACO
accountable for the quality performance of the other ACO. According to
the definition of re-entering ACO, more than 50 percent of the entity's
ACO participants must have participated together in the same ACO within
a 5-performance year lookback period. As a result, over half of the
new, re-entering ACO's ACO participants can be considered to have
contributed to the failed quality performance of this other ACO. If we
were to disregard the recent failed quality performance of this other
ACO, these ACO participants would be allowed to continue participation
in the Shared Savings Program as part of the new, re-entering ACO, and
potentially take advantage of program flexibilities, despite a pattern
of noncompliance with the quality performance standard.
We propose implementing these policies starting with performance
year 2021 and subsequent years. We acknowledge that an ACO currently
participating under a performance agreement spanning 5-years could fail
the quality performance standard for a performance year starting in
2019 under Sec. 425.502. The same ACO could then again fail the
quality performance standard under the proposed Sec. 425.512 in
performance years 2021 and 2023. In this scenario, the ACO will have
failed the quality performance standards for 3 nonconsecutive years
under the same agreement period, but the ACO would not be terminated in
this scenario because the proposed policies would apply starting with
performance year 2021. However, if the ACO decides to apply as a
renewing or re-entering ACO, we would review its history of
noncompliance with the requirements of the Shared Savings Program as
provided under Sec. 425.224(b)(1) when determining whether to approve
its application.
Under the current regulation at Sec. 425.316(c)(3), an ACO will
not qualify to share in savings in any year in which it fails to report
accurately, completely, and timely on the quality performance measures.
Consistent with the proposed revisions to the quality performance
standard under the Shared Savings Program discussed in section
III.G.1.c. of this proposed rule, we propose to specify in the proposed
new provision at Sec. 425.512 that, for performance years beginning on
or after January 1, 2021, an ACO will not qualify to share in savings
in any year it fails to meet the quality performance standard.
The termination of an ACO's participation agreement for failure to
meet the quality performance standard under the proposed approach
described in this section of the proposed rule, would also make the ACO
subject to the payment consequences of early termination as specified
in Sec. 425.221(b). Under Sec. 425.221(b)(1)(ii), if the
participation agreement is terminated at any time by CMS under Sec.
425.218, the ACO is not eligible to receive shared
[[Page 50239]]
savings for the performance year during which the termination becomes
effective. Under Sec. 425.221(b)(2)(ii)(B), an ACO participating under
a two-sided model whose participation agreement is terminated by CMS
under Sec. 425.218 is liable for a pro-rated share of any shared
losses determined for the performance year during which the termination
becomes effective. These policies would apply whenever an ACO is
terminated for non-compliance with the quality performance standard in
accordance with Sec. 425.316(c).
We propose to revise Sec. 425.316(c) to incorporate this proposed
approach for monitoring ACO compliance with the quality performance
standard for performance years beginning on or after January 1, 2021.
We also propose to make other technical and conforming changes to the
regulations at Sec. 425.316(c). In particular, we propose to amend the
existing provisions for monitoring ACO compliance with the quality
performance standards to specify that those provisions are applicable
to performance years (or a performance period) beginning on or before
January 1, 2020.
We also continue to believe in the importance of considering an
ACO's history of noncompliance with the quality performance standard in
evaluating the eligibility of a renewing ACO or a re-entering ACO to
enter a new agreement period under the Shared Savings Program. In light
of our proposed changes to Sec. 425.316(c), we propose to make
conforming changes to Sec. 425.224(b)(1)(ii)(A), which authorizes CMS
to approve or deny a renewing ACO's or re-entering ACO's application to
participate in the Shared Savings Program based on an evaluation of the
ACO's history of non-compliance with the quality performance standard.
Specifically, we propose to revise Sec. 425.224(b)(1)(ii)(A) to state
that as part of its evaluation of a renewing or re-entering ACO's
history of noncompliance with the requirements of the Shared Savings
Program, we will evaluate whether the ACO demonstrated a pattern of
failure to meet the quality performance standards or met any of the
criteria for termination under Sec. Sec. 425.316(c)(1)(ii) or
425.316(c)(2)(ii).
f. Updating the Process Used To Validate ACO Quality Data Reporting
In the CY 2017 PFS final rule, we finalized modifications to the
quality measures validation audit process. These modifications changed
the overall audit process from a 3-phased medical record review to an
audit conducted in a single phase. Under our current process, if
selected for an audit, an ACO must provide beneficiary medical records
data to substantiate the quality data reported by the ACO. As part of
the audit, CMS calculates an overall audit match rate, which is derived
by dividing the total number of audited records that match the
information reported in the CMS Web Interface by the total number of
the medical records audited. For example: (1) If the ACO has an audit
match rate of 90 percent or above it will pass the audit; (2) if the
ACO has an audit match rate of less than 90 percent, but greater than
80 percent, the ACO may be required to submit a CAP under Sec. 425.216
for CMS approval; (3) if the ACO has an audit match rate of less than
80 percent, absent unusual circumstances, we will adjust the ACO's
overall quality score proportional to the ACO's audit match rate, which
may have implications for the ACO's financial reconciliation.
Under our proposal to align the quality reporting requirements
under the Shared Savings Program with quality reporting under the APP
framework, we believe it would be appropriate to also align with the
MIPS Data Validation and Audit (DVA) process (Sec. 414.1390). Rather
than continuing to validate ACO quality data reporting under the Shared
Savings Program, we believe that it would be more appropriate for MIPS
to validate the data submitted by ACOs for the three measures in the
APP framework, as ACOs will be able to select the submission method for
these measures and the MIPS DVA is based on submission method. We
believe streamlining the approach to data validation and audit would
minimize administrative burden associated with the audit for ACOs as
they would only need to track to one validation process, and for ACOs
in a track (or payment model within a track) that does not meet the
definition of an Advanced APM, the results of the audit would be
applicable for purposes of both the Shared Savings Program and MIPS.
We propose to address the audit and validation of data used to
determine the ACO's quality performance in a new provision we are
proposing to add to the Shared Savings Program regulations at Sec.
425.510(c). Specifically, we propose that CMS would retain the right to
audit and validate the quality data reported by an ACO under Sec.
425.510(b) according to Sec. 414.1390.
g. Changes to the Extreme and Uncontrollable Circumstances Policy for
Performance Year 2021
As discussed in section III.G.1.c. of this proposed rule, we are
proposing to make changes to the quality performance standard for the
Shared Savings Program for the performance year beginning on January 1,
2021, and subsequent performance years. However, we continue to believe
it is appropriate to adjust the quality performance scores for ACOs
affected by extreme and uncontrollable circumstances. Accordingly, we
propose to update the extreme and uncontrollable circumstances policy
under the Shared Savings Program consistent with our proposal to align
the quality reporting requirements for the Shared Savings Program with
the proposed APP. Specifically, for performance year 2021 and
subsequent performance years, we would set the minimum quality
performance score for an ACO affected by an extreme and uncontrollable
circumstance during the performance year, including the applicable
quality data reporting period for the performance year, to equal the
40th percentile MIPS Quality performance category score. If the ACO is
able to report quality data and meet the MIPS data completeness and
case minimum requirements, we would use the higher of the ACO's MIPS
Quality performance category score or the 40th percentile MIPS Quality
performance category score. If an ACO is unable to report quality data
and meet the MIPS Quality data completeness and case minimum
requirements due to an extreme and uncontrollable circumstance, we
would apply the 40th percentile MIPS Quality performance category
score. We believe this approach is appropriate as it aligns with the
threshold for meeting the quality performance standard allowing
impacted ACOs to share in savings at their maximum sharing rate. We
acknowledge that using the 40th percentile may not offer the same level
of protection for ACOs incurring losses that would receive the higher
of their ACO quality score or the mean ACO score under the current
policy. Our simulation of the 2018 MIPS quality data shows that the
mean MIPS quality performance category score is between the 45th and
46th percentile, which is lower than the ACO quality mean score under
the current scoring methodology. However, for ACOs in Track 2 and the
ENHANCED track under which shared losses are determined based in part
on an ACO's quality performance, ACOs are also afforded relief from
shared losses through the application of the extreme and uncontrollable
circumstances policy under which shared losses are reduced based on the
percentage of the year and percentage of assigned beneficiaries
impacted by an
[[Page 50240]]
extreme and uncontrollable circumstance.
Under the proposed revisions to the quality reporting requirements,
we will no longer generate a CMS Web Interface quality reporting sample
for ACOs because ACOs will no longer be reporting measures via the Web
Interface; therefore, we propose to determine the percentage of the
ACO's performance year assigned beneficiary population that was
affected by an extreme and uncontrollable circumstances based on the
quarter four list of assigned beneficiaries, rather than the list of
assigned beneficiaries used to generate the Web Interface quality
reporting sample, which is currently used. We believe that using the
quarter four list of assigned beneficiaries is an appropriate
alternative because the file is generated after the end of the fourth
quarter and would offer a more complete representation of the
population of assigned beneficiaries that reside in an area that is
impacted by an extreme and uncontrollable circumstance during the
performance year. We seek comment on these proposed revisions to the
extreme and uncontrollable circumstances policy for performance year
2021 and subsequent performance years.
In addition, we are soliciting comment on a potential alternative
extreme and uncontrollable circumstances policy for performance year
2022 and subsequent years that would continue to incentivize reporting
but also acknowledge the challenges presented by extreme and
uncontrollable circumstances. We are considering creating an extreme
and uncontrollable circumstances methodology that would adjust the
amount of shared savings determined for affected ACOs that complete
quality reporting but do not meet the quality performance standard or
that are unable to complete quality reporting. This methodology would
be similar to the methodology currently used to adjust for extreme and
uncontrollable circumstances when calculating the amount of shared
losses for impacted ACOs. Under this alternative approach, instead of
determining that ACOs are affected by an extreme and uncontrollable
circumstances if 20 percent of their beneficiaries or their legal
entity are located in an area impacted by an extreme and uncontrollable
circumstance and determining shared savings using the higher of the
ACO's own quality score and the mean ACO quality score, we would
determine shared savings for an affected ACO by multiplying the maximum
possible shared savings the ACO would be eligible to receive based on
its financial performance and track (or payment model within a track)
by the percentage of the total months in the performance year affected
by an extreme and uncontrollable circumstance, and the percentage of
the ACO's assigned beneficiaries who reside in an area affected by an
extreme and uncontrollable circumstance. To illustrate this potential
approach, we provide an example of a hypothetical ACO, ACO A, which in
this example was impacted by an extreme and uncontrollable circumstance
that lasted for six months of the year and during that time, 50 percent
of its assigned beneficiaries resided in the impacted area. For this
example, we assume that ACO A did not quality report and would have
earned $100,000 in shared savings if it had met the quality performance
standard. In this example, we would multiply the percentage of the
total months in the performance year impacted by the extreme and
uncontrollable circumstance by the percentage of the ACO's assigned
beneficiaries who resided in the impacted area by the amount of shared
savings if the ACO had met the quality performance standard; 0.50 *
0.50 * $100,000 = $25,000. Under this alternative, ACO A's shared
savings would be $25,000.
As another example, if ACO B were impacted by an extreme and
uncontrollable circumstance for nine months of the year, had 50 percent
of its assigned beneficiaries residing in the impacted area, and did
report quality data but did not meet the quality performance standard
of a score equivalent to a MIPS Quality performance category score at
the 40th percentile, and ACO B would have earned $100,000 in shared
savings if it had met the quality performance standard; 0.75 * 0.50 *
$100,000 = $37,500. Under this alternative, ACO B's shared savings
would be $37,500.
As illustrated by the above examples, under this potential future
approach, the amount of shared savings that an ACO impacted by an
extreme and uncontrollable circumstance would be eligible to receive
would be greater than the amount an ACO that was not disaster impacted
would be eligible to receive if it did not report quality or did report
quality but did not obtain a score equivalent to a MIPS Quality
performance category score at or above the 40th percentile. An ACO that
was not disaster impacted and that either did not report quality or did
report quality but did not obtain a quality performance category score
equivalent to or higher than a MIPS Quality performance category score
at or above the 40th percentile would not meet the quality performance
standard and would not be eligible to receive any shared savings. In
contrast, an ACO impacted by an extreme and uncontrollable circumstance
would be eligible to receive an adjusted amount of shared savings, even
if it did not quality report or did report quality but had a quality
performance score that was lower than the 40th percentile of MIPS
Quality performance category scores. The final amount of shared savings
would be dependent on the degree to which the ACO's assigned
beneficiaries were disaster impacted during the relevant performance
year.
If an ACO impacted by an extreme and uncontrollable circumstance
does not report quality or does not meet the quality performance
standard of a quality performance score equivalent to a MIPS Quality
performance category score at or above the 40th percentile and owes
shared losses, then the existing extreme and uncontrollable
circumstances methodology that applies when calculating the amount of
shared losses would help to mitigate those losses. We note that
historically the majority of disaster-impacted ACOs report quality. For
example, for performance years (or a performance period) starting in
2019, when all ACOs were determined to be impacted by the PHE for
COVID-19, which was declared during the quality reporting period, 98.7
percent of ACOs completely reported via the CMS Web interface. Given
the historically high rates of quality reporting by ACOs impacted by
extreme and uncontrollable circumstances and the fact that, under our
proposed revisions to the quality performance standard, ACOs would
share in the maximum level of savings available under their track (or
payment model within a track) if they meet the quality performance
standard, we believe it is important to consider an extreme and
uncontrollable circumstances policy that looks at the actual impact of
an extreme and uncontrollable circumstance on a disaster-impacted ACO,
and provides for an adjusted amount of shared savings if the ACO does
not report or does not meet the quality performance standard.
We seek comment on this potential alternative extreme and
uncontrollable circumstances policy for future years.
We propose to specify our proposed policies for addressing the
effect of extreme and uncontrollable circumstances on ACO quality
performance for performance year 2021 and subsequent performance years
in the proposed new provision at
[[Page 50241]]
Sec. 425.512. In addition, we propose to include policies that
parallel the existing policies, as specified in Sec. 425.502(f), for
determining when an extreme and uncontrollable circumstance has
occurred and identifying affected ACOs. In particular, we propose to
include a provision, similar to the current provision at Sec.
425.502(f)(1), to establish our policies for determining whether an ACO
has been an affected by an extreme and uncontrollable circumstance. We
also propose to include a provision, similar to the provision at Sec.
425.502(f)(2), to establish the policies that would apply for
calculating an affected ACO's quality performance score. Similar to the
existing provision at Sec. 425.502(f)(3), we propose to specify that
we would apply determinations made under the Quality Payment Program
with respect to whether an extreme and uncontrollable circumstance has
occurred, and the affected areas. Consistent with the existing policy
under Sec. 425.502(f)(4), this new provision would also specify that
we have sole discretion to determine the time period during which an
extreme and uncontrollable circumstance occurred, the percentage of the
ACO's assigned beneficiaries residing in the affected areas, and the
location of the ACO legal entity.
h. Proposed Technical Changes To Incorporate References to Revised
Quality Performance Standard
We propose to make certain technical, conforming changes to the
following provisions to reflect our proposal to add new sections of the
regulations at Sec. 425.510 on the application of the APP to Shared
Savings Program ACOs for performance years beginning on or after
January 1, 2021, and Sec. 425.512 on determining the ACO quality
performance standard for performance years beginning on or after
January 1, 2021.
Under subpart A, which specifies general provisions
governing the Shared Savings Program:
++ In Sec. 425.100(b), the general description of ACOs that are
eligible to receive payments for shared savings under the program would
be revised for clarity and to add a reference to Sec. 425.512. In the
description of the quality performance standard that must be met for
the ACO to be receive payment for shared savings, we propose to specify
that the quality performance standards established under Sec. 425.500
are applicable for performance years (or a performance period)
beginning on or before January 1, 2020, and that the proposed quality
performance standard under Sec. 425.512 is applicable for performance
years beginning on or after January 1, 2021.
++ In Sec. 425.112(b)(2)(i), the provision specifying the ACO must
have processes to promote patient engagement including to address
compliance with patient experience of care survey requirements, would
be revised to add a reference to Sec. 425.510.
Under subpart C, which governs application procedures and
the participation agreement, we would add a reference to Sec. 425.510
in the provision at Sec. 425.200(d) specifying that ACOs must submit
measures in the form and manner required by CMS.
Under subpart D, which specifies program requirements and
beneficiary protections, we would add a reference to Sec. 425.510 in
Sec. 425.302(a)(1) specifying requirements for data submission and
certification.
Under subpart G, which specifies the program's financial
models for determining shared savings and shared losses (as
applicable), we propose to revise the description of program
requirements that phase-in over multiple agreement periods in Sec.
425.600(f)(4). Under the proposed revisions to the quality performance
standard, measurement of an ACO's quality performance would no longer
phase-in over the course of the ACO's first agreement period from pay-
for-reporting in the first performance year to pay-for-performance in
all subsequent performance years; rather, all ACOs, regardless of
performance year and agreement period, would be scored on all the
measures in the APP. Therefore, we propose to revise Sec.
425.600(f)(4)(i) to specify that the reference to the quality
performance standard as described in Sec. 425.502(a) is applicable for
performance years (or a performance period) beginning on or before
January 1, 2020.
Under subpart I, which governs the reconsideration review
process, we would add references to Sec. 425.510, Sec. 425.512, or
both to Sec. 425.800(a)(1), (a)(2) and (a)(6).
2. Revisions to the Definition of Primary Care Services Used in Shared
Savings Program Beneficiary Assignment
a. Healthcare Common Procedure Coding System (HCPCS) and Current
Procedural Terminology (CPT) Codes Used in Assignment
(1) Background
Section 1899(c)(1) of the Act, as amended by the 21st Century Cures
Act and the Bipartisan Budget Act of 2018, provides that for
performance years beginning on or after January 1, 2019, the Secretary
shall assign beneficiaries to an ACO based on their utilization of
primary care services provided by a physician who is an ACO
professional and all services furnished by Rural Health Clinics (RHCs)
and Federally Qualified Health Centers (FQHCs). However, the statute
does not specify which kinds of services may be considered primary care
services for purposes of beneficiary assignment.
In the November 2011 final rule (76 FR 67853), we established the
initial list of services, identified by CPT and HCPCS codes, that we
considered to be primary care services. In that final rule, we
indicated that we intended to monitor CPT and HCPCS codes and would
consider making changes to the definition of primary care services to
add or delete codes used to identify primary care services, if there
were sufficient evidence that revisions were warranted. We have updated
the list of primary care service codes in subsequent rulemaking to
reflect additions or modifications to the codes that have been
recognized for payment under the Medicare PFS and to incorporate other
changes to the definition of primary care services for purposes of the
Shared Savings Program.
In the June 2015 final rule (80 FR 32746 through 32748), we
expanded the definition of primary care services to include two
transitional care management (TCM) codes (CPT codes 99495 and 99496),
and one chronic care management (CCM) code (CPT 99490). As discussed in
the final rule, the TCM codes were established to pay a patient's
physician or practitioner to coordinate the patient's care in the 30
days following a hospital or SNF stay. Including these codes in the
definition of primary care services reflects our belief that the work
of community physicians and practitioners in managing a patient's care
following discharge from a hospital or nursing facility (NF) to ensure
better continuity of care for these patients and help reduce avoidable
readmissions is a key aspect of primary care.
In the CY 2016 PFS final rule (80 FR 71270 through 71273), we
revised the definition of primary care services to exclude services
billed under CPT codes 99304 through 99318, containing the place of
service 31 modifier specifying that the service was furnished in a SNF.
We also revised the definition of primary care services to include
claims submitted by Electing Teaching Amendment (ETA) hospitals.
In the CY 2018 PFS final rule, we revised the definition of primary
care services to include three additional CCM service codes, 99487,
99489, and
[[Page 50242]]
G0506, and four behavioral health integration (BHI) service codes,
G0502, G0503, G0504 and G0507 (82 FR 53212 and 53213). We further
revised the definition of primary care services in the November 2018
final rule. In the November 2018 final rule, we added new codes to the
definition of primary care services (CPT codes 99497, 99498, 96160,
96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443), and
revised how we determine whether services identified by CPT codes 99304
through 99318 were furnished in a SNF (83 FR 59964 through 59968).
For performance years beginning on January 1, 2019, and subsequent
performance years, we defined primary care services in Sec.
[thinsp]425.400(c)(1)(iv) for purposes of assigning beneficiaries to
ACOs under Sec. [thinsp]425.402 as the set of services identified by
the following HCPCS/CPT codes:
CPT codes:
(1) 99201 through 99215 (codes for office or other outpatient visit
for the evaluation and management of a patient).
(2) 99304 through 99318 (codes for professional services furnished
in a NF; services identified by these codes furnished in a SNF are
excluded).
(3) 99319 through 99340 (codes for patient domiciliary, rest home,
or custodial care visit).
(4) 99341 through 99350 (codes for evaluation and management
services furnished in a patients' home for claims identified by place
of service modifier 12).
(5) 99487, 99489 and 99490 (codes for chronic care management).
(6) 99495 and 99496 (codes for transitional care management
services).
(7) 99497 and 99498 (codes for advance care planning).
(8) 96160 and 96161 (codes for administration of health risk
assessment).
(9) 99354 and 99355 (add-on codes, for prolonged evaluation and
management or psychotherapy services beyond the typical service time of
the primary procedure; when the base code is also a primary care
service code).
(10) 99484, 99492, 99493 and 99494 (codes for behavioral health
integration services).
HCPCS codes:
(1) G0402 (the code for the Welcome to Medicare visit).
(2) G0438 and G0439 (codes for the annual wellness visits).
(3) G0463 for services furnished in ETA hospitals.
(4) G0506 (code for chronic care management).
(5) G0444 (codes for annual depression screening service).
(6) G0442 (code for alcohol misuse screening service).
(7) G0443 (code for alcohol misuse counseling service).
In the May 8th COVID-19 IFC (85 FR 27582 through 27586), we revised
the regulations to add Sec. 425.400(c)(2), specifying the definition
of primary care services for purposes of beneficiary assignment for the
performance year starting on January 1, 2020, and for any subsequent
performance year that starts during the COVID-19 PHE defined in Sec.
400.200, to include the foregoing codes specified in Sec.
[thinsp]425.400(c)(1)(iv), as well as specified codes for remote
evaluations, virtual check-ins, e-visits, and telephone evaluation and
management services.
(2) Proposed Revisions
Based on feedback from ACOs and our further review of the HCPCS and
CPT codes currently recognized for payment under the PFS, we believe it
would be appropriate to amend the definition of primary care services
used in the Shared Savings Program assignment methodology to include
certain additional codes and make other technical changes to the
definition of primary care services, for use in determining beneficiary
assignment for the performance year starting on January 1, 2021, and
subsequent performance years.
We propose to revise the definition of primary care services in the
Shared Savings Program regulations to include the following additions:
(1) Online digital evaluation and management CPT codes 99421, 99422,
and 99423; (2) assessment of and care planning for patients with
cognitive impairment CPT code 99483; (3) chronic care management code
CPT code 99491; (4) non-complex chronic care management HCPCS code
G2058 and its proposed replacement CPT code, if finalized through the
CY 2021 PFS rulemaking; (5) principal care management HCPCS codes G2064
and G2065; and (6) psychiatric collaborative care model HCPCS code
GCOL1, if finalized through the CY 2021 PFS rulemaking.
The following provides additional information about the CPT and
HCPCS codes that we are proposing to add to the definition of primary
care services used in assignment:
Online Digital Evaluation and Management Services (CPT
codes 99421, 99422, and 99423): In the CY 2020 PFS final rule (84 FR
62797), we finalized payment for new online digital assessment
services, also referred to as ``E-Visits,'' beginning in CY 2020 for
practitioners billing under the PFS. These services are non-face-to-
face, patient-initiated communications using online patient portals.
These digital assessment services are for established patients who
require a clinical decision that otherwise typically would have been
provided in the office. Practitioners who may independently bill
Medicare for evaluation and management (E/M) services (for instance,
physicians and NPs) can bill the following codes:
++ 99421 (Online digital evaluation and management service, for an
established patient, for up to 7 days, cumulative time during the 7
days; 5-10 minutes.)
++ 99422 (Online digital evaluation and management service, for an
established patient, for up to 7 days cumulative time during the 7
days; 11-20 minutes.)
++ 99423 (Online digital evaluation and management service, for an
established patient, for up to 7 days, cumulative time during the 7
days; 21 or more minutes.)
In the May 8th COVID-19 IFC (85 FR 27583), we stated that we
believe it is appropriate to include these CPT and HCPCS codes in the
definition of primary care services used for assignment for PY 2020 and
any subsequent performance year that starts during the COVID-19 PHE
because the services represented by these codes are being used in place
of similar E/M services, the codes for which are already included in
the list of codes used for assignment. We also explained our belief
that it is important to include these services in our assignment
methodology because we determine assignment to ACOs based upon where
beneficiaries receive the plurality of their primary care services or
whether they have designated an ACO professional as their primary
clinician, responsible for their overall care, and hold ACOs
accountable for the resulting assigned beneficiary population.
Subsequent to the publication of the May 8th COVID-19 IFC, we have
determined, based on the justification above, that these codes should
be included in the definition of primary care services under Sec.
425.400(c) permanently for purposes of determining beneficiary
assignment for the performance year starting on January 1, 2021, and
subsequent performance years, and should not be linked to the duration
of the COVID-19 PHE.
Assessment of and care planning for patients with
cognitive impairment (CPT code 99483): In the CY 2017 PFS final rule
(81 FR 80252-54), we finalized a G-code that would provide separate
payment to recognize the work of a physician (or other appropriate
[[Page 50243]]
billing practitioner) in assessing and creating a care plan for
beneficiaries with cognitive impairment, such as from Alzheimer's
disease or dementia, at any stage of impairment, G0505 (Cognition and
functional assessment using standardized instruments with development
of recorded care plan for the patient with cognitive impairment,
history obtained from patient and/or caregiver, in office or other
outpatient setting or home or domiciliary or rest home). In the CY 2018
PFS final rule (82 FR 53077), we deleted the interim HCPCS code G0505
and replaced it with CPT code 99483 (Assessment of and care planning
for a patient with cognitive impairment, requiring an independent
historian, in the office or other outpatient, home or domiciliary or
rest home, with all of the following required elements: Cognition-
focused evaluation including a pertinent history and examination;
Medical decision making of moderate or high complexity; Functional
assessment (e.g., Basic and Instrumental Activities of Daily Living),
including decision-making capacity; Use of standardized instruments for
staging of dementia (e.g., Functional Assessment Staging Test [FAST],
Clinical Dementia Rating [CDR]); Medication reconciliation and review
for high-risk medications; Evaluation for neuropsychiatric and
behavioral symptoms, including depression, including use of
standardized screening instrument(s); Evaluation of safety (e.g.,
home), including motor vehicle operation; Identification of
caregiver(s), caregiver knowledge, caregiver needs, social supports,
and the willingness of caregiver to take on caregiving tasks;
Development, updating or revision, or review of an Advance Care Plan;
Creation of a written care plan, including initial plans to address any
neuropsychiatric symptoms, neuro-cognitive symptoms, functional
limitations, and referral to community resources as needed (e.g.,
rehabilitation services, adult day programs, support groups) shared
with the patient and/or caregiver with initial education and support.
Typically, 50 minutes are spent face-to-face with the patient and/or
family caregiver).
CPT code 99483 includes the same elements included in the Level 5
E/M service CPT code 99215, such as, a comprehensive history,
comprehensive exam, and high complexity medical decision-making. CPT
code 99215 is included in the definition of primary care services used
for assignment. Accordingly, we believe it would be appropriate to also
include CPT code 99483 in the definition of primary care services used
for assignment under Sec. 425.400(c) for the performance year starting
on January 1, 2021, and subsequent performance years.
Chronic Care Management (CPT code 99491): In the CY 2019
PFS final rule (83 FR 59577), we finalized CPT code 99491 (Chronic care
management services, provided personally by a physician or other
qualified healthcare professional, at least 30 minutes of physician or
other qualified health care professional time, per calendar month, with
the following required elements: Multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline;
comprehensive care plan established, implemented, revised, or
monitored). This code requires two or more chronic conditions that
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, and that a comprehensive care
plan has been established, implemented, revised or monitored by the
billing practitioner for such patient. In earlier rulemaking, we
finalized the inclusion of CCM CPT codes 99487, 99489, and 99490 (codes
for chronic care management) in the definition of primary care services
for the Shared Savings Program. Refer to the June 2015 final rule (80
FR 32746 through 32748), and CY 2018 PFS final rule (82 FR 53212
through 53213). ``Non-complex'' CCM services (CPT codes 99490 and
99491), and ``complex'' CCM services (CPT codes 99487 and 99489) share
a common set of service elements, including the following: (1)
Initiating visit, (2) structured recording of patient information using
certified electronic health record technology (EHR), (3) 24/7 access to
physicians or other qualified health care professionals or clinical
staff and continuity of care, (4) comprehensive care management
including systematic assessment of the patient's medical, functional,
and psychosocial needs, (5) comprehensive care plan including a
comprehensive care plan for all health issues with particular focus on
the chronic conditions being managed, and (6) management of care
transitions. They differ in the amount of clinical staff service time
provided, the involvement and work of the billing practitioner, and the
extent of care planning performed.\42\ CPT code 99491 includes only
time that is spent personally by the billing practitioner. Clinical
staff time is not counted towards the required time threshold for
reporting this code, whereas CPT codes 99487, 99489, and 99490 include
time spent directly by the billing practitioner and by other clinical
staff that counts toward the threshold clinical staff time required to
be spent during a given month. Accordingly, CPT code 99491 cannot be
reported for a beneficiary by a billing practitioner in the same month
as CCM codes 99487, 99489, or 99490. Therefore, we believe it would be
appropriate to propose to include CCM CPT code 99491 in the definition
of primary care services under Sec. 425.400(c) for the performance
year starting on January 1, 2021, and subsequent performance years, in
order to capture these CCM services when attributing beneficiaries to
an ACO.
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\42\ Refer to CMS Medicare Learning Network, MLN Booklet
``Chronic Care Management Services'' (ICN MLN909188, July 2019);
available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement.pdf.
---------------------------------------------------------------------------
Non-Complex CCM (HCPCS code G2058 and its proposed
replacement CPT code): In the CY 2020 PFS final rule (84 FR 62690), we
finalized the creation of HCPCS code G2058 (Chronic care management
services, each additional 20 minutes of clinical staff time directed by
a physician or other qualified health care professional, per calendar
month (List separately in addition to code for primary procedure). (Do
not report G2058 for care management services of less than 20 minutes
additional to the first 20 minutes of chronic care management services
during a calendar month). (Use G2058 in conjunction with 99490). (Do
not report 99490, G2058 in the same calendar month as 99487, 99489,
99491)) for additional time spent beyond the initial 20 minutes
included in the current coding for CCM services. As described elsewhere
in this proposed rule, we are proposing the adoption of the permanent
CPT code to replace HCPCS code G2058. As described in previous
rulemaking, practitioners who choose to use G2058 can report the
initial 20 minutes of non-complex CCM under CPT code 99490 and receive
increased payment for their work under HCPCS code G2058 (84 FR 62690).
Since CPT code 99490 is currently included in the Shared Savings
Program's definition of primary care services under Sec.
425.400(c)(1)(iv), we are proposing to add G2058 to the definition,
effective for performance years starting on or after January 1, 2021,
because the services furnished during the additional time billed under
HCPCS code G2058, would be expected to be substantially similar to the
services furnished under CPT code 99490, and thus should also be
[[Page 50244]]
considered for purposes of assignment under Sec. 425.400 for the
performance year starting on January 1, 2021, and subsequent
performance years. If the proposal to adopt the permanent CPT code to
replace HCPCS code G2058 is finalized, we would instead include that
CPT code in the definition of primary care services used for purposes
of assignment under Sec. 425.400(c) for the performance year starting
on January 1, 2021, and subsequent performance years.
Principal Care Management (HCPCS codes G2064 and G2065):
The CY 2020 PFS final rule (84 FR 62692 through 62697) introduced two
new HCPCS codes (G2064 and G2065) for Principal Care Management (PCM)
services. G2064 (Comprehensive care management services for a single
high-risk disease, e.g., principal care management, at least 30 minutes
of physician or other qualified health care professional time per
calendar month with the following elements: One complex chronic
condition lasting at least 3 months, which is the focus of the care
plan, the condition is of sufficient severity to place patient at risk
of hospitalization or have been the cause of a recent hospitalization,
the condition requires development or revision of disease-specific care
plan, the condition requires frequent adjustments in the medication
regimen, and/or the management of the condition is unusually complex
due to comorbidities), for use by physicians and non-physician
practitioners (NPPs), and G2065 (Comprehensive care management for a
single high-risk disease services, e.g. principal care management, at
least 30 minutes of clinical staff time directed by a physician or
other qualified health care professional, per calendar month with the
following elements: One complex chronic condition lasting at least 3
months, which is the focus of the care plan, the condition is of
sufficient severity to place patient at risk of hospitalization or have
been cause of a recent hospitalization, the condition requires
development or revision of disease-specific care plan, the condition
requires frequent adjustments in the medication regimen, and/or the
management of the condition is unusually complex due to comorbidities),
for use by clinical staff.
We expect that most services billed under these codes will be
billed by specialists who are focused on managing patients with a
single complex chronic condition requiring substantial care management.
HCPCS code G2064 would be reported when, during the calendar month, at
least 30 minutes of physician or other qualified health care
professional time is spent on comprehensive care management for a
single high-risk disease or complex chronic condition. HCPCS code G2065
would be reported when, during the calendar month, at least 30 minutes
of clinical staff time is spent on comprehensive management for a
single high-risk disease or complex chronic condition. Comprehensive
care management codes require patients to have two or more chronic
conditions and are primarily billed by practitioners who are managing a
patient's total care over a month, including primary care practitioners
and some specialists, such as cardiologists or nephrologists. By
contrast, PCM services involve care management services for one serious
chronic condition, typically expected to last between 3 months and a
year, or until the death of the patient, that may have led to a recent
hospitalization, and/or places the patient at significant risk of
death, acute exacerbation/decompensation, or functional decline.
Specifically, we stated in the CY 2020 PFS final rule (84 FR 62693
through 62697) that we agree that the relativity between CCM CPT codes
99490 and 99491 should be preserved in PCM HCPCS codes G2064 and G2065
and crosswalked the relative value units for G2064 and G2065 to 99491
and 99490, respectively. Due to the similarity between the description
of the PCM and CCM services, both of which involve non-face-to-face
care management services, we finalized that the full CCM scope of
service requirements apply to PCM, including documenting the patient's
verbal consent in the medical record. CCM services billed under code
99490 are currently included in the Shared Savings Program's definition
of primary care services under Sec. 425.400(c)(1)(iv), and as
discussed previously, we are proposing to include CCM services billed
under code 99491 for performance years starting on or after January 1,
2021; therefore, for the foregoing reasons, we also propose to add
G2064 and G2065 to the definition of primary care services for the
performance year starting on January 1, 2021, and subsequent
performance years.
Psychiatric collaborative care model HCPCS code GCOL1: In
the CY 2017 PFS final rule (81 FR 80230-36), we established G-codes
used to bill for monthly services furnished using the Psychiatric
Collaborative Care Model (CoCM), an evidence-based approach to
behavioral health integration that enhances ``usual'' primary care by
adding care management support and regular psychiatric inter-specialty
consultation. These G-codes were replaced by CPT codes 99484, 99492,
99493, and 99494, which we established for payment under the PFS in the
CY 2018 PFS final rule (82 FR 53077 and 53078).
Elsewhere in this proposed rule, we are proposing to add a new
HCPCS code GCOL1 (Initial or subsequent psychiatric collaborative care
management, first 30 minutes in a month of behavioral health care
manager activities, in consultation with a psychiatric consultant, and
directed by the treating physician or other qualified health care
professional) in response to stakeholders who have requested additional
coding to capture shorter increments of time spent, for example, when a
patient is seen for services, but is then hospitalized or referred for
specialized care, and the number of minutes required to bill for
services using the current coding is not met. Specifically, we are
proposing to establish a G-code to describe 30 minutes of behavioral
health care manager time. This code would describe one-half of the time
described by the existing code that describes subsequent months of CoCM
services, CPT code 99493 (Subsequent psychiatric collaborative care
management, first 60 minutes in a subsequent month of behavioral health
care manager activities, in consultation with a psychiatric consultant,
and directed by the treating physician or other qualified health care
professional, with the following required elements:
Tracking patient follow-up and progress using the
registry, with appropriate documentation; participation in weekly
caseload consultation with the psychiatric consultant;
Ongoing collaboration with and coordination of the
patient's mental health care with the treating physician or other
qualified health care professional and any other treating mental health
providers;
Additional review of progress and recommendations for
changes in treatment, as indicated, including medications, based on
recommendations provided by the psychiatric consultant;
Provision of brief interventions using evidence-based
techniques such as behavioral activation, motivational interviewing,
and other focused treatment strategies;
Monitoring of patient outcomes using validated rating
scales; and