[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Proposed Rules]
[Pages 20800-20805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07525]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 512
[CMS-5527-P2]
RIN 0938-AT89
Radiation Oncology (RO) Model
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services, (HHS).
ACTION: Proposed rule.
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SUMMARY: We are proposing to delay the current start date of the RO
Model to a date to be determined through future rulemaking, and to
modify the definition of the model performance period to provide that
the start and end dates of the model performance period for the RO
Model will be established in future rulemaking.
DATES: To be assured consideration, comments must be received at one of
the addresses specified in the ADDRESSES section, by June 7, 2022.
ADDRESSES: In commenting, please refer to file code CMS-5527-P2.
Comments, including mass comment submissions, must be submitted in
one
[[Page 20801]]
of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to https://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-5527-P2, P.O. Box 8013,
Baltimore, MD 21244-8013.
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-5527-P2, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Rebecca Cole at Contact
[email protected] or 1-844-711-2664, Option 5.
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: https://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm any individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
We are committed to promoting higher quality of cancer care and
improving outcomes for Medicare beneficiaries while reducing costs. As
part of that effort, the Biden-Harris Administration has taken a number
of steps to improve the care of Medicare cancer patients, most notably
with the President's cancer agenda and the Cancer Moonshot.
Additionally, the CMS Innovation Center's Oncology Care Model (OCM)
focuses on patients with cancer who receive chemotherapy. In late 2019,
the CMS Innovation Center released an informal Request for Information
on a potential future oncology value-based model after OCM ends, and we
look forward to providing additional information as soon as possible.
In December 2015, Congress passed the Patient Access and Medicare
Protection Act (Pub. L. 114-115) and section 3(b) of this legislation
required the Secretary of the Department of Health and Human Services
to submit to Congress a report, no later than 18 months after
enactment, on ``the development of an episodic alternative payment
model'' for payment under the Medicare program for radiation therapy
(RT) services. We released the 2017 Report To Congress: ``Episodic
Alternative Payment Model for Radiation Therapy Services,'' which laid
out the potential for reforming the way Medicare pays for radiation
oncology. Based on that work, using our authority under section 1115A
of the Social Security Act, we published a proposed rule, titled
``Medicare Program; Specialty Care Models to Improve Quality of Care
and Reduce Expenditures'' (84 FR 34478), which included a proposal for
implementing a mandatory model for radiation oncology services (the RO
Model) (84 FR 34490 through 34535). The RO Model was designed to test
whether making site-neutral, prospective, episode-based payments to
hospital outpatient departments, physician group practices, and
freestanding radiation therapy centers for RT episodes of care would
preserve or enhance the quality of care furnished to Medicare
beneficiaries while reducing or maintaining Medicare program spending.
We published a final rule titled ``Medicare Program; Specialty Care
Models to Improve Quality of Care and Reduce Expenditures'' that
appeared in the September 29, 2020 Federal Register (85 FR 61114)
(hereinafter referred to as the ``Specialty Care Models final rule'').
In that final rule, we codified policies at 42 CFR part 512 subparts A
and B that included a finalized RO Model with a model performance
period that was to begin January 1, 2021 and end December 31, 2025 (85
FR 61367). We finalized that each performance year (PY) would be the
12-month period beginning on January 1 and ending on December 31 of
each calendar year (CY) during the model performance period, and no new
RO episodes may begin after October 3, 2025, in order for all RO
episodes to end by December 31, 2025.
Due to the public health emergency for the Coronavirus disease 2019
(COVID-19) pandemic, we revised the RO Model's model performance period
at 42 CFR 512.205 to begin on July 1, 2021, and to end December 31,
2025 giving RO participants an additional 6 months to prepare for the
RO Model. We implemented the revised model period via interim final
regulations included in the final rule with comment period and interim
final rule with comment period that appeared in the December 29, 2020
Federal Register titled ``Medicare Program: Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems and
Quality Reporting Programs; New Categories for Hospital Outpatient
Department Prior Authorization Process; Clinical Laboratory Fee
Schedule: Laboratory Date of Service Policy; Overall Hospital Quality
Star Rating Methodology; Physician-owned Hospitals; Notice of Closure
of Two Teaching Hospitals and Opportunity To Apply for Available Slots,
Radiation Oncology Model; and Reporting Requirements for Hospitals and
Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic
Inventory and Usage and to Report Acute Respiratory Illness During the
Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)''
(85 FR 85866) (hereinafter referred to as ``CY 2021 OPPS/ASC IFC'').
Section 133 of the Consolidated Appropriations Act (CAA), 2021
(Pub. L. 116-260) (hereinafter referred to as ``CAA, 2021''), enacted
on December 27, 2020, included a provision that prohibited
implementation of the RO Model before January 1, 2022. This
Congressional action superseded the start date of the model performance
period of July 1, 2021 established in the CY 2021 OPPS/ASC IFC. To
align the RO Model regulations with the requirements of the CAA, 2021,
we proposed to modify the definition of ``model performance period'' in
42 CFR 512.205 to provide for a 5-year model performance period
starting on January 1, 2022, unless the RO Model is prohibited by law
from starting on January 1, 2022, in which case the model performance
period would begin on the earliest date permitted by law that is
January 1, April 1, or July 1. We also proposed other modifications
both related to and unrelated to the timing of the RO Model in the
proposed rule that appeared in the August 4, 2021 Federal Register
titled ``Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical
[[Page 20802]]
Center Payment Systems and Quality Reporting Programs; Price
Transparency of Hospital Standard Charges; Radiation Oncology Model;
Request for Information on Rural Emergency Hospitals'' (86 FR 42018).
These provisions were finalized in a final rule with comment period
titled ``Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; Price Transparency of Hospital Standard Charges; Radiation
Oncology Model'' that appeared in the November 16, 2021 Federal
Register (86 FR 63458) (hereinafter referred to as the ``CY 2022 OPPS/
ASC FC'').
On December 10, 2021, the Protecting Medicare and American Farmers
from Sequester Cuts Act (Pub. L. 117-71) was enacted, which included a
provision that prohibits implementation of the RO Model prior to
January 1, 2023. The November 2021 final rule with comment specified
that the model performance period would begin on January 1, 2022 unless
the RO Model was prohibited by law from beginning on January 1, 2022,
in which case the model performance period would begin on the earliest
date permitted by law that is January 1, April 1, or July 1. As a
result, under the current definition for model performance period at 42
CFR 512.205, the RO Model will start on January 1, 2023, because that
date is the earliest date permitted by law. Given the multiple delays
to date, and because both CMS and RO participants must invest
operational resources in preparation for implementation of the RO
Model, we have considered how best to proceed under these
circumstances.
II. Provisions of the Proposed Regulations
A. Proposed Model Performance Period
We continue to believe that the RO Model would address long-
standing concerns related to RT delivery and payment, including the
lack of site neutrality for payments, incentives that encourage volume
of services over the value of services, and coding and payment
challenges. We believe the RO Model would provide payment stability and
promote high-quality care for Medicare beneficiaries. We note that we
have heard that the RO Model is valuable and needed in the radiation
oncology space from some stakeholders and that some RT providers and RT
suppliers selected to be RO participants are dedicated to preparing for
implementation of the RO Model.
However, given that there have been two legislative delays of the
RO Model, the operational resources required of CMS and RO participants
to continue to prepare for the RO Model before it can be implemented,
and some stakeholders' comments that they would not support the RO
Model unless specific changes were made, we are proposing to delay the
start of the RO Model to a date to be determined through future
rulemaking and to modify the definition of model performance period at
42 CFR 512.205 to reflect this policy. We would plan to propose a start
date through rulemaking and modify the definition of model performance
period at 42 CFR 512.205 to reflect this proposed start date no less
than 6 months prior to that proposed start date.
As noted previously, Congress has delayed the RO Model twice. There
is a substantial cost to continue funding preparation for
implementation of the RO Model in 2023. For example, funding is needed
for CMS to prepare for participant onboarding, claims systems changes,
and updates to the data used in the Model's design and participant-
specific payment amounts, among a number of other activities. The cost
of the operational funding needed to continue to prepare to implement
the RO Model takes resources away from the development of other
alternative payment models, particularly when it is not known whether
there may be further legislative delays to the start of the RO Model.
Additionally, those entities selected to be RO participants
continue to make good faith efforts to prepare to implement the RO
Model, which may involve financial, operational, and administrative
investment and resources. Given multiple delays and uncertainty about
the timing of the RO Model, delaying the RO Model indefinitely will
give RO participants the ability to pause their efforts to prepare for
implementation of the RO Model. We welcome additional dialogue with RO
participants and stakeholders about Medicare payment for RT services.
Further, RO participants and stakeholders have requested additional
changes to the RO Model's payment methodology and to other aspects of
the RO Model design and participation requirements, such as lower
discounts while keeping the geographic scope of the Model the same. In
the CY 2022 OPPS/ASC FC, we summarized comments regarding the
discounts. No commenters agreed with the proposed discounts, and many
commenters recommended that the discounts be set to 3 percent or less.
Those commenters, recommending discounts of 3 percent or less, argued
that this would be more in line with other payment models and ensure
that RO participants have sufficient capital to remain operational and
invest in the necessary resources (human and equipment) to increase
efficiency and enhance beneficiary care. As we have informed
stakeholders, if the discounts are lowered below 3.5 percent for the
professional component and 4.5 percent for the technical component, we
would need to expand the geographic scope of the RO Model to be larger
than 30 percent of Core Based Statistical Areas (CBSAs) (86 FR 63928
and 63929). If the discount amounts are significantly smaller, all else
equal, the projected savings will be smaller, and therefore, the number
of CBSAs (and episodes) in the participant group may not be sufficient
for CMS to detect an effect of the RO Model with statistical
confidence. However, we believe that some stakeholders will not support
the RO Model test moving forward with unchanged discounts and as noted
previously, these stakeholders have also requested that we not increase
the geographic scope of the Model.
Thus, for these reasons, we are proposing to delay the current
start date of the RO Model, and to establish the start and end dates
for the model through future rulemaking, which may also involve
modifications to the model design. We are proposing to modify the
definition of the model performance period at 42 CFR 512.205 to reflect
this proposed delay, by removing the provision that the RO Model begins
on January 1, 2022 and ends on December 31, 2026, unless the RO Model
is prohibited by law from starting on January 1, 2022, in which case
the model performance period begins on the earliest date permitted by
law that is January 1, April 1, or July 1. We are proposing to modify
the definition of model performance period to instead specify that CMS
will establish the start and end dates of the model performance period
for the RO Model through future rulemaking. We note that if we do not
finalize this proposal and instead proceed with a start date of January
1, 2023, we do not plan to change the CBSAs selected for participation
before that start date.
We are soliciting comments on the proposed delay of the RO Model to
a date to be determined through future rulemaking, as well as on our
proposed amendments to the definition of the model performance period
at 42 CFR 512.205 to reflect this proposed delay.
[[Page 20803]]
III. Collection of Information Requirements
As stated in section 1115A(d)(3) of the Social Security Act,
Chapter 35 of title 44, United States Code, shall not apply to the
testing, evaluation, and expansion of CMS Innovation Center Models.
Consequently, there is no need for review by the Office of Management
and Budget under the authority of the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
IV. Regulatory Impact Analysis
A. Statement of Need
The purpose of this proposed rule is to propose to delay the start
of the RO Model to a date yet to be determined, and to modify the
definition of model performance period at 42 CFR 512.205. Delaying the
start of the RO Model to a date yet to be determined does not change
the statement of need for the RO Model as described in the Specialty
Care Models final rule (85 FR 61347) and the CY 2021 OPPS/ASC IFC (85
FR 86296) and again in the CY 2022 OPPS/ASC FC (86 FR 63458).
B. Overall Impact
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
Executive Order 13132 on Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with significant regulatory actions or with economically significant
effects ($100 million or more in any 1 year). Based on our estimates,
OMB's Office of Information and Regulatory Affairs has determined this
rulemaking is ``significant''. Accordingly, we have prepared an RIA
that to the best of our ability presents the costs and benefits of the
rulemaking.
C. Detailed Economic Analysis
Delaying the start of the RO Model to a later undetermined date and
modifying the regulatory text at 42 CFR 512.205 to reflect this would
mean that the annualized/monetarized estimates of costs and transfers
policy for the RO Model presented in the CY 2022 OPPS/ASC FC (86 FR
63986) would not be realized at this time.
Similarly, the burden estimates related to implementation of the RO
Model presented in the Specialty Care Models final rule (85 FR 61358),
the CY 2021 OPPS/ASC IFC (85 FR 86297), and the CY 2022 OPPS/ASC FC (86
FR 63987) would not be realized at this time.
The regulatory impact analysis of the CY 2022 OPPS/ASC FC estimated
that on net the RO Model would reduce Medicare spending by $150 million
over the 5-year model performance period. This amount is the net
Medicare Part B impact that includes both Part B premium and Medicare
Advantage United States Per Capita Costs (MA USPCC) rate financing
interaction effects. This estimate excludes changes in beneficiary cost
sharing liability to the extent it is not a Federal outlay under the
policy. These potential impacts were estimated to occur beginning on
January 1, 2022 through December 31, 2026, in alignment with a January
1, 2022 model start. Table 1 summarizes the estimated impact of the RO
Model with a model performance period that would have begun January 1,
2022, and ended December 31, 2026. Table 2 provides additional
information about those expected impacts by year. However, because the
RO Model was not implemented on January 1, 2022, as contemplated in the
CY 2022 OPPS/ASC FC, such effects have yet not occurred.
Table 1--Estimates of Medicare Program Savings (Millions $) for Radiation Oncology Model
[Starting January 1, 2022]
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Year of model
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2022 2023 2024 2025 2026 Total *
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Net Impact to Medicare Program Spending................. -20 -30 -20 -40 -40 -150
Changes to Incurred FFS Spending........................ -20 -20 -20 -30 -30 -120
Changes to MA Capitation Payments....................... 0 -20 -20 -20 -30 -80
Part B Premium Revenue Offset........................... 0 10 10 10 10 50
Total APM Incentive Payments............................ 0 0 10 0 0 10
Episode Allowed Charges................................. 830 860 900 930 970 4,490
Episode Medicare Payment................................ 650 670 700 730 750 3,500
Total Number of Episodes................................ 53,300 54,900 56,400 58,000 59,600 282,200
Total Number of Beneficiaries........................... 51,900 53,500 54,900 56,500 58,100 250,200
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* Negative spending reflects a reduction in Medicare spending, while positive spending reflects an increase.
* Totals may not sum due to rounding and from beneficiaries that have cancer treatment spanning multiple years.
[[Page 20804]]
Table 2--Radiation Oncology Model PGP (Including Freestanding Radiation Therapy Centers) vs Hopd Allowed Charge Impacts 2022 to 2026 as Compared to
Those Not Participating in the RO Model
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2022 2023 2024 2025 2026 2022 to 2026
% Impact (percent) (percent) (percent) (percent) (percent) (percent)
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PGP (including freestanding radiation therapy centers).. 3.1 4.5 6.0 7.4 8.9 6.3
HOPD.................................................... -7.8 -8.8 -9.6 -10.6 -11.6 -9.9
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Nevertheless, and notwithstanding the RO Model delay, the analysis
uses a baseline in which the RO Model provisions of the CY 2022 OPPS/
ASC FC were effective on January 1, 2022, to calculate the monetized
estimates of the effects of this proposed rule. We maintain the
analytical approach described in the regulatory impact analysis of the
CY 2022 OPPS/ASC FC, and, for the purposes of quantifying the effects
of this proposed rule, we assume that the regulations at 42 CFR part
512 subpart B as amended by the CY 2022 OPPS/ASC FC will be in full
effect if this proposed rule is not finalized. As a result of the delay
of the start of the RO Model to a date yet to be determined, this
proposed rule would, if finalized, prevent the occurrence of the
estimated savings presented in Table 90 of the CY 2022 OPPS/ASC FC at
this time. We summarize this result in Table 1 in this section, which
illustrates, inversely, the net monetized estimates contained in Table
90 of the CY 2022 OPPS/ASC FC. The period covered shown in Table 1
begins January 2022 in alignment with Table 90 of the CY 2022 OPPS/ASC
FC.
As required by OMB Circular A-4 (available at the Office of
Management and Budget website at: https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), we have prepared an
accounting statement in Table 3 showing the classification of the
impact associated with the provisions of this proposed rule.
Table 3--Accounting Statement: Estimated Impacts From CY 2022 to CY 2026 as a Result of Provisions of This
Proposed Rule
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Units
Estimates -----------------------------------------------
Category (million) Discount rate Period
Year dollar (percent) covered
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Transfers:
Annualized Monetized ($million/year)........ $27 2020 7 2022-2026
29 2020 3 2022-2026
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From Whom to Whom............................... From the Federal Government to healthcare providers.
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D. Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other health care providers and
suppliers are small entities, either by nonprofit status or by having
revenues of less than $8 million to $41.5 million in any 1 year.
Individuals and states are not included in the definition of a small
entity. For details, see the Small Business Administration's ``Table of
Small Business Size Standards'' at https://www.sba.gov/document/support--table-size-standards.
As its measure of significant economic impact on a substantial
number of small entities, HHS uses a change in revenue of more than 3
to 5 percent. If finalized, the impact in this proposed rule as
described the CY 2022 OPPS/ASC FC would not occur. Instead, payment for
submitted claims would be made under the applicable Medicare payment
methodology. As a result, the Secretary has determined that this
proposed rule will not have a significant impact on a substantial
number of small entities.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 603 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. We are not preparing
an analysis for section 1102(b) of the Act because we have determined,
and the Secretary certifies, that the RO Model will not have a
significant impact on the operations of a substantial number of small
rural hospitals.
We welcome comments on our estimate of significantly affected
providers and suppliers and the magnitude of estimated effects for this
proposed rule.
E. Unfunded Mandates Reform Act (UMRA)
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2022, that
threshold is approximately $165 million. This proposed rule does not
mandate any requirements for State, local, or tribal governments, or
for the private sector.
F. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This rule would not have a substantial direct effect on
state or local governments, preempt state law, or otherwise have a
Federalism
[[Page 20805]]
implication because the RO Model is a Federal payment model impacting
Federal payments only and does not implicate local governments or state
law. Therefore, the requirements of Executive Order 13132 are not
applicable.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this proposed
rule, and, when we proceed with a subsequent document, we will respond
to the comments in the preamble to that document.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on March 31, 2022.
List of Subjects in 42 CFR 512
Administrative practice and procedure, Health facilities, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble and under the authority
at 42 U.S.C. 1302, 1315a, and 1395hh, the Centers for Medicare &
Medicaid Services proposes to amend 42 CFR chapter IV part 512 as set
forth below:
PART 512--RADIATION ONCOLOGY MODEL AND END STAGE RENAL DISEASE
TREATMENT CHOICES MODEL
0
1. The authority citation for part 512 continues to read as follows:
Authority: 42 U.S.C. 1302, 1315a, and 1395hh.
0
2. Section 512.205 is amended by revising the definition of ``model
performance period'' to read as follows:
Sec. 512.205 Definitions
* * * * *
Model performance period means the 5 performance years (PYs) during
which RO episodes initiate and terminate. CMS will establish the start
and end dates of the model performance period for the RO Model through
future rulemaking.
* * * * *
Dated: April 5, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-07525 Filed 4-6-22; 4:15 pm]
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