Radiation Oncology (RO) Model, 52698-52704 [2022-18541]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Rules and Regulations]
[Pages 52698-52704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 512

[CMS-5527-F2]
RIN 0938-AT89


Radiation Oncology (RO) Model

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: We are finalizing our proposal 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: These regulations are effective on October 28, 2022.

FOR FURTHER INFORMATION CONTACT: Genevieve Kehoe, 
[email protected], or 1-844-711-2664 Option 5, for questions 
related to the Radiation Oncology Model.

SUPPLEMENTARY INFORMATION:

[[Page 52699]]

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 Administration has taken a number of 
efforts to improve the care of Medicare cancer patients, most notably 
with the President's cancer agenda and the Cancer Moonshot, as well as 
the CMS Innovation Center's Oncology Care Model \1\ and Enhancing 
Oncology Model,\2\ which focus on patients with cancer who receive 
chemotherapy.
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    \1\ https://innovation.cms.gov/innovation-models/oncology-care.
    \2\ https://innovation.cms.gov/innovation-models/enhancing-oncology-model.
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    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 (the Act), we published a proposed rule, 
titled ``Medicare Program; Specialty Care Models to Improve Quality of 
Care and Reduce Expenditures'', which appeared in the Federal Register 
on July 18, 2019 (84 FR 34478), and included a proposal for 
implementing a mandatory model for radiation oncology services 
(hereinafter referred to as 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 
(HOPDs), physician group practices (PGPs), 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. More specifically, as described 
in the 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 61115) (hereinafter referred 
to as the ``Specialty Care Models final rule''), the RO Model was 
designed to include prospective payments for certain RT services 
furnished during a 90-day RO episode for included cancer types for 
certain Medicare beneficiaries. The Model was designed to test the 
cost-saving potential of prospective episode payments for certain RT 
services furnished during an RO episode and whether shorter courses of 
RT (that is, fewer doses, also known as fractions) will encourage more 
efficient care delivery and incentivize higher value care.
    In the Specialty Care Models 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 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 CY 2022 OPPS/ASC FC specified that if the RO Model 
was prohibited by law from beginning on January 1, 2022, 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 
would start on January 1, 2023, because that date is the earliest date 
permitted by law. However, 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.

[[Page 52700]]

    In a proposed rule titled ``Radiation Oncology (RO) Model,'' which 
appeared in the Federal Register on April 8, 2022 (87 FR 20800) 
(hereinafter referred to as the ``April 2022 RO Model proposed rule''), 
we proposed 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 at 42 CFR 512.205 to provide 
that the start and end dates of the model performance period for the RO 
Model will be established in future rulemaking.
    We solicited public comment on our proposal and received 
approximately 38 timely pieces of correspondence. We summarize and 
respond to public comments in this final rule.

II. Provisions of the Finalized Regulations

A. Model Performance Period

    As stated in the April 2022 RO Model proposed rule, 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 (87 FR 20802). We 
believe the RO Model would provide payment stability and promote high-
quality care for Medicare beneficiaries. We have heard that the RO 
Model is valuable and needed in the radiation oncology space from some 
interested parties 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 interested parties' comments that they would not support the 
RO Model unless specific changes were made, we proposed 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 noted that we would plan to 
propose the new 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. In the April 2022 RO Model proposed 
rule, we stated that we welcome additional dialogue with RO 
participants and interested parties about Medicare payment for RT 
services (87 FR 20802).
    Further, RO participants and interested parties 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. As we have informed interested parties, 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 interested parties will not support the 
RO Model test moving forward with unchanged discounts and as noted 
previously, these interested parties have also requested that we not 
increase the geographic scope of the Model.
    Thus, for these reasons, we proposed 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 proposed 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 proposed 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. Finally, in the April 2022 RO Model proposed rule, 
we noted 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 (87 FR 20802).
    The following is a summary of comments we received on the proposal 
to delay the RO Model to a date to be determined through future 
rulemaking in section II.A. of the April 2022 RO Model proposed rule 
and our responses to these comments:
    Comment: Many commenters supported the delay of the RO Model to a 
date to be determined in future rulemaking. CMS received a couple 
comments requesting a January 1, 2024 start date to allow for 
additional time to prepare for the Model.
    Response: We appreciate the support for the delay of the RO Model 
to a date yet to be determined and that a couple commenters requested a 
specific alternative future date for the RO Model to begin. We will 
consider whether a January 1, 2024, start date or an alternative start 
date would be feasible and whether such a date is likely to provide 
enough time to address the current challenges associated with starting 
the RO Model as we contemplate future rulemaking.
    Comment: Some commenters requested that the RO Model as it is 
currently designed be cancelled altogether. These commenters noted that 
they believe that the Model as currently designed does not align with 
the Biden Administration's Cancer Moonshot goal of increasing access to 
innovative and appropriate cancer care. Specifically, commenters were 
concerned the Model would impact equitable access to proton therapy and 
future innovation in radiation oncology. Some commenters stated that 
CMS should work with interested parties to redesign the Model with 
respect to, for example, the discounts, mandatory participation, 
billing requirements, quality and clinical reporting, included 
modalities, and the Advanced Alternative Payment Model (APM) bonus.

[[Page 52701]]

    Response: We appreciate these comments. However, we do not agree 
with the comments that the RO Model should be cancelled. As noted 
previously, we continue to believe that the RO Model will address long-
standing concerns related to delivery and payment of RT services and 
benefit RT providers and RT suppliers as well as beneficiaries, because 
of the RO Model's focus on financial predictability through 
prospective, site-neutral, episode-based payment and care improvement 
by linking payment to quality. The RO Model is designed to test an 
innovative approach to payment and service delivery in the field of 
radiation oncology. We welcome further dialogue with interested parties 
and RO participants about the design of the RO Model.
    Comment: A few commenters opposed the delay of the RO Model to a 
date to be determined through future rulemaking. These commenters 
stated that the RO Model has been delayed long enough and should begin 
on January 1, 2023. A commenter noted its disappointment in the 
continued delay of the RO Model and its frustration with the starting 
and stopping of preparation efforts. The commenter provided support for 
value-based, bundled payment for RT services to ensure payment 
stability, and urged CMS to work with interested parties to make 
necessary final refinements to the RO Model and implement it as soon as 
possible. A commenter who requested that the RO Model start January 1, 
2023 further stated that the only changes that should be considered 
with a January 1, 2023 start are those related to changes in the 
national base rates or the adjustment rates that would increase the 
revenue to RO participants, because the commenter believed that the 
cost of paying RO participants more would likely be less than the cost 
of continued delays.
    Response: Although we continue to believe that the RO Model will 
address longstanding concerns related to delivery and payment of RT 
services as described in more detail in the Specialty Care Models final 
rule (85 FR 61347) and again in the CY 2022 OPPS/ASC FC (86 FR 63911 
and 63912), such as the site-of-service payment differential that 
exists under the OPPS and PFS as well as the incentives built into the 
current fee-for-service payment system that promotes volume over the 
value of services, Congress has delayed the RO Model twice, and it is 
not known whether there may be further delays to the start of the RO 
Model that are out of CMS's control. As noted previously, there is a 
substantial cost to continue funding preparation for implementation of 
the RO Model in 2023, and the cost of such funding takes resources away 
from the development of other alternative payment models. A continued 
cycle of starting and stopping preparation efforts may also involve 
resources on the part of RO participants. Furthermore, as described in 
the Specialty Care Models final rule (85 FR 61152) and in the CY 2022 
OPPS/ASC FC (86 FR 63928 and 63929), in order to be able to detect an 
impact of the Model, changes to RO Model payment methodology may 
require changes to other aspects of the Model, such as increasing the 
size of the Model. In light of the fact that it is unknown whether 
there may be further delays to the RO Model that are out of CMS's 
control, we believe that the best course of action is to delay the 
implementation of the RO Model to a future date. While we appreciate 
commenters' request to begin the RO Model as soon as possible on 
January 1, 2023, we believe that the delay will provide us with the 
opportunity for additional dialogue with RO participants and interested 
parties about Medicare payment for RT services.
    Comment: We received a few comments requesting that CMS provide 
more than 6 months' notice in advance of the future RO Model start 
date.
    Response: We appreciate these comments. We want to emphasize that 
we would plan to propose a new start date for the RO Model at least 6 
months prior to that proposed start date, and the public would have an 
opportunity to comment on the new proposed start date as part of the 
rulemaking process. CMS is committed to the success of the RO Model and 
providing RO participants sufficient time to prepare before the RO 
Model begins. Should we receive comments indicating that a proposed 
start date provides insufficient time to prepare, CMS will consider any 
such comments in its decision of when to start the RO Model.
    Comment: Many commenters provided feedback not directly related to 
our proposal to delay the start date of the RO Model to a date to be 
determined through future rulemaking. These comments concerned a range 
of issues, including participation requirements and criteria, the 
geographic size of the Model, included modalities, Advanced APM 
incentive payment under the Quality Payment Program (QPP), and the 
Model's pricing methodology (for example, the national base rates, 
trend factor, case mix and historical experience adjustments, blend, 
and discount rates). Commenters also provided feedback related to the 
RO Model's potential impact on rural practices, health equity, and 
health disparities, as well as the burden of collecting and reporting 
the clinical data elements and the quality measures, and the burden of 
the RO Model's billing requirements. Commenters also discussed patient 
navigation tools, the beneficiary notification letter, and how the RO 
Model does or does not align with the goals of the Biden 
Administration's cancer agenda and the Cancer Moonshot.
    Response: We appreciate these additional comments, which we may 
further consider as we evaluate how best to proceed with the RO Model 
going forward. As noted previously, we continue to welcome further 
feedback and dialogue with interested parties and RO participants on 
the design of the RO Model.
    After considering public comments, we are finalizing our proposal 
to delay the start of the RO Model to a date to be determined through 
future rulemaking. Specifically, we are finalizing our proposed 
revisions to the definition of model performance period at 42 CFR 
512.205, to specify that model performance period means the 5 
performance years (PYs) during which RO episodes initiate and 
terminate, and that CMS will establish the start and end dates of the 
model performance period for the RO Model through future rulemaking.

III. Collection of Information Requirements

    As stated in section 1115A(d)(3) of the 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 (OMB) 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 final rule is 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).

[[Page 52702]]

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 regulatory 
actions 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 ``economically 
significant'' as measured by the $100 million threshold, and hence is 
also a major rule under Subtitle E of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (also known as the Congressional 
Review Act). 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 means 
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) 
will 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) will 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
                                                         -----------------------------------------------------------------------------------------------
                                                               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.


  Table 2--Radiation Oncology Model Physician Group Practice (PGP) (Including Freestanding Radiation Therapy Centers) vs Hospital Outpatient Department
                            (HOPD) Allowed Charge Impacts 2022 to 2026 as Compared to Those Not Participating in the RO Model
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           2022 to 2026
                        % Impact                             2022  (%)       2023  (%)       2024  (%)       2025  (%)       2026  ($)          (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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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[[Page 52703]]

    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 final 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 
final rule, we assumed that the regulations at 42 CFR part 512, subpart 
B, as amended by the CY 2022 OPPS/ASC FC were otherwise in full effect. 
As we are finalizing the delay of the start of the RO Model to a date 
yet to be determined, the estimated savings presented in Table 90 of 
the CY 2022 OPPS/ASC FC will not occur at this time. We summarize this 
result in Table 3 later 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 3 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 final rule.

Table 3--Accounting Statement: Estimated Impacts From CY 2022 TO CY 2026 as a Result of Provisions of This Final
                                                      Rule
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                                                     Estimates   -----------------------------------------------
                    Category                         (million)                    Discount  rate      Period
                                                                   Year  dollar         (%)           covered
----------------------------------------------------------------------------------------------------------------
Transfers:
Annualized Monetized ($million/year)............             $27            2020               7       2022-2026
                                                              29            2020               3       2022-2026
----------------------------------------------------------------------------------------------------------------
From Whom to Whom...............................       From the Federal Government to healthcare providers.
----------------------------------------------------------------------------------------------------------------

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. Because we are finalizing our proposal, the estimated 
impact of the RO Model as described in the CY 2022 OPPS/ASC FC will not 
occur. Instead, payment for submitted claims will be made under the 
applicable Medicare payment methodology. As a result, the Secretary has 
determined that this final 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 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. 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 requested comments on our estimate of significantly affected 
providers and suppliers and the magnitude of estimated effects for the 
proposed rule. We did not receive any comments.

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 final 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 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 
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.

List of Subjects in 42 CFR Part 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 amends 42 CFR 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.


[[Page 52704]]



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: August 24, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-18541 Filed 8-25-22; 4:15 pm]
BILLING CODE 4120-01-P