20800 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Proposed Rules 

the human environment. This proposed 

rule involves a safety zone lasting 48 

hours that would prohibit entry within 

100-yards of the potential hazards 

associated with the demolition of the 

replacement and removal of the overwater portion of the Gerald Desmond 

Bridge. Normally such actions are 

categorically excluded from further 

review under paragraph L of Appendix 

A, Table 1 of DHS Instruction Manual 

023–01–001–01, Rev. 1. A preliminary 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. We 

seek any comments or information that 

may lead to the discovery of a 

significant environmental impact from 

this proposed rule. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

V. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking, and 

will consider all comments and material 

received during the comment period. 

Your comment can help shape the 

outcome of this rulemaking. If you 

submit a comment, please include the 

docket number for this rulemaking, 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. 

Submitting comments. We encourage 

you to submit comments through the 

Federal Decision Making Portal at 

https://www.regulations.gov. To do so, 

go to https://www.regulations.gov, type 

USCG–2022–0181 in the search box and 

click ‘‘Search.’’ Next, look for this 

document in the Search Results column, 

and click on it. Then click on the 

Comment option. If you cannot submit 

your material by using https://

www.regulations.gov, call or email the 

person in the FOR FURTHER INFORMATION

CONTACT section of this proposed rule 

for alternate instructions. 

Viewing material in docket. To view 

documents mentioned in this proposed 

rule as being available in the docket, 

find the docket as described in the 

previous paragraph, and then select 

‘‘Supporting & Related Material’’ in the 

Document Type column. Public 

comments will also be placed in our 

online docket and can be viewed by 

following instructions on the https://

www.regulations.gov Frequently Asked 

Questions web page. We review all 

comments received, but we will only 

post comments that address the topic of 

the proposed rule. We may choose not 

to post off-topic, inappropriate, or 

duplicate comments that we receive. 

Personal information. We accept 

anonymous comments. Comments we 

post to https://www.regulations.gov will 

include any personal information you 

have provided. For more about privacy 

and submissions to the docket in 

response to this document, see DHS’s 

eRulemaking System of Records notice 

(85 FR 14226, March 11, 2020). 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T11–0181 to read as 

follows: 

§ 165.T11–0181 Safety Zone; Demolition of 

Gerald Desmond Bridge; Long Beach, 

California. 

(a) Location. The safety zone covers 

all navigable waters within 100-yards of 

the over-the-water portion of the Gerald 

Desmond Bridge, located approximately 

at mile 3.3 over Long Beach, CA. 

(b) Effective period. This section is 

effective from 12:01 a.m. on May 7, 2022 

until 11:59 p.m. on May 16, 2022. 

(c) Enforcement period. This section 

will be enforced from 12:01 a.m. on May 

7, 2022 through 11:59 p.m. on May 9, 

2022. In case of unexpected events, a 

contingency enforcement time window 

for the 48-hour closure starts at 12:01 

a.m. on May 14, 2022, and ends at 11:59 

p.m. on May 16, 2022. 

(d) Regulations. (1) In accordance 

with the general regulations in § 165.23, 

entry of vessels or persons into the zone 

is prohibited unless specifically 

authorized by the Captain of the Port 

Los Angeles Long Beach (COTP) or 

designated representative. A designated 

representative is a commissioned, 

warrant, or petty officer of the U.S. 

Coast Guard (USCG) assigned to units 

under the operational control of the 

COTP. 

(2) In the event of an emergency, 

vessels requiring entry into the safety 

zone must request permission from the 

COTP or a designated representative. To 

seek entry into the safety zone, contact 

the COTP or the COTP’s representative 

by telephone at (310) 521–3801 or on 

VHF–FM channel 16. To coordinate the 

movement of vessel traffic, vessel 

operators may contact the Jacobsen Pilot 

Station at (562) 432–0664 or the Water 

Traffic Coordinator, Andres Velasco, at 

(602) 376–5765. 

(3) Persons and vessels permitted to 

enter the safety zone must transit at 

their slowest safe speed and comply 

with all lawful directions issued by the 

COTP or the designated representative. 

(e) Information broadcasts. The COTP 

or a designated representative will 

inform the public when the safety zone 

is being enforced via a Broadcast 

Notices to Mariners. 

Dated: April 1, 2022. 

R.E. Ore, 

Captain, U.S. Coast Guard, Captain of the 

Port, Los Angeles Long Beach. 

[FR Doc. 2022–07504 Filed 4–7–22; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Proposed Rules 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 

RadiationTherapy@cms.hhs.gov 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 siteneutral, 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 


jspears on DSK121TN23PROD with PROPOSALS1
20802 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Proposed Rules 

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. 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Proposed Rules 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] 

Year of model 

2022 2023 2024 2025 2026 Total * 

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 

* 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. 


jspears on DSK121TN23PROD with PROPOSALS1
20804 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Proposed Rules 

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

% Impact 2022 

(percent) 

2023 

(percent) 

2024 

(percent) 

2025 

(percent) 

2026 

(percent) 

2022 to 2026 

(percent) 

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 

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

Category Estimates 

(million) 

Units 

Year 

dollar 

Discount rate 

(percent) 

Period 

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--tablesize-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 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Proposed Rules 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 

■ 1. The authority citation for part 512 

continues to read as follows: 

Authority: 42 U.S.C. 1302, 1315a, and 

1395hh. 

■ 2. Section 512.205 is amended by 

revising the definition of ‘‘model 

performance period’’ to read as follows: 

§ 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] 

BILLING CODE 4120–01–P 


jspears on DSK121TN23PROD with PROPOSALS1