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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
73989

TABLE 2ACCOUNTING STATEMENT: ESTIMATED IMPACTS FROM CY 2021 TO CY 2028 AS A RESULT OF THE PROVISIONS
OF THIS FINAL RULE BASED ON THE ASPE ESTIMATEContinued Units Category
Estimates Year dollar
Annualized Monetized $million/year
From Whom to Whom

4,504.9
4,638.6

Comment: A few commenters stated that, based on their own or others analyses, the OACT and ASPE estimates shown in the November 2020 MFN
Model interim final rule underestimate the negative financial impact that certain healthcare providers would likely experience had the MFN Model been implemented. Many commenters expressed concern that some of the estimated savings would be related to reduced access to care. We did not receive comments on our approach to illustrate, inversely, the monetized estimates contained in Table 17 85 FR
76247 and Table 18 85 FR 76248 of the November 2020 MFN Model interim final rule in Table 1 and Table 2 of the August 2021 proposed rule, respectively.
Response: We thank stakeholders for their comments. As we noted in the November 2020 MFN Model interim final rule and the August 2021 proposed rule, there is much uncertainty around the assumptions for both the OACT and ASPE estimates that were presented in those rules.
Final Decision: After considering the comments on the RIA of our proposal, and because we are finalizing our proposal as proposed, we are finalizing the RIA without change; that is, as presented in the August 2021 proposed rule.

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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 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
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2018
2018

Period covered 7
3

January 2021December 2027.
January 2021December 2027.

Beneficiaries to hospitals/physicians and MA plans.

Annualized Monetized $million/year
From Whom to Whom

Discount rate %

342.4
351.6

2018
2018

7
3

January 2021December 2027.
January 2021December 2027.

States to hospitals/physicians and MA plans.

Business Administrations Table of Small Business Size Standards at https www.sba.gov/document/supporttable-size-standards. The rule of thumb used by HHS for determining whether an impact is significant is an adverse effect equal to 3 percent or more of total annual revenues.
This final rule affects the vast majority of Medicare-participating providers and suppliers that submit claims for separately payable Medicare Part B drugs by preventing the impacts described in the November 2020 MFN
Model interim final rule 85 FR 76246
from being realized. Over 20,000 small entities would have been included or affected by the MFN Model if the model had been implemented. We refer readers to Table 3 and Table 8 in the November 2020 MFN Model interim final rule 85
FR 76195 and 76219, respectively to see the number of entities, as well as the types of providers and suppliers, that most likely would have been impacted by the MFN Model had it been implemented. This final rule withdraws the MFN Model, and therefore likely impacts these same entities.
Accordingly, we have determined that a Regulatory Flexibility Analysis is required. 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. We believe that this threshold will be reached by the requirements in this final rule. Therefore, the Secretary has certified that the August 2021
proposed rule and this final rule will have a significant economic impact on a substantial number of small entities.
The Regulatory Flexibility Analysis presented in the November 2020 MFN
Model interim final rule 85 FR 76245
describes the potential impact of the MFN Model, if it had been implemented, on small entities. This final rule prevents those impacts from being realized. Specifically, the lower
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drug payments and alternative add-on payments described in section III.F. of the November 2020 MFN Model interim final rule will not occur. Instead, payment for submitted claims will be made under the applicable Medicare payment methodology. This Regulatory Flexibility Analysis, together with the preamble, constitutes the required analysis.
In addition, section 1102b 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 1102b 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 estimate that this final rule will have a significant impact on small rural hospitals by preventing the impacts described in the November 2020 MFN Model interim final rule 85
FR 76246 from being realized.
Specifically, these rural entities will not experience drug payment reductions and overall payment reductions.
Instead, payment for submitted claims will be made under the applicable Medicare payment methodology. We estimate that this final rule will have a parallel significant impact on urban entities.
We welcomed comments on our estimate of significantly affected providers and suppliers and the magnitude of estimated effects for the proposed rule.
Comment: Several commenters stated that our estimate of significantly affected providers and suppliers and the magnitude of estimated effects presented in the November 2020 MFN
Model interim final rule underestimated the potential financial losses and operational impacts that health care
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