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Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Proposed Rules
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change in revenue of more than 3 to 5
percent. We do believe that this threshold will be reached by the requirements in this proposed rule.
Therefore, the Secretary has certified that this proposed will have a significant economic impact on a substantial number of small entities.
The RFA presented in the November 2020 interim final rule 85 FR 76245
describes the potential impact of the MFN Model, if it was implemented, on small entities. If finalized, this proposed rule would prevent those impacts from being realized. Specifically, the lower drug payments and alternative add-on payments described in section III.F. of the November 2020 interim final rule would not occur. Instead, payment for submitted claims would be made under the applicable Medicare payment methodology. This RFA, 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 603
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. Similar to urban entities, we estimate that this proposed rule, if finalized, would have a significant impact on small rural hospitals by preventing the impacts described in the November 2020 interim final rule 85 FR
76246 from being realized. Specifically,
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if the MFN Model was implemented, these rural entities would experience drug payment reductions and overall payment reductions similar to urban entities. Instead, if this proposed rule is finalized, payment for submitted claims would be made under the applicable Medicare payment methodology.
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 2021, that threshold is approximately $158
million. As discussed in section V.C. of this proposed rule, the financial impacts for States that is, an estimated overall reduction in State spending presented in the November 2020 interim final rule 85 FR 76235 through 76248 would not be realized. This proposed rule does not mandate any spending by State, local, or tribal governments, or by the private sector, and hence an UMRA analysis is not required.
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
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governments, preempts State law, or otherwise has Federalism implications.
As discussed in section V.C. of this proposed rule, the financial impacts for States that is, an estimated overall reduction in State spending presented in the November 2020 interim final rule 85 FR 76235 through 76248 would not be realized. Since this regulation does not impose any costs on State or local governments, preempt State law, or otherwise have Federalism implications, the requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on July 21, 2021.
List of Subjects for 42 CFR 513
Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.
PART 513REMOVED
For the reasons set forth in the preamble and under the authority at 5
U.S.C. 301, the Centers for Medicare &
Medicaid Services proposes to remove 42 CFR part 513.

Dated: August 3, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
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