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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
these alternatives and the rationale for each of our policies.
This final rule addresses a model specific to ESRD. It provides descriptions of the requirements that we will waive, identifies the performance metrics and payment adjustments to be tested, and presents rationales for our changes, and where relevant, alternatives that we considered. We carefully considered the alternatives to this final rule, including the degree that benchmark targets should be
prospectively updated to provide greater transparency to ETC Participants while preserving the expectation for model net savings for the program. For context related to alternatives previously considered when establishing the ETC
Model we refer readers to the Specialty Cares Models final rule 85 FR 61114
for more information on policy-related stakeholder comments, our responses to those comments, and statements of final policy preceding the limited modifications proposed here.

D. Accounting Statement As required by OMB Circular A4
available at https
www.whitehouse.gov/sites/
whitehouse.gov/files/omb/circulars/A4/
a-4.pdf, in Table 20, we have prepared an accounting statement showing the classification of the transfers and costs associated with the various provisions of this final rule.
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TABLE 20: Accounting Statement: Classification of Estimated Transfers and Costs/Savine:s ESRD PPS and AKI CY 2022
Catee:ory Transfers Annualized Monetized Transfers $230 million Federal government to ESRD providers From Whom to Whom Catee:ory Transfers Increased Beneficiary Co-insurance Payments $60 million From Whom to Whom Beneficiaries to ESRD providers ESRD OIP for PY 2022
Category Transfers Annualized Monetized Transfers $0
From Whom to Whom Federal government to ESRD providers.
ESRD QIP for PY 2024
Catee:orv Transfers -$17 million Annualized Monetized Transfers Federal government to ESRD providers.
From Whom to Whom ESRD QIP for PY 2025
Catee:orv Transfers -$17 million Annualized Monetized Transfers From Whom to Whom Federal government to ESRD providers ETC Model for Jan 1, 2023 through June 30, 2027
Impacts of Chane:es in the Final Rule Catee:orv Transfers Annualized Monetized Transfers -$2.00 million From Whom to Whom Federal government to ESRD facilities and Managing Clinicians
In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.

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E. Regulatory Flexibility Act Analysis RFA
The Regulatory Flexibility Act RFA
requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit
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organizations, and small governmental jurisdictions. Approximately 11 percent of ESRD dialysis facilities are considered small entities according to the Small Business Administrations SBA size standards, which classifies small businesses as those dialysis facilities having total revenues of less than $41.5 million in any 1 year.
Individuals and states are not included in the definitions of a small entity. For more information on SBAs size standards, see the Small Business Administrations website at http
www.sba.gov/content/small-business-

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size-standards Kidney Dialysis Centers are listed as 621492 with a size standard of $41.5 million.
When viewed as individual entities, as opposed to being a part of a LDO, there are approximately 1,295 17
percent of total number of ESRD
facilities ESRD facilities that provide fewer than 4,000 treatments per year.
With a low volume payment adjustment, each facility generates revenue from dialysis treatments of $1.26 million per year per facility. This is shown in the Table 21.
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