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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
located outside of a metropolitan statistical area and has fewer than 100
beds. We do not believe this final rule will have a significant impact on operations of a substantial number of small rural hospitals because most dialysis facilities are freestanding.
While there are 122 rural hospital-based dialysis facilities, we do not know how many of them are based at hospitals with fewer than 100 beds. However, overall, the 122 rural hospital-based dialysis facilities will experience an estimated 1.0 percent increase in payments.
Therefore, the Secretary has determined that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals.

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F. Unfunded Mandates Reform Act Analysis 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. This final rule does not mandate any requirements for State, local, or tribal governments in the aggregate, or by the private sector.
Moreover, HHS interprets UMRA as applying only to unfunded mandates.
We do not interpret Medicare payment rules as being unfunded mandates, but simply as conditions for the receipt of payments from the Federal Government for providing services that meet Federal standards. This interpretation applies whether the facilities or providers are private, State, local, or tribal.
G. 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.
We have reviewed this final rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of states, local or Tribal governments.
H. Congressional Review Act This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 5

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U.S.C. 801 et seq. and has been transmitted to the Congress and the Comptroller General for review.
IX. Files Available to the Public via the Internet The Addenda for the annual ESRD
PPS proposed and final rulemakings will no longer appear in the Federal Register. Instead, the Addenda will be available only through the internet and is posted on the CMS website at http
www.cms.gov/ESRDPayment/PAY/
list.asp. In addition to the Addenda, limited data set files are available for purchase at http www.cms.gov/
Research-Statistics-Data-and-Systems/
Files-for-Order/LimitedDataSets/
EndStageRenalDiseaseSystemFile.html.
Readers who experience any problems accessing the Addenda or LDS files, should contact ESRDPayment@
cms.hhs.gov.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on October 28, 2021.
List of Subjects 42 CFR Part 413
Diseases, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
42 CFR Part 512
Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as follows:
PART 413PRINCIPLES OF
REASONABLE COST
REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE
SERVICES; PROSPECTIVELY
DETERMINED PAYMENT RATES FOR
SKILLED NURSING FACILITIES;
PAYMENT FOR ACUTE KIDNEY
INJURY DIALYSIS
1. The authority citation for part 413
continues to read as follows:

Authority: 42 U.S.C. 1302, 1395dd, 1395fb, 1395g, 1395la, i, and n, 1395xv, 1395hh, 1395rr, 1395tt, and 1395ww.

2. Section 413.177 is amended by revising paragraph a introductory text to read as follows:

413.177 Quality incentive program payment.

a With respect to renal dialysis services as defined under 413.171,
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except for those renal dialysis services furnished during payment year 2022, in the case of an ESRD facility that does not earn enough points under the program described at 413.178 to meet or exceed the minimum total performance score as defined at 413.178a8 established by CMS for a payment year as defined at 413.178a10, payments otherwise made to the facility under 413.230 for renal dialysis services during the payment year will be reduced by up to 2 percent as follows:

3. Section 413.178 is amended by adding paragraph h to read as follows:
413.178

ESRD quality incentive program.

h Special rule for payment year 2022. 1 CMS will calculate a measure rate for all measures specified by CMS
under paragraph c of this section for the PY 2022 ESRD QIP but will not score facility performance on any of those measures or calculate a TPS for any facility under paragraph e of this section.
2 CMS will not establish a mTPS for PY 2022.
PART 512RADIATION ONCOLOGY
MODEL AND END STAGE RENAL
DISEASE TREATMENT CHOICES
MODEL
4. The authority citation for part 512
continues to read as follows:

Authority: 42 U.S.C. 1302, 1315a, and 1395hh.

5. Section 512.160 is amended by adding paragraph a9 and revising paragraph b6 to read as follows:

512.160

Remedial action.

a
9 For the ETC Model only, has misused or disclosed the beneficiaryidentifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the applicable data sharing agreement.
b
6 In the ETC Model only:
i Terminate the ETC Participant from the ETC Model.
ii Suspend or terminate the ability of the ETC Participant, pursuant to 512.397c, to reduce or waive the coinsurance for kidney disease patient education services.

6. Section 512.310 is amended by adding definitions for Clinical staff, Health Equity Incentive, and
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