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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations EQRS reporting requirements for the PY 2024 ESRD QIP was approximately $208 million 85 FR 71400.
As discussed in section IV.C. and section IV.D. of this final rule, we are finalizing our proposed measure suppressions that would apply for PY
2022 and updates to the scoring methodology and payment reductions for the PY 2022 ESRD QIP. In the proposed rule, we also announced an extension of EQRS reporting requirements for facilities due to systems issues. However, we believe that none of the policies finalized in this final rule would affect our estimates of the annual burden associated with the Programs information collection requirements, as facilities are still expected to continue to collect measure data during this time period. We are not finalizing any changes that would affect the burden associated with EQRS
reporting requirements for PY 2024 or PY 2025. However, we have recalculated the burden estimate for PY
2024 using updated estimates of the total number of dialysis facilities, the total number of patients nationally, and wages for Medical Records and Health Information Technicians or similar staff as well as a refined estimate of the number of hours needed to complete data entry for EQRS reporting.
Consistent with our approach in the CY
2021 ESRD PPS final rule 85 FR 71474, in the proposed rule we estimated that the amount of time required to submit measure data to EQRS was 2.5 minutes per element and did not use a rounded estimate of the time needed to complete data entry for EQRS reporting. We are further updating these estimates in this final rule. There are 229 data elements for 532,931 patients across 7,717
facilities. At 2.5 minutes per element, this yields approximately 658.94 hours per facility. Therefore, the PY 2024
burden is 5,085,050 hours 658.94 hours 7,717 facilities. Using the wage estimate of a Medical Records and Health Information Technician, we estimate that the PY 2024 total burden cost is approximately $215 million 5,085,050 hours $42.40. There is no net incremental burden change from PY
2024 to PY 2025 because we are not changing the reporting requirements for PY 2025.
VIII. Regulatory Impact Analysis lotter on DSK11XQN23PROD with RULES2

A. Impact Analysis 1. Introduction We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review September 30, 1993, Executive Order 13563 on Improving Regulation
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and Regulatory Review January 18, 2011, the Regulatory Flexibility Act RFA September 19, 1980; Pub. L. 96
354, section 1102b of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
March 22, 1995; Pub. L. 1044, Executive Order 13132 on Federalism August 4, 1999, and the Congressional Review Act 5 U.S.C. 8012.
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 3f 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 Presidents priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis RIA
must be prepared for major rules with economically significant effects $100
million or more in any 1 year. Based on our estimates, OMBs Office of Information and Regulatory Affairs has determined that this rulemaking is economically significant as measured by the $100 million threshold, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 also known as the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking. We solicit comments on the regulatory impact analysis provided.
2. Statement of Need a. ESRD PPS
As required by section 1881b14 of the Social Security Act the Act, as added by section 153b of the Medicare
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Improvements for Patients and Providers Act of 2008 MIPPA Pub. L.
110275. Section 1881b14F of the Act, as added by section 153b of MIPPA, and amended by section 3401h of the Patient Protection and Affordable Care Act the Affordable Care Act Pub. L. 111148, established that beginning calendar year CY 2012, and each subsequent year, the Secretary of the Department of Health and Human Services the Secretary shall annually increase payment amounts by an ESRD
market basket increase factor, reduced by the productivity adjustment described in section 1886b3BxiII
of the Act.
This rule finalizes updates to the ESRD PPS for CY 2022, as required by section 1881b14F of the Act. The routine updates include the CY 2022
wage index values, the wage index budget-neutrality adjustment factor, and outlier payment threshold amounts.
Failure to publish this final rule will result in ESRD facilities not receiving appropriate payments in CY 2022 for renal dialysis services furnished to ESRD beneficiaries, as required by section 1881b14F of the Act.
b. AKI
This rule also finalizes updates to the payment for renal dialysis services furnished by ESRD facilities to individuals with AKI, as required by section 1834r of the Act, as added by section 808b of the Trade Preferences Extension Act of 2015 TPEA Pub. L.
11427 enacted on June 29, 2015.
Failure to publish this final rule will result in ESRD facilities not receiving appropriate payments in CY 2022 for renal dialysis services furnished to patients with AKI in accordance with section 1834r of the Act.
c. ESRD QIP
Section 1881h1 of the Act requires a payment reduction of up to 2 percent for eligible dialysis facilities that do not meet or exceed the mTPS established with respect to performance standards for the ESRD QIP each year. This final rule finalizes updates for the ESRD QIP, including the adoption of a measure suppression policy and the suppression of several ESRD QIP measures under that measure suppression policy, updates regarding the scoring methodology and payment reductions for the PY 2022 ESRD QIP, an update to the SHR measure, and an update to the PY 2024 performance standards.
d. ETC Model The ETC Model is a mandatory Medicare payment model tested under the authority of section 1115A of the
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