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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules 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 this 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. There are 229 data elements for 532,931 patients across 7,610 facilities. At 2.5 minutes per element, this yields approximately 668.21 hours per facility. Therefore, the PY 2024 burden is 5,085,050 hours 668.21 hours 7,610 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.

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VIII. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

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. We estimate that this rulemaking is economically significant as measured by the $100 million threshold, and hence also a major rule under 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
IX. Economic Analyses
a. ESRD PPS

A. Regulatory Impact Analysis
This rule proposes a number of routine updates to the ESRD PPS for CY
2022. The proposed 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 proposed rule would result in ESRD
facilities not receiving appropriate payments in CY 2022 for renal dialysis services furnished to ESRD
beneficiaries.

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 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,
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b. AKI
This rule also proposes routine updates to the payment for renal dialysis services furnished by ESRD
facilities to individuals with AKI.
Failure to publish this proposed rule would 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.

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c. ESRD QIP
This proposed rule proposes to implement requirements for the ESRD
QIP, including a proposal to adopt a measure suppression policy and to suppress several ESRD QIP measures under that proposed measure suppression policy, proposals regarding the scoring methodology and payment reductions for the PY 2022 ESRD QIP, a proposed update to the SHR measure, and a proposed update to the PY 2024
performance standards. This proposed rule also includes a request for public comment on closing the gap in health equity, as well as a request for public comment on potential actions and priority areas that would enable the continued transformation of our quality measurement enterprise toward greater digital capture of data and use of the FHIR standard.
d. ETC Model Beneficiaries with ESRD are among the most medically fragile and high-cost populations served by the Medicare program. One of CMS goals in designing the ETC Model is to test ways to incentivize home dialysis and kidney transplants, to enhance beneficiary choice of modality for renal replacement therapy, and improve quality of care and quality of life while reducing Medicare program expenditures. The substantially higher expenditures, mortality, and hospitalization rates for dialysis patients in the U.S. compared to those for individuals with ESRD in other countries indicate a population with poor clinical outcomes and potentially avoidable expenditures. This proposed rule would refine the methodology for setting and updating achievement and improvement benchmarks for participating ESRD
facilities and Managing Clinicians serving the ESRD population over the remaining years of the ETC Model, among other proposed changes.
Notwithstanding the proposed changes, we continue to anticipate improvement in quality of care for beneficiaries and reduced expenditures under the ETC
Model inasmuch as the Model is designed to create incentives for beneficiaries, along with their families and caregivers, to choose the optimal kidney replacement modality.
As noted in section IV.B of the Specialty Care Models final rule 85 FR
61264, Medicare payment rules and a deficit in beneficiary education result in a bias toward in-center hemodialysis, which is often not preferred by patients or physicians relative to home dialysis or kidney transplantation. We provided evidence from the published literature
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