Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 413 and 512</CFR> <DEPDOC>[CMS-1830-F]</DEPDOC> <RIN>RIN 0938-AV52</RIN> <SUBJECT>Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also includes updates to the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates the requirements for the ESRD Quality Incentive Program and terminates and modifies requirements for the ESRD Treatment Choices Model. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> These regulations are effective on January 1, 2026. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">ESRDPayment@cms.hhs.gov</E> or Abigail Ryan (410) 786-4343, for issues related to the ESRD Prospective Payment System (PPS) and coverage and payment for renal dialysis services furnished to individuals with acute kidney injury (AKI). <E T="03">ESRDApplications@cms.hhs.gov,</E> for issues related to applications for the Transitional Drug Add-on Payment Adjustment (TDAPA) or Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). <E T="03">QNETSUPPORT-ESRD@cms.hhs.gov,</E> for issues related to the ESRD Quality Incentive Program (QIP). <E T="03">ETC-CMMI@cms.hhs.gov,</E> for issues related to the ESRD Treatment Choices (ETC) Model. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Current Procedural Terminology (CPT) Copyright Notice:</E> Throughout this final rule, we use CPT® codes and descriptions to refer to a variety of services. We note that CPT® codes and descriptions are copyright 2020 American Medical Association (AMA). All Rights Reserved. CPT® is a registered trademark of the AMA. Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. <HD SOURCE="HD1">Table of Contents</HD> To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents. <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions</FP> <FP SOURCE="FP1-2">C. Summary of Cost and Transfers</FP> <FP SOURCE="FP-2">II. Calendar Year (CY) 2026 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Provisions of the Proposed Rule, Public Comments, and Responses to the Comments on the CY 2026 ESRD PPS</FP> <FP SOURCE="FP1-2">C. Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)</FP> <FP SOURCE="FP1-2">D. Continuation of Approved Transitional Add-On Payment Adjustments for New and Innovative Equipment and Supplies for CY 2026</FP> <FP SOURCE="FP1-2">E. Continuation of Approved Transitional Drug Add-On Payment Adjustments for CY 2026</FP> <FP SOURCE="FP-2">III. Final CY 2026 Payment Rate for Renal Dialysis Services Furnished to Individuals With AKI</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Update of AKI Dialysis Payment Rate</FP> <FP SOURCE="FP-2">IV. Updates to the End-Stage Renal Disease Quality Incentive Program (ESRD QIP)</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Updates to Requirements Beginning With the Payment Year (PY) 2027 ESRD QIP</FP> <FP SOURCE="FP1-2">C. Updates to Requirements Beginning With the PY 2028 ESRD QIP</FP> <FP SOURCE="FP1-2">D. Requests for Information (RFIs) on Topics Relevant to ESRD QIP</FP> <FP SOURCE="FP-2">V. End-Stage Renal Disease Treatment Choices (ETC) Model</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Summary of the Proposed Provisions, Public Comments, and Responses to the Comments on the ETC Model</FP> <FP SOURCE="FP-2">VI. Collection of Information Requirements</FP> <FP SOURCE="FP1-2">A. ESRD QIP—Wage Estimates</FP> <FP SOURCE="FP1-2">B. Estimated Burden Associated With the Data Validation Requirements for PY 2028</FP> <FP SOURCE="FP1-2">C. Estimated EQRS Reporting Requirements for PY 2027 and PY 2028</FP> <FP SOURCE="FP1-2">D. Estimated ICH CAHPS Reporting Requirements for PY 2028</FP> <FP SOURCE="FP1-2">E. ESRD Treatment Choices Model</FP> <FP SOURCE="FP-2">VII. Regulatory Impact Analysis</FP> <FP SOURCE="FP1-2">A. Statement of Need</FP> <FP SOURCE="FP1-2">B. Overall Impact Analysis</FP> <FP SOURCE="FP1-2">C. Detailed Economic Analysis</FP> <FP SOURCE="FP1-2">D. Accounting Statement</FP> <FP SOURCE="FP1-2">E. Regulatory Flexibility Act (RFA)</FP> <FP SOURCE="FP1-2">F. Unfunded Mandates Reform Act (UMRA)</FP> <FP SOURCE="FP1-2">G. Federalism</FP> <FP SOURCE="FP1-2">H. E.O. 14192, “Unleashing Prosperity Through Deregulation”</FP> <FP SOURCE="FP1-2">I. Congressional Review Act</FP> <FP SOURCE="FP-2">VIII. Files Available to the Public via the Internet</FP> <FP SOURCE="FP-2">IX. Waiver of Delayed Effective Date</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose</HD> This rule finalizes changes related to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), payment for renal dialysis services furnished to individuals with acute kidney injury (AKI), the ESRD Quality Incentive Program (QIP), and the ESRD Treatment Choices (ETC) Model. <HD SOURCE="HD3">1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)</HD> On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), 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 percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule includes updates to the ESRD PPS for CY 2026. This rule also modifies the eligibility timeframe for the transitional drug add-on payment adjustment (TDAPA) and establishes a new payment adjustment for ESRD facilities in certain non-contiguous states and territories to promote efficient allocation of payments. <HD SOURCE="HD3">2. Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury (AKI)</HD> On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the TPEA amended section 1834 of the Act by adding a new subsection (r) that provides for payment for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate beginning January 1, 2017. This rule updates the AKI dialysis payment rate for CY 2026. <HD SOURCE="HD3">3. End-Stage Renal Disease Quality Incentive Program (ESRD QIP)</HD> The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is authorized by section 1881(h) of the Act. The Program establishes incentives for facilities to achieve high quality performance on measures with the goal of improving outcomes for ESRD beneficiaries. Beginning with PY 2027, this rule removes the Facility Commitment to Health Equity reporting measure, the Screening for Social Drivers of Health reporting measure, and the Screen Positive Rate for Social Drivers of Health reporting measure from the ESRD QIP measure set. In addition, this rule updates the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) clinical measure beginning with PY 2028. This rule also discusses feedback received in response to our requests for public comment on several topics relevant to the ESRD QIP. <HD SOURCE="HD3">4. End-Stage Renal Disease Treatment Choices (ETC) Model</HD> The ETC Model is a mandatory Medicare payment model tested under section 1115A of the Act. The ETC Model is operated by the Center for Medicare and Medicaid Innovation (Innovation Center). The ETC Model tests the use of payment adjustments to encourage greater utilization of home dialysis and kidney transplants, to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures. The ETC Model was finalized as part of a final rule published in the <E T="04">Federal Register</E> on September 29, 2020, titled “Medicare Program: Specialty Care Models to Improve Quality of Care and Reduce Expenditures” (85 FR 61114), referred to herein as the “Specialty Care Models final rule.” Subsequently, the ETC Model has been updated ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 528k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━