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

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 413 and 512</CFR> <DEPDOC>[CMS-1830-P]</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> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below, by August 29, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-1830-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">http://www.regulations.gov</E> . Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1830-P, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1830-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <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">ESRDQIP@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">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: <E T="03">https://www.regulations.gov</E> . Follow the search instructions on that website to view public comments. CMS will not post on <E T="03">Regulations.gov</E> public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. <E T="03">Plain Language Summary:</E> In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this rule may be found at <E T="03">https://www.regulations.gov/</E> . <E T="03">Current Procedural Terminology (CPT) Copyright Notice:</E> Throughout this proposed 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. <E T="03">Deregulation Request for Information (RFI):</E> On January 31, 2025, President Trump issued Executive Order (E.O.) 14192 “Unleashing Prosperity Through Deregulation,” which states the Administration policy to significantly reduce the private expenditures required to comply with Federal regulations to secure America's economic prosperity and national security and the highest possible quality of life for each citizen. We would like public input on approaches and opportunities to streamline regulations and reduce administrative burdens on providers, suppliers, beneficiaries, and other interested parties participating in the Medicare program. CMS has made available an RFI at <E T="03">https://www.cms.gov/medicare-regulatory-relief-rfi</E> . Please submit all comments in response to this RFI through the provided weblink. <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 Benefits</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. Proposed Provisions of 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. CY 2026 Payment for Renal Dialysis Services Furnished to Individuals With AKI</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Proposed Annual Payment Rate for 2026</FP> <FP SOURCE="FP-2">IV. Proposed 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. Proposed Updates to Requirements Beginning With the Payment Year (PY) 2027 ESRD QIP</FP> <FP SOURCE="FP1-2">C. Proposed 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. Provisions of the Proposed Rule</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. ESRD Treatment Choices Model</FP> <FP SOURCE="FP-2">VII. Response to Comments</FP> <FP SOURCE="FP-2">VIII. 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="FP-2">IX. Files Available to the Public via the Internet</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose</HD> This rule proposes 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 proposes updates to the ESRD PPS for CY 2026. Th ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 353k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━