Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, 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 410, 413, 494, and 512</CFR> <DEPDOC>[CMS-1805-P]</DEPDOC> <RIN>RIN 0938-AV27</RIN> <SUBJECT>Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, 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 2025. 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 proposed rule would update requirements for the Conditions for Coverage for ESRD Facilities, ESRD Quality Incentive Program, and 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 26, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-1805-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">https://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-1805-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-1805-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 Nicolas Brock at (410) 786-5148, 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. <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents. <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) 2025 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 2025 ESRD PPS</FP> <FP SOURCE="FP1-2">C. Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) Applications and Proposed Technical Change for CY 2025 Payment</FP> <FP SOURCE="FP1-2">D. Continuation of Approved Transitional Add-On Payment Adjustments for New and Innovative Equipment and Supplies for CY 2025</FP> <FP SOURCE="FP1-2">E. Continuation of Approved Transitional Drug Add-On Payment Adjustments for CY 2025</FP> <FP SOURCE="FP-2">III. Proposed CY 2025 Payment for Renal Dialysis Services Furnished to Individuals With AKI</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Proposal to Allow Medicare Payment for Home Dialysis for Beneficiaries With AKI</FP> <FP SOURCE="FP1-2">C. Proposed Annual Payment Rate Update for CY 2025</FP> <FP SOURCE="FP1-2">D. AKI and the ESRD Facility Conditions for Coverage</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 PY 2027 ESRD QIP</FP> <FP SOURCE="FP1-2">C. 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="FP1-2">C. Request for Information</FP> <FP SOURCE="FP-2">VI. Collection of Information Requirements</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</FP> <FP SOURCE="FP1-2">C. Impact Analysis</FP> <FP SOURCE="FP1-2">D. Detailed Economic Analysis</FP> <FP SOURCE="FP1-2">E. Accounting Statement</FP> <FP SOURCE="FP1-2">F. Regulatory Flexibility Act Analysis (RFA)</FP> <FP SOURCE="FP1-2">G. Unfunded Mandates Reform Act Analysis (UMRA)</FP> <FP SOURCE="FP1-2">H. Federalism</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 Conditions for Coverage for ESRD facilities, the ESRD Quality Incentive Program (QIP), and the ESRD Treatment Choices (ETC) Model. Additionally, this rule proposes and discusses policies that reflect our commitment to achieving equity in health care for our beneficiaries by supporting our ability to assess whether, and to what extent, our programs and policies perpetuate or exacerbate systemic barriers to opportunities and benefits for underserved communities. For example, we are proposing to expand access to home dialysis for patients with acute kidney injury, which would assist this vulnerable population with transportation and scheduling issues and allow them to have flexibility in their dialysis treatment modality. Additionally, we discuss the incorporation of oral-only drugs into the ESRD PPS bundled payment beginning January 1, 2025, which will expand access to the 21 percent of the ESRD PPS population who do not have Part D coverage. Our internal data show that a significant portion of ESRD beneficiaries who lack Part D coverage are African American/Black patients with ESRD. Our policy objectives include a commitment to advancing health equity, which stands as the first pillar of the Centers for Medicare & Medicaid Services (CMS) Strategic Plan, <SU>1</SU> <FTREF/> and reflect the goals of the Administration, as stated in the President's Executive Order 13985. <SU>2</SU> <FTREF/> We define health equity as the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.”  <SU>3</SU> <FTREF/> In the calendar year (CY) 2023 ESRD PPS final rule, we noted that, when compared with all Medicare fee-for-service (FFS) beneficiaries, Medicare FFS beneficiaries receiving dialysis are ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 476k characters. 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