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

<RULE> 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-F]</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> 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 2025. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates 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> These regulations are effective on January 1, 2025. </EFFDATE> <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">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 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> <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. Provisions of the Proposed Rule, Public Comments, and Responses to the Comments on 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 Technical Changes for CY 2025</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. Final 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. Public Comments and Responses on the Proposal To Allow Medicare Payment for Home Dialysis for Beneficiaries With AKI</FP> <FP SOURCE="FP1-2">C. 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. 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 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. 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. Congressional Review Act</FP> <FP SOURCE="FP-2">VIII. 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 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 Conditions for Coverage for ESRD facilities, the ESRD Quality Incentive Program (QIP), and the ESRD Treatment Choices (ETC) Model. Additionally, this rule finalizes 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 finalizing the proposal to allow Medicare payment for home dialysis for beneficiaries 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 these drugs 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 disproportionately young, male, African American/Black, have disabilities and low income as measured by eligibility for both Medicare and Medicaid (dual eligible status), and reside in an urban setting (87 FR 67183). In this final rule, we continue to address health equity for beneficiaries with ESRD who are members of underserved communities, including but not limited to those living in rural communities, those who have disabilities, racial and ethnic minorities, and American Indians and Alaska Natives. The term `underserved communities' refers to populations sharing a particular characteristic, including geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life. <SU>4</SU> <FTREF/> <FTNT> <SU>1</SU>  Centers for Medicare & Medicaid Services (2022). Health Equity. Available at: <E T="03">https://www.cms.gov/pillar/health-equity</E> . </FTNT> <FTNT> <SU>2</SU>  86 FR 7009 (January 25, 2021). <E T="03">https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government</E> . </FTNT> <FTNT> <SU>3</SU>  Centers for Medicare & Medicaid Services (2022). Health Equity. Available at: <E T="03">https://www.cms.gov/pillar/health-equity</E> . </FTNT> <FTNT> <SU>4</SU>  86 FR 7009 (January 25, 2021). <E T="03">https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government</E> . </FTNT> <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 a ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 852k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━