Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Part 512</CFR> <DEPDOC>[CMS-5535-F]</DEPDOC> <RIN>RIN 0938-AU51</RIN> <SUBJECT>Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) 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 describes a new mandatory alternative payment model, the Increasing Organ Transplant Access Model (IOTA Model), that will test whether performance-based upside risk payments or downside risk payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This final rule also adopts standard provisions that will apply to the Radiation Oncology Model, the End-Stage Renal Disease (ESRD) Treatment Choices Model, and mandatory Innovation Center models, including the IOTA Model, whose first performance period begins on or after January 1, 2025. The finalized standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> These regulations are effective January 3, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Thomas Duvall (410) 786-8887, for questions related to the Increasing Organ Transplant Access Model. Lina Gebremariam, (410) 786-8893, for questions related to the Increasing Organ Transplant Access Model. Christina McCormick (410) 786-4012, for questions related to the Increasing Organ Transplant Access Model. <E T="03">CMMItransplant@cms.hhs.gov</E> for questions related to the Increasing Organ Transplant Access Model. <E T="03">CMMI-StandardProvisions@cms.hhs.gov</E> for questions related to the Standard Provisions for Innovation Center Models. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Current Procedural Terminology (CPT) Copyright Notice</HD> 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 American Medical Association. Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose</HD> Section 1115A of the Social Security Act (the Act) gives the Secretary of the Department of Health and Human Services the authority to test innovative payment and service delivery models to reduce program expenditures in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) while preserving or enhancing the quality of care furnished to individuals covered by such programs. Specifically, section 1115A(b)(2)(a) of the Act states that “the Secretary shall select models to be tested from models where the Secretary determines that there is evidence that the model addresses a defined population for which there are deficits in care leading to poor clinical outcomes or potentially avoidable expenditures. The Secretary shall focus on models expected to reduce program costs under the applicable title while preserving or enhancing the quality of care received by individuals receiving benefits under such title.”  <SU>1</SU> <FTREF/> This final rule describes a new mandatory Medicare payment model to be tested under section 1115A of the Act—the Increasing Organ Transplant Access Model (IOTA Model)—which will begin on July 1, 2025, and end on June 30, 2031. In this final rule, we address payment policies, participation requirements, and other provisions to test the IOTA Model. We will test whether performance-based incentives (including both upside and downside risk payments) for participating kidney transplant hospitals can increase the number of functioning kidney transplants (including both living donor and deceased donor transplants) furnished to end stage renal disease (ESRD) patients, encourage investments in care processes and patterns with respect to patients who need kidney transplants, encourage investments in value-based care and improvement activities, and promote greater accountability by participating kidney transplant hospitals by tying payments to the value of the care provided. The IOTA Model is also intended to advance health equity by improving equitable access to the transplantation ecosystem for all patients, such as rural and underserved populations, through design features such as voluntary health equity plans to address health outcome disparities. <FTNT> <SU>1</SU>  U.S. Congress. (1940) United States Code: Social Security Act, 42 U.S.C. 1315a(b)(2)(a). </FTNT> This final rule also includes standard provisions that will apply to the RO Model, the ETC model, and all mandatory Innovation Center models whose first performance periods begin on or after January 1, 2025. The standard provisions address beneficiary protections; cooperation in model evaluation and monitoring; audits and record retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process. As we stated in the notice of proposed rulemaking, the IOTA Model will test ways to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries. We are finalizing several, but not all, of the provisions discussed in the proposed rule, and we intend to address certain other provisions discussed in the proposed rule in future rulemaking. We also note that some of the public comments were outside of the scope of the proposed rule. These out-of-scope public comments are not addressed in this final rule. We have summarized the public comments that are within the scope of the proposed rule and have included our responses to those public comments. However, we note that in this final rule we are not addressing most comments received with respect to the provisions of the proposed rule that we are not finalizing at this time. Rather, we will address them at a later time, in a subsequent rulemaking document, as appropriate. We are clarifying and emphasizing our intent that if any provision of this final rule is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further action, it shall be severable from other parts of this final rule, and from rules and regulations currently in effect, and not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other, dissimilar circumstances. Through this rule, we adopt provisions that are intended to and will operate independently of each other, even if each serves the same general purpose or policy goal. Where a provision is necessarily dependent on another, the context generally makes that clear. <HD SOURCE="HD2">B. Summary of the Provisions</HD> <HD SOURCE="HD3">1. Standard Provisions for Innovation Center Models</HD> The standard provisions for Innovation Center models will be applicable to the RO Model, the ETC Model, and all mandatory Innovation Center models whose first performance periods begin on or after January 1, 2025. We are codifying these standard provisions to increase transparency, efficiency, and clarity in the operation and governance of mandatory Innovation Center models, and to avoid the need to restate the provisions in each model's governing documentation. The standard provisions include terms that have been repeatedly memorialized, with minimal variation, in existing models' governing documentation. The standard provisions are not intended to encompass all of the terms and conditions that will apply to each mandatory Innovation Center model, as each model includes unique design features and implementation plans that may require additional, more tailored provisions, including with respect to payment methodology, care delivery and quality measurement, that will continue to be included in each model's governing documentation. We note that while we are not finalizing our proposal to apply the standard provisions to voluntary Innovation Center models, we expect to utilize the provisions in voluntary models and will incorporate them by reference into the models' governing documentation as appropriate based on the model's design. Model-specific provisions applicable to the IOTA Model are described in section III of this final rule. <HD SOURCE="HD3">2. Model Overview—Proposed Increasing Organ Transplant Access Model</HD> <HD SOURCE="HD3">a. Proposed IOTA Model Overview</HD> End-Stage Renal Disease (ESRD) is a medical condition in which a person's kidneys cease functioning on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life. <SU>2</SU> <FTREF/> The best treatment for most patients with kidney failure is kidney transplantation. Nearly 808,000 people in the United States are living with ESRD, with about 69 percent on dialysis and 31 percent with a kidney transplant. <SU>3</SU> <FTREF/> Relative to dialysis, a kidney transplant can improve survival, reduc ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 1365k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━