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

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Part 512</CFR> <DEPDOC>[CMS-5535-P]</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> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This proposed rule describes a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive 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 proposed rule also includes standard provisions that would apply to Innovation Center models whose first performance period begins on or after January 1, 2025, and also would apply, in whole or part, to any Innovation Center model whose first performance period begins prior to January 1, 2025 should such model's governing documentation incorporate the provisions by reference in whole or in part. The proposed 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> To be assured consideration, comments must be received at one of the addresses provided below, by July 16, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-5535-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-5535-P, P.O. Box 8013, Baltimore, MD 21244-8013. 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-5535-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">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> <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">http://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 encourages 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. <HD SOURCE="HD1">Current Procedural Terminology (CPT) Copyright Notice</HD> 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. All Rights Reserved. CPT® is a registered trademark of the American Medical Association (AMA). 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 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. This proposed 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 would begin on January 1, 2025 and end on December 31, 2030. In this proposed rule, we propose payment policies, participation requirements, and other provisions to test the IOTA Model. We propose to test whether performance-based incentives (including both upside and downside risk) for participating kidney transplant hospitals can increase the number of 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 kidney transplant hospital accountability by tying payments to value. The IOTA Model is also intended to advance health equity by improving equitable access to the transplantation ecosystem through design features such as a proposed health equity plan requirement to address health outcome disparities and a health equity performance adjustment. This proposed rule also includes proposed standard provisions that would apply to Innovation Center models whose first performance periods begin on or after January 1, 2025, unless otherwise specified in a model's governing documentation, as well as to Innovation Center models whose first performance periods begin prior to January 1, 2025, provided the standard provisions are incorporated into such models' governing documentation. The proposed 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. We seek public comment on these proposals, the alternatives considered, and the request for information (RFI) in section III.D. of this proposed rule. <HD SOURCE="HD2">B. Summary of the Proposed Provisions</HD> <HD SOURCE="HD3">1. Standard Provisions for Innovation Center Models</HD> The proposed standard provisions for Innovation Center models would be applicable to all Innovation Center models whose first performance periods begin on or after January 1, 2025, subject to any limitations specified in a model's governing documentation. The proposed standard provisions also would apply to all Innovation Center models whose first performance periods begin prior to January 1, 2025, provided the standard provisions are incorporated into such models' governing documentation. We are proposing to codify these standard provisions to increase transparency, efficiency, and clarity in the operation and governance of Innovation Center models, and to avoid the need to restate the provisions in each model's governing documentation. The proposed standard provisions include terms that have been repeatedly memorialized, with minimal variation, in existing models' governing documentation. The proposed standard provisions are not intended to encompass all of the terms and conditions that would apply to each Innovation Center model, because each model embodies 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 would continue to be included in each model's governing documentation. Model-specific provisions applicable to the IOTA Model proposed herein are described in section III of this proposed 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>1</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>2</SU> <FTREF/> For ESRD patients, regular dialysis sessions or a kidney transplant is required for survival. Relative to dialysis, a kidney transplant can improve survival, reduce avoidable health care utilization and hospita ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 876k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━