Proposed Rule for Kidney Transplant Hospitals Introduced

Proposed Rule for Kidney Transplant Hospitals Introduced

“The organ transplant industry, like every other part of society, is not immune to racial inequities,” U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra said recently. “Black Americans disproportionately struggle with life-threatening kidney disease, yet they receive a smaller percentage of kidney transplants. The Biden-Harris Administration is taking concrete steps to remove racial bias when calculating wait times and rooting out profiteering and inequity in the transplant process.”

Kidney transplantation is the best treatment for most individuals with end-stage renal disease (ESRD), offering better outcomes and quality of life compared to dialysis. Despite the scarcity of organs leading to increased mortality and long wait times, about 30 percent of donor kidneys go unused each year. This gap highlights issues in procurement, distribution, and utilization. In 2023, over 28,000 kidney transplants were performed, but more than 90,000 people remained on the wait list. Urgent measures are needed to improve the system’s efficacy and efficiency. My father-in-law was one of the Black Americans who died waiting for a transplant that could have saved his life.

The Centers for Medicare & Medicaid Services (CMS) has proposed a new mandatory Medicare payment model called the Increasing Organ Transplant Access Model (IOTA Model). This model aims to enhance access to kidney transplants for patients with ESRD by providing performance-based incentive payments to participating kidney transplant hospitals. The goal is to increase the number of kidney transplants while maintaining or improving the quality of care and reducing Medicare expenditures.

Key features of the IOTA Model include the following:

  • Performance-based incentives for hospitals, which include both rewards and penalties;
  • A focus on increasing the number of kidney transplants from both living and deceased donors;
  • Encouragement of investments in care processes and value-based care; and
  • Promotion of hospital accountability by linking payments to performance.

The model also seeks to advance health equity by addressing disparities in health outcomes through a health equity plan requirement and a performance adjustment based on equity.

The proposed rule includes standard provisions that would apply to Innovation Center models, starting with the first performance period on or after Jan. 1, 2025. These provisions cover areas such as beneficiary protections, model evaluation and monitoring, audits, data rights, compliance, and more. These standards aim to enhance transparency, efficiency, and clarity in the governance of Innovation Center models.

Public comments on the proposed rule must be submitted electronically via http://www.regulations.gov, by regular mail, or by express or overnight mail to the specified addresses, referencing file code CMS-5535-P. The comment period ends 60 days after the rule’s publication in the Federal Register.

For further information, questions related to the IOTA Model can be directed to CMMItransplant@cms.hhs.gov, and inquiries about the standard provisions for Innovation Center models can be sent to CMMI-StandardProvisions@cms.hhs.gov.

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Timothy Powell, CPA, CHCP

Timothy Powell is a nationally recognized expert on regulatory matters, including the False Claims Act, Zone Program Integrity Contractor (ZPIC) audits, and U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) compliance. He is a member of the RACmonitor editorial board and a national correspondent for Monitor Mondays.

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