CMS proposes mandatory organ transplant model

 CMS proposes mandatory organ transplant model

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The Centers for Medicare and Medicaid Services is proposing a new mandatory model geared at improving access for kidney transplant patients, with the goal of helping hospitals increase the quality of the transplants they perform.

The Increasing Organ Transplant Access (IOTA) Model aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), as well as to reduce disparities among those undergoing the process of receiving a transplant.

The proposed model is part of the Biden administration’s election year push to improve collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, quality measurement, transparency and regulatory oversight.


In the proposed model, participating transplant hospitals would be measured by increases in the number of transplants performed, increased organ acceptance rates, and post-transplant outcomes. The model would seek to hold kidney transplant hospitals accountable for the care they provide.

Hospitals eligible to be selected for the proposed model are non-pediatric facilities that conduct a minimum of 11 transplants each during a three-year baseline period. Out of the 257 transplant hospitals in the country, an estimated 90 would be required to participate in the proposed six-year model beginning January 1, 2025.

Additionally, the model would offer additional performance incentives to participating transplant hospitals to improve equity in the transplant process. 

It would require participating transplant hospitals to establish health equity plans to identify gaps in access among populations in their communities, and to develop strategies to address these gaps. For example, participants could establish programs to educate and support potential living donors from underserved communities, or to provide transportation assistance to patients on a wait list.

Participating transplant hospitals would also have the flexibility to address barriers related to social drivers of health, such as food insecurity and out-of-pocket prescription drug costs.

The proposed mandatory model would align with the HHS Organ Transplant Affinity Group’s strategy to coordinate a series of initiatives to increase transplantation access through payment, quality and regulatory efforts. The model would be complementary to existing and future regulatory efforts for Organ Procurement Organizations, nephrologists and dialysis facilities to improve the overall transplant system for people with ESRD.

In March 2023, HRSA launched its OPTN Modernization Initiative to strengthen accountability and the performance of the nation’s organ transplant system by focusing on improving the Organ Procurement and Transplant Network’s governance, technology and operations. Across the nearly 40-year history of the OPTN, all functions of the OPTN were managed by a single vendor rather than multiple contracts based on technical expertise in areas like IT or operations.

HRSA is also taking transformational steps to modernize organ matching technology while increasing transparency and accountability by issuing new data reporting requirements to better address pre-waitlist and organ procurement practices. The agency said this will help address inequities in the transplant waitlist process by reducing racial and ethnic variation both in patient referrals and in organ procurement.


Calling the transplant process “complex and fragmented care,” HHS said that organ transplantation varies not only by geography but also by factors such as race, ethnicity, disability status and socio-economic status.

For example, according to the Scientific Registry of Transplant Recipients Annual Data Report, 32% of waitlisted individuals were Black in 2021, but only 13.5% of recipients of a transplant from a living donor were Black. White individuals made up 35.8% of the waitlist and 61.8% of transplant recipients from a living donor.

According to HHS, people with ESRD who receive transplants have better outcomes than people who receive dialysis, but the scarcity of organs, particularly for kidney transplants, leads to increased patient mortality and a significant gap between demand and supply.

Despite this scarcity, about 30% of donor kidneys go unused annually, highlighting gaps in procurement, distribution and utilization.

Jeff Lagasse is editor of Healthcare Finance News.
Healthcare Finance News is a HIMSS Media publication.

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