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Biden-Harris Administration Acts to Improve Access to Kidney Transplants

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is announcing the Increasing Organ Transplant Access (IOTA) Model. The proposed model, which would be implemented by the CMS Innovation Center, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. This proposed model would build on the Biden-Harris Administration’s priority of improving the kidney transplant system and the collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.

“The organ transplant industry, like every other part of society, is not immune to racial inequities,” said HHS Secretary Xavier Becerra. “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 ESRD, a condition that occurs when the kidneys are no longer able to function properly. People with ESRD who receive transplants have better outcomes than people who receive dialysis, improvements in quality of life, and are freed from lengthy and burdensome dialysis treatments. However, the scarcity of organs, particularly for kidney transplants, leads to increased patient mortality and a significant gap between demand and supply. Despite this scarcity, approximately 30% of donor kidneys go unused annually, highlighting gaps in procurement, distribution, and utilization. Prolonged waiting times, averaging three to five years or more, intensify patient suffering. With just over 28,000 kidney transplants performed in 2023 and more than 90,000 people on a waitlist during that same time, urgent measures are needed to improve the efficacy and efficiency of the system.

“Modernizing the organ transplantation system is a top priority for the Biden-Harris Administration,” said CMS Administrator Chiquita Brooks-LaSure. “Kidney transplantation helps people live healthier and longer lives because they no longer have to undergo dialysis. The Increasing Organ Transplant Access Model would be an important step forward in improving the kidney transplant process for everyone on a waitlist and those who have received a transplant.”

In the proposed model, participating transplant hospitals would be measured by increases in the number of transplants, increased organ acceptance rates, and post-transplant outcomes. The Increasing Organ Transplant Access Model would 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. 

To further improve equity and access, the model would offer additional performance incentives to participating transplant hospitals to improve equity in the transplant process. The proposed model would require participating transplant hospitals to establish health equity plans to identify gaps in access among populations in their communities and 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 waitlist. 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. This 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 OPTN’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 the critical organ matching technology while increasing transparency and accountability by issuing new data reporting requirements to better address pre-waitlist and organ procurement practices, which will help address inequities in the transplant waitlist process by reducing racial and ethnic variation both in patient referrals and in organ procurement.

The current kidney transplant process is complex and fragmented care and disparities contribute to the inequitable distribution of this life-saving treatment. Access to 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 (SRTR) Annual Data Report, 32% of waitlisted individuals were African American in 2021, but only 13.5% of recipients of a transplant from a living donor were African American. White individuals made up 35.8% of the waitlist and 61.8% of transplant recipients from a living donor.  The proposed Increasing Organ Transplant Access Model is designed to address these challenges by improving the overall quality of care for patients with ESRD and increasing the number of transplants performed.

“Requiring participation in the proposed Increasing Organ Transplant Access Model would be a promising opportunity to engage participating transplant hospitals and collaborators in the model in seeking to reduce fragmentation in kidney transplantation while improving care, access, and affordability,” said Liz Fowler, CMS Deputy Administrator and Director of the CMS Innovation Center. “If finalized, CMS will work with selected participating transplant hospitals and providers to provide technical assistance so they can succeed in the model, putting us on the path to using all available kidneys and ultimately improving the quality of life for hundreds of thousands of individuals and their families.”

CMS has proposed the Increasing Organ Transplant Access Model be a mandatory model to aim to achieve a sufficient and representative national sample of participating kidney transplant hospitals that represent diverse geographic locations, familiarity with designing care focused on quality, provider performance, and the patient experience, and success with increasing transplants.  CMS is prepared and ready to partner together with transplant hospitals to be successful in their improvement efforts and will support them with additional resources and assistance. By focusing on the problem together, we will be on the path to using all available kidneys and ultimately improving the quality of life for hundreds of thousands of individuals and their families. 

The proposed rule on the Increasing Organ Transplant Access Model can be accessed from the Federal Register at Standard provisions are included in the proposed rule that would be applicable to all Innovation Center model participants that begin participation in a model on or after January 1, 2025.

View a fact sheet on the Increasing Organ Transplant Access Model. 

More information on the Increasing Organ Transplant Access Model is available on the model webpage. 


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