The Centers for Medicare & Medicaid Services (CMS) has proposed a significant new initiative aimed at improving the organ transplant system in the United States. The Increasing Organ Transplant Access (IOTA) Model, unveiled on Wednesday, is designed to address several key challenges, including limited access to transplants, racial disparities in the system, and the overall efficiency of transplant procedures in participating hospitals.
This six-year program, set to launch on January 1st, 2025, will be overseen by the CMS Innovation Center. According to a CMS fact sheet (PDF), the IOTA Model is expected to not only increase access to kidney transplants for those in need but also reduce Medicare spending and identify more potential living donors.
“Modernizing the organ transplantation system is a top priority for the Biden administration,” stated CMS Administrator Chiquita Brooks-LaSure. “Kidney transplantation helps people live healthier and longer lives because they no longer have to undergo dialysis. The IOTA 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.”
Under the proposed model (PDF), participating hospitals will be evaluated based on several key metrics, including the number of transplants performed, their organ acceptance rates, and the post-transplant outcomes of their patients, as detailed in a press release. Additionally, hospitals will be required to develop comprehensive health equity plans specifically designed to assist underserved communities. These plans could encompass initiatives like providing transportation assistance, addressing food insecurity among patients, and helping them manage out-of-pocket prescription drug costs.
With 257 transplant hospitals currently operating in the United States, the IOTA Model would require participation from approximately 90 facilities, representing roughly 35% of the total.
“The organ transplant industry, like every other part of society, is not immune to racial inequities,” said Department of Health and Human Services Secretary Xavier Becerra. “Black Americans disproportionately struggle with life-threatening kidney disease, yet they receive a smaller percentage of kidney transplants. The Biden administration is taking concrete steps to remove racial bias when calculating wait times and rooting out profiteering and inequity in the transplant process.”
Data from the Scientific Registry of Transplant Recipients underscores this point. Although African Americans represent 32% of individuals on transplant waiting lists, they make up only around 14% of transplant recipients. Conversely, while white individuals comprise 36% of the waiting list, they account for a staggering 62% of all transplant recipients.
Kidney transplants are a life-saving procedure for patients with end-stage renal disease. However, CMS reports that approximately 30% of donated kidneys go unused annually. Wait times for transplants can also be lengthy, often ranging from three to five years.
The agency further highlights that only 28,000 transplants were performed last year despite a current waitlist exceeding 90,000 individuals.
In a separate but related development, the Biden administration signed a law in September that prohibits UNOS, a non-profit organization, from acting as the sole contractor for the country’s Organ Procurement and Transplantation Network (OPTN). This move was followed by the Health Resources and Services Administration issuing requests for proposals for new contracts, along with implementing stricter data reporting and standardization requirements.
Finally, a recent letter from lawmakers urged UNOS to share details of its IT security system and overall business practices due to concerns about potential cybersecurity vulnerabilities.
