CMS proposes new mandatory organ transplant model for end-stage renal disease

The Centers for Medicare & Medicaid Services (CMS) has unveiled a new mandatory model proposal it says will improve access for individuals needing kidney transplants, reduce disparities and help selected hospitals better perform transplants.

The proposed Increasing Organ Transplant Access (IOTA) Model, announced Wednesday afternoon, is a six-year model to be carried out by the CMS Innovation Center beginning Jan. 1, 2025.

The proposed model will also help reduce Medicare spending and pinpoint living donors, according to a CMS fact sheet (PDF).

“Modernizing the organ transplantation system is a top priority for the Biden administration,” said CMS Administrator Chiquita Brooks-LaSure in a statement. “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.”

In the model (PDF), participating hospitals would be measured by number of transplants, organ acceptance rates and post-transplant outcomes, a news release said.

Hospitals would also be required to create health equity plans to help underserved communities. Examples of action items in a health equity plan could include providing transportation assistance, relieving food insecurity or addressing out-of-pocket prescription drug costs.

There are 257 transplant hospitals in the country, and 90 (or 35%) would need to participate in the IOTA model.

“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.”

Although 32% of waitlisted individuals are African American, just under 14% of recipients were African American. However, 36% of the waitlist is comprised of white individuals, yet they represent 62% of all people who receive transplants, data from the Scientific Registry of Transplant Recipients show.

Kidney transplants are commonly required for people with end-stage renal disease, but approximately 30% of donor kidneys go unused each year, CMS explained. Meanwhile, wait time durations can last from three to five years.

The agency said just 28,000 transplants were performed last year, though 90,000 people are currently on a waitlist.

In September, the Biden administration signed a law that prohibits UNOS, a nonprofit vendor, from being the sole contractor for the country’s Organ Procurement and Transplantation Network. The Health Resources and Services Administration then issued requests for proposals for contracts, along with new data reporting and standardization requirements.

A recent letter from lawmakers called on UNOS to share its IT security system and general business practices over concerns regarding cybersecurity vulnerabilities.