Feds propose to overhaul organ transplant system

Federal regulators have proposed a major shake-up of the system that allocates human organs for transplantation.

The Health Resources and Services Administration outlined plans Wednesday to reorganize the federal Organ Procurement and Transplantation Network, which the United Network for Organ Sharing, also known as UNOS, exclusively administers. The policy would invite other organizations to participate in the organ system, ending UNOS' virtual monopoly.

Having multiple contractors will strengthen the Organ Procurement and Transplantation Network and “foster competition," according to a HRSA news release. “We are taking action to both bring greater transparency to the system and to reform and modernize the [Organ Procurement and Transplantation Network]. The individuals and families that depend on this life-saving work deserve no less,” HRSA Administrator Carole Johnson said in the release.

UNOS has endorsed the proposal. "UNOS supports HRSA’s plan to introduce additional reforms into the nation’s organ donation and transplantation system. We also stand united with HRSA in our shared goal to get as many donor organs as possible to the patients in need while increasing accountability, transparency and oversight," the nonprofit organization said in a news release. "We welcome a competitive and open bidding process for the next [Organ Procurement and Transplantation Network] contract to advance our efforts to save as many lives as possible, as equitably as possible. We believe we have the experience and expertise required to best serve the nation’s patients and to help implement HRSA’s proposed initiatives."

President Joe Biden made organ transplantation a priority in his fiscal 2024 budget request, which asks Congress to nearly double what the U.S. spends on the system to $67 million. The White House also proposed that lawmakers update the National Organ Transplant Act of 1984 to eliminate a cap on the program's budget.

The Biden administration's proposals follow a Centers for Medicare and Medicaid Services regulation issued in 2020 under President Donald Trump that was designed to increase the availability of organs for transplantation.

More than 42,800 organ transplants occurred in the U.S. last year, according to UNOS. About 104,000 people are currently on waiting lists for organs, according to the Organ Procurement and Transplantation Network.

How the new initiative concerning the network will impact transplant and donor hospitals is uncertain without more information from HRSA, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association. HRSA appears to have heeded calls from Congress and others to divide responsibilities for distributing organs among multiple organizations rather than relying on UNOS alone, she said.

Some patient groups welcomed HRSA's plan.

"For too long, we have tolerated an inefficient system that has failed the patients it should serve," National Patient Advocate Foundation spokesperson Caitlin Donovan said in a statement. "Patients deserve a system that honors the sacrifices of those who donate and the lives of those who so desperately need those transplants. We hope that, going forward, we are able to create a system that is more thoughtful, transparent and effective."

Greg Segal, founder and CEO of Organize, a nonprofit group that promotes access to organ transplants, said in a statement that “it’s hard to overstate how important these reforms are for patients. UNOS has spent nearly 40 years covering up clear abuses in a failing and often corrupt industry. The first step in making the system work for patients is showing UNOS the door.”

UNOS has come under scrutiny in recent years over wasted or damaged organs, patient safety concerns and health equity issues.

“If you have an increased number of discards of organs that might have been transplanted, every discard is an additional life loss,” said Dr. Richard Gilroy, transplant hepatologist and liver transplant medical director at Salt Lake City-based Intermountain Health.

The Senate Finance Committee began a probe into the organ transplant system three years ago. Documents that UNOS turned over under subpoena revealed more than 1,000 complaints against organ procurement organizations from 2010 to 2020 and that the Organ Procurement and Transplantation Network inadequately managed patient safety and organ transportation, according to a report the committee published last year.

“Today’s announcement is a big victory for families across the country who have been fighting for a more effective organ procurement and transplantation system. For too long it’s been clear that UNOS has fallen short of the requirements for this contract and the expectations of Americans waiting for a transplant," Finance Committee Chair Ron Wyden (D-Ore.) said in a news release Wednesday.