The Health Resources and Service Administration (HRSA) on Wednesday announced plans to overhaul the U.S. organ transplant system, proposing to break up some of the functions performed by the system's manager, the United Network for Organ Sharing (UNOS).

The proposed changes

The 1984 National Organ Transplant Act established that the transplant network would be run by a nonprofit organization acting as a "quasi-governmental agency" under a single contract. Since then, UNOS has run the American transplant system.

Carole Johnson, administrator for HRSA, said the agency intends to invite other organizations to take over some of the responsibilities of UNOS — which is the only entity to ever operate the U.S. organ transplant system.

"Our goal is get best in class for all the functions we think are essential to running the transplant network," Johnson said.

Specifically, the proposal would implement a board of directors independent of UNOS, create a public dashboard for the data generated by the system, and make the process by which patients and organs are matched more transparent.

The Biden administration has allocated $67 million — nearly double the current budget — in its proposed 2024 budget towards what Johnson called a "modernization" of the transplant network.

"What's so critical to us is ensuring we are doing everything possible to improve the system that patients and families depend on," Johnson said.

Johnson added that she will ask Congress to amend the 1984 National Organ Transplant Act to raise the cap on what HRSA can spend on federal contractors, but added that she believes she has the legal authority to move forward if Congress doesn't act. Solicitations for bids could go out as soon as this fall, she said.

How the initiative will impact transplant and donor hospitals is uncertain without more information from HRSA, said Nancy Foster, VP for quality and patient safety policy at the American Hospital Association.

Reaction

In a statement, UNOS said it "supports HRSA's plan to introduce additional reforms into the nation's organ donation and transplantation system" and welcomed a competitive bidding process.

"We believe we have the experience and expertise required to best serve the nation's patients and to help implement HRSA's proposed initiatives," UNOS said.

The proposal drew praise from members of Congress in both parties. Sen. Ron Wyden (D-Ore.) said UNOS has "fallen short of the requirements for this contract and the expectations of Americans waiting for a transplant."

"Thousands of patients are dying every year and billions of taxpayer dollars are wasted because of gross mismanagement," said Sen. Chuck Grassley (R-Iowa). "The system is rife with fraud, waste and abuse, corruption, even criminality."

Patient advocates also praised the plan, noting the number of transplants each year could be much higher and that around 5,000 people annually die on transplant waiting lists. A report last year from the National Academies of Sciences, Engineering, and Medicine found the American organ transplant system was "demonstrably inequitable" and suffered from "significant nonuse of donated organs."

"If we had a fully effective system, we could actually fully service the waiting list for hearts, lungs, and livers within a couple of years," said Greg Segal, co-founder of Organize, a non-profit patient advocacy group.

Segal added that UNOS "has allowed the organ donation system to become mismanaged, unsafe and self-enriching. Today's announcement that [the government] will break up UNOS's monopoly, and bring in competent and transparent new contractors, is a transformative and unequivocal win for patients."

"For too long, we have tolerated an inefficient system that has failed the patients it should serve," said Caitlin Donovan, a spokesperson for the National Patient Advocate Foundation. "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."

However, Stephen Gray, surgical director of the liver transplant program at George Washington University Hospital, said he believes UNOS does a good job managing organs in drastically short supply.

"I really question whether getting rid of them would change anything," he said. (Bernstein, Washington Post, 3/22; Frieden, MedPage Today, 3/22; Reed, Axios, 3/23; Turner/Berryman, Modern Healthcare, 3/22; Stolberg, New York Times, 3/22)