Biden signs bill introducing more competition to US' organ transplant network

President Joe Biden signed into law Friday a bipartisan bill that overhauls the country’s organ transplant system by increasing competition among contractors and paving the way for additional funding.

The new law will “break up the current monopoly system” that for nearly four decades allowed a single private nonprofit to be the sole contractor managing the country’s Organ Procurement and Transplantation Network (OPTN), White House press secretary Karine Jean-Pierre told reporters Friday.

“Everybody knows the system has been broken for years, with heartbreaking consequences,” she said in reference to the more than 100,000 Americans awaiting a transplant at any given time. “Now, with the president’s signature, we are taking significant steps to improve it.”

The Securing the U.S. Organ Procurement and Transplantation Network Act stems from rising criticism of the United Network for Organ Sharing (UNOS) and the OPTN from lawmakers on both sides of the aisle. In 2022, the Senate Finance Committee issued a report and convened multiple hearings focusing on the various “failures” of the system that led to long waits and deaths.

“This is a banner day in the effort to improve the organ transplant system in the United States,” Sen. Ron Wyden, D-Oregon, chair of that committee and one of the act’s sponsors, said in a statement. “For too long, thousands of families have had to watch a loved one struggle while waiting for an organ transplant because the system has been inefficient and unaccountable. With this law, that starts to change: there is going to be accountability, know-how, and improvements to the [OPTN] so more Americans are connected with a life-saving transplant."

Sens. Chuck Grassley, R-Iowa; Ben Cardin, D-Maryland; Todd Young, R-Indiana; and Bill Cassidy, M.D., R-Louisiana, had joined Wyden in spearheading their chamber’s version of the bill. Reps. Larry Bucshon, M.D., R-Indiana, and Robin Kelly, D-Illinois, had introduced the House’s version.

UNOS, the sole nonprofit that has been managing the network, coordinating transplants and procurements and monitoring patient safety, has previously said that it welcomed any plans to reform the national system. The group on Friday said it does “not oppose this legislation” and reiterated its support of “a more competitive and open bidding process” in statements to reporters.

“UNOS continues to offer its expertise and experience to support our shared goals of increasing accountability, transparency, performance and oversight," it said. “… No organization knows the incredibly complex system and the transplant community as well as UNOS. As this law goes into effect, we look forward to taking part in the new bidding process and demonstrating how our expertise should remain an integral part of this system.”

Alongside the open bidding, the new law eliminates a funding cap to make way for several network reforms floated by the Department of Health and Human Services’ Health Resources and Services Administration (HRSA) back in March.

That so-called OPTN Modernization Initiative already began with a data dashboard sharing de-identified information on donors, procurement, transplant waitlists and recipients, and with the funds would continue with other IT updates and increased independence of OPTN’s board of directors through the contracting process, per plans shared by HRSA.

Achieving those goals will require the government to double its investment in organ procurement and transplantation to $67 million, according to numbers outlined in Biden's 2024 budget proposal. While the new law creates a pathway for the funds to come in, this month’s gridlock over needed appropriations bills and potential government shutdown puts any additional spending in question.

The bill’s text also instructs the Government Accountability Office to conduct a review of the organ procurement network’s “historical financing … including the utilization of registration fees among entities that have previously been awarded contracts” within the first two years.  

In a statement, the American Society of Nephrology hailed the increased transparency and access to transplant care it said the legislation brings.

“This law stands as an example of the real difference we can make in the lives of Americans by working together,” Michelle Josephson, M.D., the society’s president, said in a release. “By opening the door for continued improvements to our transplant system, this law reflects the very real possibility that exists to maximize access to kidney transplant care for the millions of Americans living with kidney diseases.”