President Joe Biden triggered a major transformation of the national system for allocating human organs for transplant by signing a bipartisan bill Friday.
The new law enables the Health Resources and Services Administration to seek bids from multiple for-profit and nonprofit organizations to participate in the Organ Procurement and Transplantation Network, which effectively ends nearly four decades of sole control by the United Network for Organ Sharing, known as UNOS. Proponents say this remade system will improve safety and more fairly distribute organs.
Related: What you need to know about the organ transplant overhaul
Congress and the Biden administration tout the updated policy as a means to a more equitable, modern system that will increase the availability of lifesaving organs. According to HRSA, 104,000 patients are awaiting organs and an estimated 17 people die each day because they don't receive transplants in time.
The Securing the U.S. Organ Procurement and Transplantation Network Act of 2023 passed the House by voice vote and the Senate unanimously in July. Rep. Dr. Larry Bucshon (R-Ind.) and Senate Finance Committee Chair Ron Wyden (D-Ore.) were the lead sponsors.
“This is a banner day in the effort to improve the organ transplant system in the United States,” Wyden said in a news release. “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 Organ Procurement and Transplantation Network so more Americans are connected with a life-saving transplant."
UNOS has operated nearly every facet of the system since the National Organ Transplant Act of 1984 designated the nonprofit organization as the sole contractor starting in 1986. UNOS oversees waiting lists, monitors organ matches, supervises logistics, manages information technology and oversees patient safety.
Critics, including a plethora of lawmakers, have sought to diminish UNOS' role in the organ transplant system for years. The law Biden signed emerged from a Finance Committee investigation that commenced in 2020 and highlighted safety, equity, logistical and technological shortcomings under UNOS' management. UNOS did not oppose the bill and plans to seek continued participation in the Organ Procurement and Transplantation Network.
In a statement, UNOS said it "supports a more competitive and open bidding process for the next Organ Procurement and Transplantation Network contracts, a centerpiece of this legislation. As HRSA pursues additional efforts to modernize the OPTN, UNOS continues to offer its expertise and experience to support our shared goals of increasing accountability, transparency, performance and oversight."
Providers, trade associations and patient advocacy groups commended the law's enactment.
"This is a monumental win for patients. Patients need a transplant system that is safe, effective and equitable. Today’s signing of the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act is the first step toward finally realizing that," Greg Segal, founder and CEO of patient advocacy group Organize, said in a statement.
In March, HRSA announced plans to modernize the IT system, award multiple management contracts, double spending on organ procurement and transplantation, and increase transparency. The White House also requested increased funding to overhaul the system in its fiscal 2024 budget proposal.
In 2020, the Centers for Medicare and Medicaid Services published a final rule to change how organ procurement organizations are assessed. The year before, then-President Donald Trump issued an executive order instructing regulators to boost the supply of kidneys, the organ in greatest need. UNOS instituted its own changes to the system in 2018.
