Biden administration plans overhaul of organ transplant system
Move follows years of scrutiny of the United Network for Organ Sharing, which operates the Organ Procurement and Transplantation Network
The Health Resources and Services Administration on Wednesday unveiled plans to break up the private nonprofit overseeing the nation’s organ transplantation system, and called on Congress to help.
The move follows years of widespread, bipartisan scrutiny of the United Network for Organ Sharing, which operates the Organ Procurement and Transplantation Network, known as OPTN. The United Network for Organ Sharing holds the sole federal contract to oversee the country's organ procurement organizations and transplant centers.
The new plan would award multiple contracts in order to "foster competition and ensure OPTN Board of Directors' independence," HRSA said.
"Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network to save the lives of their loved ones who experience organ failure," HRSA Administrator Carole Johnson said. "At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less."
HRSA also called on Congress to more than double annual program funding to $67 million, remove the appropriations cap on OPTN contracts and expand the scope of eligible contractors — specifically IT contractors.
It's unclear whether the plan will face legal challenges from UNOS, since the 1984 National Organ Transplant Act established the current system. Johnson told The Washington Post that she has the legal authority to move forward without Congress.
UNOS said in a statement that it supported HRSA's plan, including competitive bids for organ distribution oversight.
"We welcome a competitive and open bidding process for the next OPTN contract to advance our efforts to save as many lives as possible, as equitably as possible," the group said. "We believe we have the experience and expertise required to best serve the nation’s patients and to help implement HRSA’s proposed initiatives."
The plan would also revamp the network's IT system and create data dashboards with information on performance metrics, waitlists and demographics. The agency on Wednesday debuted an initial dashboard that it said it plans to refine over time.
UNOS has weathered years of federal scrutiny amid continued regulatory changes aimed at shortening waitlists for critical organs. More than 100,000 Americans are currently waiting for an organ — mainly kidneys — and an estimated 17 people die each day on the waiting list.
Lawmakers and regulators alike have scrutinized UNOS in recent years. In 2020, the Trump administration finalized more stringent performance metrics in an attempt to reduce the number of wasted organs.
And a 2018 decision by UNOS to change how livers are allocated has drawn the continued ire of lawmakers from states receiving fewer organs, like Sen. Charles E. Grassley, R-Iowa, and Sen. Jerry Moran, R-Kan.
Most recently, Grassley and Sen. Ron Wyden, D-Ore., requested data from organ procurement organizations over concerns the groups are abusing a provision that boosts performance metrics for every pancreas donated to research.
Organ groups have repeatedly defended their performance. In response to the pancreas letter, the Association of Organ Procurement Organizations noted that overall transplants of deceased donor organs increased 4.6 percent in 2022.
The association called on lawmakers to implement recommendations from the National Academies of Science, Engineering and Medicine to help eliminate the 19 percent gap in organs that are donated but not successfully transplanted.
"The need for more transplants is one of the most pressing issues in healthcare today," the group said.