HHS moves to bar Miami organ transplant agency
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Kennedy outside of the White House. Photo: Win McNamee/Getty Images.
The Trump administration said Thursday it is barring a University of Miami affiliate from the network that distributes donated organs, citing unsafe practices, administrative errors and underperformance.
Why it matters: The action, if completed, would mark the first time an organ procurement organization has been decertified, and the first time federal regulators have used their authority to pull an active contract for such work.
- Life Alliance Organ Recovery Agency (LAORA), a division of the University of Miami's health system, can appeal the decision.
- "Today's announcement leaves no doubt: When OPOs operate properly, they save lives. When they operate improperly, they are going to face decertification," Health Secretary Robert F. Kennedy Jr. said.
State of play: HHS said an investigation revealed years of unsafe practices, chronic underperformance and paperwork errors, including a 2024 case in which a mistake led a surgeon to turn down a donated heart for a patient awaiting transplant surgery.
- The organization has ranked in the lowest performance tier each year between 2019 and 2023, according to the most recently available federal data.
- LAORA and the University of Miami did not immediately respond to a request for comment.
Between the lines: The organ transplant system has been a source of bipartisan concern for years. Officials have looked to address problems like long wait times and instances in which donated organs were lost or destroyed.
- More recently, there have been complaints of organizations trying to remove organs from patients who still showed signs of life.
- HHS in July said it found evidence of systemic patient safety issues at a Kentucky organ procurement organization. The House Ways and Means Committee is investigating LAORA for possible Medicare fraud, following whistleblower complaints.
Context: Organ procurement organizations are non-profit federal contractors that come into hospitals in defined regions to gather donor organs from deceased patients. There are 55 such organizations across the U.S.
- The Centers for Medicare and Medicaid Services regulates and certifies the organizations. CMS implemented new regulations in 2020 that created more stringent performance requirements.
- Current data shows that 47% of OPOs in the country would be automatically decertified or forced into competition for their contract next year, according to the Association of Organ Procurement Organizations.
- Seven organizations sued CMS in August over the performance standards, saying they violated congressional instructions and would "cause systemic disruption to the nation's organ donation system."
What they're saying: "The Trump administration took a historic step today to cement its legacy as a protector of vulnerable organ donation patients, and HHS and congressional investigations should keep going until all corrupt and dangerous contractors are removed," Jennifer Erickson, senior fellow at the Federation of American Scientists, said in an email to Axios.
Zoom in: HHS said during the Thursday press conference that it's also committing $25 million in new funding to reduce financial burdens on living organ donors.
