Federal health officials are taking steps to cut ties with a major organ procurement organization as part of a larger initiative to overhaul the nation’s organ transplant system.
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced Thursday that the Centers for Medicare & Medicaid Services (CMS) decertified Life Alliance Organ Recovery Agency, a division of the University of Miami Health System. It marks the first time the HHS has decertified an organ procurement organization (OPO) mid-cycle, RFK Jr. said during a press conference.
"We are acting because of years of documented patient safety data failures and repeated violations of federal requirements. And we intend this decision to serve as a clear warning," RFK Jr. said during the press conference.
The HHS is making the moves following an investigation that it said uncovered "years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors."
In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery, HHS officials said in the press release.
Life Alliance Organ Recovery Agency has the option to appeal the decision and to continue operating in the interim.
But, in a statement to Fierce Healthcare late Thursday, the organization said it would not appeal the HHS' decision and "will cooperate fully with HHS to ensure a smooth transition."
"The top priority of the Life Alliance Organ Recovery Agency (LAORA) has always been safe, respectful, and compliant organ donation practices. We are aware of the decision issued today by the Department of Health and Human Services (HHS) and of the agency’s investigations into organ procurement practices across the country," organization officials said in the statement.
"We hope that other OPOs follow suit in putting patients first. Our focus remains on protecting the dignity of donors, supporting their families, and advancing the life-saving mission of organ transplantation," LAORA officials said.
The group's contract will be awarded to another procurement organization.
An OPO is a federally designated nonprofit responsible for coordinating the recovery of organs for transplantation in the U.S. Each of the 55 OPOs serves a specific geographic region, working with hospitals to identify potential donors, evaluate medical suitability, obtain authorization from families and ensure safe recovery of organs.
OPOs then match and allocate organs through the national Organ Procurement and Transplantation Network (OPTN). OPOs are regulated by the CMS and overseen by the Health Resources and Services Administration (HRSA) at the HHS.
HHS officials said CMS’ decertification of the Life Alliance Organ Recovery Agency was part of the Trump administration's reform initiative announced in July. At that time, an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation and 73 patients showed neurological signs incompatible with donation. The Trump administration contends that the previous Biden administration had closed its own investigation without action.
"The Life Alliance Organ Recovery Agency based in Miami, Florida, has a long record of deficiencies directly tied to patient harm," RFK Jr. said. "Staffing shortfalls alone, with a 65% staffing shortage consistently across the years, may have caused as many as eight missed organ recoveries each week, roughly one life lost each day."
He added, "Today's announcement leaves no doubt, when OPOs operate properly, they save lives. When they operate improperly, they are going to face decertification," RFK Jr. said Thursday.
"We are taking bold action and historic action to restore trust in the organ procurement process," he said.
The Trump administration said reforms to the nation's organ transplant system are necessary to protect the health and safety of prospective donors and recipients following reports of unsafe and unfair practices.
"Nearly 100,000 Americans are currently on transplant waitlists, and an average of 13 patients die each day waiting for an organ, even as more than 28,000 donated organs go unmatched each year," HHS officials said in the press release.
"CMS has a clear responsibility to ensure that every organ procurement organization meets the federal standards of safety, performance, and accountability,” said CMS Administrator Dr. Mehmet Oz, M.D., during Thursday's press conference. “For too long, patients and families have suffered from systemic failures. We are enforcing rigorous standards and modernizing the system with better data, stronger oversight, and innovative tools to make organ procurement safer, fairer, and more effective for every American awaiting a transplant.”
The HRSA conducted an investigation earlier this year that revealed “disturbing practices by a major organ procurement organization.”
In July, The New York Times published a report that vividly described the case of a patient taken off life support and declared dead, but whose heart and respiratory systems were found to still be active after surgeons had made an incision into her chest to secure her organs for donation.
That report, citing interviews with 55 medical workers in 19 states who told the paper they “had witnessed at least one disturbing case of donation after circulatory death,” broadly raised questions over whether pressure from the federal government and OPOs to increase the supply of donor organs has weakened patient safety procedures.
“We know that when families make that difficult decision to say yes to a donation, they are entrusting us and the national organ system with their loved one's legacy. When safety lapses occur, trust is broken, and if families lose trust, fewer will choose donation. That is simply unacceptable, and we are here to fix it. Under Secretary Kennedy's leadership, the organ procurement transplantation network modernization efforts are strengthening patient safety and restoring trust," HRSA Administrator Thomas Engels said during Thursday's press conference.
Over the last eight months, the HRSA has led “historic” modernization of the organ transplant to organ procurement and transplantation network, “transforming governance, transparency, technology, and accountability across the transplant system,” Engels said.
The HHS announced Thursday changes and new initiatives as part of its efforts to reform the OPTN. The federal agency is putting safeguards in place to prevent line skipping in organ allocation, already protecting nearly 300 patients.
The HHS said it strengthened a misconduct reporting system, giving patients and providers a direct channel for safety concerns. And the agency launched a dashboard as a transparency tool that shows when organs are allocated outside the standard match list.
On the governance front, the HRSA separated the OPTN board from its contractor and seated an independent 34-member board through a national special election. It marks the first time in 40 years there has been an independent OPTN board, Engels said. There was 83% voter turnout in that special election, he noted.
RFK Jr. is directing all OPOs to appoint an OPTN patient safety officer to oversee patient safety. These officers will be responsible for monitoring and investigating patient safety events in real time, serving as the first point of contact for families, hospital partners and the HRSA, documenting and reporting incidents and adverse events to OPTN, leading root cause analyses, and ensuring corrective actions are implemented, the HHS said.
And the agency is removing “DEI” provisions from the 2024 IOTA model to ensure fairness.