RFK Jr. announces move to decertify organ procurement organization

Kaia Hubbard
Thu, September 18, 2025 

Washington — Health and Human Services Secretary Robert F. Kennedy Jr. announced on Thursday new action to reform the nation's organ transplant system, as well as a move to decertify an organ procurement organization.

"Every American should feel safe becoming an organ donor and giving the gift of life, yet decades of ignored patient safety concerns have driven more and more Americans off the donor list," Kennedy said. "Today, under President Trump's leadership, we are taking bold action and historic action to restore trust in the organ procurement process."

Transplant experts said last year there had been a spike in people revoking organ donor registrations, after a report that a Kentucky man who'd been declared dead woke up just as a team was preparing to remove his organs. Since then, there have been more reports of attempts to remove organs from patients who had mistakenly been declared dead.

Kennedy said at a news conference that "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."


The secretary said the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, "has a long record of deficiencies directly tied to patient harm."

"Unlike the Biden administration, which ignored these problems and failed to act, the Trump administration is setting a new standard that patient safety comes first," Kennedy said.

Kennedy said along with the decertification, HHS is reforming the Organ Procurement and Transplantation Network and "investing in new ways to encourage organ donation."

Health and Human Services Secretary Robert F. Kennedy Jr. speaks during a press conference on the steps of the United States Department of Agriculture on July 14, 2025 in Washington, D.C. / Credit: Michael M. Santiago / Getty ImagesMore

In July, HHS announced a plan to begin reforming the organ transplant system, citing a federal investigation that "revealed disturbing practices by a major organ procurement organization."

Kennedy said in a statement at the time that the investigation, conducted by the Health Resources and Services Administration under HHS, showed "that hospitals allowed the organ procurement process to begin when patients showed signs of life," calling it "horrifying" and pledging to hold accountable organ procurement organizations that coordinate access to transplants.

HHS said the investigation examined 351 cases where organ donation was "authorized, but ultimately not completed," finding that nearly 30% showed "concerning features," like neurological signs in patients that the agency said are incompatible with organ donation. And at least 28 patients "may not have been deceased at the time organ procurement was initiated."

More than 100,000 people are on the national transplant waiting list, and 13 people die every day waiting for a transplant, according to the Health Resources and Services Administration. There are 55 organ procurement organizations nationwide that serve specific geographic regions.

House Ways and Means Committee Chairman Jason Smith and House Oversight Subcommittee Chairman David Schweikert wrote a letter to Life Alliance Organ Recovery Center in July demanding documents about reports that claim the organization "knowingly and deliberately engaged in a Medicare fraud scheme." The letter also cites reporting from The New York Times on a case involving the organization in which, the lawmakers said, "clinicians sedated a patient, withdrew life support, and waited for death before removing the organs of a patient who was crying and biting on his breathing tube which one Life Alliance employee interpreted as the patient not wanting to die."

"Patient safety lapses have long been a recurring issue for your organization and others like it, reflecting a history of ongoing concerns rather than isolated incidents," the chairmen wrote.

CBS News has reached out to Life Alliance Organ Recovery Agency for comment.

The Association of Organ Procurement Organizations, of which Life Alliance is a member, pledged in a statement "that we and our members will keep saving lives nationwide" and "will continue to support the team at Life Alliance to ensure South Florida organ donors, transplant patients and their families have access to organ donation and transplantation services."

"As advocates for the patients and donor families we serve, OPOs are committed to and invested in the ongoing improvement of our nation's organ donation and transplantation system," the group said. "Patient safety is the top priority for everyone involved in this lifesaving work and it guides our actions every day."

Kennedy has been pushing major changes to the nation's health care systems since he was sworn in earlier this year. And he has faced criticism in recent weeks over his leadership of the department amid a number of departures from the Centers for Disease Control and Prevention. On Wednesday, Susan Monarez, who was ousted as CDC director by Kennedy less than a month after she was confirmed, testified before a Senate committee that she faced pressure from the secretary to change the childhood vaccine schedule, regardless of whether there was scientific evidence to support doing so.

Kennedy testified before a different Senate committee earlier this month, where he defended the CDC shake-up, saying changes at the health agency were "absolutely necessary." The secretary denied pressuring the former director to preapprove upcoming vaccine recommendations, and accused her of lying about why she was fired.



RFK Jr. announces plans to shut down Florida organ transplant group citing safety issues

Swapna Venugopal Ramaswamy, 

USA TODAY
Thu, September 18, 2025 

Health and Human Services Secretary Robert F. Kennedy Jr. announced on Sept. 18 that a Florida organization responsible for coordinating organ donations in the U.S. was being shut down for "unsafe practices," calling the action a historical first.

"For the first time in the history, HHS will de-certify an organ procurement organization mid-cycle," he said. "We are acting because of years of documented patient safety data failures and repeated violations of federal requirements."

Kennedy said he intended this decision to "serve as a clear warning."


Robert F. Kennedy, Jr., Secretary of Health and Human Services, testifies about the health care agenda for the Trump administration in front of the Senate Committee on Finance in Washington, D.C., on September 4, 2025.

U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., speaks with Agriculture Secretary Brooke Rollins and Senator Roger Marshall (R-KS) ahead of a roundtable event as part of the "Make America Healthy Again" (MAHA) agenda, on Capitol Hill in Washington, D.C. on July 15, 2025.

Robert Kennedy Jr. speaks at a press conference upon his arrival at Miami International Airport on Feb. 19, 1996, after visiting Cuba with his brother Michael (L) and a delegation of US environmental and energy experts.

He said the organization, Life Alliance Oregon Recovery Agency, based in Miami, has a long "record of deficiencies directly tied to patient harm."

RFK, MAHA say how they'll confront chronic diseases in kids. Why are some disappointed?

"It had a 65% staffing shortage consistently across the years and may have caused as many as eight missed working recoveries each week. Roughly one life lost each day," said Kennedy.

An investigation uncovered years of "unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors," according to the HHS.

The action is part of a reform initiative announced in July after a federal investigation found at least 28 instances in a Kentucky-based federally funded Organ Protection Organization called the Network of Hope where the process of procuring organs for donation was initiated from people who may not have been dead.

Health and Human Services Secretary Robert F. Kennedy Jr., left, and Medicare and Medicaid Administrator Mehmet Oz at the White House in Washington, DC, on July 30, 2025.

The investigation also found that 73 patients showed neurological signs incompatible with donation at these organizations.

That organization, which is one of 55-federally funded organizations nationwide, is now undergoing an HHS directed "Corrective Action Plan" following a "serious patient safety event."

"The incident was an adverse event that required immediate action. While serious, it does not reflect a pattern of persistent noncompliance," HHS Spokesperson Emily Hillard told USA TODAY.

The plan, Hillard said, requires the organization "to correct deficiencies, strengthen safeguards, and prevent recurrence."

The action reflects HHS’s responsibility to act quickly when patient safety is at risk, while reserving "decertification for the most severe and sustained failures," according to a statement released by the HHS.

The organ donation system, as this decertification shows, is in need of reform and updating, said Arthur Caplan, founding head of the Division of Medical Ethics at NYU Grossman School of Medicine.

But reform should be handled with care, he said.

"Transplantation relies on altruism from both the living and the deceased to obtain life-saving organs and tissues. That altruism in turn requires trust," said Caplan. "In improving organ availability it is vitally important to do nothing that damages trust which is the fuel that provides treatments to those in organ failure."

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, according to the HHS

Swapna Venugopal Ramaswamy is a White House Correspondent for USA TODAY. You can follow her on X @SwapnaVenugopal

This article originally appeared on USA TODAY: RFK Jr. moves to close Florida-based organ transplant group



Opinion

An organ donor saved my life. But fear of unlikely botched donations hurts others. 

Kaitlyn Wells
Thu, September 18, 2025 

THE CONVERSATION

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As someone who is alive today because of an organ donation, I was alarmed by the news that Donate Life America, a nonprofit that oversees a national registry of organ donors, saw a 700% increase in donor registration withdrawals since July.

That startling drop in donors followed reporting by The New York Times offering horrifying details of how in extremely rare instances, teams rushed to secure organs from patients who still showed a flicker of life. A federal investigation found that at least 28 patients might not have been dead when organ procurement began. Thankfully, the surgeries weren’t completed.

I'm not here to fault The Times' reporting. But I am here to say that the reaction to vacate the registry is the wrong move. (Full disclosure: I work at Wirecutter, a product review site run by The New York Times Co.)

The reporting spotlights the differences between brain death and “donation after circulatory death.” In the latter case, surgeons stop life support with the family’s consent and recover the organs after the heart permanently stops beating. Typically, the patients noted in the federal investigation and The Times reporting qualified for circulatory death.

Yet donation after circulatory death isn’t the problem. In fact, the first human organ transplants included circulatory death donors. Rather, the cases described were rife with worrisome consent practices, subpar neurologic assessments and poor communication among teams. Still, some people have abandoned their desires to donate their organs after they die. It’s a personal choice and I respect it.

Opinion: Organ transplant investigations expose grisly stories of patient abuse

More than 103,000 people are on the national transplant waiting list, according to the Organ Procurement and Transplantation Network (OPTN). Every eight minutes, someone joins the registry. And an estimated 13 people die every day waiting for an organ transplant.
I always wanted to donate my organs. Then an organ donor saved my life.

In 2024, more than 24,000 people ‒ including 9,700 brain death and 7,200 circulatory death donors ‒ saved lives with the ultimate gift, says OPTN. If it weren’t for these generous souls and their families, many of the 48,000 transplant recipients wouldn’t be here.

That could have been me.

Author Kaitlyn Wells received a double-lung transplant after suffering from respiratory distress syndrome.

In 2024, I spent nearly 10 months in an intensive care unit for acute respiratory distress syndrome, a life-threatening lung injury that prevents the lungs from filling up with oxygen. The disease destroyed my lungs and sent me into heart failure. As expected, it led to damage in my brain, kidneys and stomach. (And just recently, I learned a kidney transplant may be in my future.)

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Like countless others, the news stories poked at my former anxiety about being a registered organ donor. I always knew I wanted to donate my organs. Yet, I feared medical staff would focus on procurement to help another, rather than try to save my life.

But while hospitalized, I saw the compassion and tears that hospital staff shed for deceased organ donors during honor walks. I felt the joy radiate from them when lives were saved thanks to the donors’ sacrifices. I signed the consent forms understanding my new, perfect set of pinkish lungs may be donated by someone who suffered either circulatory death or brain death. I witnessed firsthand the care and tenacity of the doctors, nurses and therapists who worked tirelessly to save me.

And I’m confident emergency medical staff did everything humanly possible to revive the woman from Florida whose lungs now breathe for me. (Fortunately for me, she was not one of the 950 people who recently removed themselves from Florida’s registry.)

How to become an organ donor: We can and should make it easier for everyone to become an organ donor | Opinion
Patients can wait years for a lifesaving donation

I know that in no way do reputable programs rush to throw any viable organ into the next terminally ill patient. Circulatory death donors are treated with dignity and respect, and only become donors after families choose a natural death.

While there are more than 173 million Americans on donor lists, only 3 in 1,000 people are eligible candidates when they die. If everyone on the registry died tomorrow, that means just 519,000 people would become candidates.

The seemingly serendipitous moment is the coalescence of case severity, blood type, body size, organ status, timing, tissue type and a million other things. Wait times for patients can be a week for a living liver donor, to a median of over 720 days for a high-priority heart transplant.

I waited 206 days.

Yes, attempting to prematurely remove organs, even for seemingly noble reasons, is inexcusable. What happened to those 28 patients is a beyond-the-pale anomaly.

Legislation like the Uniform Determination of Death Act and regulatory bodies like the Health Resources and Services Administration work to keep the process safe. Share your reservations and end-of-life care preferences with the people you trust. Seek out transplant recipients and living donors by contacting your local transplant hospital to learn what being an organ donor truly means.

Rather than let fear halt generosity, join or keep your name on the donor registry list. A larger donor registry gives everyone on the waiting list a better chance at a future. And what we truly should be afraid of is a world without altruism and compassion – not one where we save human lives through organ donation.

Kaitlyn Wells

Kaitlyn Wells is a double lung transplant recipient who has written about the disparities of organ and bone marrow donation within communities of color. She has a memoir in progress about adverse drug reactions and organ transplants. She works at Wirecutter, a product review site run by The New York Times Co.

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