HHS to Close University of Miami's Failing Organ Agency

WASHINGTON—September 18, 2025 — The U.S. Department of Health and Human Services (HHS) today announced it is moving to decertify a major organ procurement organization (OPO) after an investigation 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.

CMS's decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of Secretary Robert F. Kennedy, Jr.'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, 73 patients showed neurological signs incompatible with donation, and the Biden administration had closed its own investigation without action.

This systemic disregard for the sanctity of life within the nation's organ transplant system poses a grave threat to both prospective donors and recipients. 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.

"An organ procurement organization must serve as the trusted custodian of every donated organ," Secretary Kennedy said. "Its job is to honor the gift of life by ensuring trained professionals recover every organ safely, match it fairly, and deliver it quickly to the patient who needs it most. We will not allow any participant to cut corners with human life, and we hold every institution in the transplant system to the highest standards of safety and accountability."

"The Biden administration turned a blind eye to systemic failures in the organ procurement system, closing investigations even when lives were at stake," said Deputy Secretary Jim O'Neill. "That neglect not only cost patients their chance at life, but it stalled the innovation our system so desperately needed. Today, we are correcting those failures by restoring transparency and embracing forward-looking solutions to ensure every organ is used responsibly and every patient has a fair chance."

"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. "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."

HHS' reforms to restore integrity and trust in the Organ Procurement and Transplantation Network (OPTN) include:

• Safeguards that prevent line-skipping in organ allocation, already protecting nearly 300 patients.
• A special election that achieved record turnout to install an independent OPTN board.
• A strengthened misconduct reporting system, giving patients and providers a direct channel for safety concerns.
• A transparency tool that shows when organs are allocated outside the standard match list.
• Removal of "DEI" provisions from the 2024 IOTA model to ensure fairness.

Secretary Kennedy 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 HRSA, documenting and reporting incidents and adverse events to OPTN, leading root cause analyses, and ensuring corrective actions are implemented.

This reform will lead to safer, fairer, and more reliable organ procurement, while strengthening accountability and preventing repeat failures.

An Organ Procurement Organization (OPO) is a federally designated nonprofit responsible for coordinating the recovery of organs for transplantation in the United States. 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. They then match and allocate organs through the national Organ Procurement and Transplantation Network (OPTN). OPOs are regulated by the Centers for Medicare & Medicaid Services (CMS) and overseen by the Health Resources and Services Administration (HRSA) at HHS, with the mission of turning potential donations into successful transplants while upholding the highest standards of safety and accountability.