RFK Jr. Pulls Miami Organ Group’s Certification, Seeks Change (1)

US Health Secretary Robert F. Kennedy Jr. announced the decertification of an organ procurement organization following a federal investigation that he said uncovered staffing, training, and other issues endangering patients.

The US Department of Health and Human Services’ decertification of the University of Miami Health System’s Life Alliance Organ Recovery Agency on Thursday comes as part of a broader effort by the HHS to overhaul the organ transplant system, a process long known to be rife with procedural problems.

Kennedy in a Thursday press conference said the government was acting after years of patient safety failures and federal requirement violations. He said staffing shortages could have caused around eight missed organ recoveries a week.

That’s “roughly one life lost each day,” Kennedy said.

“When OPOs operate improperly, they are going to face decertification,” Kennedy said.

Kennedy is also directing certified organ procurement organizations (OPOs) to appoint safety officers who will be charged with patient safety.

‘Systemic Failures’

Calls to reform the organ transplant process have been longstanding.

Last year, medical providers and patient advocates told the House Energy and Commerce Oversight and Investigations Subcommittee of needs for improvement. Lawmakers meanwhile, pushed the HHS and the United Network for Organ Sharing, which administers the Organ Procurement and Transplantation Network (OPTN), for information on past failings and plans for improvement.

“It is critical to ensure that all entities involved in the organ procurement and transplantation process operate safely, and we are grateful to HHS for their instrumental action taken today to mitigate some of the harmful practices that have come to light through rigorous investigations by this Committee” and the HHS’ Health Resources and Services Administration (HRSA), said committee chairman Brett Guthrie (R-Ky) and John Joyce (R-Pa.), chairman of the subcommittee, in a statement Thursday.

In 2023, then-President Joe Biden signed into law a measure allowing for competitive bidding on contracts to administer the OPTN, which manages a national registry for matching donors with recipients.

The Trump administration, however, has been critical of the Biden administration’s approach to organ transplant reformation. In a statement, HHS Deputy Secretary Jim O’Neill said Biden’s team “turned a blind eye to systemic failures in the organ procurement system, closing investigations even when lives were at stake.”

In July, Trump’s HHS announced that an investigation of 351 cases in which organ donation was authorized but not completed found nearly 30% of cases had “concerning features,” including “patients with neurological signs incompatible with organ donation.”

That same investigation found that at least 28 patients possibly weren’t deceased at the time organ procurement was initiated.

Cracking Down

The HHS’ Centers for Medicare & Medicaid Services regulates OPOs. CMS Administrator Mehmet Oz said at Thursday’s press conference his office would “crack down on noncompliance with Medicare requirements.”

“We’re going to start enforcing the appropriately rigorous standards and modernize the system with stronger data, oversight, innovative tools that can make organ procurement easier, more seemless, more effortless and more effective,” Oz said.

Oz said there’s a several months-long process for Miami to appeal its decertification, and that “there will be seamless coverage” for patients in the covered area.

O’Neill, meanwhile, said at the press conference that the HHS had given the greenlight the first clinical trials for xenotransplantation, a procedure transplanting a genetically modified pig kidney to a human.

“Soon, doctors will save patients with kidney failure by giving them genetically modified pig organs,” O’Neill said. “Someday, we’ll replace failing organs with biomechanical improvements.”

O’Neill also said that via the Advanced Research Projects Agency for Health (ARPA-H), the HHS is “developing bioprinting technology and regenerative medicine” for “personalized organs on demand that will not require immunosuppressant drugs.”