Organ donation groups sue to block new US certification system
The lawsuit, filed Friday in federal court in Tampa, Florida, said the new certification process, set to begin next year, unfairly ranks providers by the number of donations and transplants they complete, using the same scale to assess organizations covering vastly different geographic areas and populations.
The plaintiffs asked the court to bar the new process before it begins, arguing it was not properly implemented under the Administrative Procedure Act and runs afoul of Congress' directive in the 1984 National Organ Transplant Act to use multiple measures to evaluate providers.
The legal challenge comes as HHS has announced increased scrutiny of organ procurement organizations and threatened to close a major provider after an HHS probe identified cases where doctors had begun to retrieve organs while patients still showed signs of life.
The organizations that filed the lawsuit, including LifeLink Foundation and OneLegacy, said they will be seeking recertification next year to retrieve donated organs in states including Texas, Florida and Georgia.
The plaintiffs in a statement said they are suing to require the agency "to comply with its statutory obligations, which is necessary to protect patients' access to lifesaving transplants and ensure the stability of our nation's organ donation and transplant system."
An HHS spokesperson declined to comment on the lawsuit but said the agency "remains committed to holding organ procurement organizations accountable and restoring integrity and transparency to organ donation and transplant policy, always putting patients first."
HHS adopted the new evaluation process in a 2020 regulation. The lawsuit said it will rank organizations based on the number of donations and transplants they completed in the last 12 months and would decertify the lowest-ranked providers.
The rule was introduced as part of HHS' effort to implement an executive order on kidney donations issued during President Donald Trump's first term. The agency said the change was meant to increase transparency and competition in the organ transplant system.
HHS announced last month it was undertaking a series of reforms for the organ transplant system, following a New York Times report and an investigation by the agency's Health Resources and Services Administration.
The probe examined 351 cases where organ donation was authorized but not completed. It found 73 patients had shown neurological signs incompatible with organ donation and at least 28 patients may not have been deceased at the time the organ retrieval process began.
The lawsuit is LifeLink Foundation v. Kennedy, U.S. District Court for the Middle District of Florida, No. 8:25-cv-02042.
For the plaintiffs: Val Leppert, Mark Polston, Ashley Parrish, Adam Robison and Christie Cardon of King & Spalding; and Brigid Merenda and Richard Hanchett of Trenam, Kemker, Scharf, Barkin, Frye, O'Neill and Mullis
For HHS: Not yet available
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