First OPO decertification in U.S. program history: HHS moves to decertify Life Alliance / University of Miami
Life Alliance Organ Recovery Agency (University of Miami Health System)
On September 18, 2025, HHS announced it was moving to decertify the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, after an investigation cited years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. HHS and the House Energy & Commerce Committee characterized this as the first time HHS has decertified an organ procurement organization in the program's history; the OPO had ranked in the lowest performance tier each year from 2019 through 2023.
House Energy & Commerce: HHS Announces Decertification of Florida OPO and Instates Further Safety Guidelines
HHS decertified an OPO for the first time in U.S. history
U.S. Department of Health and Human Services (HHS); Centers for Medicare & Medicaid Services (CMS); Life Alliance Organ Recovery Agency (University of Miami Health System)
On September 18, 2025, HHS announced it was decertifying the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System serving roughly 7 million people across six South Florida counties, described as the first mid-cycle decertification of an organ procurement organization in HHS history. CMS cited years of unsafe practices, poor training, chronic underperformance, and understaffing. CMS later set an effective decertification/termination date of March 27, 2026 to allow an orderly transition, with Nevada Donor Network named as the successor provider for the donation service area.
HHS to Close University of Miami's Failing Organ Agency (HHS.gov press release)
HHS moved to decertify University of Miami's organ procurement agency
Life Alliance Organ Recovery Agency (University of Miami Health System) / CMS / HHS
In September 2025 (announced September 18), HHS/CMS issued an intent to decertify the Life Alliance Organ Recovery Agency, a hospital-based OPO division of the University of Miami Health System, citing years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. The agency served roughly 7 million people across six South Florida counties; Nevada Donor Network was approved to assume responsibility for the service area.
HHS to Close University of Miami's Failing Organ Agency (HHS.gov)
University of Miami / Miami Transplant Institute paid $22M to settle DOJ False Claims Act allegations over medically unnecessary kidney-transplant lab tests
University of Miami (Miami Transplant Institute)
On May 10, 2021, DOJ announced the University of Miami agreed to pay $22 million to resolve three qui tam False Claims Act suits. The government alleged the university's electronic ordering system automatically prompted a set of laboratory tests at its own laboratory each time a patient was treated at the Miami Transplant Institute, several of which the government alleged were medically unnecessary, and that UM caused Jackson Memorial Hospital to submit inflated claims for pre-transplant laboratory testing in violation of related-party regulations. In a separate agreement, the United States reached a $1.1 million settlement with Jackson Memorial Hospital related to the conduct.
DOJ Office of Public Affairs: University of Miami to Pay $22 Million to Settle Claims Involving Medically Unnecessary Laboratory Tests and Fraudulent Billing Practices
Decertified Florida OPO subject of whistleblower allegations of retaliation against staff who reported understaffing and inadequate training
Life Alliance Organ Recovery Agency (University of Miami Health System)
CMS moved to decertify Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, in September 2025 after an HHS/HRSA investigation documented understaffing, inadequate training, misdirected organs, and quality-oversight deficiencies; the agency did not appeal. Separately, an organ-reform oversight compilation reports an unproven allegation that a physician and a nurse said an OPO manager physically assaulted them after they raised staffing and training concerns, and that one was fired and the other's contract was not renewed after 17 years. The decertification facts are confirmed by HHS; the assault and termination claims are unproven allegations reported in an advocacy oversight compilation.
HHS to Close University of Miami's Failing Organ Agency (HHS.gov)