Dive Brief:
- The HHS has begun the process of decertifying Network for Hope, the federally designated organ procurement organization serving Kentucky and parts of Indiana, Ohio and West Virginia, after federal reviews found persistent patient safety failures.
- The Health Resources and Services Administration reviewed 351 cases from 2021 through 2024 in which organ donation was authorized but not completed. A separate CMS review in May found continued problems involving donor evaluations, adverse-event reviews and administration.
- Network for Hope said it strongly disagrees with the decision and plans to appeal in a statement to AP News. The organ procurement group did not respond to additional questions about the basis of its appeal, its current operating status and contingency planning with hospital partners.
Dive Insight:
It’s a significant escalation in federal scrutiny of the organ donation system and could become the second recent test of whether CMS can remove a failing Organ Procurement Organization without disrupting organ donation and transplant operations in the region it serves.
The decertification also builds on years of efforts by the CMS to tighten performance standards for OPOs and introduce more donation and transplantation benchmarks.
The current investigation stems partly from a 2021 case involving Network for Hope’s predecessor, Kentucky Organ Donor Affiliates. Federal officials allege the organization pressured hospital staff to continue preparing for organ donation despite signs that a man who had overdosed was regaining consciousness. The procurement did not occur, and the man survived.
Organ procurement organizations do not declare patients dead; that determination is made by physicians at the treating hospital. HHS broadened its investigation into Network for Hope in 2025, concluding that at least 28 patients may not have been deceased when the organ procurement process was initiated.
Regulators also cited inadequate neurological assessments of donors, poor coordination with medical teams, questionable consent practices and problems involving overdose patients. HRSA subsequently ordered corrective action and monitoring last year, while CMS opened a separate review of whether Network for Hope continued to meet Medicare’s certification requirements.
HHS said both agencies independently determined that the organization had not improved enough. CMS’ May review found that earlier concerns continued to affect donor evaluations, adverse-event oversight and the organization’s administration.
Network for Hope will not be replaced immediately by another OPO if it appeals. Federal regulations give an OPO 15 business days after receiving a decertification notice to request reconsideration and can then request a hearing if CMS upholds its initial determination. Its service area cannot be opened to competitors until the administrative appeal process concludes.
CMS declined neither to comment on whether Network for Hope would appeal nor would it speculate about the outcome of any appeal. However, a CMS spokesperson said federal law provides affected organ procurement organizations with due process rights and establishes a transition period intended to preserve uninterrupted access to organ donation and transplantation services.
A spokesperson for the University of Kentucky HealthCare, which operates a donor-care unit alongside Network for Hope, said it was focused on keeping organ care consistent in the region, and that it didn’t expect a disruption in services as a result of the decertification announcement.
"For patients, families and organ donors, our message is simple: you can continue to place your trust in the UK Transplant Center,” said the spokesperson in an emailed statement.
Other experts said the decertification was a long time coming.
“Secretary Kennedy showed great leadership in saying what we've known since 2024: Network for Hope cannot be allowed to continue to operate, since it is an ongoing, deadly risk to 7 million people across Kentucky, Ohio, Indiana, and West Virginia, said Jennifer Erickson, senior fellow at the Federation of American Scientists. “If Network for Hope fights this action, it will show that it cares more about executive paychecks than patients.”
The Trump administration recently completed a similar process in South Florida. CMS decertified the University of Miami’s Life Alliance Organ Recovery Agency and selected Nevada Donor Network through a competitive process to take over the territory. CMS required the outgoing OPO to continue providing services during a coordinated transition involving personnel, records and new agreements with hospitals.
The Association of Organ Procurement Organizations said it supports corrective action or decertification when an OPO fails to meet federal standards, but urged HHS to publicly explain the evidence behind its decision and outline how it will maintain continuity for donor families, transplant programs and patients. The trade group also warned that the action should not further undermine public confidence in the broader donation system.
The case also creates a broader challenge for federal regulators: demonstrating accountability for serious safety failures without further weakening public confidence in organ donation or disrupting access for patients awaiting transplants. More than 100,000 people are currently awaiting transplants, while the United States performed more than 49,000 organ transplants in 2025 despite a decline in deceased donation.
