The federal government has moved to strip certification from the organ procurement organization serving Kentucky and parts of Indiana, Ohio and West Virginia, after reviews by two agencies found what officials described as persistent patient safety failures.
HHS Secretary Robert F. Kennedy Jr. announced the start of decertification proceedings against Network for Hope at an event in Lexington on August 5. "Federal reviewers found serious deficiencies in nearly 30% of the cases that they examined," Kennedy said, adding that some patients had been placed on the donation pathway who should never have been there.
That figure comes from a specific review with specific boundaries, and the boundaries matter. Between 2021 and 2024, the Health Resources and Services Administration examined 351 cases at Network for Hope in which organ donation was authorized but ultimately not completed. It found that 103 of them, or 29.3%, showed concerning features, including 73 patients with neurological signs incompatible with organ donation.
Where an Organ Procurement Organization Sits
Most people never encounter one of these organizations by name, which is part of why an action against one is hard to interpret.
Federally designated organ procurement organizations are nonprofits, each responsible for a defined geographic service area. When a hospital identifies a potential donor, the organization evaluates medical suitability, approaches the family about donation, manages the donor clinically, coordinates matching, arranges surgical recovery, and handles transport to transplant centers. Critically, they do not declare patients dead. That determination is made by physicians at the treating hospital.
They sit between donor hospitals and transplant centers, and they are certified by the Centers for Medicare and Medicaid Services. Losing that certification means losing the authority to operate in that role.
Network for Hope serves about seven million people across four states, according to figures the organization has cited.
Two Reviews, Two Different Findings
The distinction between the two federal reviews is the part most likely to get lost.
The HRSA review of 351 authorized-but-incomplete cases produced the 29.3% figure. According to the HHS announcement, it also raised the question of whether some potential donors were deceased at the time organ procurement was initiated, and pointed to poor neurologic assessments, lack of coordination with medical teams, questionable consent practices and misclassification of cause of death, particularly in overdose cases. HHS broadened its investigation in 2025 and concluded that at least 28 patients may not have been deceased when the procurement process began.
The basis for the decertification itself is a separate CMS review. In 2025, HRSA directed the Organ Procurement and Transplantation Network to place the organization on a corrective action plan and monitoring program, while CMS opened an independent review of whether the organization still met Medicare certification requirements. CMS conducted a comprehensive review in May of this year and concluded that prior quality concerns continued to surface in donor evaluation, review of adverse events, and organizational administration.
HRSA Administrator Tom Engels said the agency worked closely with the organization over the past year through intensive monitoring and corrective action, but that it "did not demonstrate the improvements necessary to meet federal standards."
The Organization Disputes the Findings and Will Appeal
Network for Hope has rejected the decision. Chief Executive Barry Massa said in a statement that the organization strongly disagrees with the decision and will appeal.
Massa said the organization is compliant with all OPTN policies and has implemented what he called a first-of-its-kind pause in the procedure process, allowing anyone involved in a donation case to request an immediate halt if there are concerns a patient may not be an appropriate donor. He said that process is now Kentucky law and that the organization worked with legislators and regulators on the drafting of both the law and its implementing regulations.
Massa also said organ donation declined under HRSA oversight for the first time in 14 years and that more than 3,000 people waiting for transplants would be negatively affected by the decision.
Nothing here has been adjudicated. Federal regulations give an organ procurement organization 15 business days to request reconsideration after receiving a decertification notice, and it can request a hearing if CMS upholds the initial determination. The service area cannot be opened to other organizations until that process concludes.
The scrutiny is not new. Federal officials have said the current investigation stems partly from a 2021 case involving the organization's predecessor, Kentucky Organ Donor Affiliates, in which the organization allegedly pressured hospital staff to continue preparing for donation despite signs that a man who had overdosed was regaining consciousness. The procurement did not occur, and the man survived.
Effect on Patients, Donors and Families Right Now
For people currently on a transplant waiting list in the four-state area, the immediate answer from both the organization and hospital partners is that operations continue during the appeal. A spokesperson for 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 did not expect a disruption in services. A CMS spokesperson said federal law establishes a transition period intended to preserve uninterrupted access to donation and transplantation services.
There is precedent for that transition working. CMS recently completed a similar process in South Florida, decertifying the University of Miami's Life Alliance Organ Recovery Agency and selecting Nevada Donor Network to take over the territory, while requiring the outgoing organization to keep providing services during the handover.
For registered donors, the decision does not change registration status. Registries are maintained at the state level and are not tied to a single procurement organization's certification.
The more consequential downstream risk is to public confidence. The Association of Organ Procurement Organizations said it supports corrective action or decertification when an organization fails to meet federal standards, but urged HHS to explain the evidence publicly and warned that the action should not further undermine trust in donation. More than 100,000 people are currently waiting for transplants, and the United States performed more than 49,000 transplants in 2025 even as deceased donation dipped.
Families with concerns about a specific case can report a patient safety concern directly to the OPTN, and Kennedy has directed all organ procurement organizations to appoint an OPTN patient safety officer responsible for monitoring and investigating patient safety events in real time and serving as a first point of contact for families and hospital partners.
MedicalDaily will report the outcome of the appeal and any change in the organization's operating status.
Key Questions Answered
What did the government do? HHS began the process of decertifying Network for Hope, the organ procurement organization serving Kentucky and parts of Indiana, Ohio and West Virginia.
Where does the nearly 30% figure come from? A HRSA review of 351 cases from 2021 through 2024 in which donation was authorized but not completed, of which 103 showed concerning features.
Is that the same review that triggered decertification? No. The decertification rests on a separate CMS review completed in May of this year.
What is the organization's position? It strongly disagrees, says it is compliant with all OPTN policies and will appeal.
Does this stop transplants in those four states? Not during the appeal. The service area cannot be reassigned until the administrative process concludes.
Does this change my donor registration? No. Donor registries are maintained by states and are not tied to one organization's certification.
What happens next? The organization has 15 business days to request reconsideration and can request a hearing if CMS upholds its determination.
