The Centers for Medicare & Medicaid Services finalized a rule to increase oversight of the organizations that coordinate organ donations. The rule aims to hold Organ Procurement Organizations accountable and help more donated organs reach patients, the agency said.
Organ Procurement Organizations connect donor hospitals and transplant programs by securing authorization, recovering organs and coordinating delivery. According to the agency, more than 100,000 Americans are waiting for transplants, while more than 49,000 transplants were performed in the United States in 2025.
The final rule defines unsound medical practices, clarifying when the agency can use its authority to immediately decertify a noncompliant organization. It outlines specific decertification pathways and gives organizations clearer guidance to investigate and prevent adverse events. Department of Health & Human Services Secretary Robert F. Kennedy Jr. said the measure strengthens patient safeguards and holds failing organizations accountable.
High-performing organizations can now compete for multiple donation service areas to improve access to transplants. The rule requires outgoing organizations to cooperate with incoming ones during transitions. Incoming organizations must submit a transition plan with progress updates to facilitate uninterrupted organ donation operations in the service area, according to the rule.
The rule also changes how the agency measures transplant performance to ensure scores reflect organs actually transplanted into patients. Pancreata used only for islet cell research will no longer count toward an organization’s transplantation rate, although the donor will still count toward the donation rate. Organizations must now track and record what happens to any organs sent for research.
Under the rule, an organization’s medical director is required to hold a license in at least one state or territory the organization serves. The agency noted that since a previous rule was issued in 2020, national organ donations have increased by 36% and transplants have increased by 30%. Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz said the new measure builds on those reforms to promote higher donation rates and swifter consequences for bad actors.