The Centers for Medicare and Medicaid Services finalized a rule to strengthen federal oversight of Organ Procurement Organizations, the entities responsible for recovering organs from donors and coordinating their delivery to transplant centers.
Over 100,000 Americans are currently waiting for organ transplants, while slightly fewer than 50,000 transplants were performed in 2025, according to CMS. The new rule aims to improve access by allowing high-performing OPOs to compete for multiple donation service areas and by establishing clearer standards and oversight mechanisms.
The final rule defines "unsound medical practices" — failures that create an imminent threat to patient health — and gives CMS authority to immediately decertify noncompliant Organ Procurement Organizations. It also requires OPOs to have clearer policies for identifying, reporting, investigating and preventing adverse events during the organ donation process.
The rule refines how CMS measures transplant performance, specifying that pancreata used only for islet cell research no longer count toward transplant rates in the absence of an actual transplant. OPOs must now track and document what happens to organs sent for research.
Additionally, the rule requires OPO medical directors to hold a license in at least one state or territory where the organization operates, and it codifies a process for CMS administrator review of hearing officer decisions in appeals cases.
Since CMS issued an earlier rule on OPO standards in December 2020, organ donations have increased by 36 percent nationwide and transplants have increased by 30 percent, according to the agency.