CMS Finalizes Rule to Help More Organs Reach Patients and Strengthen Accountability for Organ Procurement Organizations

CMS finalized a rule on October 30, 2026, revising the Conditions of Coverage for Organ Procurement Organizations (OPOs) under the Medicare and Medicaid programs. The rule builds on the first Trump Administration's 2020 OPO rule, which established objective performance measures and introduced competition for open donation service areas. CMS states that since the 2020 rule, organ donations have increased by 36% nationwide and transplants have increased by 30%. The final rule modifies OPO performance measurement by excluding pancreata procured solely for islet cell research from the transplantation rate, while continuing to count donors of such pancreata toward the donation rate. OPOs are now required to document and track the disposition of organs sent for research, including pancreata directed to islet cell research programs. This change is designed to ensure transplant performance scores reflect only organs actually transplanted into patients. The rule defines "unsound medical practices" to clarify the circumstances under which CMS may exercise its existing authority to immediately decertify a noncompliant OPO. It also codifies decertification pathways, establishes clearer guidance for adverse event identification, investigation, and prevention, and requires that an OPO's medical director hold licensure in at least one state or territory the OPO serves. For competition and service area transitions, the rule requires outgoing OPOs to cooperate with incoming OPOs and requires incoming OPOs to submit a transition plan with progress updates to maintain uninterrupted organ donation operations. The rule also codifies a process for discretionary CMS Administrator review of hearing officer decisions and updates appeals timeframes. A certification requirement limiting OPO certification to those recertified between 2002 and 2005 is removed.