CMS Finalizes Its 2026 Organ Procurement Organization Rule

On November 3, 2026, the Centers for Medicare and Medicaid Services (CMS) finalized a follow-up to its 2020 final rule governing conditions of participation for organ procurement organizations (OPO). CMS’s final rule in 2020 set forth outcome measures for OPOs. The latest final rule further cements the new rating structure that will determine which of the 55 OPOs will be recertified at the end of the current cycle. The final rule largely tracks CMS’s proposed rule, which we discuss here, with the following notable exceptions: 

• • Medically complex donor/organ definitions are not finalized: In its proposed rule, CMS defined “medically complex donor” as a donor whose medical history requires special or additional consideration to identify the best recipient, and “medically complex organ” as an organ recovered from a medically complex donor. Citing the lack of consensus about medical complexity, concerns that an overly broad definition would encompass too many donors and burden quality assurance and performance improvement (QAPI) activities, and changing clinical practices and technology, CMS did not finalize either definition. By extension, there is no QAPI requirement relating to medically complex donors/organs. 
  • Removal of licensing requirement: CMS’s proposed rule would have required OPOs to ensure that personnel performing clinical duties were legally authorized through licensure, certification, or registration under applicable federal, state, and local laws. CMS did not finalize this new standard in response to comments that state licensure requirements insofar as they apply to the care of living patients. 
  • CMS assignment of Donation Service Area (DSA) to OPO: CMS modified its proposed regulation to indicate that it would not open a DSA for competition following assignment of the DSA to an OPO when there is insufficient time for CMS to conduct a competition (§ 486.308(a)(4)). The assigned OPO retains the designation until the end of the certification cycle rather than serving only until a competition can be arranged. When CMS assigns an OPO to a new DSA (and the OPO attains a Tier 2 status) the OPO’s new and existing DSAs will not be opened for competition at the end of that recertification cycle until a full recertification cycle has been completed for the newly assigned DSA. CMS explained that this provides the assigned OPO time to stabilize the new area without putting its other Tier 2 areas at immediate risk. However, OPOs that serve DSA(s) classified under Tier 3 do not receive the same protection.  

CMS’s final rule also addresses the following issues: 

• • Adverse events vs. unsound medical practices: The agency adopted its proposed definitions of adverse events and unsound medical practices, drawing distinctions between the two. CMS explained that while adverse events can be “serious,” they can generally be addressed through an OPO's internal QAPI program. Unsound medical practices, however, are “failures” by the OPO in which it knows, or should have known, that its inaction, actions, or outcomes caused, or is likely to cause, serious injury, harm, impairment, or death to a potential or actual donor or an organ recipient, creating an imminent threat to patient health and safety or public safety. These practices include, but are not limited to, failures in governance; patient or potential donor evaluation and management; and procurement, allocation, and transport practices and procedures. A single incident can suffice; unsound medical practices need not involve a repeated or sustained pattern. Where an OPO has engaged in unsound medical practices, “standard compliance mechanisms such as QAPI are insufficient to address the concern,” and CMS may exercise its regulatory discretion to decertify due to “urgent need.”  
  • Organ definition and pancreatic research: CMS finalized its proposal to exclude pancreata used for islet-cell research without transplantation from the transplantation-rate measure. However, the final rule does include it in the donor definition, which will apply prospectively beginning with the 2027 assessment period. CMS reiterated that OPOs must maintain disposition records for research organs. Although commenters requested that CMS define “qualified researcher” and “bona fide research,” the agency declined to do so, stating that OPOs should turn to accepted industry standards. 
  • Nonrenewal is limited to OPO’s designation to DSA: The proposed rule describes nonrenewal of an OPO as the situation where an OPO loses a competition to retain its DSA or acquire another. But it would remain certified and be eligible to compete for another DSA during the following certification period. The final rule also makes clear that losing a competition ends the OPO’s designation agreement for that DSA, not its certification agreement.  
  • Preexisting regulatory limitation against certifying new OPOs: CMS removed the regulatory provision requiring an entity to have been recertified as an OPO between January 1, 2002, and December 31, 2005, to qualify for OPO certification. This change aligns the regulations with CMS’s new interpretation of the statute as authorizing it to certify new OPOs.  
  • Conflict of interest, automatic electronic referrals, and allocation out of sequence: CMS summarizes comments received but does not establish any new guidelines or requirements. Instead, it reserves these issues for possible future rulemaking. It discusses allocation out of sequence. This highlights the work of the OPTN in this area, including the Allocation Out Of Sequence (AOOS) Dashboard, allocation-compliance reports, and three draft OPTN policy proposals. It does not codify a new AOOS exception or allocation framework. 

By CMS’s estimation, there will be 14 Tier 3 DSAs and 21 Tier 2 DSAs, resulting in an estimated 35 DSAs opened for competition at the end of the current cycle. The agency expects it will receive 140 applications from OPOs that want to assume responsibility for these DSAs.   

We advise all stakeholders in the organ transplant community to carefully monitor this evolving landscape and take steps to prepare for what promises to be a significant transition period. Our legal team is ready and available to help health care entities navigate this unprecedented period. For further details or clarification, please contact the author of this alert or your preferred Crowell & Moring lawyer.