Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage, Final Rule (CMS 3409-F)

The Centers for Medicare & Medicaid Services (CMS) published a final rule that will continue to strengthen federal oversight of Organ Procurement Organizations (OPOs). This final rule expands on the December 2020 final rule that set the framework for performance metrics and created a tiered system to recertify or decertify OPOs based on their performance on both donation and transplant measures. It also clarifies designations to multiple donation service areas (DSAs), recertification processes, procedures for competition, appeals, information management, and other operational details.

Background

In 2019, President Trump issued Executive Order 13879 “Advancing American Kidney Health,” directing the Secretary to enhance the procurement and utilization of organs available through deceased donation and to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance. In response, CMS published the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs) rule in December 2020. In January 2026, CMS published an additional proposed rule revising the OPO CfCs to clarify outstanding procedural questions and to enable OPOs to make more informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more lifesaving organs (91 FR 4190).

This final rule revises the CfCs for OPOs to clarify outstanding procedural questions for recertification and competition. This rule also revises definitions, clarifies the designation requirements for OPOs, clarifies when an OPO’s service area will be open for competition, and updates the appeals process. CMS remains committed to holding all OPOs accountable for their performance and will be moving to decertify tier 3 OPOs as indicated in the 2020 final rule.

This final rule does not change the focus on improving donor and transplant volume, as assessed in the outcome measures, nor does it change the tier structure used for OPO recertification and decertification. The outcome measures focus on two rates — the donation rate and the transplantation rate. OPOs that have both DSAs ranking at or above the upper benchmark are placed in tier 1 and eligible for recertification for another four years. OPOs that have DSAs ranking in tier 2 are the next highest performers. Tier 2 OPO DSAs meet or exceed the lower benchmark on both measures but do not rate high enough to reach tier 1 on both measures. OPOs with DSAs that are in tier 2 are also eligible for recertification but must compete to retain their DSAs. Lastly, OPOs with tier 3 DSAs are the lowest performing OPOs with one or both measures below the lower benchmark. OPOs that only have tier 3 DSAs will be decertified and cannot compete for any other open DSA.