Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage

CMS issued a final rule on November 3, 2026 (91 FR 69390, CMS-3409-F, RIN 0938-AU54) revising the Conditions for Coverage (CfCs) for Organ Procurement Organizations (OPOs) under 42 CFR Part 486, subpart G. The rule is effective January 4, 2027. The stated purpose is to clarify procedural and operational questions that arose following the December 2020 OPO final rule (85 FR 77898) and to provide additional operational flexibility for OPOs without altering the core outcome measure framework or the three-tier re-certification and de-certification structure established in 2020. The final rule revises several definitions; removes the requirement that an OPO have been re-certified from 2002 through 2005 to be eligible for certification; revises the designation framework to account for OPOs serving more than one Donation Service Area (DSA); clarifies when a DSA is open for competition; categorizes and clarifies actions affecting OPO agreements, including non-renewal and de-certification; revises the appeal process; requires appropriate staff licensure; expands information management requirements to include records for organs procured for research; and adds new Quality Assessment and Performance Improvement (QAPI) requirements related to medically complex donors and organs. The rule also includes a regulatory refinement affecting the outcome measure calculations by incorporating pancreata used for islet cell research into those calculations. CMS declined to adopt commenter requests to modify the underlying outcome measures, risk-adjustment methodology, data sources (e.g., replacing cause, age, and location consistent with organ donation (CALC) methodology with hospital referral data), or the single-year measurement period, characterizing those requests as outside the scope of this rulemaking. CMS also declined to establish alternative remediation pathways before de-certification for outcome measure failures, reaffirming that existing QAPI corrective action requirements under Section 486.348(d) constitute the available pre-de-certification remedy. OPOs that fail to meet outcome standards in the final assessment period face de-certification under Section 486.312(a)(2) or (3), or removal of designation from a DSA under Section 486.316(a)(3). CMS estimates first-year costs of approximately $16.5 million and ongoing annual costs of approximately $7.9 million, characterized as incremental to the December 2020 framework. Estimated annual benefits total approximately $598,000, attributed to reduced compliance-interpretation and implementation inquiry burden. There are currently 54 OPOs serving 55 DSAs in the United States, and in 2025 a total of 49,065 organ transplants were performed nationally.