OPO conditions for coverage
Published November 4, 2026 · Coverage October 25–31, 2026, Pacific · Medium priority
CMS’s October 30 fact sheet describes a final rule revising organ procurement organization conditions for coverage, including adverse-event, research-organ record, designation, competition and transition provisions. The rule retains the three-tier recertification framework; an OPO losing a competition to retain a tier 2 donation service area faces nonrenewal of its agreement for designation to that donation service area, not automatic decertification of the entire OPO. Post-window publication update: CMS published CMS-3409-F on November 3, 2026, at 91 FR 69390–69444. The published rule states an effective date of January 4, 2027. Publication does not establish any particular organization’s compliance with the rule.
Suggested owner and action: OPO quality, governance and legal teams can review adverse-event and research-organ record procedures against the published rule, confirm the implementation dates and identify the provisions applicable to their organization.
CMS OPO fact sheet | OPO public-inspection rule | Published OPO rule
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