The Priority Review

Regulation Brief

CMS final rule clarifies oversight of Organ Procurement Organizations

The Centers for Medicare & Medicaid Services published a final rule that clarifies recertification, competition, and appeals processes for Organ Procurement Organizations. The rule defines unsound medical practices and requires OPOs to have QAPI programs to monitor adverse events.

Primary source

CMS fact sheet, October 30, 2026

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

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

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