Federal Register #2026-22381

CMS final rule revising Organ Procurement Organization requirements

The Department of Health and Human Services, through the Centers for Medicare & Medicaid Services, issued a final rule updating requirements for Organ Procurement Organizations (OPOs). - Government issuer: U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS); no further office details are provided. - Rule changes: Revises OPO definitions and designation requirements, clarifies when service areas may be opened to competition, and updates the appeals process. - Performance framework: Retains donor and transplant volume outcome measures and the tier structure used for OPO recertification and decertification, while providing additional operational flexibility. - Procurement status: This is a regulatory action, not a solicitation for products or services. No OEMs, vendors, products, quantities, or part numbers are identified.

Description

This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs). It clarifies procedural questions, provides operational flexibility, revises definitions and designation requirements, clarifies when service areas are open for competition, and updates the appeals process. It retains the focus on donor and transplant volumes assessed in outcome measures and the tier structure used for OPO recertification and decertification. The regulations are effective January 4, 2027.

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