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

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What it does

This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and provide additional operational flexibility for OPOs to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule revises definitions, revises the designation requirements for OPOs, clarifies when an OPO's service area is open for competition, and updates the process for appeals. We are committed to holding all OPOs accountable for their performance and this final rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re-certification and de-certification of OPOs.

The Centers for Medicare & Medicaid Services's summary, as published in the Federal Register.

What changed in the regulation

1 part of Title 42 of the Code of Federal Regulations:

42 CFR 486

Compared with

The Centers for Medicare & Medicaid Services has published 20 final rules in 2026 so far, compared with 12 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

Before this

1 earlier Federal Register document under regulation identifier 0938-AU54 since Jan. 1, 2025.

• Jan. 30, 2026 Proposed rule. Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage

What happens next and when

These regulations are effective on January 4, 2027.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket CMS-2026-0364 on Regulations.gov
• Title 42 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register