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Data / Federal rules / 2026-01833

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

The Centers for Medicare & Medicaid Services published this proposed rule in the Federal Register on January 30, 2026. Comments closed on March 31, 2026.

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What the agency says

This proposed rule would revise the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and enable OPOs to make better informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule would revise definitions, add new Quality Assessment Performance Improvement (QAPI) requirements related to medically complex organs and donors, revise the designation requirements for OPOs, clarify when an OPO's service area is open for competition, and update the process for appeals. It also includes a discussion of factors we would consider when selecting a successor OPO during a competition under the tiered approach to re-certification. We are committed to holding all OPOs accountable for their performance and this proposed 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.

Key facts

Document number
2026-01833
Type
Proposed rule
Action
Proposed rule
Agency
Health and Human Services Department; Centers for Medicare & Medicaid Services
Published
January 30, 2026
Comments due
March 31, 2026
Dates
To be assured consideration, comments must be received at one of the addresses provided below, by March 31, 2026.
Docket
CMS-3409-P
Regulation ID (RIN)
0938-AU54
Code of Federal Regulations
42 CFR 486
Topics
Medicare
Significant
Yes, under Executive Order 12866
Pages
62

The document on federalregister.gov PDF

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Everything from the Centers for Medicare & Medicaid Services · Rules on medicare · Published in January 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.