2026-22381·DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Final RuleFinal Rule

Published: Nov 3, 2026
Effective: Jan 4, 2027
Citation: 91 FR 69390
Docket: CMS-3409-F
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services

Final rule.

Summary

The Department of Health and Human Services (HHS) has issued a final rule that updates the “Conditions for Coverage” that organ procurement organizations (OPOs) must meet to receive Medicare and Medicaid funding. The changes are intended to clear up lingering procedural questions and give OPOs more flexibility in how they operate, so they can increase the number of organs successfully recovered, distributed and transplanted. While the rule tightens some definitions and the criteria for designating OPOs, it does not alter the performance metrics that track donor and transplant volumes or the tier system used to certify or decertify OPOs. The rule applies to all OPOs that serve Medicare and Medicaid beneficiaries across the United States. It revises how OPO service areas are defined, when those areas can be opened to competition, and the process OPOs must follow to appeal decisions. By clarifying these points, HHS aims to hold every OPO accountable for meeting high‑performance standards while allowing them to adapt their operations to local needs. The regulation was published in the Federal Register on November 3 2026 (91 FR 69390) and becomes effective on January 4 2027. Since this is a final rule, the comment period has already closed; the next steps involve OPOs reviewing the updated requirements, adjusting their policies and procedures as needed, and preparing for any certification or appeal actions under the new framework. HHS will monitor compliance and continue to assess OPO performance against the established outcome measures.

AI-generated summary — verify against the Federal Register text.

Official abstract

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.