# CMS Finalizes OPO Accountability Rule

The Centers for Medicare & Medicaid Services (CMS) finalized changes to the oversight and certification of Organ Procurement Organizations (OPOs). The rule changes performance measurement, documentation, adverse-event processes, decertification, appeals, and transitions between OPOs serving a donation service area. For OPOs, certification affects continued operations and the ability to compete for additional service areas; the announcement does not specify an effective date or a procurement contract vehicle.

- OPOs should assess how the revised performance, documentation, and adverse-event processes affect their certification status and operational readiness.
- Decertification and appeal provisions, along with transitions between organizations serving a donation service area, may affect continuity of service and competition for additional areas.
- Organizations pursuing additional service areas should account for the rule’s oversight and certification framework in their planning; the announcement identifies no related contract solicitation or vehicle.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Regulatory Compliance
**Published:** October 30, 2026

### Government Entities
- Centers for Medicare & Medicaid Services (CMS)
- U.S. Department of Health & Human Services (HHS)

### Key Quotes
> With today’s new rule, CMS is building on the success of organ procurement reforms from the first Trump Administration to promote clearer documentation, higher donation rates, and swifter consequences for bad actors.
> — Mehmet Oz, CMS Administrator

> Under President Trump’s leadership, we are holding failing organizations accountable, strengthening patient safeguards, and helping high-performing organizations reach more patients.
> — Robert F. Kennedy, Jr., HHS Secretary

### Sources
- [CMS Finalizes Rule to Help More Organs Reach Patients and Strengthen Accountability for Organ Procurement Organizations | HHS.gov](https://www.hhs.gov/press-room/cms-finalizes-rule-organ-procurement-organizations-transplant-accountability.html) - HHS