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What CMS proposed
CMS released a proposed rule on Jan. 28 revising the Conditions for Coverage for organ procurement organizations, and it was published in the Federal Register on Jan. 30. The agency frames it as a follow-up to the 2020 OPO rule, which introduced tiered performance measures. CMS reports that between the 2021 and 2023 evaluations, the number of top-tier OPOs rose from 15 to 30 and the number failing standards fell from 24 to 10. It also cites a 31% increase in donors and a 25% increase in transplants over four years. More than 100,000 Americans remain on the transplant waiting list.
The proposal has several parts that matter to hospital leaders:
- Performance by service area. Each donation service area would be evaluated separately. An OPO could lose a poorly performing area while keeping others, and middle-tier areas would no longer renew automatically.
- New entrants. CMS would remove a long-standing limit that effectively restricts certification to OPOs recertified between 2002 and 2005, opening a path for new organizations.
- Safety definitions. Adverse events would follow a general definition rather than a short list of examples, and a new category of unsound medical practices would cover failures in governance, donor evaluation, procurement, allocation and transport.
- Medically complex donors. New definitions and quality requirements would support placement of organs from donors with complicated histories.
Comments are due March 31.
Why donor hospitals should pay attention
The rule does not impose new direct duties on hospitals. Still, OPOs work inside hospital ICUs and emergency departments, and their compliance depends on hospital processes. Broader adverse event and unsound practice definitions could pull hospital-side events, such as delayed referrals or problems in donor management, into OPO investigations and corrective action plans.
Service area competition is the second issue. If an OPO loses a donation service area, its hospitals may need to build new relationships, agreements and workflows with a different organization, possibly on short notice.
Third, CMS is seeking comment on automated electronic referrals from donor hospitals to OPOs. That is exploratory for now, but it signals where future requirements could go. Hospitals that still rely on manual phone referrals may face integration work later.
Practical steps
- Ask your OPO for its current tier and performance in your service area.
- Review donation policies, referral timeliness data and donor management protocols with the critical care and quality teams.
- Confirm how adverse events involving donation are reported internally and to the OPO.
- Have the CIO assess what an electronic referral interface would require.
- Decide whether your organization or state association will submit comments by March 31.
Archive entry for Feb 3, 2026, added Nov. 11, 2026.
Sources
- Organ procurement organizations conditions for coverage revisions (CMS-3409-P) proposed rule (CMS, Jan 28, 2026)
- CMS pitches stricter oversight of organ procurement groups: 6 takeaways (Becker’s Hospital Review, Jan 28, 2026)
- Proposed OPO rule signals broad operational and compliance changes (Hall Render, Jan 30, 2026)