CMS Issues Guidance Clarifying OPO and Donor Hospital Responsibilities During the Organ Donation Process

On March 11, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a Quality, Safety & Oversight (“QSO”) memorandum and related updates to the State Operations Manual (“SOM”) interpretive guidance clarifying and reinforcing existing responsibilities of organ procurement organizations (“OPOs”) and donor hospitals throughout the organ donation process. While the memorandum largely reiterates existing regulatory requirements, CMS also clarifies expectations regarding regulatory compliance, oversight of OPO activities and appropriate collaboration among OPOs and donor hospitals. OPOs and donor hospitals should review the updated guidance closely, as it provides insight into CMS’s current compliance and survey focus in this area.

The guidance also aligns with CMS’s broader efforts to review oversight of the organ donation and transplantation system. In January 2026, CMS issued a proposed rule that would substantially revise the OPO Conditions for Coverage, signaling increased focus on OPO accountability and performance. The recent QSO memorandum reflects those ongoing regulatory efforts.

Key Elements of the Guidance

The QSO memorandum and updated SOM interpretive guidance address several operational and compliance areas, including:

• Separation of Medical Care and Donor Status.

CMS notes, once again, that donor hospitals must continue to provide full, life-saving medical care to all patients, regardless of whether the patient may be a potential organ donor. Patient care obligations are not affected by donor status, and clinical teams must not allow donation-related considerations to influence the degree or timing of medical care provided.

• Family Decision-Making and Freedom from Pressure.

The guidance emphasizes that families must have sufficient time to process information regarding organ donations and must not be pressured into making decisions during periods of acute grief. This particular requirement underscores the importance of thoughtful, structured processes for approaching families and documenting interactions with them.

• Limits on OPO Influence Over Clinical Decisions.

CMS reiterates that OPO representatives may not influence the timing of withdrawal of life-sustaining treatment or the declaration of death. Clinical decisions related to end-of-life care, including the declaration of death, must remain the responsibility of the treating medical team and may not be directed or influenced by the OPO.

• Death Determination Standards.

The guidance reaffirms that death determinations must be made in accordance with accepted medical standards before initiating any organ recovery procedures.

• Strengthened Survey Enforcement.

CMS also directs surveyors to cite noncompliance with these requirements once identified, even if the deficiency has been corrected before the survey concludes. Under this approach, deficiencies may be formally cited even where corrective action is taken before or during the survey process, which may increase the number of documented findings in OPO and hospital surveys.

Looking Ahead

The timing of this guidance coincides with CMS’s broader review of the organ donation and transplantation regulatory framework. As mentioned above, CMS previously indicated that it intends to finalize revisions to the OPO Conditions for Coverage later in 2026. In this context, the QSO memorandum and the pending rulemaking together reflect CMS’s ongoing efforts to update and clarify oversight expectations for OPOs and donor hospitals.

For donor hospitals in particular, the guidance highlights CMS’s expectations regarding the documentation and structure of interactions with OPOs, communication with patient families regarding donation and the separation of clinical decision-making from donation-related activities. Survey activity in this area may therefore focus not only on the presence of deficiencies, but also on how hospitals structure and document these processes.

CMS’s Continued Oversight Activities

In the press release accompanying the guidance, CMS outlines upcoming OPO oversight activities that stakeholders should be aware of, including:

• Early 2026: CMS will highlight national priorities at the 2026 CMS Quality Conference, and the public comment period for proposed revisions to the OPO Conditions for Coverage will close.
• Spring–Summer 2026: CMS will release OPO performance reports and complete onsite recertification surveys for applicable OPOs.
• Late 2026–Early 2027: CMS expects to issue the final OPO Conditions for Coverage rule, begin recertification or decertification actions for Tier 2 and Tier 3 OPOs and manage OPO agreement expirations and transitions as needed.

Practical Takeaways

• Conduct a comprehensive policy and process review. OPOs and donor hospitals should evaluate the full spectrum of the organ donation process based on the clarified guidance from CMS. This should include review of OPO access to patients and families, referral timing, documentation of family communications, and protocols ensuring end-of-life care decisions and death determinations remain solely with treating clinicians.
• Review all OPO and donor hospital agreements. Confirm that agreements align with the expectations set forth in the QSO memorandum and support compliant operational practices. CMS instructed surveyors to cite one or both entities if the agreement fails to comply with the applicable regulations.
• Prepare for survey scrutiny. Surveyors are now instructed to cite deficiencies once identified, even if corrected before or during the survey process.
• Monitor the OPO rulemaking process. CMS anticipates finalizing revisions to the OPO Conditions for Coverage later this year. Stakeholders should track the rulemaking closely and be prepared to adjust operations, agreements and compliance practices as needed.

If you have questions about this guidance or would like assistance evaluating your organization’s policies and compliance framework in light of these developments, please contact:

• Lori Wink at (414) 721-0456 or lwink@hallrender.com;
• Megan Culp at (317) 429-3644 or mculp@hallrender.com;
• Brian Betner at (303) 802-1298 or bbetner@hallrender.com;
• Joseph Krause at (414) 721-0906 or jkrause@hallrender.com;
• Amy Mackin at (919) 447-4963 or amackin@hallrender.com;
• John Williams III at (202) 370-9585 or jwilliams@hallrender.com;
• Abigail Kaericher at (202) 742-9674 or akaericher@hallrender.com;
• An additional member of Hall Render’s Transplant & Organ Procurement service line; or
• Your primary Hall Render contact.

Special thanks to Summer Associate Nick Baker for his assistance in the preparation of this article.