New CMS Guidance on Organ Donation for Hospitals and OPOs: Key Updates and Takeaways

While CMS characterizes the guidance as reinforcing existing regulatory requirements, several of its provisions carry the weight of new operational mandates. Additionally, in the press release accompanying the guidance, CMS outlined specific oversight activities that OPOs and donor hospitals should plan for in the year ahead. Together, these materials provide timely insight into CMS's current areas of focus and signal that OPOs and hospitals should prepare for increased scrutiny and survey enforcement.

Key Points & Updates

Key points addressed in the March 2026 guidance include:

• OPO-Hospital Agreements: CMS places significant emphasis on the written agreements that hospitals and their designated OPO must maintain. Agreements must clearly delineate the respective roles and responsibilities of the OPO and the hospital, including communication protocols, referral and authorization processes, and parameters around interactions between OPO staff and donor families. If actual practice diverges from the OPO-hospital agreement, or if the agreement lacks the required elements, the hospital and/or OPO must be cited.
   
• Medical Care First: CMS repeatedly stresses that donor status does not – and may not – affect a hospital's responsibility and obligation to provide complete, life-saving medical care to all patients. Any donation-related considerations, including whether a patient may be a potential donor, must not influence a hospital's patient care obligations or provision of medical treatment.
   
• Family Engagement and Decision-Making: CMS emphasizes that families must not be pressured, rushed, coerced, or forced to make decisions regarding donation. Surveyors are directed to specifically observe hospital and OPO conversations with families regarding donation and authorization and, when possible, ask families if they feel like they received enough information about the donation process prior to making the decision to donate and were not rushed or pressured into making their decision.
   
• Donor Evaluation & Management Protocols: CMS reiterates that hospitals and OPOs must maintain protocols for evaluating and managing potential donors that meet current standards of practice. For hospitals, this includes protocols addressing declaration of death, withdrawal or continuation of palliative sedation, and medications that may affect neurologic responsiveness. For OPOs, this includes protocols addressing testing, interactions with donor families, documentation requirements, use of sedatives, and donation after cardiac death (e.g., the wait time between declaration of death and the beginning of recovery).
   
• Bright-Line Prohibitions on End-of-Life Decisions: CMS reaffirms that decisions related to end-of-life care, including life support withdrawal and pronouncement of death, are solely the responsibility of the hospital physician (or appropriate hospital designee) and must be made in accordance with accepted medical standards. OPOs may not make or influence decisions regarding whether or when to withdraw life support or the subsequent declaration of death. CMS emphasizes that OPOs should verify death pronouncement compliance with applicable law and hospital policy and obtain signed documentation confirming the date and time of death before initiating any organ recovery.
   
• Survey Framework and Enforcement: CMS introduces a significant change to survey enforcement and how noncompliance is addressed during the survey process. Now, surveyors are required to cite noncompliance with federal requirements whenever identified, even if the OPO has already taken action to correct the issue before the survey concludes. In other words, although corrective action remains important, it will no longer prevent citation – a meaningful shift that increases accountability and raises the consequences of any compliance lapse. The March 2026 guidance also outlines a more comprehensive and defined survey process that includes, among other things, expanded information gathering through interviews with donor families, hospital staff, and hospital board members – not just OPO personnel.

CMS's Continued Oversight Activities

OPOs, donor hospitals, and other stakeholders should take note of the following upcoming oversight activities announced by CMS, consistent with its broader, ongoing efforts to strengthen accountability and performance:

• Spring and Summer 2026: CMS will publish 2026 OPO performance reports and complete onsite recertification surveys for applicable OPOs.
   
• Late 2026: CMS expects to issue the final OPO Conditions for Coverage Final Rule, with recertification and decertification actions for Tier 2 and Tier 3 OPOs to follow.
   
• January 2027: CMS plans to begin recertification and decertification proceedings for Tier 2 and Tier 3 OPOs and manage transitions and expirations of OPO agreements as necessary.

Proactive Compliance

To align with the March 2026 guidance and ensure compliance with applicable Medicare conditions, OPOs and hospitals should take the following actions promptly:

• Review OPO-Hospital Agreements: Review and confirm that agreements are consistent with the expectations outlined in the March 2026 guidance, including clear delineation of roles and responsibilities, and support compliant operational practices.
   
• Review Donation-Related Policies, Procedures, and Protocols: Conduct a comprehensive review of internal policies, procedures, and protocols related to the organ donation process to ensure alignment with the March 2026 guidance, compliance with current regulatory requirements, and consistency with actual practice.
   
• Training and Education: Ensure designated requestors, hospital clinical staff, and OPO personnel are appropriately trained on the updated expectations and requirements announced in the March 2026 guidance, including those related to authorization, documentation, interactions with donor families, and "signs of life" protocols.
   
• Prepare for More Thorough and Less Forgiving Surveys: Anticipate more comprehensive and in-depth surveys, including interviews with hospital and OPO staff, donor families, and hospital board members, as well as review of quality assurance and performance improvement (QAPI) plans, historical referral records, complaints, and cases in which procurement ceased prior to recovery.

Conclusion

CMS's March 2026 guidance marks a significant inflection point in the regulatory landscape for organ donation. The coordinated release of the guidance, coupled with the January 2026 proposed rule and related oversight actions, leaves no ambiguity about the direction of the regulatory environment and the agency's increased focus on accountability and performance.

For OPOs, the path forward requires immediate and sustained attention to policy alignment, documentation, training, and QAPI programs. For hospitals, it requires treating organ donation compliance as a hospital-wide obligation – one that extends beyond the transplant team to ICU staff, attending physicians, chaplains, and governance. For both, the overarching message is clear: CMS expects the organ donation system to operate with the highest standards of transparency, sensitivity, and clinical integrity, and it is prepared to enforce those expectations and apply heightened accountability.

Organizations should act now to revalidate their compliance frameworks, conduct internal audits, review agreements, and prepare for surveys that will be more targeted and more rigorous than in the past.

If you have questions about the March 2026 guidance or would like assistance with your organization's compliance framework, please contact Melodie Hengerer, Alison Schurick, McKenna Cloud, Tenia Clayton, Yann Kaufman, Sam Cottle, or any member of the Baker Donelson Organ Donation and Transplant Team.