CMS Issues Additional Guidance On The Organ Donation Process

Highlights

• The Centers for Medicare & Medicaid Services' (CMS) 2026 Organ Procurement Organization (OPO) Guidance reinforces existing donor-process safeguards while signaling increased survey scrutiny, expanded oversight authority, and stricter documentation expectations for OPOs and donor hospitals.
• The 2026 Proposed Rule and related oversight actions confirm CMS' intent to continue the tier-based recertification framework for OPOs, expand enforcement tools and apply heightened accountability during the current certification cycle.
• OPOs and donor hospitals should prepare for more rigorous CMS surveys, review policies and hospital-OPO agreements, enhance training and closely monitor rulemaking developments as CMS moves toward final Conditions for Coverage revisions in 2026.

The Centers for Medicare & Medicaid Services (CMS) issued new Quality, Safety and Oversight guidance on March 11, 2026, with respect to the organ donation process (2026 OPO Guidance). The guidance was issued as a Quality, Safety and Oversight (QCOR) memo and an update to the State Operations Manual appendix. In particular, it clarifies and reinforces the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation. CMS noted that this guidance is intended to reinforce best practices that the vast majority of OPOs already follow. This action is part of a broader U.S. Department of Health and Human Services effort to strengthen oversight of OPOs and advance transparency, accountability and patient protections across the organ donation and procurement system.

Background and Recent Rulemaking Impacting OPOs

On January 28, 2026, CMS issued a proposed rule (2026 Proposed Rule) intended to provide OPOs and donor hospitals additional guidance following CMS' issuance of the 2020 Final Rule. Comment submissions are due by March 31, 2026. The 2026 Proposed Rule arrives at a consequential moment given that the end of the first four-year recertification cycle under the 2020 Final Rule is nearing. Notably, the 2020 Final Rule fundamentally changed how OPOs are evaluated. It established a three-tier recertification system based on two outcome measures: a donation rate and a transplantation rate. Tier 1 OPOs are automatically recertified, Tier 2 OPOs must compete to retain their DSAs and Tier 3 OPOs are decertified. The current proposed rule does not revisit that architecture; it reinforces it and expands CMS' tools within it.

At the same time, CMS proposes a meaningful structural shift by assigning tier status at the Donation Service Area (DSA) level, effectively redefining the unit of accountability. The agency also clarifies that an OPO with a Tier 2 DSA would remain in compliance with outcome measures and, if it meets all other process and recertification requirements, could be recertified as a qualified OPO. However, any Tier 2 DSA would be open to competition, requiring the OPO to compete to retain that service area and making competition more continuous rather than episodic.

The 2026 Proposed Rule would further remove the regulatory limitation that has effectively restricted certification to OPOs recertified between 2002 and 2005, and CMS is soliciting comment on considerations for certifying new OPOs going forward. In addition, CMS is expanding its quality assurance and performance improvement and patient safety authority, signaling a broader enforcement posture that extends beyond performance metrics to encompass oversight of processes, systems and safety infrastructure.

According to the OPO Performance Report released by CMS on April 27, 2023,¹ based on 2021 data, the most recent data available as of this writing, approximately 42 percent of OPOs nationwide would face automatic decertification if the assessment year were based on those 12 months of performance. CMS has not released an updated OPO performance report since then; the next report, based on 2024 data, is expected to be published in spring 2026 via the CMS QCOR system. Until updated data are available, stakeholders are relying on performance assessments derived from several-year-old data, which may not fully reflect current operational performance or recent improvements across the organ donation system.

Notably, the administrative law landscape has shifted since the 2020 rule, particularly in the post-Chevron environment. This is significant as CMS explicitly cites Loper Bright in reinterpreting its certification authority, departing from the long-standing view that OPOs were required to have been certified as of January 1, 2000.

Seven OPOs have challenged the 2020 Final Rule under the Administrative Procedure Act, alleging that CMS failed to comply with required "process" measures in its recertification process as required by statute, relied on flawed state death certificate data, and imposed two highly correlated outcome measures and a confidence interval that is biased against larger OPOs. Despite the ongoing legal challenges and the fact that OPOs are largely unified in their concerns with respect to the new tiered system, CMS has signaled an intent to continue with this framework. To support its position, CMS has pointed to the median donation and transplantation rates, which have purportedly demonstrated "accelerated improvement" within the past six years, among other factors. The litigation remains ongoing.

Key Safeguards and Updated Compliance Framework in the 2026 OPO Guidance

Though the 2026 OPO Guidance largely reemphasizes existing regulatory protections that OPOs follow today, the guidance specifies areas where CMS expects increased scrutiny, as detailed below.

• Heightened Scrutiny of Interactions Between OPOs and Hospitals: The 2026 OPO Guidance emphasizes clear role separation between OPOs and hospitals, reiterating that hospitals retain responsibility for patient care and end-of-life decisions, including withdrawal of life support and declaration of death. Surveyors may closely review documentation demonstrating that OPO staff did not influence these decisions.
• Prioritizing the Patient's Medical Care: CMS repeatedly emphasizes that donor status does not alter a patient's entitlement to appropriate medical care, and clinical teams must not permit donation-related factors to affect the scope or timing of treatment provided.
• Expanded Focus on Family Engagement and Consent Processes: CMS stresses that families must not feel rushed or pressured to make donation decisions. Surveyors are instructed to review how donation conversations occur, including the timing of requests and whether trained OPO representatives or designated requestors conducted them.
• Review of OPO-Hospital Agreements: Surveyors are directed to ensure agreements clearly delineate roles and responsibilities, referral processes and procedures governing family interactions and donor management. Missing or incomplete elements in these agreements must be cited.
• Oversight of Donor Evaluation Protocols: The memo reiterates that OPO evaluation and management protocols must follow current standards of practice. Though OPOs may review medical records without consent, invasive testing generally requires consent unless otherwise permitted under state law.
• Additional Attention to Donation After Circulatory Death Processes: Surveyors are instructed to review protocols related to the declaration of death, required waiting periods before recovery begins and documentation confirming that death pronouncements comply with applicable standards.
• Potential Use of Family Interviews During Surveys: The guidance indicates surveyors may interview donor families or legally authorized representatives, where appropriate, to assess whether interactions were respectful and free from coercion.
• Greater Emphasis on Documentation: CMS repeatedly highlights the need for clear documentation regarding roles and responsibilities, family discussions, consent processes, declaration of death, and coordination between hospitals and OPO staff.

The 2026 OPO Guidance also introduces a meaningful change to how noncompliance is addressed during the survey process. Surveyors are now required to cite noncompliance with federal requirements upon identification, irrespective of any subsequent corrective action by the OPO. Although self-correction remains important, it will no longer prevent a formal citation from being recorded.

Open Questions and Ambiguities in the Donor Process

Additional clarification may be warranted to ensure alignment between donor hospitals and OPOs regarding key elements of the donation process. Certain language in the guidance could be interpreted as limiting OPO involvement with potential donor families until after decisions regarding withdrawal of life-sustaining treatment have been made. At the same time, related policy discussions and directives under consideration by the Health Resources and Services Administration (HRSA) contemplate earlier engagement to support informed decision-making during end-of-life conversations.

These potentially divergent interpretations create uncertainty around the appropriate timing and sequencing of OPO interactions with families. Further clarification from HRSA would help promote consistency in practice and reduce confusion across stakeholders.

Next Steps for CMS

In the accompanying press release issued by CMS, the agency outlined the following OPO oversight activities that stakeholders, including OPOs, donor hospitals, etc., should be aware of:

• March 2026. CMS will highlight national priorities in organ donation and transplantation at the 2026 CMS Quality Conference, reinforcing expectations for access, collaboration and accountability. In addition, the public comment period will close on the proposed Conditions for Coverage revisions.
• Spring 2026. CMS will publish the 2026 OPO performance reports, based on 2024 data, on CMS QCOR.
• Summer 2026. CMS will complete onsite recertification survey reviews for applicable OPOs to ensure compliance with federal standards.
• Late 2026. CMS anticipates issuing the OPO Conditions for Coverage Final Rule.
• Following the Final Rule Going into Effect 60 Days After Publication. CMS will initiate recertification or decertification actions for Tier 2 and Tier 3 OPOs, consistent with regulatory timelines.
• January 2027. CMS plans commence recertification or decertification proceedings for Tier 2 and Tier 3 OPOs and address OPO agreement expirations and transitions as circumstances require.

This timeline affirms that CMS intends to hold OPOs accountable for regulatory interpretations or requirements introduced after the performance period being evaluated has already begun or after the performance period has concluded. Thus, it will be applying new policies or interpretive changes retroactively to an ongoing certification cycle.

Key Takeaways for OPOs and Donor Hospitals

To ensure compliance with the shifting regulatory landscape for OPOs and the donation process, and in light of increased scrutiny of the donor process, OPOs and donor hospitals should consider taking the following actions:

1. Prepare for Heightened Survey Scrutiny. Proactive compliance is more important than ever. As discussed above, citations are now required in the event a surveyor identifies a deficiency, regardless of whether the issue has been corrected before or during the survey process. It is important that stakeholders proactively review operations, policies and processes to limit the risk that a citation will be issued.
2. Conduct a Comprehensive Policy and Process Review. OPOs and donor hospitals may consider completing a comprehensive review of their internal policies relating to the donation processes to ensure compliance with federal guidance and OPO Conditions for Coverage. Outside counsel can be a resource to help ensure that a stakeholders' policies and procedures align with current regulatory requirements.
3. Enhance Training and Education Efforts. Given the increased emphasis on patient autonomy, family engagement and role delineation, stakeholders should ensure that clinical staff, designated requestors and OPO personnel are appropriately trained on updated expectations. Regular training and scenario-based exercises may help reinforce compliant practices and reduce variability in implementation.
4. Evaluate Hospital-OPO Agreements. Stakeholders should review existing agreements to confirm that roles, responsibilities and communication protocols are clearly defined and consistent with CMS expectations. Particular focus should be given to referral processes, on-site presence and documentation of interactions with clinical teams and families.
5. Submit Comments and Closely Track the OPO Rulemaking Process. CMS is expected to finalize revisions to the OPO Conditions for Coverage this year, with comments currently due by March 31, 2026. OPOs and donor hospitals should consider submitting comments to help shape the final policy and continue to monitor developments closely, as changes may require adjustments to operations, agreements and compliance practices.

Footnote

1. CMS, Organ Procurement Organizations Annual Public Aggregated Performance Report 2023.

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