On January 30, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would substantially revise portions of the Conditions for Coverage for Organ Procurement Organizations (“OPOs”) (the “Proposed Rule”). According to CMS, the Proposed Rule is characterized as building on changes in the 2020 OPO Conditions for Coverage rule aimed at increasing accountability, clarifying and strengthening re-certification standards and reinforcing public trust in organ procurement and allocation practices, and in doing so is intended to strengthen federal oversight of OPOs, reinforce the framework for upcoming and future re-certification cycles and increase the number of viable organs available for transplantation. Although directed at OPOs, if finalized, the Proposed Rule will have important operational, compliance and strategic implications for donor hospitals and transplant programs. Stakeholders should consider submitting comments, which are due March 31, 2026.
Quality, Safety and Oversight Changes
The Proposed Rule includes several updates to OPO quality and oversight requirements:
- Outcome Measures: Pancreata used for islet cell research would be removed from the organ transplantation rate outcome measures, but would continue to count toward the donation rate to comply with statutory requirements.
- Research Organ Documentation: OPOs would be required to meet explicit information-management and recordkeeping standards for organs procured for research, including documentation of approval by an Institutional Review Board or other authorizing body.
- Appeal Process: CMS proposes to streamline the OPO appeals process by modifying timelines, clarifying appeal rights following urgent-need decertification and codifying discretionary review by the CMS Administrator. CMS states these changes are intended to ensure the timely resolution of enforcement actions.
New and Revised Definitions
The Proposed Rule also includes several changes to definitions that would affect oversight and enforcement:
- Adverse Events: CMS would clarify the definition to ensure OPOs identify incidents based on the regulatory definition rather than a limited set of examples.
- Unsound Medical Practices: CMS proposes defining this term to include failures that create an imminent threat to patient health or safety, including failures related to governance; donor evaluation and management; and procurement, allocation and transport practices.
- Donor and Organ: Revisions would clarify how pancreata used for islet cell research are treated for certification purposes.
- Medically Complex Donors and Organs: New definitions would be tied to quality assurance and performance improvement requirements, with the goal of facilitating appropriate placement and increasing organ utilization.
OPO Designation and Re-Certification Framework
CMS also proposes significant changes to how OPOs are designated and re-certified across donation service areas (“DSAs”):
- Each DSA would be evaluated separately during re-certification.
- CMS could remove the designation from underperforming DSAs, even if the OPO performs adequately elsewhere.
- OPOs performing at the lowest tier across all DSAs would be decertified.
- OPOs with at least one adequately performing DSA could remain certified but would be required to compete for underperforming DSAs.
The Proposed Rule also includes transition periods for OPOs that acquire or are assigned new DSAs and clarifies limited circumstances in which CMS may temporarily designate an OPO without competition.
Competition for Tier 2 DSAs
CMS proposes to clarify that an OPO with a Tier 2 DSA remains in compliance with outcome measures, and, if it meets all other process and re-certification requirements, would be re-certified as a qualified OPO. However, any Tier 2 DSA would be open for competition, and the OPO would be required to compete to retain that DSA. CMS has indicated that this competition process is intended to provide a mechanism for CMS to consider whether another qualified OPO is better positioned to serve the DSA. An OPO that is unsuccessful in securing a DSA through competition would remain certified but without a DSA and could ultimately be decertified if it does not obtain a DSA by the end of the re-certification cycle.
Certification of New OPOs
The Proposed Rule would remove the regulatory limitation that effectively restricts certification to OPOs recertified between 2002 and 2005. CMS is soliciting comments on considerations for certifying new OPOs in the future.
Staffing and Operational Requirements
CMS proposes to clarify and reinforce human resources requirements for OPOs, emphasizing the need for qualified clinical personnel acting within appropriate licensure and scope of practice.
Emerging Issues and Comment Solicitations
CMS is seeking public comment on several issues, including:
- Conflicts of interest in organ and tissue procurement;
- Automated electronic referrals from donor hospitals to OPOs; and
- Compliance with federal organ allocation requirements, including concerns about out-of-sequence allocations.
CMS notes that these issues relate to patient safety and public trust and may impact future regulatory requirements.
In the coming weeks, we will publish additional articles that offer expanded discussions and more detailed analyses of key components of the Proposed Rule and their implications for donor hospitals, transplant programs and OPOs. Sign up here to receive alerts via email when new information is available.
Practical Takeaways
- Consider submitting comments by March 31, 2026. Our Transplant & Organ Procurement team is available to assist donor hospitals, transplant programs and OPOs in preparing comments that reflect their operational and strategic perspectives.
- All stakeholders, including donor hospitals, transplant programs and OPOs, should evaluate how the proposed changes may affect existing operational relationships.
- In some respects, donor hospitals and transplant programs should view these proposals as an effort toward a shared-accountability approach, given the potential impact on hospital workflows, transplant outcomes and regulatory exposure.
- OPOs should assess potential impacts on performance metrics, reporting obligations and re-certification risk.
- The increasing emphasis on unsound medical practices, adverse events and governance failures could implicate donor hospital activities and lead to greater visibility or access to these issues in OPO enforcement actions.
- Donor hospitals and transplant programs should prepare for possible shifts in DSA assignments.
- Review the definition changes closely. Expanded definitions of adverse events, unsound medical practices and medically complex donors/organs may influence how OPOs classify incidents and how hospitals and transplant programs experience downstream effects in donor management and organ acceptance.
For additional information on recent organ procurement and transplantation modernization efforts, see our prior publications here.
If you have any questions or would like additional information on this topic, please contact:
- Lori Wink at (414) 721-0456 or lwink@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;
- Megan Culp at (317) 429-3644 or mculp@hallrender.com;
- An additional member of Hall Render’s Transplant & Organ Procurement Service Line; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
