In a notable move, the Department of Health and Human Services (“HHS”) has directed the Organ Procurement and Transplantation Network (“OPTN”) to suspend some routine oversight activities during the ongoing government shutdown. In early October 2025, it was reported that HHS directed the United Network for Organ Sharing (“UNOS”)—the nonprofit contractor that operates the OPTN—to pause certain compliance and policy functions. UNOS responded by canceling some committee meetings and pausing its monitoring of reports on heart and lung transplant policy implementation, citing that these activities directly impact organ allocation and multi‑organ transplantation.
Core operations remain active. Organ matching and allocation, IT support, patient communications and urgent patient‑safety functions continue. HHS has emphasized that patients can still donate organs, join the waitlist and receive transplants without interruption. However, UNOS has furloughed over 90 employees—about 25% of its workforce—due to the shutdown. The organization reports it is owed nearly $10 million for work performed since 2024. This is the first time a federal shutdown has materially disrupted OPTN operations.
The immediate and long-term implications of this HHS directive remain to be seen, especially in light of HHS’s focus on oversight of the organ procurement and transplantation system. With many elements of oversight suspended or reduced, transplant centers and organ procurement organizations (“OPOs”) are operating in a compliance gray zone. Safety functions remain in force, so the gray zone is not absolute; however, it remains unclear how deviations from paused functions will be treated once oversight resumes, or whether retroactive scrutiny will apply. The shutdown also coincides with the pending expiration of UNOS’s OPTN contract on December 29, 2025, raising concerns about potential disruptions to critical organ allocation and oversight if the contract is not renewed or a new contract is not in place in time.
Practical Takeaways
- Document and communicate: Transplant centers and OPOs should record any guidance received from UNOS or HHS and promptly relay it to clinical, compliance and administrative teams to maintain a clear record during oversight gaps.
- Plan for oversight gaps: Anticipate slower responses on policy implementation and compliance questions, particularly in areas such as heart and lung transplant protocols, and adjust internal processes accordingly.
- Monitor staffing impacts: Stay informed about UNOS furloughs and potential service limitations.
- Prepare for regulatory uncertainty: Recognize that deviations from paused functions may face retroactive scrutiny once oversight resumes, and develop internal protocols to mitigate compliance risks.
This is the first in a series of alerts we will issue as developments continue in the regulatory and compliance landscape related to organ procurement and transplantation.
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;
- Megan Culp at (317) 429-3644 or mculp@hallrender.com;
- Camilla Moreno Jimenez at (317) 429-3679 or cjimenez@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.
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.
