Since the Health Resources and Services Administration’s (“HRSA”) announcement of its modernization initiative for the nation’s Organ Procurement Transplantation Network (“OPTN”) in March 2023, the OPTN has undergone five key changes, including technology infrastructure modernization, enhanced data transparency and analytics, sweeping governance changes, operational refinement and greater promotion of quality improvement and innovation among the organization. The modernization of the OPTN has not only aimed to improve the network itself but has also sparked other changes, modifications and new laws that impact the broader organ procurement and donation community. Now, more than two years since the original March 2023 announcement and the change in federal priorities under a new administration, it is crucial to stay informed about recent changes and upcoming developments.
Minimizing Conflicts of Interest
For the past 40 years, the OPTN Board of Directors and the corporate Board of Directors for United Network for Organ Sharing (“UNOS”), the sole contract recipient of the OPTN, were the same. An investigation launched by the Senate Finance Committee in 2020 found that the OPTN had been grossly mismanaged and that “serious errors in the procurement and transplant system are shockingly common.” These findings drew congressional and administrative attention to a lack of accountability over and within UNOS.
In July 2023, the Securing the Organ Procurement and Transplant Network Act (the “Act”) was passed. The Act eliminated the mandate that the OPTN must be operated by a non-profit organization and removed the requirement for specific expertise in organ procurement and transplantation. These changes allow for-profit entities to manage and operate the OPTN, aiming to boost competition and innovation. However, they may also introduce unforeseen impacts by integrating for-profit motives and a broader range of expertise into the system.
To protect the OPTN against conflicts of interest and increase accountability within the network, HRSA advocated for the OPTN Board of Directors to be independent from UNOS. The symmetry between UNOS and the OPTN Board of Directors ended in March of 2024, when, following congressional pressure, HRSA and UNOS reached an agreement to have UNOS relinquish its members’ positions within the OPTN Board of Directors. HRSA has since awarded the OPTN Board Support contract to the American Institutes for Research, a nonprofit organization. This delegation to a group independent from the government has drawn criticism from Congress as counter to their intent. Additionally, Congress has voiced concerns that UNOS’s hiring of former administrative agents has failed to protect the OPTN from conflicts of interest.
In January 2025, HRSA announced the Transitional Nominating Committee (“TNC”), which they note as “a critical step in HRSA’s commitment to strengthen OPTN governance, mitigate conflicts of interest, and establish independence.” The new committee will support a special election for the OPTN Board of Directors in the spring of 2025, including publicly solicited candidates for the Board. This special election was augmented with the election of eight additional Board members, replacing many Patient & Donor Affairs representatives who resigned in April 2025 over concerns about the Board’s lack of concern for the patient perspective and diminishing effect on the community. These eight individuals will serve through June 30, 2025.
Election results for the new OPTN Board of Directors were recently released, and those members will be seated on July 1, 2025. These 34 recently elected Board members reflect a wide range of experience within the transplant community, with 50% of the Board being transplant physicians and surgeons; 26% being transplant patients, organ donors and their family members; and the final 24% composed of organ procurement organizations (“OPO”) representatives, hospital staff and adjacent associations and the general public. The TNC will conclude its transitional activities at a later date.
Cybersecurity Improvements
The Office of Inspector General (“OIG”) published its cybersecurity audit on OPTN’s IT in December 2024, finding the system unable to respond appropriately to most simulated cyberattacks. This audit came shortly after HRSA awarded one of its Transition Contracts for supporting OPTN IT Modernization, and against the backdrop of the previous OPTN contract holder, UNOS, allowing a data breach that compromised over a million sensitive patient records. OIG recommended that HRSA work with its contractor to eliminate its cybersecurity vulnerabilities and that the contractor be required to adhere to federally required protocols.
In January 2025, HRSA released a solicitation for a Multiple Award Blanket Purchase Agreement to allow HRSA to engage experienced vendors to develop and modernize the OPTN IT system. HRSA hopes this solicitation will support them in creating a technology infrastructure that is “agile, resilient, interoperable, and user-friendly.”
Performance Metrics
In addition to improving and expanding involvement in the OPTN, the Act also empowered the Centers for Medicare & Medicaid Services (“CMS”) to evaluate OPOs based on performance metrics and decertify those that fall below the new, stricter standards. The Act is geared toward incentivizing improvements in organ donation in the United States, which means OPOs with consistently low donation rates will most likely be decertified. With 2024 being the first year OPOs’ performance was evaluated, some are concerned that nearly half of OPOs could be decertified in 2026 under the new performance metrics. There are many unknowns surrounding the recent changes and many concerns about the ramifications of the mass decertification of OPOs on the system.
New Opportunities
While there are many uncertainties as the organ donation and procurement community navigates federal modernization and improvement initiatives, new opportunities are available to improve access to organs and the quality of care.
Organ Transplants Involving Patients with HIV
In November 2024, Health and Human Services allowed specific transplant programs to perform kidney and liver transplants from donors and recipients with HIV without needing first to obtain IRB approval, as long as standard OPTN safety and quality measures were followed. See here for Hall Render’s detailed alert on this topic.
CMS Increasing Organ Transplant Access Model
In November 2024, CMS announced a new six-year mandatory model related to kidney transplants that is anticipated to improve the quality of care for patients seeking kidney transplants through performance-based payments to participating hospitals. The current start date for this model is July 1, 2025. Hall Render will publish additional information on this model in the coming weeks.
HHS Organizational Changes
With a new administration and changing federal priorities, the U.S. Department of Health and Human Services (“HHS”) will soon add the “Administration for a Healthy America” (“AHA”). AHA will centralize activities related to primary care, HIV/AIDS, mental health, maternal health, rural health and the health care workforce. Most notably, HRSA will roll up into the new AHA agency, which oversees organ transplantation. Questions regarding who will run the agency, the programs it will manage, financing and staffing all remain crucial unknowns. The uncertainties surrounding AHA and its operations are expected to become clearer in the coming weeks and months after HHS-related staffing litigation is resolved.
OPTN will continue to evolve based on transplant community feedback and changing federal priorities.
Practical Takeaways
- Donor hospitals may notice OPOs becoming more proactive to ensure successful donations.
- OPOs and donor hospitals should review and update their policies and procedures to clarify responsibilities and streamline the donation process.
- The organ donation and procurement community must remain vigilant as the Administration addresses issues affecting organ donation and procurement.
- Hall Render can assist hospitals in taking advantage of new opportunities to improve access to organs and improve the quality of care in organ transplants.
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;
- Abigail Kaericher at (202) 742-9674 or akaericher@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.
Special thanks to Summer Associates, Nick Baker and David Yanda, for their 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.
