On March 22, 2023, the Health Resources and Services Administration (HRSA), an HHS subagency, announced major reforms for the nation’s organ transplant system. Chief among the reforms is to increase competition and accountability for the federal contract to manage the Organ Procurement Transplant Network (OPTN)—which has been held by the same private non-profit organization, United Network for Organ Sharing (UNOS), for thirty-seven years.

As background, the OPTN was established by the National Organ Transplant Act (NOTA) in 1984 for the purpose of coordinating and operating the nation’s organ procurement, allocation, and transplantation system with the aim to increase access to donor organs for patients with end-stage organ failure. NOTA requires the OPTN to operate a national waiting list of individuals needing transplants to be matched with organs from living and deceased donors. The OPTN is required to have a Board of Directors responsible for tasks including creating organ allocation policies, assisting with donor matching, increasing the organ supply, and adopting quality standards, just to name a few. UNOS was awarded the initial OPTN contract award in 1986 to develop the requirements for the operation of the OPTN, and has served as the OPTN contractor ever since.

The last several years have seen increased scrutiny on the OPTN. For instance, the OPTN changed its scheme for allocating kidneys in 2018, which was met with legal challenge by hospitals. In 2019, the President issued an Executive Order calling for modernization of the organ recovery and transplant system. In 2022, the Senate Finance Committee released a report critical of OPTN’s performance and held an oversight hearing into UNOS operations.

HRSA’s Organ Transplantation Network Modernization Initiative calls for actions that, according to the agency, aim to improve accountability and transparency in the OPTN. These actions include:

• Data dashboards detailing individual transplant center and organ procurement organization data on organ retrieval, waitlist outcomes, and transplants, and demographic data on organ donation and transplant;
• Modernization of the OPTN IT system in line with industry-leading standards, improving OPTN governance, and increasing transparency and accountability in the system to better serve the needs of patients and families;
• HRSA’s intent to issue contract solicitations for multiple awards to manage the OPTN in order to foster competition and ensure OPTN Board of Directors’ independence;
• The President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million; and,
• A request to Congress included in the Fiscal Year 2024 Budget to update the nearly 40-year-old National Organ Transplant Act to take actions such as:
  • Removing the appropriations cap on the OPTN contract(s) to allow HRSA to better allocate resources and,
  • Expanding the pool of eligible contract entities to enhance performance and innovation through increased competition.

To kick off its reforms, HRSA launched an initial data set of organ donation and transplantation data that it plans to update regularly. While the new HRSA dashboard is welcome, the data has been available on another dashboard run by the Scientific Registry of Transplant Recipients (SRTR) and even data displayed by UNOS itself. Stakeholder engagement efforts are scheduled to occur in late spring. Finally, HRSA intends to issue contract solicitations for multiple awards to manage and improve the OPTN as part of the “first phase” of the OPTN Modernization Initiative, but has not yet identified a timeline for those solicitations.

HRSA’s announcement is available here.