Organ Transplantation: HHS Action Needed to Improve Lifesaving Program

What GAO Found

Organ transplantation is the leading treatment for patients with severe organ failure, but as of May 2025, more than 100,000 individuals remained on the national waiting list. The Department of Health and Human Services (HHS) has overseen organ allocation services since 1984, using the same contractor to do so, until recently. In 2024, HHS entered into contracts to assess weaknesses in organ allocation services, as part of a modernization initiative. The assessments target issues, including inequitable organ allocation and insufficient investigation of serious events, such as beginning to recover organs before patient death. However, HHS has not yet developed detailed plans for the next initiative phase, including how it will make reforms to address identified weaknesses. Doing so is crucial to improving HHS's ability to provide organs to critically ill patients.

Organ Transplants from Deceased Donors, Percent by Type, 2024

Note: Data show organ transplant types reported by the Organ Procurement and Transplantation Network. In 2024, there were 41,119 organ transplants from deceased donors in the United States.

HHS has not assessed the risks associated with its contractor providing supplementary services outside of its HHS contract, and charging a related monthly fee, to transplant programs. Services include, for example, analytics to help transplant programs manage their waiting lists. In fiscal year 2024, the contractor received about $9.6 million from transplant programs paying the fee. These supplementary services and fee raise several concerns, including whether the services should be provided as part of the contractor's agreement with HHS and that transplant programs may be paying the fee without realizing it is optional. Assessing the risks associated with this contractor activity, and making changes as appropriate, would better position HHS to ensure it is effectively overseeing its contractor, which has a crucial role in ensuring lifesaving organs are provided to patients effectively and safely.

In 2021, HHS formed a coordination group to improve the organ transplantation system, overseen by two of its agencies. However, the group's action plan does not include specific, actionable steps with milestone completion dates and measures to gauge success of actions taken. Including these elements, consistent with the group's charter, would better enable HHS to improve the organ transplantation system through its agencies' collaborative efforts.

Why GAO Did This Study

Congress and others have raised concerns about systemic issues with organ allocation services, such as the data reliability of the organ matching IT system. In March 2023, HHS announced a modernization initiative to improve organ allocation services.

The Securing the U.S. Organ Procurement and Transplantation Network Act includes a provision for GAO to review the organ transplantation system. This report examines, in part, HHS's efforts to assess weaknesses in organ allocation services as part of its modernization initiative; the extent to which HHS assesses supplementary services and the fee charged to transplant programs by the contractor; and coordination across HHS.

To conduct this work, GAO reviewed agency and contractor documentation and interviewed officials and representatives from HHS, the contractor, and non-federal groups involved in the organ transplantation system, including providers and patients, among others.