https://www.gao.gov/products/gao-26-107434
Organ Transplantation:HHS Action Needed to Improve Lifesaving Program...More than 100,000 people waiting for life-saving organs, as of May 2025, depend on the OPTN to manage the system that procures, allocates, and transplants organs for patients in need. However, systemic OPTN issues may impede its ability to do so effectively. HHS, through its OPTN Modernization Initiative and OTAG effort, has taken some actions to begin to address these issues, including entering into assessment contracts to examine OPTN weaknesses, a positive first step to identifying potential solutions to improving the OPTN. However, further action is needed in three areas.· HRSA has not developed detailed plans for the next phase of its OPTN Modernization Initiative, including how it will make reforms to the OPTN to address its identified weaknesses. Developing plans that take into consideration GAO's leading practices for agency reform will better enable HRSA to address OPTN weaknesses that hinder its ability to provide organs to critically ill patients.
· HRSA has not assessed the risks associated with the OPTN contractor providing supplementary services and charging an associated fee to transplant programs. Assessing these risks, and making changes as appropriate, will better position HRSA to ensure it is effectively managing contract risks and overseeing its OPTN contractor. This oversight is especially important given the OPTN contractor's large role in helping ensure that the OPTN is working effectively to provide life-saving organs. It will continue to be important as HRSA moves to a multi-contractor model as part of its OPTN Modernization Initiative.
· HRSA's and CMS's organ transplantation system coordination group, OTAG, lacks specific, actionable steps with milestone completion dates and markers for measuring success of actions taken in its OTAG action plan, despite the requirement to do so per the OTAG charter. The inclusion of specific and actionable steps in the OTAG action plan will better position HRSA and CMS to ensure that OTAG is improving the organ transplantation system through their collaborative efforts.
Without taking these actions, HHS will miss key opportunities to improve the organ transplantation system responsible for providing organs that save the lives of critically ill patients....