August 2025 Update
Modernizing the nearly 40-year-old Organ Procurement and Transplantation Network (OPTN) is a complex effort that requires collaboration across the entire organ donation and transplant community. While HRSA is leading this initiative, its success depends on broad engagement and informed decision-making grounded in data, lived experience, and expert analysis. In support of this, HRSA has been working to assess and strengthen the OPTN. Through this assessment we have identified existing challenges, operational gaps, and opportunities for improvement to enhance safety, efficiency, and patient outcomes. This allows HRSA the ability to implement both short-term improvements and plan for long-term solutions.
Incorporating Discovery Task Order Recommendations
At the end of 2024, HRSA launched OPTN discovery task orders to provide insights on the current state of OPTN operations across key areas of patient safety, communications, financial management, and policymaking. Based on these valuable insights and proposed recommendations, HRSA has already begun implementing changes while laying the groundwork for long-term solutions.
For example, HRSA is advancing critical patient safety initiatives focused on addressing allocation out of sequence (AOOS) and strengthening organ donation and procurement practices. In parallel, HRSA has enhanced OPTN communications to promote greater transparency like launching new, detailed webpages on emerging issues, like the AOOS webpage and accompanying data dashboard, and sharing regular updates on the Modernization effort. Behind the scenes, HRSA has also improved financial oversight of the OPTN operating budget and has started developing a new OPTN fee collection process and public webpage to inform the community about upcoming changes. To support effective policymaking, HRSA continues to collaborate with the OPTN Board of Directors, volunteers, and contractors to address AOOS concerns and policy noncompliance, while also helping the new Board prioritize and implement policy proposals.
Read more about the insights and recommendations (PDF - 427 KB)* provided by the discovery task orders. HRSA looks forward to sharing continued progress and next steps across these four key areas of improvement.
*If you use assistive technology, you may not be able to access information in this file. For help, contact us at 800-221-9393.
Using Better Data to Strengthen Patient Safety
Informed decisions start with better data. Currently, a key data gap exists: patients for whom the organ procurement organization (OPO) documented initiating an approach or monitoring as a potential donor, but who did not progress to organ procurement, are excluded from analytical datasets. This means critical interactions between patients and OPOs, especially in cases where organ recovery was attempted but not completed, are not fully visible in existing datasets.
To address this, HRSA has directed the OPTN and the Scientific Registry of Transplant Recipients (SRTR) contractors to review and improve how patient data about organ procurement is made available for monitoring, quality improvement and research purposes under appropriate data use agreements. Complete, accurate, and reliable data is essential to ensure proper oversight, support continuous quality improvement, and enable meaningful research. By closing this data gap, HRSA is enhancing transparency and ensuring that every patient interaction within the procurement and transplant system is counted and considered.
Clarifying Organ Allocation Practices with Clear Definitions and Increased Data
Another key step in strengthening transparency, accountability and informed oversight is clarifying what happens when organs are allocated out of the OPTN-designed, OPTN-implemented, and OPTN-required sequence. Since the OPTN creates organ allocation policies, it is important that OPTN members abide by those policies when allocating donated organs.
At HRSA’s direction, the OPTN established a multidisciplinary workgroup to develop clear and consistent definitions for allocation out of sequence (AOOS). The group included members from various OPTN committees, including patients and family members, and worked collaboratively to propose, review, and finalize both operational and analytic definitions that clarify what constitutes an organ being allocated outside of the expected match sequence. These revised definitions were formally accepted by HRSA on June 6, 2025.
To promote transparency and keep the public informed, HRSA published the updated AOOS definitions on its AOOS webpage. These definitions help clarify a complex part of the organ allocation process and set a consistent standard for identifying AOOS cases across the system.
Building on this foundation, HRSA developed a publicly accessible data dashboard for AOOS using the newly adopted analytic definitions. The dashboard tracks trends and patterns of AOOS, providing increased visibility into system performance and potential areas of concern. By shining a light on AOOS activity historically and moving forward, the dashboard strengthens transparency, accountability and supports ongoing efforts to protect patient safety and uphold fairness in the organ transplant system.
Supporting Living Donors Through Outreach and Financial Assistance
HRSA’s commitment to informed decision-making also extends to individuals considering living organ donation. HRSA recently announced two new investments to expand outreach, education and financial support for living organ donors, reinforcing its commitment to improving access to organ transplantation and supporting those who choose to give the gift of life through living donation.
The National Living Donor Assistance Center (NLDAC), supported by the Mayo Clinic Arizona, received funding to continue providing financial assistance to living organ donors through HRSA’s Living Organ Donation Reimbursement Program (LODRP). If you’re eligible, you may be able to get help paying for travel, lodging, meals, childcare, and lost wages associated with the evaluation and donation process. Additionally, for the first time, HRSA awarded funding to Health Media Literacy, LLC for targeted outreach and public education efforts under the Public Education for Living Organ Donation Reimbursement Program, which will raise awareness about financial support available to living organ donors.
Are you thinking of becoming a living organ donor? Learn more and apply for help at the National Living Donor Assistance Center.
Reforming the OPTN Fee Collection Process
Congress recently authorized the Secretary of Health and Human Services (HHS), through HRSA, to directly collect monthly OPTN patient registration fees from transplant programs. These fees, which are currently collected by an OPTN Operations contractor, the United Network for Organ Sharing (UNOS), will now be collected by HRSA.
HRSA planned to begin invoicing transplant hospitals for OPTN patient registration fees for transplant candidates added to the waiting list between October 1st through 31st, 2025. However, HRSA is ahead of schedule in the development of the new process and will invoice transplant hospitals monthly starting in October 2025 for OPTN patient registration fees for transplant candidates added to the waiting list Sept. 1 through Sept. 30, 2025. For all patient registrations prior to September 1, 2025, transplant hospitals should continue paying OPTN patient registration fees to UNOS until directed by HRSA.
HRSA will continue to work closely with UNOS and keep transplant hospitals informed with timely email updates, detailed guidance, and clear timelines to support a smooth transition. Additionally, HRSA has created a new OPTN registration fees webpage to share information on the fee collection process, fees collected, and how fees are used to support OPTN operations.
Building Public Trust Through Oversight and Reform
Transparency and accountability are essential to public trust, and central to informed policymaking. In July, Dr. Raymond Lynch, Chief of HRSA’s Organ Transplantation Branch, testified before the House Committee on Energy and Commerce during a hearing titled "Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System."
Dr. Lynch provided insights into the OPTN Modernization achievements and ongoing initiatives, emphasizing HRSA’s commitment to drive system-wide improvements focused on data transparency, efficient organ distribution, accountability of the highest standards of patient care, and OPTN reforms. Throughout the hearing, Dr. Lynch emphasized HRSA’s role not only as a regulator but also as a collaborator. HRSA’s engagement with the OPTN through critical comments demonstrates its shared commitment to improve the OPTN and restore public trust in the organ donation and transplant system.
OPTN Summer Public Comment Period and Upcoming Regional Meetings
OPTN Board President Dr. John Magee recently announced that the OPTN’s summer public comment period will begin August 27 and run through October 1. During a Board Leadership meeting held on July 15, 2025, OPTN Board Officers determined that the updated date range will give the new Board of Directors time to fully review and prioritize the anticipated policy proposals from the Policy Oversight Committee (POC) following its meeting on July 24, 2025. The previous schedule–holding Executive Committee (ExCom) review the week after the POC decision meeting, followed by immediate public comment–did not allow Board leadership adequate time for thorough policy review for alignment with OPTN priorities and available resources.
To ensure input from all OPTN regions during the open public comment period, the OPTN also rescheduled four regional meetings that were scheduled to occur less than a week before August 27. All regional meeting dates are now available online.
The Path Forward: Grounded in Information, Guided by Patients
In every part of the OPTN Modernization effort, HRSA is committed to using the best available information to make decisions that are transparent, evidence-based, and centered on patient safety and public trust. Whether through better data collection, OPTN-policy compliant allocation practices, expanded support for living donors, or stronger oversight, informed decision-making is the foundation for a better, fairer donation, procurement, and transplant system.