Organ Procurement and Transplantation Network (OPTN) Modernization Initiative

Strengthening Oversight to Improve Patient Outcomes: Recent Advances in OPTN Governance and Transparency 

May 2025 Update

Transparency and strong governance are essential to improve the safety, fairness, and effectiveness of the nation’s organ donation, procurement, and transplant system. When people understand how decisions are made and see that the process is open, ethical, and well-managed, they are more likely to trust the system. This trust is crucial, whether they are considering becoming organ donors or facing the need for a transplant. Robust oversight helps prevent errors, favoritism, and misuse, ensuring that donated organs are allocated to those in greatest need. In recent months, HRSA has taken significant actions to modernize the OPTN, including enhancing transparency and strengthening governance across the system.

Strengthening OPTN Governance 

New Patient, Donor, and Family Representatives Join the OPTN Board of Directors
On May 2, the OPTN Board of Directors unanimously voted to seat eight new Patient, Donor, and Family Representatives to join the OPTN Board through June 30, 2025. These individuals were put forward by the OPTN Nominating Committee to replace the eight patient representatives who resigned from the OPTN Board in April. Collectively, these eight individuals bring a wide range of lived experiences with organ donation, transplantation, and policy. HRSA and the OPTN Board welcome and appreciate the dedication of these individuals to elevating the patient voice in OPTN policy and operations. Additional information on the eight new Board Directors will be available on the OPTN Board of Directors webpage.

OPTN Special Election Updates
For forty years, the OPTN Board of Directors has been one-and-the-same as the corporate Board of Directors for the federal government’s contractor, raising issues about potential conflicts of interest. As a part of the OPTN Modernization Initiative, HRSA separated the OPTN Board of Directors from the OPTN contractor. This includes conducting a special election to seat an entirely new Board—a critical step to strengthen OPTN governance and mitigate conflicts of interest. HRSA worked with the Transitional Nominating Committee (TNC) to identify a slate of candidates that was reviewed and approved by the Secretary of HHS.

Regional Election
The election to select 11 Regional Councillors was held from May 2–6, 2025. During this period, each OPTN member institution and individual member with voting privileges had the opportunity to cast one vote for a Regional Councillor in their respective region. The candidates who received the highest number of votes in each region will now appear uncontested on the national ballot in the upcoming national election. A separate ballot question for Associate Regional Councillors will be included in the regional section of the national ballot. HRSA is pleased with the strong voter turnout, which reflects a high level of engagement and commitment across the OPTN community.

National Election
The national election to select a new OPTN Board of Directors will be held from May 23, 2025, to June 2, 2025, at 11:59 p.m. ET. Following the election, there will be a period where the current Board and new Board overlap for continuity and knowledge transfer until the new Board is seated on July 1. In addition, there will be an opportunity for both the current and incoming board to attend the Board meeting on June 9 and 10, 2025. For more information on the special election, please see the special election webpage.

Improving Transparency and OPTN Operational Capacity Through a New Registration Fee Process

New Legislation to Improve Transparency of OPTN Registration Fee Collection and Distribution
Earlier this spring, Congress passed the 2025 Full-Year Continuing Appropriations and Extensions Act to fund the federal government. Included in this legislation, Section 1904 gives the Department of Health and Human Services (HHS) explicit legal authority to collect and distribute registration fees from OPTN member institutions to support the operations of the OPTN. These registration fees are paid by institutions for each transplant candidate they add to the national transplant waiting list.

For the past several decades, the United Network for Organ Sharing (UNOS), as the sole OPTN contractor, was responsible for collecting these fees from transplant hospitals. With this new authority, HHS will directly oversee this critical function, increasing transparency, access to multiple best-in-class experts, ultimately strengthening performance and accountability of the OPTN. The new law also calls for increased transparency measures, giving the OPTN community and public insight into the fees received. These measures ensure that the fees are utilized to support the operations of the OPTN and improve outcomes for patients and families.

In the Fall, HRSA anticipates collecting registration fees via Pay.gov, a secure, no-cost payment platform used by numerous federal agencies. As planning progresses, HRSA will collaborate closely with the current OPTN contractor, and provide transplant hospitals with detailed information about the transition process and related timelines.

Improving the Fairness, Safety, and Efficiency of the Organ Procurement and Transplant System

HRSA uses several oversight tools to enhance the safety, operations, and performance of the Organ Procurement and Transplantation Network (OPTN). One key tool is the critical comment process, outlined in the OPTN Final Rule, which allows individuals or organizations to submit written concerns about OPTN policies or practices directly to HRSA. After reviewing the issue, HRSA may choose to reject the comment, direct the OPTN to revise the policy or practice, or take other appropriate action. 

For transparency, HRSA publishes critical comments, along with OPTN’s responses and HRSA’s subsequent responses. HRSA’s ongoing data requests and oversight actions, outlined in more detail below, aim to ensure the OPTN meets its responsibility to develop safe, effective, and equitable transplant policies.

Another oversight tool is investigating patient safety complaints or allegations of misconduct. Over the past year, HRSA has received critical comments, patient safety reports, and allegations of misconduct, raising concerns about both the fairness of the transplant system and patient safety. HRSA takes these concerns seriously, coordinating with appropriate federal agencies and ensuring appropriate member-level and system-wide action is taken.

Plans to Address Allocation Out of Sequence (AOOS)
HRSA operates in accordance with the National Organ Transplant Act (NOTA), which established the national computer system for matching donor organs with patients on the waiting list. NOTA mandates strict ethical and equitable standards for organ distribution, including matching based on blood and tissue type, organ size, medical urgency, time on the waitlist, and geographic location. The practice of allocation out of sequence violates the principles of NOTA, the OPTN Final Rule, and current OPTN policies. Such deviations undermine transparency and fairness in the transplant system.

Organ allocation policy development is the responsibility of the OPTN Board of Directors, and all OPTN members are required to comply with OPTN policies and bylaws. In response to a recent critical comment, HRSA directed the OPTN Board to submit a detailed plan to improve allocation policy definitions and requirements, as well as a compliance monitoring plan to ensure all OPTN members adhere to legal and regulatory standards governing organ allocation. Additionally, HRSA called for the development of a public-facing tool to track and report how often patients are bypassed due to AOOS.

To promote transparency and facilitate community engagement, HRSA plans to create a web page documenting OPTN efforts to address AOOS. HRSA continues to work with the OPTN Board and OPTN members to address this important matter, strengthen policy definitions, and improve the transplant experience.

Development of Standards for Use of Normothermic Regional Perfusion 
HRSA recognizes that advances in clinical practice and technology may require updated policies and standards to ensure safety and ethical integrity in organ donation, procurement, and transplantation. It is the responsibility of the OPTN Board of Directors to establish standards for the acquisition of donated organs and to collect data on organ procurement practices.

In its most recent directive (PDF - 488 KB), HRSA instructed the OPTN Board to develop a comprehensive plan that includes proposals for standard practices, policy definitions, data collection protocols, and technical and quality standards to ensure patient safety for organ procurement organizations (OPOs).

Similarly to AOOS, HRSA plans to create a web page to share pertinent information and how the OPTN will be addressing patient experience and safety in organ procurement. As medical innovation continues to shape organ recovery practices, it is essential that policy development and safety monitoring keep pace to protect patients and uphold public trust.

Improving Organ Transport on Airliners 
The Federal Aviation Administration (FAA) recently issued a report, which includes 20 recommendations on improving the process for transporting human organs and biological materials on commercial airlines. The congressionally mandated report is a product of the Joint Organ Transport Working Group. This group includes representatives from FAA, TSA, HRSA, and the OPTN, and aims to address perceived regulatory barriers and develop best practices for transporting organs in the passenger cabin of commercial airlines.

This report marks an important first step in advancing safer, more efficient, and accountable air transport of organs. HRSA and the OPTN look forward to exploring ways to implement meaningful improvements in collaboration with commercial airline partners. Visit the transportation of organs on commercial airlines webpage for more information.

Ongoing Commitment to Transparency and Governance

Transparency and strong governance are essential to building and maintaining trust in the organ donation, procurement, and transplant system. They ensure that decisions are made ethically, policies are applied consistently, and the public has confidence that the system works in the best interest of patients. By promoting openness, accountability, and clear oversight, transparency, and governance help safeguard the fairness and integrity of the system—ultimately leading to better outcomes for patients.

2025 updates

• April 2025: Recognizing Donate Life Month: Expressing Gratitude for Those Who Give, and Honoring the Sesilience of Those Who Wait
• March 2025
• January 2025: HRSA Announces Key Technology and Governance Milestones in its Organ Procurement and Transplantation Network Modernization Initiative