OPTN Board approves policy to expand access for individuals living with HIV, modifies guidance for pediatric heart exception requests
Published on: Tuesday, June 17, 2025
On June 9-10, the Board of Directors of the Organ Procurement and Transplantation Network (OPTN) convened virtually for its biannual, two-day meeting. During this meeting, the Board voted on revisions to OPTN policy, including actions to address timely patient safety issues, approved policy project proposals, and discussed OPTN finances and the annual report from the Network Operations and Oversight Committee. The current Board also welcomed the incoming Board members, whose term begins on July 1, 2025.
The Board approved revisions to OPTN policy to align with the amended OPTN Final Rule and National Institutes of Health (NIH) Final Notice regarding the removal of research requirements for transplantation of kidneys and livers from donors with human immunodeficiency virus (HIV). This action will ensure patient safety is maintained while access expands for individuals living with HIV by allowing transplants of livers, kidneys, and liver-kidneys from donors with HIV to candidates living with HIV without requiring participation in NIH research criteria or OPTN HIV Organ Policy Equity Act (HOPE) Act variance. When needed, variance is a special permission granted by the OPTN to allow transplant centers to conduct research into the safety and efficacy of transplanting organs from HIV-positive donors to HIV-positive recipients.
“I want everyone to realize the significance of what just occurred,” said Richard Formica, M.D., OPTN Board President. “This was an idea that started when nobody would use an HIV positive organ to be transplanted. It was illegal in federal law … to use HIV positive organs. A group of clinicians said that's wrong. They put together a protocol. They changed the law. They conducted a research study. The research study worked. And we just made it part of a national allocation policy.”
Modified Guidance for Pediatric Heart Exception Requests to Address Temporary Equipment Shortage
The Board voted to update their Guidance for Pediatric Heart Exception Requests to respond to potential pediatric patient safety risk associated with shortage of pediatric mechanical circulatory support (MCS) devices and support equipment. The updated guidance identifies circumstances by which pediatric patients, for whom timely access to mechanical circulatory support is limited due to the ongoing device and support equipment shortage, may be eligible for status 1A by exception.
Other actions
The Board took additional actions as follows:
- Approved sharing common practices and relevant literature for transplant programs to minimize barriers related to the evaluation and follow-up of international living donors
- Approved updates to National Liver Review Board (NLRB) Guidance & further alignment with Liver Imaging Reporting and Data System (LI-RADS)
- Approved policy changes in order to provide greater equity in access to transplant by increasing access to donor hearts for stable, adult heart candidates supported by dischargeable LVADs for long periods of time
- Updated policy requirements regarding wait time modifications for kidney candidates affected by race inclusive eGFR calculations.
- Updated reporting requirements to clarify when a potential disease transmission is unexpected and therefore necessary to report
- Approved enhancements to OPTN data collection to improve lung allocation efficiency and streamline communication between OPOs and lung transplant programs
- Approved two new policy projects: Require Patient Notification for Inactive Status and Modify Lung Allocation by Candidate Biology
- Approved actions for immediate (FY25Q4) cost reduction or savings to meet current budget shortfall
Discussion items
The Board also heard and discussed status updates on HRSA directives and significant and ongoing OPTN initiatives, including:
- OPTN’s draft plans for Allocation out of sequence (AOOS) and Normothermic regional perfusion (NRP).
- Plan to propose improvements to OPTN policy that reduce risk of donor derived rabies
- Network Operations and Oversight Committee (NOOC) Annual Report which included updates on metrics and monitoring and OPTN member security policies