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HERSA outlines OPTN modernization steps, flags ‘allocation out of sequence’ compliance concerns
Summary
A HERSA official told stakeholders the agency is strengthening oversight of the Organ Procurement and Transplantation Network after finding policy non-compliance that sometimes prevented matched patients from receiving offers; HERSA outlined a remediation plan, announced new board members from a special election, and said HHS will begin collecting transplant registration fees later this year.
A Health Resources and Services Administration (HERSA) official briefed the board and community on May 25 on efforts to modernize the Organ Procurement and Transplantation Network (OPTN), highlighting a recent special election, new patient-safety reporting, a remediation plan for allocation “out of sequence” (AOS) matches and a planned transition to federal collection of registration fees.
The official said an independent transitional nominating committee ran a compressed special election that drew “a record voter turnout,” with more than 83% of OPTN members voting compared with an average of about 68% over recent years. The newly elected board begins its term July 1; two tied seats will proceed to a runoff the week of June 20 and officer elections for board leadership will follow.
Why it matters: HERSA framed the modernization work as an effort to strengthen fairness, safety and public trust in a system that serves more than 100,000 people on transplant waiting lists. The agency said its review of a critical comment revealed instances where the match-run algorithm or policy was not followed and, at times, transplant centers were not notified of organ offers—practices HERSA characterized as threats to fairness and transparency.
HERSA described AOS as a multifaceted problem and outlined steps in a remediation plan: develop shared definitions of the issue, create transparent compliance metrics and monitoring, enforce policy compliance where appropriate, and consider algorithm or policy updates if definitions or compliance criteria require change. The agency said it will publish an allocation out-of-sequence web page and dashboards so stakeholders can track progress.
The official summarized early results as encouraging, saying compliance has increased and organ non-use has declined in initial data. “In April alone, more than 200 patients received an organ in the order that the OPTN match had prescribed,” the presenter said, adding that these early trends must be tracked over a longer period.
Patient safety and procurement: HERSA said it has implemented a new process to receive, triage and investigate allegations of misconduct, giving HERSA direct oversight of complaints and coordination with other federal agencies where appropriate. The agency identified gaps in procurement policies and standards—including the donation-after-circulatory-death (DCD) pathway, which accounts for about half of donated organs—and pointed to normothermic regional perfusion (NRP) as a clinical advancement that requires consistent, safe application. HERSA said it has directed the OPTN to collect more data, assess best practices and monitor NRP use.
Operations and discovery: HERSA described discovery contracts issued to document OPTN operational functions and said those contracts will conclude with deliverables between late June and September. The agency plans to synthesize findings to inform policy and operational improvements.
Registration fees and budget context: Citing "Section 1904 of the 2025 full-year continuing resolution continuing appropriations and extensions act," the presenter said Congress gave HHS explicit authority to collect registration fees from OPTN member institutions for each transplant candidate added to the national waiting list. HHS intends to begin collecting those fees via Pay.gov in the fall and to increase transparency around fee collection and use. The official noted that OPTN operating reserves allowed the organization to avoid fee increases in recent years but that reserves have been drawn down; the finance committee and board are prioritizing projects and "there may be a need to increase the fee in the future" to fund critical policy and safety work, though amounts were not specified.
Next steps: The official said HERSA will continue oversight of remediation for allocation out of sequence, publish web pages and dashboards for transparency, continue data-directive work to strengthen procurement and monitoring, and support technology modernization. She then opened the session for questions before a scheduled closed session.
Quotes: “We found that more and more patients who were matched to an organ were not receiving that organ,” the HERSA official said, describing AOS as a fairness concern. “In April alone, more than 200 patients received an organ in the order that the OPTN match had prescribed,” she added when citing early improvement in policy compliance.
What HERSA did not specify: exact proposed registration-fee increases, dollar amounts held in OPTN reserves, or the names of new board members (the official said the full listing is posted on HERSA’s website).
