This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ Procurement and Transplantation Network ("OPTN").
On July 27, 2023, the U.S. Congress passed bipartisan legislation, "Securing the U.S. Organ Procurement and Transplantation Network Act" (H.R. 2544), which grants HRSA the authority to expand competition to manage the OPTN. Since the OPTN was first established in 1984 to maintain policies and a national registry for organ donations, only a single, private, nonprofit—the United Network for Organ Sharing ("UNOS")—has held the OPTN contract. Forty years later, the legislation would amend section 372 of the Public Health Service Act (42 U.S.C. 274) to allow HRSA to establish multiple contracts in an effort to improve the U.S. donation and transplant system.
Following years of scrutiny and the Biden administration's announcement of the "OPTN Modernization Initiative" in March 2023, the bill's passage is a key milestone in the modernization process. This overhaul responds to findings from a Senate Finance Committee investigation, which uncovered a lack of regulatory oversight of regional organ procurement organizations, outdated systems at UNOS, and inequitable and inefficient organ allocation.
To address these systemic issues, the bill gives HRSA more flexibility to manage the OPTN, including the ability to broaden participation in the network and solicit multiple bids from public and private entities. Of particular note under the new legislation, the operation of the OPTN will be overseen by a board distinct from entities under contract to operate one or more other functions of the network. This constitutes a significant change from the structure in effect for the last 37 years in which UNOS and the OPTN were served by boards consisting of the same persons. This, according to detractors, created a situation in which the OPTN contractor—UNOS—could enact policies in conflict with the mission of the OPTN. Another significant provision of the bill eliminates the funding cap, which opens HRSA's potential to attract more robust financing, in line with the administration's efforts to double resources available to HRSA in fiscal year 2024. Lastly, the bill calls upon the Government Accountability Office to prepare a report on the historical financing of the OPTN, including registration fees.
HRSA indicates that solicitations will begin in fall 2023.
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