Bill H.R. 2544 passed by unanimous vote in the Senate on 07/25/2023. The legislation will go to President Biden’s desk for signature.
The president’s fiscal year 2024 budget featured legislative proposals to “modernize statutory tools” regarding the OPTN. In March, the Health Resources and Services Administration (HRSA) of Health and Human Services (HHS) announced a massive “modernization initiative” that included competitive bidding for the OPTN contract.
The bill would give HHS the authority to expand competition for contracts related to the operation of the Organ Procurement and Transplantation Network (OPTN), which matches donor organs with patients waiting for transplants.
The United Network for Organ Sharing (UNOS) has administered the OPTN contract since 1984. Recently, UNOS has faced scrutiny regarding its oversight of underperforming organ procurement organizations.
A private nonprofit organization, UNOS has long drawn criticism from patients, lawmakers, and patient advocates. They say the organization has been slow to address technology failures, is unaccountable to patients on the organ waiting list, has allowed too many organs to go unused, and has shown little oversight over the regional organ procurement agencies that solicit and collect donated organs.
The 1984 law that created the OPTN has been interpreted over the years as preventing HHS from soliciting bids from public and private organizations to manage and operate the contract. This legislation would broaden eligibility for the contracts, including by allowing for-profit organizations to submit bids.
The current OPTN contract with UNOS is set to expire Sept. 30, 2023, and will be up for competitive bidding. In June, UNOS announced that it did not oppose the legislation.
In a statement from March 2023, UNOS said it supported “modernizing and reforming the nation’s organ donation and transplant system and working with Congress to achieve measurable results for patients.”
“As long as there is a waitlist, it is our moral obligation to ensure we are promoting progress and increasing equitable access to lifesaving transplants,” said Maureen McBride, UNOS’ CEO.
This Fall, HRSA plans a solicitation for new contracts that will support and enhance OPTN operations while the modernization process is underway. These contracts will ensure the continuation of critical OPTN support functions and enable appropriate upgrades on a parallel track with modernization. The Fall 2023 solicitation will seek multiple vendors for distinct functions – including supporting a separate OPTN Board of Directors – to ensure service continuity and increase oversight and accountability.
In Spring 2024, HRSA intends to release a solicitation for multiple vendors to support the next generation of the OPTN, which will include enhancements in technology, governance, data transparency and operations. The separate Board of Directors contract and the deliverables from this next generation solicitation will form the foundation of a new, modernized OPTN.
“The management of the U.S. organ transplant system needs serious reform,” said Sen. Bill Cassidy, R-La., a co-sponsor of the Senate companion version of the bill and the ranking member of the Senate Health, Education, Labor, and Pensions Committee. “Breaking up this monopoly will increase competition, save lives, and improve the system. Glad to see our legislation pass Congress and look forward to it becoming law.”
Dawn Levitt, Author 