Committee seeks to save lives and ensure proper implementation of new bipartisan law

Washington, D.C. — Bipartisan leaders of the Energy and Commerce Committee launched an investigation into United Network for Organ Sharing (UNOS), the sole contractor responsible for operating the Organ Procurement and Transplantation Network (OPTN). The Leaders are also seeking information from the Health Resources and Services Administration (HRSA) regarding ongoing reforms.

The effort seeks to examine issues with OPTN’s prior operation and ensure proper implementation of the bipartisan Securing the U.S. Procurement and Transplantation Network Act, which was passed unanimously by the Committee and by Congress and signed into law by President Biden on September 22, 2023.

The inquiry is led by Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr. (D-NJ); Subcommittee on Health Chair Brett Guthrie (R-KY) and Ranking Member Anna G. Eshoo (D-CA); and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL).

The Committee Leaders wrote to HRSA requesting information on how its OPTN contract solicitation plan will support fair and competitive practices during the contracting process, promote data transparency and patient safety, and ensure system security and operability.

KEY LETTER EXCERPT:

“Errors and inefficiencies in OPTN management can have deadly consequences. A HRSA-funded study found that, while Americans die each day waiting for organ transplants, as few as one in five potential donor organs have been recovered. The Committee wants to ensure HRSA’s ability to manage the successful implementation of the OPTN Modernization Initiative to improve accountability and effectiveness of the system that does not currently meet the needs of patients.”

The Committee leaders also sent questions to UNOS Chief Executive Officer Maureen McBride regarding UNOS’s system security and operability, issues with patient safety and equity, and conflict-of-interest concerns.

KEY LETTER EXCERPT:

“A 2021 report, by the United States Digital Service titled 'Lives Are at Stake' found myriad problems with UNOS technology, concluding that ‘[t]he OPTN contractor lacks sufficient technical capabilities to modernize their systems,’ ‘[t]he core systems are fragile,’ and the system uptime is ‘insufficient’ for a life-saving system that depends on consistent operation.

“An August 2022 report from the Department of Health and Human Services (HHS) OIG found multiple, basic cybersecurity failures by UNOS. The OIG report noted that UNOS’s policies and procedures for access controls, risk assessment, and system monitoring ‘were either in draft or did not exist.’ Given the highly sensitive nature of the personal patient data UNOS keeps, it is vital that strong and enforceable security measures are required and consistently met under any OPTN management contracts.

“UNOS has been the sole organization managing the OPTN, during which time concerning reports have emerged that the organ donation system has become unsafe, inequitable, self-dealing, and retaliatory. The Committee supports HRSA’s proposed reforms to make the contracting process truly competitive to help ensure patients are served by the best contractors for each function.”

BACKGROUND:

• The OPTN is a unique public-private partnership that links all professionals involved in the U.S. donation and transplantation system. 
• Since its inception, the OPTN contract has only been awarded to a single contractor—UNOS. 
• To address concerns with the donation and transplantation system, Congress passed legislation led by Rep. Larry Bucshon (R-IN) and Rep. Robin Kelly (D-IL), which was signed into law in 2023, to modernize OPTN and allow HRSA to run a competitive process to choose the best contractors for different national OPTN functions. 
• Additionally, HRSA has also announced a Modernization Initiative to improve accountability and effectiveness of the system in order to better meet the needs of patients. 
• Alarm over ignored patient safety concerns suggests that both HRSA and UNOS systematically downplayed or ignored critical patient safety concerns, risking lives and undermining trust in the national organ transplantation system.