On July 27, 2023, the U.S. Senate passed H.R. 2544 - Securing the U.S. Organ Procurement and Transplantation Network Act, which would allow competitive bidding for federal contracts under the Organ Procurement and Transplantation Network (OPTN). Significantly, the legislation allows multiple contracts for various OPTN tasks rather than the current single contract, which has been held by the same private non-profit organization, United Network for Organ Sharing (UNOS), for 37 years. Additionally, the legislation contemplates that contracts will be awarded to both public and private entities. President Biden is expected to sign the bill into law.
Background on the OPTN
Regulation of organ procurement and transplant activities first occurred when Congress passed the National Organ Transplant Act of 1984 (the Transplant Act). 42 U.S.C. § 273 et seq. The Transplant Act authorizes HHS to provide grants and other payments to a national network of nonprofit organizations tasked with acquiring, preserving and transporting donated organs, and allocating each donated organ to the highest priority patient on the transplant waiting list for that organ.
The Transplant Act established the OPTN for the purpose of coordinating and operating the nation’s organ procurement, allocation, and transplantation system with the aim to increase access to donor organs for patients with end-stage organ failure. The Transplant Act requires the OPTN to operate a national waiting list of individuals needing transplants to be matched with organs from living and deceased donors. The OPTN is a private, nonprofit entity established by Congress to perform essential functions in implementing the Transplant Act. The OPTN operates and acts through its board of directors and several committees. Often at the recommendation of its specialized committees, the board establishes and maintains transplant policies and membership bylaws that govern the OPTN.
UNOS is a private, non-profit organization that manages the OPTN under contract with the federal government. UNOS was awarded the initial OPTN contract award in 1986 to develop the requirements for the operation of the OPTN, and has served as the OPTN contractor ever since.
The last several years have seen increased scrutiny on the OPTN. Most recently, the Senate Finance Committee released a report critical of OPTN’s performance and held an oversight hearing in 2022 into UNOS operations. The Committee found that:
- The OPTN is failing to provide adequate oversight of the nation’s 57 Organ Procurement Organizations (OPOs), resulting in fewer organs available for transplant.
- The lack of oversight by UNOS causes avoidable failures in organ procurement and transplantation resulting in risks to patient safety. These failures include testing procedure errors, transportation issues resulting in life saving organs being lost or destroyed in transit, and process and procedure failures.
- UNOS lacks technical expertise to modernize the OPTN IT system, resulting in risk of system interruption or technical failure with the potential to harm patients across the country.
Organ Transplantation Network Modernization Initiative
HRSA’s Organ Transplantation Network Modernization Initiative, announced earlier this fall, set off a wave of reforms that, according to the agency, aim to improve accountability and transparency in the OPTN. These actions include:
- Data dashboards detailing individual transplant center and OPO data on organ retrieval, waitlist outcomes, and transplants, and demographic data on organ donation and transplant;
- Modernization of the OPTN IT system in line with industry-leading standards, improving OPTN governance, and increasing transparency and accountability in the system to better serve the needs of patients and families;
- HRSA’s intent to issue contract solicitations for multiple awards to manage the OPTN in order to foster competition and ensure OPTN Board of Directors’ independence;
- The President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million; and
- A request to Congress included in the Fiscal Year 2024 Budget to update the nearly 40-year-old National Organ Transplant Act to take actions such as:
- Removing the appropriations cap on the OPTN contract(s) to allow HRSA to better allocate resources; and
- Expanding the pool of eligible contract entities to enhance performance and innovation through increased competition.
Securing the U.S. Organ Procurement and Transplantation Network Act
H.R. 2544 is the first legislative step to give the Secretary of HHS the statutory authority to grant multiple contracts to various public and private entities to perform OPTN functions. This legislation likely ends UNOS’ run as the exclusive OPTN contractor. Transplant hospitals and organ procurement organizations may have to reconfigure their processes in order to coordinate, implement, and perhaps even reconcile, information from multiple organizations under the new multi-contract OPTN model.
The text of the legislation is available here.
