News reports, bipartisan congressional investigations and in-depth reports from other organizations have shed light on logistical and technological flaws in the Organ Procurement and Transplantation Network (OPTN). These flaws may have jeopardized patient safety and resulted in lifesaving organs not being transplanted. Having an effective and efficient OPTN is critical to ensuring lifesaving organs are matched with people on the transplant waiting list, including the more than 90,000 Americans who are on the waiting list for a kidney.
This blog post summarizes the current efforts in the White House Administration and Congress to modernize the U.S. organ donation and transplantation system to better serve people in need of an organ transplant.
History of OPTN
The OPTN was established nearly 40 years ago and is a public-private partnership that coordinates and operates the nation's organ procurement, allocation and transplantation system. The OPTN also aims to increase access to donor organs for people with organ failure. One of the OPTN's key responsibilities is operating a national list of people who need organs and a national computer system to match organs with the people on the waiting list.
The Health Resources and Services Administration (HRSA) is the federal agency that oversees the OPTN, and by law the OPTN is operated by a private, non-profit organization under federal contract. Since the first OPTN contract was awarded in 1986, only one contractor has administered the OPTN.
Data clearly demonstrates the need to improve the U.S. organ donation and transplantation system. In 2019, the proportion of deceased-donor kidneys recovered but not transplanted (the nonuse rate) was 20.1%, despite the persistent unmet need for transplants among people on the waiting list. Put another way, one in five deceased-donor kidneys were procured but not used. For comparison, the nonuse rate in the U.S. is nearly twice that of France.
White House Administration efforts: OPTN Modernization Initiative
In March, HRSA announced the launch of the OPTN Modernization Initiative to strengthen accountability, equity and performance in the OPTN and better serve the needs of patients and their families. The multi-year modernization initiative will focus on five key areas: (1) technology, (2) data transparency, (3) governance, (4) operations and (5) quality improvement and innovation.
As part of the first phase of the initiative, HRSA released a new data dashboard with data on organ retrieval, waitlist outcomes, transplants and demographic data from individual transplant center and organ procurement organizations. Patients, families, clinicians, researchers and others can use this data to inform their decision-making and process improvements.
Also, as part of the initiative, the President's Budget for Fiscal Year 2024 proposed a $36 million dollar increase to support HRSA's organ transplantation programs, including the modernization initiative. The President's budget included a legislative proposal to update the law that established the OPTN that would remove the appropriations cap on the OPTN contract(s), which would allow HRSA to better allocate resources. Additionally, the legislative proposal would expand the pool of organizations that could be eligible to receive the OPTN contract, which will enhance performance and innovation for OPTN through increased competition.
In a May update, HRSA described plans to release a solicitation this fall to establish new OPTN contracts that will support and enhance OPTN operations while the modernization process is underway. In spring 2024, HRSA plans 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.
Congressional efforts: The Securing the U.S. Organ Procurement and Transplantation Network Act
Bipartisan legislation has been introduced in Congress that would allow HRSA to change how they contract for the OPTN, consistent with the proposal in the President's budget. The Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544/S. 1668) would allow for increased competition for the management of the OPTN and its critical functions such as logistics and information technology.
The House bill unanimously passed in the Energy and Commerce Committee on May 24; the Senate bill was introduced on May 17 with bipartisan support.
AKF's support of OPTN modernization efforts
AKF joined other kidney organizations in a letter to HRSA welcoming the announcement of the OPTN Modernization Initiative and supporting its goals to strengthen accountability, equity and performance in the organ donation and transplantation system. We also joined a letter commending the introduction of the Securing the U.S. Organ Procurement and Transplantation Network Act.
We also encourage AKF Ambassadors – and you! – to urge Congress to support H.R. 2544/S. 1668. Click here to take two minutes to ask your member of Congress to support this bipartisan legislation that will help modernize the OPTN so that it better serves people who need an organ transplant, especially those living with kidney disease.