Organ Transplantation System Modernization

Font Size:

UNOS may no longer retain sole control of the organ transplantation network.

Font Size:

The United Network of Organ Sharing (UNOS) is the only nonprofit in history to hold the contract to run the United States organ transplantation system. Now, a 2023 law reforming the organ transplantation system is poised to end UNOS’s monopoly.

The Organ Procurement and Transplantation Network (OPTN) is an organ transplantation system that maintains the national organ registry in the United States. The Health Resources and Services Administration (HRSA) under the U.S. Department of Health and Human Services has the authority to hold a bidding process and award a nonprofit the contract to operate the OPTN in partnership with the federal government.

HRSA historically awards the contract to UNOS, which then operates the OPTN. UNOS oversees the transplant waitlist, collects organ transplantation data, and adopts organ acquisition and transportation standards. The OPTN’s board of directors is made up of industry stakeholders such as transplant physicians, transplant recipients, and representatives of transplant hospitals and organ procurement organizations. Informed by specialized organ committees, the OPTN board of directors issues OPTN policy for organ allocation and distribution. But, before a recent board separation, the OPTN board of directors was the same as the UNOS board of directors. This board unity put UNOS representatives in the position of issuing organ policy.

The OPTN has come under significant scrutiny. Some have questioned OPTN’s equitable organ allocation and its efficiency with a sole organization, UNOS, operating the entire network without competition.

Following a nearly two-year investigation, the U.S. Senate Finance Committee accused UNOS of insufficient oversight of organ procurement organizations, which harvest and transport organs between hospitals. The Committee cited incidents where harvested organs could not be transplanted due to transportation and blood type errors.

In another report, former Department of Health and Human Services Chief Technology Officers also stated that UNOS both lacks the technical expertise to run the informational technology (IT) portion of the OPTN and uses antiquated technology.

Finally, the National Academies of Science Engineering and Medicine highlighted in a report racial, gender, and socioeconomic disparities in organ access and critical data gaps in OPTN organ data collection.

HRSA followed this flurry of criticism by announcing a modernization initiative in March 2023. As a part of the initiative, HRSA requested that the U.S. Congress amend the statute that created the OPTN to allow HRSA to award multiple contracts to operate separate OPTN functions such as board governance, OPTN operations, and IT systems. HRSA’s additional modernization goals included aligning OPTN’s IT with industry standards, separating the OPTN board of directors from contract holders’ board of directors, releasing a detailed waitlist demographics data dashboard, and a request to Congress to remove HRSA’s funding cap for OPTN contractors.

Following the Senate hearing and HRSA’s modernization initiative, President Joseph R. Biden signed the bipartisan Securing the U.S. Organ Procurement and Transplantation Act into law in September 2023, making way for several OPTN contractors. The law also removed the funding cap for OPTN contracts and instructed the Government Accountability Office to review the OPTN’s historical financing.

UNOS issued a response to the new law stating that it welcomes a competitive bidding process and “believe[s] it is critical that the future transplantation system include bidders with OPTN operations experience.” UNOS also pointed to its own action agenda items aimed at reforming the OPTN system to demonstrate its consistency with HRSA’s modernization initiative.

In fact, UNOS has undertaken and proposed significant reforms in the past year.

As of March 2024, UNOS has announced a new, independent board of directors. UNOS has also rolled out a new organ allocation policy for lungs known as continuous distribution. With continuous distribution, UNOS aimed to increase organ access for medically urgent candidates. Continuous distribution removes the previous firm geographical boundaries that classified groups of candidates and instead assigns all candidates a composite allocation score based on adding up weighted attributes, such as pediatric status and proximity to donor hospital. The new composite allocation score compares all patient factors at once and prevents a single factor, such as distance from donor hospital, from determining allocation.

This system has already increased lung transplants by nearly 16 percent and is in development for all other organs. Notably, organs travel farther with continuous distribution, harkening back to the Senate Finance Committee’s concerns with UNOS organ procurement organization oversight. But continuous distribution has overall not increased the amount of organs that are harvested but not transplanted. UNOS’s proposed and completed reforms seem to address the Senate Finance Committee’s oversight concerns by proposing a centralized tracking system for organs and enhanced organ procurement organization performance measures.

In addition, UNOS’s proposed and completed reforms mirror HRSA’s modernization goals to create OPTN board independence, improving IT, and assisting in collection data directly from hospitals. Historically, though, UNOS has not always supported OPTN board independence.

Implementation of these reforms will likely depend on whether HRSA awards UNOS the contract for operating clinical OPTN functions.

HRSA issued the first multivendor bid solicitation this past fall. It is too soon to know which stakeholders aside from UNOS will bid for OPTN contracts, but change is coming to the organ transplantation system.