Through the National Organ Transplantation Act (NOTA) of 1984, Congress set up a system of monopoly contractors to supply transplant organs and, roughly speaking, gave them blank checks from the taxpayer. The results have been disastrous. Thirty-three Americans die every day waiting for a lifesaving organ transplant — a stark indicator that the nation’s organ donation system needs urgent reform.

Organ donation in the United States is managed by 57 organ procurement organizations (OPOs) that are responsible for coordinating local organ recovery efforts. An organ procurement and transplantation network (OPTN) is responsible for overseeing the national system.

Earlier this year, the Centers for Medicare and Medicaid Services identified the majority of OPOs as failing critical performance measures. The OPTN contractor, United Network for Organ Sharing (UNOS), is the subject of a bipartisan investigation by the Senate Finance Committee, which highlighted “serious concerns related to UNOS’ role in overseeing our nation’s OPOs.”

OPOs are failing those in need of a transplant by leaving an estimated 28,000 organs unrecovered each year. The House of Representatives Oversight Committee held a bipartisan hearing on the system in May 2021, noting that “OPOs have a history of poor performance and mismanagement, and they have passed costs for unnecessary luxury items onto taxpayers.” The Senate Finance Committee is investigating the OPOs for deadly patient safety issues, wasted taxpayer dollars, criminality, and the failure to recover organs. The House Appropriations Committee has highlighted the need for reform of the OPTN.

Market power / Critical ingredients of any productive reform would be for the U.S. Department of Health and Human Services to focus on the removal of barriers to entry for new organ procurers, an increase in transparency for all contractors, and hewing to basic principles of good governance and federal contracting. The logical first step would be for the Health Resource and Services Administration (HRSA) and HHS to insist upon competitive OPTN contracts consistent with standard government contracting policies.

The organ procurement policies have, in essence, prioritized OPOs’ incumbency at the expense of patients’ lives, and the monopolistic structure of the OPTN has undermined systemic pressures to improve, while patients are left to languish. While 90% of Americans support organ donation, an HHS-funded study showed that government contractors, protected by their government-enforced monopoly, recover as few as one in five organs potentially available for transplant.

UNOS performs three key functions: policymaking, technology delivery, and network member compliance. Its functions in all three have drawn criticism from congressional oversight, the media, and external stakeholders. A recent report from alumni of the U.S. Digital Service (USDS) and endorsed by all five past HHS chief technology officers remarked, “The OPTN contractor has devolved into a hostage-taking situation, where it has convinced the government that no one else can do what it does, but it doesn’t perform its functions particularly well.”

Policymaking in this realm has been divisive in the last few years and has drawn criticism from both Republican and Democratic presidential administrations. The result has been the (rightful) erosion of public trust in OPOs. For example, in 2021 a federal judge unsealed emails with incendiary statements from UNOS executives, prompting congressional concern about how policies are decided. In one instance, a UNOS board member told the CEO in an email, “The fact that some states do better than others in preventing preventable deaths and providing health care insurance coverage and access means [a person in need of a transplant is] a dumb [expletive] for living there.”

It’s also apparent that UNOS has failed to take advantage of the breathtaking gains in information technology to upgrade its systems and improve performance. The USDS alumni’s report decried the network’s “technology poverty.” For instance, UNOS data and tech are so outdated that 17% of kidney offers go to dead people, and a startling number of organs are lost or delayed on commercial flights because the network typically tracks organs with a primitive system of phone calls and paper manifests. The American Society of Nephrology observed that UNOS is 15 times more likely to lose an organ in transit than a passenger airline loses luggage.

Recommendations / To address the above failings and to best serve patients with a first-ever competitive OPTN contracting cycle, HRSA should:

  • Reform the governance of the OPTN. The network’s board should be solely focused on the interests of patients. A high-functioning national organ donation and transplantation system must be separate from the interests of any OPTN-related contractor(s).
  • Subdivide the OPTN contract into policy and technology, given the fundamentally different core competencies of these two areas.
  • Make the technology component open to all bidders, working with USDS procurement experts so that HHS can choose from the best vendors to serve patients. The need for this recommendation is evident in the USDS alumni’s report that amounted to a damning indictment of UNOS’s capabilities: “Our research indicates the vendor maintains an antiquated technology and limited technical acumen.”
  • Make all de-identified OPTN data publicly available as a practical way to show evidence of equitable and effective treatment of donor families and patients. This is something noticeably absent from the status quo.
  • Streamline organ donation policymaking through an elevated Office of Organ Policy that would address “conflicts of interest and gaps in oversight” from the OPTN.

The status quo is clearly not serving the best interest of those in need of an organ transplant, and the system has been effectively co-opted by those who profit from the status quo. HRSA and HHS should work with Congress to reform NOTA in a way that puts the interests of those in need of an organ transplant first and foremost.

Readings

  • “The Costly Effects of an Outdated Organ Donation System.” Online publication: bloomworks.digital, 2021.
  • “The OPTN Deceased Donor Potential Study: Implications for Policy and Practice,” by D.K. Klassen, L.B. Edwards, D.E. Stewart, et al. American Journal of Transplantation 16(6): 1707–1714 (June 2016).