The U.S. government recently made a transformative announcement: it is breaking up the flawed monopoly that manages the current organ procurement system, the Organ Procurement and Transplantation Network (OPTN).
This commonsense reform marks an unequivocal win for patients, and has been heralded by patient groups, equity leaders, and bipartisan Congressional offices alike.
Specifically, the announcement from HHS, unrolled as part of the OPTN Modernization Initiative, "will strengthen accountability, equity, and performance in the organ donation and transplantation system through a focus on five key areas: technology; data transparency; governance; operations; and quality improvement and innovation."
The reforms will correct a 40-year wrong in which the government was, practically speaking, unable to promote innovation or engage best-in-class expert contractors to serve patients. As a result, the organ donation system has atrophied.
A sober look at the current state of play: More than 100,000 Americans are waiting for lifesaving organ transplants, and 33 of them -- disproportionately people of color -- die every day. And despite 95% of Americans supporting organ donation, federally-funded research found in 2015 that the system recovers "only one-fifth of the true potential" for organ donors, adding that "these findings suggest that significant donation potential exists that is not currently being realized."
It's not only that snapshot that's troubling, but also the related trends: after controlling for public health trends including tragic increases in opioid overdoses, gun deaths, suicides, and car accidents -- which have increased the absolute number of organ donation-eligible deaths every year -- donation rates have not even kept pace with simple population growth over the last 10 years. The organ procurement system has already plateaued and is now regressing; it is clearly in need of more structural incentives for innovation.
The historical context is elucidating: the only organization to ever hold, or even bid for, the OPTN contract since it was first awarded in 1986 is the United Network for Organ Sharing (UNOS). In the early 1980s, the predecessor organization to UNOS lobbied heavily to create a structure that gerrymandered the contract to UNOS and would continue to do so, which is precisely how things have since played out across seven subsequent contracting cycles.
In practice, this has stifled competition and innovation by preventing organizations with unique forms of expertise or approaches from participating in the OPTN, instead giving preference to an entrenched incumbent with a highly checkered history.
What has this meant for patients? Unnecessary death or prolonged morbidity.
The U.S. Digital Service (USDS) -- the federal government's top technologists -- found that UNOS's technology is insecure and often crashes, creating periods of downtime during which lifesaving organs literally cannot be matched with recipients in need. Investigative reporting found that UNOS maintains an archaic logistics infrastructure over which organs "are typically tracked with a primitive system of phone calls and paper manifests, with no GPS or other electronic tracking required," contributing to "a startling number of lifesaving organs [being] lost or delayed after being shipped on commercial flights, the delays often rendering them unusable."
In fact, USDS's ultimate assessment was that the OPTN's technology "needs to be vastly restructured," and that UNOS "lacks sufficient technical capabilities to modernize their systems."
The Senate Finance Committee, now 3 years into a bipartisan investigation of UNOS, separately arrived at a similar conclusion: "From the top down, the U.S. transplant network is not working, putting Americans' lives at risk," and recommended that HHS break up the OPTN monopoly.
Secure and stable technology and reliable logistics management have already been deployed in other areas of American life for decades, from Amazon's rapid delivery to electronic prescriptions that improve accuracy, increase patient safety, and reduce costs. The proposed reforms from HHS now have the potential to allow transplant patients to benefit from system and technological modernization, too.
Breaking up the OPTN monopoly can also address problematic conflicts of interest. Under the historical structure, the OPTN has been responsible for oversight of its own members, which some allege has contributed to fatal consequences for patients.
An investigation from the L.A. Times found that UNOS "often fails to detect or decisively fix problems at derelict hospitals -- even when patients are dying at excessive rates...When it does act, UNOS routinely keeps findings of its investigations secret, leaving patients and their families unaware of the potential risks." The Times attributed this problem to the fact that "UNOS isn't just a regulator; it is a membership organization."
The Senate Finance Committee recognized a similar problem. In addition to thousands of unnecessary deaths resulting from unrecovered organs, the investigation identified preventable deaths resulting from errors as basic as kidneys accidentally thrown in the trash, and organ procurement organization (OPO) staff misreading bloodwork.
The problem appears to be structural: it seems the OPTN contractor has an incentive to protect industry from accountability, rather than ensure that patients are kept safe. For example, despite reassuring Congress that UNOS "provides appropriate and highly effective oversight," UNOS's own internal emails reveal its executives joking that their deeply-flawed patient safety protection process is "like putting your kids' artwork up at home. You value it because of how it was created rather than whether it's well done," and even deriding vulnerable patients as "dumb f***[s]."
HHS's reforms will now allow for discrete, non-conflicted contracts for accountable and transparent organizations to protect patient safety.
Similarly, OPTN policy making has also given preference to industry over patients. Consider 2020 federal regulations aimed at holding organ procurement organizations (OPOs) accountable by using objective -- rather than self-reported -- data to evaluate OPO performance, and, by extension, to make OPO performance metrics legally enforceable. By introducing such transparency and accountability, HHS projected that OPO performance would improve sufficiently to save more than 7,300 lives every year. Rather than serving as an unbiased data repository, however, UNOS appears to have lobbied against reforms championed by every major patient group on record, as well as celebrated by bipartisan Congressional offices and national health equity leaders.
HHS's reforms will allow for expert data scientists and epidemiologists to inform ongoing, interactive research, and can be focused -- free of conflicts -- on promoting policies aimed at increasing the number of lifesaving organ transplants for patients every year.
Some have opposed the proposed reforms by asserting that even discussing UNOS or OPO failures will "Erod[e] public trust" in organ donation, and, by extension, depress organ donation rates.
But this is simply not supported by data, and we should not shy away from any conversations that can improve patient outcomes. In fact, peer-reviewed research finds that criticisms of the system actually correspond with higher donation rates, which researchers attribute to the Hawthorne Effect standing in for oversight in a system which has been left unaccountable for decades.
Tonya Ingram, a kidney patient who testified before Congress in May 2021, called for increased system accountability, and then tragically died the following year. The suggestion that her self-advocacy was more of a threat to the system than the system's failures were to her is obscene, and only serves to further ossify the problems patients are facing.
If we are ever to truly serve patients, every stakeholder needs to be honest in identifying and discussing problems, and urgent in solving them. HHS's reforms will enable -- and continually incentivize -- exactly that.
Greg Segal is CEO of Organize, a patient advocacy group. Jennifer Erickson, MS, is a senior fellow at the Federation of American Scientists and served in the White House Office of Science and Technology Policy under President Obama, working on organ donation policy. Donna Cryer, JD, is president and CEO of the Global Liver Institute, the leading patient advocacy organization in liver health. Bryan Sivak is a healthcare investor and served as the chief technology officer of HHS under President Obama. He is on the board of directors for Organize.