Executives tasked with ensuring vital transplant organs reached the country’s sickest people engaged in a secretive scheme to force a federal policy change, curtailing life-saving liver transplants in several poorer states.
The scheme, revealed in newly unsealed court documents, is the latest evidence that the 2020 policy change was the result of a longstanding pressure campaign to bend the transplant system to the executives’ will. The court records were made public as part of a lawsuit seeking to overturn the policy, the effects of which were the subject of an investigation last year by The Markup and The Washington Post.
Poorer States Suffer Under New Organ Donation Rules, As Livers Go to Waste
Life-saving liver transplants have plummeted in some Southern and Midwestern states with higher death rates from liver disease, while New York and California have made big gains
As the U.S. Department of Health and Human Services restructures the Organ Procurement and Transplantation Network contract that has given nonprofit United Network for Organ Sharing, or UNOS, control of the country’s transplant system for four decades, the documents raise fresh questions about HHS’s ability to effectively oversee its transplant contractors.
“UNOS’s scheme to circumvent the law betrayed vulnerable patients, and, shockingly, HHS was complicit in the plan,” Sen. Chuck Grassley, R-Iowa, said. He is currently on the Senate Finance Committee, which has been investigating issues in the transplant system. “Make no mistake: any future attempts to bypass laws governing the organ donation system, including the recent bipartisan reforms I spearheaded, will not be tolerated.”
Reached multiple times by email and phone, HHS, through its branch overseeing transplants, did not provide comment as of publication.
The “acuity circles” policy at issue vastly expanded how far donated livers are initially shared beginning in early 2020. Proponents of the change said this was to give priority to the sickest patients regardless of where they lived. But The Markup and Post found that it did so at the expense of patients waiting in several poorer, more rural states in the South and Midwest and to the benefit of those in states such as New York and California. It was hurried through the normally months- or years-long policymaking process after several liver patients sued for broader sharing—a lawsuit The Markup revealed was backed by key beneficiaries of the change.
When the policy change was under discussion, leaders at UNOS, which both oversees the transplant system and creates transplant policies, said moving fast was necessary—they had a direct order from HHS because of the lawsuit. But the newly released records show the change was orchestrated long before the lawsuit was filed. At the helm of that effort was Bryan Shepard, UNOS’s former CEO, and Alexandra Glazier, current head of New England Donor Services, a Massachusetts-based nonprofit charged with procuring donated organs in the area.
Eight months before the liver patients’ lawsuit, a dying woman was in need of another kind of transplant—lungs. She asked HHS to require donated lungs to be shared more widely, and she was prepared to sue.
Transplant policy changes of that magnitude can be contentious. The process typically takes months to years of careful consideration by experts with ample time for public comment. And it’s a zero-sum game: organs are in short supply, and changes to these policies can shift who gets them, meaning many patients die on the waiting list.
Glazier saw this as “a path forward” for more than just lungs, according to emails released as part of the suit. At the time in 2017, the transplant community was five years into a heated debate over potential changes to the liver policy. She and others were outspoken proponents of broader sharing for livers, the second-most transplanted organ. Lungs, however, were less contentious—they made up about seven percent of all transplants during that time, according to federal data.
Glazier, a UNOS board member at the time, emailed a lawyer for HHS in November 2017 to explain this dynamic and press for a directive from the agency, which would allow the executive committee to bypass the standard policymaking process to share lungs more broadly for the explicit purpose of paving the way for a similar change in livers. The email came after Glazier “discussed” the matters with the lawyer earlier that day, according to another of her emails.
“This is a unique opportunity for the secretary [of HHS] to weigh in on a non-controversial topic in a way that sends an important and powerful signal about a more controversial topic without directly touching it,” Glazier said (emphasis original).
Glazier then provided sample language of what such an order might say, emphasizing that “anything less [than a] directive from the secretary” of HHS “will miss the mark on facilitating this other important policy change,” referring to the liver policy.
In an emailed response to The Markup, Glazier said it was the “fiduciary responsibility and expected of” board members to give opinions on policy, saying plaintiffs in the lawsuit “cherry-picked documents to make it look like only a small number were part of the policy discussions.”
The lung patient filed a lawsuit to require broader sharing, but the judge ultimately declined to order such a change. During court proceedings, however, a lawyer for HHS proactively volunteered the agency to order UNOS to review the lung policy. The judge codified this in an order to the agency.
Shortly after, HHS did exactly what Glazier lobbied for—ordering an emergency review of the policy. This, Glazier said, would give the committee enough cover to pass what Shepard referred to as a “laugh test” should someone question the quick process. The lung policy was changed shortly after. Shepard did not respond to requests for comment.
During the lawsuit, the emails show Glazier mentioning to Shepard the possibility that a judge requiring broader sharing for lungs could pave the way for “a liver candidate in NY (or MA or CA)” to file a lawsuit. Transplant executives in those three states, The Markup previously found, used the lung case as a blueprint the following year, backing a lawsuit filed by the same lawyer who represented the lung patient.
The liver suit resulted in the same series of events—HHS required an emergency examination of the policy, which led to a fast-paced overhaul of the system. Bolstering their argument for broader sharing were the findings of UNOS’s Ad-Hoc Geography Committee, a working group of transplant professionals that recommended all organs be shared more broadly. Shepard and Glazier conceived the idea for the group, The Markup previously reported, and Glazier served on it and helped edit its recommendations.
UNOS has previously denied that Shepard and Glazier did anything untoward. In a closed-door meeting in early 2022, its board said neither Glazier nor others “had improper motives or influence in the collective process,” according to an email from the president of UNOS at the time, commending Shepard. It declined to comment for this article, citing ongoing litigation.
UNOS and HHS have come under fire recently for a wide range of issues with the transplant system. HHS is currently in the process of breaking up the transplant contract, which could result in UNOS losing its longtime monopoly. The agency said it will issue bid solicitations this month.
“The first step to HHS holding its transplant contractors accountable is putting patients’ interests over industry’s interests,” Greg Segal, founder and CEO of advocacy organization Organize. “The unfortunate reality is that too many government officials have viewed the organ donation industry as their next employer, rather than regulated entities to oversee. Patients need HHS to mandate transparency about the money trail, and to change the revolving door culture of civil servants going to get paid by industry.”
The acuity circles policy is still in place. Shepard left UNOS in late 2022, while Glazier is still head of the New England Donor Services and an adjunct professor at Brown University’s School of Public Health.