A federal judge on Wednesday blocked a new liver allocation policy in the United States after, HHS declined to further delay the policy's implementation.
How the United States allocates donated livers
On Monday, a new liver distribution policy intended to prioritize patients with the most urgent medical needs and reduce geographic disparities in the distribution of livers for transplant went into effect.
Instead of allocating donated organs within set regions, the new policy requires livers donated from individuals who are at least 70 years old or who die from cardiorespiratory-related issues to first go to patients who live within 500 nautical miles of the donor hospital and have the most urgent medical need. After going to those patients, such livers then go to patients with a MELD or PELD score of 15 or higher who are located within 150 miles of the donor hospital.
In addition, livers donated from individuals who are younger than 18 first go to liver candidates younger than age 18 who are located within a 500 nautical-mile radius of the donor hospital.
The Organ Procurement and Transplantation Network (OPTN), which oversees organ distribution, and the United Network for Organ Sharing (UNOS) said the new policy would address instances in which a patient in one region could be on the verge of death before he or she qualified for a liver, while comparatively healthier patients received livers in other regions.
According to OPTN/UNOS, "Simulation modeling … suggests [the new policy] will reduce pre-transplant deaths and increase access for liver transplant candidates younger than age 18." UNOS estimated fewer than 50 liver candidates across the United States would qualify as priority patients "at any given moment" under the new policy.
However, fourteen transplant centers—including Emory University Hospital, Piedmont Hospital, the University of Michigan, and the University of Kansas Hospital Authority—and four transplant patients in April filed a lawsuit arguing that the changes would put patients' lives at risk and would result in "hundreds of liver transplant candidates needlessly dying."
The centers and patients alleged that HHS' decision to allow UNOS to determine the nation's liver allocation policy is unlawful, adding that the new policy is "the product of an opaque, reckless process that failed to allow for full public comment and transparent discussion."
The lawsuit argues that, "[b]ased on the government's own data," transplant centers under the new policy will perform 256 fewer transplants per year and at least 20% fewer liver transplants in "the most socioeconomically disadvantaged regions in the country."
According to the transplant centers, performing fewer transplants each year would leave more than 200 candidates "at risk of imminent death absent the transplant they would have otherwise received."
The plaintiffs requested that HHS and UNOS strike down the new policy and "develop a policy that complies with the law," and they asked for a preliminary injunction to temporarily block the new policy from taking effect.
HHS in response delayed the policy's implementation to May 14, so the court would have time to consider the matter.
Judge rejects request for preliminary injunction
U.S. District Judge Amy Totenberg initially rejected the plaintiffs' request for a preliminary injunction to block the new policy from taking effect. Instead, she asked HHS to voluntarily delay the policy until the Supreme Court ruled on a similar case in coming weeks.
However, HHS allowed the policy to take effect and, on Wednesday, Totenberg decided to step in and issue a nationwide injunction. Totenberg argued that patients on the liver transplant list and the group of hospitals challenging the policy would be harmed if the new rules were implemented.
"Given the gravity of the medical issues and risk of disruption in the transplant system and the concrete likelihood of harm to the plaintiffs and the public at large if the status quo is not maintained, the court finds that the public interest is best served" by using the old policy, Totenberg wrote.
Totenberg criticized HHS for moving forward with the new policy when the Supreme Court is about to rule on a case that could have a direct bearing on the transplant case. The case before the Court challenges a 22-year-old precedent that says judges generally should defer to how a federal agency interprets regulations governing that agency.
According to the Post, the Department of Justice, which is representing the government in the case, declined to comment (Bernstein, Washington Post, 5/15; Luthi, Modern Healthcare, 5/14; Neergaard, AP/Daily Hampshire Gazette, 5/15; Marso, Kansas City Star, 5/14).
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