A federal judge last week lifted an injunction that had blocked HHS' new liver allocation policy, allowing the policy—which requires livers to first be allocated to the sickest patients within a 500-mile radius of the donor hospital's location—to take effect.
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Background: Judge blocks HHS' new liver allocation policy
HHS last year finalized 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. 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. If there's no match or recipient, the livers can 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, under the new policy, livers donated from individuals who are younger than 18 first must be made available to 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) 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.
The new policy took effect in May 2019, but fourteen transplant centers—including Emory University Hospital, Piedmont Hospital, the University of Michigan, and the University of Kansas Hospital Authority—and four transplant patients 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 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."
Further, the centers and patients alleged that HHS' decision to allow UNOS to determine the nation's liver allocation policy was 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 plaintiffs requested that the court order HHS and UNOS to 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.
U.S. District Judge Amy Totenberg issued an injunction, which blocked the policy nationwide. Totenberg at the time ruled that patients on the liver transplant list and hospitals challenging the policy would be harmed if the new requirements remained in effect.
Totenberg lifts injunction
However, Totenberg last week lifted her preliminary injunction, allowing the policy to once again take effect.
Totenberg in her latest ruling said the federal government and UNOS had followed the law when adopting and implementing the new policy and provided plaintiffs due process by giving them opportunities to express their views on the new requirements.
Still, Totenberg said her decision was "difficult and wrenching," acknowledging that the new policy could have negative effects for some patients. She said organizations should monitor how the changes effect the liver transplant system.
A spokesperson for UNOS said the agency plans to implement the new liver distribution system in a few weeks, after all participating parties are notified. UNOS in a statement said Totenberg's latest decision "will allow a national liver transplant policy to begin saving more lives and increasing fairness in the donor matching process."
However, the hospitals and patients involved in the lawsuit could appeal Totenberg's ruling and request that the policy once again be put on hold. Plaintiffs in the case as of last week said they still were reviewing the ruling, the Atlanta Journal-Constitution reports (Hart, Atlanta Journal-Constitution, 1/16; Bernstein, Washington Post, 1/17).