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Liver Donation Policy Change Followed Right Protocol (Corrected)

Sept. 25, 2019, 10:21 PMUpdated: Sept. 26, 2019, 5:26 PM

A federal appeals court ruled that a new policy on liver donations developed by the United Network for Organ Sharing was not required to go through an administrative review process.

The U.S. Court of Appeals for the Eleventh Circuit held Sept. 25 that the health and human services secretary was not required to refer the new policy to the Advisory Committee on Organ Transplantation or post it in the Federal Register for public comment before implementing it.

But the appeals court remanded the case so the trial judge can determine whether the secretary’s actions in adopting the new policy were arbitrary and capricious or deprived those challenging it of due process. The court said the district court never addressed those two claims.

The new policy remains on hold. Judge Amy Totenberg, of the U.S. District Court for the Northern District of Georgia, ordered the administration on May 15 to cease and desist implementation of the policy pending the Eleventh Circuit’s decision. But the appeals court affirmed her ruling in part and sent part of the case back to Totenberg for additional fact-finding.

Four patients and more than a dozen hospitals are challenging the new policy, which would expand that geographic region for eligible recipients. Liver donations would be offered to patients with the highest medical urgency registered at a transplant hospital within a 500-mile radius. Under the current policy, donated livers are offered first to people with the highest medical urgency registered at a transplant hospital within the donor’s region.

The Eleventh Circuit said the district court never addressed the challengers’ claims that the secretary’s actions in adopting the new policy were arbitrary and capricious and deprived plaintiffs of due process.

“We are wary of diving head-first into claims that the district court hasn’t yet considered, and we are especially wary of doing so with respect to these claims—both of which will likely turn on fact- and context-intensive questions that the district court is better equipped to decide in the first instance,” the appeals court said.

About 60% of Americans are registered as organ donors and about 13,000 people are now waiting for liver transplants, according to the hospitals and patients challenging the policy change.

The case is Callahan v. HHS, 11th Cir., No. 19-11876, 9/25/19

(Corrects a Sept. 25 story to reflect that the appeals court affirmed a lower court's ruling that the administration didn't have to go through administrative review. A previous version said the appeals court remanded that issue to the district court.)

To contact the reporter on this story: Lydia Wheeler in Washington at lwheeler@bloomberglaw.com

To contact the editor responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com

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