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Liver Distribution Suit Claims Trimmed, Implementation Date Set

Jan. 21, 2020, 8:44 PM

HHS won’t have to defend its new donated liver allocation policy against claims that the agency unlawfully failed to notify the public of the policy change and take comments before implementing it, a federal court in Georgia said Tuesday.

The U.S. District Court for the Northern District of Georgia partially dismissed a lawsuit in which transplant patients and centers where transplants are performed challenged a new Health and Human Services Department policy for determining how and where donated organs are assigned to liver transplant patients.

Specifically, the plaintiffs can’t proceed on claims that Secretary Alex M. Azar was required to refer the new policy to the Advisory Committee on Organ Transplantation and post it in the Federal Register for public comment before adopting it, the court said.

The lawsuit will move forward on questions of whether HHS acted arbitrarily and capriciously, or deprived those challenging it of due process during the new policy’s adoption, the court said. The plaintiffs properly pleaded their reasons for making those claims, it said.

The decision followed Judge Amy Totenberg’s Jan. 15 denial of the plaintiffs’ motion to block the policy’s implementation on those grounds, which she explained in a 100-page opinion Jan. 16.

The plaintiffs didn’t show at this pretrial stage that they were likely to win because it wasn’t “entirely irrational” for HHS to conclude that a new liver allocation policy was needed, given criticisms leveled at the old policy, the court said. But Totenberg nevertheless denied HHS’s motion to dismiss the claims.

Implementation Date Set

The policy will be implemented Feb. 4, according to the United Network for Organ Sharing, the private nonprofit organization that manages the U.S. organ transplantation system under contract with HHS. UNOS is a co-defendant in the lawsuit.

UNOS praised the denial of the plaintiffs’ motion to delay the policy, saying the court’s decision “will allow a national liver transplant policy to begin saving more lives and increasing fairness in the donor matching process.”

Under the new policy, donated livers will be offered first to patients with the highest medical urgency registered at a transplant hospital within a 500-mile radius. Under the old policy, donated livers were offered first to people with the highest medical urgency registered at a transplant hospital within the donor’s region.

“The decision reaffirms our confidence that the liver policy, designed to ensure appropriate transplant access for the sickest patients, was developed appropriately,” it said.

Jones Day attorneys who represent the patients and transplant centers challenging the law weren’t available to respond to Bloomberg Law’s request for comment.

Policy Helps and Hurts

The American Society of Transplantation told Bloomberg Law Tuesday that it doesn’t have a formal position on whether HHS acted properly, but it said the new policy has both advantages and disadvantages. AST is an organization of over 4,000 transplant professionals dedicated to advancing the field of transplantation and improving patient care,

The new policy will help the sickest patients, because it allocates donated livers based on the estimated severity of patients’ liver dysfunction, rather than geographic borders, Dr. David Foley, a member of AST’s board of directors and a past chair of its Liver and Intestine Community of Practice, told Bloomberg Law.

But the new policy may hurt patients with less severe medical conditions, for whom wait times will be longer, Foley said. There also “is a significant concern that access to transplant will decrease for patients in rural areas, one of the main arguments against the policy,” because organs likely will be sent to larger inner-city medical centers that have a higher proportion of sicker patients than smaller, more rural area transplant centers, he said.

Jones Day represents the plaintiffs. The U.S. Department of Justice represents HHS. Gordon Rees Scully Mansukhani LLP and Winston & Strawn LLP represent UNOS.

The case is Callahan v. U.S. Dep’t of Health & Human Servs., N.D. Ga., No. 19-cv-1783, 1/21/20.

To contact the reporter on this story: Mary Anne Pazanowski in Washington at mpazanowski@bloomberglaw.com

To contact the editors responsible for this story: Rob Tricchinelli at rtricchinelli@bloomberglaw.com; Nicholas Datlowe at ndatlowe@bloomberglaw.com

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