FEDERAL COURT ENJOINS IMPLEMENTATION OF NEW LIVER ALLOCATION POLICY

On May 15, 2019, Judge Amy Totenberg of the Federal District Court of the Northern District of Georgia enjoined implementation of the new liver allocation policy, which would have significantly changed how livers are allocated for transplantation.

For patients with end-stage liver disease, transplantation is the only option. In order to receive a liver for transplantation, patients must first be evaluated and found to be eligible by a transplant program and listed on that program’s liver waiting list. Currently, when a liver becomes available for transplantation, it is first offered within 11 geographic regions using a formula that considers, among other things, the severity of a patient’s disease and the length of time the patient has spent on the waiting list. For several reasons, including differences in the rate of donation in the different regions, the time patients spend waiting on the list differs widely by region.

The policy at issue would significantly change the current system, eliminating the regions and allocating livers based on three circles of acuity, with the widest 500 nautical miles (575 miles) from the hospital where the donor liver became available. The effect of this policy would be to require livers to be made available in a wider geographic area. Because donation rates are higher in the south and midwest than they are in parts of the northeast, the effect of the policy would be to take livers donated in the south and midwest and transport them to the northeast for transplantation. Supporters of the new policy argue that it would make the system more equitable. Critics of the policy argue that it would increase the number of deaths of patients waiting for transplantation and would increase costs.

The new policy was scheduled to take effect April 30, 2019. Several liver patients and transplant centers located in the south and midwest filed suit, alleging that the Department of Health and Human Services did not follow the Administrative Procedures Act in adopting the new policy, including a failure to publish the policy for public comment in the Federal Register. Plaintiffs sought a temporary restraining order and an injunction preventing the new policy from taking effect.

After a full day hearing, Judge Totenberg denied the temporary restraining order, primarily because under current Supreme Court precedent, she was bound to afford great deference to an agency’s interpretation of its rules. In her ruling, however, she noted that that precedent could change when the Supreme Court rules in the case of Kisor v. Wilkie, which was argued this term. After the Defendants refused to delay the policy pending a Supreme Court ruling in Kisor, the plaintiffs moved for an injunction pending appeal.

On May 15, 2019, Judge Totenberg granted the injunction, stating: “The Court, in its previous Order, stated up front that it ‘harbors serious reservations concerning Defendants’ position with respect to the level of deference [that it should be accorded] to HHS’ interpretation of its own procedural review regulation….” She also found that the plaintiffs had “presented credible evidence that the new allocation policy will adversely impact the health of their patients, heighten the risk (and numbers) of deaths and liver wastage, increase institutional and liver transplantation costs, and leave a higher percentage of their patients without transplantation.”

The case is Callahan, et al., v. United States Department of Health and Human Services, Civil Action No. 1:19-CV-1783 pending in the Northern District of Georgia. The Court’s opinion is linked here.