On May 15, 2019, United States District Judge Amy Totenberg ordered HHS to “immediately cease and desist” from further implementing its April 2019 liver allocation policy pending appellate review in Callahan, et al. v. Azar, No. 1:19-cv-1783 (N.D. Ga.). The plaintiffs, which include several transplant centers, universities, and individual transplant patients, are seeking appellate review of the district court’s denial of their request for a temporary restraining order regarding the liver allocation policy. Meanwhile, plaintiffs sought an injunction pending the Eleventh Circuit’s review. The district court granted plaintiffs’ injunction request to “maintain the pre-May 14, 2019 status quo and minimize[] major disruption in the liver transplant medical field pending further order of the [Eleventh Circuit.]”
Under HHS’s oversight, the board of directors of the Organ Procurement and Transplant Network (OPTN) and the United Network for Organ Sharing (UNOS) (the OPTN/UNOS Board) adopted a revised version of their national liver distribution policy on December 3, 2018 (Revised Policy). The OPTN/UNOS Board is the governing body that oversees and develops policies for operating the OPTN to equitably allocate organs to patients on the national transplant waiting list.
Under the former policy, liver transplants were distributed based on geographic boundaries drawn around 58 donor service areas (DSAs) and 11 transplant regions. The Revised Policy, described in detail here, prioritizes liver offers for most deceased adult donors to candidates with the highest medical urgency listed at transplant hospitals within 500 nautical miles of the donor hospital, eliminating DSAs. The Revised Policy also provides special rules for livers from certain donor categories, including deceased donors under the age of 18 to give priority to pediatric transplant candidates listed at any transplant hospital within 500 nautical miles of the donor hospital. King & Spalding previously wrote about bipartisan congressional outreach to resolve concerns with the Revised Policy. The Callahan case is focused on the procedural correctness of the adoption of the Revised Policy, among other things, in light of the Administrative Procedure Act, 5 U.S.C. § 706.
Judge Totenberg’s May 15, 2019 order enjoined OPTN/UNOS’s enforcement of the Revised Policy just after it had become effective on May 14, 2019. Although OPTN/UNOS previously agreed to continue the effective date of the Revised Policy by two weeks from its initial rollout date of April 30 at the Court’s request, the district court noted that further “hitting the pause button” on the Revised Policy served the public interest and avoided putting transplant patients and the liver transplant system at large “unnecessarily at great risk.” The district court made it clear that further guidance was needed from the Eleventh Circuit, particularly due to the Supreme Court’s “imminent decision” in Kisor v. Wilkie, No. 18-15 (oral argument held March 27, 2019), regarding deference to an agency’s interpretation of its own rules, also at issue in Callahan.
King & Spalding will continue to monitor the Callahan litigation and its resulting effects on OPTN/UNOS’s revised liver allocation policy.
