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November 18, 2021

National Organ Transplant Act: Eighth Circuit Affirms Denial Of Preliminary Injunction Upholding OPTN’s Kidney Fixed Circle Policy

The Eighth Circuit, in Adventist Health System/SunBelt, Inc. v. United States Department of Health and Human Services, has affirmed a district court’s denial of a preliminary injunction sought by hospital systems and a patient on the kidney waitlist against the Organ Procurement and Transplantation Network (OPTN). In December 2019, OPTN adopted a new kidney “Fixed Circle Policy” that grants kidney allocation priority to candidates within 250 nautical miles of the donor’s hospital. Just before the policy was supposed to go into effect in December2020, the plaintiffs sued to enjoin the policy as unlawful under the National Organ Transplant Act and the Administrative Procedure Act (APA). The district court held, and the Eighth Circuit affirmed, that the one-year delay rebutted the plaintiffs’ claims of irreparable harm. The court also determined that the hospitals were unlikely to succeed on the merits, including on their claim that the policy was arbitrary and capricious under the APA because OPTN failed to publish the policy in the Federal Register for public comments, as is required for OPTN’s “significant proposed policies.” The policy finally took effect on March 15.