New Kidney Transplant Allocation Policy Survives Eighth Circuit Legal Challenge

King & Spalding

On November 8, 2021, the Eighth Circuit affirmed a district court order that denied an attempt to preliminarily block the Organ Procurement and Transplant Network’s (OPTN) policy changing the manner in which donor kidneys are allocated to transplant patients. The challenged policy, known as the “Fixed Circle Policy,” gives priority to transplant candidates within 250 miles of the donor hospital. The Fixed Circle Policy is a departure from the longstanding method by which donated organs were first offered to transplant candidates within the donor hospital’s “defined service area” (DSA).

The OPTN is a private, non-profit entity established by Congress to perform essential functions in implementing the National Organ Transplant Act of 1984, 42 U.S.C. § 273 et seq. (Transplant Act). The Transplant Act requires Organ Procurement Organizations (OPOs)--the not-for-profit organizations within the United States responsible for recovering organs from deceased donors for transplantation--to have a DSA and “effective agreements” with a substantial majority of the healthcare entities in its service area that “have facilities for organ donation.” § 273(b)(1)(E), (b)(3)(A). An OPO’s DSA is generally based on state or metropolitan area boundaries.

According to the Eighth Circuit, the DSA-based organ allocation policy was subject to criticism. The decision cites to an example that under the DSA policy, “if an organ became available in Charleston, South Carolina, it would be offered to a moderately ill patient in Memphis, Tennessee (600 miles away) before a critically ill patient in Atlanta, Georgia (266 miles away) -- and indeed, would have to be flown directly over Atlanta en route to Memphis.”

In 2018, the OPTN identified an alternative scheme to the DSA- and region-based policy. The alternative, known as the Fixed Circle Policy, gives priority to donor candidates within 250 nautical miles of the donor’s hospital. On December 3, 2019, the OPTN Board adopted the 250-mile Fixed Circle Policy and set an implementation date for December 2020.

The hospital plaintiffs in the case sought preliminary injunctive relief against the Fixed Circle Policy. The plaintiffs alleged that the policy was arbitrary and capricious and failed to undergo notice and comment rulemaking under the Administrative Procedure Act, and violated the Transplant Act because it would result in fewer total kidney transplants, worse outcomes, and greater donated kidney wastage. The district court denied the hospital’s motion for a temporary restraining order and preliminary injunction on March 12, 2021. The hospital plaintiffs appealed to the Eighth Circuit.

In agreeing with the district court, the Eighth Circuit found the hospital plaintiffs could not make the required showing of: 1) a likelihood to succeed on the merits, 2) irreparable harm, and 3) a balance of the equities and public interest in their favor to warrant a preliminary injunction. Among its findings, the Eighth Circuit concluded that criticisms of the DSA-based policy vitiated the plaintiffs’ claim of arbitrariness and also reasoned that the timing of the hospitals’ concerns “on the eve” of the implementation of the Fixed Circle Policy undermined a showing of irreparable harm.

The Eighth Circuit’s Opinion is available here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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