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Monday, February 26, 2024 | Back issues
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Eighth Circuit upholds new federal organ transplant procedure

A group of hospitals sought an injunction against the changes, claiming they were arbitrary and capricious and would cause a decline in the number of transplants.

ST. LOUIS (CN) — A federal appeals court on Monday denied a motion made by a group of hospitals seeking an injunction to block a change made to federal organ transplant distribution policies.

The U.S. Department of Health and Human Services changed the organ distribution policy in December 2019 from allocating organs within 57 regions that generally follow state lines to a “fixed circle policy” that gives priority to candidates at transplant centers within a 250-nautical-mile circle around an organ donor’s hospital.

A three-judge panel of the Eight Circuit upheld a lower court’s decision to dismiss the injunction request, finding that “the district court concluded, and we agree, that the Hospitals have shown injury in fact, but not irreparable injury warranting the preliminary injunctive relief they seek.”

Adventist Health System/Sunbelt Inc. of Orlando, Florida, and five state university hospitals in the South and Midwest that operate kidney transplant programs sued HHS over the shift in policy last year.

The hospitals claim the change from distributing organs within designated regions to a national system will not only create winners and losers among the states within the current regions — diverting donated kidneys from less populated areas to large urban centers — but will cause a decline in the overall number of transplants.

The government countered by arguing that the previous policy advocated by the hospitals was heavily reliant on arbitrary geographic boundaries that created stark differences in access to transplants across the country. The new policy, the HHS claims, is expected to sharply reduce those disparities.

Most of the arguments during the June hearing before the Eighth Circuit centered around the complex procedural administrative rules questions surrounding the case.

The hospitals argued that an injunction was warranted because HHS did not follow mandatory regulatory procedures in making the changes, namely not allowing for public comment.

“The Hospitals suggest that our interpretation nullifies ACOT’s [Advisory Committee on Organ Transplantation] role, but the Final Rule provides that the Secretary ‘may’ seek ACOT’s comment on any nonsignificant policy,” Organ Procurement and Transplantation Network proposes, wrote U.S. Circuit Judge James Loken, a George W. Bush appointee, in the 23-page opinion.

“In addition, the district court noted, since 2010 ACOT has recommended that the Secretary ‘take steps to ensure the OPTN develops evidence-based allocation policies which are not determined by arbitrary administrative boundaries,’” the opinion continues.

The hospitals also argued that the HHS acted arbitrarily and capriciously in adopting the “fixed circle policy.”

Again, the Eighth Circuit was not swayed, noting that the former process had been attacked for decades by ACOT and OPTN as contrary to the commands of Congress.

“Viewed in this light, it is apparent that [the Health Resources and Services Administration] did not arbitrarily and capriciously ‘beg[i]n with its conclusion.’ The merits of the conclusion were well understood and supported by a majority of the transplant community,” Loken wrote. “The Secretary exercised oversight authority over OPTN that Congress explicitly granted in enacting the Transplant Act’s public-private effort.”

U.S. Circuit Judges Ralph Erickson, a Donald Trump appointee, and Jane L. Kelly, a Barack Obama appointee, joined Loken in the decision.

Attorneys for both sides did not immediately respond to a request for made late Monday afternoon.

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Categories / Appeals, Health, Science

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