Two recent federal appellate court opinions have brought my attention to an issue that is literally a matter of life and death – namely, a change in the policy for allocating donated organs among patients awaiting transplants. The cases (filed barely over a week apart) are Adventist Health System/SunBelt v. United States Department of Health and Human Services (No. 21-1589, 8th Cir., 11/8/2021), https://ecf.ca8.uscourts.gov/opndir/21/11/211589P.pdf, and Callahan v. United Network for Organ Sharing (No. 20-13932, 11th Cir., 11/17/2021), https://media.ca11.uscourts.gov/opinions/pub/files/202013932.pdf.
The Eleventh Circuit’s opinion in Callahan sets the stage (citations omitted):
Organ donation saves lives—but whose? To ensure a uniform national policy answering this question, Congress enacted the National Organ Transplant Act, which authorizes a partnership between the federal government and private professionals involved in organ donation. For the past thirty-five years, the United Network for Organ Sharing [UNOS] has overseen that partnership through a contract with the United States Department of Health and Human Services. In this unique role, UNOS works with the organ transplant community to generate policies that will equitably allocate organs among potential recipients.
About three years ago, UNOS developed and approved a new liver allocation policy that changed the geographic parameters guiding which patients received donated organs. UNOS says the policy is intended to provide more liver transplants to the patients in greatest need, even if they are farther away from donors. Its opponents say the policy will result in fewer transplants, especially in socioeconomically disadvantaged areas.
The Eighth Circuit’s opinion in Adventist Health explains what was wrong with the old policy and why UNOS, after many years of research and deliberation, found it necessary to change it:
The Transplant Act explicitly requires a qualified OPO [Organ Procurement Organization] to have a “defined service area” (DSA) and “effective agreements” with a substantial majority of the health care entities in its service area that “have facilities for organ donation.” Thus, it is hardly surprising that the policies initially adopted by the UNOS board of directors for acquiring and allocating donated kidneys were built around the relationships between OPOs and the transplant facilities in their DSAs. There are currently 58 DSAs….Each area – usually statewide or metropolitan – serves one OPO, one or more transplant programs, and one or more donor hospitals. The initial UNOS allocation policies, which persisted for three decades, provided that donated kidneys were first offered to transplant candidates in the donor hospital’s DSA who are in the same medical category and priority. [Emphasis in original.] If no transplant center in the DSA accepted the kidney, it was then offered to candidates in the same UNOS Region before being offered to candidates nationally. There are eleven geographic UNOS Regions, each consisting of DSA clusters.
…. Concerns about potential inequities inherent in a DSA-Region allocation model quickly surfaced…. UNOS data showed geographic disparities in transplant candidate wait times, with median times for kidney transplants varying widely across DSAs. Research indicated that differences in DSA composition and performance were the largest contributor to disparities in kidney allocation….
Critics…called for eliminating DSAs from organ allocation policy because they are not a “good proxy” for distance between donor and patient and lead to “geographic disparities in patient access to transplantation.” Two examples illustrate these disparities….[U]nder the DSA model, a kidney donated in Minneapolis could be offered to a candidate in Bismarck (383 miles away) before a candidate in Des Moines (234 miles)….[Another example:] Under the current, DSA-based policy, if a liver becomes 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. [Citations and footnote omitted.]
As a result of these irrationalities and geographic inequities, the UNOS changed the liver, kidney and pancreas distribution policies. The new policies give priority to transplant hospitals within a specified distance from the donor hospital, regardless of which DSA the transplant hospitals are in. UNOS describes the new liver policy at https://unos.org/policy/liver-distribution/:
Livers from adult deceased donors first are offered to a wide area for candidates in the most urgent (Status 1A and 1B) designations, because they are at great risk of imminent death without a transplant….Under the new policy, livers from all deceased donors are offered for compatible Status 1A and 1B candidates listed at transplant hospitals within a radius of 500 nautical miles of the donor hospital. After that, livers from deceased adult donors are distributed in one of two ways depending on the donor’s age and mechanism of death.
The “after that” distribution sequence is complex – it creates concentric circles of 150 and 250 nautical miles within the 500 mile maximum, and which transplant hospitals (more local or more distant) get priority is based on the urgency of the potential recipient’s need is as well as the donor’s age and cause of death. If you’re interested in the details, go to the UNOS site linked above. The new kidney and pancreas policies are similar, except the maximum distance for priority allocation to the sickest patients is 250 nautical miles instead of 500.
To return to the Eleventh Circuit’s opinion in Callahan, the court pulls no punches in its description of the consequences of the liver policy change:
No matter which side has the better of the argument, every rule change has winners and losers. And the new organ transplant policy meant a shift in who would receive donated organs – ultimately, a change in which patients would live and which patients would die. Hospitals and patients who were on the losing end of that equation did not accept it quietly. A few months after the new liver policy was approved, they sued UNOS and HHS, alleging violations of the Administrative Procedure Act and the Due Process Clause of the Fifth Amendment. The hospitals also sought preliminary injunctive relief, which the district court denied based on its review of one of the APA claims. On interlocutory appeal, this Court affirmed that denial. [This second interlocutory appeal is unrelated to the merits and addresses a side issue: Whether emails between UNOS’s top-level personnel and outside policymakers, obtained by the plaintiffs through discovery and attached to their renewed motion for a preliminary injunction, were “judicial records” and therefore open to the public.]
In the Eighth Circuit, the plaintiffs filed suit before the effective date of the new kidney policy and moved for an emergency temporary restraining order and preliminary injunction to prevent the policy from going into effect the following week. The district court denied the motion; the Eighth Circuit denied the plaintiffs’ request for a stay of the new policy pending appeal; and ultimately, in the opinion I’m discussing today, the court affirmed the district court’s denial of a preliminary injunction.
It is a sad fact there are aren’t, and never will be, enough donated organs available to meet the needs of patients – according to UNOS, more than 1200 people died waiting for a liver transplant in 2019. It’s not surprising that the hospitals disadvantaged by the new policies sued, and it’s equally unsurprising that their motions for preliminary injunctive relief were denied by two federal district courts and two federal courts of appeal. Predictions made at the turn of this century that lab-grown organs would soon be available have turned out to be premature. But progress is being made, and I have no doubt that lab-grown organs will replace donated organs before the turn of the next century. See, e.g., https://www.drugtargetreview.com/news/81080/new-tissue-engineering-process-brings-lab-grown-organs-one-step-closer/, https://www.mewburn.com/news-insights/the-future-of-organ-transplantation-growing-organs-from-scratch, https://www.fiercebiotech.com/medtech/how-far-are-we-from-lab-grown-organ-transplants-y-combinator-startup-printing-a-road-map, and https://www.drugtargetreview.com/news/81080/new-tissue-engineering-process-brings-lab-grown-organs-one-step-closer/.
