The Geography of Life and Death: Evidence and Values in the Evolution of U.S. Liver Transplant Rules

• Published date: 01 September 2021
• Author: Logan Patrick Moore,David L. Weimer
• Date: 01 September 2021
• DOI: http://doi.org/10.1002/wmh3.409

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doi: 10.1002/wmh3.409

© 2021 Policy Studies Organization

The Geography of Life and Death: Evidence and Values

in the Evolution of U.S. Liver Transplant Rules

Logan Patrick Moore and David L. Weimer

For a quarter‐century, the Organ Procurement and Transplantation Network (OPTN)has confronted

the role of geography in the allocation of deceased‐donor livers for transplantation. An historical

legacy of a geographical hierarchy giving priority to patients within the same local Donor Service Area

(DSA)as the donor gradually evolved to give some regional and national patients priority. However,

in 2020, an eight‐year process resulted in the allocation system being revised to centralize the granting

of exemptions to the quantitative severity index and eliminate the DSA and region as relevant

geographic units in favor of direct distance measures called acuity circles. In this account, we focus on

the roles of expertise, values, and interests during this development to assess the OPTN as a form of

stakeholder rulemaking. We find extensive use of medical evidence that may make such stakeholder

rulemaking worthy of consideration as a governance alternative in evidence‐rich applications.

KEY WORDS: liver transplant, organ procurement and transplantation, organ donation, rulemaking

Introduction

Patients with a variety of liver diseases can usually obtain a higher quality of

life from receiving liver transplants; patients with liver failure face imminent death

without transplants. Unfortunately, the supply of livers for transplant falls far short

of the demand. In the United States, at the beginning of 2020, approximately 12,700

patients were on the waiting list for liver transplants, but in 2019 there were only

8,896 liver transplants, and 1,161 patients died while on the waiting list (OPTN,

2020a). As the donation of a fraction of a liver from a living donor involves both

donor risk and inconvenience, both substantially greater than for the relatively

common living kidney donations, it is not surprising that in 2019 over 94 percent of

liver transplants were from deceased rather than living donors. Thus, livers from

deceased donors are a scarce and highly valuable resource. As federal law since the

1984 National Organ Transplant Act (Public Law 98‐507)has prohibited private

exchange of solid organs, the limited supply of deceased‐donor livers has been

allocated by rules developed by the Organ Procurement and Transplantation

Network (OPTN). As these rules literally have life and death implications, their

content has at times been hotly debated.

Two features of the rules for liver allocation have been the primary topics of

controversy. First, the definition of medical necessity determines what types of

patients receive the highest priority for liver transplants. Conflicts over whether

acute and chronic patients should be treated differently and how classifications

could be made more objective, and therefore less susceptible to manipulation, were

especially important in the major changes made to allocation rules in the late 1990s.

Second, and intertwined with definitions of medical necessity, the role of geog-

raphy has been a continuing source of conflict. The initial priority for allocation of

deceased‐donor livers to local transplant centers was replaced initially by a shift in

some priority from the local to the regional and, more recently and the subject of

this analysis, to distance‐based priority.

Geographic priority in organ allocation initially stemmed from the OPTN as a

formalization of voluntary sharing arrangements among transplant centers to avoid

wasting organs that could not be used locally (Weimer, 2006). Beyond this institutional

legacy, there were initially several reasons potentially justifying the local allocation of

deceased‐donor livers (Weimer, 2007). First, the livers have relatively short cold ischemic

times (the period of viability once livers are removed from donors)so that long delays

between their recovery and transplantation reduce the likelihood of successful grafts.

Local allocation reduced delays. Second, the recovery of deceased‐donor livers often

involves a substantial effort by surgeons, often including rushed travel by small planes

to intensive care units in hospitals located far from transplant centers (Mezrich, 2019).

The incentive to make this effort is greatest when the recovered transplant organs are

available for patients in the surgeon's transplant center and declines as the probability of

sharing the organs with other transplant centers increases. Third, transplant centers that

invested heavily in the recovery of livers feared that other transplant centers would

game the rules to take a disproportionate share of recovered livers. Centers could game a

system emphasizing medical necessity by fraudulently listing patients as sicker than

they are. For example, in 2003, three Chicago area transplant centers paid fines for listing

liver transplant candidates as being in intensive care when in fact they were living in the

community (Murphy, 2004).

Over the last 20 years, the definition of medical necessity and the priority given to

geography in the OPTN liver allocation rules have evolved incrementally. In December

2018, however, the OPTN adopted a major change in allocation rules that shifted priority

from historically defined regions to “acuity circles”based on the distance between where

the organ is recovered and the transplant centers where qualified transplant recipients

are registered. Although the rule is being challenged in federal court, in January 2020,

the court ruled that it would not issue an injunction against implementation, allowing

the implementation to begin in February.

In this essay, we explore the development of the new liver allocation rules.

Although the substantive importance of the rules justifies our attention, our pri-

mary motivation is understanding the effectiveness of the OPTN, a forum for

stakeholder rulemaking, in balancing values, interests, and expertise. In other

words, we seek to understand the strengths and weaknesses of the OPTN as a form

of medical governance that might be used in other applications, a timely topic in

light of fears of overt political pressure on federal agencies during the current

pandemic. Our investigation parallels the analysis of a substantial change in the

kidney allocation rules implemented in 2014 (Weimer & Wilk, 2019). Specifically,

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