Constitutional Challenges to Liver Transplant Policy

Abstract

Background:

Liver transplant candidacy determination can be contentious. When transplantation is declined for reasons perceived as violating fundamental rights or discriminating against a protected class – e.g. age, race, religion, nationality – the case may involve a constitutional claim. Judicial review of such cases may result in decisions with sweeping implications for transplant policy.

Methods:

We reviewed all published court opinions involving liver transplantation in two legal databases (Lexis Nexus and WestLaw). We included all cases that involved a denial of liver transplant candidacy in violation of constitutional rights

Results:

The search returned 1,562 cases; 290 involved the denial of insurance coverage for a transplant due to a patient’s failure to abstain from drinking, 273 cases involved incarcerated inmates who were denied a liver transplant; 2 involved a constitutional claim for patient requesting a bloodless transplant for religious reasons; and 2 cases arose from age discrimination in transplant criteria. These cases highlight legal pitfalls related to the First Amendment (religious freedom), Eighth Amendment (cruel and unusual punishment), and the Fourteenth Amendment (equal protection and due process).

Conclusions:

The risk of a constitutional claim highlights concrete steps needed to ensure the equity of transplant policy. These include efforts to standardize transplant candidacy criteria across payers for candidates with alcohol-related liver disease and advanced age. Efforts to constrain emerging liabilities related to the citizenship of transplant candidates and the definition of donor service areas are also discussed.

Introduction

Liver transplantation is the only cure for end-stage liver disease. Although the annual national liver transplant volume is now greater than 8,000, doubling in the past 20 years, 11,000 patients are added to the waitlist each year, up to 4 in 10 of whom die waiting.¹ Each transplant costs in excess of $800,000,² supported primarily by public payers. Transplantation is further complicated by its dependence on a scarce resource, one typically donated by altruistic families following a tragedy. Outcomes are closely scrutinized given these stakes.

Transplant outcomes can be optimized by careful patient selection, which means deciding to NOT transplant some patients. Patients can present from troubled environments in a state of multi-organ failure for which no operation other than transplantation itself would be deemed safe. Medical and social factors are equally weighted as patients are evaluated for their ability to survive transplant and thrive thereafter as good stewards of the donated allograft.

Transplant candidacy rules, though center and payer specific, are expected to be transparent, medically appropriate, and just. The decision by a payer or transplant committee to forego wait-listing for liver transplantation may lead to the patient’s death. Disagreements may therefore lead to legal action. The complexity of the resulting litigation can be heightened by features specific to the causes of cirrhosis and the social circumstances of afflicted patients. When transplantation is declined for reasons perceived as violating fundamental rights or discriminating against a protected class – e.g. age, race, religion, nationality – the case may involve a constitutional claim. Understanding potential constitutional challenges to transplant policy will allow for preparedness to promote justice in transplantation and avoid legal pitfalls.

Methods

We searched two databases (Lexis Nexis and West Law). We sought to shed light on situations involving liver transplants most likely to lead to constitutional violations against transplant candidates. Though the facts of each case may vary (e.g. age of patient) the legal and medical issues are often the same. Our goal was to identify core issues rather than specific cases. In our search, we included constitutional issues raised by the conduct of medical professionals, hospitals, and agencies, as well as Medicaid and private insurance providers. We searched for all cases that included mention of liver transplantation (“liver” and “transplant” within 50 words) without time limits. This study is exempt from ethics review.

Results

Characteristics of All Retrieved Cases

The search returned 1,562 cases. The largest category of litigated cases (n = 290) involved the denial of insurance coverage for a transplant due to a patient’s failure to abstain from drinking. with 214 arising in Federal Circuit court and 76 in state court. The largest group—39—of the Federal Circuit cases were litigated in the Sixth Circuit, which covers Kentucky, Michigan, Ohio, and Tennessee. The largest number of state court cases came from both Louisiana and Ohio, which both had 6 cases.

The second largest category involved incarcerated inmates who were denied a liver transplant. 273 cases fell into this group. 249 arose in Federal Circuit court and 24 in state courts. Of the Federal Circuit cases involving inmates, the largest amount—59—were litigated in the Ninth Circuit, which covers Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington. Of the 24 state court cases involving inmates, the largest number arose out of California and Pennsylvania, which both litigated 6 of these cases.

Only 2 cases involved a constitutional claim for patient requesting a bloodless transplant for religious reasons. There were also only 2 cases litigated about violations arising from age discrimination in transplant criteria practices. The remaining cases were unrelated to liver transplantation or meaningful constitutional claims. The latter category is explained as follows: 131 cases involved an insurance provider’s denial to cover the liver transplant due to a debate over whether the surgery was “medically necessary,” where a patient did not meet minimum medical criteria (e.g. low model for endstage liver disease score). When these cases involved Medicaid, given that it is a governmental payer, claims citing the Fourteenth Amendment were often forwarded.

Constitutional Claims in Liver Transplant

Table 1 provides representative cases grouped according to constitutional amendment: 2 cases involved the First Amendment (religious freedom), 273 cases involved the Eighth Amendment (cruel and unusual punishment), and 292 cases involved the Fourteenth Amendment (equal protection and due process).

Table 1:

Categories of Constitutional Challenges to Liver Transplant Policy

Population Affected	Constitutional Claim	Exemplary case(s)	Core Issue(s)	Outcome(s) in favor of:
Religious groups	First Amendment Free Exercise Claim	Stinemetz v. Kan. Health Policy Auth., 45 Kan. App. 2d 818	Refusal to transplant patients with religious exemption to blood transfusion. An out-of-state hospital would perform a bloodless transplant but defendant would not approve services	Plaintiff
Incarcerated individuals	Eighth Amendment Cruel and unusual punishment	New v. Shelton, 2015 (Oregon). Rosado v. Alameida, 2007 (S. California). Horton v. Ward, 123 Fed. Appx. 368 Campbell v. Martinez, 2003 (N. Texas)	Refusal to add a prisoner to the liver transplant waitlist. Judgements of transplant candidacy based on medical criteria (e.g. low Model for Endstage Liver Disease score) are qualifiedly immune	Defendant
Alcohol related liver disease	Fourteenth Amendment Lack of due process; arbitrary and capricious standards	Neal v. Christopher & Banks Comprehensive Maj. Med. Plan, 2009 (Wisconsin); Allen v. Mansour, 681 F. Supp. 1232, 1986 (Michigan).	Denial of insurance coverage for liver transplants: Neal was denied coverage inability to show abstinence from alcohol for 6 months. Allen involved a state Medicaid regulation that required a 2-year abstinence period.	Outcomes are conflicting: Defendant won in Neal; Plaintiff won in Allen
Advanced age	Fourteenth Amendment general age discrimination claim, or discrimination based on age, sex, and poverty grounded in Civil Rights Act, Title VII.	Haaland v. Presbyterian Health Plan, 2018 (New Mexico); Wheat v. Massachusetts, 994 F.2d 273, 5th Circ. (1993)	Haaland involved the refusal to authorize transplant for a patient aged 70 years. Wheat involved a patient who died on the transplant list whose insurance did not cover transplants, Plaintiff’s family alleged hospital discriminated against her	Haaland was remanded for new trial. Wheat was dismissed

Table 1 details the results of our search of 2 databases (Lexis Nexis and West Law) for all cases that included mention of liver transplantation (“liver” and “transplant” within 50 words) without time limits. We reviewed each case for the presence of constitutional claims. The search returned 1,562 cases; 290 involved the denial of insurance coverage for a transplant due to a patient’s failure to abstain from drinking; 273 involved incarcerated inmates who were denied a liver transplant; 2 involved a constitutional claim for patient requesting a bloodless transplant for religious reasons; 2 arose from age discrimination in transplant criteria. The remaining cases were unrelated to liver transplantation or meaningful constitutional claims. The latter category involved a Medicaid denial of transplant coverage where a patient did not meet minimum medical criteria. Claims citing the Fourteenth Amendment are forwarded when the payer is a governmental agency.

Discussion

When Congress passed the National Organ and Transplant Act in 1984, it called for the development of a singular transplant network under federal contract. The result was a government agency (the Organ Procurement and Transplantation Network) empowering a private, non-governmental actor (United Network for Organ Sharing, UNOS) to make decisions that affect the distribution of a precious resource. These decisions are subject to judicial review.³ If, in a legal decision, an action by an agent of a governmental agency is found in violation of constitutional rights, the result is a precedent with potentially sweeping implications for health policy and healthcare delivery. In this review of published legal cases relating to liver transplant candidacy, we inform institutional and national practices by identifying multiple areas at risk for constitutional claims.

The Fourteenth Amendment Guarantees Due Process

To avoid constitutional torts invoking the Fourteenth Amendment, patients must be protected against arbitrary and capricious candidacy criteria. There are 4 key areas to address. First, wide variability in the required duration and steps to demonstrate proof of sobriety is a liability.⁴ Most lawsuits uphold the center’s ability to decline candidacy for conditions felt to adversely impact transplant outcomes. Recent data, however, demonstrate that post-transplant outcomes are equivalent for patients with alcohol-related liver disease either with or without pre-transplant sobriety.^5,6 Yet, payer requirements for candidacy determination in alcohol-related liver disease are highly variable.⁴ If unsupported by outcomes data, variation in payer criteria may be characterized as arbitrary and capricious, presenting a legal pitfall. Insurers could limit liability by seeking uniformity or abandoning arbitrary sobriety periods, granting the individual centers the flexibility to carefully select appropriate candidates. Within this framework, centers and other stakeholders could work toward a consensus regarding patient selection for alcohol-related liver disease that addresses the psychosocial, therapeutic, and ethical strategies needed to optimize patient outcomes and promote equity for all recipieints.

Second, similar pitfalls exist with respect to age, a protected category that may lead to a constitutional tort citing the Fourteenth Amendment (i.e. Haaland and Wheat). Centers must identify which older patients will do poorly after transplantation. Carefully selected patients aged >60 years can be transplanted without worse post-transplant survival.⁷ To this end, and in contrast to age itself, a useful and less legally contentious criterion is frailty. Reflecting increased vulnerability to stressors and diminished physiological reserve,⁸ frailty predicts poor transplant outcomes independently of chronological age.⁸ Frailty assessments range from the subjective ‘eye-ball’ test or Karnofsky index to objective indices (e.g. hand-grip strength, walk-speed).⁸. Subjective assessments are highly variable between centers.⁹ They are also susceptible to gaming (to improve risk-adjusted outcomes).⁹ For the majority of candidates evaluated, objective measures of frailty may prove more generalizable across centers and limit the risk of moral hazard. National adoption of frailty standards are advisable and recommended by a solid-organ transplantation workgroup sponsored by the American Society of Transplantation.¹⁰

Third, although undocumented immigrants typically lack standing in court (hence their absence in cases from our search), they present an important dilemma for transplant centers. As in a recent high-profile instance in Oregon,¹¹ denying a transplant for such patients may generate an intense backlash on moral grounds. Furthermore, the definition of protected classes is also subject to expansion over-time. There is more than a century of legal precedent where the constitution was said to apply to and protect the rights of non-US citizens, from U.S. v. Wong Kim Ark (1898) to the recent cases involving travel and Trump administration. Developing deliberate regulations for access to transplantation by non-citizens will avoid future characterization as arbitrary/capricious.

Finally, at a time when donor liver allocation policy is undergoing transformation, it is notable that Fourteenth Amendment challenges to allocation policy have been successful in lung transplantation.¹² Attorneys in the Holman case were able to persuade judicial intervention in lung allocation policy by highlighting due process violations related to arbitrary geographic disparities in wait-times and organ availability for persons of equivalent disease severity. The December 3^rd revision of UNOS liver allocation policy, particularly those amendments involving re-districting of MELD-based organ allocation, may be vulnerable to similar litigation if outcomes disparities emerge for protected classes.

Accommodating Religious Freedom

First Amendment claims such as religious exemptions from blood transfusions may render transplantation more complex but not impossible. For this reason, hospitals ill-equipped to accommodate exemptions from blood transfusion must work with payers to identify and arrange transfer to a suitable alternative center if possible. The Stinemetz case provides a clear precedent which is likely to increase the success of plaintiffs in future cases

Prisoners’ Rights

Eighth Amendment claims by prisoners are among the most common claims in liver transplant medicine. Despite their frequency, they typically fail in court when medical decision making is well-documented with reference to objective clinical standards. It is, however, important to note that prisoners are a marginalized group and incarceration does not in-and-of-itself preclude transplant candidacy. Indeed, prison can be a stable housing environment, one with readily accessible medical care, allowing for adequate stewardship of the liver allograft in the critical year after transplant when immune rejection is most likely.

Limitations

These data must be interpreted in the context of the study design. First, only published legal cases can be searched. The choice to publish a case typically occurs for cases decided on appeal which is why most cases discussed are from superior courts. However, though the facts of each case may vary (e.g. age of patient) the legal and medical issues are often the same. Second, the political or policy impact of a given court’s decision is variable and related to many contextual factors beyond the scope of this study. Third, we did not discuss many cases related to donor selection given the scope of our study. Notably, however, Fourteenth Amendment claims are present in cases involving donor-related issues. In Hollingshead v. Blue Cross (2007), for example, attorneys argued that an insurance coverage benefit for ‘one organ transplant’ was arbitrary and capricious when a patient was denied reimbursement for the re-transplantation performed for early graft failure. Though not explicitly related to candidacy determination, judicial decisions such as these are nonetheless important because they quantify the potential financial risk associated with each donor type to which a candidate consents.

Conclusion

These data underscore gaps in clinical guidelines that may increase the risk of constitutional torts. We outline the resultant opportunities for change in Table 2. Efforts to close these gaps will be beneficial not solely to avoid litigation, but also to identify opportunities for improving on vague rules and procedures, affirming the mission of transplantation, and limiting the possibility for discrimination and exclusion.

Table 2:

Summary of Opportunities to Address the Risk of Constitutional Claims in Liver Transplant

Constitutional Claim	Example	Level of Response	Response
First Amendment Free Exercise Claim	Religious exemption to blood transfusions	Institutional	If unable to accommodate, attempt arrange transfer of care elsewhere
Eighth Amendment Cruel and unusual punishment	Prisoners denied liver transplant	Institutional	Clear documentation of objective medical rationale for denial of transplant waitlisting
Fourteenth Amendment Lack of due process; arbitrary and capricious standards	Variable pre-transplant sobriety standards	Payers Multicenter consensus	Standardized criteria for insurer approval of candidates with alcohol-related liver diseases
Fourteenth Amendment general age discrimination claim	Declining candidacy for patients because of age	Payers Multicenter consensus	Standardized criteria for the selection of older candidates including objective measures of physical function.