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The Forgotten Member of Patient Selection Committees

The US Constitution

Millis, J. Michael MD1; Cronin, David C. MD, PhD2; Millis, M. Andrew MD, MPH3

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doi: 10.1097/TP.0000000000002794
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The article by Tapper et al1 in this issue of Transplantation sheds light on an underappreciated aspect of candidate selection—the constitutional rights of patients and the general lack of focus on these rights by patient selection committees and insurance companies.

The number of cases presented is small when compared with the larger number of liver transplants performed (<1%)2 and the even larger number of candidate selection decisions made; however, the impact of constitutional violations that potentially prohibit access to life-saving treatment can be substantial. Many of the rights we take as granted emanate from individual case law, for example, the “right to a lawyer” originated from a man who was denied legal counsel and had to represent himself in court, Gideon v. Wainwright.3 Any selection criteria used to determine who receives life-saving therapy in a resource-restricted environment must be transparent which assists in ensuring equity, social justice, and constitutional compliance. Tapper et al1 provide advice on how all interested parties can work to avoid constitutional liabilities and continued societal support. Social support is mandatory for transplantation which requires social support as demonstrated by the predetermined, self-sacrifice of ordinary citizens to become donors and inherently requires physicians and citizens to jointly participate in one of the greatest advances in Medicine over the past 100 years.

The field of solid organ transplantation has stimulated truly revolutionary success and progress in medicine. In <50 years, US society now expects life-saving organ replacement as a matter of standard medical care. However, what continues to constrain the broader application of transplantation as a life-saving therapy is the limited number of organs suitable for transplantation. As the demand continues to expand relative to the supply of organs, programs and the transplant networks are required to have a process to determine listing candidacy and prioritization for organ allocation that optimizes patient and graft survival. These processes should abide by constitutional-based laws and regulations. Adherence to the principles outlined in the National Organ Transplant Act (NOTA), which enumerates that candidate selection must avoid discrimination based on race, age, nationality, sex, religious preference, sexual preference, etc., is enforced by regulation.4 Tapper et al1 discuss the intersection of constitutional rights and transplant policy through the analysis of individual case law. The authors highlight 1 of the eventual and expected outcomes when restrictions are placed on life-saving therapy, that is, patients who are denied access but are sophisticated and have time in the setting of life-threatening illness, may seek legal recourse to have their case heard and rights enumerated.

In situations in which civil rights have been violated and selection criteria had been applied in an arbitrary and capricious manner to deny transplant candidacy, we must take the data presented by Tapper et al1 to heart and work to eliminate such civil rights violations. For example, denying incarcerated individuals the right to medical care based solely on their incarceration is a violation of the Eighth Amendment (cruel and unusual punishment). Although the Supreme Court decision (Estelle v. Gamble) establishing the precedent did not explicitly include transplantation (the decision was made in 1976),5 denial of transplant care has subsequently been included as an Eighth Amendment violation.6 Further, the United Network of Organ Sharing Ethics Committee position statement on convicted criminal and transplant evaluation states “one’s status as a prisoner should not preclude them from consideration for a transplant.”7

However, we caution that the authors’ recommendation to develop and apply standard selection criteria across all programs might ultimately be counterproductive to improving access to transplantation. Candidate selection criteria have expanded dramatically in the past 50 years. In liver transplantation, hepatocellular cancer and cholangiocarcinoma, previously considered contraindications, are now acceptable indications (within well-defined criteria) for liver transplantation. In addition, there have been increases in the acceptable level of patient body mass index, recipient age, and the inclusion of medical comorbidities (portal vein thrombosis, previous abdominal surgery, portopulmonary syndrome, hepatopulmonary hypertension) as well as criteria expansion for multiorgan transplantation (heart–liver–kidney, heart–liver, lung–liver, multivisceral, and liver–kidney). The expansion of acceptable indications for transplantation (positive candidate selection criteria) has further increased the gap between those listed and the number of organs available. These expansions in indications and donor organs are the result of the slow, measured calculus of risk assessment for the transplant candidate and individual transplant programs. Although many programs share basic selection criteria and abide by United Network of Organ Sharing regulatory requirements in organ allocation, it is the unique expertise and experience among liver transplant programs and the ability of programs to tailor selection criteria to their program’s needs and strengths that are invaluable. However, program-specific criteria must be applied uniformly within each program and avoid arbitrary and capricious application and constitutional violations.

Outcomes have been the verifiable measure of transplant program success both medically and financially. As nearly all liver transplantation is supported by government or third-party insurance, those payers have a stake in the enterprise. As such, they require minimum expected outcomes for their financial investment. Data from the article by Tapper et al1 demonstrate that insurance companies are frequent violators of constitutional rights especially for those in which alcohol is the cause of the liver disease (14th Amendment—equal protection and due process). These denials are typically based on an arbitrary “6-month rule” of abstinence.8 Those with knowledge and financial resources can fight these insurance rulings, making the application of these insurance denials capricious and leaving those without resources more likely to die. We agree with the authors that violations of constitutional rights are not permissible and that exclusion criteria applied in an arbitrary and capricious manner are illegal and unconstitutional.

We support and encourage development and adherence to prospective and transparent selection criteria developed for the unique resources contained in each program. The pursuit for perfection in outcomes and uniformity in selection criteria across the field may limit the expansion of accepted indications for patients to benefit from transplantation. Further, we would suggest that expanding the metrics by which programs are evaluated beyond observed/expected outcomes is long overdue. We advocate the use of modernizing metrics, as opposed to weakening external oversight of quality. In addition to patient and graft survival metrics, programs should additionally be evaluated on metrics that seek to apply life-saving transplantation to more candidates, that is, innovation, split liver transplantation, live donor transplantation, pump-based technology, etc.

REFERENCES

1. Tapper EB, Wexler R, Goldman E, et al. Constitutional challenges to liver transplant policy.Transplantation2019103e378–e381
2. Sharing UNOSNational Data.2019Available at https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/#TransplantsbyDonorTypeU.S.TransplantsPerformed:January1,1988-February28,2019ForOrgan=Liver. Accessed March 29, 2019
3. Black H. Gideon v. Wainwright, 372 U.S. 335 (1963). In: Court USS, ed. 372. US 335 Vol 155 1963.Available at https://supreme.justia.com/cases/federal/us/372/335/
4. National Organ Transplant Act of 1984. Pub L. 98-507, 98 Stat. 2339-2348 (Oct. 19, 1984).
5. Marshall J. Estelle v Gamble. In: Court USS, ed. 429 US 97. Vol 75-929 1976.Available at https://supreme.justia.com/cases/federal/us/429/97/
6. Jones N. Rosado C v, Alameida E. In California United States District Court for the Southern District of California. Civil Number 03CV1110 J 349 F. Supp 2nd 13402004.Available at http://www.aele.org/law/2005JBSEP/rva.html
7. Sharing UNOSUNOS ethics committee position statement regarding convicted criminals and transplant evaluation.2015Available at https://optn.transplant.hrsa.gov/resources/ethics/convicted-criminals-and-transplant-evaluation/. Accessed April 24, 2019
8. Rice JP, Lucey MR. Should length of sobriety be a major determinant in liver transplant selection?Curr Opin Organ Transplant201318259–264
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