The Short Circuit: Privatized Organ Allocation Policymaking Violates Fundamental Fairness

• Publication year: 2021

The Short Circuit: Privatized Organ Allocation Policymaking Violates Fundamental Fairness

Sean F. Driscoll

THE SHORT-CIRCUIT: PRIVATIZED ORGAN ALLOCATION POLICYMAKING VIOLATES FUNDAMENTAL FAIRNESS

Abstract

The successful development of organ transplantation brought with it a new challenge—how to share the scarce organs that are donated. To resolve this challenge, Congress contracted out to the United Network for Organ Sharing, a non-profit corporation composed of transplantation stakeholders, the responsibility of developing, implementing, and administering organ allocation policies under the oversight of the Department of Health and Human Services. However, increased scrutiny due to ongoing litigation between transplantation stakeholders has called into question the accountability and objectivity of this quasi-governmental agency.

This Comment argues that the delegation of organ allocation policymaking to the United Network for Organ Sharing violates the Fifth Amendment Due Process Clause. When private actors are delegated regulatory authority that rises to state action, the protections of the U.S. Constitution apply. The Supreme Court has further recognized that due process is violated where self-interested state actors are delegated regulatory authority without sufficient agency oversight. This Comment argues that (1) the United Network for Organ Sharing should be considered a state actor subject to constitutional constraints, (2) the individual members of its Board of Directors are self-interested, and (3) the Department of Health and Human Services does not have sufficient oversight over the United Network for Organ Sharing to mitigate potential self-interest.

To ensure fundamental fairness, this Comment proposes relegating the United Network for Organ Sharing to an advisory committee for the purposes of developing organ allocation policies. Such a proposal empowers the Secretary of the Department of Health and Human Services to maintain substantive control of organ allocation policymaking, thus satisfying the due process inquiry. This proposal also balances mitigation of perceived conflicts of interest and maintenance of stakeholder participation in policymaking.

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Introduction...........................................................................................1007

I. Organ Scarcity & Due Process ................................................1010

A. The Development of the Organ Procurement and Transplantation Network........................................................ 1010

1. Policymaking Power......................................................... 1012
2. Administrative Power ....................................................... 1014

B. Geography, Scarcity, and Competition .................................. 1015
C. Delegation & Due Process ..................................................... 1019

II. UNOS Is a State Actor Subject to the Due Process Clause............................................................................................1023

A. UNOS Serves a Public Function ............................................ 1025
B. The UNOS-HHS Nexus Is Sufficient ....................................... 1026

III. Self-Interest in the Organ Procurement & Transplantation Network........................................................1027

A. Transplant Doctors and Hospitals ......................................... 1028

1. Lobbying for Preferential Organ Allocation Policies ...... 1029
2. Gaming the System for Financial Advantage ................... 1031
3. Litigating Preferential Organ Allocation Policies ........... 1032

B. Transplant Patients ................................................................ 1033

1. Litigating Preferential Transplant Outcomes................... 1033
2. Transplant Tourism .......................................................... 1035

IV. HHS's Oversight over UNOS Is Insufficient..........................1037

A. The Secretary Cannot Substantively Override UNOS's Allocation Policies .................................................................. 1037
B. The Secretary Otherwise Lacks Sufficient Oversight to Ensure Due Process............................................................................ 1038

1. Limitations of Secretarial Oversight ................................ 1039
2. Limitations on Judicial Review ........................................ 1042

V. UNOS Should Be Relegated to an Advisory Capacity to Ensure Due Process.....................................................................1044

A. Advisory Committees Are Consistent with the Due Process Clause ..................................................................................... 1044
B. Advisory Committees Are Commonly Used in Fields Requiring Scientific Expertise ................................................................. 1046

Conclusion...............................................................................................1047

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Introduction

The moment a man is declared dead by a medical professional, the deceased has the opportunity to save the lives of up to eight people.¹ If he has consented to donating his organs, a federally designated organ procurement organization (OPO) will harvest and preserve his viable organs.² The OPO will then enter the donor's information into a computer algorithm maintained by the United Network for Organ Sharing (UNOS), which compares the donor's organs against the patients on organ waitlists.³ The algorithm first screens out all waitlisted patients that are ineligible to receive the donor's organs due to blood type, height, and weight.⁴ The algorithm then ranks the remaining potential organ donation recipients based on UNOS-approved metrics of medical urgency, distance between the donor and recipient, and other organ-specific factors.⁵ Finally, the OPO offers the organ to the top-ranked patient and that patient's transplant hospital.⁶

After the top-ranked patient receives his or her life-saving operation, over 109,000 patients in the United States will still be waiting for an organ transplant as of September 2020.⁷ Of those 109,000 people, approximately seventeen will die each day.⁸ Patients on organ transplant waitlists may also be surpassed by one of the new patients added every nine minutes.⁹ Although organ donation more than doubled between 1991 and 2018,¹⁰ the patients waiting for an organ

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in the same time period nearly quintupled.¹¹ The number of patients waiting for an organ transplant continues to exceed the number of organs donated, thus creating an organ shortage.¹²

Unless organ shortages are resolved, organ rationing is unavoidable.¹³ Organ rationing forces the difficult process of selecting which patients receive the few organs available for transplant.¹⁴ This selection "becomes literally a question of pronouncing a death sentence upon those to whom organ transplantation is denied."¹⁵ To make this difficult decision, Congress contracted out the role of "distribut[ing] organs equitably among transplant patients" at the federal level to UNOS, a private non-profit entity.¹⁶

UNOS balances competing factors to determine which patient deserves a specific organ before every other patient on the waitlist.¹⁷ Most controversial among these factors is the role of geography because patients who are less sick, but closer in proximity to a donated organ, receive priority in allocation.¹⁸ Geographic boundaries have caused "radically different chances of receiving an organ even though [patients have] comparable medical conditions—livers [can] go to relatively healthy candidates while a much sicker patient continue[s] waiting in another locale."¹⁹ For example, a patient living in Kentucky or Tennessee has a better chance of obtaining a liver transplant within a year than a patient living in California or New York.²⁰

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The delegation of authority to develop organ allocation policies to private parties questions the notion of fundamental fairness.²¹ UNOS, which is composed of transplant hospitals, transplant doctors, waitlist patients, OPOs, and other transplantation stakeholders, develops—with minimal federal oversight—the metrics that determine who receives a lifesaving procedure.²² Although it is sensible to involve subject matter experts in making these decisions, each stakeholder has a vested interest in maximizing their access to the few organs available: patients seek to survive, transplant hospitals seek to profit, and transplant doctors seek to both help their patients and further their professional careers. Due to the scarcity of available organs, the members of UNOS actively compete to advance their own personal or organizational interests.²³ These competing interests have aligned into two coalitions of transplantation stakeholders that use UNOS as a means to develop and promulgate favorable organ allocation policies to the detriment of the other coalition.²⁴

This Comment argues that the existing public-private framework for organ policymaking violates the Fifth Amendment Due Process Clause. The due process analysis rests on three prongs. First, UNOS must be a state actor subject to constitutional constraints. Second, the individuals delegated regulatory power, the members of UNOS's Board of Directors, must be self-interested parties. Third, the delegated regulatory power must lack effective government oversight. A court finding these three prongs satisfied would short-circuit the existing organ allocation algorithm by invalidating the delegation of organ allocation policymaking to UNOS. To prevent such a short-circuit, this Comment proposes that UNOS be relegated to an advisory committee for the purposes of developing organ allocation policies.

Part I of this Comment explains the current organ transplantation framework and its relation to due process in the context of private delegations. To do this, Part I first examines the scope of UNOS's authority to...