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May 2022  Volume 16Issue 1
Journal of Health and Life Sciences Law

Disparities in Access to Solid Organ Transplant Services—Past, Present, and Future

  • May 23, 2022
  • Courtney Carrell , Jones Day
  • Daniel Peters , The University of Kansas Health System

ABSTRACT: Human organs for transplant represent the epitome of a scarce medical resource. Every nine minutes, a new person is added to the organ transplant waitlist in the United States, but seventeen will die each day while awaiting an organ. Policymakers, bioethicists, and medical personnel alike have struggled with how to allocate donated organs ever since the first successful transplant in 1954, resulting in legal frameworks that aim to allocate organs based on fairness and need. However, the impossibility of quantifying “fairness” and “need” has resulted in a system in which not all patients have equal access to life-saving organs. In particular, the organ allocation system has disadvantaged Black patients, rural patients, and patients with lower socioeconomic status. This article examines the socioeconomic conditions that affect a patient’s access to organ transplantation and describes the racial, social, and geographic disparities. It analyzes the historical developments in medicine and policy that led to the current framework, and identifies new policies and technologies that may reduce disparities in the future.

Introduction

The allocation of donated organs for transplant is inherently shaped by scarcity and uncertainty. There are more than 106,000 patients on organ transplant waiting lists across the country, yet only 39,000 transplants were performed in 2020.1 Each organ allocated to one patient means another patient goes without a life-saving organ—the epitome of a zero-sum game. The American Medical Association’s Code of Medical Ethics instructs that allocation should be based on medical need, including the urgency of need,2 but it is impossible to rank-order patients precisely based on need. Although medical testing and other predictive tools estimate how likely a patient is to die without an organ transplant and how successful a transplant may be, no one can predict the exact moment at which a particular patient will lose his/her/their life to organ failure. Moreover, research suggests that a patient’s access to transplantation and likelihood of loss of life are contingent upon many factors that go beyond clinical markers, including the patient’s social, geographic, and financial circumstances.

In this article, we explore the socioeconomic conditions that affect a patient’s access to organ transplantation, starting with the history of organ transplantation and the development of the legal framework, followed by a discussion of the disparities that have existed in organ transplantation since the advent of the legal framework and which persist today. Finally, we address developments and opportunities for change that may reduce these disparities in the future.

History of Organ Transplantation and the Legal Framework

In 1954, the kidney was the first human organ to be transplanted successfully.3 By the late 1960s, doctors had also performed successful liver, heart, and pancreas transplants.4 Subsequent advances in immunosuppression treatment improved transplant survival rates, with one-year survival for liver transplant recipients in 1981 being reported at nearly 70%.5 Notably, between the mid-1950s and the early 1970s, the organ transplant process was entirely decentralized. Organ procurement organizations (OPOs) developed as non-profit entities that managed organ recovery within their local communities. They coordinated with nearby hospitals, but there was limited interaction among OPOs and no national infrastructure to link donor organs with suitable recipients.6 Consequently, if donated organs could not be used at a local hospital, there was no way to transfer those organs elsewhere. The organs would likely go to waste.7

In 1968, recognizing the benefits that could arise out of collaboration, the organ transplant community began to organize with the founding of the South-Eastern Organ Procurement Foundation (the Foundation), a regional association of donation and transplant professionals.8 That same year, the National Conference of Commissioners on Uniform State Laws drafted the Uniform Anatomical Gift Act, which when enacted by the states, enabled anyone over the age of 18 to legally donate their organs upon death.9 This new model legislation spurred the growth of the transplant community. In 1977, the Foundation implemented the first computer-based organ matching system and named it the United Network for Organ Sharing (UNOS).10 UNOS allowed each of the Foundation’s transplant center members to list candidates and find matches for viable organs that could not be placed locally.11 The service offered a much needed way to reduce waste of life-saving organs, but it was still a limited, largely regional system.12

In the early 1980s, transplant science was rapidly advancing. The period saw the opening of many new transplant programs, the beginning of lung and intestine transplantation, and an increase in the frequency of kidney, liver, and heart transplant surgeries.13 However, there was a significant shortage in the availability of donated organs. Organs were being recovered from less than 15% of potentially suitable organ donors.14 Congress attributed the low organ donation rate to the lack of organization in the nation’s organ procurement efforts.15 At the time, there were 120 OPOs independently operating around the country, each with an effective monopoly over a specific service area and limited sharing of organs.16 Several private and public organizations existed to facilitate matches between donor organs and patients, including UNOS and other registries, but the patchwork infrastructure was not sufficient.

The Enactment of the National Organ Transplant Act of 1984

Extensive media coverage made organ transplantation one of the most widely discussed health issues of the early 1980s.17 Desperate families publicized their need for organs, and President Ronald Reagan made the plight of some such families the subject of one of his Saturday radio broadcasts.18 Medical ethicists questioned whether voluntary organ donations, as set forth in the Uniform Anatomical Gift Act, was the best approach or whether the heightened demand for organs warranted a shift to a presumed consent model, which would require Americans to opt out of organ donation instead of opting in.19 Ultimately, the national dialogue propelled Congress to take up the issue.20 In 1984, Congress passed the National Organ Transplant Act (NOTA), which retained the voluntary donation model, made the sale of human organs illegal, and created an entity to establish a national transplant list known as the Organ Procurement and Transplantation Network (OPTN).21 The OPTN was to be operated by a private non-profit entity under federal contract.22 In 1986, the U.S. Department of Health and Human Services (HHS) awarded the contract to UNOS, the Foundation’s computer registry system, which had since been incorporated as its own non-profit organization.23 The same year, Congress amended the Social Security Act to make OPTN membership and compliance with OPTN’s requirements mandatory for transplant programs participating in Medicare and all organ procurement organizations.24 Thus, like other health care providers, organ transplant programs and OPOs are governed by rules implemented by the Centers for Medicare & Medicaid Services (CMS), but organ transplantation is also regulated by UNOS in its capacity as the OPTN.

Since NOTA’s enactment, the statute has been amended four times. The OPTN’s original focus under NOTA was to establish and maintain the computer system to match donated organs with recipients and to assist OPOs in distributing organs they could not otherwise match within their respective service areas.25 In 1988, NOTA was amended so that the statutory language did not unintentionally limit the distribution of organs to the service area of the OPO that procured the organ.26 As part of this amendment, the OPTN was also tasked with establishing the “medical criteria for allocating organs and provid[ing] to members of the public an opportunity to comment with respect to such criteria.”27 In 1990, the statute was amended again to reflect that the OPTN should play a significant role in increasing organ donations. Specifically, Congress added that the OPTN should “work actively to increase the supply of donated organs” and assist OPOs with the distribution of organs nationwide.28 In 2000, NOTA was amended a third time to require the OPTN to “carry out studies and demonstration projects for the purpose of improving procedures for organ donation procurement and allocation, including but not limited to projects to examine and attempt to increase transplantation among populations with special needs, including children and individuals who are members of racial or ethnic minority groups.”29 Finally, in 2013, the HIV Organ Policy Equity Act amended NOTA to allow donated organs from HIV-positive individuals to be used for transplantation into HIV-positive candidates.30

U.S. Department of Health & Human Services—Proposed Rulemaking

In April 1993, John Tisdale, a Little Rock attorney who worked for President Bill Clinton’s former law firm, contacted the White House on behalf of a hospital client to discuss the allocation of organs for liver transplant.31 In the early 1990s, patients who were candidates for liver transplants were designated a “status” within the UNOS computer system based on severity of illness, with Status 1 being the least sick patients and Status 4 being the sickest. Under the UNOS policy at the time, donated livers were offered to patients in order of status first within the donor OPO’s service area, and if not accepted in the service area, then the organs were made available nationally.32 As a result, a Status 1 patient within the OPO area could be offered an organ ahead of a sicker Status 4 patient outside the area. This “local first” approach was supported by many within the transplant community, in part because when transplant medicine first developed, there was very little time that an organ could be preserved to be functional for the recipient.33 Local use of organs was the only option. As science advanced, however, the nation began to debate whether organs could or should be allocated to patients beyond the local OPO.

Shortly after the amendment of NOTA authorizing the OPTN to establish medical criteria for organ allocation, many of the ethical and theoretical issues underlying this critical policymaking came to the forefront. One such issue was the tension between conceptualizing donated organs as a national resource and conceptualizing donated organs as a gift to the community from the donor and family. As discussed below in Developments to Reduce Disparities on page 133, OPOs vary significantly in their effectiveness to identify organ donors and recover organs. With OPOs functioning as monopolies in their assigned geographic region, their effectiveness at organ donation could affect a patient’s ability to be transplanted within the OPO’s territory. As a result, whether an organ was a national resource or a directed gift carried significant import. This conceptual tension was reflected in a 1991 OIG Report that quoted competing physician viewpoints.34 One physician argued that “[o]rgan donation is a ‘donation’ . . . it is inequitable to force efficient OPOs to by-pass their own patients to subsidize the inefficiency of other OPOs.”35 Another physician argued that “we need to foster the notion that organs for transplantation are a national resource which should be used in the most efficient and successful manner possible.”36

The Little Rock attorney, Tisdale, represented large transplant centers from across the country that pursued nationalized distribution of organs,37 which some argued would financially benefit Tisdale’s clients.38 Tisdale and other aligned stakeholders regularly communicated with White House and HHS officials to encourage HHS to adopt a policy that donated organs “should be allocated on the largest geographic area medically feasible to the most medically appropriate patients.”39 Others in the transplant community, including UNOS and some within HHS, were concerned that offering organs to patients anywhere in the United States would lead to (i) increased organ wastage due to logistical complexities with transporting organs; (ii) smaller centers closing because larger centers would always have greater numbers of Status 4 patients, and as a result of the closures, there would be diminished access to transplantation for low-income patients in their home communities; and (iii) more deaths post-transplant because of the sicker patient population, yielding a greater number of collective years of life lost in the long term.40

In 1994, HHS issued its notice of proposed rulemaking which, among other things, established an OPTN Board of Directors to develop “medical criteria and related policies for the fair and equitable allocation of human donor organs.”41 In the rulemaking, HHS recognized the “difficult issues” inherent in creating policies to rank order patients.42 As the agency explained, “efforts to promote service to the sickest patients first versus those likely to survive the longest may conflict. Similarly, some policies intended to maximize transplant outcomes and based on sound scientific data may have adverse implications for one ethnic group in particular, or for residents of particular geographic areas.”43 HHS “committed to a full public debate on these and related issues that arise in the context of organ allocation policies” and further provided for federal oversight to “ensur[e]” that “the processes by which the OPTN allocates organs for transplantation . . . are fair and equitable.”44

The Final Rule

On April 2, 1998, four years after the issuance of the proposed rule and following significant lobbying efforts by stakeholders,45 HHS published a supposedly final rule that was to govern the operation of the OPTN.46 In the rulemaking, HHS sided with Tisdale and his large hospital clients that had advocated for a more national approach to transplantation. HHS criticized the then-current OPTN allocation policies for not creating a “truly national system” and for failing to reflect the “broader sharing possible under current views of appropriate cold ischemic time.”47 HHS declared that “[h]uman organs that are donated for transplantation are a public trust” to be “equitably allocated among all patients, with priority to those most in need.”48 The preamble argued that the “enormous geographic disparities in the time patients must wait to receive transplants” was evidence of an inequitable system.49 The 1998 version of the final rule even required that allocation policies minimize variances in waiting time across transplant programs.50

Based primarily on issues raised at public hearings during the four years between the proposed rule and the final rule, HHS added a new requirement that “the OPTN modify or issue policies to reduce inequities resulting from socioeconomic status to help patients in need of a transplant be listed and obtain transplants without regard to ability to pay or source of payment.”51 HHS further noted that “the Secretary has an affirmative obligation to make sure that policies and actions of the OPTN do not violate the civil rights of candidates for organ transplants.”52

Notwithstanding the new requirement that the OPTN reduce socioeconomic inequities, the issuance of the final rule and its focus on national allocation further heightened the debate regarding the most equitable way to allocate organs. Stakeholders expressed concerns that the rule and proposed organ allocation “would increase the cost of transplantation, force the closure of small transplant centers, adversely affect access to transplantation [for] minorities and low-income patients, discourage organ donation, and result in fewer lives saved.”53 Before the rule could be implemented, Congress intervened and suspended implementation of the rule for one year.54 Congress instructed the then-Institute of Medicine (IOM) (now the National Academy of Medicine) to conduct a study on the potential impact of the rulemaking on low-income populations, racial and ethnic minority groups, organ donation rates, waiting times, patient survival, and transplant costs.55 In its 1999 report, the IOM opined, among other things, that concerns about potential closures of small transplant programs were overblown, but it validated concerns regarding access to transplantation for minority and low-income populations. In addition, the IOM concluded that median waiting time in different regions of the country, which had been “cited as an indicator of the unfairness of the current system,” was “a poor measure of differences in access to transplantation.”56

After reviewing the IOM report, HHS issued a new rule (the Final Rule) to take effect on November 19, 1999 which, among other things, removed the requirements regarding minimizing wait time variances.57 The agency also included new language that required the OPTN to develop allocation policies that “seek to promote access to transplants.”58 Under the implemented Final Rule, allocation policies must “be based on sound medical judgment,” “seek to achieve the best use of donated organs,” “be designed to avoid wasting organs, to avoid futile transplants, to promote patient access to transplantation, and to promote efficient management of organ placement.”59 Further, allocation policies “[s]hall not be based on the candidate’s place of residence of place of listing” except to the extent “required” by the prior requirements.60

The Final Rule also includes a requirement that the OPTN develop “[p]olicies that reduce inequities resulting from socioeconomic status,” including but not limited to:

(i) Ensuring that payment of the registration fee is not a barrier to listing for patients who are unable to pay the fee; (ii) Procedures for transplant hospitals to make reasonable efforts to obtain from all available sources, financial resources for patients unable to pay such that these patients have an opportunity to obtain a transplant and necessary follow-up care; (iii) Recommendations to private and public payers and service providers on ways to improve coverage of organ transplantation and necessary follow-up care; and (iv) Reform of allocation policies based on assessment of their cumulative effect on socioeconomic inequities.61

Thus, the law requires UNOS, in its role as the OPTN, to pursue organ allocation policies that promote access to transplantation and reduce socioeconomic inequities. Unfortunately, research demonstrates that UNOS has not been successful in this mission.

Disparities in Access to Transplantation

As discussed further below, UNOS has devoted significant attention to the way organs are distributed geographically to candidates already on the waitlist, but it has focused far less attention on other elements of organ transplantation that lend themselves to disparities in access to transplantation. The process of receiving a donor organ takes into account a series of medical, biological, and social variables that come into play long before a patient is placed on a waitlist. First, the treating physician must identify the patient as a potential candidate for transplantation and refer the patient to a specialist for evaluation.62 Second, the specialist must confirm that the patient is a suitable transplant candidate and present the patient to the hospital or transplant center’s multi-disciplinary team. Third, the multi-disciplinary team— typically comprised of additional physicians, pharmacists, social workers, and financial counselors—evaluates the patient for inclusion on the waitlist based on criteria set by each individual hospital or transplant center. Because of the scarcity of donated organs, transplant medicine is particularly unique in that patients are evaluated both on medical and non-medical criteria,63 as discussed further below. Although some clinical markers demonstrating organ failure are required for a patient to be added to the national waitlist, each hospital or transplant center has discretion to develop its own selection policies.64

Once placed on the national waitlist and an organ becomes available, patients on the waitlist are assessed to determine compatibility with the available organ based on factors such as blood type, tissue type, and organ size.65 UNOS uses these variables to produce a “match list” for each available organ, ranking patients in order of priority. Specifically, as allocation policies exist today, the following factors are considered in varying weights when generating the match list:

  • Kidney: Waiting time, donor/recipient immune system compatibility, whether the patient is a prior living kidney donor, the distance from the donor hospital,66 pediatric status, and the patient’s survival benefit.67
  • Lung: Survival benefit, medical urgency, waiting time, distance from donor hospital, and pediatric status.68
  • Liver: Medical urgency, distance from donor hospital, and pediatric status.69
  • Heart: Medical urgency, distance from donor hospital, and pediatric status.70

Importantly, “medical urgency” is an imperfect clinical approximation that itself may yield disparities in access. For example, experts have criticized the primary clinical marker for kidney disease, which “systematically raises” the estimated kidney function of Black patients by as much as 16% compared to other races, making Black patients appear healthier and thus less likely to receive a transplant.71 For liver transplant candidates, organ allocation is dependent in part on a clinical score known as MELD, which stands for Model for End-Stage Liver Disease.72 MELD is intended to serve as a predictor of survival, with higher scores indicating sicker patients.73 However, the likelihood of mortality with the same MELD scores varies based on certain non-clinical characteristics, including the patient’s geographic residence.74 The OPTN’s annual report acknowledged that factors affecting waitlist mortality rates “may include access to healthcare in general and to high-quality specialty care for [] disease, referral and waitlist registration practices, and pretransplant patient management.”75 In addition, even narrowly focusing on clinical criteria, there are some conditions that make patients extremely ill but do not result in a high MELD score, such as autoimmune hepatitis or primary biliary cirrhosis.76

Once an organ is offered to the transplant center or hospital with the candidate who is highest on the UNOS match list, the transplant team decides if it will accept the organ, again taking into account certain medical criteria and the relative aggressiveness of the surgeon and institution.77 Some transplant centers will accept organs that others would not have chosen for the same patient.78

Because the need for donated organs far outweighs the supply, non-medical criteria are evaluated “to uphold the principle of utility” by selecting patients who facilitate “optimal stewardship of a scarce resource.”79 Transplant centers evaluate whether the patient has adequate social resources to be a transplant candidate, including, for example, the ability to adhere with compliance in taking post-transplant medications80 and the availability of transportation to return to the clinic for regular follow-up appointments.81 These non-clinical criteria and unique practices create opportunities for heightened disparities to exist in transplantation as compared to other sophisticated medical services. As such, to meet its legal obligation to develop “policies that reduce the inequities resulting from socioeconomic status,”82 UNOS must consider the impact that socioeconomic status, race, and other factors have on a patient’s medical urgency and likelihood of receiving a transplant in the nation’s current system.

Racial and Socioeconomic Inequities

At the direction of Congress, the IOM began analyzing racial and socioeconomic inequities in transplantation beginning in the 1990s and found significant variances in patient access. The IOM reported that the most significant barrier to accessing transplants for minorities and low-income individuals was getting on a waiting list.83 “African American patients are less likely than white patients to be referred for evaluation and are placed on waiting lists at a slower rate, as are low-income patients of all racial and ethnic groups.”84 In the preamble to the 1994 proposed rule, HHS observed “that blacks experience problems getting on kidney transplant waiting lists” not fully explained by medical or biologic variables.85 The disparities in access to kidney transplantation were especially concerning because Medicare covers the costs for end-stage kidney disease (including transplants), regardless of the patient’s age, so disparities in access could not readily be attributable to an inability to pay for the transplant surgery.86 Regarding liver transplant waitlists, the Howard University Chair of Surgery opined that based on clinical data, Black patients should have accounted for 20% of the kidney transplant waitlist, but they actually accounted for no more than 10%, which the Howard Chair attributed to “green screen” practices87 that excluded patients from the transplant waitlist if they did not have financial resources.88

Unfortunately, more than 20 years later, racial disparities still persist in transplantation.89 One study found that Black patients are 59% less likely to receive a transplant compared to White patients.90 Importantly, researchers found that socioeconomic factors explained 30% of the reduced rate of transplant, but substantial racial disparities existed even after accounting for demographic, clinical, and other socioeconomic factors, particularly in referral for transplant and the rate of transplantation among waitlisted patients.91 Factors contributing to this disparity include “perceived differences in patient preferences, differential rates and timing of referrals, variation in the rates and timeliness of the completion of transplant evaluations, and organ allocation policies favoring highly matched donors and recipients.”92 At the earliest stages of disease, racial minorities and patients with low socioeconomic statuses are less likely to be referred to physicians who offer transplantation services.93 In short, inequities in transplantation cannot be resolved without addressing the inequities in access to the transplant waitlist.

Researchers have also examined the effects of socioeconomic status at the county level, rather than individual income, and have concluded that “counties with poverty rates higher than the national average were more likely to have lower rates of kidney transplantation.”94 Moreover, counties of relative wealth surrounded by other prosperous areas had even higher rates of transplantation compared to similarly wealthy counties that were surrounded by areas of relative poverty. The researchers suggested that this finding indicated that access to transplantation was not merely related to an individual’s socioeconomic status but was “perhaps also a function of geographical proximity to more affluent areas with better healthcare resources including perhaps transplant centers.”95 Thus, even though the OPTN does not currently track transplant candidates’ income,96 it could evaluate socioeconomic disparities by examining transplant opportunities based on county.97 Looking at broader socioeconomic factors on a county level, transplant researchers have assigned counties across the United States cumulative “community risk” scores that reflect the community’s prevalence of health risks such as obesity, smoking, high numbers of preventable hospitals stays, and low median household income.98 In high-risk communities, the death rate from end-stage liver disease is almost twice that of counties in the lowest tier of risk.99

Additional racial disparities exist in “living donor” transplantation100 as well as “preemptive” kidney transplantation.101 Living donor surgeries—where a healthy person donates an organ—are options for kidney and liver transplantation, but they require a very careful match to justify surgery for the living donor. The vast majority of living donor matches are from persons of the same race,102 and Black patients are less likely to be eligible to serve as living donors because of an increased prevalence of certain genetic variants predisposing them to high blood pressure and kidney disease.103 Because Black patients are less likely to qualify for living donor options, they are more dependent on deceased donors and UNOS’s allocation system.104

In preemptive cases, the patient receives a transplant before he/she/they needs dialysis. This approach avoids the risks of dialysis and reduces the rate of complications; accordingly, the National Kidney Foundation identifies preemptive transplantation as the ideal approach to treating end-stage kidney disease.105 However, this surgery is overwhelmingly provided to White patients. In 2019, the kidney waiting list was 38% White patients and 31% Black patients. White patients, however, received 65% of the preemptive transplants, while Black patients received only 17%.106

The waitlist selection process, as described above, also considers a series of psychosocial factors such as history of mental illness or the absence of a social support system, which might impede otherwise qualified candidates from being listed. For example, concerns that patients with preexisting mental illness may be less likely to adhere to post-transplant care is often cited as prohibitive to transplant candidacy, and mental illness continues to be viewed as a contraindication to transplantation at some transplant centers.107 This is the case despite studies suggesting no difference in attendance at follow-up appointments, frequency of filling immunosuppressant prescriptions, or three-year mortality among those with mental health diagnoses and those without.108 Similarly, transplantation programs commonly rely on judgments about patients’ social support system (the presence of family, friends, or other caregivers) when deciding whether to list them for organ transplantation.109 A national study of transplant centers in 2018 found that 10% to 22% of transplant candidates were excluded due to inadequate support, and 67% of providers believed use of social support as a criterion disproportionately impacted patients of lower socioeconomic status.110

In sum, from referral to waitlist selection to identifying a suitable organ match, there are many ways in which minorities and low-socioeconomic status individuals may be disadvantaged in accessing life-saving transplants. The concerns identified by the IOM and other stakeholders in the 1990s persist today.

Rural and Remote Patients

Individuals in rural and remote locations also suffer from inequities in access to transplantation. Waitlist registration rates for rural residents are significantly lower than they are for residents in more urban communities.111 Further, researchers have found that once rural candidates for heart transplants are placed on the waiting list, they remain on the list for significantly longer periods of time than residents of urban areas.112 These disparities exist across all regions of the United States and are therefore not likely to be an effect of other undetected factors.113 Instead, these disparities could be reflective of the tedious referral and evaluation process that is required to be placed on an organ transplant waiting list. For example, for residents of rural communities, the option of an organ transplant is not always presented as quickly as it is to patients in urban communities, who have access to multiple specialists familiar with transplantation criteria.114 Likewise, the process of obtaining a referral, driving back and forth to doctors’ appointments for testing, and completing a surgical evaluation presents financial and time barriers to patients in rural and remote areas who are far from transplant centers.115 Indeed, excess distance between a candidate’s place of residence and the nearest transplant center has been shown to lower transplant rates and decrease waitlist survival.116 In addition, patients in rural communities who lack ready access to specialists may be at greater risk for death.117 A system that is pursuing equity would recognize that transplant centers with large populations of remote or rural patients may experience higher waitlist mortality even for those patients who are comparatively “healthier” than others.118

Geographic Variances and OPO Performance

As noted above, advocates in favor of national distribution of organs in the 1990s urged policymakers that geographic discrepancies in waiting time reflected an unfair system.119 Today, UNOS—in its efforts to support changes in allocation policy—has similarly relied on geographic variances in wait time and transplant rate to argue in favor of the need for policy change.120 Importantly, the IOM found in 1999 that wait time variations did not indicate the allocation system was unfair. Rather, the report concluded that median waiting time was “a misleading metric” and was “a poor measure of the fairness or effectiveness of organ allocations” because most of the variation was attributable to transplant centers listing patients at different stages in their disease course.121 Likewise, variations in wait times today do not indicate problematic allocation. Instead, these variations can be attributed to numerous different factors that are wholly unrelated to allocation policy. In fact, wait times and transplant rates vary significantly at transplant centers that are just a few miles apart.122 If geography and allocation drove the variance in wait time, neighboring transplant centers (which have always been eligible to receive identical organs from the local OPO) would have nearly identical wait times, but that is not so.

Wait time varies across transplant centers regardless of geography because transplant programs have different waitlist practices, different organ offer acceptance practices, and different patient populations. Even within small geographic areas with a shared organ supply, there is still a 9.8-fold variation in the probability of transplantation.123 Such variation itself cannot be attributable to organ supply and is instead driven by differences in how the hospital accepts organs for its patient.124 Transplant surgeons decide whether to accept an organ offered for their patient, and part of the purported geographic variance in access to transplantation reflects variances in organ offer acceptance practices.125

While transplant center behavior plays a key role in so-called geographic disparities, some geographic differences in access to transplant are attributable to organ supply and the variation in OPO performance. Although there was a 9.8-fold variation within geographic areas that shared organ supply, the same researchers identified a 16-fold difference in the probability of transplantation for candidates across centers nationwide.126 OPOs play a fundamental role in the national organ transplant system—they are the only organizations that can legally facilitate organ donation. Within their assigned service area monopolies (as designated by the federal government), OPOs provide public education regarding organ donation, interface with donor families, and arrange for the procurement and transport of donated organs to intended recipients.127 As CMS has explained, “An OPO that is efficient in procuring organs and delivering them to recipients will help more people on the waiting list receive lifesaving organ transplants, which could ultimately save more lives.”128

In 2020, CMS concluded that the regulatory structure did not “properly incentivize the adoption of best practices and optimization of donation and organ placement rates.”129 According to research from the University of Pennsylvania, there are approximately 28,000 additional available organs each year from deceased donors that do not get transplanted due to breakdowns in the current system.130 Similarly, the Senate Finance Committee observed that OPOs are failing to recover or transplant thousands of eligible organs.131 Recovering an additional 28,000 organs would result in an additional 25,000 lives saved.132 This could save the federal government approximately $12 billion over five years from reductions in dialysis costs otherwise covered by Medicare.133 As summarized by CMS, “[w]hen OPOs are inefficient or ineffective, donor hospitals are reluctant to refer potential donors, and transplant programs have fewer organ offers for patients on the waiting list. The end result is a bottleneck within the system that leads to avoidable deaths and increased national health care spending.”134

Although all OPOs have government-designated monopolies, OPO performance varies significantly, with some OPOs facilitating donations from over 50% of potential donors, while other OPOs obtain donations from only 25% of potential donors.135 This discrepancy could lead to geographic disparities in the availability of transplantation, with transplant centers near higher performing OPOs having access to more organs for their patients.136

Developments to Reduce Disparities

In recent years, UNOS has argued that changes to allocation policy will reduce geographic variances and other disparities in access to transplant.137 It has spent a significant amount of time, energy, and financial resources changing allocation policies so that “local” candidates who are prioritized for organ allocation are defined as those within a 250 nautical mile circle of the donor’s hospital rather than those within the OPO’s service area.138 But as Rep. Thomas Barrett (D-WI) explained in the 1990s rulemaking:

We are asking the wrong questions and settling on the wrong solution by concentrating on physically reallocating organs. It’s like changing the criteria for who gets the lifeboats on the Titanic. Changing our allocation policies does nothing more than create winners and losers . . . . The answer is supply, supply, and supply. Let’s get more lifeboats.139

Unfortunately, UNOS has spent considerably fewer resources on expanding and improving donation efforts.140 Instead of re-allocating the finite number of organs, the OPTN should comply with its legal obligation to “work actively to increase the supply of donated organs.”141 By fulfilling this legal mandate, UNOS can reduce the impact of disparities by making transplant more accessible to all.

Policies

There are several opportunities for improved policymaking to reduce inequities in access to transplantation. First, with respect to OPOs, revised policies for CMS certification are set to take effect in 2022.142 Under the current organ procurement system, reliable data about OPO performance is simply not available. OPOs self-collect and self-report their own data, deciding which individuals should be classified as potential donors, allowing the OPOs to control the denominator of the quotient by which they are judged.143 As to be expected, systemic underreporting of donor potential is common, making some OPOs look better than they really are. As one OPO executive persuasively explained, “OPOs are given blank checks and participation trophies while patients die . . . .”144

In late 2020, CMS issued a rule change that will lead to more transparency and accountability for the OPO community by changing the way in which donation data is collected and analyzed.145 While the regulation received bipartisan support and was generally praised within the transplant community, certain OPO and UNOS leaders lobbied to prevent the new regulation from taking effect.146 Following these lobbying efforts, six OPOs left the OPO trade group, the Association of Organ Procurement Organizations, concluding that the association’s lobbying efforts were in contrast with “the federally designated roles assigned to OPOs, including prioritizing patient outcomes.”147 The six departing OPOs joined the Federation of American Scientists’ OPO Innovation Cohort, which plans to conduct a year-long, granular analysis of OPO data to inform OPO policy and best practices. This includes an assessment of hospital-level deaths, organ acquisition charges and other OPO financials, and staffing models, with the goal of mining datasets for performance improvement insights.148 Supporters of the rule change are optimistic that it will create better data to improve OPO accountability and allow for identification and consistent implementation of best practices, which will increase organ donation nationally, reduce geographic differences in organ availability, and result in better access to transplantation for all.149

One of the strategic goals of the OPTN is to “provide equity in access to transplants.”150 To date, UNOS’s focus on equity has largely centered on addressing geographic disparities in transplantation through reallocation of organs. But as explained above, these geographic differences are not fully explained by organ allocation policies.151 In fact, one empirical analysis found that measures of sickness relied upon by UNOS in claiming geographic inequities “have been manipulated and therefore suffer from significant biases.”152 Further, UNOS has failed to adequately explore how allocation policies could be used to improve socioeconomic disparities in transplant, especially given the differences in access to living donor options. Finally, UNOS has done little to affect the inequities that exist in accessing the waitlist. In fact, the OPTN has repeatedly stated that its legal obligation to “promote patient access to transplantation”153 is limited to only those persons who are transplant candidates already on the waitlist.154 Recently, however, the President-Elect of the UNOS Board of Directors expressed that “African Americans and Hispanics are not referred [for transplant] or preemptive transplants as much as others . . . . It’s the people who are in the low middle class and lower economic classes that are probably most disadvantaged. That’s really what needs to be worked on.”155 It is hoped that this commentary represents a shift in UNOS’s thinking and an understanding that promoting patient access to transplantation must start with pursuing policies that reduce inequities in access to the transplant waitlist.156

New Technologies

In addition to policy proposals that aim to reduce disparities in organ allocation, a proliferation of new medical technologies provides another avenue to achieve the same goal. New technological innovations present ways to reduce waste and error in the organ transportation process, such as through utilization of Global Positioning Systems (GPS) for organs in transit. New technologies can also reduce the scarcity of organs through utilization of man-made artificial organs and organs from other species. By improving delivery of organs and increasing the sources for organs, technological innovation can, in Rep. Thomas Barrett’s words, provide “more lifeboats,” creating more access for all.

Tracking Organs

A study performed by the Kaiser Health Initiative and the Center for Investigative Reporting revealed that many organs that are transported on commercial flights are lost in transit or subject to excessive delays that reduce or completely eliminate the viability of the organs.157 Specifically, in 2014–2019, nearly 170 organs could not be transplanted due to mishaps that occurred during transportation.158 Additionally, almost 370 organs were classified as “near misses” after delays and other transportation errors significantly interfered with the delivery of those organs.159 Given that organs are such valuable and scarce resources, these mistakes are alarming, especially in light of the availability of GPS and other technology to better track the organs in transit.

When the first human kidney was transplanted in 1954, GPS technology was virtually unknown.160 It was not until 1959 that the U.S. Navy began using transit system satellites to track naval submarines.161 However, since 2000, commercial GPS use has increased exponentially.162 Today, cellphones, wallets, food delivery orders, and packages in the mail are only a handful of the countless items that 21st century Americans are accustomed to tracking. Low-cost tracking devices facilitate the tracking of these everyday objects, but lifesaving organs en route from an organ donor’s hospital to the hospital of the recipient are not tracked using any real-time GPS devices. Instead, the locations of these organs are monitored through old-fashioned phone calls and paperwork.163 Given the fact that GPS tracking of commercial and insignificant objects has become an expectation in daily life, there is no reason why organs awarded to waitlist candidates should be left in airports or get lost in transit.164 By requiring that simple GPS tracking systems be attached to organs in transit, the OPTN and organ transplant centers could increase the number of lifesaving organ transplants that occur each year.

New Sources of Organs for Transplantation

Organ allocation policies are the source of significant debate primarily because organs are scarce resources. Although the OPTN is under a legal mandate to increase the supply of donated organs, enhanced recruitment of organ donors is unlikely to increase the organ donation supply to such a degree that every individual awaiting a lifesaving organ would be able to receive an organ transplant before it is too late.165 However, in recent years, advances in medical technology have suggested that it may be possible to increase the organ donor supply by completing animal-to-human organ transplants or using man-made artificial organs.

Specifically, scientists studying xenotransplantation have made progress toward being able to genetically modify pig organs so that the organs can be successfully transplanted into humans without being rejected or spreading life-threatening viruses.166 Pigs have long been considered the best potential donors for animal-to-human transplants because the biological materials in pig organs are similar to the materials in human organs, and the variety of sizes among pig breeds allows scientists to harvest pig organs that are the ideal sizes for various human recipients.167 Nevertheless, pig-to-human organ transplants have not been a possibility in the past because “molecular incompatibility” between pigs and humans would likely result in a human immune system rejecting the pig organ.168 However, “[a]dvances in genetic engineering have made it possible to modify the genome of donor animals in a way that prevents the recognition of their organs by the human recipient’s immune system and inhibiting the processes leading to xenograft rejection.”169 One such genetically-engineered kidney was used in the first successful pig-to-human transplant, performed by a team of surgeons at New York University Langone Health on September 25, 2021.170 The two-hour operation involved transplantation to a brain-dead patient who was kept alive on a ventilator and whose family consented to the experimentation.171 The genetically-engineered kidney was maintained outside her body, allowing researchers to study organ functioning and signs of rejection over a period of 54 hours.172 Ultimately, the team concluded that no signs of rejection were detected and the transplanted pig kidney had key functionality indicators equivalent to what is seen in human kidney transplants.173 Just a few months later, in January 2022, another major advancement in xenotransplantation took place at the University of Maryland Medical Center—the first successful pig-to-human heart transplant.174 The patient who received the transplant was not eligible for a human heart transplant and was at risk of dying from heart failure. The patient lived for two months with the xenotransplanted heart before he died without a cause of death identified.175 Despite the patient’s passing, the transplant is still considered an important step forward in xenotransplantation because the pig heart was not immediately rejected. The transplantation of pig organs into humans serves as a key milestone for drastically expanding the supply of life-saving organs, which may help to reduce inequities in transplant medicine.176

Similarly, scientific innovation in the development of man-made artificial organs has the potential to vastly increase the organ supply. The first permanent artificial heart was successfully implanted in a human in 1982, but it had limitations and required the patient to be connected to a 400-pound air compressor for the rest of his life.177 Today, a new generation implantable prosthetic heart, which operates on an external power supply and includes biological valves derived from bovine tissue, is available.178 This new artificial heart has already been approved for use in Europe and was successfully implanted for the first time in the U.S. by a surgical team at Duke University in July 2021.179 In addition, researchers at U.C.L.A., in collaboration with the U.S. Kidney Research Corporation and the University of Arkansas, announced in January 2021 that they were developing an artificial kidney that could be worn inside a backpack, and if research proceeds as hoped, a similar device could be implanted in the body as an artificial organ within a few years.180

Acknowledging the transformative power of man-made organs, HHS and the American Society of Nephrology announced in January 2021 a multi-phase competition to accelerate the development of artificial kidneys toward human clinical trials.181 The KidneyX Artificial Kidney Prize will award up to $10 million for kidney replacement therapies that provide “transformational treatment options beyond current dialysis methods” which includes artificial kidneys that are wearable, implantable, bioengineered, developed as chimera organ, or any other solutions not yet conceived.182 Notably, when evaluating submissions, judges must assess the patient impact of each proposed technology, a criterion that puts social determinants of health center stage.183

If there were an adequate number of organs available for all patients on the waitlist, then disparities for those on the waitlist would be significantly diminished. In addition, if there were not such a scarcity of organs, then socioeconomic considerations would not play as large of a role in determining who should be considered a candidate for transplant. At that time, inequities would be more like those seen in any highly complex medical service line.

Utilization of Telehealth

Telehealth services have rapidly expanded during the COVID-19 pandemic and may be another avenue to address issues of organ access.184 On the front end, telehealth platforms can be used to evaluate candidates for transplantation, reducing the number of times a patient needs to travel to a hospital or transplant center.185 While candidates will ultimately need to be seen by transplant providers in person, telehealth can be used to conduct initial screening and evaluation of patients in accordance with the hospital or transplant center’s unique protocol.186 In an analysis of the partnership between Northwell Health, New York’s largest health system, and the local OPO, officials found that use of a telehealth platform increased the number of organ referrals by 121% while improving the donation rate by almost 34% and increasing the number of transplants by 36%.187 Similarly, a study of patients who underwent evaluation for liver transplantation at the Richmond VA Medical Center found that telehealth was associated with a reduction in the time from referral to evaluation and referral to placement on the transplant waitlist.188

On the back end, telehealth can be utilized for post-operative appointments and other follow-up care. Telehealth can help physicians recognize early signs of decompensation, reduce readmission rates, and increase patient satisfaction. While the immediate post-operative period typically requires frequent clinical visits and laboratory testing to manage any possible complications, stable patients can benefit from replacing some in-person visits with virtual visits over time.189 Long-term post-transplant care through telemedicine has been successfully used in recipients of kidney and lung transplants, resulting in reduced need for travel and cost savings.190

For rural and remote patients residing significant distances from hospitals and transplant centers, telehealth services obviate the need for excessive travel. For low-income individuals who struggle to access transportation or take time away from work, utilizing telehealth services for pre- and post-operative care can also help curb those barriers.

Conclusion

Congress, HHS, and the IOM all expressed concerns about socioeconomic inequities in transplantation when the legal framework for organ transplant oversight was being developed in the 1990s. Sadly, there has been little improvement in these disparities over the years. To fulfill its legal mandate to reduce socioeconomic disparities, the OPTN must consider the socioeconomic factors that affect medical urgency and access to transplantation. The OPTN should formally examine the disparities that exist in accessing the transplant waitlist— especially those that are unique to transplantation because of waitlist screening—and develop policies aimed at reducing these disparities. In addition, the OPTN should pursue collecting additional socioeconomic data from transplant candidates and those individuals who are not accepted for the waitlist so that further research can be done to identify non-clinical characteristics of those who are denied the opportunity for transplantation.

Forthcoming changes to the OPO system offer reason to be optimistic for the future. These changes are expected to increase the number of organs available for transplant nationwide by holding accountable poor performing OPOs and raising the bar for each organization. In turn, more organs will be available to all. Likewise, new technologies may one day significantly diminish the reliance on deceased donor organ allocation. Eliminating the need for organ rationing and allocation would not eliminate all disparities in organ transplantation, but it would help increase access to transplants to all those who suffer from end-stage organ failure.


Author Profiles

Courtney A. Carrell is a partner at Jones Day specializing in health care regulatory, compliance, and litigation matters. For more than a decade, Courtney has advised health care industry clients on compliance with the Stark Law, False Claims Act, Anti-Kickback Statute, Affordable Care Act, Medicare and Medicaid reimbursement regulations, as well as state, federal, and international privacy laws. Courtney has appeared in numerous trial and appellate courts across the country, representing academic medical centers in health care policy and transplant medicine disputes. Courtney also specializes in digital health and telemedicine matters and routinely advises clients on structuring cross-border digital health programs. Contact her via email at [email protected].

Daniel W. Peters is Senior Vice President and General Counsel for The University of Kansas Health System in Kansas City, Kansas. Dan graduated from the University of Denver, College of Law and from Washburn University of Topeka with a BBA in Economics & Finance. He is admitted to practice law in Kansas and Missouri. Prior to joining the University of Kansas Health System, Dan served as general counsel for Kansas City Cancer Center and was a partner with a major law firm in Kansas City, Missouri. Dan is also a past president/chair of the Health Law Section of the Kansas City Metropolitan Bar Association and frequently participates in local and national speaking engagements on health care issues. He has also been involved in various charitable and civic organizations in the Kansas City area. Contact him via email at [email protected].

The authors wish to thank Mikayla M. Paolini, Associate at Jones Day, for her assistance and insightful comments on earlier drafts. In addition, the authors are grateful for research assistance from Olivia Horton, J.D. Candidate at the University of Texas School of Law. The views and opinions expressed in this article are the personal views of the authors and do not necessarily reflect the views of Jones Day or the University of Kansas Health System.


1 Organ Donation Statistics, Health Res. & Servs. Admin., https://www.organdonor.gov/statistics-stories/statistics.html (last reviewed Oct. 2021).

2 Allocating Limited Health Care Resources, Am. Med. Ass’n, https://www.ama-assn.org/delivering-care/ethics/allocating-limited-health-care-resources (last visited Apr. 24, 2022).

3 History of transplantation, United Network for Organ Sharing, https://unos.org/transplant/history/ (last visited Apr. 24, 2022).

4 Id.

5 Thomas E. Starzl et al., Liver Transplantation, 321 New Eng. J. Med. 1092 (1989).

6 History of UNOS, United Network for Organ Sharing, https://unos.org/about/history-of-unos/ (last visited Apr. 24, 2022).

7 Id.

8 Id.

9 Unif. Anatomical Gift Act (Nat’l Conf. of Comm’rs on Unif. State L. (1968).

10 History of transplantation, United Network for Organ Sharing, https://unos.org/transplant/history/ (last visited Apr. 24, 2022).

11 History of UNOS, United Network for Organ Sharing, https://unos.org/about/history-of-unos/ (last visited Apr. 24, 2022).

12 See H.R. Rep. No. 98-575, at 7 (1984).

13 History of transplantation, United Network for Organ Sharing, https://unos.org/transplant/history/ (last visited Apr. 24, 2022).

14 S. Rep. No. 98-382, at 2 (1984).

15 H.R. Rep. No. 98-575, at 7.

16 S. Rep. No. 98-382, at 3.

17 Id. at 13.

18 S. Rep. No. 98-382, at 3.

19 See Arthur L. Caplan, Organ Transplants: The Costs of Success, 13 Hastings Ctr. Rep. 23 (1983). Under a presumed consent model, individuals “opt out” of organ donation instead of the current U.S. “opt in” system. Presumed consent is used in Austria, Belgium, Singapore, Spain, and many other countries. Luke J. DeRoos et al., Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant, 2 JAMA Network Open 1 (Oct. 2, 2019), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2752089. Based on model simulations, researchers have predicted that adoption of a presumed consent policy in the United States could result in “modest but important improvement in the number of organ transplants” and years of life gained for patients. Id.

20 S. Rep. No. 98-382, at 13.

21 National Organ Transplant Act of 1984, Pub. L. No. 98-507, 98 Stat. 2339 (codified as amended at 42 U.S.C. §§ 273–274).

22 42 U.S.C. § 274(a), (b)(1)(A) (2021).

23 History of UNOS, United Network for Organ Sharing, https://unos.org/about/history-of-unos/ (last visited Apr. 26, 2022); History of transplantation, United Network for Organ Sharing, https://unos.org/transplant/history/ (last visited Apr. 26, 2022).

24 Omnibus Budget Reconciliation Act of 1986, Pub. L. No 99-509, § 9318, 100 Stat. 1874, 2009.

25 National Organ Transplant Act § 372.

26 Health Omnibus Programs Extension of 1988, Pub. L. No. 100-607, § 402, 102 Stat. 3048, 3114 (codified at 42 U.S.C. § 274(b)(2)(B)).

27 Id. § 403.

28 See Transplant Amendments Act of 1990, Pub. L. No. 101-616, § 202, 104 Stat. 3279, 3283 (codified at 42 U.S.C. § 274(b)(2)(K)).

29 See Children’s Health Act of 2000, Pub. L. No. 106-310, § 2101, 114 Stat. 1101, 1156 (codified at 42 U.S.C. § 274(b)(2)(N).

30 HIV Organ Policy Equity Act of 2013, Pub. L. No. 113-51, 127 Stat. 579 (codified at 42 U.S.C. § 274(b)(3)).

31 Letter from John R. Tisdale, Wright, Lindsey & Jennings, to Carol Rasco, Dir., Domestic Pol’y Council, White House (Apr. 9, 1993) (on file with author).

32 Letter from David M. Matter, to William J. Clinton, President of the United States (Sept. 30, 1996) (on file with author).

33 Putting Patients First: Resolving Allocation of Transplant Organs: Joint Hearing before the Subcomm. on Health & Env’t of the H. Comm. on Commerce & the S. Comm. on Labor & Hum. Res., 105th Cong. 4 (1998) (statement of Sen. Bill Frist) (“[I]n this whole field of science we didn’t used to be able to preserve organs very long, we really did need to transplant organs locally for the heart . . . . We got better preservation fluids . . . so it makes this possibility of sharing organs a reality.”).

34 U.S. Dep’t of Health & Hum. Servs. Off. of Inspector Gen., OEI-01-89-00550, The Distribution of Organs for Transplantation: Expectations and Practices, at 14‒16 (1991).

35 Id. at 15.

36 Id.

37 Letter from John R. Tisdale, Wright, Lindsey & Jennings, to Carol Rasco, Special Assistant for Domestic Pol’y, White House (Jun. 14, 1993) (on file with author).

38 Id.

39 Id.; Letter from John R. Tisdale, Wright, Lindsey & Jennings to Carol Rasco, Special Assistant for Domestic Pol’y, White House (Apr. 29, 1993) (on file with author).

40 Letter from Judith B. Braslow, Dir., Div. of Organ Transplantation, U.S. Dep’t of Health & Hum. Servs., to Dr. Andreas Tzakis (Dec. 22, 1993) (on file with author).

41 Organ Procurement and Transplantation Network, 59 Fed. Reg 46482, 46497 (proposed Sept. 8, 1994) (to be codified at 42 C.F.R. pt. 121).

42 Id. at 46486.

43 Id.

44 Id. at 46483.

45 See e.g., Letter from J. Stevenson Bynon, Univ. of Ala. at Birmingham, to Bruce Reed, Assistant to the President for Domestic Pol’y, White House (May 2, 1997) (on file with author) (“As long as there is a shortage of available organs, there will be no ideal solution, but in our view, local primacy operates as a reasonable balance among several goals and results in the best overall outcome for patients[.]”); Letter from David M. Matter to Bruce R. Lindsey, Ass’t to the President & Deputy White House Couns., White House (Apr. 15, 1997) (on file with author) (“The current UNOS system of organ allocation, which traps livers in 70 small geographic areas, is, at the very least, ethically questionable and, quite simply, bad public policy.”); Letter from David M. Matter to President William J. Clinton (Feb. 7, 1997) (on file with author) (“I don’t want in any way to abuse our friendship over a substantive policy issue, but I feel so strongly about this that I just had to bring it to your attention again with a personal letter.”); Letter from Charles E. Fiske, Nat’l Transplant Action Committee, to Bruce Reed, Deputy Assistant to the President for Domestic Pol’y, White House (Apr. 14, 1997) (“It’s my hope that through the intervention of your office, public policy can be developed in a way that reflects the best interest of all citizens no matter where they live.”).

46 Organ Procurement and Transplantation Network, 63 Fed. Reg. 16296 (Apr. 2, 1998) (to be codified at 42 C.F.R. pt. 121).

47 Id. at 16298.

48 Id.; see also id. (quoting the Report of the Task Force on Organ Transplantation and stating that “organs are a national resource”); id. at 16300 (“Human organs that are given to save lives are a public resource and a public trust.”). A “public trust” is a resource held by the government “as sovereign” in trust for public use. See Ill. Cent. RR. Co. v. Ill., 146 U.S. 387, 458–59 (1892). Notably, federal regulations provide that “[c]ontracts shall not be used for the performance of inherently governmental functions,” and further establish that “inherently governmental functions” include “[t]he administration of public trusts.” 48 C.F.R. § 7.503(a), (c)(19) (2021). But UNOS, the entity tasked with administering the so-called “public trust” of donated organs, states that it “is the private, non-profit organization that serves as the nation’s organ transplant system . . . under contract with and oversight by the federal government.” The national organ transplant system, United Network for Organ Sharing, https://unos.org/about/national-organ-transplant-system. This position is in tension with the idea that donated organs are a public trust.

49 Organ Procurement and Transplantation Network, 63 Fed. Reg. at 16298.

50 Id. at 16335.

51 Id. at 16309.

52 Id.

53 Inst. of Med., Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 3 (1999).

54 See Pub. L. No. 105-277, § 213, 112 Stat. 2681, 359–60 (1998).

55 Inst. of Med., Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 3 (1999).

56 Id. at 10.

57 Organ Procurement and Transplantation Network, 64 Fed. Reg. 56650, 56656 (Oct. 20, 1999) (to be codified at 42 C.F.R. pt. 121).

58 Id.

59 42 C.F.R. § 121.8(a)(1), (2), (5) (2021).

60 Id. § 121.8(a)(8).

61 Id. § 121.4(a)(3).

62 The Organ Transplant Process, Health Res. & Servs. Admin., https://www.organdonor.gov/learn/process/transplant-process (last reviewed Apr. 2021).

63 General Considerations in Assessment for Transplant Candidacy, Organ Procurement and Transplantation Network, https://optn.transplant.hrsa.gov/resources/ethics/general-considerations-in-assessment-for-transplant-candidacy; see David Weill, Opinion: Of course unvaccinated people should be barred from receiving transplant organs, Wash. Post (Oct. 14, 2021, 9:00 AM) (“During the course of my career, I have been closely involved in carefully considering the hundreds of factors that go into making good decisions when it comes to who among our patients . . . is listed for a life-saving transplant.”).

64 For example, many transplant centers use body mass index as a selection criterion for transplant but the upper range may vary, with some hospitals excluding patients with BMIs that exceed 35, while others transplant patients with a BMI up to 45. Krista L. Lentine et al., Obesity and Kidney Transplant Candidates: How Big is Too Big For Transplantation?, 36 Am. J. Nephrology 575 (2012), https://www.karger.com/Article/PDF/345476. Recently, some transplant centers have required patients to receive the COVID-19 vaccine to be added to or kept on the transplant waitlist. See David Weill, Opinion: Of course unvaccinated people should be barred from receiving transplant organs, Wash. Post (Oct. 14, 2021, 9:00 AM).

65 The Organ Transplant Process, Health Res. & Serv. Admin., https://www.organdonor.gov/learn/process/transplant-process (last reviewed Apr. 2021).

66 This factor considers the distance from the donor hospital to the transplant center where the patient is registered for the waitlist. This does not take into consideration where the patient lives or whether the donor or the donated organ are first moved to an organ procurement center before being allocated to the recipient. How we match organs, United Network for Organ Sharing, https://unos.org/transplant/how-we-match-organs (last visited Apr. 26, 2022).

67 A survival benefit-based allocation system seeks to reduce mortality rates in the patient population as a whole by prioritizing patients based on the lifetime that they will gain if they receive a transplant. See D.E. Schaubel et al., Survivor Benefit-Based Diseased-Donor Liver Allocation, 9 Am. J. Transplant 970, 971 (2009).

68 How we match organs, United Network for Organ Sharing, https://unos.org/transplant/how-we-match-organs (last visited Apr. 26, 2022).

69 Id.

70 Id.

71 Nada Hassanein, For Black Americans, lack of ‘rigorous scientific evidence’ led to test that leaves some off kidney transplant list, USA Today (Oct. 13, 2021, 5:01 AM). In October 2021, the American Kidney Fund endorsed a more equitable metric proposed by a national task force. Id.

72 Model for End-stage Liver Disease (MELD), UpToDate, https://www.uptodate.com/contents/model-for-end-stage-liver-disease-meld (last updated Feb. 4, 2021).

73 Id.

74 See Jayme E. Locke et al., Quantifying Sex-Based Disparities in Liver Allocation, 155 JAMA Surgery 1, 8 (May 20, 2020), https://jamanetwork.com/journals/jamasurgery/fullarticle/2765985 (finding that “MELD score is imperfect and has exacerbated certain inequities”); Lara C. Pullen, Lawsuits Drive Transplant Community Debate Over Liver Allocation, 19 Am. J. Transplantation 1251, 1254 (2019), https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.15382 (“Patients in South Carolina with MELD scores of 28 are dying on the waitlist, whereas those in New York are not.”); cf. Elizabeth C. Verna et al., Center-related Bias in MELD Scores Within a Liver Transplant UNOS Region: A Call for Standardization, 104 Transplantation 1396 (2020) (finding significant differences in MELD scores for the same patient based on different laboratories within a single geographic region, which “could lead to dramatically different access to transplant based upon laboratory technique rather than upon the inherent risk of poor outcomes.”).

75 W. R. Kim et al., OPTN/SRTR 2017 Annual Data Report: Liver, 19 Am. J. Transplantation 184 (2019).

76 See Elizabeth L. Godfrey et al., The Decreasing Predictive Power of MELD in an Era of Changing Etiology of Liver Disease, 19 Am. J. Transplantation 3299 (2019), https://onlinelibrary.wiley.com/doi/10.1111/ajt.15559 (finding that the accuracy of MELD in predicting mortality has decreased since it was originally implemented because the MELD score does not correlate with mortality as well for clinical conditions that are increasing in prevalence).

77 Transplant process, Organ Procurement & Transplantation Network, https://optn.transplant.hrsa.gov/learn/about-transplantation/transplant-process/ (last visited Apr. 26, 2022).

78 See Kristen L. King et al., Major Variation across Local Transplant Centers in Probability of Kidney Transplant for Wait-Listed Patients, 31 Am. Soc’y Nephrology 2900, 2906 (2020) (“There are substantial differences across centers in the criteria used to determine offer acceptance.”).

79 General Considerations in Assessment for Transplant Candidacy, Organ Procurement & Transplantation Network, https://optn.transplant.hrsa.gov/resources/ethics/general-considerations-in-assessment-for-transplant-candidacy (last visited Apr. 26, 2022).

80 Financial resources are a consideration to identify which patients can afford the transplant surgery itself, but perhaps more importantly are considered in determining which patients can afford the long-term post-transplant care and immunosuppression medication. Because donated organs are such a scarce resource, the transplant system seeks to avoid “wasting” organs on patients who are unable to take care of the organs, whether that is because of an existing substance abuse disorder, for example, or the inability to afford the necessary medications to maintain the donated organ’s function. Kidney transplantation is especially unique because Medicare covers the costs of treatment for end-stage kidney disease, regardless of the age or income of the patient. Thus, in theory, the financial resources of a patient should not factor into patient candidacy for kidney transplant. However, for patients who receive Medicare only because of kidney failure, coverage ends 36 months after kidney transplant, leaving patients to foot the bill for lifelong immunosuppression drugs costing thousands of dollars per month. See Centers for Medicare and Medicaid Services, CMS Product No. 11360, Medicare’s Coverage of Dialysis & Kidney Transplant Benefits, (2021) https://www.medicare.gov/Pubs/pdf/11360-Medicare-Dialysis-Kidney-Transplant.pdf. As a result, transplant programs still consider the financial resources of a patient when determining who is appropriate to list for a kidney transplant, even though the surgery itself is covered by Medicare. The difference in states’ adoption of Medicaid expansion may also create inequities in the impact of financial resources upon an individual hospital’s considerations for inclusion on the waitlist.

81 General Considerations in Assessment for Transplant Candidacy, Organ Procurement & Transplantation Network, https://optn.transplant.hrsa.gov/resources/ethics/general-considerations-in-assessment-for-transplant-candidacy (last visited Apr. 26, 2022).

82 42 C.F.R. § 121.8 (2021).

83 See Putting Patients First: Resolving Allocation of Transplant Organs: Joint Hearing Before the Subcomm. on Health & Env’t of the H. Comm. on Commerce & the S. Comm. on Labor & Hum. Res., 105th Cong. (1998).

84 Inst. of Med., Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 11 (1999).

85 Organ Procurement and Transplantation Network, 59 Fed. Reg 46482, 46484 (proposed Sept. 8, 1994) (to be codified at 42 C.F.R. pt. 121).

86 Id. The rulemaking cited a research study sponsored by HHS which concluded “Blacks in America have a history of suffering worse health care outcomes and having greater problems in gaining access to the health care system than white Americans * * *. Yet kidney transplantation causes special concern about issues of fairness, because of federal entitlement to medical care services . . . .” Id. But see supra note 80 (explaining that Medicare beneficiaries may still be rejected for transplant for socioeconomic considerations because of concerns regarding the future costs of immunosuppression medications).

87 As noted above, although OPTN and UNOS do not track patient income, hospitals and transplant centers have discretion to evaluate a patient’s financial resources when making waitlist determinations.

88 Letter from Clive O. Callender, Professor of Surgery, Howard Univ. Hosp., to Donna Shalala, Sec’y. U.S. Dep’t of Health & Hum. Servs. (Jan. 22, 1997) (on file with author).

89 See, e.g., Jesse D. Schold et al., Failure to Advance Access to Kidney Transplantation over Two Decades in the United States, 32 J. Am. Soc’y Nephrology 913 (2021); Cindy L. Bryce et al., The Effect of Race, Sex, and Insurance Status on Time-to-Listing Decisions for Liver Transplantation, 2010 J. Transplantation 1 (2010).

90 R. E. Patzer et al., The Role of Race and Poverty on Steps to Kidney Transplantation in the Southeastern United States, 12 Am. J. Transplantation 358 (2012).

91 Id.

92 David A. Axelrod et al., Rates of Solid-Organ Wait-listing, Transplantation, and Survival Among Residents of Rural and Urban Areas, 299 J. Am. Med. Ass’n 202 (2008).

93 Jesse D. Schold et al., Failure to Advance Access to Kidney Transplantation over Two Decades in the United States, 32 J. Am. Soc’y Nephrology 913 (2021). One single-center study found that racial differences in access to the transplant waitlist were no longer statistically significant when adjustment was made for socioeconomic factors, but the researchers still observed significant differences in access to transplantation based on patient income levels and insurance coverage. Jesse D. Schold et al., Barriers to Evaluation and Wait Listing for Kidney Transplantation, 6 Clin. J. Am. Soc’y Nephrology 1760, 1763 (2011), https://cjasn.asnjournals.org/content/clinjasn/6/7/1760.full.pdf?with-ds=yes.

94 Sumit Mohan et al., Kidney transplantation and the intensity of poverty in the contiguous United States, 98 Transplantation 640 (2014), https://journals.lww.com/transplantjournal/Fulltext/2014/09270/Kidney_Transplantation_and_the_Intensity_of.10.aspx.

95 Id.

96 Elizabeth C. Miller, Public Comment Proposal: Liver and Intestine Distribution Using Distance from Donor Hospital, OPTN/UNOS Liver & Intestine Transplantation Comm. 31 (2018), https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf.

97 The OPTN has previously stated that it could not rely on county-level data because each individual within the county may not have the same disadvantages as the community at large. Elizabeth C. Miller, Briefing Paper: Liver and Intestine Distribution Using Distance from Donor Hospital, OPTN/UNOS Liver & Intestine Transplantation Comm. 21 (2018), https://optn.transplant.hrsa.gov/media/2766/liver_boardreport_201812.pdf. (“[T]he measures of socio-economic status are not tracked at a patient level, and often areas where some of the population is very wealthy also include people in poverty.”). However, the cited research suggests that even though the degree of inequality may vary on an individual level, those living in low-income counties have decreased access to transplant compared to those in more affluent areas. For recent allocation rule changes, the OPTN has indicated that it has studied the rule’s effect on socioeconomically disadvantaged populations by examining predicted changes in transplant rate by candidate payment status (i.e., Medicare, Medicaid, private insurance). Scott Castro, Briefing to the OPTN Board of Directors on Elimination of DSA and Region from Kidney Allocation Policy, OPTN/UNOS Kidney Transplantation Comm. 28–29 (2019), https://optn.transplant.hrsa.gov/media/3406/kidney_bp-update-121019.pdf. Payment status is at best an imperfect proxy for socioeconomic status, especially in assessing the nationwide impact of a policy change intended to alter the geographic allocation of donated organs. If a policy is predicted to result in a larger number of Medicaid recipients receiving transplants, it is unclear if the policy is actually broadening access to transplant for low-income communities or merely sending more organs to states that adopted Medicaid expansion.

98 Jesse D. Schold et al., The association of community health indicators with outcomes for kidney transplant recipients in the United States, 147 Archives Surgery 520, 523 (2012), https://jamanetwork.com/journals/jamasurgery/fullarticle/1150117.

99 K. Ross et al., Sociodemographic Determinants of Waitlist and Posttransplant Survival Among End-Stage Liver Disease Patients, 17 Am. J. Transplantation 2879, 2885 (2017), https://onlinelibrary.wiley.com/doi/10.1111/ajt.14421.

100 Hannah Wesselman et al., Social Determinants of Health and Race Disparities in Kidney Transplant, 16 Clin. J. Am. Soc. Nephrology 262 (2021), https://cjasn.asnjournals.org/content/clinjasn/16/2/262.full.pdf?with-ds=yes; Peter P. Reese et al., Eliminating Racial Disparities in Access to Living Donor Kidney Transplantation: How Can Centers Do Better?, 59 Am. J. Kidney Diseases 751 (2012), https://www.ajkd.org/article/S0272-6386%2812%2900564-1/fulltext; Tanjala S. Purnell et al., Association of Race and Ethnicity With Live Donor Kidney Transplantation in the United States From 1995 to 2014, 319 J. Am. Med. Ass’n 49 (2018), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833543/.

101 Peter P. Reese et al., Racial disparities in preemptive waitlisting and deceased donor kidney transplantation: Ethics and solutions, 21 Am. J. Transplantation 958 (2021).

102 Id.

103 Jayme E. Locke, et al., Apolipoprotein L1 and Chronic Kidney Disease Risk in Young Potential Living Kidney Donors, 276 Annals Surgery 1161 (2018).

104 Although there is little research on the experience of multiracial patients in accessing transplantation, these patients experience challenges when seeking bone marrow transplants, which require even more genetic similarity between donor and recipient than organ transplants due to the risk that the new white blood cells will attack the host body. According to the national Be the Match bone marrow registry, only about 3% of donors identify as mixed race, resulting in a much smaller chance of finding a match than White patients. Ted C. Bergstrom et al., Stem Cell Donor Matching for Patients of Mixed Race, 12 B.E. J. Econ. Analysis & Pol’y 19 (2012).

105 Peter P. Reese et al., Racial disparities in preemptive waitlisting and deceased donor kidney transplantation: Ethics and solutions, 21 Am. J. Transplantation 958 (2021).

106 Id.

107 Katherine I. Cahn-Fuller & Brendan Parent, Transplant eligibility for patients with affective and psychotic disorders: a review of practices and a call for justice, 18 BMC Med. Ethics 72 (2017), https://bmcmedethics.biomedcentral.com/track/pdf/10.1186/s12910-017-0235-4.pdf.

108 Sarah Faeder et al., Psychiatric aspects of organ transplantation and donation, 28 Current. Op. Psychiatry 357 (2015).

109 Kelsey N. Berry et al., Should Lack of Social Support Prevent Access to Organ Transplantation?, 11 Am. J. Bioethics 13 (2019).

110 Keren Ladin et al., Excluding patients from transplant due to social support: Results from a national survey of transplant providers, 19 Am. J. Transplantation 193 (2018), https://onlinelibrary.wiley.com/doi/10.1111/ajt.14962.

111 David A. Axelrod et al., Rates of Solid-Organ Wait-listing, Transplantation, and Survival Among Residents of Rural and Urban Areas, 299 J. Am. Med. Ass’n 202 (2008).

112 Notably, once rural residents are placed on kidney and liver transplant waiting lists, the disparities between wait times of urban and rural residents are not statistically significant. Id.

113 Id.

114 Id. at 205.

115 Id.

116 Luca Cicalese et al., Increased Risk of Death for Patients on the Waitlist for Liver Transplant Residing at Greater Distance from Specialized Liver Transplant Centers in the United States, 100 Transplantation 2146 (2016), https://journals.lww.com/transplantjournal/Fulltext/2016/10000/Increased_Risk_of_Death_for_Patients_on_the.23.aspx.

117 See Alex Kacik, Lacking specialist access drives health disparities, Mod. Healthcare (Dec. 9, 2019, 4:00 PM), https://www.modernhealthcare.com/providers/lacking-specialist-access-drives-health-disparities.

118 See, e.g., K. Ladin et al., Geographic Disparities in Liver Availability: Accidents of Geography or Consequences of Poor Social Policy?, 17 Am. J. Transplantation 2277, 2282 (2017), https://onlinelibrary.wiley.com/doi/10.1111/ajt.14301 (“[B]y redistributing a single advantage (i.e. available organs) without redistributing any of the disadvantages (e.g. preventable death), existing disparities may be exacerbated.”).

119 Organ Procurement and Transplantation Network, 63 Fed. Reg. 16296, 16298 (Apr. 2, 1998) (to be codified at 42 C.F.R. pt. 121).

120 See Elizabeth C. Miller, Public Comment Proposal: Liver and Intestine Distribution, OPTN/UNOS Liver & Intestine Transplantation Comm. 4–5 (2018), https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf; Scott Castro, Public Comment Proposal: Eliminate the Use of DSA and Region from Kidney Allocation Policy, OPTN/UNOS Kidney Transplantation Comm. 19–21 (2019), https://optn.transplant.hrsa.gov/media/3104/kidney_publiccomment_201908.pdf.

121 Inst. of Med., Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 61, 88 (1999).

122 See Raymond J. Lynch et al., Moving past “think local, act global”: A perspective on geographic disparity, 19 Am. J. Transplantation 1907 (2018), https://onlinelibrary.wiley.com/doi/10.1111/ajt.15079; Kristopher P. Croome et al., Intraregional model for end-stage liver disease score variation in liver transplantation: Disparity in our own backyard, 24 Liver Transplantation 488 (2018), https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/lt.25021; cf. Inst. of Med., Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 66 (1999) (finding that “numerous factors influence the waiting times” of patients).

123 Kristen L. King et al., Major Variation across Local Transplant Centers in Probability of Kidney Transplant for Wait-Listed Patients, 31 J. Am. Soc’y Nephrology 2900, 2905 (2020), https://jasn.asnjournals.org/content/jnephrol/31/12/2900.full.pdf?with-ds=yes.

124 Id.

125 Id. at 2906.

126 Id. at 2905.

127 OPO Services, Ass’n of Organ Procurement Orgs., https://www.aopo.org/opo-services/ (last visited Apr. 26, 2022).

128 Medicare and Medicare Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations, 85 Fed. Reg. 77898 (Dec. 2, 2020) (to be codified at 42 C.F.R. pt. 486).

129 Id.

130 Reforming Organ Donation in America: Saving 25,000 Lives per Year and $13 Billion in Taxpayer Funds over Five Years, The Bridgespan Group, at 5, https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.

131 Letter from Charles E. Grassley, Ron Wyden, Todd Young, & Benjamin L. Cardin, U.S. Senate Comm. on Fin., to Brian Shepard, Chief Exec. Officer, United Network for Organ Sharing (Feb. 10, 2020), https://www.finance.senate.gov/download/grassley-wyden-young-cardin-to-unos_-information-request-on-organ-transplant-system.

132 Reforming Organ Donation in America: Saving 25,000 Lives per Year and $13 Billion in Taxpayer Funds over Five Years, The Bridgespan Group, at 5, https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.

133 Id.

134 Medicare and Medicare Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations, 85 Fed. Reg. 77898, 77899 (Dec. 2, 2020) (to be codified at 42 C.F.R. pt. 486).

135 Reforming Organ Donation in America: Saving 25,000 Lives per Year and $13 Billion in Taxpayer Funds over Five Years, The Bridgespan Group, at 11–12, https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.

136 Raymond J. Lynch et al., Moving past “think local, act global”: A perspective on geographic disparity, 19 Am. J. Transplantation 1907 (2019), https://onlinelibrary.wiley.com/doi/10.1111/ajt.15079.

137 Elizabeth C. Miller, Public Comment Proposal: Liver and Intestine Distribution, OPTN/UNOS Liver & Intestine Transplantation Comm. 4–5 (2018), https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf; Scott Castro, Public Comment Proposal: Eliminate the Use of DSA and Region from Kidney Allocation Policy, OPTN/UNOS Kidney Transplantation Comm. 19–21 (2019), https://optn.transplant.hrsa.gov/media/3104/kidney_publiccomment_201908.pdf.

138 See Geographic distribution efforts ongoing, UNOS (Feb. 11, 2019), https://unos.org/news/geographic-distribution-efforts-ongoing; Maggie Koerth, Our Organ Donation System Is Unfair. The Solution Might Be Too, FiveThirtyEight (Apr. 3, 2019, 5:21 PM), https://fivethirtyeight.com/features/our-organ-donation-system-is-unfair-the-solution-might-be-too/ (describing the controversy of organ allocation changes); Benjamin J. McMichael, Stealing Organs?, 97 Ind. L.J. 135, 152–57 (2022), https://www.repository.law.indiana.edu/cgi/viewcontent.cgi?article=11436&context=ilj (describing changes to liver allocation policy); Anji E. Wall et al., Cost Analysis of Liver Acquisition Fees Before and After Acuity Circle Policy Implementation, 156 JAMA Surgery 1051 (2021) (describing higher costs associated with the change in liver allocation policy).

139 This is consistent with the advice that Carol H. Rasco, Assistant to the President for Domestic Policy, gave to President Clinton in December 1996. In a memo, she told the President “the most important thing you can do on this issue is, quite frankly, urge people to become organ donors.” Memorandum from Carol H. Rosco, Assistant to President for Domestic Pol’y, White House, to William J. Clinton, President of the U.S. (Dec. 18, 1996) (on file with author).

140 See supra note 139; cf. Kimberly Kindy et al., Lives Lost, Organs Wasted, Wash. Post (Dec. 20, 2018), https://www.washingtonpost.com/graphics/2018/national/organ-transplant-shortages/ (observing that the organ transplant system has failed to increase organ supply); Letter from Charles E. Grassley, Chairman, & Todd Young, Member, U.S. Senate Comm. on Fin., to Joanne M. Chiedi, Acting Inspector Gen. (Dec. 18, 2019), https://www.finance.senate.gov/imo/media/doc/CEG.Young%20to%20HHSOIG%20(OPO%20Oversight)%20Dec.18.2019.pdf (questioning the effectiveness and independence of UNOS and identifying significantly underperforming OPOs); Press Release, Chuck Grassley, Grassley, Wyden Subpoena The United Network For Organ Sharing As Part Of Continued Investigation Into U.S. Organ Transplant System, https://www.grassley.senate.gov/news/news-releases/grassley-wyden-subpoena-the-united-network-for-organ-sharing-as-part-of-continued-investigation-into-us-organ-transplant-system (noting that “various gaps and conflicts in UNOS management of the organ donation system”).

141 42 U.S.C. § 274(b)(2)(K) (2021).

142 Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations, 85 Fed. Reg. 77898 (Dec. 2, 2020) (effective Feb. 1, 2021, except for amendment number 3 (further amending § 486.302), which is effective July 31, 2022).

143 Seth J. Karp et al., Fixing Organ Donation: What Gets Measured, Gets Fixed, JAMA Surgery (May 27, 2020).

144 Lenny Bernstein, Organ collection agencies told to improve performance or face tighter rules, Wash. Post (May 4, 2021, 6:34 PM), https://www.washingtonpost.com/health/organ-collection-agencies-told-to-improve-performance-or-face-tighter-rules/2021/05/04/68847bce-ad06-11eb-acd3-24b44a57093a_story.html.

145 Organ Procurement Organizations Conditions for Coverage, 85 Fed. Reg. at 77898; see Seth J. Karp et al., Fixing Organ Donation: What Gets Measured, Gets Fixed, JAMA Surgery (May 27, 2020).

146 See, e.g., David C. Mulligan, CMS’s new rules on organ donation and transplantation ‘will bring chaos’, STAT (Nov. 23, 2020), https://www.statnews.com/2020/11/23/organ-donation-transplantation-new-rules-will-bring-chaos (Then-President of the UNOS and OPTN Boards of Directors, David C. Mulligan, arguing that the CMS revisions “will lead the world’s best organ donation transplant system into significant uncertainty and chaos”). Compare Editorial, Regarding America’s world-beating national organ transplant system: If it ain’t broke, don’t fix it, Dall. Morning News (Feb. 9, 2021, 2:00 AM), https://www.dallasnews.com/opinion/editorials/2021/02/09/regarding-americas-world-beating-national-organ-transplant-system-if-it-aint-broke-dont-fix-it (quoting UNOS CEO, Brian Shepard, saying that the CMS rule change “creates more uncertainty and risk than it does quality improvement”) with Patti Niles, Opinion, The U.S. organ donation system needs transparency and accountability, Dall. Morning News (Feb. 12, 2021, 1:30 AM), https://www.dallasnews.com/opinion/commentary/2021/02/12/the-us-organ-donation-system-needs-transparency-and-accountability (CEO of the Dallas-based OPO urging that the transplant system is “broken, and reforms are absolutely necessary. Patients are dying every day due to a lack of transparency and accountability, and we have a duty to fix that.”).

147 Mark E. Neumann, Organ procurement trade group loses members as US House committee begins investigation, Healio News (May 13, 2021), https://www.healio.com/news/nephrology/20210513/organ-procurement-trade-group-loses-members-as-us-house-committee-begins-investigation; see The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients: Hearing Before the H. Comm. on Oversight & Reform, 117th Cong. 18 (2021), https://oversight.house.gov/sites/democrats.oversight.house.gov/files/Wadsworth%20Testimony.pdf (statement of Matthew D. Wadsworth, President & CEO, Life Connection of Ohio).

148 FAS Announces Organ Procurement Organization Innovation Cohort, Fed’n of Am. Scientists (May 4, 2021), https://fas.org/press-release/fas-announces-organ-procurement-organization-innovation-cohort/; see also Brianna L. Doby et al., Improving OPO performance through national data availability, 19 Am. J. Transplantation 2675, 2676 (2019), https://onlinelibrary.wiley.com/doi/10.1111/ajt.15508 (concluding that improved data transparency “would likely yield insights that can improve organ donation rates and reduce variability in OPO performance by ensuring accountability and identifying best practices”).

149 See, e.g., Seth J. Karp et al., Fixing Organ Donation: What Gets Measured, Gets Fixed, JAMA Surgery (May 27, 2020). Additionally, on January 1, 2021, financial accountability began under CMS’s Kidney Care Choices (KCC) Model. The KCC Model builds upon the existing Comprehensive End Stage Renal Disease Care (CEC) Model structure in incentivizing providers to manage the care for Medicare beneficiaries with chronic kidney disease and end stage renal disease. Specifically, the KCC Model incorporates financial incentives to promote greater utilization of transplants, and aims to support beneficiaries before, during, and after the transplant. Kidney Care Choices (KCC) Model, CMS.gov, https://innovation.cms.gov/innovation-models/kidney-care-choices-kcc-model (last updated Jan. 13, 2022).

150 Goal 2, Organ Procurement & Transplantation Network, https://optn.transplant.hrsa.gov/governance/strategic-plan/goal-2/ (last visited Apr. 26, 2022).

151 In fact, UNOS’s own data shows that after changing allocation policy in a manner urged by UNOS to eliminate certain geographic boundaries, the UNOS metric of equity in access to transplant remains unchanged. In lung transplant, for example, which underwent a fundamental change in organ allocation in 2017, UNOS today reports that “[T]hough the overall disparity metric for access to deceased donor lung transplants among candidates on the waiting list has fluctuated over the past decade, the overall level of disparity in 2019 remains about the same as it was in 2010.” Equity in Access to Transplant, United Network for Organ Sharing, https://insights.unos.org/equity-in-access/ (last visited Apr. 26, 2022). Moreover, “the factor most associated with unintended disparities in deceased donor lung transplant access” is the candidate’s geographic region (specifically, the OPO service area within which they reside). As UNOS explains, its analysis does not reveal the cause of the disparities, “which may be explained by a combination of factors such as geographic variation in inherent organ supply relative to demand; transplant hospital offer acceptance practice variation; OPO performance in maximizing the availability of organs; and (historically) allocation policy priority for ‘local’ candidates.” In other words, these variations are not solely attributable to organ supply, and four years after changes to the lung allocation policy, geographic disparities in access persist.

152 Benjamin J. McMichael, Stealing Organs?, 97 Ind. L.J. 135, 193 (2022); see also id. at 195 (“[T]he evidence developed here suggests that the move to a national allocation system was not only unsupported by reliable evidence but may have been the result of a concerted effort to effect manipulation of the allocation system on a grander scale.”); see also Press Release, Roy Blunt: U.S. Senator for Mo., Blunt, Moran Demand HHS Reverse Flawed Liver Allocation Policy (Dec. 21, 2021), https://www.blunt.senate.gov/news/press-releases/blunt-moran-demand-hhs-reverse-flawed-liver-allocation-policy (stating that email communications from UNOS personnel “show a pattern of collusion” and “include profane and disparaging comments about people living in the South, demonstrating a clear bias against these areas in the policymaking process”).

153 42 C.F.R. § 121.8(a)(5) (2022).

154 In discussing its regulatory requirements under the Final Rule to “promote patient access” to organ transplantation, the OPTN/UNOS has concluded that it does not have responsibility for patients who are not on the waitlist. See Elizabeth C. Miller, Public Comment Proposal: Liver and Intestine Distribution Using Distance from Donor Hospital, OPTN/UNOS Liver & Intestine Transplantation Comm. 31 (2018), https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf (“In considering patient access, the OPTN has interpreted these requirements to apply to patients who are registered for organ transplantation—as opposed to all patients with end stage organ failure, who may or may not be registered . . . .”); Elizabeth C. Miller, Briefing Paper: Liver and Intestine Distribution Using Distance from Donor Hospital, OPTN/UNOS Liver & Intestine Transplantation Comm. 46 (2018), https://optn.transplant.hrsa.gov/media/2766/liver_boardreport_201812.pdf (“The group of patients for whom the proposal is intended to promote access are liver and intestine candidates on the waitlist, as this is an allocation policy developed under the auspices of §121.8(a) of the OPTN Final Rule . . . .”). Notwithstanding this position, UNOS’s CEO recently acknowledged that UNOS should be “[t]hinking beyond the waitlist” and suggested the need for improvement in the “ability to access the waitlist” to achieve “the ultimate form of equity.” Brian Shepard, Equity means providing a transplant for every single patient that needs one, United Network for Organ Sharing Blog (Aug. 17, 2021), https://unos.org/blog/equity-transplant-for-every-patient-that-needs-one/. To date, however, UNOS has not considered the inequity in waitlist access in its allocation policy development.

155 Jerry McCauley, The road to racial equity in kidney transplantation, Voices in Transplant (Aug. 18, 2020), https://unos.org/voice/the-road-to-racial-equity-in-kidney-transplantation/.

156 UNOS has also announced a “feasibility study involving the collection of data related to social determinants of health.” UNOS to study data collection related to social determinants of health, UNOS (Feb. 8, 2021), https://unos.org/news/sdoh-data-collection/.

157 JoNel Aleccia, How Lifesaving Organs For Transplant Go Missing in Transit, Kaiser Health News (Feb. 10, 2020), https://khn.org/news/how-lifesaving-organs-for-transplant-go-missing-in-transit/.

158 Id.

159 Id.

160 History of GPS satellites and commercial GPS tracking, Geotab (June 23, 2020), https://www.geotab.com/blog/gps-satellites/.

161 JoNel Aleccia, How Lifesaving Organs For Transplant Go Missing in Transit, Kaiser Health News (Feb. 10, 2020), https://khn.org/news/how-lifesaving-organs-for-transplant-go-missing-in-transit/; History of GPS satellites and commercial GPS tracking, Geotab (June 23, 2020), https://www.geotab.com/blog/gps-satellites/.

162 History of GPS satellites and commercial GPS tracking, Geotab (June 23, 2020), https://www.geotab.com/blog/gps-satellites/.

163 JoNel Aleccia, How Lifesaving Organs For Transplant Go Missing in Transit, Kaiser Health News (Feb. 10, 2020), https://khn.org/news/how-lifesaving-organs-for-transplant-go-missing-in-transit/.

164 Id.

165 See Luke J. DeRoos et al., Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant, 2 JAMA Network Open 1 (Oct. 2, 2019), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2752089 (observing that even a presumed consent model “is not likely to solve organ shortages in the United States).

166 David K.C. Cooper et al., Will the Pig Solve the Transplantation Backlog?, 53 Ann. Rev. Med. 133 (2002).

167 Id.

168 Id.

169 David K.C. Cooper et al., Will the Pig Solve the Transplantation Backlog?, 53 Ann. Rev. Med. 133 (2002); Karen Weintraub, A CRISPR startup is testing pig organs in monkeys to see if they’re safe for us, MIT Tech. Rev. (June 12, 2019), https://www.technologyreview.com/2019/06/12/239014/crispr-pig-organs-are-being-implanted-in-monkeys-to-see-if-theyre-safe-for-humans; Kelly Servick, Eyeing organs for human transplants, companies unveil the most extensively gene-edited pigs yet, Sci. (Dec. 19, 2019), https://www.sciencemag.org/news/2019/12/eyeing-organs-human-transplants-companies-unveil-most-extensively-gene-edited-pigs-yet.

170 Nancy Lapid, U.S. surgeons successfully test pig kidney transplant in human patient, Reuters (Oct. 20, 2021), https://www.reuters.com/business/healthcare-pharmaceuticals/us-surgeons-successfully-test-pig-kidney-transplant-human-patient-2021-10-19/.

171 Press Release, NYU Langone Hosps., Progress in Xenotransplantation Opens Door to New Supply of Critically Needed Organs (Oct. 21, 2021), https://nyulangone.org/news/progress-xenotransplantation-opens-door-new-supply-critically-needed-organs.

172 Nancy Lapid, U.S. surgeons successfully test pig kidney transplant in human patient, Reuters (Oct. 20, 2021), https://www.reuters.com/business/healthcare-pharmaceuticals/us-surgeons-successfully-test-pig-kidney-transplant-human-patient-2021-10-19/.

173 Press Release, NYU Langone Hosps., Progress in Xenotransplantation Opens Door to New Supply of Critically Needed Organs (Oct. 21, 2021), https://nyulangone.org/news/progress-xenotransplantation-opens-door-new-supply-critically-needed-organs.

174 Roni Caryn Rabin, Patient in Groundbreaking Heart Transplant Dies, N.Y. Times (Mar. 9, 2022), https://www.nytimes.com/2022/03/09/health/heart-transplant-pig-bennett.html.

175 Id.

176 See Jonathan Lambert, What does the first successful test of a pig-to-human kidney transplant mean?, Sci. News (Oct. 22, 2021), https://www.sciencenews.org/article/xenotransplantation-pig-human-kidney-transplant.

177 Peta Owens-Liston, The First Artificial Heart, 30 Years Later, Univ. of Utah Health (Dec. 2, 2012, 1:00 AM), https://healthcare.utah.edu/healthfeed/postings/2012/12/120212ArtificialHeart30YearsLater.php.

178 New Generation Artificial Heart Implanted in Patient at Duke – First in U.S., Duke Univ. Sch. of Med. (July 16, 2021), https://medschool.duke.edu/about-us/news-and-communications/med-school-blog/new-generation-artificial-heart-implanted-patient-duke-%E2%80%93-first-us.

179 Id.

180 Tina Daunt, Artificial kidney could supplant dialysis, the decades-old standard treatment for kidney failure, UCLA Health (Jan. 29, 2021), https://connect.uclahealth.org/2021/01/29/artificial-kidney-could-supplant-dialysis-the-decades-old-standard-treatment-for-kidney-failure/.

181 About the Artificial Kidney Prize, KidneyX, https://akp.kidneyx.org/about-the-artificial-kidney-prize/ (last visited Apr. 26, 2022).

182 Id.

183 Kat Jerich, $10M artificial kidney prize now live via HHS, American Society of Nephrology, Healthcare IT News (Jan. 08, 2021, 9:10 AM), https://www.healthcareitnews.com/news/10m-artificial-kidney-prize-now-live-hhs-american-society-nephrology.

184 Mohammad Abuzeineh, Telemedicine in the Care of Kidney Transplant Recipients With Coronavirus Disease 2019: Case Reports, 52 Transplantation Proc. 2620 (2020), https://reader.elsevier.com/reader/sd/pii/S0041134520326294?token=02BA48D15822E187B6343B34B1973AD84D8589C71FCA5003DAB61E7B9B34F09DD44922244B077A07DF52073BA10564F8&originRegion=us-east-1&originCreation=20220117033617.

185 Beatrice P. Concepcion & Rachel C. Forbes, The Role of Telemedicine in Kidney Transplantation: Opportunities and Challenges, 1 Kidney360 420 (2020), https://kidney360.asnjournals.org/content/kidney360/1/5/420.full.pdf?with-ds=yes.

186 Id.

187 Eric Wicklund, Telemedicine Gives Northwell Health a Better Path to Organ Donations, MHealth Intelligence (Feb. 8, 2018), https://mhealthintelligence.com/news/telemedicine-gives-northwell-health-a-better-path-to-organ-donations.

188 Binu V. John et al., Use of Telehealth Expedites Evaluation and Listing of Patients Referred for Liver Transplantation, 18 Clinical Gastroenterology & Hepatology 1822 (2020), https://www.cghjournal.org/article/S1542-3565(19)31501-0/fulltext. The study found that telehealth did not necessarily reduce the time to transplantation itself, but that is not surprising given that time to transplantation is dependent in part on clinical need and allocation (as discussed above). The authors also indicate that more studies are needed, particularly outside of the VA Health System, to confirm that telehealth is a safe and effective way to expand access for patients undergoing liver transplantation.

189 Beatrice P. Concepcion & Rachel C. Forbes, The Role of Telemedicine in Kidney Transplantation: Opportunities and Challenges, 1 Kidney360 420 (2020), https://kidney360.asnjournals.org/content/kidney360/1/5/420.full.pdf?with-ds=yes.

190 Andrew N. Barraclough et al., Telehealth model of care for routine follow up of renal transplant recipients in a tertiary centre: A case study, 26 J. Telemedicine & Telecare 232 (2018); Aman Sidhu et al., Outcomes of telehealth care for lung transplant recipients, 33 Clin. Transplantation (2019). Note that many of the above studies were conducted during the COVID-19 pandemic, in response to which many states lowered or eliminated regulatory barriers to the practice of telemedicine. This includes waivers that allowed physicians to practice telemedicine across jurisdictions, and to do so through an expanded list of modalities. However, these waivers vary from state to state, and many are set to expire upon the conclusion of state public health emergency declarations. What remains to be seen is how policies governing telehealth will transform in a post-pandemic environment and how telehealth can be integrated into existing care systems, including transplant, to achieve interoperability going forward. See U.S. States and Territories Modifying Requirements for Telehealth in Response to COVID-19, Fed’n State Med. Bds. (last updated Jan. 11, 2022), https://www.fsmb.org/siteassets/advocacy/pdf/states-waiving-licensure-requirements-for-telehealth-in-response-to-covid-19.pdf.

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