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Excerpted From: Courtney A. Carrell and Daniel W. Peters, Disparities in Access to Solid Organ Transplant Services--past, Present, and Future, 16 Journal of Health & Life Sciences Law 113 (2022) (190 Footnotes) (Full Document)
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. 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, 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.
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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. 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, 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.
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. 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, pediatric status, and the patient's survival benefit.
• Lung: Survival benefit, medical urgency, waiting time, distance from donor hospital, and pediatric status.
• Liver: Medical urgency, distance from donor hospital, and pediatric status.
• Heart: Medical urgency, distance from donor hospital, and pediatric status.
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. 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. MELD is intended to serve as a predictor of survival, with higher scores indicating sicker patients. However, the likelihood of mortality with the same MELD scores varies based on certain non-clinical characteristics, including the patient's geographic residence. 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.” 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.
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. Some transplant centers will accept organs that others would not have chosen for the same patient.
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.” 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 medications and the availability of transportation to return to the clinic for regular follow-up appointments. 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,” 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. “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.” 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. 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. 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” practices that excluded patients from the transplant waitlist if they did not have financial resources.
Unfortunately, more than 20 years later, racial disparities still persist in transplantation. One study found that Black patients are 59% less likely to receive a transplant compared to White patients. 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. 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.” 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. 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.” 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.” Thus, even though the OPTN does not currently track transplant candidates' income, it could evaluate socioeconomic disparities by examining transplant opportunities based on county. 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. In high-risk communities, the death rate from end-stage liver disease is almost twice that of counties in the lowest tier of risk.
Additional racial disparities exist in “living donor” transplantation as well as “preemptive” kidney transplantation. 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, 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. Because Black patients are less likely to qualify for living donor options, they are more dependent on deceased donors and UNOS's allocation system.
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. 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%.
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. 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. 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. 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.
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.
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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.