Patient and graft survival

The overarching utilitarian goal of solid organ transplantation emphasizes the “maximum benefit for all transplants”Footnote ⁷¹—therefore, the ethical principle of utility—and aims to maximize the benefit of an organ transplant, ultimately directing viable organs away from potential recipients who will not derive maximum medical benefit from the transplant, nor maximize a net overall societal good.Footnote ⁷² But utilizing patient and graft survival as the sole basis for eligibility decisions could undermine the equitable distribution of a scarce resource by directing viable organs toward one particular patient population.Footnote ⁷³ Undoubtedly, the ethical duty of stewardship—an ethical duty focused on utilizing limited medical resources to preserve and promote communal health—imposes an affirmative obligation on transplant centers to consider patient and graft survival when making eligibility decisions.Footnote ⁷⁴ However, a priori denials of eligibility for intellectually disabled persons focused on patient and graft survival assume that this class of individuals will not obtain the same number of life-years or quality-adjusted life years as other non-disabled individuals because of other existing comorbidities.Footnote ⁷⁵

In fact, available empirical data indicates that patient and graft survival is similar between individuals with and without an I/DD.Footnote ⁷⁶ Several studies evidence similar rates of patient and graft survival between transplant recipients with chromosomal abnormalities (e.g., Down Syndrome) and transplant recipients without a genetic disease.Footnote ⁷⁷ Recognizing that an I/DD may be independent of a genetic disease, other studies evaluating an I/DD of any origin share similar results.Footnote ⁷⁸ These studies underscore that existing comorbidities of a transplant candidate with an I/DD should be weighed in a similar manner to the existing comorbidities of a person who is not intellectually disabled. Similarly, existing data supports the inclusion of individuals with I/DDs within the national pool of transplant candidates instead of categorical exclusions of intellectually disabled persons. Some commentators argue that a pre-defined minimal threshold of expected life-years respective to each organ system should be equally applied to individuals with and without I/DDs.Footnote ⁷⁹ Potential solutions aside, a transplant center is legally required to evaluate existing comorbidities, whether associated with an I/DD (or not), and its potential impact on transplant candidacy on an individual basis.

Quality of life concerns

Some argue that individuals with I/DDs should be excluded from the national waitlist because individuals with I/DDs do not enjoy a comparable quality of life (QOL) to non-disabled individuals. As in Amelia’s case, the underlying assumption is that an organ transplant for an individual with an I/DD would not enhance the individual’s QOL, and that therefore, the recipient would not derive as much benefit from the medical intervention as would a recipient without an I/DD.Footnote ⁸⁰ The World Health Organization defines QOL as an “[individual’s] perception of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.”Footnote ⁸¹ The utilization of QOL as a unique consideration for determining transplant candidacy for an individual with I/DD is problematic when transplant teams make value-laden judgments about QOL based on widely-accepted societal benchmarks and standards.Footnote ⁸² A recent study evaluating physicians’ biases about disabled individuals evidenced that 82.4% of physicians who participated in the study believe that individuals with significant disability have a “worse” quality of life than nondisabled persons.Footnote ⁸³

These biased presumptions about QOL are worrisome because ample empirical evidence firmly establishes a “disability paradox:” individuals with disabilities rate their QOL higher than do physicians, healthcare professionals, and families members of disabled persons.Footnote ⁸⁴ The gaps in attitudes about disability result from disproportionate focus on changes in lifestyle without giving attention to the opportunities for and types of adaptation that arises from disability.Footnote ⁸⁵ “Ableist” assumptions—assumptions that rate an individual’s social value based on her physical, mental, and sensory capabilities—undervalue the QOL of intellectually disabled persons.Footnote ⁸⁶ These types of assumptions have subsequent negative implications for a transplant physician’s understanding of improvements in an intellectually disabled person’s QOL that are derived from solid organ transplantation.Footnote ⁸⁷

Nonadherence concerns

Nonadherence is another concern proffered as a justification for excluding individuals with I/DDs from the qualifying pool of eligible transplant candidates. The nonadherence argument posits that an intellectually disabled individual’s inability to understand complex medical regimens, including multiple medications and recurring doctor’s appointments, will always result in nonadherence to post-transplant responsibilities and treatment. The nonadherence argument incorrectly assumes that individuals with I/DDs do not have strong and well-established support systems to ensure post-transplant adherence.Footnote ⁸⁸ Supportive services provided for by federal and state welfare (e.g., Medicaid) and entitlement programs are an integral part of a larger support system that help individuals with I/DDs meet their daily needs and actively participate in the community.Footnote ⁸⁹ Different jurisdictions’ supported decision-making statutes—laws that permit a disabled individual to enter into an agreement with another person for purposes of assisting with decision-making—provide additional safeguards and protections aimed at ensuring that a disabled individual can understand the information being presented and communicate her choice.Footnote ⁹⁰ A supporter, a person that helps the disabled person engage in decision-making, is particularly helpful during the organ transplantation evaluation process given the complex medical information that providers and other allied healthcare professionals present to potential candidates during the informed consent process. In addition to federal and state protections, a potential transplant candidate may have individualized support structures tailored to her specific needs. For example, family members may participate in clinical appointments for purposes of helping an individual with an I/DD communicate with providers and other healthcare professionals via adaptive technologies.

Exclusion on the grounds of nonadherence is particularly troubling given the evidentiary indication that individuals with I/DDs do not pose a significantly higher risk of nonadherence than non-disabled individuals.Footnote ⁹¹ Given the wide range, types, and degrees of intellectual disabilities, some individuals with I/DDs will require additional (and in some cases, intensive) support to adhere to post-transplant regimens.Footnote ⁹² This Article does not suggest that the lack of social support or nonadherence are irrelevant evaluative criteria: social support is a well-studied predictive value of transplant success for individuals with or without an I/DD.Footnote ⁹³ Rather, anticipated concerns about nonadherence alone cannot serve as an appropriate basis for outright exclusion of individuals with I/DDs from the national waitlist when nonadherence is highly prevalent in other patient populations.Footnote ⁹⁴

Presumptive biases that influence the development and application of selection criteria at transplant centers result in the exclusion of individuals with I/DD from the national waitlist. The discretionary nature of selection criteria and eligibility decisions can disguise discriminatory selection practices behind a veil of clinical judgments of medical and psychosocial eligibility.Footnote ⁹⁵ The absence of federal guidance of the application of existing anti-discrimination statutes to the organ transplantation evaluation process coupled with the variance in eligibility criteria at transplant centers lends itself to considerable allegations of discrimination.Footnote ⁹⁶

Title II and Section 504

Generally, Title II of the ADA (“Title II”) prohibits disability-based discrimination by requiring public entities to make reasonable modifications that enable qualified individuals to participate in programs and services provided by the public entity.Footnote ¹²² A hospital is a public entity under Title II when it is affiliated with a state or county hospital or a state university. Footnote ¹²³ Given that Title II’s protections extend to all operations of the public entity, transplantation services offered at transplant centers fall within the scope of Title II.Footnote ¹²⁴

Section 504 of the Rehabilitation Act, a sister statute to Title II, imposes similar affirmative obligations on entities receiving federal funding.Footnote ¹²⁵ Most hospitals and transplant centers receive some form of federal funding (e.g., Medicare), so any part of a program or service that receives federal funding remains subject to Section 504.Footnote ¹²⁶

For purposes of Title II, a hospital or transplant center cannot discriminate against a qualified individual on the basis of disability if the potential candidate comes within the statutory definition of disability and—with or without reasonable modifications—meets the essential eligibility requirements of a program or service.Footnote ¹²⁷ In Olmstead, two women who were voluntarily admitted at the state-run Georgia’s Regional Hospital filed a discrimination suit after remaining involuntarily institutionalized despite multiple physician recommendations that the two women receive mental health treatment in a community setting. Involuntarily retaining the two women in a segregated environment constituted discrimination under Title II of the ADA. In its decision, the Olmstead Court opined that Title II and Section 504 protections contemplate intellectual disabilities.Footnote ¹²⁸ Assuming that individuals with I/DD are qualified individuals, transplant centers must therefore make reasonable modifications for individuals with I/DDs that ensure equal access to, and participation in, the transplant program and its other transplant-related services.Footnote ¹²⁹ For example, the ADA would require a transplant center to modify the format and font text of educational materials for an individual with I/DD so that the individual can actively participate in the decision-making process, which has significant implications for informed consent.

Ultimately, the ADA’s prohibition of invidious discrimination requires transplant centers to conduct individualized assessments and make reasonable modifications that support the intellectually disabled person’s candidacy for solid organ transplantation.Footnote ¹³⁰ Still, hospitals or transplant centers may be exempt from statutory obligations if the requested modification would fundamentally alter the nature of the program or service offered, or create an undue burden (e.g., cost) for the entity.Footnote ¹³¹

Title III

Title III of the ADA (“Title III”) prohibits public accommodations from utilizing eligibility criteria that “subjects an individual…on the basis of disability…to a denial of the opportunity of the individual…to participate in…the services…of an entity.”Footnote ¹³² Private hospitals are a public accommodation for purposes of Title III. Thus, the anti-discriminatory mandate within Title III reaches transplantation services offered at private hospitals. Footnote ¹³³ Title III prohibits a public accommodation from utilizing eligibility criteria that screens out or tends to screen out an individual or class of individuals from the equal use and full enjoyment of the goods or services that the entity offers.Footnote ¹³⁴ A public accommodation is required to make the necessary reasonable modifications to its policies, practices, and procedures so that a disabled individual equally participates in its services or accommodations.Footnote ¹³⁵

Within the context of an evaluation of transplant candidacy for an intellectually disabled individual, a transplant center may be required under Title III to remove I/DD as an absolute contraindication for organ transplantation from its medical or psychosocial evaluative criteria. Similar to Title II, Title III contemplates reasonable modifications tailored to the disabled individual requesting an organ transplant evaluation. A public accommodation must demonstrate that the modification would fundamentally alter the nature of the service or accommodation in order to avoid Title III’s antidiscrimination provision.Footnote ¹³⁶

Underenforcement and claim scarcity

Titles II and III of the ADA are underenforced, and one potential culprit is the lack of claims filed with the Office of Civil Rights or another appropriate administrative agency. The scarcity of claims could be premised by a myriad of factors. For example, a potential candidate may not file a claim because she does not know that she was subject to disability-based discrimination violative of federal law. Commentors identify a major obstacle to optimal enforcement: an ineffective and weak public enforcement mechanism.Footnote ¹⁵³ The Department of Justice (DOJ), as the public avenue for enforcement of the ADA, has assigned only a small number of lawyers assigned to disability rights enforcement whose scope of enforcement responsibility extends to both state and local governments and private businesses.Footnote ¹⁵⁴ As a consequence, private enforcement is a necessary element of the ADA’s effectiveness. That is, the ADA’s ability to curtail and eliminate disability-based discrimination remains largely dependent upon individual lawyers in need of profit to sustain their practices.Footnote ¹⁵⁵

While private enforcement is the primary avenue of enforcement, the limited remedies available under Title II and Title III disincentivize lawyers from litigating these types of cases. Under Title II, private plaintiffs may generally sue for compensatory damages.Footnote ¹⁵⁶ To be entitled to compensatory damages, courts have generally required that private plaintiffs prove discriminatory intent.Footnote ¹⁵⁷ Given the courts’ deference to physicians’ determinations of transplant eligibility, discriminatory intent may be difficult for the private plaintiff to prove. Consider a case in which a transplant center denies an individual eligible for transplant because the transplant center’s psychosocial criteria lists a severe intellectual disability as an absolute contraindication to transplant. A court may be hesitant to second guess the transplant center’s eligibility criteria and the transplant physician’s medical judgment. In this case, discriminatory intent could be masked, or even legitimized, behind a denial of transplant eligibility based on the transplant center’s psychosocial criteria.

Unlike Title II, Title III affords private litigants only equitable relief and attorney’s fees as an exclusive source of compensation.Footnote ¹⁵⁸ Whereas private counsel with fee-paying clients can be paid for expended hours on cases won or lost, plaintiff’s counsel are entitled to payment from the hours expended on cases they have won.Footnote ¹⁵⁹ The statutory compensation scheme alone discourages lawyers from taking on disability-discrimination cases when incoming profits are necessary to maintain private practice.

Paucity of case law: lack of expediency clause

One noted shortcoming of federal legislation is the ambiguity surrounding the relevance and applicability of these statutes to the initial stages of the organ transplant process. Footnote ¹⁶⁰ The lack of clear resolution is due, in part, to the scarcity of litigation that strikes at the core issue: the nexus between current anti-discrimination legislation and transplant center selection practices.Footnote ¹⁶¹ Lots of time is required to thoroughly litigate discrimination claims in federal court.Footnote ¹⁶² Applicable federal statutes do not permit or mandate a court to expedite review of a claim that challenges discriminatory selection criteria and procedures. The potential for a worsening disease trajectory may deter some intellectually disabled individuals from filing a claim in federal court. Moreover, advanced disease may cause an intellectually disabled individual to become too ill to pursue a federal discrimination claim based on a denial of eligibility.Footnote ¹⁶³ And if a change in clinical status poses a high risk for poor clinical post-transplant outcomes, the individual will be medically incompatible for solid organ transplant, which may render the discrimination claim moot.Footnote ¹⁶⁴

Just fourteen states have enacted legislation prohibiting disability-based discrimination in the evaluation of transplant candidacy.Footnote ¹⁶⁵ Of the fourteen that have passed state-level anti-discrimination legislation, a smaller number of states explicitly prohibit discrimination on the basis of an intellectual disability. Footnote ¹⁶⁶ The widespread legislative inattention—federal and state alike—to intellectual disability-based discrimination leaves a majority of the intellectually disabled population left unprotected. To offset the extended period needed to litigate claims in federal courts, some states, like California, have included an expediency clause that provides for the court’s ability to prioritize claims of discrimination for those seeking remedy under the statute.Footnote ¹⁶⁷ It remains unclear if the time-sensitive nature of eligibility decisions and potential for acute medical decompensation undercuts the effectiveness of these types of clauses.

Vagueness: lack of federal guidance

There is no question that federal anti-discrimination legislation is applicable to medical decision-making,Footnote ¹⁶⁸ so it is somewhat curious that executive and administrative agencies do not provide more specific guidance describing what constitutes discrimination throughout the entirety of the organ transplant evaluation process. Footnote ¹⁶⁹ The sizeable gap in federal guidance is not for lack of authority:

Despite a congressional petition to the Health and Human Services (HHS) Office of Civil Rights (OCR) for federal guidance on the issue, HHSOCR has remained silent.Footnote ¹⁷¹ Transplant physicians and transplant teams are thus unaware of the applicability of antidiscrimination legislation to eligibility decisions.Footnote ¹⁷² In other words: in all likelihood, at least some practices and procedures at transplant centers are not compliant with federal mandates to make reasonable modifications to policies and procedures to persons with I/DDs.Footnote ¹⁷³

Federal guidance may motivate transplant centers to make changes to policies and procedures that provide for equitable access to organ transplantation for individuals with I/DDs. Recall that some states have clarified the ambiguity of federal statutes by passing legislation that prohibits discrimination on the sole basis of disability vis-a-vie the proscription of appropriate evaluation criteria and the weighing of such criteria in eligibility decisions.Footnote ¹⁷⁴ Again, disability-based discrimination can result from an intentional act to mask it using neutral eligibility criteria or the influence of unconscious processes on good-faith eligibility decisions.Footnote ¹⁷⁵ The nature of disability-based discrimination remains covert, which renders state counterparts to federal legislation equally as difficult to enforce.

Aside from enforcement issues, the scope and content of state-level statutes vary.Footnote ¹⁷⁶ For example, some states’ statutory protections do not extend to individuals with I/DDs.Footnote ¹⁷⁷ The disparity among state legislation, coupled with conflict of law principles, has the potential to disrupt the “utility versus justice equation” embedded within a national transplant system.Footnote ¹⁷⁸ The national equation attempts to balance the maximization of transplant success (i.e., utility) by directing organs to medically compatible individuals and an equitable distribution of available organs (i.e., justice) among a national pool of transplant candidates. Absent clarifying guidelines for transplant medicine, transplant teams and transplant physicians are left to self-regulate against a priori eligibility decisions based on implicit and negative biases that accompany intellectually disabled individuals.Footnote ¹⁷⁹

Deference to physician judgment

Given courts’ deference to a physician’s clinical judgments, the ADA’s broad sweeping protections fall short of its intended goal to eliminate disability-based discrimination within the context of health care.Footnote ¹⁸⁰ In University Hospital, Baby Jane Doe was born with spina bifida, microcephaly, and hydrocephaly. Physicians informed Baby Jane Doe’s parents that corrective surgeries could improve her prognosis. Baby Jane Doe’s parents elected to forgo surgery. After University Hospital refused to turn over Baby Jane Doe’s medical records, the DOJ filed suit to obtain the medical records to assess whether Baby Jane Doe was subject to disability-based discrimination. The Second Circuit Court of Appeals affirmed the dismissal of the claim for discrimination under Section 504 where the hospital, who at the directions of the child’s parents, did not perform corrective surgeries for Baby Doe.

The court’s reasoning suggested that applicable federal statutes would require physicians to perform medical interventions unrelated to disability. As in University Hospital, a physician’s refusal to provide or offer medical treatment may not be violative of federal mandates when the disability will limit the individual’s ability to benefit from the proposed treatment.Footnote ¹⁸¹ The “bona fide medical judgment” standard focuses on the physician’s determination of whether a patient’s disability will limit the anticipated benefits of the proposed medical treatment.Footnote ¹⁸² So long as the treatment is related to the disability and the disability imposes limitation on the anticipated benefits from the treatment, then the physician may avoid the affirmative obligations of antidiscrimination legislation.Footnote ¹⁸³

An important question emerges from this rationale: is any disability-related limitation, regardless of degree or severity, sufficient to satisfy the standard? This question has not been formally litigated. The standard also erroneously assumes that the physician’s determination contemplates only her technical medical expertise absent any value-laden considerations of social worth. This assumption alone is problematic when available empirical evidence suggests that physicians are susceptible to implicit biases that disfavor individuals with disabilities.Footnote ¹⁸⁴

Existing co-morbidities and medical complications are legitimate disability-related medical variables that may preclude transplant candidacy.Footnote ¹⁸⁵ In light of the limited availability of organs, clinical expertise is necessary to prevent the loss of a viable organ due to medical complications resulting from post-transplant non-adherence.Footnote ¹⁸⁶ It is important to preserve the integrity and autonomy of a transplant physician’s medical decision-making because courts lack sufficient clinical expertise and competency to understand the complexities of solid organ transplant eligibility decisions.Footnote ¹⁸⁷ But an accepted standard of judicial deference to a transplant physician’s clinical judgments makes disability-based discrimination difficult to prove, and consequently, inappropriately insulates providers from civil liability under the ADA and Section 504.Footnote ¹⁸⁸ Judicial hesitancy, rooted in reliance upon medical expertise as evidenced in University Hospital, promotes disability-based eligibility decisions, which run contrary to the language and purpose of federal antidiscrimination legislation.Footnote ¹⁸⁹

General prohibitions and affirmative obligations

More specifically, the Act explicitly prohibits transplant centers, their transplant teams, and transplant physicians, from denying transplant services to a qualified individual on the basis of disability.Footnote ¹⁹³ As discussed above, a qualified individual, for purposes of Title II, is an individual who with or without reasonable modifications meets the essential eligibility requirements of a program or service offered. Title II requires that a covered entity make reasonable modifications that ensures a qualified individual’s ability to participate in the program or service offered. A public accommodation, under Title III, must make reasonable modifications that ensure that a disabled individual enjoys the full and equal enjoyment of the accommodation. The Act tailors the broader language of Title II and Title III to the organ transplantation arena. If the individual requesting a transplant who, with or without reasonable modification(s), support service(s), or the provision of auxiliary aids, meets the eligibility requirements, then the individual is a “qualified individual” under the Act.Footnote ¹⁹⁴ The definition of disability references the definition of disability within the ADA,Footnote ¹⁹⁵ and therefore, consistent with Olmstead, the scope of the Act’s antidiscrimination mandate extends to intellectually disabled individuals.Footnote ¹⁹⁶ If the Act becomes federal law, it would provide coverage to the larger national population of intellectually disabled individuals who may currently fall outside state-level antidiscrimination statutes.Footnote ¹⁹⁷

Like other federal statutes, the Act imposes affirmative obligations upon providers to make transplant-related services available to individuals with I/DDs. Recall that under the ADA, a covered entity may escape the ADA’s affirmative obligations if the covered entity can demonstrate that the requested modification would result in an undue burden. Under the Act, if a transplant team can demonstrate that the provision of auxiliary aids and servicesFootnote ¹⁹⁸ would “fundamentally alter the nature of the services being offered or result in undue burden,” then the transplant team could be exempt from the Act’s legal requirements.Footnote ¹⁹⁹ For purposes of ensuring equitable selection practices, the Act would require a transplant center to acquire assistive technologies (e.g., FM listening system) unless the cost of purchasing these types of devices, for example, would create an undue burden for the transplant center. A transplant physician may consider a disability when she determines, after an individualized assessment of the potential candidate, that the intellectual disability is “medically significant to the provision of the anatomical gift.”Footnote ²⁰⁰ Ultimately, a transplant team could not deny eligibility or transplant-related services to an individual with I/DD unless the transplant physician could provide, after an individualized assessment of the individual, medically relevant justifications for denying candidacy.

Available remedies

The available remedies under the Act are intended to guarantee equitable access to organ transplantation and other transplant-related services for intellectually disabled individuals. The Act’s affirmative obligations and remedies require transplant centers to evaluate an intellectually disabled individual’s eligibility for transplant in the same or similar manner to organ transplant evaluations for nondisabled persons. If a plaintiff successfully challenges a disability-based denial of transplant eligibility, the Act permits a court to grant equitable and injunctive relief.Footnote ²⁰¹ A court could require a covered entity to (1) make available auxiliary aids and services to the plaintiff,Footnote ²⁰² (2) make reasonable modifications to a policy, practice, or procedure of a covered entity,Footnote ²⁰³ or (3) make facilities of the covered entity readily accessible and usable.Footnote ²⁰⁴ The provision of any remedy, or some combination thereof, offsets default presumptions of an intellectually disabled person’s ineligibility for organ transplantation. In their application, these remedies create a single threshold of transplant eligibility for both disabled and nondisabled persons.

However, in its current form, the Act’s available remedies do not protect an intellectually disabled individual from instances of pure discrimination. Consider a scenario in which a transplant physician performs a transplant evaluation, but deems the individual ineligible for transplant solely on the basis of the individual’s I/DD. The individual successfully sues the transplant center, and the court grants injunctive relief. Even with the provision of reasonable modifications or auxiliary aids and services, a transplant physician, could still deny the potential transplant candidate on the basis of medical or psychosocial ineligibility, which makes a showing of disability-based discrimination difficult. Absent an enforcement mechanism, the Act may have little success in preventing disability-based discrimination.

HHS, as a regulatory agency, is responsible for the enforcement of Titles II and III of the ADA and Section 504 of the Rehabilitation Act.Footnote ²⁰⁵ As the Act passes through the legislative process, a future iteration of the Act could include language that, like current federal antidiscrimination legislation, authorizes HHS to enforce the Act and provide for additional administrative remedies.

Relevance to Transplant Medicine

Currently, hospitals with transplant programs receive minimal guidance about the applicability of the ADA to its eligibility decisions, so it oftentimes is unclear when a denial of eligibility constitutes illegal discrimination. In an effort to advance the goal of resolving the ambiguity of the applicability of antidiscrimination statutes, the Act specifically addresses discrimination within the context of the organ transplant process.Footnote ²⁰⁶ It requires that transplant teams make reasonable modifications to its policies, practices, and procedures to ensure that all of its transplant-related services are made available to qualified individuals with I/DDs at each step of the transplant process.Footnote ²⁰⁷ Reasonable modifications must factor into the individualized assessment and determination of the individual’s eligibility for transplant.Footnote ²⁰⁸

The Act further contemplates that reasonable modifications include individuals (e.g., caregivers) who support the transplant recipient and larger support networks (e.g., community-based services).Footnote ²⁰⁹ Consideration of support systems permits a substitution of responsibility for post-transplant medical treatment that lessens the opportunity to utilize psychosocial risk factors (e.g., independence) as camouflage for discriminatory selection practices.Footnote ²¹⁰ Identifying the types of reasonable modifications that a transplant center must make when an individual with an I/DD requests an evaluation clarifies the relevance of this and other federal anti-discrimination mandates to the initial stages of the organ transplantation evaluation process. The reasonable modification mandate provides a buffer between evidence-based eligibility decisions and discriminatory selection practices that account for the intellectual disability and accompanying negative assumptions.Footnote ²¹¹

Expedited review

The paucity of case law litigating discrimination in the organ transplant evaluation process is, in part, due to the substantial length of time needed to litigate a claim in the federal court system.Footnote ²¹² The length of time either deters an individual from filing a claim or prognostic uncertainties prevent an individual from pursuing the claim to its final disposition.Footnote ²¹³ Without providing a definite time period, the Act contains a provision that requires a federal court to advance the discrimination claim for priority review.Footnote ²¹⁴ Expeditious resolution of the claim through the federal court system makes organ transplantation services more readily accessible to individuals with I/DDs.

One concern associated with expediated review is the potential for judicial infringement on a transplant physician’s independent clinical determinations of a disabled individual’s eligibility for organ transplant. However, the remedies do not permit a court to order a transplant physician to list an intellectually disabled individual for organ transplant, and therefore stops short of impeding upon the independent practice of transplantation medicine. The available remedies under the Act are limited: requiring reasonable modifications to policies, practices, and procedures; or the provision of auxiliary aids or services. These remedies become relevant to eligibility because physicians must consider the reasonable modifications made to policies or procedures, or the provision of auxiliary aids and services when determining eligibility for solid organ transplantation. Even with the provision of reasonable modifications or auxiliary aids and services, an individual may still be ineligible for transplant on grounds of medical unsuitability. Thus, the available remedies preserve the autonomous medical decision-making of the transplant physician while rectifying disability-based eligibility decisions.

Mandated individualized assessment

The Act contains a general prohibition against disability-based discrimination: “a covered entity may not, solely on the basis of a qualified individual’s…disability deem such individual ineligible to receive an anatomical gift or transplant.”Footnote ²¹⁵ The Act’s antidiscrimination mandate applies to the entire spectrum of transplantation services, which starts with a referral to a transplant center and concludes with post-transplant treatment.Footnote ²¹⁶ Although the Act is narrow in scope, its application to the entirety of the transplant evaluation process would help syphon out the negative biases associated with intellectual disability from the evidence-based selection criteria that should govern eligibility decisions. The antidiscrimination provisions prevent the utilization of selection criteria that deny eligibility for organ transplant based on an individual’s membership to a class with a shared characteristic, namely I/DD.

The Act requires compliance with the affirmative obligations set forth in Titles II and III of the ADA.Footnote ²¹⁷ A failure to perform an individualized assessment risks making an determination of eligibility based on the individual’s membership in a group, and consequently, exclude a whole class of individuals from transplant on the basis of disability alone.Footnote ²¹⁸ An individualized consideration of disability required by the ADA is of significance to the organ transplantation process because it would require a transplant team, or transplant physician, to perform an individualized evaluation of candidacy for organ transplant.Footnote ²¹⁹ In Abbott, a dentist refused to perform a dental surgery on an HIV-positive female patient. The question for the Supreme Court was whether a “direct threat” of HIV transmission, under Title III of the ADA, should be viewed from the perspective of the physician refusing to perform the operation. The Court reasoned that the risk of transmission should be viewed from the perspective of the physician, but the physician’s assessment must be based on objective evidence.

Similar to the Supreme Court’s reasoning in Bragdon v. Abbott, eligibility for transplant should be evaluated from the perspective of the transplant team, and other physician stakeholders (e.g., surgeons).Footnote ²²⁰ However, the denial of transplant candidacy must be based on the objective and evidence-based results of an evaluation for eligibility, rather than on the unfavorable biases associated with intellectual disability.Footnote ²²¹ Good-faith subjective beliefs about prognostic post-transplant clinical outcomes (e.g., post-transplant adherence) alone will not shield a transplant physician from civil liability, unless those beliefs are supported by objective evidence.Footnote ²²² Given that some available evidence indicates that post-transplant outcomes for intellectually disabled individuals are similar to nondisabled organ transplant recipients, harmful prejudices will likely remain unjustified bases for a denial of transplant candidacy.Footnote ²²³

“Medically significant”

Certain psychosocial factors may jeopardize the success of an organ transplant and are legitimate considerations that may be appropriate grounds for denial.Footnote ²²⁴ The consideration of psychosocial criteria becomes invidious when transplant teams use these criteria as mechanisms for covert determinations of social worth.Footnote ²²⁵ Disproportionate weight placed on psychosocial risk factors for intellectually disabled individuals results in a variance in the stringency of application of selection criteria between intellectually disabled and nondisabled individuals.Footnote ²²⁶ Burdening intellectually disabled individuals with higher eligibility thresholds is likely violative of the statutory prohibition on holding disabled individuals to a higher standard of anticipated benefits from solid organ transplantation.Footnote ²²⁷

The Act permits the consideration of an I/DD as a contraindication if the disability contributes to clinical incompatibility for solid organ transplantation.Footnote ²²⁸ For example, some suggest that it may be medically reasonable to consider I/DD as a relative contraindication for solid organ transplant when genetic disorders increase the risk of malignant comorbidities or post-transplant medical complications (e.g., infections).Footnote ²²⁹ The “medically significant exception” narrows the scope of the transplant team’s or transplant physician’s discretion in eligibility decisions, which may mitigate concerns discussed above. Under the Act, selection committees and its transplant physicians could no longer deny eligibility on psychosocial grounds alone, but rather, the transplant physician would need to articulate medically relevant reasons that disqualify the individual from eligibility.Footnote ²³⁰

The Act thus creates a shift in the default for intellectually disabled persons. As with nondisabled persons, an intellectually disabled individual who could medically benefit from an organ transplant is, by default, eligible for a transplant, unless the disability is medically significant to the provision of transplant-related services. If the intellectual disability does not have medical significance for measurable post-transplant outcomes (e.g., length of patient and graft survival), then the intellectual disability cannot be considered a contraindication to organ transplantation.Footnote ²³¹

Individuals whose cognitive or intellectual disabilities pose high risks for medical complications post-transplant may be legitimately denied transplant eligibility.Footnote ²³² The exception strikes a balance between the unjustified regulation of the practice of transplant medicine and the physician’s professional obligation to prevent the premature loss of a viable organ because of medical incompatibility or post-transplant nonadherence.Footnote ²³³

Enactment-related difficulties

Enacting new legislation can be challenging.Footnote ²³⁴ Unlike the rapid surge of attention during the COVID-19 pandemic to the disability-based discrimination baked into multiple states’ crisis standards of care plans, discriminatory transplant eligibility decisions have not enjoyed the same rise to national attention.Footnote ²³⁵ Congressional priorities would be the first hurdle that proponents of the Act will need to address. The Act’s codification into federal law will be challenging if Congress fails to prioritize anti-discrimination legislation. Absent national focus on — and awareness of—disability-based eligibility practices and procedures, Congress is unlikely to demonstrate sufficient interest to prioritize the Act.Footnote ²³⁶ Proponents may need to consider more modest alternative legislative strategies that would achieve the same goal, namely, a congressional amendment to the ADA or the National Organ Transplant Act.Footnote ²³⁷

Additionally, the Act’s language, as written, may stir opposition from large professional organizations and societies (e.g., American Medical Association), which could argue that the Act would unfairly impede on the independent practice of transplantation medicine, specifically a transplant physician’s clinical judgments.Footnote ²³⁸ As discussed above, the Act protects the integrity of a transplant physician’s clinical determinations to the extent that those determinations are not discriminatory in nature. With recent media attention to crisis standards of care plans and disability-based discrimination, disability-rights activists and advocates significantly influenced public policy over the course of the COVID-19 pandemic.Footnote ²³⁹ These types of partnerships have the ability to shift the scope of social and political discussion surrounding disability-based transplant eligibility decisions from academic discourse to policy development.Footnote ²⁴⁰ Therefore, partnering with national intellectual disability organizations (e.g., American Association on Intellectual and Developmental Disabilities) and advocacy groups could help counter opposition and foster collaboration between competing constituents.

Creating national guidelines for the evaluation of transplant candidacy for intellectually disabled individuals could be well within the capacity of the United States Access Board, which is an independent federal agency that develops accessibility guidelines and standards for covered entities with relevant stakeholders, including transplant physicians and individuals with disabilities.Footnote ²⁴¹ Access Board guidelines could serve as regulatory companions necessary to ensure compliance with the Act’s affirmative obligations on transplant centers. The Access Board could offer recommended model guidelines for transplant centers to integrate into existing policies, procedures, and practices.

An additional advantage of utilizing the Access Board is that representation from key stakeholders in the drafting of transplant evaluation guidelines may reduce anticipated objections from professional medical organizations and disability-rights activists. The swift shift away from the categorically discriminatory language present in states’ earlier Crisis Standards of Care plans resulted from negotiations between policy makers and disability-rights activists. The participation of disabled persons in the development of appropriate psychosocial evaluative criteria can help avoid errors in the application of psychosocial evaluations for transplant.Footnote ²⁴²

The challenges accompanying national legislative framework

New federal legislation would clarify the relevance of anti-discrimination legislation to the organ transplantation process and serve as a national repudiation of discrimination on the basis of intellectual disability.Footnote ²⁴³ Self-imposed regulations on transplantation medicine result in differences in enforcement and stringency in implementation among transplant centers.Footnote ²⁴⁴ A national legislative framework would offer a uniform approach that protects individuals with I/DDs from insidious discrimination that denies access to organ transplantation.Footnote ²⁴⁵ The Act improves upon current federal legislation by creating a standard definition of discrimination within the context of the organ transplantation evaluation process.

But the proposed legislative solution mirrors state-level statutes whose framework is borrowed from a federal anti-discrimination framework, which has proven to be unenforceable in transplant eligibility decisions.Footnote ²⁴⁶ The Act alone is a piece-meal resolution that will present the same enforcement gaps in existing state and federal legislation. It is advisable that selection committees, and its transplant physicians, retain broad discretion in eligibility decisions to the extent that they do not exclude intellectually disabled individuals from organ transplant eligibility on the basis of disability alone. Given the potential for covert discrimination under the guise of neutral selection criteria, clarifying the legality (or illegality) of considering evaluative psychosocial criteria in eligibility decisions would help ensure rejections are based on “medically significant” grounds.Footnote ²⁴⁷ For example, in Section 3(b)(2) (entitled “Clarification”) a later iteration of the Act could include language that explicitly outlaws denial of eligibility on the basis of psychosocial criteria alone unless the physician can articulate medically relevant reasons for the denial.Footnote ²⁴⁸ On the other hand, the Act could clarify that it bars rejection of eligibility if the potential candidate can demonstrate support systems or services that mitigate risk variables that negatively impact post-transplant outcomes.Footnote ²⁴⁹ This challenge underscores the need for a robust systematic initiative that includes a regulatory companion to the Act and other existing federal statutes.Footnote ²⁵⁰

Enforcement challenges

Lack of awareness about the Act and its affirmative obligations may stymie its enforceability.Footnote ²⁵¹ An intellectually disabled individual or her legally authorized representative may not be aware that she has been subject to discrimination or, if she is aware of discriminatory motives at work, may not have knowledge of available remedies under the Act. Passage of the Act will garner attention from health care facilities with transplant programs, but it does not guarantee that disabled individuals have knowledge of the Act. Similar to enforcement issues of other federal statutes, the individual who has been subject to discrimination will need to consider whether to pursue a claim in the face of prognostic uncertainty and opportunities to seek evaluation elsewhere. It would be advantageous for proponents of the Act to partner with a national coalition of disability organizations to develop educational strategies to increase public knowledge of available remedies. An amended version of the statute could include a provision that requires transplant centers to provide a copy of policies and procedures addressing its transplant-related services to those seeking an evaluation.

Although the Act clarifies the relevance of existing federal statutes to the organ transplantation process, similar enforcement downfalls will likely frustrate its intended goals. Theoretically, litigation promotes enforcement, and increased enforcement motivates increased institutional compliance.Footnote ²⁵² A private right of action under Title III of the ADA does not allow plaintiffs to recover damages.Footnote ²⁵³ Like the ADA, the Act’s available remedies are limited to equitable and injunctive relief, and therefore, do not permit a damages award.Footnote ²⁵⁴ But the Act’s remedies are significantly narrower than Title III’s available remedies.Footnote ²⁵⁵ Title III permits courts to assess civil penalties up to $50,000 for the first violation and $100,000 for subsequent violations and award damages to the plaintiffs at the Attorney General’s request.Footnote ²⁵⁶

Similar to its state counterparts,Footnote ²⁵⁷ the Act does not contain strong enforcement mechanisms, like civil penalties, that would incentivize compliance with the Act and other statutory requirements within federal legislation.Footnote ²⁵⁸ In its current version, the Act’s limited remedies are not likely to yield the significant litigation exposure that would encourage hospitals with transplant programs to create preventative robust risk management strategies and compliance programs aimed at eliminating discrimination in its eligibility decisions.Footnote ²⁵⁹ Absent expansive efforts to eliminate discrimination in the transplant evaluation process, case-by-case enforcement provides for individualized relief, but does not lend itself to standardized evaluation criteria for transplant centers.Footnote ²⁶⁰

Revising transplant center policies

Transplant centers could review and revise current institutional policies to ensure basic compliance with Titles II and III of the ADA and Section 504. For example, the language of the policy could include a requirement that transplant centers conduct individualized evaluations of intellectually disabled persons’ candidacies, and based on the outcome of the evaluations, provide reasonable accommodations that support candidacy for solid organ transplantation.Footnote ²⁷² Recognizing the lack of federal regulation defining “reasonable accommodations” within the context of the initial evaluation stages, transplant centers could consult with the OCR or state-based intellectual disability organizations to identify accommodations that strengthen an intellectually disabled individual’s candidacy.

Transparent decision-making

Transplant teams and transplant physicians have wide discretion in the creation and application of their selection criteria, which results in idiosyncratic eligibility decisions.Footnote ²⁷³ Current practice lends itself to covert disability-based discrimination that is difficult for plaintiffs to prove.Footnote ²⁷⁴ To disincentivize this type of discrimination, institutional policies and procedures could require transplant physicians provide a signed written explanation of their decision to deny transplant eligibility to the patient (or the patient’s legal representative) and include the statement within the patient’s medical record.Footnote ²⁷⁵ A written statement detailing the rationale for a denial of eligibility would be an attestation that the decision is not based solely on the individual’s intellectual disability to the extent that it is not medically significant to the clinical outcomes of the transplant.Footnote ²⁷⁶ Components of the statement could include (1) a description of the individualized evaluation provided, (2) medical and psychosocial barriers that precluded transplant, (4) reasonable modifications provided to support the individual’s candidacy, (4) language disavowing that the consideration of the intellectual disability alone was determinative of eligibility, and (5) circumstances under which, if present, the transplant center would consider revaluation of the individual. Increasing transparency by written communication with the potential candidate increases a transplant physician’s accountability to make evidence-based clinical decisions regarding transplant eligibility for intellectually disabled individuals and avoid determinations of social worth.

Standardized psychosocial evaluation tools

The use of I/DDs as a contraindication, whether absolute or relative, remains unsettled within the practice of transplantation medicine.Footnote ²⁷⁷ For example, calls for standardized psychosocial criteria identify mental status as an appropriate domain for evaluation.Footnote ²⁷⁸ Mental status itself may be uncontroversial and is likely a medically relevant criterion for transplant candidacy; however, mental status by nature contemplates deficits in an individual’s cognitive function.Footnote ²⁷⁹ As a psychosocial evaluation criterion, cognitive function could be a placeholder for discriminatory determinations of social worth because unfounded misconceptions about intellectually disabled individuals’ functional capabilities negatively influence eligibility decisions.Footnote ²⁸⁰

The development of Crisis Standards of Care during the COVID-19 pandemic made clear that objective evaluation tools can exacerbate existing inequities between (intellectually) disabled and non-disabled persons when they do not account for necessary reasonable modifications specific to the disabled community.Footnote ²⁸¹ Accounting for impairments in cognitive function coupled with the position that higher cognitive functioning could increase post-transplant adherence and participation in complex treatment regimens risks systematically poorer psychosocial evaluation results for intellectually disabled individuals.Footnote ²⁸²

Other widely accepted psychosocial criteria (e.g., independence) pose the same types of risks.Footnote ²⁸³ For example, some disabilities require continual (bedside) support from the disabled individual’s caregivers.Footnote ²⁸⁴ Psychosocial evaluation tools that do not account for the need for caregiver support will result in a poorer psychosocial evaluation outcome than a nondisabled person. Federal antidiscrimination laws, as discussed above, require reasonable modifications to policies, practices and procedures to a service or program unless it fundamentally alters the nature of the program.Footnote ²⁸⁵ Incorporation of adaptive functioning into the psychosocial evaluations could hardly be considered a fundamental alteration when, as others have noted, the modifications enhance the purpose of the psychosocial evaluation: to identify psychosocial factors that impact post-transplant success. Thus, if psychosocial evaluations, as risk stratification tools, do not account for reasonable modifications and the necessary auxiliary aids and services that individuals with I/DDs require, then transplant centers risk the unfair—and illegal—treatment of a whole class of individuals.

Furthermore, an emerging consensus suggests that cognitive function is an inadequate measure of an individual’s intellectual disability.Footnote ²⁸⁶ The social model of disability focuses on the interaction between social attitudes toward disability, the environment, and pathology.Footnote ²⁸⁷ This model suggests that disability is a social construct that results from environmental conditions that disadvantage a group of people.Footnote ²⁸⁸ Consistent with this model of disability, an intellectually disabled individual’s level of functioning is more accurately measured by the practical or “day-to-day” skills (e.g., communication) necessary to interact with her environment.Footnote ²⁸⁹ Adaptive behavior is the “social and practical skills that enable people to function in their everyday life.”Footnote ²⁹⁰ Incorporating adaptive behavior evaluations into eligibility assessments of an intellectually disabled individuals’ candidacy provides a more expansive view of the intellectually disabled person’s daily functioning with and without auxiliary aids and services. Within the context of psychosocial evaluations, the degree of cognitive function as measured by an adaptive functioning evaluation would help inform clinical determinations of whether an intellectual disability, or disability-related psychosocial risk variables, are medically significant factors that should preclude organ transplantation.

Integration of adaptive behavior assessments into candidacy evaluations presents logistical challenges. Intellectually disabled individuals often require additional support from a multidisciplinary transplant team to coordinate complex psychosocial care plans.Footnote ²⁹¹ Hiring additional social workers or transplant coordinators with expertise in conducting adaptive behavior evaluations may be cost prohibitive.Footnote ²⁹² Further, adopting these types of evaluations as a component of transplant protocols will require education and training for transplant social workers and coordinators whose time is limited.Footnote ²⁹³ A workable alternative may be to task another member of the multidisciplinary team, like a transplant psychiatrist, to conduct the adaptive behavior evaluation. Hospital and transplant center operations administrators will need to generate creative solutions that ensure the incorporation of adaptive behavior instruments into transplant center evaluation procedures for individuals with I/DDs.