Comments

Kelly Dineen | 03/23/2021

Thank you for the opportunity to comment on the OPTN White Paper: General Considerations in Assessment for Transplant Candidacy. I am a bioethicist, a lawyer, a former abdominal transplant ICU nurse. As an academic, I study legal and ethical issues impacting highly stigmatized populations, including people with substance use disorder. I have assigned the 2015 white paper in previous years and this revision to my current bioethics and the law class. The comments below are a combination of my personal comments and the comments offered by law students at Creighton University School of Law. Our comments follow the outline of the white paper. Under the heading “Revised in 2020,” the last sentence states each “candidate should be examined individually and any and all guidelines should be applied without any type of ethnicity bias.” Bias based on ethnicity is just one of myriad biases, including, but not limited to, race, sexual orientation and gender identity, and disability-based biases. We recommend you either remove the term ethnicity or add others. In the preamble, references are made to distributive justice. Procedural justice is just as essential given the topic of the white paper. Candidacy criteria should be transparent, non-discriminatory, and build trust in the transplant team (i.e. trustworthiness). In addition, definitions of utility and futility would enrich the discussion of ethical issues, as would explicit discussion of resolving conflicting principles. In the Life Expectancy section, we appreciate the inclusion of relevant law. There remain concerns that discussions of longevity could be used as a pretext for age discrimination and therefore it may be useful to clarify that this is not ethically or legally acceptable. Under Potentially Injurious Behavior, there are significant issues and omissions. Most importantly, the omission of relevant law is concerning, especially in the context of comparison to the Life Expectancy section and inclusion of relevant age discrimination law. Similarly, multiple anti-discrimination laws (including the Americans with Disabilities Act, the Rehabilitation Act, and Section 1557 of the ACA) prohibit transplant programs from discriminating against people in treatment for substance use disorders, as a recent settlement with the Department of Justice, Dist. Of Massachusetts made clear when Massachusetts General unlawfully excluded a patient on medication for opioid use disorder from consideration for listing. It is a violation of a patient’s civil rights to deny them access to or full participation in health care services and programs, including transplant candidacy, on the basis of their disability. We strongly recommend the inclusion of this information in the final paper. The evidence is inconclusive linking this category to outcomes. Unless and until it is established, it is ethically problematic to consider these factors, such as a substance use disorder, given the many misunderstandings and myths around the condition and the existing evidence of discrimination in health care. It is ethically impermissible to adopt a position of discriminating until proven wrong. The use of the term “abuse” should also be removed because it is stigmatizing and leads to more discriminatory treatment of patients with substance use disorders (lawyers are more likely to endorse punishment over treatment and doctors are less likely to endorse a biopsychosocial model of addiction in studies in which the only difference is the description of abuse v. substance use). The discussion of personal choice is irrelevant and reflects the deeply held bias against people with substance use disorders. This bias continues to lead to discrimination against people with substance use disorders in a range of settings, including health care, where it is well documented that patients are refused care, denied admission to post-acute care treatment, and often neglected because of their substance use disorder. Just as noted with social supports and immigration status, the existence of a substance use disorder alone should never preclude candidacy for transplant. Just as was stated in regard to non-adherence, a consideration for providing resources and support to people with substance use disorder is warranted here. If the concerns here are ultimately adherence, perhaps this category should be placed under adherence. The self-injurious behavior list is a list of qualities, characteristics, and disabilities for which there exists widespread and often socially accepted (and in medical circles) stigmatization and discrimination. Incarceration history This section is quite vague. It would be helpful to be more explicit in the considerations. For example, are there issues regarding sentencing, setting, and quality of care? If so, those should be included. Concerns about exacerbating existing social determinants of health and structural discrimination. In truth, each of the factors risks this, not just the use of social support criteria. In the end, better case management may address many of these issues.

Anonymous | 03/23/2021

This is a very dense revised proposal relating to all solid organ transplants, not only thoracic organ transplantation. The focus of the paper is the use of non-medical criteria in determining transplant candidacy and how inconsistent and subjective use of such criteria may result in unequal distribution of transplants to potential recipients, undermining the ethical principles of equity and justice. The paper proposes an evaluation process for these non-medical criteria, which is transparent, consistently applied to all individuals without bias, evidence-based and revisable. The non-medical criteria which are included and discussed in this white paper are as follows: Life expectancy (such as age) Potentially injurious behavior (drug, alcohol use, smoking, etc) Adherence Repeat transplantation Incarceration status Immigration status Social support In general, the recommendation proposed for each of these criteria is not to use them solely to exclude a candidate from transplantation. The arguments for this recommendation include potential violation of justice and respect for persons as well as lack of clear-cut evidence linking some of these criteria (such as adherence or social support) with post-transplant outcomes. However, these issues are extremely complex, difficult to objectively measure and assess, closely interlinked (such as potentially injurious behavior and adherence), and there are numerous other potential barriers to successful transplant outcomes above and beyond the patient and the transplant program. Examples of these barriers may include lack of health insurance, drug rehabilitation, or support programs for many patients in the U.S., or the risk of deportation for an undocumented transplant recipient, who then will not be able to receive the care and medications (s)he will need, resulting in poor transplant outcomes. Although I personally welcome, appreciate and support the importance of thoughtful consideration of each of these non-medical factors in determining transplant candidacy, a lot more has to be done at a societal level to alleviate numerous disparities and lack of support/health insurance/systems to take care of individuals with challenging non-medical factors so that proper care and successful outcomes can be offered to each and every transplant recipient. Without these systems in place, transplant programs will have a very difficult time not using non-medical factors in their decision to select candidates for listing. In the meantime, transplant programs should work on developing more objective ways of determining the significance of these non-medical factors and apply them to each factor and transplant candidate consistently without bias and be transparent about the process. This topic should be the focus of a multicenter research grant to allow the study of non-medical factors and how they relate to candidate selection as well as posttransplant outcomes. Perhaps a useful, quantitative scoring system can be developed for more objective patient assessment related to non-medical factors. Lastly, I do not think it would be appropriate to use my individual view regarding this OPTN paper as ISHLT’s stance regarding this topic as this is a very complex area that would need to be discussed amongst members from all different backgrounds. However, I understand that there is no time to do this as a large group. Therefore, it may be fair to say that although the topic could not be discussed amongst all the members in SC (or amongst other relevant groups), we support careful consideration of non-medical factors in the determination of transplant candidacy while balancing the concepts of utility, justice and respect for persons and propose the importance of research focusing on this important area.

American Society for Histocompatibility and Immunogenetics | 03/23/2021

ASHI supports this proposal and values the opportunity to comment.

Region 10 | 03/23/2021

Region 10 sentiment: 3 Strongly Support, 14 Support, 2 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose. Comments: One member expressed support for the work of the committee and agrees that there is implicit bias with current listing practices, which the white paper addresses. Other members suggested that the white paper also consider financial considerations as well as cognition or memory concerns. Another member stated that the psychosocial evaluations is an extremely important component and is the leading cause of non-compliance related graft loss. It was also stated that transplant centers exist to offer the opportunity for transplant to those in need, and they are stewards of an incredibly limited resource. Transplant centers have an obligation to society to utilize this resource in the best possible manner. Thusly, they need to include a great deal of nonmedical evaluation points to ensure successful transplant and survival of both the recipient and the organ. Lastly, another member stated that it is important for everyone to realize that the point of the white paper is to consider non-medical reasons for transplant candidacy consistently. However, for young patients, particularly age 17-24, the cause of graft loss is greatest and related to poor adherence. Attention to adherence as a marker of transplant readiness has to be weighted significantly. In the pediatric population, patients are sometimes declined due to poor adherence or medical caregiver non-adherence. The transplant program must then enact a plan to overcome these barriers in order for the patient to be reconsidered for transplant eligibility.

OPTN Minority Affairs Committee | 03/23/2021

The OPTN Minority Affairs Committee appreciates the opportunity to comment on Revise General Considerations in Assessment for Transplant Candidacy. The Minority Affairs Committee supports the efforts of the Ethics Committee in this work. The Minority Affairs Committee asks the ethics committee to consider developing a review board to evaluate patient psychosocial support in a more objective manner. The Minority Affairs Committee acknowledges that certain patients will not be eligible for transplant due to non-medical criteria or their inability to continue treatment after transplant, but that patients should not be turned away from transplant if the reason for the denial has a viable solution.

Region 2 | 03/23/2021

Region 2 sentiment: 4 Strongly Support, 10 Support, 5 Neutral/Abstain, 1 Oppose, 1 Strongly Oppose. Comments: Overall the members in the region are supportive of the revised white paper. One member did express some concerns with the white paper. They commented that an absence of scientific data makes it harder to use psychosocial factors and medical criteria are also often subjective. For example, how hemodynamic values are interpreted can be quite different. So, the white paper makes an inaccurate argument about the subjectivity. There is no dispute that the listing evaluation needs to be performed consistently, but the paper’s criticism of social workers and their ‘inconsistent’ application of the factors goes too far. The member suggests that the tone of the document needs to be more generous to social workers.

OPTN Patient Affairs Committee | 03/23/2021

The Patient Affairs Committee (PAC) appreciates the work of the Ethics Committee in developing this white paper and the opportunity to comment on it. Overall, the PAC supports the efforts of the paper to aid transplant programs in evaluation of potential transplant candidates, but believes that the paper could go further in achieving its goals. Specifically, the paper could include more discussion related to marginalized groups, such as inmates and nursing home residents. The importance of a strong support system cannot be understated and it is often not the fault of the patients for shortcomings in support. Transplant Centers should participate in a larger system of equity and support. Furthermore, the paper could include a greater emphasis on patient education and increasing equity and access to resources. PAC suggests considering cognitive functioning, behavioral health, weight management, and substance abuse as nonmedical criteria that should be considered and all nonmedical criteria should be standardized. There needs to be clarity on how candidates, recipients, living donors, and families of recipients and donors will be impacted. Ultimately, the PAC considers that the implications and conclusions of this white paper should be strengthened. This conversation is extremely important and PAC wants to continue to encourage and support these ethical priorities.

Region 9 | 03/23/2021

Region 9 sentiment: 1 strongly support, 5 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. The region generally expressed support for this proposal. A member thought it would be a good idea for the committee to also develop a similar paper for living donors. Another commented that this is a complicated, but important issue to have because there is plenty of evidence demonstrating the unconscious bias that comes into play when evaluating candidates for transplant. The member suggested that some parts of the evaluation, especially regarding social support, can be very vague and having minimum standards would help. It also was suggested that perhaps the evaluation shouldn’t be based on one individual’s assessment alone. The member also commented that while the white paper does not compel anyone to take certain actions, hopefully it will make programs stop and think about why they are turned down a candidate. A couple attendees commented on the use of incarceration status and that care should be taken to not exacerbate existing racial disparities in health equity.

Society for Transplant Social Workers | 03/23/2021

The Society of Transplant Social Workers (STSW) was founded in 1985 with the goal of supporting social workers in transplant settings, networking, and establishing best practices in a highly complex healthcare setting. We appreciate the work of the OPTN Ethics Committee in reviewing the General Considerations in Assessment for Transplant Candidacy which focuses on the non-medical criteria used in determining transplant candidacy by the multidisciplinary team. We agree with the goals set out by the Ethics Committee to balance the ethical principles of autonomy, justice and utility for the individual person being considered, donor families, and transplant programs as well as for the larger society all the while considering the “first do no harm” axiom. Racial and ethnic disparities in transplantation are well documented and must be mitigated by the work of the patient, community and the multidisciplinary transplant team to ensure a good outcome after transplant. Poor outcomes are not just negative numbers on a spreadsheet; they reflect morbidity and mortality for transplant recipients. There is variability on whether a person is considered a transplant candidate based on criteria, medical and non-medical, across transplant centers. Transplant candidacy criteria should be transparent and equally applied within the transplant program itself. Transplant candidates should understand the importance of getting a second opinion if found to not be a candidate at one center, whether for medical or non-medical reasons. STSW appreciates the opportunity to add our comments to this work. ? Transplant centers are encouraged to develop their own guidelines for transplant consideration. Each potential transplant candidate should be examined individually and any and all guidelines should be applied without any type of ethnicity bias. (lines 65-67) o We would support broadening the attention to bias in its many facets. ? Life Expectancy… Age does not offer the full picture in determining the life expectancy and it precludes the possibility of some individuals being listed who might otherwise have made good candidates, thereby not respecting their autonomy. (lines 108, 120-122) o While this guideline is not uniquely in the purview of transplant social workers and the 1 and 3 year graft and patient statistics are important and mandated, perhaps from a patient autonomy perspective the calculation could also be focused on longevity with transplant in comparison to medical management of the end organ failure. o We support that age in and of itself should not serve as a sole criterion. ? Potentially Injurious Behavior…Ethical concerns persist with using potentially injurious behaviors (e.g. substance abuse, unhealthy eating, non-adherence to medical recommendations, etc.) as criteria to rule out transplant candidacy.(lines 124-126) o Understanding a person’s actions contextually is a critical part of comprehensive assessments by all members of the multidisciplinary healthcare team. For patient safety, along the transplant continuum, many matters are important to optimize prior to transplant such as reducing risk of substance use relapse, improving mental health and optimizing nutritional health. o Additional research should be done to better identify factors that are predictive of a person participating in potentially injurious behavior post-transplant and what interventions are most likely to reduce that risk. ? Adherence… Adhering to a medical regimen post-transplant increases the likelihood of a successful transplant, increasing utility. Thus, transplanting patients who will be adherent is supported by the principle of utility. (lines 158, 161-162) o We agree that not only does adherence to the complex post-transplant regimen increase the utility of the transplant; it also is intended to promote patient safety. o Additional research does need to be done to identify reliable, objective measures of adherence to medical recommendations, what factors are most predictive of post-transplant adherence to medical recommendations and what interventions are most likely to reduce the risk that they can pose. ? Immigration Status… While immigration status may be tightly intertwined with other psychosocial and financial factors that affect a person’s candidacy for transplantation immigration status alone should neither determine nor exclude a person’s candidacy for organ transplantation as these would be unduly compromise justice 203 and respect for persons. (lines 196, 200-203) o Access to resources needed to manage a transplanted organ is one of the many factors taken into account when considering transplant candidacy. In our current healthcare system, there are fewer resources for undocumented immigrants which can make post-transplant management more complex. o Perhaps UNOS should consider removing immigration status from the database questions when listing a person for transplant. o An opportunity for advocacy exists to expand health care resources to include people who are undocumented. ? Social Support… Transplant teams using social support criteria commonly require a potential transplant candidate to demonstrate existing social support to assist with the wide range of post-transplant requirements, such as transportation, medication management, and monitoring symptoms. (lines 219, 222-224) o We agree that the term “social support” is broad, defined in literature in a variety of ways and defined differently by various transplant centers. o Comprehensive assessments include assessing whether a person and/or their support system can manage complex post-transplant care needs for the patient’s safety in the short and long terms. o Additional research would be beneficial to identify which factors are most predictive of post-transplant challenges that could negatively impact success after transplant and what interventions are most likely to reduce the risk that they may pose. o An advocacy opportunity exists to develop additional community supports to address some of the unmet needs patients sometimes find. o KDIGO highlights that while there is little evidence that “absence of social support is an absolute contraindication to transplantation. However, in light of the complexities of progressive kidney failure, its treatment, and the associated demands of post-transplant recovery and rehabilitation, we recommend that patients who are unable to engage independently in self-care activities have an identified support system in place prior to transplantation.” Virtually all people will experience some postoperative recovery needs. We are committed to our National Association of Social Workers Code of Ethics aligns with the OPTN Guidelines imperative of applying listing criteria without bias: Social workers should not practice, condone, facilitate, or collaborate with any form of discrimination on the basis of race, ethnicity, national origin, color, sex, sexual orientation, gender identity or expression, age, marital status, political belief, religion, immigration status, or mental or physical ability. The comprehensive psychosocial assessment is intended to identify a potential candidate’s strengths and areas that need to be addressed prior to successful transplant. Potential candidates may be asked to optimize certain factors as a result of the assessment with accompanying resources, when available, being offered. Transplanting people who do not have the necessary pieces in place, puts them at risk for serious complications after transplant up to and including graft failure and death. Balancing autonomy, justice, utility and safety are critical for the transplant community to hold as a high standard across all disciplines and all evaluation criteria. The Society for Transplant Social Workers strongly supports research efforts to identify which non-medical factors are most predictive of post-transplant challenges that could negatively impact success after transplant and what interventions are most likely to reduce the risk that they may pose. We would be happy to participate in conversations related to that effort. There are many factors in the transplant realm that are hard to quantify, apply uniformly across transplant programs and it is difficult to do prospective studies from medical and ethical perspectives. In 2018 we participated in consensus building work with the International Society for Heart and Lung Transplantation (ISHLT) around the psychosocial evaluation of adult cardiothoracic transplant and long-term mechanical support candidates. Some of the literature that we rely on, as transplant and mechanical support social workers, when developing best practices, include the following: ? KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation, Revised January 6, 2020. Steven J. Chadban, BMed, PhD, et al. ? The Stanford Integrated Psychosocial Assessment for Transplant is Associated with Outcomes Before and After Liver Transplantation, December 15, 2020. Sasha DeutschLink, MD, et al. ? The 2018 ISHLT/APM/AST/ICCAC/STSW Recommendations for the Psychosocial Evaluation of Adult Cardiothoracic Transplant Candidates and Candidates for LongTerm Mechanical Circulatory Support. July 1, 2018. Mary Amanda Dew, PhD, et al ? Why It is Important to Consider Social Support When Assessing Organ Transplant Candidates? October 24, 2019. Jose R. Maldonado, MD Thank you for the opportunity to share our thoughts on this important work. We look forward to working together in the future.

View attachment from Society for Transplant Social Workers

American Society of Transplant Surgeons | 03/23/2021

The American Society of Transplant Surgeons (ASTS) applauds the OPTN Ethics Committee for addressing the use of non-clinical considerations in transplant candidate assessment and supports this proposal with recommendations. ASTS believes that it is critical to ensure that transplant candidate assessment criteria do not discriminate among potential candidates based on race, ethnic origin, socio-economic status, gender, and other non-clinical factors that have the potential to have a significant discriminatory impact. We also recognize that the use of nonmedical criteria may compound the effect of other health care disparities that result in underreferral of minority and lower income patients for transplant evaluation. We support the OPTN position as set forth in the White Paper entitled, General Considerations in Assessment for Transplant Candidacy, which makes it clear that: 1. Repeat transplantation, incarceration status, immigration status, and social support should not be considered as a single criteria in determining whether a potential candidate should be waitlisted. 2. Age and “potentially injurious behaviors” alone should not disqualify a potential candidate from being waitlisted. 3. A “history of consistent and documented treatment non-adherence” may be considered so long as any mitigating factors beyond the control of the potential candidate are given full consideration We would recommend that the White Paper be modified to specifically address discrimination based on disability. Along these lines we urge that the White Paper explicitly state that a potential candidate’s disability alone should not disqualify him or her from being waitlisted. We believe it may be helpful for the White Paper to include a discussion of the legal and moral ramifications of considering disability as a factor in waitlist determinations. ASTS looks forward to the finalization of the White Paper and plans to urge Transplant Centers to examine their candidate assessment policies to ensure that the White Paper recommendations are implemented in clinical practice expeditiously.

Anonymous | 03/23/2021

OPTN Ethics Committee presented by George Bayliss, MD Comments: One member asked why the committee did not address financial considerations given that socio-economic status and its intersectionality with race is a primary determinant of access to transplant candidacy and therefore key to understanding disparities? The Committee member agreed this is a consideration and expressed support for collection of better data on transplant candidates to understand the issues related to socio-economic status. Another member commented that there are studies regarding the types of considerations in assessing transplant candidacy that can be discriminatory. Region 1 sentiment: 4 strongly support, 4 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplantation | 03/22/2021

The American Society of Transplantation is generally supportive of this paper in concept. This is an important and timely topic, particularly in the context of the AST's Inclusion, Diversity, and Access to Life (IDEAL) Task Force work. The paper tackles difficult issues and urges the reader to apply approaches consistently. We appreciate the revision’s intent to define a more standardized process for non-medical considerations that are vital for consideration when assessing transplant candidacy, including medication access and adherence, but do believe that it may fall short of serving as not only an advocate of these concerns but as a steward of how to address them. The white paper covers ethical principles which are germane to consideration of the psychosocial issues which are frequently confronted by transplant programs. The strength of the document is the key message to consider all candidates equally, and not base adverse determinations only on the psychosocial aspects. While we appreciate and agree with many statements within this document, we believe that the inclusion of applied clinical ethics and relevant empirical literature from both organ transplantation and broader behavioral research will make it more robust. Additionally, we believe that it should also include specific guidance on how to operationalize these principles. The determination of transplant candidacy is a complex clinical synthesis, which intertwines empirical, evidence-based assessments with normative judgments. Many normative judgments germane to transplant candidacy are predicated on the accurate prediction of future behaviors, assumptions about volitional and financial capacities for conforming to a recommended post-transplant management regimen, and structural inequalities in our healthcare system and society. As the paper outlines, these judgments are often made in the absence of a robust evidence base, can be subject to a host of misleading heuristics and biases, which by extension can result in discounting or invalidating the candidacy of vulnerable individuals. That said, these forward-looking predictions and clinical judgments are, to some extent, unavoidable. Non-medical factors, while an important part of the holistic assessment of the transplant candidate, are often poorly defined, based on limited data, susceptible to bias, and used by programs to reject patients that may be more challenging to manage. Unfortunately, these patients are more likely to be ethnic and racial minorities, lower SES, and socially isolated. We emphatically support efforts to improve the transplant process by increasing consistency, minimizing or eliminating bias, and furthering the empirical literature on evaluation criteria for listing. Dismantling structural racism and other biased processes is of the highest priority. Equal application of standards without regard to ethnicity, socioeconomic status and immigration status is of the utmost importance. The background section criticizes the inclusion of non-medical transplant evaluation criteria but does not clearly define “non-medical criteria” nor suggest how these criteria can be relevant and/or helpful. The overall tone seems rather negative about this aspect of the evaluation process and without fully showing appreciation that these are not simple decisions determined at point of contact and recognition that transplant personnel try to work with patients to identify and mitigate risk factors for negative outcomes and foster positive ones. We suggest including some information about the benefit/importance of including these criteria as there is substantial evidence to suggest that various psychosocial criteria are related to outcomes. Line 67: We appreciate it stating “ethnicity bias” but we suggest broadening this statement to include sexual orientation, gender, etc. or simply be stated as bias. Lines 79-80: “Non-medical criteria” should be defined. Are you referring to psychosocial variables in general? Mental health status and history is a significant piece of “non-medical” criteria that is not currently included in this document and would benefit from the addition. Lines 84-86: We believe that this is perhaps the most important statement in the document. We agree that inconsistent and/or subjective use of non-medical criteria leads to inconsistent distribution of medical goods. However, given the existing empirical literature on the impact of “non-medical” factors on outcomes, both in general and related to organ transplantation, perhaps recommendations should focus more on greater clarity, transparency, and refinement of these guidelines. Life expectancy Lines 109-122: This section largely discusses/focuses on “age” rather than life expectancy. We agree that using age alone, without the consideration of life expectancy, is a bias. However, evidence suggests medical criteria (e.g., comorbid conditions, frailty, etc.) impacts life expectancy. Therefore, we suggest that life expectancy is a medical criterion. We believe that separating age and life expectancy for discussion purposes here is important. Potentially injurious behavior First, we applaud the new title for this section. The prior version of this section was Organ Failure Caused by Behavior and in this version, it is Potentially Injurious Behavior. This new title is more encompassing of the complex behaviors known to impact health and health outcomes and less focused on the stigmatization of behaviors that may have contributed to organ failure. However, the included paragraphs do not show full understanding of the clinical complexities of the included behaviors. Also, collapsing these behaviors minimizes some of their complexities. For example, substance use disorders are quite different than not having access to healthy food choices. While there can be overlapping individual, sociocultural, and environmental factors across behaviors, determining the individual’s specific risks for negative outcomes deserves individual assessment and intervention (by personnel with the relevant expertise) in order to mitigate negative outcomes. In some cases, that will defer or prevent listing (e.g., active suicidal intent with plan, ongoing cocaine abuse). Each presentation warrants thorough evaluation, entails its own unique ethical considerations (for example, please see Beauchamp [1993] discussion on suicide, autonomy and mental capacity), and intervention as appropriate for the benefit of the patient. Lines 125-131: Sources 30 and 31 are outdated. We respectfully disagree agree with the broad statement that the evidence is “essential but currently inconclusive” as we put forward that it depends on which behaviors are being examined. As one example, there is also a growing body of research that opioid use is linked to poor transplant outcomes (sources below). - Lentine KL, Lam NN, Naik AS, et al. Prescription opioid use before and after kidney transplant: Implications for posttransplant outcomes. American journal of transplantation, 2018;18(12):2987-2999. - Lentine KL, Lam NN, Schnitzler MA, et al. Predonation Prescription Opioid Use: A Novel Risk Factor for Readmission After Living Kidney Donation. American journal of transplantation. 2017;17(3):744-753. - Lentine KL, Lam NN, Xiao H, et al. Associations of pre-transplant prescription narcotic use with clinical complications after kidney transplantation. American journal of nephrology. 2015;41(2):165-176. - Lentine KL, Shah KS, Kobashigawa JA, et al. Prescription opioid use before and after heart transplant: Associations with posttransplant outcomes. American journal of transplantation. 2019;19(12):3405-3414. - Lam NN, Schnitzler MA, Axelrod DA, et al. Outcome Implications of Benzodiazepines and Opioid Coprescriptions Before Kidney Transplantation. American journal of transplantation. 2018;18 (Supplement 4):295. Lines 133-136: Some of the references should be updated or do not support the premise proposed. Specifically, Goldblatt et al is from 1965 and the relevant obesity literature has been considerably updated. Also, Adler, Glymour, and Fielding (2016) outlines that these behaviors contribute over a third of premature deaths. However, Adler et al. do not make comment on genetic factors nor do they explicitly state that these behaviors are or are not within the patient’s ability to improve. Rather the article presents general policy recommendations to make resources for improving these behaviors more accessible to a wider cohort of individuals. We suggest that the statement referenced by #33 be removed, as simply because there is a genetic or economic basis to a condition does not render it non-modifiable. Lines 140-143 and 145-147: These statements appear to assume that individuals who are assessing these behaviors are either not aware of or disregarding of the clinical knowledge necessary to assess and recommend appropriate mitigation strategies. Rather, in the interest of the patient, we should be intervening or assist in facilitating appropriate interventions to improve the patient condition (when indicated/appropriate). Lines 154-156: Given the range of behaviors outlined here, it is difficult to fully support this statement as it does not allow for the clinical seriousness of some of these behaviors on the patient and the graft. While we agree that a patient with a history of substance abuse should not be excluded based solely on this history, if the candidate currently actively engaging in self-injurious behavior, it is our ethical duty to our patients to intervene. Depending on the specific behavior that may require deferring or ruling out organ transplantation until intervention can be performed and the self-injurious behavior can be improved. We agree this should be done in the context of the most up-to-date empirical literature, both based upon patient presentation and in relation to organ transplantation. Also, of note reference 36 is on the Americans with Disabilities Act (ADA) and organ transplant: under the ADA, illicit substance abuse histories are eligible for disability status but only if the patient is no longer using/abusing illicit substances and actively participating/participated in rehabilitation. Regarding alcohol abuse, the ADA does offer protections for individuals with alcohol use disorders, but an employer can prohibit alcohol use in the workplace, may discipline, discharge, or deny employment if alcohol use adversely affects job performance, etc. This is consistent with the clinical approach to illicit substance and/or alcohol use disorders in organ transplantation. Namely, patient engagement in minimization of adverse effects in relation to organ transplant which can include abstinence, intervention, etc. We also note that this section is missing a discussion regarding relapse to alcohol use. Many, if not most liver transplant programs will deny or de-list a patient who has relapsed to alcohol use. This is a common criterion, accordingly discussion of this issue is warranted and would be of benefit. Adherence We put forward that there are some objective measures of adherence, some of which (e.g., adherence to dialysis, attending transplant evaluation appointments) have been directly linked to post-transplant adherence. Therefore, we suggest modifying the section to state that we should rely on these objective indicators of adherence when available and, as previously noted, to assist patients in problem-solving and resolving barriers when feasible. We support the last sentence of this section as a critical and accurate statement shown time and time again, both in and out of transplantation. We believe that this section would benefit from updated citations. Lines 169-171: We find this to be another important statement but believe that it is important to call it what it is… “implicit biases” rather than “implicit perceptions. Repeat transplantation We agree with this section. Incarceration status We agree that incarceration status should not a priori exclude a patient from being considered for transplant. However, the logistics of such pose challenges and have to be weighed in the context of appropriate utilization of resources (e.g., time taken from other patients to coordinate this complex care). Immigration status We agree with this section and support associated revisions. Social support Although we appreciate the ethical considerations proposed by opposing social support as a criterion for transplant listing, the consideration for social support should be viewed with more nuance and requires a delicate balance of both ethical values and clinical considerations. Further, the existing literature examining social support factors on outcomes has significant limitations and does not account for existing routine clinical interventions aimed at strengthening social support. Also, additional literature cited in this report provides subjective data (providers’ perceptions) rather than objective percentages/number of patients declined due to lack of social support. Given the call for more objective indicators, it is important to obtain objective data (vs perceptions, which have a high risk of recall bias) before making significant regulatory changes. Supporting this, the cited research reported 70% of the providers surveyed supported the development of a more objective, standardized social support evaluation across all transplant centers, which can arguably create more equitable access to transplantation. Thus, the suggestion is not that social support does not matter or should not play a role in transplant candidacy. Rather, that it be measured objectively and in consideration of the needs of the patient to successfully care for a new organ. We agree that teams should help patients with limited supports find ways to meet their support needs and to do so in an equitable manner. However, we also find it reasonable for a transplant program to decline patients when patients and/or social supports do not participate in efforts to mobilize support systems. Note: reference 48 and 49 appear to be the same reference. Summary/Conclusion We suggest adding to the Summary/Conclusion: “Ultimately, the use of judgment in candidacy evaluations must be understood in the context of the ultimate moral and professional responsibility for post-transplant outcomes accorded transplant physicians and surgeons. Historically, adverse patient outcomes attributable to (for example) demonstrated nonadherence, financial unsuitability, a lack (or foreseeable loss) of social support has not been judged to release transplant professionals and transplant programs from responsibility for patient outcomes. This ultimate responsibility inherently requires use of (fallible) judgment in candidacy determination. In parallel, it may be not preferable to penalize programs for making judgments which may result in adverse patient outcomes, in service to the goal of improving access to transplantation." We offer the following additional comments for consideration: • From an access standpoint, pharmacy benefits coverage should not only be assessed at the time of transplant listing but should be encouraged to be reassessed periodically or at minimum closer to anticipated transplantation. While we understand this is a dynamic, complicated process with many involved, patients’ ability to have access to and coverage for their medications post-transplant is paramount to their success as data have shown non- adherence to be associated with a higher rate of rejection and graft loss.1-8 Multidisciplinary team members should utilize available validated tools when able to objectively assess adherence, literacy, and comprehension as part of pre-transplant evaluation. Lastly, although social support alone should not preclude candidates for listing, a lack of support systems that may impact vital post-operative demands, specifically medication management, should to be taken into consideration in order to address factors that may contribute to medication non-adherence and influence transplant outcomes. Transplant programs should proactively develop resources promoting adherence to assist candidates pre-transplant and to optimize post-transplant outcomes for recipients. References o Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: A systematic review. Transplantation. 2004; 77: 769–789. o Sellarés J, de Freitas DG, Mengel M, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence: attributing causes of kidney transplant loss. Am J Transplant. 2012;12(2):388-399. o Berquist RK, Berquist WE, Esquivel CO, Cox KL, Wayman KI, Litt IF. Non-adherence to post-transplant care: Prevalence, risk factors and outcomes in adolescent liver transplant recipients. Pediatr Transplant. 2008;12(2):194-200. o Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009;9(11):2597-2606. o Oliva M, Singh TP, Gauvreau K, Vanderpluym CJ, Bastardi HJ, Almond CS. Impact of medication non-adherence on survival after pediatric heart transplantation in the U.S.A. J Heart Lung Transplant. 2013;32(9):881-888. o Nevins TE, Robiner WN, Thomas W. Predictive patterns of early medication adherence in renal transplantation. Transplantation. 2014;98(8):878-884. o Hart A, Gustafson SK, Wey A, et al. The association between loss of Medicare, immunosuppressive medication use, and kidney transplant outcomes. Am J Transplant. 2019;19(7):1964?1971. o Woodward RS, Schnitzler MA, Lowell JA, Spitznagel EL, Brennan DC. Effect of extended coverage of immunosuppressive medications by medicare on the survival of cadaveric renal transplants. Am J Transplant. 2001;1(1):69-73. • We recognize that this is a large topic and the white paper focuses on adults and does not address pediatric patients or patients with disabilities. We suggest review of the AAP April 2020 recommendations. If pediatrics is not included, we would recommend that the introduction state that it focuses on adult patients. • The document doesn’t explore the reality that a past history of injurious behaviors, lack of social support or a history of repetitive non-adherence present grave risks to the loss of organs, that, once transplanted, cannot be reallocated to others if initial pre-transplant concerns prove to be well founded. The verbiage lays responsibility on the transplant centers to find methods to “fix” the issues for the candidates which is not always practical or possible. For example, a patient without a car or a phone, doesn’t take his medicines or keep his appointments or lacks any support system is highly unlikely to have a successful transplant outcome. We believe that it is incumbent upon transplant professionals to be good stewards of a precious resource. We should not take this document as free license to allocate organs when there is a “high degree of certainty: that there will be a poor outcome. The must be a balance of advocacy for a patient and stewardship for the donor. • The white paper does not address financial support as a barrier to transplantation and care. It would seem that this would be an important aspect to consider in a document such as this that addresses the ethical considerations raised by the use of non-medical criteria. The white paper is descriptive, not prescriptive, and ultimately it the transplant center's prerogative to transplant patients with psychosocial risk factors based on their risk averseness, available resources, and prior center outcomes. The goal of the white paper is to urge centers to reconsider individuals facing the challenges described in the white paper and try to provide resources and support to navigate the process of transplant. The intent of white paper is good, but it would be very helpful if it directed centers to additional resources that may be needed to help higher risk patients. The white paper also makes no comment on changing transplant center reporting metrics to exempt them from potential poorer graft and patient outcomes due to the inclusion of such high-risk patients which may be helpful in incentivizing transplantation in these patients.

Colleen O'Donnell Flores | 03/22/2021

I applaud the Ethics Committee’s proposal to update resources for transplant programs in considering non-medical criteria for candidate evaluations. The stated goal of the white paper is, “to refine the use of these criteria to ensure equitable access to transplantation”. However, the revised proposal still includes ‘Incarceration Status’. Past incarceration status is irrelevant in the evaluation for transplant candidacy. To include a candidate’s past incarceration status systematically introduces bias into the process. A previously incarcerated individual has not been sentenced by society to an additional punishment impacting their consideration to receive medical services. Furthermore, it is well documented that racial disparity is evident in mass incarceration. We do not want to inadvertently introduce this inequity into the transplant process. I suggest the Committee name the inclusion of incarceration status as racially biased criteria and/or explicitly state that it be eliminated as non-medical criteria.

NATCO | 03/22/2021

NATCO commends the Ethics Committee for revisiting this white paper and suggesting these revisions since all supporting documents should be reviewed on a periodic basis to ensure they are still relevant and inclusive. NATCO supports the inclusion of the suggested criteria to assess for potential transplant candidacy. We understand these are well-thought out suggestions for centers to include in their evaluation and are not required to be part of the evaluation. All the suggested additional criteria are not only helpful in assessing candidates for transplant, but also assuring transplantable organs are maximized by placing them with individuals who will more likely have longer post-transplant life expectancy. There is some concern regarding candidates who are medically suitable for transplant. Would adopting the suggested criteria lead to potentially ruling out medically suitable candidates and does this create an inherent bias with those reviewing candidates since we are broadening the scope to include criteria that is more subjective in nature?

Anonymous | 03/22/2021

While I agree that these are important areas to consider and I appreciate the emphasis on justice and respect for persons, I feel that this white paper leans too heavily away from the ethical principle of utility. From a kidney transplant perspective, transplant is an elective procedure, with the alternate treatment modality of dialysis. In that sense, it changes the ethical perspective slightly as it is not a matter of life and death as in heart, lung, or liver transplant. Our patients (for the most part) do have time to optimize their candidacy prior to approval for listing. In addition, if guidelines are going to change, then are governing bodies such as UNOS and CMS also going to change their outcome expectations to account for centers approving less-prepared candidates, which will likely lead to an increase in negative outcomes? Rather than summarily eliminating psychosocial aspects of transplant workup (potentially injurious behavior, adherence, social support), I would prefer to see a recommendation that transplant centers have clear criteria that can be objectively assessed to balance ethical principles and minimize bias. For example, at our kidney transplant center, we have set numbers (lab value cutoffs, number of missed or shortened treatments) for patients to demonstrate adherence to dialysis treatment and diabetes management, which can directly affect transplant outcomes. If adherence does not meet criteria, or if substance abuse or mental health stability are concerns, we give the patient time frames to show improvement or complete tasks in order to move forward with transplant and optimize post-op success. Social support is also vital. When patients do not have support people who can take them to follow-up appointments and care for them at home while they have driving and lifting restrictions, they miss their clinic appointments and lab draws, and we cannot properly dose immunosuppressants. This paper recommends transplant centers offer support/interventions to provide equitable access, but smaller centers often do not have the staffing or resources to do so. Correctional facilities are notoriously awful to coordinate care with, as they do not like to bring inmates out of the prison/jail or paying to send an armed guard with the inmate to specialist appointments. These patients tend to be reliant on the prison medical staff to provide post-transplant care. As generalists and not specialists, this is not medically appropriate. There are insurance-related/financial considerations directly tied to immigration status that make that proposal problematic as well. Patients who are undocumented may have obtained insurance coverage under false pretenses, and if we proceed with documenting their status, we have seen insurance companies drop their coverage and that of their whole family, leaving them in a worse situation overall. Not documenting what we have been told is ethically compromising as well. Further, if these patients are placed in deportation proceedings, they may not have access to transplant medications or post-transplant care.

Transplant Coordinators Committee | 03/19/2021

The Transplant Coordinators Committee thanks the Ethics Committee for presenting its proposal “Revise General Considerations in Assessment for Transplant Candidacy” and offers the following feedback: A member expressed concern for the exclusion of pediatric candidates. Despite belonging to a specific category of recipients, younger pediatric patient’s accessibility to transplantation is often based on nonmedical, psychosocial factors associated with their families and caregivers that are to no fault of the child. For example, in California transplant professionals sometimes have to call Child Protective Services (CPS) to have pediatric candidates placed into Medical Foster Care in order to proceed with transplantation. It was suggested that this argument could be added to the existing ‘Social Support’ header calling for special attention to be taken in the case of pediatric candidates. Pediatric concerns were also expressed in regards to children with intellectual and developmental disabilities. The final pediatric concern was in protections for children who have U.S. citizenship but their parents do not. A member applauded the work done by the Ethics Committee to provide uniform guidelines for improving practices, but expressed concern that the ‘medical literacy’ issue surpasses just medical literacy to become ‘transplant literacy’ which needs to be addressed either on a national or local level. A member addressed the need for financial considerations to be included in the white paper since transplantation is unique in the ongoing need to pay for medication following transplantation. A member suggested implementing a standardized scoring system to add a level of objectivity to something that is so subjective. The member suggested that a project like this would need involvement and guidance from the Ethics Committee but rely more strongly on the organ specific committees to build out their existing needs.

dawn freiberger | 03/18/2021

This is such an important topic to take under consideration at this time. It is a very difficult topic. Boston Children's Hospital is actively having these types of discussions. If psycho/social criteria are loosened moving forward, which they should be in my opinion, governing bodies such as UNOS and CMS also need to consider this if there is a negative reflection in outcomes because of a change in listing practices. Adult hospitals also need to be more lenient in accepting these patients for transition as they reach adulthood. Children are particularly vulnerable when there are social issues within the family, to no fault of their own. Safety nets need to be up in place as much as possible. The support and safety nets need to be carried through to adult transition/hospitals to help these families through out their post transplant life.

Region 11 | 03/18/2021

Region 11 sentiment: 1 strongly support, 10 support, 4 neutral/abstain, 0 opposed, 0 strongly opposed During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general support for this proposal. One attendee stressed the importance of keeping social support as an evaluation criterion for listing; adding that it is important for success after transplant. There was some discussion around including financial criteria, however the presenter pointed out that the committee focused on subjective and psychosocial factors in this paper.

Region 7 | 03/12/2021

Region 7 sentiment: 3 Strongly Support; 5 Support; 2 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee asked if measures of healthcare literacy that can be evaluated in terms of risk for lower patient and graft survival and if this paper should address that. Another attendee commented that adopting a standardized measure for compliance may be useful in evaluations.

George Mallory | 03/09/2021

It is easy to believe that socioeconomic class should not count against any given transplant candidate. We all agree. However, the problem is that we do not transplant classes of patients but individual patients. With pediatric patients the family is a key component of the candidate's evaluation. Like it or not, It is fact that untreated mental illness, unhealthy home environments, tobacco smoke exposure and non-adherence are all more common in members of lower socioeconomic class status. We owe it to donor families to place organs in individuals who are most likely to use the donation in a productive way. We should wrestle with this issue but understand its complexity. When possible, we should identify modifiable barriers to transplant candidacy and give time and resources (if possible) to ameliorate the situation.

Region 6 | 03/09/2021

Region 6 sentiment: 9 strongly support, 16 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Overall the region supported the public comment item with attendees remarking that this is great work and long overdue. One member commented that centers should really consider these questions in terms of what is evidence-based and what is motivated by other considerations. Another member shared that with heart transplants, there is a lot of weight placed on having social supports, which can be a very subjective area.

Stephanie Little | 03/09/2021

Very appreciative towards this committee for opening the discussion on ethical considerations for listing. In review, one area that stood out as concerning is this being a resource guide for centers. While I know it is more than likely not feasible, it would be ideal if centers could come out with across the board standards. For example: being incarcerated in itself should never be an excluding factor for listing. It is a human right to have access to healthcare, which prisons must adhere to, and excluding that population would be morally wrong (with possible legal ramifications). Other areas that would be of interest to discuss include cognitive status (neuro and otherwise), marijuana use, BMI, and insurance limitations (falling under the psychosocial umbrella). One issue I found with this white paper is that it was simply too short, though at no fault of the writers. I believe it has opened up minds and ideas from others who know want to see an extended version with other areas included. This is a great jumping off point and I commend the committee/authors for bringing this forth. It is difficult to ensure utility, justice, and respect for persons are met all at the same time, yet they are taking on the task to tackle it. I believe public comment (in addition to presentations at committee meetings, like the PAC – in which I am a member) will open the topic up for further evaluation, as well as expand what is already being seen as an ethical dilemma.

Region 8 | 03/09/2021

Region 8 sentiment: Strongly support-4, Support–9, Neutral/abstain-3, Oppose-0, Strongly oppose-0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Attendees were interested in this work and had a productive discussion with a number of suggestions. One member commented that issues that socially disadvantaged people face with access to transplant and that the disproportionate burden of evaluating people with limited means has to be part of the consideration. Another member expressed concern that the proposed inclusion of immigration status in the evaluation could have the potential to disenfranchise noncitizens. A member commented that certain state statutes could require hospitals to decline services to patients who do not have legal immigration status. Another member commented that the committee should also consider discussions about immigration status of parents and the potential impact on a pediatric transplant. An attendee commented that for a pediatric patient, mental health issues in the parents can be problematic to follow up. A member commented on how many community resources and social support social workers and others have managed to provide patients and that if the transplant community partnered with others to build in more resources and support for patients on the transplant list they would have more results. Another member followed up and suggested that although these are great ideas, compliance and legal departments should be consulted regarding inducement regulations. An attendee commented that the financial and the social are intertwined and must both be considered by the committee. A member commented that social determinants of health care are a struggle and not cut and dry. He said there can be fundamental barriers to care that can be addressed and fixed and we should not make simple conclusions about why someone can’t be transplanted. One member commented that as long as transplant centers are scrutinized by outcomes, utility is going to be more heavily weighed than justice and that many non-medical criteria are not revisable or the transplant centers don't have the necessary resources. A member commented that the white paper does not provide guidance that transplant centers need. One attendee suggested that the committee develop templates centers might use to develop consistent criteria for some of these difficult decisions. Another member commented that it would be beneficial for transplant hospitals to share resources and best practices.

Anonymous | 02/25/2021

ANNA supports this proposal.

Region 5 | 02/19/2021

Region 5 sentiment: 7 strongly support, 24 support, 10 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member asked if ethics committee discussed the tension between what is appropriate for the patient versus the system? For example, a transplant for a patient with limited life expectancy but who can still benefit from quality of life considerations. Another member commented that there is an inordinate amount of time is spent discussing social support. The ethics representative agreed there is a lot of time and resources are spent on those discussions and it is an important consideration but one that ought not to exclude people from access to life saving treatment.

Region 3 | 02/18/2021

Region 3 sentiment: Strongly Support-2, Support-13, Neutral/abstain - 6, Oppose -0, Strongly Oppose - 1. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. A member voiced support for a more standardized process that does not rely on the subjective decisions of individual transplant programs. He also supported the use of feedback measures. Another member recommended that once a candidate is listed, the new factors being considered factor into a "handicap score" to level the playing field compared to those without adverse psychosocial factors. An attendee suggested that objective metrics such as zip code data or census track data be considered and also commented that data relates to incarceration and immigration status would be a small subset of the waitlist. Another member commented that as well as access to transplant, social, financial and legal aspects should also be considered. They suggested that an algorithm that identified patients early as candidates as candidates for transplant would be helpful.

Region 4 | 02/04/2021

Region 4 sentiment: 2 strongly support; 14 support; 2 neutral/abstain; 1 oppose; 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee suggested that the committee include considerations for the practice of liver transplantation for alcoholic hepatitis patients. Another attendee commented that the proposal does not address pediatric patients or patients with disabilities and suggested reviewing the AAP April 2020 recommendations.

Anonymous | 01/25/2021

As a recipient family, I'm strongly in support of these revisions. In particular, the social support revision. It can be a struggle to show traditionally-expected social support in lower income families. The recognition that this shouldn't factor into consideration for candidacy is greatly appreciated. My only wish is that this was published sooner, as that was something my family struggled with.