Comments

Joseph Hillenburg | 03/24/2020

Public sentiment on this policy is fairly clear, so I will address a point that will be relevant in potential future iterations: If such data is ever collected, tight technical and procedural controls should be enacted to increase public confidence and reduce the possibility of data misuse.

OPTN Transplant Administrators Committee | 03/24/2020

A TAC member noted that this data will only be collected for people who make it to the waitlist, and the main problem is the people who are not getting access to the waitlist. There was a suggestion on drilling down to zip code from patient data (which is not an option due to liability issues). A TAC member described how just looking at income alone without looking at other resources and support systems, e.g. insurance access and fundraisers, doesn’t show the whole picture, but asking more information would be a data burden. A concern was raised that requesting this information breaks down trust between the patient and the transplant program. Is the data going to be rich enough to give enough gain to compensate for this potential risk? Patients who do not understand how listing or allocation work may be concerned that transplant programs are trying to preference some patients over others. Vote: 1 Strongly Support, 3 Support, 0 Neutral/Abstain, 2 Oppose, 3 Strongly Oppose

Region 7 | 03/24/2020

2 Strongly Support, 2 Support, 2 Neutral/Abstain, 4 Oppose, 3 Strongly Oppose Members of the region raised several concerns about the proposal. One member noted that the proposal only proposes collecting data on those patients that make it onto the waitlist. In order to get a better understanding of how socioeconomic status affects access to transplant data should also be collected on those patients that are referred for transplant but do not get listed. There was a concern that patients of lower socioeconomic status will not give accurate answers because it may be perceived that their income could inhibit their chance of being listed. Another member noted that this would increase the administrative burden that is already imposed on transplant coordinators and administrators. It was noted that social workers typically collect this data in their patient narratives, but it would be a lot of extra work to comb through the narratives to find the answers. There was some support of the proposal from members in the audience but they recognized that collecting this data would be difficult and would suggest the committee look at novel ways of collecting the data such as geotagging or census track data.

Region 10 | 03/24/2020

7 Strongly Support, 6 Support, 2 Neutral/Abstain, 1 Oppose, 3 Strongly Oppose Overall, the members of the region supported the proposal. The comment was made that instead of collecting a number for annual salary, it would be less intrusive to ask for a salary range. Patients would be more apt to provide that data. Members of the region also felt that only asking for these two data points at time of listing will not help paint the whole picture since income will change drastically throughout a candidate’s wait for transplant. It was suggested that it may help to collect the data at time of listing and again at time of transplant. Concerns were raised that cost of living varies greatly across the nation, and that the Committee should consider that as part of the proposal. Another commenter suggested that instead of collecting this data the committee should instead access data on various state financial aid programs as a proxy. From the online comments there concern was raised over the increased data burden for transplant center staff and unintended consequences that could arise from collecting this data. Lastly, if this data is collected, it is very sensitive data. There needs to be a lot of security around protecting this data.

OPTN Region 9 | 03/24/2020

Strongly support (1), Support (8), Neutral/Abstain (2), Oppose (0), Strongly Oppose (1) The region generally supports the proposal. A member asked if there was concern that patients wouldn’t be forthright with reporting all sources of income due to fear it would jeopardize their Medicaid or SSI benefits. The presenter explained that they wouldn’t be asking for a breakdown of sources of income, rather it would be a total over an entire year, but that this was a good point to bring back to the committee. Some members expressed that this is important and necessary data to collect. Another member was concerned about the additional data burden this could present, as well as how patients would receive this kind of request. A member also asked if there were other ways to collect this data via other electronic sources.

Deepa M | 03/23/2020

While the underlying intention of this proposal is of sound reasoning, the practicality and utility of this particular means of achieving the goal of improving outcomes for some of the most vulnerable patients seems to do little to achieve that goal. In speaking with our transplant social workers and coordinators, there is almost unanimous agreement in the discomfort in asking direct questions about household income as part of any transplant evaluation or follow-up. I agree with many who have commented that the simple act of asking the question comes with the implication that it factors into a patient's candidacy. As a Pediatric provider, this has the potential to be perceived as a *child's* transplant candidacy being affected by parent's income. There is plenty of other demographic data that is routinely collected (Insurance type/status, Parent's education level, Zip Code, etc) that have been useful in studying SES and health-related issues that is well described in public health literature. The potential benefit of a direct question about income does not add to these other metrics in a manner that outweighs the possible unintended consequences of distrust in the transplant center by the patients and families.

American Society of Transplantation | 03/23/2020

The American Society of Transplantation constituencies and leadership have carefully considered this proposal from the OPTN Minority Affairs Committee (MAC) to add annual household income and household size fields to the Transplant Candidate Registration Form (TCR). Not unexpectedly, no consensus among AST membership was achieved. The American Society of Transplantation appreciates the intent of this proposal and agrees that lower socioeconomic status (SES) has potential negative impacts on access to the waitlist, access to living donation and post-transplant outcomes. Given that inequities in transplantation have been – and continue to be – widespread at all phases of the care continuum, efforts to capture meaningful metrics that attend to these inequities are essential. We commend the Minority Affairs Committee for offering this proposal for public comment. That said, some membership found concerns with the proposal as written. The following comments (supportive and not supportive) from the AST are offered to the OPTN MAC for their deliberations going forward recognizing that the lack of consensus within the AST membership likely mirrors a lack of consensus regarding this proposal nationwide among the public and the transplant community. • Pre-transplant collection of annual household income and documentation by social workers and finance specialists in the electronic medical record, while perhaps being performed at some centers, is not a component of “routine practice” nationwide. While all candidates have a social work and financial review, these evaluations relate to assessment of adequate insurance and resources to cover transplant and immunosuppression, and the availability of social support to enable compliance with appointments and posttransplant care. There is no standard practice or mandate with regard to documenting household income in any medical record. • Complying with this policy mandate would require a change in practice without a well-grounded justification. While more granular income information may prove valuable, an interest in the impact of supplying additional information is more a question for research than national policy mandate. • With regard to patient comfort in supplying household income information, there is recent experience in HRSA-supported SRTR Living Donor Collective pilot. This effort to construct a national living donor registry began with a pilot program at 10 transplant centers, with part of the goal of the pilot to assess the feasibility of data collection (Am J Transplant 2017;17(12):3040-3048. PMID: 28520316). The baseline instrument included a question on household income with well-intentioned purpose of helping identify candidates who may qualify for grants such as support from the National Living Donor Assistance Center (NLDAC). After two years of experience, the widespread feedback was that patients were commonly uncomfortable with this question and the most common response was “declined to answer”. • The OPTN MAC rationale for this proposal, as written lack sufficiently robust rationale for the need for patient -level household income collection, combined with an inadequate appreciation of the implications of adding this data collection requirement for transplant programs and patients • Alternative sources of information, such as US Census block group data would include information on household income but also additional constructs such as neighborhood property level, median property value, household crowding, education and employment. These are establish indices for converting these publicly available data to measures of socioeconomic status such as the SES index developed by the AHRQ (https://archive.ahrq.gov/research/findings/final-reports/medicareindicators/). The AHRQ SES index has previously been correlated with both transplant access and outcomes (Clin J Am Soc Nephrol 2010; 5: 2276–2288; PMID: 20798250), based on simple linkages of the information through residential ZIP Code at registration. While it is correct that collection of census data is episodic, inadequate justification has been provided in the proposal to support the assertion that addition of data collection at the individual level for each registration is necessary to overcome the “low accuracy” of the publicly available data, and to justify the additional data collection burden. • Transplant candidates may be reluctant to provide truthful information because of concerns that their access to the waitlist and eventual transplantation may be further limited by the perception that lower SES may correlate with non-adherence. • Transplant centers may preferentially place organs from non-directed live donors to higher SES candidates who are perceived to be more capable of making their follow-up visits, have uninterrupted medication coverage and to be at lower risk for being lost to follow-up in the transplant program’s zeal to honor the non-directed donor gift. • Non-citizen candidates may be concerned about information sharing between government entities and lower SES may be seen as dependent on or vulnerability to becoming dependent on government aid which may, in turn, hinder their ability to become citizens. • The proposal does not consider cost of living index • There was concern for potentially linking SES status to post-transplant clinical outcomes, which in turn might allow in the future, socioeconomic data to increase disparity in access to organ transplantation, with programs declining low-income patients. • There was concern that household size and household income might not accurately represent SES since households are comprised of many different combinations of people including: Married but separated, roommates, and cohabitating but not sharing finances. Depending on cultural background, it may be custom for a household to be comprised of several generations and extended family members (who may not share finances). • There was concern that the current proposal assumes that family households share traditional mainstream financial norms, specifically related to financially supporting all members in a household (e.g., “when a candidate is too sick to work but is monetarily supported by another member of the household”). This may not be true especially for marginalized or lower SES patients. • The proposal justification contends that the CDC and local health departments collect self-reported income and are considered reliable enough to be studied by various levels of the government. In addition to the shame many marginalized populations already experience, pre-transplant candidates are particularly vulnerable to impression management and over-compensation given the critical nature of their disease state and likely death if not approved for transplant. The uniqueness of this population puts them in a different category than samples collected from the CDC potentially making this population uniquely motivated to minimize financial distress, maximize educational and occupational experiences, and present as favorably as possible making the data collected unreliable. • Consideration could be given to collecting occupational history since many patients are not working due to being on disability, being retired, etc so checking “no” potentially inflates the size of the lower SES group. • Will the “and financially supporting the patient” be assessed prior to collecting the household income? This may be confounded by the fact that many disadvantaged families share homes but do not collect enough individual incomes to help support family members even in dire situations. • Four variables to capture that would provide some useful measure of SES, it would be educational attainment, occupation, household income, and household composition. OPTN already captures education. OPTN captures whether someone is working for income or not, but does not capture the specific occupation (which can be derived from a standardized SES list of occupations) or the circumstances surrounding lack of employment. The decision by the MAC Committee to not expand this data element (as is currently done for Living Donors) should be reconsidered. Not knowing if the limited household income (new data element) is secondary to being retired (data element the committee decided not to expand) is problematic when measuring SES. In addition to expanding the yes-no working variable, strong consideration should be given to capturing the patient’s occupation, which is an important element when assessing SES. • It should be noted that the two new proposed data elements will not be helpful in determining access to transplant waiting lists, since the data will be captured only for those who have made it to the waiting list. Thus, it will measure access to transplantation only from wait-listing to transplant surgery – nothing else. This limitation should be acknowledged and noted. Its utility in measuring access to transplantation more broadly is negligible. • It is unclear whether the Committee consulted with a demographer in selecting these two metrics. But if not, this should be done before moving forward. Capturing these two metrics is supported by considerable literature showing that household income is associated with healthcare access, broadly defined. Household income should be defined with more granularity and specificity to ensure that it is captured consistently across programs and providers. When being prompted for household income, for instance, patients should be told that it includes total income, earned or unearned, from all sources (e.g., wages and salaries, dividends and interest, Social Security, unemployment insurance, disability income, etc.). • Both household income and household size are necessary to determine if someone meets the federal definition of poverty. The concept of poverty is critical to investigators and health policy experts, so adding these two variables would – for the first time – provide the transplant community with the ability to determine what proportion of transplant patients live in poverty and to assess that in the context of transplant access and outcomes. • It should be acknowledged that these two metrics proposed to be collected, like working status, are fluid and not static; they change based on the patient’s illness status, wellness, and functional capacity to work; they change based on their primary caregiver needs and the caregiver’s decline in income to care for the patient; etc. So, these data tell a story – albeit an important one – at only one point in time, i.e., at wait-listing registration • Some may believe that patients will not want to provide household income because it is too sensitive. Thus, there may be some concern that programs may be deemed noncompliant due to missing data for this element. The concern about the sensitivity of household income data is understandable, as some patients may have undeclared sources of income they do not want to reveal or they may fear losing state or federal benefits (health, nutritional, etc.) by reporting household income data to a federally contracted entity. To that end, providing patients with a range of categorical options for household income may be better than asking for a precise income amount.

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) supports this proposal. There are national disparities in access to transplantation and post-transplantation care for low socio-economic status (SES) groups (2-8). Overcoming barriers to transplantation requires identification and resource allocation. We agree that socioeconomic status (SES) of the individual heavily influences access to transplantation and may be a modifiable predictor of transplantation outcomes. Identifying high-risk patient populations, i.e. low SES, for listing and graft failure could help transplant teams better understand and allocate resources to candidates at risk. However, in order to accomplish improved access and allocation, a greater understanding of the breath of disparity is required with objective, granular, individual, and reliable information. Policies to require timely referral for transplantation have been considered by the Centers of Medicare and Medicaid Services (CMS), but are difficult to implement without national data on referrals (9-13). Presently, the only SES variables that UNOS and OPTN collect are: primary source of payment, highest level of education, and whether the candidate is working for income. We support data collection by larger regulatory bodies such as UNOS/OPTN and/or CMS in the form of household size and household income to avoid the inaccuracy of data collection based on ZIP code. Such a proposal is presently going through public comment through UNOS/OPTN (14). With household income and size date, it would be possible to calculate the official poverty index, a variable that is well validated and used by the U.S. government to decide on the eligibility of assistance programs (15). This data collection is confidential and will not be shared. This will not lead to a significant data collection burden since this data is already collected by most transplant centers during the psych-social and financial evaluation and during the transplant evaluation phase. The income would be sent to UNOS as ranges and not absolute numbers. Reporting this information to UNOS will not affect patients’ allocation in any way. Access to transplantation is essential to upholding the OPTN Final Rule of Transplantation (16). Without understanding and attempting to modify barriers to transplantation with regulatory and governmental support, the disparity gap will persist and patients with low SES will be disadvantaged. In addition, obtaining validated and individual SES data will support initiatives to provide targeted interventions (e.g., psycho-social support, medication compliance, public policies for immunosuppression coverage) to our underserved transplant population. Regarding use of Zip code as SES: Zip code data is not granular and is likely misclassifying individuals. Furthermore, our zip code data collection on patients has known issues. We do not assess the quality of those zip codes as they are reported due to the following inaccuracies: state of zip code differs from state reported for patient, missing/truncated zip code digits, digits that are obviously transposed, zip codes reported that do not exist or which are not considered residential zip codes for which the Census won’t have poverty or income measures. References: 1. Stevens MA et al. HOUSES index as an innovative socioeconomic measure predicts graft failure among kidney transplant recipients. Transplantation. 2020 Jan 23. doi: 10.1097/TP.0000000000003131. [Epub ahead of print] 2. Waters HR. Measuring equity in access to health care. Soc Sci Med. 2000. 51(4):599-612 3. Braveman P. Health disparities and health equity: concepts and measurement. Annu Rev Public Health. 2006. 27:167-194. 4. Ross LF et al. Equal opportunity supplemented by fair innings: equity and efficiency in allocating deceased donor kidneys. Am J Transpl. 2012. 12(8):2115-2124. 5. Mathur AK et al. Geographic variation in end-stage renal disease incidence and access to deceased donor kidney transplantation. Am J Transpl. 2010. 10(4 Pt 2):1069-1080. 6. Health Resources and Services Administration (HRSA). https://www.organdonor.gov/statistics-stories/statistics.html 7. Luyckx et al. The global burden of kidney disease and the sustainable development goals. Bulletin of the World Health Organization. 2018. 96:441-422 8. Wang V et al. The Economic Burden of Chronic Kidney Disease and End-Stage Renal Disease. Seminars in Nephrology. 2016. 36(4):319-330 9. Stewart DE et al. Measuring and monitoring equity in access to deceased donor kidney transplantation. Am J Transplant. 2018 Aug. 18(8):1924-1935 10. Patzer RE, Pastan SO. Policies to promote timely referral for kidney transplantation. Semin Dial. 2020 Jan. 33(1):58-67 11. Patzer RE et al. Variation in dialysis facility referral for kidney transplantation among patients with end-stage renal disease in Georgia. JAMA. 2015. 314(6):582-594. 12. Gander JC et al. Association Between Dialysis Facility Ownership and Access to Kidney Transplantation. JAMA. 2019 Sep 10. 322(10):957-973 13. Patzer RE et al. Dialysis facility referral and start of evaluation for kidney transplantation among patients treated with dialysis in the Southeastern United States. Am J Transplant. 2020 Jan 25. doi: 10.1111/ajt.15791. 14. https://optn.transplant.hrsa.gov/media/3542/data-collection-to-assess-socioeconomic-status-and-access-to-transplant.pdf 15. ASPE Office of Assistant Secretary for Planning and Evaluation. U.S. Federal Poverty Guidelines Used to Determine Financial Eligibility for Certain Federal Programs. U.S. Department of Health and Human Services. https://aspe.hhs.gov/poverty-guidelines. 1/2020 The organ procurement and transplantation network final rule of 2000, 42 U.S.C. §§ 121. https://www.ecfr.gov/cgi-bin/text-idx?SID+bb60e0a7222f4086a88c31211cac77d1&mc=true&node=pt42.1.121&rgn=div5.

NATCO | 03/23/2020

NATCO is strongly opposed to the proposal requiring transplant hospital staff to ask candidates, at the time of registration on the waitlist, their annual household income and household size. While the stated purpose of the proposal is that the data is NOT intended for analysis of access to to placement on the waiting list, we strongly believe that such a question will impact the PERCEPTION that a candidate’s income will be a determining factor in their ability to receive a timely transplant, or to receive one at all. We further believe that a reluctance on the part of the candidate to want to answer this question may negatively affect the truthfulness of responses to other questions and will impair the communication between the transplant hospital staff and the candidate.

OPTN Region 3 | 03/22/2020

• It is important to look at populations that are not going to waitlist and not just those that are on the waitlist or transplanted. Collecting this data on the TCR will not get this information for all populations • Patients may be more inclined to lie if they think it will either benefit or penalize them • This could exacerbate the perception that wealth gets you advantages in transplant • This is crucial data for helping improve access • We would support measures to help us understand barriers to transplantation but don't think this data will get us there • This is for research and would not influence allocation so should not be asked • Census track data is more accurate than zip code and could be better data to assess SES Vote: 2 strongly support, 4 support, 5 neutral/abstain, 6 oppose, 4 strongly oppose

Region 11 | 03/19/2020

Strongly support (5), Support (7), Neutral/Abstain (2), Oppose (4), Strongly Oppose (3) Region 11 generally supports the proposal. During the discussion the following feedback was provided: • Concern was expressed about additional responsibilities being added for transplant and data coordinators - the data is not always available/easily to obtain. Perhaps a UNOS sponsored study or UNOS led project as a retro-statistical study might be better. • We need to be sensitive to increased workloads on centers. In addition, we need to look for data that is already available that can be used as surrogates for some of these data points. • We already know ultimately what the data will show and whether any actual policy changes would be made to level the playing field for the low SES patients with poor access to care. Self-reported information may lead to inaccurate results with little/no validity. • Would encourage an income range for people to respond instead of an exact dollar amount. Some will be hesitant to submit income to a medical provider. It may make candidates fearful that care will be withheld because they "don't make enough money". Patients will not being forthcoming with this information. • Proposing additional data collection should include analyzing epidemiological and demographic data. • The proposed data collections should include patients never referred for transplantation and this should be a priority. Their information is just as important. • UNOS should not extend its reach into the business referral patterns of Transplant Centers. • Would consider the following data elements: does patient live alone? Does patient drive and have a car how far does the patient live from a transplant center? Does the patient live in a rural or urban/suburban area? Does the patient have a defined primary caregiver? • Consider looking at median county household income – surrogate marker since patients may not be truthful, but collect county poverty rates – get it online to get a surrogate marker on the disparity status. • Concern about transplant programs being required to maintain some sort of supporting documentation regarding transplant candidate annual income or validate the information that is reported. Patient reported unmet healthcare needs, such as not filling prescriptions because of cost, needed mental healthcare or counseling services and could not get due to financial burden, unable to afford needed dental care, etc. may provide better insight into SES or effect on transplant. • Financial situations change depending on where patients are in the process. • Socioeconomic inequity data is available. Members in the region can see the disadvantages in region 11 already. Concern was expressed that this looks at the selected population that can get to be a transplant candidate. Need to look at large communities and their overall access to care. This could be used to say that it’s not a problem when it actually is. • Patients may be uncomfortable answering these questions as they are already careful to present themselves in a favorable light. • Agree with discussion, access to transplant center and even end stage organ care is key part of inequity. • Need access to pre-listing SES data. • We need granular data if we are going to truly understand the disproportionate impact access (or lack of access) to transplant has on our citizens based on resources. This work is necessary to dismantle the structural racism that is built into healthcare.

American Nephrology Nurses Association (ANNA) | 03/18/2020

ANNA opposes this proposal. We do not feel it is appropriate to ask candidates their annual household income; asking such sensitive information may cause suspicion or mistrust in the system.

Patient Affairs Committee | 03/17/2020

The Patient Affairs Committee appreciates the opportunity to submit comment on this proposal. The committee members expressed a number of concerns about the proposal from a patient perspective. Many felt like patients wouldn’t feel comfortable sharing this type of information or might lie about their answers. Questions arose about what the ultimate use of this data would be, like for quotas possibly, and considering the public’s general lack of trust in the organ allocation system, some felt that asking questions about income and who lives in their house would do further damage to that trust. Several members brought up the increasing number of multigenerational households and how that doesn’t necessarily equal multi-income. A member asked if there were other questions that were less intrusive that could be used to get at the same information. There was discussion around the idea that access to health care is a huge issue, and access to transplant is just one small part of that – some questioned whether an attempt at addressing this small piece would really accomplish anything. Vote - Strongly Support (0), Support (1), Neutral/Abstain (2), Oppose (6), Strongly Oppose (4)

PALV | 03/13/2020

Strongly Oppose

Anonymous | 03/12/2020

I am opposed to requiring Transplant Centers to report transplant recipients' household income on TCR Forms. Household income does not determine if a patient can afford a transplant, post transplant care or survival of the organ. Insurance coverage for transplant care, including immunosuppressant drugs coverage is a more accurate indicator of being able to afford a transplant. Recording primary insurance coverage in TCR Form is already a requirement. NC Medicaid patients are more likely due to drug coverage and options for transportation to be able to afford transplants than are many private payors recipients whose household income is higher. Household income is not an accurate modeling predictor of patient's ability to receive a transplant. Household income does not consider a patient's net worth and ability to pay. Ability to pay is not only based on household income but also savings, investments and business revenue from other sources. Ability to pay is also based on access to grant and other financial assistance programs, which frequently are only extended to patients' with lower household incomes. Additionally, unless you require copies of submitted federal tax forms or W-2 statements, a subset of all patients will not provide accurate household income and another subset of patients will feel their privacy is being violated by sharing this information publicly, disrupting provider-patient relationships and care. The costs, burdens, and inefficiency of requiring for compliance sake to enter this data far outweigh any valuable benefits of tracking this data.

Jennifer Milton | 03/10/2020

I have several comments for the committees consideration regarding the proposed addition of data fields related to socioeconomic status to the TCR. 1) My understanding is that any data entered into UNet is evaluated by the SRTR's (lasso methodology) for its predictive value of outcomes. Should low household income at the time of listing correlate to poorer outcomes- would it influence or bias candidate selection behaviors? What assurances can be provided that this data would not in the future be analyzed or risk adjusted? 2) At the Region 4 meeting, Craig Conners showcased UNOS's planned development of a patient decision aid. He theorized that with this kind of tool and forecasting--- in the future allocation policy could be centered on the best predictive outcome. If socioeconomic status is added, and it is shown to be predictive and assigned a beta/risk adjustment - could the very candidates this committee is trying to help, be harmed? 3) If the currently collected TCR data is not used to risk adjust, nor is felt to be relevant for assessing socioeconomic status (like "education level" or having "Medicaid" entered as a primary insurance) then we should remove those fields to reduce the data burden to the centers and their staff. Although one or two additional fields may at first glace be considered "tiny," the last published study on the cost per form to transplant centered showed a single UNet form can cost a Transplant Center over $200. Reducing the fields per form would improve the integrity of collected data. 4) At Region 4 we were informed that this collected data would not be adjusted by geography. My understanding it that national poverty data is geographically adjusted. Were experts in the field/study of poverty consulted to ensure the proposed data feilds is valid & relevant as planned? 5) Since Medicaid eligibility is income based, why doesn't this data provide the relevant information?

Region 1 | 03/10/2020

Strongly support (0), Support (5), Neutral/Abstain (1), Oppose (2), Strongly Oppose (2) Region 1 was split on this proposal and had a good discussion with multiple comments. Comments: Were there any other elements that were being collected? • Primary source of payment. • Highest level of education. • Working for income. Concern that income questions may not be answered accurately and worried about the therapeutic relationship with the patients being damaged. Patients may fear that it will impact their candidacy. Information that would be gathered would only then be entered at time of listing. • Anything outside of this would not be captured and outside purview of OPTN • Not taking into account the time that candidate would be waiting for organ; data would be stagnant Concern: for people in mid- and high- level income • Would not be threatened to reveal this information • Fear of reporting (accurate) information may result in consequences (ex: loss of specific benefits that rely on income or number of people in household) How is this going to provide information for access to transplant?

Transplant Coordinators Committee | 03/04/2020

Minority Affairs Committee: Data Collection to Assess Socioeconomic Status and Access to Transplant The Committee agrees that there is need to better determine how socioeconomic status impacts transplantation, and that the data that is currently collected by the OPTN is insufficient to do so. However, the Committee has many concerns about the proposal’s method of addressing this inequality. There is already difficulty in obtaining patient trust in the transplantation process, and many patients are already concerned that a low socioeconomic status could negatively impact their ability to receive an organ offer. This could create a large bias in the information that is reported, and could potentially lead to a decrease in lower socioeconomic status patients being listed for transplant due to patient distrust. The Committee is also concerned about the data needing to be adjusted for cost of living, as well as the data being updated as household income fluctuates, and this proposal only addresses data collection at time of listing. In addition, this data would not fully address the issue of access to transplant, since this would not include those patients who are unable to be listed for transplant. Those patients are often unable to be listed due to an inability to travel to appointments, lack of support, and inability to pay for medications, which is largely impacted by socioeconomic status. 0 Strongly Support, 0 Support, 2 Neutral/Abstain, 5 Oppose, 5 Strongly Oppose

Andrea Burkholder | 03/04/2020

I think as long as the data is used to help address the fact that lower SES is correlated with less likelihood to be listed for transplant then I think it is good to collect it. Transplant Centers already are looking at financial ability to pay for cost of transplant care. People with lower SES are less likely to have health insurance, less likely to have available caregivers, and typically have other barriers that make it difficult to get a transplant. Perhaps more coverage from health insurance for recovery post transplant in a care facility would be helpful.

Anonymous | 02/28/2020

1 Strongly Support, 13 Support, 4 Neutral/Abstain, 12 Oppose, 4 Strongly Oppose The region had mixed opinions on this proposal. Some members voiced support of the collection of this data as the OPTN does not currently collect adequate socioeconomic status data, but there needs to be safe guards on this data due to the sensitive nature of what is being proposed. These data should never be used in any allocation purposes. There was some variability between hospitals in the region over whether this data is currently collected by either transplant social workers or financial coordinators. Some hospitals are collecting this data whereas some are not currently collecting these data points. Some members voiced concerns on the collection of these data. There is a concern of the unintended consequences of collecting such data and protecting candidate information. If the data is used improperly it will result in the loss of community trust. One member added that the two proposed data points do not do enough in terms of assessing socioeconomic status since multiple factors contribute to a candidate’s socioeconomic status. Another member added that special consideration should be given to veterans as they do not fit into standard socioeconomic statuses.

Kristin Vines | 02/28/2020

I would like to express a comment related to the proposed plan of capturing the household size and annual income of patients on the transplant list. I am opposed to this practice. I do not think that it serves a useful purpose to record the annual incomes of our patients, unless it is in reference to applying for a specific program. I also finances with patients to determine if they are able to manage financially, but I think it is intrusive to ask about specific numbers, unless I am trying to determine if they qualify for assistance. I also do not think that much useful information will be able to be gleaned from putting this information in a database. Unless it leads to the develop of an assistance program, I do not think it will help to provide better care for our patients. In the end, I think this information would be intrusive and unnecessary to gather.

Anonymous | 02/27/2020

I believe these data will only be valuable if insurance information is included, i.e. Medicare, Medicaid, Employer/Private, or Marketplace. For example, a very low income patient in Virginia will have full Medicaid coverage and medical transportation, and will experience less impact on their finances after transplant than a patient with a somewhat higher income who has Medicare only and will be responsible for 20% of all their outpatient medical bills after transplant. Or a middle-income family with inadequate prescription coverage through their commercial plan may experience a significant financial impact and difficulty paying for medications. I believe that insurance coverage combined with income data gives more insight into access to transplant than household income alone.

Marcella Herriott-Ilori | 02/21/2020

I am a Transplant Financial Coordinator and I am opposed to this proposal mainly because our center is located in a " urban economic depressed area." Many of our patients are Medicaid only. Patients are already worried about not being listed because they don't have "a large bank account." Patient are more likely to balk about giving us the information or lie about their income. Can anyone guarantee that the information will not be used to "weed out" financially undesirable candidates.

Anonymous | 02/21/2020

knowing a persons household income does not amount to if someone can afford a transplant or not. It does not change their bills if they have over extended themselves. Knowing household size would only be for statistical reasons as this does not change a persons income outside of being eligible for Medicaid. We ask information of who is living in the home. That definitely does not equate to support both physically or financially at times. In our program this would be a financial counseling job as they assess for Medicaid and other insurance supports available.

Region 5 | 02/21/2020

Strongly support (5), Support (10), Neutral/Abstain (3), Oppose (11), Strongly Oppose (2) Comments: Region 5 was split on this proposal. There was some active discussion and questions regarding data that is currently collected, potential burden of collecting more data and the accuracy of the suggested data points. • What data points are already been collected? • Even if you were using annual household income there is often additional people not in the home that are being supported by that income • Patients may not be honest with income because of qualifying for benefits • Household size can vary throughout the year, the patient might be working at the time of listing but not if the y get sicker • Income is already a field that is really hard to define, this will be an additional burden and hard to keep consistent • Will there be a risk adjustment? • Collecting this data may contribute to internal biases, was this discussed by the committee? • Applaud the effort to understand the problem, how will this data truly be able to impact patient access to transplant? • How would this change allocation?

Catherine Rea | 02/21/2020

I am struggling with this proposal for a number of reasons; many have been discussed very well in other public comments. This will add a significant burden on our coordinators and could harm the trust and their compassionate relationship with our patients and families. Our families are scared at the prospect of a transplant for their child. The last thing we would want is to have them worry about answering these questions, especially about income. It feels very intrusive to me. Our patients and families trust that we accept them for who they are; we do not judge in regards to race, religion, sexual orientation, socioeconomic status. I don't agree we should make this change. It should not be a requirement for listing. Our social work colleagues are wonderful at asking families about their finances and then helping them get assistance as needed. They also ask about the family's support structure and living arrangements to ensure a child who receives a transplant will be safe and cared for appropriately once leaving the hospital. In my opinion, these questions should not be a requirement for listing.

Anonymous | 02/20/2020

While we recognize the value of data collection for analysis and correlation, we do not agree that it is appropriate to assess for this information. Also, due to the sensitive nature of this personal information, the data collected may not be accurately reported by the patient, may not be provided at all and is not verifiable, therefore making this information unreliable. Lastly the request for this information may seem invasive and could suggest that programs are screening out patients with lower socio-economic resources.

Anonymous | 02/20/2020

As a transplant social worker, I'm struggling to support this proposal for the following reasons: 1) Data collection burden on centers- The proposal states that centers already collect this data at some point during the evaluation. This is not the case at our center. We ensure that a patient has adequate insurance but we do not ask for their actual household income. 2) SES can be reasonably attained with zip codes, especially in conjunction with highest level of education- which is already collected for the TIEDI forms. The proposal does point out that zip codes can be broad and include many different levels of household income, but is the variation really going to be great enough to significantly affect the purpose of the data collection? Why not use data we already have, that has been demonstrated to reasonably reflect SES, without making patients uncomfortable, and risking bias from transplant professionals. 3) Asking a patient for their household income is uncomfortable for many patients for a variety of reasons. They may not want to share this information for fear of being judged one way or another. They may exaggerate the number one way or another depending on whether they think having a higher income may make them more likely to be listed, or whether having a lower income may help them obtain more assistance. Furthermore, some patients honestly do not know what the dollar amount of their household income is. When assessing patients, social workers typically talk to the patients about what resources they already have- Medicaid, SNAP, HEAP, housing assistance, etc. Instead of asking a patient's household income amount, could the question on the TIEDI form simply say "Is patient currently receiving any benefits/resources based on their income?" Since most of these state and federal benefits maintain eligibility requirements that the patient fall below the federal poverty level, it's reasonable to assume that if the answer is "yes", then they fall in the low SES range. 4) Collecting this specific piece of data has the potential to add bias to listing patients and transplanting them, specifically if a center is concerned about outcomes and decides not to list or transplant a patient based on their income, in fear of poor outcomes. 5) What is the detailed purpose of this data? The proposal states it could be used in the future to affect policy in attempts to eliminate disparities in transplant, which as a social work I am all for. But what specific policies? What actual action can be taken to improve disparities in transplant based on SES? And is SES ascertained from zip codes and education level really going to skew whatever policy changes may happen?

Laura Hulse | 02/19/2020

Income inequality has been implicated in perpetuating health disparities through its effects on the provision of healthcare, not just access to transplant. The addition of annual household income and household size may help provide better insight into regional disparities, although I am unclear what social policies or interventions the OPTN would implement to resolve these. As these data would be collected for research analysis, an issue of validity of data reported (annual household income) would arise. Intentional or unintentional misclassification or misrepresentation of household income by a transplant candidate would contribute to an underestimation or overestimation of the effect of income. Would transplant programs be required to maintain some sort supporting documentation regarding transplant candidate annual income or validate what is reported? Patient reported unmet healthcare needs, such as not filling prescriptions because of cost, needed mental healthcare or counseling services and could not get due to financial burden, unable to afford needed dental care, etc., may provide better insight into SES or effect on transplant.

Anonymous | 02/19/2020

This proposal is unethical for all the reasons outlined by others. Rather than enhance transplantation it has the risk of alienating patients.The data is very likely to be inaccurate. Finally, it imposes an necessary burden on transplant centers to collect the data.

Anonymous | 02/18/2020

1) I recently spoke with a transplant recipient who was treated in a biased manner re: waitlist candidacy when she was queried about her household income. She said that the social worker assumed that she couldn't afford to have a transplant, and pay for monthly meds, due to low level of income. She said that the social worker never asked her about any 401Ks, CDs, savings, inheritance, other properties, etc. that she might also have. She said that if the social worker had asked about those additional resources, the social worker would have realized that she could very comfortably afford the meds. 2) I believe it's discriminatory to insist that patients must first have a certain amount of money saved up, such as $5000, towards post-transplant expenses before they can be put on a transplant waitlist. Some low-SES patients do not have adequate support networks to help them raise such a comparatively large amount of money. Our team does a lot of work with low-SES patients, after transplant, to help them obtain grants to cover the cost of their meds. It's a lot of work, but we believe they should have the same right to transplants as patients with higher levels of incomes and savings accounts.

Peter Kapinos | 02/18/2020

With dossier being read, I don't fully understand the motivation or the clear functional output as to what exact details this data will do once compiled; basically, it appears like collecting data for future unknown use. Also, why is it part of "minority affairs committee" and not part of the greater good of OPTN, the data it already collects? Is there an underlying assumption that hasn't been stated or a hypothesis to confirm? What will be the data function if the hypothesis isn't confirmed? A great deal of transplant kidney transplant patients are unemployed regardless of race. If I was to present to a health care facility and be asked these questions at time of registration, I'd have to believe it is relevant to a future care quality. Please state the ideal results from this data. Stipulated: additional work burden of collection.

Anonymous | 02/18/2020

Agree with Region 4, and many other comments about the validity of this study (ie, is this test actually measuring what it claims to measure). 1. There is a great deal of research that supports disparities in health based on zip code, which may be a more accurate measure of access to transplant than income. Income varies based on cost of living, and I do not believe it can be applied broadly. 2. Another concern is the assumption that LSES leads to poorer outcomes. However, we all have patients who have LSES and are resilient, resourceful and adherent to recommendations and medications. And there are other patients who make more than what would qualify as LSES, but still cannot afford the costs of transplantation. I am also concerned about the reliability of the data that would be gathered. 1. Will we have a good, reliable data set if some patients are providing this information and others are opting out? 2. Helping patients with prescription assistance, I have learned that many patients do not know their actual household income and provide an inaccurate guess. 3. Patients are already overwhelmed and afraid going through the scrutiny of an evaluation process. Providing income is sensitive personal information, which culturally we are taught not to share with others. Patients are told that everything in the evaluation process can impact their candidacy. Considering these factors, even if we explain to patients that providing this information would not impact their candidacy, might they still feel fearful of how that information could be used? Might vulnerable populations feel further stigmatized by providing this information? Would patients feel they have the ability to say no or not comply with providing this information? Ultimately, with questions like these in mind, will patients feel they can be forthcoming about their income status? And will they feel like they can be forthcoming about their fears or discomfort with such questions? I think this proposal is well intended, but it could lead to unintended consequences. At this stage, I also think the validity and reliability are too questionable to draw conclusions from the data that would be collected.

OPTN Region 8 | 02/18/2020

MAC- Data Collection to Assess Socioeconomic Status and Access to Transplant • Income level was largely rejected as a question by living donors in the living donor registry project • It would be difficult to obtain income data. The issue is access to the healthcare system and not as much about being listed. • This is not a normal question to ask. There is an issue of pride – some people might not be honest because of this. It would be better to make it an optional field or include option for “not disclosed” • Poverty level would be a better data point than income, adjusted for household size • If the data is incorrect your analysis would not be reliable. Reporting income to a national database may not be a good idea • Knowing the income level of our veterans is not indicative of whether they will receive a transplant. It would not add any value • Cost of living varies widely, knowing the household income is only part of the equation. There is a better way to analyze if finances are a barrier to access to healthcare Vote on proposal as written: 0 Strongly Support, 3 Support, 2 Neutral/Abstain, 13 Oppose, 2 Strongly Oppose Vote on amendment to use percentage of poverty line as data field/indicator of SES: 1 Strongly Support, 7 Support, 3 Neutral/Abstain, 8 Oppose, 4 Strongly Oppose

Anonymous | 02/18/2020

I oppose gathering financial information on potential transplant candidates socioeconomic status. Gathering household income and household size without factoring in household expenses, debts, potential for re-entry into workforce, or geographic differences in cost of living makes the data useless. Besides, who is going to verify that what the patients states is actually correct? I have no desire to go through patient bank statements to confirm that the information they gave to me is valid. It seems potentially discriminatory and at the very least would increase a patient's feelings of being judged during an already stressful evaluation process. I know of no other major medical treatment for which access is dependent on an individual's income or resources, only their ability to access insurance coverage and ability to pay for care. Unless there are clearly laid plans for how the data would be used to facilitate programmatic changes designed to improve access to and equity around transplant, I am opposed to collecting this data.

Anonymous | 02/18/2020

I am absolutely opposed to transplant centers collecting this data on their candidates; it feels unethical to me and I am pretty certain it will cause an additional layer of anxiety for patients who are already in a very anxiety-laden situation.

Rebecca Pirozzi | 02/18/2020

The transplant coordinator gathers enough information from the patients in order to fill out tie dies. Any socioeconomic information needed post transplant should be in the form of surveys sent to the home from UNOS and data entered from them as well.

OPTN Region 6 | 02/18/2020

Strongly support (0), Support (2), Neutral/Abstain (4), Oppose (10), Strongly Oppose (1) Region 6 did not support the proposal. While there was one comment in support of gathering this data, the rest of the comments expressed a number of concerns. Patients who get listed on the waiting list are already a highly selected group, those who are extremely disadvantaged don’t even make it to the list. Some patients could be offended to be asked for this information. Transplant staff are already uncomfortable asking patients for their citizenship status, they would also be uncomfortable asking for this information. Members raised the point that many patients would feel the need to lie when asked these questions, whether to artificially inflate or deflate their income. Several shared concerns that the collection of this data could backfire, resulting in less access for those with a lower socioeconomic status. Specifically, if it is found that patients from lower socioeconomic backgrounds tend to have poorer outcomes, that could factor into the transplant centers’ decision to evaluate, list and transplant these patients for fear of punitive measures regarding poorer transplant outcomes.

Dawn Freiberger | 02/18/2020

I support this proposal with some significant hesitation. I believe this data should be collected and that UNOS should be looking at it to determine if there is a bias in who is being listed and transplanted. I agree 100% that families need to be able to afford transplant medications and need to be able to get to their transplant center, etc, however, there are too many patients being turned down for transplant because of their social/economic class. Patients with more money have greater access to transplant than those with less. That should not be. The problem is how is that fixed? How do we support patients who have difficulty with transportation, medications, hotels, and meals during travel. Few state Medicaid programs support these additional expenses. I don't see that changing any time soon. I share the concern of other comments written here, that if this information is disclosed to the transplant center, it could be a reason that the transplant center declines a patient for listing, thus making the bias even worse. I am not sure how to overcome that. Also, there are many patients that never make it to listing. Many of them are for financial reasons. This system proposed does not capture these patients. So I am not sure how accurate the data would actually be in the end.

Angie Korsun | 02/18/2020

While I can appreciate the rationale for wanting this data collected, it’s unclear what OPTN/UNOS would be doing with this data. Its no surprise that patients with limited fiscal means and from lower SES are challenged in accessing healthcare overall and that includes transplant. Ascertaining someone’s household income and size is only one of several factors that may impact someone’s ability to access care. Lack of gas money or not having a driver’s license or a functioning car could create difficulties even if household income does not. In addition, what will OPTN/UNOS do with the information other than potentially issue a statement that lower SES negatively impacts access to care. We know that already. UNOS/OPTN does not have the means to change social policy or alter the societal factors that reduce access to healthcare.

Anonymous | 02/18/2020

Socioeconomic status is unquestionably a factor in the success of the post transplant population, however, it is not a barrier to seeking the services of a transplant center. If the patient has the resources to support the costs of post transplant care (the reality of which exists whether it seems fair or not) the success rate is increased. There are numerous resources available for disadvantaged patient populations. The bottom line is if they don't have the financial and social support, and those resources cannot be obtained, the success is unlikely. Placing the patient in a position to ultimately fail because we don't take that into consideration is unethical. Centers already do the work of assuring these avenues are thoroughly explored and no matter what the income/dependent information might show, the likelihood of success of the post transplant patient is the salient point of the end result. The addition of these intrusive and potentially misleading questions generates more work and not enough gain to warrant it.

Dori Muench | 02/17/2020

While i can appreciate the motivation behind the collection of this data, I do not know how it would improve access to transplant. There is already documentation and data available on SES and access to transplant. I find it more valuable to consider household income vs expenses as a more valuable tool. This, of course, would be time burdensome.

Wanda Gbemudu | 02/17/2020

While I do see some benefit in obtaining this information from a research standpoint, I would have some concern about the ethical stance on obtaining this information. Will this information have any bearing on a patient's opportunity or access to transplant? What other ways might this information be used in the assessment of the potential recipient? Can this lead to a bias towards those of lower socioeconomic status?

STSW | 02/17/2020

I have concerns about this proposal and I think this data can already be traced by insurance coverage, such as Medicaid. We know low SES is more prominent in minority populations, and we do not need to continue to add extra barriers to their candidacy. Even though financial issues can potentially affect graft function, I am afraid this action could single out people even more. As long as the family can manage their care, nobody should miss an opportunity for a life changing procedure, because of their SES. I believe in the future, this could potentially negatively affect hospitals that serve more of this population as well.

Anonymous | 02/17/2020

A transplant candidate's income is a very sensitive topic, and patients may have concern that the information is being used to determine candidacy. There is great focus on paying for medications after transplant, so one would naturally assume that their income would be considered by the center when determining candidacy, even if adequate health insurance is in place. For this reason, I don't know that patients would be honest about it. I do agree that this should be studied, but having it as required information from patients into a governmental system is not the best way to study it. Several good points also listed about understanding expenses and what part of the country in which one lives.

Anonymous | 02/17/2020

Collecting financial information is not the responsibility of the transplant coordinators. It interferes with the attempt to establish trust with the patient. It is highly variable based on the stage of the patient's disease process - a kidney patient might be employed fulltime at the time of evaluation, progress to disabled while waiting, and able to go back to work 3 months post transplant, become divorced and pay child support, for instance. Number in the household can also be highly variable. Marriage, college, dependents can all vary from year to year. Do you ask for what they fill out on their IRS forms? Update every year? Asking for this information is intrusive, makes patients question why these questions are being asked. Lastly, it is another burden for the transplant coordinators and the information provided is highly unreliable.

Anonymous | 02/17/2020

I currently work as a Kidney Transplant Financial Coordinator. I oppose this proposal for the following reasons: 1. It will put extra documentation burden on the transplant center. 2. It could cause patients unecessary worry that their financial status will be a deciding factor when a deceased donor transplant becomes available. 3. At our center, before a patient is approved for active listing for a transplant, we evaluate all aspects of a patient (medical, financial, psychosocial) to make sure they are ready for a transplant. Asking for financial data at the time of listing would not help us.

Anonymous | 02/17/2020

I do feel that this is an issue in our selection criteria that we are eliminating many candidates with a lower socio economic status. I do not feel this is intentional by any means. I think that having the data would allow us to study if this is a bias in our criteria, selection process etc. I do not know the best way to collect this information at the centers, as I fear lower socioeconomic status would then relate directly to selection criteria and candidacy decisions. I think that perhaps having the patient submit this data online anonymously, or in a way that the center would not have access could be one solution. I know that psychosocial factors have a huge role in post transplant success, however I worry that we are weeding out all candidates of lower socio economic status and by keeping the data we would see this correlation, which could allow for changes to be made.

OPTN Region 4 | 02/08/2020

Strongly support (3), Support (9), Neutral/Abstain (6), Oppose (4), Strongly Oppose (3) Comments: Region 4 supported the proposal but there were concerns around the reliability of the data and the data entry burden on centers. There was a recommendation that if the data is collected, it will need to correct for the cost of living index to be meaningful. In addition to income, it is also important to look at expenses. People can make a lot of money and still live pay check to pay check. Only collecting income will give the committee a very narrow view of SES. There was a recommendation to also include zip code data to account for the living environment and neighborhoods. These factors have a huge impact on access to healthcare and follow-up. Some commented that in addition to the proposed data, the committee should also consider how transplant hospitals are utilizing programs that offer financial assistance.

Anonymous | 02/07/2020

Assuming that the data collection is for research purposes that will hopefully assist with forming future policies that will ensure equity in transplants, this policy can be beneficial if handled correctly. Rather than requiring transplant hospital staff to collect this information, perhaps a better approach would be to have it be part of an optional survey that candidates have the choice to complete after their transplant evaluation. There should be a clear explanation that neither participation in the survey nor their answers will affect their ability to receive a transplant and that the sole purpose of the survey is to ensure fair access to transplants for all candidates. Information about their annual household income and household size could be sensitive information, so it should be treated in a sensitive manner and in a way to prevent any misunderstandings or mistrust.

Darnell Waun | 02/06/2020

I am concerned about the ethical issues related to use of this added data set. If the data show that there is a relationship between SES and transplant equity/outcomes will this lead to "quotas" being developed that could disadvantage overall organ transplant in certain populations. The proposal is not clear on how SES will be stratified. All income levels are not equal across the nation and no adjustment has been spelled out. While I believe that household income and number of people may be valid parameters for identifying SES, I think the disparities in actual utilization of this data set has strong potential to put this on a slippery slope.

Nancy Long | 02/02/2020

It is well known that patients from lower socioeconomic populations don't do as well post-transplant. Placing an additional burden on transplant centers to add even two more fields of data that are not going to give new information is unreasonable. The fact that the income data is not going to be geographically cost adjusted makes it essentially useless. Based upon what patients tell us in other areas, I believe that the accuracy of the data will be questionable at best. Lastly, the accuracy of the data of number of people in a household will also be questionable at best, particularly if patients think that data could be shared with government agencies that could change or withdraw their financial aid.

Stephanie L | 01/31/2020

This proposal was presented in a way that was easy to read and understand the points being made by the sponsoring committee. From a patient perspective, it does make me slightly worried. Specifically, what happens when someone comes forth and the income level is below a certain level, what if that the transplant center deems that too low for transplant? It’s fairly common knowledge that you have to have insurance in order to receive a transplant. But will this now change transplant centers to look at overall income as part of their criteria when listing someone? If someone has a low household income, and numerous family members, will the center discount them as being a quality candidate? I think, from an ethics standpoint, there needs to be some type of follow-through with the committee ensuring that transplant centers cannot discriminate against those with lower incomes. You need to be able to afford the transplant and post-transplant medications (of course); but there are resources that can be explored with the candidate and transplant center. Resources including Medicaid, SNAP, etc. And those resources should be highlighted even more so if this is put into place. I understand that this proposal is not saying that those with lower incomes should not get a transplant – however, an ethics section to clarify and add context to what can be done in the grand scheme of implementing this proposal could help individuals support this.