Comments

OPTN Transplant Coordinators Committee | 09/29/2022

The OPTN Transplant Coordinators Committee thanks the Minority Affairs Committee and Kidney Transplantation Committee for their work and for the opportunity to comment on this proposal. One member commented that this proposal has the potential to create logistical issues and increase burden and work load for transplant programs. For example, if a patient had a qualifying eGFR a year ago, then the transplant program would need to go through numerous lab values to determine when they met the criteria for a race neutral eGFR. She further noted that it can be more complicated if the patient had tests done at an outside lab. One member commented that currently wait time starts when a candidate is listed or at the initiation of dialysis. She expressed concern about identifying a qualifying eGFR result two years prior to the dialysis start date because it could disadvantage some patients. She also noted that there are wide variations in the number of black kidney transplant candidates at transplant programs. She noted that her transplant program is approximately 80% black candidates. Another member noted a high percentage of black kidney transplant candidates at his center as well. One member noted that review of social economic data would show that black candidates are disadvantaged not just for access to transplant, but to healthcare in general. While it may be an administrative burden, it is the right thing to do for this population of candidates. The member explained that these candidates have been historically disadvantaged and this would create equal advantage for them. One member expressed concern about the 365-day timeframe and the fact that this is not mandatory. This could cause further disparity because some transplant programs will make the adjustment while others will not. Additionally, patients may not be aware of this when they are evaluating transplant programs. Finally, the member expressed concern about how this might affect candidates that were listed after the most recent policy changes in 2018. Several members agreed that the proposal should be mandated, though this could be very difficult for transplant programs operationally and logistically. One member commented that it is unclear how far back transplant programs need to go to identify a qualifying eGFR. This could add to the inconsistent application of this policy change. The member recommended incorporating some guideline on how far back a program needs to look. Another member pointed out that, if it’s not a requirement, many candidates would be further disadvantaged by inconsistent application of the waiting time modification policy. One member recommended that programs be given the option to unlock certain forms and update the waiting times themselves, and allow programs to be audited on their modifications at their regular site survey. The member added that paper is very burdensome, and that a paper form could be difficult. Some members agreed. One member added that programs could end up saying that they reviewed their list without actually reviewing it. Members supported programs providing an attestation that they have review all of their candidates. One member commented that in order to assist transplant programs, reports should be made available to programs. It was noted that the reports can provide a certain amount of information, however the OPTN does not collect which formula was used and if it was inclusive or exclusive of race. Members agreed that any assistance to transplant programs to make the process less cumbersome would be helpful. Members noted that the volume of patients to review is the issue, not the process, and that education may not make much of a differences. Members recommended leveraging EMRs to compile a list of candidates and potentially find records for candidates, including finding the earliest example of GFR hitting below a certain threshold. One member suggested that the committee review data to identify the impact of this change. For example, does it impact wait time by six months or two years?

Anonymous | 09/29/2022

he UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Modify Waiting Time for Candidates Affected by Race-Inclusive Estimated Glomerular Filtration Rate (eGFR) Calculations. CASD strongly support restitution of lost waiting time for Black and African American candidates who have been historically disadvantaged by a flawed medical system relying on antiquated notions. We do however have some concerns regarding the proposed pathway outlined in the policy. If equity truly is the goal, review and modification of waiting time should be required for all centers with Black or African American candidates listed, as opposed to voluntary. Absent such a requirement, candidates at some centers will remain unfairly disadvantaged simply because the center either cannot or will not provide the immense administrative manpower that would be required to complete the record review and application process. • Do community members agree with the proposed eGFR waiting time modification pathway? While CASD does support an eGFR waiting time modification pathway, we would encourage the Committee consider an alternative to the application process proposed. Similar to the way the system was unlocked when the initial eGFR modification policy was implemented, centers should be trusted to enter correct, updated lab data into the candidate’s record. There should be no concern over attempts to “game the system” – centers are audited routinely. If there is concern the next audit period would not happen soon enough, centers could submit to a brief desk audit of a small sample of those candidates who had waiting time modified. • What kind of education resources would assist programs in participating? The OPTN should be able and willing to provide centers a list of impacted candidates for review, at minimum. • What potential unintended consequences or challenges should be considered during this proposal’s development? Do those consequences or challenges outweigh the benefits of the proposed waiting time modification pathway? The process of collecting lab data that may be several years old and outside the center’s EMR (other hospitals, doctors offices, dialysis centers, etc) poses a significant logistical challenge. Additionally, the pen and paper application process strikes us as antiquated and overly burdensome. We do not believe that these challenges outweigh the proposed pathway however because we believe that this is the correct thing to do for Black and African American candidates, ethically. However, as described above we do think that there are alternative, less burdensome processes that should be considered. • Are there other waiting time modification scenarios that the members would like the committees to consider? The four scenarios detailed seem inclusive. • Does the community agree with the proposed scope, timeframe and required documentation? Generally, yes however we would recommend that the Committee consider a 6-month review of the volume of actual applications received compared the anticipated number and conduct a community check in to determine if there are barriers preventing the timely submission of this information that may not have been accounted for at the time of proposal. If in fact there are, the Committee may consider extending the application period.

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Anonymous | 09/29/2022

The Transplant Administrators Committee thanks the Minority Affairs Committee and the Kidney Transplantation Committee for their proposal. Members vocalized concern about leaving this modification optional. Programs that are not up to date on changes and policy may not know they can make these modifications which could potentially disadvantage some candidates. This could decrease equity and access. Members also suggested providing education to programs on how to efficiently pull the report of candidates that will be affected by this change. There were no further comments from the committee.

Anonymous | 09/29/2022

ANNA supports this proposal but has concerns about how patients will be informed.

Calvin Henry | 09/28/2022

The work that both the OPTN Minority Affairs Committee and Kidney Transplantation Committee have contributed toward this proposal is commendable. I support further work in revising allocation and transplant policy rooted in inaccurate and biased assumptions about historically disadvantaged groups. As of September 25, 2022, Black kidney candidates make up just over ¼ (26%) of the entire UNOS waitlist registry (per OPTN data). Not just 26% of the kidney waitlist, 26% of the entire registry. Also, more than 1400 Black kidney candidates die each year while waiting for a kidney transplant. An OPTN assessment isn’t available to inform how many of these candidates would be affected by this proposal, but it is apparent that the potential impact is significant. This significance is the lens through which I view how I think the resulting policy should be approached. Although I don’t agree with the proposal exactly as written, I do agree with the framework but strongly believe the following enhancements would make the proposal much stronger:

1) Establish this policy as a requirement Varying degrees of burden from this proposal will occur, but certainly none that overrides what should be the principal goal: restorative justice for Black kidney candidates that were unfairly disadvantaged by an inequitable medical policy. An optional policy, rather than a requirement, falls short and doesn’t convey the magnitude, gravity, and urgency of the issue and creates further distrust for disadvantaged groups in a transplant system with an unfortunate history of inequitable treatment. Without a requirement, this barrier in access to transplant hasn’t been removed and one of the stated goals of this proposal cannot be accomplished with certainty. It also places transplant centers, that may decide not to follow policy, in a position where they may have to defend the choice of not removing a barrier in access to transplant especially when patients realize other transplant centers may follow policy.

2) No end date to submit eGFR modifications but require assessment to begin within 30 days after policy implementation Although I think transplant centers should implement this policy as soon as possible, I can understand the burden the resulting policy will place on larger kidney transplant programs and would not desire any patient to be negatively affected should a 365 day timeline not be attainable. I also note that approximately 60% of the 256 kidney transplant programs currently have waitlists <100 patients with a large number of those that have <50 patients. I would hope that those programs would have no significant issues in submitting modification requests much sooner than a 365 day timeline.

3) The OPTN establish basic guidelines to assist in a standardized implementation

The proposal isn’t transparent in how the process is to be implemented when approved and it seems that transplant centers could be left to figure it out on their own. To assist with standardization and transparency, I believe a framework should apply to all transplant centers including: a) Waitlist assessments should commence within the 1st 30 days of the period start date, b) Inform candidates whether they qualify for modifications and, if not, provide the reasoning, c) OPTN needs to define start/end dates, d) Ensure that a race-neutral eGFR result (or recalculation) from the earliest available date is chosen, e) A letter of documentation from the transplant center sent to each Black candidate documenting specifics such as: numerical change from a race-inclusive to race-neutral result, date of submission to UNOS requesting modification of the update, indicate type of eGFR calculation/recalculation being used, time requirement/process for UNOS to validate requests and update UNet to reflect modifications.

4) UNOS-authored communication to Black candidates and other stakeholders.

UNOS, as the OPTN, should craft a letter with information on the policy change and send directly to each Black kidney waitlisted candidates as well as stakeholders like ASN, NKF, AAKP, dialysis providers, and others. This is important since the vast majority of transplant candidates do not visit the UNOS/OPTN website and this proposal presentation has recommended that Black candidates should reach out to their transplant center to check on their status. Transplant centers should also notify UNOS if they will be participating (if no requirement) prior to policy implementation date.

University of Arkansas for Medical Sciences - Solid Organ Transplant Program | 09/28/2022

UAMS Transplant program strongly supports this proposal. Black transplant patients who have been impacted by race-inclusive eGFR calculation deserve to regain waiting time they could have received if a race-neutral calculation was used. UAMS Transplant program is in favor of this proposal due to the direct impact it has on reducing health disparities and supporting health equity. If mandatory, this would also address a recommendation from the NASEM report to eliminate variations in transplant center performance.

National Kidney Foundation | 09/28/2022

The National Kidney Foundation appreciates the opportunity to comment on this policy proposal. We strongly support modifying wait time for patients affected by race-based eGFR formulas. Please review our attached comment letter. Thank you.

View attachment from National Kidney Foundation

Anonymous | 09/28/2022

Sentiment: 14 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | The region supported this proposal. During the discussion one attendee noted that one year may not be long enough for centers to make all the modifications depending on the size of their list and if they are required to send letters to patients. Another attendee commented that there may be a potential for misclassification of other ethnic groups if there is not a new equation that is truly race independent and recommended this be considered moving forward. One attendee recommended having a petition process for patients to make their coordinators aware of a miscalculation of time.

Anonymous | 09/28/2022

The OPTN Membership and Professional Standards Committee (MPSC) appreciates the opportunity to provide feedback on the OPTN Minority Affairs and Kidney Transplantation Committees’ proposal Modify Waiting Time for Candidates Affected by Race-Inclusive Estimated Glomerular Filtration Rate (eGFR) Calculations. Committee members expressed strong support for this proposal noting that waiting time should be regained for Black candidates who were negatively impacted by race-inclusive eGFR calculations. The Committee added that making this policy change mandatory for programs should be considered because if it is left as optional it may continue inequity in the system. Discussion also included possible unintended consequences that should be considered for candidates who may have also been affected by eGFR, but would not qualify for a waiting time modification and possible misuse of the waiting time modifications given the sometimes complicated nature of kidney candidate referral to transplant programs.

Anonymous | 09/28/2022

The Data Advisory Committee thanks the Kidney Transplantation and Minority Affairs Committees for their work in developing the proposal Modify Waiting Time for Candidates Affected by Race-Inclusive Estimated Glomerular Filtration Rate (eGFR) Calculations. The Committee is in favor of this proposal, but has the following suggestions: 1) When a program updates its practice, the program should indicate the formula from a list provided by the OPTN and specify whether it is race agnostic or not. Collecting such information may reveal center-level variation; 2) If a program has a black candidate and the center indicates that they are using an eGFR calculation that includes a black race coefficient, the OPTN should capture how a program determines the GFR so that future changes/corrections can be applied more easily (such as measured vs estimated, method/formula); 3) The number of candidates impacted by this proposal whose programs submitted wait time modification forms as well as the changes made should be tracked over time by the OPTN, thus allowing for the OPTN to contact programs before the conclusion of the policy who have not voluntarily submitted modification forms. It was strongly indicated by members of the Data Advisory Committee that the policy needs to collect information on which programs are changing candidates’ eGFR values as well as the formula used such that programs level variation in practice can be reduced and those program that do not submit changes can be identified. It was suggested that the sponsoring committees should consider adding education for patients to ensure they understand why their eGFR score is or is not impacted; this data is incredibly meaningful to patients as this impacts their opportunity to receive an organ. In order for this to happen, programs are going to need to find an earlier creatinine at the threshold and so the change in the data is going to be a change in the date of eligibility to start to accrue allocation points. This may not be easily available or available at all for a subset of patients so there is a need to know which patients did not get a correction and potentially why.

Anonymous | 09/28/2022

Sentiment: 8 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Overall, the members of the region support the proposal with many members in support of making this proposal mandatory for all transplant programs. One member stated that it is unacceptable to not mandate a policy that aims to correct systemic discrimination of patients. There were also some suggestions that the deadline for wait time modifications be changed from 365 days to a shorter deadline of six months, with others noting that hospital staff resources to complete the wait time modifications needs to be taken into consideration. Some members expressed concerns over mandating the policy due to limited staff resources. Members of the region were split over broadening the scope of the proposal to include wait time modification eligibility for dialysis candidates. One member noted that despite the increase workload this broadening might cause for transplant programs, it is the responsibility of the transplant program, and the community as whole, to do the best for the patients. Others suggested that in order to not overburden transplant program staff, the onus should be on the OPTN to conduct the review of eligible candidates and make the necessary wait time modifications.

Anonymous | 09/28/2022

The Patient Affairs Committee thanks the OPTN Kidney Transplantation & Minority Affairs Committees for their efforts on the Modify Candidate Waiting Time Dates Affected by Race-Based eGFR Calculation proposal. The Committee strongly endorses making this proposal a mandatory requirement. The Committee emphasizes that an optional implementation does not reflect the importance or urgency of this issue. The Committee requests that existing mechanisms for transplant program accountability be considered for application to this proposal in order to implement a mandatory requirement. Several Committee members suggest the 365 timeframe be shortened, and propose a six-month or less timeframe, to emphasize the urgency of requesting these waiting time modifications. One Committee member notes concern that 365 days may be too short of a timeframe for large volume transplant programs and was concerned about unintended consequences, for example, if patients miss out on this opportunity because transplant programs do not respond in time. The Committee states that communication to every patient, every transplant program, and relevant stakeholders and societies is necessary. The Committee strongly recommends that the OPTN impose a requirement to notify every affected transplant candidate. The Committee emphasizes that communication and education is necessary. More detailed responses from the Committee members are submitted as an attachment.

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NATCO | 09/28/2022

NATCO appreciates the opportunity to provide the following feedback to the OPTN Minority Affairs and Kidney Transplantation Committee. NATCO supports this proposal, and recommends that the recalculation is mandatory, not optional, for transplant centers to increase effectiveness. We are concerned that if this is not mandatory, and the candidates do not know about this opportunity, there will continue to be inequity. This policy will result in additional work for transplant coordinators, although this is only for a few patients in each center. Do those consequences or challenges outweigh the benefits of the proposed waiting time modification pathway? NATCO agrees that the consequences of additional work do not outweigh the benefits to patients.

Anonymous | 09/27/2022

Sentiment: 4 strongly support, 9 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose | The majority of members supported the proposal with suggested for refinement. Several members inquired why the policy would sunset after 365 days – and that this should be always available to those patients who are not referred prior to dialysis. A member supported the proposal overall and suggested that the committee consider giving points to patients referred late due to race inclusive eGFR after the 365 days. The member pointed out that it may not be practical or possible to go back before dialysis. A member pointed out that it is important to ensure that patients referred late (more than a year after implementation) aren't negatively impacted by referring physicians using race based eGFR formulas. Several members supported making this mandatory. A member inquired as to the extent of burden if this was mandatory. A member explained that she agrees that this needs to be done and that all time should be credited with no cap. But the member pointed out that from a patient perspective, she doesn’t agree with some aspects of the pathway proposal. Without exception this should be mandatory for all transplant centers that utilized the race-inclusive calculation and the burden should not be on the patient to ensure that this modification is completed (since the patient was not responsible for the original estimation method). The transplant coordinator should be required to educate their patients as to what this means and keep them informed of the progress of their eGFR waiting time modifications. The timeframe to complete this modification should be shortened to 180 days. Further, the member asked: (How long did it take the transplant center to calculate the race-inclusive eGFR? How will registered black kidney candidates know that this pathway is available to them if all transplant centers are not required to participate in the modification? How long does it realistically take to obtain the required documentation for option 1 or option 2? Will this result in a scenario where only patients with access to information and who can advocate for themselves benefit?) A member explained there needs to be more information collected and communicated. The member expressed a concern for how they receive referrals from nephrologists and whether they the nephrologists understand the importance of early referral.

Anonymous | 09/27/2022

Sentiment: 8 strongly support, 5 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose | Members of the region support this proposal, and several members voiced their support in making it mandatory for transplant programs to submit wait time modifications for Black patients negatively impacted by the use of a race based eGFR formula. If this policy were to be optional it would only increase disparity. Others noted that there needs to be a mechanism for candidates to be notified of the policy and that they may qualify for more waiting time. Another member suggested that there needs to be outreach to referring nephrologists that there has been a change in acceptable eGFR calculations. Lastly, one member noted that the timeline for this proposal needs to be fast tracked and programs should submit their wait time modifications within 6-9 months after implementation.

Anonymous | 09/27/2022

The Pancreas Committee thanks the OPTN Minority Affairs Committee for the opportunity to review their Modify Waiting Time for Candidates Affected by Race-Inclusive Estimated Glomerular Filtration Rate (eGFR) Calculations proposal. The Committee provides the following feedback: The Committee suggests these modifications being mandatory in some form to support those patients who may not be in a position to advocate for themselves. The Committee added that having a timeline would help encourage this policy being mandatory. Additionally, there should be consideration for a pathway for candidates who have already received a transplant to gain wait time back. The Committee voiced concern on whether programs would be willing to go through the efforts of reviewing their lists and identifying those patients to correct these values, which could present a disadvantage despite these efforts. Additionally, there was concern raised on the pathway outlined resulting in staff burden as it may be difficult for programs to complete the requirements due to staff turnover. There was a comment that there are challenges in knowing what candidates are listed pre-emptively without conducting a holistic review of their full candidate list. The Committee suggested that apart from education on this update, there should also be consideration in automation within the system as well. One suggestion included the ability to identify patients and document whether or not any modification to the eGFR is needed in the system. Other members also suggested an eGFR may be able to be recalculated based on a candidate’s creatinine level included in their original calculation.

American Society of Transplantation | 09/27/2022

The American Society of Transplantation (AST) offers the following comments in response to the proposal, “Modify Waiting Time for Candidates Affected by Race-Inclusive Estimated Glomerular Filtration Rate (eGFR) Calculations:” The proposal provides examples of 4 candidates: candidates A (not accruing waiting time), B (accruing waiting time), C (accruing waiting time as of registration date), and D (accruing waiting with dialysis criteria). In each example, a transplant center may increase the candidate’s accrued wait time by submitting documentation of an earlier qualifying date by race-neutral eGFR. The verbiage can be simplified by stating that for all candidates the new qualifying wait time starts whenever the race-neutral eGFR was/is 20 or less, irrespective of dialysis status. The AST strongly recommends all kidney programs review available data for each of its listed candidates to assess if their accrued wait time would be positively impacted by utilization of a race-neutral eGFR calculation. We also suggest that this policy modification be applicable to candidates registered after July 27, 2022, if they are subsequently found to have data supporting an earlier qualifying date. The OPTN should review these changes in a year to determine if they should be extended, expanded upon, or ended. The AST recognizes the pros and cons of the one-year timeline currently proposed for programs to address this policy change. While there is a desire to quickly submit the wait time modification for each candidate impacted, imposing a shorter time period for addressing it may place undue burden on programs in a time where staffing and data entry challenges could make this difficult depending upon the number of candidates impacted. Shortening this time period could lead to some candidates not receiving this benefit and even potential compliance issues that could impact overall access to care in the long term. The one-year window seems to be a reasonable goal to allow for each program to comprehensively review its often lengthy kidney waiting list and relevant data to determine which candidates are impacted and make the appropriate changes needed. There is also value to leaving this waiting time modification open indefinitely for those pre-emptively referred for transplant who were impacted by the use of a race-based calculation of eGFR. The AST is not aware of any reason why any candidate found to be impacted by this would be excluded from this waiting time modification in the future. While awareness and education regarding the removal of this practice is underway, there is still opportunity for this to impact candidates at day 366 and beyond. There could be opportunity for recognizing programs who complete this request in a shorter time, including a letter of recognition and thanks from the OPTN or HRSA. This proposal does not specify requirements or recommendations for notifying patients they have been affected by race-independent eGFRs or provide guidance on how to provide such notifications. Increasing the transparency in the policy change for patients and the impact it may have on their waiting time is necessary to empower patients and allow them to become more active participants in their care. Concerns were raised that these proposed changes may be difficult to implement, impose a significant burden on transplant centers, and may create medical legal issues.

View attachment from American Society of Transplantation

OPTN Ethics Committee | 09/27/2022

The Ethics Committee appreciates the work of the Minority Affairs and Kidney Transplantation Committees in developing this proposal and for the opportunity to comment on it. The Ethics Committee was a strong supporter of removing race from eGFR calculations and is pleased to see a proposal to correct the harms of the race-inclusive eGFR calculation. The Ethics Committee believes this proposal could be strengthened by requiring centers to review and modify their patient’s wait time, as opposed to allowing voluntary review. Members suggest providing more detailed guidance on how far back into patients’ medical records centers are required to review and provide guidance on how to proceed when unable to locate documentation. This is especially pertinent for patients who have switched transplant centers or have lost files due to administrative failures. A member suggested allowing patients who were transplanted with a race-inclusive eGFR to qualify for a wait time modification in the event that they require re-transplantation in the future. Members suggested developing patient-directed communication to inform patients of this change, which would enhance patient autonomy and allow them to follow up with their provider regarding their wait time modification. Members emphasized the necessity of communicating this change and apologizing directly to patients who have been harmed in order to provide the restorative justice they deserve. Overall, the Ethics Committee appreciates the opportunity to provide feedback and recommendations to strengthen this much needed policy proposal.

Christopher Johnson | 09/26/2022

The plan is too broad if it includes backdating patients who were listed after initiation of dialysis. The purpose of the proposal is to restore waiting time for those patients who were disadvantaged by race-inclusive eGFR calculations. Most clearly, this would include patients in Scenario A of the white paper - those patients who were registered for kidney transplant but were not gaining wait time due to a nonqualifying eGFR. By recalculating their eGFR they would have gained time from the point of registration. At a minimum, all of those patients should receive wait time going back to the point of registration. However, some patients may have been delayed in referral and/or listing due to an estimated GFR above 20. They were eventually listed at a race-inclusive eGFR below 20, but may have been referred, evaluated, and registered sooner using a race-neutral eGFR. Those are the patients in Scenarios B and C, and an argument can be made for backdating to the qualifying race-neutral eGFR to err on the side of maximal benefit. Extending this relief to all Black patients listed after the start of dialysis, however, will create a large and unfair impact on the wait list as a whole. Many patients of all backgrounds are not listed until after initiation of dialysis. The causes are innumerable, including limited access to care, medical complexity, provider education, and even patient reluctance. I would posit that for those patients who are not listed until after dialysis initiation, the role of the eGFR calculation is negligible. Changing that start time from dialysis to eGFR < 20 for only Black patients will create a major disruption. I strongly suggest that the committee break up the two proposed changes: 1. For Black patients registered prior to the start of dialysis, do you support backdating their waiting time to race-neutral eGFR < 20? 2. For Black patients registered after the start of dialysis, do you support backdating their waiting time to documented race-neutral eGFR < 20? I do not think it would be fair to have one set of listing standards for patients who identify as Black (listing goes back to first documented eGFR

Anonymous | 09/26/2022

Sentiment: 13 strongly support, 5 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose Comments: There was broad support voiced for this proposal. There were several questions and comments about how the data needed to adjust the waiting time would be identified; one attendee stated that they would need to get data from referring nephrologists, as they may not have that data in their records. Another attendee stated that most Black patients at their center are listed after starting dialysis due to various factors including lack of insurance until dialysis starts. From the perspective of these patients, waiting time should start at dialysis initiation.

American Society of Transplant Surgeons | 09/26/2022

The American Society of Transplant Surgeons (ASTS) appreciates the opportunity to provide the following feedback to the OPTN Minority Affairs and Kidney Transplantation Committee. Do community members agree with the proposed eGFR waiting time modification pathway? Yes. Do community members propose an alternative eGFR waiting time modification pathway? No. What kind of education resources would assist programs in participating? ASTS suggests a webinar advertised on the UNOS homepage. What potential unintended consequences or challenges should be considered during this proposal’s development? This policy will result in additional work for transplant coordinators, although this is only for a few patients in each center. Do those consequences or challenges outweigh the benefits of the proposed waiting time modification pathway? No. ASTS feels this is an important proposal. Are there other waiting time modification scenarios that the members would like the committees to consider? No. Does the community agree with the proposed scope, timeframe and required documentation? Yes, however, ASTS feels that reporting could be improved if it was mandatory to increase adherence to the policy.

View attachment from American Society of Transplant Surgeons

Anonymous | 09/23/2022

I support the idea behind this proposal but not how the policy will operationalize it. If a GFR

Anonymous | 09/21/2022

Sentiment: 5 strongly support, 3 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: Region 1 attendees supported the proposal. One attendee commented that as a stand-alone policy proposal, this is important and addresses an inequity. They continued to discuss the historic lack of referrals and that this can be used as a proof of concept for a transparent way to give credit for advanced chronic kidney disease with late referral to other patients as well. There was discussion about how many patients this could potentially impact. Another attendee confirmed that this would allow a patient that had a GFR of 19 two years pre-dialysis to get that time back. An attendee suggested that OPTN be explicit about the evaluation plan when implemented. An attendee also suggested determining how to accurately and transparently develop a protocol to capture pre-evaluation eGFR will allow the OPTN to begin to move into the issue of referrals. Another attendee stated this should be mandatory so that no patients are disadvantaged if a center decides not to make updates. Finally, an attendee suggested that this should only pertain to patients who were in evaluation for renal transplant listing and the date was delayed until eGFR was less than 20 and would have been < 20 by another formula. Otherwise, if pre-listing evaluation, inequities in referral affect many people with ESRD and the mathematical issue by race based GFR becomes a mechanism for privileging specific a population.

Pamela Cyr-Long | 09/21/2022

I strongly support this initiative and would challenge UNOS to make this mandatory for all transplant centers. On a systemic level, the transplant community owes it to current and future patients and their ancestors to do everything in our power to ensure equity in transplant and repair past harms caused by a racist system we now acknowledge to be racist.

Anonymous | 09/21/2022

I think this change is important for providing equity for all patients. This recalculation should be mandatory for all transplant centers and additionally, all affected patients should be notified of the change.

Anonymous | 09/20/2022

Sentiment: 7 strongly support, 7 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose | Comments: The region was generally in support of the proposal. Many supported making the waiting time adjustments mandatory for kidney transplant program. One attendee commented that while in support of the proposal, the issue is that African American candidates have limited access to early referral and healthcare. They went on to comment that the current criteria for a GFR of 20 was established years ago without data and it would make more sense to use a number closer to when patients need to initiate renal replace therapy. They added that the community needs to explore the role of preemptive referrals and the discriminatory impact it has on minority candidates. Another attendee commented that allowing 365 days for kidney centers to make the updates is too long and recommended shortening the deadline to six months. Other attendees agreed that the updates should be made as quickly as possible. Some had concerns about shortening the timeframe especially for centers with large waiting lists. One attendee encouraged the committee to consider how to create the interoperability for center to make these changes. There was also a recommendation to develop and provide talking points to explain the changes to affected candidates.

Region 2 | 09/13/2022

Sentiment: 13 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose Members of the region overwhelmingly support the proposal, and several comments were made in support of making the waiting time adjustments mandatory for kidney transplant programs. It was suggested that global restitution should be considered for Black patients. Additionally, the proposal should apply to patients who were deferred from listing due to not meeting eGFR of 20 mL/min or less and remain in an evaluation status. Several commenters suggested that if the proposal is not made mandatory then programs should be required to inform patients that they are not adjusting their waiting times. Additionally, there should be a pathway for patients to request that programs adjust their waiting time. One member noted, while in support of mandatory waiting time adjustments, they wonder how much of an impact this will have on patients since patients are likely referred for transplant before their eGFR goes below 20 mL/min. It was also stated that transplant programs will jump at the chance to improve their patients’ chances of getting a kidney transplant, but the committee should be cognizant of the administrative burden this will add to transplant coordinators and it will take time to work through a program’s waiting list. Lastly, one member noted that there should be guidance to transplant programs on how to appropriately and uniformly implement this policy across the country.

Anonymous | 09/12/2022

Sentiment: 5 strongly support, 4 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: Region 9 supported this proposal. Several attendees commented that it should be mandatory for centers to evaluate their waiting lists and submit waiting time modifications for all candidates who were disadvantaged.

Anonymous | 09/09/2022

Strongly Support

Anonymous | 09/08/2022

Sentiment: 17 strongly support, 10 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose | • Comments: A member pointed out that a lot of the public comment feedback, on the OPTN website, for this proposal supports changing this to mandatory, and that the policy should be rewritten to include a mandatory requirement. A member asked how to re-calculate eGFR for black candidates and asked for the OPTN to provide a simple calculator in order to efficiently recalculate the effected candidates wait times. Another member supported changing the policy to a mandatory requirement. A member suggested to provide education opportunities to transplant community health in order to bring organ donation awareness to different ethnic populations

Paul Morrissey | 09/07/2022

The MDRD and CKD-Epi equations with a race-based calculator overestimate GFR is some patients with self-reported Black race. The original calculations (Levy, 1999, Ann Int Med) showed that including Black race improves the prediction of GFR based on serum creatinine values within a population. However, Black race is not biologically defined and characteristics that might alter the relationship between creatinine and GFR (muscle mass, e.g.) vary between individuals of the same race. Further, the number of Blacks in the study was small. Larger studies showed that when GFR is between 20-25 CKD-Epi with a race adjustment overestimates GFR by 5 ml/min/1.73 m2 when compared with iothalamate clearance (Zelnick, 2021, JAMA). This could lead to (1) delayed referral for transplant evaluation or (2) delayed listing until the eGFR was < 20. A policy to correct this inequity based on a mathematical inconsistency seems appropriate. HOWEVER: (1) Creatinine clearance < 20 is not required for referral. (2) Most patients referred for transplant evaluation are already on dialysis, so the vagaries of eGFR calculations did not affect their referral or wait time listing. (3) Referral for transplantation is multi-factorial and eGFR (perceived or measured extent of kidney disease) is an infrequent reason for delay. WHO WAS DISADVANTAGED BY eGFR CALCULATION? Black patients referred and evaluated for renal transplant, not on dialysis at the time, whose TRANSPLANT LISTING was delayed because their eGFR was > 20 using a race-based calculation were disadvantaged. This is a small group of patients who were clearly harmed (accrued less wait time) due to the use of race-based equations. Their eGFR should be recalculated and wait time restored to a point after referral when the eGFR is < 20 using a race neutral formula. A PROBLEM WITH THE PROPOSED POLICY: The policy as written would allow any Black patient who had an eGFR calculated with a race neutral formula < 20 at any time (even years prior to referral) with source documentation (Lab slip) and signature of a transplant provider to “jump the list” by adding that time difference. There is a myriad of reasons for kidney transplant referrals happening late in the course of CKD or after dialysis. Some are structural and based on racial disparities, but most are not. Allowing such a “look back” for Black patients alone would dramatically alter the wait list in transplantation. Many, possibly most, clinicians at the Region 1 UNOS meeting I attended were unaware of this possibility with the proposed policy. The policy should be revised to prevent this unintended adjustment that goes far beyond correction of the racial differences generated by once standard, race-based GFR formulas.

Bhavna Chopra | 09/01/2022

Who this applies to (timing of referral - just to AA patients referred pre-emptively or all AA patients even if on dialysis when referred) — I think if we restrict modifying wait time to only those who were pre-emptively referred; we would provide justice to a very small fraction of the disadvantaged group; who was referred at a pre-emptive stage. Over 90% of AA referral to transplant centers are after they start dialysis. Ideally every AA patient should have the ability to gain the time if appropriate documentation of race neutral GFR of < 20 can be provided. This will bring a lot of AA potential recipients higher on the list. Eventually this should become applicable to all ethnic groups; to provide equitable health care. Whether it is mandatory or not: —It makes sense that this advantage is provided to all AA at all states and is not selective in different regions. But also the transplant centers should have the liberty to decide if they want to make use of this opportunity to provide excess wait time to the their AA waitlisted candidates. So for now as we introduce the concept and it can be optional; and over time seeing the advantages; it should be made mandatory. Whether the 365 days to complete the application is too long, too short or fine — I think 365 days to complete the application is appropriate; as the transplant center will get adequate time to get historic lab data.

Anonymous | 08/31/2022

The purpose of this policy is to increase equity in access to transplantation, it is crucial that the policy focuses on the candidates affected by this issue. If a transplant program does not chose to assess their waiting list for candidates that have been negatively impacted by the use of race-inclusive eGFR, there is no recourse for the candidates that qualify for waitlist modification under this policy. The evaluation of waiting lists should be mandatory. Furthermore, to encourage accountibility, candidates should be notified if their waiting time was affected by a race-inlcusive eGFR calculartion. Many candidates may not be aware that their waiting time could be modified. Additionally, there should be no sunset for this corrective policy action if a truly equity-driven solution is being sought.

Anonymous | 08/26/2022

Sentiment: 7 strongly support, 11 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose | Comments: Region 4 generally supports this proposal. Several attendees commented that centers should be required to modify the waiting time for any candidates who lost waiting time due to the use of an eGRF calculation with a race coefficient. Another attendee commented that if we know the modification would itself reduce disparities, it should not be optional. One attendee commented that unless this is mandated it will not work and the patients will be left to figure out the process. An attendee commented that the 365 day time period needs to be clarified as to when the timing starts. Another attendee commented that leaving this as a guideline will create new opportunities for barriers to transplant.

Lorrinda Gray-Davis | 08/16/2022

I will strongly support if there are mechanisms in place to ensure all Black patients are notified, outreach and communication at a grass roots effort in Black Communities and education throughout ALL communities. Do you agree with the proposed eGFR waiting time modification pathway for registered Black kidney candidates affected by race-inclusive eGFR calculations? As the former Director of Diversity Affairs for Perini Building Company I have an understanding in community outreach. In the construction industry, having requirements and goals without consequences never went anywhere. Companies that didn’t have the minority companies as part of the terms and conditions, in the contract, would NEVER reach the “GOAL” The explanation of not meeting the goal; we made a “Good Faith Effort”, and no minority companies could be found or responded. What does that mean? An ad was purchased in a newspaper that the community does not read, advertising the project in very small print, to never achieve the goal. The contractors would not be penalized because they did the absolute minimum, needed to meet the requirements, meanwhile the communities suffered. Would you propose an alternative eGFR waiting time modification pathway for these candidates? The first thing that should happen is one eGFR calculation throughout the country. The responsibility of the hospital to audit every Black candidate’s chart, collect and submit the data will not be done because it is not enforced. The largest number of transplant candidates are waiting for a kidney, my thoughts go to the Black candidates that qualified previously, or on dialysis and sadly most will never hear of this eGFR “opportunity”. Are there other waiting time modification scenarios that you would like the committees to consider? As I read the proposal the qualifying population, waiting time will be restored to Black kidney candidates whose waiting time was affected by the race-inclusive eGFR calculations by meeting documentation and timeframe requirements. Transplant candidates do not come at the same time. The SRTR website data shows as of 12/31/21 there were 41, 483 Black kidney patients on the transplant list. In Region 4 there are 10,145 Black kidney patients. If this guideline is not mandated it will be left to the patient to find the information, get with the transplant center for the documentation, and hope it makes it to UNOS for the modification. Since there is no mechanism to correct their waiting time retrospectively. While limiting the scope and giving the hospitals the “opportunity” (no mandates) again Black kidney patients suffer, this will not provide restorative justice. Do you have any questions about the proposal or additional feedback? As stated above if the calculations are not done the same throughout the country, this will continue to inhibit the “guideline” to the “opportunity” for transplant hospitals. In all communities the lack of trust, transparency, education is missing. With the complexity of our systems, we have made it easy to disqualify the “right” people from qualifying. After discounting generation after generation why should they trust the healthcare system. Only with an entire cultural shift and a grass roots effort of community communication will things change. We need to stop creating opportunities for barriers to exist.

Anonymous | 08/16/2022

Recalculation using a race neutral calculation for eGFR should be mandatory for all Transplant Centers and waitlist times should be granted. A letter explaining the use of race neutral calculations should be sent to ALL Kidney waitlisted patients--for transparency. Education should be provided to all transplant centers regarding change to race neutral calculations for eGFR and included in the consent process. OPTN should lobby for largest Laboratories QUEST and LABCORP to use race neutral calculations for eGFR to standardized.

Sam Dey | 08/16/2022

Absolutely, it's high time to remove the race criterion. Incidentally, what about the other non-caucasian races. How come there wasn't a calculation specific to each race?

Anonymous | 08/13/2022

I congratulate the group on their work to address this disparity. Like the other commenters, I strongly advise that it must be made mandatory. Making it optional simply exacerbates the existing inequity. I there any acceptable reason not to apply this adjustment? If there isn't, make it mandatory.

LifeGift | 08/11/2022

Important step to address / adjust for previous disparities in waiting times based on race. Should be mandatory application, not optional by program.

Milton Mitchell | 08/11/2022

In support of this change. More importantly, mandatory requirement of all transplant centers is necessary - Please include. Thank you.

Nicole Seefeldt | 08/08/2022

It’s long past time to treat this long standing disparity. I’m for any policy that increases equality for marginalized groups due to racism, stigma and bias. This issue needs attention. It’s been a glaring problem for years. People have died and been harmed by lack of action on this issue. Medical racism needs to be abolished.

Kenny Laferriere | 08/08/2022

I support this change but I believe it should be a mandatory requirement of all transplant centers. I am unsure why it would be optional. How can we provide equity for all patients across the country if centers can choose to not participate.

Rebecca Baranoff | 08/07/2022

I support this proposal however I think it should be mandatory for all transplant programs to participate. I do not however support the idea of participating programs being responsible for assessing their waiting list for qualifying candidates. If this is the only way to modify the candidates waiting time, then there should be guidelines for a program to follow so that all possible candidates are viewed and reviewed to ensure all those affected by the Race-inclusive eGFR are given a fair opportunity for a modified waiting time. My additional questions are: 1. How will the candidates time be updated? What method will be used?

Kidney Donor Conversations | 08/04/2022

Support this measure to regain waiting time for Blacks with revisions: - Make it mandatory for all centers and allow ALL Patients to benefit. - If OPTN is not going to mandate, in order to be transparent, provide this information to all Black patients on the waiting list so they can be informed of this change and advocate for themselves to have the transplant center submit the necessary information.