Comments

National Kidney Foundation | 04/02/2021

The National Kidney Foundation (NKF) expresses our gratitude to the Executive Committee of the Organ Procurement and Transplant (OPTN) Network for the opportunity to comment on the 2021- 2024 OPTN Strategic Plan. NKF strongly supports the four goals outlined in the draft plan; to increase the number of transplants, increase equity in access to transplants, promote living donor and recipient safety, and improve waitlisted patient, living donor, and transplant recipient outcomes. Increase the Number of Transplants NKF supports this goal and the described objectives. NKF stands for patient choice. Every patient who wishes to and who is medically eligible to receive a kidney transplant deserves the opportunity to receive one. Due to the dramatic gap between demand and supply, however, too many patients never have the chance to benefit from the advantages that a kidney transplant can provide. A key pillar of NKF’s advocacy agenda is reducing the number of kidney discards by instituting policies that balance equity and utility. Clinically valuable organs continue to be discarded as a result of inaccurate characterization of organ quality, logistical challenges resulting in prolonged cold ischemic times, and fear of the repercussions of early graft failure on centers’ publicly reported outcomes. In 2017, NKF convened a Consensus Conference on Decreasing Kidney Discards. The experts convened for the conference put forth a set of policy and operational discard conference recommendations, including the creation of expedited placement pathways within allocation policy that directly offer organs at risk of discard to centers that have a demonstrated commitment to accepting and transplanting these organs.1 In short, allocation policies that expedite placement from the first offer for a subset of kidneys that are otherwise likely to be discarded. NKF hopes to work with the Executive Committee and the Kidney Committee on the development of a draft expedited placement policy for the consideration of the UNOS membership. NKF believe that metrics and monitoring approaches have an important role in performance improvement, particularly as it pertains to increasing the number of transplants by improving the organ supply. NKF is a longstanding supporter of implementing an appropriately adjusted organ offer acceptance rate measure for transplant centers as a means to improve organ utilization and thus bring clinically valuable organs to patients who are waiting. Organ acceptance rate combined with post-transplant outcomes that are measured against dialysis mortality reflect what patients truly want. 1 https://onlinelibrary.wiley.com/doi/full/10.1111/ctr.13419 We encourage the Membership Professional Standards Committee (MPSC) to incorporate transplant center organ offer acceptance into the evaluation of center performance. The measure should be carefully designed to ensure that centers are not penalized for matching the right organ to the right recipient. Better transparency into turndowns is also important to patients. We recommend that UNOS work with the Scientific Registry of Transplant Recipients (STtR) to provide these data to the community. Such an effort would complement an organ offer acceptance rate measure. Finally, while NKF is a strong supporter of increasing geographic equality on behalf of patients waiting for kidney transplants across the country, we note that the elimination of the DSA and region policy has created unprecedented logistical and economic challenges. We recommend that UNOS closely monitor discard rates to ensure that the policy change does not increase the discard rate. We also note that broader allocation is likely to increase transplant center costs. Although we acknowledge that Medicare payment policy is not in scope for OPTN, it would be wise for policy development to consider the financial implications of policy revision on patients, providers, and payers. Doing so would enable organizations like NKF to advocate for the need for payment reform proactively as policy is debated and implemented, thus increasing the likelihood that policies that have financial impacts will successfully meet their objectives. Provide Equity in Access to Transplants NKF is pleased that UNOS continues to focus on improved equity. We strongly support this goal and its objectives. Structurally disadvantaged populations fall behind at every step of the transplant process. Payer status, social economic factors, and education are all correlated with lower waitlisting rates, yet none of these issues sufficiently limits success of transplant to justify exclusion of medically acceptable candidates. In addition, Black or African American patients are disadvantaged in access to the waitlist by race-based estimates of GFR that overestimate their kidney function. Improving equity in access to transplant for candidates of all races, ethnicity, and socioeconomic statuses is an obligation that every organization involved in transplantation shares. With regards to examining differences in access to transplant among ethnic, economic, and geographic grounds and developing strategies to address identified disparities, NKF is especially interested in better data collection and accountability to ensure timely transplant referrals and evaluations. It is hypothesized that referral and time to evaluation are bottlenecks for patients of racial and ethnic minorities, non-urban dwellers, and non-English speakers. Like many issues of importance to kidney patients, referral to transplant and time to evaluation involve numerous physician and provider stakeholders and must be addressed holistically. Although dialysis facilities are obligated by CMS regulations to evaluate patients for suitability for referral within the first 30 days of dialysis initiation and annually thereafter, it is well known that many patients are never referred for transplant, referred late, or are not regularly updated on their suitability for referral. Nephrologists are the gatekeepers for referral but have no formal accountability for transplant referral. NKF is working on these issues with CMS and the dialysis and nephrology communities. As it relates to the transplant community, we recommend that UNOS works with transplant centers and the ESRD Networks to develop metrics to assess and track timeliness of referral, time to activation, and proportion of the waiting list that is inactive. NKF supports strategies to incentivize proactive implementation of approaches to reduce delays in evaluation and listing. Promote Living Donor and Transplant Recipient Safety NKF supports this vital goal and its objectives. We do note that donor safety is more than physical. NKF is a longtime support of removing financial disincentives to living donation. We encourage UNOS to work with HRSA to continue to reform the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program administered by the National Living Donor Assistance Center (NLDAC) to remove the means testing of the recipient and to increase the income eligibility threshold for both donor and recipient. We further recommend that UNOS is ensuring that living donors receive information on all possible economic assistance in order to prevent financial barriers from precluding donation. Finally, UNOS should work with centers to ensure that differences in candidacy for donation including race and ethnicity are based on assessments of donor renal function that do not use estimated equations or other methods that include race modifiers but instead use assessments that measure actual function (e.g., 24-hour urine creatinine clearance or nuclear medicine scan). Improve Waitlisted Patient, Living Donor, and Transplant Recipient Outcomes NKF supports this goal however we would encourage the MPSC to continue to lessen the focus on post-transplant outcomes, which is not the outcome that matters most to patients.2 Getting on the waitlist and reducing time on the waitlist are highest priorities for patients. We recommend that UNOS work with the SRTR and organizations like NKF to develop outcome measures that reflect patient’s priorities for the care. On this point, we would note again the importance of an organ offer acceptance rate measure that ensures patient access to transplant is not reduced by operational barriers, poor data, or unwarranted center concerns about citations for poor outcomes.3 NKF hopes to be a partner to UNOS in implementing the recommendations contained herein. Please contact Miriam Godwin (miriam.godwin@kidney.org) to discuss further. Sincerely, Kevin Longino CEO and transplant patient 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6314030/ 3 https://pubmed.ncbi.nlm.nih.gov/26954720/

View attachment from National Kidney Foundation

Anonymous | 03/24/2021

The Histocompatibility Committee is supportive of this proposal.

National Catholic Bioethics Center | 03/23/2021

See letter, attached.

View attachment from National Catholic Bioethics Center

Anonymous | 03/23/2021

The Pediatric Committee thanks the OPTN Executive Committee for the opportunity to review their 2021 – 2024 Strategic Plan update. The Committee provides the following feedback: Typically pediatric initiatives have fallen under Goal 2 and Goal 4 of the Strategic Plan, although there’s often overlap if the initiatives increase the number of transplants overall. The Committee agreed that the 2021-20124 priorities work well for pediatric initiatives, in general, although they would like to see more concentration on overall outcomes. A member suggested that increasing the weight of Goal 4 could increase the focus on outcomes; however, having more details on the type of projects that would fall into Goal 4 would help with making recommendations. A member noted that the weight of these goals could be an acknowledgement of the good waiting list and recipient outcomes recently. Hence, the Strategic Plan is prioritizing increasing the number of transplants in order to attain good outcomes. A member inquired about the meaning of equity in Goal 2 – is this referring to health equity or providing equal opportunity of good outcomes? The member suggested having more finite metrics so the transplant community can better understand the impact of the efforts to improve equity.

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

ASHI supports the strategic plan and appreciates the opportunity to comment on the strategic plan.

OPTN Heart Transplantation Committee | 03/23/2021

The Heart Transplantation Committee appreciates the opportunity to provide feedback on the 2021-2024 OPTN Strategic Plan. Members support the focus on recipient longevity and commented that this is an important ethical concern, especially as advancements widen access to transplant to recipients who are more medically urgent. A member raised a concern about the completeness of longevity data as recipients may not be followed by a program beyond a certain timeframe or the recipient may move addresses. A member commented that the use of DCD donors for hearts is not as far advanced as it is for other organs. Therefore, it is important to remember that increasing the number of DCD donors should supplement, not come at the expense of the number of hearts procured from brain death donors. Members support increasing the priority to increase the volume of transplants.

Region 10 | 03/23/2021

Region 10 sentiment: 3 Strongly Support, 15 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: A member expressed concern over the lack of the word Donation in any of the proposed goals. They understand that it is covered in Goal #1, but the OPO, donor, and donation deserve recognition.

OPTN Minority Affairs Committee | 03/23/2021

The OPTN Minority Affairs Committee appreciates the opportunity to comment on the 2021-2024 Strategic Plan. The Minority Affairs Committee supports the strategic plan and agrees that 30% of the effort for goal 2, increase equity in access to transplants, is appropriate. The Minority Affairs Committee suggests providing more clarity in goal 2 by including specific prioritization of the projects that will provide equity in access to transplant. The Minority Affairs Committee also supports the prioritization of pediatric patients across multi- organ transplantation.

Region 2 | 03/23/2021

Region 2 sentiment: 8 Strongly Support, 11 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: The region is supportive of the proposed Strategic Plan. One member suggested that the OPTN should share near miss situations with the community at large in order for programs to learn and improve their own practices. Another member expressed concern with the project looking to revise the current list of refusal codes and is skeptical that adding more refusal codes will provide clearer data to the community.

OPTN Patient Affairs Committee | 03/23/2021

The Patient Affairs Committee (PAC) appreciates the work of the Executive Committee in developing the Strategic Plan and the opportunity to comment on it. Overall, the PAC generally supports the plan and believes that it addresses the main issues but considers that it could go further in a more patient centric approach. The PAC encourages improvements to be made such as the specification of brain dead and cardiac death donors and explaining the acronyms used to make the document more patient friendly. The PAC finds that since there is only one initiative under Goal 3, it could be possible to reduce the percentage allocated and expand on Goal 4. Outcomes are measured in more than just numbers and there should be a larger emphasis on qualitative data, such as quality of life for transplant patients. The PAC suggests increasing the allocated percentage for Goal 4 and include initiatives to make data more accessible to patients. The PAC believes there are room for improved representation by patients on the Minority Affairs Committee and Living Donor Committees and that Committee representation should reflect the waitlist. Overall, the PAC is supportive of the Executive Committee’s Strategic Plan and is appreciative of the opportunity to provide the unique patient perspective.

Region 9 | 03/23/2021

Region 9 sentiment: 2 strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. The region generally supports this proposal. A member shared that the goals identified are really good goals and that it’s important for members to work together to make them a reality.

Association of Organ Procurement Organizations | 03/23/2021

The Association of Organ Procurement Organizations (AOPO) appreciates the opportunity to comment on the 2021-2024 draft OPTN Strategic Operating Plan. AOPO supports the draft strategic plan generally and specifically appreciates the OPTN’s identification of a 50% resource allocation benchmark for increasing organ transplant. Identification of this Goal 1 as primary in the OPTN’s strategic operating plan is well-aligned with AOPO’s recently announced Bold Goal of 50,000 organ transplants annually by 2026. See https://www.aopo.org/50k-transplants/ AOPO fully supports the initiatives under Goal 1 including increasing the use of organs from older donors and DCD donors for transplant, and facilitating emerging organ perfusion technologies. It is through these efforts the system will be able to increase transplantation for the benefit of patients in need. AOPO also agrees with inclusion of the efficiency initiatives under the umbrella of increasing transplants in Goal 1 and urges the OPTN to continue moving those projects forward including implementing offer filters and addressing operational inefficiencies that exist with misuse of provisional, inconsistent biopsy practices, late turn downs and differing expectations for local surgical recovery services. All of these efficiency projects are urgently needed in the current context of broader distribution and, if effectively addressed, will result in system performance improvement and increased organ transplants. AOPO notes that well-defined metrics will be critical to measure progress towards Goal 1 and that metrics must be aligned between all of the system components - OPOs and Transplant Programs - to drive systemwide results. AOPO also notes the importance of Goal 2 and suggests that OPTN consider initiatives to address the racial and socio-economic disparities in obtaining candidacy assessment and access to the transplant waitlist.

Southeastern Kidney Transplant Coalition | 03/23/2021

We appreciate the opportunity to comment on the proposed 2021-2024 OPTN Strategic Plan. For over ten years, our Southeastern Kidney Transplant Coalition’s grassroots efforts have focused collaborative, research, and quality improvement efforts on identifying and reducing barriers to kidney transplantation, with emphasis on early steps in the transplant process. Thus, our Coalition’s goal to improve access to transplant and reduce disparities for patients with kidney disease is well-aligned with the OPTN Strategic Goals to 1) increase the number of transplants and 2) provide equity in access to transplant. We have established an Early Transplant Access data registry among nine transplant centers in the End-Stage Renal Disease (ESRD) Network 6 across three states (GA, NC, and SC) and we are currently expanding data collection on patients referred for transplant to three other ESRD Networks (1, 2, and 9) including the Northeast, New York, and the Ohio River Valley, with data collection ongoing now in more than 20 transplant centers on a voluntary basis. We have demonstrated feasibility of data collection as well as the importance of these data, with multiple publications detailing the variability in transplant referral rates and rates of transplant evaluation, the differences in patient barriers at different steps of the transplant process, and the effectiveness of multi-component interventions at reducing disparities in early transplant steps. Collection of national referral and evaluation data also has implications for transplant quality metrics; kidney transplant program performance in the U.S. is commonly measured by post-transplant outcomes, inclusion of pre-transplant measures could provide a more comprehensive assessment of transplant program performance, and thereby provide necessary information for patient decision-making. Using our Early Transplant Access Registry data, we have proposed a new metric for transplant programs, the waitlisting rate, defined as the ratio of patients who are waitlisted in a center relative to the person-years referred for evaluation to a program. Utilizing a waitlisting rate metric in addition to a transplant rate metric may be appropriate for evaluating access to transplantation for patients, patients’ family members, and their referring nephrologist or providers. In summary, to address the OPTN Strategic Goal of increasing access to transplant, and increase equity, we strongly urge the prioritization of the collection of referral and evaluation data nationally so these data can be used to improve quality and equity in access to transplantation, including steps prior to waitlisting. Stephen Pastan, MD Professor, Emory University School of Medicine Chair, Southeastern Kidney Transplant Coalition Rachel Patzer, PhD, MPH Professor, Emory University School of Medicine Data Chair, Southeastern Kidney Transplant Coalition

American Society of Transplant Surgeons | 03/23/2021

The American Society of Transplant Surgeons (ASTS) supports this proposal with revisions outlined below. The ASTS appreciates the thoughtful strategic plan proposed by the OPTN and finds that the goals are appropriate and reasonably weighted. However, the initiatives to reach the stated goals do not place sufficient effort on eliminating crucial barriers experienced by transplant centers to improve access, safety, and outcomes around transplantation. Therefore we propose 8 additional initiatives (and associated metrics) that better align with the overall goals of the OPTN Strategic Plan and that we believe will be more impactful for transplant recipients and donors. The OPTN Board of Directors Executive Committee requests feedback on: 1. Do you agree with the Board’s proposed areas of strategic focus for the 2021-2024 plan? A. Goal 1: Increase the Number of Transplants 1) Performance Metrics (increase from 1-2 to comprehensive dashboard) a) New Initiative #1: Eliminate current performance metrics that discourage use of marginal organs for transplantation. Current approaches to evaluate center performance discourage liberal organ acceptance practices. Although the proposed OPTN Plan positively calls for a dashboard of quality metrics to reflect comprehensive outcomes, this initiative does not go far enough to impact organ acceptance. Transplant center star ratings based on patient and graft survival should be eliminated. Replacement ratings available to the public should be designed to meet patient informational needs, such as describing outcomes relative to the alternative treatment (i.e. dialysis in the case of kidney transplantation). Outcome triggers for MPSC performance review of transplant centers should not grade transplant centers on a curve. b) New Initiative #2: Develop new transplant center, OPO and, system performance metrics that are congruent and encourage use of higher risk organs. Transplant center quality expectation should be based on a minimal floor for graft and patient survival that encourages increased utilization of organs at risk of discard. The current one-year graft and patient survival rates are currently very high and it is not reasonable or realistic to expect a continuous increase, nor are they the main metrics upon which we should be focused that best describe success in transplantation. OPO centric metrics should reflect parameters that are directly under their control. c) New Initiative #3: Ensure sufficient stakeholder participation in deliberations regarding performance metrics (OPO, transplant center and system metrics) to avoid the adoption of metrics that conflict with Goal 1 of increasing the number of transplants. ASTS recognizes the complexity of developing OPO, transplant performance and systems metrics. The ASTS “White Paper on Optimization of Transplant Center Assessment” outlines the complexity, issues, and recommendations for a successful approach to this endeavor that will facilitate affirmation of new metrics by the transplant community. A key principle of the approach to this goal is to engage a broad enough group of stakeholders beyond UNOS committee members to ensure sufficient deliberation and consideration of unintended consequences to avoid metrics that conflict with Goal 1 of increasing the number of transplants. 2) Pursue policies and system tools that promote system efficiency and increase organ utilization. We generally agree with the intent of initiatives, however 2) a-f we recommend that 2f should be integrated into a new overarching initiative that receives higher priority than 2a-e and the addition of: a) We recommend integration of 2f into a new overarching initiative New Initiative #4: Enhance the Efficiency and Quality of Organs Procured for Transplant through the establishment of innovations such as organ recovery centers and collaboratives focused on best practices for organ recovery (including higher risk organs). ASTS leadership initiated a new collaborative entitled the Organ Recovery Collaborative Network (ORCN) taskforce that engages a broad group of stakeholders and is designed to enhance local recovery, reduce team travel, and standardize best practices for organ recovery and transport. Thus, we recommend that the OPTN continue to engage with ORCN as part of new initiative #4. b) New Initiative #5: Optimize Organ Transportation Efficiency. Transportation issues result in prolonged cold ischemia time and subsequent organ refusals. We recommend the addition of the following key initiative for Goal 1. We agree with the focus on efficiency as part of Goal 1 and recommend that the OPTN focus on transportation efficiency to minimize CIT. With the expected increase in transportation of organs, it is important to maximize transportation efficiency and minimize CIT which will optimize utilization and increase the number of transplants. OPTN increased engagement with transportation arrangements to facilitate more efficient transport of organs would benefit the transplant community. In addition, we recommend tracking organ transport data, including costs to further our understanding of this critical barrier. c) New Initiative #6: Enhance the Efficiency of Placing Higher Risk Organs. Placement of organs at high risk for discard is inefficient in our current allocation system, translating to time lost and organ discard or patient morbidity. There should be a dedicated focus on alternative allocation that allows faster placement of organs at risk for discard and policies for local back-up that minimize cold time. d) Increase use of DCD organs: we agree with this initiative but recommend integrating this within the new initiative #4 (see 2a above). e) Review policies to determine whether future changes will be necessary to encourage or facilitate emerging organ perfusion technologies: we agree with this initiative and recommend integrating this initiative within the new broader initiative #4 (see 2a above). f) Enhance the effectiveness of paired living donation programs: we agree. Goal 1 Key Metrics are appropriate and will be enhanced by adoption of the new initiatives proposed above. B. Goal 2: Provide Equity in Access to Transplants An initiative for this goal in the Plan is to implement a continuous distribution policy framework in all allocation policies to increase equity and provide more flexible, patient-focused allocation policies. However, the impact of socioeconomic status (SES) in transplant access as a result of current and future intended allocation remains incomplete, since previous models measured only individual surrogates of SES like urbanity, payment status, and income by zip code. To ensure that all underserved communities have equitable access to transplantation, we recommend a more comprehensive analysis of SES factors in organ access, such as by using the cumulative community risk score as indicated below. 1) Improve equity in transplant opportunities for multi-organ and single organ candidates: we recommend promoting research towards this initiative to better define the optimal clinical indicators of need for multi-organ transplant and optimal timing of multi-organ transplantation (concurrent, sequential). 2) Implement continuous distribution policymaking framework: we recommend a more comprehensive analysis of SES factors in organ access, such as by using the cumulative community risk score. We also recommend serial assessment of the impact of continuous distribution policy especially upon small transplant center viability, access to transplant for patients who live in rural areas or communities that are geographically distanced from a transplant center. While the intent of continuous distribution is to enhance equity, there may be unintended consequences on certain populations who are benefited by the access to smaller transplant centers closer to their community. 3) Increase the ability for allocation policies to be dynamic and incorporate changes in faster policy cycles to respond to post-implementation findings. Agree. 4) Examine differences in access to transplant among different ethnic, economic, and geographic groups and develop strategies as indicated to address any identified disparities. Agree and we recommend a more comprehensive analysis of SES factors in organ access, such as by inclusion of the cumulative community risk score. 5) Ensure diversity in the decision makers on the OPTN Board and committees: we agree with the goal and initiatives to diversify OPTN governance and decision makers. Goal 2 Key Metrics are appropriate. C. Goal 3: Promote Living Donor and Transplant Recipient Safety 1) Educational and collaborative efforts to share best practices: we agree with efforts to promote education and collaboration. 2) We recommend adding a new Initiative New Initiative #7: Enhance public education about the safeguards and safety of living donation (including kidney paired donation) in order to encourage more living donor transplants. In addition there should be a focused effort for public education on recipient safety and improved outcomes with living donation. 3) We recommend adding a new Initiative New Initiative #8: Enhance public education about resources to minimize financial barriers to living donation (NLDAC) in order to encourage more living donor transplants. Key Metrics for Goal 3 are appropriate. We recommend adding two new key metrics associated with the recommended new initiatives #7 and #8 above. Add the key metrics: 1) “Promote education to increase the number of living donor transplants performed annually.” 2) “Promote education to increase applications to NLDAC for support of living donors.” D. Goal 4: Improve Waitlisted Patient, Living Donor and Transplant Recipient Outcomes 1) We recommend elimination of the initiative to “Include recipient longevity in transplant center metrics.” While recipient longevity is desirable, the transplant center does not have influence on factors contributing to longevity including recipient genetics, risky behaviors, socioeconomic circumstances, or geographic mobility, transfer of care to other centers or failure to comply with transplant center follow-up. 2) We recommend revision (in parentheses) of this initiative to state…Evaluate effective methods for assessing living donor outcomes (without increasing data collection burden on the transplant center. We recommend that the OPTN take the lead in collecting living donor outcomes through centralized on-line platforms). 3) We recommend revision (in parentheses) (of this initiative to state) Enhance (the development of OPTN managed) tools and education in the selection and follow-up of living donors. (We recommend revising this initiative so that the OPTN (not the transplant center) takes the lead in the development of tools and collection of data on living donor). 4) Develop tools to calculate the survival benefit to inform center practices, patient management and OPTN policy development. We agree. 5) Improve patient tools for understanding the allocation process and organ acceptance strategies. We agree. 6) Improve the process/management of donor information that becomes available after transplantation (blood cultures, sputum cultures, urine cultures etc.) We agree. Goal 4 Key metric to 1) reduce waitlist mortality is appropriate. We recommend the key metrics 2) and 3) to increase 1 and 5 year graft and patient survival rates respectively be removed. The 1-year graft survival rate for some organs are already extraordinarily high that it is not reasonable or realistic to establish this as an initiative. Instead, resources to support research grants investigating the causes of chronic rejection should be allocated and communicated as “Request for Applications” to the transplant community. Until the biologic and other factors responsible for chronic rejection are identified and clinical approaches can be developed, it is not reasonable to establish a metric of increased 5-year graft and patient survival. 2. Is a goal or initiative missing from this plan that should be considered a strategic priority? Will resource allocation benchmarks need to be changed to accommodate the addition? 1) See comments above for Goal 1 regarding the addition of new initiatives 1a-c, 2a-c. Resource re-allocation will be necessary to address new initiative to enhance Organ Transportation Efficiency. Yes resource allocation benchmarks will require modification (increase resource allocation to Goal 1 from 50% to 60% and decrease resource allocation for Goal 2 from 30% to 20%) to accommodate addition of new initiatives in Goal 1 which are likely to require additional personnel and development of tools. 2) Goal 2 recommendations include revisions to the proposed goals and likely do not need change in resource allocation. 3) Goal 3 recommendations are to prioritize the proposed two new initiatives that promote living donor and transplant recipient safety through a) focused effort on public education about the safeguards and safety of living donation (including kidney paired donation) in order to encourage more living donor transplants, b) focused effort for public education on recipient safety and improved outcomes with living donation and c) focused effort on public education about resources to minimize financial barriers to living donation (NLDAC). 4) Goal 4 recommendations include removal of one proposed initiative and revisions of other proposed initiatives. 5) A change in resource allocation for Goal 3 and Goal 4 is not needed. 3. Are there goals or initiatives that should not be included in this plan? If so, should they be maintained in the OPTN’s future operations or discontinued altogether? See above comments in Goal 4 that Initiative 1 “include recipient longevity in transplant center metrics” should be removed from the strategic plan and discontinued permanently. 4. Are the stated performance metrics sufficient, measurable, and specific? A. Goal 1 Metrics: Yes B. Goal 2 Metrics: Yes C. Goal 3 Metrics: We recommend revision to add metrics for the additional initiatives of increasing public education about living donor safety and recipient safety, improved outcomes with living donation, and availability of NLDAC resources for living donors. Add the key metrics: 1) “Promote education to increase the number of living donor transplants performed annually.” 2) “Promote education to increase applications to NLDAC for support of living donors.” D. Goal 4 Metrics: We recommend revision. 1) Goal 4 Key metric to 1) reduce waitlist mortality is appropriate. 2) We recommend removal of the following two key metrics 2) increase 1- and 5-year graft and patient survival rates respectively. The 1-year graft survival rate for some organs are already extraordinarily high that it is not reasonable or realistic to establish this as an initiative. Until the biologic and other factors responsible for chronic rejection are identified, it is not reasonable to establish a metric of increased 5-year graft and patient survival. Instead, OPTN resources to support research grants investigating the causes of chronic rejection and late graft losses should be allocated and communicated as “Request for Applications” to the transplant community. Add the metric: a) Increase research funding that will enhance innovations to increase the longevity of transplanted organs

Anonymous | 03/23/2021

OPTN Executive Committee presented by David Mulligan, MD, FACS Comments: One member stated increasing number of transplants is great, but increasing number of living donor transplants overall should be a separate sub-goal and not just part of KPD. Another member stated that from the POC perspective, they went through the process of creating strategic policy priorities and POC will be able to align strategic policy priorities with the strategic plan in a more sequenced manner. POC was pleased to see increasing efficiency goal being folded into increasing transplants. This work of the strategic plan will help POC align the policy portfolio. One member commented that there is nothing more draconian as holding one-year survival as the most important metric. It does not make sense that mortality (for any cause) is included in the post-transplant metrics for transplant programs. This needs to change. Need a more reasonable and rational way to approach evaluating and benchmarking transplant outcomes. Addressing this misalignment will result in more transplants by removing fear that your program will be shut down or flagged for not meeting specific regulatory requirements. Region 1 sentiment: 4 strongly support, 3 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/23/2021

Members questioned the rationale of combining Goals #1 and #3. Members were concerned that combining these two goals will lose focus on efficiency. Members discussed the interconnection of Goals #1 and #2 in which an increase in transplants would occur if there was a greater focus on equity and access to transplantation across all populations, specifically those who have been underserved. A member commented that presumably the increase in transplantation will decrease waitlist mortality so why is that not a primary metric within the Strategic Plan. Although the metric is within Goal #1, it is not enough of an emphasis. Ultimately, the OPTN needs to remember that transplant centers have an obligation to patients as soon as they are placed on the waitlist. However, the focus of all the metrics is on outcomes while ignoring the obligations for patient care during the process of receiving an organ transplant. Members were concerned over the 30% dedication to equity, articulating that it does a disservice to the transplant community by limiting resources available for equity focused projects. Another member added that the vast majority of transplant metrics are connected to Goal #4, while the goal holds only 10% of the focus on the Strategic Plan. Thus, the remaining three goals of the Strategic Plan are unattainable for members to accomplish. Members vocalized that the OPTN should focus on quality of transplants, not merely quantity of transplants and members were concerned about outcomes. Members shared concerns about their ethical obligations to their patients ensuring that they were making the best medical decisions for the individual and not making decisions based on the OPTN Strategic Plan. Ultimately, a member shared that due to the practical implications of the OPTN Strategic Plan this needs to be a constant conversation and not a static decision.

OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) | 03/23/2021

The Ad Hoc Disease Transmission Advisory Committee (DTAC) appreciates the opportunity to review this proposal. The DTAC recognizes the importance of the new Strategic Plan and notes the alignment of DTAC work in reviewing cases of potential disease transmission with the Strategic Plan Goal 3: promote living donor and transplant recipient safety.

American Society of Transplantation | 03/22/2021

The American Society of Transplantation is supportive of the proposed 2021-2024 strategic plan. The Society is supportive of working on goals that increase efficient matching and continuous distribution but also believes that increasing living donation should be an area of focus. Focusing only on increasing deceased donation may not result in improved outcomes or increased overall transplant volume. The collective goal should be about increasing access to transplantation for all. In response to the specific questions posed by the Executive Committee: 1) Do you agree with the Board’s proposed areas of strategic focus for the 2021-2024 plan? The ID COP agrees with the Board’s proposed areas of strategic focus. Increasing the number of transplants, and improving equity, safety, and outcomes of transplantation are important goals. We especially want to emphasize a) the importance of increasing collaboration and performance improvement activities between OPOs and transplant programs as part of Goal 1, and b) improving equity in access to transplantation in racial minorities, patients of lower SES, and patients with geographic limitations. To that end, we include feedback under question #2 below. 2) Is a goal or initiative missing from this plan that should be considered a strategic priority? Will resource allocation benchmarks need to be changed to accommodate the addition? Under Goal 1, we feel that there should be specific incentives to encourage increased collaboration between OPOs and transplant programs. The wide variability of approaches depending on region is something we feel needs to be tackled as a strategic priority. Actually having incentives in place to reduce this variability by encouraging the sharing of best practices and joint performance improvement activities between OPOs and transplant programs would be important. We also feel there should be more specific emphasis on ways to improve equity in access to transplantation in racial minorities, patients of lower SES, and patients with geographic limitations. To understand the barriers to access and implement solutions will need to involve specific resource allocation. 3) Are there goals or initiatives that should not be included in this plan? If so, should they be maintained in the OPTN’s future operations or discontinued altogether? We feel all the goals and initiatives included in this plan are important and do not feel any should be removed. 4) Are the stated performance metrics sufficient, measurable and specific? The stated performance metrics are measurable and specific. We should ensure that the implementation of projects to achieve these metrics are given the resources they need to make sure UNOS is successful in achieving these important goals. We appreciate the focus on efficiency and equity over the next 3 years. It is understood that the OPTN is not seeking efficiency at cost of safety/outcomes. Specific feedback on the individual goals, include: GOAL 1 • The alignment of goals and metrics between OPOs and transplant programs will not happen without increasing transplants. We must ensure the accountability of both sides is aligned and enforced to help the transplant community achieve this goal. This might be achieved by implementing incentives and outcomes metrics, oversight, and accountability. • The initiatives listed focus on increasing deceased donor transplants. In addition to increasing utilization of deceased donor organs, promoting living donation has to be a key ingredient of policy aimed at increasing overall transplantation. Initiatives in this direction, for example, educating wait-list patients on using social media as a tool to help find living donors, should be included. • OPTN should consider a mentorship program where programs with a data proven track record of high acceptance rates and good outcomes could invite programs who wish to improve their numbers to have them spend a few days with the mentor program to learn what practices have led to their success. • We support the need to develop transplant center metrics that go beyond 1-year graft survival. As has been proposed before, this is key to maximizing utilization of “less good” kidneys including high KDPI. • We concur with the resource allocation for this goal, as the initiatives carry a substantial amount of effort, time and work force. The initiative for the development of transplant center metrics (beyond one-year outcomes) parallels work done over the last few years in both KPCOP and TCCCOP. There have been two AST consensus conferences (one in kidney and now one in heart) working on this issue. The Society agrees with working collaboratively with transplant centers, OPTN, AOPO, individual OPOs, AST and other transplant societies to identify strategies to improve interactions between OPO’s and transplant centers to improve the number of transplants performed. • We agree it will be beneficial to evaluate system efficiency in order to increase organ utilization using a number of unique approaches. GOAL 2 • We ask that this goal include an effort to improve equity for pediatric candidates. • Make sure there is an adequate representation of non-academic transplant centers with OPTN. • We ask that the practice of creating policies based on broad perspectives from a varied group of advisors, volunteers to assure equitable access across all patient populations be continued and expanded, including adequate representation of non-academic transplant centers. GOAL 3 • We concur with initiatives directed at decreasing waitlist mortality, increasing one-year graft and patient survival and increasing 5 year graft and patient survival rates. GOAL 4 • We would suggest that these metrics include a key metric pertinent to living donor outcomes as well.

OPTN Liver & Intestinal Organ Transplantation Committee | 03/22/2021

The OPTN Liver and Intestinal Organ Transplantation Committee appreciates the opportunity to comment on the 2021-2024 OPTN Strategic Plan. The Liver Committee asks the Executive Committee to monitor strategic plan goals to ensure that they do not compete. The Liver Committee noted that programs focused on their outcomes may be discouraged to use higher risk organs and therefore unintentionally decrease the number of transplants. The Liver Committee suggests the Executive Committee revise the goal allocation for goal 2, as Continuous Distribution will likely take more than 30% of overall efforts. Some committee members expressed support for the goals of the strategic plan, as they acknowledge the community’s concerns and encourage discussion.

Paragonix Technologies, Inc. | 03/22/2021

As the Co-Founder, President, and CEO of Paragonix Technologies, Inc. I respectfully submit this comment on behalf of the company in response to the proposed OPTN/UNOS Strategic Plan for 2021-2024. Paragonix Technologies, Inc. is a medical device company headquartered in Cambridge, MA, that designs, produces, and markets organ transportation devices that safeguard human organs intended for transplant during the journey between the donor procurement facility and the transplant recipient center. The use of mechanical transport support has increased significantly in recent years underpinning the need for OPTN/UNOS policies to adequately reflect the growth in their development and utilization. Paragonix is supportive of the OPTN/UNOS Strategic Plan in principle, specifically as it relates to Goal #1: Increase the Number of Transplants, Item #4: Review policies to determine whether future changes will be necessary to encourage or facilitate machine perfusion of organs, however, requests clarification of the intentional change in wording of the term – “mechanical preservation” – in Goal #1, Item #4 (a term used in OPTN Policies 16.3.B., 16.3.E., 16.3.E.ii., and 16.3.F.) to “machine perfusion” and recommends retaining the original terminology, “mechanical preservation,” to accommodate the full range of preservation devices currently available on the market. Furthermore, utilizing a more broadly stated term such as “mechanical preservation” is 1) consistent with the general terminology used in the 2020 Consensus Statement of the International Society for Heart and Lung Transplantation [“ . . .new technologies for packaging to prevent freezing.”] and 2) allows for the inclusion of transport devices currently cleared by the FDA and those in the future that rely upon preservation methods other than perfusion. Similarly, Paragonix recommends the proposed metric for Goal #1 (Metric #7: An increase in the number of transplants of machine perfused organs) have conforming language to the recommended language for Goal #1 to avoid confusion, remain consistent with existing OPTN/UNOS policies, and for the reasons stated above. This will ensure Goal #1 and Metric #7 reflect the breadth of innovative approaches to mechanical preservation devices currently on the market and those that will be introduced over the next three years during the span of the strategic plan. Paragonix appreciates the opportunity to comment on the OPTN/UNOS Strategic Plan and welcomes collaborating with the OPTN/UNOS to achieve this goal and assess new technologies that optimize organ preservation.

Colleen O'Donnell Flores | 03/22/2021

We know that the racial makeup of our current transplant waitlists do not match the racial makeup of the disease. If provided additional benchmarking data, transplant programs could increase equity in access to transplant (Goal #2). Specifically, there is data within the SRTR Program Specific Report which compares the ethnic/racial distribution of a program’s waitlist to the distribution within the region and nation (Table B2. Demographic characteristics of waiting list candidates). However, it is not linked to the prevalence of the disease. In many parts of the PSR, programs have ‘expected data’ which are utilized to benchmark. We are missing this expected value in the ethnic/racial breakdown of the waitlist. We need additional ethnic/racial data to help us identify gaps in waitlist distributions thereby supporting the goal of the OPTN.

NATCO | 03/22/2021

NATCO thanks the Executive Committee for including the OPTN Strategic plan in public comment. NATCO supports the proposed plan including the suggested benchmarks with Goal 1 far outweighing the other 3 goals. Including initiatives such as defining a process for expediting offers will increase efficiency and placement of organs that would otherwise not get utilized. To help meet the goals, some work may need to be done on further defining the key metrics supporting the initiatives. While the metrics are specific, many are not measurable as written. Additionally, NATCO suggests including initiatives and metrics separately for pediatrics under Goal 1 since pediatrics are different with unique needs.

National Kidney Donation Organization | 03/22/2021

The National Kidney Donation Organization (NKDO) is commenting specifically on Goal 1.5, “Increase the Effectiveness of Paired Living Donation Programs”. The single most effective way in which the number of transplants can be markedly and immediately increased is by requiring transplant centers to properly and fully inform living donors and patients of the different modalities of donation available throughout the transplant system, and then let those individuals make an informed decision of the trade-offs as they relate to the individuals’ specific circumstances. This may best be illustrated by an example of a case we had this past week and is typical of the situations we deal with every day. A patient in need of a transplant is registered at transplant center #1. The male patient is 99% PRA. The patient has several people who want to be tested to donate to him. Given his level of sensitization and the fact that center #1 will only test one donor at a time as a potential direct match, the patient has been months awaiting these tests for his donors and the likelihood of a given donor being a direct match is extremely slim. Center #1 does not tell the patient or the donor candidates that there is another mode of donating, the standard voucher donation. As a voucher donor, the donor candidate does not need to be a match for the patient. By donating as a voucher donor, the donor candidate starts a chain just as a non-directed donor does, thereby taking multiple patients off the waiting list. Upon donation, the voucher is activated for the patient, who becomes the last recipient in a subsequent chain. NKDO has facilitated numerous voucher donations and in our experience every voucher recipient has received a transplant within 12 weeks of the voucher donation. This is not guaranteed, and some cases will take longer, but this is our experience. Because a center that performs voucher donations, center #2, is a plane ride away from the patient’s home near center #1, this patient has to decide if traveling to another center is the right thing for him. In this case, it was an easy decision for the patient given his level of sensitivity. After being informed of his options, he is transferring to center #2. If the patient is not nearly as sensitized and has circumstances that suggest a direct match may occur in a reasonable time frame, staying with center #1 may be the preferred option. But a patient who is ignorant of the options because the transplant center chooses not to inform him is a patient who is ill-served by the professionals who have, at the least, a moral obligation for full disclosure. If the transplant centers will properly disclose the relevant facts about the different modes of donation, the industry will see a marked increase in the number of transplants.

View attachment from National Kidney Donation Organization

Morrison Stepp Jr | 03/22/2021

I’ve been on the list for 2 years with no exception points but 8-9 weeks a year in hospital for infection of the bile ducts. We need more exceptions points for this type of issue.

Transplant Coordinators Committee | 03/19/2021

The Transplant Coordinators Committee thanks the Executive Committee for presenting its proposal “2021-2024 OPTN Strategic Plan” and offers the following feedback: Members feel that the goals are focused and clear with concrete reasoning on combining Goal 1 and Goal 3. In addition, the Policy Oversight Committee (POC) initiatives, specifically the aim of broader distribution, will help keep the OPTN in alignment with the Strategic Plan moving forward.

Anonymous | 03/19/2021

The Vascularized Composite Allograft (VCA) Transplantation Committee appreciates the opportunity to comment on the proposed 2021-2024 OPTN Strategic Plan. The VCA Committee supports the goal to increase the number of transplants but notes that reimbursement for VCA transplants remains a challenge for expanding the number of institutions that perform these transplants. While payment issues fall outside the scope of the OPTN’s purview, the VCA Committee will continue its work to align policies and practices for VCA with those of other organs to promote growth in the field. The VCA Committee will monitor data collection on VCA recipients and refine it as needed to assess meaningful patient outcomes in terms of health and function, as these data can also help support growth in the field. The VCA Committee looks forward to working with the OPTN to increase these life-enhancing transplants.

Kidney Transplantation Committee | 03/18/2021

The Kidney Committee appreciates the opportunity to provide feedback on the 2021-2024 OPTN Strategic Plan and supports the proposal. The Committee does provide the following comments from members: the broader goal of increasing living donation should address all kinds of living donation, and not focus just on kidney-paired donation. The metrics proposed are measureable and specific, but there should be some consideration towards revised benchmarks for membership and professional standards flagging criteria, particularly with removal of DSA for kidney and pancreas allocation.

Region 11 | 03/18/2021

Region 11 sentiment: 1 strongly support, 10 support, 1 neutral/abstain, 0 opposed, 0 strongly opposed During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. One attendee commented that the OPTN has two competing objectives; one is increase DCD utilization and the other is to improve outcomes. They went on to site data on the number of liver transplants, discards and expected one year survival rates commenting that if there were lower expected outcomes, the community would save more lives by allowing centers the leeway to go after high risk donors. They also commented that centers are reluctant to go after high-risk organs and list higher risk patients due to concern about outcomes.

Claudia Amendola | 03/18/2021

Strongly Support

Living Donor Committee | 03/17/2021

The Living Donor Committee thanks the OPTN Executive Committee for their efforts in developing this public comment proposal, 2021 – 2024 OPTN Strategic Plan. The Committee requests clarity on sub-metric No. 2 under Goal 4: “evaluate effective methods for assessing living donor outcomes”. Currently, the OPTN conducts short-term living donor follow-up (at 6, 12, and 24 months post-donation). It does not assess living donor outcomes (long-term implications). The Committee requests that the OPTN Executive Committee bring clarity to Submetric No. 2 about methods for assessing living donor outcomes. Clarity would assist the Living Donor Committee's development of projects in furtherance of this important Goal. In the same way that sub-metric No.2 seeks to prioritize longevity of recipients, sub-metric No. 1 emphasizes the importance of living donor health over the long-term. The Committee supports that emphasis and looks forward to contributing to the achievement of Goal No. 4. The Committee observes that there are sub-metrics related to education and tools for programs and recipients. The Committee requests specific sub-metrics related to education and tools for living donors. Education about living donation is directly connected to living donor outcomes, discussed above, and to Goal No. 2, improving equity in access to transplantation. The Committee enthusiastically supports the objective of improving equity in access to living donor transplantation. The Committee requests that the OPTN Executive Committee clarify the intent and significance of each goal’s weight. The purpose of such clarification is to ensure that readers - patients, donors, and their families and friends - do not perceive that the weight assigned to Goal No 3 - "Promote Living Donor and Transplant Recipient Safety (10%)" - reflects that a relatively small percent of the OPTN focus is on their safety. This clarity should be in the four corners of the document to avoid any misimpression. Patient safety is, of course, paramount to all, and so the presentation of the weighting should make its meaning clear. Finally, the Committee highlights the inherent challenge of encouraging, at once, utilization of organs of poorer quality and having metrics regarding recipient longevity. The former leads to the potential of resulting lower graft function. The Strategic Plan should recognize and speak to the inherent tension of the two objectives; each has strong merit when standing alone, but when joined create unavoidable tension. The Committee appreciates the chance to review the Plan and the Executive Committee's consideration of our feedback.

Ad Hoc International Relations Committee | 03/17/2021

The Ad Hoc International Relations Committee thanks the OPTN Executive Committee for their efforts in developing this public comment proposal, 2021 – 2024 OPTN Strategic Plan. The Committee supports this proposal. The Committee requests further evaluation on the metric regarding transplant program organ utilization. The Committee suggests holding transplant programs accountable for utilizing available organs, in order to increase the number of transplant. The Committee also requests metrics regarding multi-organ transplant outcomes to be developed.

OPTN Operations & Safety Committee | 03/12/2021

The Operations and Safety Committee thanks the OPTN Executive Committee for their efforts in developing this public comment proposal, 2021 – 2024 OPTN Strategic Plan. The Committee supports this proposal. The Committee suggests that benchmarking and timely process improvement should be emphasized as a goal. The Committee supports for adding efficiency into increased number of transplants, considering the future of increased organ travel. However, the Committee expressed concern over how to determine increased efficiency given the complicated nature of broader sharing, as well as taking into consideration that increased number of transplants does not necessarily equate to increased efficiency.

Region 7 | 03/12/2021

Region 7 sentiment: 4 Strongly Support; 4 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. There was discussion around the time frames and over-all OPTN factors. The strategic plan was largely supported.

Region 6 | 03/09/2021

Region 6 sentiment: 3 strongly support, 23 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Overall the region supported the proposal. A member commented that increasing access for candidates is important, but so is addressing barriers to being listed for transplant. Another member commented that in terms of metrics, it would be nice to include quality-adjusted life years (QALYs) in the assessment of outcomes.

Stephanie Little | 03/09/2021

Appreciate the Board of Directors providing a draft Strategic Plan for review. Overall, I support the initiatives. There are some areas in which clarification, additions, or changes could help better suit the patient population. First, patient’s would benefit greatly from additional education on transplant as a whole, with a focus on items that directly impact their daily live (e.g., waitlist). Along with this piece includes the need for a glossary that is patient-friendly. Acronyms are helpful for professionals, and may aid patients after they become familiar, but it is a lot of information at once. A glossary with more detail that what is already provided (or one catered to their situation, such as a heart transplant glossary) should be included in their packet when they meet with their transplant center (as well as made available online). Patients should be more involved in the process, which could be done through extended calls of patient guidance throughout the year (instead of just at public comment) and through the Patient Affairs Committee. For diversity, there needs to be a concentrated effort to increase diversity throughout the committees, boards, workgroups, etc. However, diversity must also include different backgrounds and areas of residence. Rural communities needs more representation at the table, as do Native Americans and those able to communicate the needs of rural populations and Native American reservations. Instead of eliminating positions within UNOS if a spot is filled, add more spots for diverse members that may not necessarily fit a specific pointed role, but can at least provide valuable insight and perspective. Increase committee sizes by 1-2 slots. Embrace a mentorship program that encourages members that may otherwise feel intimidated (e.g., patients, donor family members, etc.) to have someone there to walk alongside with them.

OPTN Organ Procurement Organizations Committee | 03/09/2021

The OPO Committee appreciates the opportunity to provide input on the 2021-2024 OPTN Strategic Plan. Committee members provided the following comments: Include more initiatives focusing on allocation efficiency, particularly identifying transplant center responsibilities as OPOs work to increase the number of DCD donors and attempt to place marginal organs. Ensure that transplant centers thoroughly evaluate offers pre-recovery in order to cut down on post-clamp cold time. DCD donors often have a significantly s allocation timeframe due to family constraints, and that rapid, thorough evaluation is critical to placing DCD organs effectively. More emphasis given to placement of marginal kidneys that most centers would not accept. Address transplant center and OPO communications and collaboration in efficient organ placement. More clarity on programming and development timelines to better understand UNOS IT capacity and project statuses.

Region 8 | 03/09/2021

Region 8 sentiment: Strongly support-4, Support–10, Neutral/abstain-, Oppose-0, Strongly oppose-0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. A member commented that with recent negative press in the OPO community, it would be beneficial for HRSA and CMS to have an aligned understanding of the work that is being done. Another member commented that there is a potential of an increased burden of reporting in goal 3 and that they support getting more patients transplanted but the risk for bad patient outcomes needs to be considered.

OPTN Data Advisory Committee | 03/09/2021

The Data Advisory Committee supports the strategic plan as drafted. A member commented that the goals presented are strong, smart, and achievable. The DAC can uniquely support the goal to increase equity in access to transplant as well as promote the equitable allocation of organs through data initiatives, especially those relating to the identification of pre-waitlist disparities. The DAC recommends prioritizing systematic improvements that promote robust and valid data collection, as meaningful data is essential for furthering all OPTN initiatives.

OPTN Pancreas Transplantation Committee | 03/08/2021

The Pancreas Committee thanks the OPTN Executive Committee for the opportunity to review their 2021 – 2024 Strategic Plan update. The Committee agreed that the outlined goals are straightforward and the proposed performance metrics are a good starting point. The Committee provides the following feedback: There was a suggestion to having pancreas procurement surgeons being present at the time of transplant to increase the yield of usable transplantable pancreata. This could be a potential project idea for the Committee that aligns with the goal of increasing the number of transplants. It was pointed out that the goal of improving duration of transplant only accounted for 10% of the Strategic Plan. A member inquired if the OPTN is potentially sacrificing medium to long-term outcomes in order to increase the number of transplants. For example, if we know what the pancreas or kidney graft half-life is, but only measuring 3 year statistics then there is almost no accountability for time after 3 years. This poses a question of utility in the system and it was suggested that this should be emphatically stated.

Organ Transplant Awarenss Prog | 03/08/2021

Goal 2 Increase equity in transplant opportunities. I believe there should be a focus in on the State of New Mexico where candidates must travel out of state for organs except kidney and pancreas. This a burden for a state where approximately 75% of the candidates are minorites and many candidates come from rural areas.

OPTN Transplant Administrators Committee | 03/05/2021

The Transplant Administrators Committee appreciates the opportunity to comment on the 2021 – 2024 Strategic Plan. Overall, the members support the plan. A member commented that they support the efforts to increase the diversity of the Board of Directors and committee members as well as initiatives relating to increasing equity in access to transplant.

Anonymous | 02/25/2021

ANNA supports this proposal; however, we recommend an addition to Goal 1 to increase the number of living donor kidney transplants to increase the total number of transplants.

Policy Oversight Committee | 02/24/2021

The Policy Oversight Committee (POC) appreciates the opportunity to comment on the proposed 2021-2024 OPTN Strategic Plan. Of the three strategic policy priorities previously identified by the POC, the efficient matching policy priority aligns with the strategic plan goal to increase the number of transplants (Goal 1), and the continuous distribution and multi-organ transplantation policy priorities align with the strategic plan goal to provide equity in access to transplants (Goal 2). Members believe that living donation is a key mechanism by which the OPTN can increase the number of transplants, particularly kidney transplants, and recommend placing a higher emphasis on increasing the effectiveness of all living donation programs, rather than just paired living donation programs. A member suggested that increasing the number of transplants in of itself may not be the right goal if it dampens the volume of living donation, as this may not improve quality and access for the whole population of candidates. Accordingly, the member recommends that the OPTN evaluate how increases in deceased donation impact living donation. A member noted that efficiency is a significant problem in the current allocation system and should continue to be addressed under the goal to increase the number of transplants (Goal 1). The POC appreciates that the strategic plan will provide guidance to the POC for prioritizing OPTN work. The POC also plans to use the strategic plan as a guide for developing future strategic policy priorities, once more progress has been made in the current strategic policy priorities.

Region 5 | 02/19/2021

Region 5 sentiment: 10 strongly support, 20 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. No comments or questions

Region 3 | 02/18/2021

Region 3 sentiment: Strongly support-1, Support-15, Neutral/abstain- 4, Oppose -0, Strongly oppose - 0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. One member recommended that the priority should be to develop system wide aligned metrics that measures the interactions between OPOs and Transplant centers with a focus on increased transplants overall as the top priority.

Anonymous | 02/11/2021

There is a common theme surrounding efficiency and outcome improvements. I'm curious if there is a workgroup looking at the development of access to EMR's by developing API's that would enable OPOs and Tx's quicker access to deceased and living donor medical records?

Anonymous | 02/10/2021

There remains tremendous opportunity to improve and standardize donor management for the purposes of increasing organ utilization and transplants. UNOS/OPTN has been uniquely positioned to promote/support much needed research in the field of donor management but has sadly lacked the ambition to broaden its scope to include this. I wholeheartedly agree that the primary goal should be to increase transplants but there must be a research initiative to facilitate this goal. No other organization is positioned to coordinate and support this type of research. Why not make quality research a focus of UNOS/OPTN? Why the lack of ambition?

Region 4 | 02/04/2021

Region 4 sentiment: 7 strongly support; 11 support; 0 neutral/abstain; 0 oppose; 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee encouraged the DTAC to approach the CDC about the challenges presented by the 10-year living donor sample storage requirement. Another attendee commented that the OPTN should consider looking at the financial burden from the wider allocation strategies, which can eventually result in transplant program closures, transplant team burnout with no significant clinical impact. This attendee also recommend more oversight and data collection in transplant center practices regarding liver transplants for alcoholic hepatitis.

Kidney Donor Conversations | 02/03/2021

As a nonprofit that provides education and support for living kidney donation, we have specific concerns there is not any focus in the 2021-2024 OPTN Strategic Plan to increase the number of living kidney donors, especially since this provides the best patient outcomes for those with ESKD (End Stage Kidney Disease). Providing public awareness about Living Kidney Donation should be a high priority now. This focus could also help to discover more non-directed donors, which in turn helps the most number of people on the kidney transplant waiting list by starting chains. If OPTN wants to increase the number of successful kidney transplants and help people live longer, it is time to stop the silence of living kidney donation and focus actions on this important public outreach initiative.