Comments

Response to Representative Buetler letter | 10/16/2019

A PDF VERSION OF THIS COMMENT IS AVAILABLE UPON REQUEST FROM MEMBER.QUESTIONS@UNOS.ORG. THIS LETTER IS DATED OCTOBER 1, 2019. IT WAS RETROACTIVELY ADDED TO THE PUBLIC COMMENT RECORD FOR THIS PROPOSAL ON OCTOBER 16, 2019. October 1, 2019 The Honorable Jaime Herrera Beutler U.S. House of Representatives Washington. DC 20515 Dear Representative Herrera Beutler: Health Resources and Services Administration Rockville. MD 20857 Thank you for your July 29, 2019, letter to the Health Resources and Services Administration (HRSA) and for your interest in how the current kidney allocation policies may affect pediatric organ transplant recipients. After receiving your letter, we directed the United Network for Organ Sharing (UNOS) to respond to your specific questions (see enclosure). Congress enacted the National Organ Transplant Act of 1984, as amended (NOTA), to establish the Organ Procurement and Transplantation Network (OPTN) and directed it to operate by contract. The OPTN is primarily responsible for establishing organ allocation policy with oversight by the Department of Health and Human Services. Accordingly, as per statute, HRSA contracts with a non-profit private entity, the United Network for Organ Sharing, to administer the OPTN. NOTA requires the OPTN to "recognize the differences in health and organ transplantation issues between children and adults throughout the system and to adopt criteria, policies, and procedures that address the unique health care needs of children." 42 U.S.C. 274(b)(2)(M). As such, HRSA and the OPTN take their obligation to monitor pediatric transplant candidates and their individual needs very seriously. The OPTN continues to monitor how kidney allocation scores impact pediatric kidney transplant candidates as well as other demographic groups. OPTN allocation policies are continuously under review, and revisions are made, as necessary. OPTN approved an update to the kidney allocation policy regarding the use of kidneys procured from small pediatric donors, which is scheduled to be implemented in September 2019 and is expected to benefit pediatric kidney transplant candidates. In addition. a proposal to modify kidney allocation to address geographic disparities, which was recently developed by the OPTN Kidney Transplantation Committee and published for public comment (https://optn.transplant.hrsa.gov/governance/public-comment/eliminate-the-use-of-dsa-and­ region-in-kidney-allocationp- olicyD. includes proposed changes to increase priority for pediatric kidney transplant candidates. HRSA encourages anyone with an interest in this issue to submit comments to the OPTN as part of the public comment process. The public comment period closes on October 2, 2019, and the OPTN public comment page is at https://optn.trans.plant.hrsa.gov/governance/public-comment/. We have submitted your letter to the OPTN for inclusion in the record of its consideration of the proposed policy, as part of the pending public comment process. The Honorable Jaime Herrera Beutler Page2 I hope that the enclosed responses provide sufficient information to answer your questions regarding the current Kidney Allocation System and pediatric kidney transplantation. If you or your staff have any questions, please feel free to contact Leslie Atkinson, Director of the Office of Legislation, at 301-443-1890. Sincerely, Thomas J. Engels Acting Administrator Enclosure Responses from the United Network for Organ Sharing to Questions from Representative Herrera Beutler 1. Since the enactment of KAS, have wait times for kidney transplant increased or decreased for children? Response: The Kidney Allocation System (KAS) went into effect on December 4th, 2014. The table below is a recent analysis comparing median waiting time (MWT) pre- and post-KAS implementation. For all pediatrics, the median waiting time did increase under KAS, though no statistical significance testing was performed. It’s also worth noting that the number of pediatric registrations overall increased post-KAS as well. Candidate Age Group KAS Era N of Registrations Median Waiting Time (Days) 0-5 Pre-KAS 845 1005 0-5 Post-KAS 915 * 6-10 Pre-KAS 642 879 6-10 Post-KAS 707 895 11-17 Pre-KAS 2452 680 11-17 Post-KAS 2533 790 All Pediatrics Pre-KAS 3939 774 All Pediatrics Post-KAS 4155 993 Adults Pre-KAS 143430 * Adults Post-KAS 146598 * *These values cannot be computed because less than 50 percent of registrants have received deceased donor transplants. There are several reasons why calculating MWT for pediatric candidates can be especially difficult and thus produce unreliable results. First, MWT calculation can use competing risk methods that do not account for some reasons why a candidate may be removed from the waiting list, including for receiving a living donor transplant. Because living donors among pediatric recipients is high, this can potentially lead to challenges calculating MWT. • Have wait times increased or decreased for adults? Response: MWT for adults is not estimable (shown with a ‘*’ in the table above) given that at least 50% of adult candidates in each cohort have not received deceased donor kidney transplantation. 2. Since the enactment of KAS, have rates of delayed graft function (DGF) increased or decreased for pediatric recipients? • Have rates of DGF increased or decreased for adults? Response: Though overall delayed graft function DGF rates (for pediatric and adult kidneys combined where the recipient requires dialysis within the first week of kidney transplant) increased immediately following the implementation of KAS, these rates have since mostly decreased to levels observed pre-KAS. The overall DGF rate was 23.3% in December 2013 (one year prior to KAS implementation) and as of September 2018, the overall DGF rate stood at 25.5%. No statistical significance testing was performed to determine which changes are statistically significant. Pediatric DGF rates remain much lower than adults. The table below illustrates the effects on DGF rates by age group for pre-KAS and post-KAS implementation. For further reference, a study was recently published regarding DGF in the pediatric population pre- and post-KAS: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6029615/. 3. Since the enactment of KAS, how has the proportion of pediatric donor kidneys that are being received by children changed compared to before KAS? Response: The OPTN calculates that the mean donor age for pediatric recipients was 24 years in the 2nd year post-KAS compared to a mean donor age of 22 years pre-KAS. Post-KAS, 90% of pediatric recipients nationwide received a kidney from a donor ? 35 years old, compared to 99% pre-KAS. Furthermore, OPTN en bloc kidney policy, currently slated for implementation in Q3 of 2019, will prioritize pediatric candidates for kidneys with greater longevity, which have Kidney Donor Profile Indexes (KDPI) of 20 percent or lower. This is because this policy will ignore the KDPI for allocation of very small pediatric donor kidneys that will be transplanted together, or “en bloc.” En bloc kidney transplantation was not previously addressed in OPTN policy. Because these kidneys have greater projected longevity, pediatric recipients will have priority for these kidneys. 4. Under the current policy, why are pediatric donor kidneys not allocated to pediatric patients? Response: Many pediatric donor kidneys, specifically those with a KDPI less than 35%, are prioritized for pediatric candidates under current policy in KAS. Research has shown that donor kidneys from younger pediatric donors have shorter longevity than kidneys from middle-aged adult donors.1 This is due in part to these smaller pediatric donor kidneys having a significantly smaller renal mass. Therefore, during the development and implementation of KAS, pediatric priority was changed in order that pediatric candidates would receive kidneys with the greatest longevity, recognizing that KDPI has stronger association with graft longevity than donor age alone. Therefore, pediatric priority was changed from “donor age less than 35 years” to “donor kidney KDPI less than 35%.” 5. What are the rates of deceased donor transplants and living donor transplants among pediatric recipients pre-KAS and post-KAS? Response: Based on data presented to the OPTN Kidney Transplantation Committee in early 2018, almost 40% of pediatric kidney-alone transplants nationwide were due to living donor kidney transplantation between December 4, 2016 and December 3, 2017 (the 2nd year post- KAS).2 This did not change from the year immediately preceding KAS. 6. Has there been a change in transplant rates for highly sensitized pediatric recipients since the implantation of KAS? If yes, what is the impact of this change? Response: Yes. The transplant rate for highly sensitized candidates, specifically for Calculated Panel Reactive Antibodies (cPRA) 99% and 100% candidates, increased dramatically under KAS. These results apply to all highly sensitized candidates. Pediatric candidates are much less likely to be highly sensitized, and therefore that candidate cohort is small, making results difficult to evaluate. Only 11 pediatric candidates in the first two years of KAS implementation had a cPRA of 99 or 100 percent. The transplant rate for candidates with a cPRA of 99% increased from 0.1 in the year preceding KAS implementation to 0.3 in the second year post-KAS implementation. The transplant rate for candidates with a cPRA of 100% increased from 0.03 in the year preceding KAS implementation to 0.3 in the second year post-KAS implementation. Post-KAS implementation data (through two years) can be found here: https://unos.org/wp- content/uploads/unos/KAS_First-two-years_041917.pdf 1 Rao, P. S., Schaubel, D. E., Guidinger, M. K., Andreoni, K. A., Wolfe, R. A., Merion, R. M., ... & Sung, R. S. (2009). A comprehensive risk quantification score for deceased donor kidneys: the kidney donor risk index. Transplantation, 88(2), 231- 236. 2 Meeting Summary for January 8, 2018 meeting. OPTN Kidney Transplantation Committee, https://optn.transplant.hrsa.gov/media/2419/kidney_meetingsummary_20180108.pdf (accessed July 31, 2019). Subsequently, transplant rates for lower cPRA candidates decreased, as a finite number of kidneys are allocated each year. This means that as a direct result of higher cPRA candidates being allocated more organs, candidates with lower cPRAs were allocated fewer organs. 7. Was the Kidney Donor Profile Index (KDPI) metric developed and validated only in donors over 18 years of age? Response: The Kidney Donor Risk Index (KDRI) was not developed and validated in adult donors only. The KDRI (and its derivative, the Kidney Donor Profile Index (KDPI)) was developed using all donors, not just donors over age 18. That said, the KDRI was developed only on recipients age 18 or older, so it was not developed including pediatric recipients. • If yes, what are the potential flaws in application of an adult donor metric to pediatric donors? Response: The KDRI is not an adult donor metric since it was developed on a population of both pediatric and adult donors and can be applied to both. But since it was developed to assess outcomes in an adult recipient population, not a pediatric population, refinements may be possible to improve performance of a kidney scoring system for pediatric recipients. A report estimated that KDPI>=35% kidneys conferred a 1.28 increased risk of graft failure compared to KDPI 34% kidneys. 10. It is my understanding that the best pediatric donors have a KDPI of under 35, which is typically found in multi organ donors. Under KAS, are multi organ donor transplants prioritized over pediatric transplants? Response: Yes, multi-organ recipients (e.g., liver-kidney, kidney-heart, and kidney-pancreas) are prioritized over all candidates on the kidney-alone waiting list. Because pediatric candidates can receive multi-organ transplants, these candidates would receive the same priority over all kidney alone candidates, including other pediatrics. This policy has been in place since for nearly three decades and did not change with the implementation of KAS. Regardless of donor age, a component of KDRI, a lower KDPI indicates a lower risk of post- transplant graft failure. In an analysis prepared in response to a data request from the OPTN Ethics Committee in 2018, recipients of multi-organ transplants involving a kidney typically receive a kidney of lower KDPI than recipients of a kidney-alone transplantation due to their absolute priority in allocation.5 • If yes, what has been the impact of this on pediatric patients? Response: Because this policy, prioritizing multi-organ candidates ahead of all other candidates, did not change with KAS implementation, analyses have not been performed to assess the impact of multi-organ priority compared to pediatric patients with respect to KAS. Analyses have been performed that show that multi-organ recipients tend to receive lower KDPI kidneys, which may affect pediatric patient access to KDPI

Jaime Herrera Beutler, Member of Congress | 10/16/2019

A PDF VERSION OF THIS COMMENT IS AVAILABLE UPON REQUEST FROM MEMBER.QUESTIONS@UNOS.ORG. THIS LETTER IS DATED JULY 29, 2019. IT WAS RETROACTIVELY ADDED TO THE PUBLIC COMMENT RECORD FOR THIS PROPOSAL ON OCTOBER 16, 2019. July 29, 2019 George Sigounas, MS, Ph.D. Administrator Health Resources and Services Administration Parklawn Building 5600 Fisher's Lane, Room 14-05 Rockville, MD 20857 Sue Dunn, RN, BSN, MBA President and Chief Executive Officer Organ Procurement and Transplantation Network Post Office Box 2484 Richmond, Virginia 23218 Brian Shepard Chief Executive Officer United Network for Organ Sharing Post Office Box 2484 Richmond, Virginia 23218 Dear Administrator Sigounas, Ms. Dunn, and Mr. Shephard: I am writing to request information on our nation's current organ allocation policies and the potential impacts on pediatric recipients. I am aware of concerns that have been raised123 that the Kidney Allocation System (KAS) may disadvantage children and limit the donor pool for pediatric recipients. Specifically, following the enactment of KAS in 2014, transplant surgeons have reached out to express their concern over a change in both the quality of kidneys going to children and an increase in wait times for the youngest patients. It is my understanding that, under KAS, the pediatric allocation was altered from pediatric candidates being given priority for kidneys from donors less than 35 years of age to preferential allocation of kidneys of the highest quality, which is determined by Kidney Donor Profile Index (KDPI) value < 35. In light of concerns that this change may inadvertently disadvantage pediatric recipients, I request your response to the following questions: 1. Since the enactment of KAS, have wait times for kidney transplant increased or decreased for children? • Have wait times increased or decreased for adults? 2. Since the enactment of KAS, have rates of delayed graft function (DGF) increased or decreased for pediatric recipients? • Have rates of DGF increased or decreased for adults? 3. Since the enactment of KAS, how has the proportion of pediatric donor kidneys that are being received by children changed compared to before KAS? 4. Under the current policy, why are pediatric donor kidneys not allocated to pediatric patients? 5. What are the rates of deceased donor transplants and living donor transplants among pediatric recipients pre-KAS and post-KAS? 6. Has there been a change in transplant rates for highly sensitized pediatric recipients since the implantation of KAS? If yes, what is the impact of this change? 7. Was the Kidney Donor Profile Index (KDPI) metric developed and validated only in donors over 18 years of age? • If yes, what are the potential flaws in application of an adult donor metric to pediatric donors? 8. What steps could be taken to have a stronger pediatric donor representation in the development of the KDPI? 9. Do most pediatric donors carry a KDPI over 35? • If yes, are most pediatric donors therefore inaccessible to pediatric recipients under KAS? 10. lt is my understanding that the best pediatric donors have a KDPI of under 35, which is typically found in multi organ donors. Under KAS, are multi organ donor transplants prioritized over pediatric transplants? If yes, what has been the impact of this on pediatric patients? 11. In what ways could KAS limit the ability of transplant surgeons to make customized choices that best suit the needs of individual recipients? 12. What improvements could be seen among pediatric recipients if the policy reverted back to pediatric donors being prioritized for children (pre-KAS policy)? 13. Given that the implementation of KAS was not intended to disadvantage children, what changes could be made to ensure that children have higher access to kidney transplant in the algorithm of distribution, and are not inadvertently being placed below other patient populations? It is critical that accurate assessments of all patient populations be included in the development of organ allocation policies that impact children and adults alike. It is concerning that even though KDPI is an adult donor metric, the centrality of this metric within KAS has led to its application to pediatric donors, for whom it was not formulated or validated. An accurate assessment of the risk of pediatric kidneys across recipient populations seems incumbent upon our nation's Kidney Allocation System to ensure equitable allocation. Thank you for your attention to this issue, I look forward to your response and working with you on this important issue. Sincerely, Jaime Herrera Beutler, Member of Congress 1 https:/ / www.ncbi.nlm.nih.gov/pmc/ articles/ PMC 602961S/ pdf/nihm s-976543.pdf 2 https :/ / www.ncbi.nlm.nih.gov/pmc/ articles/ PMC5812849/ 3 https:/ / jamanet work.com/ journals/ jamapediatrics/ article -abstract/ 2702205 cc: The Honorable Alex M. Azar JI Department of Health and Human Services 200 Independence Avenue, S.W. Washington D.C. 20201

UC San Diego Center for Transplantation | 10/02/2019

Support in concept, but would propose the Committee more seriously consider broader ranges including 750 and 1000 NMs as 500 NM is unlikely to significantly impact patient populations awaiting transplant in more densely populated areas and particularly in San Diego, in a positive manner. We would also endorse a similar system with no proximity points or a shallow curve for proximity points to allow for wider sharing.

Anonymous | 10/02/2019

I have just finished reading comments from several Transplant Hospitals. These are the people who work on the front lines of performing kidney transplants. They are the ones who know situation the best. They all strongly oppose the proposal. One comment that struck me the most: "At best, there will be 300 fewer kidney transplants performed annually under the Proposal, and based on the prior KPSAM modeling, there may be a decrease of as many as nearly 1,800 transplants annually. The only probable result of such a policy is that more patients with end-stage renal disease will die." How anyone in the right mind can even think about adopting this proposal? If medical profession cannot stop UNOS bureaucrats from pushing this proposal through -- it should be brought to the attention of our elected officials on both state and federal level to kill this proposal once and for all. Press needs to be notified as well. How our medical profession can live with this proposal that violates Hippocratic Oath of "do no harm"? How can we accept that 1,800 lives will be potentially discarded by accepting this proposal?

Transplant Hospitals Listed In Comment | 10/02/2019

THIS IS PART TWO OF A TWO PART COMMENT. A PDF VERSION OF THIS COMMENT IS AVAILABLE UPON REQUEST AT MEMBER.QUESTIONS@UNOS.ORG. Transplant centers are indeed more likely to accept marginal organs from their local OPO, regardless of the allocation system, because the local OPO knows what organs its local centers will take as well as the centers’ preferred approaches to handling and pumping the organ. The ability to pump marginal kidneys during transport is critical to whether a transplant center will accept that organ, and as discussed above, remote OPOs are not likely to pump organs for distant recipient transplant centers. Nevertheless, UNOS sought to improve the data results by eliminating the assumption that a transplant center would be more likely to accept an organ from its local OPO. In response to UNOS’s request, SRTR proposed two new approaches to the acceptance model: (i) Model 1, known as the “Donor & Candidate Characteristics” model, which used the offer number and donor factors to predict acceptance, as well as the distance the organ would have to travel to its intended candidate recipient, and (ii) Model 2, known as the “Donor Characteristics” model, which used only offer number and donor factors to predict acceptance and did not include the distance the organ would travel to the candidate.39 The Workgroup voted 57% to 43% to use Model 2 for the revised KPSAM model.40 Thus, the KPSAM model relied on by the Proposal does not consider how far the organ must travel to the recipient transplant center in predicting whether a transplant center will accept or decline the organ offer. Notably, in the UNOS- drafted meeting summary, there is no record of the Workgroup’s discussion regarding the decision to exclude the distance the organ traveled or how such a decision was consistent with the evidence before the Committee regarding organ acceptance behavior. There is also no discussion of whether it was possible for KPSAM to run both models. However, the meeting minutes do reflect that in selecting Model 2 over Model 1, UNOS and the Workgroup were aware that Model 1 was “[m]ore likely to predict a decrease in transplant” while Model 2 was “[l]ess likely to predict a decrease in transplant.”41 The presence of such information (and no other explanation for selecting Model 2) suggests the new KPSAM model was chosen intentionally to eliminate the predicted decrease in the number of transplants seen in the earlier modeling, not because Model 2 was more predictive of likely organ acceptance behavior. In practice, the distance the organ must travel to reach the transplant center (as an approximation of time) is absolutely a factor that physicians take into consideration when 38 Id. 39 SCOTT CASTRO & ABBY FOX, ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK, BRIEFING PAPER: KIDNEY/PANCREAS WORKGROUP BOARD REPORT 9 (2019), https://optn.transplant hrsa.gov/media/2990/kidney_pancreas_boardreport_201906.pdf . 40 Minutes, OPTN/UNOS Kidney-Pancreas Workgroup (Mar. 22, 2019), https://optn.transplant hrsa.gov/media/3030/20190322_kp_workgroup_min.pdf. The Workgroup minutes do not list the number of voting members at the meeting or the vote counts. 41 Minutes, OPTN/UNOS Kidney Transplantation Committee, (Mar. 25, 2019), https://optn.transplant hrsa.gov/media/2935/20190325_kidney_meeting_minutes.pdf. determining whether or not to accept an organ. If the transplant surgeon knows he or she can personally procure an organ that would require minimal ischemic time to return to the transplant center, the surgeon is more likely to accept such an organ as compared to the same organ a further distance away that would be procured by a different surgical team and require many hours of travel before reaching the transplant center. As an example, consider the Hays, KS donor described above. Just based on the offer number and donor characteristics, the transplant center in Shreveport may wish to accept the offered organ for its patient. However, upon learning that the organ is nearly 500 nautical miles away—requiring the organ to take at least a seven-hour flight and risk being put on the wrong plane during the layover in Denver—the Shreveport transplant center is much more likely to decline the organ. This reality is not incorporated into the revised KPSAM model in any way. Although the inclusion of distance alone between the donor and recipient transplant center still does not capture the commercial flight complexities, at a minimum, KPSAM should incorporate the distance between the donor and candidate in the acceptance model as an approximation for cold ischemic time. Because the second-round KPSAM completely excludes any consideration of the time it takes an organ to reach the intended transplant center when predicting acceptances, the transplant count estimates are wholly unreliable. IV. Conclusion An organ allocation policy that results in fewer transplants, increased waitlist mortality, increased graft failures, and increased costs is not a lawful policy. There is no benefit to patients or the transplant community in adopting the Proposal. In addition, there are other pending significant changes that affect kidney transplantation, including aspects of the Executive Order as well as pending changes to OPO performance metrics, all of which could significantly affect the kidney transplant landscape and may eliminate any perceived geographic inequities. Making a dramatic change to allocation in the midst of these other initiatives is not sound public policy. If HRSA continues to insist that the OPTN change DSAs and Regions in the near-term, the OPTN should pursue incremental change while the other policy adjustments are taking place. The OPTN certainly should not adopt a policy that will cost patient lives simply to avoid the term “DSA.” Respectful Submitted, Emory Healthcare Henry Ford Health System Indiana University Health Michigan Medicine Oregon Health & Science University Saint Luke’s Hospital of Kansas City University of Iowa The University of Kansas Health System University of Kentucky University of Virginia Health System Vanderbilt University Medical Center VCU Health System Washington University in St. Louis/Barnes Jewish Hospital Transplant Center Appendix A Variation in Transplant Rates Within Same DSA* Boston Area Transplant Centers: Transplant Center Deceased Donor Adult Transplant Rate Massachusetts General Hospital 8.1 Beth Israel Deaconess 8.6 UMass Memorial Medical Center 10.3 Boston Medical Center 11.2 Brigham & Women’s Hospital 12.9 Tufts Medical Center 15.5 San Francisco Area Transplant Centers: Transplant Center Deceased Donor Adult Transplant Rate University of California San Francisco 4.9 Stanford Health Care 5.5 California Pacific Medical Center 8.0 * Data from July 2019 SRTR Program-Specific Reports

Transplant Hospitals Listed In Comment | 10/02/2019

THIS IS PART ONE OF A TWO PART COMMENT. A PDF VERSION OF THIS COMMENT IS AVAILABLE UPON REQUEST AT MEMBER.QUESTIONS@UNOS.ORG Comment Regarding OPTN’s Public Comment Proposal Eliminate the Use of DSA and Region from Kidney Allocation Policy October 2, 2019 I. Introduction The undersigned institutions (collectively, the “Centers”) strongly oppose the policy set forth in Eliminate the Use of DSA and Region from Kidney Allocation Policy (the “Proposal”). Based on the SRTR modeling, the proposed policy will (i) decrease the number of kidney transplants performed annually, (ii) increase or leave unchanged the waitlist mortality rate, and (iii) increase the graft failure rate per patient year.1 In addition, the increased logistical complexity of the allocation system will inevitably increase the cold ischemic time and cost of procuring kidneys and will disproportionately affect those in non-metropolitan areas without access to major airports.2 The transplant community cannot defend such a policy, nor should UNOS. The Proposal manufactures support for the policy change by claiming that variation in transplant rates across DSAs is indicative of geographic disparities in access to transplantation, which the Proposal urges is a problem that must be resolved through a change in the allocation policy. However, the Proposal completely disregards the fact that transplant rates also vary within the same DSA—where transplant centers currently have exactly the same access to the same organs. If allocation were the solution to the supposed problem of variation in transplant rates, then transplant centers that have equivalent access to the same supply of organs would have similar transplant rates. But as explained below, this is simply not the case. Moreover, the Proposal plainly does not comply with the Final Rule and is inconsistent with the directive in the Executive Order on Advancing American Kidney Health, which requires the HHS Secretary to “streamline and expedite the process of kidney matching and delivery to reduce the discard rate.”3 Under the current allocation model, about 20% of donated kidneys are discarded each year. That number will only increase under the Proposal, which creates numerous operational inefficiencies—particularly with respect to transporting organs on commercial flights. Transplant candidates in rural and low socioeconomic communities are most likely to be negatively impacted by the Proposal, but inexplicably UNOS has not asked the SRTR to evaluate the Proposal based on the most comprehensive metric of a policy’s effect on underserved areas—cumulative community risk score. Finally, the process through which the Proposal has been developed lacks transparency and does not reflect sound scientific judgment. As part of the policy development, SRTR completely changed the KPSAM algorithm, but only after the results of the initial data model raised significant red flags about the Proposal. Rather than seriously reconsidering the broader 1 SALLY GUSTAFSON ET AL., SCI. REGISTRY OF TRANSPLANT RECIPIENTS, ANALYSIS REPORT: UPDATE 10 (June 21, 2019), https://optn.transplant.hrsa.gov/media/2985/ki2019_01_analysisreport.pdf [hereinafter 2019 SRTR Analysis]. 2 See infra Section III.B.1. 3 Exec. Order No. 13879, 84 Fed. Reg. 33817, 33818 (2019), https://www.whitehouse.gov/presidential- actions/executive-order-advancing-american-kidney-health. sharing approach and the Proposal itself, UNOS directed the data model to be changed to produce the results it wanted. If any medical researcher took this approach in a clinical trial, the scientific community would scoff. But UNOS presents the new KPSAM results as though they are entirely legitimate and reliable and asks the transplant community to forget the original KPSAM analysis. For these reasons, as explained more fully below, the Centers request that the Kidney Committee vote against the Proposal and reconsider the approach to eliminating DSAs and Regions in kidney allocation policy. II. Background According to the Background section of the Proposal, the impetus for the Proposal was HRSA’s directive to the OPTN to eliminate the use of DSAs and Regions in organ allocation policies.4 Importantly, no court of law or other legal authority has ever declared that incorporating DSAs or Regions into allocation policies is unlawful. Based on findings made by the OPTN and the OPTN’s own failures to provide a justification as to how DSAs and Regions meet the requirements of the Final Rule, HRSA notified the OPTN in July 2018 that “DSAs and Regions have not and cannot be justified.”5 HRSA then directed the OPTN “to submit a detailed report . . . outlining the OPTN’s plans to eliminate DSAs and Regions” from organ allocation policies.6 However, HRSA noted that “geographic constraints may be appropriate if they can be justified in light of the regulatory requirements.”7 Thus, the only directive from HRSA was to eliminate DSAs and Regions. There was no directive to eliminate the concept of local and regional sharing more generally, especially to the extent that such approaches to allocation avoid organ wastage, promote organ placement, or achieve other requirements of the Final Rule. The Centers appreciate that UNOS is seeking to follow HRSA’s direction, and the Centers support efforts to evaluate and improve allocation policies, but following HRSA’s directive also requires that any change to policy comply with the Final Rule. Here, the Proposal goes well beyond its original intended goal of eliminating DSAs and Regions and creates an unwieldy approach to organ sharing that itself violates the Final Rule—with no benefit to patients. 4 OPTN/UNOS Public Comment Proposal, Eliminate the Use of DSA and Region from Kidney Allocation Policy at 8, https://optn.transplant.hrsa.gov/media/3104/kidney_publiccomment_201908.pdf [hereinafter Policy Proposal]. 5 Letter from George Sigounas, HRSA Administrator, to Sue Dunn, President, OPTN President (July 31, 2018), https://unos.org/wp-content/uploads/unos/HRSA_to_OPTN_Organ_Allocation_20180731.pdf. If UNOS leadership had supported DSAs, they might very well have presented a compelling justification for continuing the current policy. 6 Id. 7 Id. III. The Proposed Allocation Policy A. The Proposal reduces the number of kidney transplants, does not positively impact waitlist mortality, and increases the graft failure rate—without any benefit to the national transplant community. Under the Final Rule, allocation policies must, among other things, “seek to achieve the best use of donated organs” and “be designed to avoid wasting organs.”8 The OPTN’s first strategic goal enumerated in its Strategic Plan for 2018-2021 is to increase the number of transplants.9 Similarly, UNOS’s vision statement is “[a] life-saving transplant for everyone in need.”10 The Proposal acts against these aspirations and the Final Rule’s requirements by making significantly fewer organs available for those in need. At best, there will be 300 fewer kidney transplants performed annually under the Proposal, and based on the prior KPSAM modeling, there may be a decrease of as many as nearly 1,800 transplants annually. The only probable result of such a policy is that more patients with end-stage renal disease will die. According to the second-round SRTR modeling,11 the 500nm sharing policy will reduce the national kidney transplant count by approximately 300 transplants. The Proposal asserts that when kidney-only transplants are combined with kidney-pancreas transplants, the total number of kidney transplants remains essentially unchanged. But this predicted increase in kidney- pancreas transplants is flawed because it fails to take into account the highly technical nature of pancreas procurement and the fact that most transplant surgeons are unwilling to accept pancreata procured by surgeons they do not trust. In addition, pancreata have a lower tolerated ischemic time that affects acceptable travel distance and further limits the likelihood that broader sharing will increase the number of kidney-pancreas transplants. When UNOS was faced with modeling data that predicted a decrease in liver transplantation, it defended its desired policy by urging that patient lives would be saved, despite fewer annual transplants, because the policy decreased waitlist mortality rates.12 Here, however, UNOS does not make the same argument—because the data does not support it. According to the KPSAM analysis, the waitlist mortality and graft failure rates will increase under the Proposal’s preferred 500nm policy.13 If the policy results in fewer transplants and increased 8 42 C.F.R. § 121.8(a)(2), (5). 9 ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK, OPTN/UNOS STRATEGIC PLAN 2018-2021 2, https://optn.transplant hrsa.gov/media/2392/executive_publiccomment_strategicplan_20180122.pdf. 10 UNOS, Mission, Vision and Values, https://unos.org/about/mission-values/ (last visited Oct. 1, 2019). 11 2019 SRTR Analysis, supra note 1, at 10. The first-round modeling was completed in September 2018 and identified a significant decrease in the number of transplants, as explained below in Section III.C. 12 See ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK, EXECUTIVE SUMMARY OF OPTN APPROVAL OF POLICIES TO ELIMINATE THE USE OF DSAS AND REGIONS IN LIVER ALLOCATION 10, https://optn.transplant hrsa.gov/media/2779/board_executivesummary_liver_201812.pdf (“In seeking to achieve the best use of donated organs, the Board and committees consider whether policy will impact the number of transplants and waitlist mortality rate.”); id. at 11 (“The reduction of deaths on the waitlist was considered a measure of best use of transplanted organs, and was an influencing factor in the Board’s ultimate decision to adopt the Acuity Circles model instead of the B2C model.”). 13 2019 SRTR Analysis, supra note 1, at 10. waitlist mortality, even UNOS must admit that more patients will die under such a policy, and a policy that causes more loss of life and discards more organs is not compliant with the Final Rule, let alone the life-saving mission of UNOS and the transplant community. But instead of facing this reality, UNOS turns to the variation in transplant rates across DSAs as a justification for the kidney allocation change.14 The Proposal asserts that these variable rates are indicative of inequities in allocation, which are attributable to certain DSAs unfairly having better access to organs than other DSAs. UNOS contends that the proposed allocation policy revision will result in greater equity in transplant rates. If UNOS’s arguments were valid, and variation in transplant rate was simply reflective of allocation policy, then transplant centers within the same DSA—with access to an identical pool of organs—would have similar transplant rates. But that is far from the reality. For example, according to the July 2019 SRTR Reports, the adult deceased donor transplant rate at New York University is 39.5 while the transplant rate at Mt. Sinai—in the same DSA with access to the same organs—is 5.9. Does that mean the allocation within the DSA is flawed and the national policy needs to be changed? No. Similarly, in Chicago’s DSA, the average transplant rate is 13.7. But there are dramatically different transplant rates at individual transplant centers within that DSA, as reflected in the chart below.15 Transplant Center Deceased Donor Adult Transplant Rate Advocate Christ Medical Center 8.5 University of Chicago Medical Center 9.8 Northwestern Memorial Hospital 13.6 University of Illinois Medical Center 14.6 Loyola University Medical Center 23.1 Following UNOS’s logic, if allocation policy should be based on transplant rates, then Loyola University should never be offered organs ahead of the University of Chicago or Advocate. Of course, UNOS does not propose such a policy. Yet UNOS leadership endorses a national allocation policy designed in a way that is intended to equalize organ transplant rates across DSAs, which—on a more macro scale—is essentially equivalent to requiring that organs be offered to University of Chicago ahead of Loyola University, simply because of the difference in their transplant rates. Transplant rates vary across DSAs because transplant rates vary across transplant centers. Transplant rates are affected by, among other things, each transplant center’s waitlist population 14 Policy Proposal, supra note 3, at 6, 19-21. In addition to graphical presentations of variations in transplant rate across DSAs, the Proposal also relies on the UNOS-developed “Access to Transplant Score” (ATS) metric to indicate that DSA plays an outsized role in determining access to transplant. Importantly, ATS is defined by disparities in deceased donor transplant rates. See D.E. Stewart et al., Measuring and Monitoring Equity in Access to Deceased Donor Kidney Transplantation, 18 AM. J. TRANSPLANTATION 1924 (2018), https://onlinelibrary.wiley.com/doi/pdf/10.1111/ajt.14922. Thus, ATS is simply another way of referring to transplant rate variance. Moreover, the graph cited in the Proposal only incorporates data from the extremely limited timeframe of January 1 to March 31, 2017. See id. at 1928. 15 Additional data for Boston and San Francisco are provided in Appendix A. and waitlist management, organ acceptance practices, and the availability of living donor transplants, in addition to local OPO performance. Importantly, the transplant rate is directly affected by the number of candidates on the waitlist, including inactive candidates,16 many of whom are added to the waitlist by certain transplant programs before the initial work-up has been complete.17 Inactive candidates, of course, are not eligible to receive an organ offer, but they currently comprise approximately 40% of overall waitlisted kidney candidates.18 Thus, the listing of numerous inactive status patients may significantly decrease a given DSA’s transplant rate without reflecting any type of geographic inequity in allocation. Moreover, some DSAs only have one transplant center so that particular transplant center’s practices, including waitlist enrollment and management, control the DSA-level data. Notably, UNOS does not even attempt to consider the reasons for why the variation in transplant rates across DSAs exists—it simply takes as a given that such variation is problematic and is the result of a flawed allocation policy. But in light of the inherent variation in transplant rates across transplant centers within the same DSA, for reasons unrelated to organ allocation, variation in transplant rate is not defensible as the driving force behind allocation policy change. B. The Proposal will result in operational inefficiencies that will lead to more organ discards rather than optimal organ placement as required by the Executive Order and will especially harm transplant candidates in non- metropolitan areas and low-income communities. Efficient placement of organs—a requirement of the Final Rule and Executive Order— requires close coordination among OPOs and transplant centers,19 which is complicated by large allocation circles that require OPOs to work with numerous transplant centers and facilitate more complex organ transport. Previous efforts to distribute organs across large geographic areas have resulted in a decrease in transplantation. With the transition to the KAS system, which distributed high KDPI kidneys over larger regional areas, several increased inefficiencies were observed, including poor organ utilization, high discard rates, and fewer patients transplanted.20 16 The SRTR defines transplant rate as the number of candidates who received a transplant (numerator) divided by the person-years observed at the program (denominator, which reflects how many candidates were on the waiting list and for how long). See SCI. REGISTRY OF TRANSPLANT RECIPIENTS, USER GUIDE 1 (July 8, 2019), https://www.srtr.org/document/pdf?fileName=\072019_release\pdfPSR\GAEMTX1KI201905PNEW.pdf. “Candidates who are inactive on the waiting list are included in the calculations for this table.” Technical Methods for the Program-Specific Reports, SCI. REGISTRY OF TRANSPLANT RECIPIENTS, https://www.srtr.org/about-the- data/technical-methods-for-the-program-specific-reports#tableb4 (last visited Oct. 1, 2019). 17 A. HART ET AL., SCI. REGISTRY OF TRANSPLANT RECIPIENTS, OPTN/SRTR 2017 ANNUAL DATA REPORT: KIDNEY 83 (2019), https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajt.15274 (finding that 5,205 of new candidates, or 65.7%, were listed as inactive because of an incomplete work-up). 18 National Data Reports, Organs by Status, ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK, https://optn.transplant hrsa.gov/data/view-data-reports/national-data/# (based on data as of Sept. 30, 2019, showing 59,950 active waitlisted candidates and 36,592 inactive waitlisted candidates). 19 See K.P. Croome et al., Noneligible Donors as a Strategy to Decrease the Organ Shortage, 17 AM. J. TRANSPLANTATION 1649, 1654 (2017). 20 See Darren E. Stewart & David K. Klassen, Early Experience with the New Kidney Allocation System: A Perspective from UNOS, 12 CLINICAL J. AM. SOC’Y NEPHROLOGY 2063 (2017), https://cjasn.asnjournals.org/content/clinjasn/12/12/2063 full.pdf; John J. Friedwald & Nicole Turgeon, Early (Similar inefficiencies, including more discards and increased costs, have transpired as part of the change to lung allocation.21) After KAS, the discard rate rose by 10%.22 There was also a sharp drop in pumping high-KDPI kidneys, which a UNOS senior researcher noted contributed to the increase in discards.23 The decline in pumping is almost certainly attributable to the fact that OPOs are unlikely to pump organs for remote (non-local) transplant center recipients, and in the Centers’ collective experience, OPOs will never send one of their pumps on an airplane with an organ that must be flown to the intended recipient. Despite the historical challenges with implementing broader sharing, the Proposal states that change is necessary to resolve the current allocation policy’s supposed conflict with the Final Rule’s provision that allocation policies “not be based on the candidate’s place of residence or place of listing” except to the extent required by the other requirements of the Final Rule.24 Specifically, the Proposal states that “[l]ocation should not hinder access to transplant.”25 However, by dramatically increasing reliance on commercial flights to distribute almost half of deceased donor kidneys, the Proposal itself creates a scenario where location will hinder access to transplantation for candidates listed at transplant centers in smaller cities and rural areas that have limited access to direct flights. The proposed policy will exacerbate the challenges those centers already encounter in obtaining organs because they cannot accept organs at the same rate as centers in urban areas with larger airports. But the Proposal has entirely failed to consider the effect that limited access to direct flights will have on cold ischemic time and the subsequent impact on candidates’ access to transplantation. 1. Increased commercial air transportation The Proposal anticipates that over 40% of kidneys will need to travel more than 250nm and require air transportation to reach the intended recipient. Such a significant increase in air travel will increase organ wastage and thus is contrary to the Final Rule’s requirement that Experience with the New Kidney Allocation System: A Perspective from a Transplant Center, 12 CLINICAL J. AM. SOC’Y NEPHROLOGY 2060 (2017), https://cjasn.asnjournals.org/content/clinjasn/12/12/2057 full.pdf. 21 See, e.g., REBECCA R. LEHMAN & BOB CARRICO, OPTN THORACIC TRANSPLANTATION COMMITTEE, MONITORING OF THE LUNG ALLOCATION CHANGE, 1 YEAR REPORT (2019), https://optn.transplant hrsa.gov/media/2815/20190116_thoracic_committee_report_lung.pdf; Varun Puri et al., Unintended Consequences of Changes to Lung Allocation Policy, 19 AM. J. TRANSPLANTATION 2164 (2019) (observing that the cost of donor lungs increased substantially after implementation of the broader sharing policy). With respect to increased costs, the March 5, 2019 Kidney Committee meeting summary states that a Fiscal Impact Workgroup report will be submitted to the Board, but such report does not appear to be publicly available. The financial impact of the increase in flights and discards is critical for the public to review and comment on as part of the policy development process. Minutes, OPTN/UNOS Kidney-Pancreas Workgroup (Mar. 5, 2019), https://optn.transplant hrsa.gov/media/3027/20190305_kp_workgroup_min.pdf. 22 Darren Stewart, Senior Research Scientist, UNOS, Presentation at Am. Soc’y for Transplantation Comference, Waste Not, Want Not: An Analysis of Discarded Organs (Feb. 2017), https://www myast.org/sites/default/files/ceot2017/AST%20CEOT%2001%20Stewart%20- %20No%20Organ%20Left%20Behind%20-%20S3.pdf. 23 Id. 24 Policy Proposal, supra note 3, at 1, 3, 8. 25 OPTN/UNOS Public Comment Proposal, Eliminate the Use of DSA and Region from Kidney Allocation Policy, Proposal at a Glance, https://optn.transplant hrsa.gov/media/3104/kidney_publiccomment_201908.pdf allocation policies avoid wasting organs and promote the efficient management of organ placement.26 Marginal organs are less likely to be accepted and transplanted when cold ischemic times are prolonged due to longer travel distances. As travel increases, programs will be required to rely on unaffiliated teams to procure organs, which will further affect the likelihood of acceptance of marginal organs. Moreover, although UNOS claims that the new policy will not result in a decrease in the number of kidney transplants, the KPSAM does not factor in additional discards based on missed flights, bad weather, or other logistical challenges that will inevitably result when 40% of kidneys are transported by commercial aircraft. In other contexts, UNOS itself has acknowledged the risks inherent in commercial air travel for organs,27 but in the Proposal, these risks are ignored. According to UNOS data published in 2016, approximately 1.5% of deceased donor organ transport shipments failed by not making it to the intended destination. Nearly 4% of shipments experienced a “near miss,” which is a delay of two or more hours. Commercial flights were the method of transport in over 90% of those shipments that experienced a failure or near miss.28 With more than 40% of kidneys needing to fly under the Proposal (compared to less than 20% in the current policy), the volume of failures and near misses will certainly increase. In addition, under the Proposal, a transplant center’s ability to accept organ offers will be dependent on the availability of direct flights to/from the donor city. Inescapably, a policy that increases the percentage of organs traveling by air disadvantages centers that lack access to major airports. For example, under the Proposal, an organ donated in Hays, KS could be allocated to patients at transplant centers in Shreveport, LA or Bismarck, ND, both of which are within 500 nautical miles of Hays. But neither of these transplant centers is likely to accept the organ. To fly from Hays to Shreveport, if the procurement surgery is timed exactly right, the organ might be able to make a commercial flight with a three-hour layover in Denver and arrive in Shreveport after over seven hours of travel. Similarly, the trip to Bismarck would also require a three-hour layover in Denver and take at least six hours. If the surgery falls at the wrong time, however, commercial flights from Hays to Shreveport or Bismarck could take the organ well over 24 hours to reach its intended destination, with two or three layovers required. Even if the shorter flight with a single layover could be guaranteed, the organ would not be pumped during transit. Therefore, transplant candidates in Shreveport and Bismarck will not receive this organ, even if they are the highest acuity patient with the greatest need. But as a hub airport for United Airlines, transplant centers in Denver would gladly accept the organ arriving from Hays on a direct flight. Thus, transplant centers in cities with larger airports will have a distinct advantage under the new system. But the benefit for patients listed at these centers is inconsistent with the Proposal’s stated goal of avoiding geographic inequities and complying with the Final Rule’s provision that allocation policies shall not be based on a candidate’s place of listing. Thus, in 26 42 C.F.R. § 121.8(a)(5). 27 UNITED NETWORK FOR ORGAN SHARING, TRANSPORTING LIVING DONOR KIDNEYS IN THE OPTN KPD PILOT PROGRAM (May 9, 2019), https://unos.org/wp-content/uploads/unos/KPD_Transportation_Options.pdf. 28 UNITED NETWORK FOR ORGAN SHARING, FAQ FOR KPD LIVING DONOR KIDNEY TRANSPORTATION FROM RECOVERY HOSPITAL TO RECIPIENT HOSPITAL (Sept. 26, 2016), https://www.transplantpro.org/wp- content/uploads/sites/3/FAQ_Transporting_KPD_Kidneys.pdf?x18629. essence, the Proposal creates a new geographic inequity, based on the arbitrary metric of how far the candidate’s listing transplant center is from a major airport. 2. Lack of comprehensive analysis on the policy’s socioeconomic effects The Proposal purports to be concerned about the impact of the policy change on low socioeconomic status candidates, but the Proposal’s analysis regarding underserved communities is deficient. First, the Proposal acknowledges that KPSAM predicts a decrease in transplant rate for all non-metropolitan areas, and then suggests that this decrease is appropriate because it “equalize[s]” access to transplant by bringing non-metropolitan transplant rates down to the level of metropolitan rates.29 But such claims of equity ignore the additional negative effects excluded from the modeling. Even assuming a decrease in transplant rates generally could be defended under the Final Rule, the negative effects on non-metropolitan communities will be even greater than the modeling shows because of the logistical challenges described above that harm non- metropolitan areas but were excluded from the modeling, including air travel considerations. The impacts to candidates in these areas must be considered to ensure the policy complies with the Final Rule and does not disadvantage candidates in certain geographic regions. Second, SRTR did not model the impact of the policy based on cumulative community risk scores, which is a metric specifically designed to assess the impact of socioeconomic factors in kidney transplantation.30 The only modeling regarding socioeconomic effects cited by the Proposal is that regarding payment status, median household income in the zip code, and urbanicity. The Proposal claims that low socioeconomic candidates will have increased access to transplant because of the increase in Medicaid recipients, but this data is unduly influenced by geography in light of inconsistent Medicaid expansion.31 For example, an increase in Medicaid recipients could simply mean an increase in recipients from New York, California or other states that adopted Medicaid expansion, while similarly situated low-income candidates in Texas and Florida would not be counted as Medicaid beneficiaries. Notably, the SRTR data for transplant rates based on household income shows decreases for candidates in zip codes with median incomes of $35k to $70k and a slight increase in transplant rates for those in zip codes with median incomes exceeding $70k.32 Thus, at best, the data from SRTR is inconclusive with respect to the effect of the proposed policy on candidates of lower socioeconomic status. The Committee and the OPTN Board would benefit from modeling of the policy’s impact on candidates based on community risk score, which reflects a more comprehensive picture of socioeconomic status as compared to median household income. However, this score is not addressed in the KPSAM model or the Proposal, despite the fact that SRTR modeled this score as part of the LSAM analysis in the liver allocation proposal. 29 Policy Proposal, supra note 3, at 29, 44. 30 Jesse D. Schold et al., The Association of Community Health Indicators With Outcomes for Kidney Transplant Recipients in the United States, 147 ARCHIVES OF SURGERY 520 (2012), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880685/. 31 See Medicaid Coverage in Your State, https://www healthinsurance.org/medicaid/ (last visited Oct. 1, 2019). 32 Policy Proposal, supra note 3, at 55. C. The changes made to the KPSAM analysis resulted in a data model that does not accurately reflect the realities of transplant medicine, rendering the simulated data unreliable. The Proposal is predicated upon SRTR analysis that was altered in a manner inconsistent with sound scientific principles, leading the Centers to conclude that the proposed policy may result in dramatically lower transplant rates than the second-round KPSAM predicts. The September 2018 KPSAM analysis reported that the proposed policy changes would result in at least 1,000 fewer kidney transplants performed nationally each year, possibly almost 2,000 fewer transplants depending on the policy selected.33 The KPSAM also predicted an increase in the waitlist mortality count and graft failure rate. When discussing these results, the Kidney-Pancreas Workgroup “expressed concerns regarding the significant drops in transplant rates and counts.”34 In December 2018, the Workgroup concluded it needed additional information before it could recommend a new allocation framework, but UNOS staff urged the Workgroup to publish a “concept paper” for public feedback,35 which it did. In March 2019, the Workgroup met to discuss feedback from the concept paper, and a member “expressed the need to address the repetitive feedback about the drop in transplant rates and counts.”36 According to the UNOS-prepared meeting summaries, the initial KPSAM report “was negatively received due to the notable decreases in the number of transplants In response, SRTR began investigating” different modeling approaches.37 In other words, there was no identified concern with the modeling approach until the data did not turn out how UNOS leadership wished and was poorly received by the community. Only then did UNOS ask SRTR to consider new ways to approach the model. Such actions do not reflect sound scientific principles and fair-minded thinking. In altering the KPSAM algorithm, SRTR proposed to change the “acceptance model,” which as the name implies is the part of the KPSAM intended to reflect the likelihood that a transplant center will accept a certain simulated organ offer. The original acceptance model was based on historical data, which included a parameter that the organ was more likely to be accepted if it was offered from the local DSA. SRTR staff said this contributed to the model identifying lower transplant counts because fewer offers at the beginning of the match run were 33 SALLY GUSTAFSON ET AL., SCI. REGISTRY OF TRANSPLANT RECIPIENTS, DATA REQUEST FROM THE OPTN KIDNEY TRANSPLANTATION COMMITTEE: PROVIDE KPSAM SIMULATION DATA ON EFFECT OF REMOVING DSA AND REGION FROM KIDNEY/PANCREAS/KINDEY-PANCREAS ORGAN ALLOCATION POLICY 6 (Sept. 24, 2018). 34 Minutes, OPTN/UNOS Kidney Transplantation Committee (Dec. 19, 2018), https://optn.transplant hrsa.gov/media/2835/20181219_kidney_committee_minutes.pdf. 35 Id. Notably, at that meeting “HRSA and UNOS leadership . . . stated the importance that a formal public comment proposal be submitted in the Fall of 2019 for consideration at the December 2019 OPTN Board meeting.” Id. 36 Minutes, OPTN/UNOS Kidney-Pancreas Workgroup (Mar. 5, 2019), https://optn.transplant hrsa.gov/media/3027/20190305_kp_workgroup_min.pdf/. 37 Minutes, OPTN/UNOS Kidney Transplantation Committee, (Mar. 25, 2019), https://optn.transplant hrsa.gov/media/2935/20190325_kidney_meeting_minutes.pdf (emphasis added). made within the same DSA under the simulated broader sharing proposals.38 According to UNOS, the acceptance model should be revised because under the new allocation policy, transplant centers would no longer be more likely to accept an organ that was offered by its local OPO. However, in the Centers’ collective experience, this justification for the change in model does not align with transplant practice.

Anonymous | 10/02/2019

According to the submitted comments about 95% of the respondents oppose the proposal. If this proposal will be adopted by OPTN/UNOS it would further erode the confidence of all transplant professionals and organizations in OPTN/UNOS. As OPTN/UNOS leadership probably already knows they are not held in high regard by the transplant professionals -- being dismissive of the community concerns, heavy handed, politicized, and self serving. The proposal, as written, would result in lost lives (conservative estimates as provided in the comments being at least 140 lost kidneys per year) due to additional discards and reduced kidney longevity due to increased ischemic time and travel mix-ups. There would be less donors as grieving families would be unwilling to donate the kidney of loved ones to someone located 600 miles away (500 miles nautical). Seems like rather than trying to follow the Final Rule -- this proposal is actually further violatesthis rule. This proposal would also result in increased cost in transporting the kidneys. Underserved (rural) communities would suffer the most (20k per kidney with 14,000 kidney transplants per year would result in 280 million extra expendentures per year). Additional costs will occur as some hospitals being overwhelmed with additional kidneys and some hospitals finding that they have no kidneys to transplant. The proposal, as written, would simply encourage non-performing OPO to perform even less (as the hospitals in their area would just get kidney from someone else). It seems we would be so much better just adjusting/modifying what we already have with existing regions and OPOs-- and something that worked reasonably well in the past -- rather than going 500 nautical mile radius (note that the area covered by 500 NAUTICAL miles is 1.44 bigger than the area covered by 500 REGULAR miles). If the whole proposal cannot be scrapped -- should we just start with 150 mile radius as a pilot program in one region -- learn what it does and go from there? Congress House representatives from Florida already expressed their displeasure with this proposal (see comments). More House representatives form states such as Wisconsin, Kansas, Utah, Oregon, etc are expected to be put on notice that their communities would be adversely affected by this proposal -- there would be a strong expectations that congressional hearings would follow if the proposal is adopted (or law suits would follow) -- would it better to scrap/significantly modify this proposal to make it more acceptable to avoid this? Especially in view of the current climate where President Trump took an initiative in revamping the organ donation landscape? As has been suggested in the comments the OPTN/UNOS appear to be barking up the wrong tree -- by playing with the allocation algorithms which do not bring any new kidneys -- but actually results in more discards. The OPTN/UNOS energy should be channeled into reducing the number of organs that end up in a grave -- as the recovery rate of cadaveric kidneys hovers only at about 50%. Why not initiate a nation wide campaign encouraging the grieving families to donate the organs of loved ones? For example lobby states for automatic opt-in (rather than making opt-out to be a default) on the driver licence for the kidney to be donated. Spain which adopted this policy -- leads the world in donated kidneys. Or provide non-direct incentive (such as subsidizing funerals, life or health insurance to the next of keen, etc). If the donation rate can be increased even by 15% -- it would save a lot lives and reduce expenses associated with dialysis.

AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS | 10/02/2019

ASHI appreciates the efforts put forth by the OPTN Kidney Transplantation Committee on the development of a revised allocation policy that addresses concerns with the current policy as it relates to the OPTN final rule. ASHI is supportive of the overall policy proposal as it recognizes donated organs as a national resource and addresses the concerns with the use of DSA and Region in kidney allocation while promoting equity and efficiency in allocation. However, ASHI is concerned with the lack of consideration, at least as presented in the public comment proposal, of the potential impact on the logistics of histocompatibility testing. With broader sharing comes uncertainties about the logistics of sharing tissues for crossmatching. In lieu of physical crossmatching, virtual crossmatching will be very important to support broader sharing. As the committee may be aware, the CLIA amendments still do not recognize virtual crossmatching as an alternative to the physical crossmatch. This situation has been addressed with CMS at least 4 years ago without resolution. ASHI urges the committee to work closely with the UNOS Histocompatibility Committee to address the potential impact of broader sharing on histocompatibility testing logistics as well as promoting recognition by CMS of the virtual crossmatch as a viable alternative to the physical crossmatch.

UPMC Hamot | 10/02/2019

The kidney transplant program at UPMC Hamot (PAPH) opposes the proposal of removing DSA and Region from the Kidney Allocation Policy. The change to the use of 500 NM circles will profoundly and adversely affect all programs. The disadvantage to programs serving those patients in areas with less population density is first demonstrated through the distribution of donor hospitals. When looking at the western part of what is considered Region 2, there is a much smaller density of donor hospitals than in the eastern part of the region. This map is misleading, as it represents any hospital that has had any type of deceased organ donor, not just kidney and does not show actual volumes of kidney recoveries by area. A better visualization would have been to show heat maps of where deceased donor kidneys are being recovered and adjust distribution accordingly. Also, while using UNOS’s own maps, viewing Region 1, Region 2 and Region 9 side by side show large overlaps due to the 500NM. The transplant centers in the western parts of Region 2 will be at an extreme disadvantage due to the concentration of transplant centers (as well as donor hospitals) in the eastern part of Region 2 as well as all of Region 1 and Region 9. This disadvantage will then transfer to the patients of the transplant centers in the less populated areas. While locality points are meant to alleviate some of these issues, the range of points is not enough due to the higher wait times for eastern seaboard patients. For a kidney recovered in Erie, PA the difference in locality points between a patient listed with PAPH and one listed in New York City would be 2.4 which is probably not enough to keep the organ local based on wait times. The inclusion of a circular 500NM area from the donor hospital is as arbitrary as our current regional boundaries. The specific disadvantage of this is from programs based in geographic locations with less population density bordering areas without donor hospitals. For example, Erie, PA abuts Lake Erie and the Canadian border. This means the patients served by the program at UPMC Hamot would be unfairly disadvantaged with the proposed system, as they would be no offers in the 500NM circle portion coming from Lake Erie or Canada. The regulatory change as it is currently proposed will inadvertently and significantly disadvantage a group of patients in underserved, non-metropolitan areas that depend on their local program. Many patients cannot afford to travel to other areas for potential transplants and therefore will choose to remain on dialysis. This will represent a large cost increase within the healthcare industry as the dialysis costs over a lifetime of a patient are much higher than the costs of a transplant. Additional concerns center around increased costs for obtaining the deceased donor organs. As the cost to the OPOs will increase, that additional cost will be pushed to the transplant centers.. The final issue PAPH has concerning the new kidney allocation proposals is shown on page 38 of the proposal itself. With the proposed 500NM circle plus proximity points, data is reflecting a decrease of 321 total kidney transplants from the current baseline numbers. While the proposal continuously uses the term “minimal variation,” any projected decrease in transplants is life threatening for the patients we treat. Once again, these decreases will most likely occur in small rural / underserved areas as organs move to more metropolitan areas for transplant. In our estimation, any decrease in the total number of kidney transplants is reflective of a proposal that does not serve the needs of its constituents, the end stage renal disease population for whom these transplants are life saving. In summary, the proposal, as it stands, is not in the best interest of the transplant community and the patients we treat. Modeling has demonstrated a potential increase in waitlist mortality and a projected decline in overall kidney transplant volume and is not in the best interests of the patients who depend on transplantation for long term survival.

Anonymous | 10/02/2019

While I support the intention to reduce disparities and optimize access to transplantation for all, I oppose the 500nm proposal. The current proposal would reward underperforming OPOs, would add unknown costs to the system, may not deliver the greatest benefit to the greatest number, and has the potential to influence waitlist practice patterns that, applied to the aggregate, may not benefit the system in the long run. I would advocate that better metrics to assess transplant access be deliberated, constructed, and worked into new models. Additionally, OPTN Bylaws allow for variances of allocation in compliance with the National Organ Transplant Act (NOTA) and the Final Rule. These variances, if demonstrated to be beneficial to patients, should be retained under any new proposal.

Gift of Life Donor Program | 10/02/2019

Gift of Life Donor Program (the OPO serving the eastern half of Pennsylvania, southern New Jersey and the state of Delaware) believes any policy for broader sharing of kidneys needs to address the practical implications for OPOs and transplant centers. Kidney recovery and transplantation and the success we have enjoyed as a national system has greatly benefited from the relationship of the local transplant center and the local OPO working together in their community to impact patients awaiting kidney transplantation in their community. We strongly believe the kidney committee needs to evaluate these concerns and have effective policies to address some potentially significant unintended consequences sharing kidneys may have on decreasing donation and increasing kidney discards. We have listed some of these concerns below. Additionally the committee should eliminate any concentric circle model as urgency for kidney transplantation is different than in the extra renal organs and the concentric circle model in the densely populated mid-Atlantic area has a much more deleterious effect than in other less densely populated areas of the USA. Effect on innovation: DCD donation has had significant growth in the last 15 years and is really a great example of the effect of local transplant center and local OPO cooperation. Fundamental to its success was the inherent benefit derived for local candidates from the significant local resources needed to get a program off the ground. This type of investment and risk would not have occurred with out the incentive of being able to prioritize local candidates for these organs. With broader sharing rules in place this type of innovation will be hampered and the committee should consider the potential future effects of stifling innovation and what effects it may have on performing donor intervention research. Effect on transplant center cooperation with the local OPO: Unlike other organs kidney recoveries are not performed by the surgeon who is accepting for a particular candidate. Transplant centers rely on the local team to perform this function. OPOs have agreements in place for local surgeons to perform kidney recoveries with the knowledge the kidney will most likely be offered first to a local program (with obvious exceptions for current limited mandatory sharing). We recognize now that many of the kidney recoveries are performed by liver centers and would most likely continue (although there is no rule that liver team must do this) We are concerned however that kidney only donor recoveries (DCD and kidney donors at the margin) it may be difficult to locate a recovery surgeon given lack of potential benefit to local candidates. The recovery of organ responsibility will then fall on the OPO and while a few have begun to hire independent recovery surgeons, we believe in the short term it will have a dampening effect on recovering what are considered marginal donors and could actually decrease organ availability. Effect on efficient allocation: Our OPO due to the number of kidney centers (14) and the largest kidney recovery and distribution in the US over the last decade has had the unique benefit of experiencing some of the unintended consequences of sharing with a large number of centers and has developed local "rules" to allow the process to be more efficient. This has greatly enhanced our ability to not only increase the number of kidneys recovered and transplanted but to also increase the efficiency at which kidney placement takes place. However when we attempt to place kidneys outside our local DSA, we routinely experience that other transplant centers and OPOs have not adopted some of these practices. To have a more efficient national system it will be important for the committee to consider the following: 1) Rules re: when a cross-match (virtual or serologic) needs to be completed and in what time frame 2) Rules re: transplant center locating, medically clearing and candidate accepting 3) Rules re: accepting center having appropriate back up in place 4) Rules on OPOs sharing blood pre-recovery 5) Rules: on transplant center role in kidney recovery 6) Rules on number of candidates cleared 7) Rules on transplant centers accepting more than one kidney at a time (particularly important in dense geographic areas as mid Atlantic region, that will have multiple simultaneous donors of same blood type will be significantly difficult to work through the allocation 8) Rules on waivers, what do they mean? 9) Increased complexity of allocation will decrease overall efficiency and will lead to an increase in kidney discards 10) Rules on biopsy of kidneys (local determination?) 11) Requirement for back up patients and a definition of what that means 12) Role of third party screening services for transplant centers 13) accurate candidate listing by transplant center and monitoring of inappropriate organ turndowns Effect on organ preservation 1) Shift of organ pulsatile preservation from OPOs to transplant centers? 2) What kidney gets pumped who determines? Effect on costs: 1) Increase in travel costs (ground and air) 2) Increase in OPO workload coordinating not only your local activity but now import activity 3) Increase in transplant center workload with the number of offers Gift of Life, and its 14 affiliated transplant centers and our local community hospitals have demonstrated our commitment to candidates awaiting transplantation by consistently increasing donation over the past 45 years. We have also shared the largest volume of organs outside our DSA to take care of ill patients across the United States. We would ask that the committee and the OPTN seriously consider the unintended consequences of broader kidney sharing and have effective policies and tools in place to mitigate these concerns before any policy is implemented. Gift of Life is committed to be an active participant in improving our nations organ donation. In summary, Gift of Life Donor Program and its 14 kidney transplant centers believe a system change for kidney allocation should be based on a combination of the patients waiting for kidney transplant and organ donor (kidney donor) volume. That proportion should be designed as a model and be consistent throughout the United States. In other words, have the numbers of donors and active kidney patients in a particular area be equivalent throughout the country. Utilizing the current proposals of concentric geographic circles for kidney sharing does not make common sense in especially high population areas (like the mid-Atlantic region) vs. the Western or mid-west parts of the country and should not be used for allocation. The sharing models should be equivalent based on donor volume and patients waiting for a kidney throughout the country -along with the practical issues when sharing kidneys that we have bought up in this comment letter.

Anonymous | 10/02/2019

This proposal would increase the wait times of local patients to receive transplant.

Betty Chan | 10/02/2019

We are a group of 14 people from Las Vegas Nevada and would like to support the personal comments provided in Review Journal dated September 28 2019 by Mr. John Ham, Medical Director of University Medical Center for Transplantation. It is summarized as follows: 1) “If you are going to make equity in sharing, you need to make equity in procurement first” 2) “Transporting kidneys longer distances can result in less than optimal outcomes” We agree totally that we cannot think of any good reason to like the proposed rule changes either. We also want to add our personal opinions: 3) The organ donors should be given their choice of Donation State 4) Whoever has made kidney donation before should be given priority if they need another kidney transplant afterwards. As a luck recipient, I have joined the Nevada Donor Network as a volunteer and have the first hand experience eye-witnessed how hard those people have worked to gain more donors and provide undisputed professional help to Donor families. The community has supported organ donation is a result of our hard work in bringing the awareness of the importance to be an organ donor. We should be entitled a right to allow organs donated in Southern Nevada stays in Southern Nevada.

Gift of Hope | 10/02/2019

Gift of Hope generally supports the proposal to replace DSAs and Regions with circles for the allocation of all organs. We also support the more sophisticated concept of using proximity points to drive more utilization of organs closer to the donor hospital. However, we believe smaller circles with higher proximity points makes the most sense for the system. It is important to remember that the primary reason we must implement this policy is that the current one does not make any logical sense and violates the Final Rule. The idea of using broader sharing to reduce transplant disparity is secondary to using an allocation scheme that makes sense and meets the law. We believe that too much emphasis has been given to using this allocation policy to reduce or eliminate disparities in access to transplant. The single greatest factor in determining if a patient is going to get a kidney transplant is not their geographic location, it's the practices of the individual transplant program they are associated with. The largest kidney transplant program in the country in 2018, received less than 20% of their kidneys from their local DSA. The vast majority of their kidneys came from national offers for kidneys that were turned down for literally thousands of patients. UNOS should recognize that broader sharing of ALL organs will result in huge increases in transportation costs and increased logistical challenges. The bigger the circle the higher the cost. At the same time, the impact on disparity reduction is marginal at best. UNOS should look at policies to drive more consistent transplant program practices instead to reduce disparities. If there is still a need to reallocate organs, then simply reallocate the organs needed instead of all organs. For example, if ILIP is deemed to have 100 too many kidneys and San Diego has 100 too few, then simple have ILIP offer 100 randomly selected kidneys to programs in San Diego. The system could be adjusted annually and optimized to minimize the movement of organs and eliminate disparity. In summary, we would suggest 150 mile circles with 4 to 8 proximity points be implemented. Additionally, UNOS should propose new policies to encourage greater utilization of kidneys, especially marginal kidneys, by all transplant programs and simplified programs to direct only the organs needed to move from high supply areas to high demand areas.

Doctors Hospital at Renaissance | 10/02/2019

Dear Public Comment Coordinator: Doctors Hospital at Renaissance Health System (DHR Health) thanks you for the opportunity to submit feedback on the proposed policy changes eliminating the use of Donor Service Area (DSA) and Region in kidney allocation. About DHR Health DHR Health is a homegrown, grassroots physician-owned community health system developed by local physicians with the goal of eliminating the need for our local residents to seek medical services outside the region by addressing all of the health care needs of our community. Located in the Rio Grande Valley of Deep South Texas, we serve an area of over 1.3 million people, and provide access to high quality health care in one of the poorest regions of the country. We are a safety-net hospital where 44% of our patients are Medicaid and 25% Medicare (by discharge). We are a full-service health system with 500+ beds, 600+ physicians, and 1,400+ nurses providing the full continuum of care in over 70 specialties and sub-specialties. We provide the most comprehensive and specialized health care in the Rio Grande Valley and we are continually working to forge an integrated health care delivery model that incorporates patient navigation, electronic medical records, population-based care, graduate medical education and superior quality and efficiency to meet every patient’s needs. Our innovative advancements and willingness to break the mold have shaped DHR into the leading health system of the Rio Grande Valley. Since 2017, DHR Health has evaluated hundreds of patients for a kidney transplant. We currently have 190 patients listed on the UNOS wait list, and have successfully transplanted 39 patients. Thousands of the 1.3 million residents in the Rio Grande Valley are diagnosed with CKD and ESRD. Our region is also known as the “hot spot” for diabetes and liver disease. Given that we are the only adult kidney transplant center within a 230 mile radius, you would expect transplantation at a much higher rate. With confidence, we can attest to providing the highest quality and most efficient care to our patients, however, we are faced with many geographic barriers and will certainly face more if the proposed kidney allocation policy is adopted. As we explain in more detail below, DHR strongly opposes the OPTN Kidney Transplantation Committee’s recommendations to eliminate the use of DSA and Region in Kidney Allocation and to allocate proximity points based on location to a donor hospital: The OPTN Kidney Transplant Committee’s proposal to remove DSA and Regional boundaries used in the current kidney allocation system and change the allocation process to utilize a 500 nautical mile (NM) fixed-distance circle around a donor hospital will severely impact DHR, but most importantly our patients. We are geographically located in the Southern United States along the Mexico and Gulf of Mexico borders. Within our current DSA, we have 4 kidney transplant centers. Expanding to a 500 NM radius will increase the number of donor hospitals in our fixed-distance circle, but will also increase the number of transplant centers as well. This includes some of the largest and busiest metropolitan centers in the nation, with a high rate of registered organ donors, making it nearly impossible for DHR to stand up against. Decreasing the distance from 500 NM to 250 NM will give South Texas a more comparable position to how we operate now, and will certainly be in line with the Final Rule 121.8 b(3) to “distribute organs over as broad a geographic area as feasible.” With regard to proximity points allocations, the current Final Rule, section 121.8 a(8) states allocation policies “Shall not be based on the candidate’s place of residence or place of listing.” The proposal to award proximity points provides candidates closest to the donor hospital an advantage. How is assigning proximity points not a determinate to access? How would this be equitable to our candidates at DHR? The RGV has few donor hospitals, along with a low registered organ donor rate with a low conversion rate of approximately 50%. Under the committee’s proposal, our centers candidates will be awarded less proximity points leading to reduced offers and offers the major metropolitan transplant centers decline, ultimately adding cold ischemic time to the kidney due to distance and transport. Shipping kidneys poses additional issues for us in South Texas. With few direct flights into our regional airport, ground transport while pumping a kidneys has been the most efficient manner to ensure the best outcomes for our patients. Of the 39 transplants we have performed, we had one import flown in from Dallas, the fourth busiest airport in the world. Initially, it was announced to us that the kidney had missed its flight. Once it arrived to McAllen (earlier than expected because it had in fact made the earlier flight but was not properly tracked), the contracted courier was unable to locate the cargo bay causing a further delay to the case. The iced kidney was finally released to the hospital’s courier service. In this particular case, the travel time via plane from Dallas ended up being longer than it would have taken to transport the kidney via ground. In analyzing this proposal, one must ask which populations will be most impacted by these changes. The Rio Grande Valley and other non-metropolitan areas in the country will definitely be at a disadvantage if this proposal is adopted. A decision to eliminate the use of DSA and Region in Kidney Allocation Policy will decrease transplant rates in non-metropolitan areas and increase access and equity with metropolitan candidates as noted through the research by the OPTN Kidney Transplantation Committee. DHR agrees with the committee’s recommendations to maintain kidney prioritizations for pediatric and living prior donor patients and the medical urgency and import backup proposal. We appreciate the committee’s recommendation on kidney prioritization remain in place for pediatric and living prior donor patients. Living donors exhibit true altruism when donating an organ to a person in need. Therefore, we too must remain committed to helping them should they need and organ transplant in the future. Their selflessness should be protected and reciprocated if needed. In addition, our pediatric patients must also remain a priority when allocating a kidney. A kidney transplant can potentially increasing their quality of life for up to 25 additional years, enabling them to reach their true potential and realize their dreams. We also agree with the committee’s medical urgency and import backup proposal. As previously mentioned, time is of the essence when trying to match and transplant a kidney with a patient in need. We support a receiving center being allowed to keep a kidney within 150 NM in the event that the original recipient is unable to move forward with the transplant due to unforeseen circumstances. We believe maintaining an organ within 150 NM will maintain the integrity of the kidney and allow for a faster transplant to take place. In closing, DHR respectfully request the OPTN consider a smaller fixed-distance radius of 250 NM instead of the 500 NM proposed and reject the proposal to allocate proximity points based on the distance to a donor hospital. We ask the OPTN adopt the committee’s recommendations to continue to assign priority to pediatric and prior living donor candidates and their proposal regarding medical urgency and import backup. *** DHR appreciated the opportunity to provide these comments and we look forward to working with the OPTN to encourage the delivery of equitable and quality care to patients in need of a kidney transplant. If you have any additional questions, please do not hesitate to contact our Transplant Administrator, Ms. Laura Disque RN, by phone at (956) 362-8020 or by email at l.disque@dhr-rgv.com. Respectfully, Dr. Jose Almeda Transplantation Surgeon Transplant Program Director Doctors Hospital at Renaissance Health System

Nonprofit Kidney Care Alliance | 10/02/2019

Dear Kidney Transplantation Committee: On behalf of the Nonprofit Kidney Care Alliance (NKCA), I write to offer our views on the Committee’s proposal to eliminate the use of DSA and Region in kidney allocation policy. NKCA represents six nonprofit dialysis providers: Centers for Dialysis Care; Dialysis Center of Lincoln; Dialysis Clinic, Inc.; Independent Dialysis Foundation, Inc.; Northwest Kidney Centers; and The Rogosin Institute. Collectively, we serve more than 21,000 patients at more than 300 facilities in 30 states. In an effort to keep patients off dialysis, we also serve more than 5,700 patients with chronic kidney disease (CKD) with the goal of avoiding, or at least delaying, the onset of end-stage renal disease (ESRD). We are committed to promoting transplant, eliminating barriers to access, and reducing discards. The Department of Health and Human Services’ Advancing American Kidney Health (AAKH) initiative includes a focus on increasing transplant, an objective we strongly support. For instance, new models of care announced by the Centers for Medicare and Medicaid Innovation (CMMI) would promote expanded access to transplant, but without access to additional organs, this goal may not be attainable. We believe it is critical that transplant policies not run counter to this objective and that any new policy or system that may decrease the transplantation of organs which runs counter to critical efforts to improve kidney care should not be implemented. As transplant and kidney care advocates looking ahead to these changes we believe it is critical that the Committee take the time to seek further stakeholder input broadly from the entire industry through an open and transparent process and provide further information on the basis of its proposed policy. We stand ready to assist the Committee and UNOS in ways to increase transplantation. If you have any questions, please feel free to contact Martin Corry at 202-580-7707 or info@nonprofitkidneycare.org. Sincerely, Martin Corry, Executive Director

Virtua Our Lady of Lourdes Hospital | 10/02/2019

On behalf of Virtua Our Lady of Lourdes Hospital, part of Virtua Health, thank you for the opportunity to comment on the Organ Procurement and Transplant Network’s proposed elimination of the use of DSA and region in the kidney allocation policy. Virtua Our Lady of Lourdes Hospital, in addition to New Jersey’s other kidney transplant centers, Hackensack University Health Center, Saint Barnabas Medical Center, and Robert Wood Johnson University Hospital, as well as New Jersey Sharing Network (NJSN), the state’s main Organ Procurement Organization (OPO), collectively care for the highest population density of transplant patients experiencing severe condition acuity. We believe that the current proposal from United Network for Organ Sharing (UNOS), while laudable in its goal to create a more equitable distribution of deceased donor kidneys, will yield adverse and severe consequences for the transplant population in our region. Specifically, the State of New Jersey will experience a significant inequity in recipient waiting times for life saving kidney transplants when compared to neighboring donation service areas (DSAs), most notably New York City. This imbalance is not due to the DSA system in operation for more than three decades, but due to various other factors, including the failure of individual, underperforming DSA practices and partnerships of a neighboring OPO that have not been adequately held accountable in the past. Decreased Access for New Jersey Kidney Patients: The implementation of the proposed policy would suddenly and disproportionately decrease access to transplants for the patients we serve in New Jersey. Kidney transplant allocation – unlike livers, lungs, or hearts – is prioritized based on wait-time, as opposed to the severity of the patient’s need. On average, current wait times in New Jersey are 3-4 years shorter than wait times in the neighboring New York City region’s DSA. Therefore, under the proposed model, patients who have been waiting longer for a kidney in New York, but who may be in better health than patients waiting in New Jersey, will receive priority for the first several years. In fact, very few patients in New Jersey will receive deceased donor transplants (despite proximity points), due to the long accumulated waiting times of thousands of patients in adjacent New York. For patients at New Jersey transplant centers, the elimination of DSAs will likely increase average wait times by at least three years, contribute to an estimated 300-500 avoidable deaths, and adversely affect thousands of other patients by delaying their receipt of life-saving transplants. Worse Outcomes for New Jersey Kidney Patients: The proposed changes will not only decrease the total number of transplants, but will also lead to worse transplant outcomes. Prolonged cold ischemic times from the proposed broader sharing, with its attendant complications, will cause more delayed allograft function, a direct correlate of transplant outcomes. Moreover, a large, sudden influx of available kidneys at centers in DSAs with historically long waiting times would lead to worse outcomes, due to mismatches between existing center resources/staffing and the abrupt increase in volume. It is well documented that transplant centers which experience sudden volume increases also experience decreases in graft and patient survival. The current UNOS proposal will, in short shrift, result in this misallocation of available organs and the inevitable poor outcomes. Decreased Kidney Donation in New Jersey: Although donors are a national resource, deceased donation is almost entirely driven by local efforts and led by OPOs. New Jersey has a historically high rate of voluntary kidney donation, and the decision to donate is often very personal and emotional. While donors know that they cannot earmark their donated organs, they do often prefer their organs be transplanted locally. The UNOS proposal, at least in the short-to-medium run, will result in almost all locally procured kidneys being shared outside the DSA to recipients in other states. Increased Administration Burden: the proposal will cause transplant centers like Virtua Our Lady of Lourdes Hospitals to incur additional administrative burdens to coordinate kidney allocation with a corresponding lower volume of transplants as a result. Recommendation: Accordingly, we strongly urge UNOS not to approve or finalize this proposal in its current form. Instead, we propose a more moderate and gradual change to the current system, based primarily on the long-established tradition of procurement programs being a state resource. A more gradual shift would limit drastic changes for waiting populations, support the established transplant and OPO practices, and fulfill the transplant needs of local communities, while still ultimately promoting equity. In addition to a more phased-in implementation, we propose that wait-listed patients be assigned extra allocation points if the donor organ is procured in their own DSA. These assigned points can be reduced on a yearly basis until the assigned points reach zero, thus allowing the majority of wait-listed patients to receive a transplant within their anticipated wait-time. In the meantime, educational programs regarding these new policy changes can be geared toward newer wait-listed patients, allowing them to make more informed decisions on where they wish to wait-list. We also suggest that the new policy maintain the current policy that kidneys not accepted locally for transplant be directed to the areas of greatest need. The benefits of such a system would continue local DSA sharing practices to minimize risk to donor organs and recipients, maintain DSA accountability for organ yield, reduce organ discards by promoting expedited sharing, and bridge the equity gap by promoting expedited placement to disadvantaged DSAs. We believe that these modest modifications to the current policy, as opposed to the overhaul promulgated by the proposed policy, will best serve to achieve our mutual goals in reducing geographic disparities in waiting times and improve the overall equitable procurement and distribution of kidneys for transplant. Again, thank you for the opportunity to comment on this important proposal.

Anonymous | 10/02/2019

The OPTN Histocompatibility Committee received a presentation on the Kidney Committee’s proposal during their monthly teleconference on September 10, 2019. The Committee was not in total agreement towards this proposal however, they supported the concept. Below are some concerns they had: • In regards to import back up, members felt as though the 150 NM circle around the intended recipient transplant hospital is not logical for donor service areas because an OPO could be hours away from the recipient hospital. A suggestion of moving the circle around where the organ is for reallocation. • There was some confusion about how the proximity points were chosen especially outside the circle and why such a high number (8 points). • Lastly, members commented that this intermediate system seems strange; it does not make intuitive sense, and would like to go to continuous distribution, but understands that this intermediate step is necessary. The Committee appreciated the opportunity to provide feedback on this proposal.

New England Donor Services - CTOP and MAOB | 10/02/2019

NEDS supports the removal of DSA and region as units of distribution in kidney allocation with the following input: - NEDS supports use of concentric circles (whether 250 or 500) for distribution of kidneys as an initial and transitional step towards a continuous distribution framework which NEDS believes will better serve patients and the system. - NEDS supports the implementation of an Emergency Kidney status with qualifying criteria for such status. In such a circumstance emergency kidney candidates should have access to kidneys from all compatible blood groups to provide greater opportunity to undergo renal transplantation. - When considering the re-allocation of kidneys as a back-up if a local program declines the kidney, or the intended candidate is deemed not suitable, the exporting OPO should be responsible for the reallocation within a reasonable parameter of the originally intended center rather than rely on the receiving/importing OPO. The re-allocation of kidneys in such circumstances introduces a layer of operational complexity and additional responsibility by an OPO that may not have even been involved with the initial placement and import of the kidney (and that OPO will not be held accountable from a CMS or OPTN regulatory perspective for that placement - the original/exporting OPO will). It should also be noted, additional cold ischemic time in the re-allocation of a kidney post recovery may necessitate the bypass of offers to highly sensitized candidates rather than perform additional crossmatches which, if positive, would result in additional cold time on the kidney and risk of discard.

Stephen Pastan | 10/02/2019

Comment from Stephen Pastan, MD and Rachel Patzer, PhD (Emory Transplant Center, Emory Health Services Research Center; Atlanta, GA); We have reviewed the proposal carefully and have attended the regional meetings to listen to the talks and the discussions about the newly proposed changes to the kidney allocation policy, an we have several comments for consideration. • While we champion any efforts to improve equity in access to kidney transplantation, we believe the measure for equity in this UNOS proposal is not the correct measure of equity. The new proposal targets reducing geographic disparity for patients on the kidney transplant waiting list. We believe that all patients who have kidney disease, and are eligible for kidney transplantation, including those with ESRD and advanced chronic kidney disease, should have an equal change of receiving a kidney transplant, and should be included in any denominator of an equity assessment. The proposed measure of equity is based upon kidney transplant candidates on the waiting list, but does not consider all of the patients who have end-stage kidney disease who could benefit from a transplant, but who have difficulty accessing the waiting list. For example, the Southeastern region of the United States, we have among the lowest rates of kidney transplantation in the nation when all ESRD patients are considered in the denominator. Multiple factors contribute to this low transplant rate, but lower access to the early steps of the transplant evaluation process, including lower referral rates, limit access to the transplant waiting list. A higher prevalence of racial minorities, a larger population of patients of low socioeconomic status, and a smaller number of transplant centers relative to the ESRD population also contribute to a lower transplant rate in our region. We believe that focusing on geographic disparity of waitlisted patients is not specified in the Final Rule, and focuses too narrowly on waitlisted patients only. We would propose that UNOS carefully study how this new proposal would impact areas with low waitlisting but higher burden of ESRD prior to implementation. • The proposal also moves kidneys from DSAs with higher kidney procurement rates to areas where OPOs are not as efficient the kidney procurement process. We believe the remedy for this disparity are programs to address the underlying problem, which is disparity in OPO quality, as was recently highlighted in the Presidential executive order -- not by changing the patterns of kidney distribution. • The overall decrease in the number of transplants projected by the model is concerning, and is likely to be more than anticipated. With increased travel times for organs, it is likely that organ turndown and organ discard (which has increased over time since 2010), will also increase. This is concerning, and we would propose more monitoring of organ discard by regions an organ turndown measures to monitor quality. • Significant geographic differences are projected to continue to exist under this new proposal (even if based on waitlisted candidates). It seems less valuable to pass a proposal that does not more completely address the equity disparity. Overall, we strongly suggest that UNOS examines the effect of the policy on access to transplant among all end-stage kidney patients, not just those on the waiting list, to ensure that end-stage kidney disease patients who are not yet waitlisted are not disadvantaged.

NJ Sharing Network | 10/02/2019

New Jersey Sharing Network, NJTO, New Jersey’s primary OPO, welcomes the opportunity to provide comments regarding the UNOS proposal to eliminate the use of donation service areas (DSAs) and regional boundaries in kidney allocation. Our four transplant centers and the NJTO agree with UNOS that more equitable distribution of deceased donor kidneys is laudable and needed. Our comments are as follows. FIRST, we believe that the goal of any allocation policy change should be that of increasing transplants in the targeted patient community not maintaining or possibly decreasing them. The KPSAM model does not provide confidence that any more patients will be transplanted. Our read of the models is there might be a small increase in deaths on the wait list. This would be unacceptable. In essence – as with the broader sharing liver allocation policy – transplants will not increase - only different patients will be transplanted. We believe that the implementation of the proposed policy will suddenly and disproportionately decrease access to transplant for the patients in New Jersey. Current waiting times in NJ are a few years shorter than waiting times in the adjacent DSA in New York. Under the proposed model, for the first several years, we believe very few patients in New Jersey will receive deceased donor transplants (despite proximity points), due to the long accumulated waiting times of thousands of patients in adjacent New York. For patients at New Jersey centers, the elimination of DSAs for allocation will likely increase average wait times by at least 3 years, contribute to an estimated 300-500 unnecessary deaths, and adversely affect thousands of other patients by delaying their receipt of life-saving transplants. The candidates on the waitlist in New Jersey have made “life decisions” based upon their anticipated wait-time for a kidney transplant, and the current proposal will upend these choices. SECOND, the proposed changes will not only slightly decrease the total number of transplants, but will also lead to worse transplant outcomes. Prolonged cold ischemic times from proposed broader sharing will cause more delayed allograft function, with its attendant complications. More subtly, a large bolus of kidney transplants at centers in DSAs with historically long waiting times may lead to worse outcomes, due to mismatches between existing center resources/staffing and abruptly increased volume. In the past, transplant centers that have suddenly increased their volume have almost inevitably experienced an ensuing decrease in their graft and patient survival (leading to UNOS oversight!). The current UNOS proposal will cause such detrimental spikes in volume. THIRD, the current proposal may inadvertently discourage local donation in New Jersey. The UNOS proposal will cause almost all locally procured kidneys to be shared outside the DSA to recipients in other states, at least for the first few years, and this phenomenon may have the unintended effect of decreasing local donation rates. Although donors are a national resource, deceased donation is almost entirely driven by local efforts, led by OPOs. FOURTH, under the proposed changes, transplant centers and OPOs will have to juggle many more organ offers from a large nautical mile radius. The ensuing higher costs and increased complexity will not even lead to an increase in transplant, but will instead be part of a system that knowingly decreases transplant. FIFTH, CMS just published new rules regarding transplant performance measures that essentially return the ability of transplant centers to be more aggressive in acceptance of organs without increased concern regarding one year outcomes. This change could lead to fewer discarded organs. Since this was not factored into the KPSAM, it will not be known what impact this change in performance rules will have on the availability of kidneys that may currently be discarded to patients in the New York City DSA. For these reasons, the NJTO strongly urges UNOS to NOT approve or finalize the plan as it is currently written. We respectfully submit 3 suggestions regarding this proposal, and these suggestions reflect our belief that any alterations in organ allocation should be less sudden. A more gradual shift would limit drastic changes for waiting populations, support the established transplant and OPO practices, and fulfill the transplant needs of local communities, while still ultimately promoting equity. FIRST, we suggest that to implement the proposed changes gradually, the proposal could include an organ-sharing limit per year, outside of the local DSA. For example, in any given year, the number of shared kidneys could be capped at a to-be-determined percentage of a DSA’s total number of procured kidneys from the prior year. Alternative caps could be proposed. Such a cap would still reduce the disparities in waiting times among DSAs, while also enabling a smoother transition to broader sharing. SECOND, wait-listed patients could be assigned extra allocation points if the donor organ is procured in their DSA. These assigned points can be reduced on a yearly basis until the assigned points reach zero, and this gradual phase-out will allow the majority of the wait-listed patients to receive a transplant within their anticipated wait-time. For example, currently wait-listed patients can receive 3 additional allocation points if the organ is procured in the DSA where they are listed, and this assigned point can be reduced by 0.5 each year; as a result, by year 6, this assigned point will be zero. Use of such points will also allow equitable distribution of organs to occur. In the meantime, newer wait-listed patients will be educated about the new policy change and can use the new anticipated wait-times to make their decisions on where they wish to wait-list. This temporary use of local allocation points, in addition to proximity points, will ensure that rates of deceased donor transplant do not suddenly spike or crash due to this new policy, while still promoting broader sharing and less disparities in waiting time. THIRD, we suggest that kidneys that are not accepted locally for transplant should be directed to the areas of greatest need using any nautical mile radius instead of regional and national allocation. This new allocation system could first be added as third tier after local and regional allocation. This alternative would mirror the intentions of the UNOS Kidney Accelerated Placement Project (KAPP) program. The benefits of such a program would maintain local DSA sharing practices to minimize risk to donor organs and recipients, maintain DSA accountability for organ yield, reduce organ discards by promoting expedited sharing, and bridge the equity gap by promoting expedited placement to disadvantaged DSAs. In CONCLUSION, NJTO agrees that reduction in geographic disparities in waiting time is desirable, and they also agree that the current UNOS proposal should be modified and improved before any implementation.

OneLegacy | 10/02/2019

• What factors should be used to select a circle size that distributes kidneys broadly and efficiently? o The Committee should be commended for the work done to evaluate circle size according to the proposal. o OneLegacy supports the removal of DSA as a unit of allocation. We greatly prefer the use of “Continuous Distribution” over “Circles”, but understand that Circles are the quickest way to eliminate DSA as a unit of allocation. Ideally we support a composite score as outlined in the Continuous Distribution Model proposed by the Ad Hoc Geography Committee. o Anticipating Circles are adopted, we ask the committee model broader circles at 750 and 1000NM’s. 500NM is significant, but the kidney is more resilient to cold time than the other organs and has proven to tolerate travel time via the 100-99% CPRA sharing and 500NM is less valuable in accomplishing broader sharing in the Western US. • Should proximity points be used inside the 500 NM circle? Should they be used outside the distribution circle? How should the assigned values be weighted in relation to other kidney allocation points? o At OneLegacy we advocate for ZERO proximity points both inside and outside of the circle. Sharing of organs at the National and Regional level occurs currently due to the 100% and 99% CPRAs. As kidneys can tolerate the most cold time of all organs, the leveling out of PTRs in the circle seems appropriate. Additional, we see no benefit to assigning points to PTRs outside of the circle. In fact the implementation of KAPP seems to be counterintuitive to assigning proximity points to PTRs outside of the circle. If a kidney has been declined by all PTRs in 500NM radius, then the more aggressive centers outside of the 500 NM radius are the best bet to get the kidney transplanted. • What priority do you think is appropriate for pediatric candidates? Should prioritization be applied inside the distribution circle? Should prioritization be applied outside the distribution circle? o OneLegacy feels that pediatrics should get priority inside and outside of the circle as the pediatric population is very small compared to the adult waitlist. Giving pediatrics more priority should not significantly impact the adult population wait time, considering the relatively low number of pediatric patients on the waitlist. o Additionally, we advocate that the Pediatrics be given access right behind the Prior Living donors on the Sequence C lists KDPI 35-85%. o Due to the small population of prior living donors and pediatric PTRs, the committee should consider making their allocation classification National instead of one classification within 500NM and one classification outside of 500NM. • What priority do you think is appropriate for prior living donor candidates? Should prioritization be applied inside the distribution circle? o OneLegacy agrees to let the prior living fall behind the 100-99% CPRAs as outline in the proposal, for both inside and outside the circle. • What operational concerns should the committee consider as this policy is being prepared for OPTN board action and implementation? o The committee should consider the impact of prospective HLA crossmatching needs and the impact on increased sharing. • Should medical urgency criteria be defined? If so, what specific conditions would qualify? Where should the new medically urgent classification be placed within allocation tables? Should placement within allocation tables vary depending on the KDPI of the donor kidney? How should two medically urgent candidates be prioritized should two appear on the same match run? o OneLegacy supports the proposed medical urgency proposal to create a national medical urgency subcommittee. We have had a successful practice for years granting medical urgency to local PTRs based on lack of vascular access as determined by two vascular surgeon consults and lack of ability to perform peritoneal dialysis. We would support the committee restricting the criteria to vascular access issues only. Adding additional criteria may open the door to too many potential reasons to consider a PTR medically urgent. o We suggest time limits for the approved Medically Urgent PTRs to receive allocation priority, such as 30 days. o We agree with the ranking suggestions proposed in the policy. • When import back up is granted, do you support the use of an import match run for the import OPO to reallocate the kidney? Should the match run use the same size circle as the original allocation but with increased points for proximity? Should the circle size be smaller? If so, what distance will promote the efficient reallocation of kidneys? o Smaller circles (150NM?) would seem more efficient to promote prompt allocation of reallocated kidneys.

Dialysis Clinic, Inc. | 10/02/2019

Dear Kidney Transplantation Committee: On behalf of Dialysis Clinic, Inc. (DCI), I appreciate your acceptance of comments on the recently release proposal to eliminate the use of DSA and Region in kidney allocation policy. DCI is the largest nonprofit provider of care for patients with kidney disease in the country and was founded forty-eight years ago (two years before Medicare covered dialysis services) to save the lives of eight patients in Nashville, TN while awaiting a transplant. We currently care for more than 15,000 patients in 245 facilities in 28 states. Our goal in caring for dialysis patients and others with kidney disease is to provide the best care possible by improving patients’ quality of life, reducing the risk of kidney failure and increasing the number of kidney disease patients who receive kidney transplants. As part of that mission, we run three organ procurement organizations (OPOs) located in Tennessee, New Mexico and Northern California. Because of the hard work of the staff at DCI Donor Services, 625 people received a kidney transplant in 2018. We believe to adopt the UNOS proposal to substitute sharing within concentric circles of either 250 or 500 miles for the current allocation policy would be a mistake as it likely would result in increased discard of kidneys and a decreased number of kidney transplants performed. Currently the allocation of deceased donor kidneys by an OPO gives initial priority to the donor service area (DSA) of the OPO that serves the hospital in which the donation takes place. Thus the transplant programs within the same service area have the first opportunity to use the organs from these donors. There were three reasons that the allocation system was set up in this way: 1. By sharing the organs in this way, recipients from the same area that provided the organs have priority to benefit from their donation. 2. The proximity of the transplant hospital to the donor hospital allows for a shorter time between the time of donation and the time of transplant, thereby shortening the preservation time and improving the physiologic quality of the organs being transplanted and thus the likelihood of a successful outcome and decreasing the chance of organ discard. 3. By transplanting a larger proportion of the organs closer to the place where they were donated, transportation and logistics costs are lessened and the process is accomplished efficiently from the financial point of view as well. Of course, if no suitable recipient can be located within the local area, the system then provides for the ability to share the organ outside the local area – first regionally then nationally. We believe that the UNOS proposal, if adopted, is likely to result in an increase in the discard rate for kidneys and a decrease in the number of transplants being performed, as was shown in the modeling of the proposed system by UNOS itself. The modeling of the proposed system of sharing as presented at the recent Organ Procurement and Transplantation Network (OPTN) Region 11 meeting suggested that 1,500 fewer transplants per year would be performed under the new allocation system than are currently being performed due to an increased discarding of kidneys. It seems likely that the increased kidney discard predicted would be a result of increased preservation times and more complex logistics inherent with the proposed system. Clearly any new system that seems likely to decrease the transplantation of, and increase the wastage of organs, is counterproductive and should not be implemented. Particularly with the growing attention to promote transplant from the Administration through the Advancing American Kidney Health (AAKH) initiative, it is not appropriate to be promoting any policy that would lead to a decrease in organ availability. We would be pleased to continue to discuss our concerns with the Committee. If you have any questions, please feel free to contact me. Sincerely, Keith Johnson, MD Chairman of the Board Doug Johnson, MD Vice Chairman of the Board

UMCSN, Center for Transplantation | 10/02/2019

As the only Transplant Center in Nevada, we strongly oppose the proposed kidney distribution changes. The 500-mile radius is too large and will lead to significantly decreased access to kidney transplants for Nevadans despite being a very high registered donor area. Approximately 60% of Nevadans are registered donors and expect that their kidneys will go to other Nevadans and not be shipped out of state. The proposed allocation changes are concerning for both the patients needing a kidney transplant in Nevada and the ability to maintain a viable transplant program in Las Vegas, Nevada. The following changes noted specifically in the proposal will occur if the modeling is a good estimate of the change: 1. Cold time for kidney transplants will go up. This is notable because modeling of median distance of travel for kidney is 314 nautical miles vs 2.5 miles currently. This will result in: a. More delayed graft function b. More rejection episodes c. Decreased long term graft survival 2. The rate of transplantation will go down from 89 to 26 cases per year(modeled) leading to financial hardships to maintain a viable program a. Rate goes to .123 from .499 b. List size has increased since 2016 from 160 listed patients to 200 listed patients, so the rate may even be less c. It is highly likely that costs will increase Nationally the rate for kidney transplant will go down. Discards will go up. Who will explain that to donor families who donated their loved one’s kidney, only to find that the kidney was discarded because of logistical issues of transporting kidneys from near to far? Decreased access to transplantation for rural & isolated Americans violates the Final Rule. Donation is fundamentally a local issue whether in church, business, politics and in scarce resource utilization such as donor organs. If you take a scarce resource away from a local community that is highly giving, and give it to an underperforming metropolitan area where the donation rate is significantly less, you will likely incur displeasure and negative consequences in donation and in other political issues, knowing that your local population will be discriminated against in favor of an under giving metropolitan area. The proposal includes false logic: “…most urgent candidates are prioritized, thereby promoting greater equity in access to transplantation.” Urgency does not equate to equity, in fact, it increases transplant morbidity & mortality. The proposal ignores the larger issue that potential organs are not being acquired due to underperforming OPOs. This proposed change in organ distribution does not take into account the disparity in donation rates at the DSA level, and will remove incentives to change policies and procedures to improve donation and service in those underperforming areas. Is UNOS and the OPTN merely a distribution network looking for an Orwellian distribution equity enhancing 26% of DSAs, or does it really care about donation equity(normalization)? The poorest performing DSA in the country will import nearly 550 kidneys resulting in an increase in kidney transplants by 136%. 74% of the remaining DSAs will decrease in numbers of transplants. One must first know/have the entire pool of organs before then determining how best to share that pool. We need a broader look and a broader plan to assure the best use of a scarce resource. The proposal acknowledges that the model that it is based upon is flawed. UMCSN, Center for Transplantation strongly opposes the kidney distribution changes being proposed.

AdventHealth | 10/02/2019

AdventHealth advises the OPTN to slow the process of broadening geographic sharing to more effectively account for the impact on donor organs and transplant candidates, and to better reflect the other requirements of the OPTN Final Rule. We believe the policy change to a 500-Nautical-Mile circle will significantly decrease access to kidney transplants in the communities we serve, particularly in coastal states. In Florida, for example, the proposed circle from the center of the state is largely comprised of miles of ocean. According to local Organ Procurement Organization (OPO) data, if the 500 NM policy was implemented, approximately 60 percent of kidneys recovered in Florida would be exported to other states. However, Florida is not the only state that would be negatively impacted by this policy. We urge the OPTN to account for unique geographic situations (such as exist in Florida) when setting allocation regions. Overall, the proposed changes reduce access for end-stage kidney failure patients in these regions, running contrary to the OPTN’s policy goal of advancing transplant equity. The change adds complexity to an already challenging system and will result in both greater organ waste and fewer patient transplants. For these reasons, we respectfully request that you reject a “one-size-fits-all” approach to organ allocation and reconsider the proposed kidney allocation policy change.

Anonymous | 10/02/2019

Strongly support (3), Support (8), Neutral/Abstain (0), Oppose (2), Strongly Oppose (1) The region is supportive of the broader distribution of kidneys, but is concerned about the logistics associated with a 500 NM circle with proximity points (4,8). Several members think that the number of points given to candidates within the first circle is too high, in fact the opinion is that the committee should consider awarding no points in the first circle, and deemphasize the points in the larger circle. One proximity point equals one year of waiting time, and the assignment of 4 and 8 proximity points advantages candidates closer to the donor hospital to a degree that might not be appropriate or necessary. A member commented that broader distribution of kidneys will allow for more equitable allocation of kidneys, and it is the right thing to do. The region has several concerns about logistical issues. A member did comment that OPOs are stewards of the organ donation and want a successful outcome for the donor family. But there are operational realities that must be acknowledged. Members stressed that the committee cannot discount the logistical issues associated with sharing kidneys and pancreas in a 500 NM circle. The following issues were raised: 1) Cross matching candidates: there will be an increased number of candidates in the first circle, particularly in the Northeast, and the OPO will not have enough tissue or blood to send for cross matching 2) the # of late declines is also likely to increase as transplant hospitals receive more offers and decline due to receiving better quality kidney offers. The member suggested the committee consider limiting the number of acceptances a program can have for a candidate at a time (similar to liver policy) 3) With the high likelihood of kidneys being sent out of the local area, smaller volume OPOs with fewer local transplant hospitals will struggle with recovering kidneys from organ donors where only kidneys are recovered that will be sent out of the local area. While broader distribution is supported by the region, the region is concerned with the logistics associated with a 500 NM circle and some suggest the 250.250.2.4 variation might help reduce concerns about the logistical realities. Other members are supportive of the 500 NM circle, but concerned about logistical issues associated with this level of sharing, and the number of proximity points assigned. The committee should address the logistical concerns so that is isn’t necessary to give more priority through a high number of proximity points. A concern was also expressed about how increased equity affects transplant counts for programs in rural or less-populated areas. A member commented that kidney allocation should use KDRI instead of KDPI. Medical urgency: the region would like the committee to consider implementing a time limit as to how long a candidate can be listed as medically urgent. Import back-up: there are concerns that generating a new match run will increase cold ischemic time.

Carolina Donor Services | 10/02/2019

Carolina Donor Services supports the OPTN goal of removing the DSA and region from kidney distribution. We support policies that maximize transplantation and therefore have concerns about logistical inefficiencies, increase costs, and the likely increase in organ discards that will result with a 500-NM circle. A 250-NM circle is a more appropriate distance to initiate a change that eliminates DSA and Regions from distribution. Additionally, the committee must monitor the impact that any rule change has on the rural and under served populations of the Southeastern US. We support the development of criteria for medical urgency.

West Virginia University Medicine | 10/02/2019

While we support efforts to increase equity in organ allocation, we believe this proposal misses the mark and requires amendment. The current proposal will increase the number of kidneys requiring air travel, increase cost, and increase cold ischemic time. It will also disadvantage rural patient populations. For our rural, Appalachian population, access to a waiting list and transplant center is already difficult. Poor roads, mountains, and geographic isolation, common in Appalachia and other rural areas, will exacerbate the effects of increased organ travel distance and cold ischemic times. Additionally, we encourage the committee to consider whether the donor hospital or the OPO operating room will be considered the center of the circle. Methods to improve disparities between OPO performance should also be considered. We would support an amendment to this proposal that changes the radius to 250 nautical miles. We also encourage further clarification of some of the questions remaining including OPO performance disparities. Respectfully, Lynsey Biondi, MD, FACS, West Virginia University Hospital Physician Director of Transplantation and Shelley Zomak, RN, MS, CCTC, WVUH Director of Operations and Compliance

American Society of Transplant Surgeons | 10/02/2019

The American Society of Transplant Surgeons (ASTS) opposes this policy proposal as written. We recommend the OPTN take an iterative approach to all new organ allocation policies by taking small steps with regular reassessments (e.g., one year) to identify successes and unintended consequences, particularly concerning logistical issues. 1. What factors should be used to select a circle size that distributes kidneys broadly and efficiently? We do not agree with the working committee that utilizing a circle of 500 NM would be optimal for maximizing deceased donor kidney utilization and minimizing organ discards. We support a 250.250.2.4 model. This would also be consistent with our recommendation of the pancreas allocation system. These two would have among the lowest negative impact on the total number of kidneys estimated to be transplanted. The 250.250.4.2 model for kidney allocation would also substantially smooth out the kidney transplant rate by DSA. It would also have one of the highest transplant rates per patient-year. It also would have the lowest waitlist mortality rate per patient-year. It also has the best predicted the shape of travel distribution and distribution of travel distance giving it an advantage in travel logistics. Kidneys from older donors especially those with higher KDPI do not tolerate longer cold ischemia times. Also, it takes longer to transport kidneys to smaller rural centers whose cities are distant from a major airline hub where the organs are initially flown in when coming in from long distances greater than 250 NM. Being away from a major airline hub considerably extends transportation times because the organs are often transported by road from a city with a major airline hub. Overextending the circle size to 500 nm will worsen the transportation times and result in increased risk of discard rates. 2. Should proximity points be used inside the 500 NM circle? Should they be used outside the distribution cycle? How should the assigned values be weighted in relation to other kidney allocation policies? The use of proximity points within the 250 NM range could certainly help with operational efficiency and minimize cold preservation times. Once the distance to travel increases between 250 and 500 NM the proximity points still help, however, greater than 500 NM, there is little value in allocating proximity points, since the kidneys probably traveled by plane, and it is unlikely that any gains in preservation times could be achieved. The assigned values of proximity points should take into consideration the donor quality and age. This could certainly reduce the discard rates for the higher KDPI and order kidneys. 3. What priority do you think is appropriate for pediatric candidates? Should prioritization be applied inside the distribution circle? Should prioritization be applied outside the distribution circle? There are several concerns regarding pediatric candidates in this proposal. I. Although the modeling suggests that the pediatric candidates could receive higher priority, the eventual outcome could be otherwise. For example, after implementation of KAS there was a decrease in the number of pediatric transplants. II. More importantly, this proposal does not address the organs from the pediatric donors. The organs from pediatric donors should be first allocated to pediatric recipients. Perhaps, this could be national allocation as these younger donors could tolerate longer, cold ischemia times. III. The pediatric allocation priority: pediatric candidates should be listed above the candidates that receive multi-organ transplants. 4. What priority do you think is appropriate for prior living donor candidates? Should prioritization be applied inside the distribution circle? The number of candidates receiving transplants that had prior living donation are small in number. They should receive higher priority inside the distribution circle. 5. What operational concerns should the committee consider as this policy is being prepared for OPTN board action and implementation? This proposal does not significantly show any advantage of increasing organ transplants, decreasing waitlist mortality or increasing utilization of organs. The committee should consider these elements when performing the modeling prior to OPTN board action. ASTS suggests an interim review of this policy after 1 year to consider unique geographic challenges and to look at the data to ensure the policy is achieving its objectives. 6. Should medical urgency criteria be defined? If so, what specific conditions would qualify? Where the new medically urgent classification should be placed within allocation tables? Should placement within allocation tables vary depending on the KDPI of the donor kidney? How should two medically urgent candidates be prioritized - should two appear on the same match run? We do not believe that there are many cases of kidney allocation predicated on medical urgency. The committee should provide data on the number of medically urgent transplants that have been performed in each region by year for, say, the past 5 years, and the specific conditions for which medical urgency was utilized. Perhaps utilizing this data, criteria should be defined. We believe most of these cases are according to loss of vascular access as the medical urgency. We do not believe that specific medical conditions as the etiology of kidney disease should be used as a classification of a medical urgency. If there are medically urgent patients (i.e., loss of vascular access), those candidates should be offered transplantation with the next available kidney as is the current practice. Waiting time should be used to prioritize two medically urgent candidates. 7. When import back up is granted, do you support the use of an import match run for the import OPO to reallocate the kidney? Should the match run use the same size circle as the original allocation but with increased points for proximity? Should the circle size be smaller? If so, what distance will promote the efficient reallocation of kidneys? Once a kidney is imported and declined by the primary center, it is very likely that the kidney would have had significant cold ischemia time. The kidney is likely to be at the OPO office. To minimize discards, it would be advantageous to place the kidney as quickly as possible. Perhaps a smaller circle of 150 NM from the receiving OPO should be used to match run to promote efficient reallocation of the kidney. Also, there should be some discretion given to the OPO to emergently place the organ according to their judgement in as timely a manner as possible to avoid an unnecessary discard.

American Society of Pediatric Nephrology | 10/02/2019

October 2, 2019 OPTN Kidney Transplantation Committee Public Comment Coordinator United Network for Organ Sharing 700 North 4th Street Richmond, VA 23219 re: Proposal to Eliminate the Use of DSAs and Regions in Kidney Allocation Policy To Whom It May Concern: The American Society of Pediatric Nephrology (ASPN) appreciates the opportunity to provide comments on the proposal to Eliminate the Use of Donation Service Areas (DSAs) and Regions in Kidney Allocation Policy. Founded in 1969, ASPN is a professional society composed of pediatric nephrologists whose goal is to promote optimal care for children with kidney disease and to disseminate advances in the clinical practice and basic science of pediatric nephrology. ASPN currently has over 700 members, making it the primary representative of the Pediatric Nephrology community in North America. Our members provide end stage kidney disease care prior to transplant and post-transplant medical care to children who have received kidney transplants. As a community, we have three major concerns with the proposal as it is presented. These concerns are related to: the increased risk of delayed graft function, the projected increase in kidney pancreas volume and the attempt to resolve inequity in access without a more comprehensive proposal that would deal with other aspects of organ allocation which contribute to inequity in access. While we recognize that the current DSA and regional boundaries used in the kidney allocation system are arbitrary and fail to provide equal access across the nation, ASPN is concerned the proposed models do not address the lack of uniform performance of Organ Procurement Organizations (OPOs), which contributes to the variation in access and transplant rates. The proposal to allocate kidneys using a 500 nautical mile (NM) circle does not account for factors relating to the lack of available resources and capacity, particularly for rural areas where fewer commercial transportation options are available. Several adverse consequences that could result from an increase in mean travel time include the impact on logistics and resources, clinical procurement teams and organs, and consequently increased cold ischemia times. The proposal under consideration does include encouraging predictions of pediatric kidney transplant total volume, but those predictions do not and cannot take into account changes in organ acceptances practices for children that may result from the increase cold ischemia times related to the increase in median and mean distance an organ will travel and the subsequent concerns for increased rates of delayed graft function. The modeling undertaken does not capture the potential impact of delayed graft function on children receiving kidney transplants since long term outcomes are not captured in one-year graft survival rates. ASPN urges UNOS/OPTN leadership to thoroughly consider this concern prior to adopting these changes. The proposed monitoring plan does not specifically address the concerns of the pediatric transplant community relating to the projected increase in the volume of kidney-pancreas transplants. If done in isolation, without consideration of the effect of prioritization of kidney-pancreas recipients within allocation sequence, the proposed allocation policy would potentially further adversely impact pediatric patients that are within proximity of high-volume kidney-pancreas transplant centers. The pediatric nephrology community remains concerned with the current prioritization of kidney-pancreas patients above children. We would request, at minimum, a comprehensive plan for assessment and monitoring of current and future kidney-pancreas transplant volume effects on pediatric kidney transplant volume and rates if this proposal is adopted as policy. Thank you again for the opportunity to submit comments on the proposal to Eliminate the use of DSAs and Regions in Kidney Allocation Policy. Please contact our Executive Director, Connie Mackay, at Connie@aspnneph.org, if we can provide additional information or clarification regarding ASPN’s comments. Sincerely, Patrick Brophy, MD, MHCDS President, American Society of Pediatric Nephrology

Roxana Carmenate | 10/02/2019

Please don't limit patient choice and the chance of an organ more quickly available to our patients. They should continue to be able to choose the transplant or transplant centers of their choice and the wait period should remain low due to quicker transplants. This will also lower the cost of dialysis for Medicare/Medicaid and commercial policies which helps the costs of the working population. Thank you.

Evan Kozlow | 10/02/2019

As a patient at Advent Health Transplant Institute in Orlando, I want to voice my strong opposition to the proposal to change the donation service area to a 500 nautical mile radius of the donor hospital. This policy, while well intentioned, will have the adverse impact it desires. Implementing this policy will increase the disparity between candidates and transplant centers, and in Florida will devastate the patients waiting for kidneys. For the state of Florida, changing the DSA to the 500 nautical mile radius is projected to negatively impact Florida’s programs by, increasing patient wait times for transplant, increasing kidney cold time which may result in delayed function of the transplant, decrease efficiency in organ placement leading to an increase in organs being discarded, and very specifically to a projected 25%-40% decrease in the number of transplants performed in the state of Florida. Not only will this have a profound impact on the kidney centers, but that is a catastrophic blow to kidney disease patients, who in many cases already wait years for that call that a kidney is available. Adopting this new proposal will have the one intended impact that all proposals must be vetted and ensured not to do – further harm the patient! Please reject the 500 nautical mile radius and reconsider alternative solutions that provide fairness for ALL kidney programs and ultimately bring shorter wait to times for patients in all regions of the country.

OPTN Operations and Safety Committee | 10/02/2019

The Operations and Safety Committee (OSC) thanks the OPTN Kidney Committee for their efforts in developing this public comment proposal to eliminate the use of DSAs and region in kidney allocation policy. The Committee feels that the proposed 500 NM circle is too large and proposed using the 250 NM circle instead. There was concern raised in using the proposed 150 NM circle for import back up. The host OPO should be considered as the allocator in the backup circumstance. Additionally, if an organ is being allocated to another DSA without specimen to do crossmatches, this would present challenges for the accepting program to get their own crossmatch done on a kidney with potentially significant ischemic time. There should be some flexibility for the host OPO in allocating to either the center directly or to centers that are served by the same tissue typing lab. This could also be in collaboration with the host OPO and recipient hospital. It was suggested that there be restrictions on back up candidates to avoid allocations to highly sensitized candidates within a certain area to prevent discards. When thinking about ischemic time, there needs to be a more strategic approach to candidates. In regards to emergency kidney candidates, it is the hope that these candidates would have access to compatible bloody types and not just identical blood types so that these candidates would have a greater change to receive a transplant in the short time period required. The Committee indicated the following sentiments for the proposal: Strongly Support -10%, Support - 20%, Neutral/Abstain -0%, Oppose -60%, Strongly Oppose -10%

Michael Moritz | 10/02/2019

My comments reflect my 33 years of transplant surgery experience in kidney, pancreas and liver transplantation at both adult and pediatric centers. I accept that continuous distribution has the potential to address many of the issues in organ allocation, yet is just beginning. The ability to apply continuous distribution to kidney allocation is years away. Issue Number 1 is multi-organ transplantation, and has not been addressed in the current proposal, yet needs to be addressed. 1. A serious flaw to our current and all proposed allocation systems is the siphoning of a significant fraction of the best donor kidneys to multiorgan transplant recipients. There is little more frustrating than the offer to a 100% cPRA recipient seemingly always conditional upon the various multi-organ candidates turning down the offer. 2. The new allocation schemes for non-renal organs increase the numbers of multi-organ candidates exposed to more offers and better donors and will encourage more multi-organ transplantation, with fewer kidneys trickling down to the kidney-only candidates. This is a forseeable consequence of wider non-renal allocation yet there is no limit placed to the number or proportion of kidneys lost from the kidney-only candidate pool. 3. Note that the move to continuous distribution, which eliminates some issues does not address this issue which is key to fairness. The majority of kidney candidates are older adults who form a “silent majority” who’s needs and priorities have been lost amongst the greater attention granted higher priority populations. The priority populations on the kidney wait list have rational bases—the multi-organ candidate priority does not. Issue Number 2 is the confusion between the 2 OPTN initiatives: eliminating DSA vs. increasing sharing. 1. There is a huge difference between the 2 directives. Eliminating DSA’s from allocation is a separate issue from wider allocation. In combining the two, the proposals are confusing, complicated, and divisive. UNOS/OPTN would be wise to focus on the more important former directive, eliminate DSA’s from allocation, as an important and key step. 2. Eliminating DSA can be accomplished much more readily than increasing sharing. Increasing sharing will always be more controversial and difficult, given the biologic fact that all organs are deteriorating once they have been removed from the donor’s body. While this phenomenon is complex, non-linear, and may be effected by technology, the underlying principle remains true: longer cold ischemia time is deleterious. 3. Eliminating DSA can be accomplished via relatively small circles, e.g. 150 miles for the inner circle, which does not cause a huge shift in transportation mode or ischemic time. While this represents an imperfect solution to allocation’s challenges, aiming for a perfect solution at this stage (when no path to continuous distribution has yet been accomplished) is unnecessarily complex, controversial, more likely to fail, and more likely to have unintended negative consequences such as an increase in discards. Issue Number 3 is the failure to develop a sharing framework which is based on optimal list size. 1. Fixed circles have no rational or medical basis. They have unfair and discriminatory boundary effects. Distance and travel time correlate poorly, especially in population dense areas. 2. Given the dependence of allocation on “trickle-down” phenomena, the proportion of organs that trickle down is dependent on the number of candidates in the pool. Ignoring the size of the population of candidates over which an organ is being allocated violates the framework upon which the allocation policy has been developed. Michael J. Moritz, M.D., F.A.C.S.

Medical University of South Carolina | 10/02/2019

October 2, 2019 RE: Eliminate the use of DSAs and Region in Kidney Allocation Policy To whom it may concern: I am writing this public comment on behalf of the Medical University of South Carolina Transplant Program. I strongly objection to this policy for reasons that are well described in many dissenting public comments. Instead, I wish to focus my comments specifically on the practical aspects to implementing this policy. As readers know, there are almost 114,000 people waiting for deceased donor kidney transplants. Each year, approximately 15,000 deceased donor kidney transplants are performed and almost twice as many people are delisted for being too ill or dying while waiting. Due to the massive size of kidney transplant waitlists in concert with low transplant volumes, implementation of this policy is likely to dramatically alter transplant volumes at many programs for years during the “equilibration period”. Current UNOS modeling simply does not come close to estimating the effect of the new allocation system for many programs. For example, the Medical University of South Carolina has 3 programs within 250 miles where the average KAS score for an unsensitized patient differs by 4 points (1 year dialysis time= 1 KAS point). These programs collectively have 3000 more waitlisted patients than us. Last year, our DSA produced 266 transplantable kidneys. The UNOS KPSAM predicts a 23% decline in transplant volumes for South Carolina under the new system. This is mathematically impossible. We are likely to experience a near halt in deceased donor kidney transplant volumes for several years. This issue is not unique to South Carolina. There are many patients and programs that are in similar situations that will experience either dramatic reductions or increases in deceased donor transplant rates. I strongly encourage the Kidney Subcommittee and the UNOS Board to consider an incremental plan for implementation of the kidney allocation policy. Could not the policy be implemented for half of deceased donor kidneys (right kidney: new policy; left kidney: previous policy), or alternate the new policy on even days and old policy on odd days, etc.? This could be done for a period of time to cushion the effects of the implementation. It remains patient-centric and still allows UNOS to achieve the same goal. By mitigating the new policy’s introduction, we can assure the success of both the transplant institutes and their patients, and the success of the UNOS vision for kidney allocation. Without temperance, I fear that the new policy will create more harm than good to our regional transplant communities. Derek DuBay, MD, MSPH Professor of Surgery Director of Abdominal Transplant Surgery Medical University of South Carolina

American Society of Pediatric Nephrology | 10/02/2019

To Whom It May Concern: The American Society of Pediatric Nephrology (ASPN) appreciates the opportunity to provide comments on the proposal to Eliminate the Use of Donation Service Areas (DSAs) and Regions in Kidney Allocation Policy. Founded in 1969, ASPN is a professional society composed of pediatric nephrologists whose goal is to promote optimal care for children with kidney disease and to disseminate advances in the clinical practice and basic science of pediatric nephrology. ASPN currently has over 700 members, making it the primary representative of the Pediatric Nephrology community in North America. Our members provide end stage kidney disease care prior to transplant and post-transplant medical care to children who have received kidney transplants. As a community, we have three major concerns with the proposal as it is presented. These concerns are related to; the increased risk of delayed graft function, the projected increase in kidney pancreas volume and the attempt to resolve inequity in access without a more comprehensive proposal that would deal with other aspects of organ allocation which contribute to inequity in access. While we recognize that the current DSA and regional boundaries used in the kidney allocation system are arbitrary and fail to provide equal access across the nation, ASPN is concerned the proposed models do not address the lack of uniform performance of Organ Procurement Organizations (OPOs), which contributes to the variation in access and transplant rates. The proposal to allocate kidneys using a 500 nautical mile (NM) circle does not account for factors relating to the lack of available resources and capacity, particularly for rural areas where fewer commercial transportation options are available. Several adverse consequences that could result from an increase in mean travel time include the impact on logistics and resources, clinical procurement teams and organs, and consequently increased cold ischemia times. The proposal under consideration does include encouraging predictions of pediatric kidney transplant total volume, but those predictions do not and cannot take into account changes in organ acceptances practices for children that may result from the increase cold ischemia times related to the increase in median and mean distance an organ will travel and the subsequent concerns for increased rates of delayed graft function. The modeling undertaken does not capture the potential impact of delayed graft function on children receiving kidney transplants since long term outcomes are not captured in one-year graft survival rates. ASPN urges UNOS/OPTN leadership to thoroughly consider this concern prior to adopting these changes. The proposed monitoring plan does not specifically address the concerns of the pediatric transplant community relating to the projected increase in the volume of kidney-pancreas transplants. If done in isolation, without consideration of the effect of prioritization of kidney-pancreas recipients within allocation sequence, the proposed allocation policy would potentially further adversely impact pediatric patients that are within proximity of high-volume kidney-pancreas transplant centers. The pediatric nephrology community remains concerned with the current prioritization of kidney- pancreas patients above children. We would request, at minimum, a comprehensive plan for assessment and monitoring of current and future kidney-pancreas transplant volume effects on pediatric kidney transplant volume and rates if this proposal is adopted as policy. Thank you again for the opportunity to submit comments on the proposal to Eliminate the use of DSAs and Regions in Kidney Allocation Policy. Please contact our Executive Director, Connie Mackay, at Connie@aspnneph.org, if we can provide additional information or clarification regarding ASPN’s comments. Sincerely, Patrick Brophy, MD, MHCDS President, American Society of Pediatric Nephrology

Anonymous | 10/02/2019

This proposal for Elimination of DSA is flawed in many aspects. First, there are 7 seven states along the east coast that do not participate in "First Person Authorization" which limits the number of donor organs available in those states. In order to eliminate DSA from the kidney allocation, all states should participate in "First Person Authorization". Second, this proposal penalizes OPO's that perform well and there are OPO's on the east coast that are in need or revamping. In addition, the metrics in which OPO's are evaluated are flawed. Third, the wrong variables are being used in the model. These variables don't assess the burden of ESRD in a state or how patients are listed. Fourth, cost and CIT will increase in the current proposal. The increase in CIT will lead to more DGF which will affect long term allograft survival. Lastly, transplant rate does not reflect transplant disparity. Transplant rate is affected by WL management at each transplant center. In order to eliminate DSA, the appropriate metrics need to be used to determine geographic disparity.

Susan Witzel-Kreuter | 10/02/2019

As a Renal Social Worker and a family member of a past dialysis patient I feel that the recommendations of changing from the DSA system to the 500 nautical mile system would adversely effect our patients. I agree with many who have addressed the added impact of cost as well as the potential damage and loss of organs in delays. Our system is stressed enough and there are too few donors to risk even one extra discarded organ. Our South Florida wait times will certainly increase, which is unfair to our patients. Please reconsider and perhaps come up with an alternate plan while utilizing the current manner in which kidneys are allocated. Thank you.

Hackensack Meridian Health Network | 10/02/2019

Dear OPTN Board of Directors, We, Hackensack University Medical Center (NJHK), part of the Hackensack Meridian Health Network, together with the other kidney transplant centers from the state of New Jersey (Saint Barnabas Medical Center, Robert Wood Johnson University Hospital, and Virtua Our Lady of Lourdes, as well as New Jersey Sharing Network (NJSN), the state’s main Organ Procurement Organization (OPO), collectively care for the highest population density of transplant patients experiencing severe condition acuity. It is our shared view that the current proposal from United Network for Organ Sharing (UNOS), while laudable in its goal to create a more equitable distribution of deceased donor kidneys, will yield adverse and severe consequences for the transplant population in our region. Specifically, the State of New Jersey will experience a significant inequity in recipient waiting times for life saving kidney transplants when compared to neighboring donation service areas (DSAs), most notably New York City. This imbalance is not due to the DSA system created 35 years ago, but rather a constellation of other factors, including the failure of individual, underperforming DSA practices and partnerships of a neighboring OPO that have not been adequately held accountable in the past. Decreased Access for New Jersey Kidney Patients. The implementation of the proposed policy would suddenly and disproportionately decrease access to transplants for the patients we serve in New Jersey. Kidney transplant allocation – unlike livers, lungs, or hearts – is prioritized based on wait-time, as opposed to the severity of the patient’s need. On average, current wait times in New Jersey are 3-4 years shorter than wait times in the neighboring New York City region’s DSA. Therefore, under the proposed model, patients who have been waiting longer for a kidney in New York, but who may be in better health than patients waiting in New Jersey, will receive priority for the first several years. In fact, very few patients in New Jersey will receive deceased donor transplants (despite proximity points), due to the long accumulated waiting times of thousands of patients in adjacent New York. For patients at New Jersey transplant centers, the elimination of DSAs will likely increase average wait times by at least three years, contribute to an estimated 300-500 avoidable deaths, and adversely affect thousands of other patients by delaying their receipt of life-saving transplants. Worse Outcomes for New Jersey Kidney Patients. The proposed changes will not only decrease the total number of transplants, but will also lead to worse transplant outcomes. Prolonged cold ischemic times from the proposed broader sharing, with its attendant complications, will cause more delayed allograft function, a direct correlate of transplant outcomes. Moreover, a large, sudden influx of available kidneys at centers in DSAs with historically long waiting times would lead to worse outcomes, due to mismatches between existing center resources/staffing and the abrupt increase in volume. It is well documented that transplant centers which experience sudden volume increases also experience decreases in graft and patient survival. The current UNOS proposal will, in short shrift, result in this misallocation of available organs and the inevitable poor outcomes. Decreased Kidney Donation in New Jersey. Although donors are a national resource, deceased donation is almost entirely driven by local efforts and led by OPOs. New Jersey has a historically high rate of voluntary kidney donation, and the decision to donate is often very personal and emotional. While donors know that they cannot earmark their donated organs, they do often prefer their organs be transplanted locally. The UNOS proposal, at least in the short-to-medium run, will result in almost all locally procured kidneys being shared outside the DSA to recipients in other states. Recommendation. Accordingly, the aforementioned New Jersey transplant centers and OPO strongly urge UNOS not to approve or finalize its proposal in its current form. Instead, we propose a more moderate and gradual change to the current system, based primarily on the long-established tradition of procurement programs being a state resource. A more gradual shift would limit drastic changes for waiting populations, support the established transplant and OPO practices, and fulfill the transplant needs of local communities, while still ultimately promoting equity. In addition to a more phased-in implementation, we propose that wait-listed patients be assigned extra allocation points if the donor organ is procured in their own DSA. These assigned points can be reduced on a yearly basis until the assigned points reach zero, thus allowing the majority of wait-listed patients to receive a transplant within their anticipated wait-time. In the meantime, educational programs regarding these new policy changes can be geared toward newer wait-listed patients, allowing them to make more informed decisions on where they wish to wait-list. We also suggest that the new policy maintain the current policy that kidneys not accepted locally for transplant be directed to the areas of greatest need. The benefits of such a system would continue local DSA sharing practices to minimize risk to donor organs and recipients, maintain DSA accountability for organ yield, reduce organ discards by promoting expedited sharing, and bridge the equity gap by promoting expedited placement to disadvantaged DSAs. We believe that these modest modifications to the current policy, as opposed to the overhaul promulgated by the proposed policy, will best serve to achieve our mutual goals in reducing geographic disparities in waiting times and improve the overall equitable procurement and distribution of kidneys for transplant. We respectfully submit this document on behalf of New Jersey Transplant Professionals for comment. Sincerely, Michael J. Goldstein MD, FACS Director of Organ Transplantation Director, Kidney & Pancreas Transplantation Division of Organ Transplantation Hackensack University Medical Center Associate Professor of Surgery Hackensack Meridian School of Medicine at Seton Hall University

Anonymous | 10/02/2019

The OPTN Minority Affairs Committee appreciates the opportunity to provide feedback on this public comment proposal, and commends the OPTN Kidney Transplantation Committee for all of their hard work. Overall, the committee supports the direction of the proposal, but some members wanted the OPTN Kidney Transplantation Committee to consider a smaller circle size than the proposed 500NM circle. Please note that some MAC members were in favor of the 500 NM radius. A member raised the concern that smaller cities have limited access to direct flights, thus potentially increasing cold ischemic time during transportation. A smaller circle size would allow for more driving of kidneys, keeping cold ischemic times lower. It was also mentioned that the Kidney committee should also consider adding a safety net provision for multi-organ candidates, specifically for thoracic/kidney allocation (to model after the current liver/kidney provision already in place) to discourage unnecessary kidney listing. Lastly, a committee member raised the concern about Alaskan donors. Since there are no transplant centers in Alaska, all kidneys from Alaska would go straight to national allocation, and that could potentially be an inefficient allocation scheme. The committee supports the proposal but would like the Kidney committee to consider adding language to the proposal that would consider any kidney donor in Alaska as originating from the Seattle-Tacoma International Airport (Sea-Tac) in Seattle, Washington.

Hackensack University Medical Center | 10/02/2019

Hackensack University Medical Center (NJHK), part of the Hackensack Meridian Health system, together with the other kidney transplant centers from the state of New Jersey (Saint Barnabas Medical Center , Robert Wood Johnson University Hospital, and Virtua Our Lady of Lourdes, as well as New Jersey Sharing Network (NJSN), the state’s main Organ Procurement Organization (OPO), we collectively care for the highest population density of transplant patients experiencing severe condition acuity. It is our shared view that the current proposal from United Network for Organ Sharing (UNOS), while laudable in its goal to create a more equitable distribution of deceased donor kidneys, will yield adverse and severe consequences for the transplant population in our region. Specifically, the State of New Jersey will experience a significant inequity in recipient waiting times for life saving kidney transplants when compared to neighboring donation service areas (DSAs), most notably New York City. This imbalance is not due to the DSA system created 35 years ago, but rather a constellation of other factors, including the failure of individual, underperforming DSA practices and partnerships of a neighboring OPO that have not been adequately held accountable in the past. Decreased Access for New Jersey Kidney Patients. The implementation of the proposed policy would suddenly and disproportionately decrease access to transplants for the patients we serve in New Jersey. Kidney transplant allocation – unlike livers, lungs, or hearts – is prioritized based on wait-time, as opposed to the severity of the patient’s need. On average, current wait times in New Jersey are 3-4 years shorter than wait times in the neighboring New York City region’s DSA. Therefore, under the proposed model, patients who have been waiting longer for a kidney in New York, but who may be in better health than patients waiting in New Jersey, will receive priority for the first several years. In fact, very few patients in New Jersey will receive deceased donor transplants (despite proximity points), due to the long accumulated waiting times of thousands of patients in adjacent New York. For patients at New Jersey transplant centers, the elimination of DSAs will likely increase average wait times by at least three years, contribute to an estimated 300-500 avoidable deaths, and adversely affect thousands of other patients by delaying their receipt of life-saving transplants. Worse Outcomes for New Jersey Kidney Patients. The proposed changes will not only decrease the total number of transplants, but will also lead to worse transplant outcomes. Prolonged cold ischemic times from the proposed broader sharing, with its attendant complications, will cause more delayed allograft function, a direct correlate of transplant outcomes. Moreover, a large, sudden influx of available kidneys at centers in DSAs with historically long waiting times would lead to worse outcomes, due to mismatches between existing center resources/staffing and the abrupt increase in volume. It is well documented that transplant centers which experience sudden volume increases also experience decreases in graft and patient survival. The current UNOS proposal will, in short shrift, result in this misallocation of available organs and the inevitable poor outcomes. Decreased Kidney Donation in New Jersey. Although donors are a national resource, deceased donation is almost entirely driven by local efforts and led by OPOs. New Jersey has a historically high rate of voluntary kidney donation, and the decision to donate is often very personal and emotional. While donors know that they cannot earmark their donated organs, they do often prefer their organs be transplanted locally. The UNOS proposal, at least in the short-to-medium run, will result in almost all locally procured kidneys being shared outside the DSA to recipients in other states. Recommendation. Accordingly, the aforementioned New Jersey transplant centers and OPO strongly urge UNOS not to approve or finalize its proposal in its current form. Instead, we propose a more moderate and gradual change to the current system, based primarily on the long-established tradition of procurement programs being a state resource. A more gradual shift would limit drastic changes for waiting populations, support the established transplant and OPO practices, and fulfill the transplant needs of local communities, while still ultimately promoting equity. In addition to a more phased-in implementation, we propose that wait-listed patients be assigned extra allocation points if the donor organ is procured in their own DSA. These assigned points can be reduced on a yearly basis until the assigned points reach zero, thus allowing the majority of wait-listed patients to receive a transplant within their anticipated wait-time. In the meantime, educational programs regarding these new policy changes can be geared toward newer wait-listed patients, allowing them to make more informed decisions on where they wish to wait-list. We also suggest that the new policy maintain the current policy that kidneys not accepted locally for transplant be directed to the areas of greatest need. The benefits of such a system would continue local DSA sharing practices to minimize risk to donor organs and recipients, maintain DSA accountability for organ yield, reduce organ discards by promoting expedited sharing, and bridge the equity gap by promoting expedited placement to disadvantaged DSAs. We believe that these modest modifications to the current policy, as opposed to the overhaul promulgated by the proposed policy, will best serve to achieve our mutual goals in reducing geographic disparities in waiting times and improve the overall equitable procurement and distribution of kidneys for transplant. We respectfully submit this document on behalf of New Jersey Transplant Professionals for comment.

Anonymous | 10/02/2019

o Public Comment Proposal: Remove DSA and Region from Kidney Allocation Policy (Scott Castro, UNOS Staff) The OPTN Transplant Coordinators Committee heard a presentation on the Kidney Committee’s proposal during a meeting on September 9, 2019. Members shared their general understanding of the concept, adding greater clarity in points and circles would be beneficial (e.g.: simulated match run lists). Several members suggested the use of different sized circles influenced by the kidney donor profile index (KDPI) with several member supporting larger distribution circles for low KDPI donor kidneys. Other members expressed concern that that frequent use of a donor recovery center as the center of the circle could concentrate kidneys. To better support equity in access to transplantation, members suggested consistently using the donor hospital where the donor was identified rather than an OPOs recovery center. Members also mentioned managing import back-up is an added administrative responsibility for an OPO. This translates to the use of staff and financial resources that are unpredictable in nature. They suggested the UNOS Organ Center manage import offers to mitigate the potential for an importing OPO with low vested interest in allocating organs from a donor outside their DSA. Transplant Coordinators Committee members expressed their support for a broader policy revision using the continuous distribution framework approved by the Board in December 2018. Such an approach may make more inroads to reducing lengthy candidate waiting times. The speaker acknowledged this sentiment and shared it was mentioned by many others in the past several weeks. In short, the current proposal to replace DSAs and regions with a 500 NM concentric circle centered on the donor hospital was a step in that direction. The speaker reminded the Committee the current proposal was intended to achieve greater compliance with the OPTN Final Rule and make what gains could be possible at this time. Future efforts, including the use of the continuous distribution framework, will be pursued. This could include opportunities to consider a “KDPI-circle size ratio” and factoring population density in organ distribution. The Committee appreciated the opportunity to provide feedback on this proposal.

Zachary Sutton | 10/02/2019

There have been numerous public articles that we waste roughly 3,500 kidneys a year (see Washington Post, New York Times and US Today articles from this year). Further, we know that about 12 patients a day die waiting for an organ in the United States. Why would we do anything that worsens this problem. We know that a majority of UNOS regions and transplant professionals are against this proposal and further all early evidence suggest that this will increase costs, travel requirements and lower OPO outcomes. What is the benefit to the patients, the families of donors, and to our society? I am a living kidney donor who donated altruistically to the South Carolina waiting list in 2009. South Carolina is unique as we only have one transplant center. It is good that we do not have a lengthy wait but we still do have a lot of people waiting. We are plagued by a multi-factorial problem relating to end stage renal disease that is intertwined with race, education, socioeconomic status, rural areas, etc. Removing regional organ allocation would only help larger states, larger centers of population and states where they already have more resources, more people, more access to healthcare, better education, etc. If kidneys or any other organs come from our region, they should go to someone locally. We already have a tough time getting people from the upstate of South Carolina to our transplant Center in Charleston but it is not because of the distance or four hour drive. It is because they do not have social support, ability to get a ride, money to cover surgery/medications and other social issues. This proposal would only worsen the issues we face locally. As a living donor who donated to our waitlist altruistically, I am against this change.

Anonymous | 10/02/2019

Strongly Support (2), Support (15), Neutral/Abstain (7), Oppose (15), Strongly Oppose (15) The members of the region do not support this policy as written. They asked if the committee considered the practice of multi listing and would there be limits to those types of practices. Trauma centers have many donors, so anyone listed at that hospital will be greatly advantaged over other local transplant centers. • The committee did look at the zone of equivalency; points plateau up to a certain distance (150NM). Any candidate within that area will get the same number of proximity points. • A step wise approach to implementation might be considered. One member asked what happens if there aren’t any kidney programs within the 500 NM circle. In Alaska there are no kidney programs within 1500 NM. How will this affect OPOs? • From the OPO perspective, they do not anticipate much of an impact; the OPOs job is to maximize the gift and get the organs allocated. Some concerns were raised regarding pediatric candidates, while pediatric patients are advantaged within the circles they stand to lose out to KP patients. The committee will need to monitor how pediatric patients fare under the proposed changes. • There was a suggestion to add pediatric priority to sequence C. 500 NM will expose peds to more donors, how does the CIT and delayed graft function play into their acceptance. It looks like peds will benefit, but we need to look at the data to evaluate. There is concern regarding the accuracy of the modeling. What will the impact actually be on the number of kidneys transplanted? There is potential for the KP counts to increase which will contribute to fewer kidney alone candidates being transplanted. One member stated where there is higher competition it is likely we will see a big change in behavior resulting in increased transplants. We know we cannot model behavior, but we can learn from it. It is likely that we will see the same changes in behavior that are already evident and the committee should consider this. The question was raised regarding the 36.3% increase in pancreas, was this an unintended outcome and is this modeling accurate. One member stated that this might be a concern from a pediatric perspective. The region was asked what it could support: • The specifics are challenging, 8 points for national sharing does not make sense (it is too high) this will result in disadvantaging high CPRA patients. • 500NM is problematic and will cause numerous logistical challenges, a smaller circle would be better. We need to start with a smaller circle, work out the issues and then move on to continuous distribution and see what the practical hurdles are. • This policy does not take into account population density, and it should. It does not achieve the goal for high waiting time areas, there is not much change for these candidates and continues to be a large burden from an operational standpoint in these areas. There were opinions expressed about Alaska. The donor hospital location should be SEA TAC or something similar. The bottom line is that the region wants to give access for all Pacific Northwest patients to Alaska donors.

Vaune Morris | 10/01/2019

My son is currently on the list and we need your help please .However this proposal could place him further down the list. PLEASE hear us we need your help and the help of your colleagues.

The National Kidney Foundation | 10/01/2019

The National Kidney Foundation (NKF) is pleased to provide comments on the proposal to eliminate the use of Donation Service Areas (DSA) and regions in allocation of deceased kidneys to increase equity in access to kidney transplantation. We support the goals of the proposal to improve equity in access to transplant and to address geographic disparities caused by the DSA, however we do have concerns that the proposal may have unintended consequences that have not been captured by the modeling requests. We offer the following comments and alternative recommendations as follows. The National Kidney Foundation is the largest, most comprehensive and longstanding patient centric organization dedicated to the awareness, prevention and treatment of kidney disease in the U.S. We have provided evidence-based clinical practice guidelines for all stages of chronic kidney disease (CKD), including transplantation, since 1997 through the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI). NKF supports the development of more appropriate guidelines for the allocation of scarce organs. We agree that that DSA boundaries were designed for organ recovery purposes rather than for organ allocation and further recognize that DSAs and regions vary considerably in geographic size, population and transplant volume. Given that the DSA where the transplant candidate is located is the most significant factor resulting in disparities in access to transplant, we support the need for more equitable policies. We are concerned, however, that the modeling requests do not fully reflect the complex nuances of real-world implementation that will impact every stakeholder in the transplant system, most importantly, patients and their families. We recommend a more stepwise approach to implementation, beginning with a more manageable 250 NM circle while evaluating key patient-centered metrics such as equity, access, outcomes, as well as transplant center, OPO, and donor hospital activity under the new rules. After appropriate evaluation, expansion to 500 NM could be implemented if it is determined greater gains can be realized by increasing the distribution area. If implemented as proposed, we are concerned that some of the fixed-distance circles will result in territories that are seriously diminished by the presence of large bodies of water such as the Great Lakes and along the coasts. We encourage OPTN to consider how equity in access to transplant may be affected by this geographic issue. We also are concerned about increasing the amount of time organs may spend in cold storage as the median distance from donor hospital to transplant center increases from 72 NM to 199 NM. It may be wise to consider a change to the transplant center regulations to create allowances for worse outcomes as a result of longer cold ischemic times. While we understand the modeling that OPTN commissioned indicated that there would not be meaningful changes in waitlist mortality count or rate or graft failure, we note and are concerned that the projections are based on modeling data alone, which we believe has its limitations. We believe our recommendation to more cautiously implement the proposal will better enable OPTN to monitor and mitigate any unintended consequences of the policy, especially as they pertain to access, outcomes, and the significant operational, logistical, and transportation hurdles that will result from a broader distribution of organs among many more transplant centers and thousands of patients. In conclusion, though we support the goals of the proposal, we believe the potential for unintended consequences is high. OPTN must be sufficiently thoughtful about the unintended effects in the real world setting and how they can be reasonably mitigated with a less dramatic initial circle size or through other policy approaches. We are sympathetic to the reliance on modeling data but emphasize that modeling does not capture the nuances of how the proposal may function in the real world, especially for kidney patients who are the most important stakeholder in this discussion. We therefore note that extensive monitoring and data collection will be paramount. Thank you for your consideration of our concerns. Please contact Miriam Godwin, Health Policy Analyst, at Miriam.godwin@kidney.org if you require further information.

American Society of Transplantation | 10/01/2019

The American Society of Transplantation appreciates the opportunity to comment on the proposed models for kidney allocation that remove Donor Service Areas (DSA) and regional boundaries from kidney allocation policy. The Society leadership and constituencies acknowledge that to be compliant with the Final Rule, it is necessary to modify the allocation policy with the intent to decrease variance in access and transplant rates related to geography. We recognize that the OPTN Kidney Transplantation Committee has been tasked with the challenging mandate to analyze the problem and put forth to the community, what they have determined is the best option moving forward to improve equity in access and to move kidney allocation closer to a continuous distribution model. While it is recognized that the current DSA and Regions are arbitrary and do not allow for equity in access nationally, some of our members have expressed concern that the proposal does not address other substantial factors that contribute to variation in access. Specifically, they are concerned that the proposed broader distribution will shift available organs from areas that have high performing OPOs to areas with lower-performing OPOs without mandating improved/minimum OPO performance standards and expectations. The shortcoming of the proposal to “Eliminate the Use of DSAs and Regions in Kidney Allocation” is the attempt to take a complex, multifaceted problem of access to transplant and put forth a narrowly focused solution. While this policy proposal does fulfill the HRSA mandate to be compliant with the Final Rule, it falls short of addressing other significant components of the allocation system (beyond DSA) that contribute to inequity in access. The Society, which includes representatives from DSAs all over the country, including those in regions with both shorter and longer candidate wait times, ultimately supports any efforts to improve equity and organ availability on a national level. Regrettably, given the diversity of our Society, the concerns related to this narrowly focused proposal, and the need for a multi-pronged approach to address system performance and inequities, The American Society of Transplantation is unable to endorse the proposal “Eliminate the Use of DSAs and Regions in Kidney Allocation” put for by the OPTN Kidney Transplantation Committee in its current form. The Society offers the following comments regarding this proposal for consideration: • Costs and Resources o This proposed change in allocation will increase distances for organ and procurement team travel. The added costs and resources, the potential for further reduction in efficiencies in allocation, the adverse consequences for transplant programs and the potential for increased cold ischemia time/delayed graft function and organ discards are of concern to many of our members. We recognize the OPTN Operations and Safety Committee for proactively addressing these concerns with the proposed policy currently out for public comment “Data Collection to Evaluate the Logistical Impact of Broader Distribution”. • Cold Ischemia Time and Organ Quality o Although challenging to model, there is no data projecting the incidence and outcomes of DGF although projected increased mean and median organ travel distances will likely increase DGF rates. This is of particular concern to our pediatric community since any proposal that increases DGF rates will likely increase adverse long term outcomes that are not captured in 1-year graft survival rates. The projected increased volume for pediatric transplants does not take into account the potential for increased offer decline rates for pediatric candidates on the basis of distance and concern for prolonged cold ischemia times and increased DGF risk. • Wait List Mortality o Although the projected number is small, the proposed allocation model, as well as all the broader distribution models, project an increase in waitlist mortality which is not projected in the smaller distribution models ie; 250 and 150 NM radius models. If the 500 NM proposal is adopted into policy, particular attention will need to be paid to the monitoring of waitlist mortality in general and specifically as it occurs in relationship to a candidate’s place of listing (rural, metropolitan, etc). • Medical Urgency o Medically urgent criteria may be more appropriately addressed as a separate policy proposal particularly since criteria for the designation of “medically urgent” have yet to be determined and are likely to require public comment and discussion if there is a desire to achieve uniformity across the nation. • Vulnerable Populations o The proposal under consideration does include encouraging predictions of pediatric kidney transplant total volume although the predictions do not take into account potential changes in physician acceptance patterns related to longer cold ischemia times and higher risk of delayed graft function. The Society’s pediatric membership would like to see more specific data on how the proposed policy implementation would impact pediatric recipients at a more granular level. The monitoring plan proposed includes monitoring transplant rates by age but does not specifically address the concerns of the pediatric transplant community relating to the projected increase in the volume of kidney-pancreas transplants. The proposed allocation policy, done in isolation without consideration of the effect of prioritization of kidney-pancreas recipients within allocation sequence, will potentially further adversely impact, with an uneven distribution, pediatric patients that are within proximity of high-volume kidney-pancreas transplant centers. The pediatric constituency has asked that the OPTN Kidney Committee address these concerns and include a comprehensive plan for assessment and monitoring of current and future kidney-pancreas transplant volume effects on pediatric kidney transplant volume and transplant rates at a more granular level than national. o The modeling projects decreased transplant rates in small town and rural areas. Some of our members have concern that the proposed allocation system may divert organs away from rural and low-income communities in the South, Midwest and Northwest and to larger metropolitan areas. The analyses performed looked at these issues on a national level but not more regionally. • Multiorgan Transplants o The current prioritization of multiorgan candidates at the top of the allocation sequence is of concern to the Society. The proposal under consideration projects an increase in volume of kidney pancreas transplants which has raised concerns from our pediatric constituency. Given the requirement to make major changes in allocation to be compliant with the Final Rule, this would seem to be an opportune time to address broader community concerns with how multiorgan transplants are prioritized and allocated. The proposed allocation policy, done in isolation, without consideration of the effect of prioritization of kidney-pancreas recipients within allocation sequence will potentially adversely impact not only pediatric candidates but also the highly sensitized, prior living donors and adult kidney-alone candidates that are within proximity of high volume kidney-pancreas transplant centers. • Considerations other than DSA that Contribute to Inequities in Access o Some of The Society constituents believe that the 11 Regions and 58 DSAs that were created years ago as part of the national allocation system can ultimately meet The Final Rule’s “equity in access for all that is not limited by geography” mandate. This would require all OPOs to be held to the goals that HRSA and the OPTN have set forth. There is concern that the current broader distribution will shift available organs away from areas that have high performing OPOs without mandating improved/minimum OPO performance standards and expectations. Additionally, if system performance improvements are made to both OPOs and transplant programs, this would likely increase the supply and utilization of donated organs available for transplant. While The Society leadership recognizes that it is not feasible to think the variance in access and transplantation related to geography is likely to be improved without the elimination of DSA and Regions from allocation policy, they are also respectful of The Society’s members who have expressed dismay that there is nothing included in this proposal to address uneven OPO performance or transplant program organ acceptance practices. The Society leadership recognizes and encourages ongoing OPTN and OPO efforts to identify standardized metrics by which OPOs and transplant centers can be held accountable and by which access may be improved. o The Society membership has also expressed concern that multiple demographic factors such as; lack of access to healthcare, higher concentrations of poverty, residential segregation, higher proportions of uninsured patients, low health literacy rates, fewer transplant centers, long distances to a transplant center, for-profit dialysis facilities and lower organ availability (especially in southeastern states) which affect DSAs in an uneven distribution, will continue to adversely impact potential transplant candidates in the allocation model proposed. While we recognize that such considerations were beyond the scope of the OPTN Kidney Committee charge, such factors may negate the projected improvements in access that are strived for with the proposal under consideration. o We feel the need to reiterate a point that has been made previously in prior public comment periods. The nautical mile allocation solution will disadvantage some centers more than others. Not all centers will have access to the full nautical mile radius (i.e. coastal areas). Some areas like the Northeast will have more advantages as they will have access to more donor hospitals, while areas like California and Texas will likely be unchanged in overall net access. If this proposal is adopted into policy, we suggest close monitoring of the downstream effects specifically on coastal regions.

Anonymous | 10/01/2019

Geographically my center would be at a great disadvantage should the committee remove DSA. Our client base is made up of our local area on South to the border. Transplant offers are few and far between for us as is. It seems when an offer comes up we are always behind multi-viscerals. With the new proposal we will be geographically out. Children should come first. Most are born with kidney disease and all they know is appointments and medications, hospitalizations. I've been asked by a kiddo on Dialysis, "When is it my turn to get a kidney? Why is it taking so long?" To see there faces when they get a call that there may be an offer, to come on in just in case. They live 2-3 hrs away and time is of necessity. They get here and we are told it went elsewhere. I have to say, "That just wasn't meant to be for you, a better offer will come along." "We just have to be patient." I have had pediatric clients on dialysis wait as long as 2 and 3 years. I've had to watch a mom carry in her 14 yo son because his legs hurt so bad, hyperphosphatemia, high PTH. He could not walk. He was like this from having been on dialysis too long. As a dialysis nurse and now a transplant coordinator I feel it's my duty to fight for the children. To plead that when you make your decision that you remember the children. My hospitals motto is "We are here for the kids". We all need to be here for the kids. Thank you.

Teresa Smith | 10/01/2019

The "nautical mile" approach, in my opinion, will result in a decrease in the number of kidney transplants conducted in Florida. It does not seem plausible for a significant number of recovering kidneys to be shipped to transplant centers outside of Florida. This will cause increased wait times for patients who have already been waiting years in Florida for a kidney transplant.

New Jersey Hospital Association | 10/01/2019

Dear Sir or Madam: On behalf of the New Jersey Hospital Association (NJHA) and its over 400 hospital, health system, PACE and post-acute members, thank you for the opportunity to comment on the Organ Procurement and Transplant Network’s proposed elimination of the use of DSA and region in the kidney allocation policy. NJHA is proud to count all of New Jersey’s kidney transplant centers, Hackensack University Health Center, Saint Barnabas Medical Center, Robert Wood Johnson University Hospital and Virtua Our Lady of Lourdes, as members. They, as well as New Jersey Sharing Network (NJSN), the state’s main Organ Procurement Organization (OPO), collectively care for the highest population density of transplant patients experiencing severe condition acuity. It is our shared view that the current proposal from United Network for Organ Sharing (UNOS), while laudable in its goal to create a more equitable distribution of deceased donor kidneys, will yield adverse and severe consequences for the transplant population in our region. Specifically, the State of New Jersey will experience a significant inequity in recipient waiting times for life saving kidney transplants when compared to neighboring donation service areas (DSAs), most notably New York City. This imbalance is not due to the DSA system created 35 years ago, but rather a constellation of other factors, including the failure of individual, underperforming DSA practices and partnerships of a neighboring OPO that have not been adequately held accountable in the past. Decreased Access for New Jersey Kidney Patients The implementation of the proposed policy would suddenly and disproportionately decrease access to transplants for the patients we serve in New Jersey. Kidney transplant allocation – unlike livers, lungs, or hearts – is prioritized based on wait-time, as opposed to the severity of the patient’s need. On average, current wait times in New Jersey are 3-4 years shorter than wait times in the neighboring New York City region’s DSA. Therefore, under the proposed model, patients who have been waiting longer for a kidney in New York, but who may be in better health than patients waiting in New Jersey, will receive priority for the first several years. In fact, very few patients in New Jersey will receive deceased donor transplants (despite proximity points), due to the long accumulated waiting times of thousands of patients in adjacent New York. For patients at New Jersey transplant centers, the elimination of DSAs will likely increase average wait times by at least three years, contribute to an estimated 300-500 avoidable deaths, and adversely affect thousands of other patients by delaying their receipt of life-saving transplants. Worse Outcomes for New Jersey Kidney Patients The proposed changes will not only decrease the total number of transplants, but will also lead to worse transplant outcomes. Prolonged cold ischemic times from the proposed broader sharing, with its attendant complications, will cause more delayed allograft function, a direct correlate of transplant outcomes. Moreover, a large, sudden influx of available kidneys at centers in DSAs with historically long waiting times would lead to worse outcomes, due to mismatches between existing center resources/staffing and the abrupt increase in volume. It is well documented that transplant centers which experience sudden volume increases also experience decreases in graft and patient survival. The current UNOS proposal will, in short shrift, result in this misallocation of available organs and the inevitable poor outcomes. Decreased Kidney Donation in New Jersey Although donors are a national resource, deceased donation is almost entirely driven by local efforts and led by OPOs. New Jersey has a historically high rate of voluntary kidney donation, and the decision to donate is often very personal and emotional. While donors know that they cannot earmark their donated organs, they do often prefer their organs be transplanted locally. The UNOS proposal, at least in the short-to-medium run, will result in almost all locally procured kidneys being shared outside the DSA to recipients in other states. Recommendation Accordingly, we strongly urge UNOS not to approve or finalize this proposal in its current form. Instead, we propose a more moderate and gradual change to the current system, based primarily on the long-established tradition of procurement programs being a state resource. A more gradual shift would limit drastic changes for waiting populations, support the established transplant and OPO practices, and fulfill the transplant needs of local communities, while still ultimately promoting equity. In addition to a more phased-in implementation, we propose that wait-listed patients be assigned extra allocation points if the donor organ is procured in their own DSA. These assigned points can be reduced on a yearly basis until the assigned points reach zero, thus allowing the majority of wait-listed patients to receive a transplant within their anticipated wait-time. In the meantime, educational programs regarding these new policy changes can be geared toward newer wait-listed patients, allowing them to make more informed decisions on where they wish to wait-list. We also suggest that the new policy maintain the current policy that kidneys not accepted locally for transplant be directed to the areas of greatest need. The benefits of such a system would continue local DSA sharing practices to minimize risk to donor organs and recipients, maintain DSA accountability for organ yield, reduce organ discards by promoting expedited sharing, and bridge the equity gap by promoting expedited placement to disadvantaged DSAs. We believe that these modest modifications to the current policy, as opposed to the overhaul promulgated by the proposed policy, will best serve to achieve our mutual goals in reducing geographic disparities in waiting times and improve the overall equitable procurement and distribution of kidneys for transplant. Again, thank you for the opportunity to comment on this important proposal. Should you have any questions, please contact Jonathan Chebra, Senior Director, Federal Affairs.

Goran Klintmalm | 10/01/2019

To take away organs from areas that are working hard to increase organ donation and retrieval and send them to areas that are ignoring the responsibility to provide organs to their populations is simply offensive. 'the current proposal simply ignores the logistical issues and cost of organ distribution, at a time when we are struggling to find tax money for basic medical needs. And, there are not sufficient number of aircraft or pilots to provide the services - in our society when demand for a product with a set production level goes up, the price goes up. sometimes even horribly so. In the current proposals, not a word is said about increasing utility of this limited resource, the donated kidneys. The higher the PRA is the higher the priority - so a patient who lost a graft, often from non-compliance, thus having elevated PRA has priority over patients never previously transplanted with low PRA. This is simply unethical. And recipients with a PRA>60 has a graft half-life of 11.5 years, when patients with PRA

Anonymous | 10/01/2019

I strongly oppose the proposed kidney allocation policy. 500 NM is too large a circle for allocation. This would mean flying more organs, increasing costs, increasing rate of discards and decreasing efficiency. This particularly affects northern states like Ohio where there is Canada and lake Erie in the north (not many organs coming from across the border!). This also disenfranchises smaller centers serving more rural populations. This will lead to centralization of transplant care to a few big institutions in the metros and close down the smaller efficient transplant centers serving more rural populations. A smaller allocation circle with a 250 NM radius might be a better proposition allowing kidneys to be driven rather than flown, thus decreasing cost, cold time and rate of discards.

Anonymous | 10/01/2019

This proposal absolutely does not support the tenet of the Final Rule that it purports to be addressing. The 500 mile radius is too wide and will lead to increased discard rates for kidneys. The simulations are already predicting that the total number of transplants may decrease based on this proposed allocation schema.

Anonymous | 10/01/2019

Strongly support (0), Support (1), Neutral/Abstain (0), Oppose (8), Strongly Oppose (15) The members of Region 10 do not support the proposal as written. It was noted that the proposed proximity point equation did not appear to be a linear function since it was stated that a transplant center 320 NM from the donor hospital would receive 2.56 proximity points. Being as that transplant hospital is over 250 NM from the donor hospital, if it were a linear function then a patient at that transplant center should receive less than 2 points. There was concern that the modelling showed a drop in kidney transplant rate and it would be balanced by the increase in kidney/pancreas transplants. If the two organs will have to travel further, there may not be as much of an increase in kidney/pancreas transplants since pancreata cannot withstand the same amount of cold ischemia time as kidneys. There was consensus with those in attendance that 500 NM was too large of a circle for allocation. One member noted that 500 NM would result in having to fly more organs, whereas a 250 NM circle would allow more kidneys to be driven. Besides the increased costs for flights, there is also much uncertainty with flight availability due to weather conditions. Many different allocation schemes were mentioned, state based allocation, circles based on population density, but overall the members supported a smaller circle size for allocation. Although they did not settle on a specific nautical mile circle there was support for more proximity points both inside and outside the circle than what is being proposed. One member suggested having a two circle allocation system with a very small nautical mile circle then a larger circle, and then “national” allocation after that. There was support for giving increased priority to pediatric patients and prior living donors. One member suggested allowing both groups equal priority with multi-organ transplants. Members were less supportive of the proposed import backup solution. One member noted that it would not be efficient to have the importing OPO be responsible for reallocation. Some OPOs are not aware when a transplant center accepts a kidney, so they would be unprepared to execute reallocation. Another member supported allowing the accepting transplant center the responsibility for reallocation.

Anonymous | 10/01/2019

After discussion with my close personal friend on the kidney donor list, I have come to a better understanding of what the proposed policy change would mean to her. The change in policy could make the wait longer for her to receive a donated organ - I object to the proposed policy change. The change in policy would negatively effect those patients in Oregon waiting for an organ transplant.

MUSC | 10/01/2019

This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. This policy may further dis-advantage pediatric patients in need of kidney transplant.

University Hospitals Cleveland Medical Center | 10/01/2019

1. The geography of our state puts our patients at a disadvantage due to the lake and canada to the north of ohio 2. The potential for kidneys from ohio leaving to go 490+ miles away incurring ischemia time does not appeal to the patient population I have surveyed, 3. By doing this , it may deter donation and impact transplantation 4. Significant socioeconomic impact on transplantation rates 5. Potential for increased costs to move kidneys around for potentially increased LOS and DGF, patients are impacted more so than the current system 6. Low EPTS transplant rates will be decreased Does not seem to be congruent with the KAS overall, are we going backwards ?

john dean | 10/01/2019

My wife is on dialysis and has been on the active transplant list for 19 months, as i understand the proposed 500 NM mile process it is my opinion and the opinion of her transplant team that we would / could be losing an available organ that under the DSA format would have stayed here in state. Unless you can 100% guarantee that this is not the case i am begging you to not do anything to risk my wife's life.

Charles Van Buren | 10/01/2019

The proposal to eliminate DSAs to place cadaver donor kidneys for transplant is fatally flawed for several reasons: 1) There is no infrastructure to support such a distribution system. Crossmatches currently performed within the DSA will be replaced by virtual crossmatches, which discriminate against African Americans. UNOS's own data on the preferential placement of 99-100% PRA recipients based upon virtual crossmatch supports this contention. The efforts at modelling are bound to be ineffective, since they are based on prior behavior. There is no precedent for large-scale placement of most kidneys based upon virtual crossmatch. If one wishes to expand the distribution area, establish a central laboratory to perform crossmatches upon all patients in the catchment area. The example of how to do this has been established by OPAM, the state OPO in Michigan, and the state of Illinois, which also has a central lab. If one wishes to expand the distribution area, invest in infrastructure first. 2) This concept fundamentally violates principals of altruistic giving. All successful charitable donation organizations emphasize local benefits as well as overall good of donation. The deemphasis on local use critically damages the major points used by successful OPO's, namely the emphasis on community benefit. 3) The proposal, by dissociating the community from the distribution scheme, makes governance of the donor system problematic. In fact this point has already been demonstrated by a number of large OPO's seeking to gain control of smaller organizations. If the community loses most of the benefit of the donation efforts, and is irrelevant, then the next logical step is to consolidate OPO's to expand power and impact overall public policy.

Pacific Northwest Transplant Bank | 10/01/2019

The Pacific Northwest Transplant Bank supports the removal of DSAs and Regions from kidney allocation, but strongly opposes the proposed policy as written. The policy proposed decreases the number of transplants, and increases logistical challenge and risk. A smaller circle would allow the first allocation of kidneys to be largely transported by ground to the receiving center. Once an organ goes further than 125 or 250 miles, kidneys must be transported by air. This transportation is performed by couriers and freight handlers, who may be less aware of, or concerned with, the lifesaving gift they are delivering. A routing error or delay greatly increases the potential for loss of a lifesaving organ. In addition, the policy, as written, will have a substantially negative impact on the transplant population in Oregon, a state where the population strongly supports donation and the registry.

Anonymous | 10/01/2019

I firmly believe in NOT eliminating the use of DSAs and Regions in Kidney Allocation. This policy would have direct negative effects on the availability of donor organs for Oregonians in need of transplants. The life of a very close friend on the kidney donor list could be lost if an organ is sent out of state instead of giving her the chance to receive a lifesaving transplant. That life could also be mine were I ever in need of a lifesaving transplant organ.

University of Toledo Medical Center | 10/01/2019

The proposed changes to kidney allocation policy have significant downside risk that does not justify the gains for the system. The policy as proposed has been simulated and the results suggest that it will decrease the overall transplant rate (especially for kidney alone transplant numbers). The modelling of the new proposal shows that it will not lead to a change in the median time on dialysis at the time of transplant, so it will not lead to patients being freed from dialysis any faster than the current model. The new proposal does not address organ procurement organization (OPO) performance at all, and in our opinion, this should be a first step. Center behavior such as aggressive deceased donor acceptance activity at transplant centers and the changes the new system might cause in this behavior has not been factored into the simulation. Population density was not considered in the current model. The proposed changes could compromise the use of high KDPI & DCD kidneys due to increased cold time and decreased ability for pumping practices that transplant centers have in place. Shipping kidneys over greater distances will increase the cost of kidneys and longer cold ischemic times will undoubtedly lead to an increase in discard rate. Medical urgency will no longer be under the purview of the centers within a donor service area, but will now require a new approach leading to increased administrative burden and potential gaming. The current import offer process is not designed for shipping a kidney without local backup—so that if reallocation is required, the new OPO will not be as prepared (nor as financially/oversight motivated) as the original OPO for re-allocation—ultimately leading to higher discard rates. With all of the considerations noted above, it is evident that the current model is not ready for implementation. It is important to remember that the final rule states that allocation should achieve the following goals with first priority: 1. Use of sound medical judgement; 2. Achieve the best use of organs; 3. Preserve the ability for transplant programs to accept an offer; 4. Avoid wasting organs; 5. Avoid futile transplants; 6. Promote patient access to transplantation; 7. Promote efficient management of organ placement. Only after these goals have been achieved, should the allocation policy: 8. Avoid allocation based on the candidate’s place of residence or place of listing. In our opinion, more research is required to develop a model that achieves the goals of the final rule. We believe a first step is to focus on OPO performance and organ discard which will increase the overall number of transplantable organs. A new policy that leads to: decreased overall transplant rate; compromised use of high KDPI & DCD kidneys; increased cold ischemic times; reduced efficiency by shipping kidneys over greater distances; increased cost; and, increased administrative burden; is not a good change in allocation policy. Surely we can do better. Michael Rees, MD PhD Deepak Malhotra, MD PhD Jennifer Holloway, RN BSN CCTC

Anonymous | 10/01/2019

This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally.

Anonymous | 10/01/2019

I strongly oppose this method of disbursement for Kidneys. We are already at the mercy of Hospitals that act as "God" with the do what we say or we will blacklist you and now this... Example: California has one of the highest times to receive a kidney transplant. If you are a patient you will be lucky to be alive by the time 7 to 10 years comes around. Doctors treat the patients horribly! At first they seem to want you to learn all you can learn about Kidney Disease, about what to eat and not eat, understand your treatment, the expectations and the possible side effects of dialysis and or peritoneal, you must must jump through hoops. Once a patient is educated about their disease and begins to questions their care that is when the Doctors become angry and really take it out on the patients. For ONOS to also get involved even more and longer wait times will occur for those states that are smaller and give their patients a better opportunity to have a chance for a transplant sooner while the patient is in better health, strong, and healthy (as one can be with kidney failure). Do not punish those states that give their kidney patience a glimpse of light.... Doctors at hospitals such as UC Davis should also not have the power to play God if they do not like the patients... Such a sad and disgusting practice and one day all will have to face their maker.....

Danielle Scheurer | 10/01/2019

This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. This policy may further dis-advantage pediatric patients in need of kidney transplant.

NATCO | 10/01/2019

NATCO continues to value the opportunity to comment on public proposals, especially those that will have a profound impact on many of its member’s day to day roles, as well as the health and care of their patients. NATCO also commends the committee’s efforts to update kidney and pancreas allocation and to better align with the OPTN Final Rule’s requirements for allocation policies to include sound medical judgment, best use of organs, the ability for centers to decide whether to accept an organ offer, to avoid wasting organs, to promote efficiency, and not be based on the candidate’s place of residence or place of listing, except to the extent required by the previous requirements. Although the NATCO kidney and pancreas community understands the need to remove the DSA and region from allocation, the general consensus of our membership is that the proposed hybrid framework falls short in a number of areas and will have unintended and deleterious consequences for our patients. First and foremost, the modeling of the kidney allocation scheme predicts less transplants and poorer outcomes for our patients. Certainly modeling has its limitations, but we find it difficult to accept a proposal that could have deleterious impact on our patients. Furthermore, although such widespread changes to the existing system will broaden sharing, it will also inevitably lead to decreased efficiency, increased logistical complexity, increased cost, and more discards. Many members feel a step-wise, slower approach with continuous impact assessment would be a more prudent process. Secondly, we are concerned that a one-size fits all concept, primarily based on fixed geographic circles, will have negative impacts on different parts of the country. Where one lives will still be a key factor of waiting time in the hybrid framework. Many in the community still believe that a population-adjusted model or a variable concentric circle model capturing a standard proportion of population or the wait-list would be a more equitable and efficient alternative that would also better align with The Final Rule. We agree. We would suggest re-examining the work of Sanjay Mehorta in this regard (Transplantation, February 2018). Although his group proposed using existing DSAs, the underlying constraints were population, contiguousness and a reasonable organ transport time. The NATCO community members had very specific concerns with the hybrid framework proposal for kidney allocation. All proposed hybrid models did not improve the number of kidney transplants or waitlist mortality. Eliminating variation in wait time should not be the only outcome considered. Logistics and efficiency will be greatly impacted, especially in the 500 nautical mile framework. For many centers and OPOs on either coast, a majority of the circle is the ocean. Shipping distances will rise, leading to increased cold ischemic time (CIT), increased incidence of delayed graft function, increased cost, and increased reliance on air transportation. Over-utilization of commercial aircraft will lead to more delays, increased CIT, and in some instances, kidney discard. OPOs and their local transplant centers have built relationships and developed allocation principles to increase its efficiency. These relationships have also contributed to the rise in DCD donation. Our members believe strongly that any change to kidney and pancreas allocation cannot stunt the growth of one of the most innovative advances in organ donation. Regarding the size of the geographic circles proposed, our members expressed that the first allocation unit is the most important. This is where all of the pre-recovery preparation and identification of suitable recipients based on donor characteristics is completed. The larger the initial circle, the more centers will be included in the allocation process, especially in the more densely populated regions of the country. In particular, in the 500 nm framework, there will be multiple donors being offered to many of the same centers, increasing the complexity and burdens on many centers. There are concerns that these increased complexities may result in increased cold ischemia and will make it difficult for surgeons to accept the more challenging donors. Although we do not support the hybrid framework we would suggest that if adopted, it should utilize the smallest possible concentric circle. This will allow for the community to adjust to the changes, build relationships, and to establish best practices, to increase efficiency. We support proximity points to mitigate distance and shipping concerns. We also recommend careful consideration be given to the following factors prior to implementation: KDPI effect on circle size with the higher the KDPI, the smaller the circle (2014 KAS mixed regional list is example of failure with broadening sharing that was eliminated with new dual allocation policy), timing of prospective cross-matching and sharing of pre-recovery HLA specimens, biopsy and pulsatile preservation, accurate candidate listing, and accountability for organ turn down or acceptance of multiple offers. NATCO supports the inclusion of pediatric, prior living donor, top 20 % EPTS, and 0-antigen mismatch priority in the first allocation unit. Some members would like policies to further address the impact of multi-organ transplants on these kidney -only priority candidates. In the current system, medical urgency candidates are very rare, but handled at the DSA level. Eliminating the DSA will require defining medical urgency and establishing oversight rules. However, as we believe was discussed in every UNOS Regional meeting, the current proposal for local back-up is critically flawed, and must be re-addressed. Any policy on local back-up should start with pre-recovery identification of back-up candidates by the potential accepting transplant center. There must be flexibility to ensure successful placement of these organs. Most of our members concerns were with the hybrid framework kidney proposal. The Board and members of NATCO appreciate the committee’s work on this proposal and the opportunity to provide comments.

Zach Weddle | 10/01/2019

I am writing bacause I I just read about the new alogation systems proposed to kidney transplant rules and regulations regarding the southern Nevada Patients. Please re conciser this proposal. The closer to 100% that a kidney transplant will be successful the better off all the patients will be. Because the organ will be in transportation longer, statistically it will be less likely to be a successful healthy kidney. This proposal is a step backwards in the eyes of many patients. These surrounding states need to look at their organ donor programs and encourage others to participate in these programs and Express how one person can save several people with their one decision. It is a unfair proposal to the patients in Nevada as well because now their lives got altered again and they must begin the waiting game once more. Please think about my message and I hope it helps persuade you to see this issue thru my eyes. thank you for your time

MUSC | 09/30/2019

Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients.

MUSC | 09/30/2019

This policy may further dis-advantage pediatric patients in need of kidney transplant The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Debra Cassidy | 09/30/2019

The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Cristine Candland | 09/30/2019

This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs.

Anonymous | 09/30/2019

We should not accept the current proposal to eliminate the use of DSA and region from kidney allocation. The current proposal benefits a very small number of transplant centers at a high cost and does not fully address the issue of disparity in access to transplant. Based on modeling, patients in New York will have an additional 34% more donor kidney available while patients in San Francisco with similar waiting times will only gain 4%. The costs of this redistribution may be substantial. It is relatively easy to model how far kidneys will travel but we don’t know how much this will effect costs. A recent publication in the American Journal of Transplantation showed that the change to a circle model in lung allocation lead to a doubling in median organ cost from 34,000 to 70,000 dollars. In general, there is a lower margin for kidney transplant than other organ transplants. If kidney transplant centers are not able to absorb this cost it could lead to reduced access to transplantation. This publication also noted that the utilization of lungs decreased in nearly every region following the change. This would be a similar effect to the introduction of KAS which showed an increase in kidney discards with wider regional sharing. The logistics of organ distribution will be substantially more complicated in kidney transplantation compared to lung transplantation due to the higher number of organs, candidates and centers. Bottlenecks in access to flights, couriers, multiple organ offers may limit efficient allocation and utilization. This proposal offers most patients reduced access to transplantation and gives additional priority to patients who already have higher transplantation rates including sensitized patients, pediatric patients and kidney pancreas candidates. If this proposal is the only possible alternative, I believe the following suggestions would be an improvement. 1 Eliminate proximity points beyond the 500-mile circle. The 8 proximity points could cause problems for highly sensitized patients on the west coast. We already ship these kidneys around the country and it really does not matter how far they go. The difference in travel time between 500 miles and 2500 miles is probably more dependent on access to appropriate flights and less dependent on the actual distance. Eliminating the proximity point outside the 500-mile circle would also divert organs into candidates who have the greatest need and reduce geographic disparity. 2 Begin with a smaller circle. A smaller circle of 150, or 250 nm would be logistically much easier to start with. If this is successful, UNOS could examine proposals for reducing geographic disparity or move onto models of continuous distribution. Fixing a broken system won’t be easy and will keep us from examining better alternatives. Smaller circle sizes also reduce the additional priority given to sensitized, pediatric and SPK patients. These patients are already have much higher transplantation rates. 3 The medical urgency proposal could be a bigger issue than one thinks. Meld exceptions in liver transplant are currently about 30 % of transplants. It is possible that with longer kidney waiting times many more patients will be transplanted based on medical urgency. The national liver review board has objective criteria but I think the dialysis access cases may be more subjective and require a more substantial effort to review.

Shane Oakley | 09/30/2019

I oppose this due to the increase in cost of shipping a kidney, logistical issues which would increase CIT to the organ this would in turn have more kidneys thrown away. Deciding we are going to be "fair" does not mean we have to decide that we are not going to logically think about the consequences of our actions. If we make it "more fair" then we will throw away more gifts given to recipients, which should be our primary consideration.

Rusty Copeland | 09/30/2019

Greetings. I'm taking some time to post my thoughts on this topic as I am directly affected by this potential policy change. I'm not a doctor nor a statistician however from what I have been able to read and view in the recorded webinar this proposed policy change has issues. While the idea is a good idea it needs much more work. Organ distribution. The 500 nautical mile (NM) circle seems like a good idea for areas back east like parts of the east coast and the midwest. There are lots of hospitals that perform transplants and this kind of matching scheme I think will work. However, out west there are fewer transplant hospitals and this scheme will cause problems. Let's look at the situation between California and Oregon. California has a very great need yet they have a very high population density. Oregon has a lower population density and a lower organ need but a need all the same. If this policy were to be implemented I foresee many of the organs procured in Oregon leaving Oregon and I see no reciprocity as the need is so high in California none of the organs procured in California would make it to Oregon. Hence, wait time for Oregonians would increase substantially. Cost. During the August webinar regarding this topic, I won't post a link in case it violates posting guidelines, a caller mentioned the cost of flying organs to other transplant hospitals. I have to agree, the cost would be quite high. And while I don't understand all the intricacies of whom pays for the cost of transplants; I do know the cost for transplants is already significantly high and increases do not help anyone. I can't see this as being a very effective. Don't get me wrong, I am sympathetic and compassionate towards the people that need organ transplants; I am one that needs a transplant but I don't think this proposed system is the answer, it needs more work. While I focused my points on the Oregon-California situation during the webinar callers from Florida expressed their issues with the 500 NM circle as they are surrounded by ocean. I do have ideas but I believe those comments fall outside of this discussion.

MUSC | 09/30/2019

1. This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4. The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6. Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7. This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

I support the concept of broader sharing to address the inequity of organ allocation. I do have the following concerns: The current proposal does not address Alaskan donors as there is not a transplant hospital within 500NM. I suggest that Alaskan donors have a Sea Tac zip code, but are not assigned proximity points within the 500NM circle.

Kathy Lewis | 09/30/2019

In Response to the upcoming change to the National Kidney Allocation Policies. I cannot express the hopelessness I felt upon reading that Oregon kidneys would be sent to other states decreasing available kidneys for Oregonians who have supported this state. Some kidney patients may not have that added time including children. I am currently in my 2nd year on the transplant list praying that I will receive a kidney within the next 3 years. Speaking for myself and other kidney patients please do not make this change. Many lives depend on keeping donations as they are. Thankyou!

Anonymous | 09/30/2019

This is proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients

Michael Daily | 09/30/2019

Once again, OPTN is asking for public comments on the updated proposal to “Eliminate the use of DSA and Region in Kidney allocation policy”. I certainly hope that someone reads these comments. The stated reason for the policy change is to come into compliance with The Final Rule. I am in agreement with that goal. The Final Rule is not a straightforward as you might think, and I encourage anyone interested to review it. The primary tenant is that we should use 'sound medical judgement' achieve the 'best use of organs'. Any changes to organ allocation should be done to 'promote efficiency', avoid futility, and achieve the most 'broad geographic sharing' (within the confines of medical feasibility). Unfortunately, it seems some people are getting hung-up on the 'broad geographic sharing' bit, while minimizing the 'best use of organs', 'efficiency', and 'sound medical judgement' parts. Regarding this 'broad geographic sharing' tenant; whether a river, or state-line should keep organs contained is a more difficult question than it might appear. Certainly, I would not propose failing to ship an organ across a bridge, if it could be better used on the other side, but what if the difference was a month of waiting time? Or a minute? Before you send that organ across the bridge, please consider the reason that organ was available on the other side in the first place. If it is because of local initiatives on one side of the bridge, which have not been replicated on the other side of the bridge, then why must the better prepared side be compelled to share it? There has been a great deal said about the inequity of waiting times in cities like New York, but relatively little said about how poorly the conversion rate at NYRT compares with the conversion rate at adjacent OPO’s. If it is true that local initiatives improve organ donation, then shouldn’t the local recipients be rewarded? If not, what is the incentive for the local initiative in the first place? A corollary is why argue about who gets a bigger piece of the pie, when the pie could be made bigger? With regards to the 500 mile circles, one need look no farther than a map with 500 mile circles drawn around Manhattan, Chicago, Houston, Los Angeles, and San Francisco to see why 500 mile circles were chosen. A 500 mile radius around almost every hospital in the country will include one of these cities and over a dozen of the busiest transplant centers in the country. I also think the “distributed over as broad a range as feasible” should be examined. As I mentioned earlier, 500 miles was an arbitrary distance which happens to allow the biggest programs in the country access to almost all of the kidneys. If this range was determined with best use of organs in mind, clinically relevant information, like “additional cold ischemic time” would have been used instead of distances. A question everyone needs to ask themselves is: how much additional money or delayed graft function are we willing to spend to share more broadly? The studies have not been done, but placing kidneys on a plane, will certainly increase both the time and money required to transplant a kidney that could be used locally with better outcomes, less ischemic time, and less financial resources, and no chance of missing a connecting flight, or getting lost in an airport. This strains the tenant of 'sound medical judgement'. Fortunately, there has already been some modeling on how broader sharing will impact kidney transplant. You will have to look closely for the results to find them, though. Figure 12 shows how the modeling predicts fewer kidney transplants for every circle size but one. How did the proposed policy fare? It is predicted to result in 2.4% fewer kidney transplants per year! So much for making the 'best use of organs'. So, of the tenants of the final rule, the proposed policy does not appear to show 'sound medical judgement'. It also does not appear to 'promote efficiency', or the 'best use of organs'. It does all this to encourage 'broader sharing', without mentioning why 'broader sharing' is important, how much more 'broader sharing' will cost, or why 'broader sharing' should take priority over transplanting more kidneys. Instead, I propose a continuous distribution of organs, with significant proximity points. Contrary to the current proposal, this will promote efficiency, while removing geographic barriers. This will incentivize local initiatives on organ donation. I have been told such a proposal will be "too hard”, but it is clear to me that this is the only solution that will promote all four tenets of the final rule. Anything else is a compromise.

Saint Barnabas Medical Center | 09/30/2019

Saint Barnabas Medical Center, part of the RWJBarnabas Health system, together with the other kidney transplant centers from the state of New Jersey (Hackensack University Medical Center, Robert Wood Johnson University Hospital, and Virtua Our Lady of Lourdes Hospital) and along with the state’s main OPO (New Jersey Sharing Network, NJSN), has 4 main comments and an additional 3 suggestions regarding the UNOS proposal to eliminate the use of donation service areas (DSAs) and regional boundaries in kidney allocation. Our four transplant centers and the NJSN OPO agree with UNOS that more equitable distribution of deceased donor kidneys is laudable and needed. Our comments are as follows. FIRST, the implementation of the proposed policy will suddenly and disproportionately decrease access to transplant for the patients we serve in New Jersey. Current waiting times in NJ are a few years shorter than waiting times in the adjacent DSA in New York. Under the proposed model, for the first several years, very few patients in New Jersey will receive deceased donor transplants (despite proximity points), due to the long accumulated waiting times of thousands of patients in adjacent New York. For patients at New Jersey centers, the elimination of DSAs for allocation will likely increase average wait times by at least 3 years, contribute to an estimated 300-500 unnecessary deaths, and adversely affect thousands of other patients by delaying their receipt of life-saving transplants. The candidates on the waitlist in New Jersey have made “life decisions” based upon their anticipated wait-time for a kidney transplant, and the current proposal will upend these choices. SECOND, the four New Jersey centers note the proposed changes will not only slightly decrease the total number of transplants, but will also lead to worse transplant outcomes. Prolonged cold ischemic times from proposed broader sharing will cause more delayed allograft function, with its attendant complications. More subtly, a large bolus of kidney transplants at centers in DSAs with historically long waiting times may lead to worse outcomes, due to mismatches between existing center resources/staffing and abruptly increased volume. In the past, transplant centers that have suddenly increased their volume have almost inevitably experienced an ensuing decrease in their graft and patient survival (leading to UNOS oversight!). The current UNOS proposal will cause such detrimental spikes in volume. THIRD, the current proposal may inadvertently discourage local donation in New Jersey. The UNOS proposal will cause almost all locally procured kidneys to be shared outside the DSA to recipients in other states, at least for the first few years, and this phenomenon may have the unintended effect of decreasing local donation rates. Although donors are a national resource, deceased donation is almost entirely driven by local efforts, led by OPOs. FOURTH, under the proposed changes, transplant centers and OPOs will have to juggle many more organ offers from a large nautical mile radius. The ensuing higher costs and increased complexity will not even lead to an increase in transplant, but will instead be part of a system that knowingly decreases transplant. For these 4 reasons, the New Jersey transplant centers and NJSN OPO strongly urge UNOS to NOT approve or finalize the plan as it is currently written. We respectfully submit 3 suggestions regarding this proposal, and these suggestions reflect our belief that any alterations in organ allocation should be less sudden. A more gradual shift would limit drastic changes for waiting populations, support the established transplant and OPO practices, and fulfill the transplant needs of local communities, while still ultimately promoting equity. FIRST, we suggest that to implement the proposed changes gradually, the proposal could include an organ-sharing limit per year, outside of the local DSA. For example, in any given year, the number of shared kidneys could be capped at a to-be-determined percentage of a DSA’s total number of procured kidneys from the prior year. Alternative caps could be proposed. Such a cap would still reduce the disparities in waiting times among DSAs, while also enabling a smoother transition to broader sharing. SECOND, wait-listed patients could be assigned extra allocation points if the donor organ is procured in their DSA. These assigned points can be reduced on a yearly basis until the assigned points reach zero, and this gradual phase-out will allow the majority of the wait-listed patients to receive a transplant within their anticipated wait-time. For example, currently wait-listed patients can receive 3 additional allocation points if the organ is procured in the DSA where they are listed, and this assigned point can be reduced by 0.5 each year; as a result, by year 6, this assigned point will be zero. Use of such points will also allow equitable distribution of organs to occur. In the meantime, newer wait-listed patients will be educated about the new policy change and can use the new anticipated wait-times to make their decisions on where they wish to wait-list. This temporary use of local allocation points, in addition to proximity points, will ensure that rates of deceased donor transplant do not suddenly spike or crash due to this new policy, while still promoting broader sharing and less disparities in waiting time. THIRD, we suggest that kidneys that are not accepted locally for transplant should be directed to the areas of greatest need using any nautical mile radius instead of regional and national allocation. This new allocation system could first be added as third tier after local and regional allocation. This alternative would mirror the intentions of the UNOS Kidney Accelerated Placement Project (KAPP) program. The benefits of such a program would maintain local DSA sharing practices to minimize risk to donor organs and recipients, maintain DSA accountability for organ yield, reduce organ discards by promoting expedited sharing, and bridge the equity gap by promoting expedited placement to disadvantaged DSAs. In CONCLUSION, the kidney transplant centers of New Jersey and the NJSN OPO agree that reduction in geographic disparities in waiting time is desirable, and they also agree that the current UNOS proposal should be modified and improved before any implementation.

Association of Organ Procuremement Organizations | 09/30/2019

The Association of Organ Procurement Organizations (AOPO) strongly supports the goal of the UNOS Board and the organ-specific UNOS committees to align organ allocation policies with the Final Rule. In support of this goal, organ procurement organizations remain committed to partnering with transplant programs to adapt to changes in allocation policy and to develop innovative new approaches for increasing transplantation, with a focus on efficiency, minimizing discards and cost-effectiveness. We advocate for policy that prioritizes medical urgency of patients and is sensitive to specific cases, such as those involving hard to match candidates, pediatric patients and prior living donors, in order to maximize equity in access for these populations. We also advocate for policy that allows for flexibility when taking into account special geographic considerations such as areas like Hawaii and Puerto Rico that are non-contiguous to the states. We support allocation policies that maximize the utilization of all kidneys, including marginal kidneys. Further we maintain that any policy change must, at a minimum, not decrease utilization of organs. We support changes that result in an increase in the number of kidneys transplanted. What should be considered to select a circle size that distributes kidneys broadly and efficiently? Ideally, circle size will be selected based on modeling data that shows maximum use of kidneys aligned with the policy priorities identified above while accounting for cold ischemia time, cost and process efficiencies. The number of kidneys available for transplantation should not be impacted by broader sharing. Any policy proposal that is expected to result an increased number of discards is not supportable. Air travel challenges also must be considered. For many areas of the country, travel is limited during the night, with weather and operational delays posing a further risk of not being able to transport kidneys. Because these factors directly relate to the efficient management of the system and potential for organ wastage, they should be considered, consistent with the Final Rule, in selecting a circle size. With 250 NM, about 10% of organs are predicted to require air travel versus 40% in the 500-NM circle. The system may over-time adjust and innovate solutions to transportation but these are current challenges. For this reason, AOPO supports a 250-NM circle over a 500-NM circle as a compromise first step in removing the DSA from kidney distribution. Proximity points are intended to contribute to efficiency in the broader distribution of kidneys. Should they be used inside the distribution circle? Should they be used outside the distribution circle? How should the assigned values be prioritized in relation to other allocation points in the kidney allocation system? Proximity points should be used, with a greater emphasis put on those closest to the donor hospital and a reduction in the number of points as the distance grows. AOPO supports the proposal of proximity points both inside and outside the circle, as defined. What prioritization do you think is appropriate for pediatric candidates? Should prioritization be applied inside the distribution circle? Should prioritization be applied outside the distribution circle? Pediatric patients within the distribution circle should be prioritized over adults. Once the allocation moves outside the determined radius, pediatric patients should again be prioritized over adults in that expanded circle. What prioritization is appropriate for prior living donor candidates? Should prioritization be applied inside the distribution circle? Should prioritization be applied outside the distribution circle? Living donor candidates who later find themselves needing a kidney transplant should have priority nationally. What operational concerns should the committee consider as this policy is being prepared for OPTN board action and implementation? Under this proposed policy, OPOs – who have historically placed many of their kidneys within their DSA – will be placing more organs outside their DSA. This will require additional time, added travel expenses and greater coordination of the donation process. While we do not think these are exclusively limiting factors, they nonetheless need to be considered. We believe that strict monitoring of any new system must occur to minimize and respond quickly to unintended consequences, such as increased discards and/or a dramatic increase in donor recovery expenses. Should medical urgency criteria be defined? If so, what specific conditions would qualify? Where should they fall in the allocation classification? Since the intent of all allocation policies is to reduce the number of deaths on the transplant waiting list, we do believe medical urgency criteria should be developed. These criteria, when present, should receive additional points both within and outside the proximity circle. We do not believe we are in the position to recommend what the criteria should be; however, the criteria should be life-threatening in nature and, as applied in the allocation of other organs such as heart and lung, have urgency as a priority. One such example may be immediate loss of vascular access for dialysis patients. When local backup is granted, do you support the use of an import match run for the import OPO to reallocate the kidney? Should the match run use the same size circle as the original allocation but with increased points for proximity? Should the circle size be smaller? If so, what distance will promote the efficient reallocation of kidneys? AOPO supports the use of an import list if an importing center cannot use the kidney and needs to reallocate. We support the original OPO having the choice to place the kidney themselves or to release it to the OPO that covers the import center. We note that some OPOs do not currently get involved with imported kidneys and that this work would require standardization of varied practices which have operational and financial implications for OPOs. We support the use of a 150-NM radius for the import list, with proximity points given to patients closest to the original transplant center.

Luauna Dean | 09/30/2019

I strongly believe in the elimination of the use of DSA's and Regions in kidney allocation. These decisions directly affect the availability of donor organs for myself and all Oregonians in need of transplants. Particularly those without living donors. Please carefully consider this as it not only affects recipients, but Oregon families and children as well.

Anonymous | 09/30/2019

Some major concerns: 1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

I firmly believe in eliminating the use of DSAs and Regions in Kidney Allocation. This policy would have direct negative effects on the availability of donor organs for Oregonians in need of transplants. The life of a very close friend on the kidney donor list could be lost if an organ is sent out of state instead of giving her the chance to receive a lifesaving transplant. That life could also be mine were I ever in need of a lifesaving transplant organ.

Anonymous | 09/30/2019

Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs.

Anonymous | 09/30/2019

1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Jack Woolard | 09/30/2019

Seems like the plan to require distribution of kidneys wirhi a 500 mile radius and override current state policies will add to cost by introducing transport where none existed before and would adversely affect successful transplant outcomes.

David Stoll | 09/30/2019

Elimination of the use of DSAs and Regions in Kidney Allocation would be a major disservice to the underserved patients of South Carolina.

MUSC | 09/30/2019

This proposal will - increase waiting time for South Carolina kidney failure patients. - increases travel requirements for up to 40% of organs transplanted - increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. - decrease kidney transplant rates - re-distribute organs from areas of better OPO performance to areas of lower OPO performance. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward?

Medical University of South Carolina | 09/30/2019

This policy will increase cold ischemia time and likely kidney discards. This will also pose a challenge with logistics and cost of transporting a kidney outside of the region. Once a kidney outmigrates, returning it to the local region (should there be any issues with intended primary recipient) will prove to be challenging. Chances are the kidney will have to be offered to the local backup at that time. In the end, the policy attempts to benefit sensitized recipients but this might be at the expense of local recipients who might have been on dialysis for a long time. Working in a single transplant center-single OPO model, we enjoy the advantage of shorter waiting time for our patients. This is extremely beneficial for our local recipients as our state has one of the highest rates of CKD, particularly in the African American population. This is a disparity that our transplant center has been trying to address. However, with this proposed policy change, this might mean longer waiting time for our waitlisted patients due to increased outmigration of kidney offers.

Anonymous | 09/30/2019

1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. This policy may further dis-advantage pediatric patients in need of kidney transplant. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs.

Michael Casey | 09/30/2019

I am very concerned about the proposal because I believe it will lead to more kidney discards and overall lower number of kidney transplants performed nationwide. It may also disadvantage pediatric patients on the waitlist too. South Carolina has a very high proportion of underserved patients and this will only disadvantage them further by decreasing transplant rates and increasing wait times.

Matthew Mulloy | 09/30/2019

Dear UNOS Kidney Committee, The proposal to eliminate DSA and region from kidney allocation appears to be going down the right path, but unfortunately misses the mark. The circle size of 500 NM is simply not one that will lead to efficient or affordable distribution of organs. In your own modeling you were given the information that with a 500 NM circle more than 40% of kidneys would be reliant on air travel to reach their intended recipient. This will add undue expense to the distribution of organs as well as be exceedingly difficult logistically for locations without major airports. In the last month alone our program, which is located a stone's throw from one of the country's largest airports, has lost the opportunity to transplant 3 kidneys that were supposed to be sent to us by commercial airlines. One organ was delayed due to weather and the next available flight wasn't till the next day. Another organ made it to the airport, but was never placed on the intended flight. The third organ was mistakenly taken to the wrong airport and missed the intended flight. I can't stress enough that commercial airlines were not intended to be organ distribution networks and simply should not be over relied upon to distribute organs. A 250 mile circle makes much more sense logistically and comes exceedingly close to achieving the same goals. I'll start by saying that in your regional presentation the slide showing overall change in transplant rate for the various modeled scenarios was, I think, purposefully misleading as the scale for difference in transplant rate was 0.02%. Therefore, the real difference in transplant rate between a 250 NM circle and 500 NM circle was almost imperceptible, but it was made to look significant. I would expect more honesty in the presentations moving forward. In a 250 mile circle the estimates for organs requiring air travel was approximately 10% versus 40% for a 500 NM circle. It would seem to us that if there were no real differences in number of transplants or transplant rate with a 250 versus 500 NM circle staying with the circle that allowed the majority of the organs to be driven to their location rather than flown would be the logical choice. In our regional meeting we were told that COST hadn't been modeled and that it would be difficult to do so. I know the point is to comply with the final rule, but - as far as I know - no one will be paying us extra for organs that are flown. If transplant centers start losing money on renal transplants it will undoubtedly cause some programs to decrease their number of transplants, or worse, to close their transplant program. There are ways to model costs, ie, using 100% CPRA kidneys as a marker and comparing the costs of these organs to local organs. The thought of approving a 500 versus 250 NM circle without analyzing the effect in cost would seem to me to be lazy at best. Although the final rule that states that geography shouldn't be a barrier to distribution it also notes that this must be balanced with the logical and efficient placement of these incredible gifts. I would ask the kidney committee to query all OPOs across the country and see how many feel like they could effectively distribute kidneys with a 500NM circle. While the kidney is an important organ, we all know that it is not instantly life saving as hearts, lungs and livers are. Therefore, I can't see how we can justify such a wide distribution when we know that the logistical burden on OPOs will be untenable and that this will dramatically increase costs. The logical next step to eliminate DSA and region would be a 250 NM circle with proximity points within the circle. This was a counter proposal approved by Region 4 in our most recent meeting. This achieves the goal of eliminating DSA and Region in a logical and cost effective manner without drastically altering the logistics of placing and transporting kidneys. I would hope that the Kidney committee will take all recommendations to heart and rethink the current proposal. Those advocating for a wider circle are not taking all aspects of transplantation and the final rule into consideration. Eliminating DSA and Region is a good goal, but it must be done with common sense in mind. If the majority of the Regions do not support this proposal I would quite alarmed if the proposal given to the board wasn't changed. How can we trust in UNOS and OPTN if the wishes of the transplant community aren't heard? Furthermore, why have regional meetings and committees if the UNOS Board will blatantly disregard the recommendations of their own committees as they did with the Liver Committee proposal for elimination of DSA and Region? We are hopeful that the feedback from Regional meetings and public comment will enable to Kidney Committee to adopt the proposal put forth by Region 4 to move to a 250NM circle with proximity points.

Anonymous | 09/30/2019

1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Jerry Mansfield | 09/30/2019

As a result of a tragic accident, my 16 y/o brother-in-law became and organ/tissue donor. Since that time, my wife and her former parents (now deceased) talk about some measure of comfort in that Patrick was able to help others through his untimely death. As a Registered Nurse, I witness countless opportunities of patients and families - not only to donate, but to receive life-giving organs. The allocation process will hamper the process by: a) increase the number of kidney discards, decrease transplant rates and negatively impact health outcomes for South Carolinians.

Anonymous | 09/30/2019

1. This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4. The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6. Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7. This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide additional comment on this proposal. The current Kidney Allocation System (KAS) was implemented 5 years ago. One of the goals of KAS was to optimize the matching of donor kidneys to appropriate recipients. This system is based on stratifying each donor by the Kidney Donor Profile Index (KDPI) which gives a lower value to better quality organs. Currently, pediatric recipients receive priority for kidneys from a donor with KDPI 35. This has created a challenge in certain pediatric recipients (generally under 20kg) which due to the limitations in their vascular anatomy and in combination with their size, require smaller kidneys from a pediatric donor. These recipients may be on dialysis with challenging dialysis access issues which increases their risk of mortality while on the waitlist. Currently, these pediatric patients are disadvantaged since the kidneys they require, from a small pediatric donor, will likely have a KDPI > 35. The current allocation system preferentially allocates these pediatric kidneys to adults and thus bypassing the children on the waitlist. The effects of KDPI and KAS on the pediatric population in is nicely analyzed in a 2018 publication (Nazarian et al.The Kidney Allocation System Does Not Appropriately Stratify Risk of Pediatric Donor Kidneys: Implications for Pediatric Recipients, American Journal of Transplanation, 2018; 18(3): 574-579) . We believe that the current allocation system disadvantages certain pediatric recipients by decreasing access to kidneys from pediatric donors. Therefore, the OPTN Pediatric Committee is advocating for consideration of prioritization of children such that they will have more access to pediatric donor kidneys with KDPI > 35. OPTN Pediatric Committee proposes to work in collaboration with the OPTN Kidney Committee and the SRTR in order to develop a more equitable allocation system for the pediatric population without disadvantaging the adult population.

Karyn Rae | 09/30/2019

1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Daniel Stanton | 09/30/2019

I am writing to comment against the most recent efforts to change kidney organ allocation. In general, I continue to believe in “more broad sharing”; however, the method in which we change the organ allocation system must be more purposeful and logical. I am extremely concerned that the most recent efforts to change the allocation of thoracic organs has resulted in a significantly more costly and complex system. This proposal would do the same for kidney allocation on a much larger scale. I strongly oppose this proposal for several reasons: 1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. I cannot support any proposal which knowingly reduces the number of lifesaving transplants performed. 2) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. This additional cost will almost certainly reduce the number of lifesaving transplants that centers will be willing and able to complete. 3) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 4) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If a great majority of the transplant professional community feels this is a poor change, why would we push this forward? 5) This policy may further dis-advantage pediatric patients in need of kidney transplant. I strongly urge the OPTN to consider a more favorable approach to organ re-allocation that maintains (or reduces) the number of organ discards, maintains of reduces the cost of transportation, and allows for input from the community and professionals in the field. I appreciate the opportunity to provide this feedback, Daniel Stanton MHA, MBA, FACHE Administrator, transplant Medical University of South Carolina Charleston, SC 29425

Medical University of South Carolina | 09/30/2019

This proposal is bad for several reasons; it will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. Locally it will decrease kidney transplant rates and significantly increase waiting times for kidney failure patients in our state. Three fourths of the UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a harmful change, why would consideration be given to approve this plan? The proposal greatly increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs associated with this plan. Current proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance which does not encourage OPO performance improvement. The initial data from the recent lung allocation change suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These significant concerns should be further considered prior to implementing similar changes to kidney allocation.

University of Alabama at Birmingham Comprehensive Transplant Institute | 09/30/2019

On behalf of the University of Alabama at Birmingham Comprehensive Transplant Institute: One of the challenges in assessing access to kidney transplantation and “equity” is choosing the proper metrics to compare programs, donor service areas (DSAs), and geographic regions. The two metrics most frequently used by the Scientific Registry of Transplant Recipients (SRTR) and in modeling geographic distribution have been transplant rate and time on the waiting list (e.g. used to estimate both median time to transplant and waitlist mortality). The SRTR defines center-specific transplant rates by the number of transplants performed (as the numerator) divided by total patient time on the waitlist (as the denominator) at a given center for the performance period. Time on the waitlist is the time from listing (post-KAS, dialysis initiation) to transplant, death or waitlist removal. These 2 measures are essentially equivalent. With true “equity,” transplant rate and time on waitlist would be more uniform across the United States and would not differ based on geography. However, both measures are more heavily influenced by the denominator (waitlist size) than the numerator (actual transplants performed). The use of transplant rate with waitlisted patients as the denominator is highly problematic. Transplant centers have wide latitude and variability in waitlist practices. On one hand, a center may limit additions to waitlist to make the transplant rate improve while limiting access to transplant for a larger population of patients with ESRD. On the other hand, other centers may list far more patients than they could transplant, causing many to languish while waiting for transplant. Such variability in waitlist practices would have a strong impact on access to transplant and could account for much of the geographic differences seen in previous studies. Moreover, kidney transplant waitlists in the US are composed of both active and inactive patients. From 2006 to 2014, the rate of inactive patients being listed outpaced the listing rate for active patients and inactive patients accounted for nearly 40% of the overall waitlist. The fate of inactive patients (transplanted, converted to active, death on waitlist, etc.) remains unknown. Since patients with inactive status do not appear on kidney match runs, patients who have accrued the longest wait time are less likely to be offered an available kidney from a deceased donor. Appropriate evaluation and re-evaluation of a larger center waitlist (with a large inactive population) is expensive, labor intensive and time consuming. Waitlist management of a very large waitlist is daunting at best and overwhelming at worst. UNOS and the OPTN do not have metrics or means for tracking how centers manage their own waitlists. Without a better understanding of waitlist practices, waitlist management, and how likely inactive patients are to get transplanted, transplant rate or time to transplant to assess equity in access remain flawed measures. One might question if the geographic disparity in kidney transplant access is a waitlist issue or a supply/demand issue? The likely answer is that “inequity” is related to both factors and possibly more. A better understanding of all of the issues involved in this disparity is needed before any proposed redistribution should be implemented. If any proposed solution does not account for waitlist practices and ESRD burden of disease, the current distribution proposal could exacerbate existing inequities or introduce new inequities rather than accomplishing the stated goal of mitigating geographic disparities. A simple solution to a very complicated problem may not serve the greater good for patients awaiting kidney transplantation and deserves continued thoughtful debate and more rigorous research regarding appropriate measures. Michael J. Hanaway, MD, FACS Surgical Director, Kidney Transplantation Martha Tankersley, RN, BSN, CNP Transplant Administrator Jayme E. Locke, MD, MPH, FACS, FAST Director, Comprehensive Transplant Institute

Anonymous | 09/30/2019

This would greatly affect our patient population here in SC leading to increased number of discarded organs, increased travel time of organs and longer wait times for patients in SC.

Kat Taylor | 09/30/2019

A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation.

Anonymous | 09/30/2019

This policy may further dis-advantage pediatric patients in need of kidney transplant

Matthew Long | 09/30/2019

Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation.

amy hauser | 09/30/2019

1. This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4. The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6. Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7. This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

1. This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4. The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6. Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7. This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Sarah German | 09/30/2019

1. This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2. Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3. This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4. The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5. A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6. Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7. This policy may further dis-advantage pediatric patients in need of kidney transplant.

Robert Metzger | 09/30/2019

Advent Health Transplant Institute and the OurLegacy OPO oppose the UNOS kidney allocation policy proposal: Eliminate the use of DSA and Region in kidney allocation policy. The OPTN kidney allocation proposal, altering the current system to one using the determination of the match list to include all potential candidates located within a 500 nautical mile radius of the donor hospital, will have the impact of increasing disparity for many candidates and transplant centers! Our transplant center, Advent Health Transplant Institute, Orlando, sits in the middle of the Florida Peninsula with water 45 miles to the East, 90 miles to the West and130 miles to the South. There are no donor hospitals over these waters until you get 1500 miles out to Puerto Rico! Similar situations exist for the transplant centers in Florida to the north and west of us. Because of this well-known geography, our candidates will have access to many fewer organs than those in transplant centers located over more land and more centrally located in the U.S., and even in large metropolitan areas on the Northeast and West Coasts. In reviewing the proposal, SRTR modeling predicts that our Transplant Institute volume will decline from 120 deceased donor kidney transplants per year to less than 40 per year! As a general and transplant nephrologist, I moved to Orlando in 1972 in order to provide total kidney care to the central Florida population. My partners and I established a strong nephrology practice, Nephrology Associates of Central Florida, which stimulated the development of other nephrology practices throughout East Central Florida, increasing access to and for residents throughout central and north central Florida. We opened multiple in-center and in-home training dialysis programs to provide dialysis access in our area. We performed our first kidney transplant at Florida Hospital, now Advent Health Orlando, in 1973. With our surgical colleagues, we established the Advent Health Transplant Institute, and have now performed over 4300 kidney transplants, usually transplanting about one third of our wait list annually! We are doing our part to assure the patients in our community spend as little time on dialysis as possible. That will disappear in Central and North Central Florida if the proposal is approved by the OPTN! In fact, like all areas of the country that have worked hard to increase donation and remove patients from the wait list through organ transplantation, what should be a badge of honor/recognition for a job well-done, has become a bullseye for other areas of the country. UNOS’ efforts, if successful, would result in a dismantling of our program with donor organs and patients sent elsewhere, to other states and communities. This is indeed a perverse outcome. Along with the development of our transplant program, our efforts, from the beginning were focused on maximizing local organ donation efforts, which simultaneously involved starting a local organ procurement program, which has ultimately morphed into what is now OurLegacy OPO (formerly called TransLife), one of the higher performing OPOs in the country with well over 40 donors per million population, as well as a high rate of donors per potential of 1000 hospital deaths. We have cultivated the local population and donor hospitals to support organ donation. We have always been a “more give than take” population! In 2018, 54% of the kidneys procured in our donation service area (DSA) were transplanted in other parts of the country. Perhaps the criticism of OPO performance should be tempered by studying the local population’s willingness to donate once inside the hospital doors (Donate Life America: Eligible Deceased Donor Rate 2018: National 33%, New York 15%, Maryland 7%, Florida 38%), rather than using polls on the street to estimate donor potential. How is it conscionable for UNOS to consider reducing transplants by over 65% in Orlando by taking kidneys from our community, a community that already “shares” – contributing to the national ‘good’ – over 50% of its kidneys? How can that even be an option? Orlando has already been negatively impacted by the new heart allocation policy, with a 50% reduction in heart transplants this year. It is questionable whether our Institute could continue to function with the predicted 65% (and likely more) reduction in kidney transplants and the current loss of heart transplants, let alone the negative effects of loss of liver transplants that will occur should the fatally flawed UNOS Acuity Circle liver allocation policy prevail in the courts! During my tenure as President of OPTN/UNOS, I participated in the efforts to eliminate the multiple variances that existed in local allocation that resulted in ever increasing costs and headaches for programming. However, the disparities that this new proposal will force on patients in North Central and Central Florida and their transplant centers, producing significant inequities for them (and potential closure of programs) may require considering local variances again, if this 500 NM radius is established! Robert A. Metzger, MD Medical Director Kidney Transplant and Living Donor Programs Advent Health Transplant Institute Medical Director, OurLegacy OPO Past President OPTN/UNOS

Kelly Perritt | 09/30/2019

1) This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally. 2) Decreases kidney transplant rates and significantly increases waiting time for South Carolina kidney failure patients. 3) This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. 4) The proposal does not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 5) A majority (8 out of 11) UNOS regions in the US voted down this proposal. If nearly 75% of the transplant professional community feels this is a poor change, why would we push this forward? 6) Data from the recent lung allocation changes is just becoming available. The initial data suggests significant increases in cost, discard rates, and continued significant variations in wait times across transplant regions. These are significant concerns that must first be addressed prior to implementing similar changes to kidney allocation. 7) This policy may further dis-advantage pediatric patients in need of kidney transplant.

Anonymous | 09/30/2019

I applaud the attempt by the Committee to reduce geographical disparity. However, due to the great discrepancy in both patient population density and number of transplant centers across the country, any radius selected will have a different impact depending on the region. Variable radius sizes should have been modeled based on these factors to achieve substantial and similar results across the country. We have an opportunity here to go beyond the "one size fits all "model and be the most impactful.

Anonymous | 09/29/2019

I am a kidney patient, on dialysis, and awaiting a kidney transplant opportunity. It seems to me that no definitive case has been made for these kidney allocation changes, given that the result, it appears, would be fewer kidney transplants, greater costs, and longer wait times here in Oregon, This together with the many other issues highlighted in the previous public comments suggests that the decision must be put on hold. I recommend that you focus on increasing the availability of donor organs in those areas you consider unfairly treated rather than ship our local organs farther away. Allow our local transplant professionals to continue to guide our local program.

Anonymous | 09/29/2019

Transport time and additional costs are a concern to me. 500 nm seems like a great distance and, having a son in need of a kidney transplant, it concerns me that kidneys could be lost due to the distance required to get to the person receiving the kidney. 250 nm has been noted in several comments and that seems more appropriate. Having said that, I do not want my son to lose his place due to this change. He is only 25 and has been waiting 4 years already. His status changes to inactive due to other medical issues in his body and to have to wait even longer because of this change seems to be unfair to some degree.

Jen Lau | 09/29/2019

Overall, I support the proposal as it provides priority for pediatric candidates and is structured to help the outcomes for the general pediatric population. I do share the same concerns as stated in the pediatric committee statement which could have certain pediatric patients lose priority to kidney/pancreas candidates and do feel there needs to be more collaboration among committees to hash this out. Lastly and most important, I would like to address the rude comment that social status should have a part in determining priority, and take offense to the lack of common decency towards the pediatric population. Children are the most innocent and vulnerable population, and it is up to us to advocate for them and be their voices. As I respect for an individual to share their opinion, I do not respect the nature of the comments made and I ask that you please disregard the comment from consideration of the proposal.

Joseph Hillenburg | 09/29/2019

Kidney: I will likely be making similar comments to the Pancreas proposal, so pardon if you think you're reading double. I support the proposal as an interim path toward Continuous Distribution, though please note that I prefer 250nm circles. While I understand the concerns of many of the commenters with respect to other changes that could be made instead, the fact of the matter is that, while there are many changes that can be done (increasing OPO performance, discussing opt-in vs. opt-out, etc.), those other changes should be considered separately. That is, this proposal is not mutually exclusive to other such changes, and this change is important to both fulfill the requirements of NOTA/Final Rule, and to ensuring that we are taking every individual step we can to improve the system. Unfortunately, this is the world we are in, but delaying this change will put the system at legal risk, which is a jeopardy many of us are now all too familiar with. It should also be recognized that this is just a stepping stone to what we know is our actual goal, and that is Continuous Distribution. I do want to call out (as has been noted by others) the concerns in terms of the pediatric population potentially losing priority to Kidney/Pancreas candidates, and would ask that the Kidney and Pancreas committees, in collaboration with the Ethics committee, ensure that these concerns are given attention. Education and communication with respect to this change is important. It is key that providers are aware of how to best deal with said changes, and that patients are aware of the benefits to them. This will hopefully lessen the "dip" (followed by recovery and improvement) to transplant rates that we have seen in the past when major allocation changes are made. The strong support by the patient community should be noted in considering this proposal. Lastly, I take exception to the impertinent and rude comment suggesting that career choice and accomplishment should have some role in determining priority. That is an extremely dangerous path toward marginalizing disadvantaged groups, and would certainly not be compliant with the Final Rule. That contributor's comment should be discounted from consideration.

Nebraska Medicine | 09/29/2019

The policy put forth by UNOS to eliminate the use of Donor Service Areas (DSA) and Region from the Kidney Allocation Policy, as advanced by the OPTN Kidney Transplantation Committee, proposes to address disparities in kidney allocation. Central to this proposal is the use of a fixed 500 NM radius circle around the donor hospital as a “more rationally determined unit of distribution”, to replace “local” in the current policy. As a transplant hospital member of the OPTN, we oppose the policy as put forth, and respectfully submit this comment to address our concerns. 1. The proposal is centered on the use of “transplant rate” (TR) as a metric of disparity. Indeed, as published repeatedly, the TR varies widely among DSAs and even among hospitals within the same DSA. However, the TR is not a true measure of patient access to kidney transplantation, given the variability in center practice surrounding the decision to place patients on the waitlist. Disparity in access undoubtedly exists, but a more direct assessment for comparison may be the proportion of prevalent ESKD patients with transplant as the modality of treatment, based on USRDS data. At the least, reviewing such data should give pause to one reviewing this policy proposal. Review of USRDS data shows the percent of ESKD patients listed for transplant in each state varies widely, ranging from 9% to almost 25% of patients listed for transplant. The percent of patients on the transplant waiting list correlates poorly with the ESKD disease burden (patients per million population) in each state. In addition, the number of transplants performed per 100 years on dialysis in each state does not correlate well with the percent of patients listed, the burden of ESKD, and (where DSA and state boundaries are comparable) to the SRTR-reported transplant rate (TR). Several examples are presented to illustrate: According to USRDS data, in 2016 South Carolina had over 10,000 non-transplant patients with ESKD. OPTN data for 2016 shows that patients in South Carolina received 252 kidney transplants (199 DDRT and 53 Living donor). At the same time Minnesota has just under 5,000 non transplant ESKD patients, but 353 received a kidney transplant (178 deceased donor and 175 living donor). Thus, despite having a higher burden of disease and doing fewer transplants, SRTR data for the South Carolina DSA calculates a transplant rate about twice that of Minnesota’s, demonstrating the affect that waitlisting practices have on this metric. Despite having the 4th lowest USRDS transplant fraction for dialysis patients (2.4 transplants per 100 years on dialysis), KPSAM modeling for the 500.500.4.8 allocation scheme would lower the number of DD kidney transplants in South Carolina. As another example, Maryland has a low calculated TR, and the KPSAM modeling presented shows that the 500.500.4.8 allocation scheme would increase its TR. Meanwhile, Nevada has a high TR, and the same scheme is predicted to dramatically reduce its TR. However, per USRDS data, Maryland already has a higher percent of ESKD patients treated with transplant than Nevada (31.2% vs. 25.3%) and a higher rate of transplants per 100 years on dialysis (4.0 vs 2.9) . The policy change would direct more kidneys to Maryland and fewer to Nevada, and widen the transplant modality gap and worsen the access disparity. To us, using the total ESKD population (or ideally advanced CKD + ESKD population) would be a considerably better denominator for assessing “transplant rate”, and would avoid the confounding issues surrounding waitlisting practices. 2. The Final Rule admits within its own wording that its requirements will conflict with each other. As the proposal reminds us, it states that allocation policies “shall not be based on candidate’s place of residence…except the extent required” by the other requirement—including avoiding wasting organs and promoting the efficient management of the OPTN. This policy in fact is predicted to increase the kidney graft loss rate, increase the waitlist mortality, and dramatically increase the median travel distance per transplanted kidney. At our regional meeting, the predicted increase in grafts lost was referred to as “trivial”, which we take issue with, given that the limited organ supply is the number one problem in transplantation. At the least, we would ask that patient-centered organizations such that AAKP, PKD foundation, etc., be given the opportunity to comment on the issues of a fall in overall transplant rate, increase in grafts lost, and increase in waitlist mortality, all predicted to occur with the 500.500.4.8 proposal. With regard to the increased travel, we feel that the detrimental impact to OPTN efficiency has been underestimated, and the actual cost has not been estimated at all, despite numerous requests. In the proposal, it is predicted that the percentage of kidneys that travel >250 NM (fig 25) will increase from 18% to 42%. The 250 NM value was presented as a surrogate for flying vs. driving. Thus, the prediction is that there will be a 230% increase in the number of organs that are transported by air (typically commercial). Our center already experiences issues with airline and airport service, as do many others. If our dependence on them more than doubles, then unpredictable air travel issues like weather and crew delays, as well as known issues like the airport being “closed”, will become that much more common. These impacts on efficiency—and access—are not included in the modeling, and left essentially as unknowns. 3. The financial impact has continued to be downplayed, and to our knowledge, no estimates have been released. As above, the increase in travel will incur significant cost. However, as patients on average wait longer for transplants, there will be an increased cost to the payers (predominantly Medicare) due to an increase in dialysis time, and fewer preemptive transplants. While it is impossible to predict behavior, it seems likely that individual centers will add more patients to their list, incurring costs of evaluations, registrations, and waitlist management testing. Given no predicted increase in the number of transplants (and in fact fewer isolated kidneys), this equates to a higher cost per transplant to the system. 4. Reviewing the data presented in this proposal, the DSAs with a high calculated TR tend to be in less populous areas with smaller transplant lists and transplant numbers. They are generally dwarfed by the DSAs with low TR. Ranking the DSAs by their TR, the top 30 DSAs (with the highest TR) have fewer candidates listed for transplant than the bottom 10 DSAs (24,785 vs. 33,769). In fact, the 20 DSAs with the highest TR have fewer candidates than the two DSAs with the lowest TR (12,851 vs. 15,538). Redirecting available kidneys from the high TR DSAs to more populous areas with longer lists would likely provide a clinically insignificant reduction in their TR (and waiting times) while dramatically increasing the waiting times in less populous areas. The downstream effects of this flux are difficult to predict, but one likely consequence would be relatively smaller transplant hospitals maintaining significantly larger waiting lists, and potentially a disproportionate decrease in elderly candidates being transplanted. It is our opinion that this policy proposal has not been vetted thoroughly enough to be sent to the Board for consideration. Bear in mind that the last change to KAS took nearly decade to reach that point. We concede that DSA boundaries are arbitrary and that moving toward an eventual continuous system is important (although we would point out that state lines are just as arbitrary and have myriad significant impacts on people’s lives, including direct impacts on healthcare access…). We would advocate for models to be explored using the diseased population as the denominator in lieu of the waitlisted subpopulation, that more attention be paid to estimating the costs of these proposals, and that the transplant community not be satisfied with any proposal that threatens transplant numbers, transplant outcomes, or waitlist mortality.

Phillip Grossman | 09/29/2019

Do not reduce the supply of kidneys for transplant in Nevade

Anonymous | 09/29/2019

As of today (9-29-19) the following OPTN regions have contributed public feedback: Regions 4, 7, 3, 5, 2, 1, 11, and 8. Based on their public votes, Strongly Support (12); Support (54), Neutral/Abstain (10); Oppose (37); and Strongly Oppose (88). In summary, 8 of the 11 Regions have voted. Votes in favor of the proposal (66); votes in opposition to the proposal (125); votes with no stated opinion (10)). Thus, based on actual votes to date among Regions, and supported by many additional comments from other stakeholders, this proposed policy does not appear to have significant public support at this time. In fact, opposition has a 2:1 advantage in votes to date.

Joan Wilks | 09/28/2019

Kidneys should not be shipped out of the Las Vegas area when they are needed here!

Sandra Chamberlin | 09/28/2019

Seems like the plan to require distribution of kidneys wirhi a 500 mile radius and override current state policies will add to cost by introducing transport where none existed before and would adversely affect successful transplant outcomes.

Anonymous | 09/28/2019

You're punishing people who live in areas with successful donor drives and rewarding states that ignore their responsibilities. While I live in California and could someday personally benefit from this, I still find it to be very unfair. Instead of forcing Nevada (and other states with more donors) to share its organs, force California and New York to step up their efforts to secure more donors. They have the populations to do it. You're giving them an easy way out, which will ultimately result in less successful outcomes and more deaths. It would be one thing if extra/overflow organs were shared across state lines. But you're taking away from some people just to reward others, for no reason other than politics.

Anonymous | 09/27/2019

I believe a change is needed to the distribution process; however, I’m not happy with the points system. The modeling by consultants did not show enough variability in the modeled subjects. I also feel points for wait times should be a greater factor in the distribution process. If all things are equal with a patient except the distance from a transplant facility, the recipient with the longest wait time should receive the organ. I also believe transplant centers have a lot of room to “quote” game the system related to organ refusal. This area should be reviewed as well. Centers are held accountable for their transplant rates, but are they held equally accountable for their rejection rate? Are the deaths for patients on a transplant centers waitlist figured into their program success rate. All of these factors impact the lives of the recipients on the waitlist and their families. If this is approved like the liver program, what are the affects to those already on the waitlist? How will the changes impact individuals, has modeling been done to show the change for all patients and what it would mean? I would prefer actual data, instead of a hypothesis. I agree changes should be made, but the actual impact must be shared, as well as looking at the entire process from start to finish, instead of impacting one piece of the whole process.

AdventHealth Transplant Institute | 09/27/2019

Any OPTN policy proposal that would introduce a decrease in kidneys procured for transplant is a nonstarter for our transplant program and should be for any transplant program in the USA. There are many reasons we do not support this proposal but the main reason is the data presented by the OPTN kidney committee indicates many programs in the USA will have a net decrease of kidney transplants performed. 1. The final rule requires patients to have access to transplant programs. With the proposed OPTN model many kidney programs including our program could see a net loss of 40% -60% of transplanted kidneys. With these projected volume losses it will greatly impact our budgets and staffing that we have strategically planned for during the coming 3-5 years. As I discuss this with other transplant administrators potential losses like this could have adverse effect like a closing of a kidney transplant center and leading to patients not having access to kidney transplant programs. 2. The logistics of transporting kidney around the USA will increase cold ischemic time to the procured kidney. This longer ischemic time will cause increased delayed graft function or non-function. The longer ischemic times will increase the need to increased procedures and tests to the transplanted patient to include longer length of stays after transplant, increased use of pharmacy and labs, and increased utilization of dialysis. 3. The cost involved with this kidney proposal will cause increased cost for organ acquisition and increased cost for the transplant patient stay. CMS has mandated Valued Based for healthcare providers and facilities. Why as a transplant community would we consider sending out a proposal that would increase cost for care with potentially worst outcomes for a patient due to delayed graft function due to longer cold ischemic times? 4. The state of Florida is disadvantaged with the 500 nautical mile rule. Due to the topography of Florida most of our 500 miles for potential donor sharing of kidneys is water. The OPTN’s main reaons for altering the organ allocation is due to the removal of regions and geography as a determinant of allocation of organs. Geography is real and patients in Florida are disadvantaged in a significant way due to the 500 NM proposal. The OPTN should strongly re-consider the following and revoke this policy proposal; 1.Monitor and constructively work with OPO’s who are meeting or not meeting the organs recovered per donor recommended. Many OPO’s in the USA are exceeding the expected organs recovered per donor and those centers can teach the OPO’s how to exceed the number of organs per donor. 2.While OPTN COIN projects have improved utilization of kidneys at transplant programs not all kidney transplant programs are utilizing transplantable kidneys due to fear of poor outcomes and flagging by the OPTN. The OPTN should work with HRSA and CMS to ensure transplantable kidneys can be used without transplant centers being penalized . Centers that are not using transplantable kidneys should be educated on how to best use those kidney at their transplant center. 3.The OPTN should consider reviewing the liver, lung, and heart allocation models and survey there membership to check on the success of the allocation changes. Our program has had negative effects from a logistical perspective. The cost associated with procurement due to fly outs has increased and has jeopardized the safety of our recovery team. 4.We strongly oppose this proposal. Barry Friedman Sr. Administrative Director AdventHealth Transplant Institute

Anonymous | 09/27/2019

Until we understand the reasons for discrepancies in wait time, I do not feel a just system can be implemented. There are too many unknowns in DSA variation for organ donor eligibility (see Patterns of geographic variability in mortality and eligible deaths between organ procurement organizations. Robert M. Cannon et al. https://doi.org/10.1111/ajt.15390); as well as consent rates, organ recovered, OPO and transplant center acceptance rates (DCD, HCV, ECD, Dual transplants, etc.). Possibly known but under-reported are listing rates by population - we do know that iin some areas of the country private providers of HD tend to under-refer for renal transplant. It is unclear if vast differences in wait time are related primarily to populations, centers, OPOs, missed donors, failed consent opportunities, and a host of other factors from donor recognition in the ICU to organ acceptance after recovery. Until this in known and explained there will be great resentment in the areas of the country that suffer under the new proposal (possibly they are being penalized despite their "best and even exemplary efforts" while other areas are being rewarded for inferior (perhaps overly conservative) past performance.

Anonymous | 09/27/2019

Members of Region 8 were not supportive of this proposal and provided the following feedback: • The disparity across DSAs is impacted by OPO performance • This will be an incredibly expensive project to implement; there will be a 250% increase in the number of kidneys that fly. • For import back up, the circle should be around the receiving OPO and not the receiving transplant center. The OPO should be used because crossmatch occurs before transplant program receives the organ. It was acknowledged that the logistics are different in different DSAs. • Import backup requirements should be KDPI specific • Questions about medical urgency: do we need a policy for this at all? Are any kidneys medically urgent? Should age be part of the criteria? • Data that relies on the size of the waitlist does not represent true geographic disparity as it is an administrative metric. Disease burden should be used in modeling. • Link USRDS data more closely to OPTN data - it's not the patients' fault that they don't get listed - when you look at the USRDS data, Nebraska/Region 8 doesn't look like they are doing much better at getting patients with renal disease transplanted - using the flawed transplant rate metric the trend looks very different • Make sure that there is no negative impact to pediatric patients • A member commented that using proximity points from the donor hospital does not make much sense if the donor is brought back to an OPO procurement center. • A member commented that the median wait time was calculated using data from 2015-2016 and stated that more recent data should be used. It was stated that data from this timeframe could have been impacted by the implementation of KAS and not reflective of current disparity. • A member commented that the transplant rate in the modelling is based on program-specific information, such as who to put on the waitlist and when they are put on the waitlist. The member suggested looking at transplant rate in candidates with specific diseases/conditions. • A member commented that they should start with smaller circles instead of immediately going to broader distribution. • Members commented that they would like more data on geographic disparity in access to transplant and felt that transplant rate was an incomplete metric to show geographic disparity. • Several members indicated they would support the proposal if the circle size was changed to 250NM Vote: Strongly support (0), Support (2), Neutral/abstain (4), Oppose (5), Strongly oppose (10)

Ken Andreoni | 09/27/2019

I strongly disagree with the current geography policy proposal of 500 NM radius circles being considered by the OPTN Board of Directors and then the Secretary of HHS. The undisputed outcomes of this proposed policy will be a decrease in the number of transplants performed, an increase in the number of donated kidneys discarded nationally, a significant increase in cost to the transplant centers of providing transplantation to patients, and a decrease in working relationships between local transplant centers and their nearby OPOs. The original simulation modelling of the SRTR clearly shows a decrease in transplantation due to increase in discards from longer travel distances and times. This outcome is not disputable and has been supported by our current national practice, especially the lack of improved utilization of KDPI over 85 kidneys by going first to regional share over local share; this has NOT improved utilization of these organs. The convenient decision to eliminate this common sense conclusion of decreased transplants due to the simulation modelling being ‘unable to predict future behavior’ is an embarrassment to honesty in this process. One of the points highlighted in the proposal is the need to increase geographical allocation distances since it is listed as number EIGHT in the Final Rule of eight goals for policy development. Goal NUMBER EIGHT, should rightfully follow in importance after the prior goals, especially when this last goal is specifically stated to be applicable ONLY if it does not interfere with the preceding goals (specifically goals 1 to 5). These prior goals emphasize increasing the best use of donated organs and avoiding organ wastage, as well as efficient management of organ placement. Using this mandate to increase geographic allocation distances above all else is absolutely AGAINST the FINAL RULE as stated in the Federal Registry (https://www.ecfr.gov/cgi-bin/text-idx?SID=bb60e0a7222f4086a88c31211cac77d1&mc=true&node=pt42.1.121&rgn=div5). The emphasis on ‘transplant rates’ is not logical as this rate depends greatly on individual center listing practice behavior. Centers who list many patients with no real intention of transplanting them appears to have an artificially low transplant rate. This measurement is not a metric that is reliable and reproducible across centers, therefore should not be used in a national simulation model by a government contracting agency (SRTR and OPTN contractors). To summarize, my transplant patients and center have the following major issues: 1. Decreased Number Transplants: the increased travel time, increased CIT, and large number of simultaneous offers must lead to increased organ discards 2. Decreased Graft Survival due to increased Cold Ischemic time and delayed graft function that will lead to decreased life years with transplant across the country 3. Center closure due to drastic changes in transplant numbers over the first few years of implementation and this will decrease access for challenged socioeconomic patients, such as those in my area of North Florida 4. Severe challenges to centers away from large airports with disproportional increases in cold ischemic time and delayed graft function 5. We would like to see the new proposal with transplant ‘counts’ and not transplant ‘rates’ as the denominator for transplant rates is very gameable based on center practice 6. The candidates who have the most to lose will be the low EPTS patients, that is the younger adults who are expected to live longer after a transplant, since centers will be least likely to accept higher KDPI organs for these candidates. Therefore, this outcome will be counter to the main goals of the current KAS 2014 allocation system which attempts to give increased access to these patients. 7. For my area in particular, since so much of the state of Florida’s 500 nm circle encompasses water and no donor hospitals, we may consider putting forth a variance that would be our state based on health payment policies such as state Medicaid. 8. For my academic center that is in a more rural area than other centers in my region, my Medicaid and Medicare dominated candidates will be more disadvantaged than other patients in urban areas with lower percentages of socioeconomically disadvantage patients since the trauma centers are closer to the urban transplant programs. This is counterproductive to the goal of this policy and the Final Rule.

Anonymous | 09/27/2019

At the Region 2 meeting, serious and appropriate concerns were raised about how the elimination of DSAs in the current proposal would complicated Kidney and Pancreas allocation and perhaps increase discards. The concentric circle models of 250miles incorporated multiple large metropolitan areas in the north east of the country and this could mean that the offering OPOs may have to communicate with an inordinately large number of transplant programs. Proposals that create circle sizes that take population density into account ought to be given greater consideration.

albany medical center | 09/27/2019

I understand the difficulties related to inequities in waiting time across the country for patients awaiting a kidney transplant. However, some programs with "shorter" waiting times have achieved this partly due to the efficiency of the program. Other issues obviously also exist, but the more efficient a program the shorter the waiting times are likely to be. Eliminating DSA's completely may negatively affect efficient programs particularly if the allocation area now includes other programs with longer waiting times. I hope that within the new allocation system consideration is given to "smaller programs" with "comparatively"short waiting times whose programs may face closure as allocation areas expand to include programs with waiting times that are much longer. Our program is one such program, we are 150 miles away from several transplant programs that have 5-7 year waiting times, while our average wait time is 3-4 years. Including these programs in our allocation system may result in 2-3 years of our program not being allocated deceased donor kidneys for transplantation. This would likely be a catastrophic event for our program and likely force our institution to stop providing resources to the program resulting in closure. This would be a huge burden for the patients that we care for as they and their families would need to travel long distances for transplant services. Again, I understand the difficulties with the current inequity of wait times across the US, and I hope that a new allocation system to address this issue takes smaller programs into account so that they are not forced to close. Phasing in of a new system rather than an abrupt change may allow these smaller programs that provide essential transplant services to their community to survive the allocation adjustment

Sandra Amaral | 09/27/2019

I believe that the proposed models increase complexity and cost without significantly improving transplant rates. This seems opposite of the vision and goals of the OPTN and UNOS. While the proposals are put forward to reduce geographic disparities, I am not convinced by the data that this will be achieved since the proposals include fixed distances and do not account for differences in population density. It seems that we are merely reshuffling the deck but not improving transplant rates. I worry that UNOS is attempting to achieve improved equity at the expense of utility. The new proposals will be tremendously complicated, costly and burdensome. If we must move forward with one of these models, I would favor smaller fixed distance circles with a hybrid framework and I agree with prioritization of pediatric candidates just after prior living donors and 100% highly sensitized candidates.

Jacqueline Lappin | 09/27/2019

The Final rule sets requirements for allocation policies developed by the OPTN to "include the use of sound medical judgement, achieving the best use of organs, preserving the ability for transplant programs to decide whether to accept an organ offer, avoiding wasting organs...….etc. What I can discern with the proposed new policy with the elimination of DSA and Regions in Kidney allocation, is the very real potential for a very expensive waste of organs. What am I missing ?

Baystate Medical Center | 09/27/2019

At the most recent Region 1 meeting we reviewed and discussed the proposal to “eliminate the use of DSAs and Regions from Kidney Allocation Policy.” The proposed change is being made to align kidney allocation policy with the “Final Rule”. Although this is certainly a laudable goal, the system as proposed certainly does not fulfill this requirement. As we all know, organ allocation is a zero sum game and this proposed system will shift longer waiting times from one group of patients to another. There is minimal effect on the longest waiting OPO’s (California, New York), but certain OPO’s will be severely and unfairly affected. Specifically, patients served by Life Choice donor services (CTOP), already one of the OPO’s with a long waiting time, will see their waiting times increase further from the national average toward the extreme of waiting. This is also true of New England Organ Bank as well as NTWN (Buffalo). Implementing a system which is supposed minimize the differences in waiting times should not result in even longer waiting times for patients who already wait longer than national average. This is an unfair cost that our patients will be forced to bear for no obvious reason. It will hardly be a “patient based allocation system” for the patients in Life Choice donor services. The new system will not increase the number of transplants performed. It will be less efficient. It will cause disruption for centers and their patients, and increase the costs of shipping organs, the time required for allocation, and the cold ischemia time. Ultimately, these unintended consequences will lead to increased delayed graft function and increased monetary and patient “costs” due to the need for acute dialysis and longer hospitalizations. Ironically, the proposed system will still be geographically based. Instead of DSA, it will be based upon geographic circles. Wait times will still be determined by the recipient’s geographic location. Those fortunate enough to have financial resources will still be able to move to areas with shorter waits. Those less fortunate without those resources will be, in essence, discriminated against. Finally, I believe that a drastic change that will cause such a large disruption to the system and individual centers should be phased in over a number of years. This can easily be done by initially increasing the number of points for local donors, and then decreasing them to a set value over several years.

Darren Soto, Gus M. Bilirakis, Kathy Castor, Members Congress of the United States, Washington, DC | 09/27/2019

Dear Secretary Azar: We write to you today to voice concern about the recently proposed change to the kidney allocation process by the Organ Procurement Transplantation Network (OPTN). The OPTN kidney committee is proposing to eliminate Donation Service Areas (DSAs) for allocation, instead expanding the distribution area to a 500 nautical mile (NM) circle. It is our belief this policy change will be grossly unfair to patients in the communities across Florida, in both geographic disparities leading to increased cost, and diminished availability of vital viable organs. Enacting the 500 NM policy would severely limit access to these life-saving transplant procedures and increase the wait time, while diminishing the availability of kidneys for the entire state of Florida, as a 500 NM circle from the center is largely ocean. The longer an organ travels to reach the transplant recipient, the greater the risk of the organ having delayed graft function (DGF) or even non-function once transplanted. The proposal will also increase the overall cost of transplantation. Broadening the service regions will inflate the cost of transporting organs, and the teams of physicians that perform the procedures. Broadening these service areas could increase DGF or the need to have dialysis after transplantation. This will only proliferate negative patient outcomes such as increased hospital stays and increased readmission rates. We appreciate your full and fair consideration of all the ramifications of this change to the kidney allocation process by the Organ Procurement Transplantation Network (OPTN). Sincerely, Darren Soto Member of Congress Gus M. Bilirakis Member of Congress Kathy Castor Member of Congress

James Sharrock | 09/26/2019

It is appropriate to eliminate DSAs and Regions from the process of kidney allocation, but the proposed policy as written will impose unnecessary logistical challenges and have a severe impact on kidney patients in Oklahoma. Through the combined efforts of the transplant community in Oklahoma over the last six years, the number of organ donors has doubled. The proposed policy as written will result in allocation of most of those organs to other states, depriving Oklahomans of the efforts made in our state. The projected outcome differential between a 500 NM circle and a 250 NM circle is insignificant, and the application of the smaller circle will not only greatly reduce logistical challenges but also allow more Oklahomans to benefit from the growth in organ donation in our state. I support a modification of the proposal to reduce the proposed circle to 250 NM.

John Friedewald | 09/26/2019

I thank the Kidney Committee for their work in advancing this proposal. I support changes to the allocation policy that aim to reduce geographic disparity in access to kidney transplantation. I have seen firsthand how radically different waiting time in neighboring donor service areas can result in unequal access to transplant based on candidate resources. And for candidates that can travel to multiple list, the current requirements for patient follow up are not designed around what is best for the patient and their family. That said, I have some concerns about the current proposal, mostly from a logistics standpoint. The current circle size will mean different things in different parts of the US, which may be unavoidable. But having had the experience of region-wide allocation of high KDPI kidney for the last five years, we have learned of the challenges this presents. Those challenges are rarely present with a highly desirable kidney, but with harder to place kidneys, the list of willing candidates will be all over the place. I worry that discards will increase due to cold ischemic time from lack of ability to transport organs efficiently. This has less to do with distance than it does with travel routes, as long as we plan to stay with commercial air travel. As an example, Denver falls within the edge of Chicago’s 500 nm radius but realistically is much closer than a number of OPOs in between simply because of the variety of daily flights between the two cities. For this reason, I am not sure simply reducing the radius to 250 nm will help much (although it will allow for automotive transport in some settings). In any of these scenarios with hard to place kidneys, a primary allocation with local backup seems to be the most sensible way to avoid organ discard. Also, from an operations standpoint, advancing practices like sending kidneys on a pump outside of a DSA, digital pathology for sharing biopsies, and standardized protocols for crossmatching and sending blood ahead of procurement will help utilization rates. I feel that proximity points will only serve to regress to our current system in most places and not achieve the stated goals of removing geographic disparities. The common argument that all disparity is due to variation in OPO quality may be true to some degree, but for candidates living in a certain OPO, there is little they can do to effect change in OPO practice. So, while working to improve OPO performance and transplant center practice should be an important parallel goal, I believe it is in the best interest of patients to continue to work to make access more uniform through changes in allocation.

Anonymous | 09/26/2019

Strongly support (0), Support (4), Neutral/Abstain (1), Oppose (3), Strongly Oppose (15) Region 11 did not support the proposal. The following concerns were raised during the discussion: • Areas of the country with shorter waiting time will be most affected. There needs to be an effort to phase this in so that there are not massive shifts in allocation overnight that will take years to normalize. The more time we take to implement this the more accurate we can be in determining the outcome. Going smaller to begin with will allow for course correction. • Kidneys do not travel like other organs. Any modeling needs to consider airline schedules, particularly as they apply to rural areas that have multiple connections. • Practice patterns have a huge effect on number of transplants and performance (listing/acceptance patterns). Acceptance patterns for local offers are very different than for import offers. Increasing the number of import offers will increase discards. • Removing DSA and Region from lung allocation has resulted in increased cost, increased discards and increase in pre-transplant deaths. This will be amplified in kidney allocation. • Disparity is driven by OPO performance and there are no accurate metrics to measure OPO performance. The committee should consider same-cause donation rates. • Rural communities will be disadvantaged • Modeling is flawed and can’t be used to predict what will happen in real life. There is still a lot we don’t know about what effect these changes will actually have on centers and patients. • Disparity metric should be based on waiting time of patients who receive a transplant and not waiting time of patients listed. Areas with huge waiting lists have inflated median waiting time. • There are multiple logistical challenges for OPOs • Committee needs to consider financial impact, OPO performance and impact on rural communities before moving forward with any proposal • We need to focus more on people who are not on the waiting list. Access to the list needs more attention. • Based on Trump’s exec order, we should focus on OPO performance and increase in transplant. How does this proposal address and comply with the order from the White House. Some members suggested using specific criteria to designate areas of need and have broader sharing to those areas without disrupting the entire system. Some members suggested having one system for high KDPI and DCD organs using a 250 NM circle and one for standard donors using a 500 NM circle. Some commented that import backup should be to the accepting center to increase efficiency and utilization Several members supported changes to policy so that pediatric donor kidneys are allocated first to pediatric candidates. Those who supported the proposal commented that OPOs with a small population can’t compete with larger population OPOs. Until you have population based OPOs we need to remove DSA as the first level of allocation. There was an amendment to support the proposal using a 250NM circle with 2 points inside the circle and 4 points outside of the circle. The amendment was not supported by the region. Strongly support (6), Support (4), Neutral/Abstain (1), Oppose (4), Strongly Oppose (8)

Anonymous | 09/26/2019

The OPTN Transplant Administrators Committee appreciates the work of the Kidney Committee and the opportunity to provide feedback on this public comment proposal. The Committee is concerned that the proposed 500 mile radius may be too large because the distance may increase travel time for blood samples, organs and recovery teams, adding costs and more complex logistics. The distance may also require increased coordination and burden within areas dense with transplant hospitals, such as urban Northeast corridor metro areas. Multiple hospitals could be involved in a single offer and this opens the potential to have multiple simultaneous offers for one candidate. The Committee agrees that a 250 mile radius may be a more feasible distance, with staff sharing that other stakeholders and the Kidney Committee considered the 250 mile radius. The TAC is opposed to the proposal in its current state. TAC members request clarification about whether or not local teams will procure kidneys. Staff explained that discussions are currently under way within the Committee to clarify procurement expectations.

LifeShare Transplant Donor Services of Oklahoma | 09/26/2019

LifeShare (OKOP) embraces the concept of removing DSAs and Regions from kidney allocation. However, LifeShare strongly opposes the policy proposal as written. There is no effective difference in outcome between the proposed 500 nm circle and the smaller 250 nm circle. In addition, the policy as written will have substantial negative impact on the transplant population in Oklahoma; given that our citizens and our donor hospitals have supported our OPO to the extent that we have doubled the number of organ donors recovered annually in just six years, and with no outcome benefit to justify increased logistical challenges, we oppose the proposed 500 nm circle and strongly suggest/support a similar model utilizing the 250 nm circle instead.

Anonymous | 09/26/2019

Thank you for the opportunity to provide comments on the OPTN Kidney Transplant Committee’s proposal, “Eliminate the Use of DSA and Region in Kidney Allocation Policy”. While I support the concept of broader sharing to address allocation inequity, I have the following concerns and questions about the proposed policy: • The proposal does not address Alaskan donors who are well outside the 500 NM range of any transplant program. I propose that Alaskan donors be assigned the Sea-Tac airport zip code and that no proximity points be applied to their allocation within the 500 NM circle. • The proposal does not include a requirement for OPOs to provide HLA Labs pre-procurement blood for compatibility testing, or even a requirement for a virtual crossmatch. This proposal should be amended to include both compatibility assessment strategies given the experience with the >98% CPRA program to avoid instances where kidneys are shipped for an incompatible recipient when a compatible recipient closer to the donor hospital would have otherwise received the kidney with a short CIT. • Fixed circles represent hard boundaries that disadvantage waitlist candidates who live on coastlines as well as in sparsely populated areas. A more equitable and logistically viable approach may take into consider population density and geographic factors that are likely to impact logistics (e.g. mountain ranges, commercial air transportation routes/schedules). • While allocation policies should not be based on a patient’s residence or listing location, neither should access to transplantation, which includes distance to the transplant center for evaluation and care. Therefore, it is critical to maintain the operational and financial viability of smaller transplant programs that serve residents of more remote, sparsely populated areas. Given that many of these programs will see a decrease in organ offers and transplant rates, the agencies with financial and performance oversight must be prepared to accommodate the effects of this proposal on those programs. A smaller circle of 250 NM may help mitigate the logistical, operational and financial challenges that will face smaller, geographically isolated transplant centers. • The proposal may incentivize patients to pursue dual listing, especially in locations whose allocation and transplant rates are likely to decrease. This adds cost and burden to the system and advantages those with the financial means to travel. • The models predict that already advantaged KP patients will benefit at the expense of kidney alone patients. While there may be a system advantage to performing more KP transplants, it is unclear whether or not there is a clinical advantage of doing more KPs. • Proximity points added to the existing national share programs such as >98% CPRA may disadvantage those highly sensitized patients who have been waiting longer for a rare compatible organ. • Some DSAs and regions are already routinely allocate kidneys beyond the proposed 500 NM range. The costs and logistics of sharing kidneys over long distances are known and should be extrapolated to a larger data set to gain a more accurate depiction of the proposal’s actual feasibility and costs. These costs to programs and to the system should be measured against the benefit of shifting allocation of a relatively small number of kidneys to population dense areas with very large waiting lists. • Is there a way to pilot at least the 500 NM circle in one or more geographic distinct regions and learn from that experience before applying it nationally?

Anonymous | 09/26/2019

I disagree with any proposal that decreases the transplant rate, risks increasing waitlist mortality and potentially jeopardies allograft function. Availability of flights, increased transportation costs and longer cold ischemic time are major drawbacks to this proposal. The local import back-up plan should be redesigned to allocate as quickly as possible in the area where the kidney is physically located at the time of the kidney of re-allocation. This will help to decrease discard of kidneys due to prolonged cold ischemia times. OPO performance variation needs to be addressed. I also strongly recommend that consenting patients for kidneys with a KDPI greater than 85% should only occur at the time of the organ offer when accurate clinical information about the donor kidney being offered, such as biopsy results, etc. are available.

OurLegacy | 09/26/2019

I cannot support the OPTN kidney allocation proposal. Kidneys are a precious and irreplaceable resource. While I don’t disagree they should be considered a national resource and there is a need for some broader sharing, I disagree with any policy that does not sufficiently protect organs from harm between the time they are procured and then safely transplanted. For the last few years the OPTN has begun implementing broader sharing policies for hearts, lungs and livers. Although legitimate concerns have been raised over the cost and availability of private jet transportation, at no time was concern for the safety of the organ or its ability to arrive at the intended transplant program on time raised. Extra-renal organs are always accompanied by at least one person from donor hospital to recipient hospital. They are transported in ambulances ensuring rapid and safe passage to an airport’s exclusive fixed based operator (FBO) and promptly whisked onto private jets. Takeoff is immediate and upon landing another ambulance awaits to transport organs to their intended destination. Extra-renal organs are safe, protected, and experience neither loss nor delays in transit. The same is not true for kidneys. When kidneys leave our office I hold my breath and say a prayer they arrive safely and on time. Every OPO has experienced the horror of kidneys being discarded because they arrived later than expected to a transplant center, only to be refused because of excessive cold ischemic time. Kidneys are transported by a series of intermediaries who have little or no accountability to the OPO and who are not measured for on time and safe performance. If an airline forgets to place a kidney on a plane, there is no consequence to them. If a courier is late because he got lost or stuck in traffic on the way to the airport, thereby missing a flight, there is not consequence. But the consequence to the donor family of the discard of a loved one’s kidney and the consequence to the OPO of no reimbursement for the activities needed to make that kidney available are real. Those consequences are not addressed in the OPTN kidney allocation proposal. The premise of the proposed policy is to broaden kidney sharing, which will require more frequent transportation of kidneys via courier and commercial airlines. Kidneys should not be placed in the hands of entities who are in no way accountable for their welfare. Before the OPTN continues its efforts to broaden geographic sharing, it and HRSA should be accountable to create a credible strategy for the safe and timely transportation of renal organs. That strategy should include development of an overarching entity that is notified of, and tracks, kidneys moving via commercial transportation; that can immediately intervene with couriers and/or the airlines when kidneys become waylaid; that is recognized by the aviation and ground transportation industries as a federally designated entity requiring their full support, cooperation, and accountability; and that ensures the safe and timely movement of every kidney that leaves its original donation service area (DSA). At this point in time, the OPTN is poorly prepared to ensure the safety of the organs it proposes to put at risk. Until such a safety support network is provided for the large-scale movement of kidneys throughout the U.S., I cannot support any policy proposing broader geographic sharing. I am not willing to tell one more donor family that the “system” did not value their loved one’s gift enough to ensure its safe and timely arrival to a transplant center.

Brenda Thrasher | 09/26/2019

I appreciate the work of the Kidney Committee and the efforts made regarding the tremendous task of trying to eliminate DSAs. I agree with the goal, but I think this proposal is too much, too fast and strongly oppose it. I fear the bolus effect from utilizing a 500 -mile radius will result in significantly fewer transplants in centers that currently have excellent transplant rates and work with high performing OPOs …essentially punishing them AND their patients. There are vast differences in consent rates among similar geographic areas. I would think that that is the place to put energies and resources into finding and sharing best practices among those OPOs with high consent rates. This plan is rewarding the poor performing OPOs. Reviewing the most recent SRTR OPO Report regarding donation rates per 100 eligible deaths: Out of the 58 OPOs, 29 have less than the national average rate. Taking out the 2 that are doing better than their expected rate, still leaves 27 OPOs that have opportunity for improvement. While improving acceptance rates among transplant centers is important, I feel the COIIN project should have started with OPOs to help share best practices. OPOs need to be held accountable for their performance. A sense of “community” is a vital part of promoting organ donation; shipping organs across country will negate those efforts. I feel the actual number of transplants will diminish and the cost will rise. These are not the outcomes you want. The modelling cannot accurately predict some of these changes or costs. Areas without major airline hubs will have kidneys flying for hours, increasing CIT and DGF. I do think this plan is a step in the right direction. Perhaps 250-mile radius would cause less drastic effects. I do not want to look my patients in the face and tell them that they will be on dialysis years longer because of this change. I appeal to the Board to continue the progress being made, but this proposal is not the answer.

Live On Nebraska | 09/25/2019

Live On Nebraska supports the goal of the UNOS Board and the organ-specific UNOS committees to align organ allocation policies with the Final Rule. We support allocation policies that maximize the utilization of all kidneys, including marginal kidneys. Further we maintain that any policy change must, at a minimum, not decrease the utilization of organs. Most importantly, we support policy changes that result in an increase in the number of kidneys transplanted. Ideally, circle size will be selected based on modeling data that shows maximum use of kidneys while accounting for cold ischemia time, cost and process efficiencies. The number of kidneys available for transplantation should not be impacted by broader sharing. Any policy proposal that is expected to result in an increased number of discards is not supportable. Air travel challenges also must be considered. For many areas of the country, including ours, commercial travel and airport cargo operations are limited during evenings and weekends, with weather and operational delays posing a further risk of not being able to transport kidneys. Because these factors directly relate to the efficient management of the system and potential for organ wastage, they must be considered in selecting a circle size. Living donor candidates who later find themselves needing a kidney transplant should have priority nationally. Delegating allocation responsibility to an importing OPO is an ineffective solution to best facilitate kidney placement. The importing OPO has a minimally vested interest and in many cases limited information about the donor organ being allocated. Our recommendation is to pass local backup allocation to the UNOS Organ Center or leave it in the hands of the host OPO to avoid involvement from the importing OPO. We support the use of a 150-NM radius for the import list, with proximity points given to patients closest to the original transplant center.

Anonymous | 09/25/2019

Overall this is a step in the right direction. The current system is very unfair to people who cannot afford to travel to multiple list in a place where waiting times are shorter. Ideally, there should not be any circles that produce sharp cutoffs - logistically there is little difference between 499 and 501 miles distance and access to airports will likely have a much larger impact on organ travel time. This should be studied. I think the backup plan is reasonable - the recovering OPO can decide which organs to give up - which I think is fair to all involved. I hope this proposal will encourage smaller centers to accept higher risk organ offers. To help this, the kidney committee (and others) should consider what 'standards' patients would really expect of a program. Is 97% 1-year graft survival necessary for a patient to be willing to undergo a transplant, or would a 85% chance of success be ok? If we measured programs based on what patients expect, as opposed to what current statistics model, smaller programs will have more of an incentive and a bit of room to accept lower quality organs - which should help with patient access (don't have to travel to a larger, more aggressive center), and minimize cold times (small centers can keep marginal kidneys without causing themselves to be reviewed for decreasing outcomes).

Anonymous | 09/25/2019

While the goal of more fair allocation is desirable, not considering differences in regional organ procurement success leaves a significant component of the problem unaddressed.

Steve Almond | 09/24/2019

Organ allocation polices have used donor service areas (DSA) as the unit of distribution for over 20 years. Recent legal cases determined these policies violate the Final Rule because DSAs allocate organs “based on the candidates place of residence or place of listing.” Therefore, the courts have instructed the OPTN to remove DSA from policy and develop a new unit for organ distribution. This ruling has stimulated the interest of governmental agencies, the legal system and the pubic to learn more about how organ allocation policies are developed. The questions generated are fair and focus on understanding the governmental regulations on which our policies are based. They also are aimed at determining if we, the transplant professionals, are familiar with these regulations and that any new policies will be compliant. Through this process, the public has learned what we have known for years. Organ allocation policies are based on the Final Rule, the National Organ Transplant Act, and the Children’s Health Care Act. The National Organ Transplant Act and the Children’s Health Care Act require, among other things, that the special needs of children (ie growth and development) be addressed through organ allocation policy. The Final Rule, in addition to eliminating geographic discrimination, also requires that organ allocation policies “(1) be based on sound medical judgment; (2) seek to achieve the best use of donated organs; (4) be specific for each organ type or combination of organ types to be transplanted into a transplant candidate;(5) be designed to avoid wasting organs, to avoid futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement. The new kidney allocation proposals’ unit of distribution will be a “circle encompassing 500 nautical miles (NM) with the donor hospital at its center”. If approved, the policy will achieve the goal of removing DSA but may continue to violate various components of the Final Rule and some of the other, above-mentioned regulations. For example, the new proposal will continue to violate the geography requirement. Recipients living in widely spaced, smaller cities, and transplant programs with smaller donor populations will continue to have lower transplant rates. Take my city of Corpus Christi. We are a small city of 400,000 people, about 150 miles from any similar sized city. Being on the coast, we also loose 50% of current and future donor/population growth since half of our distribution circle is in the Gulf of Mexico. Therefore, our donor pool may shrink under the new system as we may, depending on the circle size, loose exposure to donors from Dallas, El Paso, Temple and/or Galveston; cities currently in our DSA. The new allocation policy also does not address other factors that have been shown to affect transplant rates. For example, the presence of a multiorgan transplant center within a DSA is associated with a statistically significantly lower pediatric transplant rate. Similarly, low supply to demand ratio of KDPI < 35 kidneys, has also been associated with a decrease in pediatric transplant rates. These data suggest pediatric renal transplant candidates living/listed in circles containing an MOT, and those with a low supply of KDPI < 35 kidneys, will have lower transplant rates that those living in circles without MOT centers and a high supply of KDPI < 35 kidneys. In addition to these data, the public may be concerned that allocating a kidney to any adult, ahead of a child, violates the NOTA and the Children’s Health Care Act. These and other data suggest that our current practice of considering allocation polices in isolation, may not be sustainable. On point, our critics may suggest that continuing to allow MOT allocation to occur before renal allocation, violates the Final Rule, NOTA and the Children’s Health Care Act. In addition, this practice may give the appearance of putting convenience, economics and self interest ahead of “sound medical judgment” and “the best use of organs”. Similarly, the wide variability in listing and number of MOT transplants between transplant centers strongly suggest that MOT allocation policies are based on personal preferences and not ‘sound medical judgment’ . Unlike kidney allocation, MOTs have been performed for over 20 years with little to no listing criteria and little monitoring. This suggests MOT allocation policies were not developed to be specific “for each organ or combination of organ types…”. Recent presentations at ATC in Boston suggest that 20-50% of SLK recipients may not have required a simultaneous kidney transplant, suggesting to the public that we may be “wasting organs.” Finally, since MOT candidates (listed for a non-renal/renal transplant) are offered every kidney before every pediatric kidney alone candidate, and these are the highest quality kidneys, many may feel this policy violates the NOTA and the Children’s Health Care Act. The question that will come before us will be, if MOT policies interfere with and prevent the Kidney Allocation Policy from fully complying with government regulations, do they need to also be changed? The new policy may also be a bit unclear, inconsistent and contradictory. For example, the size of the circle is unclear. On page 39 in the Public Comment Proposal, Fall 2019, the policy proposes, “removing DSA within kidney allocation policy in favor of a single fixed distance circle encompassing 500 nautical miles (NM) with the donor hospital at its center.” This could be interpreted that the radius is 250 NMs and the diameter 500 NMs. However, page 49, figure 6 shows the donor hospital in the center of a circle with a 500 NM radius; ie a circle of 1000 NMs. So, it may be important to clarify “the size of the circle”. Regardless of the answer to this question, the public perception may be that we, the transplant community, knew the regulations surrounding organ allocation, and for some reason, chose to ignore them. We do, however, have several defenses. One defense is that we are a transparent organization. Specifically, we have tried to engage and educate the public through the UNOS website. We have included lay-persons on the UNOS Board and put our policies out for Public Comment. Nevertheless, due to the complexity of government regulations, changing allocation policies, knowledge about where to find information and motivation to get involved, the larger public may still be transplant naïve. These individuals, our future donors, have entrusted us to distribute deceased donor organs without bias, according to American values. And, when we violate their trust, they will let us know through lower donation rates and lawsuits. To the general public, organ allocation policies should be a reflection of American values. In situations involving a limited resource, two of these values are fairness and protection for vulnerable individuals, like children. The support for these values is deep and broad founded on religious, legal and maritime traditions, customs, and laws. Most Americans believe that when resources are limited, every adult deserves equal opportunity to that resource and children ( a vulnerable population) should come before adults. With this view, there are three allocation practices that the public may find objectionable. The first is giving two organs to one recipient. The second is giving a second organ to a recipient ahead of a recipient who has never had one. Finally, and to me most importantly, is the allocation of a kidney to an adult ahead of a child In summary, donated organs are a national resource and the public will ultimately determine how they are distributed. The public has forced us to do what we should have done a long time ago; allocate organs fairly. To the public, fair appears to mean several things. First, it means follow the rules. Second, the rules need to reflect American values of fairness and caring for vulnerable populations, like children. The new allocation system may satisfy one component of the Final Rule (remove DSA) but not all of them.

Prabhakar Baliga | 09/24/2019

Eliminate the Use of DSA and Region in Kidney Allocation Policy I am writing this comment based on my experience as a kidney transplant surgeon in practice in a large program in the Southeastern US and have been actively involved with the OPTN for almost three decades. To start with I have fundamental differences with the approach of the policy since it does not uphold the intent of the Final Rule “sound medical judgement, best use of organs, preserving the ability for transplant programs to decide whether to accept an organ offer, avoiding wasting organs, promoting patient access to transplant, avoiding futile transplants, and promoting efficiency”. Every aspect of this rule will be compromised under this current proposal. This proposal will increase the number of kidney discards, which will reduce the number of lifesaving kidney transplants performed nationally; Decreases kidney transplant rates and significantly increases waiting time for several communities that are highly giving and have high organ donation rates . This proposal notably increases travel requirements for up to 40% of organs transplanted. This cost is substantial, and there is no modeling completed to project additional costs. Suggesting that this proposal is supporting the principles of the Final Rule is truly creative. Based on my experience with liver allocation proposal I am skeptical that UNOS listens to its constituents anymore and this proposal like prior ones feel like a marketing campaign to push an agenda vs a 360 evaluation of the problems and a proposal that is truly helpful to patients or moving the field of transplant forward. DSA vs concentric circles is a fascinating argument for me which somehow seems to justify that arbitrary circles are appropriate vs a logical distribution system that has been set up and has worked well no different than efficient distribution systems in other areas outside the health system. Access to care and social determinants that affect access are widely ignored with crude parameters. Much of access is determined by state of residence has been well established e.g. ACA states or SE or types of dialysis units of patients. The true difference in disparity based on organ procurement and utilization once again remains widely ignored. Hence reading the proposal feels like “a cut and paste” of statements that are placed out of context in a social media campaign to debunk DSA. On what basis and what is the conviction that concentric circles are a fair distribution system? I live in SC and so is there going to be a “fudge” factor to make this fair for SC vs internal states? How do rural states with low population density survive against a distribution system that favors high-density populations and those who can get easier access for socioeconomic reasons? A broad and crude measure of equity will not uncover these real disparities. There seems to be an additional campaign to suggest that taking donors away from these giving communities will not matter as long as it serves humanity. I would be anxious that in the end these kind of proposals would particularly affect the minority community that has a significant distrust of the health system. With the above concerns, I cannot answer the questions of the proposal but to start out I believe there should be a real conversation and proposal to address best practices on organ donation and utilization. No region or transplant center should be allowed to import organs until they have maximized their local potential. We need to define equity differently with covariates that affect access to care and not just utilizing waitlists. We potentially can utilize USRDS data to ensure the appropriate access and transplant rate that should be maintained for each local community so no community is left behind. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4167710/ I believe that 8 out of 11 regions have voted against the proposal, perhaps it is a good time to have a reset button Prabhakar Baliga, M.D. Professor and Chair of Surgery Medical University of South Carolina

Anonymous | 09/24/2019

The OPTN Ethics Committee thanks the OPTN Kidney Transplantation Committee for its effort in developing this public comment proposal that describes removing DSAs and Regions from kidney allocation policy. The Committee expresses its support regarding increasing the prioritization for pediatric and prior living donor candidates. The Committee believes that prioritization of these vulnerable populations deserve further analysis regarding the balance between equity and utility that the system encourages. The Committee also expresses concern regarding the proposed medical urgency classification. The Committee wants to ensure that this classification has well defined criteria that promote a fair standardized process that will prevent any manipulation of the waitlist priority in the allocation system. The Committee members indicated 27% strongly support, 53% support and 20% neutral/abstain sentiments for the proposal.

Anonymous | 09/24/2019

Region 1 voted and had the following comments: Strongly support (2), Support (8), Neutral/Abstain (0), Oppose (2), Strongly Oppose (2) Region 1 was generally supportive of the proposal. Some members were concerned about the increase in time on dialysis and waiting time in certain areas- particularly for those centers close to large metropolitan areas. There was also concern that patients would be referred to the centers with the lowest waiting time resulting in some centers having a large decrease in transplants. There was a suggestion that the committee should consider adding more proximity points in the first level of distribution. Some members commented that there may be unforeseen circumstances with such a large change and suggested that the committee should consider a phased approach. Region 1 has a stringent set of criteria that they use to approve medical urgency for candidates and would recommend that the committee carefully consider the criteria for this priority. There was a recommendation that policy for import back-up be different for standard versus mandatory shared kidneys. Some members were concerned about sharing blood and tissue typing for prospective cross-matching.

Gift of Life Michigan | 09/23/2019

Gift of Life Michigan (GOLM) strongly supports the goal of the UNOS Board and the organ-specific UNOS committees to align organ allocation policies with the Final Rule. We are committed to adapting to these changes in allocation policy and to developing innovative new approaches for increasing transplantation, with a focus on efficiency, minimizing discards and cost-effectiveness. What should be considered to select a circle size that distributes kidneys broadly and efficiently? Ideally, circle size will be selected based on modeling data that shows maximum use of kidneys aligned with the policy priorities identified above, while accounting for cold ischemia time, cost and process efficiencies. GOLM feels strongly that the number of kidneys available for transplantation should not be impacted by broader sharing and ideally the number of transplants performed will increase. Any policy proposal that is expected to result in an increased number of discards is not supportable. Air travel challenges also must be considered. Michigan is a large state and much of our state is not serviced by a large metropolitan airport. Flights are limited during the night, with weather and operational delays posing a further risk of not being able to transport kidneys. Because these factors directly relate to the efficient management of the system and potential for organ wastage, they should be considered. For this reason, GOLM supports a 250-NM circle over a 500-NM circle. With 250 NM, about 10% of organs are predicted to require air travel versus 40% in the 500-NM circle. The increase in utilization between 250 and 500 is not significant enough to add these barriers to transplant. Most kidneys within 250 NM’s can be driven and perhaps even be transported on a pump, which many centers prefer for more marginal kidneys. While cost is difficult to model, any system that unnecessarily adds extreme increases in cost cannot be supported by GOLM. Proximity points are intended to contribute to efficiency in the broader distribution of kidneys. Should they be used inside the distribution circle? Should they be used outside the distribution circle? How should the assigned values be prioritized in relation to other allocation points in the kidney allocation system? Proximity points should be used, with a greater emphasis put on those closest to the donor hospital and a reduction in the number of points as the distance grows. AOPO supports the proposal of proximity points both inside and outside the circle, as defined. What prioritization do you think is appropriate for pediatric candidates? Should prioritization be applied inside the distribution circle? Should prioritization be applied outside the distribution circle? Pediatric patients within the distribution circle should be prioritized over adults. Once the allocation moves outside the determined radius, pediatric patients should again be prioritized over adults in that expanded circle. What prioritization is appropriate for prior living donor candidates? Should prioritization be applied inside the distribution circle? Should prioritization be applied outside the distribution circle? Living donor candidates who later find themselves needing a kidney transplant should have priority nationally. What operational concerns should the committee consider as this policy is being prepared for OPTN board action and implementation? Under this proposed policy, GOLM – who has historically placed many of kidneys within our DSA – will be placing more organs outside our DSA. This will require additional time, added travel expenses and greater coordination of the donation process. While we do not think these are exclusively limiting factors, they nonetheless need to be considered. We believe that strict monitoring of any new system must occur to minimize and respond quickly to unintended consequences, such as increased discards and/or a dramatic increase in donor recovery expenses. Should medical urgency criteria be defined? If so, what specific conditions would qualify? Where should they fall in the allocation classification? Since the intent of all allocation policies is to reduce the number of deaths on the transplant waiting list, we do believe medical urgency criteria should be developed. These criteria, when present, should receive additional points both within and outside the proximity circle. We do not believe we are in the position to recommend what the criteria should be; however, the criteria should be life-threatening in nature and, as applied in the allocation of other organs such as heart and lung, have urgency as a priority. One such example may be immediate loss of vascular access for dialysis patients. When a local backup is granted, do you support the use of an import match run for the import OPO to reallocate the kidney? Should the match run use the same size circle as the original allocation but with increased points for proximity? Should the circle size be smaller? If so, what distance will promote the efficient reallocation of kidneys? GOLM supports the use of an import list if an importing center cannot use the kidney and needs to reallocate. However, we support having the ORIGINAL OPO that offered the import generate the import list and conduct allocation, To ask the receiving transplant center’s OPO to perform this task will be inefficient, because that OPO has no knowledge of the donor and in many instances is unaware the center even imported a kidney until called. We support the use of a 150-NM radius for the import list, with proximity points given to patients closest to the original trans

Anonymous | 09/22/2019

I strongly oppose this proposal. Oregon's OHSU, a leading transplant hospital opposes these changes. The 500 mile radius is too large and will lead to less access to kidney transplants in Oregon due kidneys being shipped out of state. I plead with you that the DSA is not eliminated and to keep transplants in control of local regions.

Anonymous | 09/22/2019

This proposal is a huge mistake. One unintended consequences of this proposal that suddenly transplant candidates in short wait list hospitals who were expected to get a transplant in the next year or so would suddenly be pushed back by many years as they will be "overtaken" by candidates who get priority from the long wait list hospitals within 500 mile radius. Furthermore, the hospitals that used to have short wait list time would suddenly find themselves with no cadaveric kidney to transplant for several years as all their candidates would be pushed back. On the other hand, the hospitals who had a long wait list -- would find a tremendous influx of kidneys to transplant as their transplant candidates would suddenly "jump" the waiting list. Thus, transplant teams in some hospitals would be idling while other transplant teams overwhelmed with work. Even after 5 years or so when the initial influx/decrease in patients would subside. The problem would continue to persist as some hospitals would continue to receive more kidney transplants than before while other hospitals (especially in more rural areas) would be idling. What is the OPTN/UNOS is expecting the transplant teams to do? --pick up their families and start relocating to the new location? If the whole program cannot be scrapped -- at least much smaller radius of 250 miles should be considered. Also before implementing this program -- it would be highly desirable to have some sort of pilot program. Without such program we are asking for a huge potential disaster.

Anthony Matison | 09/21/2019

I Strongly Oppose the Elimination of the Use of DSAs and Regions in Kidney Allocation. I am the son of a kidney recipient/candidate. My mother received a kidney at the end of 2018 and after waiting over 5 years on the waitlist was told that the new kidney only had less than 5% function and that she would have to go back on the list. I've watched her on her good days and on her bad days on dialysis. I am so thankful to have such a strong and amazing mother who has the passion for life to keep fighting this tiresome fight. I am thankful for kidney transplant research and the organ donors out there who are trying to allow her to stay with our family for as long as possible. If the elimination of the use of DSAs and regions in kidney allocation is allowed to go through my mom will continued to have diminished quality of life waiting on an even longer waitlist. This proposal isn't the right solution. Existing transplant programs have finite resources and if you continue adding to their pool instead of investing in more programs throughout Oregon you'll exacerbate the issue of access. Help my mother. Help other transplant candidates. Help Oregon. Please OPPOSE the elimination of the use of DSAs and regions in kidney allocation. Tell the writer's of this proposal to think of the bigger picture and expand transplant programs throughout Oregon; not to expand existing candidate pools and hobble hospitals like OHSU. Thank you to everyone at OHSU's Kidney Transplant Progam for all your hard work.

Deanna Matison | 09/21/2019

I strongly oppose the Elimination of the Use of DSAs and Regions in Kidney Allocation. I am a kidney recipient and repeat candidate. My transplant didn't take and I am back on dialysis after waiting 5+ years already for this kidney that has less than 5% function. If this proposal goes through myself and other candidates in the Greater Portland Metropolitan Area would be forced to spend even longer periods of time on the waitlist and have higher risks of not surviving long enough to receive this life-saving organ. I am grateful for my treatment but you can understand how I would like to have my life back and not be bound to a machine for so much of it. The writers of this proposal should look to furthering transplant research and programs in other areas throughout the state to allow more opportunities for Oregon's citizens. Robbing from Peter to pay Paul isn't a long term solution. If you truly care about Oregon and her future you should NOT Eliminate the use of DSAs and Regions in Kidney Allocation and you SHOULD put your time and resources into furthering programs throughout the state to benefit the many.

Anonymous | 09/20/2019

I would like to see more information on the anticipated costs to Transplant centers and OPOs and if any of these centers are at risk for closure. This should take into consideration the regional resources and impact to the patients in those regions. Additionally, part of the problem is organ availability, which is not addressed in this proposal. I disagree with the proposal and request the committee to rethink it to include the above information.

Anonymous | 09/20/2019

Region 2 voted as follows and had the following comments: Strongly support (1), Support (5), Neutral/Abstain (0), Oppose (7), Strongly Oppose (15) The region was not supportive of the proposal as written. A majority of the opposition was in regards to logistics for both OPOs and transplant centers related to allocation within a 500 NM circle. Sharing out to 500 NM will result in more kidneys flying which limits the number of kidneys that can travel on pump since those have to be driven. Since the modeling cannot predict behavior changes, it would make more sense to start with a smaller circle size to monitor how eliminating DSA and region affects allocation. A few members expressed interest in population density modeling and basing allocation not on nautical miles but population within circles. Additional feedback included concern in the reduction in transplant rate for non-metropolitan candidates, and an increase in organ discards for high KDPI kidneys. In terms of medically urgent candidates, they should appear on the match after high CPRA patients but before pediatric and prior living donor patients. It was also noted that the Executive Order in regards to OPO performance should be considered with the proposal. The region proposed an amendment to the proposal utilizing a smaller circle size for allocation since the modeling showed similar outcomes between a 250 NM circle and 500 NM circle. There was support for two proximity points within the 250 NM circle and four proximity points outside the circle. Region 2 amendment: Use a 250 NM fixed circle with 2 proximity points within the circle and 4 proximity points outside the circle: Strongly support (2), Support (16), Neutral/Abstain (2), Oppose (4), Strongly Oppose (10)

American Nephrology Nurses Association | 09/20/2019

American Nephrology Nurses Association supports this proposal. We agree with sharing to promote equity in access to transplants. However, we have concerns with logistics, cost, and increased cold ischemia times and the potential for jeopardizing graft and patient outcomes. Perhaps a 250 NM radius would be more realistic due to organ time constraints. We agree with proximity points and increasing priority for pediatric patients and prior living donors.

Kathyrm D. Hutchinson | 09/19/2019

My name is Kathyrn Hutchinson, i have been on the kidney transplant list for 5+ years in the state of Oregon. I am stating that I do not agree with expanding the kidney transplant area to out of state recipients while those on the transplant list have been waiting for numerous years to receive an organ that will not only increase the quality of ouir lives, but in most transplant reciepents will give us a chance to live out our lives to normal age limits instead of our lives being severely shortened with failed organs !! If the transplant area is largely increased in size and organs are to be shipped to other states that will greatly decrease my chance of receiving a kidney after waiting 5+ YEARS !! Or if organs are shipped to Oregon from long distances from other states, there is a much greater chance that a usable organ will be disgarded to to fact that time is of essence in getting the organ to the tranplant Hospital as quick as possiple in order to have a sucsessful transplant without the chance of having a disgarded organ or an organ that is rejected, this being due to that the kidney was not received in a fresh condition to the transplant hospital. After waiting for 5+ years to receive a kidney from the state of Oregons transplant area I feel that all of us that have been waiting to receive a transplant should have priority to receive an organ that is a match, instead of the organ we would have received, is shipped to another state where it might possibly be disgarded due to it was not received in the time limit allowed to be transplanted. So as a kidney transplant recipient with 5+ years of waiting I have to disagree to the proposed National kidney allocation proposal that will expand the transplant area and allow needed organs be shipped to other states for all of the reasons I have given in my above statements !! Thank You for allowing me to give my opinions as I have first hand knowledge of how it feels to wait and wait and to be so very close to being picked to receive a kidney and then being notified that another person was to receive the kidney that you have been waiting for. It is very devastating to deal with. Not only for me personally but for my family also. Sincerely Kathyrn Hutchinson

Lifebanc | 09/19/2019

In an effort to address the final rule for broader sharing and eliminate the DSA, Lifebanc opposes the 500 nautical mile radius and recommends that the OPTN begin at a 250 nautical mile radius. In doing so, the majority if not all of kidneys can be transported via ground transportation vs. air transportation. With typical issues tied to air transportation surrounding lack of direct flights, costs, weather, etc., beginning with the 250 nautical mile radius make the most sense. Lifebanc would recommend that UNOS and committees evaluate the results after one year and make further changes if necessary. Again, this recommendation would eliminate DSA and meet final rule.

Anonymous | 09/19/2019

I strongly oppose the proposal. It will increase ischemic time due to longer travel to retrieve the kidney. Overburden kidney retrieval teams. Put additional strain on SOME of the hospitals in seeing sudden increase in number of transplants. Increase probability of mixups due additional strain on the system. As well as decrease kidney donations as grieving families will be unwilling to donate kidneys outside of their immediate area of residence. Considering the above, I conservatively expect (unless OPTN/UNOS can perform a study contradicting this assumption) additional 1% of kidneys to be lost in the shuffle. With roughly 14,000 cadaver kidney donations per year -- this will correspondingly result in 140 lost kidneys per year. IS MEDICAL COMMUNITY, OPTN/UNOS AND MORE SPECIFICALLY THE TRANSPLANT COMMITTEE ARE WILLING TO ACCEPT the corresponding death of additional 140 people per year due to inability of these people to receive the needed transplant? Would it make sense to at least perform additional study to see more precisely how many lives will be lost due to this proposal? Unfortunately the current proposal totally fails to address these unanticipated consequences.

W. Scott Burns | 09/18/2019

I'm a UNOS ambassador and listened to the webinar on September 16th. It was explained that UNOS has been spending time to work out any potential glitches in the "Roll out". I think that you should do one geographic area first, maybe 6 months or a 1 year earlier, to find the unexpected glitches before the national roll out. It will be the transplant centers and donor hospital personal that will have the have the glitches, and I think there will be more than expected. Having a smaller area to test would be helpful . I'm in southern California, but I thought that the transplant wait time in Donate Network West and Sierra Donor Services areas were at either end of the spectrum, maybe trying the first area there could be work. In any case, I'm 4 years with my new Kidney and I appreciate your organization's work

Maine Medical Center | 09/18/2019

We have reviewed the proposal carefully and participated in one of the educational webinars describing the proposal and expected outcomes. The proposal was also discussed at the recent Region 1 Meeting attended by our UNOS Representative and Program Director. The proposal is clearly a dramatic change in how kidneys are allocated, and will have a major impact on all kidney transplant centers in the country. • The proposed change is confusing, difficult to understand, and would be difficult to explain to patients. Although we understand and applaud the stated intent of the proposed changes (i.e. increase equity), our rigorous review of all available materials has left us with a major gap in understanding of the true impact of the change on organ availability and transplant rates at our Center. In order to completely understand the proposal and its impact, insufficient information has been provided to transplant centers to quantify the impact on their center. Although broad modeling has been completed, transplant centers are entitled to more specific modeling for their region and their center. As a center with an active donor hospital and current high organ acceptance rates, we could surmise a positive impact, but without quantifiable modeling on the impact of the addition of several thousand candidates with long waiting times to our “circle”, we cannot form a reasonable opinion on either an overall positive or negative impact. This is a concern given the statement on the UNOS website that by implementing this system, some areas of the country will see an increase in kidney transplants and others will experience a decrease. Our success as a donor hospital could be diminished by the much broader sharing of organs with very large transplant programs within our “circle”. • Based on our current understanding of the Proposal, two key issues that heavily impact organ utilization are absent and remain unaddressed: the high organ discard rate in the United States, and the differential organ acceptance rates by various programs. Incentivizing programs to use high KDPI kidneys and collaboration with CMS on the removal of penalties for lesser than positive outcomes as a consequence would be a more reasonable approach with a less deleterious expected impact on transplant programs. • As a membership organization, we would expect UNOS to be entirely transparent, collaborative, and responsive to legitimate inquiries and concerns about this far reaching proposal. During the recent webinar, we were disappointed in the approach to very thoughtful and important questions about the impact of this proposal on transplant programs. Overall, the responses were dismissive and gave the impression that the change in allocation is a forgone conclusion, without consideration of the major impact on transplant programs that may experience a decrease in transplants in the “winners” and “losers” paradigm of this Proposal. As the 2nd major KAS proposal in less than five years, the lack of reflection on negative impacts of the 2014 changes is additionally concerning. As the only kidney transplant program in the state of Maine, we are especially concerned based on our experience with the 2014 change which did result in a decrease in kidney transplant volumes. • The financial impact of organs traveling further in the proposed model appears to have been ignored and requires additional review and communication to transplant centers, which along with the OPOs will bear the cost of this change. We are requesting that the Proposal be suspended until additional program and region specific impact modeling can occur, and the financial impact to OPOs and transplant centers can be quantified. We cannot go forward with a proposal where “equity” merely means that there are new “winners” and new “losers” in the kidney allocation system.

Daren Lott | 09/18/2019

These changes will result in many organs being shipped to recipients out of our state and will significantly decrease Oregonians access to kidney transplants. It will result in longer waitining times and time on the dialysis in our state.

Anonymous | 09/18/2019

I am a lifelong Oregonian. I have been listed as an organ donor for over 20 years. I would want my organ to be given to another Oregonian. , I am now on the transplant list for a kidney. I specifically chose OHSU as my transplant hospital. My estimated wait time for a deceased kidney is 5 years. If this change takes effect my wait time will increase as there will be more competition for the kidneys.

Anonymous | 09/18/2019

I have been a resident of Oregon all my life. I have listed myself as an organ donor for over 20 years. I am currently on the list for a kidney transplant. I am opposed to changing the catchment area of kidney transplants. I believe that organs donated in Oregon should stay in Oregon.

Anonymous | 09/17/2019

our own friends and family should have access to transplant organs before the organs are used elsewhere. These viable organs are much needed in our own neighborhoods. It is unfair to deny them fist access. It is unfair to deny Oregonians the right to normal life with no illness, that is only achieved through these transplants.

David Brussee | 09/17/2019

As a guiding principle, any solution that disadvantages one stakeholder in favor of advantaging another stakeholder is bad public policy. Solutions that merely exist to "share the pain" are not really very compelling. Having attended the public webinar, read the draft proposal, and familiarized myself with various pro and con articles, I feel sufficiently informed to have an opinion. The disparity between wait times for kidneys is indeed striking. However, the draft proposal seeks not to fix the underlying problem(s) but merely spreads the problem across the nation. As I understand one of the causative factors driving the disparity, it is the very real difference in the percentage of adults who have agreed to donate organs. In New York, for example, one of the states with the longest wait time, only 32% of adults have agreed to become organ donors. This is the lowest in the United States. Conversely, in my state of Missouri, one of the states with the shortest wait time, the percent of adults seeking to be organ donors is 73% -- and that is not even the highest rate seen in the United States. It would seem that the solution to a local problem should focus on a local solution. Perhaps UNOS and New York, for example, could conduct outreach and try to increase the donor rate to at least the national average. This would focus the effort on the problem and does not require other states to subsidize poor behavior of long wait-time states. If UNOS is compelled to seek a national solution, I would prefer that they direct their attention to working with states to enact an "opt out" policy for organ donation, rather than today's system that requires an affirmative action to "opt in" to become an organ donor. Perhaps UNOS could improve their public outreach to communicate the critical shortage of organs. Or work with various organizations to help improve the extremely murky living donor process. Asking individuals to undertake their own pleading campaigns via Facebook is far, far from an efficient way of connecting those willing to donate with those needing kidneys. And from a purely personal point of view, I studied the statistics when I knew that my ESRD would proceed to the need for a transplant. As a result of my research, I relocated my family from Philadelphia (where the wait lists or long) to St. Louis where wait lists or shorter. And I sought to be listed in multiple regions so as to improve my chances. And I have conducted significant outreach to try to find a living donor. My point: those who have taken personal responsibility for their health should not subsidize bad behavior of those who have not.

Anonymous | 09/17/2019

Whenever the government gets involved even with good intentions it becomes bloated and inefficient. I foresee the success rate suffering because of this proposal. The current system is working very well. The medical professionals know what works and what doesn't. Please keep the current policies in place.

Anonymous | 09/17/2019

Why bother submitting comments as OPTN would approve the requested change anyway as they have done on essentially all proposals in the past? Anyway, 500 miles radius will waist valuable kidneys as the delivery kidney time will increase. Can OPTN just concentrate on more cadaveric kidneys to be made available -- just help grieving families with the funeral expenses -- this should dramatically increase the donation rate from the current minuscule rate of 54%. One kidney donation is worth well over 1 million in medical expense savings. How difficult would that be to give say $10,000 to the donor family. The OPTN bureaucracy is conflating this with paying for living donor donations. As it is obvious to any lay person paying for living donor kidney and cadaveric kidney is two completely different issues.

Luke Preczewski | 09/13/2019

There is no doubt that DSA boundaries are arbitrary, and I absolutely support the concept of replacing them should we identify a better system, and of broadly sharing organs as needed to improve outcomes. Indeed, kidneys should be and are shared nationally as needed for highly sensitized patients, as they can fly on commercial flights at low cost, and while cold time matters, kidneys have a much longer window. This differs from the situation in thoracic and liver transplantation, where most flights have to be chartered and even small increases in travel time can result in discard or other poor patient outcomes. However, this proposal will do nothing to solve the critical reasons people are dying on the kidney waiting list: donation rates that are lower than they should be and discard of usable kidneys. Many of the centers with extremely long waiting time show organ acceptance behavior left of the national average. These centers are turning down kidneys now that go on to be successfully used elsewhere. Redirecting organs to them, and away from centers whose acceptance behavior is well right of the average, only further incentivizes those centers to refuse usable organs, prolonging waiting time and waitlist mortality for their patients. Meanwhile, it punishes the patients at centers who are doing the most important thing we can to improve this problem: using more organs. It does so by redirecting their best local organs away to the more conservative centers. A system that rewards centers with low acceptance rates and punishes innovative centers with high acceptance rates is bad for the patients at all centers. It is convenient when the right thing to do is also the one most consistent with the legal requirements, and that is the case here. While the Final Rule indeed mentions avoiding geographic disparity, it also makes that clause plainly subordinate to avoiding organ wastage. As this proposal would likely result in fewer transplants (i.e. more discards) for the purpose of attempting to address geographic variation, it is not permissible under the Final Rule and should be rejected. If the OPTN wishes to address the core issue here, it needs to focus on the following things: 1. Do everything possible to ensure the highest possible rates of donation. 2. Remove disincentives for centers whose one-year post-transplant outcomes are marginally lower because they have found ways to use the organs that other centers can’t or won’t, increasing transplantation, decreasing waiting times, and dramatically improving outcomes for patients with ESRD. 3. Avoid incentives for centers with lower acceptance rates, requiring them to increase their acceptance before they become eligible for any broader sharing. 4. Once these things have been accomplished, allocate some kidneys nationally as needed to address any true remaining inequity that arises from geographic and demographic luck, rather than these addressable issues. Any proposal to change how kidneys are allocated should first and foremost demonstrate a likely significant positive increase on number of transplants. Any that does not should not even be put forward for comment, let alone be adopted.

Anonymous | 09/12/2019

I am strongly opposed to the new allocation policy. Longer travels for the organ increases the risk of the organ's viability and can increase logistic mistakes that result in non-transplants. This change also will increase wait times for patients that have already been waiting a long time. In my particular case, finding a match is already challenging because of my medical criteria and this new policy will cause my best match donation to go outside of my state. My life and health is at stake with the proposed changes!

Anonymous | 09/12/2019

The OPO Committee offers the following comments on the Kidney Transplantation Committee’s proposal to eliminate the use of DSA and Region in kidney allocation policy: One Committee member voiced support for the medical urgency classification process outlined in the proposal. Another member asked if the candidates within the medical urgency classification were ABO identical or compatible. Some OPOs open it up to compatible blood groups in order to provide an increased opportunity for medically urgent candidates. One Committee member expressed concern about the import process and the potential to not have enough samples for cross matching if the kidney needs to be reallocated. Another Committee member noted that the proposed process for import match runs will be an adjustment for some OPOs. This is due to the fact that it will no longer be just the importing OPO’s geographically local centers because of the proposed 150 circle around the recipient hospital. The member also noted that the number of transplant hospitals within that 150 mile circle will vary across the country. 1 strongly support, 4 support, 1 neutral/abstain, and 1 oppose

Paul Morrissey | 09/11/2019

At our Region meeting we reviewed the proposal to “Eliminate the Use of DSAs and Regions from Kidney Allocation Policy.” No rationale or historical background was given for making this change except that the Final Rule requires that allocation policies “shall not be based on the candidate’s place of residence or place of listing….” I found the presentation highly biased. Emphasized was the goal of geographic equity mentioned in the Final Rule, while costs and inefficiencies, also part of the Final Rule, were barely mentioned. Data were presented that the number of kidney transplants was projected to fall (albeit by a small percent). We were told these projections “may not be accurate” – raising the concern that some, many or none of the projections may be accurate. We were told that the median time on dialysis varies in DSA from 1.5 years to >10 years, highlighting two national extremes and ignoring the fact that the vast majority of allocations occur to patients who have been waiting 3-5 years. It is clear that the new system will not increase the number of transplants. If the number of kidneys transplanted is the same (or a little less) then it becomes a zero-sum game: there will be winners and losers. Bar graphs depicting median years on dialysis until transplantation reflect minor changes in most regions but profound increases in wait times for patients on dialysis in CTOP (Hartford) and NYWN (Buffalo). The OPTN documents do not define any rationale for the variance between DSAs: fewer or greater listings, more or less organ acceptances, fewer or greater numbers of available or actual donors. Why waiting time in these two DSAs increases so dramatically under the modeling wait is also unknown (or unsaid); though one postulates it has something to do with kidneys being sent to NYC where wait times are considerably longer. Disruptions and cost to the system were not addressed: time to allocation, costs of shipping organs, dealing with staff from multiple DSAs, accurate transmission of data across Regions, complex transportation and shipping arrangements, crossmatch testing, etc. Presumably the loss of kidneys in this new schema is related to these complex logistics and longer cold ischemia times. A system based on 500 nautical miles was advocated by the OPTN, although a system based on 250 nautical miles showed remarkably similar results and would presumably be far less disruptive. Finally, the proposed system, while eliminating DSAs uses pure geographic criteria to allocate kidneys: not one based on rivers, city locations and state boundaries, but rather one based on nautical miles with graduated “points” offered to recipients based on geographic distance from the donor hospital. DSAs, and their entire infrastructure, will remain intact. Circles on a map are just another form of geography and do not account for ocean borders, population density or transplant center proximity. Overall, the system will create great disruption, not increase the number of transplants, largely keeps local kidneys local, shifts some kidneys from areas of low waiting time to higher waiting time making allocation more EQUAL across the country. Whether this system is more “equitable” is unclear (42 C.F.R. 121.8). The new allocation rule does not “avoid wasting organs”, does not “promote patient access to transplantation” (it just normalizes wait times) and certainly will not “promote efficiency” as the Final Rule requires.

Anonymous | 09/11/2019

The Pancreas Committee thanks the Kidney Committee for its work developing this proposal and for the opportunity to provide feedback. A Committee member questioned whether it was appropriate to use proximity points for highly sensitized candidates – given how rare it is that these candidates receive compatible offers, should geography be part of that consideration at all? Committee members also discussed the potential change in policy for medical urgency, noting that medical urgency is rarely invoked now. Medically urgent candidates are allocated out of sequence, but Committee members found it confusing to understand how medically urgent candidates would appear on match runs and whether they would appear ahead of 100% cPRA candidates. The Chair expressed support for having a national medical urgency standard for all programs to follow. A Committee member asked about candidates with significant waiting time getting multiple simultaneous offers. The presenter explained that notification limits are not part of policy and not being modified through the proposed solution, but would be part of the programming implementation. The Chair noted that the kidney allocation system uses points for HLA matching and geography, and multiple offers may be less of an issue than anticipated because of how the points impact the order of the match run. It will still likely be more of a challenge than it is in the current system. The Committee members indicated 75% strongly support and 25% oppose sentiments for the proposal.

Anonymous | 09/11/2019

This program will almost certainly cause smaller programs to struggle or possibly even close. If even one program closes as a result of this proposal, then how does this increase transplant equity? There a multiple unintended consequences that could occur as a result of this decision that need to be considered, discussed, and prepared for.

Anonymous | 09/11/2019

Kidney Transplantation Committee, Eliminate the use of DSA and Region in Kidney Allocation Strongly Support (1), Support (10), Neutral/Abstain (0), Oppose (14), Strongly Oppose (10) Amendment (Kidney) - 500 NM circle with no proximity points inside or outside the circle: Strongly Support (3), Support (18), Neutral/Abstain (3), Oppose (3), Strongly Oppose (6) • A major concern was brought up that the number of proximity points being awarded outside the 500NM circle is too high. Assigning eight years of wait time perpetuates geographic inequity. A candidate (inside or outside the circle) shouldn’t be disadvantaged by being listed at a transplant hospital further away than another candidate (and possibly has more waiting time). There is disappointment that the committee did not model two points inside the circle (this should be the maximum allowed points inside the circle). • It was suggested the removal of all proximity points or at least points outside of the initial circle. Based on current behavior it does not make sense to add any proximity points. Once the kidney must be flown, policy should not be awarding proximity points beyond that point. A one hour flight time versus two hours is not significant. Local proximity should have much lower priority and to consider a zone of equivalency out to 250 NM. • There is concern about the steepness of the curve. • One member stated with the policy as written, these kidneys are basically just national offers for Region 5. • It was expressed that 500 NM may not be large enough to address access equity on the West Coast and 1,000 NM should be considered. • It was brought up that geography is a reality, and one member questioned if this policy proposal reduces the number of transplants for some median incomes and rural populations. This was addressed by the presenter and there are only marginal changes across income subgroups and that broader distribution is not disadvantaging non-metropolitan candidates compared to metropolitan candidates, it is creating more equitable access across urbanicity. It was also noted that obstacles to rural populations involve many other factors such as referrals, insurance, etc. not just allocation. • There is concern that small programs might close or at least be negatively impacted. One member also commented that these same comments were made with every liver allocation change. It was stated that this did not happen after share 35; liver programs did not close. • To address the medical urgency section of the proposal, members said that dialysis access failure is deemed medically urgent and that the requirement should be that a physician independent of the transplant program conduct an independent review to avoid gaming. Additionally it was suggested that medical urgency should be based on loss of vascular access with more than one transplant surgeon confirming such loss of access. • At One Legacy, Medical urgency is defined by dialysis access failure. They have implemented a process by which at least two clinicians validate the urgency, of which one is an independent referee. • It was brought up that policy changes for dual and en bloc kidney allocation will be implemented soon. We should continue to evaluate how these fit into the proposed policy change. • Feedback was given that the ratio of donors to recipients should be considered, and OPO and center performance should be considered when changing allocation. • 150 NM may be too large for local backup.

Clarence Carlos | 09/11/2019

Please, help people who need a kidney that would Drastically change there lives!!!

Anonymous | 09/10/2019

I strongly disagree with this proposal, this will decrease available kidney’s to local recipients resulting longer wait times and longer time on dialysis.

Ginger Offield | 09/10/2019

Let the hospitals keep control they know what they can do better than a government agency who has no clue

Monica Hodges | 09/10/2019

I am a 31 year old Oregonian. I am a wife, a sister, a daughter, a friend. I recieved my first transplant when I was 19 through OHSU. I am now in need a of a second transplant along with so many others. If you send our eligible kidneys out if state, it will have a devastating effect on myself and other patients in Oregon needing a transplant. Having gone through dialysis already with my first rejection, I know the toll it takes on the human body, telling a person they have to be on dialysis longer because our eligible kidneys are being pushed to other states is an unnecessary demand. People are sick, they are tired, trying g to survive day to day tasks that you take advantage of, something simple like getting up and going to work is a daunting task for a patient going into failure and trying to survive on dialysis. Dont make this horrific situation us patients are already going through worse. There is nothing more scary than going through kidney failure in itself but to tell us we will have longer waiting times on the list and on dialysis because our state is sending organs elsewhere. How much more do we have to endure? This is not something that should be questioned, help and to make things easier for transplant patients.

Anonymous | 09/10/2019

Simply said, such policies at the outset appear discriminatory and will most likely result in increased deaths among those dialysis patients waiting to receive a kidney. As a social worker in a local dialysis clinic, I strongly oppose such measures.

Allison Connor | 09/10/2019

I would urge you to rethink this change to policy regarding reallocating kidney distribution to out of state recipients. While I sympathize with all those in need of an organ donation, those in our own state with be greatly impacted. My Father is in need of a kidney and on dialysis. He is older and therefore has a much shorter window for finding a donor. This would greatly reduce his chances at ever having the opportunity to receive this life saving treatment at all. For my Father, our family and all the other families in similar situations, I implore you to reconsider the change to policy and leave the system as it stands. Thank you.

Gayl Wallace | 09/09/2019

This change would affect my family member that is on the kidney transplant waiting list in a negative way. She has been on the list for over 2 years. This change could possibly make her wait be even longer. She is a very difficult match so anything that would possibly route organs out of our area would be very detrimental. Please do not make it harder for my daughter to get a kidney. She is a valuable asset to our community. She is my precious daughter and the single mom to two children herself.

Prince Mohan | 09/09/2019

First, I would like to thank the committee for working hard and coming up with the plan. My issues are: 1) Increase in discard rate especially for high KDPI organs 2) we can not include human behaviour in our models and thats a mjor issue 3) Increase cost and travel time (hence more cold ischemis time and more discard)

Bobbi Hite | 09/09/2019

My mother is currently on the wait list to receive a kidney transplant and she is currently receiving dialysis. With the proposed policy change which would allow organs to be shipped to recipients out of state would significantly decrease her chances of ever receiving a transplant. I urge you to reconsider this policy as many patients lives are at risk if they don't receive a transplant and to delay it due to this new policy would be devastating.

David Dick | 09/08/2019

As an impacted patient and being on dialysis I do not want organs being shipped to recipients out of state and will significantly decrease my access to my kidney transplant!!

Anonymous | 09/08/2019

Our Oregon transplant hospital OHSU is well-respected and does not support elimination of DSAs and Regions in Kidney allocation. I have a dear friend on Dialysis here in Oregon and she’s waiting, waiting for a transplant. Please don’t make her situation worse with this change in procedure.

Anonymous | 09/07/2019

• Concern that travel distance will lead to more discards • Disparities in OPO and Transplant Center performance need to be addressed • Circles may not be the best solution and are still geography that affects access • Variability in the availability and effectiveness of transport makes such a big move to broader sharing concerning • The modeling results create several concerns including a lack of center specific data and although organ discards are not modeled, the results imply more discards. • Any proposal that predicts even one fewer transplant should not be considered • We should not address removing DSA and broader sharing at the same time. This should be done one at a time to allow for evaluation. • There was a repeated theme with concern about a sense of urgency of the project. • Changes in geographical distribution should start with smaller distances to allow for adaptation and evaluation. • Geography weighs too much in the OPTN interpretation of the Final Rule. Efficiency and avoiding wasting organs need more weight. • An epidemiologic approach should be utilized. This proposal will decrease access to transplant in areas with the highest ESRD burden. Transplant programs have worked hard to increase access for their patients. The disease burden also affects donors. When the overall health is poor, there are fewer good donors. • The circle model concerns representatives from Florida which is surrounded by water on three sides and is predicted to see a significant decrease in kidney transplants • There are not many medically urgent candidates • The local backup approach may lead to more discards. The size used for reallocation should be reconsidered • Region 3 requests that the proposal come back for approval from Region 3 prior to it becoming policy. Strongly support (1), Support (4), Neutral/Abstain (1), Oppose (5), Strongly Oppose (21)

Anonymous | 09/06/2019

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide feedback on this public comment proposal. Furthermore, the Pediatric Committee applauds the Kidney and Pancreas Committee’s efforts to include the pediatric perspective throughout the policy development process. The Pediatric Committee strongly supports the increased priority for pediatric candidates in the proposed allocation sequence. The Pediatric Committee would like to make particular note of the improved outcomes for the pediatric population as a positive aspect of the proposal. However, The Pediatric Committee is concerned that the increased number of kidney-pancreas transplants will disadvantage certain pediatric candidates. Under the current system, there are pockets of pediatric candidates who are disadvantaged because they compete with aggressive kidney-pancreas programs. The Pediatric Committee is concerned that these pediatric candidates will be further disadvantaged under the proposed allocation system. The Pediatric Committee requests that this aspect of the proposal be monitored. The Pediatric Committee is also concerned that pediatric candidates will need to compete with all multi-organ candidates for offers. The Pediatric Committee noted that the current calculation of kidney donor profile index (KDPI) does not accurately reflect the value of kidneys from pediatric and adolescent donors. As a result, the majority of kidneys from pediatric and adolescent donors are allocated to adults instead of pediatric candidates. The Pediatric Committee will continue to advocate for increased access to these high-quality kidneys for pediatric candidates and appreciates the continued collaboration of the Kidney Committee in all efforts. The Pediatric Committee is also concerned about the impact of the proposal on delayed graft function due to increased cold ischemic time. Overall, the Pediatric Committee supports the proposal as it provides additional priority for pediatric candidates and is modelled to improve outcomes for the pediatric population. However, the Pediatric Committee does have some concerns and will continue to advocate for the changes noted above.

Alesha Luxon | 09/06/2019

I support the change to the 500 mile radius for allocation. However, included in the change should be the tracking of costs compared to current allocation. There does not seem to be good cost data in the models done thus far. A cost analysis could/should be done before the change takes place as well as modeling for 'lost organs' due to CIT, delayed flights, etc. Changes in recipient outcomes should be monitored, but will ta long time to see. All should be monitored carefully.

Anonymous | 09/03/2019

Region 7 comments are as follows: Breakout session attendees shared several feedback items on this proposal. This included: • The need for greater understanding of the practical implications of proximity points. It would be very helpful for examples of match run lists to help illustrate what this would “look” like. The test match run lists that were made available with the liver allocation policy changes were very helpful. • Support for the proposal from the Pediatric Committee representative. Also advocated to maintain pediatric prioritization inside the 500 NM circle, and inclusion of pediatric candidates in sequence “C”. This individual shared concern that pediatric candidates in need of solitary kidney would continue to be disadvantaged as a result of kidneys allocated with pancreata for candidates registered for a kidney/pancreas transplant as shown by the KPSAM. • Attendees asked how transition to UNOS Organ Center for allocating kidneys would work under the proposed changes. • Recommendation for a standardized approach and a “steep bar” for medical urgency, and asked the Committee consider OPTN data on kidney candidate medical urgency and candidates that “exhausted dialysis access”. Also recommended a way to capture if “medical urgency” was due to patient noncompliance. • Requested the Committee think about the “safety net” and the time requirement in this policy. • Inquired about what difference was seen in KPSAM re: high KDPI kidneys. • This proposal does not appear to address organ availability or usage. Requested the Committee examine kidney utilization rates and availability rates and see if there are linkages between these data. • KDPI is a good calculator for deceased donor kidneys. However it does not work well for kidneys from living donors that are allocated to the list. Request to develop a better calculator to more accurately reflect the latter kidneys. • Was there a role for “points” for high KDPI kidneys to reduce discards? • The Committee was encouraged to consider the issue of OPO performance, and hoped there was space in this proposal to incentivize kidney transplant programs to use high KDPI kidneys. • OPO staff in attendance supported the 150 NM import back-up. There was split sentiment whether it was more appropriate to have the center of the circle be the importing OPO and not the accepting transplant program, and vice versa. Another alternative was to center the circle on the physical location of the organ at the time the import back-up was initiated. Also recommended a smaller circle for high KDPI kidneys, though a distance was not suggested. Region 7 voted as follows: 4 strongly support, 9 support, 2 neutral/abstain, 4 oppose, 0 strongly oppose

Anonymous | 09/03/2019

The OPTN Patient Affairs Committee had the following comments: • The PAC commends the addition of the Proposal at a Glance portion of the proposal. In addition to the current content, PAC recommends adding a history section, to include the proposal timeline, so the reader has some context for the proposal and a glossary of transplant-specific terms • Historically, PAC supports the goal of continuous distribution. Evolving away from DSA, a 30+ year old policy, complies with the Final Rule but a concentric circle distribution method is also much easier for the Patient community to understand. Patients will likely defer to the experts when it comes to making the final decision on circle size but do want the circle to be as large as is operationally feasible. Patients will understand that transportation time may impact the health of an organ so there is a potential for too large of a circle. • We understand the move away from DSA will require a new way of doing business for the various parties along the value chain, proximity points appear to be a way of “easing” into a new policy. Yes, proximity points are appropriate inside the 500NM circle. There is uncertainty if they are required outside the 500NM circle. Over time, might the policy allow for the removal of proximity points? Recognizing that over time, as the Transplant Community successfully adapts to the change in policy, might we scale back the deployment of proximity points? Would this afford an easier transition towards the ultimate goal of continuous distribution? • Pediatric priority is supported by the Committee for both inside and outside the 500NM circle. • Priority points for living donors is supported by the Committee • Logistic and cost concerns are well documented. Probably the same two concerns identified back in the 1980s when DSAs were first established. Communication: the Patient Community must believe the new policy is in their best interest. Highlighting “why” this new policy will benefit the Patient is critical. Donor families and recipients must have confidence that the new policy is safe and equitable. There must be a common message coming from the Transplant Community or there is a risk of losing Patient support. If the Patient Community has doubts, then operational slowdowns may occur. Communicate, often, the reasons why this benefits the Patient Community. • Medical urgency should be defined. If urgency is defined, then the results may be measured. There is some concern that “medical urgency” may result in unequal sharing of a national life source. The Patient Community will believe the system is “fair” provided there are documented rules. Currently, medical urgency is defined differently depending on the Region so this policy must make the definition uniform across the nation. The priority points system could be used to determine which of two medically urgent patients should be prioritized (Distance, Age, Dialysis Time, Prior Living Donor status, etc.). • Time is of the essence under this situation. Broad discretion should be afforded to OPOs but they must document how they chose to allocate, in case questions arise about equity. • Pleased to see the modeling does not anticipate a reduction in transplantation. Opinions shared include, “financial status may no longer impact access to transplantation,” “living donors will appreciate that their prior sacrifice will be acknowledged should they need a transplant in the future” and “this policy will be easier to understand than under DSA.” • The language, illustrations and figures used in the proposal are difficult for the general public to understand. The “Proposal at a Glance” section is a nice summary. Expand in this area. Definitions that the general public may need to know in order to understand more accurately are missing. Might there be electronic links in the proposal for acronyms and medical terms? • It appears there have been lengthy discussions on potential impacts, positive and negative, and many stakeholders were consulted. The results after the policy change goes into effect will inform us if we are successful of not, however, it seems the professionals present an appropriate policy. Yes, PAC supports this policy. First and foremost, where you live should not hinder access to transplant. This policy change, after 30+ years, points us in the direction towards continuous distribution, a policy supported by the vast majority of PAC. • Most Committee members agreed that this proposal should be framed as creating more equity across the entire country. In this way, it is important for people to understand equity, and how this proposal can benefit the sickest candidates. • There was some confusion about how proximity points are defined in the paper. For example, patients might take the word “proximity” to mean how close one is to getting a transplant, versus “proximity” actually referring to geographical location. • The issue of water boundaries was discussed, and a perceived lack of income for transplant centers due to these water boundaries. • Using the word “may” multiple times gives the proposal an impression of uncertainty. • Transplant centers and candidates should look at other opportunities outside of deceased donor organs, such as living donation, especially if there is a change in the number of transplants for done for a transplant center. • The PAC voted on this proposal and the results are as follows: Strongly support (23%), Support (69%), Neutral/Abstain (0%), Oppose (8%), Strongly Oppose (0%).

Anonymous | 09/03/2019

The OPTN Living Donor Committee appreciates the opportunity to provide feedback on this public comment item. The Committee is supportive of the Kidney Committee’s efforts to broaden organ distribution. A Living Donor Committee member strongly advocated for the Kidney Committee to evaluate and consider disease burden nationwide in addition to the modeling. The Living Donor Committee is in support of the proposal.

Mike O’Rourke | 08/30/2019

This proposal as far as I can see does not take into account actual travel time between donor and recipient. It’s conceivable that a donor could be farther in distance but hours closer in time.

OPTN Region 4 | 08/30/2019

Strongly support (2), Support (1), Neutral/Abstain (0), Oppose (3), Strongly Oppose (20) Region 4 was generally not supportive of using 500NM as a unit of distribution for kidneys. Those in attendance provided the following feedback: • A 250 NM circle would allow most kidneys to be driven. The region noted that, according to modeling provided with the proposal, approximately 40% of kidneys would be flown with the 500nm circle model. The 250nm circle modeling predicts approximately 10% of kidneys will be flown. • Logistics of flying are already challenging with cost, kidney’s missing flights, etc., the current proposal would increase logistical issues and cost. • Disparities in OPO performance should be addressed. • Cost is a real issue and should be calculated/modeled. • 500 NM as a unit of distribution might mean using more charter flights or organs having increased ischemic time. This is particularly problematic in areas with limited flights and few direct flights. Members pointed out that kidneys will be flying on commercial flights, and that those will reduce system efficiency and drive up cost. Using a 250nm circle would mitigate those adverse changes while preserving most or all of the benefits of the 500 nm circle. • Flying a kidney often means that either an OPO cannot pump the kidney, or if the kidney is on a pump, it would need to be removed prior to shipping if the kidney is not driven. • There are limited blood/tissue typing samples that can be shipped causing problems when the blood is flown to the recipient center and the intended recipient is not transplanted. • The 250/250 model shows the same increase in equity as the 500/500 NM model, and the 250/250 model is more efficient in regards to logistics, cost and ischemic time. • Sections of NOTA and the final rule other than geography should also be considered. Region 4 amendment: Use a 250 NM fixed circle with 2 proximity points within the circle and 4 proximity points outside the circle: Strongly support (9), Support (12), Neutral/Abstain (1), Oppose (3), Strongly Oppose (0)

OPTN Membership & Professional Standards Committee | 08/30/2019

The Membership and Professional Standards Committee (MPSC) thanks to the Kidney Transplantation Committee for presenting its proposal. MPSC members mainly focused their questions and feedback for the Kidney Committee Chair on the proposed import backup and medical urgency policies. 1. Some OPOs move donors from hospitals to a regional donation center at the OPO. Will the circle be drawn around the original hospital, or will it be drawn around the donation center at the OPO? The circle will be drawn around the original hospital. 2. In the proposed import backup policy, does the host OPO get to choose whether to use the existing match run or to run a new match? The new process will be somewhat similar to the current process. The host OPO can choose whether to continue down the original match run or to give local/import backup if it makes sense from an efficiency or organ placement standpoint. The new process will require the original accepting transplant program’s OPO to assist with reallocating the organ. The Committee picked a 150 NM circle because data shows that distance to be the most efficient for organs that have flown. 3. Will centering the backup circle on the hospital of the original intended recipient direct more kidneys to the primary transplant hospital? Currently, import offers could go anywhere in the DSA. The Committee does not think the kidney should just stay at the hospital of the original intended recipient; instead, there should be a way to equitably redistribute an organ that has already shipped while minimizing cold time for the organ. The new 150 NM circle is based on driving distance and may include hospitals that weren’t in the original circle. 4. Why did the Kidney Committee decide to allow the host OPO to decide whether to delegate backup since it introduces variability? The proposed policy mirrors the current policy that allows the host OPO to make that decision. The Committee wants OPOs to continue to have that flexibility so kidneys don’t have to fly back and forth and risk becoming unusable. 5. Will the KAS system still be operating, just with a 500-mile circle to replace the DSA? Yes, the allocation sequences are still based in KAS. There are a few minor changes since there will no longer be DSA or regions in allocation. The Committee also put pediatric candidates and prior living donors higher in the sequences to give them a little extra benefit. 6. What criteria will define “medical urgency”? The policy will need to include objective measures for medically urgent candidates in order for the MPSC to be able to review potential issues in the future. The Committee appreciates the feedback. Since the current policy is managed at the DSA level, the Committee is relying on feedback from the community to help them define the objective measures. Several MPSC members stated that the import backup policy made sense and would provide some consistency to the backup process. The MPSC tried to define “local backup” several years ago and found that there is no consistency in how OPOs grant local backup – some organs are backed up within the DSA, and others are backed up at the original accepting transplant hospital. Another MPSC member recommended that truly medically urgent kidney candidates should receive a higher priority on the match than currently proposed, including higher than pediatric candidates and candidates who are prior living donors.

Anonymous | 08/28/2019

I appreciate the efforts of the committee, but I'm deeply concerned about the impact this proposal will have for kidney transplant candidates living in North Dakota. Due to our very rural location, I foresee significantly increased cold ischemic times for organs accepted within the 500 nm circle. There are limited numbers of inbound commercial flights to our community and reliance on ground transportation surely will increase cold ischemic times. I truly feel kidney transplant candidates in rural communities, such as North Dakota, will be harmed at the expense of candidates in metropolitan communities.

Geoffrey Ellis | 08/27/2019

Existing medical criteria for the allocation of kidneys is sensible, except that children get additional allocation points, giving a world class scientist who contributes much to society a lower score than a child who contributes nothing, other criteria being equal. This is backwards -- the high contributor should get the additional points. Of course, if the child is the next Mozart, who composed music from the age of five, then points can be given for that. There is nothing in the existing criteria that considers whose life is most worth saving, a cowardly approach to making life and death decisions on the allocation of kidneys.

Medical City Dallas Transplant Institute | 08/26/2019

Dear UNOS Kidney Committee, The proposal to eliminate DSA and region from kidney allocation appears to be going down the right path, but unfortunately misses the mark. The circle size of 500 NM is simply not one that will lead to efficient or affordable distribution of organs. In your own modeling you were given the information that with a 500 NM circle more than 40% of kidneys would be reliant on air travel to reach their intended recipient. This will add undue expense to the distribution of organs as well as be exceedingly difficult logistically for locations without major airports. In the last month alone our program, which is located a stone's throw from one of the country's largest airports, has lost the opportunity to transplant 3 kidneys that were supposed to be sent to us by commercial airlines. One organ was delayed due to weather and the next available flight wasn't till the next day. Another organ made it to the airport, but was never placed on the intended flight. The third organ was mistakenly taken to the wrong airport and missed the intended flight. I can't stress enough that commercial airlines were not intended to be organ distribution networks and simply should not be over relied upon to distribute organs. A 250 mile circle makes much more sense logistically and comes exceedingly close to achieving the same goals. I'll start by saying that in your regional presentation the slide showing overall change in transplant rate for the various modeled scenarios was, I think, purposefully misleading as the scale for difference in transplant rate was 0.02%. Therefore, the real difference in transplant rate between a 250 NM circle and 500 NM circle was almost imperceptible, but it was made to look significant. I would expect more honesty in the presentations moving forward. In a 250 mile circle the estimates for organs requiring air travel was approximately 10% versus 40% for a 500 NM circle. It would seem to us that if there were no real differences in number of transplants or transplant rate with a 250 versus 500 NM circle staying with the circle that allowed the majority of the organs to be driven to their location rather than flown would be the logical choice. In our regional meeting we were told that COST hadn't been modeled and that it would be difficult to do so. I know the point is to comply with the final rule, but - as far as I know - no one will be paying us extra for organs that are flown. If transplant centers start losing money on renal transplants it will undoubtedly cause some programs to decrease their number of transplants, or worse, to close their transplant program. There are ways to model costs, ie, using 100% CPRA kidneys as a marker and comparing the costs of these organs to local organs. The thought of approving a 500 versus 250 NM circle without analyzing the effect in cost would seem to me to be lazy at best. Although the final rule that states that geography shouldn't be a barrier to distribution it also notes that this must be balanced with the logical and efficient placement of these incredible gifts. I would ask the kidney committee to query all OPOs across the country and see how many feel like they could effectively distribute kidneys with a 500NM circle. While the kidney is an important organ, we all know that it is not instantly life saving as hearts, lungs and livers are. Therefore, I can't see how we can justify such a wide distribution when we know that the logistical burden on OPOs will be untenable and that this will dramatically increase costs. The logical next step to eliminate DSA and region would be a 250 NM circle with proximity points within the circle. This was a counter proposal approved by Region 4 in our most recent meeting. This achieves the goal of eliminating DSA and Region in a logical and cost effective manner without drastically altering the logistics of placing and transporting kidneys. I would hope that the Kidney committee will take all recommendations to heart and rethink the current proposal. Those advocating for a wider circle are not taking all aspects of transplantation and the final rule into consideration. Eliminating DSA and Region is a good goal, but it must be done with common sense in mind. If the majority of the Regions do not support this proposal I would quite alarmed if the proposal given to the board wasn't changed. How can we trust in UNOS and OPTN if the wishes of the transplant community aren't heard? Furthermore, why have regional meetings and committees if the UNOS Board will blatantly disregard the recommendations of their own committees as they did with the Liver Committee proposal for elimination of DSA and Region? We are hopeful that the feedback from Regional meetings and public comment will enable to Kidney Committee to adopt the proposal put forth by Region 4 to move to a 250NM circle with proximity points.

Anonymous | 08/22/2019

I like the idea of equity; however, I strongly oppose the proposed hybrid model with 500 nm. UNOS identified DSA as the single factor responsible for inequitable Kidney and pancreas organ allocation. The two factors that affect this variable are local OPO performance and transplant rates at local transplant centers. To expedite this new allocation model, UNOS conveniently chose to ignore OPO performance to factor into the model and only chose transplant center rates for the model. Transplant rates are determined by number of transplants per number of waitlisted patients. What was again ignored was the fact that lot of patients who are inactive on the list or status 7 never get transplanted but account for lower transplant rates at the center. A lot of those status 7 patients should not even be on the list. Ideally only patients active on the list should account for transplant rates. So the very basis of modeling is flawed. What this new model does is only reduce transplant rates in high performing centers with high performing OPOs without actually increasing the rates in low performing centers with low performing OPOs. This does not really achieve equity as intended. I would like readers to read this article by Goldberg published in AJT in 2019 which highlights the benefits of improving OPO performance - https://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.15492 OPO performance cannot and should not be ignored in this modeling exercise. This is complicated but UNOS needs to do their due diligence instead of doing what is convenient. A UNOS staff member at the Region 5 meeting in Las. Vegas on 8/21/2019 in response to a comment on OPO performance stated this is beyond the scope of the project which is THE WRONG ANSWER. This is going to affect the lives of thousands of transplant recipients so UNOS needs to do their due diligence. This entire modeling exercise as proposed is flawed and so are its results.

Live On Nebraska | 08/21/2019

Our only concern with this proposal is in regards to "local backup". Delegating allocation to a receiving OPO seems to be an ineffective solution to best facilitate maximizing kidney placement. The receiving OPO has minimal vested interest and in many cases limited information about the donor organ being allocated. This change will no doubt require changes to staffing models and processes to facilitate the allocation of organs from another OPO. Our recommendation is to pass local backup allocation to the UNOS Organ Center or leave it in the hands of the host OPO to avoid involvement from the receiving OPO.

Gwen McNatt | 08/16/2019

The proposed allocation scheme is a disservice to our patients. In the model, this scheme decreases the transplant rate, increases waitlist mortality (39 more deaths) and graft failure as well as increasing time on dialysis. How can we support such outcomes? Additionally, costs and ischemic time will certainly be increased. There is also increased risk of losing kidneys in transportation, which I don’t believe were considered in the model. The local import back-up scheme seems fairly unworkable, it should be redesigned to consider where the kidney is at time of reallocation. We must do better than this. I believe we need to look at OPO performance variation as well as incentives for transplant centers to use high KDPI kidneys.

Brianne Marchelletta | 08/14/2019

The proposed allocation system fails to address the increased strain that will be forced upon OPOs and the ripple effect that will occur. First, OPOs will see a significant increase in costs for transportation of both cross match materials and kidney shipments since early offers will be going out to centers that are not within reasonable driving distance of the donor hospital. UNOS needs to do better at encouraging or enforcing centers to conduct a virtual cross match rather than slowing down the allocation process and increasing stress on the donor family because a center has to wait for blood to arrive to perform a cross match. As for kidney shipments, more kidneys will be accepted at a greater distances as well, which means that more kidneys will be sent via airlines and are subject to their flight times, fees, delays and routing errors. These factors already increase the costs to OPOs and CIT on kidneys and in some cases result in the discard of the organ, so to increase the number of kidneys being shipped on airlines will only compound the ongoing problem. Even if UNOS could mandate shipping costs with airlines, nothing can be done to improve flight times or to prevent weather/mechanical delays and routing errors that increase the CIT. Another area that has not been addressed is who will be allocating to the centers within the 500NM circle. Currently, an OPO makes all local and regional offers and are then required to pass national points offers over to the Organ Center who can then apply the Minimal Acceptance Criteria screening tool to the match which can expedite placement. If allocation is left to the OPO and the MAC tool cannot be applied then many centers will receive unnecessary offers and allocation time will be increased due to these unnecessary offers. However, if the Organ Center has to be involved in every kidney match to apply the MAC tool then they will be overwhelmed with cases and with current staffing I don't see how they could possibly operate in a timely manner. Overall, I don't see how this model is an improvement to kidney allocation, the predicted data shows a marginal decrease in placement and in no scenario should that be acceptable. The goal is to fully maximize every donor gift, so we cannot say it is acceptable to lose a few for the sake of change. Until improvements are made in transportation availability, required virtual cross matching and OPO use of the Minimal Acceptance Criteria screening tool I cannot support this model as a viable option. Please consider all the repercussions that will be faced by OPOs, transplant centers and ultimately the donor families and recipients who have the most to lose when it comes to time delays and placement failures.

University of Arkansas | 08/13/2019

Before implementation, we would like to see a model that includes variables such as organ utilization and donation rates of a particular area.... if possible.

Anonymous | 08/13/2019

It appears that the better the OPO the more they are punished for doing a great job. Why not leave everything the way it is and try to understand why some OPOs don't have the outcomes others do? Why reward poor producers with more organs? How fair is that?

Anonymous | 08/13/2019

The proposed changes would disadvantage centers that are not in the middle of the country or at least 500 NM from an ocean or foreign country on all sides. Transplant centers in San Diego would be severely negatively impacted because we will be sending kidneys further away under the new model (to as far north as San Francisco and northeast to Las Vegas). Instead of keeping donor kidneys in San Diego for the recipients in San Diego. There is no option for a "circle" from San Diego as we are bordered by an ocean to the west and Mexico to the south. So, San Diego has basically access to a "quarter" of a circle. There could be the occasional kidney that would come to San Diego from San Francisco, Las Vegas, or Arizona but most of the kidney would be going out.

Wake Forest Baptist Health | 08/13/2019

I don't disagree with the hybrid framework model to replace DSA as a method of kidney distribution but the 500 NM radius is much too large. When I use the interactive map and use our center (NCBG) as the donor hospital, the distribution/proximity circle in essence encompasses nearly all of the continental US east of the Mississippi River! This represents much too large of a geographic area in order to facilitate efficient placement and transplantation of recovered kidneys. The logistics involved in such an undertaking are staggering, cumbersome, and counterproductive to optimal utilization of donor kidneys. I would favor lowering the proximity circle to either 150 or 250 NMs.

Richard Formica | 08/11/2019

I support the OPTN/UNOS Kidney Committee proposed allocation system of Model Number 3 (M3) or “500.500.4.8.”) for the following reasons. 1. The 500 mile distance meets the intention of larger geographic sharing. 2. The outcomes across all the models are essentially the same, likely reflecting the good overall outcomed of kidney transplantation, and therefore, there is no reason to choose a smaller area. 3. The larger circle by encompassing more donors will provide opportunities to transplant more immunologically challenging individuals. 4. The steeper proximity curves (4:8 allocation points) will prevent kidneys from traveling for similar candidates in different locations. Region one used to have population distance points so in effect this experiment has been done. The community must remember that kidneys are not allocated based upon waiting time but rather allocation score. 1 allocation point is equivalent to 1 year of waiting time. Therefore a like candidate (CPRA and DR match) 500 miles away will have to have waited an additional 4 years to pull a kidney from a candidate listed at the hospital the donor was in. 5. I believe that this approach will by necessity force programs to better manage their lists. Better list management, i.e. ensuring candidates are both appropriate and optimized for kidney transplantation, will lead to better outcomes and therefore better stewardship of donated organs. 6. Finally, there is a potential benefit to programs. When population distance points were in place in region 1 (it will remain to be seen if this remains true when the distance and hence population is larger) often a program would have multiple candidates in sequence for a given organ (the proximity points cause this). This allowed the program to decline the organ for a candidate that was not considered appropriate for that type of organ because they knew that the next candidate in sequence who was more appropriate for that organ was also their candidate. Hence better donor - recipient matching. It is my assumption, I have only read the SRTR reports on outcomes and have not seen the Kidney Transplantation Committee's plan to map KAS onto these new geographic subunits, that the allocation for the 100/99/98 % cPRA candidates will now be National/1000/500. If this is the case I would recommend a closer look at the sliding scale points allowed. As we have learned, within that group 98.5+ to 99.4 cPRA there may be too much advantage awarded. Additionally, the 98% candidates, previously receiving DSA priority only, may now not require that given the larger number of patients encompassed and perhaps this group can be addressed by the addition of a certain number of additional allocation points. In lieu of making a more complicated allocation system, perhaps adjusting the points given will correct this.

LifeGift | 08/08/2019

Proposed policy is consistent with our support for broader distribution not using arbitrary boundaries. In addition, this policy provided additional consideration for pediatric candidates and prior living donors. Thank you for the opportunity to comment.

Randee Bloom | 08/08/2019

Each and every living organ donor provides the gift of life to another, never knowing their personal health future. I believe all organ distribution policies should specifically detail the prioritization methodology should a prior living donor become a listed donor candidate. Specifically, yes, prioritization should be applied to within, and beyond, a designed distribution circle. Our community's system of highly valuing the living donation must match this with highly valuing the living donor's future welfare. A significant level of priority, clearly noted for all potential needed transplants, can provide needed messaging that we highly value the welfare of living donors.

Ryutaro Hirose | 08/06/2019

I fully support the notion of eliminating DSA and UNOS region from any distribution system in this country for all organs. 1) I disagree with the 500 nm circle - it definitely should not be any smaller but - I am not sure why it 750 nm and even larger ones weren't modelled. They would likely ameliorate geographic disparity to access more effectively and kidneys can clearly travel that distance and be successfully used. 2) I would minimize or preferably eliminate proximity points and the advantage that more local candidates would have (Again, I would eliminate them altogether) Why should a patient within or without any circle be disadvantaged by living or being listed at a center somewhat further than another candidate? Otherwise, I support the effort of the Kidney committee to eliminate the use of illogical and random DSA and Regional boundaries in organ distribution altogether

Laura | 08/06/2019

This proposal will greatly reduce transplants in general as the further an organ has to travel and the longer time it is out of the body, the less likely it can be used for successful transplantation. This is a harmful solution. Helpful solutions to this problem include automatic deceased organ registry (with an opt out option) for driver's licenses/IDs and education regarding deceased and living donation, especially in those areas where donation rates are low. Our donors deserve to have their gifts given the best chance to save someone's life.

Anonymous | 08/05/2019

The foundation the geography committee is used to make recommendations is wrong. The entire reason for geographic discrepancies is OPO performance. OPO self report data. When actual data is use Donors per/million or donors/10000 deaths, the data is unbelievable. Am J Transplant. 2019;00:1–6. Goldberg reported. "Our work calls into question the principle that inherent differences in supply leads to geographic inequity in access to transplants using our objective, standardized OPO performance metric. In 2018, 169 patients died or were delisted as too sick in NYRT. If NYRT performed at the same level as the Gift of Life Donor Program in Philadelphia, they would have had an additional 303 organ donors, which would have dramatically decreased the number of patients who died waiting for a liver (and kidney, heart, or lung) transplant in the region. The results of our analysis and the success of other OPOs with changes in their organizational structure suggest that the capacity for this level of performance exists and that unmet need may best be addressed with critical reassessment of local effort rather than reliance on the efforts of others. " UNOS needs to address this fundamental problem. Stop pushing forward with expensive, inefficencent, non effective ideas that decrease the number of transplants and increase the number of discards. With the presidential mandate on organ transplantation. Major goals, decrease discards, get more people transplanted and improve OPO performance. UNOS needs to get on board. The problem is OPO performance. Changing allocation will have a negative effect and make this problem worse. The unitended consequences of lung allocation. No more patients transplant, increased flights, increased costs and worse outcomes. AJT 2019 1-4. V. Puri. One hospital reported and increase in cost of 1.8 million for 7 months after the change. If this was annualized for the national number of 2500 lungs thats 85,000,000 increase in cost one can only imagine the increased cost for kidney transplants with more travel and longer ischemic times. I strongly oppose for the following reasons. Increase cost, decrease efficeincey, decrease number of transplants, increase discards. The main reason. OPO performace is the main problem. This was never addressed so the entire geography committee findings need to be disgarded.

Anonymous | 08/02/2019

What priority do you think is appropriate for prior living donor candidates? I think it is important to maintain or improve priority given to prior living donors. A major concern for living donors and their families and loved ones is what happens if the living donor someday needs a transplant. It is comforting to know that priority is given to prior living donors. I believe that removing or reducing this benefit would reduce the number of people willing to be a living kidney donor.