Calculate Median MELD at Transplant around the Donor Hospital and Update Sorting within Liver Allocation At a glance Current policy When candidates waiting for a liver transplant do not have a model for end-stage liver disease (MELD) or pediatric end-stage liver disease (PELD) score that appropriately reflects their medical urgency for transplant, the transplant program may request an exception score. Currently, many exception scores are assigned based on the median MELD score at transplant (MMaT) around the transplant program where the candidate is listed. This results in higher exception scores for candidates listed at transplant programs with a higher MMaT. Candidates are currently sorted within classifications on the match run using multiple factors, including waiting time at current MELD or PELD score and time spent on the waitlist at a higher MELD or PELD score. Supporting media Presentation View presentation slides Proposed changes MELD exception scores will be based on the MMaT around the donor hospital rather than the transplant program where the candidate is registered. The area around the donor hospital used for calculating MMaT will: Need to meet a minimum threshold of at least two transplant programs and 10 transplants in the previous 365-day period. Start with a 150 NM circle around the donor hospital and increase in 50 NM increments until minimum thresholds are met. For donor hospitals in Hawaii and Puerto Rico, be modified so that the two transplant program threshold will not be required, but the 10 transplant threshold will. If there have not been 10 transplants within the prior 365-day period, the timeframe of evaluation will be extended to 730 days. Waiting time used for sorting exception candidates on the match run will change to be length of time since the candidate’s earliest approved exception. Non-exception candidates will be ranked ahead of the exception candidates when they have the same MELD or PELD score and blood type compatibility with the donor. Anticipated impact What it's expected to do A candidate’s exception score will be based on a MMaT around the donor hospital MELD exception scores will change with each match run due to varying MMaT’s for each donor hospital Rank non-exception candidates ahead of exception candidates when they have the same MELD or PELD score and blood type compatibility with the donor What it won't do Will not change how median PELD score at transplant (MPaT) is calculated Themes Circle size used to calculate MMaT around donor hospital Minimum number of transplant programs and number of transplants used to calculate MMaT Calculation of MMaT at Hawaii and Puerto Rico donor hospitals Ranking candidates with a non-exception MELD or PELD score above candidates with an exception MELD or PELD score when thescore and blood type compatibility is the same Terms to know Candidate: An individual on the organ transplant waiting list. Donor Hospital: The hospital where the deceased or living donor is admitted. Transplant program: An organ specific facility within a transplant hospital Model for End-Stage Liver Disease (MELD): The scoring system used in allocation of livers to candidates who are at least 12 years old that is based on a combination of the candidate’s clinical lab values. Pediatric End-Stage Liver Disease (PELD): The scoring system used in allocation of livers to candidates who are under 12 years old Median Model for End-Stage Liver Disease at Transplant (MMaT): The MMaT for each transplant program is calculated by using the median of the MELD scores at the time of transplant of all recipients at least 12 years old who were transplanted at hospitals within 250 nautical miles (NM) of the candidates listing hospital in a 365-day period. Match run: A process that filters and ranks waiting list candidates based on donor and candidate medical compatibility and organ-specific allocation criteria. Classification: A collection of potential transplant recipients grouped by similar characteristics and within a given geographical area. Classifications are used to rank potential recipients of deceased or living donor organs. Click here to search the OPTN glossary Comments Region 10 | 03/23/2021 Region 10 sentiment: 2 Strongly Support, 7 Support, 8 Neutral/Abstain, 3 Oppose, 0 Strongly Oppose. Comments: Overall the region supported the proposal but there was a suggestion that instead of using waiting time as the tiebreaker for MELD exceptions another metric should be used. Suggestions included using lab MELD score, severity of illness, or degree of risk. Another member disagreed with the smaller circle size for calculating MMaT for each donor hospital. They think that 150NM is too small and could disadvantage patients in areas with low MMaT scores. They would support a larger circle size of 250NM or 500NM. Region 2 | 03/23/2021 Region 2 sentiment: 11 Strongly Support, 6 Support, 6 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose. Comments: The region is supportive of the proposal and it was noted that this change would help in achieving geographic, center-based parity. Another member added their support of the proposal as a way to correct the unintended disparity with the initiation of acuity circles and MMaT for allocation. The purpose of the acuity circle system was to level the mismatch between wait list demand and donor supply by removing geography as a barrier for allocation. For those patients who are ranked by their calculated MELD score, this new system has achieved greater parity. However, for those patients who are listed by their exception score, this has created geographic inequity in several areas of the country. Several members in the region expressed concern of including PELD scores in the proposal. It was suggested that PELD be excluded from the prioritization of lab based over exception scores due to increased wait list mortality of children and the harsh reality that 40% of children with PELD scores are transplanted only with exception points. Additionally, if PELD is not removed from the proposal it could have a negative impact on the number of split livers. Another member recommended that the all PELD/MELD scores for pediatric candidates be considered lab scores in the algorithm so that children with exception scores not be ranked below adults. There should also be a specific monitoring plan to track the impact of policy change on pediatric candidates, with a special focus on adolescent candidates. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition | 03/23/2021 The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) appreciates the opportunity to voice its strong opposition to rank non- exception liver transplantation candidates ahead of the exception candidates when they have the same model for end-stage liver disease (MELD) or pediatric end-stage liver disease (PELD) score and blood type compatibility with the donor. Comprehensive comments attached. Attachment Region 9 | 03/23/2021 Region 9 sentiment: 0 strongly support, 2 support, 3 neutral/abstain, 2 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. The region was mixed in their support of this proposal. Some members commented that while perhaps this change might be needed, they did not feel that there was enough data to support it at this time, especially since the bulk of the data was collected during the COVID-19 pandemic. A member commented that improving equity is important. A comment was made that this proposal was developed considering HCC patients but not how it would impact other exception patients, and perhaps it did not consider other aspects of these transplants such as which other patients were transplanted out of turn, were DCD livers used for these transplants, or were these livers that had previously been turned down. The member strongly urges that there be a robust education effort for this if this change is made. One attendee remarked that the problem for exception patients in Region 9 especially is that they have a very hard time getting access to organ offers and the most important thing they can rely on to help them is waiting time, so eliminating that from the calculation really disadvantages them. Association of Organ Procurement Organizations | 03/23/2021 The Association of Organ Procurement Organizations (AOPO) supports the policy proposal to calculate Median MELD around the donor hospital rather than the transplant program. We agree this change will better align the geographic units used in the calculation of MMaT with the geographic units used in liver allocation. AOPO fully supports the exceptions included in this policy proposal for both Hawaii and Puerto Rico and thanks the committee for including this important aspect. We encourage the committee to continue to evaluate the potential impact of the proposed policy change on the pediatric population. AOPO fully supports this policy change. American Society of Transplant Surgeons | 03/23/2021 The American Society of Transplant Surgeons (ASTS) generally supports this proposal with the following concerns. The proposed system may place HCC patients at a disadvantage if priority is given to patients with a calculated MELD score over those with a MELD exception score. We recognize that HCC patients have a lower drop-out rate compared to non HCC biological MELD. ASTS, however, remains concerned that patients with MELD exception scores would likely have to wait even longer than they do under the current system, since it can take up to 6 months to obtain an exception score. Also under the proposed system, a patient’s MELD score would change based on the donor location. This may have the unintended consequence of building complexities into the system that could be overwhelming for patients and their caretakers. ASTS recommends the OPTN use a standard adjustment score across the board instead of calculating an adjustment score. We suggest the OPTN review the policy in one year and cap the median meld at -3 of 28 and refrain from sharing for an exception on the first run when using the 50NM circle. To the OPTN’s Liver and Intestinal Organ Transplantation Committee’s request for feedback, ASTS recommends: 1. What is the minimum number of transplant programs and transplants needed to calculate MMaT, as well as the use of only transplant programs that have performed a qualifying transplant? As suggested in the proposal, MMaT should be calculated at 250NM from the donor hospital. The number of transplant programs will be irrelevant. 2. MMaT calculation exclusions, update schedule, and cohort timeframe should be updated more frequently, in the realm of every three months. 3. On the proposal to calculate MMaT for donor hospitals in Alaska, we suggest the OPTN continue using the Seattle-Tacoma International Airport (Sea-Tac) as a point of reference for organ allocation. 4. On the proposed sorting approach, specifically ranking candidates with a calculated MELD or PELD score ahead of exception candidates with the same score and blood type compatibility, we believe candidates with a calculated PELD score should be ranked 1st, followed by those with a calculated MELD score, then by PELD exceptions, and then by MELD exceptions. 5. There should be no difference regarding the distinction between approved vs. assigned exceptions policy. 6. On requesting score adjustments as opposed to specific scores and if that change will be feasible for transplant programs, score adjustments would be preferred. 7. Should a 150NM circle be used to calculate the MMaT for donor hospitals or should a different circle be utilized? ASTS recommends using a 250NM circle. 8. We agree with the plan to increase the geographic basis used to calculate MMaT by 50NM increments when the minimum cohort size is not met. 9. ASTS recommends the minimum exception score should be 15, however the committee needs to determine what the equivalency of MELD 15 is for MELD-Na. Region 1 | 03/23/2021 OPTN Liver and Intestinal Organ Transplantation Committee presented by James Markmann, MD, PhD Comments: One member asked how are edge effects being accounted for? The comment was made that it is based on the fact that population densities on the coasts are larger but that the distribution units have not been mathematically optimized. This is something that can be better addressed in the continuous distribution framework. One member asked how does this proposal impact equitable access for liver candidates given that there are still geographic inequities that may be reflected in the MMaT score. Another member asked if there has been any analysis on how this would affect children? One member observed that some centers have large proportion of low MELD scores and asked does this observation impact MMaT score? Those with low MELD scores are probably not getting transplanted and the MMaT score excludes more marginal donors. Because low MELD transplants often occur with more marginal donors, at least in Region 1, these low MELD transplants will not impact the MMaT. Region 1 sentiment: 2 strongly support, 6 support, 2 neutral/abstain, 0 oppose, 1 strongly oppose Society for Pediatric Liver Transplantation | 03/23/2021 The Society for Pediatric Liver Transplantation (SPLIT) would like to raise the following concerns about the proposal to rank all patients at a given calculated PELD/MELD score above patients with exception PELD/MELD scores at the same score: • The Committee’s justification for this change is based entirely on data from adults, in whom calculated MELD is associated with higher risk of waitlist mortality than exception MELD. The proposal acknowledges that this is driven by—and that this proposed change is meant to address—HCC exceptions in adults. • Although the proposal will change allocation for children 12-17 years old with MELD scores and 0-12 year olds with PELD scores, there is NO evidence that children with calculated PELD/MELD scores are at higher risk than those with the same exception scores—OR that children with exception PELD/MELD scores are at LOWER risk of death than adults with the same calculated MELD scores. • In fact, the opposite is true in children. UNOS data shows that: o In children, calculated PELD/MELD scores significantly underestimate waitlist mortality for children awaiting liver transplant. o More than 40% of children listed for liver transplant require MELD/PELD exception scores to appropriately reflect their risk, and to access life-saving transplant. o To equalize age-adjusted mortality of children and adults on the liver waitlist, a revised PELD score based on recent UNOS data had to add 9.4 points to children’s scores—suggesting that children’s current calculated PELD/MELD scores drastically underestimate their waitlist risk relative to adults’ calculated scores. We are concerned that ranking candidates at any given calculated score above those with the same exception score: o Will reduce children’s access to adult deceased donor livers, which currently accounts for almost 1/3 of pediatric liver transplants. Because calculated PELD/MELD scores underestimate waitlist mortality for children awaiting liver transplant, children often rely on exception PELD/MELD scores to compete with adults for adult donor livers. o Will decrease the overall number of liver transplants, and likely reduce split liver transplant opportunities for children and adults: Offers of adult donor livers to children trigger almost all split liver transplants—creating 2 liver transplants from 1 liver. Ranking children with exception PELD/MELD scores below adults with the same calculated MELD scores will reduce children’s access to adult donor livers, thus potentially reducing split liver transplants and the overall number of liver transplants. o Is particularly disadvantageous to adolescents – who are listed with MELD scores, and often are transplanted with small adult donors or split livers. Already in the current system, extended right lobe split grafts are often offered to the adult list first even if the donor was a child (<18). We recommend that the Liver Committee and UNOS change the proposal to: 1. Consider all PELD/MELD scores for pediatric candidates as “calculated” scores in this algorithm so that children with exception scores are not ranked below adults – children with exception scores are not necessarily at lower risk of waitlist mortality than those with calculated scores of the same value, as is the case in adults. If the algorithms cannot be coded to accomplish this, we propose that other solutions be explored again to avoid disadvantaging children with exception scores relative to other candidates with calculated scores. 2. Include a specific plan in the proposal to track the impact of this policy change on pediatric candidates – with specific focus on adolescent (12-17 year old) candidates, on the youngest children, and on the utilization of split liver transplants. This is particularly important because the impact of this proposal was not specifically modelled before it was proposed. REFERENCES: Hsu E, Schladt DP, Wey A, Perito ER, Israni AK. Improving the predictive ability of the pediatric end-stage liver disease score for young children awaiting liver transplant. Am J Transplant. 2021 Jan;21(1):222-228. Braun HJ, Perito ER, Dodge JL, Rhee S, Roberts JP. Nonstandard Exception Requests Impact Outcomes for Pediatric Liver Transplant Candidates. Am J Transplant. 2016 Nov;16(11):3181-3191. Ge J, Perito ER, Bucuvalas J, Gilroy R, Hsu EK, Roberts JP, Lai JC. Split liver transplantation is utilized infrequently and concentrated at few transplant centers in the United States. Am J Transplant. 2020 Apr;20(4):1116-112. Chang CH, Bryce CL, Shneider BL, Yabes JG, Ren Y, Zenarosa GL, Tomko H, Donnell DM, Squires RH, Roberts MS. Accuracy of the Pediatric End-stage Liver Disease Score in Estimating Pretransplant Mortality Among Pediatric Liver Transplant Candidates. JAMA Pediatr. 2018 Nov 1;172(11):1070-1077. Lemoine C, Brandt K, Carlos Caicedo J, Superina R. Internal split liver transplants reduce the waiting list time for teenagers with a low calculated Model for End-stage Liver Disease score. Pediatr Transplant. 2021 Mar;25(2):e13874. Presbyterian/St. Luke's Transplant Center | 03/23/2021 Presbyterian/St. Luke's Transplant Center opposes this proposal as currently written. While we understand the committee's aim to decrease mortality in adults with high calculated MELD, we are concerned about how this proposal will affect pediatric patients. Over 40% of pediatric patients are listed with exception scores since MELD/PELD does not accurately represent waitlist mortality risk. By ranking calculated scores over exception scores we expect to see a decrease in liver transplant offers to pediatric patients as well as increased mortality. In addition, by decreasing the number of adult offers to pediatric patients, split livers are likely to be decreased thus decreasing overall number of liver transplants. Anonymous | 03/22/2021 I strongly support updating the MELD scoring system. As a recipient of several transplants I know all to well how certain patients are discriminated against in the current system. I have spent nearly 1/4 of my life on a transplant list. Symptoms that often ended with hospitalization were never taken into account, leaving me sick, helpless and depressed. My quality of life was so bad, that I contemplated ending it on several occasions. It was so bad at one point that I was researching to see if my life insurance policy would still cover my family. If it weren't for my wife and children, I would most certainly be dead by my own hand, because of the discrimination by the current MELD system. I also have friends that passed away because once they were sick enough on the current system, they withered away so much that the surgery itself would have been a death sentence. These new changes will help so many. They will take quality of life into consideration and will, as a result, save so many lives. Thank you for considering these changes! American Society of Transplantation | 03/22/2021 The American Society of Transplantation offers the following comments regarding this proposal. The proposal has received uniform support as it pertains to assuring that two exception candidates with the same exception diagnosis who are listed at different transplant programs (with variations in MMaT at those centers) do NOT receive different MELD exception scores on that match run. This proposal will clearly solve this issue. However, there have been several areas of critical concern that the AST would like to convey. 1. Concern about impact on pediatric waitlisted patients: The AST’s Liver and Intestinal Community of Practice (COP) pediatric subcommittee and the Pediatric COP understand the reasons for this new proposal to address the waitlist issues in adults. However, they feel that this proposal may have significant negative impact on organ offers to pediatric patients, particularly the 12-18-year-olds listed with MELD exception scores. More than 40% of pediatric patients are listed with exception scores due to calculated MELD/PELD not accurately representing their waitlist mortality. We are concerned that the proposed modifications to rank sorting with prioritization of patients with a calculated MELD will decrease organ offers particularly to 12-18-year-olds and likely increase their waitlist morbidity and mortality. There has been no modeling of this new proposed system on how it will affect pediatric patients. Accordingly, we recommend that specific consideration or modeling on the impact of children on the waitlist be performed prior to this proposal being considered. Furthermore, this proposal does not take into consideration that children have different reasons for exemptions than adults. As noted above the proposal will potentially reduce children’s access to all types of liver transplant (whole and split). The Liver and Pediatric Committees are actively working on a PELD score revision that aims to increase utilization of calculated PELD scores and reduce reliance on exception scores. We strongly recommend that this score be developed before this proposal is considered. We ask that the committee consider allowing patients under the age of 18 to have their exception MELD or PELD considered as calculated in the new rank sorting system. 2. Access to LT for exception point candidates may be reduced: On a general note, the AST also raises concerns that exception point candidates will be disadvantaged relative to calculated MELD patients, as they will automatically be prioritized below “calculated” MELD patients with the same allocation MELD, regardless of time on the list. This may be particularly problematic for exception candidates who are listed at transplant programs with a higher MMaT, who will likely now have very little access to organ offers originating from donor hospitals with lower MMaT. 3. Critical short-term analysis of consequences is necessary: The AST feels strongly that there is a plan in place for critically evaluating access to liver transplant and waitlist outcomes for all exception candidates following implementation of this proposal. As a general concern, the acuity circles allocation model was just implemented last February, which coincided with the COVID pandemic. The pandemic has had unpredictable effects in transplant behavior so that we do not believe that the true impact of the acuity circles allocation model has been evaluated. Making yet another change without having robust data on the impact of AC risks creating disparities that were not intended. It is critical that this is looked at closely, with plans in place to remedy any unintended consequences. Global Liver Institute | 03/22/2021 As indicated in the proposal, there is currently nonalignment in the liver allocation process. In the present median MELD at transplant (MMaT) scoring, there are unintended disparities where some candidates with the same exception diagnosis can have different exception scores. The current MELD system does a poor job of ensuring that women, children, and minority populations receive proper placement within liver transplant prioritization. Thus, the imperfect solution of exception scores were previously created as a way to increase equity for these disadvantaged groups. In this proposal, there is no longer prioritization for individuals with exception scores over those without them. What is the purpose of exception scores when they will not be considered under this policy change? We strongly support a change to the current transplant scoring system, and the recognition of a MELD issue by OPTN is a good first step towards a more equitable, patient-friendly solution. OPTN anticipates that the proposed calculation and updated sorting changes are going to increase equity; yet, we pose concerns that these changes are not enough to eventually reflect the most equitable transplant system possible. This proposal only further confuses a broken system and these changes are inadequate to accomplishing proper equity. Attachment NATCO | 03/22/2021 NATCO appreciates the Liver and Intestine Committee bringing this issue to public comment in an effort to ensure those who are sickest on the waitlist are transplanted. NATCO supports the proposal overall; however, there is some concern regarding the lack of guidance for pediatric patients. Anonymous | 03/22/2021 I strongly support the change in guidelines for the MELD score calculation. Transplant Coordinators Committee | 03/19/2021 The Transplant Coordinators Committee thanks the Liver and Intestinal Transplantation Committee for presenting its proposal “Calculate Median MELD at Transplant around the Donor Hospital and Update Sorting within Liver Allocation” and offers the following feedback: Members praised the proposal for improving equity in transplantation for patients with exception scores. However, members were very concerned with education, necessary for both the transplant center and the patient. Patient education was an important topic that would need to be focused on when these policies were implemented, specifically in ranges of MELD scores and where they land on the waitlist. Additionally, members inquired if there was enough existing data to identify if this was a problem in the first place. Anonymous | 03/18/2021 I support the change in calculating the MELD score. At my age it probably won’t help me but it could save the lives of a lot of young people. I was diagnosed in 2006. Region 11 | 03/18/2021 Region 11 sentiment: 1 strongly support, 9 support, 6 neutral/abstain, 0 opposed, 0 strongly opposed During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general support for this proposal. Two attendees commented that the problem with using MMaT around the transplant hospital was anticipated by our region, but not acted upon during the development of the acuity circle policy. There was discussion and comments about the circle size used for allocation. One attendee recommended 75 NM, while another attendee recommended 500 NM depending on the local geography. Some attendees commented that there was not enough data to know the appropriate circle size. There was also discussion around the data available to support the change. A few attendees wanted to know what impact this change would have on individual transplant centers. One attendee asked if there was data on the rate of transplant and mortality on the waitlist for candidates with exceptions and those without. Two attendees commented that exception scores for the same diagnosis should be standardized nationally. One added that not standardizing the scores would propagate geographic differences in median MELD at transplant moving forward. One attendee commented that HCC candidates can develop other cancers while waiting and should be allowed to get exception points upon listing. One attendee suggested that the median MELD should be calculated using only lab MELD scores. Another attendee commented that there may be a perception problem if lab score and exception scores are not treated equally and recommended the committee think about how to address that disparity. One attendee recommended giving exception patients half points to help solve the perception issue. Penn State Health Milton S Hershey Medical Center | 03/16/2021 Penn State Health strongly supports this proposal to “Calculate MMaT around the Donor Hospital and Update Sorting within Liver Allocation Classifications”. With the current system there has been an unintended disparity with MMaT-3 MELD exceptions associated with implementation of the acuity circle allocation in 2020. The resultant geographic inequity has affected not only Region 2 but other areas of the United States, and it violates HRSA’s mandate to UNOS to remove geography as a barrier to transplant. The current system perpetuates an unfair disparity that allows all newly listed exception score patients at a center with higher MMaT to move ahead of all exception patients at a center with lower MMaT when the centers are within geographic proximity and share a common pool of deceased donors. This places patients at transplant centers with lower MMaT at an unfair disadvantage, with a resultant increase in waiting time and a greater risk of death. Also, the original plan to recalculate MMaT every 6 months to allow eventual evening out of the difference in MMaT between geographically proximate transplant centers has not been seen yet in Region 2, and will more likely result in continued perpetuation of geographic differences in MMaT in the future. We believe that this new proposal which changes the MMAT calculation for exception patients to the donor center will greatly reduce the current geographic inequity created by MMaT calculated around the transplant center and it is the most immediate fix to the MMaT exception MELD problem. We feel that that the UNOS Board has a responsibility to address as rapidly as possible the unintended consequence of geographic disparity that has been created, as a matter of fairness and equity, and it is important to allow an equal chance for survival for liver wait list patients with the same MELD exception diagnosis. Reading Hospital / Tower Health Transplant Institute | 03/14/2021 We strongly support the proposal. MMAT-3 was created to provide equity for HCC patients but it has had the opposite effect. For example, identical HCC patients at two centers within geographic proximity may be assigned different exception MELD scores and thus have unequal access to the same pool of donors. Furthermore, recalculating MMaT every 6 months hasn’t fixed the inequity; rather, the exception score inequality is inadvertently being perpetuated. Changing MMAT calculation for exception patients to the donor center will reduce the geographic inequity created by MMaT calculated around the transplant center. University of Pennsylvania | 03/12/2021 We strongly support the proposal “Calculate MMaT around Donor Hospital and Update Sorting within Liver Allocation Classifications” as a way to correct the unintended disparity and unfair circumstances created by UNOS with the initiation of acuity circle and MMaT for allocation in 2020. The purpose of the acuity circle system was to level the mismatch between wait list demand and donor supply by removing geography as a barrier for allocation. For those patients who are ranked by their calculated MELD score, this new system has achieved greater parity. However, for those patients who are listed by their exception score, this has created geographic inequity in several areas of the country. We outlined many of our concerns in a letter sent to the UNOS Board in March of 2020. The following summarizes our support for the calculation of MMaT around the donor hospital and outlines the most egregious problems with the utilization of MMaT for exception patients. 1. While not perfect, we believe that changing MMAT calculation for exception patients to the donor center will greatly reduce the geographic inequity created by MMaT calculated around the transplant center. As we see it, this is the most immediate fix to the unfair MMaT exception MELD problem. 2. Under the current acuity circle system, two identical patients who are listed with a MELD of 30 for chronic liver failure due to viral hepatitis or other etiology, and thus have equal risk of removal or death on the wait list, but are listed at different centers within geographic proximity, have equal access to a shared pool of donors. However, identical patients who have hepatocellular carcinoma with the same risk of removal or death on the wait list who are listed at two centers within geographic proximity, may be assigned different exception MELD scores. Thus they have unequal access to the same pool of donors. The current system is blatantly unfair as patients with the same disease and same risk of wait list death and removal are given unequal access to a common pool of donors. In fact, the same exact patient could be listed with differential access to transplant in two centers in fairly close geographic proximity, thus incentivizing patients to list at centers further from their home to increase access to transplant, the direct opposite of the intended effect of the MMaT policy. 3. Calculation of MMAT at the recipient hospital has created a new form of geographic inequity for patients listed with exception scores. This violates the intention of the acuity circle system as well as HRSA’s mandate to UNOS to remove geography as a barrier to transplant. 4. The current system further perpetuates this inequity as it allows all newly listed exception score patients at a center with higher MMaT to move ahead of all exception patients at a center with lower MMaT when the centers are within geographic proximity and share a common pool of deceased donors. This can occur even if the patients at the center with a lower MMaT have several years of waiting time, unjustly placing them at greater risk of death. This system is resolutely unfair. 5. The current system is supposed to recalculate MMaT every 6 months and eventually even out the difference in MMaT between geographically proximate transplant centers. However, this has not occurred in our region. We as well as many others believe that the method to recalculate MMaT is flawed and likely to perpetuate geographic difference in MMaT. The exception score inequality is self-perpetuated in that it is then used to calculate MMaT in the future. In the meantime, the geographic inequity created by UNOS will cause patients undue harm and suffering 6. Prior to voting to accept the MMaT system for exception patients, UNOS and the UNOS Board were aware that adopting this system could lead to geographic inequity for exception patients. As we approach the one-year anniversary for the initiation of MMaT among MELD exception patients, it is imperative that the UNOS Board address the unintended consequence of geographic inequity that they created. Although UNOS followed a multi-year process to develop the acuity circle and MMaT model of allocation, adjustments cannot be delayed and must be delivered rapidly. It is a matter of fairness, and frankly the lives of patients on the liver waitlist hang in the balance. Failure to do so will undoubtedly lead to redress through the legal system from frustrated patients impacted by this inequity. Region 7 | 03/12/2021 Region 7 sentiment: 2 Strongly Support; 3 Support; 4 Neutral/Abstain; 0 Oppose; 2 Strongly Oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee pointed out that in some areas, there is a greater number of donor hospitals and programs, that may benefit from being in some more populated areas vs. programs in less dense areas. The attendee suggested that there be a modification to the circles, based on population density. Another attendee asked if there has been any modeling on how this may impact the transplant rates of the MELD exception patients and would patients listed in high MMAT transplant programs just have to wait longer for their transplants? One attendee voiced concern from the Pediatric Committee, regarding the sorting and allocation in the proposal. There were also other comments regarding exception scores and how this sorting would affect the pediatric population. OPTN Pediatric Transplantation Committee | 03/11/2021 The Pediatric Committee thanks the OPTN Liver Committee for the opportunity to review their Public Comment proposal. The Committee provided the feedback below: The Committee is concerned about an adverse impact on pediatric candidates caused by the plan to rank all patients with calculated PELD/MELD scores above all patients with exception PELD/MELD scores. We note that this public comment proposal does not cite any pediatric data to justify the change nor to anticipate its impact on pediatric transplant candidates. The proposed changes are justified in this proposal specifically to consider how HCC exceptions impact adult liver transplant candidates and subsequent waitlist outcomes. In developing this proposal there is no specific evidence reviewed regarding pediatric exceptions; consequently there does not appear to be a consideration of the adverse impact on pediatric candidates. The Committee commented that pediatric candidates tend to receive exception scores for different reasons than adult candidates. In addition, more than 40% of children receive PELD/MELD exceptions; ultimately this policy change may impact a large percentage of children. The Committee is concerned that this proposal will reduce access to transplant and worsen waitlist outcomes for specific pediatric candidates. This includes the youngest children, who are likely to have reduced access to adult donors for split liver transplants in these candidates, and adolescents, who will also likely have reduced access to adult donors. In stark contrast to adults, patients with PELD/MELD exceptions may be sicker than those with calculated PELD/MELD scores. While the majority of adult exceptions are for candidates with HCC, who have lower waitlist mortality, pediatric exception candidates typically have complications of liver disease that are not accounted for in the PELD/MELD score or under-estimated by the calculated score. Calculated PELD is known to significantly underestimate waitlist mortality for many children. The Committee discussed considering all pediatric exception candidates as lab candidates for the purposes of this proposal, so that children with PELD/MELD exceptions are not disadvantaged. We recognize that this would require coding adjustments, as waiting time is accrued differently for lab and exception candidates. But we continue to feel that this should be considered as a solution; waiting time could still be counted as PELD/MELD at a specific exception (e.g. time with MMaT – 3, or time with MPaT +2). While PELD exception scores are often higher scores than MELD exceptions, adolescent candidates are listed by MELD and often have exceptions that are lower than PELD exceptions. In addition, a larger proportion of adolescent candidates have MELD exception scores than adult candidates. We are concerned that the impact on adolescent access to adult donor livers, which currently account for 1/3 of adolescent deceased donor transplants, was not considered in the design of this proposal – and that these candidates will be unintentionally but critically disadvantaged by ranking all adults with calculated MELDs above adolescents with exception MELDs. Region 6 | 03/09/2021 Region 6 sentiment: 3 strongly support, 17 support, 7 neutral/abstain, 1 oppose, 0 strongly oppose. This proposal was supported by the region overall. Several members shared that while this is a complicated issue, this is a great proposal. A member brought up that there is not the same evidence in pediatrics to support the rationale that mortality for exceptions is less than for the lab MELD or PELD. The member also noted that another high mortality exception population is pediatric liver/intestine candidates and that it is important for them to maintain what access the currently have. One attendee commented that there is a need to understand if this proposal may favor exception score candidates over medical MELD candidates. Region 8 | 03/09/2021 Region 8 sentiment: Strongly support-3, Support–5. Neutral/abstain-5. Oppose-3, Strongly oppose-0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Several members commented that there is concern for how this proposal will impact pediatrics, including reducing access for pediatric exception candidates to adult donors and concern about pediatric liver-intestine candidates’ waitlist mortality. Members commented that without evidence based on pediatric data, there is not a way to know how the changes will affect outcomes and allocation for pediatrics. A member commented that using the donor hospital will help improve geographic disparities. Others commented that this could disadvantage non-urban patients. A member recommended consideration over time for the recovery site as the calculation point vs donor hospital as 11 free standing recovery centers will be operational by the end of the year and will change the point of origination by over 250 miles in some cases. Geisinger | 03/05/2021 Our Transplant Program strongly supports the proposal “Calculate MMaT around Donor Hospital and Update Sorting within Liver Allocation Classifications” and recommends its swift approval and implementation by the UNOS Board. While the overall MMaT policy may have addressed the concern about geography playing a major role in liver allocation, it resulted in increased geographic disparities for exception patients. The current policy places every patient in New York ahead of every patient in Pennsylvania for the same disease process regardless of waiting time. The arguments that “it will even out over time” or that a program might suffer because of a lower score relative to one region but then benefit from a higher assigned score versus a different region does not change the fact that the policy itself created a new disparity. In addition, it actually further increases potential disparity in that more “well-off” recipients with resources can travel to NY for listing so as to take advantage of the differentially-assigned MELD scores. This policy needs to be changed as soon as possible and the new proposal is a good step towards remedying this unfair policy. Edward Heiser | 03/05/2021 I strongly support changing the MMaT calculation by using geographical reference to the donor hospital. I understand that the selection process has other variables and is quite complex but the current process of calculating MMaT is unfair. Everyone’s life is precious and when it comes to fair and equitable access to a donor liver, the playing field should be as equal as possible. I am aware that the current process of treating patients with the same disease and same risk of being removed from the wait list removal (with a different priority for a liver) violates UNOS’s instruction from the U.S. government to stop unequal access based upon where you live. I have been an PA EMT since 2003 and have helped saved lives through the years. Now all I ask is that I get the same support and consideration based upon a fair and equitable process. Christopher Sonnenday | 03/04/2021 I support this change in policy, but believe it is hopefully just the first step in rectifying substantial disparities in MELD exception scores for the same diagnosis, which flies in the face of the spirit of the acuity circles policy change. There should be much more uniformity nationally in MELD exception scores. Post-hoc analysis of this policy if implemented will be important to understand how this change lessens MELD disparities and access to transplant by diagnosis. regino gonzalez-peralta | 02/19/2021 The reason for allocating exceptions points between adults (mostly cancer) and children (mostly complications of liver disease) are vastly different. There are also many more adults listed for any one MELD score than are children. Thus, ranking adults with natural MELD over children with exception MELD would potentially make it more difficult for children-adolescents to receive organs and lead to increased pediatric waitlist mortality. Region 5 | 02/19/2021 Region 5 sentiment: 6 strongly support, 12 support, 8 neutral/abstain, 5 oppose, 4 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member commented that the pediatric community is concerned that this proposal was not designed with pediatric candidates in mind and the reasons they get exceptions. The proposal mentions no pediatric data at all. The member thinks it is important that pediatric candidates get exceptions for different reasons than adults. They do not see why pediatric candidates with pediatric end-stage liver disease scores (PELD) need to have exception scores below lab score candidates when median PELD at transplant (MPaT) is national. Another member agreed that children under two still have the largest waitlist mortality and the teenagers have some of the longest waiting times because of their creatinines and the disparity created. It sounds like we would be ranking children (teens) with exception PELD/MELD below adult calculated scores, is that correct? It looks like this would decrease splits, which helps both kids and adults in our region. Another member commented – as an example a teen with primary sclerosing cholangitis (PSC) will not get the same MELD as an adult with the same diagnosis. They think what gets confusing is that teens get automatic exceptions (which they do not). So we do not give them priority as originally discussed when the concentric circles allocation was being developed. The percentage of teenagers is very small. Would the Liver Committee consider placing teens above adults before exceptions? This should not affect the number of adult liver transplants. Could this be brought back to the committee? One member asked how is the committee going to address the changes being applied to children without specific consideration or modeling about how it will impact children on the waiting list? Benjamin Philosophe | 02/18/2021 This would be a vast improvement over what we have currently. The MMAT-3 was created to provide equity for HCC patients. The irony however is as the new allocation for livers rolled out, this had the opposite effect, where HCC points varied amongst centers competing within a concentric circle. This proposed change will level out the playing field for tumor patients awaiting transplantation. Region 3 | 02/18/2021 Region 3 sentiment: Strongly support - 4, Support-12, Neutral/abstain - 6, Oppose -0, Strongly Oppose -0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. There was general support for this proposal. A member asked how the Donor Hospital calculation works for those donors that are transferred to an Organ Recovery Center, which may be located a significant distance from the original donor hospital, and it was clarified that the calculation would be based on the donor hospital. Another member said that this is a good step and that the current method needs to be changed. Cecile Aguayo | 02/11/2021 I oppose the proposal the necessitate ranking of calculated above exception scores because this change is being applied to children without specific consideration or modeling about how it will impact children. The Committee’s justification for this change is based entirely on data from adults, in whom calculated MELD is associated with higher risk of waitlist mortality than exception MELD. The committee cites NO evidence that children with calculated PELD/MELD scores are at higher risk than those with exception scores—OR that children with exception PELD/MELD scores are at LOWER risk than adults with calculated MELD scores. In fact, the opposite is true in children. Recent analyses of UNOS data show that: o In children, calculated PELD/MELD scores significantly underestimate waitlist mortality for children awaiting liver transplant. o More than 40% of children listed for liver transplant require MELD/PELD exception scores to appropriately reflect their risk, and to access transplant. o To equalize age-adjusted mortality of children and adults on the liver waitlist, a revised PELD score based on recent UNOS data had to add 9.4 points to children’s scores—suggesting that children’s current calculated PELD/MELD scores drastically underestimate their waitlist risk relative to adults’ calculated scores. This proposal will reduce children’s access to adult deceased donor livers and possibly pediatric donor livers. Adults are more likely than children to have high calculated MELD/PELD scores. Children often rely on exception PELD/MELD scores to compete with adults for adult donor livers. It will likely decrease the overall number of liver transplants, and significantly reduce split liver transplants: Offers of adult donor livers to children trigger almost all split liver transplants—creating 2 liver transplants from 1 liver. The Liver and Pediatric Committees are actively working on a PELD score revision. This PELD revision directly aims to increase utilization of calculated PELD scores and reduce reliance on exception scores. This is the first update to PELD calculation in 20 years. The MELD score for adolescents has never been validated or updated, and was derived based on adult data originally. This helps explain why the calculated scores are not adequate for ranking children on the liver waitlist, particularly when compared to adults. As we await this update to pediatric scoring, ranking adults with calculated MELD scores above children with exception MELD/PELD scores could substantially disadvantage children—decreasing their access to transplant and potentially increasing waitlist mortality for this vulnerable group. This proposal is not supported by any evidence as appropriate for pediatric candidates Cody Reynolds | 02/06/2021 If exception points aren’t going to be taken into consideration, then why have exception points? My daughter has a PELD of 30 but has exception points because of poor weight gain, NG tube, and cholangitis infections. I sincerely hope there is a better plan that will be rolled out if this proposal is approved. Shekhar Kubal | 02/05/2021 The current system has a major flaw by which it brings "geographic disparity" back to the liver allocation. The proposed change will address this issue to an extent. I strongly support this proposal. Region 4 | 02/04/2021 Region 4 sentiment: 4 strongly support; 9 support; 5 neutral/abstain; 2 oppose; 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. Two commenters pointed out that when OPOs have centralized recovery centers it can add logistical complications when considering allocation and distance. There was also a comment that there needs to be more clarification about how this will affect pediatric candidates. Anonymous | 02/03/2021 What is the justification for placing "non exception" candidates before exception candidates? After all the work that the Liver Committee has done to adjust exception scores and the NLRB, one has to question why they continue to punish candidates with exception scores. Sarah Jane Schwarzenberg | 01/29/2021 The portion of this policy that I strongly oppose is the prioritizing of candidates without exception points over those with exception points when the MELD and blood types are equivalent. First, exception points are meant to offset the inadequacy of the MELD score, particularly for women and children, who are disadvantaged by the MELD calculation. In particular, children scored under the MELD system are at substantial disadvantage, and exception points are the only means of equalizing their opportunity for transplant with that of adults. Removing their exception points during prioritization is not only medically inappropriate, but will reduce the number of children over age 12 years receiving liver transplantation. I strongly suggest that children age 12-18 be excepted from the policy of prioritizing non-exception points above exception points. Otherwise, the policy simply seems to inject more confusion into an already confusing system. Anonymous | 01/28/2021 1) The liver system is already incredibly complex. This approach makes the system even more complex and opaque without any appreciable benefits for patients. 2) This proposal walks back some of the progress made from the current system. MMaT around the transplant hospital make more sense because then the MMaT can adjust to the supply/demand dynamics in that candidate's area. 3) Since all of the organs are moving to continuous distribution, where candidates will have varying scores, why is it important that all HCC candidates on a match run have the same MELD score? Wouldn't it be better for the committee to wait until they develop continuous distribution to address these issues in a more comprehensive manner? Terry Box | 01/25/2021 This modification addresses a significant unintended consequence of the original acuity circle allocation system. Continued monitoring to confirm the new method and sorting system has desired impact will be needed. Derek Ginos | 01/25/2021 I am writing in support of this change to MMaT calculation around the donor hospital. The current policy penalizes programs who are utilizing marginal organs and working efficiently with OPOs to recover and use livers thus bringing down their medial MELD relative to other transplant programs within the same allocation radius. Although supporters of the current policy argue that this disparity will normalize over time, this assumes the differences in MELD are solely due to gaps in organ allocation from DSAs. However, COIIN and other studies have shown individual transplant program behavior can drastically influence median MELD at a given program. Revising this policy will level the playing field and assure all patients have equal opportunity for transplant regardless of the center in which they are listed.