Clarify Multi-Organ Allocation Policy At a glance Current policy Current policy addresses multi-organ combinations for heart, lung, and liver candidates on the waiting list that require a second organ. It does not address which match run is used for the second required organ or specifically define the second organ. This results in inconsistent application of the policy. Supporting media Presentation View presentation slides Proposed changes Identify criteria for when Organ Procurement Organizations (OPOs) are required to offer the liver or kidney to a heart or lung candidate, if available, from the same donor. Address heart-liver, lung-liver, heart-kidney, and lung-kidney multi-organ combinations. Establish requirements for when OPOs must offer the liver or kidney when allocating according to the heart or lung match run. Anticipated impact What it's expected to do Provide OPOs clearer direction when offering multi-organ combinations by establishing medical criteria for when OPOs must offer the liver or kidney to heart or lung candidates Heart Adult Status 1, 2, and 3, Pediatric Status 1A and 1B Lung Candidates with a lung allocation score of greater than 35 Increase “required offer” distance from the donor hospital to align with thoracic allocation Heart – increase from 250 nautical miles (NM) to 500 NM to better align with current heart allocation Lung – increase from 250 NM to 500 NM to be consistent within the proposed policy Address 84% of combinations not currently addressed in other policies (heart-liver, lung-liver, heart-kidney, and lung-kidney combinations) What it won't do Does not address medical eligibility criteria or a “safety net” as used in current simultaneous liver-kidney policy Does not establish requirements for which organs must be allocated first Themes Multi-organ policies Heart and lung match runs Terms to know Organ Procurement Organization: An organization designated by the Centers for Medicare and Medicaid Services (CMS) and responsible for the procurement of organs for transplantation and the promotion of organ donation. Match run: A computerized ranking of transplant candidates based upon donor and candidate medical compatibility and criteria defined in OPTN policies. Safety Net: A concept that would increase priority on the deceased donor kidney waitlist for previous liver alone recipients that later develop end stage renal disease. Click here to search the OPTN glossary Comments Pediatric Committee | 03/23/2021 The Pediatric Committee thanks the OPTN Organ Procurement Organization (OPO) Committee for the opportunity to review their public comment proposal. The Committee provides the following feedback: One of the main concerns of the Committee is what will happen to pediatric candidates listed for a single kidney when allocating the kidneys with the heart, lung, or liver. The Committee suggested including pediatric Heart Status 2 in the mandatory sharing criteria, since it wouldn’t be a big change and could be very important to a pediatric Status 2 candidate who may need a heart-kidney or heart-liver transplant due to re-transplant or a failed Fontan. By including pediatric Heart Status 2, it would eliminate the OPOs discretion in offering the second organ to this pediatric candidate and the additional step of potentially requesting a Status 1B exception. There was only one pediatric heart-kidney transplant in the past 5 years. The Committee agreed that 500 NM seemed reasonable for the mandatory sharing criteria. Anonymous | 03/23/2021 The Committee has asked for comments on this proposal in its entirety, but specifically asks for feedback on the following: 1.Is Heart Adult Status 1, 2, 3 and Pediatric Status 1A and 1B appropriate thresholds for when OPOs must offer a liver or kidney to a multi-organ candidate listed for those organs? No. The proposed policy disadvantages status 4,5,6 patients who may be on dialysis from receiving a combined heart/kidney transplant. We contend that any heart transplant candidate with GFR < 30 ml/min or on kidney dialysis should be offered a kidney. In addition to the stated biological disadvantage of thoracic organ candidates due to size constraints, it is clear from heart transplant studies that patients with GFR<30 ml/min survive longer post heart/kidney transplant as compared to heart alone. In fact, urgent status patients (status 1,2,3) may have AKI due to cardiogenic shock and may not actually need a simultaneous kidney transplant as their native kidneys may recover after heart transplant alone. These patients would ideally benefit from a safety net. A recommendation for heart/kidney transplant for patients with GFR<30ml/min has been stated in a recently published Consensus Conference paper (Kobashigawa J, Dadhania DM, Farr M, Tang WHW, Bhimaraj A, Czer L, Hall S, Haririan A, Formica RN, Patel J, Skorka R, Fedson S, Srinivas T, Testani J, Yabu JM, Cheng XS; Consensus Conference Participants. Consensus conference on heart-kidney transplantation. Am J Transplant. 2021 Feb 2. doi: 10.1111/ajt.16512. Epub ahead of print. PMID: 33527725.) 2.Is a lung allocation score of greater than 35 an appropriate threshold for when OPOs must offer a liver or kidney to a multi-organ candidate listed for those organs? No. The data used to support the LAS >35 threshold seems to be derived from 2019 data that all candidates who received a lung-liver or lung-kidney transplant had an LAS >35. A patient with an LAS just above 35 is not deemed to be at high risk for dying from their lung disease. We would propose a higher threshold for prioritization for dual organ transplant. 3.Is 500 NM an appropriate distance for when OPOs must offer a liver or kidney to a multi-organ candidate meeting the proposed criteria? Yes, we agree this is an appropriate distance for dual-organ candidates for consistency amongst thoracic organ recipients. 4.Do you believe all multi-organ policies should be located in the same section of policy? We have no objection to all multi-organ policies in being located in the same section of the policy. Other considerations We express concern that this proposal also allows OPOs the discretion to determine the best approach to placing organs according to OPTN policy. This may lead to some ambiguity since if an OPO decides to run a single organ match preferentially, it may disadvantage patients awaiting dual organ transplant. For example, an OPO that chose to start with liver or kidney match would place those organs before the lung or heart match was run. This would then create a situation of potentially jeopardizing a very ill dual organ candidate from surviving to transplant. For organ prioritization, acuity of the patient awaiting a single organ should be greater than that for a patient awaiting dual organ transplant. Region 10 | 03/23/2021 Region 10 sentiment: 2 Strongly Support, 10 Support, 3 Neutral/Abstain, 5 Oppose, 0 Strongly Oppose. Comments: The region is supportive of the direction of the proposal, but raised several concerns that the OPO needs to address as they continue their work with multi-organ transplant. There was support from members in the region to raise the minimum LAS requirement for multi-organ lung candidates to something higher than an LAS of 35. For heart multi-organ candidates there was also support for only including those candidates that are listed for Adult Heart Statuses 1 & 2, and not include Status 3. There was also support from members in the region to include specific qualifying criteria for other multi-organ combinations like the qualifications that are already in OPTN Policy for Liver-Kidney candidates. In addition, a safety net for Heart and Lung candidates should be developed like the current safety net for Liver candidates. There were also concerns over allocation time because multi-organ allocation greatly increases allocation time. Any changes to OPTN Policy should aim to decrease allocation time. There was one suggestion to have all potential recipients for all organs appear on one match run arranged by organ type and geographic location. There were other concerns voiced that single kidney candidates are disadvantaged by multi-organ allocation because multi-organ combinations often utilize lower KDPI kidneys. Additionally, multi-organ allocation often disadvantages pediatric kidney candidates for the same reason. There was a suggestion that a potential kidney recipient’s sensitization be given taken into consideration when assigning priority for multi-organ allocation. Another member suggested that Kidney-Pancreas candidates should have a higher priority since the pancreas is usually a difficult organ to place and those candidates have the highest mortality on the kidney waiting list. There was also a suggestion for the OPO Committee to consider late turndowns especially for thoracic organ combinations since reallocation for these organs could be very difficult. Other members suggested that the proposal should address which thoracic organ should have priority if the second organ is a liver. There was also a request for clarity in outcomes associated with multi-organ transplants with thoracic organs. Lastly, with multi-organ transplants there needs to be an order for multi-organ allocation, does a Heart/Kidney take precedence over a SLK or over a KP. Organ specific committees need to define which is the correct barometer: overall graft function or death. Region 2 | 03/23/2021 Region 2 sentiment: 7 Strongly Support, 10 Support, 7 Neutral/Abstain, 3 Oppose, 0 Strongly Oppose. Comments: The region is supportive of the proposal, but had several comments. There was concern from multiple members of how multi-organ allocation disadvantages those patients needing a single organ. Especially for single kidney candidates as the second organ in a multi-organ transplant is most often a kidney. One member expressed concern over the ethics of giving one patient multiple lifesaving organs, denying other candidates the opportunity for a transplant. Another member suggested that there should be priority for the sickest single organ candidates like Status 1 Liver candidates and 100% CPRA Kidney candidates. It was also noted that operationally, there should be clear designations on match runs as to which multi-organ candidate is a required share. Another member suggested that the proposal should include a measure that OPOs are only allowed to share one kidney with a multi-organ combination. It was also noted that the practice of multi-organ allocation is very difficult for patients to understand and the committee should provide a resource for patients. As the committee moves forward with future phases of this project one member suggested allowing discretion for split livers to allow young pediatric candidates access to the left lateral liver segments. Another member suggested that the committee look into how Heart/Lung allocation effects pediatric lung patients less than 12 years old who do not have an LAS score. Lastly, another member noted concern for Status 5 Heart candidates who are multi-organ candidates. Since the current proposal does not require that they be offered the second organ, there is concern that those patients will never receive their multi-organ transplant. Region 9 | 03/23/2021 Region 9 sentiment: 4 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. The region generally supported the proposal and appreciate the committee’s efforts to work on multi-organ allocation. There was a comment asking the committee to consider a safety net policy for heart/kidney or lung/kidney patients. One attendee discussed pediatric patients and how it might be reasonable to allow for pediatric status 1B heart patients to also be allocated a kidney. Another member commented that it is important to have specific criteria identified for when the second organ is needed for this policy. Carolina Donor Services | 03/23/2021 Carolina Donor Services (CDS) supports this step in addressing inconsistencies in placing some multi-organ combinations. We support the criteria and proposed distance for mandatory offers. CDS encourages the committee to continue to consolidate all multi-organ policies into one location. Association of Organ Procurement Organizations | 03/23/2021 The Association of Organ Procurement Organizations supports any policy change that clarifies the method to allocate organs. The current policy is ambiguous about which match run to use when allocating multi-organ combinations. The proposed modifications to the multi-organ allocation policy will clarify the policy and provide a more consistent allocation of organs, with the expectation that this policy change will provide organ procurement organizations well-defined guidance when offering multi-organ combinations. In addition to the continued efforts by the members of AOPO to increase organs donated and transplanted, AOPO fully supports this policy change. American Society of Transplant Surgeons | 03/23/2021 The American Society of Transplant Surgeons (ASTS) supports this proposal in general with recommendations. We consider this an unfinished product and an insufficient guide to good OPO practice and policy. ASTS recognizes this is a complex and controversial topic and that there are no medical criteria analogous to those adopted for liver-kidney transplants that would translate for heart-kidney and lung-kidney transplants. For this reason, we believe the UNOS/OPTN should determine what that criteria should entail as soon as possible. We offer the following responses to the questions posed by the OPTN’s OPO Committee: 1. Is the Heart Adult Status 1, 2, 3 and Pediatric Status 1A, and 1B appropriate thresholds for when OPOs must offer a liver or kidney to a multi-organ candidate listed for those organs? That would seem reasonable with the development of appropriate criteria as mentioned earlier. 2. Is a lung allocation score greater than 35 an appropriate threshold for when OPOs must offer a liver or kidney to a multi-organ candidate listed for those organs? Since LAS is listed near that, ASTS would recommend OPOs allocate the organs at a threshold of 40 to 45 which would be more equivalent to a heart status of 2-3. 3. Is 500 NM an appropriate distance for when OPOs must offer a liver or kidney to a multiorgan candidate meeting the proposed criteria? ASTS agrees that 500NM would be beneficial in increasing heart-lung multi-organ transplants. 4. Do you believe all multi-organ policies should be located in the same section of the policy? ASTS agrees with that approach. We would also advocate clarification for OPOs when there are several competing candidates or more than the available organs allocated to multiorgan candidates (e.g. a liver-kidney, a lungkidney and a heart kidney), all meeting criteria to send the kidney with the other organ. Should there be a priority set on predicted 7-day mortality? We thank the OPTN for the opportunity to provide comment on the proposal and thank the UNOS committees that are working on this important project. We would encourage the OPO and other committees to complete this unfinished and incomplete proposal to include medical criteria. Region 1 | 03/23/2021 OPTN Organ Procurement Organization Committee presented by Jillian Wojtowicz, MBA Comments: One member asked to review the definitions of heart Status 1, 2, and 3 and stated that changes to allocation should go hand-in-hand with safety net allocation like SLK. Region 1 sentiment: 3 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Ethics Committee | 03/23/2021 Members understood that currently there is very little data to use for analysis of multi-organ allocation, but articulated that once this policy has been implemented and there is a clearer set of expectations for OPOs, the next phase of this project will be increasingly evidence-based. Members inquired about eligibility criteria and whether the potential multi-organ recipient should be weighed against the potential single organ recipient to determine medical necessity of transplantation. Members clarified the need to better identify patient (and patient groups) who are harmed and helped by this new policy. Specifically, there was concern over exacerbating waiting time for kidney-only candidates, and for candidates in regions with shorter waiting times. The members felt that exporting kidneys from one region to another would cause waiting times to go up overall and place a drain on the kidney waiting list. When it comes to medical need and prioritization of one candidate over another, members stated that ethical MOT policy requires continuous monitoring and data analysis to better estimate the impact of these changes. Some members suggested that the policy be made clearer. Pancreas Committee | 03/23/2021 The Pancreas Committee thanks the OPTN Organ Procurement Organization (OPO) Committee for the opportunity to review their public comment proposal. The Committee provides the following feedback: Most pancreata transplanted are kidney-pancreas (KP) transplants and a policy like this would potentially lessen the number of KPs available for allocation, which would generally increase pancreas discards. The Committee expressed that this should be monitored in order to see how many KPs turn into pancreas alone transplants due to kidneys being allocated with other organs. A member expressed concern that, while the number of multi-organ transplants for current modeling is small, expanding the distance to 500 NM could allow for more multi-organ candidates to be ranked ahead of a kidney or KP candidate. A member reiterated that each one of these extra renal transplants that is a dual listing removes an offer for either a KP or kidney alone patient. Most of these patients have very long waiting times, longer than thoracic or liver patients, and this needs to be balanced in multi-organ allocation. A member noted that this policy doesn’t recognize the acute kidney injury experienced by those heart candidates in Status 4, who also probably are more likely to have chronic heart disease that has compromised their kidneys further. The Committee agrees with the changes made to the multi-organ allocation policy and believes this a good starting point. The Committee emphasized that their above concerns be considered during the next phase of the project, when eligibility criteria and safety nets are discussed. Members believe that a heart safety net option would be beneficial in fairly allocating kidneys to heart-kidney candidates and kidney alone or KP candidates. Lucile Packard Children's Hospital | 03/22/2021 On behalf of the Solid Organ Transplant Program at Lucile Packard Children’s Hospital, we would like to offer the following comment in response to the proposed changes in multi-organ allocation. First, we thank the OPO Committee for recognizing and addressing this issue in the proposal. Overall, this is an important step towards standardizing and clarifying the allocation questions in this complex population. With respect to the urgency status, we believe that an extension to the Adult Status 4 population is appropriate for patients with congenital heart disease, as this category includes Fontan patients, who may require heart/liver or occasionally heart/kidney transplant but do not otherwise meet higher urgency criteria, as has been widely described. We believe the same consideration should apply to pediatric status 2 patients with congenital heart disease (who also are typically Fontan patients) for the same reason. We further recommend that the policy specifically include patients who are prioritized by exception, so that there is no confusion on this point. We support the change to 500nm to allow for consistency between policies. Points that are not addressed in the current policy but that merit consideration include the extension of the “safety net” for kidney transplant, to not only include liver/kidney but also heart/kidney or lung/kidney combinations, as a way to make kidney utilization more efficient. Finally, there appears to be a potential for conflicting match runs for Heart/Kidney vs Lung/Kidney, or Heart/Liver vs Lung/Liver combination transplants, and there should be a uniform means of resolving such conflicts if they should occur. Sincerely, David Rosenthal, MD William Berquist, MD American Society of Transplantation | 03/22/2021 The American Society of Transplantation is generally supportive of the intent of this proposal, proposal in concept, we do have concerns regarding readiness and completeness to move this proposal forward, as offered, to the Board for consideration. These changes are necessary, but not totally sufficient. This is an important issue to address in policy, and we absolutely agree that national standards should be set in policy, as there is variation in how these allocations are managed today. However, the current proposal does not fully address all questions, and will benefit from further enhancement and expansion to fill these gaps before approval and implementation. As an example, we are concerned that children awaiting kidney transplant are already disadvantaged by the current priority given to multi-organ candidates. This policy has the potential to further exacerbate this negative impact for these children. We ask that this be considered prior to final approval of this policy. For example, one way to mitigate this concern would be to permit allocation of only one kidney to an adult multiorgan candidate from any pediatric donor. Possible considerations to mitigate the effect of multiorgan transplant allocation priority on children would be to permit allocation of only one kidney to an adult multiorgan candidate from any pediatric donor or any donor with a KDPI < 35. We offer the following feedback for consideration. The Committee specifically asks for feedback on the following: 1.Is Heart Adult Status 1, 2, 3 and Pediatric Status 1A and 1B appropriate thresholds for when OPOs must offer a liver or kidney to a multi-organ candidate listed for those organs? The threshold for heart does incorporate the vast majority of Heart MOTs in 2019. While 18% of heart-liver transplants and 23% heart-kidney would have been excluded, maintaining priority for the most acute patients identifies those with the most elevated urgency. The threshold would achieve a minimum cutoff, which impacts be a minimal number of transplants and if it were any lower than the threshold would essentially be rendered moot. This is probably acceptable for this rudimentary first pass. However, it is clear that ANY heart candidate with GFR<30 has a worse outcome and thus even lower Status 4-6 in adults or Status 2 in pediatrics is disadvantaged. Rapid addressment of the challenges of dual organ candidates and appropriate risk stratification methods should continue. We have concerns regarding Status 1A liver candidates being bypassed for a liver to go with a heart to Status 2 or 3 heart candidates. Often times, even the most critical of these patients are not imminently at risk of death and tend to be more stable than liver Status 1 candidates. 2.Is a lung allocation score of greater than 35 an appropriate threshold for when, OPOs must offer a liver or kidney to a multi-organ candidate listed for those organs? No. A patient with a LAS just above 35 is not at high risk for dying from their lung disease. Often times, even the most critical of these patients are not imminently at risk of death and tend to be more stable than liver Status 1 candidates. The data used to support the LAS >35 threshold seems to be based on the fact that all candidates who received a lung-liver transplant had a LAS >35, and this threshold would be inclusive of all 2019 cases. (The 2019 data has limited numbers and suggest no clear site for threshold other than a LAS of 35+.) We believe that further thought needs to be given to determining this threshold which should be higher. This policy proposal currently excludes 0-11-year-old pediatric lung multiorgan candidates because they do not have a LAS. We recommend that, rather than removing these pediatric candidates from the match run, they be included in the policy. The number of patients that would fall into this category is extremely small, as this a lung-liver or lung-kidney transplant in this age group is a rare event. We ask that the sponsoring committee explore inclusive solutions for these young pediatric candidates rather than an exclusion here, as we believe this is a gap in the current policy proposal. 3.Is 500 NM an appropriate distance for when OPOs must offer a liver or kidney to a multi-organ candidate meeting the proposed criteria? The 500 NM mandatory offer seems a foregone conclusion given that thoracic allocation already uses this distance and the OPOs are probably often already operating under this principle, although liver and kidney transplant centers may not necessarily expect this practice, hence there is a need for clarification. Although the current policy doesn’t stipulate this specifically and this protocol clarification should alleviate that confusion. From the pediatric perspective, we do have concerns about the expansion to 500NM, and its potential effect on kidney access (for example) for non-multi-organ candidates. While many of pediatric members would support the proposed change, we would also ask that there be ongoing review of the effects on access for non-multi-organ candidates. 4.Do you believe all multi-organ policies should be located in the same section of policy? Centralizing all multi-organ policies is reasonable to avoid confusion. Page 8 leads to ambiguity as it implies that the OPO decides which match to start with and thus this could negate the entire multiorgan allocation policy. An OPO that chose to start with liver or kidney match would place those organs before the lung or heart match was run. This would then create the uncomfortable situation of “withdrawing” an organ offer after acceptance or potentially jeopardizing a very ill dual organ candidate from surviving to transplant. We advocate for clarification that abdominal organs below some established level of severity (i.e. MELD under 35) are not allocated prior to a lung and heart match run to confirm no dual candidate is inadvertently skipped. Several organ specific concerns were also shared by our communities of practice: • More consideration needs to be given to allocating kidneys with hearts for Status 4 patients. • A safety net for kidneys following heart and lung transplant needs to be established prior to implementation to ensure there is some capacity to rescue patients who needed a kidney and were not able to get it based on these new regulations. • Multivisceral transplantation needs to be included with a priority to allocate other organs with an intestine, rather than having the liver be the driver of MVT. These changes will have extremely small effects in terms of allocation and are unlikely to materially affect waiting times in other organs. But for the affected patients, these are very significant issues. Implementing without addressing them may have disastrous consequences for these small but very sick patient populations. • This policy will affect roughly 200 Kidneys (allocated to Heart), 45 (liver to heart), 12 (liver to lung), and 13 (kidney to lung) candidates. This represents approximately 1% of kidney transplants. Things that could be addressed explicitly by this policy remain the following: o If kidney or liver deceased organ is not utilized for any particular reason, how will OPO’s re-allocate this organ. E.g., If the kidney or liver deceased organ has now travelled a much further distance than current policy. o Did the work group consider adding Heart Adult Status 4 to the policy? If yes, what were the pros and cons for that? If not, what were the reasons to not consider this? o We do agree with the other statuses for livers and kidneys. o Overall, we still need to have an actual definition for the criteria for needing a multi-organ transplant (esp. for kidneys), and a safety net feature for heart-CKD pts. OPTN Liver & Intestinal Organ Transplantation Committee | 03/22/2021 The OPTN Liver and Intestinal Organ Transplantation Committee appreciates the opportunity to comment on the Clarify Multi-Organ Allocation Policy proposal. The Liver Committee supports the proposed 500NM circle and criteria. The Liver Committee asks the OPO committee to consider the development of a pathway for candidates to receive a heart transplant following a liver transplant, especially for those who develop cardiac cirrhosis or have high panel reactive antibodies (PRA). NATCO | 03/22/2021 NATCO commends the OPO Committee for the work already done on multi-organ allocation and for continuing to work on this policy in an effort to improve equitable distribution of all organs. One unintended consequence of the proposed change is increased wait time for those waiting on a kidney only. Kidney candidates have the longest wait time among organs and allowing kidneys to go with thoracic organs will likely add to this already long wait time for kidney only candidates. NATCO supports the proposed thresholds for OPOs offering to multi-organ candidates. Additionally, we feel 500 NM is an appropriate distance for OPOs offering a liver or kidney to a multi-organ candidate. We also believe multi-organ policies should be located in the same section of policy. Warren Zuckerman | 03/21/2021 The proposal currently states that for heart patients listed status 1a or 1b, the OPO would be obligated to pull kidney or liver if the patient is listed for multiple organs. In thinking of what heart patients I would advocate for, I think that it would be important to include status 2 listed patients listed for heart-kidney or heart-liver as well. While I realize that this would now include all pediatric patients listed for heart and multiple organs, it is important to realize that overall these numbers will be very small, and therefore not have a large effect globally, but could in fact be very important for an individual patient. The numbers reported at our region 9 meeting was that in the past year there were 5 pediatric heart-kidney transplants and 3 were listed status 1a, 1 status 1b and 1 status 2. This shows that it is correct to think that the overall numbers are small, but that this is a true phenomenon that could have important implications for an individual pediatric patient. Status 2 patients are mostly patients listed for transplant while home and not on inotropic or VAD support. I can think of scenarios where congenital heart disease patients with heart failure or patients in need of re-transplantation would be listed for transplant and have concurrent renal or hepatic failure, and are listed for multiple organs. It would be imperative for these patients to not miss a heart offer because the additional organ was not being pulled as well. Transplant Coordinators Committee | 03/19/2021 The Transplant Coordinators Committee thanks the OPO Committee for presenting its proposal “Clarify Multi-Organ Allocation Policy” and offers the following feedback: Multiple Committee members shared praise that this proposal was ‘a much needed move in the right direction’ and felt like it would be a workable implementation. A member was concerned about the lack of existing data, since the data set was so small, and expressed concern about a potential MELD score not reflecting how sick a patient truly is. A member requested clarification on compliance to this policy if the original multi-organ offer was rejected but an organ needed for the second multi-organ offer was already accepted. A member requested additional information on which multi-organ pairing took priority. A member asked if there was any consideration for just offering one kidney for a multi-organ recipient and saving the other for a kidney only. Kidney Transplantation Committee | 03/18/2021 The Kidney Committee appreciates and thanks the OPO Committee for their efforts to clarify multi-organ allocation policy, and supports this improved clarity around required and permissible multi-organ kidney sharing. The Kidney Committee acknowledges that the Heart and Lung required sharing thresholds were established based on data from previous years’ multi-organ transplant data, and recommends that future work on extra-renal multi-organ sharing include kidney-related criteria to establish extra-renal eligibility, similar to current Simultaneous Liver-Kidney (SLK) criteria, particularly as many heart and lung recipients experience vast improvements in renal function from their thoracic transplant alone. The Kidney Committee also acknowledges that most extra-renal multi-organ transplants utilize high quality, low KDPI kidneys, and asks that future multi-organ allocation policy place further emphasis on ensuring pediatric and low EPTS candidates are not inappropriately disadvantaged. Region 11 | 03/18/2021 Region 11 sentiment: 2 strongly support, 9 support, 2 neutral/abstain, 2 opposed, 1 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 agreement and support for this proposal. However, several attendees recommended including clear eligibility requirements for thoracic/abdominal transplants in the policy. Some added that without eligibility requirements, kidney alone candidates could be disadvantaged. Another attendee commented that a safety net should be addressed by the policy (similar to SLK). One attendee added that extending the kidney safety net to heart might mitigate the need for allocating the kidney with the thoracic organ. Two attendees thought guidance for reallocation of the kidney or liver if not used with the MOT should be included in the policy. There was some discussion around the need for additional data. A few attendees were concerned about the lack of data showing how this policy would affect candidates at small rural centers who do not have heart programs. Several commenters requested more data around which thoracic recipients benefit from receiving a simultaneous kidney transplant, adding that it might be better to do transplants on higher status candidates sequentially. One attendee recommended guidance for OPOs on which organ specific list to use when beginning allocation. Another attendee expressed concern for adult congenital heart candidates (i.e. Fontan with both failing heart and liver) who would traditionally be listed as an Adult Status 4 and would be overlooked, despite having potentially greater need MOT allocation. Meghan Stephenson | 03/13/2021 The proposed policy changes will provide clarity to and consistency across OPOs when allocating multi-organ combinations. We defer recommendations on whether Heart Adult Status 1, 2, 3 and Pediatric Status 1A and 1B and a lung allocation score of greater than 35 are appropriate thresholds for when an OPO must offer a liver or kidney to a multi-organ candidate listed for those organs. From an operational perspective, increasing the distance to 500 NM to better align with heart and lung policies is sensible so long as it does not negatively impact equity. While the following recommendation is outside the scope of the requested feedback, it is pertinent for future consideration. We encourage OPTN to consider how this and future multi-organ allocation policies will be operationalized by the OPO and the OPO coordinator in real-time. It is quite challenging to manage allocation across multiple lists and determine the priority of multi-organ combinations when there are multi-organ combinations on the heart, lung, liver, intestine, and pancreas list. Which potential transplant recipient from which list has priority over all others? We would encourage the generated PTR to identify required multi-organ combination shares versus permissible shares, as the liver PTR currently does for liver-kidney combinations, especially since some required multi-organ combinations will be out-of-sequence of non-required multi-organ combinations in the proposed policy (i.e. heart classification 7 – 12 will not be required multi-organ shares while heart classification 13-14 will be required multi-organ shares). As another member commented, an algorithm, within policy, for the OPO to follow for allocation of which multi-organ combinations take priority and from which list to allocate when competing allocation scenarios are at play would be extremely beneficial to the OPO. Region 7 | 03/12/2021 Region 7 sentiment: 4 Strongly Support; 7 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. An attendee commended the committee for their work on this proposal to increase access for these patients. One member asked how the multi-organ allocation would be monitored. An attendee also asked about instances involving 3 organs, i.e., heart, liver and kidney. Several attendees agreed, that the suggestion to begin to look more carefully at outcomes for multi-organ recipients is important both to create uniformity in the regulatory environment and to provide feedback on the relative risks and benefits of transplanting the "additional" organ(s). OPTN Membership and Professional Standards Committee (MPSC) | 03/11/2021 The MPSC thanks the OPO Committee for presenting its proposal “Clarify Multi-Organ Policy” and offers the following feedback: The proposal is a good first step and will provide more consistency in multi-organ allocation across the country. However, multiple MPSC members agree that specific medical eligibility and safety net criteria similar to those created for simultaneous liver-kidney allocation need to be developed for sharing kidneys with other organs. Most candidates receiving heart transplants are at status 1, 2, or 3, which means there could still be a lot of kidneys going to heart candidates. The lack of a safety net for heart recipients who need a kidney after their heart transplant means that transplant programs may request a kidney with the heart even for candidates experiencing short-term loss in kidney function. Lastly, in the new heart allocation policy, status 5 is the dual organ category, but the status will lose its meaning because a patient at status 5 won’t be able to receive a dual organ offer. Reviewing the effects of the policy change and sharing that data with the community for transparency will be important. An MPSC member reported longer allocation times for abdominal organs under the current policy when a multi-organ candidate on a thoracic match run needs an abdominal organ. Another MPSC member suggested stratifying multi-organ allocation data by KDPI to evaluate the KDPIs of kidneys allocated for multi-organ vs. single-organ transplants. Region 6 | 03/09/2021 Region 6 sentiment: 7 strongly support, 14 support, 3 neutral/abstain, 4 oppose, 0 strongly oppose. Overall, attendees agreed that this policy proposal was necessary and a good start. Many members shared they appreciated an attempt to provide clearer guidelines for multi-organ allocation. A couple members brought up whether there could be a situation where the kidney pulled the heart, rather than the other way around. One member stated that there are instances where a center might be willing accept a heart from a donor against whom the recipient has a high level of donor-specific antibodies, but that they may not want to also accept the kidneys from that same donor. There was discussion around the concern that allocating to multi-organ candidates first could disadvantage highly acute Status 1A liver candidates, and a couple members advocated that the committee should consider allocating to Status 1A liver candidates before allocating to less acute multi-organ candidates. A few attendees mentioned the desire to consider adding Status 4 heart candidates to this policy. One suggested clarification that although it is not a requirement to allocate the kidneys or liver to a Status 4 heart candidate, it is not prohibited. A member mentioned that there are very few heart-kidney or heart-liver transplants done for Status 1 heart candidates, so this policy is not addressing the statuses where the bulk of these transplants are done. Stephanie Little | 03/09/2021 Would encourage exploration of medical eligibility criteria for liver-kidney policy (either in this proposal or a follow-up) as it is relevant to the topic being brought forward. Support the proposed addressing of the 84% of combinations that are otherwise not addressed in other policies (such as lung-kidney). Support increased nautical miles to align with thoracic allocation. Concerns on if there are repercussions for not establishing requirements for organs which must be allocated first (pros versus cons). Ideas to think about on if this will impact smaller centers that are only able to take one type of organ as multi- organ offers would subsequently remove that organ from the pool made available (e.g., transplant centers that only do kidney transplants). While there are concerns and questions, I support, with hopes moving forward that my concerns (and others) are addressed, whether it be through this or another policy/proposal/white paper. Region 8 | 03/09/2021 Region 8 sentiment: Strongly support-6, Support-8, Neutral/abstain-1 Oppose-1, Strongly oppose-0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Members overall supported the proposal and acknowledged that this is a challenging issue. One member commented that all pediatric lung candidates should be included in the mandatory category because of the small volume. Another member stated that the language and associated requirements for “if available” for allocation needs to be clarified and should not be left to individual OPO policy or procedure. Another member agreed and said that policy should specify which match should be used. A member commented that the status of the heart or lung candidate should not determine if the kidney or liver also goes to the candidate; the second organ should be allocated automatically. Two members commented that the criteria should be expanded to include status 4 heart candidates. A member commented that prioritizing multi-organs for greatest acuity is worthy and challenging issue, but should avoid futile or unnecessary transplant and the diversion of kidneys from kidney only candidates for limited or nor no gain. OPTN Heart Transplantation Committee | 03/03/2021 The Heart Committee thanks the OPTN Organ Procurement Organization Committee for their efforts in further clarifying multi-organ allocation policy. Overall, the members support this proposal as an improvement on existing policy and acknowledge that additional work will be needed to encompass all multi-organ allocation considerations. The members support the increase of distance to 500 NM in order to be more consistent with lung and heart allocation policies. The members encourage the OPO Committee to consider adding language emphasizing the importance of following the match run during allocation. Members also suggested considering the use of match run sequence thresholds (i.e. first twenty candidates on the match run) rather than medical urgency statuses currently proposed. A member raised a concern that basing multi-organ allocation on more urgent statuses will result in additional exception requests for candidates waiting for multi-organ transplants. A member also voiced concern about additional policies resulting in additional OPO time needed when allocating multiple organs. Transplant Families | 03/02/2021 Commend the hard work of this committee. Support while echoing the concerns of others making comments. Our group represents pediatric recipient parents/caregivers. Many of the congenital diseases/conditions that lead to transplant in childhood are sometimes palliated and successfully bridged to adulthood. Sadly, this is where those palliations can fail and lead to transplant later in life. This policy would be especially hard for Fontan patients that need multi-organ transplants and are listed at status 4. We hope that liver and kidney can be allocated to these heart recipients besides 1, 2, and 3. ANNA | 02/25/2021 ANNA supports this proposal. Attachment Anonymous | 02/25/2021 Appreciate the efforts of this joint committee effort. The proposal is necessary but far from sufficient. Somewhat disappointed that medical criteria did not get sorted out, at least for lung-kidney and liver-kidney candidates. This needs to be done ASAP, and should have been done by now. The success of the SLK policy and the safety net should be used as an example. This is of limited usefulness without these pieces. Please prioritize and get going. A point of clarification - as far as I know, there is no way to prioritize or triage three possible types of candidates that require sharing oft he kidney in the case that there are simultaneously liver-kidney, lung-kidney and heart kidney recipients that come up on the match run lists. The committee should try to sort out predicted 7 day mortality or other metrics to resolve this conflict in policy when it is mandated that all three types of candidates meet criteria for mandatory offer of the kidney when there are only two kidneys available. Region 5 | 02/19/2021 Region 5 sentiment: 9 strongly support, 24 support, 2 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. One member stated that knowing this is a data driven proposal, they think it is problematic for an adult status 4 heart patient to not have a kidney offered, because these patients have increasingly little options when they move up in status and get sicker in terms of support. Needing a left ventricular assist device (LVAD) and dialysis is devastating – but can be a reality for Heart status 4. Those patients tend to do poorly in the long run. Whether preemptive to dialysis or on dialysis, they should be given priority at a status 4 level. Previously, people were more amenable to allocating the kidney with the heart, but now that we are crossing over into circle based and continuous distribution allocation models, getting these things hammered out is important. The member felt if you are listed for a heart-kidney you should get the kidney no matter what priority. Otherwise, we are setting ourselves up for long-term trouble, with the patient not having as many options down the road. Another member was in agreement with the comments, stating that we need a special consideration for dual organ for congenital heart patients who are normally status 4. The increase of 500 miles for the liver to pull liver-heart may be concerning for overall ischemic time. Another member agreed that Adult Status 4 should be included for dual organ for congenital heart patients (for example Fontan procedure patients) listed for heart-liver as status 4, or heart re-transplant listed as a status 4 who needs a kidney, both have limited support options and would benefit from being able to get the liver or kidney with the heart allocation. Another member stated that when we deal with OPOs we rarely deal with, those conversations are more difficult to have. The member only had one anecdotal experience but did not know why we would not give a heart status 4 a kidney automatically if they needed it. One member stated that matching to the concentric circles seems logical but worries that by just choosing distance we may be disadvantaging some potential recipients, if the system can better stratify life years it would show more equitability. Another member stated the proposed threshold refers to the urgency of the heart or lung transplant but not necessarily urgency of the liver or kidney transplant. This proposal is a good start – they look forward to the committee's future work to tease out the relative indication of the primary and secondary organs. The member followed up; part of the problem is that right now, a lot of the urgency criteria assumes a heart-kidney and heart-liver – that the urgency of the secondary organ is what is driving mortality on the waiting list. As a nephrologist, they did not think that is settled or true. Region 3 | 02/18/2021 Region 3 sentiment: Strongly support-6, Support-11, Neutral/Abstain- 3, Oppose - 3, Strongly Oppose - 1. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Several members commented on the need to establish criteria to qualify for a kidney, comparable to the simultaneous liver kidney criteria, for all multi-organ transplants. There were several comments related to the inconsistency of multi-organ allocation and the need for standardization, including the order of matches run, and clear criteria. Several comments were made about the complication of multi-organ allocation including inconsistent local resources, variability of timing of test results, and the tremendous effort of the OPO staff. An attendee commented that multivisceral transplant candidates are being badly denied access to transplant and that liver needs to be allocated with intestine, not the other way around. Several comments were directed at the need to evaluate the anticipated benefits and consequences, including the impact on kidney allocation, and what the impact on the number of extra organs offered and transplanted would be if the distance is increased to 500 NM. Other comments included that this would exclude patients with Durable VADs without complications, that it is important that 100% pra patients are not disadvantaged, and that this does not account for either the very ill or the stable patients. Children's Hosp Los Angeles | 02/11/2021 Main concern has been raised by others... Adult congenital heart disease patients with Fontan physiology commonly are listed at status 4, often by exception, because inotropic support and VAD do not help their physiology. If also listed for liver, these patients may be disadvantaged by policy which does not pull a liver with the heart, especially as their MELD score may also not be as high as some other liver candidates. We advocate for liver to be allocated to the heart recipient at status 4 as well as at status 1,2 and 3. OPTN Operations & Safety Committee | 02/10/2021 The Operations and Safety Committee thanks the OPTN Organ Procurement Organizations Committee for their efforts in developing this public comment proposal for the Clarify Multi-Organ Allocation Policy. A member suggested the development of an algorithm related to multi-organ allocation within the system. Although this is out of scope for this project, it should be in consideration for the next phase of the project when programming is discussed. The Committee supports this proposal. The Committee agrees that 500 nautical miles is an appropriate distance for when OPOs must offer a liver or kidney to a multi-organ candidate meeting the proposed criteria. A member suggested that the OPO Committee consider maintaining consistency with Heart Adult Status 1 and 2 as it pertains to heart/lung candidates. It would be more consistent with prioritization of heart candidates above heart/lung candidates. Region 4 | 02/04/2021 Region 4 sentiment: 5 strongly support, 15 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member commented that the heart adult status 1 and 2 were the most appropriate and added that a heart-kidney safety net should be developed. One attendee commented that heart adult status 3 should also be included. Another attendee suggested using waitlist mortality as a measure where candidates should be prioritized on multi-organ lists. One attendee supported using a 500 NM threshold for sharing multiple organs. Another attendee supported 500 NM for heart adult status 1 and 2 and 250NM for status 3. One attendee commented that LAS often does not capture the severity of disease, particularly with teens with CF who also need a liver and added that waiting time for these candidates is unacceptable. OPTN Lung Transplantation Committee | 01/26/2021 The Lung Transplantation Committee appreciates the opportunity to comment on the Clarify Multi-Organ Allocation Policy proposal. The Lung Committee asks the OPO Committee to ensure that lung-liver candidates who urgently need a liver will receive adequate priority for transplant even if the candidate’s lung allocation score (LAS) falls below the LAS threshold of 35. The Lung Committee acknowledges that the LAS threshold of 35 was selected based on available data for the small population of lung-liver candidates, and appreciates that if a candidate has a high Model for End-Stage Liver Disease (MELD) score, then the liver could “pull” the lung. A member suggested allowing transplant programs to choose whether organs for lung-liver candidates are allocated primarily based on the candidate’s MELD or LAS. The Committee acknowledged that generally speaking, candidates who are listed for lung-liver are predominately listed due to their lung disease but struggle to get offers for a liver. The Committee appreciates that this proposal would help to improve access to livers for those lung-liver candidates. A member noted that using LAS to establish a threshold does not apply to patients ages 0-11, who are not assigned an LAS for allocation. While it is rare to have multi-organ candidates in the 0-11 age group, the OPO Committee may want to consider this age group in their proposal.