Revise Lung Review Board Guidelines, Guidance, and Policy for Continuous Distribution At a glance Background Continuous distribution is a new system to allocate lungs that will be implemented in 2023. This system includes a Lung Review Board to evaluate exception requests for the different components of the composite allocation score. The operational and clinical guidelines for this review board and for transplant programs are not currently outlined in policy. Supporting media Presentation View presentation Proposed changes Establish operational guidelines to outline the representation, responsibilities, and process for the review board Provide clinical guidance for what information programs should provide when submitting a request Provide guidance for review boards to consider when evaluating requests Update policy to provide more consistency across organ types Anticipated impact What it's expected to do Help make sure exception requests contain appropriate, relevant clinical information Help make sure review board members evaluate exception requests with consistency Continue efforts to standardize review boards across organ types What it won't do Create policy criteria for review board members to use when evaluating exception requests Terms to know Exception Request: When a transplant program believes that one of the parts of a candidate’s calculated composite allocation score does not accurately reflect the candidate’s condition, it may submit a request for a different score. Composite Allocation Score: The total number of points assigned to a candidate on the waiting list, which determines the candidate’s place on a match run. Click here to search the OPTN glossary Comments UC San Diego Health Center for Transplantation | 09/29/2022 The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Revise Lung Review Board Guidelines, Guidance, and Policy for Continuous Distribution. CASD applauds the committee for considering this prior to the implementation of continuous distribution and strongly supports this proposal as written. With regards to the feedback specifically requested: • Should the Committee add information in the guidance on how to request a priority 1 equivalent score for pediatric candidates in the new allocation system? Yes, CASD would support adding additional guidance on prioritizing high acuity pediatric candidate populations under the new allocation system. • Should the Chair be a voting member of the Lung Review Board? Operationally it seems reasonable to require the chair to be a voting member of the review board. • Are there other specific candidate diagnoses, symptoms, or characteristics for which the Committee should consider providing more specific guidance? Although we do not have recommendations for other candidate specific diagnoses at this time, we appreciate the Committee continuing to monitor for the need. Additionally, we believe the changes being made will positively impact the COPD/CF patient populations. • Should a quorum of review board members be required to deny an exception request? Quorum is required for approval or denial for exemption requests already. Maintaining this structure twill help the Review Board to avoid any potential bias. • Is it clear how the appeals process works? Yes, and we appreciate the tightening the deadlines for decision. We do however, we share some of the operational concerns of the ASTS regarding the initial and alternative notification during the initial review period. We would recommend notifying both the primary and alternative of case review assignment on day 1 with a clear distinction of primary vs alternative and if not response has been received by the primary by day 3, a second notification designating the alternative to cast their vote. Additionally, we think the language regarding the appeal to the Committee, “The Committee will approve or not approve each appeal no later than the next scheduled Committee call following the request to the Committee,” should be modified. While the Committees do meet routinely, there is an opportunity for a prolonged period pending approval. Anything greater than 14 days seems unreasonable given the context in which a program would be attempting to appeal a Review Board decision. • Do lung transplant programs anticipate any barriers to participating in the new Lung Review Board or using the updated exceptions process? We would not anticipate any new barriers based on this proposal. • What resources should the OPTN provide to assist lung transplant programs in submitting exception requests in the continuous distribution lung allocation system? None at this time. Attachment OPTN Transplant Coordinators Committee | 09/29/2022 The OPTN Transplant Coordinators Committee thanks the Lung Transplantation Committee for their work and for the opportunity to comment on this proposal. One member noted that geographical location, adult versus pediatric lung programs, and lung program size should be considered when it comes to the representation on the review board. The member also asked if clinical guidance would be provided to help determine what score to request. The response to this question was that the guidance would focus on how to request the score. One member provided the following comments: 1. It make sense to allow the Chair of the review board to be a voting member unless there is a reason why they should abstain from voting. 2. It should be clear if quorum is required for approval or denial of the score request. 3. The appeals process is clearly written and the deadlines for the decision are appreciated. 4. There should be a process for notifying the alternates that they may be needed during a specific time period. 5. The final committee review of appeals should be within a reasonable amount of time, anything over 14 days might have an impact on certain patient populations. OPTN Transplant Administrators Committee | 09/29/2022 The Transplant Administrators Committee thanks the Lung Transplantation Committee for their efforts in developing this proposal. A member noted it would be very helpful to add info in the guidance on how to request a priority one equivalent score for pediatric candidates in the new allocation system. There were no further comments from the committee. Region 6 | 09/28/2022 Sentiment: 4 strongly support, 13 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One attendee commented that all continuous distribution changes should rigorously and continuously assess utilization rates/discard rates as part of determining whether change was a success. Region 10 | 09/28/2022 Sentiment: 3 strongly support, 6 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose OPTN Operations and Safety Committee | 09/28/2022 The Operations and Safety Committee (OSC) thanks the Lung Committee for their work on the proposal Revise Lung Review Board Guidelines, Guidance, and Policy for Continuous Distribution, and, in particular, appreciates the Committee’s dedication to including pediatric voices in their work on Continuous Distribution and Lung policy. The Committee provided the following feedback to these questions from the Lung Committee: 1) whether the Chair is a voting member should be consistent with other review boards to maintain the goal of consistency; 2) The Lung Review Board should consider if having a percentage of reviewers would be more representative of the lung transplant community as lung programs grow and shift across the country; 3) if the updated appeals process is implemented, the language should be written such that it is understandable for patients impacted by the change. NATCO | 09/28/2022 NATCO would like to thank the Lung Transplantation Committee for the opportunity to review and comment on their proposal. With the changes coming to the LAS with the establishment of continuous distribution of lungs system, operational and clinical guidelines for the review board need to be established. Operational guidelines need to outline the representation, responsibilities, and the process of the review board. The clinical guidance is for programs that are submitting requests and the information that needs to be provided. This will help standardize the criteria and guidance in requesting exceptions for extraordinary patient circumstance and help centers find information regarding the review boards guidance and policies. We are concerned about the number of reviewers that are assigned to a case and wonder if for the pediatric committee there should be a separated pediatric lung review board. At minimum, we propose that there are always at least three pediatric reviewers on a case. If a separate committee was established, it could provide annual review of the pediatric exceptions and the outcomes of those children to support future evidence-based guidance and policy updates on appropriate priority ranking of children to reduce the need for exceptions and prevent waitlist mortality. With the changes proposed, there needs to be equitable representation from both adult and pediatric providers as well as advocates. NATCO highly recommends that these proposed changes are implemented and this be continually assessed for equity and equality amongst the adult and pediatric population. Education on the process will also need to be provided for the Lung transplant programs as well as the lung review board representatives. Region 8 | 09/27/2022 Sentiment: 1 strongly support, 11 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose | A member program recommend that the committee modify the language to ensure that pediatric representatives on the OPTN Board of Directors have contemporary pediatric lung transplant experience (i.e. involved in at least five pediatric transplants in the last five years) and at least one of the pediatric representatives has experience with infant lung transplant. Region 7 | 09/27/2022 Sentiment: 3 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member noted that the Review Board Chair should be a voting member of the Lung Review Board, the process seems clear for the first and second appeals, and supports altering the appeal process to 7 days. American Society of Transplantation | 09/27/2022 The American Society of Transplantation (AST) generally supports the changes included in the proposal “Revise Lung Review Board Guidelines, Guidance, and Policy for Continuous Distribution,” and offers the following comments for consideration: The AST recommends modifying language in the proposal to ensure that the pediatric representatives on the Review Board have real and contemporary pediatric experience (i.e., at least 5 pediatric transplants in the last 5 years) and at least one of the members has experience with infant lung transplant. There are specific nuances between adult and pediatric patients, especially infants, and adequate representation is necessary to protect this vulnerable population. The committee should provide guidance on requesting priority 1 equivalent score for pediatric candidates in the new allocation system to help appropriately refine the individual’s priority score. Making the Chair a voting member further ensures a peer reviewed approach to these requests. Additional guidance on concomitant lung disease such as combined pulmonary fibrosis emphysema (CPFE) and the addition of obstructive sleep apnea (OSA) would be helpful to objectively prioritize these patients. The AST agrees that a quorum of review board members should be required to deny or accept an exception request; however, it would be important to consider a majority minimum to make a peer reviewed decision. For example, greater than 50 percent of assigned reviewers, greater than five reviewers- instead of a majority, which in some instances could be one reviewer due to the lack of response from other reviewers. The appeals process is clearly outlined in this new proposal. Under the new system, all active transplant programs can have primary and alternative representation on the Lung Review Board allowing for a diversified approach on multiple aspects, including geographic and ethical considerations. The overlap of the terms of representation between old and new members allows ongoing expert and dynamic ideas. The AST does not think active lung transplant programs will encounter any barriers to participate in the new Lung Review Board or using the updated exceptions process. Ineligibility to participate due to the programs inactive status may be an obvious barrier. The OPTN should provide information about candidates that are currently listed to support transplant programs in submitting a fair score request. Attachment Region 11 | 09/26/2022 Sentiment: 2 strongly support, 7 support, 11 neutral/abstain, 0 oppose, 0 strongly oppose American Society of Transplant Surgeons | 09/26/2022 The American Society of Transplant Surgeons appreciates the opportunity to provide feedback to the OPTN Lung Transplantation Committee. Should the Committee add information in the guidance on how to request a priority 1 equivalent score for pediatric candidates in the new allocation system? Yes, ASTS supports adding additional guidance on prioritizing high acuity pediatric candidate populations. Should the Chair be a voting member of the Lung Review Board? Not necessarily. Are there other specific candidate diagnoses, symptoms, or characteristics for which the Committee should consider providing more specific guidance? No. Should a quorum of review board members be required to deny an exception request? Yes. Is it clear how the appeals process works? Yes, the process appears clear. However, we are concerned about the voting guidelines in the proposal. As described, nine review board members from different program would be assigned a case and would have five days to review; this seems reasonable. The difficulty arrives in the further details: reviewers who don’t respond in three days would be replaced and the review would be decided in five days even if there is only one response in that time frame. Perhaps all nine programs should receive the five days to respond and a minimum of five responses necessary for a decision. After three days, the program’s alternate reviewer might be approached or perhaps the chair would be able to cast a vote for reviews in which the minimum number of responses is not received in five days. ASTS is also concerned when the “countdown” starts for these five days, and we propose that all reviews are sent out in the morning of the first day so that a full three out of five days are available to respond. Do lung transplant programs anticipate any barriers to participating in the new Lung Review Board or using the updated exceptions process? There would not be additional major barriers to transplant centers. What resources should the OPTN provide to assist lung transplant programs in submitting exception requests in the continuous distribution lung allocation system? The OPTN should further refine the online portal. Attachment Region 1 | 09/21/2022 Sentiment: 2 strongly support, 1 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose Region 3 | 09/20/2022 Sentiment: 1 strongly support, 10 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Region 2 | 09/13/2022 Sentiment: 5 strongly support, 12 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose Region 9 | 09/12/2022 Sentiment: 2 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Region 5 | 09/08/2022 Sentiment: 7 strongly support, 13 support, 9 neutral/abstain, 1 oppose, 0 strongly oppose | Comments: A member suggested to include more pediatric representation on the review board. Specifically, the review board should have pediatric lung transplant expertise alternates (or back-ups) to ensure there are always at least three pediatric reviewers on a case. Pediatric Transplantation Committee | 09/08/2022 The Pediatric Committee thanks the OPTN Lung Transplantation Committee for the opportunity to review their public comment proposal. The Committee provides the following feedback: The Committee expressed concern about the number of reviewers assigned to a case, and particularly that the three pediatric reviewers assigned to cases would always be a minority of the experts reviewing a pediatric case (at most, 3 of 9). Members expressed concern with adult reviewers voting on pediatric cases and suggested that there should be a separate pediatric lung review board, or addition of more pediatric members to the existing review board with assignment of those pediatric specialists only to pediatric cases given the small number of pediatric pulmonologists with expertise in lung transplant. The Committee also suggested monitoring the number of pediatric exceptions in a given year and evaluating the outcomes for those children, to support future evidence-based guidance or policy updates on appropriate priority ranking of children to reduce the need for exceptions and prevent waitlist mortality. Region 4 | 08/26/2022 Sentiment: 0 strongly support, 16 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: One member commented that patient education is important with any new guidelines.