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National Heart Review Board for Pediatrics

Proposal Overview

Status: Board Approved

Sponsoring Committee: Thoracic Transplantation

Strategic Goal: Provide equity in access to transplants

Read the proposal (PDF; 01/2020)

View the Board Briefing Paper (PDF; 06/2020)

View the policy notice (PDF; 06/2020)

Contact: Sara Rose Wells

eye iconAt a glance

What is current policy and why change it?

Currently, when a transplant physician lists a candidate at a high urgency status (Status 1A or Status 1B) who does not meet the criteria for that status, they must submit justification for this exception to the OPTN for review by a Regional Review Board (RRB). Due to recent pediatric heart allocation changes, there has been an increase in pediatric candidates listed at higher statuses by exception, but pediatric transplant programs tend to be under-represented on RRBs. 

What’s the proposal?

  • Create a National Heart Review Board (NHRB) for Pediatric Candidates.
    • Each active pediatric heart program would be able to appoint one primary and one alternate representative to serve one year terms.
    • NHRB would review exception requests for Status 1A and Status 1B pediatric heart candidates.
    • Requests would be assigned to nine randomly selected representatives.
    • Decisions based on majority vote within three days.
    • Denials can appeal to same group of reviewers.
      • Additional denial can be appealed to workgroup made up of members of Thoracic Committee and Pediatric Committee with relevant expertise.

What’s the anticipated impact of this change?

  • What it’s expected to do
    • Improve quality and consistency in review of pediatric heart exceptions.
    • Work towards ensuring more medically appropriate status listings for pediatric heart patients.
  • What it won’t do
    • It will not change the way exception requests for adult heart patients are reviewed.

Themes to consider

  • How to ensure broad/equal representation on the NHRB
  • How appeals should work
  • What statuses should be reviewed
  • Plan for tiebreakers

Terms you need to know

  • Status: An indication of the degree of medical urgency for patients awaiting heart transplants.  Status 1A is most urgent.
  • Exception: When a physician places a candidate at a higher status even though the candidate does not meet the standard criteria in policy to automatically qualify for the status.
  • Review Boards: Peer review panels established to review all urgent status listings for liver and heart candidates. The review boards reviews justification forms submitted by each center documenting the severity of the candidate's illness and justifies the status at which the candidate is listed. Thoracic review boards review listings for heart candidates in Status 1A and special case heart candidates in Status 1B. These boards also consider appeals of cases initially turned down for a particular medical urgency status.
  • Click here to search the OPTN glossary.

Comments

marco ricci | 01/31/2020

I think the establishment of a National Board to evaluate exception requests is a good initiative. However, in my opinion too many exceptions can still overwhelm, and perhaps are overwhelming, the system - if exceptions become the rule, they will defeat the very purpose of allowing exceptions in the first place. To that end, I would suggest that in addition to having a National Board with appropriate program representatives evaluate exceptions, OPTN should also consider working on defining more stringent criteria to regulate exception requests inn order to decrease utilization and limit exceptions to truly extraordinary clinical situations. Perhaps OPTN can also consider instituting reasonable limits as to how many exceptions a transplant program can request over a determined period of time or how many patients can be listed by a program with an exception at any given time

OPTN Region 4 | 02/08/2020

Strongly support (3), Support (17), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Comments: Region 4 supported the proposal. Those in attendance agreed that asking adult specialists to review pediatric cases does not make sense. During the discussion, there was also agreement that Review Board members should be physicians. There was no consensus on whether a NHRB should be expanded to adult cases. There were some questions about how the cases would be assigned for the number of adult exceptions.

Clifford Chin, MD | 02/14/2020

Composition 1. Should there be criteria for randomization of reviewer assignment? (for instance, requirements to make sure there is a certain geographic representation, or balance of small and large centers, or ensure that numbers of cases are fairly evenly distributed).). If yes, what would need to be included? 1. Composition: Some balance should be used as, by randomization, it is statistically possible that the majority of reviews might come from the surrounding regions (by distance) or from very distant regions. 2. Should there be other requirements for who can be on the NHRB? For instance, should the transplant program or the physician be required to have performed at least a certain number of pediatric heart transplants in the last year, or should they be required to be a physician or surgeon? 2. Composition: Physician or surgeon although the majority of programs would have a physician rather than a surgeon given that the latter spends most of his/her time in the OR. My 18+ years of experience with surgeons is that they are so busy, getting them to submit a review in 3 days is not likely to happen. 3. Is there a need for a chair of the NHRB? If so, should the chair of the NHRB be appointed by the Thoracic Committee chair and serve a two year term? Should the chair be randomly assigned cases and vote on them as a member of the NHRB? What role would the chair serve? 3. Composition: A chair should exist for a two-year term. I favor having an election of a chair by the committee members. 4. Who should determine the members of the appeal workgroup? 4. Composition: Probably best to have the 9 who reviewed the case on the first go around. Voting 5. Is three days the right length of time to vote? 5. Voting: 3 days is perfect 6. Is there a need for an additional level of appeal, such as to the entire Thoracic Committee? 6. Voting: +/-. If an additional level of appeal is so desired, then we should have a group of 3 for the year consisting of the chair, vice-chair, and a 3rd individual. If we go that route, then under #3 above, a vote for a vice chair (2 year term) should occur for the first year and then the vice chair rotates to chair for another 2 years. Under this scenario, a vote for chair and vice chair would only occur for the launch of this proposal with a vice chair vote only for when the terms are up. 7. Is nine the correct number of reviewers to consider each application? 7. Voting: Could be less than 9 but not less than 5. 8. Does the alternate need to be notified and allowed to vote on cases that have been sent to the primary reviewer? 8. Voting: The voting would need to be done in 3 days to avoid delays. Each center would be responsible for the primary or alternate to complete the task within 3 days. 9. When both a primary and alternate representative vote on a case in the RRB system, the first vote is counted. The Thoracic Committee proposes that the primary representative’s vote be the vote that counts in that situation under the NHRB. Should it be the same for both boards, and if so, which vote should count? 9. Voting: Yes, the primary representative’s vote should be the casting vote. 10. Is a simple majority the right threshold for approval? 10. Voting: No, probably best to have a threshold, like 75% 11. Did the Committee choose the correct tiebreakers? a. Should the tiebreaker be the same on appeal as it is in the initial review? b. Would it be better to have a chair of the workgroup break ties when a case is appealed to that level? c. Should the exception request be denied when there is a tie instead of being approved? 11. Voting: Tiebreakers should be decided upon by the Appeals committee (see #6) 12. Should there be a time limit for how quickly the Thoracic committee review will take place if an application is appealed to that level? 12. Voting: Same time frame…3 days 13. If a member of the Committee-level appeal workgroup has already reviewed the application as a reviewer on the NHRB, should that reviewer participate in the review of the appeal or not? Should others be excluded from the review? 13. Voting: I would suggest keeping this as simple as possible. If a member already voted and comes to the Appeals Committee, they would vote again. Removal for failure to vote 14. Is three the right threshold for removal for failure to vote on an application? Should it be based on a percentage instead? 14. Removal for failure to vote: Three is the right threshold 15. Is two reviewers removed from the review board the right number for removing a program’s ability to appoint a member for the review board? Should it be within a certain time frame (such as two within a one-year term, or two within 5 years? 15.Removal for failure to vote: Yes, remove from the review board for 2 years. Other 16. Which diagnoses should be addressed in guidance? 16. Other: All diagnoses 17. Are the right data points for evaluating the effectiveness of the review board identified in the Post Implementation Monitoring section below? 17.Other: yes 18. Are there any other areas in which the NHRB should change to align with the way the RRBs or other organ review boards operate? 18. Other: no opinion 19. Should the Thoracic Committee consider using a NHRB for review of adult exception requests as well? 19.Other: yes Sincerely,

Ivan Wilmot, MD | 02/14/2020

Composition 1. Should there be criteria for randomization of reviewer assignment? (for instance, requirements to make sure there is a certain geographic representation, or balance of small and large centers, or ensure that numbers of cases are fairly evenly distributed).). If yes, what would need to be included? 1. A balance of geography and program size is recommended for this pediatric committee. I would require east, west and central US representation and at least 2 representatives from small, medium and large programs. 2. Should there be other requirements for who can be on the NHRB? For instance, should the transplant program or the physician be required to have performed at least a certain number of pediatric heart transplants in the last year, or should they be required to be a physician or surgeon? 2. I would recommend that all individuals participating be involved in at least 5 pediatric transplants annually. I would also recommend that NHRB members be physicians or surgeons. 3. Is there a need for a chair of the NHRB? If so, should the chair of the NHRB be appointed by the Thoracic Committee chair and serve a two year term? Should the chair be randomly assigned cases and vote on them as a member of the NHRB? What role would the chair serve? 3. I would recommend a chair be established for the NHRB as this individual could advocate for pediatric specific transplant related matters. A two year term seems appropriate. The chiar can be a voting member of the NHRB. 4. Who should determine the members of the appeal workgroup? 4. The appeal group should consist of the chair and selected review members. Voting 5. Is three days the right length of time to vote? 5. I would recommend that all cases have a weekly review day for cases, as 3 days would be difficulty to institute. 6. Is there a need for an additional level of appeal, such as to the entire Thoracic Committee? 6. There could be benefit of additional appeal level, and would recommend this include the pediatric chair and the thoracic committee. 7. Is nine the correct number of reviewers to consider each application? 7. Yes. 8. Does the alternate need to be notified and allowed to vote on cases that have been sent to the primary reviewer? 8. Yes. 9. When both a primary and alternate representative vote on a case in the RRB system, the first vote is counted. The Thoracic Committee proposes that the primary representative’s vote be the vote that counts in that situation under the NHRB. Should it be the same for both boards, and if so, which vote should count? 9. Would have the same for both boards, and would have the primary vote count. If there is concern the alternate vote would be used also. 10. Is a simple majority the right threshold for approval? 10. Yes 11. Did the Committee choose the correct tiebreakers? a. Should the tiebreaker be the same on appeal as it is in the initial review? b. Would it be better to have a chair of the workgroup break ties when a case is appealed to that level? c. Should the exception request be denied when there is a tie instead of being approved? 11. Yes would have committee chose tiebreaker and have this as the same on appeal as the initial review as this group will be familiar with the case. 12. Should there be a time limit for how quickly the Thoracic committee review will take place if an application is appealed to that level? 12. Yes, would make this within 10 business days. 13. If a member of the Committee-level appeal workgroup has already reviewed the application as a reviewer on the NHRB, should that reviewer participate in the review of the appeal or not? Should others be excluded from the review? 13. Yes Removal for failure to vote 14. Is three the right threshold for removal for failure to vote on an application? Should it be based on a percentage instead? 14. Failure to vote on a application should be dealt with by the identified Chair. 15. Is two reviewers removed from the review board the right number for removing a program’s ability to appoint a member for the review board? Should it be within a certain time frame (such as two within a one-year term, or two within 5 years? 15. Would keep it as two within a one year term. Other 16. Which diagnoses should be addressed in guidance? 16. All Congential heart disease, Cardiomyopathy and acquired pediatric heart failure should be included in the diagnosis addressed by the pediatric committee. 17. Are the right data points for evaluating the effectiveness of the review board identified in the Post Implementation Monitoring section below? 17. Post implementation monitoring should be dynamic, and may require additional data be gathered over time. 18. Are there any other areas in which the NHRB should change to align with the way the RRBs or other organ review boards operate? 18.No changes at this time. 19. Should the Thoracic Committee consider using a NHRB for review of adult exception requests as well? 19. Adults with CHD are a different population, and review of such individuals may require changes in the thoracic committee review process.

OPTN Region 6 | 02/18/2020

Strongly support (2), Support (14), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0) Region 6 is supportive of the Thoracic Committee’s proposal to establish a National Heart Review Board for pediatric candidates. The presenter commented that with the current review process, adult and pediatric practitioners are both reviewing cases, and the adult practitioners typically look to the pediatric practitioners to inform their decisions. Due to the small number of pediatric practitioners in Region 6, this essentially means that the program involved in the case has a huge influence on the outcome. There was a concern raised about the impact of this proposal on waitlist mortality, especially in regards to Region 6 since it tends to have more exceptions. There was agreement that any impact this has on waitlist mortality would need to be monitored and reviewed.

OPTN Region 8 | 02/18/2020

Thoracic Committee: National Heart Review Board for Pediatrics • General support for the proposal • Support for having pediatric exceptions reviewed by pediatric focused practitioners • Concern about timely response of reviewers even with the mitigating provisions included in the proposal • Suggestions that the committee consider having exception requests for adults with congenital heart defects through this review board as well Vote: 6 strongly support, 12 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose

Children's Hospital Los Angeles | 02/19/2020

On behalf of Children's Hospital Los Angeles, I would like to voice our approval and enthusiasm for the concept of this proposal. Pediatric heart status exceptions are relatively common, and the most recent changes to the status definitions have led to nonuniform attitudes and applications about exceptions, particularly for 1A exceptions. Adult regional review boards often have limited pediatric expertise and investment, which can lead to either misunderstanding or at least non uniformity in the criteria used to evaluate exception requests. A national pediatric review board will, in its ideal form, help provide some uniformity to decision making and help disseminate prevailing attitudes regarding the acceptable criteria for urgent status exceptions. Our center has identified the following concerns and questions regarding the policy as it is currently written: 1) There has been a move to replace phone meetings with email voting at the regional level, which we would like to extinguish with this reform. Email voting removes discussion and debate regarding policy issues, and tends to lead to more approvals of exception requests. Given that there are serious issues at hand for this board to address (including the handling of exception requests for some critically ill inotrope-dependent cardiomyopathy patients who formerly met 1A criteria, who now are 1B by default), I advocate for a mechanism in which the board can discuss cases prospectively. Phone meetings are difficult, especially across time zones, but a forum is needed for such discussion. One solution could be an option to include voting options to "approve with prejudice" or "disapprove with prejudice", which would call for the board to have a discussion about certain cases before decisions can be made. This would allow straightforward cases to be approved or declined by simple vote, but allow for identification and discussion of cases that justify the effort. 2) Acknowledging that there is an appeal process in place in this proposal, complacent Boards will tend to approve cases, not disapprove them. Appeals will not be utilized unless the Board declines cases. This is another point demonstrating the importance of prospective discussion rather than simple voting. 3) We wonder if the composition of the board will be standardized by region, or by center. Some regions have more pediatric centers. If all centers are allowed equal participation, lower density regions may be underrepresented. If all regions have equal representation, then certain centers may be over represented. 4) In our Region 5 meeting, a member proposed having different turnaround times for different urgencies, but keeping all exception approvals PROSPECTIVE rather than having 1A exceptions be retrospective. Our center supports this proposal. The urgency of 1A exception requests would require prospective turnaround within 24 hours, and 1B requests could take up to 3 days to complete. We feel that this proposal is of lower importance than the need for a review board discussion mechanism as discussed in (1). Thank you for your attention to our concerns. Again, we fully support this proposal with consideration of our viewpoints.

David Silber | 02/19/2020

I am an Adult transplant cardiologist currently serving on a regional review board which I have done for >15 years. Often I am asked to review pediatric cases and am not especially qualified to evaluate the intricacies off all the issues. There are frequently not enough members in a given region with pediatric expertise and thus having a board made up entirely of pediatric heart transplant physicians would be highly desirable. The policy was defended by myself at the recent Region 2 Spring meeting in Baltimore.

Anonymous | 02/19/2020

I agree with the authors comments. Unfortunately because the majority of members that review the status exception requests are adult cardiologist, I worry that they typically grant exception out of compassion for children. In doing so, there are probably too many exceptions being granted which bypasses the current intent of the exceptions. I think pediatric transplant cardiologist are better positioned to review these exceptions.

Peter Eckman | 02/20/2020

Dear OPTN/UNOS, I am a board-certified Advanced Heart Failure and Transplant cardiologist at the Minneapolis Heart Institute in Minneapolis, Minnesota. I have been involved in selecting and managing hundreds of candidates for heart transplant and the care of post-transplant heart recipients and have served as a Regional Review Board (RRB) member on several occasions. I have served as our center's RRB representative for the past year, and have reviewed hundreds of requests for listing by exception. A small minority of these requests are for pediatric candidates. Although I feel prepared and qualified to comment on some of the older (teen, e.g.) candidates without complex congenital disease, the bulk of the pediatric requests come from much younger children. The evaluation and management of these critically ill children is outside of my scope of expertise and I feel strongly that creation of a national pediatric heart transplant review board would be in the best interest of patients, hospitals, and physicians. As an adult cardiologist reviewing sporadic requests for exceptional status for children, my general bias in toward giving the requesting center the benefit of the doubt, and I don't believe I have ever voted to deny a request. Some may have been insufficiently meritorious, but any potential "harm" of my decision to approve these requests is to the system, and may disadvantage other more suitable candidates. The creation of a national review board, consisting of physicians with appropriate expertise is in everyone's best interest and I urge support of the proposal. Best regards, Peter Eckman, MD, FACC, FHFSA, FAHA Minneapolis Heart Institute

Anonymous | 02/20/2020

As a heart recipient as an infant myself, I think this is a great idea. We should always be trying to find the best donors to the best match when it’s needed the most.

Transplant Families | 02/20/2020

Transplant Families supports the National Heart Review Board (NHRB) proposal as it ensures that these very complex CHD and cardiomyopathy cases are primarily reviewed by pediatric (as opposed to general) cardiologists during bridging to transplant. We hope that the causal reasons for this proposal (high exception rates) will be revisited in the near future so that heart failure kids are prioritized not only by diagnosis, but by medical necessity (i.e. those who needs it the most and cannot be helped by other means, such assist devices.)

Region 5 | 02/21/2020

Strongly support (14), Support (12), Neutral/Abstain (3), Oppose (0), Strongly Oppose (0) Region 5 supported the proposal No comments or questions

Region 2 | 02/28/2020

4 Strongly Support, 16 Support, 5 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose During the Thoracic Committee breakout, attendees discussed the committee’s on-going projects, including the creation of a guidance document on the use of exceptions for Status 2 Candidates on Intra-Aortic Balloon pumps. One member said that guidance documents are better for the review board reviewers, because it provides a framework for their review; otherwise, clinicians are writing exceptions in different ways based on the composition of the board that will be reviewing their case at the time (which they noted changes frequently). The attendees were also provided an update on some of their most recently implemented projects, including Eliminate the Use of DSAs in Thoracic Distribution. Attendees commented that only a small impact had been seen at this point, but it was still very early in the implementation cycle. Attendees also provided feedback on the outcomes report by Cogswell, et al “An early investigation of outcomes with the new 2018 donor heart allocation system in the United States.” A few members discussed that the drop in survival rate may be attributed to factors such as surgeons going out on recoveries more, which increases time to recover, increased cold ischemic times, as well as the patients are just sicker. They did express concerns regarding the perceived lag time on the OPTN’s data and monitoring reports and how that may be impacting the use of the analysis overall. The attendees reviewed the proposal out for public comment- the National Heart Review Board for Pediatrics. There was widespread support for creation of the National Heart Review Board for Pediatric candidates and that it should be comprised of physicians with pediatric specialties. The group discussed the importance of requiring representatives to vote within a relatively immediate time period because it increases the chance centers will receive a decision prior to proceeding to transplant. Some expressed interest in reducing the period to 48 hours (2 calendar days) due to the severity of the cases. Most of the attendees in the session were affiliated with adult programs and were interested in seeing what lessons would be learned and applied to adult exceptions case review. However, there was a general consensus that a national heart review board for adults would have an overwhelming number of cases and may not be viable.

OPTN Pediatric Transplantation Committee | 03/06/2020

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide feedback on the “National Heart Review Board for Pediatrics” proposal. Due to the wide range of activity level among these programs, some committee members felt that programs who complete more transplants should have more representation on the review board rather than the proposed equal representation from all 65 programs. Other members expressed that some lower volume centers may still have surgeons with extensive experience. Members also suggested that the National Heart Review Board for Pediatrics may want to look to the National Liver Review Board (NLRB) for guidance during its early development. Vote: 5 Strongly Support, 3 Support

Region 1 | 03/10/2020

Strongly support (5), Support (6), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Region 1 Supported this proposal Comments: • A question was raised about how reviewers will be randomly assigned. • How many pediatric programs are there? • Will we identify voters during the voting process, o It was stated that lung does this. • Should somebody other than a physician or surgeon be allowed to review a case? o Presenter thought that you need MD for sufficient knowledge. o Another speaker mentioned workload and whether there are enough lung MDs. o Could nurse practitioners do a sufficient job? o The group agreed that it should be a clinician but might not need MD. What are some of the common scenarios when someone is turned down? • Not enough representation of clinicians on review board who are pediatric experts; majority of these cases are accepted • All review boards need to have one purpose; the process needs to be standardized so that one area is more lenient than the other • Process has to be standardized, one area is very lenient and others are not

Region 11 | 03/19/2020

Strongly support (7), Support (8), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Region 11 supports this proposal

OPTN Region 3 | 03/22/2020

Feedback: • Overall agreeance that this is a reasonable proposal: • Concern that majority of review board members are from adult programs/do not specialize in pediatrics • Concern that adult heart representatives are not voting consistently with pediatric heart representatives • Suggestion that pediatric representatives should only vote on pediatric cases if this is implemented Vote: 3 strongly support, 15 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) approves and supports the formation of the National Heart Review Board for Pediatrics. ASTS understands that these national boards are being introduced as part of the broader sharing agreements. However, we encourage the OPTN/UNOS and its various committees to engage in a conversation regarding the unintended consequences of these broad national committees as they can become themselves impediments to new innovations and the exploration of new indications in transplantation. ASTS would be pleased to collaborate on such an effort with UNOS.

NATCO | 03/23/2020

NATCO strongly supports the proposal to create a NHRB specializing in pediatric Status 1A and Status 1B exception requests. In alignment with the Thoracic and Pediatric Committees, NATCO also favors using only pediatric specialists to review exception requests for pediatric candidates. Further to the request for feedback regarding specific operation of the proposal, NATCO offers the following: 1. On composition requirements, NATCO supports a criteria that ensures a geographic balance of representation, to include centers from eastern, central, and western regions of the US, as well as representation from small and large centers. In addition, NATCO supports that membership on the NHRB be limited to pediatric surgeons and cardiologists who have at least one year of pediatric heart transplant experience, within the last year. NATCO supports the idea of identifying a chair and vice chair of the NHRB for elected 2 year terms to be responsible for ensuring the proper administration of the implementation and operation of the NHRB in accordance with policy. Consideration should be given to establishing an appeals workgroup selected by the chair from within the pool of reviewers who present the same balance as the majority of reviewers and who retain the same pediatric heart transplant expertise as the entire pool. NATCO recommends that the workgroup consist of reviewers unique to the original review group in order to present a true re-evaluation of the case. 2. On voting requirements, NATCO supports the committee’s recommendation that 9 reviewers represent a sufficient number of reviewers based on the rationale provided in the proposal. NATCO also supports the voting process, including remedies for failure to vote, and the appeal process as outlined in the proposal and does not think further levels of appeal beyond the workgroup are needed.

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is highly supportive of the proposed National Heart Review Board for Pediatric Candidates. We agree that pediatric heart transplant decisions require experts in congenital heart diseases (CHD) and children to best determine whether exceptions are justified and to decrease geographic variation that currently exists within the system to be compliant with The Final Rule. The Pediatric and Thoracic constituencies of AST have comments and answers to the questions posed by the OPTN Thoracic Committee: • Having a separate NHRB for pediatric candidates ensures that pediatric physicians are reviewing pediatric cases (for which they’re uniquely well suited); and that they are not reviewing adult cases (for which they may be less well suited). The only potential concern is one of workload but given that the field is generally enthusiastic about this proposal, it is not foreseen that there will be difficulties in enlisting help from transplant centers. • The proposal is designed to increase the likelihood that exception requests are more uniformly handled in light of (1) data that shows expected wait-list mortality of the 1A exception requests is lower than that of pediatric candidates meeting conventional 1A standard criteria and (2) in some regions, 25 % of status 1A recipients were by exception, and in other regions, 0 % of status 1A recipients were by exception. Since no data was supplied in this proposal relating to the denominator of exception requests, it is unclear as to whether this regional variation was related to over scrutiny by regional review boards, vs under-requesting (or appropriate requesting) by centers within region. Pediatric centers are skewed even more than adult centers geographically. • It is felt that as proposed, if both the primary reviewer and the alternate reviewer provide votes, only the primary reviewer’s vote will count. This seems unfair given that there was a delay in the primary reviewer’s completion of the work. We suggest that it may be more just to have the vote of the alternate reviewer count if they had been enlisted to do the work. • Given that there are very significant differences in the size of pediatric heart transplant programs, perhaps consideration should be given to having larger centers have more representation. • It seems, by the proposal as presented, that there is concern that too many exception requests may be granted by the current system of RRBs. Perhaps in the new system of pediatric NHRB consideration should be given to rather than a simple majority, that 6 of 9 votes on an initial request are necessary for approval. If a center then appeals the decision, the threshold could be a simple majority. • We would support the idea of randomization criteria for reviewer assignment. • While ideally there would be geographic balance we recommend that there should be some minimum threshold for pediatric heart cases (i.e., to be asked to participate on the board). We would agree that participants be physicians or surgeons, given the potential complexity of the medical issues involved. • We suggest that reviewers to be limited to those from centers that have actively performed at least 2 pediatric transplants within prior 12 months. • The appeal workgroup should be a standing work-group with a Chair and Vice-Chair so that it does not need to be recreated each time. The Vice-Chair being a voting member of the Workgroup and the Chair voting only in cases of tie or similar. • Three days is felt to be the correct time to review and vote but consideration should be given to a mobile app-based notification and entry • Appeal to the entire Thoracic Committee is unnecessary. Three layers of appeal is adequate. • Agree with the 72-hour time limit for voting. • If a member of the Committee-level appeal workgroup has already reviewed the application as a reviewer on the NHRB, that reviewer should be allowed to participate in the review of the appeal. • If reviewers serve limited terms, if two reviewers from one program are removed for inadequate performance, future members to the review board from the same program would be allowed. • Cardiomyopathies are the area where there is the greatest need for guidance.

OPTN Region 9 | 03/24/2020

Strongly support (6), Support (5), Neutral/Abstain (2), Oppose (0), Strongly Oppose (0) The region supports the proposal. There was overall agreement that the current system needs to be changed – adult practitioners are uncomfortable reviewing pediatric cases.

Society for Pediatric Liver Transplantation | 03/24/2020

The Society for Pediatric Liver Transplantation supports the efforts of UNOS to have pediatric heart subspecialists reviewing pediatric heart cases for consistency. Lessons learned from the implementation of the Pediatric National Liver Review Board would require an assessment of regional variation in practice and volume and ongoing monitoring of pediatric morbidity and mortality on the wait-list and post-transplant for these patients.

Region 10 | 03/24/2020

5 Strongly Support, 7 Support, 6 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose The members of the region supported the proposal. From the online comments there was concern over having a large group of reviewers reaching consensus on the document guiding referrals. There was also confusion about the appeals process. The commenter added that with a large review board those members will review only a few cases. Lastly, the commenter expressed concerns about the data collection plan suggesting that data be collected on both patients that are approved for exceptions and those that are not. This data could help guide exception request approvals later on.

St Louis Children's Hospital | 03/24/2020

We are generally supportive of the proposal for a Pediatric Review board given the unique pathology of our patients and agree with the many of the comments/concerns from our colleagues in other institutions. There are concerns regarding the logistics and structure of the board. A 3 day window may be too short a time to provide a good and full review of exception requests, especially for a delegate from a smaller program with fewer physicians and lead to unfair penalties to smaller programs. We do agree that there should be criteria for randomization for reviewers, potentially asking for reviewers from 9 different UNOS regions to mitigate regional differences in use of VAD vs Inotropes, for example. It would be reasonable for the committee to have a chair, but we would prefer that this chair be from UNOS and not one of the centers. Another question is the handling of Adult Congenital patients submitted for exception: would these patients go through this review board? Given the increasing population of ACHD patients referred for transplant evaluation, this has the potential to increase the workload significantly. The "jurisdiction" between the adult and pediatric review boards would need to be clearly defined.

Region 7 | 03/24/2020

10 Strongly Support, 4 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose The region supports the proposal. There was a comment that the proposed pediatric review board composition is set up well, but request that the adult congenital population not be included. It was also noted that reviewers from the same region as the exception request should be excluded from reviewing that case. Since the heart community is small it could be possible for a reviewer to figure where an exception request was coming from if the reviewer is in the same region. There was a suggestion to increase the number of reviewers on a given exception request.

Joseph Hillenburg | 03/24/2020

I support this proposal and believe it would be beneficial to candidate recipient families. I would urge the new committee to adopt lessons learned from the liver review board, both as an improvement measure, and to add congruence to policy.