Comments

NATCO | 03/24/2020

NATCO supports the proposed enhancements to the National Liver Review Board policies regarding the granting of automatic extension requests for HCC candidates; and, the updates which clarify the timing for recalculation of the MMaT and MPaT scores. NATCO supports the updates to the operation guidelines and recommends consideration be given to pediatric patients when developing language instructing reviewers how to evaluate candidates with unique situations. NATCO also supports the adjusted thresholds for removing inactive reviewers; and, the clarifications proposed to delegate authority for final appeal review to a subcommittee.

Region 7 | 03/24/2020

3 Strongly Support, 7 Support, 0 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Members of the region supported the proposal, but had two suggestions. First, reviewers should only evaluate the clinical circumstances of the patient. There are instances of a program’s exception request being denied because a reviewer has suggested another treatment option. Often times the center has already ruled that treatment option out for their patient. Second, there was a suggestion that adult metabolic diseases have detailed guidance similar to pediatric metabolic diseases.

UPMC Children's Hospital of Pittsburgh | 03/24/2020

UPMC Children’s Hospital of Pittsburgh (www.chp.edu) supports the work of the Liver Committee in continuously evaluating the NLRB and evaluating the way exception cases are reviewed. We support the automatic approval of HCC extension requests as long as they meet standard extension criteria. We ask for careful consideration for adult candidates with metabolic disorders. Patients with metabolic disorders not transplanted in early childhood continue to face challenges with proper allocation during adolescence and early adulthood. Older patients with urea cycle defects and organic acidemias face similar, unpredictable neurological crises and hyperammonemic episodes as younger patients, independent of quality of care or adherence. Disease severity and the morbid consequences of these underlying metabolic disorders do not subside on a patient’s 18th birthday, and we therefore strongly disagree that MMaT- 3 would give adequate priority for these underrepresented candidates and advocate that the review committee be advised that MMAT+3 is a score more in line with the status 1b that is granted children with identical metabolic diseases. We remind the committee that in the case of organic acidemias, the recipient is able to domino their liver to another recipient (REF) which would not occur if organic acidemia patients are not prioritized. Reference: Celik N, Squires JE, Soltys K, et al. Domino liver transplantation for select metabolic disorders: Expanding the living donor pool. JIMD Rep. 2019 Jun 19;48(1):83-89.

Starzl Network for Excellence in Pediatric Transplantation | 03/24/2020

The Starzl Network for Excellence in Pediatric Transplantation (www.starzltransplantnetwork.com) supports the work of the Liver Committee in continuously evaluating the NLRB and evaluating the way exception cases are reviewed. The Network supports the automatic approval of HCC extension requests as long as they meet standard extension criteria. The Network asks for careful consideration for adult candidates with metabolic disorders. Patients with metabolic disorders not transplanted in early childhood continue to face challenges with proper allocation during adolescence and early adulthood Older patients with urea cycle defects and organic acidemias face similar unpredictable neurological crises and hyperammonemic episodes as younger patients, independent of quality of care or adherence. Disease severity and the morbid consequences of these underlying metabolic disorders do not subside on a patient’s 18th birthday and we therefore strongly disagree that MMaT- 3 would give adequate priority for these underrepresented candidates and advocate that the review committee be advised that MMAT+3 is as a score more in line with the status 1b that is granted children with the identical metabolic diseases. We remind the committee that in the case of organic acidemias, the recipient is able to domino their liver to another recipient (REF) which would not occur if organic acidemia patients are not prioritized. Reference: Celik N, Squires JE, Soltys K, et al. Domino liver transplantation for select metabolic disorders: Expanding the living donor pool. JIMD Rep. 2019 Jun 19;48(1):83-89.

Region 10 | 03/24/2020

3 Strongly Support, 12 Support, 7 Neutral/Abstain, 0 Oppose, 1 Strongly Oppose Members of the region supported the proposal. There was a comment to make more of the exception requests more template driven instead of submitting narratives. From the online comments there was a suggestion to look at different exception points or to equalize MMaT similar to acuity circles. Another comment stated that MMaT -3 needs to be fixed. It is not equitable, and in their experience, they are seeing more deaths on the waitlist even though they have patients with MELDs greater than 30.

Society for Pediatric Liver Transplant | 03/24/2020

The Society for Pediatric Liver Transplantation supports the efforts of UNOS to make this process more transparent, efficient and equitable. There are two specific points in the proposal for which we suggest additional consideration: --Reviewer missing 5% of all cases may be removed from NLRB: We question whether this threshold will be appropriate for the Pediatric NLRB, in which the total volume of cases is low relatively to the other NLRBs. Initial data reports 65 providers reviewed ~500 cases in the initial 6 months. Even 1-2 cases might then be >5% of a Pediatric NLRB reviewer’s cases. Based on the distribution of missed cases, missing more than 3-5 cases in 12 months may be a more appropriate threshold for Pediatric NLRB reviewers. --We also suggest appointing a Pediatric NLRB chair, as a rotating position, to help determine these thresholds moving forward. --Adults with metabolic disease: We request clarification in whom should be considered for these MELD exceptions. The proposed language suggests that the diagnosis or symptoms must be new. In our experience, adults with known metabolic disease that had been medically manageable can also develop medically refractory, recurrent life-threatening symptoms that would also be an appropriate trigger for liver transplant. We suggest adjusting this policy language the acknowledge that either new symptoms or progression to medically refractory or life-threatening symptoms would be appropriate for an exception. We agree that starting with MMaT-3 and considering a higher priority score for life-threatening complications is reasonable for these exceptions. We would also be supportive of efforts underway to provide more clarity in assigned scores for exceptions through the exception guidance, as well as the need to address issues with PELD and status 1B in allocation priority for children.

OPTN Region 9 | 03/24/2020

Strongly support (2), Support (10), Neutral/Abstain (2), Oppose (0), Strongly Oppose (0) The region supports the proposal, and there were no comments

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is supportive of this proposal, and offers the following suggestions that have the potential to further improve NLRB efficiencies 1. Given the recent implementation of the new MMaT MELD upgrade and the acuity circle allocation system, the MELD scores at which HCC patients are being transplanted should be closely monitored to determine how the new acuity circle allocation system is impacting HCC patients. Consideration should be given to updating MMaT every 3 months instead of every 6 months to better stay abreast of the real-time impact that the new system may have on the MELD exception candidates. 2. Consideration that previously treated HCC lesions which were within Milan criteria at the time of the presentation should be granted automatic acceptance for the MELD upgrade. 3. Consideration of standardization of data presented to the NLRB to capture essential elements and minimize submissions with long and confusing narratives which may potentially lead to an unfavorable decision. 4. Monitoring of reviewer adherence to the NLRB guidance. Some AST members have noted that some cases have been declined by reviewers even when patients fit the exception criteria provided in the guidance document. For example, reviewers who have high appeal rates can be flagged for a more in-depth examination of reviews by UNOS Liver and Intestinal Committee to determine if there is a consistent trend of unjustified denials and a re-direction towards the guidance document can be implemented. 5. Consideration for a 6-month rather than 12-month period for removal of inactive reviewers.

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) generally supports this proposal, with some specific comments as noted. The purpose of the NLRB has been to empower a group of experts to uniformly and consistently review requests for MELD and PELD exceptions scores. While this is true in the majority of the cases, the NLRB might be faced with unique exception requests. NLRB members should have the latitude to use their medical judgment and holistically consider each patient’s case while operating within OPTN policy. To that end, ASTS also believes reviewers should refrain from suggesting alternative medical care on a given case and focus on the merits of the requests and supporting evidence. ASTS strongly supports removing reviewers if they do not participate in examining 5% of the caseload during a six-month interval. We believe an inactive reviewer who is permitted to remain on the board for 12 months could be detrimental to patient care. ASTS agrees with the policy for automatic approval of extensions for HCC exceptions, provided they meet standard criteria. We suggest a review of random samples every quarter to make sure that programs are meeting extension request criteria. Randomly reviewing HCC documentation (imaging and alpha fetal protein levels) may be helpful to periodically evaluate and validate the process. ASTS recommends the following with regard to the Guidance Documents: 1) Adult patients with secondary sclerosing cholangitis should be afforded similar consideration as patients with primary sclerosing cholangitis. 2) Adults with metabolic symptoms belong to a patient subgroup whose clinical presentation can vary depending on the specific metabolic defect. For example, some patients may present with very minimal symptoms and others with severe symptoms affecting quality of life. Awarded exception points should depend on each individual case. In fact, there are varying opinions regarding the use of liver transplantation in certain subgroups versus medical management. It would be deleterious to other patient subgroups if all adult patients with metabolic symptoms were awarded similar priority (MMaT-3. 3). For adult patients with hepatocellular carcinoma (HCC), we agree with proposed language to reduce ambiguity. As for recommended improvements of NLRB, ASTS recommends the OPTN Liver and Intestinal Organ Transplantation Committee use data on pediatric exceptions as a means to improve the PELD scoring system.

OPTN Region 3 | 03/22/2020

No comments Vote: 2 strongly support, 16 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

Region 11 | 03/19/2020

Strongly support (4), Support (6), Neutral/Abstain (10), Oppose (1), Strongly Oppose (0) Region 11 generally supports the proposal. During the discussion the following feedback was provided: • Some members on the review boards aren’t as familiar with the guidelines so anything that can be standardized is good • MMaT needs to be done in real time because it can change relatively quickly and has an important impact on candidates access to offers • Timeframe for assessing the allocation changes and calculations of MMaT are arbitrarily long • Committee needs to provide more guidance for pediatric exceptions • The 18 month lag of data regarding HCC exceptions will continue to exacerbate the discrepancy of patients

Anonymous | 03/11/2020

I believe that the rules for patients with metabolic liver disease or any autoimmune type of liver disease should have different meld scoring. I apologize if this is in the wrong place or not appropriate for this board, but I was not sure where to post this or how to get this message to anyone that would possibly read it. The current meld score system does not accurately state how ill someone with an autoimmune disease actually is. As patients they can be gravely ill but still have a low meld score. And for those patients that have remained active and have taken care of their bodies by eating properly and not drinking or smoking (ever), partaking in daily exercise programs, etc. this is unfair. I believe this needs to be addressed and changed.

Region 1 | 03/10/2020

Strongly support (1), Support (8), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Region 1 supports this proposal. Comments: • We need the ability to review on your phone • One commenter thinks needs to be more stringent • A guidance documents should be developed

Anonymous | 02/28/2020

2 Strongly Support, 16 Support, 6 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Members of Region 2 supported the proposal. One member commented that it would be helpful if there was an opportunity for reviewers to get answers to questions on an exception request before having to vote. Often times it is a simple clarification and it could save time to get an answer instead of denying the request. Another member commented that there needs to be additional clarification about HCC candidates who are listed, drop off for a period of time, and then get re-listed. Lastly, one member commented that it is confusing when listing an exception that the requesting program has to submit a specific MELD score but the review board only sees the MMaT -3. For consistency, the requesting program should also see the MMaT -3.

Region 5 | 02/21/2020

Strongly support (5), Support (21), Neutral/Abstain (2), Oppose (0), Strongly Oppose (0) Comments (include discussion during breakouts and general session): Region 5 supported this proposal. Members raised a few questions regarding the review and appeal process. • If a review is appealed and approved upon appeal, there should be training for the original reviewers • Subcommittee to review appeals needs appropriate representation from the three NLRB review boards.

OPTN Region 8 | 02/18/2020

Liver & Intestinal Transplantation Committee: Enhancements to National Liver Review Board • 80% of HCC exceptions were approved which tells us the auto approval is not granular enough • Support for 5% threshold for removal • Support for treating SSC and PSC the same • Adults with metabolic disorders should have the option to request additional MELD exception points. These patients are not all equal and some are at higher risk. Vote: 5 Strongly Support, 14 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

OPTN Region 6 | 02/18/2020

Strongly support (2), Support (13), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) The region supported the proposal. Members offered a variety of feedback in response to the questions asked. They thought inactive reviewers should be assessed more frequently – suggestion of every 6 months instead of 12 months. Inactive reviewers should be removed from the NLRB. Exception requests often do not follow the exception guidelines, so there was a suggestion to have guidelines easily accessible to people submitting exceptions. Since exception narratives are often lengthy and hard to follow, a member suggested shortening the narrative to a timeline of events and facts. There was general consensus that SSC guidance should mirror PSC guidance. In the breakout, there was consensus that MMaT-3 is an appropriate score for adults with metabolic disease. In the main meeting, a member asked whether MMaT-3 makes sense for pediatric patients when they become adults. In addition, there was a comment about that fact that we are now sharing liver organs in a 500 nautical mile circle based on MELD score, however our Region 6 centers designated MMaT determined by the MELD score within a 250 nautical mile nautical circle – this appears to be unjust. Portland transplant centers – Oregon Health and Science University and VA Portland Health Care System have a MMaT of 32 which is equal to the San Francisco programs’ MMaT, and hence the sharing MELD threshold, however, when determining the MELD scores for MELD exceptions – we are ,mandated to use the MMaT within 250 nautical miles – Seattle centers have a MMaT of 31 – hence, the Oregon liver transplant candidates lose a point for MELD exceptions (MMaT of 31), however, they share their liver organs based on MMaT with San Francisco programs, which is 32. This issue needs to be addressed.

Anonymous | 02/13/2020

I believe strongly that the liver transplants should remain within the 250 mile radius (as long as it is in USA). The central US has the most percentage of organ donation notations on drivers licenses and should be awarded for that service to their fellow men/women that they intend to assist.

OPTN Region 4 | 02/08/2020

Strongly support (3), Support (17), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Comments: Region 4 supported this proposal. Those in attendance agreed that this would improve the NLRB. During the discussion some members commented that while meeting the criteria established for each diagnosis is important, review board members need to follow the criteria and not impose medical judgement.

Anonymous | 02/07/2020

As a family member of a liver transplant recipient who received MELD exception points for the presence of hepatocellular carcinoma, I believe that enhancements to the National Liver Review Board will help to ensure that the MELD score reflects the candidate's condition and need for transplant and that this is done in a fair and consistent manner.