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Proposal to Establish a National Liver Review Board

This proposal aims to establish a National Liver Review Board and Transplantation Committee to address issues related to liver and intestinal organ transplantation. The proposal includes changes to the appeals process and the assignment of exception points based on standardized criteria. It also introduces new guidance documents for adult and pediatric MELD/PELD exceptions. The proposal aims to address regional variations in exception score assignments, inefficiencies causing delays, and the escalation of median MELD scores at transplant. It also aims to reduce mortality rates on the waitlist and increase transplant rates. Liver transplant programs will need to appoint representatives and adhere to the board's policies and guidelines. The implementation of this proposal will require programming changes in the UNet system.

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Proposal to Establish a National Liver Review Board

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  1. Proposal to Establish a National Liver Review Board Liver and Intestinal Organ Transplantation Committee

  2. NLRB Timeline OPTN Board June 2017 or Dec 2017

  3. Scope of NLRB Project • Policy • Structure & operations of NLRB already supported in public comment Winter 2016. New proposed policy change only relates to the appeals process (“ART”= appeals review team). • New proposed policy changes: fixed points assignment for candidates meeting standardized MELD/PELD exception criteria (versus current escalator) • Guidance documents • Adult MELD Exception Guidance Document: already supported in August 2016 public comment. Currently, minor proposed revisions to language. • NEW Pediatric MELD/PELD Exception Guidance Document • NEW HCC (non-standardized exception) Guidance Document

  4. What’s new in 2017 proposal

  5. What’s new in 2017 proposal

  6. What’s new in 2017 proposal

  7. What problems will the proposal solve? • Regional agreements lead to variation inMELD exception score assignments • Inefficiencies that lead to delays in awarding exception points • Possible contribution of current MELD exception policy of scores increasing by fixed steps every three months to the escalation of median MELD score at transplant across every region (reference on next slide )

  8. What problems will the proposal solve? • MELD “Inflation”: Northrup et al Hepatology 2015 • Death on waitlist 4.5% with exceptions versus 24.6% without exceptions. • Transplant rate 79% with exceptions, vs 40% without

  9. What are the proposed solutions? • NLRB is comprised of 3 specialty review boards • Adult HCC • Adult Other Diagnosis • Pediatrics • Representation • Every liver transplant program may appoint a representative • Rep. Responsibilities • Reps must vote within 7 days on all exception requests • Non-responsiveness may result in suspension of program’s participation in NLRB

  10. What are the proposed solutions? • Voting • Exception request is randomly assigned to five reps of the appropriate board • Appeal Process • The same five reps of the original request review the appeal • ART (Modification from January 2016 proposal) • If appeal is denied, a conference call may be requested with the Appeals Review Team (ART) • All NLRB members are assigned to serve one month each year on the ART (9 member teams, require 5 for quorum). Conference calls will be held at a fixed day each week and cancelled only if there are no cases • Following ART denial, program may initiate final appeal to the Liver Committee

  11. What are the proposed solutions? • Cap on Exception Points • Adult standard exceptions: if the candidate’s exception score would be higher than 34 based on MMaT calculation, the candidate’s score will be capped at 34 • MMaT Calculation • OPTN will re-calculate MMaT every 180 days using the previous 365-day cohort • At 180 day update: • if MMaT increases, candidates with existing standardized score will be assigned the increased score immediately • If MMaT decreases at the 180 day update, candidates with existing standardized score will not be assigned a decreased score until candidate is due for an extension. (Please Comment - the Committee prefers to revise this, to make all candidates receive new score at 6 month update)

  12. Adult Standard Exception Points MMaT = Median MELD at Transplant

  13. Pediatric Standard Exception Points for Candidates 12-17 years old

  14. Pediatric Standard Exception Points for Candidates < 12 years old

  15. Supporting Evidence • SRTR Modeling examined 1-5 points below MMaT of all recipients in the DSA where the candidate is listed • Proportion of candidates with no exceptions undergoing transplant is estimated to increase as awarded exception points in a scenario decrease. • MMaT – 3 not projected to increase waitlist mortality

  16. Supporting Evidence • Post-Transplant Mortality rates • Not projected to change, and rates are similar for recipients with no exception, HCC, and other exceptions • Transplant Rates • May decrease slightly for all patients as the number of points assigned below MMaT increases • Variation by Region • Analysis showed little variation in transplant rates, waitlist mortality, and post-transplant mortality across the five scenarios

  17. How will members implement this proposal? • Liver Transplant Programs • May appoint rep and alternate to each adult specialty boards • Become familiar with the NLRB Operational Guidelines • Guidelines detail review board process and appeals • No change to qualifying criteria for standardized exceptions in policy • No additional data collection required • Liver programs will have to submit required information in discrete data fields in UNet instead of in narrative form

  18. How will the OPTN implement this proposal? • Expected for 2017 Board Meeting • UNet programming required • Implementation • On implementation date, candidates with approved exception scores will retain their existing score, or will be assigned the new score according to policy, whichever value is higher • We’ll provide orientation training for NLRB members and instructional training for members

  19. Questions?

  20. NLRB Guidance Documents

  21. What problem will the proposal solve? • Non-standardized exceptions informally governed by regional agreements, which vary from region to region • Guidance documents complement the NLRB policy proposal • Guidance provides up-to-date information on non-standard exceptions

  22. What are the proposed solutions? Guidance documents for each of the three specialty boards • Adult MELD Exception Guidance • Supplement existing guidance for NET, PLD, PSC, POPH • Includes guidance from Fall 2016 public comment • Only difference is modification to Budd Chiari and Hepatic Adenoma • Pediatric Exception Guidance • Brand new guidance that did not previously exist • HCC Exception Guidance • For those candidates that do not meet the criteria for standardized HCC exceptions

  23. Adult Guidance

  24. Adult Guidance

  25. Pediatric Guidance

  26. Pediatric Guidance

  27. Pediatric Guidance

  28. Pediatric Guidance

  29. Pediatric Guidance

  30. Pediatric Guidance

  31. Pediatric Guidance

  32. Pediatric Guidance

  33. Pediatric Guidance

  34. Pediatric Guidance

  35. Pediatric Guidance

  36. Adult HCC Guidance

  37. Adult HCC Guidance 1. Patients with the following are contraindications for HCC exception score: • Macro-vascular invasion of main portal vein or hepatic vein • Extra-hepatic metastatic disease • Ruptured HCC • T1 stage HCC HCC MELD exception may be appropriate for patients with macro-vascular invasion of branch portal vein and ruptured HCC. 2. Patients who have a history of prior HCC >2 years ago which was completely treated with no evidence of recurrence, who develop new or recurrent lesions after 2 years should generally be considered the same as those with no prior HCC, in order to determine the current stage suitability for MELD exception, and MELD exception score assignment.

  38. Adult HCC Guidance 3. Patients beyond standard criteria who have continued progression while waiting despite LRT are generally not acceptable candidates for HCC MELD exception. 4. Patients with AFP>1000 who do not respond to treatment to achieve an AFP below 500 are not eligible for standard MELD exception, and must be reviewed by the HCC review board to be considered. In general, these patients are not suitable for HCC MELD exception but may be appropriate in some cases. 5. Patients with HCC beyond standard down-staging criteria who are able to be successfully downstaged to T2 may be appropriate for MELD exception, as long as there is no evidence of metastasis outside the liver, or macrovascular invasion, or AFP >1,000. Imaging should be performed at least 4 weeks after last down-staging treatment. Patients must still wait for 6 months from the time of the first request to be eligible for an HCC exception score. • Guidance also includes recommendations for Dynamic Contrast-enhanced CT and MRI of the Liver

  39. How will members implement this proposal? • Review board members should consult this resource when assessing exception requests

  40. How will the OPTN implement this proposal? • Develop orientation training for all NLRB representatives and alternates • Representatives must complete training before beginning their term of service • Guidance will be implemented immediately upon Board approval, and can be used by RRBs until the NLRB is implemented

  41. Questions? Ryutaro Hirose, MD Committee Chair Ryutaro.Hirose@ucsf.edu Matt Prentice, MPH Project Lead Matthew.Prentice@unos.org

  42. Supplementary Slides

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