Proposal to Establish a National Liver Review Board

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. • 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 • Post-transplant mortality is not projected to change, and rates are similar for recipients with no exception, HCC, and other exceptions. • Transplant Rates • 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.

18. 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

19. 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

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 All of the diagnosis recommendations are available in the Liver Review Board Guidance policy proposal at https://optn.transplant.hrsa.gov/

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

24. How will the OPTN implement this proposal? The OPTN/UNOS will work with the Committee to develop the orientation training all NLRB representatives and alternates must complete before beginning their term of service. The content of this guidance will be included as part of that training.

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

26. Supplementary Slides