1. Liver and Intestinal Organ Transplantation Committee
Welcome, Introduce yourself.
Fall 2015 Update

2. Recent Board Approved Projects
Membership and Personnel Requirements for Intestine Transplant Programs
3rd round of public comment, Jan.-Mar. 2015
Board approved - June 2015
Pending prioritization and OMB approval
Guidance to Liver Transplant Programs and Regional Review Boards for MELD/PELD Exceptions
2nd instillation of guidance
Includes guidance on Primary Sclerosing Cholangitis (PSC) and revisions to Portopulmonary Hypertension (POPH)
First, I would like to provide you with an update on the Liver Committee’s proposals that were most recently discussed at the Regional Meetings.
The Membership and Personnel Requirements for Intestine Transplant Programs made its third round of public comment from January-March, The Committee worked diligently to address the concerns voiced by the community during the prior public comment periods, especially in regards to the timeframes and volume requirements. We added language to describe the conditional program-approval status and the transition plan from the current system in more detail. The goal of this policy is to establish minimum standards where none currently exist without compromising quality or restricting new program formation. The Committee felt that the proposed thresholds represent a level of experience necessary to provide appropriate care to these patients. We presented this proposal to the Board of Directors in June 2015 where it was approved. We are waiting for OMB approval and prioritization before it can be implemented.
During that board meeting, we also presented the second installment of the Guidance for Liver Transplant Programs and RRBs for MELD/PELD Exceptions. This proposal was also approved. This version incorporated guidance on Primary Sclerosing Cholangitis (PSC) and revisions to Portopulmonary Hypertension (POPH). The first installment which focused on guidelines for Neuroendocrine Tumors (NET) & Polycystic Liver Disease (PLD) was approved Board in June As a guidance document, this project does not require additional programming or planned implementation and you can find this resource on the OPTN webpage.

3. Policy Implementation Dates
Project
Delay HCC Exception Score Assignment
Cap HCC Score at 34
Reinstate Override Button for Denied MELD/PELD Exceptions
MELD-NA
Public Comment
March - June, 2014
N/A
March - June, 2013
Board Approved
November, 2014
June, 2009
June, 2014
Expected Implementation Date
3rd Quarter, 2015
4th Quarter, 2015
As far as policies previously approved, pending programming and implementation, I’m happy to provide you the following updates:
In June 2009, the Board approved a proposal to reinstate the MELD/PELD exception “override” button, which was removed when a modification to the original policy was implemented. Reinstating this button will enable a treating physician to make the ultimate decision regarding the candidate’s listing in cases when the physician and the Regional Review Board (RRB) cannot reach an agreement. Such cases would be referred to the Liver Committee for additional review. This project is currently being programmed and we anticipate it will go live during the 3rd to 4th quarter of 2015.
Also currently being programmed and anticipated to go live during the 3rd quarter are the policies to Delay the HCC Exception Score Assignment and to Cap the HCC Score at 34. Candidates with a MELD/PELD score exception for HCC receive high priority on the liver waiting list, especially since their exception scores may increase automatically every three months. These candidates have significantly lower dropout rates (i.e., removal from the waiting list for death or being too sick) than non-HCC candidates, with the exception of those areas of the country with lengthy waiting times. Additionally candidates with multiple HCC exception extensions are increasingly receiving regional offers under the “Share 35 Regional” policy implemented in June This Delay HCC Exception Score Assignment policy should address the disparities in drop-out rates between patients with HCC exceptions and those without. The Cap HCC exception score at 34 policy, will in effect give candidates with calculated MELD/PELD scores of 35 and higher a better opportunity to receive regional offers under the new policy.
Finally, the board approved the policy incorporating serum sodium into the MELD Score at its June 2014 meeting with an amendment restricting the additional points for sodium to only those candidates with a MELD score of 12 or higher. Once programmed, the system will automatically calculate candidates’ new MELD score. The Committee has requested a 7-day “grace period” during implementation for those candidates whose scores would be moved from one recertification category to another, and may as a result require immediate recertification (i.e., the candidates would face an immediate “downgrade” of their MELD score). If a center has not recertified these candidates on the 8th day after implementation, the candidates will be downgraded to their previous lower MELD score as is done currently when certification expires. We anticipate programming to begin during the 4th quarter of 2015, and implementation

4. Redesigning Liver Distribution
Committee Projects
Redesigning Liver Distribution
The Committee unanimously resolved to consider additional results in modeling of concepts previously developed and to further analyze an additional concept…
Board Resolution
Concept presented to Committee
Statement to the Community
Development of Steering Committee
Concept Paper & Questionnaire
September 2014 Liver Forum
Development of the Ad Hoc Subcommittees
Additional Modeling and Analyses
June 2015 Forum
In regards to redesigning liver distribution, first let me be clear that there is no policy proposal immediately forthcoming from the Committee on this project. We do however, have a substantial update.
Following the September, 2014 Public Forum on Redesigning Liver Distribution the Committee established three Ad Hoc Subcommittees to address the following areas in their quest to reduce geographic variation in severity of illness at transplant :
metrics to assess geographic disparity
logistical/transportation considerations
financial issues
Additionally, the Committee revived and repurposed an earlier subcommittee to address this topic in a parallel effort to redesigning liver distribution, to identify issues that may apply broadly to overall system improvement.
The Ad Hocs were purposefully composed of committee members as well as additional subject matter experts. These experts had diverse opinions and differing expertise and represented a variety of populations and regions. Each of the Ad Hocs deliberated and completed additional analyses and developed data driven and consensus-based recommendations to help refine existing concepts or develop new ones. They shared their findings with the full committee and later the community in June Nearly 200 people attended the forum in person and approximately 210 more participated by webinar.
The Committee met the day after the Forum to debrief and determine a path forward. It was clear to members that they were not ready to present a proposal and based on the ideas and questions raised by the community, further work was needed. They unanimously resolved both to consider additional results in modeling of concepts previously developed and to further analyze an additional concept. Based on significant feedback, these additional analyses will include variation in candidates’ lab MELD/PELD score at transplant, to evaluate the results without the bias of varying exception point practices across the country.
Also based on community input, the Committee agreed to further investigate the newly proposed concept of using concentric circles based on the donor location, giving additional proximity points to local candidates. The Committee resolved unanimously to model the concept of 500-mile concentric circles from the donor location, with additional priority given at radii of 150 and 250 miles and to continue the emphasis on assessing the cost and transportation implications of any system of broader sharing. The Committee will continue to provide updates as the requested analyses become available.

5. Committee Projects Combine current RRBs into “Super Review Boards”
Reps serve a 2-3 year term with a two consecutive term limit
Pediatric providers would review pediatric cases and adult providers would review adult cases
Updated Operational Guidelines & related Educational Modules
Liver Review Boards
In November 2013, the Board directed the Committee to develop a plan for a National Review Board (NRB) for MELD/PELD exceptions. At the June 2014 Board meeting, the Committee presented the preliminary construct for an NRB, and requested Board feedback. The Board supported the concept and urged the Committee to continue its work. The goal of an NRB is to promote consistent reviews across the country.
The construct that the Committee initially presented to the Board is similar to one that was circulated for public comment in As the committee developed this concept, members agreed that one national liver review board posed more challenges than solutions. Additionally, it would create an exponential estimated cost to program.
The Committee is currently exploring the idea of combining current regions into “Super Review Boards.” Under this concept, regions would still be required to select representatives who would serve a 2-3 year term with a two term limit, but the number of representatives would not be limited, as long as adequate pediatric representation is maintained. The Committee is currently considering which regions are most appropriate to combine, how to ensure adequate pediatric representation on each Review Board and potentially incorporating a provision for liver-intestine case reviews. Cases submitted for review would be assigned randomly to 7 members of the review board and would be closed when 4 members have voted; much like the way the current RRB process functions. Pediatric providers would review pediatric cases and adult providers would review adult cases. The committee will develop additional standardized guidelines for approving MELD/PELD exception cases that the Super Review Boards can use to promote consistent reviews. The Committee will likely seek endorsement from the Board on this refined concept in December, 2015 and circulate a proposal during the spring 2016 public comment period.

6. Committee Projects Duties Policies Guidelines Process
In a related effort, the Committee has developed an educational module for the current RRBs. This module addresses the varying degrees of understanding RRB members have of their duties, liver allocation policies, and the RRB process. It also educates incoming and new RRB members about MELD/PELD exception policies.
The Committee will host a webinar early this fall for all RRB members to roll out these new educational materials, which were successfully piloted in Region 5 last year. The webinar will train members on the general responsibility and process of the RRBs, members’ roles in that process, and the policies and guidelines related to candidate prioritization and liver allocation. Region specific agreements will not be covered but will be made available to each region for further study.

7. Questions?
Ryo Hirose, MD Committee Chair Regional representative name (RA will complete) Region X Representative address Christine Flavin, MPH Committee Liaison