Liver & Intestinal Organ Transplantation Committee Spring 2015 Introduce yourself. 

Policy Implementation Dates Adding Serum Sodium to the MELD Score Board approved in June 2014 Implementation upon programming, should go live between December 2015-January 2016 7 day “grace period” for transition I’d like to start off with an update on previously approved policies. For those who are unaware of may not recall, once the Board approves a policy, the Executive Committee determines the prioritization of programming required for approved policies. The board approved the Liver Committee’s proposal to incorporate serum sodium into the MELD Score calculation in June 2014. The programming is scheduled to begin in the Fall of 2015 and is anticipated to go live sometime in December 2015-January 2016. The Committee has requested a 7 day “grace period” during implementation for those candidates who are moved from one recertification category to another, and may as a result, require immediate recertification. Eight days after implementation, if a center has not recertified these candidates, they will be downgraded to their previous lower MELD score just as they are today when certification expires. Efforts will be made to help centers prepare for implementation and to identify what patients will need to take priority in recertification to avoid a downgrade.

Policy Implementation Dates Cap HCC at 34 Intent: Give candidates with a calculated MELD/PELD of 35 and higher a better opportunity to receive regional offers under the Share 35 policy Board approved in Nov. 2014 Implementation upon programming, should go live between Aug.-Sept. 2015 The board approved the committee’s proposal to Cap the HCC Exception Score at 34 during the November 2014 meeting. The intent of the policy is to give candidates with a calculated MELD/PELD score of 35 and higher a better opportunity to receive regional offers under the Share 35 policy. Programming is scheduled to begin in the Summer of 2015 and is anticipated to go live in August-September 2015.

Policy Implementation Dates Delay HCC Exception Score Assignment Intent: Reduce the disparity in transplant and drop- out rates for candidates with and without HCC exceptions Board approved in Nov. 2014 Implementation upon programming, anticipated to go live Aug.-Sept. 2015 The board also approved the committee’s proposal to Delay the HCC Exception Score Assignment during the November 2014 meeting. The intent of the policy is to reduce the disparity in transplant and drop-out rates for candidates with and without HCC exceptions Programming is scheduled to begin in the Summer of 2015 and is anticipated to go live sometime in August-September 2015. It will be programmed along with the HCC Cap.

Ongoing Committee Initiatives Redesigning Liver Distribution Concept Document June 2014 694 Responses Analyzed July-August 2014 Public Forum Nearly 500 participants September 2014 Ad Hoc Subcommittees Created October 2014 The Committee continues to study ways to better ensure fair transplant access for liver candidates nationwide. Each step of the process has yielded valuable insights that the Committee has employed. These include the 694 responses we received to the concept document questionnaire, to the feedback received at the Public Forum held last September. Thank you for participating in this process! We identified some common themes in this feedback and developed three ad hoc subcommittees to further refine the metrics of access, disparity and ways to optimize distribution, to identify financial implications of alternative sharing methods, and to address transportation and logistical issues associated with potential broader sharing. The issue of increasing liver donation and utilization is a parallel effort, identifying issues that may apply broadly to any system improvement; our committee has revived an earlier subcommittee to address this topic. 1) Metrics of Disparity & Optimization of Distribution 2) Finance, Transportation 3) Logistics Parallel Effort: Increasing Liver Donation & Utilization

Ongoing Committee Initiatives Redesigning Liver Distribution Date & location to be announced at a later date Ad Hoc Subcommittees meeting between Nov. 2014 – April 2015 Develop recommendations to refine the concept of Redistricting Deliver to the Committee and the public at a Public Forum in late Spring-early Summer 2015 These groups will meet by conference call multiple times between November 2014 and April 2015. During that time they will develop consensus-based recommendations as they relate to the Liver Committee’s specific quest to reduce geographic variation in severity of illness at transplant. We believe it is crucial for these recommendations to be shared with the liver transplant community and the public. For this reason, we plan to host another public forum to share the subcommittee’s recommendations and again seek professional and public feedback to guide our policy development process. While we haven’t yet established a specific date for the forum, we are anticipating a late spring-early summer event if we are able finalize the recommendations in the next few months. We will give you more detailed information as soon as possible. As the Ad Hocs progress in their discussions, we welcome your continued interest and participation.

Ongoing Committee Initiatives National Liver Review Board Concept The problem: Varying degree of understanding amongst the current RRBs regarding duties and operations as well as liver allocation policies Significant difference in both point assignments and criteria for exceptional cases across the country The Board directed the Committee to develop a conceptual plan and timeline for the implementation of a national liver review board… The Committee is currently considering a plan to consolidate the current Regional Review Boards (RRB) into a single national Liver Review Board (LRB). A proposal for an LRB was circulated in 2004 but was not well supported. The main concerns received in public comment were that: A national LRB was premature, The current RRB system “works well”, A national LRB would take away the ability to work out discrepancies locally and may lengthen review time. Members suggested that more standardized guidelines were needed. The proposal was deferred until standardized guidelines for MELD/PELD Exception scores could be refined. In June 2009, the Board approved standardized criteria and MELD/PELD exception scores for several diagnoses. The Committee continues to explore the potential to standardize additional diagnoses. During the November 2013 meeting, the idea of an LRB resurfaced and the Board directed the Liver Committee to develop a plan to include a conceptual basis and a proposed timeline for implementation of a national Liver Review Board. The Committee is in the process of refining the concept and would like the Community’s feedback.

Ongoing Committee Initiatives National Liver Review Board Goal Promote efficient management of the OPTN Increase consistency Reduce variation in the current RRB process Action 11 Regional Review Boards 1 National Board Standardize training National Guidelines The plan is to consolidate the current eleven Regional Review Boards (RRB) into a single national Liver Review Board (LRB) to promote the efficient management of the OPTN by emphasizing consistency and reducing variation in the current RRB review process for MELD/PELD exception scores across the country. A process of consistent review would also better prioritize those candidates most in need of liver transplantation whose severity of illness is not reflected by their laboratory MELD score. It was suggested the LRB could provide a more standardized process, a potentially faster response time and reviewers who are better educated about the guidelines and review process.

Ongoing Committee Initiatives, Feedback requested National Review Board Construct One board for both pediatrics and adults 110 Total Representatives Would a population based approach be reasonable? Other suggestions to ensure equal representation? Terms: 2 years, 2 consecutive term limit, 50% turnover per year Would a 6 month, 1 year term vs. 2 year term be more feasible? Other suggestions? The Committee wants community feedback on the some of the finer points of the LRB representative construct. Given our limited time, if you have thoughts that you are unable to share today, please contact your Regional Representative, Regional Administrator or the Liver Committee Liaison, Ashley Archer-Hayes, whose email address is on the next slide. We are specifically interested in your opinions on the following: A total of 110 representatives Consider: The number of liver transplant centers range from 6-19 in each Region. Would a population based approach be more reasonable? Other suggestions to ensure equal representation? Terms: 2 years, 2 consecutive term limit, 50% turnover per year. Consider: 1 year term vs. 2 year term

Ongoing Committee Initiatives, Feedback requested National Review Board Construct Review Board should maintain a minimum of 20-30% pediatric providers The committee may need to consider alternate term limits for pediatric providers in order to ensure appropriate expertise in reviewing pediatric exceptions and would like your suggestions. The Review Board should maintain a minimum of 20-30% pediatric providers Consider: Limited number of pediatric providers. It may be hard to mandate 2-3 peds reps per Region. The committee may need to consider alternate term limits for pediatric providers in order to ensure appropriate expertise in reviewing pediatric exceptions.

Questions? David C. Mulligan, MD Committee Chair david.mulligan@yale.edu Regional Rep name (RA will complete) Region X Representative email address Ashley Archer-Hayes, MAS Committee Liaison ashley.archer-hayes@unos.org