1. Liver & Intestinal Organ Transplantation Committee
Fall 2014

2. Recent Public Comment Proposals
Cap HCC at 34
Intent: To give candidates with a calculated MELD/PELD of 35 and higher a better opportunity to receive regional offers under the Share 35 policy
Public comment was favorable
No substantial post public comment changes
Approved by the Board – November 2014
Circulated in Spring 2014, this proposal will cap the HCC exception score at 34, in effect giving candidates with calculated MELD/PELD scores of 35 and higher a better opportunity to receive regional offers under the new policy. We received 35 responses through public comment, in addition to the regional responses. 80.6% of these responses were in support of the proposal and all regions voted in favor.
General opposition focused on concern for HCC patient drop out rates and placing emphasis on individual patient cases, for example, those within Milan criteria and without extra-hepatic spread waiting longer than a year for transplant.
Both the HCC Subcommittee and the Liver & Intestinal Committee reviewed public comment and felt that no substantial post public changes were warranted. Forwarded to the Board during the November 12-13, 2014 meeting and unanimously approved, this project is currently pending prioritization for programming.

3. Recent Public Comment Proposals
Delay HCC Exception Score Assignment
Intent: Reduce the disparity in transplant and drop-out rates for candidates with and without HCC exceptions
No substantial post public comment changes
Approved by the Board – November 2014
The Proposal to Delay the HCC Exception Score Assignment was also circulated for public comment in the spring of This proposal is complimentary to the Cap HCC Score at 34 proposal, taking into account the variation in HCC transplant rates and wait times.
We received 31 responses in addition to the regional responses. Approximately 60% were in favor. 3 of the 11 regions were not supportive of this proposal. General opposition focused on a perceived lack of data, concern that tumor biology was not being considered, fear of limiting access for patients and disadvantaging minorities or income restricted candidates, as well as a concern that some centers may try to “game the system” by early listing candidates.
Both the HCC Subcommittee and the Liver & Intestinal Committee reviewed public comment and felt that no substantial post public changes were warranted. Forwarded to the Board during the November 12-13, 2014 meeting and approved with only 1 vote in opposition and 1 abstention, this project is currently pending prioritization for programming.

4. Recent Public Comment Proposals
Criteria for Intestine Surgeons and Physicians
Public comment was mixed
Committee responding to concerns and considering increasing timeframe for experience
Spring 2015 Public Comment
The Proposal for Membership and Personnel Requirements for Intestine Transplant Programs made it’s second round of public comment in the spring of 2014.
We received 17 responses in addition to the regional responses. While public comment was largely favorable with 90% in favor and only 1 region opposing, the Committee as well as the Intestinal Subcommittee think there is room to improve the proposal. It is currently being redrafted taking the concerns of the community under consideration, especially in regards to the required timeframe for experience.
This proposal will be recirculated for public comment in the spring of 2015.

5. Policy Implementation Dates
Adding Serum Sodium to the MELD Score
Board approved June 2014 with the following amendment:
Applies only to candidates with a MELD score greater than 11
Implementation upon programming, TBD
7 day “grace period” for transition
The board approved the proposal to incorporate serum sodium into the MELD Score calculation in June 2014, however they incorporated an amendment. Data from a study from the University of Michigan shows that patients with an initial MELD score below 12 would not benefit from the addition of serum sodium to their MELD score calculation. This data suggests that the incorporation of serum sodium may “bump” the patient into a higher MELD category therefore increasing the chances of transplant while transplant may not be of benefit to the patient.
Therefore serum sodium will only be incorporated into the MELD scores of patients with a MELD greater than 11.
This policy is pending prioritization for programming and will become effective upon implementation. Once programmed, the system will automatically calculate candidates new MELD-Na score. 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. On the 8th day 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.

6. Ongoing Committee Initiatives
Redesigning Liver Distribution
Concept Document released in June, accompanying questionnaire responses collected through July
692 Responses
Public Forum held in Chicago on 09/16/2014
264 people in attendance, 282 online participants
No policy proposal at this time, any developed will require public comment
Despite continued improvements in liver allocation and distribution over the last 15 years, waitlist mortality remains high for candidates with higher MELD scores. Significant disparity exists between OPOs and regions with regard to mean MELD at transplant and waitlist mortality. The Committee posed this: How do we direct liver to those most in need? The concept of Redistricting was introduced to the Committee, statistical modeling suggests that fewer geographical districts would likely reduce the variation in MELD at transplant and reduce waitlist deaths.
The Committee released a concept document along with a questionnaire seeking community input on the concept. We received 692 responses as well as 6 letters in response. We then analyzed the responses to form the agenda for the Public Forum on Redesigning Liver Distribution held in Chicago on 09/16/14.
264 people were in attendance at the Forum and an additional 282 participated online via webinar. The Forum was intended to further the conversation on concepts intended to increase equity in access to liver transplantation and special considerations in broader sharing such as cost, clinical impacts, logistical & collaborative efforts. Presenters and participants from across the country contributed to the success of the Forum.
The forum was successful in its intended purpose – to gather additional feedback, ideas and questions to help shape further policy development. The vast majority of participants agreed the OPTN should seek to ensure that candidates have timely access to liver transplantation. Opinions varied on the best metrics and methods to use in identifying and reducing geographic disparities, as well as the potential effects such efforts may have for transplant institutions in areas such as clinical practice, logistics and costs. Another theme commonly expressed was a need to optimize organ donation and utilization of available organs.

7. Ongoing Committee Initiatives
Redesigning Liver Distribution
Ad Hoc Subcommittees :
Metrics of disparity
Finance
Transportation and logistics
Parallel efforts:
Increasing liver donation and utilization
The Liver and Intestinal Organ Transplantation Committee met on Sept. 17 to discuss the feedback from the forum, as well as responses to the questionnaire distributed in June along with the concept document. The committee agreed that additional study and feedback is necessary to continue to study the issues identified. It resolved to establish several work groups, each composed partly of members of the committee and partly of additional subject matter experts, to address four key focus areas: Metrics to assess geographic disparity, Logistical/transportation considerations, Financial issues & increasing liver donation & utilization.
These work groups will develop recommendations to share with the full committee to aid in refinement of existing concepts or development of new ones. There is, at this point, no timetable for a policy proposal. It is important to note, however, that any policy proposal once developed will offer all interested parties an opportunity for public comment.

8. Ongoing Committee Initiatives
National Review Board
Construct under consideration:
10 Representatives from each region, 2-3 year terms, 2 term limit
Standard guidelines reviewed and approved by the Liver and Intestinal Committee for approving exception cases will be developed for the NRB
Spring 2015 Public Comment
The Board directed the Committee to develop a plan for a National Liver Review Board. At the June 2014 Board meeting, the Committee presented the preliminary construct for an NRB and requested Board feedback. The Board was impressed with the concept and urged the Committee to continue the work. The goal of the NRB would be to promote consistent reviews across the country. A proposal will likely be circulated in the spring of 2015 for community consideration.
Currently the Committee is considering a similar construct to that which was presented for public comment in Each region would select 10 experienced representatives, each representative would serve a 2-3 year term with a 2 term limit. Cases submitted for review will be assigned randomly to 7 members of the board & will be closed when 4 members have voted to either support or reject the exception request., much like the current RRB. Pediatric cases reviewed by pediatric providers, adult cases reviewed by adult providers.
Standard guidelines for approving exception cases will be developed to be used by the NRB to promote consistent reviews.

9. Questions? David C. Mulligan, MD
Committee Chair
Regional Rep name (RA will complete) Region X Representative address
Ashley Archer-Hayes
Committee Liaison