1. Liver and Intestinal Organ Transplantation Committee
Spring 2014 Update
I will be providing a brief update of the committee’s activities, starting with information about policy changes implemented within the last year.

2. Policy Implementation - Liver Allocation Policy
Share 15/share 35/national share for combined liver-intestine candidates
Implemented June 17, 2013
Committee monitoring impact of these changes
The “Share 15 National”, “Share 35 Regional” and the national share for liver-intestine candidates were implemented in June. The Committee has been monitoring the percentage shared locally, regionally, and nationally, the percent of MELD exceptions scores transplanted at high MELDs (35+), as well as distance traveled, cold ischemia time, organs discarded, and other results. Some early data for 120 days pre- and post-implementation are provided in the next few slides.
9.3.G.ix Compliance Monitoring
The transplant hospital must maintain documentation of the radiologic characteristics of each OPTN Class 5 nodule. If growth criteria are used to classify a nodule as HCC, the radiology report must contain the prior and current dates of imaging, type of imaging and measurements of the nodule.

3. Deceased Donor Liver Transplants by Era and Status/Score
8.8%
MELD
exceptions
This slide shows that the percentage of transplants in patients with MELD score of 35 and higher increased from 20% to nearly 25%, but the percentage of those that were based on a MELD/PELD exception decreased from 13% to 9%.

4. Deceased Donor Liver Transplants by Era and Share Type
CIT: 5.9 hrs
Distance: 22mi
M/P (lab): 21
As expected, regional sharing increased from just under 20% to 30%. There has been little overall change in cold ischemia time or distance, but the median lab MELD score increased from 23 to 30 for regional shares, although this number may decline over time.
Median Values Shown

5. Summary of National Data
Increase in regional sharing, 19.7% to 30.3%
Increase in MELD/PELD 35+ transplants
Decrease in MELD 35+ exception transplants
Increase in the median MELD/PELD for regional shares
The take home message is that the policy is doing what it was expected to do.
It is worth noting that discards decreased following Share 35 from 238 to 191.

6. Summary of National Data
Increase in the number of LI-IN transplants (9 to 35)
Increase in regional sharing for LI-KI transplant, but no overall increase in the number of transplants
Decrease in the number of discards (238 to 191)
No change in CIT or distance traveled
The take home message is that the policy is doing what it was expected to do.
It is worth noting that discards decreased following Share 35 from 238 to 191.

7. Policy Implementation – HCC Imaging Policy
October 31, 2013
Reminders: Documentation, Reporting Templates available on Transplant Pro website
content/uploads/HCC_Worksheet.pdf
The policy for improved imaging criteria for HCC exceptions was implemented on October 31st of last year, and the Committee will monitor its impacts as well once sufficient time has elapsed.
There have been some questions about what tumors must be entered and documented – policy requires centers to maintain documentation of the radiologic characteristics of each OPTN Class 5 nodule. Lesions that are not definitively HCC by the OPTN classification system (i.e., NOT class 5) should not be entered as this may result in the case going to the RRB when it may not need to. Reporting templates are also available here:

8. Recent Public Comment Proposals
Adding serum sodium to the MELD score
Public comments: 78.6% supported
Regional votes/comments: 8 in favor, 2 opposed, 1 approved with amendment
ASTS supported, AST opposed
Board did not approve; Committee will resubmit proposal in June 2014
The proposal to add serum sodium to the MELD score was not approved at the November 2013 Board of Directors meeting.  Several Board members expressed concerns about the additional points for sodium being assigned to patients who may not benefit long-term from a transplant.  The Committee was asked to investigate whether there is a certain MELD score below which patients should not receive additional points and bring it back to the Board in June The Board has also asked the Committee to develop a plan for a National Review Board for MELD exceptions, to be presented at the June Board meeting, with a possible proposal for public comment in the Fall of 2014.

9. Ongoing Committee Initiatives

10. Designing Liver Distribution for Geographic Equity
Last Regional Update: Fall 2013
Committee met on 4/1 – Reviewed:
Cost Data – Four Components
Pre-transplant care
Transportation
Transplant plus one year follow-up
2-3 years post-transplant
OPO performance and: Net import, Median MELD, eligible deaths, new listings
Potential impact by ethnicity, gender, pediatric status
There was an extensive update on this project last fall. The Liver Committee met on April 1 and reviewed additional data provided by the SRTR. This included data on the potential costs of redistricting relative to current, including the costs of Pre-transplant care, Organ transportation, the transplant procedure plus one year follow-up, and costs associated with longer term follow-up (2-3 years post-transplant). The Committee also reviewed the relationships between OPO performance various factors related to potential changes in liver distribution policy, as well as the potential effects of redistricting by ethnicity, gender, and children. The analyses were VERY extensive and it’s not possible to adequately summarize them with the time given today (and so soon after the meeting), but as I will note in the next slide, there are plans to disseminate this information to the community in a systematic way.

11. Designing Liver Distribution for Geographic Equity
Committee Meeting, 4/1 (Cont’d)
Determine Path Forward for Policy Development
Potential Path Forward:
Spring 2015 Public Comment
Maps of 4 and 8 “districts”
Educational offerings prior
Stay Tuned
The Committee discussed the path forward for potential policy development. At this point, the Committee is thinking about having something out for public comment in the Spring of 2015 that would include new maps with 4 and 8 districts each. In order to educate the Committee and provide an opportunity for your questions to be answered, a steering Committee has been put together to determine how best to do that, whether it be by preparing a document that could go to the community out this spring or summer, or hosting a town hall meeting in the fall or winter, or both. So, please be on the lookout on TransplantPro for further announcements.

12. Other Ongoing Committee Initiatives
Review of MELD/PELD exceptions and RRB practices
Working on guidelines for new standardized exceptions
Training materials for RRBs
National Review Board
The Committee has also been working on several other important projects.
The Committee has been reviewing trends in MELD exceptions, and is developing exception guidelines and templates for several diagnoses such as neuroendocrine tumors, polycystic liver disease, and primary sclerosing cholangitis, as those accounted for a large percentage of exceptions (as did those related to sodium and ascites, which should be addressed by the MELD sodium proposal).
The Committee, in conjunction with the Region 5 liver programs, is piloting an online training module for RRB members, which will be available to other regions after being piloted in Region 5. And, as mentioned earlier, the Committee is responding to the Board’s request for a proposal for a national review board.

13. Questions? David Mulligan, MD Committee Chair David.Mulligan@yale.edu
Name
Region # Representative
Ann Harper Committee Liaison