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.

Policy Implementation Share 15/share 35/national share for combined liver-intestine candidates – implemented June 17, 2013 Committee monitoring impact of these changes HCC imaging criteria: October 31, 2013 Reminders: Documentation, Reporting Templates available on Transplant Pro website http://transplantpro.org/wp- content/uploads/HCC_Worksheet.pdf 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. 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: http://transplantpro.org/wp-content/uploads/HCC_Worksheet.pdf 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.

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%.

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

Summary ↑ Regional Sharing, 19.7% to 30.3% ↑ Transplants in patients with MELD/PELD 35+ Fewer exception patients, increase in median MELD/PELD for regional shares More liver-intestine transplants, but numbers are still very low (9 to 35) No increase in liver-kidney transplants, but more are regional shares No changes in CIT or distance, fewer discards 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.

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 2014. 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.

Ongoing Committee Initiatives

Designing Liver Distribution for Geographic Equity Last Regional Update: Fall 2014 Committee meeting on 4/1 – Will Review: 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, incident listings Potential impact by ethnicity, gender, pediatric status There was an extensive update on this project last fall. The Liver Committee will next meet on April 1 and will review additional data to be provided by the SRTR. This includes 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 will also review the relationships between OPO performance and the net import/export of livers, the median MELD score at transplant, eligible deaths, and incident listings, as well as the potential effects of redistricting by ethnicity, gender, and children.

Designing Liver Distribution for Geographic Equity Committee Meeting, 4/1 (Cont’d) Review maps Determine Path Forward for Policy Development Stay tuned The Committee will also review the latest maps, and discuss the path forward for potential policy development. Updates will be provided as they are available.

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.

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