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” policies 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 MELD scores (35+), as well as distance traveled, cold ischemia time, organs discarded, and other results. Some early data for the first six months pre- and post-implementation are provided in the next few slides.

3. Deceased Donor Liver Transplants by Era and Status/Allocation Score
9.9%
MELD/PELD
Exceptions
This slide shows that the percentage of transplants in patients with MELD score of and 40+ increased from 20% to 25%. The percentage in those high-MELD categories that were based on a MELD/PELD exception decreased from 13% to 10%.
Status or MELD/PELD Score

4. Deceased Donor Liver Transplants by Era and Share Type
DRI: 1.3
CIT: 5.9 hrs
Distance: 21 mi
M/P (lab): 21
As expected, regional sharing increased, from just under 20% to 31%. 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 be declining over time.
Median Values Shown

5. Median Distance Organ Traveled, Regional Deceased Donor Liver Transplants – Pre vs. Post, By Region
Note: Median change in travel distance across regions was +4 miles.
This slide shows the change in travel distance by region for regionally shared livers pre- and post-Share 35. The diagonal line represents “no change.” As you can see, most of the dots fall along that line. Region 6 was removed due to its large scale – the median distance for its regionally shared transplants was 1332 miles prior, but 132 post.
Note: Region 6 data not included (1332 miles Pre, 132 miles post)
Pre: 12/17/2012 – 6/17/2013 Post: 6/18/2013 – 12/17/2013

6. Summary of National Data
Waiting list deaths reduced by 7%
Increase in MELD/PELD 35+ 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.

7. 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)
While the number of liver-intestine transplant has increased, the number is still small, and the number by month is on the next slide.
There was no increase in the number of liver-kidney transplants, but the number that were of a regional share increased.
It is worth noting that discards decreased following Share 35 from 238 to 191.
The Committee will continue to monitor these data. The Committee is also aware of some unintended behavioral consequences related to broader sharing and is planning to work with the OPO Committee as future policy development evolves.

8. Deceased Donor Liver-Intestine Transplants by Month
This shows that while there was an increase in LI-IN transplants initially, this number has not remained at that level.

9. 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:

10. 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 Committee plans to resubmit this proposal in June, after reviewing published data (Kim et al and Fisher et al) that suggest that low sodium does not adversely affect post-transplant outcomes.
As part of its overall discussion about the MELD score and specifically MELD exceptions, and the lack of consistency across the country, 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.

11. Ongoing Committee Initiatives

12. Designing Liver Distribution for Geographic Equity

13. Motivation: Transplant Rates, by OPO
MELD 38-39: 18% to 86%
Massie/Segev, AJT 2011
There has been a long-standing concern about geographic disparities in liver allocation. This slide from a recent AJT paper illustrates such disparity by showing the extremely wide variation in rates of transplant across the 58 OPOs; for example, a patient with a MELD score around 38 might have an 18% chance of transplant in one OPO vs. an 86% chance in another.

14. Motivation: Death Rates, by OPO
MELD 38-39: 14% to 82%
Massie/Segev, AJT 2011
This is just a reminder that variation in transplant rates leads directly to variation in death rates.

15. Final rule: “Neither place of residence nor place of listing shall be a major determinant of access to a transplant.”
Unfortunately, these disparities are inconsistent with the Final Rule.

16. Designing Liver Distribution for Geographic Equity - Recent Activity (Cont’d)
November 2012: Board tasks Committees w/ Disparity Metrics
Liver Committee Metric: Variance of median MELD at transplant across DSAs
March 2013: Liver Committee Key Decisions
Number of districts between 4 and 8
Minimum number of transplant centers per district: 6
Waitlist deaths must not be statistically significantly higher
September 2013: Committee reviewed several maps; requested additional analyses
In November of 2012, the Board approved a resolution stating that “the existing geographic disparity in allocation of organs for transplant is unacceptably high. The Board directs the organ-specific committees to define the measurement of fairness and any constraints for each organ system by June 30, The measurement of fairness may vary by organ type but must consider fairness based upon criteria that best represent patient outcome. The Board requests that optimized systems utilizing overlapping versus non-overlapping geographic boundaries be compared, including using or disregarding current DSA and region boundaries in allocation.”
The members of the Liver Committee selected the variance in the median MELD score across DSAs as the primary “disparity metric” for liver distribution.
In March 2013, the Committee reviewed sample maps designed by the SRTR. These maps showed new potential units for liver distribution. Rather than calling them “regions,” which may be confusing, the Committee is calling these “districts.” The districts were designed based on mathematical modeling, and the impacts of using those districts were simulated with LSAM. The Committee voted on several parameters or constraints to be used for designing future maps:
There should be between 4 and 8 districts, with a minimum of 6 transplants centers in each.
The maximum travel time should be 4-5 hours.
And, achieving the goal of reduced disparity must not increase waiting list deaths.
The Committee reviewed a set of potential maps in September 2013 as was reported out during the fall meetings. The Committee also requested additional analyses from the SRTR.

17. Designing Liver Distribution for Geographic Equity
Committee met on 4/1/14 – 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.

18. Designing Liver Distribution for Geographic Equity
Committee Meeting, 4/1/14 (Cont’d)
Determine Path Forward for Policy Development
Potential Path Forward:
Concept Document
Committee’s discussions to date
Maps of 4 and 8 “districts”
Survey
Forum
Spring 2015 Public Comment
Will also monitor/assess impacts of Share 35
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. This group has decided that a document describing the Committee’s discussions to date, with a survey to get your concerns, opinions, and suggestions, should go out to the community this spring, UNOS will host a town hall meeting in the fall based on feedback from that survey. You all should have received a statement from David Mulligan on April 29 outlining the Committee ‘s discussions and plans. Please be on the lookout for further announcements. The Committee has also recognized the need to assess the impacts of Share 35 before making further changes.
Stay tuned!

19. 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). A guidance document or NET and PCLD will be going to the Board in June.
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 plan to create a national review board. The Committee has reviewed the proposal circulated in 2004 and updated it to reflect a 2014 construct. The Committee has expressed some concerns about workload, costs, and the ability to apply national standards given the geographic diversity and disparities, and those concerns will be included in the presentation to the Board.

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