1. Liver and Intestinal Organ Transplantation Committee
Spring 2016

2. Policy Implementation Dates
Proposal
Board Approved
Implementation Date
Add Serum Sodium to the MELD Score
June 2014
January 11, 2016
Reinstate Override Button for Unresolved Exception Requests
June 2009
February 4, 2016
Intestine Program Membership Requirements
June 2015
No sooner than June 2016
In June 2014, the Board approved a policy to modify the MELD score to include serum sodium concentration, which is an important predictor of survival among candidates for liver transplantation. On January 11, 2016, the MELD score was recalculated to incorporate serum sodium for candidates with a MELD score greater than 11. Programs were given a 7-day grace period during implementation for candidates whose scores moved from one recertification category to give them time to obtain and report updated lab values.
Some patients and professionals have noticed that third party MELD calculators do not produce the correct MELD score now that serum sodium has been added. The MELD calculator available on the OPTN website will always produce results consistent with UNetSM. Please refer your patients to the MELD calculator on the OPTN website or double check your center’s calculator to ensure its accuracy.
If the Regional Review Board does not approve an exception application within 21 days, current policy allows a transplant physician to register the candidate at the request MELD/PELD score following a conference call with the RRB. The case would then be automatically referred to the Liver and Intestinal Organ Transplantation Committee, and potentially the MPSC, for review. When this policy was first implemented in 2002, the physician could accomplish this by selecting the “no appeal/no withdrawal” button on the application after it was denied by the RRB. The button was inadvertently removed when a modification to the policy was subsequently implemented. In June 2009, the Board approved a proposal to reinstate the override button for unresolved exception requests. This is scheduled to be implemented on February 4, 2016.
In June 2015, the Board approved intestine program requirements. All transplant hospitals with intestine programs with a current status of “Active, Approval Not Required” will be required to apply for intestine program designation. Before implementation, the Office of Management and Budget (OMB) must approve the new application forms. The OMB approval process began in November 2015.

3. Committee Projects HCC NLRB Redistricting
HCC Public Comment: Aug 2016 (est)
Revise exception eligibility criteria
NLRB Public Comment: Jan 2016
Continued development:
Revise initial exception score assignment
Eliminate automatic increases upon extension
During the second public forum last June, the Committee received overwhelming feedback from the community that regional disparities in the MELD/PELD exception system are related to geographic disparities in access to transplant. In response to this feedback, the Liver Committee is pursuing a work plan to deliver on three interrelated projects that aim to improve equity in access to liver transplantation. By advancing proposals to establish a National Liver Review Board (or NLRB) and revise HCC exception eligibility criteria, the Committee intends to build community consensus for the final redistricting proposal as well as optimize its benefits.
In a moment, I will present the proposal to establish the NLRB, which is currently out for public comment. While this proposal provides the structure and operations of the NLRB, the Committee is seeking community feedback on the optimal method for assigning MELD exception scores. I will provide more information and welcome your feedback during my presentation of the proposal.
Next, I will update you on the progress of both the HCC and Redistricting projects.

4. Revise HCC Exception Eligibility
Consider revising standard exception eligibility criteria to include candidates beyond Milan criteria and downstaged
Consider whether these candidates should not be eligible for exception scores:
Have a single, small, well-treated tumor, until evidence of recurrence
Have an AFP >1,000, until AFP is <500
In December, the Executive Committee approved the Committee to work on a new project to revise the standard exception eligibility criteria for HCC candidates. As many of you are aware, currently only candidates within Milan criteria automatically receive exception scores. However, nearly all RRBs have developed agreements in which candidates beyond Milan that meet certain downstaging criteria may also receive exception scores. Most of these agreements are very similar. The Committee is considering expanding standard HCC exception eligibility criteria to include candidates meeting specific downstaging criteria. The Committee is also considering whether the following candidates should not be eligible for exceptions scores:
• Those with a single, small, well-treated tumor, until evidence of recurrence
• Those who have an A-fetoprotein (AFP) greater than 1,000, until AFP is below 500
I welcome any input you have on this initial criteria we are considering. The Committee anticipates submitting a proposal for public comment in August 2016.

5. Redistricting
New SRTR requests based on feedback received at June Forum
October 2015: Additional analysis to determine impact of MELD/PELD exceptions on previously modeled scenarios
Spring 2016: Model 500-mile concentric circle distribution based on donor hospital location
Proximity points for local candidates at radii of 150 and 250 miles
Despite continued improvements in liver allocation and distribution over the last 15 years, waitlist mortality remains high for candidates with higher MELD/PELD scores. Significant disparity exists between OPOs and regions with regard to the mean MELD/PELD score at transplant and waitlist mortality. The Committee has been examining ways to direct livers to those most in need. Simulation modeling suggests that optimized or fewer geographic districts would likely reduce the variation in MELD/PELD score at transplant and reduce waitlist deaths.
The Committee requested analysis of multiple potential redistricting scenarios designed to address geographic disparities in access to deceased donor livers. Twenty-eight simulations were conducted, covering several redistricting schemes and multiple implementations of proximity circles. Results for these simulations were presented at the June 22, 2015 educational forum, which was attended in-person or online by over 400 people. Based on feedback received during the forum, Committee members asked for additional outputs to help determine the impacts of MELD/PELD exceptions on the various scenarios previously modeled. The Committee reviewed the results of this additional analysis at its October 20, 2015 meeting in Chicago (which I will share in a moment).
Based on feedback from participants at the forum, the Committee also requested modeling of 500-mile concentric circle distribution based on the donor hospital location, with additional proximity points given to local candidates (at radii of 150 and 250 miles). The Committee anticipates reviewing the results of this modeling at its next in-person meeting in the spring of 2016.

6. Impact of MELD Exceptions: Results
Confirmed that distribution becomes more equitable as number of districts decreases
Recipients with no exception points: variation highest of all, decreases in all scenarios
4-district scenarios offer largest reduction in variance, but 8-district also improvement over current policy
Confirmed findings from previous analysis that geographic distribution becomes more equitable as the number of distribution units decreases.
For recipients without HCC exception points, variation in allocation MELD/PELD at transplant is higher than in the overall all transplant group. This variation decreases but remains somewhat higher than the variation in the all transplant group for most scenarios, except the 4-district in-district scenario where the variation is even.
For recipients with no exception points, variation in MELD/PELD at transplant was highest of all the examined groups. This variations decreased in all redistricting scenarios, most dramatically in the 4-district, in-district scenario.
While 4-district scenarios offer the largest variance reduction, 8-district scenarios also reduce variance compared with current policy.
Conclude by saying the Committee’s next step will be to review the concentric circle modeling during its spring 2016 in-person meeting.

7. Questions? Ryutaro Hirose, MD Committee Chair
Christine Flavin, MPH
Committee Liaison

8. Variance in Median Allocation MELD/PELD at Transplant by DSA, All Transplants
Results:
The current scenario has a variance of 6.2 (range )
The largest decrease in variance is in the 4 district scenarios with in-district proximity points, where the variance is 2.1 ( ) for the 4 district, 3 point, 150 mile in district scenario.
The implementation of distribution units appears to be the driving factor in decreasing MELD/PELD variance at transplant, with 4 districts having lower variance than 8 districts or 11 regions, and in-district sharing having lower variance in both 4- and 8-district scenarios.

9. Variance in Median MELD/PELD at Transplant by DSA, Recipients with No Exception Points
This figure shows the variance in median laboratory MELD/PELD at transplant for recipients with no exception points. This population makes up about 60% of all transplants in these analyses.
Variance for this group was the highest among all population subgroups
The current scenario has a variance of 16.8 ( )
compare with 6.2 ( ) for allocation MELD for all transplants in the current scenario simulation.
The largest decrease in variance is in the 4 district scenarios with in-district proximity points, where the variance is 3.9 ( ) for the 4 district, 3 point, 150 mile in district scenario.

10. Geographic Variation in Median Allocation MELD/PELD at Transplant by DSA, All Transplants
The maps we will now show provide a different way of visualizing the same data we just reviewed in figure format. These maps are similar to those presented at the June 2015 liver forum. The only difference is that the top right map shown here is the 11 region, 3 proximity point, 150 mile, out district scenario. The in-district scenario was shown at the liver forum, but was not included in this request.
The scale at the bottom of the maps shows the median allocation MELD/PELD at transplant by DSA.
The colored box with the black outline around it shows the national median allocation MELD/PELD at transplant.
As in the previous analysis, these maps show regional concentrations of low and high MELD/PELD at transplant across DSAs for the current policy simulation.
As the number of distribution units deceases, the map tends toward less variation, with fewer DSAs in the dark green and dark blue portions of the scale.
For current policy, the national median is: 25
For 11R 3P 150 Mi Out, the national median is: 25
For 8D 3P 150 Mi In, the national median is: 25
For 4D 3P 150 Mi In, the national median is: 26.6

11. Geographic Variation in Median MELD/PELD at Transplant by DSA, Recipients with No Exception Points
For transplants in with no exception points, the pattern is similar to ‘all transplants’ and ‘no-HCC transplants’ with the current policy showing the most geographic variation and the 4-district map showing the least.
For current policy, the national median is: 24
For 11R 3P 150 Mi Out, the national median is: 26
For 8D 3P 150 Mi In, the national median is: 27.6
For 4D 3P 150 Mi In, the national median is: 29