1. Enhancing Liver Distribution
Liver and Intestinal Organ Transplantation Committee

2. What problem will the proposal solve?
Current liver distribution is limited by regional and DSA boundaries
Variation in median MELD at transplant by DSA ranges from 20 to 40
Equates to 3-month mortality without liver transplant of 11% to nearly 100%
Variation is greatest in non- exception candidates
The goal of this proposal is to improve current liver allocation by broadening the areas of distribution. Currently, liver allocation is limited by regional and DSA boundaries. This leads to a situation where a medically urgent candidate, within close proximity of the donor, but outside of the region, has limited access to this organ.
There is considerable variation in the median MELD at transplant by DSA in the nation. MELD scores ranges from 20-40, which equates to a 3-month mortality without a liver transplant of 11% to nearly 100%. This variation is greatest in non-exception candidates who are allocated by their calculated MELD score.

3. What are the proposed solutions?
Proximity circles with 150-mile radius around the donor hospital
Circles may extend out of the region
Expanded regional sharing, Share 29 to adult candidates within the region and/or circle
5 MELD or PELD points to candidates within the circle
Separate allocation for DCD donors and donors at least 70 years old
This proposal includes several proposed changes and solutions:
The proposal introduces the concept of 150-nautical mile, proximity circles around the donor hospital. These circles may extend outside of the region and are used within the allocation classifications for liver, and liver-intestine allocation.
Expanded regional sharing is proposed from the current Share 35, to candidates with a MELD or PELD of 29. The specifics of this are discussed in a later slide but it’s important to note that this increased regional sharing includes the 150-mile proximity circle around the donor hospital which may include candidates outside of the region.
Candidates within the proximity circle, regardless of whether they are in, or out of the region, will receive 5 MELD or PELD points to their score.
Finally, the Committee proposes a new allocation for DCD donors and donors at least 70 years old.

4. What are the proposed solutions?
Allocation of adult livers, non-DCD and age <70
Classificatio n
Candidates that are within the OPO’s:
And are: 1
Region or Circle
Adult or pediatric status 1A 2
Pediatric status 1B 3
Any of the following:
At least 18 years old at time of registration and calculated MELD of at least 29
12 to 17 years old at time of registration and allocation MELD of at least 29
Less than 12 years old at time of registration and allocation PELD of at least 29 4
DSA
MELD or PELD of at least 15 5 6
Nation 7 8
For the allocation of livers from adult donors, who are non-DCD and less than 70 years old, this table shows the first 10 allocation classifications. The substance of this proposal is in the 3rd classification. Following allocation to Status 1A and 1B candidates, classification 3 will include candidates as follows:
Candidates at least 18 years old with a calculated MELD of at least 29
Candidates 12 to 17 years old with an allocation MELD of at least 29
Candidates less than 12 years old with an allocation PELD of at least 29
The distinction between allocation and calculated MELD or PELD is to prioritize adult candidates with the greatest medical urgency. Data has supported the notion that non-exception candidates experience higher levels of waitlist mortality and decreased access to transplant compared to exception candidates. By prioritizing calculated MELD candidates above the sharing threshold of 29, the Committee intends to prioritize the broader sharing to candidates with the greatest medical urgency. The Committee chose to allocate to pediatrics based on allocation MELD or PELD due to the majority of pediatric candidates that are transplanted under exception. The Committee did not want to disadvantage pediatric candidates by providing them a sharing threshold based on their calculated MELD or PELD. Candidates within the classifications are sorted the same as they are now. Classification 3 does not exclude exception candidates, but exception candidates within that classification will be allocated based on their calculated MELD score. Following classification 3, the MELD or PELD score allocation is based on allocation MELD. There is no longer a distinction based on calculated versus allocation MELD or PELD.
It’s important to point out that “Region or Circle” includes candidates within the OPO’s region or 150 mile proximity circle. In several instances, the proximity circle may be fully enclosed within the region. In this situation, “region or circle” is no different than current regional sharing, except the addition of proximity points to candidates within the circle, this is discussed in the next slide.

5. What are the proposed solutions?
Candidates within the 150-nautical mile circle receive 5 MELD or PELD proximity points
Candidates in the circle (both in and out of region) receive proximity MELD or PELD points
Candidate age at time of registration on the waiting list:
Proximity Points
At least 18 years old
Five proximity points to their calculated MELD score
12 to 17 years old
Five proximity points to their allocation MELD score
Less than 12 years old
Five proximity points to their allocation PELD score
Candidates within the 150-nautical mile circle will receive 5 addition MELD or PELD points. The table describes the specifics of these points. For adult candidates (at least 18 years old) the five proximity points will be added to their calculated MELD score, not their allocation MELD which may include points based on an approved MELD exception. Like the difference in sharing threshold discussed on the previous slide, this is proposed to prioritize candidates with the greatest medical urgency. The proximity points are added to all liver candidates, for candidates with an allocation MELD based on an approved exception, the points will be added to their calculated MELD score. For adult exception candidates, if their calculated MELD score plus proximity points is greater than their exception score, they will be allocated based on this score when they are within the proximity circle.
For candidates under 18, the 5 proximity points are added to their allocation MELD or PELD score. Similar to the specifics of the sharing threshold discussed on the previous slide, this is due to the prevalence of exception candidates in pediatric liver candidates and the Committee’s intention to not disadvantage pediatric liver candidates.
As noted previously, the proximity circle and corresponding proximity points, will be provided to any liver candidate within the proximity circle, regardless of whether they are in or out of the OPO’s region. For livers recovered at a “recovery center” separate from the donor hospital, the circle will still be based on a radius around the donor hospital.

6. Proximity Circle Dashboard
Link
I will now navigate to a Dashboard that shows the donor hospitals within 150 miles around every liver transplant program in our region.
I can also demonstrate how donor hospitals within our region may be within 150 nautical miles of liver programs in other regions.

7. What are the proposed solutions?
New allocation for DCD or age > 70 donors
Prioritize local (DSA) allocation for this subset of donors
Classification
Candidates that are within the OPO’s:
And are: 1
Region or Circle
Adult or Pediatric status 1A 2
Pediatric status 1B 3
DSA
MELD or PELD of at least 15 4 7
Nation 8 9 10
MELD or PELD less than 15 11 12
The Committee is proposing a separate allocation classification for livers from DCD donors and donors at least 70 years old. The Committee recognizes that certain donor criteria make liver offers more viable for local consideration than for broader sharing. The specifics of the allocation are shown in the table. I’d like to point out how the DSA gets priority after allocating to Status 1A and 1B candidates within the Region or Circle. In , 68% of DCD liver transplants occurred locally (within the DSA that the organ is recovered) compared to 25.8% regionally, and 6.2% nationally. This data reinforced the Committee’s intentions to develop separate allocation classification for DCD livers that prioritized allocation within the OPO’s DSA. The Committee expects this change to better allocate this small subset of livers and requests feedback from the community on this topic.
In , 17% of livers recovered from donors at least 70 years were discarded, compared to 9% for donors less than 70 years old. The Committee proposes including donors less than 70 years old in the same allocation as DCD donors. The Committee believes that including DCD donors with donors at least 70 years old in a separate allocation classification will better allocate this subset of donor livers. It does this by prioritizing local allocation and limiting the logistical concerns for allocating these donor livers over broader geographical areas.

8. What are the proposed solutions?
Regional sharing will be “Region or Circle” for allocating all livers and liver-intestines (adult and pediatric)
Candidates at programs within 150 miles of the donor hospital, and outside the region, would be included in “Region or Circle” allocation.
“Regional allocation” will potentially include candidates outside the region (but within the proximity circle)
Non-DCD pediatric livers: sharing within the region or circle for all candidates
Sharing threshold does not apply
Status 1A and 1B candidates in the circle do not receive additional priority
There are a couple of other changes that are important to point out. In all of liver and liver-intestine allocation, regional sharing will be the “Region or Circle”. What we refer to as “regional sharing” will now include candidates potentially outside the region but within the 150-nautical mile radius circle. Candidates at programs within 150 miles of the donor hospital, and outside the region, would be included in “region or circle” allocation, which was previously limited to candidates within the OPO’s region. This change will only affect donors recovered at hospitals with 150 miles of liver programs outside the region. For example, a liver recovered at a donor hospital within the interior of a region (greater than 150 miles from a liver program outside the region) would be allocated regionally the same as the current distribution, however candidates within the circle will receive proximity points as discussed previously.
A small change is that for non-DCD pediatric liver donors, there will be full sharing to candidates within the region or circle. Currently, there is priority for the OPO’s DSA prior to the region for Status candidates, before allocating to any PELD in the Region. The Committee proposes altering this to allow full sharing within the region or circle, thus removing the DSA unit from pediatric liver allocation classifications. Candidates within the proximity circle will still receive proximity points for these pediatric donor livers.
It’s important to point out that, Status 1A and 1B candidates in the proximity circle will not receive priority over other Status candidates. The proximity points are provided to the MELD or PELD score and do not affect status candidates.

9. Supporting Evidence
Previous modeling showed a similar concept that reduces variation in MELD at transplant and reduces travel less than the current system
Share 35 has increased access to urgent (MELD/PELD > 35) candidates
Proximity points will prevent livers traveling beyond 150 miles for small differences in MELD or PELD points
Region + Circle sharing does not rely on supply and demand metrics
Livers can travel to urgent candidates beyond DSA and regional boundaries
Without the potential logistical issues of sharing more broadly
Preliminary modeling results have recently been shared with the community and will be highlighted on the next slide. The Committee modeled a similar concept in This concept included the same out-of-region 150 mile radius proximity circles, however it did not include a sharing threshold. The results showed that it was the only concept that reduces variation in median MELD at transplant (for exception and non-exception candidates, while also reducing travel metrics less than the current system. The percentage of organs flying and median transport distance were both reduced in this concept compared to the current system.
The two year post-implementation outcome analysis of Share35 demonstrated that, for patients with a MELD or PELD of at least 35, Share 35 increased the percentage of transplants from 19% to 27% and increased sharing within each region from 19% to 50%. The Committee intends to build upon this by expanding regional sharing to adult candidates with a calculated MELD of 29 and allocation MELD/PELD for pediatric candidates under 18, plus the introduction of the proximity circle to increase out-of-region allocation. Proximity points are not included in the current Share35 system, and this element will ensure that livers will not travel beyond 150 miles for small differences in MELD or PELD points.
Based on feedback from the community and extensive discussion over the last several years, the Committee is proposing a change that does not rely on supply and demand metrics. This proposal simply expands regional sharing to a subset of the waiting list, while introducing the idea of proximity sharing using a 150-mile radius circle around the donor hospital that includes candidates within and/or outside the OPO’s region. This allows livers to travel beyond DSA and regional boundaries to candidates in close proximity of the donor hospital, while limiting the potential logistical issues of sharing more broadly.

10. Summary of LSAM Data: Current vs M29 150m
Variance in the MMaT: All candidates 10 to 6
Allocation MMaT: to 29
Median Transport Time (hours): to 1.74
Median Distance Organs Travel (miles): to 100.7
Percent Organs Flown: to 55.2
Transplant Rate/Count : /6651 to 0.437/6651
Waiting List Mortality Rate/Count: /1455 to 0.090/1366
Post Tx Mortality Rate/Count: /686 to 0.077/682
The SRTR provided preliminary data results on August 11th. The following numbers compare current liver distribution with the proposed policy.
The variance in median MELD at Transplant decreased from 10 to 6.
The allocation median MELD at Transplant stayed the same nationally
Median Transport time, which is measured in hours, remained relatively the same from 1.7 to 1.74
Median Distance traveled, which is measured in miles, increased from 88.5 to 100.7
Percent of organs flow increased from 50.7 to 55.2
Transplant rate and transplant count, stayed the same at .444 and 6,651 total transplants
Waiting list mortality rate, and total count decreased from .097 to And, 1,455 to 1,266 total waitlist mortality
Post transplant mortality rate and count remained essentially the same
The data is in line with the Committee’s considerations for impacting variance in MM

11. How will members implement this proposal?
New relationships for liver transplant programs and OPOs outside their current region
Train OPO and Transplant Center staff on changes
No additional data collection required.
Any change to current allocation poses logistical and financial challenges. In the Committee’s development of this proposal, their goal was to enhance current allocation without creating the logistical and financial challenges of prior concepts. OPOs and transplant centers may need to devote significant effort in developing new working relationships for organ offers that travel outside of current boundaries. Transplant programs and OPOs will need to train staff on the changes. It’s important to note that there is no additional data collection required by this proposal.

12. How will the OPTN implement this proposal?
Anticipated Board of Directors Review: Dec. 2017
Significant programming effort
Educational opportunities to explain new distribution
Robust monitoring plan at 3-month intervals
Will share data with community
Recent changes to HCC and NLRB expected to be implemented before this proposal
Dependent on public comment, the Committee anticipates this proposal for consideration by the Board of Directors in December This proposal will require a large programming effort, and implementation would be pending programming and communication to members. The OPTN will provide extensive educational efforts prior to implementation to prepare the community for the change.
The Committee will employ a robust post-implementation monitoring plan with data available every 3 months that they will review and share with the community.
As discussed in the Committee Update presentation, the recent changes to HCC criteria and the recently approved NLRB proposal will be implemented before we implement this proposal.

13. Specific feedback requested
Size of the proximity circle
Number of proximity points
Providing proximity points to the recovery DSA
Sharing threshold of lab MELD 29 for adult candidates
Separate allocation for DCD and age > 70 years old
Addressing the cap at MELD 40
The Committee requests specific feedback from the regions for their continual refinement of a solution.
The Committee has had broad consensus on the 150 nautical mile proximity circle, but requests feedback on how a larger circle would affect the regions.
The Committee has proposed 5 proximity points for candidates within the circle. This has the effect of constraining the amount of travel both outside the region, and within the region. The Committee has discussed the significance of 5 MELD or PELD points and would like feedback on the idea of fewer proximity points provided to candidates in the circle.
The current proposal provides proximity points to candidates within the 150 mile circle. The Committee also modeled a concept that provides proximity points for candidates within the recovery DSA in addition to the proximity circle. The modeling shows very little difference between the two concepts on a national scale, however this will have an effect in areas of the country with large, and/or non-contiguous DSAs.
The current proposal uses a sharing threshold of lab MELD 29 for the initial broader sharing classification to adult candidates. This detail was discussed at length by the Committee and decided on based primarily on the fact that the disparity in access to transplant is greatest in non-exception candidates. However, historical liver allocation policy has maintained the idea that the lab MELD of certain candidates does not appropriately represent their medical urgency for transplant. For example, the proposed policy will exclude an exception candidate with an allocation MELD of 29, but with a low lab MELD, from the initial broader sharing classification.
Finally, the proposal presents a change in allocation for DCD and age over 70 donor livers. The Committee and members of the community propose the separate allocation to increase utilization of these organs and address concerns about the logistics and travel involved in allocating these organs over broader geographic areas. The Committee requests feedback on this change, and whether with the current proposal of 150 mile circles, a separate allocation is necessary for this subset of donor livers.
Finally, with the proposed introduction of a 5 proximity MELD or PELD points to candidates in the 150 mile circle, candidates in the MELD subset will all be capped at 40. For example, two candidates within the proximity circle, 1 with a calculated MELD of 37 and another with a calculated MELD of 39 would both have a 40 within the proximity circle. The tiebreaker would be waiting time, and the differentiation based on MELD would be lost. Thee Committee is discussing potential modifications to the MELD 40 cap to allow differentiation by MELD for the population within the proximity circle. l

14. Questions? Julie Heimbach, MD Committee Chair heimbach.julie@mayo.edu
Matt Prentice, MPH
Committee Liaison