1. Liver and Intestinal Organ Transplantation Committee
Spring 2017 Update

2. What problem does this address?
Significant variation in a candidate’s chances of receiving a liver offer depending on where the candidate is registered
Final Rule: “allocation policies must be based on sound medical judgment, seek to achieve the best use of donated organs, and shall not be based on the candidate’s place of residence or place of listing” except to the extent needed to satisfy other regulatory requirements
Currently, a liver transplant candidate’s chances of receiving a lifesaving organ offer vary significantly depending on where they live and the location of the transplant program where they are listed. In March 2000, the US Department of Health and Human Services (HHS) implemented the Final Rule, which instructs that OPTN allocation policies must, among other factors, be based on sound medical judgment, seek to achieve the best use of donated organs, and shall not be based on the candidate’s place of residence or place of listing” except to the extent needed to satisfy other regulatory requirements. These factors must all be balanced as organ allocation policies are created and modified.
The Committee has worked on many projects over the years that satisfy many aspects of the Final Rule, but has not yet addressed the geographic disparity issue. The OPTN recognizes that there are not enough organs for patients in need of lifesaving transplant and is invested in increasing the number of transplants each year by increasing donation, reducing organ discards, and improving OPO performance.

3. Recent Public Comment Proposals
Redesigning Liver Distribution Proposal - Fall 2016
As planned, the Committee did not send proposal to Board in 2016
Further evaluating 8 Districts, Concentric Circles, and Neighborhoods
The 8 Optimized Districts Proposal – Redesigning Liver Distribution was available for public comment from August to October of 2016.
After public comment period ended in October of 2016, we met and decided further evaluation was necessary. After reviewing over 1,000 public comments, we chose to look back into the other concepts for Liver distribution which we had previously researched and considered. The Committee opted to reconsider two other concepts in addition to the 8 Districts; Concentric Circles and Neighborhoods. Additional research is now underway and the updated modeling for all three options will be ready for Committee review at the end of April 2017.

4. Public Comment Themes
Related to Modeling/Methodology/Policy Development Process
Impact on Access to Transplant
Unintended Consequences/Worse Outcomes
OPO Performance
Costs/Logistics
As I mentioned, we received over 1,000 comments during the Fall of Three regions supported the proposal, while 8 were opposed.
This slide shows a high level summary of the themes that emerged during public comment. We reviewed them during our October 2016 in-person meeting in Chicago. Within each high level theme, there were a number of subthemes:
Related to Modeling/Methodology/Policy Development Process
Should use lab MELD instead of allocation MELD
Disagreement with supply, demand, and disparity metric
Should’ve used more contemporary data/data that reflect recent policy changes
Conflict of interest in developing the proposal
LSAM uses flawed methodology/should use an independent model
Impact on Access to Transplant
Disadvantage to particular populations (rural, minority, VA hospitals, Medicaid patients)
Disadvantage small centers
Unintended Consequences/Worse Outcomes
Waitlist mortality
Concern over predicted decline in # of transplants
Registered donors will rescind if their organs aren’t used locally
Worse outcomes if livers are transplanted with more CIT
Good livers will be exported, only marginal livers will stay local
Negatively impact relationship between local centers and OPO
OPO Performance
Focus on increasing # of donors or improving OPO performance
Organs will move from high to low-performing OPOs/areas of high rates of donation to areas of low rates of donation
Costs/Logistics
Financial impact to transplant centers
Financial impact to OPOs
New FAA regulations will limit charter flight
Increase allocation time

5. Liver Distribution Options
8 Districts
Optimized redistricting
Concentric Circles
Sharing to all transplant centers within a fixed distance from the donor hospital
Neighborhoods
Optimized DSA based sharing
Like I mentioned, the Committee has decided to reconsider the 8 districts, Concentric Circles and Neighborhoods. The Committee will have updated information to thoroughly evaluate these options in April of Once the committee can review the updated modeling and reports they will determine the next steps to move forward with liver redistribution. I’ll explain the details of the modeling request later, after I review in more detail each of the 3 solutions.

6. 8 Districts (Fall 2016 proposal)X B A C D
150 miles, +3 points
8 districts
150-mile radius, in-district* proximity circle
3 MELD/PELD proximity points
No proximity points for Statuses
Adult donors: district-wide sharing for MELD/PELD ≥29 before introducing local (DSA) priority
Full redistricting for pediatric donors
This proposal uses mathematical optimization to modify the boundaries of liver distribution areas to better match organ supply with demand, ensuring more equitable access for liver candidates regardless of where they register. Many industries use mathematical optimization as a systematic way of selecting the best solution, with regard to a set of criteria or “constraints”, from a set of alternatives.
The proposed 8 district distribution system minimizes the sum of disparities over all the districts, where disparity is the difference between the number of donors a region should have if organs went to the highest MELD candidate anywhere in the US and the number of donors in a proposed district.
The system is subject to the following constraints:
• Districts must respect the existing DSA boundaries and be contiguous.
• There must be a minimum of 6 transplant programs in any district.
• There cannot be a significant increase in either waiting list deaths or the waiting list death rate.
• Median volume-weighted travel time is less than 3 hours
The Committee proposed an incremental implementation of redistricting to examine its impact on reducing disparity in access to transplant among more medically urgent patients. The Committee made multiple compromises over the years in order to make the changes more incremental in fashion. The compromises are evident in some of the constraints the committee chose, such as the travel time, the creation of proximity circles and proximity points, and sub setting the waitlist for a district share only for those patients with a MELD of 29 or higher.
The rationale behind this incremental implementation is similar to the current Share 35 policy, which provides regional sharing for candidates with MELD scores of at least 35.
Based on public comment feedback the Committee continues to evaluate whether other compromises can be made.
*Organ at donor center X will first be offered to candidates at centers A and C, with center A candidates receiving 3 proximity MELD/PELD points. If organ is not accepted during district-wide allocation, organ will be offered to candidates at centers B and D, with center B candidates receiving 3 MELD/PELD proximity points.

7. Proposed 8 District Map for Liver Allocation
Example of Proximity Circle: 8 5 1 6 4 3 7 2 5 3
The Committee proposed eight mathematically-optimized districts that give additional priority of 3 MELD or PELD points to those candidates that are both within the DSA and a 150-mile radius of the donor hospital upon initial district-wide sharing. We also refer to this concept as proximity points. Candidates within the 150-mile radius of the donor hospital but outside of the district would receive an additional 3 MELD or PELD points when sharing nationally or outside of the district.
Organs distributed by 8 conceptualized districts with 3 MELD/PELD proximity points awarded to candidates listed in the same DSA in which the organ was recovered. Only patients with M/P 29+ are included in the first district level of allocation (for adult donors: district to M/P 29+, local to M/P 15+, district to M/P 15+, national to M/P 15+, local to M/P <15, district to M/P<15, national to M/P <15)
*Meant to represent 150-mile radius circle. Not to scale.

8. Concentric Circles
Share livers with all transplant candidates registered at liver programs within a fixed distance of the donor hospital
If large enough, circles may significantly reduce geographic disparity
Currently used for thoracic organ distribution
The Concentric Circles concept intends to eliminate geographic boundaries, focus on distribution based on donor location, and improve geographic sharing. Concentric Circles is an approach already implemented for thoracic organ distribution by using circles of a measured distance (in miles) around the donor hospital as areas of distribution.
The Committee is further investigating the concept of using concentric circles based on the donor location, with additional proximity points given to local candidates. The Committee resolved to model the concept of 500-mile concentric circles from the donor location, with additional priority given at radii of The Committee previously reviewed LSAM modeling using this construct, but, as I’ll describe at the end of this presentation, we have requested modifications to this modeling.

9. DSA Neighborhoods
Neighborhoods are contiguous and build upon the current DSAs
58 Neighborhoods – one for each DSA
Each Neighborhood contains groups of transplant centers based on a central donor center location
This scenario forms neighborhoods around each DSA. These neighborhoods can be optimized through a balance of supply and demand while also keeping geographic areas focused on the location of transplant centers. There are 58 DSAs nationally and as a result there would be 58 optimized neighborhoods for liver allocation. The neighborhoods are designed to keep the DSA boundaries with respect to neighboring DSAs and improve organ sharing based on existing relationships between OPOs and transplant centers with relative proximity, promoting interconnectivity. Since the Neighborhoods are contiguous, some Neighborhoods may overlap as to optimize organ sharing. To optimize sharing each neighborhood has nine or more transplant centers and a minimum population of 25 million.

10. DSA Based Neighborhood Maps
The research conducted for the Neighborhoods determined that median number of Neighborhood memberships per DSA is twelve and the number of Neighborhoods which an individual DSA is a member ranges from 5 to 20. This is an image of the neighborhoods which include the ALOB DSA and illustrate how a DSA can be included in multiple Neighborhoods.
This slide illustrates the current design of the Neighborhoods and is an example of how one DSA can have multiple Neighborhoods.
The Committee continues to evaluate the ‘Neighborhoods’ concept as defined by Dr. Sanjay Mehrotra.

11. Outcomes All scenarios:
All scenarios reduce disparity in access to liver transplantation
Minimize effects of geography on transplant access
Better satisfy the Final Rule
It’s important to note that all three of these solutions reduce disparities in access to liver transplantation compared to the current 11 regions. These disparities include equity in geographic distribution and LSAM models predict all three scenarios reduce waitlist deaths and total deaths.
Every option increases distribution equity based on evidenced-based solutions supported by vetted data, simulation modeling performed by the SRTR, and input from the broader transplant community.
These outcomes also support the Final Rule, which instructs that OPTN/UNOS allocation policies must be based on sound medical judgment, seek to achieve the best use of donated organs, and shall not be based on the candidate's place of residence or place of listing except to the extent needed to satisfy other regulatory requirements.

12. Next Steps
Committee submitted an LSAM request to evaluate all 3 solutions using:
A post-share 35 cohort
A sharing threshold of 29
3 proximity points for candidates local to the donor
Two separate definitions of local:
150 mile radius around donor hospital
DSA
LSAM results anticipated by April 30, 2017
Committee will evaluate and determine whether any solution is ready for Fall 2017 public comment
The Committee has a goal to present a solution by December 2017 to the OPTN/UNOS Board of Directors
To further vet these solutions, the Liver Committee has requested simulation analysis of these strategies:
An 8 district distribution where candidates must have M/P of 29+ to be included in the first district level of allocation, and where 3 M/P proximity points are awarded to candidates listed within either a 150 mile radius of the donor hospital or in the donor hospital DSA
A 500 mile circle distribution where candidates must have M/P of 29+ to be included in the first district level of allocation, and where 3 M/P proximity points are awarded to candidates listed within either a 150 mile radius of the donor hospital or in the donor hospital DSA
Overlapping district distribution ‘neighborhoods’ where candidates must have M/P of 29+ to be included in the first district level of allocation, and where 3 M/P proximity points are awarded to candidates listed within either a 150 mile radius of the donor hospital or in the donor hospital DSA
All of these simulations would be run using a post-Share 35 threshold, based on feedback the Committee received during public comment. Once the results are ready, the Committee will review and determine which solution or solutions are best to distribute for the next round of public comment.

13. Other Relevant Projects
System Optimizations Project
OPO Committee is looking at reducing time limits for responding to organ offers
Changes to HCC Criteria for Auto Approval
Policy 9.3.F: Candidates with Hepatocellular Carcinoma (HCC)
Modify the HCC exception criteria to accurately reflect the disease severity of candidates’ by MELD score
Public comment August 15, 2016 to October 15, 2016
National Liver Review Board (NLRB)
Structure and exception points assignment (currently out for public comment)
Guidance Documents (currently out for public comment)
For the Systems Optimizations project, the OPO Committee is looking at creating an additional time limit for final decision on organ offers and recommending changes to DonorNet which will result improvements in communication.
We also wanted to remind everyone that the HCC policy proposal was approved by the Board in December. The approved changes include modifying the criteira for HCC exceptions to more accurately reflect the disease severity of HCC candidates by focusing on two areas: The downstaging of lesions to within T2 criteria and an AFP threshold for automatic approval. Data suggests that HCC candidates successfully downstaged to within T2 exhibit a low rate of HCC recurrence and have excellent post-transplant survival, comparable to those meeting T2 without downstaging. Candidates meeting the criteria will be eligible for automatic priority following local-regional treatment, and if their residual lesions fall within T2 criteria.
This proposal contains two primary policy changes:
Candidates with lesions meeting T2 criteria but with an AFP greater than 1000 are not initially eligible for a standardized MELD exception. If these lesions fall below 500 after local-regional therapy, the candidate is eligible for a standardized MELD exception. Candidates with an AFP level greater than or equal to 500 at any time following local-regional therapy will be referred to the review board.
2. The policy addition describes the eligibility criteria for being included in the downstaging protocol. Candidates meeting the criteria will be eligible for automatic priority after they’ve had local- regional treatment, and if their residual lesions fall within T2 criteria.
We will provide ample notice and education to the community before this policy change is implemented.
Like HCC, establishing the NLRB was also part of the Committee’s work plan, and we have two proposals currently out for public comment. One establishes the structure of the NLRB and changes the way in which exception points are assigned to candidates meeting standardized exception criteria in policy, and the other proposal contains 3 guidance documents, one for each specialty review board, to help the NLRB make consistent decisions for non-standardized exception requests.

14. Access to Information https://optn.transplant.hrsa.gov
Information from the Liver and Intestines Transplantation Committee can be accessed through the OPTN website at:
Information regarding the Liver and Intestinal Transplantation Committee will be updated on the OPTN website for your review.

15. Questions?
Ryutaro Hirose, MD Committee Chair Matt Prentice, MPH Committee Liaison
Talking points regarding Liver and Intestinal Transplantation Committee public engagement:
Thank you for offering input on the 8-district proposal published for public comment last fall.
Because of your comments the board sponsored a discussion session during its December 2016 meeting and invited additional perspectives on how to address disparities in liver transplant access.
We also sought additional perspectives from a number of clinicians prior to the ASTS Winter Symposium in Miami.
Our discussion there was not a formal meeting of the committee or the board.
Representatives from our committee and the board were there, both to provide context on our approach to improving transplant equity and to get additional ideas and counsel from peers who represent a variety of views.
These meetings provided our committee with information which will be considered as we move forward.