1. National Liver Review Board (NLRB)
Liver and Intestinal Organ Transplantation Committee
Spring 2016

2. What problem will the proposal solve?
Regional review board system does not provide equivalent access to transplant for liver candidates whose calculated MELD/PELD does not accurately reflect severity of disease
RRBs have different rules regarding representation
Regional inconsistencies in submission and award practices
Awarding exception scores not correlated with disease severity negatively impacts non-exception candidates
Reviewing 2,000 standardized exception requests each year = excess work & delay in awarding points
Nov 2013: Board charged Committee with developing NLRB
Currently there is not a national system that provides similar access to transplant for liver candidates whose calculated MELD or PELD score does not accurately reflect the severity of their disease. Each Regional Review Board has different rules regarding representation, including program eligibility, length of service terms, and member rotation.
Most regions have adopted their own criteria for requesting and approving exceptions for specific diagnoses, or “regional agreements.” Some have theorized that these agreements may contribute to regional inconsistencies in exception submission and award practices, even among regions with similar organ availability. On average, 88.4% of initial, appeal, and extension requests submitted between July 1, 2014 and June 30, 2015 were approved; however, the regions approved as few as 75.8% and as many as 93.5% of requests during this timeframe. Excluding recipients transplanted as Status 1A or 1B, the proportion of recipients transplanted with an exception score ranged from 29% to 61% among the regions.
Awarding exception scores that are not correlated with disease severity or waitlist mortality negatively impacts non-exception candidates, who nationally are transplanted at higher MELD scores than those with approved exceptions.
This has led some to suggest that a national board replace the current RRB system. In November 2013, the OPTN/UNOS Board of Directors charged the Committee with developing a conceptual plan and timeline for the implementation of a national liver review board or NLRB.

3. What are the goals of the proposal?
Establish NLRB that achieves more equitable review through structural and operational changes
Improve efficiency of the review board system
The Committee proposes establishing a NLRB to provide fair, equitable, and prompt peer review of exceptional candidates. This proposal contains changes to policy and updated operational guidelines, which govern the review boards. The Committee also proposes review board system efficiency improvements to reduce the workload for reviewers and eliminate unnecessary delays in awarding exception points when appropriate.

4. How does the proposal address the problem statement?
NLRB Structure:
Create specialty boards that allow for reviewers with appropriate policy and clinical expertise to evaluate the request
Give every program the opportunity to be represented at all times
NLRB
Pediatrics
Adult HCC
Adult Other
The NLRB will be comprised of three specialty boards including Adult HCC, Adult Other Diagnosis, and Pediatrics. Assigning requests to the appropriate specialty board, rather than by geographic location, allows for reviewers with appropriate policy and clinical expertise to evaluate the request.
Every liver transplant program has the opportunity to be represented at all times on the NLRB. An active liver transplant program may appoint a representative and alternate to each of the adult specialty boards. A liver transplant program with an active pediatric component may appoint a representative and alternate to the pediatric specialty board. Each serves a one year term, which may be renewed annually as long as the representative continues to fulfill obligations to the NLRB. Individuals may serve on more than one specialty board at the same time.

5. How does the proposal address the problem statement?
NLRB Operations:
Eliminates regional agreements; Committee develops and implements national guidelines
Mandatory reviewer orientation at beginning of each service term
Institute new voting procedures
Randomly assigned to a group of five reviewers on specialty board
4 of 5 affirmative votes for approval
May appeal to different random group of 5
If denied on appeal, conference call with reviewers
This proposal eliminates the regional agreements and instead tasks the Committee with developing and implementing national guidelines to assess the most common types of exceptions. The Committee periodically reviews exception requests for opportunities to revise the MELD score or provide guidance for review board members. For example, the Board recently passed guidance to evaluate requests for candidates with neuroendocrine tumors, polycystic liver disease, primary sclerosing cholangitis, and portopulmonary hypertension. Unlike the Thoracic Organ Transplantation Committee, the Liver and Intestinal Organ Transplantation Committee currently must present review board guidance to the Board for approval. Consistent with thoracic policy, this proposal includes policy language that allows the Committee to provide specific recommendations to NLRB members without Board approval.
All NLRB members must complete orientation before they serve, which includes training on exception policy, operational guidelines, and guidance for evaluating common types of exceptions.
This proposal also institutes new voting procedures that randomly assign requests to reviewers nationally and require a super majority vote. Exception requests will be randomly assigned to five reviewers of the appropriate specialty board. A request must achieve four of five affirmative votes in order to be approved. If denied, the program has the opportunity to appeal to another random group of five reviewers. If denied on appeal, the program may request a conference call with the second group of reviewers. Ultimately, the program may appeal to the Committee if the outcome of the call is not favorable.

6. How does the proposal address the problem statement?
Improve Efficiency: Overall reduction of 2,000 requests/year
Automate standardized exceptions in policy (1,000 requests/year)
Allow standardized exception candidate to return to auto-approval after a missed extension deadline (800 requests/year)
NLRB
Pediatrics
(≈700/yr)
Adult HCC
(≈4,700/yr)
Adult Other
(≈2,200/yr)
This proposal also improves the efficiency of the exception process. The RRB Chairs review over 1,000 standardized exception requests each year (including initial requests and extensions), which they approve since the requests meet criteria in policy. Their review of these cases is an inappropriate use of the peer review system, since their medical judgment is not critical to evaluate these cases. Automatically awarding exception points to candidates meeting criteria in policy will reduce the workload for reviewers and eliminate unnecessary delays in awarding exception points. Based on OPTN data, the Committee estimates that automating the standardized exceptions will reduce the overall workload of the NLRB by nearly 2,000 requests each year.
Based on July 2014-June 2015 data, the Committee estimates that the NLRB will review approximately 7,600 initial requests, extensions, and appeals each year. Of these, approximately 4,700 will be Adult HCC, 2,200 Adult Other Diagnosis, and 700 Pediatrics.

7. Assigning Scores to Exception Candidates
Seeking community feedback on best way to assign exception scores
Consider eliminating “MELD elevator” for standard exceptions
May have contributed to the MELD escalation at transplant
Waitlist mortality higher for non-exception than exception candidates
Non-exception candidates also transplanted at higher MELD scores
Potential solution: assign fixed score 1-2 points below median MELD at transplant for DSA for standardized exceptions
Recommend same for non-standard exceptions
The Committee wants feedback from the community on the optimal method of assigning MELD score exception points. Currently, the MELD exception score for many standardized exception diagnoses begins at 22 points and automatically increases every three months to reflect a 10% increase in waitlist mortality, so long as the candidate continues to meet criteria in policy. This automatic three-month increase in standardized exception score is also referred to as the “MELD elevator.”
The MELD elevator is problematic for several reasons. The waitlist mortality for non-exception candidates actually exceeds the mortality for exception candidates. Non-exception candidates are also transplanted at higher MELD scores than those with approved exceptions. Some have suggested that the MELD elevator has contributed to the escalation in MELD score at transplant that has occurred over the past decade.
For candidates with certain standardized exception diagnoses, the Committee is considering whether it is appropriate to assign a fixed exception score that is 1 to 2 points below the median allocation MELD for the Donation Service Area (DSA) of the candidate’s transplant program. The Committee would recommend the same for non-standardized exceptions. The Committee also wants feedback from the community on whether to eliminate automatic increases in MELD score for the candidates upon extension.

8. How will members implement the final NLRB proposal?
Liver Programs
May appoint representative and alternate
Participate in instructional program that describes changes to exception request submission and review process
No new data collection but more discrete data fields, less narrative
Representatives and Alternates
Serve one year term
Complete orientation and demonstrate proficiency
Fulfill responsibilities detailed in Operational Guidelines
Liver Programs:
Every active liver transplant program may appoint a representative and alternate to each of the adult specialty boards. A liver transplant program with an active pediatric component may appoint a representative and an alternate to the pediatric specialty board. Transplant programs are encouraged to appoint representatives from both hepatology and surgery who have active transplant experience. Liver transplant programs are not required to provide a representative to the NLRB.
Members are also encouraged to participate in an instructional program to educate them on changes to policy and how it will affect their work, especially the submission of exception requests. The proposal does not require additional data collection. However, in order to automate approval of the standardized exceptions, programs will have to submit required information in discrete data fields in UNetSM instead of using the current narrative form.
Representatives and Alternates:
Representative and alternate responsibilities are detailed in the National Liver Review Board Operational Guidelines. As I mentioned earlier, each serves a one year term. All NLRB members must complete orientation before their term of service and demonstrate proficiency in exception policy and familiarity with the operational guidelines and available guidance.

9. How does this proposal support the OPTN Strategic Plan?
Goal 2: Improve Equity in Access to Transplant
Mitigate regional differences in exceptional case review
The primary goal for this proposal is to improve equity in access to transplant by establishing a national structure for exceptional case review in which all liver transplant programs have an equal opportunity for representation at all times. Specialty boards will allow for reviewers with appropriate policy and clinical expertise to evaluate the request. The NLRB seeks to mitigate regional inconsistencies in award practices by establishing new voting procedures and giving the Committee the ability to develop national guidelines for assessing common requests. By promoting the fair and equitable assignment of exception points to appropriate candidates, the NLRB also improves access to transplant for non-exception candidates.

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