1. Liver and Intestinal Organ Transplantation Committee
Spring 2018

2. Recent Policy Implementation: Automatic Approval of HCC Exceptions
Policy implemented December 12, 2017
Upper limit of AFP 1,000 that is allowed for standard MELD exception (may be treated, and if responds to below 500, also eligible)
Standardized down-staging policy uniform across regions: patients who present outside of T2 criteria but within down-staging criteria now eligible for standard MELD exception if they are successfully treated and demonstrate a reduction of tumor burden to within T2 criteria.
This policy was implemented on December 12, 2017
Upper limit of AFP 1,000 that is allowed for standard MELD exception (may be treated, and if responds to below 500, also eligible)
Standardized down-staging policy uniform across regions: patients who present outside of T2 criteria but within down-staging criteria now eligible for standard MELD exception if they are successfully treated and demonstrate a reduction of tumor burden to within T2 criteria.

3. Recent Public Comment Proposals
Modification to Hepatocellular Carcinoma (HCC) Extension Criteria
Proposal provides automatic extension of a HCC exception score for candidates with HCC lesions who met criteria for T2 at initial application, who subsequently fall below T2 lesion criteria at time of their extension because of liver-directed therapies.
Intended to revise an effect of HCC down-staging policy implemented Dec 12, 2017 whereby candidates with existing HCC appeals, who were treated to below T2, were no longer auto-approved at next extension.
Supportive public comment
Implemented Feb. 5, 2018 if approved by Executive Committee
On December 12th 2017, UNOS implemented the Changes to HCC Criteria for Auto Approval proposal. Shortly after implementation, members of the Committee identified that a candidate who initially qualified for an HCC exception, and was subsequently treated with residual lesions below T2 criteria, was not “auto-approved” at their next extension. Instead, review boards needed to approve these extension requests. The Committee’s intent is to allow these candidates to continue to receive automatic approval of their HCC exception at time of extension, as they had prior to the policy change on December 12, 2017.
The Executive Committee voted unanimously to propose policy language that allows candidates who initially qualified for an HCC exception, but have subsequently been treated with residual lesions below T2 criteria, to be subject to automatic approval of their HCC exception extensions and to not require review by the review boards for approval of their extension. This unanimous vote by the Executive Committee also authorized an expedited period of public comment (30 days) because this proposal was expected to be non-controversial.
The special 30-day public comment period for this proposal ended on Jan. 31, 2018 – all comments received were supportive of the proposal.
If the Executive Committee approves this proposal during its meeting on Feb. 2nd it will be implemented on Feb. 5th.

4. Recent policy approval: Enhancing Liver Distribution
Approved by Board - Dec 2017
3 MELD or PELD points to candidates within the circle or the DSA
Proximity circles with 150 nautical mile radius around the donor hospital
Circles may extend out of the region
The policy which is aimed to more broadly distribute livers for the most urgent candidates was approved by the Board in December of 2017.
Changes to this policy which were adopted based on public comment are highlighted in red
3 points (instead of 5 points) are added to candidates within the circle or DSA (previously those points were proposed just for the circle)
It creates a proximity circle around the donor hospital of 150 nautical miles. These circles may extend outside of existing regions. Modification of specific components of this policy in areas of the country where further change may be needed will continue to be explored by the committee.

5. Recent policy approval: Enhancing Liver Distribution
Expanded regional sharing - Share 32
Adult candidates within the region and/or circle with calculated score 32 or higher (including proximity points)
Pediatric candidates within the region and/or circle based on calculated or exception score
Adult HAT exception candidates
Separate allocation for DCD donors and donors at least 70 years old
Implementation third quarter 2018, after NLRB
This outlines the expanded regional sharing which includes a sharing threshold of 32 for candidates (instead of the originally proposed 29).
Separate allocation for DCD donors and donors at least 70 years of age which starts at Status 1A within the region or circle and works it’s way through 10 classifications.
Implementation is tentatively proposed for the third quarter of 2018 after the NLRB.

6. Upcoming Policy Implementation: NLRB
Initial phase will be implemented in 3rd quarter 2018, prior to liver distribution changes
NLRB
Establishes a NLRB with 3 specialty review boards
Scores for standardized exceptions will be tied to the median MELD at transplant in the DSA
Implementation will occur in phases
Instructional offerings will be provided to help members prepare for impact of these policy changes
In June 2017, the Board of Directors approved the proposal to establish a national liver review board (NLRB). The initial phase of the National Liver Review Board (NLRB) will be implemented in 3rd quarter of 2018.
This proposal:
Establishes an NLRB with 3 specialty boards
Regional agreements will be eliminated when we implement this proposal.
The scores for standardized exceptions will be tied to the median MELD at transplant in the DSA.
Implementation will occur in phases and instructional offerings will be provided to help members prepare for impact of these policy changes

7. NLRB: Structure NLRB is comprised of 3 specialty review boards
Adult HCC
Adult Other Diagnosis
Pediatrics
Representation
Every liver transplant program may appoint a representative
Reps Responsibilities
Reps must vote within 7 days on all exception requests
Non-responsiveness may result in suspension of program’s participation in NLRB
The NLRB is comprised of specialty boards, including:
Adult Hepatocellular Carcinoma (HCC)
Adult Other Diagnosis
Pediatrics, which reviews requests made on behalf of any candidate registered prior to turning 18 years old and adults with certain pediatric diagnoses
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 alternate to the pediatric specialty board. Individuals may serve on more than one specialty board at the same time. Liver transplant programs are not required to provide a representative to the NLRB.
Representatives must vote within 7 days on all exception requests, exception extension requests, and appeals. If a representative or alternate does not vote on an open request within 7 days on three separate instances within a 12 month period, the Chair will remove the individual from the NLRB. If a transplant program exhibits a pattern of non-responsiveness, as evidenced by the removal of two members from the NLRB, the Chair may suspend the program’s participation for a period of three months after notifying the program director.

8. NLRB: Structure Voting
Exception request is randomly assigned to five reps of the appropriate board
Appeal Process
The same five reps of the original request review the appeal
ART
If appeal is denied, a conference call may be requested with the Appeals Review Team (ART)
All NLRB members are assigned to serve one month each year on the ART (9 member teams, require 5 for quorum). Conference calls will be held at a fixed day each week and cancelled only if there are no cases
Following ART denial, program may initiate final appeal to the Liver Committee
Voting Procedure
An exception request is randomly assigned to five representatives of the appropriate specialty board. A representative may vote to approve or deny the request, or ask that the request be reassigned.
A liver program may appeal the NLRB’s decision to deny an exception request. The same five members that reviewed the original request will review the appeal. This is one of the changes we made since the previous round of public comment: we think the same 5 reviewers should review the appeal (instead of a new group of 5) because they’ll be more familiar with the case and the supplemental information the appealing program will submit. It also cuts down on workload for other review board members.
If the appeal is denied, the liver program may request a conference call with the Appeals Review Team (ART). If the ART denies the request, the liver program may initiate a final appeal to the Liver and Intestinal Organ Transplantation Committee.
ART: At the beginning of each new service term, nine NLRB members are randomly assigned to serve each month of the year on the ART. The ART meets via conference call at the same day and time each week; however calls may be rescheduled in advance to accommodate federal holidays. The ART will operate more efficiently than the current practice of trying to schedule teleconferences for appeals, because their schedules will be set far in advance..

9. NLRB: Details Changes how cases are reviewed and scores awarded
Median MELD at transplant (MMaT) score by DSA, minus 3 points, will be the default score for many candidates with standard exceptions
Eliminates the “MELD elevator”
NLRB will review non-standard exception requests
Typically related to the MMaT
Guidance documents have been created to help the NLRB and to help centers and these can be found on the OPTN website guidance/
The NLRB will change how cases are reviewed (national instead of regional) and the scores that patients will be awarded. Specifically, the median MELD at transplant (MMaT) score by DSA, minus 3 points, will be the default exception score for many candidates with standard MELD exceptions upon implementation of the NLRB. This will also eliminate the “MELD elevator” for exception points.
The NLRB will review non-standard exception requests. If they approve them, the scores will be also be typically related to the MMaT (higher, or lower, depending on the specific risk of the clinical situation).

10. NLRB: Details MMaT Calculation
OPTN will re-calculate MMaT every 180 days using the previous 365-day cohort.
At 180 day update, candidates with existing standardized score exceptions will be adjusted
UNOS will re-calculate the median allocation MELD at transplant every 180 days using the previous 365-day cohort. If there have been fewer than 10 transplants in the DSA in the previous 365 days, the median MELD at transplant will be calculated for the region where the candidate is registered.
At each 180 day update, candidates with existing standardized score exceptions will be assigned the increased score to match the re-calculated median MELD.

11. Adult Standard Exception Points
Diagnosis
Current Exception Points Assignment
Recommended Proposed Exception Points Assignment
Cholangiocarcinoma
MELD 22 (w/ 10% point escalator)
MMaT – 3 for DSA
Cystic Fibrosis
Familial amyloid polyneuropathy
Hepatic artery thrombosis
MELD 40
MELD 40 for DSA
Hepatopulmonary syndrome
MELD 22 (w/ 10% point escalator if PaO2 remains under 60 mmHg)
Portopulmonary hypertension
MELD 22 (w/ 10% point escalator if repeat heart cath shows MPAP <35)
Primary Hyperoxaluria
MELD 28 (w/ 10% point escalator)
MMaT for DSA
HCC
Delay 6 months, then 28, 30, 32, 34
MMaT - 3 for DSA (after delay)
Fixed scores for candidates meeting standard criteria for the most common MELD exceptions will be adjusted to the median MELD for the DSA
MMaT = Median MELD at Transplant

12. Pediatric Standard Exception Points for Candidates 12-17 years old
Diagnosis
Current Exception Points Assignment
Recommended Proposed Initial Exception Points Assignment for year olds
Cholangiocarcinoma
MELD 22/PELD 28 (w/ 10% elevator)
MMaT for DSA
Cystic Fibrosis
Familial amyloid polyneuropathy
Hepatic artery thrombosis (not meeting 1A criteria)
MELD 40
MELD or a PELD 40
Hepatopulmonary syndrome
Metabolic Disease
MELD/PELD 30, then status 1B after 30 days
MMaT for DSA, then 1B after 30 days
Portopulmonary hypertension
Primary Hyperoxaluria
MELD 28/PELD 41 (w/ 10% elevator)
MMaT for DSA + 3
HCC
MELD 28/PELD 41 (w/ elevator)
Fixed scores for adolescents (age 12-17) with STANDARD diagnoses will be set to the adult MMaT but will be given an increase as noted.

13. Pediatric Standard Exception Points for Candidates < 12 years old
Diagnosis
Current Exception Points Assignment
Recommended Proposed Initial Exception Points Assignment for less than 12 year olds
Cholangiocarcinoma
MELD 22/PELD 28 (w/ 10% elevator)
MMaT for region
Cystic Fibrosis
Familial amyloid polyneuropathy
Hepatic artery thrombosis (not meeting 1A criteria)
MELD 40
MELD or a PELD 40
Hepatopulmonary syndrome
Metabolic Disease
MELD/PELD 30, then status 1B after 30 days
MMaT for region, then 1B after 30 days
Portopulmonary hypertension
Primary Hyperoxaluria
MELD 28/PELD 41 (w/ 10% elevator)
MMaT for region + 3
HCC
MELD 28/PELD 41 (w/ elevator)
Candidates transplanted with PELD (age <12) will be adjusted for the MMaT for the region since organs from pediatric donors are regionally shared.

14. Questions?
Julie Heimbach, MD Committee Chair Matt Prentice, MPH Committee Liaison