Status: Board Approved
Sponsoring Committee: Liver & Intestinal Organ Transplantation
Strategic Goal 2: Provide equity in access to transplants
Revised policy notice (1/2019) PDF
Policy notice (7/2017) PDF - 453 KB
NLRB board report (6/2017) PDF - 617 K
A liver candidate receives either a priority status or MELD1 or, if less than 12 years old, a PELD2 score that is used for liver allocation. The score is intended to reflect the severity of the candidate’s disease. When the calculated score or status does not reflect the candidate’s medical urgency, a liver transplant program may request an exception. Currently there is not a national system that provides equitable access to transplant for liver candidates whose status or calculated MELD or PELD score does not accurately reflect the severity of their disease. Instead, each region has its own review board that evaluates exception requests submitted by the liver transplant programs in its region. Most regions have adopted independent criteria used to request and approve exceptions, commonly referred to as “regional agreements.” Some have theorized that regional agreements may contribute to regional differences in exception submission and award practices, even among regions with similar organ availability and candidate demographics.3,4,5
The Liver Committee previously distributed a proposal to establish a national liver review board (NLRB) in January 2016.6 Through policy and revised operational guidelines, this proposal incorporates feedback received during the first round of public comment to establish a national structure for review of MELD and PELD exception cases. The NLRB seeks to mitigate regional differences in award practices by establishing new voting procedures and giving the Committee the ability to develop national guidance for assessing common requests, which supports Goal 2 of the OPTN Strategic Plan.7 This proposal also improves the efficiency of the review board system by reducing the overall workload for reviewers and eliminating unnecessary delays in awarding exception points when appropriate.
Finally, this proposal modifies the way in which the value for exception points is determined and assigned. To achieve more nationwide uniformity in the value of exception scores awarded to candidates for standardized exceptions, the Committee proposes setting the points assigned to adult candidates to a fixed value just below the median MELD at transplant for adult recipients within the Donation Service Area (DSA). For candidates between 12 to 17 years old, the points value would be tied to the median MELD at transplant for all liver recipients in the DSA. And for pediatric candidates less than 12, the points value would be tied to the median MELD at transplant for all liver recipients in the region. This change serves a secondary goal of addressing the ever-increasing rise in median MELD at transplant, otherwise known as MELD inflation.
- Model for End-Stage Liver Disease
- Pediatric End-Stage Liver Disease
- Argo, C. K., G. J. Stukenborg, T. M. Schmitt, et al. “Regional Variability in Symptom‐Based MELD Exceptions: A Response to Organ Shortage?” American Journal of Transplantation, 11(2011), 2353-2361.
- Massie, A. B., B. Caffo, S. E. Gentry, et al. “MELD exceptions and rates of waiting list outcomes.” American Journal of Transplantation, 11(2011), 2362-2371.
- Rodriguez-Luna, H., H. E. Vargas, A. Moss, et al. “Regional variations in peer reviewed liver allocation under the MELD system.” American Journal of Transplantation, 5(2005), 2244-2247.
Read the full proposal (PDF - 1.2 M)
Related proposal: liver review board guidance
National Liver Review Board: Policy and Exception Score Assignments
- National Liver Review Board: Guidance Documents
An earlier version of this proposal was available for public comment in January 2016.
Impact summaries (6/2017) PDF - 260 K
ENTERPRISE = UNOS IT project complexity
- 13,350 = Implementation all departments
- 1,120 hours = Ongoing (annual) all departments
- Major implementation costs to hospitals include staff time to update internal procedures and appointment of clinicians to the NLRB.
- Hospital implementation time of one to six months is estimated.
- Ongoing hospital cost burden is dependent on exception volume, highly variable among regions and centers.
- Clinicians serving as NLRB representatives must dedicate additional work hours to review exceptions.
Hospital: Major implementation resources include additional staff time to adjust internal process flow and participate in training on new policy and procedures. Administrative staff must collect and report on data required to review exceptions. Clinicians must be appointed and serve as NLRB representatives, requiring time outside of practice to review exceptions. Up to $5,000 in additional clinical and administrative staff time to implement is attributed, but can likely be absorbed by standard staff hours. Institutional technology support may be required to adjust internal systems to collect data required by the NLRB. Additional data collection burden is dependent on current institutional process and tools. Estimates is based on 5-6 hours training per clinician and minimal administrative staff training.
Cost burden overall is highly dependent on total center volume and number of candidates on the waiting list. While review of exception volume nationally should remain about the same, some regions may experience higher or lower exception review volume compared to the current system, since case review is distributed more evenly among regions in this proposal. There is potential for a decrease in the NLRB’s workload, as programming will be implanted to automate repeat applications for HCC candidates whose cases fall.
Implementation timeframe is estimated at one to six months, with complex large programs requiring multiple months to adjust. Institutions should begin implementation of the process immediately if the proposal becomes effective.
Ongoing costs include clinician time and travel in serving as NLRB representative and administrative staff time in recording additional data on candidates. This is dependent on volume.
While no long term cost savings are identified yet, creating the NLRB may streamline the exception process by adapting to a national process. Indirect efficiencies may materialize from considering exceptions uniform and tracking data across institutions.
OPO and Lab: Minimal to no impact.
IT Implementation effort is enterprise level and includes 12,400 estimated hours for analysis and project management, changes to review board management and processing, and changes to the waitlist.
Instructional Innovations requires a large effort, requiring more than one offering to educate members.
Policy requires a large effort for Liver Committee review throughout implementation.
The majority of ongoing hours is attributed to IT.