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MELD exception scores during NLRB transition

Proposal Overview

Status: Review

Sponsoring Committee: Executive Committee

Strategic Goal: Provide equity in access to transplants

Read the full proposal (PDF; 1/2019)

Read NLRB conversion mini brief (PDF; 4/2019)

Read NLRB conversion policy notice (PDF; 4/2019)

Contact: Elizabeth Miller

Executive Summary

Liver allocation currently uses donor service areas (DSAs) and OPTN regions as units of distribution. That will change when recently approved allocation changes are implemented (targeted for April 30, 2019). The National Liver Review Board (NLRB) was to be implemented on January 31, 2019, but that plan was delayed because unintended consequences were identified in the plan to base the model for end stage liver disease (MELD) exception scores on median MELD at transplant within 250 NM of the transplant hospital (MMaT/250). Because the MMaT/250 for transplant programs within the same DSA can vary, similarly situated candidates at different hospitals within a DSA can have different scores, and would consistently appear lower or higher than one another on every match run while allocation is still based on DSA and region. The OPTN is now soliciting comments on a policy change that would apply only with respect to the calculation of exception scores to address this issue. This transition policy would be in effect for a brief period after the public comment period (scheduled to end March 22, 2019) and before implementation of the revised allocation policy (targeted for April 30, 2019).

In an attempt to address this situation, the OPTN Executive Committee approved the OPTN Liver Committee’s proposed temporary solution: using the median MELD at transplant in the DSA (MMaT/DSA) instead of MMaT/250 during the period between implementation of the NLRB and implementation of liver allocation changes (hereafter, “transition period”). This transition period will be interim, and will expire upon the implementation of liver allocation changes (targeted for April 30, 2019). The goal of this approach is to better align the calculation of exception scores with the current allocation system during the transition period.

Feedback requested

The Committee requests feedback on the proposed temporary solution of using the MMaT/DSA instead of MMaT/250 during the transition period. In addition to feedback on the proposed solution, the Committee welcomes comment on the other options considered by the committee as well as whether to convert exception scores that were granted by Regional Review Boards (RRB) but will expire after the implementation of the new allocation system (see pages 5-6). The Executive Committee may reconsider these alternate solutions for this proposal.

Comments

Anonymous | 02/02/2019

If the National review board cannot be implemented on time it’s better to push everything back just a few months to get it right. The uncertainty is hard in patients and their doctors. Stick with the original plan of implementing the national review board then do the allocation change 90 days later as planned. Changing too much too much too soon make it more difficult to pinpoint a problem if one arises.

Anonymous | 02/03/2019

You use too many acronyms. You have MMaT which I discovered meant "Median MELD at transplant" Your acronyms have acronyms. Here I am, a general lay person who knows someone is going to become a living donor for a friend of hers and the process intrigued me enough to read about the statistics, etc and you use so many acronyms I don't have a clue what you are talking about. Aaannd there went my interest.....(Not really but for the vast majority that would be true.)

Beth Israel Deaconess Medical Center | 02/05/2019

We are supportive of the policy of the MLRB but the following are our concerns: The policy needs to have some further consideration into the timing of implementation of the MMaT. Due to the fact that patients can keep their MELD score until the next extension but then must have a MELD score equivalent to MMaT-3, it is possible that some patients who have been listed with MELD exception score and whose extension is due soon, could be disadvantaged as they may show up on match run lower than patients who have been listed for shorter period of time but have had an extension in their exception just prior to Jan 31. For example: a patient with a MELD extension on Jan 29 would increase to a score of 34 until April 29th, yet a patient who is already on 34 with a MELD extension after Jan 29 would drop to a MELD score equivalent to MMaT-3 which could be lower than 34. This is a disadvantage to the patient who is supposed to have a high priority.

Malay Shah | 02/07/2019

What's the point in moving forward with any proposal of any kind? The organizations and institutions that regulate and support transplant have proven themselves to be incapable of directing any meaningful, thoughtful and beneficial policy of any kind. Rather than focusing any efforts into improving organ donation and identifying real healthcare disparities, efforts have been taken to only propose and pass policy as dictated by HHS and litigation. Rather than asking for public comment to this proposal, I feel that at this point, it would be more prudent to ask administrators and lawyers what they most appropriate steps would be. Clearly, the advice of stakeholders and experts in the field are not valued and not accepted.

Anonymous | 02/08/2019

Region 7 vote-6 strongly support, 7 support, 2 abstained

Mariel Carr | 02/11/2019

In order to be transparent and avoid yet another pitfall, what exactly is the MMaT/DSA for each of the 52 liver donation service areas, and especially for the identified outliers' DSAs?

Kenneth Andreoni | 02/11/2019

My opposition to this suggestion is simply that patient's illness is more fairly based on LAB MELD, and not allocation MELD. It is impossible to foresee how using Allocation MELD instead of LAB MELD will harm acutely ill patients by giving less ill patients with exception points too much relative access to organs. We must be clear in separating LAB from ALLOCATION MELD when we discuss Mean MELD at Transplant issues.

Anonymous | 02/12/2019

the premise of the liver allocation change was to remove DSA as an element of allocation. As different centers have different practices (and different MELD at txp), it seems that exception points should be specific for the center and not the DSA centers. Each liver center should have their median MELD at txp be an internal standard for exception points.

Seth Karp | 02/15/2019

As we move to a national distribution system, MELD - 3 will lead to a patients with the same disease competing for the same liver at a different MELD scores depending solely on where they live. This move to a national system for MELD exceptions has not been adequately modeled and the impact on various communities has not been adequately addressed.

GIGI (GRACE ) GAGNE | 02/15/2019

My dear husband of 50 yrs, passed away while waiting for liver and kidney transplants, from the NASH. He was Denied his transplant at Mayo-Jacksonville, FL, due to being malnourished. He could not even tolerate supplements thru NJ tube. (He had lost approx 65 lbs from Apr -Dec 2018!) He was also on a transplant list at Mass Gen Hospital, Boston. Tho, MGH tried desperately to nourish him, he lost his battle on Dec 29th. I know of several other patients who also have been denied a liver transplant, due to being malnourished. I suggest, if nourishment is detrimental in the survival of liver and other transplants, Nourishment should become an important equation of the MELD Formula. How do I get involved in this endeavor? Gigi Gagne

Region 1 | 02/18/2019

Region 1 vote -1 strongly support, 6 support, 2 abstained, 3 opposed, 1 strongly oppose

Anonymous | 02/21/2019

Region 5 Vote: 4 strongly support, 10 support, 10 abstained, 8 oppose, 2 strongly oppose Why 250 nm was selected was questioned as it inadvertently causes a disparity for exception candidates. MELD should reflect a local environment and access should be differentiated for various exceptions.

Anonymous | 02/21/2019

Region 2 Vote: 0 strongly support, 1 support, 3 neutral/abstain, 7 oppose, 17 strongly oppose The members in Region 2 were united in their dislike of the proposed changes. If MMaT is to be based on DSA in the interim period, they will lose out on livers to other nearby areas because their MMaT scores are lower than other nearby DSAs. They felt that in order to make the system as fair as possible across the nation either acuity circle distribution implementation should be delayed so that there is a three month window between NLRB implementation and acuity circle implementation so that all exception scores are renewed under the new system. The other option they put forward would be to take a systematic approach to reviewing the two-thirds of exceptions that are standard and semi-standard. For the remaining one-third of exceptions, which are non-standard, the NLRB would need to manually review those cases in the one month transition period. The region is aware that would put a heavy burden on the NLRB to review a large number of cases in a short period of time; however, since this would only be a one-time influx of reviews, it is manageable. They suggested a triage approach that the highest non-standard exception cases be reviewed first and then work down from there.

Anonymous | 02/25/2019

Region 8 vote: 1 strongly support, 12 support, 4 neutral/abstain, 0 oppose, 1 strongly oppose

Melanie Best | 02/26/2019

RE: Request for Grandfathering of Current Perihilar Cholangiocarcinoma Patients under the Current UNOS Liver Allocation Formula Dear Members of the UNOS Executive Committee: On the advice of UNOS' Patient Services department, I am submitting this urgent request for grandfathering under the current liver allocation formula of me and other perihilar cholangiocarcinoma patients on the UNOS wait list who underwent adjuvant radiation/brachytherapy on our bile ducts while the current allocation formula was in effect and with the understanding this formula would govern the allocation of livers to us. I realize the comments you are accepting on this website do not specifically pertain to my request, but Patient Services suggested this avenue as the most expeditious route to present my urgent appeal to you. As a patient with a MELD exception score on the UNOS list for liver transplant, I will be unfairly disadvantaged by the new liver-allocation formula being adopted by UNOS. Irrespective of UNOS' motivations for changing the formula going forward, without a grandfather remedy for people like me who have had their bile ducts irreparably damaged in the course of our pre-transplant radiation therapy, great harm will unnecessarily be done to us. I am in the Mayo Clinic's liver transplant program, having been diagnosed in May 2018 with de novo perihilar cholangiocarcinoma and undergone the pre-transplant radiation and chemo therapy treatments per Mayo's cholangiocarcinoma protocol in July and August of 2018 at Mayo's Rochester, MN, facilities. That treatment protocol includes brachytherapy in the bile ducts, which necessitates a liver transplant as the final stage of treatment since, subsequent to this therapy, my existing liver cannot be restored to proper functioning. I entered this treatment program assured that, under the UNOS allocation formula, I would be certain within a reasonable period to rise to the maximum possible MELD score and the top of the wait list. The new UNOS formula, by assigning a fixed, MMAT-3 score to exception patients like me, increases the risk that I will experience metastasis and/or life-threatening cholangitis from ongoing ERCP procedures while I wait indefinitely for a donor liver. Unlike wait-list patients who do not have perihilar cholangiocarcinoma, under the metastasis and cholangitis scenarios I would become ineligible for transplant; therefore, to make an appeal to get a liver at that point would be moot and quite possibly the result would be my death. By keeping perihilar cholangiocarcinoma patients who started treatment under the previous UNOS formula permanently below the median MELD score, the new UNOS formula creates a terrifying future for me and others in my situation in which we will wait indefinitely, maybe forever, for transplant. Given this situation, which affects a finite subset of patients on the UNOS wait list, I am urgently requesting that UNOS remedy this problem by grandfathering the perihilar cholangiocarcinoma patients who, in good faith, entered this bile duct-altering radiation/brachytherapy treatment protocol under the old UNOS allocation formula, to enable us to be prioritized for transplant according to that formula. Such grandfathering is the compassionate and ethical course of action and is in your power to effectuate. Thank you so much for considering my request, Melanie S. Best melaniesbest@optimum.net

Timothy Marcum | 02/26/2019

I am on the liver transplant list at Vanderbilt University, in Nashville, TN. and Mayo Clinic, in Jacksonville, FL. My blood MELD would be 18, but I have Pulmonary Hypertension and Hepatopulmonary Syndrome. With my extra points, I Meld score is 27. I am on 25 liters of oxygen and they had to order me a special regulator to get me to 25. I have been going up about 2 liters per oxygen per month, but they tell me that I cannot go any higher than 25. If the exceptional points program is changed and my points are rolled back, I will die before I get a liver transplant. Once I get the liver transplant, they say that I will be able to come off the oxygen.

Anonymous | 02/28/2019

The members of Region 10 were not in favor of the proposal. As mentioned during the Liver Committee Update, the region would like to there to be a national MMaT at time of acuity circle implementation instead of using MMaT/250NM. One member stated that they would be in favor of delaying the allocation changes so that there would still be the three month interval between NLRB implementation and acuity circle implementation. If that is not an option, the region supported the idea of reviewing all non-standard exception cases during the one month transition period, so that when acuity circles are implemented every patient has a MMaT/250NM. The region voted on the proposal as written which showed opposition to the proposal. They then voted on the proposal with the amendment that all non-standard exceptions be reviewed during the one month transition period between NLRB and acuity circle implementations. Region 10 Vote: Proposal as written: 2 strongly support, 2 support, 9 neutral/abstain, 4 oppose, 6 strongly oppose; Non-standard exceptions reviewed during one month transition amendment: 8 strongly support, 7 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Lance Stein | 03/14/2019

There are serious issues from a logistical and practical standpoint with all of the "unchecked" changes that have been proposed the last few years. The MMaT vary because transplant center behaviors vary. Standardize nationally how centers manage, list, and transplant patients. Not the outcome. The main problem with MMaT is that it is falsely elevated for the vast majority of programs, especially in the NE and West given the wonton use of MELD exceptions. MMaT should only be calculated using median lab MELD at transplant, not median transplanted MELD at transplant. Median transplanted MELD incorporating exceptions are unfairly elevated in some regions/states more than others. Patients will continue to be harmed and will die in greater numbers in some regions until transplant center behaviors, exceptions, OPOs, are all standardized across the country. These current changes including this one will only serve to regionally shift those who will be harmed. Shame on you all.

Anonymous | 03/15/2019

Region 4 vote -0 strongly support, 15 support, 7 abstained, 0 opposed, 0 strongly oppose

Randee Bloom | 03/19/2019

In light of the challenge put forth, I appreciate the consideration of an individualized review of non-standard exception scores during the one month (or longer) transition period. Additionally, a means to reach a calculated equally devised MELD score, such as median lab MELD, applied nationally appears to offer the balance and transparency we seek for all stakeholders.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation opposes the timing of the implementation of the MELD Exception Score During NLRB Transition proposal – which is a month before the acuity circle allocation system, as this shorter lag between the two implementations is projected to create disparity in patient access. The original intention was to provide a 3-month lag between the NLRB and the new acuity circle allocation system to ensure a uniform review of MELD exceptions by the NLRB, as well as to provide sufficient time between the implementation of two major policies. Furthermore, the 3-month lag would have protected against new disparities that this newest proposal would yield. Until MELD exceptions are standardized, it will be unjust to allocate over wide geographic areas- but the current proposal entails an approximately 2-month period during which livers will be allocated to patients with MELD exceptions that won’t have cycled through the NLRB. In certain parts of the USA, this will likely siphon large volumes of livers from one area to another for an unfair reason. For example, the median allocation MELD in the NYRT DSA is 34, while it is 30-31 in the PADV DSA. So, patients granted exceptions based on the MMAT-3 in the NYRT DSA will receive 31 points, while those in PADV will receive 27-28. However, once acuity circles are implemented, donors in PADV will be ‘local’ (based on 150NM circles) to recipients in NYRT, and therefore patients in NYRT who received exceptions during the period will have higher scores for the same disease as patients in their ‘local’ area (PADV), thereby creating a disparity based on geography. This will be a direct result of only having 1 month between this revised NLRB exception policy and acuity circles. We offer several potential solutions that we believe would be strong alternatives: 1. at the same time acuity circles are implemented, reset all exception points to the MMAT-3 for the 250NM circles, as proposed, rather than leave those given exception points based on their MMAT in the DSA with a potential advantage, or 2. delay the implementation of the new allocation policy by two months. The latter option offers two major advantages: 1) it prevents the creation of new geographic disparities by having the 1-month period described above; and 2) it provides sufficient time to adjust to the new NLRB system, which will help to mitigate logistical, technical, or other issues that could occur with the initiation of two major policies in rapid succession. Keeping the 3-month delay will also be honoring the initial belief of the Liver Committee and the OPTN/UNOS Board that spacing out two major policy changes is best for the system operations and for patient care.

Anonymous | 03/20/2019

I am writing in strong opposition not only to stated MELD exception scores during NLRB Transition, but to the proposed transition to overhaul the entire organ allocation system as a response to the legal action taken by an individual who did not receive the scarce "GIFT" of life through organ donation. This sets a dangerous legal and moral precedent. There are over 110,000 individuals on the waiting list, hoping to be allocated an organ. There will be roughly some 36,000 recipients of that life-saving gift in the coming year. This leaves approximately 74,000 individuals who will not. 74,000 individuals who will cling to life on dialysis or by whatever means possible. And there will be many who die. It should also be noted that, as proposed, the movement toward a new allocation system will not increase the number of those transplanted. It will merely shuffle the deck for those who are, based on geography. The issue at hand, is not where people are geographically located. It is the fact that there are not enough organs to go around. As we review geography, related to organ donation, this, too, is not a perfect system. Organ donations happen as a function of location of death, proximity to services, organ registration, and other systematic influences such as healthcare, medicare and so on. There are many forces impacting organ donation, before the process of matching even begins. Further, organs are not a commodity, they are a gift. However, the allocation system attempts to view them as a commodity, with a shelf life, and without cost of movement, nor risk to those moving them. I am disappointed that those who are attempting to change the system, are not operating from the shared viewpoint that organs are a gift, and have limited scope in terms of their ability to move, and immensely high cost and risks associated with their movement. Further, it stands to bear that organs which are forced to move longer distances could result in higher discard rates, which has been shown to occur already with changes in lung allocation. The proposal can be seen as irresponsible, through the viewpoint that actually fewer organs could be transplanted as a result of strains on the system. As a result, one death + one lawsuit could lead to many more deaths on the wait list. One not need look far for an example of a similar case. A lawsuit meant to discredit the organ donation and allocation system, as the result of individual grievances has resulted in the lowest organ donation rates in 20 years in Germany. Many more people who need organs (over 10,000 waiting in that country) will not receive organs as a result. Germany still has too few organ donors after scandal (Disclaimer, this is a link to a third party website for informational purposes) https://www.thelocal.de/20161103/germany-still-has-too-few-organ-donors-after-scandal Organ donor numbers in Germany fall to lowest level in 20 years (Disclaimer, this is a link to a third party website for informational purposes) https://www.thelocal.de/20180115/organ-donor-numbers-fall-to-lowest-level-in-20-years It is my view that those in the organ donation space have one responsibility. To increase the number of organs available to those in need. Any activity to shuffle the deck for those who receive the gift, especially while adding immense potential cost and adding risk to both patients and healthcare providers, is, in my opinion, an exercise in futility. Instead, let's calculate the proposed spend and utilize those funds to increase the number of people who can come off dialysis, to get transplants, and live healthy, productive lives. We can always make tweaks and do our best to increase transparency in the process along the way.

American Society of Transplant Surgeons | 03/22/2019

The American Society of Transplant Surgeons (ASTS) abstains on the OPTN/UNOS proposal to establish a MMaT exceptions score methodology aligned with DSA-based allocation for a one-month period when the NLRB is active, and the new allocation system starts on April 30, 2019 as this decision will have no long term impact. For the future, the ASTS strongly urges UNOS to apply NLRB MELD exceptions to the largest geographic area possible to allow for equalization of MELD exceptions that would parallel the equalization of MMaT expected with the new allocation, in as close to real time as possible. The timeline for implementation and equalization of MMaT and exception scores should be as short as possible. ASTS promotes the principle that patients in the same sharing area should have equivalent exception points.

Will Chapman | 03/22/2019

It should be alarming that we are having a public comment on something that will affect 1-month of the initial NLRB implementation, but ignoring what will happen immediately thereafter for at least the next several years under the combination of the NLRB and the new AC plan, assuming this goes into effect. I agree with the idea that sharing for exception points should be equal in any exception region based on the patients disease condition. This was the whole idea of changing exception scoring, but the NLRB was not designed to be used with a 500-mile sharing plan. Under the new plan (starting on May 1), exception score listed recipients within the 500 NM (1150 ground mile diameter) circle for a given donor will be assigned median MELD at transplant (MMAT) minus 3 based on the MMAT in a 250 NM radius around the recipient’s transplant center and compared with other patients in the 500 NM circle around the donor. Thus, if the recipient is from an area with historically elevated exception MELD scores, they will automatically be assigned higher MELD scores than other patients in the 500 NM circle with the same disease condition, and this will take YEARS to correct. Here are the specific issues that ALL should be VERY concerned about: There will be a 12 month inclusion of old (regional (RRB)) data included in the new NLRB….this lagging data will (falsely) elevate the scores in high exception areas compared to the rest of the country for the same conditions. We are moving to 500 nautical mile radius (1150 ground mile diameter) circles for sharing, yet using 250 NM circles for determining MMAT. This does not make sense…the circles for MMAT should be the same as the circles for sharing. It is not fair that Pittsburgh will have patients who will be significantly disadvantaged compared to NY for the same disease condition, in the same sharing area. It is not fair that Hartford and New Haven will be significantly disadvantaged compared to Boston for the same disease condition, in the same sharing area. The system we will switch to will vastly over prioritize areas that have had inflated MELD scores. The Liver Intestine Committee requested SRTR to model the effects of the new NLRB proposal, but were told that SRTR had too many competing interests to conduct this assessment. Why would we be concerned about this issue for the 1-month of continued DSA-based sharing, but NOT concerned about the path forward on the 500 NM circle plan? We appear to be headed to a new plan that will over-prioritize regions of the country that have been much more liberal with granting of exception scores and who have been at a very inflated exception score level. We have been working under the assumption that the NLRB would be implemented at least 3 (preferably 6) months prior to any allocation change, for the last several years, however at the last minute, UNOS has informed us that the new policies would be implemented almost simultaneously. We have been working under the assumption that “broad sharing” would only apply for laboratory MELD, not exception scores, yet at the last minute, the policy changed to include exception MELD patients. This was never the plan…..until the last minute change. For all of the above reasons, confidence in the UNOS process is at a low point, and faith in our current system is heavily compromised. As an aside, only four liver programs would be affected for the upcoming 1-month period of NLRB use under the current DSA plan (basis of current comment period), amongst the approximately 150 liver programs in the US.

Anonymous | 03/22/2019

0 strongly support, 13 support, 11 abstained, 1 oppose, 7 strongly oppose A member commented the outlined timeline seems unrealistic for success.

Anonymous | 03/22/2019

2 strongly support, 5 support, 3 abstained, 1 oppose, 22 strongly oppose Amendment: Convert all scores using a National Median MELD at Transplant on the day of implementation and continue the use of the National Median MELD at Transplant moving forward - 20 strongly support, 3 support, 5 abstain, 0 oppose, 3 strongly oppose Motion from the floor for message that region 3 supports the liver committee proposal passed by the board in December, 2017 - 14 strongly support, 6 support, 5 abstain, 2 oppose, 1 strongly oppose Comments: The region voiced strong support for a national median MELD score at transplant since we will be using NLRB. They believe using a national score would help equalize scores and more quickly equalize median Meld at transplant throughout the country. It was also recommended that exception scores should be evaluated, particularly the “other” exceptions to help reduce variance in exception scores. The region also voiced concern the state based allocation system never got equal consideration or vetting despite it achieving the same goals as AC or B2C

Anonymous | 03/22/2019

0 strongly support, 1 support, 5 abstain, 7 oppose, 14 strongly oppose Amendment: National MMaT should be used for the transition and the new allocation system 13 strongly support, 7 support, 5 abstain, 0 oppose, 0 strongly oppose Comments: The region has concerns that candidates with the same disease for the same donor liver will have different scores. It was noted that candidates that transition to the new scoring system in April may temporarily have a lower MELD score despite having a longer waiting time. Using median MELD at transplant (MMaT) for the DSA is generally problematic. An example was given of 2 cities in the same state that are within 150 miles of each other but have different MMaT. The region recommends using the national median MELD at transplant for the transition period and the new liver distribution policy.

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) supports this proposal to ensure that affected liver patients are not disadvantaged during a transition period.

Society for Pediatric Liver Transplantation | 03/22/2019

The pediatric liver transplant community represented by the Society for Pediatric Liver Transplantation (SPLIT) supports this policy in so far as the national MPaT will be applied only to those individuals with Standard Exception Requests but has concerns on the following points: 1) The calculation of national MPaT excludes large populations of pediatric recipients in its calculation, namely patients who are transplanted at Status 1A or 1B. We suggest that there be an assigned score of 50 for children transplanted at 1B and 76 for those transplanted at 1A to allow for more accurate calculations. 2) The language to account for liver/intestine exception candidates should be made more clear- all of these candidates are at high MELD/PELD scores, and they also have a high mortality rate, and will be evaluated on an individual case-by-case basis by the Pediatric NLRB. 3) This policy change seems unnecessarily complicated to be implemented for just 1 month, and may have unintended consequences and stress upon recipients and their families on the waitlist.

Anonymous | 03/23/2019

Region 9: 2 strongly support, 14 support, 2 abstain, 0 oppose, 0 strongly oppose. No Comments.